USA - engelsk - NLM (National Library of Medicine)

darby dental supply, llc - articaine hydrochloride (unii: qs9014q792) (articaine - unii:d3sq406g9x) - articaine hydrochloride 40 mg in 1 ml

USA - engelsk - NLM (National Library of Medicine)

pierrel s.p.a. - articaine hydrochloride (unii: qs9014q792) (articaine - unii:d3sq406g9x), epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh) - articaine hydrochloride 40 mg in 1 ml - orabloc is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older. orabloc is contraindicated in patients who are hypersensitive to products containing sulfites. products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people [see warnings and precautions (5.5)] . teratogenic effects-pregnancy category c. there are no adequate and well-controlled studies in pregnant women with articaine with epinephrine. articaine hydrochloride and epinephrine (1:100,000) has been shown to increase fetal deaths and skeletal variations in rabbits when given in doses approximately 4 times the maximum recommended human dose (mrhd). orabloc should be used during pregnancy only if the potential benefit justifies the potentia

USA - engelsk - NLM (National Library of Medicine)

hospira, inc. - articaine hydrochloride (unii: qs9014q792) (articaine - unii:d3sq406g9x) - articaine hydrochloride 40 mg in 1 ml

USA - engelsk - NLM (National Library of Medicine)

dentsply pharmaceutical - articaine hydrochloride (unii: qs9014q792) (articaine - unii:d3sq406g9x), epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh) - articaine hydrochloride 40 mg in 1 ml - articadent is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older. articadent is contraindicated in patients who are hypersensitive to products containing sulfites. products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people [see warnings and precautions (5.5)]. teratogenic effects - pregnancy category c. there are no adequate and well-controlled studies in pregnant women with articadent. articaine hydrochloride and epinephrine (1:100,000) has been shown to increase fetal deaths and skeletal variations in rabbits when given in doses approximately 4 times the maximum recommended human dose (mrhd). articadent should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in embryo-fetal toxicity studies in rabbits, 80 mg/kg, subcutaneously (approximately 4 times the mrhd based on body surface area) caused fetal death and increased fetal skeletal variations, but these effects may be attributable to severe maternal toxicity, including seizures, observed at this dose. in contrast, no embryo-fetal toxicities were observed when articaine and epinephrine (1:100,000) was administered subcutaneously throughout organogenesis at doses up to 40 mg/kg in rabbits and 80 mg/kg in rats (approximately 2 times the mrhd based on body surface area). in pre- and postnatal developmental studies subcutaneous administration of articaine hydrochloride to pregnant rats throughout gestation and lactation, at a dose of 80 mg/kg (approximately 2 times the mrhd based on body surface area) increased the number of stillbirths and adversely affected passive avoidance, a measure of learning, in pups. this dose also produced severe maternal toxicity in some animals. a dose of 40 mg/kg (approximately equal to the mrhd on a mg/m2 basis) did not produce these effects. a similar study using articaine and epinephrine (1:100,000) rather than articaine hydrochloride alone produced maternal toxicity, but no effects on offspring. it is not known whether articadent is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when articadent is administered to a nursing woman. when using articadent, nursing mothers may choose to pump and discard breast milk for approximately 4 hours (based on plasma half-life) following an injection of articadent (to minimize infant ingestion) and then resume breastfeeding. safety and effectiveness of articadent in pediatric patients below the age of 4 years have not been established. safety of doses greater than 7 mg/kg (0.175 ml/kg) in pediatric patients has not been established. the safety and effectiveness of articadent for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures have been established in pediatric patients ages 4 to 16 years old. safety and effectiveness was established in clinical trials with 61 pediatric patients between the ages of 4 and 16 years administered articaine hydrochloride 4% and epinephrine 1:100,000 injections. fifty-one of these patients received doses from 0.76 mg/kg to 5.65 mg/kg (0.9 to 5.1 ml) for simple dental procedures and 10 patients received doses between 0.37 mg/kg and 7.48 mg/kg (0.7 to 3.9 ml) for complex dental procedures. approximately 13% of these pediatric patients required additional injections of anesthetic for complete anesthesia. dosages in pediatric patients should be reduced, commensurate with age, body weight, and physical condition [see dosage and administration (2.2)]. in clinical trials, 54 patients between the ages of 65 and 75 years, and 11 patients 75 years and over received articadent containing epinephrine 1:100,000. among all patients between 65 and 75 years, doses from 0.43 mg/kg to 4.76 mg/kg (0.9 to 11.9 ml) were administered to 35 patients for simple procedures and doses from 1.05 mg/kg to 4.27 mg/kg (1.3 to 6.8 ml) were administered to 19 patients for complex procedures. among the 11 patients ≥ 75 years old, doses from 0.78 mg/kg to 4.76 mg/kg (1.3 to 11.9 ml) were administered to 7 patients for simple procedures and doses of 1.12 mg/kg to 2.17 mg/kg (1.3 to 5.1 ml) were administered to 4 patients for complex procedures. approximately 6% of patients between the ages of 65 and 75 years and none of the 11 patients 75 years of age or older required additional injections of anesthetic for complete anesthesia compared with 11% of patients between 17 and 65 years old who required additional injections. no overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no studies have been performed with articaine hydrochloride 4% and epinephrine 1:200,000 injection or articaine hydrochloride 4% and epinephrine 1:100,000 injection in patients with renal or hepatic impairment [see warnings and precautions (5.2)].

