REFEXXIN esomeprazole (as magnesium trihydrate) 40 mg tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
27-11-2017

Aktivna sestavina:

esomeprazole magnesium trihydrate, Quantity: 44.5 mg (Equivalent: esomeprazole, Qty 40 mg)

Dostopno od:

AstraZeneca Pty Ltd

INN (mednarodno ime):

esomeprazole magnesium trihydrate

Farmacevtska oblika:

Tablet, enteric coated

Sestava:

Excipient Ingredients: iron oxide red; microcrystalline cellulose; polysorbate 80; triethyl citrate; synthetic paraffin; titanium dioxide; crospovidone; hypromellose; purified talc; glyceryl monostearate; methacrylic acid copolymer; magnesium stearate; hyprolose; sodium stearylfumarate; macrogol 6000; maize starch; sucrose

Pot uporabe:

Oral

Enote v paketu:

30 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

REFEXXIN 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 IV 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.

Povzetek izdelek:

Visual Identification: A pink, oblong, biconvex, film-coated tablet with '40mg' on one side and 'A/EI' on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2013-06-20