Maraslavin^® (Solution) Instructions for Use

Marketing Authorization Holder

Sopharma, JSC (Bulgaria)

ATC Code

A01AD11 (Other drugs)

Dosage Form

Maraslavin®

Solution for topical use: bottle 100 ml

Dosage Form, Packaging, and Composition

Solution for topical use is turbid, of red-brown color, with an astringent-sour taste, and a specific odor; sediment may form during storage.

Excipients: ammonium chloride, wine vinegar, water.

100 ml – dark glass bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug used for periodontal diseases and gingivitis

Pharmacotherapeutic Group

Antiseptic of plant origin

Pharmacological Action

Maraslavin^® is a combined herbal preparation for topical use in dentistry. It has antimicrobial, anti-inflammatory, anti-allergic, astringent, local irritant, and analgesic effects, and improves tissue regeneration.

At the beginning of the treatment course, the application of the drug causes irritation, hyperemia, and swelling of the gum mucosa. The hypertonic solution of Maraslavin^® helps to remove toxic decay products from the gingival pockets.

Then, an increase in the number of collagen fibers is observed, the gum tissues become denser, new epithelium is formed, the normal structure of the gums is restored, and the connection of the periodontium with the cementum of the tooth root is strengthened.

In the treatment of the hemorrhagic form of periodontosis, a reduction in gum swelling and bleeding first occurs, the color of the gums becomes pale, and then pale pink, the structure of the gums becomes denser, the gingival papillae thin out and gradually press against the neck of the tooth at the subenamel-cement border. Gingival pockets decrease or disappear.

In the purulent form of periodontosis, an increase in the amount of purulent exudate is observed in the first days, then its amount gradually decreases until it completely disappears. The gingival papillae are resorbed, the edges of the gums are leveled and tightly pressed against the teeth. Stabilization of tooth mobility occurs.

Pharmacokinetics

Data on the pharmacokinetics of Maraslavin^® are not available.

Indications

• Hemorrhagic form of periodontosis with alveolar pockets;
• Purulent form of periodontosis (as part of complex therapy);
• Postoperative period after surgical treatment of periodontosis.

ICD codes

Dosage Regimen

Treatment with Maraslavin^® is carried out by a dentist and begins with the removal of supragingival dental calculus. Simultaneously, ventilation of the gingival pockets is performed with a spray or a stream of warm water.

Then, loose cotton tampons, abundantly moistened with Maraslavin^®, are inserted into the gingival and bone pockets using a probe. For this, 20-25 ml of the preparation is poured into a glass vessel, with which cotton tampons are abundantly moistened; the size of the tampons depends on the width of the alveolar or bone pocket.

The tampons are left in the pockets for 5-6 minutes. This procedure is repeated 5-6 times during the first session, sequentially on each pocket. With each change of the tampon, it penetrates easier and deeper into the alveolar pocket. The last time, the tampons are left loosely lying in the pockets until the next session. The patient is warned that in case of a rise in temperature (due to purulent exudation), they can remove the tampons themselves and consult a dentist.

At the second session, the tampons remaining from the first session are removed and subgingival dental calculus is removed. Tampons are inserted into the pocket several times, as in the first session. The last time, the tampons are also left in the pockets until the next session.

Treatment is carried out at intervals over 3 months. 17-20 treatment sessions should be conducted. The first 5-6 sessions should be conducted at 24-hour intervals. Subsequent treatment courses are prescribed by the dentist.

A control examination of the patient is carried out 5-6 months after the start of treatment. Regardless of the condition of the gums, the same areas on the alveoli are treated with Maraslavin^® 1-2 times (more if necessary) to eliminate possible pathogens. A final examination is carried out 12 months after the start of treatment.

Adverse Reactions

Possible allergic reactions.

With tight packing of the tampons, subfebrile temperature is possible, due to impaired outflow of purulent exudate, which disappears on its own after the removal of the tampons.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Data on the use of the drug during pregnancy and lactation are not available.

Special Precautions

The patient is recommended to take food rich in vitamins and additional intake of vitamins A and C.

During the treatment period, spicy and irritating foods (garlic, onions, nuts) should not be consumed.

During therapy with Maraslavin^®, one should not brush teeth with a toothbrush and toothpaste or use disinfectant liquids for mouth rinsing. The oral cavity should be rinsed with cool water in the morning and evening.

Prolonged exposure to the sun should be avoided.

Overdose

Cases of overdose with Maraslavin^® have not been observed to date.

Drug Interactions

Drug interactions of Maraslavin^® have not been established.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.