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Dayvobet® 30g ointment tube (external application)




The instruction for medical use of DAYVOBET® medicine the Trade name of Dayvobet® the International unlicensed name Is not present the Dosage form Ointment for external use of 30 g Structure 1 g of ointment contains active agents: a kaltsipotriola monohydrate of 0.052 mg (it is equivalent to a kaltsipotriol of 0.050 mg) betamethasone Dipropionas of 0.643 mg (it is equivalent to betamethasone of 0.500 mg) excipients: liquid paraffin *, polypropylene glycol stearate **, alpha tocopherol, paraffin white soft * – contains 10 ppm of alpha tocopherol ** – the Description Ointment from white till yellow color Pharmacotherapeutic group Drugs for treatment of psoriasis contains 0.1% of butyl hydroxytoluene (E321). Drugs for treatment of psoriasis for topical administration. Other drugs for treatment of psoriasis for topical administration. Kaltsipotriol, combinations. The ATX D05AX52 code the Pharmacological Pharmacokinetics System Absorption properties of a kaltsipotriol and betamethasone makes less than 1% of a dose within 12 hours when drawing on the uninjured skin. When putting drug on psoriasis plaques and under occlusive bandages the absorption of a topical corticosteroid increases. Absorption through the injured skin makes about 24%. After system influence both active ingredients – kaltsipotriol and betamethasone Dipropionas – is metabolized quickly and intensively. Linking with proteins of plasma makes about 64%. Plasma elimination half-life after intravenous administration makes 5-6 hours. Thanks to formation of depot in skin, removal after drawing on skin happens within several days. Betamethasone is metabolized generally in a liver and also in kidneys with formation of glucuronides and sulphatic ethers. The main way of removal of a kaltsipotriol through intestines, and Dipropionas betamethasone – with urine. The pharmacodynamics Kaltsipotriol represents a vitamin D analog. These in vitro show what kaltsipotriol induces differentiation and suppresses proliferation of keratinotsit. It is an expected basis of its effect in psoriasis. As well as other topical corticosteroids, betamethasone Dipropionas has anti-inflammatory, antipruritic and immunosuppressive properties, however, does not cure a basic disease. At occlusion this effect can be enhanced thanks to the raised penetration through a corneal layer. Because of this effect the frequency of side effects can increase. In general, the mechanism of anti-inflammatory effect of topical steroids is up to the end not clear. Indications – topical treatment of chronic vulgar blyashechny psoriasis at adults the Route of administration and дозыДайвобет® it is necessary to apply ointment on an affected area once a day. The maximum daily dose should not exceed 15 g. For achievement of optimum effect, it is not recommended to take a shower or a bath right after ointment use. The recommended duration of treatment is 4 weeks. Then Dayvobet® can be applied repeatedly under observation of the doctor. The processed site should not exceed more than 30% of a body surface. Side effects are listed below the observed side reactions with a frequency of their occurrence: very often (³ 1/10), it is frequent (from ³ 1/100 to & lt, 1/10), infrequently (from ³ 1/1000 to & lt, 1/100), is rare (from ³ 1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000), it is unknown (it is impossible to estimate on the available data). Often – an itching, rash, burning sensation of skin Infrequently – exacerbation of psoriasis, pain or irritation of skin, dermatitis, an erythema, a folliculitis, disturbance of pigmentation on the place of applique of ointment Is rare – pustulous psoriasis it is not known – converse effect Kaltsipotriol can cause also xeroderma, eczema, a photosensitization and reactions of hypersensitivity including very exceptional cases of a Quincke’s disease and face edema. After topical administration there can be system reactions which are extremely seldom leading to a hypercalcemia or a hypercalcuria. Connect development of an atrophy of skin, telangiectasias, striya, a folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, a depigmentation, colloidal degeneration of skin with prolonged topical use of betamethasone (Dipropionas). System effects at local use of corticosteroids rare, but sometimes heavy, can arise at prolonged use, at use on big surfaces and when using occlusive bandages: – suppression of function of bark of adrenal glands, cataract, infections, impact on metabolic control of diabetes, increase in intraocular pressure. Contraindications – hypersensitivity to any of drug components – a psoriasis erythrosis, exfoliative, pustulous psoriasis – the diseases which are followed by calcium metabolism disturbance – virus damages of skin (including herpes or chicken pox), fungal, bacterial and parasitic infections of skin, skin manifestations of tuberculosis and syphilis, perioral dermatitis, a skin atrophy, atrofichny striya, the increased fragility of vessels of skin, an ichthyosis, vulgar eels, pink eels, a rozatsea, ulcers, wounds, a perianal and genital itching. Medicinal interactions of the Research on medicinal interactions were not carried out. The special instructions Influence on endocrine системуДайвобет® ointment