Parsabiv
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Parsabiv 2.5 mg solution for injection 
Parsabiv 5 mg solution for injection 
Parsabiv 10 mg solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Parsabiv 2.5 mg solution for injection 
 
Each vial contains 2.5 mg of etelcalcetide (as hydrochloride) in 0.5 mL of solution. 
Each mL contains 5 mg etelcalcetide. 
 
Parsabiv 5 mg solution for injection 
 
Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of solution. 
Each mL contains 5 mg etelcalcetide. 
 
Parsabiv 10 mg solution for injection 
 
Each vial contains 10 mg of etelcalcetide (as hydrochloride) in 2 mL of solution. 
Each mL contains 5 mg etelcalcetide. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
 
Clear colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with 
chronic kidney disease (CKD) on haemodialysis therapy. 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended initial dose of etelcalcetide is 5 mg administered by bolus injection 3 times per 
week. Corrected serum calcium should be at or above the lower limit of the normal range prior to 
administration of first dose of Parsabiv, a dose increase, or reinitiation after a dose stop (see also dose 
adjustments based on serum calcium levels). Parsabiv should not be administered more frequently than 
3 times per week. 
 



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Dose titration 
 
Parsabiv should be titrated so that doses are individualised between 2.5 mg and 15 mg. The dose may 
be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks to a maximum dose 
of 15 mg 3 times per week to achieve the desired parathyroid hormone (PTH) target. 
 
Dose adjustments based on PTH levels 
 
PTH should be measured after 4 weeks from initiation or dose adjustment of Parsabiv, and 
approximately every 1-3 months during maintenance. Dose adjustment may be necessary at any time 
during treatment including the maintenance phase. 
 
If PTH is below 100 pg/mL (10.6 pmol/L), the dose should be reduced or temporarily stopped. If PTH 
does not return to > 100 pg/mL following dose reduction, the dose should be stopped. For patients in 
whom the dose is stopped, Parsabiv should be reinitiated at a lower dose once PTH returns to 
> 150 pg/mL (15.9 pmol/L) and pre-dialysis serum corrected calcium (cCa) ≥ 8.3 mg/dL 
(2.08 mmol/L). If the patient’s last administered dose was 2.5 mg, Parsabiv may be reinitiated at the 
2.5 mg dose level if PTH is > 300 pg/mL (31.8 pmol/L), and the most recent pre-dialysis serum cCa 
≥ 8.3 mg/dL (2.08 mmol/L). 
 
Additional recommendations related to the management of low calcium are provided in the table 
below. 
 
Parsabiv may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D 
sterols, as appropriate (see section 5.1). 
 
Missed doses 
 
If a regularly scheduled haemodialysis treatment is missed, do not administer any missed doses. 
Parsabiv should be administered at the next haemodialysis treatment at the same dose. If doses are 
missed for more than 2 weeks, then Parsabiv should be administered at 5 mg, (or 2.5 mg if that was 
the patient’s last administered dose), and titrated to achieve the desired PTH. 
 
Dose adjustments based on serum calcium levels 
 
Serum calcium should be measured within 1 week of initiation or dose adjustment of Parsabiv. Once 
the maintenance phase has been established for a patient, corrected serum calcium should be measured 
approximately every 4 weeks. In the studies total serum calcium was measured using Roche modular 
analysers. The lower limit of the normal range for corrected serum calcium was 8.3 mg/dL 
(2.08 mmol/L). Other laboratory assays may have different cut-offs for the lower limit of the normal 
range. 
 
In the event that clinically meaningful decreases in corrected serum calcium levels below the lower 
limit of the normal range occur and/or symptoms of hypocalcaemia occur, the following management 
is recommended: 
 

Corrected serum calcium 
value or clinical symptoms of 
hypocalcaemia*:  

Recommendations 

< 8.3 mg/dL (2.08 mmol/L) and 
≥ 7.5 mg/dL (1.88 mmol/L)  

 If clinically indicated: 
- start or increase calcium supplements, calcium-

containing phosphate binders, and/or vitamin D 
sterols. 

- increase dialysate calcium concentration. 
- consider reducing Parsabiv dose. 



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Corrected serum calcium 
value or clinical symptoms of 
hypocalcaemia*:  

Recommendations 

< 7.5 mg/dL (1.88 mmol/L) or 
symptoms of hypocalcaemia  

 Stop Parsabiv until corrected serum calcium levels are 
≥ 8.3 mg/dL (2.08mmol/L) and symptoms of 
hypocalcaemia (if present) have resolved. 

 If clinically indicated: 
- start or increase calcium supplements, calcium-

containing phosphate binders, and/or vitamin D 
sterols. 

- increase dialysate calcium concentration. 
 Reinitiate Parsabiv at a dose 5 mg lower than the last 

administered dose. If patient’s last administered dose was 
2.5 mg or 5 mg, reinitiate at 2.5 mg once corrected serum 
calcium levels are ≥ 8.3 mg/dL (2.08 mmol/L) and 
symptoms of hypocalcaemia (if present) have resolved.

* Total calcium was measured using Roche modular analyser. For albumin levels < 4.0 g/dL cCa (mg/dL) = 
Total Ca (mg/dL) + (4 - albumin[g/dL])*0.8. 
 
Switch from cinacalcet to Parsabiv 
 
Parsabiv should not be initiated in patients until 7 days after the last dose of cinacalcet and the 
corrected serum calcium is at or above the lower limit of the normal range (see section 5.1). 
 
Paediatric population 
 
The safety and efficacy of etelcalcetide in children and adolescents less than 18 years has not yet been 
established. No data are available. 
 
Elderly 
 
Dosing recommendations for elderly patients are the same as for adult patients. 
 
Method of administration 
 
Parsabiv should not be diluted. 
 
Parenteral medicinal products should be inspected visually for particulate matter and change in colour 
prior to administration. 
 
Parsabiv is administered into the venous line of the dialysis circuit at the end of the haemodialysis 
treatment during rinse-back or intravenously after rinse-back. When given during rinse-back at least 
150 mL of rinse-back volume should be administered after injection. If rinse-back is completed and 
Parsabiv was not administered, then it may be administered intravenously followed by at least 10 mL 
saline flush volume. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Parsabiv should not be initiated if corrected serum calcium is less than the lower limit of the normal 
range (see sections 4.2 and 4.4). 
 



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4.4 Special warnings and precautions for use 
 
Hypocalcaemia 
 
Parsabiv treatment should not be initiated in patients if the corrected serum calcium is less than the 
lower limit of the normal range (see section 4.3). 
 
Potential manifestations of hypocalcaemia include paraesthesias, myalgias, muscle spasm and 
seizures. 
 
