ZANTAC Injection (Aqueous solution) Ref.[7070] Active ingredients: Ranitidine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Glaxo Wellcome UK Ltd, T/A GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Product name and form

Zantac Injection 50 mg/2ml.

Pharmaceutical Form

Injection (Aqueous solution).

A clear colourless to pale yellow liquid, practically free from particles.

Qualitative and quantitative composition

Ranitidine Hydrochloride HSE 56.0 mg/2ml equivalent to Ranitidine 50.0 mg/2ml.

Each ampoule contains 2.9 mg (0.09 mmol) of sodium and 0.6 mg (0.015 mmol) of potassium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ranitidine

Ranitidine is a specific rapidly acting histamine H2-antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both the volume and the acid and pepsin content of the secretion. Ranitidine has a relatively long duration of action and so a single 150 mg dose effectively suppresses gastric acid secretion for twelve hours.

List of Excipients

Sodium chloride BP
Potassium dihydrogen orthophosphate HSE
Disodium hydrogen orthophosphate HSE
Water for injection BP

Pack sizes and marketing

2 ml colourless Type I glass ampoules.

Pack size: 5 ampoules.

Marketing authorization holder

Glaxo Wellcome UK Ltd, T/A GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Marketing authorization dates and numbers

PL 10949/0109

25 March 1998

Drugs

Drug Countries
ZANTAC Australia, Canada, Cyprus, Estonia, Hong Kong, Lithuania, New Zealand, Poland, Singapore, Turkey, United States, South Africa

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