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

fresenius kabi usa, llc - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), soybean oil (unii: 241atl177a) (soybean oil - unii:241atl177a), sodium acetate (unii: 4550k0sc9b) (sodium cation - unii:lyr4m0nh37, acetate ion - unii:569dqm74sc), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), sodium glycerophosphate anhydrous (unii: yp1h63lj2k) (sodium cation - unii:lyr4m0nh37, phosphate ion - unii:nk08v8k8hr), magnesium sulfate heptahydrate (un - dextrose monohydrate 9.8 g in 100 ml - kabiven is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. kabiven may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. limitations of use: kabiven is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group [see warnings and precautions (5.1) and use in specific populations (8.4)] . the use of kabiven is contraindicated in: - neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate's bloodstream [see limitations of use (1), warnings and precautions (5.5), use in specific populations (8.4)]. - pat

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fresenius kabi usa, llc - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl citrate injection is indicated for: - analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. - use as a narcotic analgesic supplement in general or regional anesthesia. - administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. - use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. fentanyl citrate injection is contraindicated in patients with: - hypersensitivity to fentanyl (e.g., anaphylaxis) [see adverse reactions (6)] risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with fentanyl citrate injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing. no evidence of malformations was noted in animal studies completed to date [see data] . the estimated 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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly. labor or delivery there are insufficient data to support the use of fentanyl in labor or delivery. therefore, such use is not recommended. opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid- induced respiratory depression in the neonate. fentanyl citrate injection is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including fentanyl citrate injection, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data fentanyl has been shown to embryocidal in pregnant rats at doses of 30 mcg/kg intravenously (0.05 times the human dose of 100 mcg/kg on a mg/m2 basis) and 160 mcg/kg subcutaneously (0.26 times the human dose of 100 mcg/kg on a mg/m2 basis). there was no evidence of teratogenicity reported. no evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered fentanyl continuously via subcutaneously implanted osmotic minipumps at doses of 10, 100, or 500 mcg/kg/day starting 2-weeks prior to breeding and throughout pregnancy. the high dose was approximately 0.81 times the human dose of 100 mcg/kg on a mg/m2 basis. risk summary fentanyl is present in breast milk. one published lactation study reports a relative infant dose of fentanyl of 0.38%. however, there is insufficient information to determine the effects of fentanyl on the breastfed infant and the effects of fentanyl on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fentanyl citrate injection and any potential adverse effects on the breastfed infant from fentanyl citrate injection or from the underlying maternal condition. clinical considerations monitor infants exposed to fentanyl through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. infertility chronic use of opioids may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6), clinical pharmacology (12.2), nonclinical toxicology (13.1)] . the safety and efficacy of fentanyl citrate injection in pediatric patients under two years of age has not been established. rare cases of unexplained clinically significant methemoglobinemia have been reported in premature neonates undergoing emergency anesthesia and surgery which included combined use of fentanyl, pancuronium and atropine. a direct cause and effect relationship between the combined use of these drugs and the reported cases of methemoglobinemia has not been established. elderly patients (aged 65 years or older) may have increased sensitivity to fentanyl. in general, use caution when selecting a dosage for an elderly patient, 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 other drug therapy. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of fentanyl citrate injection slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see warnings and precautions (5.2)] . fentanyl is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. fentanyl citrate injection should be administered with caution to patients with liver dysfunction because of the extensive hepatic metabolism. reduce the dosage as needed and monitor closely for signs of respiratory depression, sedation, and hypotension. fentanyl citrate injection should be administered with caution to patients with kidney dysfunction because of the renal excretion of fentanyl citrate injection and its metabolites. reduce the dosage as needed and monitor closely for signs of respiratory depression, sedation, and hypotension. fentanyl citrate injection contains fentanyl, a schedule ii controlled drug substance. fentanyl citrate injection contains fentanyl, a substance with a high potential for abuse similar to other opioids including hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. fentanyl citrate injection can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1)] . prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. fentanyl citrate injection, like other opioids, can be diverted for non-medical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. risks specific to abuse of fentanyl citrate injection abuse of fentanyl citrate injection poses a risk of overdose and death. the risk is increased with concurrent use of fentanyl citrate injection with alcohol and other central nervous system depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. instructions for use - microvault® figure 1: outer packaging (microvault ™ ) and prefilled syringe notes: - once removed from the bundle, inspect the outer packaging by verifying: - integrity of the tube and the cap. - tamper evident seal is intact (outer shrink wrap is not broken). do not use if the outer packaging has been damaged. - hold the outer packaging with both hands. to break the tamper evident seal, hold the tube and the cap close to the seal, and twist until broken. (see figure 2) figure 2 figure 2 - remove the cap of the outer packaging by pulling it straight away from the tube to avoid dislodging the plunger rod of the syringe. (see figure 3) figure 3 figure 3 - remove the syringe from the tube. - 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 plastic wrap label around the luer lock collar. (see figure 4) figure 4 figure 4 - 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. instructions for use – blister pack 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. us patents 9,731,082 and 10,064,998 the brand names mentioned in this document are the trademarks of their respective owners. lake zurich, il 60047 for product inquiry: 1-800-551-7176 or www.fresenius-kabi.com/us 451657a

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

fresenius kabi usa, llc - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - 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

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 usa, llc - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - 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

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.

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

fresenius kabi usa, llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, diagnosed by bone mineral density (bmd) or prevalent vertebral fracture, zoledronic acid injection reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). in patients at high risk of fracture, defined as a recent low-trauma hip fracture, zoledronic acid injection reduces the incidence of new clinical fractures [ see clinical studies (14.1) ]. zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [ see clinical studies (14.2) ]. zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [ see clinical studies (14.3) ]. zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids i

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fresenius kabi usa, llc - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - xylocaine (lidocaine hcl) injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

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

fresenius kabi usa, llc - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987) - xylocaine (lidocaine hcl) injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.