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 injections q.s.

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products 
6.3 Shelf life
15 months.
Chemical and physical in-use stability has been demonstrated for 27 days at 2ºC – 8ºC.
From a microbiological point of view, once opened, the product may be stored for a maximum of 27 days at 2ºC – 8ºC. Other in-use storage times and conditions are the responsibility of the user.

6.4 Special precautions for storage
Store in a refrigerator (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
1.2 ml of solution (corresponding to 18 MIU) in a pen made of a cartridge (type I glass) sealed at one end with a cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber).
The pack size also contains 6 injection needles and 6 cleansing swabs.
Pack size 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 in multidose pen is injected subcutaneously after attaching an injection needle and dialing the prescribed dose.

Remove the pen from the refrigerator approximately 30 minutes before administration to allow the injectable solution to reach room temperature (not more than 25°C).

Detailed instructions for the use of the product are provided with the package leaflet (refer to “How to self inject Intron A”).

Each pen is intended for a maximum 27 days use period and must then be discarded. A new injection needle must be used for each dose. After each use, the injection needle must be discarded safely and the pen must be returned immediately to the refrigerator. A maximum of 48 hours (two days) of exposure to 25°C is permitted over the 27 days use period to cover accidental delays in returning the pen to the refrigerator.
Sufficient needles and swabs are provided to use the Intron A pen for administering the smallest measurable doses. Instruct the patient that any extra needles and swabs that remain after the final dose has been taken from the pen must be discarded appropriately and safely.

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

7. LICENSE HOLDER

Merck Sharp & Dohme (Isreal-1996) Ltd., P.O.Box 7121, Petah-Tikva 49170.