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The space that now hosts Aldeia Maracanã, a building opened in 1930 by Marshal Rondon and transformed by anthropologist Darcy Ribeiro in the Indian Museum, abandoned for years by the government, was first occupied by the Indians in 2006 who started there educational, therapeutic and cultural activities such as teaching Tupi, indigenous dances and rites and selling of traditional crafts. From the beginning it was opened as a place to raise awareness of indigenous culture by the Indians themselves, a huge difference compared to other areas as the official Indian Museum in Botafogo which houses the colonial history of Brazilian Indians. The whole area was donated for the indigenous peoples of Brasil in a document.
The space would go unnoticed by the population if not for the arrival of the World Cup to Brazil which made the whole area of the Maracanã avaiable to global financial speculation. Since the announcement of the World Cup that the Indians have been preparing for battle with the first attack occurred in March this year (Forced removal of the village maracanã or how not to make a world cup). Since then, the space converged activists from many different social movements with intense activity as well as people in solidarity with our ancestral heritage. The collective project of the indíxs of Aldeia Maracanã is an Indigenous Un iversity, something still lacking in our country.
Next to the Aldeia there are two more areas within this indigenous territory in the city of Rio de Janeiro, a building recently constructed (Lanagro River - National Agricultural Laboratory of Rio de Janeiro) fitted in rooms and another one already parcially destructed for the World Cup. This fully functional building annexed to the Museum, was the place occupied by activists and índixs this Sunday March 15 during the meeting of the FIP (Popular Front Internationalist). The space would be used as the future headquarters of the Indigenous University.
This was the main motivation for this new attack. On the same day 80 policemen from Tropa de Choque invaded Aldeia without written orders and in illegality and brutal force arrested 25 people resisting in solidarity with the indigenous cause and desocuppating the whole area. A Guajajara Indian remains so far in a tree inside Aldeia, the remaining occupant in the Museum.
In the early morning of last saturday, 24/8, homeless families occupied two different areas in Sao Paulo.
More than 400 families organized by MTST (Homeless Worker's Movement) occupied a 10.000 m2 terrain in Paraisopolis, in southern Sao Paulo, one of the finest areas of the city. The terrain is right in between the Massions of the Morumbi neighborhood and the Paraisopolis community.
Another occupation took place in the city of Osasco, in the greater Sao Paulo metropolitan area, with about 100 families organized by "Movimento Luta Popular" (Popular Strugle Movement). This is the third occupation put over by the group in the last two months. Its participants are tired of awating for the so called "right to housing".
Around 10 o'clock in the morning on Saturday, August 17th, the RECUSA network (RECUSA stands for "Cultural Network of Autonomous Solidarity") initiated a protest in front of the "Novotel Jaragua" Hotel, in the centre of São Paulo, to reclaim the society's real participation in decisions about public funding for culture. The demonstration was named 1st Great RECUSA Demonstration / Coffee / Escrache / Batucada.
The coffee-escrache questioned the current model for public cultural investments, that gives the private sector the power of making decisions for public cultural policies, affecting the whole population. This is why the protest took place in front of the hotel: it was hosting a seminar to discuss public financing for culture. The participation in the seminar was dependent on a R$ 350,00 per-person coffee-break (over US$ 700,00). At noon, the protesters entered the hotel and went two floors down to the hotel's auditorium: among the protesters where people from different collectives of culture and communication, the "Fanfarra do MAL" (the "Autonomous and Libertarian Movement's Band"), and a walking radio. In the auditorium they interrupted the seminar and read a letter of claims.
The group used artistic interventions and subtle touches of sarcasm to denounce the perverse logic of the public financing system for culture in Brazil. There where theatrical interventions featuring "Carmem Miranda" and "Marta Suplicy" (Marta Suplicy is the current Minister of Culture). Carmem Miranda asked for her part of the Rouanet Law (a Brazilian law for cultural investments); and "Marta Suplicy" talked about a "culture in the axis", in allusion to the so called "Sao Paulo-Rio-de-Janeiro axis" (where most of the money for cultural projects goes), and also in allusion to "Fora-do-eixo", a very polemic Brazilian group that uses social movements' demands to gain power and visibility.
The demonstrators denounced the Rouanet Law and other Brazilian laws that allow private companies to choose, according to their interests, what artistic and cultural projects will be financed. Executives make decisions on what movies, plays, and concerts should be financed by public money. In exchange for that, they can deduct a certain percentage of the investment off the Income Tax. The interests of the population are once again subjected to the profit of private companies.
On its manifesto, the RECUSA network makes its position clear: "We want art and culture, as well as health care, education, and transports, to be taken as social rights, not as goods. We want public money for a public art, with law programs created with the participation of society".
No more coffee-break dialogs! In response to the politics of coffee-breaks we say: "cafezinho popular!"
Photos 1st part | 2nd part | 3rd part
Movie: 1st part | 2nd part | 3rd part | 4th part | 5th part
Cover Letter of RECUSA
Residents of the Favela do Moinho community in the center of Sao Paulo worked in alternate shifts for three days to put down the "Wall of Shame": a wall built by the city government in september 2012, after a fire had broken out in the favela
The wall functioned as a means to prevent the residents from reoccupying the area destroyed by the fire. According to Kassab, the mayor in 2012, the area was to be re-urbanized. That never happened. On top of that, the wall put the community in great danger, as it blocks escape routes in the case of a new fire or any other emergency. The current mayor, Haddad (from PT, the worker's party), promissed to put the wall down, but never took any action to do so.
Last Sunday, August 4th, people came together to put an end to this situation. Bearing mallets and willpower the community put down the "wall of shame". According to the residents, the area will be used for housing and revitalization of the Favela.
Putting down the wall was an action for the right to urban space. It took place during the "II Festival Moinho Vivo" (II Moinho-Alive Festival), a festival for the empowerment of suburbian culture. Musicians and artists from various collectives took part in the event: there was hip-hop, djs and an independent drums' band. The police came to the festival twice, questioning the legitimacy of the action. Putting down the wall was broadly discussed and a governmental promisse, as it is registered in one of the mayors speech.
Photos 1st part | 2nd part | 3rd part | 4th part | 5th part | 6th part | 7th part | 8th part
São Paulo - 5th Great Demostration Against Increase of Transport Fares! Monday, June 17th 2013 Meeting point at Largo da Batata - Pinheiros - São Paulo, from 17:00. The fight of São Paulo's population against the increase in the fares of the so called public transport is even bigger and stronger! But the only response of the government is even more aggressive with arbitrary police repression of all demonstrations. Last thursday, a peaceful demonstration of over than 20 thousand people, was out of the blue attacked by the police with tear gas bombs and rubber bullets. It was clear that the violence started from the police. They want to shut us, break apart and weaken us. But we won't allow this! Nobody will stop our right to protest on the streets until the fares will go down!
Whereas many times when Indymedia servers, which the IMC Brazil is part of, suffered attempts of censorship by being kidnapped by the FBI and other authorities, we also received support from several organizations that fight for freedom of speech.
Whereas when IMC San Francisco published leaked documents from Diebold proving that their electronic voting machines were not secure, the Indymedia network received a takedown notice trying to censor these documents and with the support of EFF and other organizations we were able to keep the information online.
Whereas when our volunteers are attacked, imprisoned and even murdered, as the case of volunteer Brad Will, we received support and solidarity from groups and movements around the world who struggle for the democratization of information.
And considering thousands of other examples like these, the Independent Media Center of Brazil, states its public support for the Wikileaks site and its founder Julian Assange.
Read the Full Note
On the morning of 12/11/2010, the community received another visit from a bailiff informing the start of the demolition of homes "empty," always in quotes because many of them, though unfinished, its occupants are living next door, in wooden shacks that were not registered by the City and may come down the same way.
Apparatus of the state and city government is preparing to dump Taboinhas Village (RJ)
Shock Battalion is currently invading the favela Taboinhas
Despite the brutality, resistance Village Taboinhas can win
This Saturday, March the 13th, the City of Mexico held the Resistances Festival, in which 12 bands and musicians helped gathering 10 thousand and 400 people against the criminalization of social movements and to strengthen and give notice of 9 movements of indigenous, farmers and workers: the Autonomous Regional Council of the Zona Costa de Chiapas, Council of Ejidos Communities Opposed to the Parota Dam, Popular Indigenous Council of Oaxaca Ricardo Flores Magon, Regional Coordinator of Community Authorities - Community Police, People's Front in Defense of the Land of San Salvador Atenco, Independent Francisco Villa Popular Front ? UNOPPI, Ñomndaa Radio, SME and the Widows of Pasta de Conchos.
