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FlutivateFLUTIVATEComposition: Each g of Flutivate Cream 0,05% contains: Propionato de Fluticasona 500 mcg (micronizado). Pharmaceutical form: cream. Indications: Treatment of inflammatory dermatosis: Flutivate Cream is indicated for greater young adults and of 3 months of age, for the lightening of inflammatory and pruríticas manifestations in sensible dermatosis to corticosteroides like: eccema, including eccemas atópico, infantile, and discoideo; prurigo to nodular; psoriasis (excluding psoriasis scattered in plate); neurodermatosis including simple lichen; flat lichen; seborréica dermatitis; contact dermatitis; discoide erythematous lupus; coadyuvantte to the therapy with sistémicos corticosteroides in eritoderma generalized; reactions by punctures of insects. Reduction of recurrence risk: Flutivate Cream is indicated for the reduction of the risk of recurrence of eczema atópico chronic once the acute episode has been treated indeed. Warning: the security of use of the product has not settled down, to the being applied daily by more than 4 weeks. Dosage: Treatment of inflammatory dermatosis: for adults and children on 3 months of age, to apply to a thin layer of Flutivate Cream in the areas affected of skin 1 or 2 times to the day (to see Warnings). Reduction of the recurrence risk: once an acute episode has been treated in effective form, the frequency of the application had to be reduced to a daily application, 2 times per week, without occlusion. The application had to be continued in all the areas previously affected or sites known potential recurrence. This regime must be combined with the daily emollient use. The condition must be reevaluada in periodic form. (To see Warnings). Collateral Effects: The adverse effects name later by system, organ, class and frequency. The frequencies are defined as: very common ( ³ 1/10), common ( ³ 1/100 and < 1/10), noncommon ( ³ 1/1,000 and < 1/100), rare ( ³ 1/10,000 and < 1/1,000) and very rare (< 1/10,000) including isolated reports. The very common, common and noncommon effects were determined generally with experimental clinical information. The antecedents in percentage for comparative groups with placebo and were not taken into account when assigning the categories of frequency to adverse effects derived from clinical information of experimentation, because these percentage were generally comparable with those in the group of active treatment. The rare and very rare effects derived generally from spontaneous information. Infections: Very rare: secondary infection. Secondary infection with the use of corticosteroides has been reported, particularly when using occlusive bandages or when they are involved you fold in the skin. Disorders in the immune system: Very rare: hypersensitivity. If they appear signs of hypersensitivity it must interrupt the application immediately. Endócrinos upheavals: Very rare: hipercortisolismo characteristics. The prolonged use of great amounts of corticosteroides, or treatment in extensive areas, can give like turn out a sufficient sistémica absorption to produce hipercortisolismo characteristics. It is more probable that east effect in infants and children appears, and case of using occlusive bandages. In infants, the diaper can act like occlusive bandage (to see Warnings). Upheavals vasculares: Very rare: expansion of superficial blood vessels. The treatment prolonged and intensive with powerful corticosteroides preparations can cause expansion of the superficial blood vessels. Subcutaneous upheavals in the skin and weaves: Common: prurito. Noncommon: local ardor. Very rare: thinning, striae, hipertricosis, hipopigmentación, dermatitis by allergic contact, exacerbación of dermatosis, psoriasis to pustular. Local ardor has been reported and prurito, nevertheless, in clinical studies, the incidence of these undesirable effects was generally comparable with the comparative groups of placebo and. The treatment prolonged and intensive with powerful corticosteroideas preparations can cause local atróficos changes in the skin like thinning, striae, hipertricosis, and hipopigmentación. One has reported exacerbación of signs and symptoms of dermatosis and dermatitis by allergic contact with the use of corticosteroides. The treatment of psoriasis with a corticosteroide (or its interruption) can cause the form to pustular of the disease. Contraindications: Rosaceous. Common acne. Perioral dermatitis. Primary cutaneous virales infections (by ej.: herpes simplex, varicela). Hipersensibilidad to anyone of the ingredients. Perianal and genital Pruritos. The use of Flutivate Cream is not indicated for the treatment of cutaneous injuries infected with fungi or bacteria. Dermatosis in children of less than 3 months of age, including dermatitis and eruptions in the zone of the diaper. Warnings: The application prolonged to high doses in extensive areas of the surface of the body, specially in small infants and children can cause suprarrenal deterioration. Nevertheless, it is very little probable that a manifest deterioration of axis APH appears (Adreno-Pituitario-Hipotalámico) (cortisol in the plasma in the morning < 5 mcg/dl) from the therapeutic use of Flutivate Cream unless it is more about 50% of the surface of the body of an adult and they are applied more than 20 g to the day. The infants and children have a greater area in the surface of the body in proportion to their weight compared with the adults. Therefore, in comparison with the adults, the children and infants can absorb proportionally greater amounts of topical and, therefore, to be but susceptible corticosterioides to sistémica toxicity. When using Flutivate Cream one is due to have well-taken care of to assure that the applied amount is the minim that offers therapeutic benefits. The face, more than other parts of the body, can exhibit atróficos changes after a treatment prolonged with powerful topical corticosteroides. This must consider when dealing with conditions like psoriasis, eritemade severe discoide lupus and eccema. If it is applied in the eyelids, it must make sure that the preparation does not penetrate in the eyes to avoid the risk of local irritation or glaucoma. The topical steroids can be dangerous in psoriasis for several reasons, between which continuous recidivas, development of tolerances, risk of psoriasis of pustular generalized and development of local sistémica toxicity due to deterioration in the function of barriers of the skin are included. If it is used in psoriasis, is important to have to the patient under a careful supervision. When one treats inflammatory injuries that have become infected, it will have to resort to a suitable antimicrobial therapy. Any infection that has extended requires that the therapy with topical corticosteroides is suspended, as well as the sistémica administration of antimicrobial agents. The bacterial infections are favored by conditions of humidity and heat induced by occlusive bandages, reason why the skin will have to be cleaned before applying a fresh bandage. Precautions: Use during the pregnancy and the lactancia: Pregnancy: the topical administration of pregnant corticosteroides to animals can cause abnormalitys in the fetal development. The applicability of this discovery in human beings has not settled down; nevertheless, the administration of propionato of fluticasona during the pregnancy only must consider itself if the benefit waited for for the mother is greater than any possible risk for the fetus. Lactancia: the excreción of propionato of fluticasona in human maternal milk has not been investigated. When obtaining itself measurable plasma levels in nursing rates of laboratory after the subcutaneous administration, there was evidence of propionato of fluticasona in milk. However, the levels of plasma in patients after a skin application of propionato of fluticasona to probably recommended doses are low. Effects on the capacity to handle and to use machines: none reported. Medicamentosas Interactions: They have not been reported. Sobredosificación: It is very little probable that an acute overdose appears, however, in the case of chronic overdose or bad use, can appear characteristic of hipercortisolismo, and in this situation the topical steroids must be interrupted gradually. Nevertheless, due to the risk of suprarrenal deterioration, this must become under medical supervision. Conservation: To store 30 to smaller temperatures of ºC. Not to congeal. Presentations: Package containing 15 g. Greater information available in GlaxoSmithKline Chile Farmace''utica Ltda. Avda. Beautiful Andrés 2687, floor 19, Building of the Pacific. The Counts, Santiago, Chile. Phono: 3829000. |
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