Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1    List of excipients
Glycine
Sodium chloride
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Polysorbate 80
Water for injections

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 to 8°C). This temperature range should be closely maintained until administration to the patient. Store in the original package in order to protect from light. Do not freeze or shake.

For the purpose of ambulatory use, the product may be taken out of the refrigerator, without being replaced, for a maximum period of 3 days at a temperature not above 25°C. If the medicine has not been used at the end of this period, it should be disposed of.

6.5 Nature and contents of container
EPREX 2,000 IU/mL solution for injection in pre-filled syringe
0.5 mL (1,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack size of 6.

EPREX 4,000 IU/mL solution for injection in pre-filled syringe
0.5 mL (2,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of 
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 latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack size of 6.

EPREX 10,000 IU/mL solution for injection in pre-filled syringe
0.3 mL (3,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack size of 6.

0.4 mL (4,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack size of 6.

0.5 mL (5,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle caver (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack size of 6.

0.6 mL (6,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack size of 6.

0.8 mL (8,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack size of 6.

1.0 mL (10,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack size of 6
EPREX 40,000 IU/mL solution for injection in pre-filled syringe
0.5 mL (20,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack sizes of 1,4 or 6.

0.75 mL (30,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon-faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack sizes of 1,4 or 6.

1.0 mL (40,000 IU) of solution for injection in a pre-filled syringe (type I glass) with plunger (Teflon- faced rubber) and needle with a needle cover (liner contains dry natural rubber [a derivative of latex] with polypropylene cap) and a PROTECS™ needle guard device (polycarbonate) attached to the syringe - pack sizes of 1,4 or 6.


6.6 Special precautions for disposal and other handling
The product should not be used, and discarded
•     if the seal is broken,
•     if the liquid is coloured or you can see particles floating in it, 
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•     if you know, or think that it may have been accidentally frozen, or •     if there has been a refrigerator failure.

The product is for single use only. Only take one dose of EPREX from each syringe. In case only a partial dose of the syringe is required, the cover should be removed before the plunger is pushed up to the desired graduation mark to remove unwanted solution before injection. Refer to section 3. How to use EPREX (instructions on how to inject EPREX) of the package leaflet.

The pre-filled syringes are fitted with the PROTECS™ needle guard device to help prevent needle stick injuries after use. The package leaflet includes full instructions for the use and handling of pre-filled syringes with the PROTECS™ needle guard.

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

6.7 Graduation marks
The syringe label contains numbered graduation marks to provide for the administration of a part of the dose (see Section 6.6). However, the product is for single use only. Only one dose of EPREX from each syringe should be taken

7      MARKETING AUTHORISATION HOLDER

J-C Health Care Ltd., Kibbutz Shefayim 6099000, Israel.