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

accord healthcare pty ltd - olanzapine, quantity: 5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; magnesium stearate; hypromellose; lactose monohydrate; hyprolose; titanium dioxide; polysorbate 80; macrogol 400 - olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses. ,olanzapine tablets alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. ,olanzapine tablets are also indicated for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

accord healthcare pty ltd - olanzapine, quantity: 15 mg - tablet, film coated - excipient ingredients: hyprolose; crospovidone; magnesium stearate; microcrystalline cellulose; lactose monohydrate; hypromellose; titanium dioxide; polysorbate 80; macrogol 400; indigo carmine aluminium lake - olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses. ,olanzapine tablets alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. ,olanzapine tablets are also indicated for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

accord healthcare pty ltd - olanzapine, quantity: 10 mg - tablet, film coated - excipient ingredients: hypromellose; crospovidone; microcrystalline cellulose; lactose monohydrate; magnesium stearate; hyprolose; titanium dioxide; polysorbate 80; macrogol 400 - olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses. ,olanzapine tablets alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. ,olanzapine tablets are also indicated for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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

accord healthcare pty ltd - olanzapine, quantity: 2.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; hyprolose; lactose monohydrate; microcrystalline cellulose; crospovidone; hypromellose; titanium dioxide; polysorbate 80; macrogol 400 - olanzapine tablets are indicated for the treatment of schizophrenia and related psychoses. ,olanzapine tablets alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. ,olanzapine tablets are also indicated for preventing recurrence of manic, mixed or depressive episodes in bipolar i disorder.

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)

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)

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 800 mg - tablet - excipient ingredients: colloidal anhydrous silica; brilliant blue fcf; indigo carmine; magnesium stearate; microcrystalline cellulose; croscarmellose sodium - for use in adult patients for: 1. the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients; 2. the treatment of acute attacks of herpes zoster (shingles), when the duration of rash is less than 72 hours; 3. the management of patients with advanced symptomatic hiv disease (cd4+ counts, < 150 x 10exp6/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 simples virus may influence the degree of benefit from therapy. intravenous therapy should be considered in patients in whom prostration, central nervous system involvement or inability to tak eoral medication requires hospitalisation and initiationof more aggressive management. aciclovir does not prevent the establishment of latency in primary episodes. recurrent episodes: a) 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 patiens in whom attacks are mild, last for short periods and/or occur infrequently (for example, 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 carcinogenicity, mutagenicity, effects on fertility) shoulld 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 vial shedding in patients receiving suppressive therapy. therefore, if therapy with aciclovir tablets is being used in the prenatal period (see 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 thearpy should be interrupted periodically to ascertain whether the disease has undergone spontaneous change in frequency or severity (see dosage and administration). b) intermittent treatment: for certain patients intermittent short-term treatment of recurrences is effective. although the average patient 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 was 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. the same treatment on controlled trials, aciclovir was shown to reduce acute pain and rash progression appeared to be relatively less effective in younger patients, 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 oracute pain. note: in immune-competent patients with very severe herpes zoster, immune-compromised patients or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. patients with advanced symptomatic hiv disease (cd4+ counts, < 150 x 10exp6/l) studies have shown that oral aciclovir reduced mortality in patients with advanced hiv disease. in addition, oral aciclovir provided effective prophylaxis for herpes virus disease. no significant effect was seen on prophylaxsis of cmv disease of eb v disease.

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

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 200 mg - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; lactose monohydrate; indigo carmine; croscarmellose sodium; magnesium stearate - for use in adult patients for: 1. the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients; 2. the treatment of acute attacks of herpes zoster (shingles), when the duration of rash is less than 72 hours; 3. the management of patients with advanced symptomatic hiv disease (cd4+counts, <150 x 10exp6/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 simples virus may influence the degree of benefit from therapy. intravenous therapy should be considered in patients in whom prostation, central nervous system involvement or inability to take oral medication requires hospitalisation and initiation of more aggressive management. aciclovir does not prevent the establishment of latency in primary episodes. recurrent episodes: a) 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 for short periods and/or occur infrequently (for example, less frequently than once a month). aciclovir is effective only during the period of intake and has no residula beneficial effect. it does not eradicate the body viral pool. following cessation of therapy of 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 carcinogenicity, mutagenicity, effects on 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 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). b) intermittent treatment: for certain patients intermittent short-term treatment of recurrences is effective. although the average patient 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 was 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. the same treatment on controlled trials, aciclovir was shown to reduce acute pain and rash progression appeared to be relatively less effective in younger patients, 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 complicationsor acute pain. note: in im mune-competent patients with very severe herpes zoster, immune-compromised patients or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. patients with advanced symptomatic hiv disease (cd4+ counts, <150 x 10exp6/l). studies have shown that oral aciclovir reduced mortality in patients with advanced hiv disease. in addition, oral aciclovir provided effective prophylaxis for herpes virus disease. no significant effective was seen on prophylaxsis of cmv disease of ebv disease.

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

arrow pharma pty ltd - furosemide, quantity: 40 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch - indications as at 01 jan 1991 : oedema : in adults, infants and children frusemide is indicated for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver, renal disease including nephrotic syndrome and other oedematous states amenable to diuretic therapy. hypertension : may also be used alone in the control of mild to moderate hypertension and in combination with other antihypertensive agents in the treatment of more severe cases. studies have shown that frusemide is either less effective than or equally effective as thiazide diuretics in uncomplicated hypertension. however, in patients with severe renal function impairment, a diuretic and antihypertensive response to frusemide may be achieved while thiazides have no effect.

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

sandoz pty ltd - tadalafil, quantity: 20 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; hypromellose; sorbitan stearate; magnesium stearate; titanium dioxide; purified talc; triacetin; iron oxide yellow - tadalafil sandoz is indicated for the treatment of erectile dysfunction (ed) in adult males