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

aspen pharmacare australia pty ltd - ondansetron hydrochloride dihydrate, quantity: 10 mg (equivalent: ondansetron, qty 8 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; iron oxide yellow; hypromellose - ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy

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

aspen pharmacare australia pty ltd - ondansetron hydrochloride dihydrate, quantity: 5 mg (equivalent: ondansetron, qty 4 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; iron oxide yellow; hypromellose - ondansetron (tablets, syrup, wafers, suppository and injection) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy

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

aspen pharmacare australia pty ltd - darifenacin hydrobromide, quantity: 17.857 mg (equivalent: darifenacin, qty 15 mg) - tablet, modified release - excipient ingredients: hypromellose; magnesium stearate; calcium hydrogen phosphate; titanium dioxide; purified talc; macrogol 4000; iron oxide yellow; iron oxide red - enablex prolonged-release tablets are indicated for the treatment of overactive bladder, with the symptoms of urgency, urge urinary incontinence or frequency of micturition.

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)

aspen pharmacare australia pty ltd - darifenacin hydrobromide, quantity: 8.929 mg (equivalent: darifenacin, qty 7.5 mg) - tablet, modified release - excipient ingredients: magnesium stearate; hypromellose; calcium hydrogen phosphate; titanium dioxide; purified talc; macrogol 4000 - enablex prolonged-release tablets are indicated for the treatment of overactive bladder, with the symptoms of urgency, urge urinary incontinence or frequency of micturition.

Australia - English - 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.

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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 7.5 mg - tablet, uncoated - excipient ingredients: hyprolose; lactose; microcrystalline cellulose; magnesium stearate - apo-olanzapine tablets are indicated for ? treatment of schizophrenia and related psychoses. ? short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder. ? preventing recurrence of manic, mixed or depressive episodes in bipolar 1 disorder.

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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 5 mg - tablet, uncoated - excipient ingredients: magnesium stearate; microcrystalline cellulose; lactose; hyprolose - apo-olanzapine tablets are indicated for ? treatment of schizophrenia and related psychoses. ? short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder. ? preventing recurrence of manic, mixed or depressive episodes in bipolar 1 disorder.

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

arrotex pharmaceuticals pty ltd - olanzapine, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; lactose; hyprolose; magnesium stearate - apo-olanzapine tablets are indicated for ? treatment of schizophrenia and related psychoses. ? short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes associated with bipolar i disorder. ? preventing recurrence of manic, mixed or depressive episodes in bipolar 1 disorder.