USA - engelsk - NLM (National Library of Medicine)

carestream health, inc. - articaine hydrochloride (unii: qs9014q792) (articaine - unii:d3sq406g9x), epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh) - articaine hydrochloride 40 mg in 1 ml - zorcainetm , an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. zorcaine is contraindicated in patients who are hypersensitive to products containing sulfites. products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people [see warnings and precautions (5.5)]. teratogenic effects - pregnancy category c. there are no adequate and well-controlled studies in pregnant women with zorcaine. articaine hydrochloride and epinephrine (1:100,000) has been shown to increase fetal deaths and skeletal variations in rabbits when given in doses approximately 4 times the maximum recommended human dose (mrhd). zorcaine should be used during pregnancy only if the potential benefit justifies the potential risk to th

Armenia - engelsk - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

dfl industria e comercio s.a. - articaine (articaine hydrochloride), epinephrine (epinephrine hydrotartrate) - solution for injection - 40mg/ml+ 10mcg/ml

Canada - engelsk - Health Canada

pierrel s.p.a. - articaine hydrochloride; epinephrine bitartrate - solution - 40mg; 0.009mg - articaine hydrochloride 40mg; epinephrine bitartrate 0.009mg - local anesthetics

Canada - engelsk - Health Canada

pierrel s.p.a. - articaine hydrochloride; epinephrine bitartrate - solution - 40mg; 0.018mg - articaine hydrochloride 40mg; epinephrine bitartrate 0.018mg - local anesthetics

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

specialites septodont pty ltd - articaine hydrochloride, quantity: 88 mg; adrenaline (epinephrine) acid tartrate, quantity: 0.02 mg (equivalent: adrenaline (epinephrine), qty 0.011 mg) - injection, solution - excipient ingredients: sodium chloride; sodium metabisulfite; sodium hydroxide; water for injections - deltazine 1:200,000 is indicated for local anaesthesia for simple dental procedures in adults, adolescents and children 4 years of age and older. deltazine 1:200,000 is indicated only for dental procedures

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

specialites septodont pty ltd - articaine hydrochloride, quantity: 68 mg; adrenaline (epinephrine) acid tartrate, quantity: 0.0155 mg (equivalent: adrenaline (epinephrine), qty 0.0085 mg) - injection, solution - excipient ingredients: sodium chloride; sodium metabisulfite; sodium hydroxide; water for injections - deltazine 1:200,000 is indicated for local anaesthesia for simple dental procedures in adults, adolescents and children 4 years of age and older. deltazine 1:200,000 is indicated only for dental procedures