At the same time, free and community radio stations of at least 4 countries (Mexico, Colombia, Brazil and Argentina) interconnected their playlist to the Festival and themselves, trading contents and retransmitting by the internet and in electromagnetic waves. In Brazil, the movement counted with the free radio station of the Federal University of São Carlos, in São Paulo. The Porto Aérea radio station, in Rio de Janeiro, had its first trial transmission this Saturday, and not only did it participate of the Festival but it also organized a meeting with free radios of many groups, intending to rearticulate the rhizome of free radios in the area and to propose actions to the Urban Social Forum. In the same place there was also a meeting with the Flor da Palavra rhizome, of Zapatista influence, which acts in terms of making the communication and solidarity easier between social movements and other groups, especially the ones ?from under?.
Festival?s Site: Youth in Alternative Resistance
Movements already occurred in Brazil: (2006) Rede Arrastão de Rádios ? A little story | (2006) Arrastão de rádios livres ? this weekend | (2006) International rhizome of free radios in action this saturday | (2006) Rádio Movement, now, here, in any radio (or computer connected to the internet) internet) | (2005) Sunday?s Schedule of the Rede Arrastão | (2005) Saturday?s Schedule of the Rede Arrastão
In the night of the 10th day of October of 2009, the Mexican president, Felipe Calderón, gave the police order to invade and occupy the electric state company Luz y Fuerza del Centro (LyFC) and close the company. An illegal act, for the decree that liquidated the firm was only published the following day (11/08/09). Overnight 44.000 workers lost their jobs. They are part of the Electricians Mexican Syndicate (SME), which originated in 1914 when the forces commanded by Emiliano Zapata and Pancho Villa occupied the city of Mexico. The government?s offensive against the syndicate has a clear objective, which is to weaken the state company LyFC to then privatize it.
The story dates back to July of 2009, when the SME elected its new board. Whe a syndicate elects a new board in Mexico, it must notify the Secretariat of Work and Social Prevention, which then issues the so called ?note-taking? to validate the existence of the syndicate. The thing is that the secretary, Javier Lozano Alarcón, didn?t emit the ?note-taking? and that way made the SME unrecognized by the government. Javier Alarcón claimed that there were irregularities in the SME?s elections, but never got to prove them.
From that moment on a media attack begun against the workers from the SME and the LyFC. The corporative media started to report that the LyFC was an inefficient company and to complain about the amount of money invested by the government on it. Also, the big means of communication ridiculed the benefits the workers from the SME had, reporting them as ?excesses?. For example, the access to therapy with dolphins, which deals with special children and kiss with physical deficiencies. Some members of the SME have children who need this therapy and thus the syndicate fought for such benefit, but in the TV news it became a joke and another form of attacking the syndicate.
Read the full article.
Links:(in portuguese) SME?s Blog | Audio from the speech given by Humberto Montes de Oca Luna from SME
As dawn arose on Wednesday February 24th Greece found itself totally paralyzed by a general strike spurred by rigorous methods adopted by the socialist government in attempt to save the country from a budgetary financial crisis.
The streets of the Greek capital were covered in posters and pamphlets requesting Greeks to protest their motto: "People and their needs before markets!".
Around 40 thousand people participated in a march in the centre of Athens, with protestors wielding posters with slogans such as, "tax the rich", "don't pay for the crisis of the rich", and, "don't touch our pensions".
During the morning various altercations between youths and police were reported in downtown Athens. Protestors wearing masks threw molotov cocktails at the police and broke the windows of some banks, luxury stores, multinational companies, as well as other targets. A corporate bookstore was raided and its books distributed en masse to the protesters and transients. Other corporate establishments were also expropriated.
Read the article in Full
Image Gallery: 1 | 2
Other Texts: (portuguese) Latest news | ""I want you to know that I will always be at your side"" | prisões ocorridas no início do mês de fevereiro | one more police execution | Greece: Massive Participation in General Strike | General strike mobilizes Greeks and thousands protest in Spain | Greek fascist Goverment capture another journalist (english | General Strick and confrontations |
After almost two years Free Radio Xibé (of Tefé in the Amazon region) will return to their daily programming schedule. On the 11th the collective contributors of the radio station reunited. Among those participating are 14 volunteers from Tefé's Center for Independent Media, the Regional Directory of Students (DRE in portuguese), the Amazon State Teachers Union, the Organization of People for the Indigenous People's Land Barrier Mission, the Ribeirinha Communications Network, and the (rap) group Explosão do Funk (Explosion of Funk). The proposal to unite various movements of the city in support of the radio station's return to daily program was ratified with the understanding that the groups will participate in the daily programming and management in a collective and vertical (rather than top-down) fashion. In addition to the movements educators, students and citizens from all walks of life, especially those who suffer in silence imposed by the numerous and varied processes of oppression, discrimination, and exploitation, hope to be invited to participate. This saturday is Carnaval in Xibé, with the "ajuri" (native for cooperative collective) installing anew the radio station in the University, this time in a space recently won through the mobilization of the DRE.
The radio station was originally born October 27th 2006 and cordially occupied a classroom at the Amazon State University at Tefé, soon winning the sympathies of many in the community both within and outside of the academic sphere; eventually, coming to have almost completely free daily programming schedule with some 30 people in participation. At the same time many video and lecture workshops took place in the majority of schools in Tefé and in community action extending to the university. Broadcasts continued daily until the commencement of classes in March of 2007 when the class was requisitioned due to the rising number of matriculated students. Afterwards, the radio continued broadcasting on weekends until June when their antenna was stolen during an Environment Week transmission. Thus commenced the "amateurish" phase wherein borrowed antennas from the Ribeirinha Network, and afterwards a small purchased antenna, were used. Ribeirinha gave free workshops on live broadcast radio as well as "word blossoms" (wherein a radio program abdicates it's programming to sum the actions of other groups) in neighbourhoods, communities, and native villages within the Tefé, Alvarães, Uarini, and Maraã communities and even lectures and courses in other states.
The university supported these actions through a research project taught as an extension called, "Laboratory of Free Communication", which fostered interconnection between these reflexive actions on culture, democracy, and anti-colonialism in the classroom, enabled the use of university equipment, won student grants from the state through which volunteers and students were able to fund the study of segregation in Tefé and of the processes of democratization of communications and sciences. The grants also allowed the creation of free and open mini-courses in community radio, documentary filmmaking, open software and others with the aid of visiting volunteer professors. In 2009 this project won second place in the FINEP prize for innovation in the northern region in the "Social Technology" category; this aided, along with the strengthening of the student movement, to create a favourable environment for the return of Radio Xibé's daily broadcast. Radio Xibé intends to request a community radio grant to guarantee at least one secure bastion of free expression exists in the city. However, the collective also has ideas to acquire more transmitters to start new free radio stations, as a network or not, and even a free Television station.
Photo History of Xibé's Radio: Roots of Xibe's: 2004 | 2005 | Birth of Xibé's: 2006 part 1 | 2006 part 2 | Xibé mambembe 2007 part 1 | 2007 part 2 | 2007 part 3 | 2008 part 1 | 2008 part 2 | 2008 part 3 | Xibé na Flor do Rock 2009 part 1 | 2009 part 2 | 2009 part 3 | I Festa do Movimento Cultural da Xibé (2007)
Vídeos e áudios (in portuguese): Chuva de Mídia Independente | Primeiras Entrevistas da Xibé | I Festa da Xibé | Camisetas do Cmi-Tefé | Jornal academico: entrevistas e debates com Francinete Chota | Explosão do Funk na Internet
Artigos (in portuguese): A universidade e a necessidade de rádios livres | Transformação e Reprodução Social na Experiência do Centro de Mídia Independente de Tefé | Disseminação da comunicação através de uma rádio comunitária na comunidade de Porto Braga da Reserva de Desenvolvimento Sustentável Mamirauá | O Centro de Mídia Independente de Tefé: mídias livres na educação e na organização coletiva | Rádio na escola: uma proposta pedagógica para a democracia | Um laboratório de comunicação livre no Médio Solimões | A Flor Indígena: Artes de Fazer e Mídias Livres na Barreira da Missão | A fronteira virtuosa: universidade, mídias livres e diálogo intercultural
Editoriais antigos (in portuguese): Rádio Xibé ocupa Câmara dos Vereadores de Tefé e Anatel é contactada | Rádios livres do norte se mobilizam | Flor dos Movimentos Rurais (Tefé 2006) | Flor Indígena (Tefé 2007) | Flor da Vila Pescoço (Tefé 2008) | Flor das mulheres indígenas (Tefé 2008) | Flor da Palavra e Rock na Rua (Tefé 2009)
On Monday the first of February 2010 the Rastafarian community Cajazeiras 10, a neighbourhood on the outskirts of Salvador (Bahia, Brazil) suffered a form of torment at the hands of local media and government only experienced in poor communities: repression and humiliation. Police officers from Cajazeiras 10's police precinct, during an unprovoked morning raid, invaded the houses of residents without cause for suspicion. That afternoon, with a crew from the television program "Na Mira", police conducted one such invasion into the home of a resident who had cultivated two marijuana plants producing a horrific spectacle used to serve as a deterrent to others. The man and his wife were forced to lay on the ground and publicly humiliated.
