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

ipca pharma (australia) pty ltd - lisinopril dihydrate (equivalent: lisinopril, qty 2.5 mg) - tablet, uncoated - excipient ingredients: calcium hydrogen phosphate dihydrate; magnesium stearate; mannitol; maize starch - hypertension: pip-lisinopril tablets are indicated in the treatment of hypertension. it may be used alone or concomitantly with other classes of antihypertensive agents. sufficient data have not been provided to support the use of lisinopril (as dihydrate) in severe hypertension or renovascular hypertension. congestive heart failure: pip-lisinopril tablets are also indicated in the treatment of heart failure. in such patients, it is recommended that pip-lisinopril tablets be administered with a diuretic. acute myocardial infarction: pip-lisinopril tablets are indicated for the treatment of acute myocardial infarction in haemodynamically stable patients, defined as patients who are not in cardiogenic shock and who have a systolic blood pressure greater than 100 mmhg. pip-lisinopril tablets may be initiated within 24 hours of an acute myocardial infarction.

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

arrotex pharmaceuticals pty ltd - azithromycin dihydrate, quantity: 524.05 mg (equivalent: azithromycin, qty 500 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; hyprolose; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin - apo-azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity:,1. lower respiratory tract infections:,? acute bacterial bronchitis due to streptococcus pneumoniae, haemophilus influenzae or moraxella catarrhalis. ? community acquired pneumonia due to streptococcus pneumoniae or haemophilus influenzae in patients suitable for outpatient oral treatment. ? community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. in clinical studies efficacy has been demonstrated against chlamydia pneumoniae, haemophilus influenzae, legionella pneumophilia, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus and streptococcus pneumoniae.,2. upper respiratory tract infections:,? acute sinusitis due to streptococcus pneumoniae or haemophilus influenzae. ? acute streptococcal pharyngitis. note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. however, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.,3. uncomplicated skin and skin structure infections:,? uncomplicated infections due to staphylococcus aureus, streptococcus pyogenes or streptococcus agalactiae. abscesses usually require surgical drainage.,4. sexually transmitted diseases: uncomplicated urethritis and cervicitis due to chlamydia trachomatis.,? note: at the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. as with other drugs for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required. ? apo-azithromycin is also indicated for the treatment of chlamydia trachomatis conjunctivitis and trachoma.

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

dr reddys laboratories australia pty ltd - ondansetron hydrochloride dihydrate, quantity: 5 mg (equivalent: ondansetron, qty 4 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; pregelatinised maize starch; sodium starch glycollate; colloidal anhydrous silica; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

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

dr reddys laboratories australia pty ltd - ondansetron hydrochloride dihydrate, quantity: 10 mg (equivalent: ondansetron, qty 8 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.

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

teva pharma australia pty ltd - budesonide, quantity: 320 microgram; formoterol fumarate dihydrate, quantity: 9 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: duoresp spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see section 4.2 dose and method of administration).,duoresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): duoresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. duoresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

teva pharma australia pty ltd - budesonide, quantity: 160 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: duoresp spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see section 4.2 dose and method of administration).,duoresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): duoresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. duoresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

teva pharma australia pty ltd - budesonide, quantity: 320 microgram; formoterol fumarate dihydrate, quantity: 9 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: biresp spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see section 4.2 dose and method of administration).,biresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): biresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. biresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

teva pharma australia pty ltd - budesonide, quantity: 160 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: biresp spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see section 4.2 dose and method of administration).,biresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): biresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. biresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

arrotex pharmaceuticals pty ltd - azithromycin dihydrate, quantity: 524 mg - tablet, film coated - excipient ingredients: lactose monohydrate; hypromellose; triacetin; calcium hydrogen phosphate; titanium dioxide; pregelatinised maize starch; crospovidone; sodium lauryl sulfate; magnesium stearate - azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity:,1. lower respiratory tract infections:,acute bacterial bronchitis due to streptococcus pneumoniae, haemophilus influenza or moraxella catarrhalis.,community acquired pneumonia due to streptococcus pneumoniae or haemophilus influenzae in patients suitable for outpatient oral treatment.,community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. in clinical studies efficacy has been demonstrated against chlamydia pneumoniae, haemophilus influenzae, legionella pneumophilia, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus and streptococcus pneumoniae.,2. upper respiratory tract infections:,acute sinusitis due to streptococcus pneumoniae or haemophilus influenzae.,acute streptococcal pharyngitis. note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. however, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.,3. uncomplicated skin and skin structure infections:,uncomplicated infections due to staphylococcus aureus, streptococcus pyogenes or streptococcus agalactiae. abscesses usually require surgical drainage.,4. sexually transmitted diseases: uncomplicated urethritis and cervicitis due to chlamydia trachomatis.,note: at the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. as with other drugs for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required.,azithromycin is also indicated for the treatment of chlamydia trachomatis conjunctivitis and trachoma.,azithromycin is also indicated for the prevention of infection due to mycobacterium avium-intracellulare complex (mac) disease, when used as the sole agent or in combination with rifabutin at its approved dose, in adults and children aged more than 12 years with hiv infection and cd4 cell count less than or equal to 75 cells/?l (see precautions). disseminated infection due to mycobacterium avium-intracellulare complex should be excluded by a negative blood culture prior to commencement of therapy.,azithromycin is indicated for use in children for the treatment of the following infections:,1. acute streptococcal pharyngitis/tonsillitis:,note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. the 20 mg/kg azithromycin dose appears to be as effective as penicillin in the treatment of streptococcal pharyngitis. however, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.,2. chlamydia trachomatis conjunctivitis and trachoma in children 12 months or older.

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

juno pharmaceuticals pty ltd - naloxone hydrochloride dihydrate, quantity: 440 microgram/ml (equivalent: naloxone hydrochloride?, qty 400 microgram/ml) - injection, solution - excipient ingredients: water for injections; hydrochloric acid - naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by opioids including natural and synthetic opioids, propoxyphene, methadone and the narcotic-antagonist analgesics: nalbuphine, pentazocine and butorphanol. naloxone hydrochloride injection is also indicated for the diagnosis of suspected acute opioid overdosage.