Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Powder
Sucrose
L-histidine hydrochloride monohydrate
L-histidine
Polysorbate 20

XOL_POW_API_FEB24 V4                                         Based on EU SmPC DEC23 Solvent
Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

The expiry date of the product is printed on the package materials.
After reconstitution
The chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours at 2°C to 8°C.

From a microbiological point of view, the medicinal product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 8 hours at 2°C to 8°C or 2 hours at 25°C.

6.4 Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Powder vial: Clear, colourless type I glass vial with a chlorobutyl rubber stopper and blue flip-off seal.
Solvent ampoule: Clear, colourless type I glass ampoule containing 2 ml water for injections.

Packs containing 1 vial of powder and 1 ampoule of water for injections, respectively.

6.6 Special precautions for disposal and other handling
Xolair 150 mg powder for solution for injection is supplied in a single-use vial.

From a microbiological point of view, the medicinal product should be used immediately after reconstitution (see section 6.3).

The lyophilised medicinal product takes 15-20 minutes to dissolve, although in some cases it may take longer. The fully reconstituted medicinal product will appear clear to slightly opalescent, colourless to pale brownish-yellow and may have a few small bubbles or foam around the edge of the vial. Because of the viscosity of the reconstituted medicinal product care must be taken to withdraw all of the medicinal product from the vial before expelling any air or excess solution from the syringe in order to obtain the 1.2 ml.

XOL_POW_API_FEB24 V4                                          Based on EU SmPC DEC23 Any unused medicinal product or waste material should be disposed of in accordance with local requirements.