오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - amoxicillin trihydrate, quantity: 1004.43 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 148.91 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; sodium starch glycollate; titanium dioxide; hypromellose; macrogol 6000; macrogol 4000 - augmentin duo forte is indicated for the short term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to microbiology) *urinary tract infections (uncomplicated and complicated); *lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis; *upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis; *skin and skin structure infection appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to augmentin duo forte. however when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the product information, therapy may be instituted prior to obtaining the results of bacteriological and susceptibility studies. once the results are known, therapy should be adjusted should be adjusted if appropriate. the treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to augmentin duo forte should not require the addition of another antibiotic due to the amoxycillin content of augmentin duo forte.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - esomeprazole magnesium, quantity: 41.4 mg (equivalent: esomeprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: macrogol 400; hypromellose phthalate; macrogol 6000; diethyl phthalate; microcrystalline cellulose; crospovidone; hyprolose; sodium stearylfumarate; povidone; purified talc; macrogol 4000; titanium dioxide; hypromellose; iron oxide red; maize starch; sucrose - 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 administered 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

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - esomeprazole magnesium, quantity: 20.7 mg (equivalent: esomeprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: diethyl phthalate; macrogol 4000; sodium stearylfumarate; hyprolose; purified talc; microcrystalline cellulose; macrogol 400; povidone; hypromellose phthalate; crospovidone; macrogol 6000; titanium dioxide; hypromellose; iron oxide red; maize starch; sucrose - 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 administered 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

뉴질랜드 - 영어 - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - metyrapone 250mg;   - soft gelatin capsule - 250 mg - active: metyrapone 250mg   excipient: acetanisole ethyl hydroxybenzoate as the sodium salt ethyl vanillin gelatin glycerol   ink macrogol 400 macrogol 4000 purified water sodium propyl hydroxybenzoate titanium dioxide - therapeutic applications metopirone can be employed as supplementary therapy in conditions associated with overproduction of glucocorticoids and mineralocorticoids, particularly when causal treatment is not possible. cushing's syndrome, especially when related to adrenal tumours hyperaldosteronism, resistant oedema

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - deferasirox, quantity: 360 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica; poloxamer; hypromellose; titanium dioxide; macrogol 4000; purified talc; indigo carmine aluminium lake - the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. deferasirox sandoz is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective. deferasirox sandoz is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - deferasirox, quantity: 180 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica; poloxamer; hypromellose; titanium dioxide; macrogol 4000; purified talc; indigo carmine aluminium lake - the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. deferasirox sandoz is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective. deferasirox sandoz is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - deferasirox, quantity: 90 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica; poloxamer; hypromellose; titanium dioxide; macrogol 4000; purified talc; indigo carmine aluminium lake - the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. deferasirox sandoz is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective. deferasirox sandoz is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - paliperidone palmitate, quantity: 1560 mg - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - invega hafyera, a 6-month injection, is indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months or the 3-month paliperidone palmitate injectable product following at least one 3-month injection cycle.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - paliperidone palmitate, quantity: 1092 mg - injection, suspension - excipient ingredients: polysorbate 20; macrogol 4000; citric acid monohydrate; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - invega hafyera, a 6-month injection, is indicated for the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months or the 3-month paliperidone palmitate injectable product following at least one 3-month injection cycle.

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

mcneil healthcare (ireland) ltd - domperidone - suppositories - 10 milligram