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Description
The instruction for medical use of Novosalik Torgovoye medicine a name Novosalik Mezhdunarodnoye the unlicensed name Is not present the Dosage form Ointment of 30 g Structure One gram of drug contains active agents: betamethasone of Dipropionas of 0.643 mg in terms of betamethasone of 0.500 mg, salicylic acid of 30.000 mg, excipients: paraffin white soft, liquid paraffin, isopropyl myristate, wax white. Description Homogeneous ointment of white color. Pharmacotherapeutic group Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids in a combination with other drugs. Corticosteroids strong in a combination with other drugs. Betamethasone in a combination with other drugs. The ATX D07XC01 code the Pharmacological Pharmacokinetics On properties absorption of betamethasone at topical administration influence many factors, including a condition of epidermis and also existence of occlusion. Inflammations of the skin can strengthen absorption, as well as use of occlusive bandages. System absorption after topical administration is 12-14%. About 64% of betamethasone reversibly contact proteins of plasma, and the volume of distribution is 1.4 l/kg. Betamethasone is metabolized in a liver, metabolites are removed, first of all, through bile, and their smaller part is removed through urine (about 5%). Salicylic acid at topical administration under occlusion reaches the highest concentration in plasma in 5 hours. The most part from total amount of the absorbed salicylic acid is removed in the form of metabolites, about 6% are removed through urine in not changed look. A pharmacodynamics Novosalik – a combination of a strong glucocorticosteroid, betamethasone and salicylic acid. Novosalik possesses anti-inflammatory, antipruritic, anti-proliferative, keratolytic and antimicrobic actions. Betamethasone possesses anti-inflammatory, antiallergic, anti-proliferative and antipruritic actions. When drawing, betamethasone has fast and strong effect in the inflammation center on the surface of skin, reducing expressiveness of objective symptoms (erythema, hypostasis, lichenification) and subjective feelings (itching, irritation, pain). Salicylic acid due to keratolytic action cleans sites of defeat from scales, promotes penetration of betamethasone into skin, supports acidic environment of skin, preventing development of a bacterial and fungal infection. Indications – psoriasis, eczema (especially chronic), an ichthyosis, atopic dermatitis, diffusion neurodermatitis – simple and allergic dermatitis – idle time chronic deprive (limited neurodermatitis) – a subacute and chronic dermatosis with a hyperkeratosis (including of hairy sites of skin): psoriasis, acute and chronic eczema, neurodermatitis, (especially red warty deprive), red flat deprive, a dyshydrosis, seborrheal dermatitis, an ichthyosis and other ichthyotic defeats, seborrhea of hairy sites of skin the Route of administration and doses Only for external use. Novosalik ointment is applied twice a day. A small amount of ointment is evenly distributed on affected areas of skin by 2 times a day. Some patients have a possible achievement of satisfactory effect even at less frequent use of drug. Duration of treatment is defined by expressiveness of inflammatory process, the termination of an itching, clarification of integuments, but should not exceed 14 days at adults and 5 days at children. The maximum week dose should not exceed 60 g. Side effects – burning, an itching, irritation, dryness, a folliculitis, a hypertrichosis, acneform rashes, hypopigmentation, perioral dermatitis – allergic contact dermatitis – maceration of skin, consecutive infection, an atrophy of skin, a striya, a heat rash (at use of occlusive bandages) – a growth inhibition, an Icenco-Cushing syndrome, benign increase in intracranial pressure after the end of treatment, a hyperglycemia, a glucosuria, a hypopotassemia, increase in the ABP (system manifestations of side effects of betamethasone of Dipropionas when drawing on big surfaces) – pallor, increased fatigue, drowsiness, a hyperventilation against the background of a tachypnea, nausea, vomiting, a hearing disorder, confusion of consciousness (system manifestations of side effects of salicylates when drawing on big surfaces) Contraindications – hypersensitivity to drug components – children’s age up to one year – bacterial, viral and fungus skin diseases (a pyoderma, syphilis, a tuberculosis cutis, chicken pox, herpes, actinomycosis, a zymonematosis, a sporotrichosis) – vaccine-challenged skin reactions – perioral dermatitis, a rozatse, trophic ulcers against the background of chronic venous insufficiency – skin tumors (carcinoma cutaneum, a nevus, an atheroma, an epithelioma, a melanoma, a hemangioma, a xanthoma, sarcoma) – a liver failure Medicinal interactions clinically reliable interactions with other medicines are noted. Simultaneous use of cosmetic and dermatological means for therapy of an acne, the means containing ethanol or medical soap with expressed the drying effect, etc., can in certain cases, cause irritation of skin. Special instructions of Novosalik ointment is intended only for external use on skin and/or a hairy part of the head. It is necessary to avoid hit in eyes and on mucous membranes. Prolonged use of ointment on face skin in connection with possible development of dermatitis as a rozatse, perioral dermatitis, an atrophy of skin and an acne is not recommended. It is necessary to avoid use of drug in anogenitalny area. Use of drug under an occlusive bandage, except for cases is not recommended, when necessary. At development of fungal or bacterial microflora on skin, additional use of antibacterial or antifungal agent is necessary. Pregnancy and the period of a lactation Topical administration of the drug Novosalik at pregnant women is allowed when the expected advantage for mother exceeds risk for a fruit. In such cases the use of drug has to be short and be limited to small sites of integuments. During breastfeeding the use of the drug Novosalik is possible according to strict indications, but at the same time drug cannot be applied to skin of a mammary gland before feeding. Use in pediatrics drug Novosalik Use (ointments for external use) at children has to be, as less as possible long at observance of strict measures of precaution as children have a danger of system absorption in proportion of bigger amount of active components because of prevalence of the area of integuments over the weight of body and an insufficient maturity of epidermis. It is not necessary to use drug at children under bandages and especially under the plasticized diapers that can increase risk of development of the undesirable phenomena, such as function oppression gipotalamo – a hypophysial and adrenal system, Cushing’s syndrome, a linear growth inhibition, lag in a weight increase, increase in intracranial pressure. Manifestation of adrenal suppression at children: low level of cortisol of blood plasma and lack of the response to stimulation of AKTG. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. Data on an adverse effect of the drug Novosalik on ability to run vehicles and mechanisms are not available. Overdose At long continuous use of the drug Novosalik, especially for children, on the extensive surfaces of skin, when drawing on skin with the broken integrity or when using under an occlusive bandage, the strengthened absorption of active components and manifestation of system effects is not excluded: namely Icenco-Cushing syndrome, benign increase in intracranial pressure, development of secondary insufficiency of adrenal glands or salicylates: pallor, fatigue, drowsiness, other symptoms of a salitsilizm. Treatment: in this case drug withdrawal and symptomatic therapy is recommended. The form of release and packing On 30 g of drug place in an aluminum tuba with a white polyethylene cover. 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 in the dry and protected from light place at a temperature not above 25 °C. To store out of children’s reach! 3 years not to use a period of storage after an expiration date. Prescription status According to the prescription the Producer Replek of Pharmaceutical Ltd., Skopje, the Republic of Macedonia the Name and the country of the owner of the registration certificate of Vegapharm LLP., London, Great Britain the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine: Cepheus Medical LLP (Tsefey Medikal): 050000, RK, Almaty, Panfilov St. 98, BC OLD SQUARE, office 807
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