European Union - English - EMA (European Medicines Agency)

paion deutschland gmbh - remimazolam besilate - conscious sedation - psycholeptics - remimazolam is indicated in adults for procedural sedation.remimazolam 50 mg is indicated in adults for intravenous induction and maintenance of general anaesthesia.

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

acacia pharma, ltd. - remimazolam besylate (unii: 280xq6482h) (remimazolam - unii:7v4a8u16mb) - byfavo® is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. byfavo is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40 [see warnings and precautions (5.3)]. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.4), 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 animal studies, reduced fetal weights but no evidence of malformations or embryofetal lethality were noted in a study in which pregnant rabbits were treated intravenously with 4 times the maximum recommended human dose (mrhd) of 30 mg during organogenesis. adequate rodent reproductive and develo

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: jlt pharma inc. fba ro; distributor: jlt pharma inc. fba ro - remimazolam - lyophilized powder for intravenous infusion - 50mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

eskayef pharmaceuticals ltd., tongi,gazipur - remimazolam - injection - 20 mg/vial

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

mundipharma k.k. - remimazolam besilate - injection

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

hikma pharmaceuticals usa inc. - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 2 mg in 1 ml - midazolam hcl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. midazolam hcl syrup is intended for use in monitored settings only and not for chronic or home use [see warnings]. midazolam hcl syrup is contraindicated in patients with a known hypersensitivity to the drug or allergies to cherries or formulation excipients. benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction of general anesthesia with injectable midazolam; patients with glaucoma have not been studied. midazolam hcl syrup is a benzodiazepine and is a schedule iv controlled substance that can produce drug dependence of the diazepam-type. therefore, midazolam hcl syrup

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

precision dose inc. - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 2 mg in 1 ml - midazolam hcl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. midazolam hcl syrup is intended for use in monitored settings only and not for chronic or home use [see warnings] . midazolam hcl syrup is contraindicated in patients with a known hypersensitivity to the drug or allergies to cherries or formulation excipients. benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction of general anesthesia with injectable midazolam; patients with glaucoma have not been studied. midazolam hcl syrup is a benzodiazepine and is a schedule iv controlled substance that can produce drug dependence of the diazepam-type. therefore, midazolam hcl syrup may be subject to misuse, abuse and addiction. benzodiazepines can cause physical dependence. physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. withdrawal symptoms (ie, convulsions, hallucinations, tremors, abdominal and muscle cramps, vomiting and sweating), similar in characteristics to those noted with barbiturates and alcohol have occurred following abrupt discontinuation of midazolam following chronic administration. abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. the handling of midazolam hcl syrup should be managed to minimize the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting and as required by law.

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

precision dose inc. - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 2 mg in 1 ml - midazolam hcl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. midazolam hcl syrup is intended for use in monitored settings only and not for chronic or home use [see warnings] . midazolam hcl syrup is contraindicated in patients with a known hypersensitivity to the drug or allergies to cherries or formulation excipients. benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction of general anesthesia with injectable midazolam; patients with glaucoma have not been studied. midazolam hcl syrup is a benzodiazepine and is a schedule iv controlled substance that can produce drug dependence of the diazepam-type. therefore, midazolam hcl syrup may be subject to misuse, abuse and addiction. benzodiazepines can cause physical dependence. physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. withdrawal symptoms (ie, convulsions, hallucinations, tremors, abdominal and muscle cramps, vomiting and sweating), similar in characteristics to those noted with barbiturates and alcohol have occurred following abrupt discontinuation of midazolam following chronic administration. abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. the handling of midazolam hcl syrup should be managed to minimize the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting and as required by law.

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

padagis us llc - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 2 mg in 1 ml - midazolam hcl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. midazolam hcl syrup is intended for use in monitored settings only and not for chronic or home use [see warnings] . midazolam hcl syrup is contraindicated in patients with a known hypersensitivity to the drug or allergies to cherries or formulation excipients. benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction of general anesthesia with injectable midazolam; patients with glaucoma have not been studied. midazolam hcl syrup is a benzodiazepine and is a schedule iv controlled substance that can produce drug dependence of the diazepam-type. therefore, midazolam hcl syru

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

ranbaxy pharmaceuticlas inc - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 2 mg in 1 ml - midazolam hydrochloride syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. midazolam hydrochloride syrup is intended for use in monitored settings only and not for chronic or home use (see warnings). midazolam hydrochloride syrup must be used as specified in the label. midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours (see clinical pharmacology). midazolam hydrochloride syrup is contraindicated in patients with a known hypersensitivity to the drug or allergies to cherries or formulation excipients. benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction of general anest