Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium phosphate dibasic anhydrous,
Sodium phosphate monobasic monohydrate,
Edetate disodium,
Sodium chloride,
M-cresol,
Polysorbate 80,
Water for injection

6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

18 months.
Within its shelf-life, for the purpose of transport, the solution can be kept at or below 25ºC for a period up to seven days before use. Intron A can be put back in the refrigerator at any time during this seven-day period. If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.

6.4   Special precautions for storage

Store at 2°C – 8°C.
Do not freeze.
For storage conditions of the medicinal product, see section 6.3.
6.5   Nature and contents of container

1 ml of solution (corresponding to 10 MIU) in a single dose vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Pack sizes of 1.


6.6   Special precautions for disposal and other handling
Not all dose forms and strengths are appropriate for some indications. Please make sure to select an appropriate dose form and strength.

Intron A solution for injection or infusion may be injected directly after withdrawal of the appropriate doses from the vial with a sterile injection syringe.

Preparation of Intron A for intravenous infusion: The infusion is to be prepared immediately prior to use. Any size vial may be used to measure the required dose; however, final concentration of interferon in sodium chloride solution must be not less than 0.3 million IU/ml. The appropriate dose of Intron A is withdrawn from the vial(s), added to 50 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection in a PVC bag or glass bottle for intravenous use and administered over 20 minutes.
No other medicinal product can be infused concomitantly with Intron A.

As with all parenteral medicinal products, prior to administration inspect Intron A, solution for injection or infusion, visually for particulate matter and discolouration. The solution should be clear and colourless.

Any unused medicinal product must be discarded after withdrawal of the dose and in accordance with local requirements.