Malta - English - Medicines Authority

health house pharma ltd t/as p&d pharmaceuticals ltd 38 woolmer way, bordon, hampshire, gu35 9q, united kingdom - neostigmine metilsulfate - injection - neostigmine metilsulfate 2.5 mg/ml - other nervous system drugs

Malta - English - Medicines Authority

jv healthcare limited navi buidlings, pantar road, lija, lja 2021, malta - neostigmine metilsulfate - injection - neostigmine metilsulfate 2.5 mg/ml - other nervous system drugs

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

a-s medication solutions - 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). • with 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 pregnancies, regard

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

eugia us llc - 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 in pregnant women. it is not known whether neostigmine methylsulfate 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 pregnancies, regardless of drug exposure,

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

medical purchasing solutions, llc - 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). - with 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 pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects, and 15 to 20% for pregnancy loss. no adverse effects were noted in rats or rabbits treated with human equivalent doses of neostigmine methylsulfate doses up to 8.1 and 13 mcg/kg/day, respectively, during organogenesis (0.1 to 0.2-times the maximum recommended human dose of 5 mg/60 kg person/day based on body surface area comparisons). anticholinesterase drugs, including neostigmine may cause uterine irritability and induce premature labor when administered to pregnant women near term. neostigmine methylsulfate injection should be given to a pregnant woman only if clearly needed. data animal data in embryofetal development studies, rats and rabbits were administered neostigmine methylsulfate at human equivalent doses (hed, on a mg/m 2 basis) of 1.6, 4 and 8.1 mcg/kg/day 3.2, 8.1, and 13 mcg/kg/day, respectively, during the period of organogenesis (gestation days 6 through 17 for rats and gestation days 6 through 18 for rabbits). there was no evidence for a teratogenic effect in rats and rabbits up to hed 8.1 and 13 mcg/kg/day, which are approximately 0.097-times and 0.16-times the mrhd of 5 mg/60 kg, respectively in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). the studies resulted in exposures in the animals well below predicted exposures in humans. in a pre- and postnatal development study in rats, neostigmine methylsulfate was administered to pregnant female rats at human equivalent doses (hed) of 1.6, 4 and 8.1 mcg/kg/day from day 6 of gestation through day 20 of lactation, with weaning on day 21. there were no adverse effects on physical development, behavior, learning ability, or fertility in the offspring occurred at hed doses up 8.1 mcg/kg/day which is 0.097-times the mrhd of 5 mg/60 kg on a mg/m 2 basis in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). the studies resulted in exposures in the animals well below predicted exposures in humans. the effect of neostigmine methylsulfate injection on the mother and fetus with regard to labor, delivery, the need for forceps delivery or other intervention or resuscitation of the newborn, is not known. cholinesterase inhibitor drugs may induce premature labor when given intravenously to pregnant women near term. it is not known whether neostigmine methylsulfate is excreted in human milk. caution should be exercised when neostigmine methylsulfate injection is administered to a nursing woman. neostigmine methylsulfate injection is approved for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery in pediatric patients of all ages. recovery of neuromuscular activity occurs more rapidly with smaller doses of cholinesterase inhibitors in infants and children than in adults. however, infants and small children may be at greater risk of complications from incomplete reversal of neuromuscular blockade due to decreased respiratory reserve. the risks associated with incomplete reversal outweigh any risk from giving higher doses of neostigmine methylsulfate injection (up to 0.07 mg/kg or up to a total of 5 mg, whichever is less). the dose of neostigmine methylsulfate injection required to reverse neuromuscular blockade in children varies between 0.03 mg to 0.07 mg/kg, the same dose range shown to be effective in adults, and should be selected using the same criteria as used for adult patients. [see clinical pharmacology (12.3) ] since the blood pressure in pediatric patients, particularly infants and neonates, is sensitive to changes in heart rate, the effects of an anticholinergic agent (e.g., atropine) should be observed prior to administration of neostigmine to lessen the probability of bradycardia and hypotension. because elderly patients are more likely to have decreased renal function, neostigmine methylsulfate injection should be used with caution and monitored for a longer period in elderly patients. the duration of action of neostigmine methylsulfate is prolonged in the elderly; however, elderly patients also experience slower spontaneous recovery from neuromuscular blocking agents. therefore, dosage adjustments are not generally needed in geriatric patients; however, they should be monitored for longer periods than younger adults to assure additional doses of neostigmine methylsulfate injection are not required. the duration of monitoring should be predicated on the anticipated duration of action for the nmba used on the patient. [see dosage and administration (2.3) ]. elimination half-life of neostigmine methylsulfate was prolonged in anephric patients compared to normal subjects. although no adjustments to neostigmine methylsulfate injection dosing appear to be warranted in patients with impaired renal function, they should be closely monitored to assure the effects of the neuromuscular blocking agent, particularly one cleared by the kidneys, do not persist beyond those of neostigmine methylsulfate injection. in this regard, the interval for re‐dosing the neuromuscular blocking agent during the surgical procedure may be useful in determining whether, and to what extent, post‐operative monitoring needs to be extended. the pharmacokinetics of neostigmine methylsulfate in patients with hepatic impairment have not been studied. neostigmine methylsulfate is metabolized by microsomal enzymes in the liver. no adjustments to the dosing of neostigmine methylsulfate injection appear to be warranted in patients with hepatic insufficiency. however, patients should be carefully monitored if hepatically cleared neuromuscular blocking agents were used during their surgical procedure as their duration of action may be prolonged by hepatic insufficiency whereas neostigmine methylsulfate injection, which undergoes renal elimination, will not likely be affected. this could result in the effects of the neuromuscular blocking agent outlasting those of neostigmine methylsulfate injection. this same situation may arise if the neuromuscular blocking agent has active metabolites. in this regard, the interval for re-dosing the neuromuscular blocking agent during the surgical procedure may be useful in determining whether, and to what extent, post-operative monitoring needs to be extended.

