Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Humalog Mix 25 KwikPen
Glycerol, dibasic sodium phosphate, metaCresol, liquefied phenol, zinc oxide, Protamine sulphate, water for injections. Hydrochloric acid and sodium hydroxide may have been used to adjust pH 
Humalog Mix 50 KwikPen

Glycerol, dibasic sodium phosphate, metaCresol, liquefied phenol, Protamine sulphate, zinc oxide, water for injections. Hydrochloric acid and sodium hydroxide may have been used to adjust pH 
6.2      Incompatibilities

Mixing Humalog Mix 25 or Humalog Mix 50 with other insulins has not been studied. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3      Shelf life

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
The suspension is contained in type I flint glass cartridges, sealed with halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may have been used to treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges are sealed in a disposable pen injector, called the “KwikPen”. Needles are not included.

Not all packs may be marketed.

5 x 3 ml Humalog Mix 25 100 units/ml KwikPens.
5 x 3 ml Humalog Mix 50 100 units/ml KwikPens.
6.6    Special precautions for disposal and other handling

Instructions for use and handling
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.
The Humalog Mix should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the container, giving it a frosted appearance.

Preparing a dose

The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose.

Before using the KwikPen the user manual included in the package leaflet must be read carefully. The KwikPen 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
If using a pre-filled or reusable pen 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.    Using 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.

7.      MANUFACTURER:
Eli Lilly & Company Ltd., Indianapolis, Indiana, USA