Finland - English - Fimea (Suomen lääkevirasto)

roche oy - midazolami maleas - film-coated tablet - 15 mg - midazolam

Finland - English - Fimea (Suomen lääkevirasto)

roche oy - midazolami maleas - film-coated tablet - 7.5 mg - midazolam

Canada - English - Health Canada

pfizer canada ulc - midazolam - solution - 1mg - midazolam 1mg - benzodiazepines

Canada - English - Health Canada

pfizer canada ulc - midazolam - solution - 5mg - midazolam 5mg - benzodiazepines

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

fresenius kabi usa, llc - midazolam hydrochloride (unii: w7ttw573jj) (midazolam - unii:r60l0sm5bc) - midazolam 2 mg in 2 ml - midazolam injection is indicated: - intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; - intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other cns depressants; - intravenously for induction of general anesthesia, before administration of other anesthetic agents. with the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); - continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. injectable midazolam is contraindicated in patients with a known hypersensitivity to the drug. 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 with midazolam; patients with glaucoma have not been studied. midazolam is a schedule iv control substance. midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuation of benzodiazepines, including midazolam. abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. the more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at the therapeutic levels for several months. consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. there is no consensus in the medical literature regarding tapering schedules; therefore, practitioners are advised to individualize therapy to meet patient's needs. in some case reports, patients who have had severe withdrawal reactions due to abrupt discontinuation of high-dose long-term midazolam, have been successfully weaned off of midazolam over a period of several days. figure 1: outer packaging and prefilled syringe notes: - inspect the outer packaging (blister pack) to confirm the integrity of the packaging. do not use if the blister pack or the prefilled syringe has been damaged. - remove the syringe from the outer packaging. (see figure 2) figure 2 figure 2 - visually inspect the syringe. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. - twist off the syringe tip cap. do not remove the label around the luer lock collar. (see figure 3) figure 3 figure 3 - expel air bubble(s). adjust the dose (if applicable). - administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration. - discard the used syringe into an appropriate receptacle. for more information concerning this drug, please call fresenius kabi usa, llc at 1-800-551-7176. to report suspected adverse reactions, contact fresenius kabi usa, llc at 1-800-551-7176 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. the brand names mentioned in this document are the trademarks of their respective owners. u.s. patent 9,731,082; 10,661,018 www.fresenius-kabi.com/us 451524e revised: february 2023

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)

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)

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.