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Author: Admin | 2025-04-28
Bone marrow.Carcinogenicity. The carcinogenic potential of rizatriptan was evaluated in a 106 week study in rats and a 100 week study in mice at oral doses of up to 125 mg/kg/day. Exposure data were not obtained in those studies, but plasma AUC's of the parent drug were measured in other studies and indicate that exposures to the parent drug at the highest dose level would have been approximately 150 times (mice) and 240 times (rats) average AUC's measured in humans after three 10 mg doses, the maximum recommended daily dose. There was no evidence of an increase in tumour incidence related to rizatriptan in either species.6 Pharmaceutical Particulars6.1 List of ExcipientsEach lyophilised wafer contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and Peppermint NAEFCO P0551 957685 (ARTG ID: 2890).6.2 IncompatibilitiesIncompatibilities were either not assessed or not identified as part of the registration of this medicine.6.3 Shelf LifeThe expiry date can be found on the packaging. In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).6.4 Special Precautions for StorageStore at room temperature below 30°C. For the wafer, the patient should be instructed not to remove the blister from the outer aluminium sachet until the patient is ready to consume the wafer inside.6.5 Nature and Contents of Container5 mg wafer - Supplied in packs of 2, 3 or 6 wafers.#10 mg wafer - Supplied in a starter pack of 1 wafer# or 2 wafers (sample pack only not for sale), and trade packs of 2, 3# or 6# wafers.#Presentation not currently supplied in Australia.Maxalt wafers are available in PVC/PVDC/Al blisters.6.6 Special Precautions for DisposalIn Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.6.7 Physicochemical PropertiesRizatriptan benzoate is described chemically as:
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