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Derilayf 0.05g of 50% cream in the tube




The instruction for medical use of DERILAYF medicine the Trade name Derilife Mezhdunarodnoye the unlicensed name Klobetazol Lekarstvennaya a form Cream of 0.05% Structure of 1 g of cream contains active agent – a klobetazol propionate of 0.5 mg, excipients: paraffin, propylene glycol, chlorocresol, tsetomakrogol, polioksit 40 hydrogenated castor oil (makrogolglitserol hydroxystearate), polioksit the 15th hydroxystearate, cetostearyl alcohol, the water purified. Description Uniform cream of white or almost white color. The pharmacotherapeutic Glucocorticosteroid group for topical administration. Glucocorticosteroids moderate activity. Klobetazol. The ATX D07AB01 code the Pharmacological Pharmacokinetics Average Maximum Concentration properties of a klobetazol of propionate (0.63 ng/ml) is reached in plasma in 13 hours after the first applique and in 10 hours after repeated drawing on healthy skin of 30 g of a klobetazol of propionate. System metabolism of a klobetazol of propionate after transdermal absorption was not studied. A pharmacodynamics Derilife – a glucocorticosteroid for external use. Klobetazola propionate possesses anti-inflammatory, antipruritic and vasoconstrictive action. Various mechanisms directed to suppression of products of various factors participating in inflammation are the cornerstone of anti-inflammatory action of glucocorticoids. Discharge of vasoactive substances and chemoattractants, secretion of lipases and proteases, movement of leukocytes from vessels in the inflammation centers, deduction of leukocytes in the centers of inflammation and fibrosis decreases. Due to induction of lipokortin the glucocorticoids inhibit the release of arachidonic acid mediated by a phospholipase A2, suppressing thereby development of its derivatives, highly active mediators of inflammation (prostaglandins and leukotrienes). Glucocorticoids suppress synthesis and secretion of cytokines (IL-1, IL-6, a TNF alpha, etc.) – the alarm molecules providing interaction of monocytes, macrophages, T – and V-lymphocytes in the immune response. Glucocorticoids suppress protein synthesis of a sharp phase of inflammation, including C3 complement component. When drawing, propionate has fast and strong effect in the inflammation center on the surface of skin of a klobetazol, reducing expressiveness of objective symptoms (erythema, hypostasis, lichenification) and subjective feelings (itching, irritation, pain). Klobetazola propionate treats highly active glucocorticoids for topical administration. Indications – psoriasis – eczema (various forms) – red flat deprive – a diskoidny lupus erythematosus – the skin diseases resistant to therapy of less active glucocorticosteroids for topical administration. Drug is recommended to be used at the damages of skin which are followed moknutiy and the significant inflammation. The route of administration and doses Derilife Cream is used outwardly. Cream is recommended to be used for treatment of the damp and becoming wet sites of skin. Adult and elderly patients. Cream is applied with a thin layer in the quantity sufficient for a covering of all struck area, one or twice a day, and carefully rubbed before improvements (in case of more serious conditions the use can continue within several days), then it is recommended to reduce the frequency of drawing or to switch to less active drug. After each putting drug before use of any other emollient it is necessary to allow cream to be absorbed. As well as at use of other highly active glucocorticosteroids (GKS), after achievement of control of a disease the treatment should be stopped. Improvement in the treatment outcome occurs individually, at patients who well perceive treatment, the result can appear for several days. For prevention of exacerbation of a disease it is possible to conduct repeated short courses of treatment of a klobetazol propionate. At permanent damages of skin, especially in case of a hyperkeratosis, anti-inflammatory effect of the drug Derilife can be strengthened by use of an occlusive bandage (imposing of a bandage for the night can be rather effective). When changing an occlusive bandage the skin needs to be cleaned. Further the reached effect is maintained by usual putting drug on skin without use of an occlusive bandage. Esli improvement of a state did not occur within 2 – 4 weeks, it is necessary to specify or revise the diagnosis. It is not necessary to continue treatment more than 4 weeks. Esli is required long-term treatment, it is necessary to use other, less strong drugs. The maximum week dose should not exceed 50 g a week. Treatment klobetazoly should be cancelled gradually, at once after achievement of control over a disease, and use of any other emollient has to be continued as maintenance therapy. Sudden cancellation of a klobetazol can lead to a recurrence of earlier being available dermatosis. The dermatosis which is difficult responding to treatment Patients with a frequent recurrence of a disease At achievement of effect of treatment of an acute disease, thanks to a continuous course of use of corticosteroids for external use, the possibility of its faltering use can be considered (once a day, two times a week, without occlusive bandage). It is known that such treatment effectively reduces the frequency of development of a recurrence. It is necessary to continue putting drug on all earlier affected areas of skin or on the known areas of potential aggravation. Such scheme of use has to be combined with regular daily use of any, other emollient. It is necessary to carry out the regular assessment of a state and also advantage and risk of treatment continuation. Drawing