The instruction for medical use of Afloderm Torgovoye medicine a name Afloderm Mezhdunarodnoye the unlicensed name Alklometazon Lekarstvennaya a form external use Cream, 0.05% Structure of 1 g of cream contains active agent: an alklometazona Dipropionas micronized – 0.500 mg, excipients: propylene glycol, chlorocresol, dihydrophosphate sodium a dihydrate, phosphoric acid, white soft paraffin, a macrogoal tsetostearat, cetostearyl alcohol, glyceryl PEG-100 stearate stearate, sodium hydroxide, water purified. Description Uniform cream of white color. Pharmacotherapeutic group Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids with moderate activity. Alklometazon. The ATX D07AB10 code the Pharmacological Pharmacokinetics Not properties it is applicable taking into account local action and drawing. Alklometazon’s pharmacodynamics Dipropionas – moderately strong not fluorinated synthetic corticosteroid for topical administration on skin. Renders anti-inflammatory, immunosuppressive, vasoconstrictive and anti-proliferative action. Indications Treatment of the dermatosis reacting to topical administration of corticosteroids. The route of administration and doses apply Cream with a thin layer on the struck surface 2-3 times a day, accurately rubbing before full absorption. Because of a bigger surface of integuments in comparison with the weight of body and insufficiently developed corneal layer of skin at children perhaps absorption is proportional bigger quantity of an alklometazon of Dipropionas and emergence of system toxicity. For this reason drug is appointed with bigger care, to the smallest possible term. Side effects By-effects at topical administration of an alklometazon of Dipropionas develop seldom and have reversible character. The most often found by-effects: itching, burning, reddening, xeroderma, irritation, papular rash. Local by-effects most often arise at use of drug with an occlusive bandage, such as, a folliculitis, a hypertrichosis, skin changes in a type of an acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, a skin atrophy, consecutive infections of skin, a striya and a heat rash. At prolonged use there can be a local atrophy of skin, a striya and superficial expansion of blood vessels, especially on a face. Contraindications Hypersensitivity to an alklometazon to Dipropionas or to other components of drug, a rozatse, an acne and perioral dermatitis, viral infections of skin, in particular, the infections caused by a herpes simplex virus, a vaccinia, chicken pox, fungal and bacterial infections of skin. Medicinal interactions of Interaction with other medicines are unknown. Special instructions long-term use of an alklometazon of Dipropionas on extensive sites of skin, especially with an occlusive bandage as it can cause the increased absorption and emergence of system by-effects is not recommended. Dipropionas under diapers at children as in this case diapers have the effect similar to action of an occlusive bandage is not recommended to apply an alklometazon, increasing system absorption of active agent of cream. If use of an alklometazon of Dipropionas causes reaction of hypersensitivity on skin, it is necessary to stop drug use. Patients who have an increased probability of emergence of system by-effects at use of an alklometazon of Dipropionas (children, patients with reduced function of a liver and also patients who need long-term treatment), periodically have to pass test for function control gipotalamo – a hypophysial and adrenal system (the test for free cortisol in urine and the test of stimulation of AKTG). If symptoms of suppression of the mentioned system are established, it is necessary to stop use of drug or to reduce the frequency of its use. Alklometazon Dipropionas in the form of cream cannot be applied on eyes and in eyes because of possible appearance of glaucoma or a cataract. At appearance of consecutive bacterial or fungal infection of skin it is necessary to stop topical administration of an alklometazon of Dipropionas and to begin to use antibacterial or anti-mycotic drug. Some sites of skin (inguinal area, armpits, perianal area) where there is natural occlusion, are more subject to formation of striya at topical treatment of an alklometazon Dipropionas. Use of an alklometazon of Dipropionas on such sites has to be limited. Pregnancy As safety of use of corticosteroids for pregnant women is not established, use of drug is possible only if the expected advantage for the woman exceeds potential risk for a fruit. In such cases drug has to be used quickly and on the small site of skin. A lactation It is unknown whether system absorption can cause topical administration of corticosteroids therefore use of drug for nursing mothers is possible only after assessment advantage/risk. Features of influence of drug on ability to run motor transport and potentially dangerous mechanisms it is not applicable Overdose Symptoms At topical administration of an alklometazon of Dipropionas on the extensive surfaces of the injured skin with bigger permeability, with use of an occlusive bandage, and at long use the absorption in a system blood stream and emergence of system by-effects, such as hyperglycemia, glycosuria, function suppression gipotalamo – a hypophysial and adrenal system with a growth inhibition, increase in intracranial pressure at children and Cushing’s syndrome is possible. Treatment in case of overdose it is necessary to stop drug use. The corresponding symptomatic treatment is shown. Symptoms usually have reversible character and disappear after drug phase-out. Seldom or never there can be symptoms of an abstinent state (heat, myalgia, an arthralgia, weakness). In that case it is necessary to carry out system replacement therapy by corticosteroids. Drug contains a small amount of a corticosteroid therefore there is no danger of negative effect of drug at its accidental ingestion. The form of release and packing On 20 g or 40 g of drug place in a tuba aluminum with a membrane, with internal varnish coating, closed a polyethylene cap with a pin for piercing of a membrane. On 1 tuba together with the instruction for use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not higher than 25 wasps. 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 BELUPO Producer, drugs and cosmetics of of, the Republic of Croatia, 48000, Mr. Koprivnitsa, Danits St., 5. The owner of the registration certificate of BELUPO, medicine and cosmetics of of, the Republic of Croatia the Address of the organization accepting in the territory of the Republic of Kazakhstan claims of consumers on quality of products (goods): Representative office BELUPO, drugs and cosmetics of of in Republic of Kazakhstan Almaty, Zheltoksan St., 87, office 24, 25, 26.
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