França - francês - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

zentiva france - prilocaïne 2; lidocaïne 2 - crème - 2,5 g - pour 100 g de crème > prilocaïne 2,5 g > lidocaïne 2,5 g - anesthésiques - classe pharmacothérapeutique ‑ anesthésique, local, amides : code atc : n01bb20.lidocaÏne/prilocaÏne zentiva 5%, crème contient deux substances actives appelées la lidocaïne et la prilocaïne. ces dernières appartiennent à un groupe de médicaments appelés anesthésiques locaux.lidocaÏne/prilocaÏne zentiva 5%, crème fonctionne en provoquant une anesthésie de la surface de la peau pendant une courte durée. il est appliqué sur la peau avant certains actes médicaux. cela permet d’arrêter la douleur au niveau de la peau ; cependant, vous pouvez encore avoir les sensations de pression et de toucher.adultes, adolescents et enfantsil peut être utilisé pour anesthésier la peau avant : l’insertion d’aiguilles (par exemple, si vous devez avoir une injection ou faire une prise de sang). des opérations mineures de la peau.adultes et adolescentsil peut aussi être utilisé : pour anesthésier les parties génitales avant :o de recevoir une injection.o certains actes médicaux tels que le retrait de verrues.un médecin ou un(e) infirmier/ère doit superviser l’utilisation de lidocaÏne/prilocaÏne zentiva 5%, crème, sur les parties génitales.adultesil peut aussi être utilisé pour anesthésier la peau avant : le nettoyage ou le retrait de la peau endommagée en cas d’ulcères de jambe

Estados Unidos - inglês - NLM (National Library of Medicine)

dentsply pharmaceutical - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. oraqix is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any other component of the product. pregnancy category b .reproduction studies have been performed in rats with lidocaine, prilocaine and a 1:1 (weight:weight) mixture of the two compounds. there was no evidence of harm to the fetus at subcutaneous doses of up to 30 mg/kg lidocaine (estimated exposure was approximately equivalent to the expected lidocaine exposure at the maximum recommended human dose of oraqix (lidocaine and prilocaine periodontal gel) 2.5% / 2.5% on a mg/m2 basis). following intramuscular prilocaine doses of up to 300 mg/kg (estimated exposure was approximately 11 times the expected prilocaine exposure at the maximum recommended human dose of oraqix gel on a mg/m2 basis), there was no evidence of impaired fertility or harm to the fetus. similarly, subcutaneous administration of a lidocaine and prilocaine mixture of 40 mg/kg of each compound (estimated exposures were approximately 1.5 times the expected lidocaine and prilocaine exposures at the maximum recommended human dose of oraqix gel on a mg/m2 basis) produced no teratogenic, embryotoxic, or fetotoxic effects. reproductive toxicology studies of lidocaine were also conducted in rabbits. there was no evidence of harm to the fetus at a dose of 5 mg/kg, s.c. (60 mg/m2 ). treatment of rabbits with 15 mg/kg (180 mg/m2 ) produced evidence of maternal toxicity and evidence of delayed fetal development, including a non-significant decrease in fetal weight (7%) and an increase in minor skeletal anomalies (skull and sternebral defects, reduced ossification of the phalanges). the effects of lidocaine and prilocaine on post-natal development was examined in rats treated for 8 months with 10 or 30 mg/kg, s.c. lidocaine or prilocaine (60 mg/m2 and 180 mg/m2 on a body surface area basis, respectively up to 1.4-fold the maximum recommended exposure for a single procedure). this time period encompassed 3 mating periods. there was no evidence of altered post-natal development in any offspring; however, both doses of either drug reduced the average number of pups per litter surviving until weaning of offspring from the first 2 mating periods. in a separate study, the effect of prilocaine on pre- and postnatal development was examined in rats treated with up to 60 mg/kg, s.c. (up to 2.8 times the maximum recommended human dose of prilocaine in oraqix gel on a mg/m2 basis) from day 6 of gestation to weaning. there was no evidence of altered post-natal development, viability, or reproductive capacity in any offspring. all the above calculations of exposure are assuming 100% bioavailability of lidocaine and prilocaine after oraqix administration. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, oraqix should be used during pregnancy only if the benefits outweigh the risks. reproduction studies on the oraqix drug product, including the inactive ingredients, have not been conducted. lidocaine and, possibly, prilocaine are excreted in breast milk. caution should be exercised when oraqix is administered to nursing women. safety and effectiveness in pediatric patients have not been established. very young children are more susceptible to methemoglobinemia. there have been reports of clinically significant methemoglobinemia in infants and children following excessive applications of lidocaine 2.5% topical cream [see warnings and precautions (5.1)] . of the total number of subjects in clinical studies of oraqix, 7% were aged 65 and over, while 1% were aged 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

dentsply sirona pty ltd - prilocaine hydrochloride, quantity: 30 mg/ml; felypressin, quantity: 0.54 microgram/ml - injection, solution - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide - citanest is indicated for the production of local anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques.

Canadá - inglês - Health Canada

dentsply canada limited - prilocaine hydrochloride; epinephrine (epinephrine bitartrate) - solution - 40mg; 5mcg - prilocaine hydrochloride 40mg; epinephrine (epinephrine bitartrate) 5mcg - local anesthetics

Estados Unidos - inglês - NLM (National Library of Medicine)

hospira, inc. - mepivacaine hydrochloride (unii: 4vfx2l7em5) (mepivacaine - unii:b6e06qe59j) - mepivacaine hydrochloride 10 mg in 1 ml - carbocaine is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks. the routes of administration and indicated concentrations for carbocaine are: local infiltration 0.5% (via dilution) or 1% peripheral nerve blocks 1% and 2% epidural block 1%, 1.5%, 2% caudal block 1%, 1.5%, 2% see dosage and administration for additional information. standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of carbocaine. carbocaine is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of solutions of carbocaine.

Estados Unidos - inglês - NLM (National Library of Medicine)

fresenius kabi usa, llc - mepivacaine hydrochloride (unii: 4vfx2l7em5) (mepivacaine - unii:b6e06qe59j) - mepivacaine hydrochloride 10 mg in 1 ml - polocaine (mepivacaine hcl injection, usp), is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks. the routes of administration and indicated concentrations for mepivacaine are:   see  dosage and administration   for additional information.  standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mepivacaine. mepivacaine is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of solutions of mepivacaine.

Estados Unidos - inglês - NLM (National Library of Medicine)

alvix laboratories, llc - prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r), lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - prilocaine 25 mg in 1 g - lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Estados Unidos - inglês - NLM (National Library of Medicine)

fortus pharma, llc - prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r), lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - prilocaine 25 mg in 1 g - lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:     - normal intact skin for local analgesia.     - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Estados Unidos - inglês - NLM (National Library of Medicine)

rx pharma-pack, inc. - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987), epinephrine bitartrate (unii: 30q7ki53ak) (epinephrine - unii:ykh834o4bh) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. antiseptic antiseptic skin preparation antiseptic for preparation of the skin prior to injection.

Estados Unidos - inglês - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - lidocaine 50 mg in 1 g - lidocaine ointment, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. it is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine ointment, 5%.