Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Ranitidine hydrochloride 28 mg/mL equivalent to ranitidine 25 mg/mL;
GlaxoSmithKline NZ Limited
Ranitidine hydrochloride 28 mg/mL (equivalent to ranitidine 25 mg/mL)
50mg/2mL
Solution for injection
Active: Ranitidine hydrochloride 28 mg/mL equivalent to ranitidine 25 mg/mL Excipient: Dibasic sodium phosphate Monobasic potassium phosphate Sodium chloride Water for injection
Ampoule, 2 mL ampoules, 5 dose units
Prescription
Prescription
Glaxo Wellcome Manufacturing Pte Ltd
ZANTAC Injection is indicated for the short-term treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-Ellison syndrome, and the following conditions where a reduction of gastric secretion and acid output is desirable: the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patients, the prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's) syndrome, particularly obstetric patients during labour.
Package - Contents - Shelf Life: Ampoule, 2 mL ampoules - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
1983-05-12
ZANTAC ® INJECTION 1 ZANTAC ® INJECTION _50 mg injection _ _Ranitidine hydrochloride _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start using Zantac injection. This leaflet does not have all information available about your medicine. If you have any questions about your medicine, you should ask your doctor or pharmacist. All medicines have some risks. Your doctor has weighed the risks of you using Zantac injection against the benefits he/she expects it will have for you. If there is anything you do not understand, ask your doctor or pharmacist. If you want more information, ask your doctor or pharmacist. WHAT ZANTAC IS USED FOR The medicine in your Zantac injection is called ranitidine (as hydrochloride). This belongs to a group of medicines called H2- antagonists. Zantac injection is used for short- term. It is used for: • reflux oesophagitis (also known as reflux) • stomach and duodenal ulcer disease (also known as peptic ulcer) • post-operative ulcer • Zollinger-Ellison disease – where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease. These problems are caused, in part, by too much acid in the stomach. This can lead to pain such as heartburn. Zantac works by reducing the amount of acid in the stomach. This reduces the pain and also allows the ulcer and reflux to heal. Zantac is also used to reduce stomach acid in the following situations: • prevention of bleeding from stress ulcers in seriously ill patients • prevention of later bleeding in patients with bleeding peptic ulcers • before general anaesthesia in patients at risk of inhaling their a Przeczytaj cały dokument
_ _ 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ZANTAC Injection 50 mg/2 mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ZANTAC contains 50 mg ranitidine (as the hydrochloride) in 2 mL aqueous solution (25 mg/mL) for injection . For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection ZANTAC Injection is a clear, colourless to pale yellow liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS_ _ ZANTAC Injection is indicated in adults for the short-term treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-Ellison syndrome, and the following conditions where a reduction of gastric secretion and acid output is desirable: the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patients, the prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's) syndrome, particularly obstetric patients during labour. For appropriate cases ZANTAC Tablets are also available (see ZANTAC Tablet Data Sheet). 4.2 DOSE AND METHOD OF ADMINISTRATION_ _ Dose Adults ZANTAC Injection may be given as:- - a slow (over 2 minutes) intravenous injection of 50 mg, diluted to a volume of 20 mL, every 6-8 hours. - an intermittent intravenous infusion at 25 mg/hour for two hours, repeated at 6-8 hour intervals. - an intramuscular injection of 50 mg every 6-8 hours. In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patients a priming dose of 50 mg as a slow intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/h may be preferred. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration parenteral administration may be continued until oral feeding commences. Patients _ _ 2 consi Przeczytaj cały dokument