Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Mannitol, cellulose microcrystalline, crospovidone, hypromellose, magnesium stearate, silica colloidal anhydrous, lactose monohydrate and butylated hydroxytoluene.

6.2   Incompatibilities

Not applicable.
6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.

The stability of the ready to use suspension has been demonstrated for 60 minutes. The suspension must be administered immediately after preparation. If not administered within 60 minutes, the suspension must be discarded and a new suspension must be prepared.

6.4   Special precautions for storage

Do not store above 30oC. Protect from ligth and moisture.
6.5 Nature and contents of container
Aluminium/polyamide/aluminium/PVC perforated unit-dose blister containing 10 x 1 dispersible tablets.

Votubia 2 mg dispersible tablets

Packs containing 30 dispersible tablets.
Votubia 3 mg dispersible tablets

Packs containing 30 dispersible tablets

Not all pack sizes may be marketed.


6.6   Special precautions for disposal and other handling

Instructions for use and handling

Using an oral syringe
The prescribed dose of Votubia dispersible tablets should be placed in a 10 ml oral dosing syringe graduated in 1 ml increments. A total of 10 mg of Votubia dispersible tablets per syringe using a maximum of 5 dispersible tablets must not be exceeded. If a higher dose or number of tablets is required, an additional syringe must be prepared. The dispersible tablets must not be broken or crushed. Approximately 5 ml of water and 4 ml of air should be drawn into the syringe. The filled syringe should be placed into a container (with the tip pointing up) for 3 minutes, until the Votubia dispersible tablets are in suspension. The syringe should be gently inverted 5 times immediately prior to administration. After administration of the prepared suspension, approximately 5 ml of water and 4 ml of air should be drawn into the same syringe, and the contents should be swirled to suspend remaining particles. The entire contents of the syringe should be administered.

Using a small glass
The prescribed dose of Votubia dispersible tablets should be placed in a small glass (maximum size 100 ml) containing approximately 25 ml of water. A total of 10 mg of Votubia dispersible tablets per glass using a maximum of 5 dispersible tablets must not be exceeded. If a higher dose or number of tablets is required, an additional glass must be prepared. The dispersible tablets must not be broken or crushed. Three minutes must be allowed for suspension to occur. The contents should be gently stirred with a spoon and then administered immediately. After administration of the prepared suspension, 25 ml of water should be added and be stirred with the same spoon to re-suspend any remaining particles. The entire contents of the glass should be administered.

A complete and illustrated set of instructions for use is provided at the end of the package leaflet “Instructions for use”.

Important information for caregivers

The extent of absorption of everolimus through topical exposure is not known. Therefore caregivers are advised to avoid contact with the suspension. Hands should be washed thoroughly before and after preparation of the suspension.

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, Israel