Australija - anglų - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - benzylpenicillin sodium, quantity: 600 mg - injection, powder for - excipient ingredients: - benzylpenicillin is bactericidal and is active against most gram-positive organisms. it is also active against spirochaetes such as treponema pallidum. benzylpenicillin may also be used for the prevention of bacterial endocarditis in dental and upper respiratory tract procedures and prevention of wound infections and sepsis in surgical procedures where the likely pathogens are streptococci.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - esmolol hydrochloride, quantity: 2500 mg - injection, powder for - excipient ingredients: - supraventricular tachycardia,brevibloc (esmolol hcl) is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. brevibloc is also indicated in non compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. brevibloc is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

croma australia pty ltd - letibotulinumtoxina, quantity: 50 u - injection, powder for - excipient ingredients: sodium chloride; albumin - letybo is indicated for the temporary improvement in the appearance of moderate to severe glabellar frown lines in adults.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

croma australia pty ltd - letibotulinumtoxina, quantity: 100 u - injection, powder for - excipient ingredients: sodium chloride; albumin - letybo is indicated for the temporary improvement in the appearance of moderate to severe glabellar frown lines in adults.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - rubella virus, quantity: 1000 tcid50; measles virus, quantity: 1000 tcid50; mumps virus, quantity: 12500 tcid50 - injection, powder for - excipient ingredients: hydrolysed gelatin; sorbitol; neomycin; phenolsulfonphthalein; monobasic potassium phosphate; sodium bicarbonate; monosodium glutamate monohydrate; dibasic potassium phosphate; sucrose; monobasic sodium phosphate; dibasic sodium phosphate; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - m-m-r ii is indicated for simultaneous immunisation against measles, mumps and rubella.,refer to the nhmrc australian immunisation handbook (aih) for vaccination recommendations and schedule.,there is some evidence to suggest that infants immunised against measles at less than 12 months of age, or who are born to mothers who had wild-type measles and who are vaccinated at less than one year of age may not develop sustained antibody levels when later revaccinated. the advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunisation.,infants who are less than 12 months of age may fail to respond to one or more components of the vaccine due to presence in the circulation of residual antibodies of maternal origin, the younger the infant, the lower the likelihood of seroconversion. in geographically isolated or other relatively inaccessible populations for whom immunisation programmes are logistically difficult, and in population groups in which wild-type measles infections may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. infants vaccinated under these conditions at less than 12 months of age should be revaccinated after reaching 12 to 15 months of age.,previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine to reduce the risk of exposure of the pregnant woman.,non-pregnant adolescent and adult females: immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see 4.4 special warnings and precautions for use and 4.6 fertility, pregnancy and lactation). vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury. congenital malformations do occur in up to seven percent of all live births, and their chance appearance after vaccination should be borne in mind.,women of childbearing age should be advised not to become pregnant for one month after vaccination against rubella (which is included in m-m-r ii) and should be informed of the reasons for this precaution (see 4.6 fertility, pregnancy and lactation, use in pregnancy).,the australian immunisation handbook recommends that effort should be made to identify and immunise non-pregnant seronegative women of child-bearing age.,women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. however, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing. please refer to aih for recommendations for further information regarding serological testing for immunity to rubella.,postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination against rubella (see 4.8 adverse effects (undesirable effects)).,post-partum women it has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period using an appropriate rubella-containing vaccine. (see 4.6 fertility, pregnancy and lactation, use in lactation).,revaccination children vaccinated when younger than 12 months of age should be revaccinated at 12 to 15 months of age. persons who were vaccinated originally when 12 months of age or older should be revaccinated with a mmr-containing vaccine, as per the recommended vaccination schedule. revaccination is intended to seroconvert those who did not respond to the first dose. however, data on long term persistence of antibodies are limited and continued surveillance will be required to allow firm recommendations to be made on revaccination. however, persons should be revaccinated if there is evidence to suggest that initial immunisation was ineffective.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - mumps virus, quantity: 12500 tcid50; measles virus, quantity: 1000 tcid50; rubella virus, quantity: 1000 tcid50 - injection, powder for - excipient ingredients: gelatin; neomycin; sorbitol; sucrose; dibasic potassium phosphate; monobasic potassium phosphate; phenolsulfonphthalein; dibasic sodium phosphate; monosodium glutamate monohydrate; sodium bicarbonate; monobasic sodium phosphate; albumin; bovine serum albumin; glucose monohydrate; ascorbic acid; polysorbate 80; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium; dibasic sodium phosphate dihydrate; sodium pyruvate; cystine; tyrosine; arginine; histidine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; water for injections - m-m-r ii is indicated for simultaneous immunisation against measles, mumps and rubella.,refer to the nhmrc australian immunisation handbook (aih) for vaccination recommendations and schedule.,there is some evidence to suggest that infants immunised against measles at less than 12 months of age, or who are born to mothers who had wild-type measles