Active substanceLidocaine + PrilocaineLidocaine + Prilocaine Similar drugsTo uncover Acryol Pro cream locally externally AKRIKHIN HFK, JSC Russia Emla® cream locally externally AstraZeneca AB Sweden Emla® patch externally AstraZeneca AB Sweden Dosage form: & nbspTherapeutic system. Composition:One therapeutic system (1 g of emulsion) contains:active substances: lidocaine 25.0 mg, prilocaine 25.0 mg;Excipients: macrogol glyceryl hydroxy stearate (ARLATON 289) 19.0 mg, carboxypolymethylene (carbomer 974 P) 2.2 mg, sodium hydroxide to adjust pH to 8.5-9.7 about 1.2 mg, purified water to 1.0 g. Description:The therapeutic system consists of an adherent medicinal part and a flexible support. Adhesive drug part consists of a circular cellulose disk with a diameter of 3.5 cm, attached to a flexible substrate. A cellulose disc of white or whitish color is impregnated with 1 g of a 5% emulsion emulsion.On the circumference of the cellulose disc is an adhesive tape of square shape with rounded edges. Flexible substrate of round shape with protrusions-plastic / asominium / plastic laminate. Pharmacotherapeutic group:Local anesthetic ATX: & nbspN.01.B.B.52 Lidocaine in combination with other drugs Pharmacodynamics:The EMLL therapeutic system (TC) contains, as active components lidocaine and irilocaine, which are local anesthetics of the amide type. Anesthesia of the skin is caused by the penetration of lidocaine and prilocaine into the layers of the epidermis and dermis. The degree of anesthesia depends on the dose of the drug and the duration of the application ..Intact skinAfter application of the drug for EMLL on intact skin for 1-2 hours, the duration of anesthesia after removal of the therapeutic system is 2 hours. There were no differences in efficacy (including the time to achieve an analgesic effect) and the safety of the drug on intact skin between the elderly (65-96 years) and younger patients.Due to the action of the drug EMLL on the surface vessels, temporary blanching or reddening of the skin is possible. Similar reactions in patients with advanced neurodermatitis (atopic dermatitis) can occur more quickly, after 30-60 minutes after application, indicating a faster penetration of the drug through the skin.In the course of puncture biopsy (diameter 4 mm), the use of the EMLL preparation for 60 minutes provided an anesthesia of intact skin sufficient for the introduction of the needle to a depth of 2 mm in 90% of patients, and for the use of the EMLL preparation for 120 minutes to a depth of 3 mm.Efficacy does not depend on color or skin pigmentation (type of skin I-IV).The use of the EMLA drug does not affect the average antibody titer, the rate of appearance or disappearance of specific antibodies in the serum, or the number of patients who achieved a protective or positive antibody titer after immunization, when vaccinated against infections such as measles / rubella mumps or with intramuscular vaccines against diphtheria-pertussis-tetanus-poliomyelitis, as well as infections caused by Haemophilius influenzae b, or when vaccinated against hepatitis B. Pharmacokinetics:Systemic absorption of the drug depends on the dose, the duration of the application and the thickness of the skin (depends on the area of the body), as well as other skin features. Intact skin:In adults, after the application for 3 hours, the systemic absorption for lidocaine was approximately 3% and for prilocaine 5%. Suction - slow. The maximum concentration of lidocaine (mean value 0.12 μg / ml) and prilocaine (mean value 0.07 μg / ml) in blood plasma was achieved approximately 4 hours after the application. The risk of toxic symptoms exists only when the concentration of drugs in the blood plasma is 5-10 μg / ml. Indications:Surface anesthesia of the skin with injection, puncture and catheterization of vessels and superficial surgical interventions. Contraindications:- hypersensitivity to local anesthetics of the amide type or any other component of the preparation;- Premature newborns born at the gestational age of less than 37 weeks. Carefully:When applying the drug near the eyes; before subcutaneous administration of live vaccine (eg BCG); in the case of application to the skin with a common neurodermatitis (atopic dermatitis);It is not recommended to use the combined use of the drug EMLA and drugs that cause methemoglobinemia in children aged 0 to 12 months; in patients with insufficiency of glucose-6-phosphate dehydrogenase; It is not recommended to apply the drug to open wounds. Pregnancy and lactation:PregnancyIn animal studies, there was no direct or indirect adverse effect of the drug on pregnancy, fetal development, on the process of childbirth or lostnatalyus development. In animals and in humans lidocaine and prilocaine penetrate the placental barrier and can be absorbed in the fetal tissues.It is necessary to take into account the fact that lidocaine and prilocaine were used in a large number of pregnant women and women of childbearing age. No specific violations of the reproductive process have been reported, such as an increase in the frequency of malformations or other direct or indirect adverse effects on the fetus. However, care should be taken when using the drug in pregnant women.LactationLidocaine and prilocaine are dispensed with breast milk in quantities that do not pose a risk to the child when the drug is used in therapeutic doses. Dosing and Administration:Adults: 1 or more vehicles simultaneously. Time of application: not less than 1 hour.Children from 1 year to 12 years: 1 or more vehicles simultaneously. Time of application: not less than 1 hour. Children from 3 to 12 months: 1 or 2 (maximum) TC at the same time. Time of application: 1 hour. Children from 0 to 3 months: not more than 1 TC / day (maximum dose). Application time: no more than 1 hour.Increasing the application time by more than 5 hours