The television program "Na Mira" [in sight], is one of several popular sensationalist programs which frequently exhibits police incursions, cadavers, as well as arguments and fights (always among those on societal margins) as well as interviews with prisoners in a tone of grotesque humour thus, making a mockery of what most would describe as serious. These shows invariably suggest an inherent association between violence and poverty and, therefore, a need for the state to violently repress the poor.
Although followers of the Rastafari religion (or philosophy) follow a disciplined and peaceful way of life they are victims of an enormous amount of prejudice due to they fact that they are mostly Black (of African descent) and often use Marijuana and "Dreadlock" their for religious regions. Nothing can justify the degrading spectacle promoted by the media and police nor the prejudice and common use of violence by the state to maintain control over the poorest members of the population; it is always the poor and black who are "in sight".
As of 08/02 the resident whose home was invaded remains imprisoned despite having been able to provide a fixed address and profession.
Read the Manifest letter of the comunity (just in portuguese)
Links in Portuguese:- MP entra com ação contra programa que defende tortura | Ministério Público coíbe abusos em programas na Bahia | PROGRAMA 'NA MIRA' NÃO VAI SAIR DO AR- Genocídio de população negra como política de Estado | Entidades responsabilizam Estado brasileiro por política de extermínio- O Caso de Robson Freitas, rastafari e ativista | RASTAFARI: Cultura de Resistência | SEMINÁRIO - RASTAFARI e CONSCIÊNCIA SOCIAL (2007)
As was denounced in the last CMI editorial on Honduras, in which we said that the national press stopped following the happenings in that country with the assumption that a fraudulent election under a military coup could resolve problems in the area, aggression and violations of human rights have risen. In an interview with CMI, Jose Luis Baquedano, of the National Front of the Popular Resistance, alerted that the repressions would ramp up and that Hondurans in resistance would running the risk of losing their lives. Baquedano himself and his son have already received various telephone calls threatening their lives. We publish here the translation of the communication made on the 15th of February 2010 by the Committee for the Defense of Human Rights in HOnduras (CODEH in Spanish):
We of the Committee for the Defense of Human Rights in Honduras (CODEH), are extremely worried by the systematic persecution, temporary disappearing, tortures, rapes, and murders currently directed to cause terror in those who have resisted the attack on dignity and moral abuse promoted by media and complicit in the (coup government's) harassment policy, which constitute crimes against humanity. The persecution, today, has transformed itself into selective aggression against any person who rejects with stoicism and emancipatory conscience those who today continue to enjoy impunity and commit grave crimes to legitimize those who today give continuity to the coup regime created after the military coup of June 28th 2009.
For the record CODEH has observed with profound concern:
1. - The temporary disappearing of artists Hermes Reyes, member of the Movement of Artists in Resistance by Divinity and by Justice. Three men participated in his imprisonment, supposedly paramilitaries who forced him into a vehicle where they beat him while telling him they knew that members of the National Front of Resistance against the Coup d'Etat were found meeting that Friday, the 12th of February 2010, in the city of Siguatepeque. In the torture, according to statements from those who assisted Hermens, barbed wire was used and seriously damaged one of his eyes.
*Read the complete communique*
Struggle for Justice, Freedom and Repair!
We, the families of victims of state violence Brazilian youth black and black residents of slums and suburbs, militants and citizens who are struggling and are in solidarity, we raise our voice on 10 December, International Day of Human Rights.
Once again we denounce the genocide, summary executions, the torture, mass imprisonment, the brutality of the police and prison officers (state agents). Brazil, presented as a tropical paradise where they will be held at the World Cup 2014 and 2016 Olympics, it seems more a giant concentration camp and extermination.
We denounce the racism and economic interests of elites, political corruption and police are behind so much death and violence.
We express our solidarity with social movements fighting for rights of the people and are thus criminalized and persecuted, as the landless, homeless, indigenous peoples, Afro-descendent communities threatened with eviction, trade unionists.
The judiciary can not contribute to the extermination of the black population poor! The Brazilian judicial system (judges, justices, promoters, etc.) has a wide share of responsibility in this situation.
Read the full article
Kent Police had e-mailed imc-uk-contact in the morning requesting that personal information about the judge in the Stop Huntingdon Animal Cruelty (SHAC) trial be removed from the site. However this information had already been quickly removed in line with IMC UK policy. The e-mail also requested information relating to the poster be retained. Indymedia as an open posting news service does not log such information about its sources.
The warrant, as yet not seen by Indymedia, was we believe, specifically for this one server colocated in Manchester which is a mirror of the site. So it can only be concluded that the judge didn?t check the legality and validity of the request to remove it, and that the police wanted to attack the infrastructure within the UK.
Other sites that have been affected as a result of this seizure include London Indymedia, the global Indymedia documentation project server, la Soja Mata ? an anti-GM soya campaign focusing on South American development, Transition Sheffield and a Canadian campaign against the 2010 olympics.
Other Coverage: The Register | SchNews


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Will 2009 Gator football team produce four NFL first-rounders?
SI. com's Andrew Perloff has released his "Way Early 2010 NFL Mock Draft'' and four current Gators are listed as first-round draft choices.
The players are among 13 SEC players projected as first round selections.
Here's Perloff's list:
Tennessee safety Eric Berry (Oakland Raiders' No. 2 pick), Florida cornerback Joe Haden (Seattle) with pick 12, Florida quarterback Tim Tebow (Washington) with pick 13, Florida defensive end Carlos Dunlap (Minnesota) with pick 15, Alabama defensive tackle Terrence Cody (to Atlanta) with pick 16, Florida linebacker Brandon Spikes (Miami) with pick 17, Ole Miss defensive end Greg Hardy (Seattle) with pick 18, LSU receiver Brandon LaFell (Baltimore) with pick 20, Kentucky cornerback Trevard Lindley (Dallas) with pick 23, Ole Miss quarterback Jevan Snead (San Francisco) with pick 25, Alabama cornerback and Tampa native Javier Arenas (Pittsburgh) with pick 28, Tide linebacker Rolando McClain (Giants) with pick 29 and LSU offensive tackle Ciron Black (Philadelphia) with pick 31.
Take a look at the full SI.com mock draft here.

subset: commoncrawl


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Texas DE Alex Okafor selected by Arizona Cardinals in fourth round
Former Texas Longhorns DE Alex Okafor was drafted in the fourth round (No. 103 overall) by the Arizona Cardinals.
It was a bit of a slip for Okafor, who some projected to be a first-round pick not too long ago. While Okafor probably would have fit better as a base defensive end in a 4-3 scheme, he's athletic enough to be a stand-up pass-rusher in the 3-4, where former Longhorn DE Sam Acho is thriving in Arizona.
"Alex was so unselfish. He played anywhere we asked him to," said Texas head coach Mack Brown. "When we were short on the defensive line two years ago, at 260 pounds he played all year and never griped one bit. He became a great team leader."
Okafor's career highlight was the Valero Alamo Bowl against Oregon State, where he recorded 4.5 sacks.


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VT Recognized For Being Bicycle Friendly
Blacksburg, VA - Virginia Tech is being recognized for its efforts to encourage students, staff and visitors to ride bicycles.
The League of American Bicyclists has designated Tech as a bicycle friendly university.
The university got the league's bronze award, which is the third-highest designation.
The school is one of 58 colleges and universities in the nation to receive the designation.
The school says it has invested in nine miles of shared paths, three miles of bike lanes and several covered bicycle racks.


