Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50โ58 Baggot Street Lower, Dublin 2, Ireland
VPRIV 400 Units powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. White to off-white powder. |
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 required to convert one micromole of p-nitrophenyl ฮฒ-D-glucopyranoside to p-nitrophenol per minute at 37ยบC.
** produced in an HT-1080 human fibroblast cell line by recombinant DNA technology.
Excipient with known effect: One vial contains 12.15 mg sodium.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Velaglucerase alfa |
Velaglucerase alfa supplements or replaces beta-glucocerebrosidase, the enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide in the lysosome, reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease. Velaglucerase alfa increases haemoglobin concentration and platelet counts and reduces liver and spleen volumes in patients with type 1 Gaucher disease. |
| List of Excipients |
|---|
|
Sucrose |
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.
Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, Ireland
EU/1/10/646/002
EU/1/10/646/005
EU/1/10/646/006
Date of first authorisation: 26 August 2010
Date of latest renewal: 19 June 2015
| Drug | Countries | |
|---|---|---|
| VPRIV | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States |
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