Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - 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 ).  acute pain in adult patients 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 rea

Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide injection is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) injection. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric  information. lacosamide injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures (see data) . 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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.  data animal data oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. however, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. these doses were associated with maternal plasma lacosamide exposures (auc) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (mrhd) of 400 mg/day. in two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. the no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide auc similar to that in humans at the mrhd. oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide auc less than that in humans at the mrhd. in vitro data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential adverse effects on cns development related to this activity cannot be ruled out. risk summary data from published literature indicate that lacosamide is present in human milk. there are reports of increased sleepiness in breastfed infants exposed to lacosamide (see clinical considerations) . there is no information on the effects of lacosamide on milk production.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition. clinical considerations monitor infants exposed to lacosamide through breastmilk for excess sedation. partial-onset seizures safety and effectiveness of lacosamide for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. use of lacosamide in this age group is supported by evidence from adequate and well-controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1, 14.2)] .   safety and effectiveness in pediatric patients below 1 month of age have not been established. primary generalized tonic-clonic seizures safety and effectiveness of lacosamide as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients with idiopathic generalized epilepsy 4 years of age and older was established in a 24-week double-blind, randomized, placebo-controlled, parallel-group, multi-center study (study 5), which included 37 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1) and clinical studies (14.3)].   safety and effectiveness in pediatric patients below the age of 4 years have not been established. animal data lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (auc) less than that in humans at the maximum recommended human dose of 400 mg/day. additional pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) injection. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric  information. there were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients.  no lacosamide dose adjustment based on age is necessary. in elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy [see dosage and administration (2.1, 2.4, 2.5) and clinical pharmacology (12.3)] . no dose adjustment is necessary in patients with mild to moderate renal impairment (clcr ≥30 ml/min). in patients with severe renal impairment (clcr <30 ml/min as estimated by the cockcroft-gault equation for adults; clcr <30 ml/min/1.73m2 as estimated by the schwartz equation for pediatric patients) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)].   in all patients with renal impairment, dose initiation and titration should be based on clinical response and tolerability. lacosamide is effectively removed from plasma by hemodialysis. dosage supplementation of up to 50% following hemodialysis should be considered. for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. patients with mild to moderate hepatic impairment should be observed closely for adverse reactions, and dose initiation and titration should be based on clinical response and tolerability [see dosage and administration (2.5), clinical pharmacology (12.3)]. the pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. lacosamide use is not recommended in patients with severe hepatic impairment. lacosamide injection contains lacosamide, a schedule v controlled substance. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. in a human abuse potential study, single doses of 200 mg (equal to the maximum single dosage) and 800 mg lacosamide (equal to twice the recommended daily maintenance dosage) produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a schedule iv drug. the duration of the euphoria-type responses following lacosamide was less than that following alprazolam. a high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300 to 800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). however, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. however, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - haloperidol decanoate (unii: ac20pj4101) (haloperidol - unii:j6292f8l3d) - haloperidol 50 mg in 1 ml - haloperidol decanoate injection, 50 mg/ml and haloperidol decanoate injection, 100 mg/ml are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. since the pharmacologic and clinical actions of haloperidol decanoate injection, 50 mg/ml and 100 mg/ml 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

Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin injection is indicated for: - rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. - diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. - the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. limitations of use levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin b12 , because of the risk of progression of neurologic manifestations despite hematologic remission. levoleucovorin is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid [see adverse reactions (6.2)] . risk summary there are limited data with levoleucovorin use in pregnant women. animal reproduction studies have not been conducted with levoleucovorin. levoleucovorin is administered in combination with methotrexate or fluorouracil,

Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non­-depolarizing neuromuscular blocking agents after surgery.  neostigmine methylsulfate injection is contraindicated in patients with:        • known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis).         • peritonitis or mechanical obstruction of the intestinal or urinary tract. risk summary there are no adequate or well-controlled studies of neostigmine methylsulfate injection in pregnant women. it is not known whether neostigmine methylsulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. the incidence of malformations in human pregnancies has not been established for neostigmine as the data are limited. all preg

Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients:  • as an adjunct to general anesthesia  • to facilitate tracheal intubation  • to provide skeletal muscle relaxation during surgery or mechanical ventilation.  succinylcholine chloride injection is contraindicated:  • in patients with skeletal muscle myopathies [see warnings and precautions (5.1)]   • in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5.2)]  • after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)]   • in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions (5.5), clinical pharmacology (12.5)]   risk summary   available data from published literatur

Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - tobramycin sulfate (unii: hjt0rxd7jk) (tobramycin - unii:vz8rrz51vk) - tobramycin injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: septicemia in the neonate, child, and adult caused by p. aeruginosa , e. coli , and klebsiella sp lower respiratory tract infections caused by p. aeruginosa, klebsiella sp, enterobacter   sp, serratia sp, e. coli , and s. aureus (penicillinase- and non-penicillinase-producing strains). serious central-nervous-system infections (meningitis) caused by susceptible organisms. intra-abdominal infections, including peritonitis, caused by e. coli, klebsiella sp, and enterobacter sp. skin, bone, and skin structure infections caused by p. aeruginosa, proteus sp, e. coli, klebsiella sp, enterobacter sp and s. aureus. complicated and recurrent urinary tract infections caused by p. aeruginosa, proteus sp, (indole-positive and indole- negative), e. coli, klebsiella sp, enterobacter sp, serratia sp, s. aureus, providen

Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. edema: furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide is particularly useful when an agent with greater diuretic potential is desired. furosemide is indicated as adjunctive therapy in acute pulmonary edema. the intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.  if gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. parenteral use should be replaced with oral furosemide as soon as practical. furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 15 mg in 1 ml - carefully consider the potential benefits and risks 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 ). acute pain in adult patients 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 ). pa

Amerika Serikat - Inggris - NLM (National Library of Medicine)

gland pharma limited - 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 in a daily dosage equivalent to 7.5 mg or greater