Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Sodium chloride
Sodium phosphate monobasic monohydrate
Sodium phosphate dibasic heptahydrate
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.

6.4   Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the pre-filled syringes or pens in the outer carton in order to protect from light.
After taking a syringe or a pen from the refrigerator, wait approximately 30 minutes to allow the Brenzys solution in the syringe or the pen to reach room temperature. Do not warm in any other way.
Immediate use is then recommended.

Brenzys may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Brenzys should be discarded if not used within four weeks of removal from refrigeration.

6.5   Nature and contents of container

50 mg solution for injection in pre-filled syringe
Clear glass (type I) pre-filled syringe with stainless steel needle, rubber needle cover and rubber plunger containing 0.98 ml of solution.
Brenzys is available in packs containing 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes. Not all pack sizes may be marketed.

50 mg solution for injection in pre-filled pen
Pre-filled pen containing a pre-filled syringe of Brenzys. The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and rubber plunger.
Brenzys is available in packs containing 4 pre-filled pens and multipacks containing 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.

6.6   Special precautions for disposal

50 mg solution for injection in pre-filled syringe
Before injection, Brenzys single-use pre-filled syringe should be allowed to reach room temperature (approximately 30 minutes). The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature. The solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein.

Comprehensive instructions for administration are given in the package leaflet, section 7, ”Instructions for use”.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

50 mg solution for injection in pre-filled pen
Before injection, Brenzys single-use pre-filled pens should be allowed to reach room temperature (approximately 30 minutes). The needle cover should not be removed while allowing the pre-filled pen to reach room temperature. By looking though the inspection window, the solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein.

Comprehensive instructions for administration are given in the package leaflet, section 7, “Instructions for use”.

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