Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium, Quantity: 42.29 mg (Equivalent: pantoprazole, Qty 40 mg)
Accord Healthcare Pty Ltd
Pantoprazole sodium
Injection, powder for
Excipient Ingredients: sodium hydroxide; nitrogen
Intravenous
Available in carton containing 1 vial
(S4) Prescription Only Medicine
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 whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal 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 off white lyophilized powder, in a clear glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-07-01
PANTACCORD PANTOPRAZOLE (AS PANTOPRAZOLE SODIUM) POWDER FOR INJECTION 40 MG/VIAL CONSUMER MEDICINE INFORMATION Version-1.0 2015 Page 1 of 4 Pantoprazole (as sodium) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pantaccord. 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 PANTACCORD IS USED FOR This medicine is used to treat : ULCERS Pantaccord 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 Pantaccord 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. Pantaccord is also used to prevent reflux oesophagitis from coming back. ZOLLINGER-ELLISON SYNDROME Pantaccord 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 medicines 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 do Přečtěte si celý dokument
PANTACCORD Pantoprazole Sodium for Injection 40 mg/vial Version 1.0 Page 1 of 11 PRODUCT INFORMATION PANTACCORD, PANTOPRAZOLE (AS PANTOPRAZOLE SODIUM) POWDER FOR INJECTION 40 MG/VIAL NAME OF THE MEDICINE Pantoprazole (as sodium) “( _RS_ ) ‐ 6 ‐ (Difluoromethoxy) ‐ 2 ‐ [(3,4 ‐ dimethoxypyridin ‐ 2 ‐ yl)methylsulfinyl] ‐ 1 _H-_ benzo [ _d_ ]imidazole sodium salt pKa of Pantoprazole : 3.96 CAS NUMBER: 138786-67-1 (pantoprazole sodium) EMPIRICAL FORMULA: C 16 H 14 F 2 N 3 NaO 4 S MW: 405 DESCRIPTION Pantaccord 40mg powder for injection contains 40mg pantoprazole (as sodium). Pantoprazole is a substituted benzimidazole which inhibits basal and stimulated gastric secretion. Pantoprazole sodium is a white to off white lyophilized powder. Solubility is low at neutral pH and increases with increasing pH Pantaccord powder for injection contains sodium hydroxide necessary for pH adjustment to 10.50 – 11.50. PHARMACOLOGY Pharmacodynamics Pantoprazole is a proton pump inhibitor. It inhibits specifically and dose-proportionately H + /K + - ATPase, the enzyme which is responsible for gastric acid secretion in the parietal cells of the stomach. The substance is a substituted benzimidazole which accumulates in the acidic environment of the parietal cells after absorption. There, it is converted into the active form, a cyclic sulfenamide which binds to the H + /K + -ATPase, thus inhibiting the proton pump and causing potent and long- PANTACCORD Pantoprazole Sodium for Injection 40 mg/vial Version 1.0 Page 2 of 11 lasting suppression of basal and stimulated gastric acid secretion. As pantoprazole acts distal to the receptor level, it can influence gastric acid secretion irrespective of the nature of the stimulus (acetylcholine, histamine, gastrin). Oral and intravenous pantoprazole 40mg/day for 5 days had equivalent effect on intra-gastric pH in 20 healthy adult male volunteers in a randomised, open, 2-period crossover trial with 14-day wash-out. The pre-defined equivalence range was ±20% for percentage of time Přečtěte si celý dokument