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

fresenius kabi australia pty ltd - moxifloxacin hydrochloride, quantity: 1.75 mg/ml - injection, intravenous infusion - excipient ingredients: sodium sulfate; sulfuric acid; sodium acetate trihydrate; water for injections - moxifloxacin kabi intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions:,- community acquired pneumonia (caused by susceptible organisms),- acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics,- moxifloxacin kabi intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents, (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin.,appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin kabi may be initiated, in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.

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

fresenius kabi australia pty ltd - moxifloxacin hydrochloride, quantity: 1.75 mg/ml - injection, intravenous infusion - excipient ingredients: water for injections; sodium acetate trihydrate; sodium sulfate; sulfuric acid - moxifloxacin kabi intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions:,- community acquired pneumonia (caused by susceptible organisms),- acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics,- moxifloxacin kabi intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents, (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin.,appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin kabi may be initiated, in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.

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

fresenius kabi australia pty ltd - cefepime hydrochloride monohydrate, quantity: 1189.2 mg (equivalent: cefepime, qty 1 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime kabi 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 kabi 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 kabi 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 kabi 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 kabi 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 kabi. 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)

fresenius kabi australia pty ltd - cefepime hydrochloride monohydrate, quantity: 2378.5 mg (equivalent: cefepime, qty 2 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime kabi 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 kabi 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 kabi 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 kabi 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 kabi 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 kabi. 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)

fresenius kabi australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; monobasic sodium phosphate dihydrate; water for injections; sodium chloride; sodium hydroxide; citric acid monohydrate; sodium citrate dihydrate; dibasic sodium phosphate dihydrate; polysorbate 80 - rheumatoid arthritis idacio is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,idacio can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis idacio in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis idacio is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis idacio is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (? 6 years) idacio is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis idacio is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties-clinical trials).,psoriasis in adults and children idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis idacio is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

fresenius kabi australia pty ltd - propofol, quantity: 10 mg/ml - injection, emulsion - excipient ingredients: glycerol; oleic acid; soya oil; sodium hydroxide; egg lecithin; water for injections - fresofol 1% is a short-acting intravenous anaesthetic agent suitable for the induction and maintenance of general anaesthesia in adults and children aged three years and older. fresofol 1% has no analgesic properties. although the safety and efficacy of fresofol 1% in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. fresofol 1% may also be used in adults for the sedation of ventilated patients receiving intensive care, and for monitored conscious sedation for surgical and diagnostic procedures.

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

fresenius kabi australia pty ltd - propofol, quantity: 10 mg/ml - injection, emulsion - excipient ingredients: soya oil; water for injections; egg lecithin; sodium hydroxide; oleic acid; glycerol - fresofol 1% is a short-acting intravenous anaesthetic agent suitable for the induction and maintenance of general anaesthesia in adults and children aged three years and older. fresofol 1% has no analgesic properties. although the safety and efficacy of fresofol 1% in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. fresofol 1% may also be used in adults for the sedation of ventilated patients receiving intensive care, and for monitored conscious sedation for surgical and diagnostic procedures.

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

fresenius kabi australia pty ltd - propofol, quantity: 10 mg/ml - injection, emulsion - excipient ingredients: soya oil; glycerol; oleic acid; sodium hydroxide; water for injections; egg lecithin - fresofol 1% is a short-acting intravenous anaesthetic agent suitable for the induction and maintenance of general anaesthesia in adults and children aged three years and older. fresofol 1% has no analgesic properties. although the safety and efficacy of fresofol 1% in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. fresofol 1% may also be used in adults for the sedation of ventilated patients receiving intensive care, and for monitored conscious sedation for surgical and diagnostic procedures.

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

fresenius kabi australia pty ltd - potassium chloride, quantity: 0.3 g/l; magnesium chloride hexahydrate, quantity: 0.3 g/l; sodium chloride, quantity: 6.02 g/l; sodium acetate trihydrate, quantity: 4.63 g/l - injection, intravenous infusion - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - ionolyte is indicated for:,- mild metabolic acidosis,- as a source of water and electrolytes

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

fresenius kabi australia pty ltd - potassium chloride, quantity: 0.3 g/l; magnesium chloride hexahydrate, quantity: 0.3 g/l; sodium chloride, quantity: 6.02 g/l; sodium acetate trihydrate, quantity: 4.63 g/l - injection, intravenous infusion - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - ionolyte is indicated for:,- mild metabolic acidosis,- as a source of water and electrolytes