on the person Esli is possible, courses of treatment should be limited up to five days, at the same time it is not recommended to use occlusive bandages. Elderly patients Clinical trials did not reveal any differences in efficiency of drug at elderly and younger patients. The big prevalence of reduced function of a liver or kidneys at patients of advanced age can lead to delay of removal of drug in case of its system absorption. Therefore, it has to be applied in the minimum quantity and during the minimum possible period to achievement of necessary clinical effect. A renal failure / liver in case of system absorption of drug (when drawing on the extensive surfaces of skin during the long period) his metabolism and removal can slow down, resulting in the increased risk of development of system toxicity. Therefore, it has to be applied in the minimum quantity and during the minimum possible period to achievement of necessary clinical effect. Patients need to recommend to wash hands after use of a klobetazol of propionate if only drug is not appointed for treatment of hands. Side effects the Undesirable phenomena are listed below depending on a system and organ class and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥1/10), it is frequent (≥1/100 and & lt, 1/10), infrequently (≥1/1,000 and & lt, 1/100), is rare (≥1/10,000 and & lt, 1/1,000) and is very rare (& lt, 1/10,000), including separate cases. Data of post-marketing use Infectious and parasitic diseases Very seldom – opportunistic infections of Disturbance from the immune system Very seldom – hypersensitivity – generalized rash of Disturbance from an endocrine system Very seldom – oppression gipotalamo – a hypophysial and adrenal system – signs of the Cushingoid or a hypercorticoidism: (for example, a crescent-shaped face, obesity on the central type), an increase delay a body weight / growth inhibition at children, osteoporosis, glaucoma, a hyperglycemia/glucosuria, a cataract, a hypertension, increase in weight body/obesity, decrease in levels of endogenous cortisol, an alopecia, fragility of hair. Disturbances from skin and hypodermic fabrics Often – an itching, the local burning sensation / morbidity in the site of application Infrequently – a local atrophy of skin * – warts * – teleangiectasias * Is very rare – thinning of skin * (at long and intensive treatment) – rugosity of skin *, xeroderma * – pigmentation change *, a hypertrichosis – aggravation of symptoms of a disease – dermatitis – pustulous psoriasis – an erythema, rash, an itching, urticaria, allergic contact dermatitis / dermatitis – the acne (acne rash) At emergence of signs of hypersensitivity use of drug should be stopped. Long-term and intensive treatment by highly active GKS can cause atrophic changes, such as striya and thinning of skin. In rare instances treatment of psoriasis of GKS (or its termination) can provoke a pustulous form of a disease. Long-term and intensive treatment by highly active GKS can lead to expansion of superficial blood vessels, especially during the using of hermetic bandages or rubbing in of drug in skin folds. Complications of the general character and reaction in the site of application It is very rare – the irritation and/or morbidity in the site of application * Skin manifestations are secondary in relation to local and/or system effects of oppression gipotalamo – a hypophysial and adrenal system. Providing data on undesirable side reactions of drug is very important point allowing to carry out continuous monitoring of a ratio risk/advantage of medicine. Health workers should provide information on any expected adverse reactions on the contacts specified at the end of the instruction and also through the national system of collection of information. Contraindications – hypersensitivity to drug components – infectious diseases of skin – pink and youthful eels (acne vulgaris) – a carcinoma cutaneum – nodal a prurigo of the Guide – perioral dermatitis – a perianal and genital itching – bacterial, viral and fungus diseases of skin (a herpes simplex, chicken pox, a tuberculosis cutis, actinomycosis, etc.) – widespread blyashechny and pustulous psoriasis – children’s and teenage age up to 18 years (there are no data on safety and efficiency) – the lactation period. Medicinal interactions Are not present data on interaction with other medicines. It is known that combined use of drugs which can inhibit CYP3A4 (for example, ritonavir and itrakonazol) oppresses metabolism of corticosteroids that leads to increase in system influence. Degree in which this interaction is clinically significant depends on a dose and a route of administration of corticosteroids and activity of CYP3A4 inhibitor. Special instructions Klobetazol should be applied with care at patients with existence in the anamnesis of local hypersensitivity to other corticosteroids or to any of excipients as a part of drug. Local reactions of hypersensitivity can have similarity to symptoms of the proceeding disease. Derilife cream contains propylene glycol which can cause irritation of skin, cytostearyl alcohol which can cause local, skin reactions (including contact dermatitis), chlorocresol which can cause allergic reactions. Some persons as a result of the increased system absorption of local steroids can have manifestations of a hypercorticoidism (Cushing’s syndrome) and reversible oppression gipotalamo – a hypophysial and adrenal system, leading to glucocorticosteroid insufficiency. In case of any of the above-stated manifestations, drug should be cancelled, gradually reducing the frequency of its drawing, or to replace it with less active corticosteroid. The sudden termination of treatment can lead to development of glucocorticosteroid insufficiency. The