Solcoseryl, dental adhesive paste 5 g

Pharmacotherapeutic group: other medicinal products for topical application in the oral cavity.
ATX code: A01AD11

Pharmacological properties
Pharmanodynamics
Solcoseryl is chemically and biologically standardized deproteinized dialysate derived from dairy calf blood by ultrafiltration. Solcoseryl contains a wide range of low molecular weight (up to 5000 dalton) compounds
oligopeptides, trace elements, electrolytes, intermediate products of carbohydrate and fat metabolism. Only some chemical and pharmacological properties of these compounds are described.
On various cell and tissue cultures, in studies on organs and in clinical studies it has been found that Solcoseryl:

– maintains and/or restores aerobic energy metabolism and oxidative phosphorylation in cells and, therefore, the supply of high-energy phosphates to cells deficient in them; increases oxygen utilization (in vitro ) as well as glucose transport in tissues and cells in conditions of hypoxia and metabolic exhaustion;
-improves reparation and regeneration processes in damaged tissues that are deficient in nutrients;
– prevents and/or slows down secondary dystrophic and pathological changes in reversibly damaged cells;
– increases collagen synthesis in vitro models and
– stimulates cell proliferation and migration.

This way Solcoseryl has a protective effect on the tissues that are under hypoxia and/or nutrient deficiency, stimulates restoration of the function of reversibly damaged tissues, accelerates and qualitatively improves the healing processes of the damage.
Polidocanol 600 is a local anesthetic that reversibly blocks the peripheral nerve endings. Due to high hydrophilicity anesthetic effect develops 1 – 3 minutes after application. According to the adhesive properties of the paste, the analgesic effect lasts for 1 – 5 hours, depending on the lesion and the activity of salivation.

Indications

Treatment of wounds and inflammatory diseases of the oral mucosa:

• Afts, gingivitis and periodontitis.
• Dentures from removable dentures.
• Wound surface protection after tartar removal, scraping, periodontal surgery, removal and fitting of temporary dentures
• Alveolitis
• Stomatitis,
• Vesicular mucosal damage,
• Hardening,
• Traumatic damage to the oral mucosa by mechanical, physical or chemical factors

Composition

Composition per 1 g:
Active ingredients.
Solcoseryl (deproteinized dialysate from the blood of dairy calves), in terms of cyxoe substance 2.125 mg

Polidocyanol 600 10,000 mgp>Polidocanol 600 10,000 mg

Supplementary substances

Methyl parahydroxybenzoate 1,800 mg

Propylparahydroxybenzoate 0.200 mg

Sodium carboxymethylcellulose 22.875 mg

Pearmint oil 2.925 mg

Pearmint oilp>Menthol 0.075 mg

Paste base (sodium carboxymethylcellulose, gelatin, pectin, polyethylene, liquid paraffin) 960,000 mg

How to take, the dosage

The product is intended to be used topically on the oral mucosa. Unless otherwise prescribed by the doctor, apply a strip of paste about 0.5 cm long in a thin layer on the affected area 3-5 times a day, preferably after meals and before going to bed. Treatment is carried out until symptoms disappear. Recommended course dose of the drug is 1 tube (5 g). If after 10 days of treatment the improvement does not come, or symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.
In order to improve surface contact and increase the time of treatment effect it is recommended to dry the area on which the paste will be applied previously with a cotton swab. After application the paste surface should be slightly moistened.
Solcoseryl dental adhesive paste forms a healing layer that can be held on the affected area for 3-5 hours. Do not rub the paste into the mucous membranes.
When treating bedsores from removable dentures, apply the paste to dry dentures and moisten with water.
Apply the drug only according to the indications, the method of application and in those doses that are specified in the instructions for use.

Interaction

To date, no cases of interaction of Solcoseryl dental adhesive paste with other drugs have been identified.

Special Instructions

– Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed). In case of allergic reactions the drug should be discontinued.
– It is not recommended to put the paste into the wound cavity which is formed due to extraction of molar teeth, wisdom teeth as well as – apicotomy (resection of the apex of a tooth) in case if the edges of the dental hole are tightened with the subsequent suturing.
– Solcoseryl dental adhesive paste does not contain anti-inflammatory components. In case of acute infection of the affected area to be treated with this drug it is necessary to carry out a preliminary treatment/treatment to eliminate the symptoms of inflammation.
– Grain-dry consistency of the paste provides its optimal adhesive properties and is not a sign of improper quality of the product.
– When you open the tube it is possible the release of oil, that is also not a sign of improper quality of the product.
– The tube should be carefully closed after each use to prevent the contact of the paste with moisture.
– After the first opening the paste should be used within 28 days subject to storage at 15-25 ° C.

Impact on the ability to drive vehicles, mechanisms

The use of the drug does not affect the performance of potentially hazardous activities requiring high concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms).

Synopsis

pale beige to brown-beige colored grainy, easily spreadable homogeneous mass with a peppermint odor on the surface.

Contraindications

• High sensitivity to the ingredients of the drug, as well as to parahydroxybenzoic acid, the presence of residual amounts of which is possible due to the nature of the technological process.
• Children under 2 years.

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Side effects

Classification of adverse reactions by organs and systems with indication of their frequency.
Very common ( > 1/10)
Frequent (1/100 to < 1/10) Infrequent (1/1000 to < 1/100) Rare (1/10 000 to < 1/1000) Very rare (< 1/10 000)
Frequency not determined (cannot be determined based on available data).

Immune system disorders
Very rare: hypersensitivity, allergic reactions. Nervous system disorders
Frequency not determined: changes in taste sensations
Radio respiratory system, thoracic and mediastinal organs Very rare: Shortness of breath, bronchospasm
General disorders and disorders at the injection site
Frequency not established: reaction at the application site (e.g., edema, erythema, paresthesia, burning)
Children
Pearmint oil and levomenthol may cause laryngospasm, leading to breathing problems in children

Overdose

No cases of overdose have been described.

Pregnancy use

Pregnancy
Reproductive toxicity studies in animals have shown no risk to the fetus, but controlled studies involving pregnant women have not been conducted. The use of the drug in pregnancy is possible if the expected benefits to the mother exceed the potential risk to the fetus. Before using Solcoseryl Dental Adhesive Paste if you are pregnant or think you may be pregnant or are planning to become pregnant, you should consult your physician.

Breast-feeding
Consult your doctor before using Solcoseryl Dental Adhesive Paste during breast-feeding.