3 years
After first opening: the solution for injection is for single use only. Unused solution for injection must be discarded.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
This medicinal product should not mixed with blood for transfusion or with solutions containing penicillin.
Water for injections
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. Epileptogenic activity has been observed in animals with intrathecal use of tranexamic acid.
03/2016
Pfizer Limited
Ramsgate Road
Sandwich
CT13 9NJ
UK
Packs with 5, 6 or 10 Type I glass 5 mL ampoules in an outer carton, each ampoule containing 500 mg tranexamic acid.
Packs with 10 x 1 Type I glass 5 mL ampoules in an outer carton, each ampoule containing 500 mg tranexamic acid.
Not all pack sizes may be marketed.
PL 00057/0952
Cyklokapron for injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions and dextran solutions. Heparin may be added to Cyklokapron injection.
Cyklokapron for injection is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
9th February 1987
