Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Water for injection


ILR API Dec21 V4                        Based on EU SmPC 28.09.2021
Mannitol
L-Histidine/L-Histidine hydrochloride monohydrate
Polysorbate 80 low peroxide
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.
From a microbiological point of view, the product should be used immediately after first opening.
6.4   Special precautions for storage
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package in order to protect from light.

6.5     Nature and contents of container

1 mL of solution for injection in a vial (type I glass) with a stopper (laminated chlorobutyl rubber) and flip-off cap (aluminium).

Packs containing 1 vial.

6.6   Special precautions for disposal and other handling
Ilaris 150 mg/mL solution for injection is supplied in a single-use vial for individual use.

Instructions for administration
Allow the vial to warm to room temperature before injection. The solution should be practically free of visible particles and clear to opalescent. The solution should be colourless or may have a slight brownish- yellow tint. Using an 18 G or 21 G x 2 inch needle (or similar as available on the market) and a 1 ml syringe, carefully withdraw the required volume depending on the dose to be administered. Once the required volume is withdrawn, recap and remove the withdrawal needle from the syringe and attach a 27 G x 0.5 inch needle (or similar as available on the market) to immediately inject the solution subcutaneously.

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

7. Registration Holder and Importer:

Novartis Israel Ltd.,
P.O.B 7126, Tel Aviv