Since etelcalcetide lowers serum calcium, patients should be advised to seek medical attention if they 
experience symptoms of hypocalcaemia and should be monitored for the occurrence of hypocalcaemia 
(see section 4.2). Serum calcium levels should be measured prior to initiating treatment, within 1 week 
of initiation or dose adjustment of Parsabiv and every 4 weeks during treatment. If clinically 
meaningful decreases in corrected serum calcium levels occur, steps should be taken to increase serum 
calcium levels (see section 4.2). 
 
Ventricular arrhythmia and QT prolongation secondary to hypocalcaemia 
 
Decreases in serum calcium can prolong the QT interval, potentially resulting in ventricular 
arrhythmia (see section 4.8). Serum calcium levels should be closely monitored in patients with 
congenital long QT syndrome, previous history of QT prolongation, family history of long QT 
syndrome or sudden cardiac death and other conditions that predispose to QT prolongation and 
ventricular arrhythmia while being treated with Parsabiv. 
 
Convulsions 
 
Cases of seizures have been reported in patients treated with Parsabiv (see section 4.8). The threshold 
for seizures may be lowered by significant reductions in serum calcium levels. Serum calcium levels 
should be closely monitored in patients with a history of a convulsion disorder while being treated 
with Parsabiv. 
 
Worsening heart failure 
 
Decreased myocardial performance, hypotension, and congestive heart failure (CHF) may be 
associated with significant reductions in serum calcium levels. Serum calcium levels should be 
monitored in patients with a history of congestive heart failure while being treated with Parsabiv (see 
section 4.2), which may be associated with reductions in serum calcium levels. 
 
Co-administration with other medicinal products 
 
Administer Parsabiv with caution in patients receiving any other medicinal products known to lower 
serum calcium. Closely monitor serum calcium (see section 4.5). 
 
Patients receiving Parsabiv should not be given cinacalcet. Concurrent administration may result in 
severe hypocalcaemia. 
 
Adynamic bone 
 
Adynamic bone may develop if PTH levels are chronically suppressed below 100 pg/mL. If PTH 
levels decrease below the recommended target range, the dose of vitamin D sterols and/or Parsabiv 
should be reduced or therapy discontinued. After discontinuation, therapy can be resumed at a lower 
dose to maintain PTH in the target range (see section 4.2). 
 



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Immunogenicity 
 
In clinical studies, 7.1% of patients with SHPT treated with Parsabiv for up to 6 months tested positive 
for binding antibodies. 80.3% of these had pre-existing antibodies. No evidence of altered 
pharmacokinetic profile, clinical response or safety profile was associated with pre-existing or 
developing anti-etelcalcetide antibodies. If formation of anti-etelcalcetide antibodies with a clinically 
significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing. 
Contact details are provided in section 6 of the package leaflet. 
 
Excipient with known effect 
 
Parsabiv contains less than 1 mmol sodium per vial, that is to say essentially sodium-free. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. There is no known risk of pharmacokinetic interaction 
with etelcalcetide. 
 
In vitro, etelcalcetide did not inhibit or induce CYP450 enzymes and was itself not a substrate for 
metabolism by CYP450 enzymes. In vitro, etelcalcetide was not a substrate of efflux and uptake 
transporter proteins; and etelcalcetide was not an inhibitor of common transporter proteins. 
 
Concurrent administration of other medicinal products known to reduce serum calcium and Parsabiv 
may result in an increased risk of hypocalcaemia (see section 4.4). Patients receiving Parsabiv should 
not be given cinacalcet (see section 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of etelcalcetide in pregnant women. Animal 
studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see 
section 5.3). As a precautionary measure, it is preferable to avoid the use of Parsabiv during 
pregnancy. 
 
Breast-feeding 
 
It is unknown whether etelcalcetide is present in human milk. Available data in rats have shown that 
etelcalcetide is excreted in milk (see section 5.3). 
 
A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to 
discontinue breast-feeding or discontinue/abstain from Parsabiv therapy taking into account the benefit 
of breast-feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
No data are available on the effect of etelcalcetide on human fertility. Animal studies do not indicate 
direct or indirect harmful effects with respect to fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Parsabiv has no or negligible influence on the ability to drive and use machines. However, certain 
potential manifestations of hypocalcaemia may affect the ability to drive and use machines (see 
section 4.4). 
 



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4.8 Undesirable effects 
 
Summary of safety profile 
 
Very common side effects with Parsabiv are blood calcium decreased, muscle spasms, diarrhoea, 
nausea, and vomiting. They were mild to moderate in severity and transient in nature in the majority of 
patients. Discontinuation of therapy as a result of undesirable effects was mainly due to low blood 
calcium, nausea, and vomiting. 
 
Tabulated list of adverse reactions 
 
Adverse reactions are listed below using the following convention: very common (≥ 1/10); common 
(≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare 
(< 1/10,000); not known (cannot be estimated from the available data). 
 
Table 1. Adverse reactions from controlled clinical studies and post-marketing experience 
 

MedDRA system organ class 
(SOC) 

Frequency category Adverse reactions 

Immune system disorders 
 

Not known Hypersensitivity reactions1 
(including anaphylaxis) 

Metabolism and nutrition disorders Very common Blood calcium decreased1, 4 
Common 
 

Hypocalcaemia1, 5 
Hyperkalaemia2 
Hypophosphataemia 

Nervous system disorders  Common  Headache 
Paraesthesia3 

Uncommon Convulsions6 
Cardiac disorders  Common  Worsening heart failure1 

QT prolongation1 
Vascular disorders Common Hypotension 
Gastrointestinal disorders Very common  Nausea 

Vomiting 
Diarrhoea

Musculoskeletal and connective 
tissue disorders 

Very common Muscle spasms 
Common Myalgia

1 See section on description of selected adverse reactions. 
2 Hyperkalaemia includes preferred terms of hyperkalaemia and blood potassium increased. 
3 Paraesthesia includes preferred terms of paraesthesia and hypoaesthesia. 
4 Asymptomatic reductions in calcium below 7.5 mg/dL (1.88 mmol/L) or clinically significant asymptomatic 
reductions in serum cCa between 7.5 and < 8.3 mg/dL (1.88 and < 2.08 mmol/L) (that required medical 
management). 
5 Symptomatic reductions in serum cCa < 8.3 mg/dL (2.08 mmol/L). 
6 See section 4.4. 
 
