What VPRIV contains
- The active substance is velaglucerase alfa. One vial of VPRIV 200 Units powder contains 200 Units of velaglucerase alfa. One vial of VPRIV 400 Units powder contains 400 Units of velaglucerase alfa. After reconstitution the solution contains 100 Units of velaglucerase alfa per ml.
- The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate, and polysorbate 20.
What VPRIV looks like and contents of the pack
VPRIV is a powder for solution for infusion which comes as a white to off-white powder. VPRIV 200 Units powder is packaged in a 5 ml glass vial, with 1, 5 or 25 vials per carton. VPRIV 400 Units powder is packaged in a 20 ml glass vial, with 1, 5 or 25 vials per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorization Holder
Shire Pharmaceuticals Ireland Limited
Citywest Business Campus
Shire Human Genetic Therapies AB
227 64 Lund
This leaflet was last approved in
The following information is intended for medical or healthcare professionals only.
VPRIV is a powder for solution for infusion. VPRIV requires reconstitution and dilution and is intended for intravenous infusion only. VPRIV is for single?use only and is administered through a 0.22 µm filter. Vials are single-use only. Discard any unused solution. VPRIV should not be infused with other medicines in the same infusion as the compatibility in solution with other medicines has not been evaluated. The total volume of infusion should be delivered over a period of 60 minutes.
Use aseptic technique.
Prepare VPRIV as follows:
1. The number of vials to be reconstituted is determined based on the individual patient?s weight and the prescribed dose.
2. The required vials are removed from the refrigerator. Each vial is reconstituted using sterile water for injections: Vial size Water for Injections 200 Units 2.2 ml 400 Units 4.3 ml
3. Upon reconstitution, mix vials gently. Do not shake.
4. Prior to dilution, visually inspect the solution in the vials; the solution should be clear to slightly opalescent and colourless; do not use if the solution is discoloured, or if foreign particulate matter is present.
5. The calculated volume of medicinal product is withdrawn from the appropriate number of vials. Some solution will remain in the vial: Vial size Extractable volume 200 Units 2.0 ml 400 Units 4.0 ml
6. The total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion. Mix gently. Do not shake. The infusion should be initiated within 24 hours from the time of reconstitution.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not exceed 24 hours at 2°C to 8°C.
Medicines should not be disposed of via waste water or household waste. Any unused medicine or waste material should be disposed of in accordance with local requirements