Австралія - англійська - 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 - ? septanest 1:200,000 is indicated for local anaesthesia for simple dental procedures in adults, adolescents and children 4 years of age and older. ? septanest 1:200,000 is indicated only for dental procedures

Австралія - англійська - 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 - ? septanest 1:200,000 is indicated for local anaesthesia for simple dental procedures in adults, adolescents and children 4 years of age and older. ? septanest 1:200,000 is indicated only for dental procedures

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

specialites septodont pty ltd - adrenaline (epinephrine) acid tartrate, quantity: 10 microgram/ml; articaine hydrochloride, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; sodium metabisulfite; sodium chloride - for local or regional anaesthesia for both simple and complex dental procedures in adult, adolescents and children 4 years of age and older. deltazine 1:100,000 is indicated only for dental procedures.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

specialites septodont pty ltd - adrenaline (epinephrine) acid tartrate, quantity: 18.2 microgram/ml (equivalent: adrenaline (epinephrine), qty microgram/ml); articaine hydrochloride, quantity: 40 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; sodium metabisulfite; water for injections; sodium chloride - for local or regional anaesthesia for both simple and complex dental procedures in adult, adolescents and children 4 years of age and older. deltazine 1:100,000 is indicated only for dental procedures.

Малайзія - англійська - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

n.k. luck sdn. bhd. - articaine hydrochloride; adrenaline tartrate -

США - англійська - NLM (National Library of Medicine)

septodont, inc. - articaine hydrochloride (unii: qs9014q792) (articaine - unii:d3sq406g9x), epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh) - zorcaine®  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. 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 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 zorcaine is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when zorcaine is administered to a nursing woman. when using zorcaine, nursing mothers may choose to pump and discard breast milk for approximately 4 hours (based on plasma half life) following an injection of zorcaine (to minimize infant ingestion) and then resume breastfeeding. safety and effectiveness of zorcaine 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 zorcaine 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 zorcaine 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)].

Вірменія - англійська - 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

Ізраїль - англійська - Ministry of Health

a. levy dental co. ltd, israel - articaine hydrochloride; epinephrine as bitartrate - solution for injection - articaine hydrochloride 40 mg/ml ml; epinephrine as bitartrate 5 mcg/ml ml - articaine, combinations - articaine, combinations - for infiltration anaesthesia and nerve block anaesthesia in clinical dentistry. this includes local or loco-regional dental anaesthesia.

Ізраїль - англійська - Ministry of Health

a. levy dental co. ltd, israel - articaine hydrochloride; epinephrine as bitartrate - solution for injection - articaine hydrochloride 40 mg/ml ml; epinephrine as bitartrate 10 mcg/ml ml - articaine, combinations - articaine, combinations - for infiltration anaesthesia and nerve block anaesthesia in clinical dentistry. this includes local or loco-regional dental anaesthesia.

Ізраїль - англійська - Ministry of Health

3m israel - articaine hydrochloride; epinephrine hydrochloride - solution for injection - epinephrine hydrochloride 0.006 mg/ml; articaine hydrochloride 40 mg/ml - articaine - articaine - infiltration anesthesia and nerve-block in dentistry. ubistesin is especially indicated for routine interventions such as: uncomplicated single and serial extractions. cavity and coronal stump preparations.