אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - levetiracetam, quantity: 500 mg - tablet, film coated - excipient ingredients: povidone; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - ketraccord tablets are 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) and, ? add-on therapy in the treatment of primary generalised tonic-clonic seizures (pgtc) in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - levetiracetam, quantity: 250 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; povidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - ketraccord tablets are 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) and, ? add-on therapy in the treatment of primary generalised tonic-clonic seizures (pgtc) in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amoxicillin trihydrate, quantity: 1148 mg (equivalent: amoxicillin, qty 1000 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; magnesium stearate; sodium starch glycollate type a; hypromellose; titanium dioxide; purified talc - amoxycillin sandoz is indicated in the treatment of acute exacerbation of chronic bronchitis. notes: therapy should be guided by bacteriologic studies including sensitivity tests and by clinical response. amoxycillin alone or in combination with another antibiotic, may be used in an emergency where the causative agent has yet to be identified. amoxycillin sandoz 1000mg tablets have not been shown to be bioequivalent to the 500mg and 250mg capsule formulations given in equivalent doses. therefore, amoxycillin sandoz 1000mg tablets and other forms of amoxycillin are not considered interchangeable. infections caused by pathogens with established penicllin g susceptibility should preferentially be treated with penicillin g.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amoxicillin trihydrate, quantity: 574 mg (equivalent: amoxicillin, qty 500 mg); potassium clavulanate, quantity: 149 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose; cetyl alcohol; sodium lauryl sulfate - short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. skin and skin structure infections. urinary tract infections (uncomplicated and complicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to curam tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to curam tablets should not require the addition of another antibiotic due to the amoxycillin content of curam tablets.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - amoxicillin trihydrate, quantity: 1005 mg (equivalent: amoxicillin, qty 875 mg); potassium clavulanate, quantity: 149 mg (equivalent: clavulanic acid, qty 125 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate; purified talc; povidone; silicon dioxide; triethyl citrate; hypromellose; titanium dioxide; ethylcellulose; cetyl alcohol; sodium lauryl sulfate - short-term treatment of bacterial infection at the following sites when caused by amoxycillin/clavulanic acid sensitive, beta-lactamase producing organisms. skin and skin structure infections. urinary tract infections (uncomplicated and complicated). upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to curam tablets. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in the microbiological section, 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to curam tablets should not require the addition of another antibiotic due to the amoxycillin content of curam tablets.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - naratriptan hydrochloride, quantity: 2.78 mg (equivalent: naratriptan, qty 2.5 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; lactose; titanium dioxide; hypromellose; indigo carmine; triacetin; iron oxide yellow - naramig tablets are indicated for the acute treatment of migraine attacks with or without aura.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

atnahs pharma australia pty ltd - ketorolac trometamol, quantity: 10 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose - toradol is indicated for the short-term management of moderately severe, acute pain following surgical procedures. the total duration of ketorolac use should not exceed five days. it is recommended that ketorolac parenteral be used in the immediate post-operative period. patients can then be converted to the oral formulation (dependent on their analgesic needs), as outlined in the dosage and administration section (refer to conversion from parenteral to oral therapy). the total period of treatment utilising the oral and /or intramuscular route of administration is not to exceed five days. general: toradol is not recommended for use as an obstetrical pre-operative medication or for obstetrical analgesia because it has not been adequately studied for use in these circumstances and because the known effects of drugs that inhibit prostaglandin biosynthesis on uterine contraction and foetal circulation. there is no satisfactory evidence for the use of toradol in acute exacerbations of chronic painful inflammatory conditions (e.g. rheumatoid or osteoarthritis)

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: hypromellose; lactose monohydrate; microcrystalline cellulose; propyl gallate; magnesium stearate; citric acid monohydrate; butylated hydroxyanisole; sodium lauryl sulfate; croscarmellose sodium - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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 and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,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 and simvastatin tablets is indicated as 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 and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; lactose monohydrate; citric acid monohydrate; propyl gallate; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; butylated hydroxyanisole; hypromellose - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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 and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,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 and simvastatin tablets is indicated as 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 and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet - excipient ingredients: propyl gallate; croscarmellose sodium; lactose monohydrate; citric acid monohydrate; magnesium stearate; microcrystalline cellulose; hypromellose; sodium lauryl sulfate; butylated hydroxyanisole - adults (?18 years),prevention of cardiovascular disease,ezetimibe and simvastatin tablets is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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.,primary hypercholesterolaemia,ezetimibe and simvastatin tablets is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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 and simvastatin tablets is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,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 and simvastatin tablets is indicated as 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 and simvastatin tablets is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).