Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Phenol
Polysorbate 20
L-methionine
Sodium sulphate decahydrate
Disodium hydrogen phosphate dodecahydrate
Phosphoric acid, concentrated (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)
Water for injections

6.2   Incompatibilities
Not applicable.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials In use: 28 days when stored at or below 25 °C.

6.4   Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Store in the original package in order to protect from light.
REKOVELLE may be removed from the refrigerator, without being refrigerated again, and stored at or below 25 °C for up to 3 months including the period after first use. It must be discarded afterwards.
For storage conditions after first use of the medicinal product, see section 6.3.

6.5   Nature and contents of container

REKOVELLE 12 mcg pack, contains 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). Each cartridge contains ≥ 0.427mL of solution (extractable volume).
Pack size: 1 pre-filled pen and 3 injection needles (stainless steel).
REKOVELLE 36 mcg pack, contains 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). Each cartridge contains ≥ 1.147 mL of solution (extractable volume).
Pack size:
1 pre-filled pen and 6 or 9 injection needles (stainless steel).
Not all pack size may be marketed

REKOVELLE 72 mcg pack, contains 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber). Each cartridge contains ≥ 2.225 mL of solution (extractable volume).
Pack size:
1 pre-filled pen and 9 or 15 injection needles (stainless steel).
Not all pack size may be marketed

6.6    Special precautions for disposal and other handling

The solution should not be administered if it contains particles or is not clear.
The instructions for use of the pen must be followed. Discard used needles immediately after injection.

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