5 years
Not applicable.
Glycerol
Methyl parahydroxybenzoate
Propyl parahydroxybenzoates
Sodium acetate
Acetic acid
Purified water
Single doses of piracetam yielded LD 50 values at 26 g/kg in mice but LD 50 values were not reached in rats. In dogs, clinical signs after acute oral dosing were mild and lethality was not observed at the maximum tested dose of 10 g/kg.
Repeated oral treatment for up to 1 year in dogs (10 g/kg) and 6 months in rats (2 g/kg) was very well tolerated: no target organ toxicity or signs of (irreversible) toxicity were clearly demonstrated. Safe dose levels represent a multiple of the maximum intended human daily dose of 0.4 g/kg.
In terms of exposure (Cmax) safe levels obtained in the rat and the dog represent respectively 8 fold and 50 fold of the maximum human therapeutic level. AUC levels obtained in the same animals were a multiple of the human AUC level at the maximum intended daily dose.
The only change which might eventually be attributed to chronic treatment in male, but not in female, rats was an increase of the incidence over control animals of progressive glomerulonephrosis at the dose of 2.4 g/k/day given for 112 weeks.
Although piracetam crosses the placenta into the foetal circulation, no teratogenic effects were observed at dose levels up to 4.8 g/kg/day (mice, rats) and 2.7 g/kg/day (rabbits). Furthermore, the compound affects neither fertility nor the peri- or postnatal development of the pregnancy at doses up to 2.7 g/kg/day.
Piracetam was found to be devoid of any mutagenic or clastogenic activity and does not represent any genotoxic or carcinogenic risk to man.
09/02/2017
UCB Pharma Ltd.
208 Bath Road
Slough
Berkshire
SL1 3WE
None
Glass bottle containing 125 or 300 ml solution.
Not all pack sizes may be marketed.
PL 00039/0534
No special requirements.
Date of first authorisation: 14 December 1992
Date of latest renewal: 18 November 2004
