Revasc
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Revasc 15mg/0.5ml powder and solvent for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains 15 mg desirudin. 
After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml 
 
Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges. 
 
* produced by recombinant DNA technology in yeast cells. 
** corresponding to approximately 270,000 antithrombin units (ATU) or 18,000 ATU per mg of 
desirudin with reference to the WHO Second International Standard for alpha-thrombin. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
White powder and clear, colourless solvent for solution for injection 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement 
surgery. 
 
4.2 Posology and method of administration 
 
Treatment with Revasc should be initiated under the guidance of a physician with experience in 
coagulation disorders.  Instructions for the preparation of Revasc are provided in section 6.6. 
 
Adult and elderly patients 
 
The recommended dose is 15 mg twice daily.  The first injection should be initiated 5 to 15 minutes 
before surgery but after induction of regional block anaesthesia, if used.  Treatment with desirudin is 
then continued twice daily post-operatively for 9 days up to a maximum of 12 days or until the patient 
is fully ambulant, whichever occurs first.  Currently, there is no clinical experience to support the use 
of desirudin beyond 12 days. 
 
Administration is by subcutaneous injection, preferably at an abdominal site.  Injections should be 
rotated between at least four different sites. 
 
Children 
 
There is no experience in children.  
 
Patients with renal impairment 
 
Desirudin is contraindicated in patients with severe renal impairment (creatinine clearance of less 
than 30ml/min corresponding to a serum creatinine > 2.5mg/dl or 221μmol/l; see section 4.3).  In 

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patients with mild or moderate renal impairment (creatinine clearance between 31 and 90 ml/min; see 
section 4.4) activated partial thromboplastin time (aPTT) should be monitored. 
 
Patients with liver impairment 
 
Desirudin is contraindicated in severe hepatic impairment (see section 4.3).  In patients with mild to 
moderate liver impairment (see section 4.4) aPTT monitoring is recommended. 
 
4.3 Contraindications 
 
Desirudin is contraindicated in patients: 
- with hypersensitivity to the active substance or to any of the excipients 
- with active bleeding and/or irreversible coagulation disorders 
- with severe renal and hepatic impairment 
- during pregnancy (see section 4.6) 
- with severe uncontrolled hypertension and subacute bacterial endocarditis. 
 
4.4 Special warnings and precautions for use 
 
Warnings 
 
Anaphylaxis: Revasc may cause allergic reactions including anaphylaxis and shock (see section 4.8).  
Fatal anaphylactic reactions have been reported in patients re-exposed to hirudin product therapy in a 
second or subsequent treatment course.  Although fatal reactions have not been reported with 
desirudin, alternative treatment options must be considered before the decision to re-expose a patient 
to Revasc.  As these reactions are immune-mediated, patients with previous exposure to hirudin or 
hirudin analogue may be at an increased risk.  Treatment initiation with Revasc should be undertaken 
only in a setting where medical assistance is readily available and where there is access to treatment 
for anaphylactic reactions.  Patients should be informed that they have received Revasc. 
 
Desirudin should not be administered by intramuscular injection owing to the risk of local 
haematoma. 
 
Desirudin should be used with caution in conditions with increased risks of haemorrhage such as 
major surgery, biopsy or puncture of a non-compressible vessel within the last month; a history of 
haemorrhagic stroke, intracranial or intraocular bleeding including diabetic (haemorrhagic) 
retinopathy; a cerebral ischaemic attack within the last 6 months, a known haemostatic disorder 
(congenital or acquired, e.g. haemophilia, liver disease) or a history of gastrointestinal or pulmonary 
bleeding within the past 3 months. 
 
Precautions 
 
When desirudin is administered in patients with increased risk of bleeding complications, mild to 
moderate hepatic dysfunction and/or mild to moderate renal impairment, aPTT should be monitored 
and peak aPTT should not exceed twice the control value.  If necessary, therapy with desirudin should 
be interrupted until aPTT returns to less than twice the control value at which time treatment with 
desirudin can be resumed at a reduced dose. 
 
Desirudin should be used with care in patients receiving anticoagulants, and/or platelet inhibitors, 
and/or non-steroidal anti-inflammatory medicinal products.  Monitoring for evidence of bleeding is 
advised (see section 4.5).  The concomitant use of desirudin with thrombolytics and ticlopidine has 
not been investigated in this patient population. 
 
