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

popular pharmaceuticals ltd. - ketamine - injection - 50 mg/ml

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

par pharmaceutical, inc. - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine 10 mg in 1 ml -  ketalar (ketamine hydrochloride) injection is indicated: - as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. - for the induction of anesthesia prior to the administration of other general anesthetic agents. - as a supplement to other anesthetic agents. - ketalar is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see warnings and precautions(5.1)] . - ketalar is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see adverse reactions (6)] . there are no adequate and well-controlled studies of ketalar in pregnant women. in animal reproduction studies in rats developmental delays (hypoplasia of skeletal tissues) were noted at 0.3 times the human intramuscular dose of 10 mg/kg. in rabbits, developmental delays and increased fetal resorptions were noted at 0.6 times the human dose. published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block nmda receptors and/or potentiate gaba activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. there are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans. the estimated 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 2-4% and 15-20%, respectively. ketalar use in pregnancy, including obstetrics (either vaginal or abdominal delivery), is not recommended because safe use has not been established [see warnings and precautions (5.5), use in specific populations (8.4) and nonclinical toxicology (13.2)] . animal data pregnant rats were treated intramuscularly with 20 mg/kg ketamine (0.3 times the human dose of 10 mg/kg im based on body surface area) on either gestation days 6 to 10 or gestation days 11 to 15. ketamine treatment produced an increased incidence of hypoplastic skull, phalanges, and sternebrae in the pups. pregnant rabbits were treated intramuscularly with 20 mg/kg ketamine (0.6 times the human dose of 10 mg/kg im based on body surface area) on either gestation days 6 to 10 or gestation days 11 to 15. an increase in resorptions and skeletal hypoplasia of the fetuses were noted. additional pregnant rabbits were treated intramuscularly with a single dose 60 mg/kg (1.9 times the human dose of 10 mg/kg im based on body surface area) on gestation day 6 only. skeletal hypoplasia was reported in the fetuses. in a study where pregnant rats were treated intramuscularly with 20 mg/kg ketamine (0.3 times the human dose of 10 mg/kg im based on body surface area) from gestation day 18 to 21. there was a slight increase in incidence of delayed parturition by one day in treated dams of this group. no adverse effects on the litters or pups were noted; however, learning and memory assessments were not completed. three pregnant beagle dogs were treated intramuscularly with 25 mg/kg ketamine (1.3 times the human dose of 10 mg/kg im based on body surface area) twice weekly for the three weeks of the first, second, and third trimesters of pregnancy, respectively, without the development of adverse effects in the pups. in a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on gestation day 122 increased neuronal apoptosis in the developing brain of the fetus. in other published studies, administration of either isoflurane or propofol for 5 hours on gestation day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. with respect to brain development, this time period corresponds to the third trimester of gestation in the human. the clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits [see warnings and precautions (5.5), use in specific populations (8.4), and nonclinical toxicology (13.2)] . safety and effectiveness in pediatric patients below the age of 16 have not been established. published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as ketalar, that either block nmda receptors or potentiate the activity of gaba during the period of rapid brain growth or synaptogenesis, results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately 3 years of age in humans. in primates, exposure to 3 hours of ketamine that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer of isoflurane increased neuronal cell loss. data from isoflurane-treated rodents and ketamine-treated primates suggest that the neuronal and oligodendrocyte cell losses are associated with prolonged cognitive deficits in learning and memory. the clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures with the potential risks suggested by the nonclinical data [see warnings and precautions (5.5), use in specific populations (8.1), and nonclinical toxicology (13.2)] . clinical studies of ketamine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. ketalar contains ketamine, a schedule iii controlled substance under the controlled substance act. individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of ketalar. abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. in a context of drug abuse, ketalar may produce a variety of symptoms including anxiety, dysphoria, disorientation, insomnia, flashback, hallucinations, and feelings of floating, detachment and being “spaced out”. recurrent high-dose ketamine misuse or abuse may be associated with memory and/or attention impairment. physical dependence has been reported with prolonged use of ketamine. 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 significant dosage reduction of a drug. withdrawal symptoms have been reported after the discontinuation of frequently used (more than weekly), large doses of ketamine for long periods of time. reported symptoms of withdrawal associated with daily intake of large doses of ketamine include craving, fatigue, poor appetite, and anxiety. tolerance has been reported with prolonged use of ketamine. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

