PARSABIV Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Parsabiv 2.5 mg solution for injection. Parsabiv 5 mg solution for injection. Parsabiv 10 mg solution for injection.
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 ...
Pharmaceutical form
Solution for injection. Clear colourless solution.
Therapeutic indications
Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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. ...
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, convulsions ...
List of excipients
Sodium chloride Succinic acid Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
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. ...
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.
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 ...
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.
Marketing authorization holder
Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, The Netherlands
Marketing authorization 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 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 November 2016
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