The anticoagulant effect of desirudin is poorly reversible.  aPTT levels can, however, be reduced by 
intravenous administration of DDAVP (desmopressin). 
 

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Laboratory Tests: Activated partial thromboplastin time (aPTT) should be monitored in patients with 
increased risk of bleeding and/or renal or hepatic impairment.  Peak aPTT should not exceed twice the 
control value.  If necessary, therapy with desirudin should be interrupted until aPTT falls to less than 
twice the control at which time treatment with desirudin can be resumed at a reduced dose (see also 
section 4.5). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Any agent which may enhance the risk of haemorrhage should be discontinued prior to initiation of 
desirudin therapy.  If co-administration cannot be avoided, close clinical and laboratory monitoring 
should be conducted (see section 4.4). 
 
During prophylaxis, concomitant use of medicinal products containing heparins (unfractionated and 
low-molecular weight heparins) and dextrans is not recommended.  The effects of desirudin and 
unfractionated heparins on prolongation of aPTT have been shown to be additive (see section 4.4). 
 
As with other anticoagulants desirudin should be used with caution in conjunction with medicinal 
products which affect platelet function these medicinal products include: acetylsalicylic acid and 
NSAIDs, ticlopidine and clopidogrel, glycoprotein IIb/IIIa antagonists (abciximab, eptifibatide, 
tirofiban) and iloprost. 
 
If a patient is switched from oral anticoagulants to desirudin therapy or from desirudin to oral 
anticoagulants, the anticoagulant activity should continue to be closely monitored with appropriate 
methods.  That activity should be taken into account in the evaluation of the overall coagulation status 
of the patient during the switch (see section 4.2). 
 
4.6 Pregnancy and lactation 
 
There are no adequate data from the use of desirudin in pregnant women.  Studies in animals have 
shown reproductive toxicity (see section 5.3).  The potential risk for humans is unknown.  Revasc is 
contraindicated in pregnancy (see section 4.3).  It is not known whether desirudin is excreted in 
human milk.  However, lactating mothers should be advised to avoid breast feeding or alternative 
medicinal products used. 
 
4.7 Effects on ability to drive and use machines 
 
Revasc has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
In controlled clinical trials investigating desirudin 15 mg twice daily and a standard dose of 
unfractionated heparin, the nature of the hip surgery operation and the mode of action of the two 
drugs studied account for most of the adverse experiences reported.  As with other anticoagulants, 
bleeding is the most common adverse reaction. 
 
The following related adverse reactions were listed below by system organ class and within each 
frequency grouping, adverse reactions are presented in order of decreasing seriousness: common (≥ 
1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000). 
 
Investigations 
Uncommon:  Increase in serum transaminases 
 

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Blood and the lymphatic system disorders 
Common:  Anaemia 
 
Nervous system disorders 
Uncommon:  Dizziness, insomnia, confusion 
 
Respiratory, thoracic and mediastinal disorders 
Uncommon:  Dyspnoea 
 
Gastrointestinal disorders 
Common:  Nausea 
Uncommon:  Haematemesis, vomiting, constipation 
 
Renal and urinary disorders 
Uncommon:  Haematuria, urinary retention 
 
Skin and subcutaneous tissue disorders 
Uncommon:  Rash, urticaria 
 
Metabolism and nutrition disorders 
Uncommon:  Hypokalaemia 
 
Infections and infestations 
Uncommon:  Urinary tract infection, cystitis 
 
Injury, poisoning and procedural complications 
Common:  Wound secretion 
Uncommon:  Impaired wound healing 
 
Vascular disorders 
Common:  Hypotension, deep thrombophlebitis 
Uncommon:  Epistaxis, hypertension 
 
General disorders and administration site conditions 
Common:  Fever, injection site mass, haematomas, oedema in legs 
Uncommon:  Pain in legs, pain, abdominal and chest pain 
 
Immune system disorders 
Common: Allergic reactions have been reported in the same proportion (1.6%) of patients 

treated with desirudin (N=2,367) or with unfractionated heparin (N=1,1 34) in 
clinical trials, regardless of causality. 

Rare:  Anti-hirudin antibodies have been detected upon re-exposure to desirudin in 
clinical trials. 

 
Adverse reactions irrespective of trial drug relationship reported during clinical trials were bleeding 
episodes, oliguria, hyperpyrexia and joint dislocation. 
 
