United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [see warnings and precautions (5.6) ] risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disea

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

fresenius kabi australia pty ltd - meropenem trihydrate, quantity: 1140 mg (equivalent: meropenem, qty 1000 mg) - injection, powder for - excipient ingredients: sodium carbonate - indications,meropenem kabi is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:,? community acquired lower respiratory tract infection ,? hospital acquired lower respiratory tract infection,? complicated urinary tract infection,? febrile neutropaenia,? intra-abdominal and gynaecological (poly microbial) infections,? complicated skin and skin structure infections,? meningitis,? septicaemia

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

fresenius kabi australia pty ltd - meropenem trihydrate, quantity: 570 mg (equivalent: meropenem, qty 500 mg) - injection, powder for - excipient ingredients: sodium carbonate - indications,meropenem kabi is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:,? community acquired lower respiratory tract infection ,? hospital acquired lower respiratory tract infection,? complicated urinary tract infection,? febrile neutropaenia,? intra-abdominal and gynaecological (poly microbial) infections,? complicated skin and skin structure infections,? meningitis,? septicaemia

Malta - English - Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - capecitabine - film-coated tablet - capecitabine 150 mg - antineoplastic agents

Malta - English - Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - capecitabine - film-coated tablet - capecitabine 500 mg - antineoplastic agents

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

fresenius kabi australia pty ltd - flumazenil, quantity: 0.1 mg/ml - injection, solution - excipient ingredients: acetic acid; sodium hydroxide; disodium edetate; sodium chloride; water for injections - flumazenil kabi is indicated for use in hospitalised patients for the reversal of acute benzodiazepine effects (overdose or therapeutic). hospitalised patients are patients admitted to hospital, inpatient care and under continued professional observation while under the influence of flumazenil. not to be used in outpatients or short stay patients. not to be used as a diagnostic.

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

fresenius kabi australia pty ltd - flumazenil, quantity: 0.1 mg/ml - injection, solution - excipient ingredients: water for injections; acetic acid; sodium chloride; sodium hydroxide; disodium edetate - flumazenil kabi is indicated for use in hospitalised patients for the reversal of acute benzodiazepine effects (overdose or therapeutic). hospitalised patients are patients admitted to hospital, inpatient care and under continued professional observation while under the influence of flumazenil. not to be used in outpatients or short stay patients. not to be used as a diagnostic.

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.