Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - codeine phosphate hemihydrate, quantity: 6 mg; paracetamol, quantity: 500 mg; pseudoephedrine hydrochloride, quantity: 30 mg - tablet, uncoated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; maize starch; sodium starch glycollate; microcrystalline cellulose; povidone - temporary symptomatic relief of rhinorrhoea, nasal congestion, headache, myalgia and fever in patient aged 12 years and over.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - anastrozole, quantity: 1 mg - tablet, film coated - excipient ingredients: lactose; lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type a; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000 - early breast cancer. adjuvant treatment of early breast cancer in postmenopausal women with oestrogen/progesterone receptor positive disease.,advanced breast cancer. first line treatment of advanced breast cancer in postmenopausal women with oestrogen/ progesterone receptor positive disease. treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. patients with oestrogen receptor negative disease and patients who have not responded to previous tamoxifen therapy rarely respond to anastrozole.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - cyproterone acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; maize starch; pregelatinised maize starch; lactose monohydrate; magnesium stearate; povidone - inoperable prostatic carcinoma. to suppress 'flare' with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 10 mg - tablet, uncoated - excipient ingredients: maize starch; purified talc; magnesium stearate; povidone; colloidal anhydrous silica; sodium lauryl sulfate; sodium starch glycollate - temporary relief of acute moderate pain and fever.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - paracetamol, quantity: 500 mg; codeine phosphate hemihydrate, quantity: 15 mg - tablet, uncoated - excipient ingredients: pregelatinised maize starch; maize starch; sodium lauryl sulfate; povidone; purified talc; magnesium stearate; colloidal anhydrous silica; hyprolose; stearic acid - temporary relief of acute moderate pain.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: maize starch; magnesium stearate; povidone; colloidal anhydrous silica; lactose monohydrate; pregelatinised maize starch - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism. moderately severe/severe androgen-dependent loss of scalp hair (moderately severe/severe andogenetic alopecia). moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyproterone acetate inhibits the influence of male sex hormones, which are also produced by the female. it is thus possible to treat diseases in women caused either by increases production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if meditab cyproterone is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of child bearing potential, pregnancy must be excluded at the commencement of treatment and ethinyl oestradiol taken as well to ensure contraception. this also promotes regular menstruation. . men: reduction of drive in sexual deviations. meditab cyproterone reduces the force of the sexual urge in men with sexual deviations. whilst under treatment, the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. meditab cyproterone therapy should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social re-orientation. inoperable prostatic carcinoma. to suppress "flare" with initial lhrh analogue therapy. in long term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred. in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy..

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - bevacizumab, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; dibasic sodium phosphate; polysorbate 20; trehalose dihydrate - metastatic colorectal cancer bevaciptin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. locally recurrent or metastatic breast cancer bevaciptin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 clinical trials). advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) bevaciptin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer. advanced and/or metastatic renal cell cancer bevaciptin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. grade iv glioma bevaciptin (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy. epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors. bevaciptin (bevacizumab) in combination with topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab. cervical cancer bevaciptin (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. bevaciptin (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - bevacizumab, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; trehalose dihydrate; dibasic sodium phosphate; polysorbate 20 - metastatic colorectal cancer bevaciptin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. locally recurrent or metastatic breast cancer bevaciptin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 clinical trials). advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) bevaciptin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer. advanced and/or metastatic renal cell cancer bevaciptin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. grade iv glioma bevaciptin (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy. epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors. bevaciptin (bevacizumab) in combination with topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab. cervical cancer bevaciptin (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. bevaciptin (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - lamotrigine, quantity: 200 mg - tablet, uncoated - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; maize starch; lactose monohydrate - antiepileptic drug for the treatment of partial and generalised seizures in adults and children over 12 years of age.,there is extensive experience with lamotrigine used initially as add-on therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs.,initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 pharmacodynamic properties, clinical trials).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - lamotrigine, quantity: 100 mg - tablet, uncoated - excipient ingredients: magnesium stearate; sodium starch glycollate; maize starch; lactose monohydrate; microcrystalline cellulose - antiepileptic drug for the treatment of partial and generalised seizures in adults and children over 12 years of age.,there is extensive experience with lamotrigine used initially as add-on therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs.,initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 pharmacodynamic properties, clinical trials).