Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
pantoprazole sodium sesquihydrate, Quantity: 45.4 mg (Equivalent: pantoprazole, Qty 40 mg)
Strides Pharma Science Pty Ltd
Pantoprazole sodium sesquihydrate
Tablet, enteric coated
Excipient Ingredients: colloidal anhydrous silica; hypromellose; macrogol 6000; sodium starch glycollate; mannitol; calcium stearate; sodium carbonate; crospovidone; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin
Oral
28, 14, 15, 140, 50, 56, 100, 5, 30, 60
(S4) Prescription Only Medicine
1. For symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) Duodenal ulcer; ii) Gastric ulcer; iii) Gastro-oesophageal reflux disease (GORD): Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD; Reflux oesophagitis; iv) Gastrointestinal lesions refractory H2 blockers; v) Zollinger-Ellison Syndrome. Patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.
Visual Identification: Yellow, oval, biconvex enteric-coated tablets, plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2010-02-17
PANTHRON™ ® 1 PANTHRON™ _contains the active ingredient pantoprazole _ _(as sodium sesquihydra_ _te)_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PANTHRON™. 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 PANTHRON™ 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 IS PANTHRON™ USED FOR The name of your medicine is PANTHRON™. It contains the active ingredient called pantoprazole (as sodium sesquihydrate). ULCERS: PANTHRON™ 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. PANTHRON™ may be used to prevent ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). These are medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis (inflammation of the joints). REFLUX DISEASE: PANTHRON™ is 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. PANTHRON™ is also used to prevent reflux oesophagitis from coming back. ZOLLINGER-ELLISON SYNDROME: PANTHRON™ 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUE Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION – PANTHRON TM (PANTOPRAZOLE SODIUM SESQUIHYDRATE) ENTERIC-COATED DELAYED RELEASE TABLETS 1 NAME OF THE MEDICINE Pantoprazole sodium sesquihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Panthron™ 40 mg enteric coated tablet contains 45.4 mg of pantoprazole sodium sesquihydrate equivalent to 40 mg of pantoprazole. Each Panthron™ 20 mg enteric coated tablet contains 22.7 mg pantoprazole sodium sesquihydrate equivalent to 20 mg of pantoprazole. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Panthron™ is available as 20 mg (yellow, oval shaped, plain on both sides) and 40 mg (yellow, oval shaped, plain on both sides) biconvex, enteric-coated tablets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 1. For symptomatic improvement and healing of the following gastrointestinal diseases which require a reduction in acid secretion: • duodenal ulcer • gastric ulcer • gastro-oesophageal reflux disease (GORD): i. symptomatic GORD. The treatment of heartburn and other symptoms with GORD ii. reflux oesophagitis • gastrointestinal lesions refractory to H2 blockers • Zollinger-Ellison Syndrome. Patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti- inflammatory drugs (NSAIDs) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 2 3. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non- steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non- selective NSAID treatment. 4.2 D OSE AND METHOD OF ADMINISTRATION ADULTS: Pantoprazole tablets should not be chewed or crushed but swallowed whole with a little water. DUODENAL ULCER: Pantoprazole 40 mg (one tablet) should be given once a day. In most patients freedo Прочитать полный документ