and who are vaccinated at less than one year of age may not develop sustained antibody levels when later revaccinated. the advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunisation.,infants who are less than 12 months of age may fail to respond to one or more components of the vaccine due to presence in the circulation of residual antibodies of maternal origin, the younger the infant, the lower the likelihood of seroconversion. in geographically isolated or other relatively inaccessible populations for whom immunisation programmes are logistically difficult, and in population groups in which wild-type measles infections may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. infants vaccinated under these conditions at less than 12 months of age should be revaccinated after reaching 12 to 15 months of age.,previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine to reduce the risk of exposure of the pregnant woman.,non-pregnant adolescent and adult females: immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see 4.4 special warnings and precautions for use and 4.6 fertility, pregnancy and lactation). vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury. congenital malformations do occur in up to seven percent of all live births, and their chance appearance after vaccination should be borne in mind.,women of childbearing age should be advised not to become pregnant for one month after vaccination against rubella (which is included in m-m-r ii) and should be informed of the reasons for this precaution (see 4.6 fertility, pregnancy and lactation, use in pregnancy).,the australian immunisation handbook recommends that effort should be made to identify and immunise non-pregnant seronegative women of child-bearing age.,women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. however, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing. please refer to aih for recommendations for further information regarding serological testing for immunity to rubella.,postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination against rubella (see 4.8 adverse effects (undesirable effects)).,post-partum women it has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period using an appropriate rubella-containing vaccine. (see 4.6 fertility, pregnancy and lactation, use in lactation).,revaccination children vaccinated when younger than 12 months of age should be revaccinated at 12 to 15 months of age. persons who were vaccinated originally when 12 months of age or older should be revaccinated with a mmr-containing vaccine, as per the recommended vaccination schedule. revaccination is intended to seroconvert those who did not respond to the first dose. however, data on long term persistence of antibodies are limited and continued surveillance will be required to allow firm recommendations to be made on revaccination. however, persons should be revaccinated if there is evidence to suggest that initial immunisation was ineffective.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - rubella virus, quantity: 1000 tcid50; mumps virus, quantity: 12500 tcid50; measles virus, quantity: 1000 tcid50 - injection, powder for - excipient ingredients: monobasic potassium phosphate; hydrolysed gelatin; monosodium glutamate monohydrate; monobasic sodium phosphate; sodium bicarbonate; neomycin; phenolsulfonphthalein; dibasic potassium phosphate; sorbitol; sucrose; dibasic sodium phosphate; glucose monohydrate; ascorbic acid; polysorbate 80; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium; dibasic sodium phosphate dihydrate; sodium pyruvate; cystine; tyrosine; arginine; histidine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; water for injections - m-m-r ii is indicated for simultaneous immunisation against measles, mumps and rubella.,refer to the nhmrc australian immunisation handbook (aih) for vaccination recommendations and schedule.,there is some evidence to suggest that infants immunised against measles at less than 12 months of age, or who are born to mothers who had wild-type measles and who are vaccinated at less than one year of age may not develop sustained antibody levels when later revaccinated. the advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunisation.,infants who are less than 12 months of age may fail to respond to one or more components of the vaccine due to presence in the circulation of residual antibodies of maternal origin, the younger the infant, the lower the likelihood of seroconversion. in geographically isolated or other relatively inaccessible populations for whom immunisation programmes are logistically difficult, and in population groups in which wild-type measles infections may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. infants vaccinated under these conditions at less than 12 months of age should be revaccinated after reaching 12 to 15 months of age.,previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine to reduce the risk of exposure of the pregnant woman.,non-pregnant adolescent and adult females: immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see 4.4 special warnings and precautions for use and 4.6 fertility, pregnancy and lactation). vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury. congenital malformations do occur in up to seven percent of all live births, and their chance appearance after vaccination should be borne in mind.,women of childbearing age should be advised not to become pregnant for one month after vaccination against rubella (which is included in m-m-r ii) and should be informed of the reasons for this precaution (see 4.6 fertility, pregnancy and lactation, use in pregnancy).,the australian immunisation handbook recommends that effort should be made to identify and immunise non-pregnant seronegative women of child-bearing age.,women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. however, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing. please refer to aih for recommendations for further information regarding serological testing for immunity to rubella.,postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination against rubella (see 4.8 adverse effects (undesirable effects)).,post-partum women it has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period using an appropriate rubella-containing vaccine. (see 4.6 fertility, pregnancy and lactation, use in lactation).,revaccination children vaccinated when younger than 12 months of age should be revaccinated at 