Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients


Glycerol
Metacresol
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Zinc chloride
Water for injections
6.2     Incompatibilities

Insulin medicinal products should only be added to compounds with which it is known to be compatible. Medicinal products added to the insulin solution may cause degradation of the insulin, e.g.
if the medicinal products contain thiols or sulfites.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials 
Actrapid vial (100 international units/ml)
During use or when carried as a spare: The product can be stored for a maximum of 6 weeks. Store below 25°C.

Actrapid Penfill
During use or when carried as a spare: The product can be stored for a maximum of 6 weeks. Store below 30°C.

6.4     Special precautions for storage

Before opening: Store in a refrigerator (2°C – 8°C). Do not freeze.
Actrapid vial (100 international units/ml)
During use or when carried as a spare: Store below 25°C. Do not refrigerate or freeze.Keep the vial in the outer carton in order to protect from light.

Actrapid Penfill
During use or when carried as a spare: Store below 30°C . Do not refrigerate or freeze.
Keep the cartridge in the outer carton in order to protect from light.

6.5     Nature and contents of container
Actrapid vial (100 international units/ml)
Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of solution.

Pack size of 1 vial of 10 ml.
Actrapid Penfill
Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of solution.

Pack size of 5 cartridges. .

6.6     Special precautions for disposal and other handling
Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.

Actrapid which has been frozen must not be used.

The patient should be advised to discard the needle and syringe after each injection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Needles, syringes and cartridges must not be shared.

The cartridge must not be refilled.