Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate, Quantity: 45.12 mg (Equivalent: pantoprazole, Qty 40 mg)
Sandoz Pty Ltd
Pantoprazole sodium
Injection, powder for
Excipient Ingredients: nitrogen
Intravenous
10 vials per carton, One vial per carton
(S4) Prescription Only Medicine
Pantoprazole Sandoz is indicated for short-term use where oral therapy is not appropriate for the following conditions: 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to H2 blockers, Zollinger-Ellison Syndrome. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. Note: Patients who gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory medicines, whether on first presentation or recurrence.
Visual Identification: White to yellowish powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2009-04-21
PANTOPRAZOLE SANDOZ ® 1 PANTOPRAZOLE SANDOZ ® INJECTION _Pantoprazole sodium _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pantoprazole Sandoz. 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 taking 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. WHAT PANTOPRAZOLE SANDOZ IS USED FOR This medicine is used to treat • ULCERS Pantoprazole Sandoz is used to treat and help heal duodenal and gastric 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. These can be caused in part by too much acid being made in the stomach. • REFLUX DISEASE Pantoprazole Sandoz is also used to treat reflux oesophagitis or reflux disease. This can be caused by washing back (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. Pantoprazole Sandoz is also used to prevent reflux oesophagitis from coming back. • ZOLLINGER-ELLISON SYNDROME Pantoprazole Sandoz is used to treat a rare condition called Zollinger- Ellison syndrome, where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease. This medicine contains the active ingredient pantoprazole sodium. Pantoprazole sodium belongs to a group of medicine called proton pump inhibitors (PPIs). It works by decreasing the amount of acid the stomach makes to give relief from the symptoms and allow healing to take place. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it Les hele dokumentet
210730-pantoprazole-sandoz -pi Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION PANTOPRAZOLE SANDOZ ® (PANTOPRAZOLE SODIUM) POWDER FOR INJECTION VIAL 1 NAME OF THE MEDICINE Pantoprazole sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Pantoprazole Sandoz 40 mg powder for injection contains 42.29 mg of pantoprazole sodium equivalent to 40 mg pantoprazole. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Powder for injection. Pantoprazole sodium is a white to off-white amorphous powder. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Pantoprazole Sandoz is indicated for short-term use where oral therapy is not appropriate for the following conditions: 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to H 2 blockers, Zollinger-Ellison Syndrome. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. _Note: _ Patients whose gastric or duodenal ulceration is not associated with ingestion of non- steroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory medicines, whether on first presentation or recurrence. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _ADULTS _ Duodenal ulcer, gastric ulcer, gastrointestinal lesions refractory to H 2 blockers, Zollinger-Ellison syndrome 40 mg per day Reflux oesophagitis 20 - 40 mg per day Intravenous Pantoprazole Sandoz should be replaced with oral therapy as soon as practicable. PREPARATION FOR USE A ready-to-use solution is prepared by injecting 10 mL Sodium Chloride Intravenous Infusion 0.9% into the vial containing the dry powder. This solution may be administered directly or may be administered after mixing with 100 mL Sodium Chloride Intravenous Infusion 0.9%. 210730-pantoprazole-sandoz -pi Page 2 of 14 After preparation, the solution should be administered over 2 to 1 Les hele dokumentet