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DBA, Postgres, to Stockholm, Sweden About the company; The year was 2005 and e-commerce had long been precarious. With an idea to offer secure and simple payment solutions, Klarna was founded that same year. Six years have passed and we have grown to an ambitious and creative company of 600 employees. We have been awarded Company of the Year in -07 (bragging), increased our turnover by 13 570 % (statistics) and managed to become the Nordic market leader (facts). Klarna is partly owned by Sequoia Capital, DST Global and General Atlantic - companies that have seen the same potential in Google, Facebook and Twitter as they do in us. We think that is a good start. Skills; DBA Postgres Linux Contact; Philip Engstrom pengstrom(at)astoncarter(dot)com Philip Engstrom Aston Carter International • pengstrom(at)astoncarter(dot)com<mailto:pengstrom(at)astoncarter(dot)com> ü: www.astoncarter.com<http://www.astoncarter.com> http://se.linkedin.com/in/philipengstrom P please consider the environment before printing this email [cid:image002(dot)gif(at)01CCE104(dot)FEA9EE50] ________________________________ Aston Carter is now on Twitter, please follow us at http://twitter.com/aston_carter This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. The information contained in this email are the views of the author and may not necessarily reflect those of the Aston Carter Group. If you have received this email in error please return it to the sender, delete the email and destroy any copies of it. If you no longer wish to receive email from the Aston Carter Group please notify us at removeme(at)astoncarter(dot)com<mailto:removeme(at)astoncarter(dot)com> . Any personal information submitted by you is done so with consent to the transfer of such personal information to relevant third parties within and outside of the European Economic Area for reasonable relevant and necessary recruitment purposes and processing. Aston Carter Limited, Registered office address 15 Bonhill Street London EC2A 4DN, UK. Reg. in England & Wales, Reg. No. 3309925. Aston Carter International Limited, Registered office address 15 Bonhill Street London EC2A 4DN, UK. Reg. in England & Wales, Reg. No. 04576261.
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NPLATE - romiplostim injection, powder, lyophilized, for solution
Amgen, Inc.
2.1 Recommended Dosage Regimen
2.2 Preparation and Administration
2.3 Use of Nplate With Concomitant Medical ITP Therapies
5.1 Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis
5.2 Worsened Thrombocytopenia After Cessation of Nplate
5.3 Thrombotic/Thromboembolic Complications
5.4 Lack or Loss of Response to Nplate
5.5 Malignancies and Progression of Malignancies
5.6 Labortory Monitoring
5.7 Nplate Distribution Program
6.1 Clinical Studies Experience
6.2 Immunogenicity
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
12.1 Mechanism Of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility
13.2 Animal Toxicology and/or Pharmacology
14.1 Chronic ITP
17.1 Information for Patients
17.2 FDA-Approved Medication Guide
Nplate is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.
Only prescribers enrolled in the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program may prescribe Nplate [see Warnings and Precautions (5.7)]. Nplate must be administered by the enrolled prescribers or healthcare providers under their direction.
Monitor complete blood counts (CBCs), including platelet counts and peripheral blood smears, prior to initiation of Nplate and throughout Nplate therapy. Monitor CBCs, including platelet counts, for at least 2 weeks following discontinuation of Nplate [see Warnings and Precautions (5.6)].
Use the lowest dose of Nplate to achieve and maintain a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response. Nplate should not be used in an attempt to normalize platelet counts [see Warnings and Precautions (5.3)].
The prescribed Nplate dose may consist of a very small volume (eg, 0.15 mL). Administer Nplate only with a syringe that contains 0.01 mL graduations.
Initial Dose
The initial dose for Nplate is 1 mcg/kg based on actual body weight.
Dose Adjustments
Use the actual body weight at initiation of therapy, then adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. In clinical studies, most patients who responded to Nplate achieved and maintained platelet counts ≥ 50 x 109/L with a median dose of 2 mcg/kg.
During Nplate therapy, assess CBCs, including platelet count and peripheral blood smears, weekly until a stable platelet count (≥ 50 x 109/L for at least 4 weeks without dose adjustment) has been achieved. Obtain CBCs, including platelet counts and peripheral blood smears, monthly thereafter.
Adjust the dose as follows:
Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Nplate therapy at the maximum weekly dose of 10 mcg/kg [see Warnings and Precautions (5.4)]. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate [see Warnings and Precautions (5.6)].
Nplate is supplied in single-use vials as a sterile, preservative-free, white lyophilized powder that must be reconstituted as outlined in Table 1 and administered using a syringe with 0.01 mL graduations. Using aseptic technique, reconstitute Nplate with preservative-free Sterile Water for Injection, USP as described in Table 1. Do not use bacteriostatic water for injection.
|Nplate Single-Use Vials
Total Vial Contentof Romiplostim
|Sterile Water for Injection*
|Deliverable Product and Volume
|Final Concentration
|250 mcg
|375 mcg
|0.72 mL
|250 mcg/0.5 in mL
|500 mcg/mL
|500 mcg
|625 mcg
|1.2 mL
|500 mcg/1 m in
|500 mcg/mL
Gently swirl and invert the vial to reconstitute. Avoid excess or vigorous agitation: DO NOT SHAKE. Generally, dissolution of Nplate takes less than 2 minutes. The reconstituted Nplate solution should be clear and colorless. Visually inspect the reconstituted solution for particulate matter and/or discoloration. Do not administer Nplate if particulate matter and/or discoloration is observed.
Reconstituted Nplate can be kept at room temperature (25°C/77°F) or refrigerated at 2° to 8°C (36° to 46°F) for up to 24 hours prior to administration. Protect the reconstituted product from light.
To determine the injection volume to be administered, first identify the patient's total dose in micrograms (mcg) using the dosing information in section 2.1. For example, a 75 kg patient initiating therapy at 1 mcg/kg will begin with a dose of 75 mcg. Next, calculate the volume of Nplate solution that is given to the patient by dividing the microgram dose by the concentration of the reconstituted Nplate solution (500 mcg/mL). For this patient example, the 75 mcg dose is divided by 500 mcg/mL, resulting in an injection volume of 0.15 mL.
As the injection volume may be very small, use a syringe with graduations to 0.01 mL.
Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than one dose from a vial.
Nplate may be used with other medical ITP therapies such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. If the patient's platelet count is ≥ 50 x 109/L, medical ITP therapies may be reduced or discontinued [Clinical Studies (14.1)].
Single-use vials contain 250 or 500 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder.
Nplate administration increases the risk for development or progression of reticulin fiber deposition within the bone marrow. In clinical studies, Nplate was discontinued in four of the 271 patients because of bone marrow reticulin deposition. Six additional patients had reticulin observed upon bone marrow biopsy. All 10 patients with bone marrow reticulin deposition had received Nplate doses ≥ 5 mcg/kg and six received doses ≥ 10 mcg/kg. Progression to marrow fibrosis with cytopenias was not reported in the controlled clinical studies. In the extension study, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. Clinical studies have not excluded a risk of bone marrow fibrosis with cytopenias.
Prior to initiation of Nplate, examine the peripheral blood smear closely to establish a baseline level of cellular morphologic abnormalities. Following identification of a stable Nplate dose, examine peripheral blood smears and CBCs monthly for new or worsening morphological abnormalities (eg, teardrop and nucleated red blood cells, immature white blood cells) or cytopenia(s). If the patient develops new or worsening morphological abnormalities or cytopenia(s), discontinue treatment with Nplate and consider a bone marrow biopsy, including staining for fibrosis [see Adverse Reactions (6.1)].
Discontinuation of Nplate may result in thrombocytopenia of greater severity than was present prior to Nplate therapy. This worsened thrombocytopenia may increase the patient's risk of bleeding, particularly if Nplate is discontinued while the patient is on anticoagulants or antiplatelet agents. In clinical studies of patients with chronic ITP who had Nplate discontinued, four of 57 patients developed thrombocytopenia of greater severity than was present prior to Nplate therapy. This worsened thrombocytopenia resolved within 14 days. Following discontinuation of Nplate, obtain weekly CBCs, including platelet counts, for at least 2 weeks and consider alternative treatments for worsening thrombocytopenia, according to current treatment guidelines [see Adverse Reactions (6.1)].
Thrombotic/thromboembolic complications may result from excessive increases in platelet counts. Excessive doses of Nplate or medication errors that result in excessive Nplate doses may increase platelet counts to a level that produces thrombotic/thromboembolic complications. In controlled clinical studies, the incidence of thrombotic/thromboembolic complications was similar between Nplate and placebo. To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ≥ 50 x 109/L [see Dosage and Administration (2.1)].