Description of selected adverse reactions 
 
Hypocalcaemia 
 
Most events of asymptomatic blood calcium decreased and symptomatic hypocalcaemia were mild or 
moderate in severity. In the combined placebo-controlled studies, a higher proportion of patients in the 
Parsabiv group compared with patients in the placebo group developed at least one serum cCa value 
< 7.0 mg/dL (1.75 mmol/L) (7.6% Parsabiv; 3.1% placebo), < 7.5 mg/dL (1.88 mmol/L) (27.1% 
Parsabiv; 5.5% placebo), and < 8.3 mg/dL (2.08 mmol/L) (78.6% Parsabiv; 19.4% placebo). In these 
studies 1% of patients in the Parsabiv group and 0% of patients in the placebo group discontinued 
treatment due to the adverse event of low serum calcium. For further information regarding potential 



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manifestations of hypocalcaemia and serum calcium monitoring please see sections 4.4 and 4.2 
respectively. 
 
QTc prolongation secondary to hypocalcaemia 
 
In the combined placebo-controlled studies, a higher percentage of patients in the Parsabiv group 
compared with the placebo group had a maximum increase from baseline of > 60 msec in the QTcF 
interval (1.2% Parsabiv; 0% placebo). The patient incidence of maximum post-baseline pre-dialysis 
QTcF > 500 msec in the Parsabiv and placebo groups was 4.8% and 1.9%, respectively. 
 
Worsening heart failure 
 
In the combined placebo-controlled studies, the subject incidence of adjudicated CHF events requiring 
hospitalisation was 2.2% in the Parsabiv treatment group compared to 1.2% in the placebo group. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Overdose of etelcalcetide may lead to hypocalcaemia with or without clinical symptoms and may 
require treatment. In the event of overdose, serum calcium should be checked and patients should be 
monitored for symptoms of hypocalcaemia (see section 4.4) and appropriate measures should be taken 
(see section 4.2). Although Parsabiv is cleared by dialysis, haemodialysis has not been studied as a 
treatment for overdose. Single doses up to 60 mg and multiple doses up to 22.5 mg 3 times a week at 
the end of dialysis in patients receiving haemodialysis were safely administered in clinical trials. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents. ATC code: H05BX04 
 
Mechanism of action 
 
The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal 
regulator of PTH secretion. Etelcalcetide is a synthetic peptide calcimimetic agent which reduces PTH 
secretion through binding and activation of the calcium-sensing receptor. The reduction in PTH is 
associated with a concomitant decrease in serum calcium and phosphate levels. 
 
Pharmacodynamic effects 
 
Following a single intravenous bolus administration of 5 mg etelcalcetide, PTH levels decreased 
rapidly within 30 minutes post-dose and were maximally decreased for 1 hour, before returning to 
baseline. The extent and duration of the reduction in PTH increased with increasing dose. Reduction in 
PTH levels correlated with plasma etelcalcetide concentrations in haemodialysis patients. The effect of 
reducing PTH levels was maintained throughout the 6-month dosing period when etelcalcetide was 
administered by intravenous bolus 3 times a week. 
 



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Clinical efficacy and safety 
 
Placebo-controlled studies 
 
Two 6-month, double-blind, placebo-controlled clinical studies were conducted in SHPT patients with 
CKD receiving haemodialysis 3 times per week (n = 1,023). Patients were administered Parsabiv or 
placebo at a starting dose of 5 mg 3 times per week at the end of haemodialysis and titrated every 
4 weeks through week 17 to a maximum dose of 15 mg 3 times per week to achieve target PTH level 
≤ 300 pg/mL. The median average weekly dose of Parsabiv during the efficacy assessment period 
(EAP) was 20.4 mg (6.8 mg per administration). Patients with lower screening PTH levels typically 
required lower doses (median average weekly doses of 15.0 mg, 21.4 mg, 27.1 mg, respectively, for 
patients with screening PTH levels < 600 pg/mL, 600 to ≤ 1,000 pg/mL, and > 1,000 pg/mL). Patients 
were maintained on dialysate calcium concentration ≥ 2.25 meq/L. 
 
The primary endpoint in each study was the proportion of patients with > 30% reduction from baseline 
in PTH during the EAP (EAP, defined as weeks 20 to 27 inclusive). The secondary endpoints were the 
proportion of patients with a mean PTH ≤ 300 pg/mL during the EAP, and percent change from 
baseline during the EAP for PTH, serum cCa, phosphate and calcium phosphate product (Ca x P). 
 
Demographic and baseline characteristics between the two groups in each study were similar. The 
mean age of patients across the 2 studies was 58.2 (range 21 to 93) years. Mean (SE) baseline PTH 
concentrations across the 2 studies were 846.9 (21.8) pg/mL, and 835.9 (21.0) pg/mL for the Parsabiv 
and placebo groups, respectively with approximately 21% of subjects enrolling across both studies 
having baseline PTH > 1,000 pg/mL. The average duration of haemodialysis prior to study entry was 
5.4 years and 68% of patients were receiving vitamin D sterols at study entry, with 83% receiving 
phosphate binders. 
 
Both studies demonstrated that Parsabiv reduced PTH, while lowering calcium, phosphate and Ca x P. 
Results of all primary and secondary endpoints were statistically significant and the results were 
consistent across both studies as shown in table 2. 
 
Table 2. Effects of Parsabiv on PTH, corrected serum calcium, phosphate and Ca x P in 6 month 
placebo-controlled studies 
 

 Study 1 Study 2 
 Parsabiv 

(N = 254) 
Placebo 

(N = 254) 
Parsabiv 
(N = 255) 

Placebo 
(N = 260) 

PTH     
Patients with > 30% reduction in PTH during 
the EAP, n (%) 188 (74.0)

a 21 (8.3) 192 (75.3)a 25 (9.6) 

Patients with ≤ 300 pg/mL in PTH during the 
EAP, n (%) 126 (49.6)

a 13 (5.1) 136 (53.3)a 12 (4.6) 

Mean percent change during the EAP, % 
(SE) -55.11 (1.94)

a 13.00 (2.81) -57.39 (1.91)a 13.72 (2.50) 

Corrected serum calcium     
Mean percent change during the EAP, % 
(SE) -7.29 (0.53)

a 1.18 (0.29) -6.69 (0.55)a 0.58 (0.29) 

Phosphate     
Mean percent change during the EAP, % 
(SE) -7.71 (2.16)

b -1.31 (1.42) -9.63 (1.61)a -1.60 (1.42) 

Ca x P     
Mean percent change during the EAP, % 
(SE) -14.34 (2.06)

a -0.19 (1.44) -15.84 (1.57)a -1.06 (1.42) 
a p < 0.001 versus placebo 
b p = 0.003 versus placebo 
 
Parsabiv decreased PTH regardless of baseline PTH, duration of dialysis, and whether or not patients 
were receiving vitamin D sterols. Patients with lower screening PTH levels were more likely to reach 
PTH ≤ 300 pg/mL during EAP. 



