Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
Water for injection
Hydrochloric acid (to adjust pH)
Sodium hydroxide (to adjust pH)

6.2   Incompatibilities
Not applicable.

6.3   Shelf life

The expiry date of the product is indicated on the label and packaging.
Atriance is stable for up to 8 hours at up to 30°C once the vial is opened.

6.4   Special precautions for storage

Store below 25°C. For storage conditions after first opening of the medicinal product see section 6.3.

6.5   Nature and contents of container

Clear glass (Type I) vial with a bromobutyl rubber stopper, and an aluminium seal with a red snap-off cap.

Each vial contains 50 ml of solution. Atriance is supplied in packs of 1 vial or 6 vials.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
The normal procedures for proper handling and disposal of cytotoxic anti-tumour medicinal products should be adopted, namely:

— Staff should be trained in how to handle and transfer the medicinal product.

— Pregnant staff should be excluded from working with this medicinal product.
— Personnel handling this medicinal product during handling/transfer should wear protective clothing including mask, goggles and gloves.

— All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. Any liquid waste from the preparation of the nelarabine solution for infusion may be flushed with large amounts of water.

— Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
ATR API AUG21 V1                                                                               EU SmPC 11.20 Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


8.    REGISTRATION HOLDER AND IMPORTER AND ITS ADDRESS
Novartis Israel Ltd.
POB 7126, Tel Aviv