The instruction for medical use of Advantan Torgovoye medicine a name Advantan Mezhdunarodnoye the unlicensed name of Methylprednisolonum atseponat the Dosage form Ointment of 0.1%, 15 g Structure of 100 g of ointment contain active agent – Methylprednisolonum atseponat 0.1 g, excipients: white beeswax, liquid paraffin, Dehymuls E, white soft paraffin, the water purified. The description Opaque ointment from white till yellowish color, can be slightly changed. Pharmacotherapeutic group Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids active (Group III). Methylprednisolonum atseponat. The ATX D07AC14 code the Pharmacological Methylprednisolonum Pharmacokinetics properties atseponat gets into skin from a basis of a dosage form. Its concentration decreases in the direction from a corneal layer to inside layers of skin. Methylprednisolonum atseponat it is hydrolyzed in epidermis and a derma. The main thing and the most active metabolite is 6α-метилпреднизолон-17-пропионат which contacts kortikoidny receptors of skin in comparison with initial drug stronger that indicates existence of its bioactivation in skin. Degree and intensity of transdermal absorption depends on many factors, such as chemical structure of active agent, structure of a basis of a dosage form, concentration of active agent at the heart of a dosage form, conditions when putting drug (the area of drawing, influence duration, on the open site of skin or under an occlusive bandage) and conditions of skin (type and severity of a disease, anatomic localization). The corresponding indicators after open putting Advantan® ointment on 20 g 2 times a day within 8 days were estimated as 0.65% (absorption) and 4 mkg/kg/day (kortikoidny loading). Transdermal absorption of a metiprednizolon of the atseponat through the injured skin during removal of a corneal layer leads to distinct increase in extent of absorption (13-27% of a dose). After hit in a system blood stream the product of primary hydrolysis 6α-метилпреднизолон-17-пропионат is quickly conjugated with glucuronic acid, and thus is inactivated. Atseponat Methylprednisolonum metabolites (from which main thing is 6α-метилпреднизолон-17-пропионат-21-глюкуронид) eliminirutsya, mainly, by kidneys with elimination half-life about 16 hours. After intravenous administration the excretion with urine and a stake came to the end within 7 days. Methylprednisolonum atseponat and its metabolites do not kumulirutsya in an organism. The pharmacodynamics At external use of Advantan® ointment suppresses inflammatory and allergic skin reactions, also as well as the reactions connected with the strengthened proliferation that leads to reduction of objective symptoms (an erythema, hypostasis, infiltration) and subjective feelings (itching, burning, pain). Methylprednisolonum atseponat (especially its main metabolite – 6α-метилпреднизолон-17-пропионат) contacts intracellular glucocorticoid receptors. The steroid-receptor complex contacts certain sites of DNA, thus, causing a series of biological effects. In particular, binding steroid – a receptor complex with DNA leads to macrocortinum synthesis induction. Macrocortinum inhibits release of arachidonic acid and, thereby, formation of mediators of inflammation of type of prostaglandins and leukotrienes. Immunosuppressive action of glucocorticoids can speak an ingibrovaniye of synthesis of cytokines and antimitotic effect which is still studied insufficiently. The inhibition glucocorticoids of synthesis of vazodilatiruyushchy prostaglandins or potentiation of vasoconstrictive effect of adrenaline finally is resulted in vasopressor effect. Indications – endogenous eczema (atopic dermatitis, neurodermatitis) – contact eczema – degenerative eczema – disgidrotichesky eczema – numulyarny eczema (microbic eczema) – eczema of an unknown etiology – eczema at children the Route of administration and doses As a rule, apply drug 1 time a day with a thin layer on affected areas of skin. As a rule, duration of treatment of Advantan® ointment should not exceed 12 weeks for adults. Patients of children’s age Dose adjustment is not required. As a rule, duration of treatment of Advantan® ointment at children should not exceed 4 weeks. Safety of use of Advantan® of ointment for children is younger than 4-month age is not established. Side effects At use of Advantan® of ointment with the largest frequency were observed such side reactions as burning and an itching. Often (& gt, 1/100, & lt, 1/10) – an itching, burning on the site of application of drug Infrequently (& gt, 1/1,000, & lt, 1/100) – an erythema, dryness, vesiculation, irritation, eczema, papules on the site of application of drug, peripheral hypostases – a skin atrophy, an ecchymoma, impetigo, skin oiliness With an unknown frequency – an acne Also as when using other corticosteroids for topical administration, the following local side