Hyporesponsiveness or failure to maintain a platelet response with Nplate should prompt a search for causative factors, including neutralizing antibodies to Nplate or bone marrow fibrosis [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. To detect antibody formation, submit blood samples to Amgen (1-800-772-6436). Amgen will assay these samples for antibodies to Nplate and thrombopoietin (TPO). Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg.
Nplate stimulation of the TPO receptor on the surface of hematopoietic cells may increase the risk for hematologic malignancies. In controlled clinical studies among patients with chronic ITP, the incidence of hematologic malignancy was low and similar between Nplate and placebo. In a separate single-arm clinical study of 44 patients with myelodysplastic syndrome (MDS), 11 patients were reported as having possible disease progression, among whom four patients had confirmation of acute myelogenous leukemia (AML) during follow-up. Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.
Monitor CBCs, including platelet counts and peripheral blood smears, prior to initiation, throughout, and following discontinuation of Nplate therapy. Prior to the initiation of Nplate, examine the peripheral blood differential to establish the baseline extent of red and white blood cell abnormalities. Obtain CBCs, including platelet counts and peripheral blood smears, weekly during the dose adjustment phase of Nplate therapy and then monthly following establishment of a stable Nplate dose. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1, 5.2)].
Nplate is available only through a restricted distribution program called Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program. Under the Nplate NEXUS Program, only prescribers and patients registered with the program are able to prescribe, administer, and receive Nplate. This program provides educational materials and a mechanism for the proper use of Nplate. To enroll in the Nplate NEXUS Program, call 1-877-Nplate1 (1-877-675-2831). Prescribers and patients are required to understand the risks of Nplate therapy. Prescribers are required to understand the information in the prescribing information and be able to:
Serious adverse reactions associated with Nplate in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate discontinuation [see Warnings and Precautions (5.1, 5.2)].
The data described below reflect Nplate exposure to 271 patients with chronic ITP, aged 18 to 88, of whom 62% were female. Nplate was studied in two randomized, placebo-controlled, double-blind studies that were identical in design, with the exception that Study 1 evaluated nonsplenectomized patients with ITP and Study 2 evaluated splenectomized patients with ITP. Data are also reported from an open-label, single-arm study in which patients received Nplate over an extended period of time. Overall, Nplate was administered to 114 patients for at least 52 weeks and 53 patients for at least 96 weeks.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate and 32% of patients receiving placebo. Headaches were usually of mild or moderate severity. Table 2 presents adverse drug reactions from Studies 1 and 2 with a ≥ 5% higher patient incidence in Nplate versus placebo. The majority of these adverse drug reactions were mild to moderate in severity.
|Preferred Term
(n = 84)
(n = 41)
|Pain in extremity
|Abdominal Pain
|Shoulder Pain
Among 142 patients with chronic ITP who received Nplate in the single-arm extension study, the incidence rates of the adverse reactions occurred in a pattern similar to those reported in the placebo-controlled clinical studies.
As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein. Patients were screened for immunogenicity to romiplostim using a BIAcore-based biosensor immunoassay. This assay is capable of detecting both high- and low-affinity binding antibodies that bind to romiplostim and cross-react with TPO. The samples from patients that tested positive for binding antibodies were further evaluated for neutralizing capacity using a cell-based bioassay.
In clinical studies, the incidence of preexisting antibodies to romiplostim was 8% (17/225) and the incidence of binding antibody development during Nplate treatment was 10% (23/225). The incidence of preexisting antibodies to endogenous TPO was 5% (12/225) and the incidence of binding antibody development to endogenous TPO during Nplate treatment was 5% (12/225). Of the patients with positive antibodies to romiplostim or to TPO, one (0.4%) patient had neutralizing activity to romiplostim and none had neutralizing activity to TPO. No correlation was observed between antibody activity and clinical effectiveness or safety.
Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay used in detection and may be influenced by several factors, including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to romiplostim with the incidence of antibodies to other products may be misleading.
No formal drug interaction studies of Nplate have been performed.
Pregnancy Category C
There are no adequate and well-controlled studies of Nplate use in pregnant women. In animal reproduction and developmental toxicity studies, romiplostim crossed the placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality. Nplate should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Pregnancy Registry: A pregnancy registry has been established to collect information about the effects of Nplate use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the Nplate pregnancy registry by calling 1-877-Nplate1 (1-877-675-2831).
In rat and rabbit developmental toxicity studies no evidence of fetal harm was observed at romiplostim doses up to 11 times (rats) and 82 times (rabbit) the maximum human dose (MHD) based on systemic exposure. In mice at doses 5 times the MHD, reductions in maternal body weight and increased postimplantation loss occurred.
In a prenatal and postnatal development study in rats, at doses 11 times the MHD, there was an increase in perinatal pup mortality. Romiplostim crossed the placental barrier in rats and increased fetal platelet counts at clinically equivalent and higher doses.
It is not known whether Nplate is excreted in human milk; however, human IgG is excreted in human milk. Published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nplate, a decision should be made whether to discontinue nursing or to discontinue Nplate, taking into account the importance of Nplate to the mother and the known benefits of nursing.
The safety and effectiveness in pediatric patients (<18 years) have not been established.
Of the 271 patients who received Nplate in ITP clinical studies, 55 (20%) were age 65 and over, and 27 (10%) were 75 and over. No overall differences in safety or efficacy have been observed between older and younger patients in the placebo-controlled studies, but greater sensitivity of some older individuals cannot be ruled out. In general, dose adjustment for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
No clinical studies were conducted in patients with renal impairment. Use Nplate with caution in this population.
No clinical studies were conducted in patients with hepatic impairment. Use Nplate with caution in this population.
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. In this case, discontinue Nplate and monitor platelet counts. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations [see Dosage and Administration (2.2)].
Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology in Escherichia coli (E coli).
Nplate is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous injection. Two vial presentations are available, which contain a sufficient amount of active ingredient to provide either 250 mcg or 500 mcg of deliverable romiplostim, respectively. Each single-use 250 mcg vial of Nplate contains the following: 375 mcg romiplostim, 30 mg mannitol, 15 mg sucrose, 1.2 mg L-histidine, 0.03 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0. Each single-use 500 mcg vial of Nplate contains the following: 625 mcg romiplostim, 50 mg mannitol, 25 mg sucrose, 1.9 mg L-histidine, 0.05 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0 [see Dosage and Administration (2.2)].
Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO.
In clinical studies, treatment with Nplate resulted in dose-dependent increases in platelet counts. After a single subcutaneous dose of 1 to 10 mcg/kg Nplate in patients with chronic ITP, the peak platelet count was 1.3 to 14.9 times greater than the baseline platelet count over a 2- to 3-week period. The platelet counts were above 50 x 109/L for seven out of eight patients with chronic ITP who received six weekly doses of Nplate at 1 mcg/kg.
In the long-term extension study in patients with ITP receiving weekly treatment of Nplate subcutaneously, the pharmacokinetics of romiplostim over the dose range of 3 to 15 mcg/kg indicated that peak serum concentrations of romiplostim were observed about 7 to 50 hours post dose (median: 14 hours) with half-life values ranging from 1 to 34 days (median: 3.5 days). The serum concentrations varied among patients and did not correlate with the dose administered. The elimination of serum romiplostim is in part dependent on the TPO receptor on platelets. As a result, for a given dose, patients with high platelet counts are associated with low serum concentrations and vice versa. In another ITP clinical study, no accumulation in serum concentrations was observed (n = 4) after six weekly doses of Nplate (3 mcg/kg). The accumulation at higher doses of romiplostim is unknown.
The carcinogenic potential of romiplostim has not been evaluated. The mutagenic potential of romiplostim has not been evaluated. Romiplostim had no effect on the fertility of rats at doses up to 37 times the MHD based on systemic exposure.
In a 4-week repeat-dose toxicity study in which rats were dosed subcutaneously three times per week, romiplostim caused extramedullary hematopoiesis, bone hyperostosis and marrow fibrosis at clinically equivalent and higher doses. In this study, these findings were not observed in animals after a 4-week post treatment recovery period. Studies of long-term treatment with romiplostim in rats have not been conducted; therefore, it is not known if the fibrosis of the bone marrow is reversible in rats after long-term treatment.
The safety and efficacy of Nplate were assessed in two double-blind, placebo-controlled clinical studies and in an open-label extension study.