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Parsabiv was associated with reductions in bone metabolism markers (bone specific alkaline 
phosphatase and type I collagen c-telopeptide) and fibroblast growth factor 23 (exploratory endpoints) 
at the end of the study (week 27), compared with placebo. 
 
Active-controlled study 
 
A 6-month, double-blind, active-controlled study compared the efficacy and safety of Parsabiv with 
cinacalcet in 683 SHPT patients with CKD on haemodialysis. The dosing regimen for Parsabiv was 
similar to that in the placebo-controlled studies (starting dose of 5 mg titrated every 4 weeks with 
2.5 mg to 5 mg increments to a maximum of 15 mg 3 times a week). The starting dose of cinacalcet 
was 30 mg daily, titrated every 4 weeks in 30 mg increments or 60 mg for the last uptitration to a 
maximum dose of 180 mg daily following the cinacalcet prescribing information. The median average 
weekly dose of Parsabiv during the EAP was 15.0 mg (5.0 mg per administration) and of cinacalcet 
was 360.0 mg (51.4 mg per administration). The primary endpoint was non-inferiority for the 
proportion of patients who achieved > 30% reduction from baseline in mean PTH during the EAP 
(weeks 20 to 27). Key secondary endpoints were the proportion of patients who achieved > 50% and 
> 30% reductions from baseline in mean PTH during the EAP and the mean number of days of 
vomiting or nausea per week in the first 8 weeks, sequentially tested for superiority. Mean (SE) 
baseline PTH concentrations were 1,092.12 (33.8) and 1,138.71 (38.2) pg/mL for the Parsabiv and 
cinacalcet groups respectively. Demographics and other baseline characteristics were similar to the 
placebo-controlled studies. 
 
Parsabiv was non-inferior to cinacalcet for the primary endpoint, and was superior to cinacalcet for the 
secondary endpoints of proportion of patients achieving > 30% reduction from baseline in mean PTH 
during the EAP (68.2% Parsabiv versus 57.7% cinacalcet; p = 0.004); and proportion of patients 
achieving > 50% reduction from baseline in mean PTH during the EAP (52.4% Parsabiv versus 40.2% 
cinacalcet; p = 0.001). No statistically significant difference between the two groups was observed for 
the secondary endpoint evaluating the mean number of days of vomiting or nausea per week in the 
first 8 weeks. 
 
“Switch study” 
 
Results from a study which evaluated changes in corrected serum calcium levels when switching 
patients from cinacalcet to Parsabiv showed that treatment with Parsabiv, at a starting dose of 5 mg, 
could be safely initiated after a 7-day discontinuation of cinacalcet, provided that the corrected serum 
calcium was ≥ 8.3 mg/dL (2.08 mmol/L). 
 
Open-label extension study 
 
A 52-week, single arm extension study to the placebo-controlled and “switch” studies described above 
was conducted to characterise the long term safety and efficacy of Parsabiv in 891 SHPT patients with 
CKD on haemodialysis. All subjects received Parsabiv at a starting dose of 5 mg 3 times a week. The 
dose of Parsabiv could be titrated at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to 
achieve target PTH levels ≤ 300 pg/mL while maintaining serum cCa concentrations. 
 
At the end of 52 weeks, Parsabiv was not associated with any new safety findings and demonstrated 
maintenance of treatment effect as evidenced by a decrease in pre-dialysis PTH by > 30% from 
baseline in 2/3rd of patients. In addition, Parsabiv decreased pre-dialysis PTH to ≤ 300 pg/mL in more 
than 50% of patients and decreased mean PTH, cCa, cCa x P, and phosphate from baseline. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Parsabiv in one or more subsets of the paediatric population in the treatment of hyperparathyroidism 
(see section 4.2 for information on paediatric use). 
 



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5.2 Pharmacokinetic properties 
 
Distribution 
 
In the population pharmacokinetics model, volume of distribution at steady-state was approximately 
796 L. Etelcalcetide is predominately bound to plasma albumin by reversible covalent binding. Non-
covalent binding of etelcalcetide to plasma proteins is low with a fraction unbound ratio of 0.53. The 
ratio of blood-to-plasma [14C]-etelcalcetide concentrations is approximately 0.6. 
 
Biotransformation 
 
Etelcalcetide is not metabolised by CYP450 enzymes. Etelcalcetide is biotransformed in blood by 
reversible disulphide exchange with endogenous thiols to predominantly form conjugate with serum 
albumin. The plasma exposure of biotransformation products was approximately 5-fold higher than 
that of etelcalcetide and their concentration-time course parallels that of etelcalcetide. The 
predominant biotransformation product (albumin bound) was minimally active in vitro. 
 
Elimination 
 
Intravenous administration 3 times per week at the end of a haemodialysis session resulted in an 
effective half-life of 3 to 5 days. Etelcalcetide is rapidly cleared in subjects with normal renal function, 
whilst in CKD patients requiring haemodialysis, etelcalcetide was predominantly eliminated by 
haemodialysis. Etelcalcetide was efficiently removed with a haemodialysis clearance value of 
7.66 L/hour. Following a single radiolabelled dose of etelcalcetide in CKD patients with secondary 
HPT receiving haemodialysis, approximately 60% of dosed [14C]-etelcalcetide was recovered in 
dialysate and approximately 7% recovered in urine and faeces combined over 175 days of collection 
period. The inter-subject variability of the system clearance in the patient population is approximately 
70%. 
 
Linearity/non-linearity 
 
The pharmacokinetics of etelcalcetide is linear and does not change over time following single (5 to 
60 mg) and multiple intravenous doses (2.5 to 20 mg) in CKD patients with secondary HPT receiving 
haemodialysis. Following 3 times a week intravenous dosing at the end of each 3 to 4 hour 
haemodialysis session in CKD patients, etelcalcetide plasma levels reached near steady-state 4 weeks 
after dosing with an observed accumulation ratio of 2- to 3-fold. 
 
Renal impairment 
 
No specific pharmacokinetic studies of etelcalcetide have been conducted in patients with mild to 
severe kidney impairment. The pharmacokinetics of etelcalcetide was characterised in CKD patients 
receiving haemodialysis. Etelcalcetide is intended for CKD patients receiving haemodialysis. 
 
Hepatic impairment 
 
No specific study in patients with hepatic impairment was performed. 
 
Body weight, gender, age, race 
 
No body weight, gender, age, or race-related pharmacokinetic differences have been observed in adult 
patients studied. 
 
5.3 Preclinical safety data 
 
The expected pharmacological effect of decreased PTH and calcium in blood were observed in animal 
studies at clinical exposure levels. Reductions in serum calcium associated with tremoring, 



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convulsions and stress-related findings were observed at clinical exposure levels. All effects were 
reversible upon cessation of treatment. 
 
