Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi limited - sodium chloride; potassium chloride; calciumchloride dihydrate; sodium lactate solution 50% - solution for infusion - %v/v - solutions affecting the electrolyte balance; electrolytes

Israel - English - Ministry of Health

fresenius medical care israel p.b., ltd. - calcium chloride dihydrate; calcium chloride dihydrate; glucose monohydrate; glucose monohydrate; magnesium chloride hexahydrate; magnesium chloride hexahydrate; sodium chloride; sodium chloride; sodium hydrogen carbonate; sodium hydrogen carbonate - solution for peritoneal dialysis - sodium chloride 11.57 g/l; calcium chloride dihydrate 0.5145 g/l; magnesium chloride hexahydrate 0.2033 g/l; glucose monohydrate 25.0 g/l; magnesium chloride hexahydrate 0.1017 g/l; calcium chloride dihydrate 0.2573 g/l; sodium hydrogen carbonate 2.940 g/l; sodium chloride 5.786 g/l; sodium hydrogen carbonate 5.880 g/l; glucose monohydrate 50.00 g/l - combinations of electrolytes - combinations of electrolytes - end-stage (decompensated ) chronic renal failure of any origin treated with peritoneal dialysis.17/10/2017 בקשה לשינוי משטר מינון שינוי משטר מינון בהתאם למאושר באירופה

Israel - English - Ministry of Health

fresenius medical care israel p.b., ltd. - calcium chloride dihydrate; calcium chloride dihydrate; glucose as monohydrate; glucose monohydrate; magnesium chloride hexahydrate; magnesium chloride hexahydrate; sodium chloride; sodium chloride; sodium hydrogen carbonate; sodium hydrogen carbonate - solution for peritoneal dialysis - sodium chloride 11.57 g/l; calcium chloride dihydrate 0.5145 g/l; magnesium chloride hexahydrate 0.2033 g/l; glucose as monohydrate 93.50 g/l; glucose monohydrate 46.75 g/l; magnesium chloride hexahydrate 0.1017 g/l; calcium chloride dihydrate 0.2573 g/l; sodium hydrogen carbonate 2.940 g/l; sodium chloride 5.786 g/l; sodium hydrogen carbonate 5.880 g/l - combinations of electrolytes - combinations of electrolytes - end-stage (decompensated ) chronic renal failure of any origin treated with peritoneal dialysis.17/10/2017 בקשה לשינוי משטר מינון שינוי משטר מינון בהתאם למאושר באירופה

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi limited - sodium acetate trihydrate; sodium chloride; potassium chloride; magnesium chloride hexahydrate ; sodium hydroxide - solution for infusion - unknown - electrolytes - electrolytes - ionolyte is indicated for: - predominantly extracellular dehydration, regardless of cause (vomiting, diarrhea, fistulas, etc.) - hypovolemia regardless of cause (hemorrhagic shock, burns, peri-operative water and electrolyte loss) - mild metabolic acidosis

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 - gemcitabine hydrochloride, quantity: 227.72 mg (equivalent: gemcitabine, qty 200 mg) - injection, concentrated - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic non-small cell lung cancer. gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. gemcitabine kabi, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. gemcitabine kabi, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. gemcitabine kabi, in combinatin with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

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

fresenius kabi australia pty ltd - sodium glycerophosphate hydrate, quantity: 6.122 g (equivalent: sodium glycerophosphate, qty 4.32 g) - injection, concentrated - excipient ingredients: hydrochloric acid; water for injections - glycophos? is indicated in adult and paediatric patients as a supplement to parenteral nutrition to meet the daily requirements of phosphate.

Israel - English - Ministry of Health

fresenius medical care israel p.b., ltd. - calcium chloride dihydrate; calcium chloride dihydrate; glucose monohydrate; glucose monohydrate; magnesium chloride hexahydrate; magnesium chloride hexahydrate; sodium chloride; sodium chloride; sodium hydrogen carbonate; sodium hydrogen carbonate - solution for peritoneal dialysis - sodium chloride 11.57 g/l; calcium chloride dihydrate 0.5145 g/l; magnesium chloride hexahydrate 0.2033 g/l; sodium chloride 5.786 g/l; glucose monohydrate 33.0 g/l; glucose monohydrate 16.5 g/l; magnesium chloride hexahydrate 0.1017 g/l; calcium chloride dihydrate 0.2573 g/l; sodium hydrogen carbonate 2.940 g/l; sodium hydrogen carbonate 5.880 g/l - combinations of electrolytes - end-stage (decompensated ) chronic renal failure of any origin treated with peritoneal dialysis.17/10/2017 בקשה לשינוי משטר מינון שינוי משטר מינון בהתאם למאושר באירופה

New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - water for injection 100%{vol} - solution for injection - active: water for injection 100%{vol} - water for injection bp is used to dissolve or dilute substances or preparations for parenteral administration. water for injection bp may also be used as an irrigating solution for small wounds or during minor surgical procedures.