Studies 1 and 2
In Studies 1 and 2, patients with chronic ITP who had completed at least one prior treatment and had a platelet count of ≤ 30 x 109/L prior to study entry were randomized (2:1) to 24 weeks of Nplate (1 mcg/kg subcutaneous [SC]) or placebo. Prior ITP treatments in both study groups included corticosteroids, immunoglobulins, rituximab, cytotoxic therapies, danazol, and azathioprine. Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies. Rescue therapies (ie, corticosteroids, IVIG, platelet transfusions, and anti-D immunoglobulin) were permitted for bleeding, wet purpura, or if the patient was at immediate risk for hemorrhage. Patients received single weekly SC injections of Nplate, with individual dose adjustments to maintain platelet counts (50 x 109/L to 200 x 109/L).
Study 1 evaluated patients who had not undergone a splenectomy. The patients had been diagnosed with ITP for approximately 2 years and had received a median of three prior ITP treatments. Overall, the median platelet count was 19 x 109/L at study entry. During the study, the median weekly Nplate dose was 2 mcg/kg (25th–75th percentile: 1–3 mcg/kg).
Study 2 evaluated patients who had undergone a splenectomy. The patients had been diagnosed with ITP for approximately 8 years and had received a median of six prior ITP treatments. Overall, the median platelet count was 14 x 109/L at study entry. During the study, the median weekly Nplate dose was 3 mcg/kg (25th–75th percentile:
2–7 mcg/kg).
Study 1 and 2 outcomes are shown in Table 3. A durable platelet response was the achievement of a weekly platelet count ≥ 50 x 109/L for any 6 of the last 8 weeks of the 24-week treatment period in the absence of rescue medication at any time. A transient platelet response was the achievement of any weekly platelet counts ≥ 50 x 109/L for any 4 weeks during the treatment period without a durable platelet response. An overall platelet response was the achievement of either a durable or a transient platelet response. Platelet responses were excluded for 8 weeks after receiving rescue medications.
Study 1Nonsplenectomized Patients
Study 2Splenectomized Patients
(n = 41)
(n = 21)
(n = 42)
(n = 21)
|Platelet Responses and Rescue Therapy
|Durable Platelet Response, n (%)
|25 (61%)
|1 (5%)
|16 (38%)
|0 (0%)
|Overall Platelet Response, n (%)
|36 (88%)
|3 (14%)
|33 (79%)
|0 (0%)
|Number of Weeks With Platelet Counts ≥ 50 x 109/L, average
|Requiring Rescue Therapy, n (%)
|8 (20%)
|13 (62%)
|11 (26%)
|12 (57%)
|Reduction/Discontinuation of Baseline Concurrent ITP Medical Therapy
|Receiving Therapy at Baseline
|(n = 11)
|(n = 10)
|(n = 12)
|(n = 6)
|Patients Who Had > 25% Dose Reduction in Concurrent Therapy, n (%)
|Patients Who Discontinued Baseline Therapy, n (%)†
In Studies 1 and 2, nine patients reported a serious bleeding event [five (6%) Nplate, four (10%) placebo]. Bleeding events that were grade 2 severity or higher occurred in 15% of patients treated with Nplate and 34% of patients treated with placebo.
Extension Study
Patients who had participated in either Study 1 or Study 2 were withdrawn from study medications. If platelet counts subsequently decreased to ≤ 50 x 109/L, the patients were allowed to receive Nplate in an open-label extension study with weekly dosing based on platelet counts. Following Nplate discontinuation in Studies 1 and 2, seven patients maintained platelet counts of ≥ 50 x 109/L. Among 100 patients who subsequently entered the extension study, platelet counts were increased and sustained regardless of whether they had received Nplate or placebo in the prior placebo-controlled studies. The majority of patients reached a median platelet count of 50 x 109/L after receiving one to three doses of Nplate, and these platelet counts were maintained throughout the remainder of the study with a median duration of Nplate treatment of 60 weeks and a maximum duration of 96 weeks.
Nplate is supplied in single-use vials containing 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01).
Store Nplate vials in their carton to protect from light until time of use. Keep Nplate vials refrigerated at 2° to 8°C (36° to 46°F). Do not freeze.
See FDA-Approved Medication Guide.
Prior to treatment, patients should fully understand the risks and benefits of Nplate. Inform patients that the risks associated with long-term administration of Nplate are unknown and that they must enroll in the Nplate NEXUS Program, which provides for the proper use of Nplate in ITP patients.
Inform patients of the following risks and considerations for Nplate:
(Amgen Logo)
Nplate™ (romiplostim)
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
This product, its production, and/or its use may be covered by one or more U.S. Patents, including U.S. Patent Nos. 6,835,809 and 7,189,827, as well as other patents or patents pending.
© 2008 Amgen Inc. All rights reserved.
1-877-Nplate1 (1-877-675-2831)
Nplate™ (N-plāt)
Read this Medication Guide before you start Nplate and before each Nplate injection. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about Nplate?
Nplate can cause uncommon but serious side effects:
When you are being treated with Nplate, your healthcare provider will closely monitor your Nplate dose and blood tests, including platelet counts.
See "What are the possible side effects of Nplate?" for other side effects of Nplate.
What is Nplate?
Nplate is a man-made protein medicine used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP), when other medicine to treat your ITP is not the best choice for you or surgery to remove the spleen has not worked well enough.
Nplate is only:
It is not known if Nplate works or if it is safe in people under the age of 18.
Nplate is for treatment of certain people with low blood platelet counts caused by chronic ITP, not low platelet counts caused by other conditions or diseases.
What should I tell my doctor before taking Nplate?
Tell your doctor about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take Nplate?
To receive Nplate, you must first talk with your healthcare provider and understand the benefits and risks of Nplate. You must agree to and follow all of the instructions in the Nplate NEXUS Program.
Before you can begin to receive Nplate, your healthcare provider will:
Nplate is given by your healthcare provider as a subcutaneous (SC) injection under the skin one time each week.
Your healthcare provider will check your platelet count every week and change your dose of Nplate as needed. This will continue until your healthcare provider decides that your dose of Nplate can stay the same. After that, you will need to have blood tests every month. When you stop receiving Nplate, you will need blood tests for at least 2 weeks to check if your platelet count drops too low.
Tell your healthcare provider about any bruising or bleeding that occurs while you are receiving Nplate.
If you miss a scheduled dose of Nplate, call your healthcare provider to arrange for your next dose as soon as possible.
What should I avoid while receiving Nplate?
Avoid situations that may increase your risk of bleeding, such as missing a scheduled dose of Nplate. You should arrange for your next dose as soon as possible. Call your doctor or the Nplate NEXUS Program at 1-877-Nplate1 (1-877-675-2831).
What are the possible side effects of Nplate?
Nplate may cause serious side effects. See "What is the most important information I should know about Nplate?"
The most common side effects of Nplate are:
These are not all the possible side effects of Nplate. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the Nplate NEXUS Program at 1-877-Nplate1 (1-877-675-2831) or FDA at 1-800-FDA-1088.
General information about the safe and effective use of Nplate
This Medication Guide summarizes the most important information about Nplate. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Nplate that is written for health professionals.
What are the ingredients in Nplate?
Active ingredient: romiplostim
Inactive ingredients: L-histidine, sucrose, mannitol, polysorbate-20 and dilute hydrochloric acid
Nplate™ (romiplostim)
Manufactured by:
Amgen Inc..
One Amgen Center Drive
Thousand Oaks, California 91320-1799
This product, its production, and/or its use may be covered by one or more U.S. Patents, including U.S. Patent Nos. 6,835,809 and 7,189,827, as well as other patents or patents pending.
© 2008 Amgen Inc. All rights reserved.
1-877-Nplate1 (1-877-675-2831)
v1 Issue Date: 08/2008
This Medication Guide has been approved by the U.S. Food and Drug Administration.
romiplostim injection, powder, lyophilized, for solution
romiplostim injection, powder, lyophilized, for solution


text:
Avoiding Privileging Disputes
Tips for Avoiding a Privilege Dispute
Scope-of-practice issues have been and will continue to be a crucial battleground for family physicians. Although turf battles typically originate from political and economic motives rather than true quality-of-care concerns, they are not to be taken lightly because they can ultimately limit a physician's scope of practice.
At the heart of this struggle is the process of credentialing and privileging, which, if done correctly, ensures both quality patient care and the ability of qualified, well-trained family physicians to provide that care. A family physician needs to know what to do when faced with a privileging battle.