Etelcalcetide was mutagenic in some strains of bacteria (Ames), however was not genotoxic in in vitro 
and in vivo mammalian genotoxicity assays and therefore is considered non-genotoxic in humans. In 
mouse and rat carcinogenicity studies, there were no etelcalcetide-related tumours up to exposure of 
0.4-fold clinical exposure levels. 
 
There was no effect on male or female fertility when etelcalcetide was administered to rats at exposure 
levels up to 1.8-fold higher than clinical exposures levels achieved in patients receiving etelcalcetide 
at 15 mg three times per week. 
 
There were no effects on embryo-foetal development in rats and rabbits when exposed to up to 1.8 to 
4.3 times clinical exposure levels during organogenesis. In a pre- and post-natal development study in 
rats there was a minimal increase in perinatal pup mortality, delay in parturition and transient 
reductions in post-natal growth associated with maternal toxicities of hypocalcaemia, tremoring, and 
reductions in body weight and food consumption at 1.8 times clinical exposure levels. 
 
Studies in rats showed [14C]-etelcalcetide was excreted in the milk at concentrations similar to plasma. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Succinic acid 
Water for injections 
Hydrochloric acid (for pH adjustment) 
Sodium hydroxide (for pH adjustment) 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products. 
 
6.3 Shelf life 
 
4 years. 
 
Once removed from the refrigerator: 
 Parsabiv is stable for a maximum of 7 cumulative days if stored in the original carton. No 

special temperature storage requirements are needed. 
 If removed from the original carton Parsabiv is stable for a maximum of 4 hours if protected 

from direct sunlight. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Keep the vial in the outer carton in order to protect from light. 
 
6.5 Nature and contents of container 
 
Parsabiv 2.5 mg solution for injection 
 
Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminium 
seal with flip-off dust cover. Each vial contains 0.5 mL solution for injection. 
 



13 

Parsabiv 5 mg solution for injection 
 
Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminium 
seal with flip-off dust cover. Each vial contains 1 mL solution for injection. 
 
Parsabiv 10 mg solution for injection 
 
Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminium 
seal with flip-off dust cover. Each vial contains 2 mL solution for injection. 
 
Pack sizes of 1, 6, 12 and 42 vials. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
For single use only. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
Parsabiv 2.5 mg solution for injection 
EU/1/16/1142/001 - 1 vial 
EU/1/16/1142/002 - 6 vials 
EU/1/16/1142/003 - 12 vials 
EU/1/16/1142/004 - 42 vials 
Parsabiv 5 mg solution for injection 
EU/1/16/1142/005 - 1 vial 
EU/1/16/1142/006 - 6 vials 
EU/1/16/1142/007 - 12 vials 
EU/1/16/1142/008 - 42 vials 
Parsabiv 10 mg solution for injection 
EU/1/16/1142/009 - 1 vial 
EU/1/16/1142/010 - 6 vials 
EU/1/16/1142/011 - 12 vials 
EU/1/16/1142/012 - 42 vials 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 11 November 2016 
 
 
10. DATE OF REVISION OF THE TEXT 
 
  



14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 



15 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
Netherlands 
 
Amgen NV 
Telecomlaan 5-7 
1831 Diegem 
Belgium 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic safety update reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder shall submit the first periodic safety update report for this 
product within 6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 
 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 
 

  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

A. LABELLING 



18 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Parsabiv 2.5 mg solution for injection 
etelcalcetide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 2.5 mg of etelcalcetide (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 vial (0.5 mL) 
6 vials (0.5 mL) 
12 vials (0.5 mL) 
42 vials (0.5 mL) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous use. 
Single use only 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



19 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Keep in the original 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 
 
Amgen Europe B.V. 
Minervum 7061, 
4817 ZK Breda, 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1142/001 
EU/1/16/1142/002 
EU/1/16/1142/003 
EU/1/16/1142/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 



20 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Parsabiv 2.5 mg solution for injection 
etelcalcetide 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 mL 
 
 
6. OTHER 
 
 
 
 



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Parsabiv 5 mg solution for injection 
etelcalcetide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 5 mg of etelcalcetide (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 vial (1 mL) 
6 vials (1 mL) 
12 vials (1 mL) 
42 vials (1 mL) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous use. 
Single use only 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



22 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Keep in the original 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 
 
Amgen Europe B.V. 
Minervum 7061, 
4817 ZK Breda, 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1142/005 
EU/1/16/1142/006 
EU/1/16/1142/007 
EU/1/16/1142/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
  



23 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Parsabiv 5 mg solution for injection 
etelcalcetide 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 mL 
 
 
6. OTHER 
 
 
 
 



24 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Parsabiv 10 mg solution for injection 
etelcalcetide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 10 mg of etelcalcetide (as hydrochloride). 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, succinic acid, water for injections, hydrochloric acid, sodium hydroxide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection. 
1 vial (2 mL) 
6 vials (2 mL) 
12 vials (2 mL) 
42 vials (2 mL) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous use. 
Single use only 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



25 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Keep in the original 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 
 
Amgen Europe B.V. 
Minervum 7061, 
4817 ZK Breda, 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/16/1142/009 
EU/1/16/1142/010 
EU/1/16/1142/011 
EU/1/16/1142/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 



26 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Parsabiv 10 mg solution for injection 
etelcalcetide 
IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2 mL 
 
 
6. OTHER 
 
 
 
 
  



27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

B. PACKAGE LEAFLET 



28 

Package leaflet: Information for the patient 
 

Parsabiv 2.5 mg solution for injection 
Parsabiv 5 mg solution for injection 

Parsabiv 10 mg solution for injection 
etelcalcetide 

 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or nurse. 
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Parsabiv is and what it is used for 
2. What you need to know before you use Parsabiv 
3. How to use Parsabiv 
4. Possible side effects 
5. How to store Parsabiv 
6. Contents of the pack and other information 
 
 
1. What Parsabiv is and what it is used for 
 
Parsabiv contains the active substance etelcalcetide, which reduces parathyroid hormone known as 
PTH. 
 
Parsabiv is used to treat secondary hyperparathyroidism in patients with serious kidney disease who 
need haemodialysis to clear their blood of waste products. 
 
In secondary hyperparathyroidism too much PTH is produced by the parathyroid glands (four small 
glands in the neck). “Secondary” means that the hyperparathyroidism is caused by another condition, 
e.g. kidney disease. Secondary hyperparathyroidism can cause the loss of calcium from the bones, 
which can lead to bone pain and fractures and problems with blood and heart vessels. By controlling 
the levels of PTH, Parsabiv helps to control calcium and phosphate in your body. 
 
