Source: Health Products Regulatory Authority (ZA) Revision Year: 2012 Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196
Onicit is indicated for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
For intravenous use.
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before the start of chemotherapy. ONICIT should be injected over 30 seconds.
Repeated dosing of ONICIT within a seven day interval is not recommended.
The efficacy of ONICIT in the prevention of nausea and vomiting induced by highly emetogenic chemotherapy may be enhanced by the addition of a corticosteroid administered prior to chemotherapy.
Use in patients under 18 years of age is not recommended until further data becomes available.
No dosage adjustment is necessary in the elderly.
No dosage adjustment is necessary for patients with impaired renal function.
No data is available for patients with end stage renal disease undergoing haemodialysis.
No dosage adjustment is necessary for patients with impaired hepatic function.
Single use only, any unused solution should be discarded.
No case of overdose has been reported.
Doses of up to 6 mg have been used in clinical trials. The highest dose group showed a similar incidence of adverse events compared to the other dose groups and no dose response effects were observed. In the unlikely event of overdose with ONICIT, this should be managed with supportive care. Dialysis studies have not been performed, however, due to the large volume of distribution; dialysis is unlikely to be an effective treatment for ONICIT overdose
Store at or below 25°C. Do not refrigerate.
Protect from light. Store vial in carton until required for use.
Upon opening of the vial, any unused solution should be discarded.
Keep out of reach of children.
ONICIT is supplied in a Type I glass vial with grey chlorobutyl rubber stopper and blue aluminium cap. It is available in packs of 1 vial containing 5 ml of solution.
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