Australia - English - 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.

Australia - English - 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.

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

accord healthcare pty ltd - clopidogrel hydrogen sulfate, quantity: 97.875 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; hydrogenated castor oil; hyprolose; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red - for prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,acute coronary syndrome: clopidogrel tablets is indicated in combination with aspirin for patients with: ,- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or pci, with or without stent); ,- st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

sandoz pty ltd - clopidogrel hydrogen sulfate, quantity: 97.875 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: hydrogenated castor oil; colloidal anhydrous silica; hyprolose; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red - for prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,acute coronary syndrome: clopidogrel tablets is indicated in combination with aspirin for patients with: ,- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or pci, with or without stent); ,- st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

accord healthcare pty ltd - clopidogrel hydrogen sulfate, quantity: 97.875 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: hyprolose; hydrogenated castor oil; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; microcrystalline cellulose - for prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,acute coronary syndrome: clopidogrel tablets is indicated in combination with aspirin for patients with: ,- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or pci, with or without stent); ,- st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

pharmacor pty ltd - clopidogrel hydrogen sulfate, quantity: 97.875 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: hyprolose; colloidal anhydrous silica; hydrogenated castor oil; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; microcrystalline cellulose - for prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,acute coronary syndrome: clopidogrel tablets is indicated in combination with aspirin for patients with: ,- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or pci, with or without stent); ,- st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

pharmacor pty ltd - clopidogrel hydrogen sulfate, quantity: 97.875 mg (equivalent: clopidogrel, qty 75 mg) - tablet, film coated - excipient ingredients: hyprolose; hydrogenated castor oil; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide red; microcrystalline cellulose - for prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. ,acute coronary syndrome: clopidogrel tablets is indicated in combination with aspirin for patients with: ,- unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel tablets is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or pci, with or without stent); ,- st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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

sandoz pty ltd - aciclovir, quantity: 800 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; copovidone; magnesium stearate - adults; treatment of first episode (primary or nonprimary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. the management of patients with advanced symptomatic hiv disease (cd4+ counts <150 x 10 6/l). genital herpes initial episodes. the duration of viral shedding is reduced very significantly; the duration of pain and time to healing are also reduced. the promptness of initiation of therapy and/or the patient's prior exposure to herpes simplex virus may influence the degree of benefit from therapy. intravenous aciclovir should be considered in patients in whom prostration, cns involvement or inability to take oral medication requires hospitalisation and initiation or more aggressive management. aciclovir does not prevent the establishment of latency in initial episodes.,recurrent episodes. suppression. in patients with frequent recurrences, suppressive therapy prevents or reduces the frequency and/or severity of recurrences in a high proportion of patients. abortive episodes (prodromal symptoms without vesicle formation) and occasional breakthrough episodes may, however, continue to occur during suppressive therapy. suppressive therapy is not considered appropriate for patients in whom attacks are mild, last short periods and/or occur infrequently (e.g. less frequently than once a month). aciclovir is effective only during the period of intake and has no residual beneficial effect. it does not eradicate the body viral pool. following cessation of therapy, the time to onset of recurrences, their frequency, severity and duration remain generally unaffected. some patients may experience increased severity of the first episode following cessation of therapy. the risk of inducing viral resistance and of potential long-term adverse effects (see precautions, carcinogenesis, mutagenesis and impairment of fertility) should be weighed carefully before initiating suppressive therapy. asymptomatic cases of genital herpes are known to shed the virus with a high frequency. however, at present only limited data are available on the extent and frequency of viral shedding in patients receiving suppressive therapy. therefore, if therapy with aciclovir tablets is being used in prenatal period (see precautions, use in pregnancy), it should not be assumed that viral shedding has ceased. pregnancy should be managed according to considerations normally applicable to patients with genital herpes. in view of the complex and variable natural history of genital herpes, suppressive therapy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see dosage and administration). intermittent treatment. for certain patients, intermittent short-term treatment of recurrences is effective. although the average patients would derive limited benefits from such treatment, a minority of patients who have experienced severe, prolonged recurrent episodes or recurrences complicated by eczema, burns or immunosuppression may experience more appreciable benefits. in those patients, intermittent treatment may be more appropriate than suppressive therapy when recurrences are infrequent. herpes zoster. in controlled trials aciclovir tablets were shown to reduce acute pain and rash progression in adult patients of all ages with herpes zoster in whom the duration of rash was less than 72 hours. aciclovir tablets appeared to be relatively less effective in younger adults, in whom herpes zoster is generally a milder disease. in ophthalmic zoster, oral aciclovir has been shown to reduce the incidence of stromal keratitis and both the incidence and severity of anterior uveitis, but not other ocular complications or acute pain. note. in immunocompetent patients with very severe herpes zoster, immunocompromised patients, or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. advanced symptomatic hiv disease. studies have shown that oral aciclovir reduced mortality in patients with advanced hiv disease (cd4+ count < 150 x 10 6/l). in addition, oral aciclovir provided effective prophylaxis for herpes virus disease. no significant effect was seen on the prophylaxis of cytomegalovirus (cmv) disease or epstein-barr virus (ebv) disease.

