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 (<2%).
However, measurable concentrations were observed in subcutaneous tissue at the site of
application and surrounding muscle tissue. V Blood and urine samples was detected escin.
According to the results of animal studies and the information given in literature salicylate
absorbs much better. Level measurement in blood after topically applied therapeutic dose
not toxic.
3.5 Preclinical safety
Local tolerance was observed in rats, rabbits and pigs.
Reparil - Gel N was applied at doses of 200 and 500 mg of the skin on the back of rats and
rabbits for 4 weeks and pigs doses of 300, 1500 and 4000 mg / kg for 12 weeks.
Macroscopic and histological examination revealed no specific local skin lesions.
While watching the local tolerance of the mucous membranes were given a single 100 mg
Reparilu - N gel into the conjunctival sac of the eye of rabbits.
Inflammatory reactions were observed in the conjunctiva of moderate to high intensity.
Observed reactions were reversible. Washing the eye after application over 2 minutes resulted
complete disappearance irritation.
Whereas those data would Reparil - Gel N should not be applied to mucous membranes or
wounds.
Appropriate studies reproductive toxicity Reparilu - gel N have been performed. Was not
conducted studies on fertility and postnatal effects at exposure in utero. Experience with use
in Pregnancy and lactation are periods.
6. PHARMACEUTICAL PARTICULARS
6.1 List excipients
L e vandul oic oil, oil of bitter orange blossom lemon, ethoxylated monodiacylglyceroly
saturates, disodium edetate, carbomer 980, trometamol, isopropyl alcohol, purified water.
6.2 Incompatibilities

Not applicable.
6.3 Shelf
aluminum tuba - 5 years
5-ply laminate tube - 3 years
7-layer laminate tube - 3 years
4.6 Special precautions for u chovvn
This product does not require any special storage conditions
6.5 Nature and contents of container
Lacquered aluminum tubes with HDPE screw cap.
5-layer laminated tube (inner layer HDPE) PP screw cap
7-layer laminate tube (inner layer HDPE) PP screw cap
Pack sizes: 40, 100 g. the market may not be all pack sizes.
6.6 Special precautions for disposal and treatment him
No special requirements
7. MARKETING HOLDER
MADAUS G mbH, 5110 1 K o l s n Cologne, G ERMANY
8. Marketing Authorisation Number
85/335/95-C
9. DATE OF FIRST AUTHORISATION / RENEWAL OF REGISTRATION
May 31, 1995 / 18.6. 2008
10. DATE OF REVISION OF THE TEXT
January 27, 2010
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