USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - glycine (unii: te7660xo1c) (glycine - unii:te7660xo1c) - glycine 1.5 g in 100 ml - 1.5% glycine irrigation, usp is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. it may be used for lavage of an indwelling catheter to maintain patency. anuria.

USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), histidine (unii: 4qd397987e) (histidine - unii:4qd397987e), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), alanine (unii: of5p57n2zx) (alanine - unii:of5p57n2zx), glycine (unii: te7660xo1c) (glycine - unii:te7660xo1c), arginine (unii: 94zla3w45f) (arginine - unii:94zla3w45f), proline (unii: 9dlq4ciu6v) (proline - unii:9dlq4ciu6v), glutamic acid (unii: 3kx376gy7l) (glutamic acid - unii:3kx376gy7l), serine (unii: 452vly9402) (serine - unii:452vly9402), aspartic acid (unii: 30kyc7miai) (aspartic acid - unii:30kyc7miai), tyrosine (unii: 42hk56048u) (tyrosine - unii:42hk56048u) - valine 1.44 g in 100 ml - prosol is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. prosol may be used to treat negative nitrogen balance in patients. the use of prosol is contraindicated in: risk summary limited published data with injectable amino acids solutions, including prosol in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. however, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see clinical considerations]. animal reproduction studies have not been conducted with injectable amino acids solutions, including prosol. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. clinical considerations disease-associated maternal and/or embryo-fetal risk severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary there are no data available to assess the presence of injectable amino acids, including prosol in human milk, the effects of prosol on the breastfed infant or the effects on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of prosol to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prosol and any potential adverse effects on the breastfed child from prosol or from the underlying maternal condition. neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects [see dosage and administration (2.7)]. plasma electrolyte concentrations should be closely monitored in the pediatric patients who may have impaired ability to regulate fluids and electrolytes. hyperammonemia is of special significance in infants (birth to two years). this reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. it is essential that blood ammonia be measured frequently in infants [see warnings and precautions (5.7)]. because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with prosol may be at risk of aluminum toxicity [see warnings and precautions (5.8)]. patients, including pediatric patients, may be at risk for pnald [see warnings and precautions (5.9)]. clinical studies with prosol have not been performed to determine whether subjects aged 65 and over respond differently from other younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. in patients with impaired renal function, parenteral nutrition solutions containing prosol should be administered with caution. frequent clinical evaluation and laboratory tests to monitor renal function such as serum electrolytes (especially phosphate and potassium) and fluid balance should be conducted [see dosage and administration (2.6) , and warnings and precautions (5.10)]. in patients with impaired liver function, parenteral nutrition solutions containing prosol should be administered starting at the low end of the dosing range [see dosage and administration (2.5)]. frequent clinical evaluation and laboratory tests to monitor liver function such as bilirubin and liver function parameters should be conducted [see warnings and precautions (5.7) ].

USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin 1 g in 200 ml - vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin is indicated for initial therapy when methicillin‑resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin is effective in the treatment of staphylococcal endocarditis. its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. when staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by streptococcus viridans or s. bovis . for endocarditis caused by enterococci (e.g., e. faecalis ), vancomycin has been reported to be effective only in combination with an aminoglycoside. vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by s. epidermidis or diphtheroids. specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin 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.

USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3) - cefepime 1 g in 50 ml - cefepime injection is indicated for pneumonia (moderate to severe) caused by streptococcus pneumoniae, including cases associated with concurrent bacteremia, pseudomonas aeruginosa, klebsiella pneumoniae, or enterobacter species. cefepime injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. insufficient data exist to support the efficacy of cefepime monotherapy in such patients [see clinical studies (14)]. cefepime injection is indicated for uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by escherichia coli or klebsiella pneumoniae, when the infection is severe, or caused by escherichia coli, klebsiella pneumoniae, or proteus mirabilis, w

USA - engelsk - NLM (National Library of Medicine)

rx pharma-pack, inc. - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987), epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. antiseptic antiseptic skin preparation antiseptic for preparation of the skin prior to injection.

USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - ceftriaxone sodium (unii: 023z5br09k) (ceftriaxone - unii:75j73v1629) - ceftriaxone 1 g in 50 ml - before instituting treatment with ceftriaxone injection, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone injection and other antibacterial drugs, ceftriaxone injection 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. ceftriaxone injection is indicated for the treatment of the following infections when caused by susceptible organisms: lower respiratory tract infections caused by streptococcus pneumoniae, staphylococcus aureus, haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, escherichia coli, enterobacter aerogenes, proteus mirabilis or serratia marcescens. acute bacterial otitis media caused by streptococcus pneumoniae, haemophilus influenzae (including beta-lactamase producing strains) or moraxella catarrhalis (including beta-lactamase producing strains). note: in one study lower clinical cure rates were observed with a single dose of ceftriaxone compared to 10 days of oral therapy. in a second study comparable cure rates were observed between single dose ceftriaxone and the comparator. the potentially lower clinical cure rate of ceftriaxone should be balanced against the potential advantages of parenteral therapy. skin and skin structure infections caused by staphylococcus aureus, staphylococcus epidermidis, streptococcus pyogenes , viridans group streptococci, escherichia coli, enterobacter cloacae, klebsiella oxytoca, klebsiella pneumoniae, proteus mirabilis, morganella morganii ,* pseudomonas aeruginosa, serratia marcescens, acinetobacter calcoaceticus, bacteroides fragilis * or peptostreptococcus species. urinary tract infections (complicated and uncomplicated) caused by escherichia coli, proteus mirabilis, proteus vulgaris, morganella morganii or klebsiella pneumoniae . uncomplicated gonorrhea (cervical/urethral and rectal) caused by neisseria gonorrhoeae , including both penicillinase-and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of neisseria gonorrhoeae . pelvic inflammatory disease caused by neisseria gonorrhoeae . ceftriaxone, like other cephalosporins, has no activity against chlamydia trachomatis . therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. bacterial septicemia caused by staphylococcus aureus, streptococcus pneumoniae, escherichia coli, haemophilus influenzae or klebsiella pneumoniae . bone and joint infections caused by staphylococcus aureus, streptococcus pneumoniae, escherichia coli, proteus mirabilis, klebsiella pneumoniae or enterobacter species. intra-abdominal infections caused by escherichia coli, klebsiella pneumoniae, bacteroides fragilis, clostridium species (note: most strains of clostridioides difficile are resistant) or peptostreptococcus species. meningitis caused by haemophilus influenzae, neisseria meningitidis or streptococcus pneumoniae. ceftriaxone has also been used successfully in a limited number of cases of meningitis and shunt infection caused by staphylococcus epidermidis * and escherichia coli .* *efficacy for this organism in this organ system was studied in fewer than ten infections. surgical prophylaxis: the preoperative administration of a single 1 gm dose of ceftriaxone may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g. , vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g. , during coronary artery bypass surgery). although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. when administered prior to surgical procedures for which it is indicated, a single 1 gm dose of ceftriaxone provides protection from most infections due to susceptible organisms throughout the course of the procedure. ceftriaxone injection is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products. hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone injection. in vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a possible risk of bilirubin encephalopathy in these patients. ceftriaxone injection is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing iv solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see clinical pharmacology, warnings and dosage and administration). a small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving ceftriaxone and calcium-containing fluids. in some of these cases, the same intravenous infusion line was used for both ceftriaxone and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. at least one fatality has been reported in a neonate in whom ceftriaxone and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. there have been no similar reports in patients other than neonates.

USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - oxacillin sodium (unii: g0v6c994q5) (oxacillin - unii:uh95vd7v76) - oxacillin 1 g in 50 ml - oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. (see clinical pharmacology - susceptibility test methods.) oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. oxacillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus , therapy should not be continued with oxacillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin injection, usp and other antibacterial drugs, oxacillin 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. a history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication. solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - scopolamine (unii: dl48g20x8x) (scopolamine - unii:dl48g20x8x) - scopolamine 1 mg in 3 d - transderm scŌp is indicated in adults for the prevention of: transderm scŌp is contraindicated in patients with: risk summary eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous or intramuscular scopolamine. avoid use of transderm scop in patients with severe preeclampsia [see warnings and precautions (5.3) and data] . available data from observational studies and postmarketing reports with scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes. in animal studies, there was no evidence of adverse developmental effects with intravenous administration of scopolamine hydrobromide revealed in rats. embryotoxicity was observed in rabbits at intravenous doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data in published case reports, two pregnant patients with severe preeclampsia were administered intravenous and intramuscular scopolamine, respectively, and developed eclamptic seizures soon after scopolamine administration [see warnings and precautions (5.3)] . animal data in animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. an embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. scopolamine administered parenterally to rats and rabbits at doses higher than the dose delivered by transderm scŌp did not affect uterine contractions or increase the duration of labor. risk summary scopolamine is present in human milk. there are no available data on the effects of scopolamine on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for transderm scŌp and any potential adverse effects on the breastfed child from transderm scŌp or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. pediatric patients are particularly susceptible to the adverse reactions of scopolamine; including mydriasis, hallucinations, amblyopia and drug withdrawal syndrome. neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported. clinical trials of transderm scŌp did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. in other clinical experience, elderly patients had an increased risk of neurologic and psychiatric adverse reactions, such as hallucinations, confusion, dizziness and drug withdrawal syndrome [see warnings and precautions (5.2 ,5.5 )]. consider more frequent monitoring for cns adverse reactions during treatment with transderm scŌp in elderly patients [see warnings and precautions (5.2)] . transderm scŌp has not been studied in patients with renal or hepatic impairment. consider more frequent monitoring during treatment with transderm scŌp in patients with renal or hepatic impairment because of the increased risk of cns adverse reactions [see warnings and precautions (5.2)]. transderm scŌp contains scopolamine, which is not a controlled substance. termination of transderm scŌp, usually after several days of use, may result in withdrawal symptoms such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. these withdrawal symptoms indicate that scopolamine, like other anticholinergic drugs, may produce physical dependence. the onset of these symptoms, generally 24 hours or more after the transdermal system has been removed, can be severe and may require medical intervention [see warnings and precautions (5.5)] .

USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - milrinone lactate (unii: 9k8xr81mo8) (milrinone - unii:ju9yax04c7) - milrinone 0.2 mg in 1 ml - milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. the facility for immediate treatment of potential cardiac events, which may include life-threatening ventricular arrythmias, must be available. the majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. there is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. milrinone is contraindicated in patients who are hypersensitive to it. solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

USA - engelsk - NLM (National Library of Medicine)

baxter healthcare corporation - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate 300 mg in 50 ml - clindamycin injection usp in 5% dextrose products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. clindamycin injection usp in 5% dextrose products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. because of the risk of antibiotic-associated pseudomembranous colitis, as described in the boxed warning , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. indicated surgical procedures should be performed in conjunction with antibiotic therapy. clindamycin injection usp in 5% dextrose is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below: lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, streptococcus pneumoniae , other streptococci (except e. faecalis ), and staphylococcus aureus . skin and skin structure infections caused by streptococcus pyogenes , staphylococcus aureus , and anaerobes. gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. septicemia caused by staphylococcus aureus , streptococci (except enterococcus faecalis ), and susceptible anaerobes. bone and joint infections including acute hematogenous osteomyelitis caused by staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin injection usp in 5% dextrose and other antibacterial drugs, clindamycin injection usp in 5% dextrose 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. this drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.