Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder:
Sucrose
Hydrolysed gelatin (porcine)
Urea
Sodium chloride
Monosodium L-glutamate monohydrate
Sodium phosphate dibasic
Potassium phosphate monobasic
Potassium chloride

Solvent:
Water for injections
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.
After reconstitution, the vaccine should be used immediately. However, the in-use stability has been demonstrated for 30 minutes when stored at 20 °C – 25 °C.

6.4   Special precautions for storage

Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre- filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) with one or two unattached needles in a pack size of 1.

Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre- filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) without needle in pack size of 1.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Before mixing with the solvent, the powder vaccine is a white to off-white compact crystalline plug. The solvent is a clear colourless liquid. When reconstituted, ZOSTAVAX is a semi-hazy to translucent, off- white to pale yellow liquid.

Avoid contact with disinfectants as they may inactivate the vaccine virus.

To reconstitute the vaccine, use the solvent provided.
It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.

One needle should be used for reconstitution and a separate, new needle for injection.

Reconstitution instructions
To attach the needle, it should be firmly placed on the tip of the syringe and secured by rotating a quarter of a turn (90°).
Inject the entire content of the solvent syringe into the vial containing the powder. Gently agitate to dissolve completely.

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, discard the vaccine.


It is recommended that the vaccine be administered immediately after reconstitution, to minimise loss of potency. Discard reconstituted vaccine if it is not used within 30 minutes.

Do not freeze the reconstituted vaccine.

Withdraw the entire content of the reconstituted vaccine from the vial into a syringe, change the needle, and inject the entire volume by subcutaneous route.

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