following belongs to risk factors of strengthening of system effects: – activity and a dosage form of topical steroid – use duration – putting drug on extensive sites of skin – use on the closed areas of skin (i.e. in intertriginozny zones or under occlusive bandages) – the increased hydration of a corneal layer of skin – use in areas with thin skin, such as person – drawing on the injured skin or at other states which can be followed by disturbance of integrity of a skin barrier – in comparison with adults at children can be noted bigger percent of absorption of corticosteroids for external use in this connection this category of patients is more subject to risk of development of system side effects. It is caused by the fact that children have an unripe skin barrier and bigger value of the relation of surface area of a body to body weight in comparison with adults. Risk of developing an infection at use of occlusive bandages the Warm damp conditions in skin folds and also created when imposing an occlusive bandage promote developing of a bacterial infection. Therefore when using occlusive bandages before imposing of a new bandage it is necessary to clean skin carefully. Use in psoriasis For treatment of psoriasis corticosteroids for external use should be used with care since it was in certain cases reported about resuming of symptoms of a disease, development of stability to drug, risk of a generalized pustulous form of psoriasis and development of local or general toxicity because of disturbance of barrier function of skin. At treatment of psoriasis the attentive observation of the patient is important. The accompanying infection At accession of consecutive infection it is necessary to carry out the corresponding antibacterial therapy. At any signs of spread of an infection it is necessary to stop use of corticosteroids for external use and to carry out the corresponding treatment by antibacterial drugs. Before use of hermetic bandages it is necessary to clean skin as heat and humidity which are formed under a bandage promote developing of a bacterial infection. Chronic ulcers of shins Corticosteroids for external use are sometimes used for treatment of the dermatitis arising around chronic ulcers of shins. However such use can be followed the hypersensitivity increased by the frequency of emergence of local reactions and the increased risk of developing local infections. Drawing on the person Drawing on face skin is undesirable since this area is more subject to development of atrophic changes. In case of drawing on face skin the treatment should be limited for 5 days. Drawing on eyelids Putting drug on eyelids is undesirable. When drawing on eyelids it is necessary to watch that drug did not get into eyes because repeated influence of drug can cause a cataract and glaucoma. At hit of drug in eyes, it is necessary to wash out a large amount of water. Fertility of the corticosteroids Given about influence for external use on reproductive function there are no people. Pregnancy Data on use of a klobetazol at pregnant women are limited. Topical administration of corticosteroids can cause anomalies of fetation in pregnant animals, including sky crevices (wolf mouth), a delay of pre-natal development. The value of these results for people is not defined. Klobetazol it is necessary to apply during pregnancy only if the potential advantage for mother exceeds risk for a fruit. It is necessary to use the minimum quantity during minimum possible period. The lactation period Safety of use of corticosteroids for external use in the period of a lactation is not established. It is unknown whether leads topical administration of corticosteroids to sufficient system absorption for discharge of noticeable quantity with maternal milk. Klobetazol it is necessary to apply during breastfeeding only if the potential advantage for mother exceeds risk for the baby. If klobetazol it is used during a lactation, it should not be applied on area of a breast in order to avoid accidental ingestion by the baby. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of Researches on studying influence of a klobetazol on ability to run vehicles or to work with mechanisms it was not carried out. Proceeding from a profile of side reactions of a klobetazol for external use, any adverse influence on such types of activity it is not expected. Overdose Development of acute overdose is improbable. However in case of chronic overdose or the wrong use, hypercorticoidism symptoms can develop that demands gradual cancellation
to an arat pra under observation of the doctor. Treatment in case of overdose, klobetazol it has to be cancelled gradually, reducing the frequency of use or by replacement with less strong corticosteroid, in connection with risk of development of glucocorticosteroid insufficiency. The form of release and packing On 50 g of drug place in tubas aluminum, sealed by membranes and closed by the screw-on plastic covers. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer/owner of the registration certificate “Uorld Meditsin Ilach Sang. ve Tidzh. A.Sh.”, Turkey (Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1B Zemin 4-5-6, Istanbul, Turkey) “World Medicine İlaç San. ve Tic. A.Ş.”, Turkey (Bağcılar İlçesi, Güneşli, Evren Mahallesi, Cami Yolu Cad. No: 50 K. 1B of Zemin 4-5-6, İstanbul, Turkey) the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products Republic of Kazakhstan, Almaty, Turksibsky district, Suyunbaya Ave., 222 Ph. / fax: 8 (7272) 529090, the Address of the organization responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP, Almaty, Suyunbaya Ave., 222 Cellular ph. +7 701 786 33 98 (24-hour access). e-mail:
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