VPRIV Powder for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
VPRIV 400 Units powder for solution for infusion.
Qualitative and quantitative composition
One vial contains 400 Units* of velaglucerase alfa**. After reconstitution, one ml of the solution contains 100 Units of velaglucerase alfa. * An enzyme unit is defined as the amount of enzyme that is ...
Pharmaceutical form
Powder for solution for infusion. White to off-white powder.
Therapeutic indications
VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.
Posology and method of administration
VPRIV treatment should be supervised by a physician experienced in the management of patients with Gaucher disease. Posology The recommended dose is 60 Units/kg administered every other week. Dose adjustments ...
Contraindications
Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Hypersensitivity Hypersensitivity reactions, including symptoms consistent with anaphylaxis, have been reported in patients in clinical studies and in post-marketing experience. The majority of hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Women of childbearing potential Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium. A risk-benefit assessment ...
Effects on ability to drive and use machines
VPRIV has no or negligible influence on the ability to drive or use machines.
Undesirable effects
Summary of the safety profile The data described below reflect exposure of 94 patients with type 1 Gaucher disease who received velaglucerase alfa at doses ranging from 15 to 60 Units/kg every other week ...
Overdose
There is no experience with overdose of velaglucerase alfa. The maximum dose of velaglucerase alfa in clinical studies was 60 Units/kg. See section 4.4.
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products – enzymes ATC code: A16AB10 Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results ...
Pharmacokinetic properties
There were no apparent pharmacokinetic differences between male and female patients with type 1 Gaucher disease. None of the subjects in the pharmacokinetic studies were positive for anti-velaglucerase ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and toxicity to reproduction and development.
List of excipients
Sucrose Sodium citrate dihydrate (E331) Citric acid monohydrate (E330) Polysorbate 20
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years. Reconstituted and diluted solution for infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C under protection from light. From a microbiological ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see ...
Nature and contents of container
20 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal, and flip-off cap. Pack sizes of 1, 5 and 25 vials. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
VPRIV requires reconstitution and dilution, and is intended for intravenous infusion only. It is for single-use only and is administered through a 0.22 µm filter. Aseptic technique must be used. Prepare ...
Marketing authorization holder
Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, Ireland
Marketing authorization number(s)
EU/1/10/646/002 EU/1/10/646/005 EU/1/10/646/006
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 August 2010 Date of latest renewal: 19 June 2015
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