Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars

6.1 List of excipients

Phenol (preservative)
Isotonic buffer solution*
*Composition of the isotonic buffer solution:
Sodium Chloride
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
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.
Solution for injection in a multi-dose vial: any opened vials remaining at the end of the immunization session (within six [6] hours of first opening), should be discarded.

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
0.5 mL of solution in a prefilled syringe (type I glass) with a plunger stopper - Boxes of 1 and 20.
20 doses x 0.5 mL of solution in a vial of 10 ml (glass) with a stopper (chlorobutyl) -
Box of 1 or 10 vials
Not all pack sizes and presentations may be marketed.

6.6 Special precautions for disposal and other handling
The vaccine should be visually inspected before administration for discolouration or any particulate matter. Shake well immediately before use.
For needle free syringes, the needle should be pushed firmly on to the end of the pre- filled syringe and rotated through 90 degrees.
Any unused product or waste material should be disposed of in accordance with local requirements.