Preempt the Dispute
The best way to guarantee you never lose a privileging conflict is to never have one in the first place. Your hospital's privileging process should grant privileges based on documented training, experience, and current clinical competence. Privileging based on any other factors is contrary to the written standards of the Joint Commission on Accreditation of Health Care Organizations. When privileging battles go to court, they are won principally because the privileging process deviated from this standard. Specialty designation is not grounds for granting or denying any privilege.
You must be completely familiar with your hospital's privileging process and bylaws and, if needed, must work to change them so that they are equitable. The following elements are essential to a fair process:
1. Full Clinical Departments
Your hospital should provide a full clinical department of family medicine, not just an administrative department. The department of family medicine must function in exactly the same manner as any other department in the hospital and must have membership standards that keep it from becoming a dumping ground for hard-to-place physicians.
Ideally, membership in the department would be limited to family physicians who:
- Are residency trained and board certified
- Are board certified although not residency trained
- Have several years of experience and demonstrated competence as family physicians, even though they are not residency trained or board certified
2. Full Credentialing Authority
The privileging and credentialing processes in the hospital's family medicine department must occur exactly as they do in any other department, without exception.
Family physicians must be credentialed and considered for privileges by their own departments, just as other specialists are. Privilege recommendations from the department of family medicine should then be forwarded directly to the credentials committee; the assent or approval of other departments is not needed.
When the recommended privileges fall outside the normal scope-of-practice of the department making the recommendation, the use of hospital-wide criteria can be very helpful. For example, an established criteria for Cesarean section, which any physician (regardless of specialty) uses when applying for that privilege. As a result, the family medicine department may evaluate applicants and send recommendations directly to the credentials committee without going through the obstetrics/gynecology department.
The establishment and use of hospital-wide criteria does not preclude any department from seeking input and advice from any other department.
3. Board Ownership of Privileging
No department owns any privilege. The role of clinical departments and credentials committees must be limited to evaluating physicians' applications for privileges and forwarding recommendations to the next level.
Legally, only the governing board of the hospital has the right to grant privileges, taking under advisement the recommendations from both the physician's department and the credentials committee. Governing boards have been held accountable in court for the privileges they grant, bringing to an end the days when recommendations from the medical staff were simply "rubber stamped."
Hospital boards have a fiduciary responsibility to the institution and the community to take credentialing and privileging very seriously, which brings the process out into the open. This is as good for patient care as it is for family medicine departments.
4. Access to Consultation
Sometimes physicians in another hospital department will refuse to consult with family physicians. To prevent such problems, request that a statement such as the following be added to your hospital bylaws:
"It shall be the policy of the medical staff that all staff physicians have access to consultation when deemed necessary and that such consultation, when requested in a timely and appropriate manner, shall not be unreasonably refused."
5. Meaningful Peer Review
The bylaws must state that all departments have the obligation of conducting meaningful peer review of their members on an ongoing basis, along with having the authority to recommend privileges.
Charts should be peer reviewed in the department that recommended the privilege in question. For example, a case under review due to a complication in diabetes management should be reviewed in the department that originally recommended the physician's privileges. Family medicine departments should not be any different than other departments when it comes to peer review.
When Privileging Disputes are Unavoidable
Privileging is unquestionably a local issue. If the privileging principles outlined by the Joint Commission on Accreditation of Health Care Organizations are followed, conflicts will almost certainly be resolved within the committee structure of your hospital. The AAFP can be most useful by providing the knowledge that helps members work effectively in their hospital structure. Local efforts by the physicians involved are the best way to effect change and successfully conclude privilege struggles.
Your state chapter is ideally situated to provide help to members facing privilege disputes. Involve your chapter at the earliest possible time so that they can intervene on behalf of those caught up in privileging disputes. A united front presented by a state organization that is part of a national organization has tremendous potential for effecting a positive outcome.
Learn more about resolving privilege problems.
Excerpted and adapted with permission from Fighting for Hospital Privileges. Family Practice Management 2004;Vol11(3):69-74. Copyright © American Academy of Family Physicians. All rights reserved.
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text:
Project Status Report: Adventures in the Archive
The Mysterious Library of Maurice Rapf
Compiling a bibliography for Political Cinema has kept me buried in the B-Level of the Rock all this week (and a good chunk of last week). Down there, in the PN 1993's to 1997's, I've been able to dig up all sorts of interesting texts, some of which were relevant to the course. Of the material that wasn't, "Z for Zagreb" proved particularly interesting. A short overview on the Yugoslavian animation industry in the 1960's, "Z for Zagreb" was interesting not only for its rare content, but for its bookplate, which explained that it was originally part of the "Maurice Rapf Film Studies Library" a part of the "Brown Film Society." While the Brown Film Society certainly exists today, it has clearly changed dramatically since it had its own private film studies library. Today, the BFS screens recent pop movies (like "Across the Universe") and does theme shows that focus on the time of year (like a "Home Alone" special or a Halloween Horror Movie show).
As shocked as I was to see that the BFS once had some serious academic clout (though perhaps, given the time period of the 1970's before a formal film program this is not so suprising) I was more perplexed by the name of the library. Who the hell was "Maurice Rapf"? A little goggling brought out some answers. Turns out Maurice Rapf was a Professor at Dartmouth, founder of their Film Studies program, and a former screenwriter in Hollywood. His communist/union sympathies got him blacklist in 1947, so he was forced into academia and film reviews, something that he became quite apt at apparently. When he died in 2003, the NY Times ran an obituary. One of his most enduring achievements was a popular text-book/introduction on thinking critically about the movies called "All About the Movies." It is amazing what one little bookplate can teach you.
But all of the connections have not yet been made. There are two outstanding questions that the little bookplate in "Z for Zagreb" prompted of me. The first is how many books are part of the Maurice Rapf "Film Studies Library"? Are they all here at Brown? Do they focus on only American movies? Where can I find a list? The second question is why did Brown get Maurice Rapf's film library when it appears that he was a lifelong Dartmouth man (attended as an undergraduate, then became a lifelong professor)? I am still trying to find someone in the Brown Library System who can tell me more.
Keeping Track of the Bibliography
Getting back to the real task at hand, I have been somewhat up in the air about which technology to use to compile my bibliography. I have decided to go (for the time being) with a Google Doc that can be found here. I know there are better, more efficient and useful bibliography tools out there, but I have yet to find a really practical one. Again, a question to ask the library staff when I finally corner one.
Rescuing the Missing Books
Whenever I find a book that is particularly notable (does not simply need to be entered into the bibliography, but actually looked over/read/scanned) I check it out to my carrel. Twice now, I have checked out books that the Library Staff said had been missing. Ironically, these were two of the most interesting books I have come across, the first being Leni Riefenstahl's "A Memoir" and the second a small BFI publication from 1979 on Jean Rouch called "Antropology -Reality - Cinema". The librarians were thrilled to see these books found ("Two missing books in the same day! Good work! Do you want some candy?") but I really hadn't done anything notable. I've just been going shelf by shelf, because I don't know what exactly I want, but I'll know it when I see it.


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When/Where: Wednesday, April 30, 2014 at 9:00am ET
The National Conference Center
Washington D.C.
What: Police and Private Companies Against Cybercrime"
9:00 – 9:50 a.m. ET
North Building - n3.264
Track: Legal
During his presentation, Roel Schouwenberg will discuss the details about trends in cybercrime that companies are now up against. He will highlight the evolution of cybercriminals, and how they have become a truly global problem. Roel will also outline Kaspersky Lab's mission to help bring security to the cyber-world, stressing that it is only possible to achieve this goal by combining the efforts of law enforcement bodies and private cybersecurity companies.
Who: Kaspersky Lab Principal Security Researcher Roel Schouwenberg. As a Principal Security Researcher for Kaspersky Lab North America, Roel is responsible for monitoring the regional malware situation and in-depth analysis of cyber incidents. Roel focuses on targeted attacks - including those used in cyber warfare - and proactive technologies. In addition, Roel also investigates new platforms and technologies. Roel brings nearly a decade of malware research and analysis experience.
About Kaspersky Lab
Kaspersky Lab is the world's largest privately held vendor of endpoint protection solutions. The company is ranked among the world's top four vendors of security solutions for endpoint users*. Throughout its more than 16-year history Kaspersky Lab has remained an innovator in IT security and provides effective digital security solutions for large enterprises, SMBs and consumers. Kaspersky Lab, with its holding company registered in the United Kingdom, currently operates in almost 200 countries and territories across the globe, providing protection for over 300 million users worldwide. Learn more atwww.kaspersky.com.