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

hikma pharmaceuticals usa inc. - neostigmine methylsulfate (unii: 98imh7m386) (neostigmine - unii:3982twq96g) - neostigmine methylsulfate injection, usp is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. neostigmine methylsulfate injection, usp 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, usp in pregnant women. it is not known whether neostigmine methylsulfate injection, usp 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 pregnancies, regardless of drug exposure, have a background risk of 2 to 4% for major birth defects and 15 to 20% for pregnancy loss. no adverse effects were noted in rats or rabbits treated with human equivalent doses of neostigmine methylsulfate doses up to 8.1 and 13 mcg/kg/day, respectively, during organogenesis (0.1 to 0.2 times the maximum recommended human dose of 5 mg/60 kg person/day based on body surface area comparisons). anticholinesterase drugs, including neostigmine, may cause uterine irritability and induce premature labor when administered to pregnant women near term. neostigmine methylsulfate injection, usp should be given to a pregnant woman only if clearly needed. data animal data in embryofetal development studies, rats and rabbits were administered neostigmine methylsulfate at human equivalent doses (hed, on a mg/m2 basis) of 1.6, 4 and 8.1 mcg/kg/day and 3.2, 8.1, and 13 mcg/kg/day, respectively, during the period of organogenesis (gestation days 6 through 17 for rats and gestation days 6 through 18 for rabbits). there was no evidence for a teratogenic effect in rats and rabbits up to hed 8.1 and 13 mcg/kg/day, which are approximately 0.097 times and 0.16 times the mrhd of 5 mg/60 kg, respectively, in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). the studies resulted in exposures in the animals well below predicted exposures in humans. in a prenatal and postnatal development study in rats, neostigmine methylsulfate was administered to pregnant female rats at human equivalent doses (hed) of 1.6, 4 and 8.1 mcg/kg/day from day 6 of gestation through day 20 of lactation, with weaning on day 21. there were no adverse effects on physical development, behavior, learning ability, or fertility in the offspring at hed doses up to 8.1 mcg/kg/day which is 0.097 times the mrhd of 5 mg/60 kg on a mg/m2 basis in the presence of minimal maternal toxicity (tremors, ataxia, and prostration). the studies resulted in exposures in the animals well below predicted exposures in humans. risk summary neostigmine methylsulfate has not been studied in lactating women. it is not known whether neostigmine methylsulfate is present in human milk, or if neostigmine methylsulfate has effects on milk production or the breastfed child. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s need for neostigmine methylsulfate and any potential adverse effects on the breastfed child from neostigmine methylsulfate or from the underlying maternal condition. neostigmine methylsulfate injection, usp is approved for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery in pediatric patients of all ages. recovery of neuromuscular activity occurs more rapidly with smaller doses of cholinesterase inhibitors in infants and children than in adults. however, infants and small children may be at greater risk of complications from incomplete reversal of neuromuscular blockade due to decreased respiratory reserve. the risks associated with incomplete reversal outweigh any risk from giving higher doses of neostigmine methylsulfate injection, usp (up to 0.07 mg/kg or up to a total of 5 mg, whichever is less). the dose of neostigmine methylsulfate injection, usp required to reverse neuromuscular blockade in children varies between 0.03 mg - 0.07 mg/kg, the same dose range shown to be effective in adults, and should be selected using the same criteria as used for adult patients [see clinical pharmacology (12.3)]. since the blood pressure in pediatric patients, particularly infants and neonates, is sensitive to changes in heart rate, the effects of an anticholinergic agent (e.g., atropine) should be observed prior to administration of neostigmine to lessen