12 to 15 months of age. persons who were vaccinated originally when 12 months of age or older should be revaccinated with a mmr-containing vaccine, as per the recommended vaccination schedule. revaccination is intended to seroconvert those who did not respond to the first dose. however, data on long term persistence of antibodies are limited and continued surveillance will be required to allow firm recommendations to be made on revaccination. however, persons should be revaccinated if there is evidence to suggest that initial immunisation was ineffective. m-m-r ii is indicated for simultaneous immunisation against measles, mump and rubella. the australian nh&mrc immunisation handbook recommendations for mmr vaccination are as follows. mmr vaccine is recommended for all children at 12 months of age and again at 4 years of age unless there is a genuine contraindication. in populations with a high incidence of early measles, vaccination at 9 months of age is recommended. because of the risk to aboriginal children, the northern territory health authority has adopted a practice of administering the first dose of mmr vaccine to aboriginal children at the age of 9 months. this conforms with who recommendations for such populations. the second dose should be given at 12-15 months of age (see paragraph infants who are less than a 15 months for explanation). unimmunised children in the following groups are at particular risk from severe measles infection: children with chronic conditions such as cystic fibrosis, congenital heart or kidney disease, failure to thrive, down syndrome; children from the age of 1 year upwards in child care centres, family day care and playgroups; children living in institutions; aboriginal and torres strait islander children. hiv positive individuals may be given measles, mumps, rubella combined vaccines in the absence of other contraindications

Australija - anglų - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - cefepime hydrochloride monohydrate, quantity: 595 mg (equivalent: cefepime, qty 500 mg) - injection, powder for - excipient ingredients: arginine - adults: cefepime-aft is indicated in the treatment of the infections listed below when caused by susceptible bacteria. ? lower respiratory tract infections, including pneumonia and bronchitis. ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. ? skin and skin structure infections. ? intra-abdominal infections, including peritonitis and biliary tract infections. ? gynaecological infections. ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) cefepime-aft is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. in this indication it is essential that metronidazole also be administered. paediatrics: cefepime-aft is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: ? pneumonia ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections ? skin and skin structure infections ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. empiric therapy with cefepime-aft may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. because of its broad spectrum of bactericidal activity against gram-positive and gram-negative bacteria, cefepime-aft can be used appropriately as monotherapy prior to identification of the causative organisms(s). in the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with cefepime-aft. in patients who are at risk of mixed aerobic-anaerobic infection, including infections in which bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - cefepime hydrochloride monohydrate, quantity: 2.378 g (equivalent: cefepime, qty 2 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime-aft is indicated in the treatment of the infections listed below when caused by susceptible bacteria. ? lower respiratory tract infections, including pneumonia and bronchitis. ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. ? skin and skin structure infections. ? intra-abdominal infections, including peritonitis and biliary tract infections. ? gynaecological infections. ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) cefepime-aft is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. in this indication it is essential that metronidazole also be administered. paediatrics: cefepime-aft is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: ? pneumonia ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections ? skin and skin structure infections ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. empiric therapy with cefepime-aft may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. because of its broad spectrum of bactericidal activity against gram-positive and gram-negative bacteria, cefepime-aft can be used appropriately as monotherapy prior to identification of the causative organisms(s). in the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with cefepime-aft. in patients who are at risk of mixed aerobic-anaerobic infection, including infections in which bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - cefepime hydrochloride monohydrate, quantity: 1.189 g (equivalent: cefepime, qty 1 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime-aft is indicated in the treatment of the infections listed below when caused by susceptible bacteria. ? lower respiratory tract infections, including pneumonia and bronchitis. ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. ? skin and skin structure infections. ? intra-abdominal infections, including peritonitis and biliary tract infections. ? gynaecological infections. ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) cefepime-aft is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. in this indication it is essential that metronidazole also be administered. paediatrics: cefepime-aft is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: ? pneumonia ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections ? skin and skin structure infections ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. empiric therapy with cefepime-aft may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. because of its broad spectrum of bactericidal activity against gram-positive and gram-negative bacteria, cefepime-aft can be used appropriately as monotherapy prior to identification of the causative organisms(s). in the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with cefepime-aft. in patients who are at risk of mixed aerobic-anaerobic infection, including infections in which bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.