ESOMEPRAZOLE SPIRIT esomeprazole magnesium dihydrate 40mg tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

下载 公众评估报告 (PAR)
27-11-2017

有效成分:

esomeprazole magnesium dihydrate, Quantity: 43.5 mg

可用日期:

Medis Pharma Pty Ltd

INN(国际名称):

esomeprazole magnesium dihydrate

药物剂型:

Tablet, enteric coated

组成:

Excipient Ingredients: purified water; crospovidone; calcium hydrogen phosphate dihydrate; hypromellose; microcrystalline cellulose; self-emulsifying glyceryl monostearate; purified talc; polysorbate 80; hyprolose; sodium lauryl sulfate; triethyl citrate; methacrylic acid - ethyl acrylate copolymer (1:1); colloidal anhydrous silica; mannitol; magnesium stearate; propylene glycol; titanium dioxide; maltodextrin; iron oxide yellow; iron oxide red; polydextrose; medium chain triglycerides

给药途径:

Oral

每包单位数:

7, 15, 30, and 100 tablets

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

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 IV Esomeprazole solution by intravenous infusion.,Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion ,In combination with appropriate antibiotics for: ,? healing of duodenal ulcer associated with Helicobacter pylori ,? eradication of Helicobacter pylori in patients with active or healed peptic ulcer

產品總結:

Visual Identification: Pink, oblong, biconvex, film coated tablet, with '40' engraved on one side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 15 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2013-12-11