Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Powder
Sucrose
Disodium phosphate dihydrate
Sodium dihydrogen phosphate monohydrate
Methionine
Polysorbate 20
Phosphoric acid, concentrated (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Solvent
Water for injections

6.2    Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3    Shelf life

Unopened vials
3 years.
Reconstituted solution
Pergoveris is for an immediate and single use following first opening and reconstitution therefore the product may not be stored once opened and reconstituted.

6.4    Special precautions for storage

Do not store above 25°C.
Store in the original package in order to protect from light.
6.5    Nature and contents of container
Powder: 3 ml vials (Type I glass) with a stopper (bromobutyl rubber) and aluminium flip- off cap.
1 vial contains 11 micrograms r-hFSH and 3 micrograms r-hLH.

Solvent: 3 ml vials (Type I glass) with a Teflon coated rubber stopper and aluminium flip- off cap.
1 vial of solvent contains 1 ml of water for injections.

The package contains: 1 powder vial and 1 solvent vial.

6.6    Special precautions for disposal and other handling

For immediate and single use following first opening and reconstitution.

Reconstitution
The pH of the reconstituted solution is 6.5-7.5.
Pergoveris must be reconstituted with the solvent before use by gentle swirling.
The reconstituted solution should not be administered if it contains particles or is not clear.

Pergoveris may be mixed with follitropin alfa and co-administered as a single injection.

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


7.     MARKETING AUTHORISATION NUMBER
145-07-33159-00

8.  REGISTRATION HOLDER
Merck Serono Ltd, 18 Hakishon,Yavne 81220