Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Metacresol
Sodium chloride
Trometamol
Polysorbate 20
Hydrochloric acid, concentrated
Sodium hydroxide
Water for injections
6.2    Incompatibilities

Apidra 100 Units/ml, solution for injection in a vial
Subcutaneous use
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except NPH human insulin.
When used with an insulin infusion pump, Apidra must not be mixed with other medicinal products.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
Shelf life after first use or removal from the refrigerator:

Apidra 100 Units/ml, solution for injection in a vial
Shelf life after first use or removal from the refrigerator of the vial: The product may be stored for a maximum of 4 weeks at a temperature not exceeding 25°C away from direct heat or direct light. Keep the vial in the outer carton in order to protect from light.
It is recommended that the date of the first use from the vial be noted on the label.


Apidra 100 Units/ml, solution for injection in a pre filled pen SoloStar Shelf life after first use or removal from the refrigerator of the pen The product may be stored for a maximum of 4 weeks at a temperature not exceeding 25°C away from direct heat or direct light.
Pens in use must not be stored in the refrigerator. The pen cap must be put back on the pen after each injection in order to protect from light.


.
6.4    Special precautions for storage

Apidra 100 Units/ml solution for injection in a vial

Unopened vials
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.

Opened vials
For storage conditions after first opening of the medicinal product, see section 6.3.

Apidra 100 Units/ml solution for injection in a pre-filled pen SoloStar 
Not in-use pens
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the pre-filled pen in the outer carton in order to protect from light.

In-use pens
For storage conditions after first opening of the medicinal product, see section 6.3.
.

6.5    Nature and contents of container

Apidra 100 Units/ml solution for injection in a vial
10 ml solution in a vial (type I colourless glass) with a stopper (flanged aluminium overseal, elastomeric chlorobutyl rubber) and a polypropylene tear-off cap. Packs of 1, 2, 4 and 5 vials are available. Not all pack sizes may be marketed.



Apidra 100 Units/ml solution for injection in a pre-filled pen SoloStar 3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric bromobutyl rubber) and a flanged cap (aluminium) with a stopper (elastomeric bromobutyl rubber). The cartridge is sealed in a disposable pre-filled pen. Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pens are available. Not all pack sizes may be marketed.


6.6    Special precautions for disposal and other handling
Apidra 100 Units/ml, solution for injection in a vial
Subcutaneous use
Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with an insulin pump system (see section 4.2).
Inspect the vial before use. It must only be used if the solution is clear, colourless, with no solid particles visible. Since Apidra is a solution, it does not require resuspension before use.
Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins (see section 4.4).

Mixing with insulins
When mixed with NPH human insulin, Apidra should be drawn into the syringe first. Injection should be given immediately after mixing as no data are available regarding the mixtures made up a significant time before injection.

Continuous subcutaneous infusion pump
Refer to sections 4.2 and 4.4 for advice.

Apidra 100 Units/ml solution for injection in a pre-filled pen SoloStar 
Apidra SoloStar 100 units/ml in a pre-filled pen is only suitable for subcutaneous injections. If administration by syringe or infusion pump is necessary, a vial should be used. Before first use the pen must be stored at room temperature for 1 to 2 hours.

Inspect the cartridge before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency. Since Apidra is a solution, it does not require resuspension before use.
Empty pens must never be used and must be properly discarded.
To prevent any kind of contamination, the use of the pre-filled pen should remain strictly for a single patient use.
Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins (see section 4.4).

Handling of the pen
The patient should be advised to read the instructions for use included in the package leaflet carefully before using the pre-filled pen SoloStar.



Schematic diagram of the pen

Important information for use of SoloStar:
•   Before each use, a new needle must always be carefully attached and a safety test must be performed. A dose should not be selected and/or the injection button should not be pressed without a needle attached. Only use needles that are compatible for use with SoloStar.
•   Special caution must be taken to avoid accidental needle injury and transmission of infection.
•   SoloStar must never be used if it is damaged or if the patient is not sure if it is working properly.
•   The patient must always have a spare SoloStar available in case the SoloStar is lost or damaged.

Storage instructions

Please check section 6.4 of this SPC for instructions on how to store SoloStar.
If SoloStar is in cool storage, it should be taken out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.

The used SoloStar must be discarded as required by your local authorities.

Maintenance
SoloStar has to be protected from dust and dirt.

The outside of the SoloStar can be cleaned by wiping it with a damp cloth.

The pen must not be soaked, washed or lubricated as this may damage it.
SoloStar is designed to work accurately and safely. It should be handled with care. The patient should avoid situations where SoloStar may be damaged. If the patient is concerned that the SoloStar may be damaged, he must use a new one.


Step 1       Check the insulin

The label on the pen should be checked to make sure it contains the correct insulin. The Apidra SoloStar is blue. It has a dark blue injection button with a raised ring on the top. After removing the pen cap, the appearance of insulin should also be checked: the insulin solution must be clear, colourless, with no solid particles visible, and must have a water-like consistency.

Step 2       Attach the needle

Only needles that are compatible for use with SoloStar should be used.
A new sterile needle will be always used for each injection. After removing the cap, the needle should be carefully attached straight onto the pen.

Step 3       Perform a safety test

Prior to each injection a safety test has to be performed to ensure that pen and needle work properly and to remove air bubbles.

A dose of 2 units has to be selected.
The outer and inner needle caps should be removed.

While holding the pen with the needle pointing upwards, the insulin reservoir should be tapped gently with the finger so that any air bubbles rise up towards the needle.

Then the injection button should be pressed in completely.

If insulin has been expelled through the needle tip, then the pen and the needle are working properly.
If no insulin appears at the needle tip, step 3 should be repeated until insulin appears at the needle tip.
Step 4       Select the dose

The dose can be set in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If a dose greater than 80 units is required, it should be given as two or more injections.

The dose window must show “0” following the safety test. The dose can then be selected.

Step 5       Inject the dose
The patient should be informed on the injection technique by his health care professional.

The needle should be inserted into the skin.
The injection button should be pressed in completely. Then the injection button should be held down 10 seconds before withdrawing the needle. This ensures that the full dose of insulin has been injected.

Step 6       Remove and discard the needle

The needle should always be removed after each injection and discarded. This helps prevent contamination and/or infection, entry of air into the insulin reservoir and leakage of insulin. Needles must not be reused.

Special caution must be taken when removing and disposing the needle. Recommended safety measures for removal and disposal of needles must be followed (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

The pen cap should be replaced on the pen.

Manufacturer: Sanofi-Aventis Deutschland GmbH, Germany.