الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - sugammadex sodium - neuromuscular blockade - all other therapeutic products - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - vasopressin -

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fresenius kabi usa, llc - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - sodium chloride injection, usp, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. it is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. after available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from sodium chloride injection, usp, 23.4% and diluted for use. sodium chloride injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. isotonic sodium chloride injection should be limited to cases in which the chloride loss is greater than the sodium loss, as in vomiting from pyloric obstruction, or in which the loss is about equal, as in vomiting from duodenal, jejunal or ileal obstruction and in the replacement of aspirated gastrointestinal fluids. the toxic symptoms that follow various for

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fresenius kabi usa, llc - gentamicin sulfate (unii: 8x7386qrlv) (gentamicin - unii:t6z9v48ikg) - gentamicin 40 mg in 1 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin injection, usp and other antibacterial drugs, gentamicin injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. gentamicin injection, usp is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: pseudomonas aeruginosa, proteus species (indole-positive and indole-negative), escherichia coli, klebsiella-enterobacter-serratia species, citrobacter species and staphylococcus species (coagulase-positive and coagulase-negative). clinical studies have shown gentamicin injection to be effective in bacterial neonatal sepsis; bacterial septicemia and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. gentamicin injection may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. the decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection and the important additional concepts contained in the boxed warnings. if the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. in serious infections when the causative organisms are unknown, gentamicin injection may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. if anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. gentamicin injection has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by pseudomonas aeruginosa. it has also been found effective when used in conjunction with a penicillin-type drug for treatment of endocarditis caused by group d streptococci. gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections. while not the antibiotic of first choice, gentamicin injection may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. it may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. in the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin. hypersensitivity to gentamicin is a contraindication to its use. a history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fresenius kabi usa, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin 40 mg in 1 ml - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa , e. coli , and klebsiella sp. lower respiratory tract infections caused by p. aeruginos a, klebsiella sp, enterobacter sp, serratia sp, e. coli , and s. aureus (penicillinase- and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli , klebsiella sp, and enterobacter sp. skin, bone, and skin-structure infections caused by p. aeruginosa , proteus sp, e. coli , klebsiella sp, enterobacter sp, and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa , proteus sp (indole-positive and indole-negative), e. coli , klebsiella sp, enterobacter sp, serratia sp, s. aureus , providencia sp, and citrobacter sp. aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. if susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. in patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. the decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the warnings box above. to reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. a hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin. a history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fresenius kabi usa, llc - gentamicin sulfate (unii: 8x7386qrlv) (gentamicin - unii:t6z9v48ikg) - gentamicin 40 mg in 1 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin injection, usp and other antibacterial drugs, gentamicin injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. gentamicin injection, usp is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: pseudomonas aeruginosa, proteus species (indole-positive and indole-negative), escherichia coli, klebsiella-enterobacter-serratia species, citrobacter species and staphylococcus species (coagulase-positive and coagulase-negative). clinical studies have shown gentamicin injection to be effective in bacterial neonatal sepsis; bacterial septicemia and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. gentamicin injection may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. the decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection and the important additional concepts contained in the boxed warnings. if the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. in serious infections when the causative organisms are unknown, gentamicin injection may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. if anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. gentamicin injection has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by pseudomonas aeruginosa. it has also been found effective when used in conjunction with a penicillin-type drug for treatment of endocarditis caused by group d streptococci. gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections. while not the antibiotic of first choice, gentamicin injection may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. it may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. in the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin. hypersensitivity to gentamicin is a contraindication to its use. a history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fresenius kabi usa, llc - gentamicin sulfate (unii: 8x7386qrlv) (gentamicin - unii:t6z9v48ikg) - to reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin injection, usp and other antibacterial drugs, gentamicin injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. gentamicin injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: pseudomonas aeruginosa , proteus species (indole-positive and indole-negative), escherichia coli, klebsiella-enterobacter-serratia species, citrobacter species, and staphylococcus species (coagulase-positive and coagulase-negative). clinical studies have shown gentamicin injection to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity. specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin. gentamicin may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. the decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the boxed warnings above. if the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. in serious infections when the causative organisms are unknown, gentamicin may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin type drug before obtaining results of susceptibility testing. if anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued. gentamicin has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by pseudomonas aeruginosa. it has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group d streptococci. gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections. while not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. it may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms. in the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin. hypersensitivity to gentamicin is a contraindication to its use. a history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fresenius kabi usa, llc - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa , e. coli , and klebsiella sp. lower respiratory tract infections caused by p. aeruginos a, klebsiella sp, enterobacter sp, serratia sp, e. coli , and s. aureus (penicillinase- and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli , klebsiella sp, and enterobacter sp. skin, bone, and skin-structure infections caused by p. aeruginosa , proteus sp, e. coli , klebsiella sp, enterobacter sp, and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa , proteus sp (indole-positive and indole-negative), e. coli , klebsiella sp, enterobacter sp, serratia sp, s. aureus , providencia sp, and citrobacter sp. aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use. bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. if susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. in patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. the decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the warnings box above. to reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. a hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin. a history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fresenius kabi usa, llc - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. none known. check flexible container solution composition, lot number, and expiry date. do not remove solution container from its overwrap until immediately before use. use sterile equipment and aseptic technique. - turn solution container over so that the text is face down. using the pre-cut corner tabs, peel open the overwrap and remove solution container. - check the solution container for leaks by squeezing firmly. if leaks are found, or if the seal is not intact, discard the solution. - do not use if the solution is cloudy or a precipitate is present. - identify white additive port with arrow pointing toward container. - immediately before injecting additives, break off white additive port cap with the arrow pointing toward container. - hold base of white additive port horizontally. - insert needle horizontally through the center of

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fresenius kabi usa, llc - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. none known. check flexible container solution composition, lot number, and expiry date. do not remove solution container from its overwrap until immediately before use. use sterile equipment and aseptic technique. to open - turn solution container over so that the text is face down. using the pre-cut corner tabs, peel open the overwrap and remove solution container. - check the solution container for leaks by squeezing firmly. if leaks are found, or if the seal is not intact, discard the solution. - do not use if the solution is cloudy or a precipitate is present. to add medication - identify white additive port with arrow pointing toward container. - immediately before injecting additives, break off white additive port cap with the arrow pointing toward container. - hold base of white additive port horizontally. - insert needle horizontally through the center of white additive port's septum and inject additives. - mix container contents thoroughly. preparation for administration - immediately before inserting the infusion set, break off blue infusion port cap with the arrow pointing away from container. - use a non-vented infusion set or close the air-inlet on a vented set. - close the roller clamp of the infusion set. - hold the base of blue infusion port. - insert spike through blue infusion port by rotating wrist slightly until the spike is inserted. note: see full directions accompanying administration set. warning: do not use flexible container in series connections.