Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium, Quantity: 44.528 mg (Equivalent: esomeprazole, Qty mg)
Lupin Australia Pty Limited
Esomeprazole magnesium
Tablet, enteric coated
Excipient Ingredients: polysorbate 80; hypromellose phthalate; pregelatinised maize starch; macrogol 6000; light magnesium oxide; purified water; povidone; glyceryl monostearate; silicon dioxide; microcrystalline cellulose; crospovidone; macrogol 400; purified talc; iron oxide red; lactose monohydrate; methacrylic acid - ethyl acrylate copolymer (1:1); hyprolose; titanium dioxide; hypromellose; maize starch; sucrose
Oral
75 CC HDPE with 38 mm neck (with induction sealing liner) containing molecular sieve desiccant canister) of 30's, HDPE bottle pack (120CC HDPE bottle with 38 mm neck (with induction sealing liner) containing molecular sieve desiccant canister.) of 56's
(S4) Prescription Only Medicine
Esomeprazole enteric-coated tablet indicated for:,1] 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),2] 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.,3] Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion.,4] 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
Visual Identification: Pink coloured, oblong, biconvex, coated tablets debossed with '40' on one side and 'CE' on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2014-05-27
Esomeprazole GH CMI v2 Sep2017 Page 1 of 5 CONSUMER MEDICINE INFORMATION ESOMEPRAZOLE GH esomeprazole What is in this leaflet This leaflet answers some of the common questions people ask about Esomeprazole GH enteric- coated tablet. It does not contain all the information that is known about Esomeprazole GH enteric- coated tablet. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Esomeprazole GH enteric-coated tablet 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 GH is used for Reflux Oesophagitis Esomeprazole GH enteric- coated tablet 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 GH enteric- coated tablet 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 GH enteric- coated tablet 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 GH enteric- coated tablet 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 GH enteric- c Pročitajte cijeli dokument
AUSTRALIAN PI - ESOMEPRAZOLE GH (ESOMEPRAZOLE MAGNESIUM) ENTERIC-COATED TABLETS 1 NAME OF THE MEDICINE Esomeprazole magnesium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Esomeprazole GH (esomeprazole enteric-coated 20 mg and 40 mg tablets) is comprised of enteric- coated pellets containing esomeprazole (as magnesium amorphous). The tablets contain the following inactive ingredients: Sugar Spheres (non-pareil seeds 40-50), hydroxypropylcellulose, crospovidone, sucrose, maize starch, magnesium oxide-light, purified talc, macrogol 6000, Methacrylic acid- ethyl acrylate copolymer (1:1), glycerol monostearate (40-55), macrogol 400, polysorbate 80, hypromellose phthalate, microcrystalline cellulose, povidone, pregelatinised maize starch, silicon dioxide. The 20 mg and 40 mg tablets are coloured with titanium dioxide, iron oxide red, and 20mg tablet also contain iron oxide yellow. 3 PHARMACEUTICAL FORM ESOMEPRAZOLE GH 20 MG: Light pink coloured, oblong, biconvex, coated tablets debossed with '20' on one side and ‘CE’ on the other. ESOMEPRAZOLE GH 40 MG: Pink coloured, oblong, biconvex, coated tablets debossed with '40' on one side and ‘CE’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esomeprazole GH (esomeprazole enteric-coated 20 mg and 40 mg tablet) is indicated for: • GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD): o treatment of erosive reflux oesophagitis. o long-term management of patients with healed oesophagitis to prevent relapse. o symptomatic treatment of gastro-oesophageal reflux disease (GORD). • PATIENTS REQUIRING NSAID THERAPY: o short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy. o healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non- Esomeprazole GH PI v3 Page 2 of 32 selective and COX-2 selective) therapy. o prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug NSAID (non-selective and COX Pročitajte cijeli dokument