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

juno pharmaceuticals pty ltd - esomeprazole sodium, quantity: 42.5 mg (equivalent: esomeprazole, qty 40 mg) - injection, powder for - excipient ingredients: sodium hydroxide; water for injections; disodium edetate - the short-term management of gastro-oesophageal reflux disease (gord) in patients with oesophagitis and/or severe symptoms of reflux as an alternative when oral therapy is inappropriate.,prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers.,short-term management in patients requiring continued non-steroidal anti-inflammatory drug (nsaid) therapy when oral therapy is inappropriate:,? healing of gastric ulcers associated with nsaid therapy,? prevention of gastric and duodenal ulcers associated with nsaid therapy, in patients at risk,note: esomeprazole iv should be replaced with oral therapy as soon as practicable.

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

viatris pty ltd - amoxicillin sodium, quantity: 1060 mg (equivalent: amoxicillin, qty 1000 mg) - injection, powder for - excipient ingredients: - fisamox is indicated in the treatment of infections due to susceptible strains of the organisms listed below. fisamox powder for injection is intended for use where the patients condition precludes the administration of the oral form. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. however in emergency cases where the causative organism has not yet been identified, therapy with amoxycillin may be useful. clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. septicaemia (bacterial) h. influenzae, e. coli (see microbiology), p. mirabilis, streptococci, s. pneumoniae, s. faecalis and salmonella typhi. skin and skin structure streptococci, non-beta-lactamase-producing staphylococci, e. coli (see microbiology). respiratory, acute and chronic h. influenzae, streptococci, s. pneumoniae, non-beta-lactamase-producing staphylococci, e. coli (see microbiology). genito-urinary tract (complicated and uncomplicated), acute and chronic e. coli (see microbiology), p. mirabilis and s. faecalis. gonorrhoea n. gonorrhoeae (non-beta-lactamase-producing) prophylaxis of endocarditis fisamox may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with prosthetic heart valves or those who have previously had endocarditis.

Australia - English - 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).

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

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

csl behring australia pty ltd - fibrinogen -

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

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

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

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

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

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 500 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.