Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - haloperidol decanoate (unii: ac20pj4101) (haloperidol - unii:j6292f8l3d) - haloperidol 50 mg in 1 ml - haloperidol decanoate injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. since the pharmacologic and clinical actions of haloperidol decanoate injection are attributed to haloperidol as the active medication, contraindications, warnings, and additional information are those of haloperidol, modified only to reflect the prolonged action. haloperidol is contraindicated in patients with: - severe toxic central nervous system depression or comatose states from any cause. - hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see warnings, hypersensitivity reactions and adverse reactions). - parkinson's disease (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies). - dementia with lewy bodies (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies).

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate 0.4 mg in 1 ml - atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia. none. risk summary limited available data with atropine sulfate injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes (see data).  there are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see clinical considerations).   animal reproduction studies have not been conducted with atropine sulfate injection. 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

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium lactate (unii: tu7hw0w0qt) (sodium cation - unii:lyr4m0nh37, lactic acid - unii:33x04xa5at), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb, chloride ion - unii:q32zn48698) - lactated ringer's injection is indicated as a source of water and electrolytes or as an alkalinizing agent. as for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and lactated ringer's injection is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate's bloodstream). in patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including lactated ringer's injection, through the same infusion line (e.g., via y-connector). if the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid. lactated ringer's injection is contraindicated in patients with a known hypersensitivity to sodium lactate. 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. 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. to add medication prior to solution administration - 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. - prepare medication site. - insert an 18 to 23 gauge needle horizontally through the center of white additive port's septum and inject additives. - mix container contents thoroughly. for high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. to add medication during solution administration - close the clamp on the set. - identify white additive port with arrow pointing toward container. - immediately before injecting additives, if the cap has not been broken off, break off white additive port cap with the arrow pointing toward container. - hold base of white additive port horizontally. - prepare medication site. - using a syringe with an 18 to 23 gauge needle, horizontally insert through the center of white additive port's septum and inject additives. - remove container from iv pole and/or turn to an upright position. - mix container contents thoroughly. - using aseptic technique, repeat steps 4-7 as necessary. - return container to in use position and continue administration. warning: do not use flexible container in series connections. manufactured for: lake zurich, il 60047 made in norway www.fresenius-kabi.com/us 451533 issued: november 2018

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data] . the estimate

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium injection is indicated for the treatment of myxedema coma. limitations of use: not recommended as a substitute for oral levothyroxine sodium because the relative bioavailability of levothyroxine sodium injection to oral levothyroxine sodium has not been established and there is a risk of inaccurate dose conversion. uncorrected adrenal insufficiency [see warnings and precautions (5.2)] risk summary there is no available data with use of levothyroxine sodium injection in pregnant women. the clinical data in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not reported increased rates of major birth defects, miscarriages, or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with myxedema coma in pregnancy (see clinical considerations) . animal reproduction studies have not been conducted with levothyroxine sodium. the estimated background risk of major birth defects and miscarriage for the indicated populatio

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium injection is indicated for the treatment of myxedema coma. limitations of use: not recommended as a substitute for oral levothyroxine sodium because the relative bioavailability of levothyroxine sodium injection to oral levothyroxine sodium has not been established and there is a risk of inaccurate dose conversion. uncorrected adrenal insufficiency [see warnings and precautions (5.2)] risk summary there is no available data with use of levothyroxine sodium injection in pregnant women. the clinical data in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not reported increased rates of major birth defects, miscarriages, or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with myxedema coma in pregnancy (see clinical considerations) . animal reproduction studies have not been conducted with levothyroxine sodium. the estimated background risk of major birth defects and miscarriage for the indicated populatio

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - caffeine citrate (unii: u26eo4675q) (caffeine - unii:3g6a5w338e) - caffeine citrate 20 mg in 1 ml - caffeine citrate injection is indicated for the treatment of apnea of prematurity. caffeine citrate is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - haloperidol decanoate (unii: ac20pj4101) (haloperidol - unii:j6292f8l3d) - haloperidol decanoate injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. since the pharmacologic and clinical actions of haloperidol decanoate injection are attributed to haloperidol as the active medication, contraindications, warnings, and additional information are those of haloperidol, modified only to reflect the prolonged action. haloperidol is contraindicated in patients with: - severe toxic central nervous system depression or comatose states from any cause. - hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see warnings, hypersensitivity reactions and adverse reactions). - parkinson's disease (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies). - dementia with lewy bodies (see warnings, neurological adverse reactions in patients with parkinson's disease or dementia with lewy bodies).

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium injection is indicated for the treatment of myxedema coma. limitations of use: not recommended as a substitute for oral levothyroxine sodium because the relative bioavailability of levothyroxine sodium injection to oral levothyroxine sodium has not been established and there is a risk of inaccurate dose conversion. uncorrected adrenal insufficiency [see warnings and precautions (5.2)] risk summary there is no available data with use of levothyroxine sodium injection in pregnant women. the clinical data in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not reported increased rates of major birth defects, miscarriages, or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with myxedema coma in pregnancy (see clinical considerations) . animal reproduction studies have not been conducted with levothyroxine sodium. the estimated background risk of major birth defects and miscarriage for the indicated populatio

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. this highly concentrated, ready-to-use potassium chloride injection is intended for the maintenance of serum k + levels and for potassium supplementation in fluid restricted patients who cannot accommodate additional volumes of fluid associated with potassium solutions of lower concentration. when using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance. potassium chloride injection is contraindicated in patients with: - hyperkalemia - known hypersensitivity to potassium chloride injection 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. see precautions for information on the avoidance of air embolism. 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. 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. manufactured for: lake zurich, il 60047 made in norway www.fresenius-kabi.com/us 451699b revised: september 2023 01-59-16-006b