ZANTAC INJECTION 25 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RANITIDINE AS HYDROCHLORIDE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

A02BA02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

RANITIDINE AS HYDROCHLORIDE 25 MG/ML

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

GLAXO SMITHKLINE MANUFACTURING S.P.A., ITALY

Therapeutic group:

RANITIDINE

Therapeutic area:

RANITIDINE

Therapeutic indications:

Adults:Zantac Injection is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post - operative ulcer, reflux oesophagitis, Zollinger - Ellison Syndrome and the following conditions where reduction of gastric secretion and acid output is desirable.The prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson’s Syndrome), particularly obstetric patients during labour. Children (6 months to 18 years):Zantac Injection is indicated for the short term treatment of peptic ulcer and the treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.

Authorization date:

2013-02-28

Summary of Product characteristics

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ZANTAC INJECTION 25 MG/ML
1.
NAME OF THE MEDICINAL PRODUCT
Zantac Injection 25 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ranitidine Hydrochloride 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.
3.
PHARMACEUTICAL FORM
Injection (Aqueous solution)
A clear colourless to pale yellow liquid, practically free from
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults:
Zantac Injection is indicated for the treatment of duodenal ulcer,
benign
gastric ulcer, post-operative ulcer, reflux oesophagitis,
Zollinger-Ellison
Syndrome and the following conditions where reduction of gastric
secretion
and acid output is desirable.
The prophylaxis of gastrointestinal haemorrhage from stress ulceration
in
seriously ill patients and before general anaesthesia in patients
considered to
be at risk of acid aspiration (Mendelson’s Syndrome), particularly
obstetric
patients during labour.
Children (6 months to 18 years):
Zantac Injection is indicated for the short term treatment of peptic
ulcer and
the treatment of gastro-oesophageal reflux, including reflux
oesophagitis and
symptomatic relief of gastro-oesophageal reflux disease.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
(See section 5.2 Pharmacokinetic properties – Other special
populations)
Posology
Adults (including elderly) / Adolescents (12 years and over)
Zantac Injection may be given either as a slow (over 2 minutes)
intravenous
injection up to a maximum of 50 mg, after dilution to a volume of 20
ml per
50 mg dose, which may be repeated every 6 to 8 hours; or as an
intermittent
intravenous infusion at a rate of 25 mg per hour for two hours; the
infusion
may be repeated at 6 to 8 hour intervals, or as an intramuscular
injection of 50
mg (2 ml) every 6 to 8 hours.
Prophylaxis of haemorrhage from stress ulceration:
In the prophylaxis of haemorrhage from stress ulceration in seriously
ill
patie