Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Sodium chloride, Human serum albumin, Aluminium hydroxide, hydrated, Disodium phosphate-dihydrate, Potassium dihydrogen phosphate, Sucrose, Formaldehyde, Protamine sulfate, Neomycin and gentamicin, Water for injection

6.2     Incompatibilities

In the absence of compatibility studies, this 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.

6.4     Special precautions for storage
Store in a refrigerator (2°C - 8°C). Keep the syringe in the outer carton in order to protect from light.
Do not freeze.

6.5     Nature and contents of container

0.5 ml of suspension for injection in pre-filled syringe (type I glass) with a plunger stopper (halogenobutyl rubber). Pack sizes of 1, 10, 20 and 100 are available. The pack may include no needles or 1 separate needle per syringe. Needles are sterile and for single use only. Not all pack sizes may be marketed.

Each pre-filled syringe is packed in a blister. The opening in the blister seal is intended and allows for the equilibration of moisture during the recommended warm-up prior to the administration of the vaccine. Open the blister by removing the lid to take out the syringe. Do not press the syringe through the blister.

For subcutaneous administration, see section 6.6.

6.6     Special precautions for disposal and other handling
The vaccine should reach room temperature before administration. Shake well prior to administration to thoroughly mix the vaccine suspension. After shaking, TicoVac 0.5 ml is an off-white, opalescent homogenous suspension. The vaccine should be inspected visually for any foreign particulate matter and/or variation in physical appearance prior to administration. In the event of either being observed, discard the vaccine.

After removing the syringe cap, attach the needle immediately and remove the needle shield prior to administration. Once the needle is attached, the vaccine must be administered immediately. In the exceptional cases of subcutaneous administration, an appropriate needle should be used.

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

The administration of the vaccine should be documented by the physician, and the lot number recorded. A detachable documentation label is attached to each preloaded syringe.