Land: Israel
Språk: engelska
Källa: Ministry of Health
RANITIDINE AS HYDROCHLORIDE
GLAXO SMITH KLINE (ISRAEL) LTD
A02BA02
SOLUTION FOR INJECTION
RANITIDINE AS HYDROCHLORIDE 25 MG/ML
I.M, I.V
Required
GLAXO SMITHKLINE MANUFACTURING S.P.A., ITALY
RANITIDINE
RANITIDINE
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.
2013-02-28
Page 1 of 10 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. Page 2 of 10 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 Läs hela dokumentet