Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Water for injections.
Glycine,
Disodium hydrogen phosphate,
L-Leucine,
L-Isoleucine,
Calcium chloride,
Sodium dihydrogen phosphate,
Sodium chloride,
L-Threonine,
L-Glutamic acid,
L-Phenylalanine,
Polysorbate 20,
Urea

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product should 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).
Keep the pre-filled syringe in the outer carton, in order to protect from light.

For the purpose of ambulatory use, the patient may remove the medicinal product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.

6.5   Nature and contents of container

Pre-filled syringe (Type I glass) with a tip cap and a plunger stopper (bromobutyl rubber) with an injection needle (27G1/2).
- Recormon, 4000 IU/0.3 mL, 5000 IU/0.3 mL, 6000 IU/0.3 mL, 10, 000 IU/0.6 mL Pre-filled Syringes: Pack sizes of 6 pre-filled syringes and 6 needles.
- Recormon 30,000 IU / 0.6 mL Pre-filled syringe: Pack size of 4 pre-filled syringes and 4 needles.
Not all pack sizes may be marketed
6.6   Special precautions for disposal and other handling

First wash your hands!
1.     Remove one syringe from the pack and check that the solution is clear, colourless and practically free from visible particles. Remove the cap from the syringe.
2.     Remove one needle from the pack, fix it on the syringe and remove the protective cap from the needle.
3.     Expel air from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards. Keep pressing the plunger until the amount of Recormon in the syringe is as prescribed.
4.     Clean the skin at the site of injection using an alcohol wipe. Form a skin fold by pinching the skin between thumb and forefinger. Hold the syringe barrel near to the needle, and insert the needle into the skin fold with a quick, firm action. Inject the Recormon solution. Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.

This medicinal product is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.


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

8.    LICENSE NUMBERS

Recormon 4000 IU Pre-filled Syringe: 121 08 30142 00
Recormon 5000 IU Pre-filled Syringe: 114 42 29586 00
Recormon 6000 IU Pre-filled Syringe: 121 40 30195 00
Recormon 10, 000 IU Pre-filled Syringe: 114 43 29587 00
Recormon 30, 000 IU pre-filled Syringe: 132 41 31158 00