 
2. What you need to know before you use Parsabiv 
 
Do not use Parsabiv if you are allergic to etelcalcetide or any of the other ingredients of this medicine 
(listed in section 6). 
 
Do not use Parsabiv if you have very low levels of calcium in your blood. Your doctor will monitor 
your blood calcium levels. 
 
Warnings and precautions 
Before you are given Parsabiv, tell your doctor if you have or have ever had: 
 heart problems, such as heart failure or arrhythmias (abnormal heart rhythm); 
 seizures (fits or convulsions). 
 



29 

Parsabiv reduces calcium levels. Please tell your doctor if you have spasms, twitches, or cramps in 
your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, 
confusion or loss of consciousness while being treated with Parsabiv. For additional information see 
section 4. 
 
Low calcium levels can cause abnormal heart rhythm. Tell your doctor if you experience an unusually 
fast or pounding heartbeat, if you have heart rhythm problems or heart failure or if you take medicines 
that can cause heart rhythm problems, while receiving Parsabiv. For additional information see 
section 4. 
 
Very low levels of PTH over long periods can result in a type of abnormal bone structure known as 
adynamic bone which can only be diagnosed by biopsy. Your PTH levels will be monitored during 
treatment with Parsabiv and your dose of Parsabiv may be reduced if your PTH levels become very 
low. 
 
Children and adolescents 
It is not known whether Parsabiv is safe and effective in children less than 18 years of age as it has not 
been studied in these patients. 
 
Other medicines and Parsabiv 
Tell your doctor if you are taking, have recently taken or might take any other medicines, including 
those medicines obtained without a prescription, or any other medicines that lower serum calcium. 
 
You should not receive Parsabiv together with cinacalcet. Tell your doctor if you are taking cinacalcet 
or have recently taken cinacalcet. 
 
Pregnancy and breast-feeding 
Parsabiv has not been tested in pregnant women. It is not known whether Parsabiv can harm your 
unborn baby. Tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant 
when taking Parsabiv. You and your doctor should decide if you should use Parsabiv. 
 
It is not known whether Parsabiv can pass into breast milk. Tell your doctor if you are breast-feeding 
or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to 
stop taking Parsabiv, considering the benefit of breast-feeding to the baby and the benefit of Parsabiv 
to the mother. 
 
Driving and using machines 
Parsabiv has no or negligible influence on the ability to drive and use machines. However certain 
symptoms of low calcium levels (such as fits or convulsions) can affect your ability to drive or operate 
machinery. 
 
Important information about some of the ingredients of Parsabiv 
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Parsabiv 
 
The recommended starting dose for Parsabiv is 5 mg. It will be given by a doctor or nurse at the end of 
your haemodialysis treatment through the tube (bloodline) that connects you to the haemodialysis 
machine. Parsabiv will be given 3 times per week. The dose may be increased up to 15 mg or lowered 
down to 2.5 mg depending on your response. 
 
You may need to take calcium and vitamin D supplements while being treated with Parsabiv. Your 
doctor will discuss this with you. 
 
If you have any further questions on the use of this medicine, ask your doctor or nurse. 



30 

 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
If you start to get numbness or tingling around your mouth or in your extremities, muscle aches or 
cramps and seizures (fits), you should tell your doctor immediately. These may be signs that your 
calcium levels are too low (hypocalcaemia). 
 
Very common: may affect more than 1 in 10 people 
 Nausea 
 Vomiting 
 Diarrhoea 
 Muscle spasms 
 Low calcium levels in blood with no symptoms 
 
Common: may affect up to 1 in 10 people 
 Low calcium levels in blood with symptoms such as tingling around the mouth or in the 

extremities, muscle aches or cramps and seizures (fits) 
 High potassium levels in blood 
 Low phosphate levels in blood 
 Headache 
 Numbness or tingling sensation 
 Worsening heart failure 
 Disturbances in the heart’s electrical activity seen as QT prolongation on electrocardiogram 
 Low blood pressure 
 Muscle pain 
 
Uncommon: may affect up to 1 in 100 people 
 Seizures (fits or convulsions); for additional information see section 2 
 
Not known: frequency cannot be estimated from the available data 
 Allergic reactions (including anaphylactic reactions) 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Parsabiv 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date 
refers to the last day of that month. 
 
Store in a refrigerator (2°C – 8°C). 
Keep the vial in the outer carton in order to protect from light. 
 



31 

Once removed from the refrigerator: 
 Parsabiv is stable for a maximum of 7 cumulative days if stored in the original carton. No 

special temperature storage requirements are needed. 
 If removed from the original carton Parsabiv is stable for a maximum of 4 hours if protected 

from direct sunlight. 
 
Do not use this medicine if you notice it has particles or it has changed colour. 
 
For single use only. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Parsabiv contains 
- The active substance is etelcalcetide. 

Parsabiv 2.5 mg solution for injection: Each vial contains 2.5 mg of etelcalcetide in 0.5 mL 
solution (5 mg/mL). 
Parsabiv 5 mg solution for injection: Each vial contains 5 mg of etelcalcetide in 1 mL solution 
(5 mg/mL). 
Parsabiv 10 mg solution for injection: Each vial contains 10 mg of etelcalcetide in 2 mL 
solution (5 mg/mL). 

- The other ingredients are sodium chloride, succinic acid, water for injections, hydrochloric acid, 
and sodium hydroxide. 

 
What Parsabiv looks like and contents of the pack 
Parsabiv is a clear and colourless liquid. 
 
Parsabiv is a solution for injection in a vial. 
 
Pack sizes of 1, 6, 12 and 42 vials. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Marketing Authorisation Holder 
Amgen Europe B.V. 
Minervum 7061 
4817 ZK Breda 
The Netherlands 
 
Manufacturer 
Amgen NV 
Telecomlaan 5-7 
1831 Diegem 
Belgium 
 



32 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
s.a. Amgen n.v. 
Tel/Tél: +32 (0)2 7752711 
 

Lietuva 
Amgen Switzerland AG Vilniaus filialas 
Tel: +370 5 219 7474 

България 
Амджен България ЕООД 
Тел.: +359 (0)2 424 7440 
 

Luxembourg/Luxemburg 
s.a. Amgen 
Belgique/Belgien 
Tel/Tél: +32 (0)2 7752711 

Česká republika 
Amgen s.r.o. 
Tel: +420 221 773 500 
 

Magyarország 
Amgen Kft. 
Tel.: +36 1 35 44 700 

Danmark 
Amgen, filial af Amgen AB, Sverige 
Tlf: +45 39617500 
 

Malta 
Amgen B.V. 
The Netherlands 
Tel: +31 (0)76 5732500 

Deutschland 
AMGEN GmbH 
Tel.: +49 89 1490960 
 

Nederland 
Amgen B.V. 
Tel: +31 (0)76 5732500 

Eesti 
Amgen Switzerland AG Vilniaus filialas 
Tel: +372 586 09553 
 

Norge 
Amgen AB 
Tel: +47 23308000 

Ελλάδα 
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. 
Τηλ.: +30 210 3447000 
 

