GRANTRYL Solution for injection Ref.[51215] Active ingredients: Granisetron

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686

Product name and form

Grantryl 1 mg/1 ml.

Grantryl 3 mg/3 ml.

Pharmaceutical Form

Injection.

Qualitative and quantitative composition

GRANTRYL 1 mg/1 ml: Ampoules containing granisetron 1 mg (as hydrochloride) in 1 ml aqueous solution.

GRANTRYL 3 mg/3 ml: Ampoules containing granisetron 3 mg (as hydrochloride) in 3 ml aqueous solution.

Sugar free.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Granisetron

Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors). Pharmacological studies have demonstrated that granisetron is effective against nausea and vomiting as a result of cytostatic therapy.

List of Excipients

Citric acid monohydrate
Sodium citrate
Sodium chloride
Water for injection
Nitrogen

Pack sizes and marketing

Identification

GRANTRYL 1 mg/1 ml: A clear Type 1 glass ampoule containing a clear colourless solution. The content allows withdrawal of 1 ml.

GRANTRYL 3 mg/3 ml: A clear Type 1 glass ampoule containing a clear colourless solution. The content allows withdrawal of 3 ml.

Presentations

GRANTRYL 1 mg/1 ml: Packs of 5 × 1 ml Type I glass ampoules, packed in a PVC tray, contained in a cardboard carton

GRANTRYL 3 mg/3 ml: Packs of 5 × 5 ml Type I glass ampoules, packed in a PVC tray, contained in a cardboard carton.

Marketing authorization holder

Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686

Marketing authorization dates and numbers

GRANTRYL 1 mg/1 ml: 44/5.7.2/0892
GRANTRYL 3 mg/3 ml: 44/5.7.2/0893

Registration date: 27 November 2014

Drugs

Drug Countries
GRANTRYL South Africa

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