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

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 4 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; macrogol 3350; iron oxide yellow; lactose; titanium dioxide; macrogol 400; iron oxide red; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; water for injections; sorbitol - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

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

janssen-cilag pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: magnesium stearate; purified talc; polyvinyl alcohol; macrogol 3350; crospovidone; colloidal anhydrous silica; microcrystalline cellulose; sunset yellow fcf aluminium lake; titanium dioxide - adult patients,prezista ( with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents, for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,prezista (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

janssen-cilag pty ltd - golimumab, quantity: 50 mg - injection, solution - excipient ingredients: polysorbate 80; water for injections; histidine; sorbitol - simponi,rheumatoid arthritis (ra),simponi, in combination with methotrexate, is indicated for:,the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. simponi has also been shown to inhibit the progression of joint damage as measured by x-ray.,psoriatic arthritis (psa),simponi, alone or in combination with methotrexate, is indicated for:,the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. simponi has also been shown to inhibit the progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.,axial spondyloarthritis,ankylosing spondylitis (as),simponi is indicated for:,the treatment of active ankylosing spondylitis in adult patients. non-radiographic axial spondyloarthritis (nr-axial spa),simponi is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (nsaids).,ulcerative colitis (uc),simponi is indicated for: the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. patients should show a clinical response within 6 weeks of treatment to continue treatment beyond that time (see section 5.1 pharmacodynamic properties, clinical trials).

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

janssen-cilag pty ltd - bortezomib, quantity: 1 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - - velcade, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. - velcade, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. - velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

janssen-cilag pty ltd - etravirine, quantity: 100 mg - tablet - excipient ingredients: hypromellose; croscarmellose sodium; magnesium stearate; lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica - 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 - hydromorphone hydrochloride, quantity: 64 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; indigo carmine aluminium lake; macrogol 400; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

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

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 32 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; iron oxide yellow; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; macrogol 400; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

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

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 16 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; iron oxide yellow; macrogol 400; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.

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

janssen-cilag pty ltd - hydromorphone hydrochloride, quantity: 8 mg - tablet, modified release - excipient ingredients: polyethylene oxide; povidone; magnesium stearate; butylated hydroxytoluene; sodium chloride; iron oxide black; cellulose acetate; hypromellose; lactose; macrogol 3350; lactose monohydrate; titanium dioxide; triacetin; iron oxide red; macrogol 400; propylene glycol; isopropyl alcohol; purified water - jurnista is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. jurnista is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. jurnista is not indicated as an as-needed (prn) analgesia. not for use in opioid na?ve patients.