ONICIT Solution for injection Ref.[50456] Active ingredients: Palonosetron

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2012  Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196

Product name and form

ONICIT (solution for injection).

Pharmaceutical Form

Solution for injection.

Clear, essentially colourless solution free from evidence of contamination.

Qualitative and quantitative composition

Each 1 ml of solution contains 50 micrograms palonosetron (as hydrochloride).

Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride). ONICIT solution is an isotonic solution for injection.

Inactive excipients: Mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injection, sodium hydroxide solution and hydrochloric acid solution.

Active Ingredient Description
Palonosetron

Palonosetron is a selective high-affinity receptor antagonist of the 5HT3 receptor.

List of Excipients

Pack sizes and marketing

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.

Marketing authorization holder

Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196

Marketing authorization dates and numbers

A40/5.10/0322

Drugs

Drug Countries
ONICIT Brazil, Mexico, New Zealand, South Africa

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