Österreich 
Amgen GmbH 
Tel: +43 (0)1 50 217 

España 
Amgen S.A. 
Tel: +34 93 600 18 60 
 

Polska 
Amgen Biotechnologia Sp. z o.o. 
Tel.: +48 22 581 3000 

France 
Amgen S.A.S. 
Tél: +33 (0)9 69 363 363 
 

Portugal 
Amgen Biofarmacêutica, Lda. 
Tel: +351 21 4220606 

Hrvatska 
Amgen d.o.o. 
Tel: +385 (0)1 562 57 20 
 

România 
Amgen România SRL 
Tel: +4021 527 3000 

Ireland 
Amgen Ireland Limited 
Tel: +353 1 8527400 
 

Slovenija 
AMGEN zdravila d.o.o. 
Tel: +386 (0)1 585 1767 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
Amgen Slovakia s.r.o. 
Tel: +421 2 321 114 49 



33 

Italia 
Amgen S.r.l. 
Tel: +39 02 6241121 
 

Suomi/Finland 
Amgen AB, sivuliike Suomessa/Amgen AB, filial 
i Finland 
Puh/Tel: +358 (0)9 54900500 

Kύπρος 
C.A. Papaellinas Ltd 
Τηλ.: +357 22741 741 
 

Sverige 
Amgen AB 
Tel: +46 (0)8 6951100 

Latvija 
Amgen Switzerland AG Rīgas filiāle 
Tel: +371 257 25888 
 

United Kingdom 
Amgen Limited 
Tel: +44 (0)1223 420305 

 
This leaflet was last revised in 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what parsabiv is and what it is used for', 'Section_Content': 'parsabiv contains the active substance etelcalcetide, which reduces parathyroid hormone known as pth. parsabiv is used to treat secondary hyperparathyroidism in patients with serious kidney disease who need haemodialysis to clear their blood of waste products. in secondary hyperparathyroidism too much pth is produced by the parathyroid glands (four small glands in the neck). "secondary" means that the hyperparathyroidism is caused by another condition, e.g. kidney disease. secondary hyperparathyroidism can cause the loss of calcium from the bones, which can lead to bone pain and fractures and problems with blood and heart vessels. by controlling the levels of pth, parsabiv helps to control calcium and phosphate in your body.', 'Entity_Recognition': [{'Text': 'parsabiv', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'the active substance etelcalcetide', 'Type': 'TREATMENT', 'BeginOffset': 18, 'EndOffset': 52}, {'Text': 'parathyroid hormone', 'Type': 'PROBLEM', 'BeginOffset': 68, 'EndOffset': 87}, {'Text': 'parsabiv', 'Type': 'TREATMENT', 'BeginOffset': 102, 'EndOffset': 110}, {'Text': 'secondary hyperparathyroidism', 'Type': 'PROBLEM', 'BeginOffset': 128, 'EndOffset': 157}, {'Text': 'serious kidney disease', 'Type': 'PROBLEM', 'BeginOffset': 175, 'EndOffset': 197}, {'Id': 21, 'BeginOffset': 207, 'EndOffset': 220, 'Score': 0.5830560326576233, 'Text': 'haemodialysis', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Text': 'waste products', 'Type': 'TREATMENT', 'BeginOffset': 245, 'EndOffset': 259}, {'Text': 'secondary hyperparathyroidism', 'Type': 'PROBLEM', 'BeginOffset': 264, 'EndOffset': 293}, {'Id': 1, 'BeginOffset': 326, 'EndOffset': 344, 'Score': 0.9364908933639526, 'Text': 'parathyroid glands', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 2, 'BeginOffset': 351, 'EndOffset': 363, 'Score': 0.6701446175575256, 'Text': 'small glands', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 3, 'BeginOffset': 371, 'EndOffset': 375, 'Score': 0.9861472249031067, 'Text': 'neck', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'the hyperparathyroidism', 'Type': 'PROBLEM', 'BeginOffset': 401, 'EndOffset': 424}, {'Id': 15, 'BeginOffset': 462, 'EndOffset': 476, 'Score': 0.8883463144302368, 'Text': 'kidney disease', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9563911557197571}]}, {'Id': 16, 'BeginOffset': 478, 'EndOffset': 507, 'Score': 0.3504442274570465, 'Text': 'secondary hyperparathyroidism', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9589735865592957}]}, {'Text': 'the loss of calcium from the bones', 'Type': 'PROBLEM', 'BeginOffset': 518, 'EndOffset': 552}, {'Id': 18, 'BeginOffset': 572, 'EndOffset': 581, 'Score': 0.8799144625663757, 'Text': 'bone pain', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.7764319181442261}]}, {'Id': 19, 'BeginOffset': 586, 'EndOffset': 595, 'Score': 0.9887639284133911, 'Text': 'fractures', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9430336952209473}]}, {'Id': 20, 'BeginOffset': 600, 'EndOffset': 637, 'Score': 0.3353033661842346, 'Text': 'problems with blood and heart vessels', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SIGN', 'Score': 0.4056284725666046}]}, {'Id': 7, 'BeginOffset': 624, 'EndOffset': 629, 'Score': 0.5321111083030701, 'Text': 'heart', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'pth', 'Type': 'TREATMENT', 'BeginOffset': 668, 'EndOffset': 671}, {'Text': 'parsabiv', 'Type': 'TREATMENT', 'BeginOffset': 673, 'EndOffset': 681}, {'Text': 'calcium and phosphate', 'Type': 'TREATMENT', 'BeginOffset': 699, 'EndOffset': 720}, {'Id': 8, 'BeginOffset': 729, 'EndOffset': 733, 'Score': 0.7559342384338379, 'Text': 'body', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}]}
{'Title': '2. what you need to know before you use parsabiv', 'Section_Content': "do not use parsabiv if you are allergic to etelcalcetide or any of the other ingredients of this medicine (listed in section 6). do not use parsabiv if you have very low levels of calcium in your blood. your doctor will monitor your blood calcium levels. warnings and precautions before you are given parsabiv, tell your doctor if you have or have ever had: heart problems, such as heart failure or arrhythmias (abnormal heart rhythm); seizures (fits or convulsions). parsabiv reduces calcium levels. please tell your doctor if you have spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, confusion or loss of consciousness while being treated with parsabiv. for additional information see section 4. low calcium levels can cause abnormal heart rhythm. tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems or heart failure or if you take medicines that can cause heart rhythm problems, while receiving parsabiv. for additional information see section 4. very low levels of pth over long periods can result in a type of abnormal bone structure known as adynamic bone which can only be diagnosed by biopsy. your pth levels will be monitored during treatment with parsabiv and your dose of parsabiv may be reduced if your pth levels become very low. children and adolescents it is not known whether parsabiv is safe and effective in children less than 18 years of age as it has not been studied in these patients. other medicines and parsabiv tell your doctor if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription, or any other medicines that lower serum calcium. you should not receive parsabiv together with cinacalcet. tell your doctor if you are taking cinacalcet or have recently taken cinacalcet. pregnancy and breast-feeding parsabiv has not been tested in pregnant women. it is not known whether parsabiv can harm your unborn baby. tell