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Composition:

3 ml of solution for injection containing 150mg Troxerutin and 1.5mg Carbazochrome. Properties: Troxerutin ( 3-hydroxyethyl –rutoside), also known as vitamin P4, is a bioflavonoid that acts by increasing vasal resistance (capillary protective action) and diminishing permeability , thus preventing the excessive leakage of the liquid component of blood to tissues (anti- permeabilising and anti- edemigenic action) . Carbazochrome (adenochromosemicarbazone), an orthoquinone derived from adrenalin through oxidation and lateral chain cycling, is totally devoid of sympathomimetic action, owing to the absence of the secondary amine function and the ortho-diphenolic grouping, and it shortens the haemorrhage time through a local vasoconstrictive action on small vessels in the bleeding area.

Therapeutic Indications:

Symptomatic venous insufficiency; states of capillary fragility in post – hemorrhoidectomy patients.

Posology and method of administration:

1-3 ampoules a day by intramuscular injection. The content of the ampoules must not be mixed with solutions containing ascorbic acid.

Contraindications: Hypersensitivity to the active substances or to any of the excipients. Special warnings and precautions for use: None. Interactions with other medicinal products and other forms of interaction: None reported. Pregnancy and lactation: For Fleboton® no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

Effects on ability to drive and use machines: Fleboton® has no influence on the ability to drive and use machines. Undesirable effects: Some cases of local and generalised erythema have been reported in patients receiving Fleboton® solution for injection via the intradermic or subcutaneous route (mesotherapy). The use of Fleboton® solution for injection in mesotherapy is not approved since there are no controlled clinical studies showing the efficacy and safety of these methods of administration. Overdose: No case of overdose has been reported.

Incompatibilities: Fleboton®solution for injection should not be mixed with ascorbic acid.

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