the probability of bradycardia and hypotension. because elderly patients are more likely to have decreased renal function, neostigmine methylsulfate injection, usp should be used with caution and monitored for a longer period in elderly patients. the duration of action of neostigmine methylsulfate is prolonged in the elderly; however, elderly patients also experience slower spontaneous recovery from neuromuscular blocking agents. therefore, dosage adjustments are not generally needed in geriatric patients; however, they should be monitored for longer periods than younger adults to assure additional doses of neostigmine methylsulfate injection, usp are not required. the duration of monitoring should be predicated on the anticipated duration of action for the nmba used on the patient [see dosage and administration (2.3)] . elimination half-life of neostigmine methylsulfate was prolonged in anephric patients compared to normal subjects. although no adjustments to neostigmine methylsulfate injection, usp dosing appear to be warranted in patients with impaired renal function, they should be closely monitored to assure the effects of the neuromuscular blocking agent, particularly one cleared by the kidneys, do not persist beyond those of neostigmine methylsulfate injection, usp. in this regard, the interval for re-dosing the neuromuscular blocking agent during the surgical procedure may be useful in determining whether, and to what extent, post-operative monitoring needs to be extended. the pharmacokinetics of neostigmine methylsulfate in patients with hepatic impairment have not been studied. neostigmine methylsulfate is metabolized by microsomal enzymes in the liver. no adjustments to the dosing of neostigmine methylsulfate injection, usp appear to be warranted in patients with hepatic insufficiency. however, patients should be carefully monitored if hepatically cleared neuromuscular blocking agents were used during their surgical procedure as their duration of action may be prolonged by hepatic insufficiency whereas neostigmine methylsulfate injection, usp, which undergoes renal elimination, will not likely be affected. this could result in the effects of the neuromuscular blocking agent outlasting those of neostigmine methylsulfate injection, usp. this same situation may arise if the neuromuscular blocking agent has active metabolites. in this regard, the interval for re-dosing the neuromuscular blocking agent during the surgical procedure may be useful in determining whether, and to what extent, post-operative monitoring needs to be extended.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

advanz pharma - neostigmine metilsulfate; glycopyrronium bromide - solution for injection - 2.5mg/1ml ; 500microgram/1ml

Australia - English - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - glycopyrronium bromide, quantity: 0.2 mg/ml - injection, solution - excipient ingredients: water for injections; sodium hydroxide; sodium chloride; hydrochloric acid - 1.as a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric contents. 2.as a preoperative or intraoperative antimuscarinic to attenuate or prevent intraoperative bradycardia associated with the use of suxa-methonium or due to cardiac vagal reflexes. 3.to protect against the peripheral muscarinic actions (eg. bradycardia and excessive secretions) of anticholinesterases such as neostigmine or pyridostigmine given to reverse neuromuscular blockade produced by nondepolarising muscle relaxants.

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - neostigmine methylsulfate -

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - rocuronium bromide, quantity: 100 mg - injection, solution - excipient ingredients: glacial acetic acid; water for injections; sodium acetate trihydrate; sodium chloride - rocuronium bromide injection is indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, children and infants over 1 month of age.,rocuronium is also indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated, however, this has not been studied in infants and children.,rocuronium is also indicated as an adjunct in the intensive care unit (icu) to facilitate mechanical ventilation.