Awstralja - Ingliż - 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.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - dantrolene sodium hemiheptahydrate, quantity: 20 mg - injection, powder for - excipient ingredients: sodium hydroxide; mannitol - dantrium for injection is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crisis. it should be administered by intravenous injection as soon as the malignant hyperthermia reaction is recognised (i.e. tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilisation of anaesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 132.85 mg (equivalent: hydrocortisone, qty 100 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate - 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

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - tazobactam sodium, quantity: 536.6 mg (equivalent: tazobactam, qty mg); piperacillin sodium, quantity: 4.17 g (equivalent: piperacillin, qty g) - injection, powder for - excipient ingredients: - piperacillin/tazobactam kabi is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1. lower respiratory tract infections. 2. urinary tract infections (complicated and uncomplicated). 3. intra-abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections.,,children under the age of 12 years:,in hospitalised children aged 2 to 12 years, piperacillin/tazobactam kabi injection is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years.,while piperacillin/tazobactam kabi injection is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to piperacillin/tazobactam. therapy with piperacillin/tazobactam, however, may be initiated before results of such tests are known when there is a reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued.,in serious infections, presumptive therapy with piperacillin/tazobactam kabi may be initiated before susceptibility test results are available.,combination therapy with piperacillin/tazobactam kabi and aminoglycosides may be used in the treatment of serious infections caused by pseudomonas aeruginosa. both drugs should be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - piperacillin sodium, quantity: 2.085 g (equivalent: piperacillin, qty g); tazobactam sodium, quantity: 268.3 mg (equivalent: tazobactam, qty mg) - injection, powder for - excipient ingredients: - piperacillin/tazobactam kabi is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1. lower respiratory tract infections. 2. urinary tract infections (complicated and uncomplicated). 3. intra-abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections.,,children under the age of 12 years:,in hospitalised children aged 2 to 12 years, piperacillin/tazobactam kabi injection is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years.,while piperacillin/tazobactam kabi injection is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to piperacillin/tazobactam. therapy with piperacillin/tazobactam, however, may be initiated before results of such tests are known when there is a reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued.,in serious infections, presumptive therapy with piperacillin/tazobactam kabi may be initiated before susceptibility test results are available.,combination therapy with piperacillin/tazobactam kabi and aminoglycosides may be used in the treatment of serious infections caused by pseudomonas aeruginosa. both drugs should be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: nitrogen; water for injections; sulfobutyl betadex sodium - voriconazole ? aft is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - hydrocortisone hydrogen succinate, quantity: 127.6 mg (equivalent: hydrocortisone, qty 100 mg) - injection, powder for - excipient ingredients: sodium hydroxide; monobasic sodium phosphate monohydrate; dibasic sodium phosphate - 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, hydrocortisone 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.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - micafungin sodium, quantity: 101.73 mg (equivalent: micafungin, qty 100 mg) - injection, powder for - excipient ingredients: citric acid; sodium hydroxide; lactose monohydrate - mycamine is indicated for: ? treatment of invasive candidiasis in children and adults ? treatment of oesophageal candidiasis in adults, adolescents greater than or equal to 16 years of age and the elderly patients for whom intravenous therapy is appropriate ? prophylaxis of candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/?l) for 10 or more days.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - micafungin sodium, quantity: 50.86 mg (equivalent: micafungin, qty 50 mg) - injection, powder for - excipient ingredients: citric acid; sodium hydroxide; lactose monohydrate - mycamine is indicated for: ? treatment of invasive candidiasis in children and adults ? treatment of oesophageal candidiasis in adults, adolescents greater than or equal to 16 years of age and the elderly patients for whom intravenous therapy is appropriate ? prophylaxis of candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/?l) for 10 or more days.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - thiopental sodium, quantity: 0.5 g - injection, powder for - excipient ingredients: - indications as at 08 dec 1993 : pentothal may be used : 1. as the sole anaesthetic agent for brief surgical procedures; 2. for the induction of anaesthesia prior to the administration of other anaesthetic agents; 3. for the short-term control of condvulsive states; 4. to supplement regional anaesthesia or low potency agents such as nitrous oxide.