Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
α,α Trehalose dihydrate
Sodium dihydrogen phosphate monohydrate
Disodium phosphate anhydrous
Polysorbate 20
Sterile Water for injections

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



Shelf life of the diluted medicinal product
Chemical and physical in-use stability has been demonstrated for 30 days at 2°C to 8°C plus an additional 48 hours at 2°C to 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
Do not shake the vial.

Avastin should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution. A sterile needle and syringe should be used to prepare Avastin.

The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution for injection.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 Avastin 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 Avastin and polyvinyl chloride or polyolefine bags or infusion sets have been observed.

Avastin 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.

7.    MARKETING AUTHORISATION HOLDER
Roche Pharmaceuticals (Israel) Ltd., P.O.Box 6391 Hod Hasharon 4524079.

8.    MARKETING AUTHORISATION NUMBER(S)
131.59.31060.00