In post-marketing surveillance, rare reports of major haemorrhages, some of which were fatal; and 
rare reports of non-fatal anaphylactic or anaphylactoid reactions leading to shock have been received. 
 
 

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4.9 Overdose 
 
There is no antidote for desirudin.  Overdosage of desirudin could lead to bleeding complications.  In 
such cases desirudin should be discontinued.  If necessary, plasma expanders and/or blood transfusion 
may be used. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anticoagulant, ATC code: B01AE01 
 
Mechanism of action 
 
Desirudin is a highly potent and selective inhibitor of free circulating and clot-bound thrombin.  A 
mean peak aPTT prolongation of around 1.4 times baseline value is observed following a 
subcutaneous (SC) b.i.d. injection of 15mg desirudin.  At therapeutic serum concentrations it has no 
effect on other enzymes of the haemostatic system such as factors IXa, Xa, kallikrein, plasmin, tPA, 
or activated protein C.  In addition, it does not display any effect on other serine proteases, such as the 
digestive enzymes trypsin or chymotrypsin, or on complement activation by the classical or 
alternative pathways. 
In two controlled double blind clinical trials, the overall rate of thromboembolic events in patients 
treated with desirudin 15mg s.c. b.i.d. (N=370) was half that in patients treated with a standard dose 
of unfractionated heparin (N=396) (p<0.0001); the rate of proximal deep venous thrombosis was only 
one fifth that observed with the heparin (p<0.0001).  To date clinical data are available on hip surgery 
only. 
 
Pharmacodynamic effects 
 
The anticoagulant properties of desirudin are demonstrated by its ability to prolong the clotting time 
of human or rat plasma whether induced directly (thrombin time) or via the intrinsic (aPTT) or 
extrinsic (PT) pathways.  Desirudin has no profibrinolytic activity. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Mean absorption time of subcutaneous (SC) desirudin is 4.1, 4.5 and 5.4 h for dose levels of 0.1, 0.3 
and 0.5 mg/kg, respectively (overall mean = 4.6 h).  Absorption is complete based on mean area under 
the curve (AUC) values. 
 
Following administration of single SC doses of 0.1-0.75 mg/kg, plasma concentrations of desirudin 
increased rapidly to maximum levels (Cmax) between 1 and 3 h.  Both Cmax and AUC values are dose 
proportional. 
 
Distribution 
 
Desirudin is distributed in the extracellular space with a distribution volume at steady state of 
0.251/kg independently of the dose. 
 
Metabolism and elimination 
 
The disappearance of desirudin from plasma is rapid in the first phase with approximately 90% of an 
intravenous (IV) bolus dose disappearing from the circulation within 2 hours of the injection.  A 
slower terminal elimination phase follows with a dose-independent mean terminal elimination half-

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life of 2 to 3 h. The mean residence times are 1.7-2 h and 6-7 h after IV and SC administration, 
respectively. 
 
The total urinary excretion of unchanged desirudin amounts to 40-50 % of the administered dose. 
Metabolites lacking one or two C-terminal amino acids constitute a minor proportion of the material 
recovered from urine (<7%).  In vitro and in vivo animal data indicate that desirudin is for the most 
part eliminated and metabolised by the kidney.  Hepatic elimination of desirudin or the thrombin-
desirudin complex does not appear to be significant. 
 
Total clearance of desirudin has been found to be in the same range following either SC or IV 
administration (ca 1.95-2.20ml/min/kg) and was dose-independent.  The total and renal clearances of 
desirudin are slightly reduced in elderly subjects compared to young volunteers.  This decrease can be 
considered unlikely to be of clinical significance, thus requiring no dose reduction. 
 
5.3 Preclinical safety data 
 
Reproductive toxicology studies in animals showed desirudin to be teratogenic with changes 
comprising spina bifida in rabbits and omphaloceles in rats.  Non-clinical data reveal no special 
hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, 
genotoxicity and carcinogenic potential.   
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder: magnesium chloride  
  sodium hydroxide 
Solvent: mannitol (E 421) 
  water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other 
medicinal products. 
 
6.3 Shelf life 
 
3 years. 
 
From a microbiological point of view, the product should be used immediately.  If not used 
immediately, in-use storage times and conditions prior to use are the responsibility of the user and 
would normally not be longer than 24 hours at 2 to 8°C when reconstitution has taken place in 
controlled and validated aseptic conditions. 
 
