Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
omeprazole sodium, Quantity: 42.56 mg (Equivalent: omeprazole, Qty 40 mg)
Sandoz Pty Ltd
omeprazole sodium
Injection, powder for
Excipient Ingredients: nitrogen; sodium hydroxide; disodium edetate
Intravenous
5 x 10mL vials
(S4) Prescription Only Medicine
Short-term use when omeprazole cannot be administered orally for, or during, the following conditions. Treatment of duodenal ulcer, gastric ulcer and ulcerative oesophagitis. Treatment of Zollinger-Ellison syndrome. Long-term prevention of relapse in healed severe reflux oesophagitis (grades 3 and 4), and gastric and duodenal peptic ulceration in patients proven to be Helicobacter pylori negative whose ulceration is not associated with ingestion of NSAIDs, when oral therapy is not possible. Omeprazole Sandoz IV should be replaced with oral therapy as soon as practicable
Visual Identification: White to almost white powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2008-02-15
OMEPRAZOLE SANDOZ IV 1 OMEPRAZOLE SANDOZ IV _Omeprazole Powder for Injection _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Omeprazole Sandoz IV. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT OMEPRAZOLE SANDOZ IV IS USED FOR THIS MEDICINE IS USED TO TREAT AND HELP HEAL PEPTIC ULCERS. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. Ulcers can be caused in part by too much acid being made in the stomach. THIS MEDICINE IS ALSO USED TO HELP PREVENT GASTRIC OR DUODENAL ULCERS FROM COMING BACK. _REFLUX OESOPHAGITIS _ This medicine is used to treat and prevent reflux oesophagitis. This can be caused by "washing back" (reflux) of food and acid from the stomach into the oesophagus (food pipe). Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. _ZOLLINGER-ELLISON SYNDROME _ THIS MEDICINE IS ALSO USED TO TREAT A RARE CONDITION CALLED ZOLLINGER- ELLISON SYNDROME, WHERE THE STOMACH PRODUCES VERY LARGE AMOUNTS OF ACID, MUCH MORE THAN IN ULCERS OR REFLUX DISEASE. _HOW OMEPRAZOLE SANDOZ IV _ _WORKS _ Omeprazole Sandoz IV belongs to a group of medicines called proton pump inhibitors. It works by decreasing the amount of acid made by the stomach. This does not stop food being digested in the normal way. It helps reduce the pain and also allows the ulcer to heal. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for Прочетете целия документ
191120-Omeprazole Sandoz IV-pi Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION OMEPRAZOLE SANDOZ ® (OMEPRAZOLE SODIUM) IV 40 MG POWDER FOR INJECTION 1. NAME OF THE MEDICINE Omeprazole sodium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Omeprazole Sandoz IV powder for injection contains omeprazole sodium, which occurs as a white or almost white powder, hygroscopic, freely soluble in water and in alcohol, soluble in propylene glycol, very slightly soluble in methylene chloride. The reconstituted solution appears as a clear, colourless solution. Each 10 mL glass contains 42.56 mg omeprazole sodium equivalent to 40 mg omeprazole. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Omeprazole Sandoz ® IV 40 mg powder for injection. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Short-term use when omeprazole cannot be administered orally for, or during, the following conditions: • treatment of duodenal ulcer, gastric ulcer and ulcerative oesophagitis • treatment of Zollinger-Ellison syndrome • long-term prevention of relapse in healed severe reflux oesophagitis (grades 3 and 4), and gastric and duodenal peptic ulceration in patients proven to be _Helicobacter pylori_ negative, whose ulceration is not associated with ingestion of NSAIDs, when oral therapy is not possible. Omeprazole Sandoz IV should be replaced with oral therapy as soon as practicable. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE Omeprazole Sandoz IV should only be used where oral medication is inappropriate, e.g. in severely ill patients. Omeprazole Sandoz IV should be replaced with oral therapy as soon as practicable. If intravenous therapy is necessary for more than five days, consideration should be given to reducing the daily dose. The product is for single use in one patient only. _DUODENAL ULCER, GASTRIC ULCER AND ULCERATIVE REFLUX OESOPHAGITIS _ Omeprazole Sandoz IV 40 mg given intravenously once daily is recommended. This produces an immediate decrease in intragastric acidity and Прочетете целия документ