Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - memantine hydrochloride, quantity: 5 mg (equivalent: memantine, qty 4.15 mg) - tablet, film coated - excipient ingredients: purified talc; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400 - treatment of the symptoms of moderately severe to severe alzheimer's disease (see pharmacology; precautions).

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

mwi/vetone - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine 100 mg in 1 ml - zetamine™ 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. zetamine™ is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency. zetamine™ 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.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

macleods pharmaceuticals limited - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 2 mg in 1 ml - memantine hydrochloride solution is indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride solution is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. teratogenic effects pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginning pre-mating and continuing through the postpartum period. slight maternal toxicity and decreased pup weights were also seen at this dose in a study in which rats were treated from day 15 of gestation through the postpartum period. the no-effect dose for these effects was 6 mg/kg, which is 3 times the mrhd on a mg/m2 basis. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when memantine hydrochloride is administered to a nursing mother. safety and effectiveness in pediatric patients have not been established. the majority of people with alzheimer's disease are 65 years and older. in the clinical studies of memantine hydrochloride the mean age of patients was approximately 76; over 90% of patients were 65 years and older, 60% were 75 years and older, and 12% were at or above 85 years of age. the efficacy and safety data presented in the clinical trial sections were obtained from these patients. there were no clinically meaningful differences in most adverse events reported by patient groups ≥65 years old and <65 year old. no dosage adjustment is needed in patients with mild or moderate renal impairment. a dosage reduction is recommended in patients with severe renal impairment [see dosage and administration (2) and clinical pharmacology (12.3)] . no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride should be administered with caution to patients with severe hepatic impairment [see dosage and administration (2) and clinical pharmacology (12.3)].

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

lannett company, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 2 mg in 1 ml - memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginning pre-mating a

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

patrin pharma - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 2 mg in 1 ml - memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m 2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which ra

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

henry schein animal health - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine 100 mg in 1 ml - ketathesia 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. ketathesia is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency. ketathesia 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.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

vedco, inc. - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine 100 mg in 1 ml - ketaved 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. ketaved is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency. ketaved 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.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

henry schein animal health - ketamine hydrochloride (unii: o18yuo0i83) (ketamine - unii:690g0d6v8h) - ketamine 100 mg in 1 ml - indications ketathesia 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. contraindications ketathesia is contraindicated in cats and subhuman primates suffering from renal or hepatic insufficiency. ketathesia 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.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

biomed aust pty ltd - ketamine hydrochloride, quantity: 115.3 mg (equivalent: ketamine, qty 100 mg) - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections - 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. biomed ketamine 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.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

fresenius kabi usa, 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 10 mg/kg. in rabbits, developmental delays and increased fetal resorptions were noted at 0.6 times the