Pharmaceutical particulars : מידע רוקחי

 6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Protamine sulphate, metaCresol, liquefied phenol, glycerol, dibasic sodium phosphate, zinc oxide, water for injection. hydrochloric acid solution 10% and sodium hydroxide solution 10% may be used to adjust pH.

6.2   Incompatibilities

Mixing Humalog Mix50 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

Before use
The expiry date of the product is indicated on the packaging materials.
After cartridge insertion
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 cartridge insertion
Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the needle attached.

6.5   Nature and contents of container

Cartridge
The suspension is contained in type I flint glass cartridges, sealed with butyl or 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.


5 x 3 ml Humalog Mix50 Cartridges for a 3ml pen.
6.6   Special precautions for disposal and other handling

Instructions for use and handling
To prevent the possible transmission of disease, each cartridge 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 Mix50 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

Cartridges containing Humalog Mix 50 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.
Humalog Mix50 cartridges are to be used with a Lilly reusable insulin pen and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.

The instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.

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

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