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

pfizer australia pty ltd - calcium folinate, quantity: 10.8 mg/ml (equivalent: folinic acid, qty 10 mg/ml) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid - leucovorin calcium injection usp is indicated following high dose methotrexate therapy to reduce toxicity (leucovorin rescue). it is also indicated after inadvertent overdosage with methotrexate and in impaired methotrexate elimination.

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatment of patients with her2 positive advanced adenocarcinoma of the stomach or gastrooesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

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

celltrion healthcare australia pty ltd - rituximab, quantity: 100 mg - injection, concentrated - excipient ingredients: polysorbate 80; water for injections; sodium chloride; sodium citrate dihydrate - non-hodgkin?s lymphoma truxima is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma; - cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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

celltrion healthcare australia pty ltd - rituximab, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; polysorbate 80; water for injections; sodium chloride - non-hodgkin?s lymphoma truxima is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma; - cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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

pfizer australia pty ltd - bupivacaine hydrochloride monohydrate, quantity: 105.4 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid - bupivacaine injection is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: surgical anaesthesia - epidural block for surgery - field block (minor and major nerve blocks and infiltration). analgesia - continuous epidural infusion or intermittent bolus epidural administration for analgesia in post operative pain or labour pain. - field block (minor nerve block amd infiltration). the choice of 2 strengths, 0.25% and 0.5%, makes it possible to vary the degree of motor blockade.

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

pfizer australia pty ltd - cytarabine, quantity: 1 g - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - primarily for induction and maintenance of remission in acute myelocytic leukaemia of both adults and children. it has also been found to be useful in the treatment of other leukaemias such as acute lymphocytic leukaemia, chronic myelocytic leukaemia (blastphase) and erythroleukaemia. may be used alone or in combination with other antineoplastic agents, the best results often being obtained with combination therapy. children with non-hodgkin's lymphoma have benefited from a combination drug program (lsa 2l2) that includes cytarabine. indications as at 24 october 2001: cytarabine is indicated primarily for: induction and maintenance of remission in acute myelocytic leukaemia of both adults and children. it has also been found to be useful in the treatment of other leukaemias such as acute lymphocytic leukaemia, chronic myelocytic leukaemia (blast phase). cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combined therapy. children with

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

pfizer australia pty ltd - cytarabine, quantity: 100 mg - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections; hydrochloric acid - primarily for induction and maintenance of remission in acute myelocytic leukaemia of both adults and children. it has also been found to be useful in the treatment of other leukaemias such as acute lymphocytic leukaemia, chronic myelocytic leukaemia (blastphase) and erythroleukaemia. may be used alone or in combination with other antineoplastic agents, the best results often being obtained with combination therapy. children with non-hodgkin's lymphoma have benefited from a combination drug program (lsa 2l2) that includes cytarabine. indications as at 24 october 2001: cytarabine is indicated primarily for: induction and maintenance of remission in acute myelocytic leukaemia of both adults and children. it has also been found to be useful in the treatment of other leukaemias such as acute lymphocytic leukaemia, chronic myelocytic leukaemia (blast phase). cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combined therapy. children with

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

celltrion healthcare australia pty ltd - trastuzumab, quantity: 440 mg - injection, powder for - excipient ingredients: histidine hydrochloride; histidine; polysorbate 20; trehalose dihydrate - early breast cancer herzuma? is indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer herzuma? is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herzuma?.,metastatic breast cancer herzuma? is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormonereceptor positive metastatic breast cancer.,advanced gastric cancer herzuma? is indicated in combination with cisplatin and either capecitabine or 5-fu for the treatment of patients with her2 positive advanced adenocarcinoma of the stomach or gastro- oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.