your doctor if you are pregnant, think you may be pregnant, or plan to get pregnant when taking parsabiv. you and your doctor should decide if you should use parsabiv. it is not known whether parsabiv can pass into breast milk. tell your doctor if you are breast-feeding or plan to do so. your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking parsabiv, considering the benefit of breast-feeding to the baby and the benefit of parsabiv to the mother. driving and using machines parsabiv has no or negligible influence on the ability to drive and use machines. however certain symptoms of low calcium levels (such as fits or convulsions) can affect your ability to drive or operate machinery. important information about some of the ingredients of parsabiv this medicine contains less than 1 mmol sodium (23 mg) per 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{'Title': '3. how to use parsabiv', 'Section_Content': 'the recommended starting dose for parsabiv is 5 mg. it will be given by a doctor or nurse at the end of your haemodialysis treatment through the tube (bloodline) that connects you to the haemodialysis machine. parsabiv will be given 3 times per week. the dose may be increased up to 15 mg or lowered down to 2.5 mg depending on your response. you may need to take calcium and vitamin d supplements while being treated with parsabiv. your doctor will discuss this with you. if you have any further questions on the use of this medicine, ask your doctor or nurse.', 'Entity_Recognition': [{'Text': 'parsabiv', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 34, 'EndOffset': 42, 'Score': 0.6662748456001282, 'Text': 'parsabiv', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9136059880256653, 'RelationshipScore': 0.9993290901184082, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 46, 'EndOffset': 51, 'Text': '5 mg.', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '5', 'Type': 'NUMBER', 'BeginOffset': 46, 'EndOffset': 47}, {'Text': 'your haemodialysis treatment', 'Type': 'TREATMENT', 'BeginOffset': 104, 'EndOffset': 132}, {'Text': 'the tube (bloodline)', 'Type': 'TREATMENT', 'BeginOffset': 141, 'EndOffset': 161}, {'Text': 'the haemodialysis machine', 'Type': 'TREATMENT', 'BeginOffset': 183, 'EndOffset': 208}, {'Text': 'parsabiv', 'Type': 'TREATMENT', 'BeginOffset': 210, 'EndOffset': 218}, {'Text': '3', 'Type': 'NUMBER', 'BeginOffset': 233, 'EndOffset': 234}, {'Text': '15', 'Type': 'NUMBER', 'BeginOffset': 283, 'EndOffset': 285}, {'Text': '2.5', 'Type': 'NUMBER', 'BeginOffset': 308, 'EndOffset': 311}, {'Id': 6, 'BeginOffset': 364, 'EndOffset': 371, 'Score': 0.9847114086151123, 'Text': 'calcium', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 7, 'BeginOffset': 376, 'EndOffset': 397, 'Score': 0.9968194961547852, 'Text': 'vitamin d supplements', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 423, 'EndOffset': 431, 'Score': 0.6548522114753723, 'Text': 'parsabiv', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 521, 'EndOffset': 534}]}
{'Title': '4. possible side effects', 'Section_Content': "like all medicines, this medicine can cause side effects, although not everybody gets them. if you start to get numbness or tingling around your mouth or in your extremities, muscle aches or cramps and seizures (fits), you should tell your doctor immediately. these may be signs that your calcium levels are too low (hypocalcaemia). very common: may affect more than 1 in 10 people nausea vomiting diarrhoea muscle spasms low calcium levels in blood with no symptoms common: may affect up to 1 in 10 people low calcium levels in blood with symptoms such as tingling around the mouth or in the extremities, muscle aches or cramps and seizures (fits) high potassium levels in blood low phosphate levels in blood headache numbness or tingling sensation worsening heart failure disturbances in the heart's electrical activity seen as qt prolongation on electrocardiogram low blood pressure muscle pain uncommon: may affect up to 1 in 100 people seizures (fits or convulsions); for additional information see section 2 not known: frequency cannot be estimated from the available data allergic reactions (including anaphylactic reactions) reporting of side effects if you get any side effects, talk to your doctor or nurse. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.", 'Entity_Recognition': [{'Text': 'parsabiv', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 13, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9650274515151978, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 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{'Title': '5. how to store parsabiv', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton after exp. the expiry date refers to the last day of that month. store in a refrigerator (2 8). keep the vial in the outer carton in order to protect from light. once removed from the refrigerator: parsabiv is stable for a maximum of 7 cumulative days if stored in the original carton. no special temperature storage requirements are needed. if removed from the original carton parsabiv is stable for a maximum of 4 hours if protected from direct sunlight. do not use this medicine if you notice it has particles or it has changed colour. for single use only. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': [{'Text': 'parsabiv', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': 'the outer carton', 'Type': 'TREATMENT', 'BeginOffset': 249, 'EndOffset': 265}, {'Text': '7', 'Type': 'NUMBER', 'BeginOffset': 370, 'EndOffset': 371}, {'Text': 'special temperature storage requirements', 'Type': 'PROBLEM', 'BeginOffset': 425, 'EndOffset': 465}, {'Text': '4', 'Type': 'NUMBER', 'BeginOffset': 550, 'EndOffset': 551}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 604, 'EndOffset': 617}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what parsabiv contains - the active substance is etelcalcetide. parsabiv 2.5 mg solution for injection: each vial contains 2.5 mg of etelcalcetide in 0.5 ml solution (5 mg/ml). parsabiv 5 mg solution for injection: each vial contains 5 mg of etelcalcetide in 1 ml solution (5 mg/ml). parsabiv 10 mg solution for injection: each vial contains 10 mg of etelcalcetide in 2 ml solution (5 mg/ml). - the other ingredients are sodium chloride, succinic acid, water for injections, hydrochloric acid, and sodium hydroxide. what parsabiv looks like and contents of the pack parsabiv is a clear and colourless liquid. parsabiv is a solution for injection in a vial. pack sizes of 1, 6, 12 and 42 vials. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'parsabiv', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 49, 'EndOffset': 62, 'Score': 0.9644947052001953, 'Text': 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