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

janssen-cilag pty ltd - etravirine, quantity: 200 mg - tablet - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; hypromellose; magnesium stearate - etravirine, in combination with other antiretroviral agents is indicated for the treatment of hiv-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.,this indication is based on 24-week analyses from 2 randomised, double-blind, placebo controlled trials of etravirine. both studies were conducted in clinically advanced, 3-class antiretroviral (nnrti, n(t)rti, pi) treatment-experienced adults (see section 5.1 pharmacodynamic properties ? clinical trials).,treatment history of patients and genotypic testing should be performed to guide the use of etravirine.

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

janssen-cilag pty ltd - methylphenidate hydrochloride, quantity: 54 mg - tablet, modified release - excipient ingredients: sodium chloride; phosphoric acid; stearic acid; iron oxide yellow; carnauba wax; povidone; polyethylene oxide; cellulose acetate; hypromellose; iron oxide black; succinic acid; butylated hydroxytoluene; poloxamer; iron oxide red; titanium dioxide; lactose monohydrate; triacetin; propylene glycol; isopropyl alcohol; purified water; macrogol 400 - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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

janssen-cilag pty ltd - methylphenidate hydrochloride, quantity: 36 mg - tablet, modified release - excipient ingredients: stearic acid; poloxamer; polyethylene oxide; butylated hydroxytoluene; iron oxide black; iron oxide yellow; phosphoric acid; cellulose acetate; hypromellose; succinic acid; carnauba wax; sodium chloride; povidone; titanium dioxide; lactose monohydrate; triacetin; macrogol 400; propylene glycol; isopropyl alcohol; purified water - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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

janssen-cilag pty ltd - methylphenidate hydrochloride, quantity: 18 mg - tablet, modified release - excipient ingredients: iron oxide yellow; sodium chloride; povidone; butylated hydroxytoluene; iron oxide black; stearic acid; polyethylene oxide; cellulose acetate; succinic acid; phosphoric acid; hypromellose; carnauba wax; poloxamer; macrogol 400; titanium dioxide; lactose monohydrate; triacetin; propylene glycol; isopropyl alcohol; purified water - concerta is indicated for the treatment of attention deficit hyperactivity disorder (adhd). treatment should be commenced by a specialist.,a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.,need for comprehensive treatment programme concerta is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational and social) for patients with this syndrome. stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician?s assessment of the chronicity and severity of the patient?s symptoms.,long term use the effectiveness of concerta for long-term use has not been systematically evaluated in controlled trials. therefore the physician who elects to use concerta for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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

janssen-cilag pty ltd - epoetin alfa, quantity: 10000 iu/ml - injection, solution - excipient ingredients: water for injections; sodium chloride; glycine; dibasic sodium phosphate dihydrate; 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.

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 - 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.