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

allergan, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t), donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - memantine hydrochloride 14 mg - namzaric is indicated for the treatment of moderate to severe dementia of the alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. namzaric is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of namzaric or its active ingredients (memantine hydrochloride and donepezil hydrochloride) in pregnant women. adverse developmental effects (mortality and decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine or donepezil during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the recommended daily dose of namzaric [see data ] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recogni

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

par pharmaceutical inc. - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine 10 mg in 1 ml

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

hameln pharma ltd - ketamine hydrochloride - solution for injection - 50mg/1ml

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

dechra veterinary products - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine hydrochloride injection may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. it may be used in subhuman primates for restraint. ketamine hydrochloride injection is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency. ketamine hydrochloride injection is detoxified by the liver and excreted by the kidneys; therefore, any preexistent hepatic or renal pathology or impairment of function can be expected to result in prolonged anesthesia; related fatalities have been reported.

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

covetrus north america - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine hydrochloride injection may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. it may be used in subhuman primates for restraint. ketamine hydrochloride injection is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency. ketamine hydrochloride injection is detoxified by the liver and excreted by the kidneys; therefore, any preexistent hepatic or renal pathology or impairment of function can be expected to result in prolonged anesthesia; related fatalities have been reported.

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

henry schein, inc. - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - 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. - ketamine hydrochloride injection is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see warnings and precautions (5.1)]. - ketamine hydrochloride injection 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 ketamine hydrochloride injection 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

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

medical purchasing solutions, llc - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - 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. - ketamine hydrochloride injection is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see warnings and precautions (5.1)] . - ketamine hydrochloride injection is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see adverse reactions (6)] . risk summary there are no adequate and well-controlled studies of ketamine hydrochloride injection 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

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

hospira, inc. - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine hydrochloride injection is indicated: risk summary there are no adequate and well-controlled studies of ketamine hydrochloride injection 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 defe

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

sagent pharmaceuticals - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - 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. - ketamine hydrochloride injection is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see warnings and precautions (5.1)] . - ketamine hydrochloride injection is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see adverse reactions (6)] . risk summary there are no adequate and well-controlled studies of ketamine hydrochloride injection 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

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

gland pharma limited - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - 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. - ketamine hydrochloride injection is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see warnings and precautions (5.1) ]. - ketamine hydrochloride injection is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see adverse reactions (6) ]. risk summary there are no adequate and well-controlled studies of ketamine hydrochloride injection 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