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1. NAME OF PRODUCT

REPARIL N-GEL

Gel

2. Qualitative And Quantitative Composition

100 g of gel contain:

Escinum 1 g, 5 g of diethylamine salicylas.

Complete list omocn p s e k methacrylate see section 6.1.

3. PHARMACEUTICAL FORM

gel Product description: Transparent gel with lavender scent.

4. CLINICAL DATA

1.4 Therapeutic and ndikace

Improvement difficulties during the acute phase of blunt injuries such as sprains, contusions, hematoma and extravasation when using only topical preparations indicated.

2.4 Dosage and method of administration

Gel is applied to the skin at the site swelling, pain or injury 1-3 times daily until the acute difficulties subsided, but not longer than for 7-14 days. The gel does not need to rub. In children, the use of a doctor decides.

4.3 Contraindication

Age 2 years, known hypersensitivity to any component of the product, hemorrhagic diathesis, purpura, thrombocytopenia, hemophilia, a bleeding tendency states.

Reparil - N Gel should not be applied on damaged skin (wounds), mucous membranes or skin that has been exposed to radiotherapy. V therapeutic doses were observed teratogenic or embryotoxic effects.

4.4 Special warnings and precautions for use

Should not be used on irradiated skin sites, use caution when co-administering anticoagulants.

5.4 Even with nterakce other medicinal products and other forms of interaction

When topically applied, were not clinically significant interactions.

6.4 Pregnancy and lactation

Long term treatment (after consultation doctor up to 3 weeks) of large areas is not suitable for pregnant women and during breast-feeding may not be applied to the gel in the breast.

4.7 Effects on ability of manufacture and dit handled, hovat machine e The product does not affect attention.

8.4 Side effects

Very rarely occurring reactions Hypersensitivity reactions such as redness and scaling of the skin or may occur in the skin dryness application site.

9.4 Overdose

Overdose with topical application is unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic properties

Farmakoterautick group: Venofarmaka, anti-inflammatory drugs

ATC code: M02AX

The site of action escine the vascular wall. At increased permeability of the vascular wall based on escin inhibits exudation inflammation, by reducing the passage of fluids into the extravascular space of tissues and accelerating reabsorption already formed swelling. The mechanism of action is based on a change in permeability of the capillaries. Escin also supports resistance capillaries, inhibit the inflammatory process and improves microcirculation.

Diethylamine salicylate (DES) has anlagetick effects. Goes through the skin and apply the analgesic effect of deep affected area. Antiinflammatory effect of DES increases caused by anti-inflammatory medicine escine and thus counteracts the cause of the disease.

2.5 Pharmacokinetic Properties

After topical administration, in various animal species and in humans absorbs only a small amount of escin (