Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1   List of excipients
Magnesium chloride
L-Arginine
Polysorbate 80
Neomycin sulphate
Polymyxin B sulphate
Water for injection


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 vaccine is indicated on the label and packaging.

After opening, the multidose vial must be kept in the refrigerator (between 2°C and 8°C) and ideally used  within 8 hours.

6.4   Special precautions for storage
Store in a freezer (-20°C).

Store in the original package in order to protect from light.

The vaccine can be stored for up to 6 months in the refrigerator (between 2°C and 8°C).
For vaccine storage conditions after opening, see section 6.3.

6.5   Nature and contents of container

Vial (of type I glass) containing 20 doses, equipped with a rubber closure and tear-off aluminium cap and with a polyethylene dropper provided separately - box of 100.


6.6   Special precautions for disposal and other handling

Before administration, the vaccine must be inspected visually to detect the presence of any foreign particles.

Due to minor variation of its pH, Polio Sabin One and Three (oral) may vary in colour from yellow to pink.
Changes of the colour of the vaccine within this range do not signify deterioration of the vaccine.
One dose of vaccine consists of two drops that are delivered with the polyethylene drop counter supplied with the multidose vial.

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