Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Sucrose
Succinic acid
Polysorbate 80
Edetate Disodium edetate (EDTA)
Sodium hydroxide (for pH adjustment)
Water for injection

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

A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).

6.3    Shelf life

Vial (unopened)
The expiry date of the product is indicated on the packaging materials.

Diluted medicinal product

Chemical and physical in-use stability has been demonstrated for a period of up to 35 days at 2°C to 8°C after dilution and a period of up to 48 hours at temperatures not exceeding 30°C in sodium chloride 9 mg/ml (0.9%) solution for injection. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.


6.4     Special precautions for storage

Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.

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

4 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 100 mg of bevacizumab.
16 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.

Pack of 1 vial.

6.6     Special precautions for disposal and other handling
Zirabev should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.

The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution for injection. The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/ml to 16.5 mg/ml. In the majority of the occasions the necessary amount of Zirabev can be diluted with 0.9% sodium chloride solution for injection to a total volume of 100 mL.

Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.

No incompatibilities between Zirabev and polyvinyl chloride or polyolefine bags or infusion sets have been observed.

Zirabev is for single-use only, as the product contains no preservatives. Any unused medicinal product or waste material should be disposed in accordance with local requirements.