Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sucrose
Sodium citrate dihydrate
Citric acid monohydrate
Polysorbate 20

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
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 point of view, the medicinal product 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.

6.4   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 section 6.3.

6.5   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 size of 1 vial.
Each vial contains 400 Units lyophilized powder for solution for infusion.


6.6   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.

VPRIV has to be prepared 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 400 Units vial is reconstituted with
4.3 ml of sterile water for injections.
3.  Upon reconstitution, vials should be mixed gently. Vials should not be shaken. Each vial will contain an extractable volume of 4.0 ml (100 Units/ml).
4.  Prior to further dilution, the solution in the vials should be visually inspected; the solution should be clear to slightly opalescent and colourless; the solution should not be used if it is discoloured or if foreign particulate matter is present.
5.  The calculated volume of medicinal product is withdrawn from the appropriate number of vials and the total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion. The diluted solution should be mixed gently. It should not be shaken. The infusion should be initiated within 24 hours from the time of reconstitution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.