Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1    List of excipients
Sucrose
L-arginine hydrochloride
L-histidine hydrochloride monohydrate
L-histidine
Polysorbate 80
Water for injections

6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


6.3    Shelf life
The expiry date of the product is indicated on the packaging materials After removal from refrigeration, may be kept at room temperature (20°C - 25°C) when protected from light for a maximum of 8 hours. After this time, the syringe must be discarded.

6.4    Special precautions for storage

Store in a refrigerator (2°C - 8°C). Do not freeze.
Do not shake or expose to direct heat.
Keep the pre-filled syringe in the outer carton in order to protect from light.

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

6.5    Nature and contents of container
Siliconised Luer lock Type I glass pre-filled syringe with a FluroTec-coated plunger stopper.

Each pre-filled syringe contains 0.5 mL or 1 mL solution.

Pack sizes:

•         1 or 5 pre-filled syringe(s) without needles.

•         1 pre-filled syringe packaged with two separate needles of different sizes.
Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling

This medicinal product should be administered by a trained healthcare professional using aseptic techniques to ensure sterility.

Visually inspect the medicinal product for particulate matter and discolouration prior to administration. The medicinal product is a clear to opalescent, colourless to yellow solution. Do not inject if the liquid is cloudy, discoloured, or it contains large particles or foreign particulate matter.

Do not use if the pre-filled syringe has been dropped or damaged or the security seal on the carton has been broken.


Instructions for administration

Beyfortus is available in a 50 mg and a 100 mg pre-filled syringe. Check the labels on the carton and pre-filled syringe to make sure you have selected the correct 50 mg or 100 mg presentation as required.

Beyfortus 50 mg (50 mg/0.5 mL) pre-filled              Beyfortus 100 mg (100 mg/1 mL) pre-filled syringe with a purple plunger rod.                     syringe with a light blue plunger rod.



Purple                                               Light Blue



Refer to Figure 1 for pre-filled syringe components.
Figure 1: Luer lock syringe components


Finger grip        Rubber stopper            Syringe cap


Plunger rod                 Syringe body         Luer lock


Step 1: Holding the Luer lock in one hand (avoid holding the plunger rod or syringe body), unscrew the syringe cap by twisting it counter clockwise with the other hand.

Step 2: Attach a Luer lock needle to the pre-filled syringe by gently twisting the needle clockwise onto the pre-filled syringe until slight resistance is felt.

Step 3: Hold the syringe body with one hand and carefully pull the needle cover straight off with the other hand. Do not hold the plunger rod while removing the needle cover or the rubber stopper may move. Do not touch the needle or let it touch any surface. Do not recap the needle or detach it from the syringe.

Step 4: Administer the entire contents of the pre-filled syringe as an intramuscular injection, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.

Step 5: Dispose of the used syringe immediately, together with the needle, in a sharps disposal container or in accordance with local requirements.

If two injections are required, repeat steps 1-5 in a different injection site.

Disposal
Each pre-filled syringe is for single-use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7.   IMPORTER AND MARKETING AUTHORISATION HOLDER AND ITS ADDRESS
Sanofi Israel Ltd., Greenwork Park, P.O box 47, Yakum