Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Water for injections
Mannitol
Sodium sulphate anhydrous
L- Methionine
Sodium dihydrogen phosphate monohydrate
Poloxamer 188
Diluted Hydrochloric acid
Sodium hydroxide diluted solution

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials 
6.4   Special precautions for storage

Store in a refrigerator (2˚C – 8˚C).
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 30°C for one single period of 1 month. Once removed from the refrigerator the medicinal product must be used within this period.


6.5   Nature and contents of container
Pre-filled syringe (type I glass) with laminated plunger stopper (bromobutyl rubber) and tip cap (bromobutyl rubber) and a needle 27G1/2.
Prefilled syringes 50, 75, 100, 150 and 200 micrograms contain 0.3 ml solution.

Pre-filled syringe 360 micrograms contains 0.6 ml solution.
Pack size of 1 pre-filled syringe.

6.6   Special precautions for disposal and other handling
The pre-filled syringe is ready for use. The sterile pre-filled syringe does not contain any preservative and is to be used for a single injection only. Only one dose should be administered per syringe. Only solutions which are clear, colourless to slightly yellowish and free of visible particles must be injected.
Do not shake.
Allow the pre-filled syringe to reach room temperature before injecting.

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)

MIRCERA 50 mcg/0.3 ml              1 pre-filled syringe          138.53.31749.00 MIRCERA 75 mcg/0.3 ml              1 pre-filled syringe          138.54.31750.00 MIRCERA 100 mcg/0.3 ml             1 pre-filled syringe          138.55.31751.00 MIRCERA 150 mcg/0.3 ml             1 pre-filled syringe          138.56.31752.00 MIRCERA 200 mcg/0.3 ml             1 pre-filled syringe          138.57.31753.00 MIRCERA 360 mcg/0.6 ml             1 pre-filled syringe          140.01.31905.00 
**Not all strengths may be marketed.