Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Powder for solution for injection (vial):
Mannitol
Hydrochloric acid (for pH adjustment)
Solvent (ampoule):
Sodium chloride
Hydrochloric acid (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 packaging materials 
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
The reconstituted solution must be used immediately after reconstitution.

6.5 Nature and contents of container
Type I glass vial with bromobutyl rubber stopper and type I glass ampoule.
The vial contains terlipressin acetate 1 mg. The ampoule has a coloured dot indicating the cut area and contains 5 ml of clear, colourless solvent.
Pack size. The package contains 5 sets of 1 vial + 1 ampoule

6.6 Special precautions for disposal and other handling
Reconstitute Glypressin with the solvent provided immediately prior to use. For single use only. Discard any unused solution.

7.    Manufacturer:
Ferring GmbH, Germany.