contains powerful group steroid III and therefore it is necessary to avoid simultaneous use with other steroids. Side reactions such as suppression of function of bark of adrenal glands or influence on metabolic control over diabetes which arise during system treatment by corticosteroids can also arise at topical administration of corticosteroids owing to system absorption. It is necessary to avoid use of occlusive bandages as it increases system absorption of corticosteroids. It is also necessary to avoid putting ointment on big sites of the injured skin, under occlusive bandages, on mucous membranes or in skin folds as it increases system absorption of corticosteroids. Influence on metabolism of calcium Because of existence in structure of a kaltsipotriol, the hypercalcemia when exceeding the maximum day dose (15 g) can develop. However, serum calcium quickly returns to normal values after the treatment termination. The risk of a hypercalcemia is minimum at observance of the recommendations concerning a kaltsipotriol. It is necessary to avoid processing of more than 30% of surface area of a body Local collateral persons of a reaktsiikozh and genitals are very sensitive to corticosteroids. Therefore it is not necessary to apply Dayvobet® on these areas. The patient has to be instructed rather correct use of Dayvobet® to avoid drawing and accidental hit of ointment on a face, a mouth and eyes. It is necessary to wash hands after each use of drug to avoid its accidental hit on these areas. The accompanying skin infections At again infected skin damages it is necessary to connect antimicrobic therapy. However, if there is an aggravation of an infection, then it is necessary to stop treatment by corticosteroids. The termination of treatment At the termination of treatment of psoriasis local corticosteroids, exists risk of developing generalized pustulous psoriasis or converse effect. Therefore after treatment it is necessary to continue observation at the expert. Long primeneniyepr long use there is a risk of emergence of local or system side effects of corticosteroids. Treatment needs to be stopped in case of the side effects connected with long use of corticosteroids Unvalued treatment there Is no experience of use of Dayvobet of ointment in tear-shaped psoriasis. Joint treatment and UF-radiation does not exist experience of use of this medicine on head skin. By Dayvobet ointment for psoriasis on other parts of the body it was used in combination with Dayvobet gel for head skin psoriasis, but there is no experience of a combination of Dayvobet to other relevant anti-psoriasis products on the same area of treatment, other anti-psoriasis medicines were entered systemically or with phototherapy. During Dayvobet’s treatment by ointment, doctors have to advise patients to limit or avoid excess impact of natural or artificial sunlight. Topical treatment kaltsipotrioly together with Ural federal district is carried out only if the doctor and the patient consider that the possible advantage exceeds potential risks. Adverse reactions on auxiliary веществаДайвобет® ointment contains butyl hydroxytoluene (E321) which can cause local skin reactions (for example, contact dermatitis), or irritation of eyes and mucous membranes. Use for children Efficiency and safety of use of the drug Dayvobet® for children is younger than 18 years is not established. Therefore concerning a dosage of this drug at children 18 years are younger than any recommendations is not present. Pregnancy and the period of a lactation Safety of use of the drug Dayvobet® at pregnancy is not established therefore drug can be used only when, according to the doctor, the advantage exceeds risk for a fruit. Betamethasone gets into breast milk, but the risk of an adverse effect on the child is improbable at use of drug in therapeutic doses. There are no data on penetration of a kaltsipotriol into breast milk. It is necessary to be careful when prescribing Dayvobet® ointment to women during feeding by a breast. It is necessary to instruct the patient that it is not recommended to apply ointment on a breast. Has no feature of influence of drug on ability to run the vehicle or potentially dangerous Dayvobet® mechanisms or has insignificant impact on ability of driving and use of cars. Overdose Symptoms: increase in content of calcium in blood, suppression of function of a gipofizarnonadpochechnikovy system with development of secondary adrenal insufficiency. Treatment: to cancel drug and to carry out symptomatic therapy. In cases of chronic toxicity the glucocorticosteroids should be cancelled gradually. The form of release and packing On 30 g of drug place in tubas aluminum/epoxyphenolic with the polyethylene screwing-up cap. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! A period of storage 2 years After opening – 12 months. Not to use drug after expiry date Prescription status According to the prescription of Proizvoditel LEO Leboratoris Limited, Dublin, Ireland, the Name and the country of the owner of the registration certificate of LEO Pharmaceutical Products Ltd. A/S (LEO of Pharm And / C), Ballerup, Denmark the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): “Takeda Osteuropa Holding GmbH” (Austria) in Kazakhstan Almaty, Begalin St. 136 “and”
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