Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
ranitidine hydrochloride, Quantity: 28 mg/mL (Equivalent: ranitidine, Qty 25 mg/mL)
Aspen Pharmacare Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride
Intravenous
5x2mL
(S4) Prescription Only Medicine
INDICATIONS AS AT 2 NOVEMBER 1993: 1. Short-term treatment of proven duodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage. 2. Maintenance treatment to reduce the risk of relapse in duodenal ulcer. 3. Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer. 4. Treatment of gastrinoma (Zollinger-Ellison syndrome). 5. Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative anti-reflux measures and simple drug therapies such as antacids.INDICATIONS AS AT 11 FEBRUARY 2005: 6. Maintenance treatment to reduce the risk of relapse of reflux oesophagitis. 7. Treatment of scleroderma oesophagitis. The intravenous injection is indicated where oral treatment is inappropriate.
Visual Identification: Clear colourless to pale yellow liquid, practically free from visible particles.; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-08-13
ZANTAC ® INJECTION 1 ZANTAC ® INJECTION _ranitidine hydrochloride _ CONSUMER MEDICINE INFORMATION ABOUT YOUR ZANTAC INJECTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN YOUR MEDICINE BY A DOCTOR OR NURSE. This leaflet does not have the complete information available about your medicine. If you have any questions about your medicine, you should ask your doctor or pharmacist (also known as chemist). All medicines have some risks. Sometimes new risks are found even when a medicine has been used for many years. If there is anything you do not understand, ask your doctor or pharmacist . If you want more information, ask your doctor or pharmacist. WHAT IS IN MY ZANTAC INJECTION? The medicine in your Zantac injection is called ranitidine (as hydrochloride). This belongs to a group of medicines called H2- antagonists. WHAT DOES MY ZANTAC INJECTION DO? Zantac injection is used to stop ulcers bleeding and other conditions caused by too much acid in the stomach. Zantac works by reducing the amount of acid in the stomach. This reduces the pain and also allows the ulcer and reflux to heal. BEFORE YOU HAVE A ZANTAC INJECTION? _DO NOT TAKE IF: _ You must not take Zantac if: • you have ever had an allergic (hypersensitive) reaction to ranitidine or any of the ingredients listed towards the end of this leaflet. • the expiry date (EXP) printed on the pack has passed • the packaging is torn or shows signs of tampering _TELL YOUR DOCTOR IF _ You must tell your doctor if: • you are allergic to foods, dyes, preservatives or any other medicines • you have ever had an allergic (hypersensitive) reaction to ranitidine or any of the ingredients listed towards the end of this leaflet. • you are allergic to any medicine, • you have stomach cancer • you have kidney disease • you have heart disease, • you have had stomach ulcers before and you are taking Non- Steroidal Anti-Inflammatory (NSAID) medicines. • you have a disease known as acute porphyria. • you are over 65 years of age. • you have lung dise Прочетете целия документ
Zantac ranitidine (as hydrochloride) PI Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION ZANTAC RANITIDINE (AS HYDROCHLORIDE) TABLETS, DISPERSIBLE TABLETS, EFFERVESCENT TABLETS, ORAL LIQUID AND INJECTION 1. NAME OF THE MEDICINE: Ranitidine hydrochloride. 2. AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Zantac 150 mg tablets are white film-coated tablets engraved “RAN 150” on one face and plain on the other. The tablets contain 150 mg ranitidine (as hydrochloride). Zantac 300 mg tablets are white capsule-shaped, film-coated tablets engraved “RAN 300” on one face and plain on the other. The tablets contain 300 mg ranitidine (as hydrochloride). Zantac 150 mg dispersible tablets are white, capsule-shaped, film-coated tablets with a breakline on one face. The tablets contain 150 mg ranitidine (as hydrochloride). These tablets also contain saccharin sodium as an excipient. Zantac 150 mg effervescent tablets are white to pale yellow, round, bevelled tablets debossed “GS LHK” on one side and flat on the other. The tablets contain 150 mg of ranitidine (as hydrochloride). Each 150 mg tablet contains 328 mg (14.3 mEq) sodium, as well as aspartame and sodium benzoate as excipients. Zantac 300 mg effervescent tablets are white to pale yellow, round, bevelled tablets debossed “GS MJG” on one side and flat on the other. The tablets contain 300 mg of ranitidine (as hydrochloride). Each 300 mg tablet contains 479 mg (20.8 mEq) sodium, as well as aspartame and sodium benzoate as excipients. Zantac oral liquid is a clear pale yellow liquid containing 150 mg ranitidine (as hydrochloride) in each 10 mL. It also contains butyl hydrozybenzoate, propyl hydroxybenzoate, ethanol and saccharin sodium as excipients. Zantac injection is a clear colourless to pale yellow liquid, practically free from visible particles containing 50 mg ranitidine (as hydrochloride) in 2 mL ampoules. For the full list of excipients, see Section 6.1 List of excipients. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Sh Прочетете целия документ