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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 668.5 mg (equivalent: hydrocortisone, qty 500 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; sodium hydroxide - when oral therapy is not feasible, and the strength, form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, solu-cortef powder for injection is indicated for intravenous or intramuscular use in the following conditions: 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplements may be necessary, particularly when synthetic analogues are used). preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcaemia associated with cancer. 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis. 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic dermatomyositis (polymyositis) acute rheumatic carditis. 4. dermatological diseases pemphigus severe erythema multiforme (stevens-johnson syndrome) exfoliative dermatitis bullous dermatitis herpetiformis severe seborrhoeic dermatitis severe psoriasis mycosis fungoides. 5. allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma drug hypersensitivity reactions contact dermatitis urticarial transfusion reactions atopic dermatitis serum sickness acute noninfectious laryngeal oedema (adrenaline is the drug of first choice). 6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus iritis, iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis. 7. gastrointestinal diseases to tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy) regional enteritis (systemic therapy). 8. respiratory diseases symptomatic sarcoidosis loeffler?s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis. 9. haematological disorders acquired (autoimmune) haemolytic anaemia erythroblastopenia (rbc anaemia) idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated) secondary thrombocytopenia in adults congenital (erythroid) hypoplastic anaemia. 10. neoplastic diseases for palliative management of: leukaemias and lymphomas in adults acute leukaemia in childhood. 11. oedematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus. 12. miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurological or myocardial involvement.

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

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 334.25 mg (equivalent: hydrocortisone, qty 250 mg) - injection, powder for - excipient ingredients: dibasic sodium phosphate; monobasic sodium phosphate; sodium hydroxide - when oral therapy is not feasible, and the strength, form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, solu-cortef powder for injection is indicated for intravenous or intramuscular use in the following conditions: 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplements may be necessary, particularly when synthetic analogues are used). preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcaemia associated with cancer. 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis. 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic dermatomyositis (polymyositis) acute rheumatic carditis. 4. dermatological diseases pemphigus severe erythema multiforme (stevens-johnson syndrome) exfoliative dermatitis bullous dermatitis herpetiformis severe seborrhoeic dermatitis severe psoriasis mycosis fungoides. 5. allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma drug hypersensitivity reactions contact dermatitis urticarial transfusion reactions atopic dermatitis serum sickness acute noninfectious laryngeal oedema (adrenaline is the drug of first choice). 6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus iritis, iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis. 7. gastrointestinal diseases to tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy) regional enteritis (systemic therapy). 8. respiratory diseases symptomatic sarcoidosis loeffler?s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis. 9. haematological disorders acquired (autoimmune) haemolytic anaemia erythroblastopenia (rbc anaemia) idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated) secondary thrombocytopenia in adults congenital (erythroid) hypoplastic anaemia. 10. neoplastic diseases for palliative management of: leukaemias and lymphomas in adults acute leukaemia in childhood. 11. oedematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus. 12. miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurological or myocardial involvement.

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

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 134 mg (equivalent: hydrocortisone, qty 100 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; sodium hydroxide - when oral therapy is not feasible, and the strength, form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, solu-cortef powder for injection is indicated for intravenous or intramuscular use in the following conditions:, 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplements may be necessary, particularly when synthetic analogues are used). preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcaemia associated with cancer., 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis synovitis of osteoarthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) acute and subacute bursitis epicondylitis acute nonspecific tenosynovitis acute gouty arthritis psoriatic arthritis ankylosing spondylitis., 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic dermatomyositis (polymyositis) acute rheumatic carditis., 4. dermatological diseases pemphigus severe erythema multiforme (stevens-johnson syndrome) exfoliative dermatitis bullous dermatitis herpetiformis severe seborrhoeic dermatitis severe psoriasis mycosis fungoides., 5. allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma drug hypersensitivity reactions contact dermatitis urticarial transfusion reactions atopic dermatitis serum sickness acute noninfectious laryngeal oedema (adrenaline is the drug of first choice)., 6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus iritis, iridocyclitis chorioretinitis diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia anterior segment inflammation allergic conjunctivitis allergic corneal marginal ulcers keratitis., 7. gastrointestinal diseases to tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy) regional enteritis (systemic therapy)., 8. respiratory diseases symptomatic sarcoidosis loeffler?s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis.,9. haematological disorders acquired (autoimmune) haemolytic anaemia erythroblastopenia (rbc anaemia) idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated) secondary thrombocytopenia in adults congenital (erythroid) hypoplastic anaemia., 10. neoplastic diseases for palliative management of: leukaemias and lymphomas in adults acute leukaemia in childhood., 11. oedematous states to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus., 12. miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurological or myocardial involvement.

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

alphapharm pty ltd - vancomycin hydrochloride, quantity: 1.026 g (equivalent: vancomycin, qty 1 g) - injection, powder for - excipient ingredients: nitrogen; hydrochloric acid; water for injections - vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial medicine, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg enterococcus faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

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

alphapharm pty ltd - vancomycin hydrochloride, quantity: 513 mg (equivalent: vancomycin, qty 500 mg) - injection, powder for - excipient ingredients: hydrochloric acid; water for injections; nitrogen - vancomycin hydrochloride for intravenous infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial medicine, including the penicillins and cephalosporins. vancomycin is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. once sensitivity data are available, therapy should be adjusted accordingly. vancomycin is effective alone or in combination with an aminoglycoside for endocarditis caused by strep. viridans or strep. bovis. for endocarditis caused by enterococci (eg enterococcus faecalis), vancomycin is effective only in combination with an aminoglycoside. vancomycin is effective for the treatment of diphtheroid endocarditis. vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by staph. epidermidis or diphtheroids. the effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. when staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by c. difficile). parenteral administration of vancomycin alone is inappropriate for this indication. vancomycin is not effective by the oral route for other types of infections. for oral administration the parenteral formulation may be used. some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.

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

takeda pharmaceuticals australia pty ltd - water for injections, quantity: 5.4 ml - injection, solution - excipient ingredients: - adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia a (congenital factor viii deficiency) patients for:,? control and prevention of bleeding episodes,? routine prophylaxis to prevent or reduce the frequency of bleeding episodes,? perioperative management (surgical prophylaxis),adynovate is not indicated for the treatment of von willebrand disease.