6.4 Special precautions for storage 
 
Do not store above 25°C. 
Keep the vial and ampoule in the outer carton in order to protect from light. 
For storage conditions of the reconstituted medicinal product, see section 6.3. 
 

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6.5 Nature and contents of container 
 
15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film 
(fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass). 
 
Pack size of 1, 2 or 10. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
To prepare the reconstituted aqueous solution, 0.5ml of the accompanying mannitol solvent is added 
under aseptic conditions to the vial containing the powder for solution for injection.  The active 
substance is rapidly redispersed by shaking gently producing a clear solution. 
 
The reconstituted solution should be used as soon as possible (see section 6.3 above). 
 
Any unused product or waste material should be disposed in accordance with local requirements. 
 
Do not use reconstituted vials containing visible particles. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Canyon Pharmaceuticals Limited 
7th Floor 
52-54 Gracechurch Street 
London EC3V 0EH 
United Kingdom  
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/l/97/043/001  2 vials/2 ampoules of solvent 
EU/1/97/043/002  10 vials/10 ampoules of solvent 
EU/1/97/043/003  1 vial/1 ampoule of solvent 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 9 July 1997 
Date of latest renewal: 9 July 2007 
 
 
10. DATE OF REVISION OF THE TEXT 
 

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ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURING AUTHORISATION 

HOLDER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OF THE MARKETING AUTHORISATION 

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A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Boehringer Ingelheim RCV GmbH & Co KG (BI RCV) 
Dr. Boehringer Gasse 5 - 11 
1121 Vienna  
Austria 
 
Name and address of the manufacturer responsible for batch release 
 
Canyon Pharmaceuticals GmbH 
Unter Gereuth 10 
D-79353 Bahlingen a.K. 
Germany 
 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2). 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
• OTHER CONDITIONS 
 
Pharmacovigilance system 
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the 
Marketing Authorisation, is in place and functioning before and whilst the product is on the 
market. 
 
 
 

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ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

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A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON: FOR 2 VIALS (15mg/vial) AND 2 AMPOULES 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Revasc 15mg/0.5ml powder and solvent for solution for injection 
Desirudin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000 
ATU per vial. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: magnesium chloride, sodium hydroxide 
Solvent: mannitol, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
15mg of powder in a vial and 0.5ml of solvent in an ampoule 
 
Pack size of 2 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Reconstitute immediately before use with solvent provided.  Read the package leaflet before use. 
 
Subcutaneous use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 

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9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25ºC. 
After reconstitution, immediate use is recommended.  However, the in-use stability has been 
demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator). 
 
Keep the vial and ampoule in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Canyon Pharmaceuticals Limited 
7th Floor 
52-54 Gracechurch Street 
London EC3V 0EH 
United Kingdom  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/043/001 
 
 
13. BATCH NUMBER 
 
Batch 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON: FOR 10 VIALS (15mg/vial) AND 10 AMPOULES 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Revasc 15mg/0.5ml powder and solvent for solution for injection 
Desirudin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000 
ATU per vial. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: magnesium chloride, sodium hydroxide 
Solvent: mannitol, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
15mg of powder in a vial and 0.5ml of solvent in an ampoule 
 
Pack size of 10 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Reconstitute immediately before use with solvent provided.  Read the package leaflet before use. 
 
Subcutaneous use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 

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9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25ºC. 
After reconstitution, immediate use is recommended.  However, the in-use stability has been 
demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator). 
 
Keep the vial and ampoule in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Canyon Pharmaceuticals Limited 
7th Floor 
52-54 Gracechurch Street 
London EC3V 0EH 
United Kingdom  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/043/002 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON: FOR 1 VIAL (15mg/vial) AND 1 AMPOULE 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Revasc 15mg/0.5ml powder and solvent for solution for injection 
Desirudin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000 
ATU per vial. 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: magnesium chloride, sodium hydroxide 
Solvent: mannitol, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
15mg of powder in a vial and 0.5ml of solvent in an ampoule 
 
Pack size of 1 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Reconstitute immediately before use with solvent provided.  Read the package leaflet before use. 
 
Subcutaneous use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 

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9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25ºC. 
After reconstitution, immediate use is recommended.  However, the in-use stability has been 
demonstrated for 24 hours between 2ºC and 8ºC (in a refrigerator). 
 