reactions can be noted: – an atrophy of skin, a striya, a folliculitis on the site of application of drug, a hypertrichosis, telangiectasias, perioral dermatitis, a skin diskoloration, and allergic skin reactions to any of components of a dosage form. System effects of corticosteroids can be observed at their topical administration owing to drug absorption. Contraindications – hypersensitivity to active agent or to any of drug excipients – tubercular or syphilitic processes in the field of putting drug – viral diseases (for example, chicken pox, shingles) in the field of putting drug – a rozatse, perioral dermatitis, ulcers, acne rash, atrophic diseases of skin, vaccine-challenged skin reactions in the field of putting drug Medicinal interactions are not established Special instructions in the presence of a bacterial dermatosis and/or dermatomycoses in addition to therapy of Advantan® by ointment it is necessary to carry out specific antibacterial or anti-mycotic treatment. At use of Advantan® of ointment it is necessary to be careful to avoid hit of drug in eyes, deep open wounds and on mucous membranes. At use of Advantan® of ointment of 0.1% for 60% of a surface of skin within 22 hours under an occlusive bandage, suppression of level of cortisol in blood plasma and influence on a circadian rhythm at adult healthy volunteers was observed. Causing excessively large number of local corticosteroids on the extensive surfaces of skin or for a long time, especially under an occlusive bandage, can increase risk of development of system side effects considerably. It must be kept in mind that diapers can have occlusal effect. As well as at use of system corticosteroids, glaucoma at use of local corticosteroids can develop (for example, after high doses, or at extensive putting drug for a long time, uses of occlusive bandages or putting drug on skin around eyes). Pregnancy and the period of a lactation Adequate data on use of drug during the period the period of pregnancy are absent. As a rule, it is necessary to avoid use of the local drugs containing corticosteroids during the first trimester of pregnancy. In particular, during pregnancy it is necessary to avoid putting drug on the big surfaces of skin, prolonged use or drawing under an occlusive bandage. There are epidemiological data indicating perhaps increased risk of development of not fusion of the sky at newborns whose mothers received treatments by glucocorticoids during the first trimester of pregnancy. At the clinical indication for treatment of Advantan® ointment during pregnancy it is necessary to weigh carefully potential risk and the expected advantage of treatment for mother. It is unknown whether it is allocated Methylprednisolonum atseponat with breast milk as system corticosteroids which as it is reported, can cosecrete with breast milk. It is unknown whether can lead topical administration of Advantan® of ointment to the sufficient system absorption of a metiprednizolon of the atseponat sufficient for its identification in breast milk. Therefore the feeding women should be careful when prescribing drug. At nursing mothers drug cannot be applied on mammary glands. It is necessary to avoid putting drug on the big surfaces of skin, prolonged use or drawing under an occlusive bandage in the period of a lactation. Use in pediatric practice of Advantan® cannot be used under an occlusive bandage. It must be kept in mind that diapers can create occlusal effect. Safety of use of Advantan® of ointment for children is younger than 4-month age is not established. Careful assessment risk advantage is necessary at use of Advantan® of ointment for children from 4-month age to 3 years. Features of influence of medicine on ability to drive the car or potentially dangerous mechanisms. The Overdose When studying acute toxicity of drug does not influence any risk of acute intoxication at excessive single skin use was not revealed (putting drug on the big square under the conditions favorable for absorption) or inadvertent intake. The form of release and packing On 15 g of ointment place in tubas aluminum with aluminum membranes and the wound plastic covers. 1 tuba together with the instruction for medical use in the state and Russian languages is put in a cardboard pack. To Store storage conditions at a temperature not over 25 ºС. To store out of children’s reach! A period of storage 3 years not to use drug after the expiration date specified on packing. Prescription status According to the prescription the Producer/packer Bayer Helsker Manufacturing of Neuter of l., Segreyt, Italy the Holder of the registration certificate of Bayer Pharm AG, Berlin, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of a product (goods): TOO Bayer KAZ Timiryazev St., 42, business center Expo-City, peahens. 15 050057 Almaty, Republic of Kazakhstan
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