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

general injectables & vaccines, inc - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketalar (ketamine hydrochloride) injection is indicated: - as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. - for the induction of anesthesia prior to the administration of other general anesthetic agents. - as a supplement to other anesthetic agents. - ketalar is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see warnings and precautions(5.1)]. - ketalar is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see adverse reactions(6)]. 8.1 pregnancy risk summary there are no adequate and well-controlled studies of ketalar in pregnant women. in animal reproduction studies in rats developmental delays (hypoplasia of skeletal tissues) were noted at 0.3 times the human intramuscular dose of 10 mg/kg. in rabbits, developmental delays and increased fetal resorptions were noted at 0.6 times the human dose. published studies in pregnant primates d

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

henry schein, inc - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketalar (ketamine hydrochloride) injection is indicated: - as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. - for the induction of anesthesia prior to the administration of other general anesthetic agents. - as a supplement to other anesthetic agents. - ketalar is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see warnings and precautions(5.1)]. - ketalar is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see adverse reactions(6)]. 8.1 pregnancy risk summary there are no adequate and well-controlled studies of ketalar in pregnant women. in animal reproduction studies in rats developmental delays (hypoplasia of skeletal tissues) were noted at 0.3 times the human intramuscular dose of 10 mg/kg. in rabbits, developmental delays and increased fetal resorptions were noted at 0.6 times the human dose. published studies in pregnant primates d

Malta - English - Medicines Authority

p & d pharmaceuticals limited 38 woolmer way, bordon hampshire gu35 9qf, united kingdom - ketamine - solution for infusion or injection - ketamine 50 mg/ml - anesthetics

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - ketamine hydrochloride 115.3 mg/ml equivalent to 100 mg/ml ketamine - solution for injection - 100 mg/ml - active: ketamine hydrochloride 115.3 mg/ml equivalent to 100 mg/ml ketamine excipient: benzethonium chloride water for injection - ketalar is recommended: 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. ketalar is best suited for short procedures and it can be used with additional doses, for longer procedures; 2. for the induction of anaesthesia prior to the administration of other general anaesthetic agents; 3. to supplement low-potency agents, such as nitrous oxide.

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

hospira australia pty ltd - ketamine hydrochloride, quantity: 115.3 mg/ml (equivalent: ketamine, qty 100 mg/ml) - injection, solution - excipient ingredients: benzethonium chloride; water for injections - ketalar is recommended: 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. ketalar is best suited for short procedures and it can be used with additional doses, for longer procedures; 2. for the induction of anaesthesia prior to the administration of other general anaesthetic agents, and 3. to supplement low-potency agents, such as nitrous oxide.

Israel - English - Ministry of Health

pharmalogic ltd - ketamine as hydrochloride - solution for injection / infusion - ketamine as hydrochloride 50 mg / 1 ml - ketamine - as the sole anaesthetic agent for diagnostic and surgical procedures. when used by intravenous or intramuscular injection, ketamin is best suited for short procedures. with additional doses, or by intravenous infusion, ketamin can be used for longer procedures. if skeletal muscle relaxation is desired a muscle relaxant should be used and respiration should be supported. for the induction of anaesthesia prior to the administration of other general anaesthetic agents. to supplement other anaesthetic agents. specific areas of application or types of procedure: when the intramuscular route of administration is preferred. debridement, painful dressings and skin grafting in burned patients as well as other superficial surgical procedures. neurodiagnostic procedures such as pneumoencephalograms, ventriculograms, myelograms and lumbar punctures. diagnostic and operative procedures of the eye, ear, nose and mouth including dental extractions. (note: eye movement may persist during ophthalmological procedures). anaesthesia in poor-risk patients with depression of vital functions or where depression of vital functions must be avoided if at all possible. orthopaedic procedures such as closed reduction, manipulation femoral pinning, amputations and biopsies. sigmoidoscopy and minor surgery of the anus and rectum, circumcision and pilonidal sinus. cardiac catheterization procedures. caesarian section: as an induction agent in the absence of elevated blood pressure. anaesthesia in the asthmatic patient, either to minimise the risk of an attack of bronchospasm developing or in the presence of bronchospasm

Canada - English - Health Canada

searchlight pharma inc - ketamine (ketamine hydrochloride) - solution - 50mg - ketamine (ketamine hydrochloride) 50mg - miscellaneous general anesthetics

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

hospira australia pty ltd - ketamine hydrochloride; ketamine -