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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 128.5 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; calcium hydrogen phosphate; microcrystalline cellulose; sodium stearylfumarate; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - januvia (sitagliptin phosphate monohydrate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin,(see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.

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

arrotex pharmaceuticals pty ltd - alendronate sodium monohydrate, quantity: 81.24 mg (equivalent: alendronic acid, qty 70 mg) - tablet, uncoated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; magnesium stearate - treatment of osteoporosis, including glucocorticoid induced osteoporosis. osteoporosis must be confirmed by the finding of low bone mass of at least two standard deviations below the gender specific mean for young adults or by the presence of history of osteoporotic fracture. paget's disease of bone.

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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 500 mg; sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg) - tablet, modified release - excipient ingredients: povidone; hypromellose; colloidal anhydrous silica; sodium stearylfumarate; propyl gallate; macrogol 3350; kaolin; microcrystalline cellulose; carnauba wax; titanium dioxide; hyprolose; indigo carmine aluminium lake - janumet xr (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

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

dr reddys laboratories australia pty ltd - donepezil hydrochloride monohydrate, quantity: 5.22 mg (equivalent: donepezil hydrochloride, qty 5 mg) - tablet, film coated - excipient ingredients: pregelatinised maize starch; microcrystalline cellulose; magnesium stearate; lactose monohydrate; hyprolose; titanium dioxide; hypromellose; macrogol 400 - treatment of mild, moderate and severe alzheimer's disease.

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

dr reddys laboratories australia pty ltd - donepezil hydrochloride monohydrate -

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

avallon pharmaceuticals pty ltd - donepezil hydrochloride monohydrate, quantity: 10.43 mg (equivalent: donepezil hydrochloride, qty 10 ) - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; lecithin - treatment of mild, moderate and severe alzheimer's disease.

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

avallon pharmaceuticals pty ltd - donepezil hydrochloride monohydrate, quantity: 5.22 mg (equivalent: donepezil hydrochloride, qty 5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; lecithin - treatment of mild, moderate and severe alzheimer's disease.

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.