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)

csl behring australia pty ltd - normal immunoglobulin, quantity: 4 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 4 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 2 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 1 g - injection, solution - excipient ingredients: water for injections; proline; polysorbate 80 - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima 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.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima 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. remsima may be administered in combination with methotrexate.,psoriasis remsima 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 remsima 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 remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais 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)

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima 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.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima 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. remsima may be administered in combination with methotrexate.,psoriasis remsima 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 remsima 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 remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais 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)

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima 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.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima 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. remsima may be administered in combination with methotrexate.,psoriasis remsima 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 remsima 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 remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais 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)

sanofi-aventis australia pty ltd - insulin aspart, quantity: 3.5 mg/ml - injection, solution - excipient ingredients: metacresol; phenol; polysorbate 20; sodium hydroxide; hydrochloric acid; water for injections; zinc chloride; sodium chloride - for the treatment of diabetes mellitus

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

celltrion healthcare australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: acetic acid; polysorbate 80; sodium acetate trihydrate; glycine; water for injections - rheumatoid arthritis,yuflyma is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. yuflyma can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis,polyarticular juvenile idiopathic arthritis,yuflyma in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis,yuflyma is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis,yuflyma is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis,yuflyma is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. crohn?s disease in adults and children (6 years and older),yuflyma is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or,,? who have lost response to or are intolerant to infliximab,ulcerative colitis,yuflyma is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties - clinical trials).,psoriasis in adults and children,yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis,yuflyma is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.