Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sucrose 92.35 mg per vial
L-Histidine
L-Histidine hydrochloride monohydrate
Polysorbate 80
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 printed on the package materials.
After reconstitution, from a microbiological point of view, the product should be used immediately. 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 24 hours at 2°C - 8°C.

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.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5     Nature and contents of container

150 mg of powder for solution for injection in a vial (type I glass) with a stopper (coated chlorobutyl rubber) and flip-off cap (aluminium).

Packs containing 1 vial or multipacks containing 4 (1X4) vials.

ILA API MAR17 CL V6                                         REF EMA SmPC APP 2.3.17 Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

Ilaris 150 mg powder for solution for injection is supplied in a single-use vial for individual use. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Instructions for reconstitution
Using aseptic technique, reconstitute each vial of Ilaris at room temperature (typically 15°C to 25°C) by slowly injecting 1 ml water for injections with a 1 ml syringe and an 18 G x 2 inch (50 mm) needle. Swirl the vial slowly at an angle of about 45° for approximately 1 minute and allow to stand for about 5 minutes.
Then gently turn the vial upside down and back again ten times. If possible, avoid touching the rubber stopper with your fingers. Allow to stand for about 15 minutes at room temperature to obtain a clear to opalescent solution. Do not shake. Do not use if particles are present in the solution.

Tap the side of the vial to remove any residual liquid from the stopper. The solution should be free of visible particles and clear to opalescent. The solution should be colourless or may have a slight brownish- yellow tint. If the solution has a distinctly brown discolouration it should not be used. If not used immediately after reconstitution, the solution should be kept at 2°C to 8°C and used within 24 hours.

Instructions for administration
Carefully withdraw the required volume depending on the dose to be administered (0.1 ml to 1.0 ml) and subcutaneously inject using a 27 G x 0.5 inch (13 mm) needle.

Disposal
The healthcare professional should dispose of, by appropriate procedure, the vials, syringes and needles in accordance with local requirements.


7. Manufacturer:
Novartis Pharma Stein AG, Stein, Switzerland for Novartis Pharma AG, Basel, Switzerland.
8. Registration Holder:
Novartis Israel Ltd., 36 Shacham St., Petach-Tikva.