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

exela pharma sciences, llc - cysteine hydrochloride (unii: zt934n0x4w) (cysteine - unii:k848jz4886) - elcys is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (tpn) and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require tpn. it can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. elcys is contraindicated in: risk summary appropriate administration of elcys is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with cysteine hydrochloride. the estimated background risk for major birth defects and miscarriage for the indicated populations 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 defect and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary data available on the effects of cysteine hydrochloride on infants, either directly or through breastmilk, do not suggest a significant risk of adverse events from exposure. although there are no data on the presence of cysteine hydrochloride in human or animal milk or the effects on milk production, appropriate administration of elcys is not expected to cause harm to a breastfed infant. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for elcys and any potential adverse effects on the breastfed infant from elcys or from the underlying maternal condition. elcys is approved for use in pediatric patients, from birth to 17 years of age, for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants, including preterm infants, requiring total parenteral nutrition (tpn) and pediatric patients with severe liver disease who may have impaired enzymatic processes and require tpn. the safety profile for elcys use in pediatric patients includes risks of acid-base imbalance and hyperammonemia. acid-base imbalance, including metabolic acidosis, may occur with elcys administration in preterm infants. frequent clinical and laboratory assessments are necessary to monitor and manage fluid balance, electrolyte concentrations, and acid-base balance during parenteral nutrition therapy [see warnings and precautions (5.4)] . hyperammonemia is of special significance in infants (birth to two years of age). 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 (5.6)]. because of immature renal function, preterm infants receiving prolonged pn treatment with elcys may be at higher risk of aluminum toxicity [see warnings and precautions (5.7)]. clinical studies with elcys have not been performed to determine whether patients aged 65 and over respond differently from younger patients. monitor patients with impaired renal function receiving pn solutions containing the recommended dosage of elcys with frequent clinical evaluation and laboratory tests to assess renal function, including serum electrolytes and fluid balance [see dosage and administration (2.4), warnings and precautions (5.8)]. monitor patients with impaired liver function receiving pn solutions containing the recommended dosage of elcys with frequent clinical evaluation and laboratory tests to assess liver function, such as bilirubin and liver function parameters [see dosage and administration (2.4), warnings and precautions (5.8)].

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

exela pharma sciences,llc - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride in dextrose injection is indicated for the temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. diltiazem hydrochloride in dextrose injection is indicated for rapid conversion of paroxysmal supraventricular tachycardias (psvt) to sinus rhythm. diltiazem hydrochloride injection is contraindicated in: risk summary the available data from the published literature over decades of use with diltiazem during pregnancy have not identified a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, decreased embryo and fetal survival rates, and skeletal abnormalities have been observed at oral doses five to ten times the human oral antianginal therapeutic dose, and reduction in pup weights was also observed. at 20 times the human oral antianginal therapeutic dose, an increase in stillbirths was observed (see data) . the estimated background risk for major birth defects and miscarriage for th

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

exela pharma sciences, llc - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glyrx® -pf is indicated: in anesthesia (all ages) in peptic ulcer (adults) glyrx® -pf is contraindicated in: limited data available with glycopyrrolate use during pregnancy have not identified a drug-associated risk of birth defects and miscarriage, however, most of the reported exposures occurred after the first trimester. most of the available data are based on studies with exposures that occurred at the time of cesarean-section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant apgar scores (see data). in animal reproduction studies in pregnant rats and rabbits administered glycopyrrolate orally (rats) and intramuscularly (rabbits) during the period of organogenesis, no teratogenic effects were seen at 640-times and 10-times the maximum recommended human dose (mrhd) of 1 mg (on a mg/m2 basis), respectively (see data) . the estimated background risk for major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a backgroun

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

exela pharma sciences, llc - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam in sodium chloride injection is indicated: continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. midazolam in sodium chloride injection is contraindicated in patients with: acute narrow-angle glaucoma risk summary neonates born to mothers using benzodiazepines, including midazolam, late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.10), and clinical considerations] . available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see data). in pregnant rats and rabbits, midazolam did not cause adverse effects to the fetus at doses of up to 1.85 times the human induction dose of 0.35 mg/kg based on body surface area comparisons. published studies in pregnant prim

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

exela pharma sciences, llc - ganciclovir (unii: p9g3ckz4p5) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 2 mg in 1 ml - ganciclovir injection is indicated for the treatment of cytomegalovirus (cmv) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14)] .  ganciclovir injection is indicated for the prevention of cmv disease in adult transplant recipients at risk for cmv disease [see clinical studies (14 )] . ganciclovir injection is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir or acyclovir. risk summary inanimal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure at the recommended human dose (rhd) [see data] . although placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and on at least one case report in a pregnant woman, no adequate human data are a

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

exela pharma sciences, llc - acetylcysteine (unii: wyq7n0bpyc) (acetylcysteine - unii:wyq7n0bpyc) - acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (rsi). acetylcysteine injection is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see warnings and precautions (5.1)] . risk summary limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see clinical considerations]. reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. the estimated background risk of major birth defects and mi

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

exela pharma sciences, llc - erythromycin lactobionate (unii: 33h58i7glq) (erythromycin - unii:63937kv33d) - erythromycin lactobionate for injection, usp is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. intravenous therapy should be replaced by oral administration at the appropriate time. upper respiratory tract infections of mild to moderate degree caused by streptococcus pyogenes (group a beta-hemolytic streptococci); streptococcus pneumoniae (diplococcus pneumoniae); haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of h. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (see appropriate sulfonamide labeling for prescribing information.) lower respiratory tract infections of mild to moderate severity caused by streptococcus pyogenes (group a beta-hemolytic streptococci); streptococcus pneumoniae (diplococcus

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

exela pharma sciences, llc - betamethasone sodium phosphate (unii: 7bk02scl3w) (betamethasone - unii:9842x06q6m), betamethasone acetate (unii: ti05ao53l7) (betamethasone - unii:9842x06q6m) - when oral therapy is not feasible, the intramuscular use of betamethasone sodium phosphate and betamethasone acetate injectable suspension is indicated as follows: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (stevens-johnson syndrome). congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. to tide the patient over a critical period of the disease in regional enter

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

exela pharma sciences, llc - cupric chloride (unii: s2qg84156o) (cupric cation - unii:8cbv67279l) - cupric chloride injection, usp 0.4 mg/ml is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (tpn). administration helps to maintain copper serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms. none known. none known.

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

exela phrama sciences, llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - vazculep is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data] . there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data] . the estimated background risk of major birth defects and miscarriage for the in