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

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 150 mg - injection, solution - excipient ingredients: polysorbate 20; histidine; arginine hydrochloride; histidine hydrochloride monohydrate; water for injections - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

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

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 75 mg - injection, solution - excipient ingredients: arginine hydrochloride; water for injections; histidine; histidine hydrochloride monohydrate; polysorbate 20 - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

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

aft pharmaceuticals pty ltd - granisetron hydrochloride, quantity: 3.36 mg (equivalent: granisetron, qty 3 mg) - injection, concentrated - excipient ingredients: water for injections; sodium chloride; nitrogen; citric acid monohydrate; sodium citrate dihydrate - granisetron injection is indicated in:,adults: - for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy - for the prevention of nausea and vomiting induced by radiotherapy,children: - for the prevention of nausea and vomiting induced by cytotoxic chemotherapy

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

aft pharmaceuticals pty ltd - granisetron hydrochloride, quantity: 1.12 mg (equivalent: granisetron, qty 1 mg) - injection, concentrated - excipient ingredients: water for injections; sodium chloride; nitrogen; sodium citrate dihydrate; citric acid monohydrate - granisetron injection is indicated in:,adults: - for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy - for the prevention of nausea and vomiting induced by radiotherapy,children: - for the prevention of nausea and vomiting induced by cytotoxic chemotherapy

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

fresenius kabi australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; monobasic sodium phosphate dihydrate; water for injections; sodium chloride; sodium hydroxide; citric acid monohydrate; sodium citrate dihydrate; dibasic sodium phosphate dihydrate; polysorbate 80 - rheumatoid arthritis idacio 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.,idacio can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis idacio 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). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis idacio 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 idacio 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 idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (? 6 years) idacio 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 idacio 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 idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,idacio 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) idacio 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 idacio 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.

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

fresenius kabi australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sodium citrate dihydrate; sodium hydroxide; water for injections; citric acid monohydrate; polysorbate 80; mannitol; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate - rheumatoid arthritis idacio 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.,idacio can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis idacio 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). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis idacio 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 idacio 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 idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (? 6 years) idacio 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 idacio 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 idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,idacio 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) idacio 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 idacio 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.