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

roche products pty ltd - emicizumab, quantity: 60 mg - injection, solution - excipient ingredients: poloxamer; arginine; aspartic acid; water for injections; histidine - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 30 mg - injection, solution - excipient ingredients: arginine; water for injections; histidine; aspartic acid; poloxamer - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 150 mg - injection, solution - excipient ingredients: aspartic acid; histidine; arginine; poloxamer; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 105 mg - injection, solution - excipient ingredients: arginine; poloxamer; aspartic acid; histidine; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

southern xp ip pty ltd - dexamethasone sodium phosphate, quantity: 4.37 mg (equivalent: dexamethasone phosphate, qty 4 mg) - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium hydroxide; creatinine; sodium citrate; disodium edetate - replacement therapy - adrenocortical insufficiency,dexamethasone has predominantly glucocorticoid activity and therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. when so supplemented, dexamethasone is indicated in:,? acute adrenocortical insufficiency - addison's disease, bilateral adrenalectomy;,? relative adrenocortical insufficiency - prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. the reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. steroid therapy should therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns, or severe infections where specific antibiotic therapy is available;,? primary and secondary adrenocortical insufficiency.,disease therapy,dexamethasone is indicated for therapy of the following diseases:,collagen diseases: systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, giant cell arteritis, adjunctive therapy for short-term administration during an acute episode or exacerbation, acute rheumatic carditis ? during an exacerbation or as maintenance therapy.,pulmonary disorders: status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency.,blood disorders: leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia.,rheumatic diseases: rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis.,skin diseases: psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis.,gastrointestinal disorders: ulcerative colitis, regional enteritis.,oedema: cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis).,eye disorders: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy.,neoplastic states: cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children.,endocrine disorders: adrenal insufficiency.,preoperative and postoperative support,dexamethasone may be used in any surgical procedure when the adrenocortical reserve is doubtful. this includes the treatment of shock due to excessive blood loss during surgery.,shock,dexamethasone may be used as an adjunct in the treatment of shock. dexamethasone should not be used as a substitute for normal shock therapy.

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

southern xp ip pty ltd - dexamethasone sodium phosphate, quantity: 8.74 mg (equivalent: dexamethasone phosphate, qty 8 mg) - injection, solution - excipient ingredients: water for injections; disodium edetate; sodium citrate; hydrochloric acid; sodium hydroxide; creatinine - replacement therapy - adrenocortical insufficiency,dexamethasone has predominantly glucocorticoid activity and therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. when so supplemented, dexamethasone is indicated in:,? acute adrenocortical insufficiency - addison's disease, bilateral adrenalectomy;,? relative adrenocortical insufficiency - prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. the reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. steroid therapy should therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns, or severe infections where specific antibiotic therapy is available;,? primary and secondary adrenocortical insufficiency.,disease therapy,dexamethasone is indicated for therapy of the following diseases:,collagen diseases: systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, giant cell arteritis, adjunctive therapy for short-term administration during an acute episode or exacerbation, acute rheumatic carditis ? during an exacerbation or as maintenance therapy.,pulmonary disorders: status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency.,blood disorders: leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia.,rheumatic diseases: rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis.,skin diseases: psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis.,gastrointestinal disorders: ulcerative colitis, regional enteritis.,oedema: cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis).,eye disorders: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy.,neoplastic states: cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children.,endocrine disorders: adrenal insufficiency.,preoperative and postoperative support,dexamethasone may be used in any surgical procedure when the adrenocortical reserve is doubtful. this includes the treatment of shock due to excessive blood loss during surgery.,shock,dexamethasone may be used as an adjunct in the treatment of shock. dexamethasone should not be used as a substitute for normal shock therapy.

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

csl behring australia pty ltd - water for injections, quantity: 40 ml - injection, solution - excipient ingredients: - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

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

csl behring australia pty ltd - water for injections, quantity: 20 ml - injection, solution - excipient ingredients: - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

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

csl behring australia pty ltd - water for injections, quantity: 3 ml - injection, diluent for - excipient ingredients: - berinert iv is indicated for the treatment of acute attacks in patients with hereditary angioedema (hae).

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

samsung bioepis au pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: water for injections; sucrose; monobasic sodium phosphate monohydrate; polysorbate 80; dibasic sodium phosphate heptahydrate - renflexis is indicated for the treatment of:,rheumatoid arthritis in adults renflexis, 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.,renflexis should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate,ankylosing spondylitis renflexis is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis renflexis 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.,renflexis may be administered in combination with methotrexate.,psoriasis renflexis 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 to 17 years) renflexis 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 renflexis 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) renflexis is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.