Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 2 mg in 2 ml - midazolam injection is indicated: - intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; - intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other cns depressants; - intravenously for induction of general anesthesia, before administration of other anesthetic agents. with the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); - continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. injectable midazolam is contraindicated in patients with a known hypersensitivity to the drug. benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction with midazolam; patients with glaucoma have not been studied. midazolam is a schedule iv control substance. midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuation of benzodiazepines, including midazolam. abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. the more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at the therapeutic levels for several months. consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. there is no consensus in the medical literature regarding tapering schedules; therefore, practitioners are advised to individualize therapy to meet patient's needs. in some case reports, patients who have had severe withdrawal reactions due to abrupt discontinuation of high-dose long-term midazolam, have been successfully weaned off of midazolam over a period of several days. figure 1: outer packaging and prefilled syringe notes: - inspect the outer packaging (blister pack) to confirm the integrity of the packaging. do not use if the blister pack or the prefilled syringe has been damaged. - remove the syringe from the outer packaging. (see figure 2) figure 2 figure 2 - visually inspect the syringe. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. - twist off the syringe tip cap. do not remove the label around the luer lock collar. (see figure 3) figure 3 figure 3 - expel air bubble(s). adjust the dose (if applicable). - administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration. - discard the used syringe into an appropriate receptacle. for more information concerning this drug, please call fresenius kabi usa, llc at 1-800-551-7176. to report suspected adverse reactions, contact fresenius kabi usa, llc at 1-800-551-7176 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. the brand names mentioned in this document are the trademarks of their respective owners. u.s. patent 9,731,082; 10,661,018 www.fresenius-kabi.com/us 451524e revised: february 2023

Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 15 mg in 1 ml - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration, and adverse reactions ). patients should be switched to alter

Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - polymyxin b 500000 [usp'u] - 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 use

Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 30 mg in 1 ml - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration, and adverse reactions ). patients should be switched to alter

Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - mepivacaine hydrochloride (unii: 4vfx2l7em5) (mepivacaine - unii:b6e06qe59j) - mepivacaine hydrochloride 10 mg in 1 ml - polocaine (mepivacaine hcl injection, usp), is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks. the routes of administration and indicated concentrations for mepivacaine are:   see  dosage and administration   for additional information.  standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mepivacaine. mepivacaine is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of solutions of mepivacaine.

Estados Unidos - inglês - 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

Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 2 mg in 1 ml - naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. surgical anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration acute pain management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 5 mg in 1 ml - naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. surgical anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration acute pain management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 5 mg in 1 ml - levofloxacin in 5% dextrose injection is indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.  levofloxacin in 5% dextrose injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).  levofloxacin in 5% dextrose injection is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae .  adjunctive therapy should be used as clinically indicated.  where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (

Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 5 mg in 5 ml - metoprolol tartrate injection is indicated in the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy. hypersensitivity to metoprolol tartrate injection and related derivatives, or to any of the excipients; hypersensitivity to other beta blockers (cross sensitivity between beta blockers can occur). metoprolol tartrate injection is contraindicated in patients with a heart rate <45 beats/min; second-and third-degree heart block (unless a functioning pacemaker is present); significant first-degree heart block (p-r interval ≥0.24 sec); systolic blood pressure <100 mmhg; or decompensated cardiac failure. risk summary available data from published observational studies have not demonstrated an association of adverse developmental outcomes with maternal use of metoprolol during pregnancy (see data). untreated hypertension and heart failure during pregnancy can lead to a