Australie - anglais - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: butylated hydroxyanisole; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; propyl gallate; citric acid monohydrate; lactose monohydrate; 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).

Australie - anglais - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - amoxicillin trihydrate, quantity: 574 mg (equivalent: amoxicillin, qty 500 mg); potassium clavulanate, quantity: 149 mg (equivalent: amoxicillin, qty 500 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 - 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 amoxycillin/clavulanic acid 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

Australie - anglais - Department of Health (Therapeutic Goods Administration)

aubex pharma pty ltd - flecainide acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: hydrogenated vegetable oil; purified water; microcrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; magnesium stearate - bpa-flecainide is indicated for:,1. supraventricular arrhythmias:,a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes,b) due to dual av nodal pathways in patients with debilitating symptoms,c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms,although bpa-flecainide may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, bpa-flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of bpa-flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs.,bpa-flecainide tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.,prescribers should also consult the "special warnings and precautions for use" section of this product information.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

aubex pharma pty ltd - flecainide acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: pregelatinised maize starch; magnesium stearate; microcrystalline cellulose; hydrogenated vegetable oil; purified water; croscarmellose sodium - bpa-flecainide is indicated for:,1. supraventricular arrhythmias:,a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes,b) due to dual av nodal pathways in patients with debilitating symptoms,c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms,although bpa-flecainide may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, bpa-flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of bpa-flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs.,bpa-flecainide tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.,prescribers should also consult the "special warnings and precautions for use" section of this product information.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

emcure pharmaceuticals pty ltd - flecainide acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate - flec-em is indicated for:,1. supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes b) due to dual av nodal pathways in patients with debilitating symptoms c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms,although flec-em may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, flec-em should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of flec-em in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs. flec-em tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

emcure pharmaceuticals pty ltd - flecainide acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; magnesium stearate - flec-em is indicated for:,1. supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. wolff-parkinson-white and lown-ganong-levine syndromes b) due to dual av nodal pathways in patients with debilitating symptoms c) paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms,although flec-em may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. in these patients, particularly in the presence of impaired left ventricular function, flec-em should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,use of flec-em in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. life threatening ventricular arrhythmias not controlled by other drugs. flec-em tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals 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 - 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 apx-amoxicillin/clavulanic acid 875/125 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 apx-amoxicillin/clavulanic acid 875/125 tablets should not require the addition of another antibiotic due to the amoxycillin content of apx-amoxicillin/clavulanic acid 875/125 tablets. 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/muric 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/muric tablets should not require the addition of another antibiotic due to the amoxycillin content of curam/muric tablets.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals 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 - 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 apx-amoxicillin/clavulanic acid 500/125 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 apx-amoxicillin/clavulanic acid 500/125 tablets should not require the addition of another antibiotic due to the amoxycillin content of apx-amoxicillin/clavulanic acid 500/125 tablets.

Irlande - anglais - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - milbemycin oxime; praziquantel - tablet - 12.5, 125.0 mg/tablet - milbemycin oxime, combinations - dogs - endectoparasiticides

Irlande - anglais - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - milbemycin oxime; praziquantel - tablet - 2.5, 25.0 mg/tablet - milbemycin oxime, combinations - dogs - endectoparasiticides