Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Cysteine hydrochloride monohydrate
Disodium phosphate dihydrate
Hydrochloric acid
Mannitol
Sodium hydroxide
Water for injections.

6.2 Incompatibilities

PERFALGAN should not be mixed with other medicinal products.
6.3 Shelf life

2 years.
From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Text for the 50ml vial:
If diluted in 0.9% sodium chloride or 5% glucose, the solution should also be used immediately.
However, if the solution is not used immediately, do not store for more than 1 hour (infusion time included).

6.4 Special precautions for storage

Do not store above 30°C. Do not refrigerate or freeze.
6.5 Nature and contents of container 

50 ml and 100 ml Type II clear glass vial with bromobutyl stopper and a aluminium/plastic Flip-Off cap.
Pack size: pack of 12 vials.

6.6 Special precautions for disposal 
Use a 0.8 mm needle and vertically perforate the stopper at the spot specifically indicated.

Before administration, the product should be visually inspected for any particulate matter and discoloration. For single use only. Any unused solution should be discarded.
The diluted solution should be visually inspected and should not be used in presence of opalescence, visible particulate matters or precipitate.