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)

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)

teva pharma australia pty ltd - imatinib mesilate, quantity: 477.877 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatinib-teva (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatinib-teva (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatinib-teva (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatinib-teva (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatinib-teva (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatinib-teva (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatinib-teva (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatinib-teva (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatinib-teva (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

teva pharma australia pty ltd - imatinib mesilate, quantity: 119.469 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatinib-teva (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatinib-teva (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatinib-teva (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatinib-teva (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatinib-teva (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatinib-teva (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatinib-teva (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatinib-teva (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatinib-teva (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

actor pharmaceuticals pty ltd - tibolone, quantity: 2.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; ascorbyl palmitate; magnesium stearate; potato starch - indications ? short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women.,? second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss.,after careful selection of users, tibogen should be prescribed for the shortest duration consistent with treatment goals. review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at the moment (including cardiovascular disease and breast cancer, refer clinical trials and precautions). tibogen should only be continued for as long as the benefit outweighs the risks.

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

southern cross pharma pty ltd - tibolone, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; potato starch; ascorbyl palmitate; magnesium stearate; mannitol - - short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women.,- second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss.

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

southern cross pharma pty ltd - tibolone, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: mannitol; lactose monohydrate; magnesium stearate; potato starch; ascorbyl palmitate - - short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women.,- second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss.

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

sun pharma anz pty ltd - aciclovir, quantity: 200 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - aciclovir tablets are indicated 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 10(6)/l). in accordance with details specified in the "indications" and the "dosage and adminsitration" sections of the approved product information provided as attachment 1.