Keep the vial and ampoule in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Canyon Pharmaceuticals Limited 
7th Floor 
52-54 Gracechurch Street 
London EC3V 0EH 
United Kingdom  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/043/003 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL: 15mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Revasc 15 mg/0.5 ml 
Powder for injection 
Desirudin 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
15mg of desirudin 
 
 

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
AMPOULE LABEL: 0.5ml SOLVENT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Revasc 15 mg/ 0.5ml 
Solvent for parenteral use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5ml of water for injections with 3% (w/v) of mannitol 
 
 

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B. PACKAGE LEAFLET 

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PACKAGE LEAFLET:  INFORMATION FOR THE USER  
 

Revasc 15mg/0.5ml powder and solvent for solution for injection 
 

Desirudin 
 

Read all of this leaflet carefully before you start using this medicine. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, nurse or your pharmacist. 
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or nurse. 
 
In this leaflet:  
 
1. What Revasc is and what it is used for 
2. Before you use Revasc 
3. How to use Revasc 
4. Possible side effects 
5. How to store Revasc 
6. Further information 
 
 
1. WHAT REVASC IS AND WHAT IT IS USED FOR 
 
The common name of the active substance in Revasc is desirudin.  Desirudin is a recombinant DNA 
product derived from yeast cells.  Desirudin belongs to a group of medicines called anticoagulants, 
which prevent blood clots from forming in the blood vessels. 
 
Revasc is used to prevent blood clotting after elective hip or knee replacement surgery, as harmful 
blood clots can form in the blood vessels of the legs.  It is often given for several days after operations 
because blood clots are most likely to form when you are resting in bed. 
 
 
2. BEFORE YOU USE REVASC 
 
You must not be given Revasc 
 
-  if you are hypersensitive (allergic) to natural or synthetic hirudin, including desirudin or any of the 

other ingredients of Revasc 
- if you are bleeding a lot or have any serious bleeding disorder (e.g. haemophilia) 
- if you have serious kidney or liver disease 
- if you have a heart infection 
- if you have an uncontrolled high blood pressure 
- if you are pregnant. 
 
Take special care with Revasc 
 
Make sure you tell your doctor if you are likely to have an increased risk of bleeding, which may be 
the case if you have, or have had: 
- bleeding disorders or a family history of bleeding disorder 
- stomach ulcers or any other bleeding disease of the gut 
- history of a stroke, or bleeding within the brain or eye 
- a recent operation (including dental surgery) or biopsy or pricking of a blood vessel within the last 

month 
- recently a brief shortage of blood supply to a part of the brain within the last six months 

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- bleeding in the gut or lung within the past three months. 
 
Your risk of bleeding may also be increased: 
- if you have recently given birth, fallen, or suffered a blow to the body or head 
- if you are already taking medicines, especially blood-thinners (see below). 
 
If any of the above apply to you, the doctor or nurse will monitor your blood for clotting activity and 
may change your dose or dosing schedule accordingly. 
 
Cross-sensitivity to other hirudin products is possible.  You should also inform your doctor if you 
have ever received Revasc, hirudin or an hirudin analogue. 
 
Children 
There is no experience with Revasc in children.  
 
Taking other medicines 
 
Please tell your doctor if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription. 
It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one 
of the medicines.  This applies to both prescription and non-prescription medicines, especially: 
 
- medicines used to prevent blood-clotting (warfarin, heparin and dicoumarol) 
- medicines which affect the function of platelets (particles in the blood involved in blood- 

clotting), e.g. acetylsalicylic acid, a substance present in many medicinal products used to 
relieve pain and lower fever, and other non-steroidal anti-inflammatory agents. 

 
Pregnancy and breast-feeding 
 
You should not be given Revasc if you are pregnant.  Revasc can cause serious harm to your baby.  It 
is therefore important to tell your doctor if you are pregnant or planning to become pregnant.  If you 
are of a child-bearing age, a pregnancy test may be done by your doctor to make sure you are not 
pregnant. 
 
It is advisable not to breast-feed during treatment. 
 
 
3. HOW TO USE REVASC 
 
You will be given Revasc as an injection under the skin. 
 
Administration is by subcutaneous injection, preferably at an abdominal site.  Injections should be 
rotated between at least four different sites.  The first injection should be initiated 5 to 15 minutes 
before surgery but after induction of regional block anaesthesia, if used.  Treatment with desirudin is 
then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully 
mobile, whichever occurs first.  Currently, there is no clinical experience to support the use of Revasc 
beyond 12 days. 
 
