GRANISETRON Concentrate for solution for injection or infusion Ref.[8216] Active ingredients: Granisetron

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: hameln pharma plus gmbh, Langes Feld 13, 31789, Hameln, Germany

Product name and form

Granisetron 1 mg/ml concentrate for solution for injection or infusion.

Pharmaceutical Form
Concentrate for solution for injection or infusion. The solution for injection is a clear, colourless liquid.

Qualitative and quantitative composition

The active substance is granisetron hydrochloride.

1ml concentrate for solution for injection or infusion contains 1.12 mg granisetron hydrochloride equivalent to 1 mg granisetron.

3 ml concentrate for solution for injection or infusion contains 3.36 mg granisetron hydrochloride equivalent to 3 mg granisetron.

This medicine contains:

a maximum of 27.7 mg (or 1.2 mmol) sodium per 1 ml ampoule, equivalent to 1.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
a maximum of 83.1 mg (or 3.6 mmol) sodium per 3 ml ampoule, equivalent to 4.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

For the 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
Sodium chloride Citric acid monohydrate Sodium hydroxide (for pH adjustment) Water for injections

Pack sizes and marketing

1 and 3 ml colourless ampoules.

Pack sizes: 5 × 1 ml, 10 × 1 ml, 5 × 3 ml and 10 × 3 ml

Not all pack sizes may be marketed.

Marketing authorization holder

hameln pharma plus gmbh, Langes Feld 13, 31789, Hameln, Germany

Marketing authorization dates and numbers

PL 25215/0019

Date of first authorisation: 04/07/2008
Date of latest renewal: 11/05/2013

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