Not applicable.
Repeated dose toxicity studies of six months duration in dogs and 18 months duration in albino rats revealed no clinically relevant harmful effects at dose levels in the range 2.5 to 120 mg. kg -1. Vertiserc is devoid of mutagenic potential and there was no evidence of carcinogenicity in rats. Tests conducted on pregnant rabbits showed no evidence of teratological effects.
Chronic toxicity
Adverse reactions affecting the central nervous system were seen in dogs and baboons after intravenous doses of 120 mg / kg and higher.
Studies on chronic oral toxicity over a period of 18 months in rats with a dose of 500 mg / kg and for 6 months in dogs with a dose of 25 mg / kg indicate that betahistine is well tolerated without definitive toxicity.
Mutagenic and carcinogenic potential Betahistine has no mutagenic potential.
In an 18-month chronic toxicity study in rats with a dose up to 500 mg / kg, there was no evidence of carcinogenic potential.
Reproductive toxicity
During reproductive toxicity studies, effects were only seen at exposures considered to be well above the maximum human exposure, indicating minimal relevance during clinical use.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