Usual dosage 
 
Always take Revasc exactly as your doctor has instructed you.  You should check with your doctor or 
pharmacist if you are unsure.  The usual dosage is 15mg injected twice a day for 9 days to a maximum 
of 12 days.  You will be given the first injection within 5 to 15 minutes before the operation.  If you 
need treatment for longer than 12 days, the doctor may switch you to another similar medicine. 
 

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If you have a kidney or liver disease, the doctor or nurse will monitor your blood for clotting activity 
and may change your dose or dosing schedule accordingly. 
 
If you are given more than you should 
 
Overdose with Revasc may lead to bleeding.  If this occurs, Revasc will be stopped and treatment 
given for the bleeding. 
 
If a dose is missed 
 
If a dose of this medicine is missed, it should be given to you as soon as possible.  If it is almost time 
for the next dose you will skip the missed dose and go back to the normal dosage schedule.  The dose 
should not be doubled. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Revasc can cause side effects, although not everybody gets them.  Some of these 
side effects may be similar to the effects of surgery.  The most likely side effect is bleeding. 
 
Tell the doctor or nurse as soon as possible if any of the following side effects occur, some of which 
may be confused with side effects of surgery: 
 
Common reported side effects (likely to affect between 1 in 10 and 1 in 100 patients): 
Unusual tiredness or weakness (anaemia), nausea, oozing of fluid from wounds, low blood pressure, 
fever, inflammation of veins sometimes accompanied by a clot, lumps at injection sites, bruising, 
swelling of the legs caused by fluid retention, non-fatal allergic reactions. 
 
Uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients):  
Increase in liver enzymes, dizziness, sleeplessness, confusion, feeling breathless, vomiting (with or 
without blood), constipation, blood in your urine, difficulty in urinating, rash, itching (urticaria), low 
levels of potassium in the blood, burning feeling when passing urine with also an increased frequency 
of urination, slow healing of wounds, nose bleeds, high blood pressure, pain (including pain in legs, 
stomach and/or chest). 
 
Rare side effects (likely to affect between 1 in 1,000 and 1 in 10,000 patients): 
Anti-hirudin antibodies have been detected upon re-exposure   
 
Isolated cases of fatal bleeding have been reported. 
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor, nurse or pharmacist. 
 
 
5. HOW TO STORE REVASC 
 
Keep out of the reach and sight of children. 
 
Do not use Revasc after the expiry date which is stated on the carton and the pack. 
 
Do not store above 25°C.  Keep the vial and ampoule in the outer carton. 
 
After reconstitution, immediate use is recommended.  However, the in-use stability has been 
demonstrated for 24 hours between 2°C and 8°C (in a refrigerator). 
 
Do not use Revasc if you notice that the solution for injection contains visible particles. 

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Medicines should not be disposed of via wastewater or household waste.  Ask you pharmacist how to 
dispose of medicines no longer required.  These measures will help to protect the environment. 
 
6. FURTHER INFORMATION 
 
What Revasc contains 
 
The active substance is desirudin (15mg/0.5ml powder).   
The other ingredients in the powder are magnesium chloride and sodium hydroxide.  In the solvent the 
ingredients are mannitol and water. 
 
Important information about some of the ingredients of Revasc 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i.e. essentially ‘sodium-
free’. 
 
What Revasc looks like and contents of the pack 
 
Revasc consists of a vial containing a white powder and an ampoule containing clear, colourless 
solvent for solution for injection. 
 
Pack sizes:  1 vial and 1 ampoule in one package 
  2 vials and 2 ampoules in one package 
  10 vials and 10 ampoules in one package 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
The marketing authorisation holder is: 
Canyon Pharmaceuticals Limited 
7th Floor 
52-54 Gracechurch Street 
London EC3V 0EH 
United Kingdom  
 
The manufacturer is: 
Canyon Pharmaceuticals GmbH 
Unter Gereuth 10 
D-79353 Bahlingen a.K. 
Germany 
 
 
 
