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

generic health pty ltd - ursodeoxycholic acid, quantity: 250 mg - capsule, hard - excipient ingredients: magnesium stearate; colloidal anhydrous silica; maize starch; titanium dioxide; iron oxide yellow; gelatin - ursodox gh (ursodeoxycholic acid) capsule is indicated in the treatment of chronic cholestatic liver diseases.

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

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 100 mg - injection, concentrated - excipient ingredients: hydrochloric acid; lactic acid; sodium hydroxide; water for injections; sorbitol - irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 40 mg - injection, concentrated - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid; sorbitol; lactic acid - irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

accord healthcare pty ltd - docetaxel, quantity: 80 mg - injection, concentrated - excipient ingredients: polysorbate 80; ethanol absolute; citric acid - breast cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease adjuvant treatment of breast cancer docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2 docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of = 1 cm and < 7 cm. non small cell lung cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, including those who have failed platinum-based chemotherapy. ovarian cancer docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. prostate cancer docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. head and neck cancer docetaxel in combination with cisplatin and fluorouracil, is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

accord healthcare pty ltd - docetaxel, quantity: 160 mg - injection, concentrated - excipient ingredients: citric acid; ethanol absolute; polysorbate 80 - breast cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease adjuvant treatment of breast cancer docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2 docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of = 1 cm and < 7 cm. non small cell lung cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, including those who have failed platinum-based chemotherapy. ovarian cancer docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. prostate cancer docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. head and neck cancer docetaxel in combination with cisplatin and fluorouracil, is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

generic health pty ltd - simvastatin, quantity: 80 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; magnesium stearate; citric acid monohydrate; ascorbic acid; microcrystalline cellulose; lactose monohydrate; butylated hydroxyanisole; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red; iron oxide black - simvastatin generichealth tablets are indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin generichealth tablets are indicated in patients at high risk of chd (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitilisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin generichealth tablets are indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

generic health pty ltd - simvastatin, quantity: 40 mg - tablet, film coated - excipient ingredients: lactose monohydrate; ascorbic acid; citric acid monohydrate; pregelatinised maize starch; butylated hydroxyanisole; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide red; iron oxide black - simvastatin generichealth tablets are indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin generichealth tablets are indicated in patients at high risk of chd (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitilisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin generichealth tablets are indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

generic health pty ltd - simvastatin, quantity: 20 mg - tablet, film coated - excipient ingredients: magnesium stearate; pregelatinised maize starch; ascorbic acid; microcrystalline cellulose; butylated hydroxyanisole; lactose monohydrate; citric acid monohydrate; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red; iron oxide black - simvastatin generichealth tablets are indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin generichealth tablets are indicated in patients at high risk of chd (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitilisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin generichealth tablets are indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

generic health pty ltd - simvastatin, quantity: 10 mg - tablet, film coated - excipient ingredients: butylated hydroxyanisole; pregelatinised maize starch; magnesium stearate; microcrystalline cellulose; ascorbic acid; lactose monohydrate; citric acid monohydrate; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red - simvastatin generichealth tablets are indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin generichealth tablets are indicated in patients at high risk of chd (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitilisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin generichealth tablets are indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

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

accord healthcare pty ltd - sildenafil citrate, quantity: 28.1 mg (equivalent: sildenafil, qty 20 mg) - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; hypromellose; calcium hydrogen phosphate; croscarmellose sodium; titanium dioxide; lactose monohydrate; triacetin - used to treat patients with pulmonary arterial hypertension classified as who functional classes ii and iii, to improve exercise capacity. efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. the efficacy of sildenafil citrate 20 mg has not been evaluated in patients currently on bosentan therapy.