Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Glycerol
MetaCresol
Dibasic sodium phosphate.
Zinc oxide
Water for injections
Hydrochloric acid and sodium hydroxide may be used to adjust pH.
6.2     Incompatibilities

These medicinal product should not be mixed with any other insulin or any other medicinal product.

6.3     Shelf life
Before use
The expiry date of the product is indicated on the packaging materials.

After first use
28 days.

6.4     Special precautions for storage
Do not freeze. Do not expose to excessive heat or direct sunlight.

Before use

Store in a refrigerator (2°C - 8°C).
After first use
Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.

6.5   Nature and contents of container

KwikPen
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads, and are secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plungers, and/or the glass cartridges.

The 3 ml cartridges are sealed in a disposable pen injector, called the “KwikPen”. Needles are not included.

Pack size: 5 x 3 ml Humalog 100 units/ml KwikPens

Junior KwikPen
Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml cartridges are sealed in a disposable pen injector, called the “Junior KwikPen”. Needles are not included.

Pack size: 5 x 3 ml Humalog 100 units/ml Junior KwikPens

6.6   Special precautions for disposal and other handling
Instructions for use and handling

To prevent the possible transmission of disease, each pre-filled pen must be used by one patient only, even if the needle on the delivery device is changed. The patient should discard the needle after every injection.

The Humalog solution should be clear and colourless. Humalog should not be used if it appears cloudy, thickened, or slightly coloured or if solid particles are visible.

Handling of the pre-filled pen
Before using the KwikPen or the Junior KwikPen the user manual included in the package leaflet must be read carefully. The pre-filled pen has to be used as recommended in the user manual.

Pens should not be used if any part looks broken or damaged.

Injecting a dose
Refer to the detailed instructions for preparing the pen and injecting the dose, the following is a general description:

1.     Wash your hands

2.     Choose a site for injection.
3.     Clean the skin as instructed.

4.     Stabilise the skin by spreading it or pinching up a large area. Insert the needle and inject as instructed.

5.    Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.

6.    Dispose of the syringe and needle safely. For an injection device use the outer needle cap, unscrew the needle and dispose of it safely.

7.    Use of the injection sites should be rotated so that the same is not used more than approximately once a month.

Any unused product or waste material should be disposed of in accordance with local requirements.