Singapore - English - HSA (Health Sciences Authority)

fresenius medical care singapore pte. ltd. - general hospital - fresenius blood lines, tubing systems, and accessories are intended for use in the extracorporeal purification of blood in the framework of renal replacement therapy.

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

fresenius kabi usa, llc - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) to permit the emergency use of the unapproved product, fresenius propoven 2% (propofol 20 mg/ml) emulsion 100 ml, to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit (icu) setting. caution: there is a risk of unintentional overdose with this unapproved product. fresenius propoven 2% emulsion contains the same active ingredient, propofol, as fda-approved diprivan injectable emulsion usp 10 mg/ml, but contains double the concentration. because of this difference in concentration between this unapproved product and the fda-approved product, there is a risk of unintentional overdose. fresenius propoven 2% emulsion 100ml is not an fda-approved drug in the united states. however, fda has issued an eua permitting the emergency use of fresenius propoven 2% emulsion during the covid-19 pandemic. the scope of the eua is limited as follows

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

fresenius kabi austria gmbh - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) to permit the emergency use of the unapproved product, fresenius propoven 2% (propofol 20 mg/ml) emulsion 100 ml, to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit (icu) setting. caution: there is a risk of unintentional overdose with this unapproved product. fresenius propoven 2% emulsion contains the same active ingredient, propofol, as fda-approved diprivan injectable emulsion usp 10 mg/ml, but contains double the concentration. because of this difference in concentration between this unapproved product and the fda-approved product, there is a risk of unintentional overdose. fresenius propoven 2% emulsion 100ml is not an fda-approved drug in the united states. however, fda has issued an eua permitting the emergency use of fresenius propoven 2% emulsion during the covid-19 pandemic. the scope of the eua is limited as follows

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

fresenius medical care australia pty ltd - 11226 - dialyser, peritoneal unit - to treat renal failure by removing fluid and metabolic wastes from the blood by peritoneal dialysis.

European Union - English - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - busulfan - hematopoietic stem cell transplantation - alkyl sulfonates - busulfan fresenius kabi followed by cyclophosphamide (bucy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (hpct) in adult patients when the combination is considered the best available option.busulfan fresenius kabi followed by cyclophosphamide (bucy4) or melphalan (bumel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.

European Union - English - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - pemetrexed - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed fresenius kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed fresenius kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.pemetrexed fresenius kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed fresenius kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Singapore - English - HSA (Health Sciences Authority)

fresenius medical care singapore pte. ltd. - general hospital - the capd system consists of pd catheters and accessories that are specially designed to provide access to the peritoneal cavity for peritoneal dialysis.

Singapore - English - HSA (Health Sciences Authority)

fresenius medical care singapore pte. ltd. - general hospital - the diasafe®plus is intended for the preparation of ultrapure fluid for use in dialysis. attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. ro system, central delivery system)

Singapore - English - HSA (Health Sciences Authority)

fresenius medical care singapore pte. ltd. - gastroenterology & urology - fx low-flux dialysers are designed for single use in chronic haemodialysis.

Singapore - English - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - general hospital - the agilia sp mc syringe pump is intended for use on adults, pediatrics, and neonatal patients for the intermittent or continuous delivery of parenteral fluids (such as solutions, colloids, parenteral nutrition), medications (such as diluted drugs, chemotherapy, anesthesia drugs), blood and blood derivatives, and medications through clinically accepted routes of administration.