Australia - English - Department of Health (Therapeutic Goods Administration)

pharmaco australia ltd - clonazepam, quantity: 2.5 mg/ml - oral liquid, solution - excipient ingredients: saccharin sodium; propylene glycol; brilliant blue fcf; glacial acetic acid; flavour - tablets. most types of epilepsy in infants and children, especially absences (petit mal), myoclonic seizures and tonic-clonic fits, whether due to primary generalised epilepsy, or to secondary generalisation of partial epilepsy. in adults all varieties of generalised epilepsy, (including myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial epilepsy (including psychomotor seizures). injection. intravenous use for status epilepticus only. note. efficacy by the intramuscular route has not need demonstrated.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - oseltamivir phosphate 39.4 mg/g equivalent to oseltamivir 12 mg/ml when reconsituted with 52 ml of water (1.182 g per bottle);   - powder for oral suspension - 12 mg/ml - active: oseltamivir phosphate 39.4 mg/g equivalent to oseltamivir 12 mg/ml when reconsituted with 52 ml of water (1.182 g per bottle)   excipient: saccharin sodium sodium benzoate sodium citrate sorbitol titanium dioxide tutti frutti flavour 11900-31 xanthan gum - · tamiflu is indicated for the treatment of influenza in adults and children 1 year of age and older. · tamilfu is indicated for the prophylaxis of influenza in adults and children 1 year of age and older.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - oseltamivir phosphate 39.4 mg/g equivalent to oseltamivir 6 mg/ml when reconstituted with 55 ml of water (0.5122 g per bottle);   - powder for oral suspension - 6 mg/ml - active: oseltamivir phosphate 39.4 mg/g equivalent to oseltamivir 6 mg/ml when reconstituted with 55 ml of water (0.5122 g per bottle)   excipient: monosodium citrate saccharin sodium sodium benzoate sorbitol titanium dioxide tutti frutti flavour 11900-31 xanthan gum - · tamiflu is indicated for the treatment of influenza in adults and children 2 weeks of age and older who have been symptomatic for no more than 2 days. · tamiflu is indicated for the prophylaxis of influenza in adults and children 1 year of age and older.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate - adults (greater than or equal to 18 years),primary hypercholesterolaemia,ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,ezetimibe is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post-menarche),heterozygous familial hypercholesterolaemia (hefh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: hyprolose; hypromellose; indigo carmine aluminium lake; lactose; colloidal anhydrous silica; calcium stearate; titanium dioxide; crospovidone; macrogol 8000 - tenofovir disoproxil fumarate in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels or evidence of active inflammation.

Australia - English - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - ezetimibe -

Australia - English - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - ezetimibe -

Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - moxifloxacin hydrochloride, quantity: 1.75 mg/ml - injection, intravenous infusion - excipient ingredients: sodium sulfate; sulfuric acid; sodium acetate trihydrate; water for injections - moxifloxacin kabi intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions:,- community acquired pneumonia (caused by susceptible organisms),- acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics,- moxifloxacin kabi intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents, (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin.,appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin kabi may be initiated, in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - levetiracetam, quantity: 100 mg/ml - solution - excipient ingredients: propyl hydroxybenzoate; maltitol; purified water; sodium citrate dihydrate; glycerol; ammonium glycyrrhizinate; methyl hydroxybenzoate; acesulfame potassium; citric acid monohydrate; flavour - apo-levitiracetam oral solution is indicated for:,? use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment,of partial onset seizures with or without secondary generalisation,,? monotherapy in the treatment of partial onset seizures, with or without secondary,generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,? add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12,years of age with juvenile myoclonic epilepsy (jme),,? add-on therapy in the treatment of primary generalized tonic clonic (pgtc) seizures in adults and,children from 4 years of age with idiopathic generalized epilepsy (ige).

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - olopatadine hydrochloride, quantity: 1.11 mg/ml (equivalent: olopatadine, qty 1 mg/ml) - eye drops - excipient ingredients: sodium hydroxide; water for injections; dibasic sodium phosphate; benzalkonium chloride; sodium chloride; hydrochloric acid - for the treatment of the signs and symptoms of seasonal allergic conjunctivitis. treatment may be maintained for up to 14 weeks, if considered necessary.