Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Sucrose
L-Histidine
Glacial Acetic Acid
Polysorbate 20
Sterile Water for Injection

6.2     Incompatibilities

Glucose (5%) solution should not be used to dilute Perjeta since it is chemically and physically unstable in such solutions.

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

6.3     Shelf life

Unopened vials
The expiry date of the product is indicated on the packging materials.
Diluted solution

Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C and up to 30 days at 2°C to 8°C protected from light.
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 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

Vial (Type I glass) with a stopper (butyl rubber) containing 14 ml of solution.
Pack of 1 vial.

6.6     Special precautions for disposal and other handling

Perjeta does not contain any antimicrobial preservative. Therefore, care must be taken to ensure the sterility of the prepared solution for infusion and should be prepared by a healthcare professional.

Perjeta is for single use only.

The vial must not be shaken. 14 ml of Perjeta concentrate should be withdrawn from the vial using a sterile needle and syringe and diluted into a 250 ml PVC or non-PVC polyolefin infusion bag of sodium chloride 9 mg/ml (0.9%) solution for infusion. After dilution, one ml of solution should contain approximately 3.02 mg of pertuzumab (840 mg/278 ml) for the initial dose where two vials are required and approximately 1.59 mg of pertuzumab (420 mg/264 ml) for the maintenance dose where one vial is required.
The bag should be gently inverted to mix the solution in order to avoid foaming.

Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration. If particulates or discoloration are observed, the solution should not be used. Once the infusion is prepared it should be administered immediately (see section 6.3).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Perjeta is compatible with polyvinylchloride (PVC) or non-PVC polyolefin bags including polyethylene.

7.      MARKETING AUTHORISATION HOLDER

Roche Pharmaceuticals (Israel) Ltd., P.O.B 6391, Hod Hasharon 4524079.

8.      MARKETING AUTHORISATION NUMBER(S)

149.26.33749.00