Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars
6.1 List of excipients
Phenoxyethanol, Aluminum phosphate, Ethanol, Polysorbate 80, Water for injection.
For adjuvant see section 2.
Manufacturing Process Residuals:
The final product may contain trace amount of formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B, bovine serum albumin (trace).
6.2 Incompatibilities
In the absence of compatibility studies, ADACEL-POLIO 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 at 2°C to 8°C.
Do not freeze. Discard the vaccine if it has been frozen.
Keep the container in the outer carton in order to protect from light.

6.5 Nature and contents of container
0.5 mL of suspension in pre-filled syringe (glass) with a plunger stopper (chlorobutyl elastomer), without attached needle, with a tip-cap (synthetic isoprene-bromobutyl elastomer) - pack size of 1, 10 or 20.
0.5 mL of suspension in pre-filled syringe (glass) with a plunger stopper (chlorobutyl elastomer), without attached needle, with a tip-cap (synthetic isoprene-bromobutyl elastomer ) and 1 or 2 separate needles - pack size of 1 or 10.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
Instructions for use
Parenteral products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration. In the event of either being observed, discard the medicinal product.
The normal appearance of the vaccine is a uniform cloudy, white suspension which may sediment during storage. Shake the prefilled syringe well to uniformly distribute the suspension before administering the vaccine.
For needle free syringes, the needle should be pushed firmly on to the end of the prefilled syringe and rotated through 90 degrees.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Needles should not be recapped.