אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - potassium chloride; sodium chloride - solution for infusion - 0.15% w/v + 0.9 percent weight/volume - solutions affecting the electrolyte balance; electrolytes

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - potassium chloride - concentrate for solution for infusion - 15 percent weight/volume - electrolyte solutions; potassium chloride

ארצות הברית - אנגלית - 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.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

fresenius kabi usa, llc - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin for injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly, or pulmonary plethora on chest x-ray. indomethacin for injection is contraindicated in neonates: - with proven or suspected infection that is untreated - who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding - with thrombocytopenia or coagulation defects - with or who are suspected of having necrotizing enterocolitis - with significant impairment of renal function - with congenital heart disease in whom patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic b

ארצות הברית - אנגלית - 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.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

prodigy innovation, llc. - amikacin sulfate (unii: n6m33094fd) (amikacin - unii:84319sgc3c) -

ארצות הברית - אנגלית - NLM (National Library of Medicine)

fresenius kabi usa, llc - polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - acute infections caused by susceptible strains of pseudomonas aeruginosa . polymyxin b sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and blood-stream caused by susceptible strains of ps. aeruginosa . it may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of ps. aeruginosa . it may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: h influenzae, specifically meningeal infections. escherichia coli, specifically urinary tract infections. aerobacter aerogenes, specifically bacteremia. klebsiella pneumoniae, specifically bacteremia. note: in meningeal infections, polymyxin b sulfate should be administered only by the intrathecal route. to reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin b and other antibacterial drugs, polymyxin b should be us

ארצות הברית - אנגלית - NLM (National Library of Medicine)

american pharmaceutical ingredients llc - amikacin sulfate (unii: n6m33094fd) (amikacin - unii:84319sgc3c) -

בנגלדש - אנגלית - DGDA (Directorate General of Drug Administration)

apex pharma ltd. - amikacin - injection - 500 mg/2 ml

ישראל - אנגלית - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - amikacin as sulfate - solution for injection - amikacin as sulfate 250 mg / 1 ml - amikacin - amikan is indicated in the short-term treatment of gram-negative organisms, including pseudomonas and some gram-positive organisms.sensitive gram-negative organisms include; pseudomonas aeruginosa, escherichia coli., indole-positive and indole-negative proteus spp., klebsiella, enterobacter and serratia spp., minea-herralae, citrobacter freundii, salmonella, shigella, acinetobacter and providencia spp.the principal gram-positive organism sensitive to amikacin is staphylococcus aureus, including some methicillin-resistant strains. amikan has some activity against other gram-positive organisms including certain strains of streptococcus pyogenes, enterococci and diplococcus pneumoniae.