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

janssen-cilag pty ltd - epoetin alfa, quantity: 10000 iu/ml - injection, solution - excipient ingredients: monobasic sodium phosphate; polysorbate 80; dibasic sodium phosphate dihydrate; glycine; water for injections; sodium chloride - eprex is indicated for the treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. eprex is also indicated for the treatment of anaemia and reduction of transfusion in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy. eprex is also indicated in adult patients with mild- to-moderate anaemia (haemoglobin > 100 to <= 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. eprex is also indicated to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to pre-deposit their complete peri-operative blood needs.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 10000 iu/ml - injection, solution - excipient ingredients: sodium chloride; glycine; monobasic sodium phosphate; polysorbate 80; dibasic sodium phosphate dihydrate; water for injections - eprex is indicated for the treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. eprex is also indicated for the treatment of anaemia and reduction of transfusion in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy. eprex is also indicated in adult patients with mild- to-moderate anaemia (haemoglobin > 100 to <= 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. eprex is also indicated to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to pre-deposit their complete peri-operative blood needs.

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

janssen-cilag pty ltd - rabeprazole sodium, quantity: 20 mg - tablet, enteric coated - excipient ingredients: mannitol; magnesium stearate; carnauba wax; titanium dioxide; purified talc; hypromellose phthalate; diacetylated monoglycerides; ethylcellulose; magnesium oxide; hyprolose; iron oxide yellow; butan-1-ol; shellac; iron oxide red; ethanol absolute; glyceryl monooleate - pariet is indicated for treatment and prevention of relapse of gastro-oesophageal reflux disease; symptomatic treatment gastro-oesophageal reflux disease; treatment of duodenal ulcers; treatment of gastric ulcers. patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. pariet is also indicated, in combination with clarithromycin and amoxycillin, for eradication of helicobacter pylori in patients with peptic ulcer disease or chronic gastritis; and healing of peptic ulcers in patients with helicobacter pylori associated ulcers.

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

janssen-cilag pty ltd - rabeprazole sodium, quantity: 10 mg - tablet, enteric coated - excipient ingredients: purified talc; magnesium stearate; iron oxide red; magnesium oxide; titanium dioxide; mannitol; carnauba wax; hypromellose phthalate; hyprolose; ethylcellulose; diacetylated monoglycerides; butan-1-ol; shellac; ethanol absolute; iron oxide black - pariet is indicated for treatment and prevention of relapse of gastro-oesophageal reflux disease; symptomatic treatment gastro-oesophageal reflux disease; treatment of duodenal ulcers; treatment of gastric ulcers. patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. pariet is also indicated, in combination with clarithromycin and amoxycillin, for eradication of helicobacter pylori in patients with peptic ulcer disease or chronic gastritis; and healing of peptic ulcers in patients with helicobacter pylori associated ulcers.

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

janssen-cilag pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; polysorbate 80; sucrose - rheumatoid arthritis in adults: remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: patients with active disease despite treatment with methotrexate; patients with active disease who have not previously received methotrexate. remicade should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate. ankylosing spondylitis: remicade is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease. psoriatic arthritis: remicade is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remicade may be administered in combination with methotrexate. psoriasis: remicade is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established. crohn's disease in adults and in children and adolescents (6-17 years): remicade is indicated for the treatment of moderate to severe crohn's disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies. refractory fistulising crohn's disease: remicade is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients. ulcerative colitis in adults and in children and adolescents (6 to 17 years); remicade is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 40000 iu/ml - injection, solution - excipient ingredients: polysorbate 80; dibasic sodium phosphate dihydrate; glycine; water for injections; sodium chloride; monobasic sodium phosphate - eprex is indicated for the treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. eprex is also indicated for the treatment of anaemia and reduction of transfusion in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy. eprex is also indicated in adult patients with mild- to-moderate anaemia (haemoglobin > 100 to <= 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. eprex is also indicated to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to pre-deposit their complete peri-operative blood needs.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 40000 iu/ml - injection, solution - excipient ingredients: glycine; sodium chloride; dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; monobasic sodium phosphate - eprex is indicated for the treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. eprex is also indicated for the treatment of anaemia and reduction of transfusion in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy. eprex is also indicated in adult patients with mild- to-moderate anaemia (haemoglobin > 100 to <= 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. eprex is also indicated to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to pre-deposit their complete peri-operative blood needs.

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

janssen-cilag pty ltd - risperidone, quantity: 0.5 mg - tablet, film coated - excipient ingredients: titanium dioxide; hypromellose; propylene glycol; maize starch; sodium lauryl sulfate; magnesium stearate; purified talc; iron oxide red; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose - risperdal is indicated for the treatment of schizophrenia and related psychoses. risperdal is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. risperdal is also indicated for the treatment of behavioural disturbances in dementia. risperdal is indicated in the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent (see clinical trials for maintenance data). risperdal is indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see clinical trials).

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

janssen-cilag pty ltd - epoetin alfa, quantity: 10000 iu/ml - injection, solution - excipient ingredients: sodium chloride; dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; glycine; monobasic sodium phosphate - eprex is indicated for the treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. eprex is also indicated for the treatment of anaemia and reduction of transfusion in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy. eprex is also indicated in adult patients with mild- to-moderate anaemia (haemoglobin > 100 to <= 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. eprex is also indicated to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to pre-deposit their complete peri-operative blood needs.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 10000 iu/ml - injection, solution - excipient ingredients: glycine; dibasic sodium phosphate dihydrate; sodium chloride; water for injections; monobasic sodium phosphate; polysorbate 80 - eprex is indicated for the treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions. eprex is also indicated for the treatment of anaemia and reduction of transfusion in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy. eprex is also indicated in adult patients with mild- to-moderate anaemia (haemoglobin > 100 to <= 130 g/l) scheduled for elective surgery with an expected moderate blood loss (2-4 units or 900 to 1800 ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery. eprex is also indicated to augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to pre-deposit their complete peri-operative blood needs.