Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients

MetaCresol
Glycerol
Dibasic sodium phosphate. 7H 2 O
Zinc oxide
Water for injections
Hydrochloric acid and sodium hydroxide maybe used to adjust pH.
6.2     Incompatibilities

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

Vial
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3     Shelf life

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

After first use of the vial/ after cartridge insertion
28 days.

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

Vial
Before use
Store in a refrigerator (2°C - 8°C).
After first use
Store below 30°C.

Cartridge
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.

Use in an External Insulin Pump
Change the Humalog in the reservoir at least every 7 days, change the infusion sets at least every 48 hours or after exposure to temperatures that exceed 37°C.

6.5    Nature and contents of container

Vial
The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the vial stoppers.

10 ml Vial: Pack of 1.

Cartridge
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.

3 ml Cartridge: Pack of 5.

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. Patients using vials must never share needles or syringes. The patient should discard the needle after every injection.

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

Do not mix insulin in vials with insulin in cartridges. See section 6.2.

Preparing a dose
Vial
The vial is to be used in conjunction with an appropriate syringe (100 unit markings).
 i)      Humalog

1.      Wash your hands.
2.      If using a new vial, flip off the plastic protective cap, but do not remove the stopper.

3.      If the therapeutic regimen requires the injection of basal insulin and Humalog at the same time, the two can be mixed in the syringe. If mixing insulins, refer to the instructions for mixing that follow in Section (ii) and 6.2.

4.     Draw air into the syringe equal to the prescribed Humalog dose. Wipe the top of the vial with a swab. Put the needle through the rubber top of the Humalog vial and inject the air into the vial.

5.     Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand.
6.     Making sure the tip of the needle is in the Humalog, withdraw the correct dose into the syringe.

7.     Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.


8.     Remove the needle from the vial and lay the syringe down so that the needle does not touch anything.
 ii)    Mixing Humalog with longer-acting Human Insulins (see section 6.2) 
1.     Humalog should be mixed with longer-acting human insulins only on the advice of a doctor.

2.     Draw air into the syringe equal to the amount of longer-acting insulin being taken. Insert the needle into the longer-acting insulin vial and inject the air. Withdraw the needle.
3.     Now inject air into the Humalog vial in the same manner, but do not withdraw the needle.

4.     Turn the vial and syringe upside down.

5.     Making sure the tip of the needle is in the Humalog, withdraw the correct dose of Humalog into the syringe.

6.     Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.

7.     Remove the needle from the vial of Humalog and insert it into the vial of the longer-acting insulin.
Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the insulin, withdraw the dose of longer-acting insulin.

8.     Withdraw the needle and lay the syringe down so that the needle does not touch anything.

Cartridge
Humalog 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.     Stabilize 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.