国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium dihydrate, Quantity: 43.5 mg
Alphapharm Pty Ltd
esomeprazole magnesium dihydrate
Tablet, enteric coated
Excipient Ingredients: glyceryl monostearate; crospovidone; polysorbate 80; triethyl citrate; hyprolose; purified talc; magnesium stearate; microcrystalline cellulose; povidone; methacrylic acid - ethyl acrylate copolymer (1:1); hypromellose; sodium stearylfumarate; macrogol 6000; titanium dioxide; macrogol 400; iron oxide red; iron oxide yellow; maize starch; sucrose
Oral
7, 100, 30
(S4) Prescription Only Medicine
It is indicated for:,Gastro-Oesophageal Reflux Disease (GORD): treatment of erosive reflux oesophagitis, long-term management of patients with healed oesophagitis to prevent relapse and symptomatic treatment of gastro-oesophageal reflux disease (GORD).,Patients requiring NSAID therapy: short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy, healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy and prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk.,Prevention of rebleeding of gastric or duodenal ulcers following treatment with IV Esomeprazole solution by intravenous infusion (intravenous dosage form can be available from other brands).,Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion, in combination with appropriate antibiotics for: healing of duodenal ulcer associated with Helicobacter pylori and eradication of Helicobacter pylori in patients with active or healed peptic ulcer.
Visual Identification: elliptically shaped, biconvex, pink enteric coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-07-30
ESOMEPRAZOLE MYLAN _esomeprazole (as magnesium dihydrate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ESOMEPRAZOLE MYLAN. 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 ESOMEPRAZOLE MYLAN 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 ESOMEPRAZOLE MYLAN IS USED FOR _REFLUX OESOPHAGITIS_ ESOMEPRAZOLE MYLAN is taken to treat reflux oesophagitis. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus). Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. ESOMEPRAZOLE MYLAN is also taken to help stop reflux oesophagitis coming back or relapsing. _UPPER GASTROINTESTINAL_ _SYMPTOMS ASSOCIATED WITH_ _NON-STEROIDAL ANTI-_ _INFLAMMATORY DRUGS_ _(NSAIDS) THERAPY_ ESOMEPRAZOLE MYLAN is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation. ESOMEPRAZOLE MYLAN is also taken to help heal and prevent ulcers caused by NSAIDs. _PEPTIC ULCERS ASSOCIATED_ _WITH HELICOBACTER PYLORI_ _INFECTION_ Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach. 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 from the stomach. If you have a peptic ulcer, your doctor will prescribe ESOMEPRAZOLE MYLAN with antibiotics. When ESOMEPRAZOLE MYLAN and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics. _ZOLLIN 完全なドキュメントを読む
AUSTRALIAN PRODUCT INFORMATION ESOMEPRAZOLE MYLAN _esomeprazole (as magnesium dihydrate) enteric-coated tablet _ 1 NAME OF THE MEDICINE Esomeprazole (as magnesium dihydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ESOMEPRAZOLE MYLAN 20 mg tablet: each enteric-coated tablet contains 21.75 mg of esomeprazole magnesium dihydrate (equal to 20 mg base) as the active ingredient. ESOMEPRAZOLE MYLAN 40 mg tablet: each enteric-coated tablet contains 43.50 mg of esomeprazole magnesium dihydrate (equal to 40 mg base) as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ESOMEPRAZOLE MYLAN 20 mg is a light pink, elliptically shaped, biconvex, enteric-coated tablet. ESOMEPRAZOLE MYLAN 40 mg is a pink, elliptically shaped, biconvex, enteric-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ESOMEPRAZOLE MYLAN is indicated for: GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) • treatment of erosive reflux oesophagitis • long-term management of patients with healed oesophagitis to prevent relapse • symptomatic treatment of gastro-oesophageal reflux disease (GORD) PATIENTS REQUIRING NSAID THERAPY • short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti- inflammatory drug NSAID (non-selective and COX-2 selective) therapy. • healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy • prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk. PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING TREATMENT WITH ESOMEPRAZOLE SOLUTION BY INTRAVENOUS INFUSION (INTRAVENOUS DOSAGE FORM CAN BE AVAILABLE FROM OTHER BRANDS). PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME AND IDIOPATHIC HYPERSECRETION. IN COMBINATION WITH APPROPRIATE ANTIBIOTICS FOR: • healing of duodenal ulcer associated with _Helicobacter 完全なドキュメントを読む