This leaflet was last approved on. 
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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OF THE MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '3. how to use revasc', 'Section_Content': 'you will be given revasc as an injection under the skin. administration is by subcutaneous injection, preferably at an abdominal site. injections should be rotated between at least four different sites. the first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used. treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully mobile, whichever occurs first. currently, there is no clinical experience to support the use of revasc beyond 12 days. usual dosage always take revasc exactly as your doctor has instructed you. you should check with your doctor or pharmacist if you are unsure. the usual dosage is 15mg injected twice a day for 9 days to a maximum of 12 days. you will be given the first injection within 5 to 15 minutes before the operation. if you need treatment for longer than 12 days, the doctor may switch you to another similar medicine. if you have a kidney or liver disease, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly. if you are given more than you should overdose with revasc may lead to bleeding. if this occurs, revasc will be stopped and treatment given for the bleeding. if a dose is missed if a dose of this medicine is missed, it should be given to you as soon as possible. if it is almost time for the next dose you will skip the missed dose and go back to the normal dosage schedule. the dose should not be doubled.', 'Entity_Recognition': [{'Text': 'revasc', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 4, 'BeginOffset': 18, 'EndOffset': 24, 'Score': 0.6400228142738342, 'Text': 'revasc', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 'Attributes': [{'Type': 'ROUTE_OR_MODE', 'Score': 0.28756046295166016, 'RelationshipScore': 0.9999977350234985, 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, revasc can cause side effects, although not everybody gets them. some of these side effects may be similar to the effects of surgery. the most likely side effect is bleeding. tell the doctor or nurse as soon as possible if any of the following side effects occur, some of which may be confused with side effects of surgery: common reported side effects (likely to affect between 1 in 10 and 1 in 100 patients): unusual tiredness or weakness (anaemia), nausea, oozing of fluid from wounds, low blood pressure, fever, inflammation of veins sometimes accompanied by a clot, lumps at injection sites, bruising, swelling of the legs caused by fluid retention, non-fatal allergic reactions. uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients): increase in liver enzymes, dizziness, sleeplessness, confusion, feeling breathless, vomiting (with or without blood), constipation, blood in your urine, difficulty in urinating, rash, itching (urticaria), low levels of potassium in the blood, burning feeling when passing urine with also an increased frequency of urination, slow healing of wounds, nose bleeds, high blood pressure, pain (including pain in legs, stomach and/or chest). rare side effects (likely to affect between 1 in 1,000 and 1 in 10,000 patients): anti-hirudin antibodies have been detected upon re-exposure isolated cases of fatal bleeding have been reported. if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.', 'Entity_Recognition': [{'Text': 'revasc', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Id': 8, 'BeginOffset': 20, 'EndOffset': 26, 'Score': 0.4470086395740509, 'Text': 'revasc', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 9, 'BeginOffset': 37, 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{'Title': '5. how to store revasc', 'Section_Content': 'keep out of the reach and sight of children. do not use revasc after the expiry date which is stated on the carton and the pack. do not store above 25. keep the vial and ampoule in the outer carton. after reconstitution, immediate use is recommended. however, the in-use stability has been demonstrated for 24 hours between 2 and 8 (in a refrigerator). do not use revasc if you notice that the solution for injection contains visible particles. medicines should not be disposed of via wastewater or household waste. ask you pharmacist how to dispose of medicines no longer required. these measures will help to protect the environment.', 'Entity_Recognition': [{'Text': 'revasc', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'revasc', 'Type': 'TREATMENT', 'BeginOffset': 56, 'EndOffset': 62}, {'Text': '25.', 'Type': 'NUMBER', 'BeginOffset': 148, 'EndOffset': 151}, {'Text': 'the vial and ampoule in the outer carton', 'Type': 'TREATMENT', 'BeginOffset': 157, 'EndOffset': 197}, {'Text': 'reconstitution', 'Type': 'TREATMENT', 'BeginOffset': 205, 'EndOffset': 219}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 307, 'EndOffset': 309}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 324, 'EndOffset': 325}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 330, 'EndOffset': 331}, {'Text': 'revasc', 'Type': 'TREATMENT', 'BeginOffset': 364, 'EndOffset': 370}, {'Text': 'the solution', 'Type': 'TREATMENT', 'BeginOffset': 390, 'EndOffset': 402}, {'Text': 'visible particles', 'Type': 'PROBLEM', 'BeginOffset': 426, 'EndOffset': 443}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 445, 'EndOffset': 454}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 553, 'EndOffset': 562}, {'Text': 'these measures', 'Type': 'TREATMENT', 'BeginOffset': 583, 'EndOffset': 597}]}
