ESOMEPRAZOLE-WT esomeprazole magnesium dihydrate 40mg tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
27-11-2017

有効成分:

esomeprazole magnesium dihydrate, Quantity: 43.5 mg

から入手可能:

Medis Pharma Pty Ltd

INN(国際名):

esomeprazole magnesium dihydrate

医薬品形態:

Tablet, enteric coated

構図:

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

投与経路:

Oral

パッケージ内のユニット:

7, 15, 30, and 100 tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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

製品概要:

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

認証ステータス:

Licence status A

承認日:

2013-12-11