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

sandoz pty ltd - aciclovir, quantity: 200 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; copovidone; magnesium stearate - adults; treatment of first episode (primary or nonprimary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. the management of patients with advanced symptomatic hiv disease (cd4+ counts <150 x 10 6/l). genital herpes initial episodes. the duration of viral shedding is reduced very significantly; the duration of pain and time to healing are also reduced. the promptness of initiation of therapy and/or the patient's prior exposure to herpes simplex virus may influence the degree of benefit from therapy. intravenous aciclovir should be considered in patients in whom prostration, cns involvement or inability to take oral medication requires hospitalisation and initiation or more aggressive management. aciclovir does not prevent the establishment of latency in initial episodes.,recurrent episodes. suppression. in patients with frequent recurrences, suppressive therapy prevents or reduces the frequency and/or severity of recurrences in a high proportion of patients. abortive episodes (prodromal symptoms without vesicle formation) and occasional breakthrough episodes may, however, continue to occur during suppressive therapy. suppressive therapy is not considered appropriate for patients in whom attacks are mild, last short periods and/or occur infrequently (e.g. less frequently than once a month). aciclovir is effective only during the period of intake and has no residual beneficial effect. it does not eradicate the body viral pool. following cessation of therapy, the time to onset of recurrences, their frequency, severity and duration remain generally unaffected. some patients may experience increased severity of the first episode following cessation of therapy. the risk of inducing viral resistance and of potential long-term adverse effects (see precautions, carcinogenesis, mutagenesis and impairment of fertility) should be weighed carefully before initiating suppressive therapy. asymptomatic cases of genital herpes are known to shed the virus with a high frequency. however, at present only limited data are available on the extent and frequency of viral shedding in patients receiving suppressive therapy. therefore, if therapy with aciclovir tablets is being used in prenatal period (see precautions, use in pregnancy), it should not be assumed that viral shedding has ceased. pregnancy should be managed according to considerations normally applicable to patients with genital herpes. in view of the complex and variable natural history of genital herpes, suppressive therapy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see dosage and administration). intermittent treatment. for certain patients, intermittent short-term treatment of recurrences is effective. although the average patients would derive limited benefits from such treatment, a minority of patients who have experienced severe, prolonged recurrent episodes or recurrences complicated by eczema, burns or immunosuppression may experience more appreciable benefits. in those patients, intermittent treatment may be more appropriate than suppressive therapy when recurrences are infrequent. herpes zoster. in controlled trials aciclovir tablets were shown to reduce acute pain and rash progression in adult patients of all ages with herpes zoster in whom the duration of rash was less than 72 hours. aciclovir tablets appeared to be relatively less effective in younger adults, in whom herpes zoster is generally a milder disease. in ophthalmic zoster, oral aciclovir has been shown to reduce the incidence of stromal keratitis and both the incidence and severity of anterior uveitis, but not other ocular complications or acute pain. note. in immunocompetent patients with very severe herpes zoster, immunocompromised patients, or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. advanced symptomatic hiv disease. studies have shown that oral aciclovir reduced mortality in patients with advanced hiv disease (cd4+ count < 150 x 10 6/l). in addition, oral aciclovir provided effective prophylaxis for herpes virus disease. no significant effect was seen on the prophylaxis of cytomegalovirus (cmv) disease or epstein-barr virus (ebv) disease.

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

viiv healthcare pty ltd - abacavir sulfate, quantity: 702 mg (equivalent: abacavir, qty 600 mg); lamivudine, quantity: 300 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; sunset yellow fcf; polysorbate 80; macrogol 400 - kivexa tablets are a combination of two nucleoside analogues (abacavir and lamivudine). kivexa is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age.