{'Title': '6. further information', 'Section_Content': "what revasc contains the active substance is desirudin (15mg/0.5ml powder). the other ingredients in the powder are magnesium chloride and sodium hydroxide. in the solvent the ingredients are mannitol and water. important information about some of the ingredients of revasc this medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i.e. essentially 'sodium- free'. what revasc looks like and contents of the pack revasc consists of a vial containing a white powder and an ampoule containing clear, colourless solvent for solution for injection. pack sizes: 1 vial and 1 ampoule in one package 2 vials and 2 ampoules in one package 10 vials and 10 ampoules in one package not all pack sizes may be marketed.", 'Entity_Recognition': [{'Text': 'revasc', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 45, 'EndOffset': 54, 'Score': 0.8350748419761658, 'Text': 'desirudin', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 'Score': 0.8498375415802002, 'RelationshipScore': 0.9998290538787842, 'RelationshipType': 'STRENGTH', 'Id': 1, 'BeginOffset': 56, 'EndOffset': 66, 'Text': '15mg/0.5ml', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.9699887037277222, 'RelationshipScore': 0.9999798536300659, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 67, 'EndOffset': 73, 'Text': 'powder', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.6786152124404907, 'RelationshipScore': 0.9907982349395752, 'RelationshipType': 'FORM', 'Id': 3, 'BeginOffset': 105, 'EndOffset': 111, 'Text': 'powder', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'the powder', 'Type': 'TREATMENT', 'BeginOffset': 101, 'EndOffset': 111}, {'Id': 4, 'BeginOffset': 116, 'EndOffset': 134, 'Score': 0.9997313618659973, 'Text': 'magnesium chloride', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.6786152124404907, 'RelationshipScore': 0.9035685062408447, 'RelationshipType': 'FORM', 'Id': 3, 'BeginOffset': 105, 'EndOffset': 111, 'Text': 'powder', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 5, 'BeginOffset': 139, 'EndOffset': 155, 'Score': 0.9991148114204407, 'Text': 'sodium hydroxide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.6786152124404907, 'RelationshipScore': 0.9462240934371948, 'RelationshipType': 'FORM', 'Id': 3, 'BeginOffset': 105, 'EndOffset': 111, 'Text': 'powder', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 6, 'BeginOffset': 192, 'EndOffset': 200, 'Score': 0.8091871738433838, 'Text': 'mannitol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.6786152124404907, 'RelationshipScore': 0.5909895300865173, 'RelationshipType': 'FORM', 'Id': 3, 'BeginOffset': 105, 'EndOffset': 111, 'Text': 'powder', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'revasc this medicinal product', 'Type': 'TREATMENT', 'BeginOffset': 267, 'EndOffset': 296}, {'Id': 8, 'BeginOffset': 316, 'EndOffset': 329, 'Score': 0.31584709882736206, 'Text': '1 mmol sodium', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 'Score': 0.5543382167816162, 'RelationshipScore': 0.9998076558113098, 'RelationshipType': 'STRENGTH', 'Id': 9, 'BeginOffset': 331, 'EndOffset': 336, 'Text': '23 mg', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9155011773109436, 'RelationshipScore': 0.999985933303833, 'RelationshipType': 'DOSAGE', 'Id': 10, 'BeginOffset': 342, 'EndOffset': 348, 'Text': '0.5 ml', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '0.5', 'Type': 'NUMBER', 'BeginOffset': 342, 'EndOffset': 345}, {'Id': 11, 'BeginOffset': 368, 'EndOffset': 381, 'Score': 0.46047016978263855, 'Text': "sodium- free'", 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'the pack revasc', 'Type': 'TREATMENT', 'BeginOffset': 422, 'EndOffset': 437}, {'Text': 'a vial', 'Type': 'TREATMENT', 'BeginOffset': 450, 'EndOffset': 456}, {'Text': 'a white powder', 'Type': 'TREATMENT', 'BeginOffset': 468, 'EndOffset': 482}, {'Text': 'an ampoule', 'Type': 'TREATMENT', 'BeginOffset': 487, 'EndOffset': 497}, {'Text': 'injection', 'Type': 'TREATMENT', 'BeginOffset': 552, 'EndOffset': 561}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 575, 'EndOffset': 576}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 586, 'EndOffset': 587}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 611, 'EndOffset': 612}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 623, 'EndOffset': 624}, {'Text': '10', 'Type': 'NUMBER', 'BeginOffset': 649, 'EndOffset': 651}, {'Text': '10', 'Type': 'NUMBER', 'BeginOffset': 662, 'EndOffset': 664}]}