Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Recombinant human hyaluronidase (rHuPH20)
Sucrose
α,α-Trehalose Dihydrate
L-Histidine Hydrochloride Monohydrate
L-Methionine
L-Histidine
Polysorbate 20
Water for injections

6.2   Incompatibilities
Phesgo is a ready to use solution which should not be mixed or diluted with other products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Once transferred from the vial to the syringe the medicinal product is physically and chemically stable for 28 days at 2 °C-8 °C protected from light and for 24 hours (cumulative time in the vial and the syringe) at ambient temperature (maximum 30 °C) in diffused daylight.

As Phesgo does not contain any antimicrobial-preservative, from a microbiological point of view, the medicinal 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 preparation of the syringe 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. Do not shake.
Keep the vial in the outer carton in order to protect from light.

For storage conditions of the opened medicinal product, see sections 6.3 and 6.6.

6.5   Nature and contents of container

Phesgo 600 mg/600 mg solution for injection

Pack of one 15 mL type I borosilicate glass vial tapered with fluororesin-laminated rubber stopper, containing 10 mL solution of 600 mg of pertuzumab and 600 mg of trastuzumab.
The stopper is sealed with aluminium and covered by an orange plastic flip-off cap.

Phesgo 1200 mg/600 mg solution for injection

Pack of one 20 mL type I borosilicate glass vial tapered with fluororesin-laminated rubber stopper, containing 15 mL solution of 1200 mg of pertuzumab and 600 mg of trastuzumab.
The stopper is sealed with aluminum and covered by a cool green plastic flip-off cap.

6.6   Special precautions for disposal and other handling

Phesgo should be inspected visually to ensure there is no particulate matter or discolouration prior to the administration. If particulate matter or discoloration is observed the vial should be discarded per local disposal guidelines.

Do not shake the vial.

A syringe, a transfer needle and an injection needle are needed to withdraw Phesgo solution from the vial and inject it subcutaneously. Phesgo may be injected using hypodermic injection needles with gauges between 25G-27G and lengths between 3/8"(10 mm)-5/8"(16 mm). Phesgo is compatible with stainless steel, polypropylene, polycarbonate, polyethylene, polyurethane, polyvinyl chloride and fluorinated ethylene polypropylene.

As Phesgo does not contain any antimicrobial-preservative, from a microbiological point of view, the medicinal product should be used immediately. If not used immediately, preparation should take place in a controlled and validated aseptic conditions. After transfer of the solution to the syringe, it is recommended to replace the transfer needle by a syringe closing cap to avoid drying of the solution in the syringe and not compromise the quality of the medicinal product. Label the syringe with the peel- off sticker. The hypodermic injection needle must be attached to the syringe immediately prior to administration followed by volume adjustment to 15 mL if Phesgo 1200 mg/600 mg is used or 10 mL if Phesgo 600 mg/600 mg is used.

Phesgo is for single use only. Any unused medicinal product or waste material should be disposed of 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)
Phesgo 1200 mg/600 mg – 168-67-36651-00
Phesgo 600 mg/600 mg – 168-66-36650-00