Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Glycerol
Disodium phosphate dihydrate
Hydrochloric acid (for pH adjustment)
Metacresol
Phenol
Sodium hydroxide (for pH adjustment)
Protamine sulphate
Zinc
Water for injections

6.2    Incompatibilities
Insulin medicinal products should only be added to compounds with which it is known to be compatible. Insulin suspensions should not be added to infusion fluids.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials 
Insulatard 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.

Insulatard 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.
Insulatard 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.

Insulatard 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

Insulatard 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 suspension.

Pack of 1 vial of 10 ml.

Insulatard Penfill
Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of suspension. The cartridge contains a glass ball to facilitate resuspension.

Pack of 5 cartridges.

6.6    Special precautions for disposal and other handling
After removing Insulatard vial or cartridge from the refrigerator, it is recommended to allow the Insulatard vial or cartridge to reach room temperature before resuspending the insulin as instructed for first time use.

Do not use this medicinal product if you notice that the resuspended liquid is not uniformly white and cloudy.

Insulatard 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.