Австралия - английски - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - sulfasalazine, quantity: 500 mg - tablet, enteric coated - excipient ingredients: white beeswax; propylene glycol; magnesium stearate; colloidal anhydrous silica; cellacefate; purified talc; macrogol 20000; povidone; carnauba wax; maize starch; glyceryl monostearate - ulcerative colitis and crohn's disease: adjunct in the treatment of ulcerative colitis with the usual supportive and dietary measures. for the management of severe, acute attacks of ulcerative colitis, rectal and systemic corticosteroid therapy appears to be clinically superior to sulfasalazine, but sulfasalazine may be more effective than corticosteroids in reducing the number of relapses in patients on maintenance therapy. in the treatment of active crohn's disease, especially in patients with colonic involvement. rheumatoid arthritis: pyralin en tablets are indicated for rheumatoid arthritis which has failed to respond to non-steroidal anti-inflammatory drugs (nsaids).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - clozapine, quantity: 100 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; maize starch; purified talc; magnesium stearate; povidone - clozaril is indicated in treatment-resistant schizophrenic patients only, i.e. schizophrenic patients who are non-responsive to, or intolerant of other antipsychotic drugs. non-responsiveness is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs prescribed for reasonable durations. intolerance is defined as the impossibility to achieve adequate benefit with other antipsychotic drugs because of severe and untreatable neurological adverse reactions (extrapyramidal side effects or tardive dyskinesia).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - clozapine, quantity: 25 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; maize starch; colloidal anhydrous silica; povidone; magnesium stearate; purified talc - clozaril is indicated in treatment-resistant schizophrenic patients only, ie. schizophrenic patients who are non-responsive to, or intolerant of other antipsychotic drugs. non-responsiveness is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs prescribed for reasonable durations. intolerance is defined as the impossibility to achieve adequate benefit with other antipsychotic drugs because of severe and untreatable neurological adverse reactions (extrapyramidal side effects or tardive dyskinesia).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

echo therapeutics pty ltd - buprenorphine hydrochloride, quantity: 0.216 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; mannitol; maize starch; povidone; magnesium stearate; citric acid; sodium citrate dihydrate - temgesic sublingual tablets are indicated for the short-term (not more than one week) management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. temgesic is not recommended for use in children. temgesic does not have an approved role in opioid dependence rehabilitation programmes.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

medreich australia pty ltd - amoxicillin trihydrate, quantity: 575 mg; potassium clavulanate, quantity: 148.875 mg - tablet, film coated - excipient ingredients: propylene glycol; magnesium stearate; croscarmellose sodium; dichloromethane; purified talc; microcrystalline cellulose; ethylcellulose; hypromellose; isopropyl alcohol; titanium dioxide; hyprolose; industrial methylated spirit - amoxyclav generichealth 500/125 and amoxyclav generichealth 875/125 tablets are indicated for 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 amoxicillin and clavulanic acid tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. once these results are known, therapy should be adjusted if appropriate.,the treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets should not require the addition of another antibiotic due to the amoxicillin content of these products.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

medreich australia pty ltd - amoxicillin trihydrate, quantity: 1006.25 mg; potassium clavulanate, quantity: 148.875 mg - tablet, film coated - excipient ingredients: purified talc; propylene glycol; isopropyl alcohol; hypromellose; ethylcellulose; croscarmellose sodium; dichloromethane; microcrystalline cellulose; magnesium stearate; titanium dioxide; hyprolose; industrial methylated spirit - amoxyclav generichealth 500/125 and amoxyclav generichealth 875/125 tablets are indicated for 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 amoxicillin and clavulanic acid tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. once these results are known, therapy should be adjusted if appropriate.,the treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets should not require the addition of another antibiotic due to the amoxicillin content of these products.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - metformin hydrochloride, quantity: 500 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; magnesium stearate; povidone; hypromellose - treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. metformin modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - metformin hydrochloride, quantity: 1000 mg - tablet, modified release - excipient ingredients: hypromellose; povidone; magnesium stearate; colloidal anhydrous silica - treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. metformin modified release tablets may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - esomeprazole magnesium, quantity: 22.264 mg (equivalent: esomeprazole, qty mg) - tablet, enteric coated - excipient ingredients: purified water; purified talc; lactose monohydrate; crospovidone; light magnesium oxide; macrogol 400; hyprolose; macrogol 6000; glyceryl monostearate; methacrylic acid - ethyl acrylate copolymer (1:1); polysorbate 80; silicon dioxide; iron oxide red; pregelatinised maize starch; povidone; microcrystalline cellulose; hypromellose phthalate; titanium dioxide; hypromellose; iron oxide yellow; maize starch; sucrose - 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

Австралия - английски - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - esomeprazole magnesium, quantity: 44.528 mg (equivalent: esomeprazole, qty mg) - 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 - 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