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

alphapharm pty ltd - dexamethasone sodium phosphate, quantity: 4.4 mg (equivalent: dexamethasone phosphate, qty 4 mg) - injection - excipient ingredients: sodium citrate; creatinine; water for injections - 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 the following: ? 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 - 1. 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. 2. pulmonary disorders. status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency. 3. blood disorders. leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia. 4. rheumatic diseases. rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis. 5. skin diseases. psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis. 6. gastrointestinal disorders. ulcerative colitis, regional enteritis. 7. oedema. cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis). 8. eye disorders. allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy. 9. neoplastic states. cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children. 10. 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. refer to section 4.2 dose and method of administration. dexamethasone should not be used as a substitute for normal shock therapy.

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

alphapharm pty ltd - dexamethasone sodium phosphate, quantity: 8.8 mg (equivalent: dexamethasone phosphate, qty 8 mg) - injection - excipient ingredients: water for injections; sodium citrate; 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 the following: ? 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 - 1. 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. 2. pulmonary disorders. status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency. 3. blood disorders. leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia. 4. rheumatic diseases. rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis. 5. skin diseases. psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis. 6. gastrointestinal disorders. ulcerative colitis, regional enteritis. 7. oedema. cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis). 8. eye disorders. allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy. 9. neoplastic states. cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children. 10. 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. refer to section 4.2 dose and method of administration. dexamethasone should not be used as a substitute for normal shock therapy.

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

juno pharmaceuticals pty ltd - dexamethasone sodium phosphate, quantity: 8.74 mg (equivalent: dexamethasone phosphate, qty 8 mg) - injection, solution - excipient ingredients: sodium citrate; water for injections; disodium edetate; 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 - Kiingereza - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - dexamethasone sodium phosphate, quantity: 4.37 mg (equivalent: dexamethasone phosphate, qty 4 mg) - injection, solution - excipient ingredients: disodium edetate; water for injections; sodium citrate; creatinine; sodium hydroxide - 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 - Kiingereza - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - dexamethasone sodium phosphate, quantity: 8.75 mg (equivalent: dexamethasone phosphate, qty 8 mg) - injection, solution - excipient ingredients: water for injections; disodium edetate; sodium hydroxide; sodium citrate dihydrate; 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 - Kiingereza - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - dexamethasone sodium phosphate, quantity: 4.37 mg (equivalent: dexamethasone phosphate, qty 4 mg) - injection, solution - excipient ingredients: sodium citrate dihydrate; creatinine; water for injections; sodium hydroxide; 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 - Kiingereza - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - ibuprofen, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: hydrochloric acid; water for injections; arginine - caldolor injection is indicated in adults for the management of acute mild to moderate post-operative pain and moderate to severe post-operative pain with adjunctive reduced morphine dosage, where an intravenous route of administration is considered clinically necessary.,caldolor is indicated for the reduction of fever in adults where an intravenous route of administration is considered clinically necessary.

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

glaxosmithkline australia pty ltd - sotrovimab, quantity: 500 mg - injection, concentrated - excipient ingredients: water for injections; histidine hydrochloride monohydrate; histidine; polysorbate 80; methionine; sucrose - xevudy has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require initiation of oxygen due to covid-19 and who are at increased risk of progression to hospitalisation or death (see section 5.1 pharmacodynamic properties, clinical trials).,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

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

novartis pharmaceuticals australia pty ltd - secukinumab, quantity: 75 mg - injection, solution - excipient ingredients: trehalose dihydrate; histidine hydrochloride monohydrate; methionine; polysorbate 80; water for injections; nitrogen - plaque psoriasis,cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,cosentyx is indicated for the treatment of adult patients with active psoriatic arthritis including axial manifestations of psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (dmard) therapy has been inadequate.,axial spondyloarthritis (axspa) with or without radiographic damage,ankylosing spondylitis (axspa with radiographic damage),cosentyx is indicated for the treatment of adult patients with active ankylosing spondylitis.,non-radiographic axial spondyloarthritis (axspa without radiographic damage),cosentyx is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change, who have had an inadequate response to, or are intolerant to, nsaids.,juvenile idiopathic arthritis (jia),enthesitis-related arthritis (era),cosentyx is indicated for the treatment of active enthesitis-related arthritis in patients 4 years and older who have had an inadequate response or were intolerant to at least one nsaid and at least one dmard.,juvenile psoriatic arthritis (jpsa),cosentyx is indicated for the treatment of active juvenile psoriatic arthritis in patients 2 years and older who have had an inadequate response or were intolerant to at least one nsaid and at least one dmard.,hidradenitis suppurativa (hs),cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

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

novartis pharmaceuticals australia pty ltd - secukinumab, quantity: 300 mg - injection, solution - excipient ingredients: trehalose dihydrate; histidine hydrochloride monohydrate; methionine; polysorbate 80; water for injections; nitrogen - plaque psoriasis,cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,cosentyx is indicated for the treatment of adult patients with active psoriatic arthritis including axial manifestations of psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (dmard) therapy has been inadequate.,axial spondyloarthritis (axspa) with or without radiographic damage,ankylosing spondylitis (axspa with radiographic damage),cosentyx is indicated for the treatment of adult patients with active ankylosing spondylitis.,non-radiographic axial spondyloarthritis (axspa without radiographic damage),cosentyx is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change, who have had an inadequate response to, or are intolerant to, nsaids.,juvenile idiopathic arthritis (jia),enthesitis-related arthritis (era),cosentyx is indicated for the treatment of active enthesitis-related arthritis in patients 4 years and older who have had an inadequate response or were intolerant to at least one nsaid and at least one dmard.,juvenile psoriatic arthritis (jpsa),cosentyx is indicated for the treatment of active juvenile psoriatic arthritis in patients 2 years and older who have had an inadequate response or were intolerant to at least one nsaid and at least one dmard.,hidradenitis suppurativa (hs),cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.