Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS

6.1      List of excipients
For Humulin Soluble preparations: glycerol m-cresol water for injections

The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide 
For Humulin Isophane and Mixture preparations: glycerol dibasic sodium phosphate 7H2O m-Cresol
 phenol
protamine sulphate zinc oxide water for injections
The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide 

6.2      Incompatibilities
Humulin preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.


6.3      Shelf life
Unused vial/cartridge
Humulin R cartridges: 2 years
Humulin R, N, 70/30 vials, Humulin N, 70/30 cartridges: 3 years.

After first use
28 days.

6.4      Special precautions for storage

Unused vials and Cartridges
Store in a refrigerator (2°C – 8°C). Do not freeze. Do not expose to excessive heat or direct sunlight.

After first use
Vials: Once in use the vials may be used for up to 28 days. Do not use beyond this period.
Store below 30°C. Do not freeze. Do not expose to excessive heat or direct sunlight.

Cartridges: Once in use the cartridges may be used for up to 28 days. Do not use beyond this period. 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 content of container
Humulin vials
10 ml of solution or suspension in a vial (type I glass) with a stopper (rubber) sealed with a seal (aluminum) combined with a flip top (plastic).
Pack size 1.

Humulin cartridges
3 ml solution or suspension in a cartridge (type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber).
Pack size of 5.

6.6      Special precautions for disposal and other handling

Do not reuse needles. Dispose of the needle in a responsible manner. Needles and pens must not be shared. Vials and Cartridges can be used until empty, then properly discard. Any 
unused medicinal product or waste material should be disposed of in accordance with local requirements.

Instructions for use and handling
Vial
A solution or suspension for injection in a 10 ml vial to be used in conjunction with an appropriate syringe (100 IU/ml markings).

Cartridge
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 cartridges should only be used in conjunction 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.
 a) Preparing a dose

Vials or cartridges containing Humulin Soluble formulation do not require resuspension and should only be used if it is clear, colorless, with no solid particles visible and if it is of water- like appearance.

Vials containing Humulin Isophane and Mixtures formulations should be rotated several times in the palms of the hands before use to completely resuspend the insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed.

Cartridges containing Humulin Isophane and Mixture formulations should be rolled in the palms of the hands ten times and inverted 1800 ten times immediately before use to resuspend the insulin until it appears uniform 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.

The cartridges and vials 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 cartridge or vial, giving a frosted appearance.

The cartridges are not designed to allow any other insulin to be mixed in the cartridge.
Cartridges are not designed to be refilled.

Mixing of insulins: The shorter acting insulin should be drawn into the syringe first, to prevent contamination of the vial by the longer acting preparation. It is advisable to inject directly after mixing. However, if a delay is necessary, a consistent routine must be followed.

Alternatively, a separate syringe or, separate cartridges of Humulin Soluble and Isophane, can be used for administration of the correct amount of each formulation.

Vials
Prepare your syringe prior to injection, as directed by your doctor or diabetes specialist nurse.
Use an insulin syringe marked for the strength of insulin being administered.

Cartridges
The manufacturer's instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.
 b) Injecting a dose

Inject the correct dose of insulin, as directed by your doctor or diabetes specialist nurse.
Use of the injection sites should be rotated so that the same is not used more than approximately once a month.

Each pack contains a patient information leaflet with instructions on how to inject insulin.

7. MANUFACTURER:

Lilly S.A., Alcobendas, Madrid, Spain (Vials)
Or
Eli Lilly & Company Ltd., Indianapolis, Indiana, USA (Cartridges)