Pharmaceutical particulars : מידע רוקחי

6        PHARMACEUTICAL PARTICULARS
6.1      List of excipients

•     Sodium phosphate-buffered isotonic sodium chloride solution o Sodium chloride o Monobasic sodium phosphate o Dibasic sodium phosphate o Water for injections
•     Octoxinol-9

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 6.4     Special precautions for storage

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

6.5     Nature and contents of container

0.7 ml of suspension in pre-filled syringe (Type I glass) without needle, equipped with a plunger stopper (bromobutyl rubber) and a tip-cap – pack size of 1, 5 or 10.

0.7 ml of suspension in pre-filled syringe (Type I glass) with separate needle, equipped with a plunger stopper (bromobutyl rubber) and a tip-cap – pack size of 1, 5 or 10.
Not all pack sizes may be marketed.

6.6     Special precautions for disposal and other handling

The vaccine should be allowed to reach room temperature before use.
Shake before use.

The vaccines should be inspected visually for particulate matter and/or discoloration prior to administration whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

The syringe is intended for single use only and should not be reused. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.