Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Glycine
Sodium chloride
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Polysorbate 80
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
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 packging materials.

6.4 Special precautions for storage
Store and transport refrigerated (2°C-8°C).
This temperature range should be closely maintained until administration to the patient.
Do not freeze or shake.
Store in the original package in order to protect from light.
For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days. If the medicinal product has not been used at the end of this period, it should be disposed of.

6.5 Nature and contents of container
Pre-filled syringes (glass type I) with or without a needle safety guard, with plunger stopper (Teflon-faced rubber) sealed in a blister.
Pack of 1 or 6 syringes.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
Binocrit should not be used and be discarded
- if the liquid is coloured or you can see particles floating in it,
-        if the seal is broken,
-        if you know, or think that it may have been accidentally frozen, or -        if there has been a refrigerator failure.
The pre-filled syringes are ready to use (see section 4.2). The pre-filled syringe should not be shaken. Syringes are embossed with graduation rings in order to enable partial use if required.
Each graduation ring corresponds to a volume of 0.1 ml. The product is for single use only.
Only take one dose of Binocrit from each syringe discarding unwanted solution before injection.
Using the pre-filled syringe with a needle safety guard
The needle safety guard covers the needle after injection to prevent needle stick injury. This does not affect normal operation of the syringe. Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. While maintaining pressure on the plunger, remove the syringe from the patient. The needle safety guard will cover the needle when releasing the plunger.

Using the pre-filled syringe without a needle safety guard
Administer the dose as per standard protocol.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.