* The company was rated fourth in the IDC rating Worldwide Endpoint Security Revenue by Vendor, 2011. The rating was published in the IDC report "Worldwide Endpoint Security 2012–2016 Forecast and 2011 Vendor Shares (IDC #235930, July 2012). The report ranked software vendors according to earnings from sales of endpoint security solutions in 2011.
For the latest in-depth information on security threat issues and trends, please visit:
Securelist | Information about Viruses, Hackers and Spam
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Media Contact
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TAMPA — A one-year-old girl was run over by a car backing out of a driveway at about noon today.
Deanna L. Wallace, 27, was babysitting her two young sisters, ages 1 and 2 this afternoon. She drove them to 10108 N 10th St. to visit someone, and as she pulled into the driveway, Sabyne Collin, 27, also pulled up in a silver Ford Taurus, Tampa police said.
Wallace took the kids out of the car and walked over to the passenger side of the Taurus. She thought the passenger was the person she came to visit.
When she realized it wasn't, she walked back around the Taurus. As they were behind the left rear bumper, the car began to reverse. The driver didn't know they were there, Tampa police said.
The 1-year-old, Camora Pink, let go of Wallace's hand to wipe her nose and was knocked to the ground and then rolled over. She was pronounced dead at the scene.
The child's mother, Deneice K. Ramsay, 25, of Tampa, went to the scene and was distraught, according to police.


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Post-qualifying FIA press conference from Shanghai in China with Nico Rosberg, Lewis Hamilton and Michael Schumacher.
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Drivers: Nico Rosberg (Mercedes), Lewis Hamilton (McLaren) and Michael Schumacher (Mercedes).
Questions from the floor
Q: (Michael Schmidt - Auto, Motor und Sport).
Nico, you only had one run in Q3; was it because you didn't have any tyres any more or did you save one set?
Nico Rosberg:
It was just a decision to save another set of tyres. It was a good lap, I didn't know if it was going to be enough or not, but it was definitely a good lap and saving a set is very good for the race, so we just took the decision to go for that, because the race is where the points are, not in qualifying.
Q: (Michael Schmidt - Auto, Motor und Sport).
You could have had two runs, did you save a set of tyres beforehand, then?
Michael Schumacher:
Yup, same (as Nico).
Q: (Frederic Ferret - L'Equipe).
Nico, what was your feeling when you discovered that you had pole?
Nico Rosberg:
First of all, it was strange beforehand because I was standing there on my own and everybody else was still going round, but I couldn't do anything any more, so it was strange. And then slowly but surely, I saw the sector times and I saw that it was definitely going to be enough so fantastic, very excited.
Q: (Michael Schmidt - Auto, Motor und Sport).
Nico, you said that tomorrow might be good if the temperature goes down a little bit, because it might be better for the rear tyres, but yesterday, wasn't it a problem that the low temperatures created some graining on the front?
Nico Rosberg:
Yeah, that's true, that's why it's difficult to foresee tomorrow and our performance compared to the other top teams. We just need to wait. We're in a good position now, we've done our homework over the last couple of days, we've optimised what we have with the knowledge that we have. Of course, we're still learning a lot with the car, a lot of things are different but we will see. Difficult to say.
Q: (China Radio International - Peng Yan Yuan).
Michael, you came back last year, and now you're doing well this year and we have Kimi coming back this year. So who's going to be the next former World Champion coming back to Formula One?
Michael Schumacher:
Well, there are plenty of elder champions around so I don't know. Ask around!
Q: (Xinmin Evening News - Li Ran Ran).
Nico, this year you have your first pole, do you feel pressure with Hamilton and Michael behind you?
Nico Rosberg:
Of course. Of course I'm very proud, the first pole is great, for the whole team, it's a special moment for the whole team and the first of many moments to come, great results and everything. And it's great to share the qualifying podium here with Lewis and Michael. With Lewis, in the year 2000, we were saying how we imagined one day we were going to be one and two in F1 and now here in qualifying that's the case, so that's nice. Of course, having Michael to share the front row with is fantastic for the team, so it's good.


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"May God have mercy on you because i won't."
[[SandForge]]Created by: BIGGnelsonDescription: "The Perfect Canvas" (Mistake Free(Find one and you get sexy points))Mods if there is any better place for this please feel free to moveWHY?Sandforge was created because I have been annoyed by every canvas/stacked map out there so far so i created Sandforge to be the perfect canvas map on Sandbox. On some canvas maps the creator forgot to move objectives or there objects are simply in the way!Its annoyingFear not this has been solvedI instead of stacking all the objects in the Skybox, crypt, or just in the sand thought of a better alternative. I will have them floating outside of the skybox that way where ever you are buliding the objects are not in your way. There is a teleporter outside the map that will take you to the crypt and if you need to take stuff to the sand just fly down in. You need it in skybox?? Just fly in there is nothing stopping you.Towers BlockedTowers are also blocked because I thought it would be nice to have them there and if you do not need them just simply delete them. This dramatically increases the size of the sand section of Sandbox i hope that I have set the standard for the best canvas map and that i have made it more convenient for you as well as myself.
I'm queing this up for when I get the pack as DLC, sounds like you put alot of effort into it.
good map, please more maps
I haven't tried this map out yet but i know its going to be kickass.
can somebody tell me where to get the hellhornet?!?
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Seen from Above: Dolphins Hitch a Free Ride from Migrating Gray WhaleJune 28, 2013
|In the photo below, a group of long-beaked common dolphins are hitching a free ride on the bow wave of a migrating gray whale. Taken near Catalina Island off the coast of Southern California, the photo was shot from about 600 feet by scientists with the Cetacean Health and Life History Program at NOAA's Southwest Fisheries Science Center.
Photo caption: A group of long-beaked common dolphins surf the bow wave of a migrating gray whale. This photo was shot by
NOAA scientists off Southern California as they conducted their annual gray whale aerial survey. Credit: NOAA
Every year, almost the entire population of eastern North Pacific gray whales migrates from their feeding grounds in the Arctic down to their breeding and calving grounds off the coast of Baja California, Mexico. And most years, NOAA scientists survey and photograph the whales from the air. By analyzing the high-resolution photos, scientists can tell how well nourished the animals are, how many females are pregnant, and how many new calves are born.
One reason for doing this is to keep an eye on the health of the gray whale population. But in addition to that, the photographic study is an indirect way of monitoring the Arctic ecosystem.
The primary feeding grounds for the eastern north Pacific population of gray whales are in the Arctic. The rest of the year they fast or eat very little. So their physical condition during migration reflects conditions in their feeding grounds in the Arctic.
"We know the Arctic is changing, and changing pretty rapidly," said Wayne Perryman, a biologist with NOAA's Cetacean Health and Life History Program. "We want to know how this is impacting the gray whale population."
For example, many of the species that gray whales feed on are shifting northward as the Arctic warms. This means that gray whales have to migrate farther north to feed. For pregnant females, who by the time they arrive in the Arctic have been fasting for many months, this extra travel may be energetically taxing. One of the things that Perryman and his colleagues are studying is the relationship between the length of the migration and the rate of successful pregnancies.
"Gray whales integrate the impacts of climate change into their physical condition, then they swim right by our coast," said Perryman. "So we can actually do Arctic research right here from San Diego."
For dolphins, however, migrating whales mean only one thing. And that's a free ride.
Photo caption: A very pregnant female gray whale. Aerial photos such as these allow scientists to monitor how healthy and
well-nourished the animals are, how many are pregnant, and how many successfully give birth. Credit: NOAA
How Do We Study Whales?
The aerial survey of gray whales is just one component of a comprehensive research program. NOAA scientists also survey the migrating whales from stations on land, and they collect DNA samples from the animals then do genetic analyses that reveal gray whale population structure.
Together, these studies allow NOAA scientists and others to monitor and protect gray whale populations. Thanks in part to efforts like these, the eastern North Pacific population of gray whales was declared recovered under the Endangered Species Act in 1994.
Gray whale populations in other parts of the world remain endangered, however, and all gray whales are protected under the Marine Mammal Protection Act. Learn more about gray whale research at NOAA's Southwest Fisheries Science Center, and check out the Center's Office of Protected Resources.
New Technology Gives Scientists New Perspective
NOAA scientists are at the forefront of using new technology, such as unmanned aerial vehicles, to study marine mammal populations. For instance, NOAA scientists are using aerial drones to Spy on Sperm Whales and also to get A Whole new Perspective on life in Antarctica.
Gray whales still sometimes surprise scientists with their unexpected migrations.