does not lead to an increase in anesthesia.In children with advanced neurodermatitis (atopic dermatitis), the time of application should be reduced to 30 minutes. Side effects:Adverse reactions caused by the use of local anesthetics occur in less than 1/1000 patients.Frequent (> 1%, <10%): Skin: Transient local reactions in the application area, such as pallor, redness and swelling.Infrequent (> 0,1%, <1%): Skin: at the first moment after application, slight burning, itching and sensation of heat (in the area of application of the drug).Rare (> 0.01%, <0.1%): General: allergic reactions, in the most severe cases - anaphylactic shock. Methemoglobinemia.There are isolated reports of cases of local reactions in the area of drug application, such as hemorrhagic rash or pinpoint hemorrhages, especially after prolonged use in children with atopic dermatitis or molluscum contagiosum. Accidental ingestion of the drug in the eye can cause irritation of the cornea. Overdose:When observing the recommended dosage regimen, development of signs of systemic toxicity is unlikely. Symptoms of intoxication are probably the same as when using other local anesthetics, for example, excitation of the central nervous system (CNS), and in severe cases - CNS depression and heart activity.In rare cases, the development of clinically significant methemoglobinemia was noted.Prilocaine in high doses can cause an increase in the level ofmethemoglobin.Surface application of 125 mg of prilocaine lasting 5 hours caused the development of moderate methaemoglobinemia in a 3 month old child. Surface application of lidocaine in a dose of 8.6 - 17.2 mg / kg caused severe intoxication in newborns.TreatmentSevere neurological symptoms (seizures, central nervous system depression) require symptomatic treatment, including the appointment of anticonvulsants and, if necessary, artificial ventilationlungs. In the case of development of methemoglobinemia, the antidote is methylene blue.Due to the slow systemic absorption of the drug, patients should be monitored within a few hours of initiating treatment for intoxication. Interaction:In patients receiving drugs that induce the development of methemoglobinemia (for example, preparations containing a sulfo group), the preparation of EMLA can promote an increase in the concentration of methemoglobin in the blood.When treated with other local anesthetics and structurally similar drugs (including tokaine), the risk of enhancing systemic effects when applying high doses of the drug should be taken into account.Special studies to assess the interaction of lidocaine / prilokain with antiarrhythmic drugs of the III class have not been conducted, caution should be exercised when using drugs together.Drugs that reduce the clearance of lidocaine (for example, cimetidine or beta-blockers) can cause potentially toxic plasma concentrations when repeated high doses of lidocaine are used for an extended period of time. This interaction is not clinically relevant for short-term therapy with lidocaine (eg, the therapeutic system of EMLA) at recommended doses. Special instructions:Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methaemoglobinemia are more at risk of developing drug-dependent methemoglobinemia.Care should be taken when applying the drug near the eyes, because the drug causes eye irritation.Also, loss of protective reflexes can make possible irritation and damage to the cornea. If the product gets into the eyes, immediately flush eyes with water or saline or protect the eyes before restoring the protective reflexes.Care should be taken when applying the drug to the skin with a common neurodermatitis (atopic dermatitis); The time of application should be reduced (15-30 minutes).The effectiveness of the drug in neonates is not established in the procedure for taking blood samples from the heel.In children under 3 months of age, the safety and efficacy of the EMLA drug was determined after a single dose. Such children after the application of the drug often experienced a temporary increase in levels of msthemoglobin in the blood up to 13 hours. However, the observed increase in levels of msthemoglobin in the blood probably does not have clinical significance.Do not apply the drug to open wounds.Lidocaine and prilocaine in concentrations above 0.5-2% have bactericidal and antiviral properties. In this regard, it is recommended to pay special attention to the use of the drug before subcutaneous administration of a live vaccine (for example, BCG).In the absence of data, the combined use of the drug EMLA and drugs that cause methaemoglobinemia is not recommended in children aged 0 to 12 months. Effect on the ability to drive transp. cf. and fur:There was no decrease in the reaction with the use of the drug EMLA. Form release / dosage:Therapeutic system. Packaging:1 therapeutic system in contour non-jammed packaging consisting of protective laminate (plastic / aluminum / plastic laminate) and separating pads (laminated paper). The protective laminate is hermetically connected to the flexible substrate by means of an annular zone around the cellulose disc.For 2 or 20 contour non-jawed packages with instructions for use in a cardboard bundle with the control of the first opening. Storage conditions:At temperatures not higher than 30 ° C, in places inaccessible to children.Do not freeze. Shelf life:2 years. Do not use after the expiry date printed on the package. Terms of leave from pharmacies:Without recipe Registration number:P N011054 Date of registration:29.08.2008 Expiration Date:Unlimited The owner of the registration certificate:AstraZeneca ABAstraZeneca AB Sweden Manufacturer: & nbspRecipharm Karlskoga AB Sweden Representation: & nbspAstraZeneca Pharmaceuticals Ltd.AstraZeneca Pharmaceuticals Ltd. Information update date: & nbsp2016-08-19 Illustrated instructions × Illustrated instructions Instructions