Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl alcohol
Sodium chloride
Sodium acetate, anhydrous
Acetic acid
Polysorbate 80
Water for injections

6.2   Incompatibilities

Not applicable.
6.3   Shelf life

Besremi 250 micrograms/0.5 mL, solution for injection in pre-filled pen The expiry date of the product is indicated on the packaging materials.

Besremi 500 micrograms/0.5 mL, solution for injection in pre-filled pen The expiry date of the product is indicated on the packaging materials.

After first use
The pre-filled pen may be stored for a maximum of 30 days in the refrigerator (2 °C - 8 °C) when stored with the pen cap on and kept in the outer carton in order to protect from light. The pre-filled pen may be used up to two times within these 30 days. Any medicinal product remaining in the pre-filled pen after the second use and/or after 30 days must be discarded.

6.4   Special precautions for storage

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

6.5   Nature and contents of container

Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a grey push button and the strength “250 mcg/0.5 mL” highlighted in grey on the label. It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg and 250 μg.
Each click and each dot in the dosing window represents 5 micrograms. Every other click and dot is additionally labelled with the number of micrograms (i.e. in 10 micrograms steps).

Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen is available in : - Packs containing 1 pre-filled pen and 2 injection needles.


Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a blue push button and the strength “500 mcg/0.5 mL” highlighted in blue on the label. It delivers doses of 50 micrograms, 100 micrograms, 150 micrograms, 200 micrograms , 250 micrograms , 300 micrograms, 350 micrograms, 400 micrograms, 450 micrograms and 500 micrograms.

Each pack of Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen contains: - 1 pre-filled pen and 2 injection needles.


Each pre-filled pen contains a cartridge (type 1 colourless glass) with a- grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl rubber). The cartridge is sealed in a pen injector. Each cartridge contains 0.5 mL of solution.


6.6   Special precautions for disposal and other handling
Before use, the pre-filled pen should be brought to room temperature (15 °C - 25 °C) for up to 15 minutes.

Since Besremi is a solution, it does not require resuspension before use. Inspect the solution before use. It may only be used if the solution is clear, colourless to pale yellow, with no particles visible.

The pre-filled pen label must always be checked before each injection to avoid medication errors between Besremi 250 micrograms/0.5 mL solution for injection and Besremi 500 micrograms/0.5 mL solution for injection. The 250 micrograms/0.5 mL pre-filled pen has a grey push button. The 500 micrograms/0.5 mL pre-filled pen has a blue push button.

A new, sterile needle as provided with the pre-filled pen must be carefully attached onto the pre-filled pen before each injection. Needles must be discarded immediately after use.

If the pre-filled pen is used for the first time, the pen is prepared for injection by turning the dose knob until the icon of a “drop” in the display window is seen. While holding the pre-filled pen with the needle pointing upwards, tap the pre-filled pen gently with the fingers so that any air bubbles rise towards the needle. Then press the push button until the display window shows “0”. This may be repeated up to six times. Once a droplet of liquid appears at the needle tip, the pre-filled pen and the needle are working properly.

The dose can be selected by rotating the dose knob. If a certain dose cannot be set, an insufficient quantity of medicinal product may be left in the pen and a new pen must be used.

The needle should be inserted into the skin. The push button should be pressed in completely and held down for at least 10 seconds before removing the needle.

To prevent possible transmission of disease or any kind of contamination, the use of Besremi pre-filled pen should remain strictly for a single patient, even when the needle is changed. The pre-filled pen may not be used more than twice and must be discarded 30 days after the first use, regardless of any medicinal product remaining in the pre-filled pen.

Empty pens must never be reused and must be properly discarded.

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


7.    REGISTRATION HOLDER
AOP Orphan Pharmaceuticals Israel Ltd.
Brodetsky 43 P.O.B 39995,
Tel Aviv 6139803