VISCOFLU спрей за уста 20ml
1. DESCRIPTION, COMPOSITION AND PURPOSE OF THE MEDICAL DEVICE
1.1. DESCRIPTION AND PURPOSE
Viscoflu spray for oral mucosa is a medical device containing Ectociclina-PROg - a mixture of propolis, grapefruit extract and ectoin. Viscoflu spray for oral mucosa is indicated for the prevention of inflammatory processes of the throat and oral mucosa.
1.2. CONTRAINDICATIONS AND ADVERSE REACTIONS
Hypersensitivity to the active substances or to any of the excipients. Viscoflu spray for oral mucosa is contraindicated in children under the age of 3 years. Viscoflu spray for oral mucosa is contraindicated in persons suffering from asthma and in people allergic to propolis. The medical device may delay or reduce the absorption of concomitantly administered drugs due to the content of grapefruit extract, which inhibits the CYP450 enzyme that metabolizes certain drugs. Therefore, consult your doctor before using Viscoflu oral mucosal spray, especially if you are taking medicines that slow blood clotting (aspirin, clopidogrel, dalteparin, enoxaparin, heparin, ticlopidine, warfarin and others), cyclosporine and simvastatin. Viscoflu oral mucosal spray may cause allergic reactions, especially in people allergic to bee stings or bee products. In some cases, it can cause irritation in the mouth or cause mouth ulcers, headache, fatigue, gastrointestinal disturbances. In any case, it is recommended to consult your doctor before taking Viscoflu oral mucosa spray. The high concentration of water-glycerin extract of propolis and grapefruit may cause a slight burning sensation after application; this effect wears off after a few seconds. Adherence to the instructions in the leaflet reduces the risk of side effects.
1.3. COMPOSITION
The 20 ml bottle contains: 6.4 g Ectociclina-PR0g® (6 g water-glycerin extract of propolis and grapefruit, 0.4 g ectoine); purified water, glycerin, lemon flavoring, mint flavoring; stabilizer: citric acid; preservatives: sodium benzoate, potassium sorbate.
1.4. MECHANISM OF ACTION
Viscoflu spray for oral mucosa protects the mucous membrane of the throat and mouth through the physico-chemical action of the Ectociclina-PRQg® mixture contained in it, in which: - The water-glycerin extract of propolis and grapefruit synergistically combines the resinous fraction of propolis, consisting of polysaccharides, which can form a protective barrier on the inflamed mucous membrane, with grapefruit bioflavonoids, which have an antioxidant effect, thus indirectly counteracting inflammation and protecting the respiratory tract from the aggressive action of pathogens.
- Ectoin is an organic substance that binds to water molecules and has a moisturizing-softening effect.
2. TYPE OF PACKAGING
Solution in a glass bottle with a volume of 20 ml with an injection device in a sealed bag.
3. METHOD OF ADMINISTRATION AND DOSE TO BE ADMINISTERED
The package contains a dosing device in a sealed bag. Place the dispenser on the bottle, remove the cap from the dispenser, shake the bottle before use. It is recommended to apply the following doses in the oral cavity using the special dosing device:
Children aged 3 to 6 years: apply 1-2 sprays of the solution in the oral cavity; repeat up to 3 times daily.
Adults and children over 6 years: apply 2-4 sprays of the solution in the oral cavity; repeat up to 5 times daily.
In case of a small area, apply directly to the affected area. It is possible to have a small precipitate due to the high concentration of the extracts, which is not a sign of a violation of the quality of the product. Do not use for more than 10 consecutive days, depending on the clinical picture being treated. It is possible to repeat the treatment several times during the year, taking a break of at least a week between individual cycles. Use the product within 2 months of first opening.
3.1. UNWANTED REACTIONS
The high concentration of the water-glycerin extract of propolis and grapefruit may cause a slight burning sensation after application; this effect wears off after a few seconds. Adherence to the instructions in the leaflet reduces the risk of side effects.
4. CONDITIONS OF STORAGE
Store at room temperature away from light and heat sources. This shelf life applies to a product that is intact and has been stored properly.
5. WARNINGS AND PRECAUTIONS
Wash the injector with water after each application. It is recommended to carefully close the injection device with the special cap after each application. Do not use in case of hypersensitivity or allergic reaction to any of the product's ingredients. Prolonged use of topical products may lead to sensitization; in case such an event occurs, it is necessary to interrupt the treatment and consult a doctor. Keep the product out of the reach of children. Do not use the medical device after the expiration date. Do not use the product if the packaging is damaged. Consult a doctor before using the product during pregnancy or breastfeeding. Do not drink the contents of the bottle. Avoid splashing in the eyes. The use of the same bottle by more than one person can facilitate the transmission of infections.
6. DISPOSAL
When the expiration date has passed or the product has to be discarded, the medical device must be disposed of in accordance with the local waste handling requirements of the relevant competent authorities. Do not dispose of the product or its packaging in the environment. GLUTEN FREE Pharma Line Srl
Via Bertani, 2 – 20154 Milan, Italy
Distributor:
Orbiko Bulgaria EOOA,
Chelopeshko Shose St. 24, 1839 Sofia
Phone: +359 (2) 40 24 500
Email: info.bg@orbico.com
6.4 g Ectociclina-PR0g8 (b g water-glycerine extract of pronolis and grapefruit, 0.4 g ectoine); purified water, glycerin, flavoring lemon flavor, flavoring mint flavor; stabilizer: citric acid; preservatives: sodium benzoate, potassium sorbate
