Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder
Sucrose
Sorbitol
Gelatin (hydrolyzed porcine)
Urea
Sodium chloride
Sodium phosphate
Medium 199 with Hanks’ Salts
Monosodium L glutamate Monohydrate
Minimum Essential Medium, Eagle
Sodium bicarbonate
Potassium phosphate
Potassium chloride
Neomycin
Phenol red
Hydrochloric acid (to adjust pH)
Sodium hydroxide (to adjust pH)

Solvent
Water for injections.
6.2   Incompatibilities

In the absence of compatibility studies, the vaccine 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, in-use stability has been demonstrated for 30 minutes when stored between 20°C and 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 (Type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in a pack size of 1 and 10.


Powder in a vial (Type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (Type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or two unattached needles, in a pack size of 1 and 10.

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 pale yellow compact crystalline cake.
The solvent is a clear colourless liquid. When completely reconstituted, the vaccine is a clear pale yellow to light pink liquid.

To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other antiviral substances, which might inactivate the vaccine.

It is important to use a separate sterile syringe and needle for each individual 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.

ProQuad must not be mixed in a syringe with other vaccines.
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 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 minimize loss of potency. Discard if reconstituted vaccine 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 or intramuscular route.

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