Universal reference book for medicines
Name of the drug: Mardil Selen (MARDILSELEN)

Active substance: nonappropriate

Type: The drug for topical treatment of benign skin lesions with cauterizing and mummifying effect

Manufacturer: OXYGON (Russia) manufactured by FARMCENTER VILAR (Russia)
Composition, form of production and packaging
Solution for external use
in the form of a transparent colorless or pale yellow liquid with a specific odor;
a slight deposit is allowed.
1 g

selenious acid solution 0.9% in 90% 2,2-dichloropropionic acid 0.78 g

Auxiliary substances: purified water 0.22 g / 1 g.

0.5 ml - bottles of dark glass (1) in a package with glass microcapillaries (5 pcs.) - containers of foam plastic (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Mardil Selen is a solution of selenious acid (0.45% in terms of selenium) in 70% of 2.2-dichloropropionic acid.
When applied externally on affected areas of the skin, the drug is capable of interrupting the growth and vital functions of pathologically altered cells, incl. benign neoplasms of the skin and malignant nonmetastatic skin tumors by means of angiocoagulation, dehydration and devitalization. The effect of the drug on the affected area of ​​the skin provides a direct intravital fixation followed by mummification of the pathologically altered tissue with which the drug comes into contact. The immediate effect of the drug is expressed in the appearance of a characteristic whitish-gray or grayish color. Devitalized after the effect of the drug, the tissue is dehydrated and, as it mummifies, becomes dark brown in color. The formed mummified scab exfoliates after complete re-epithelization, after 2-4 weeks. The healing takes place without complications, especially in the absence of secondary infection, leaving no significant scars and scars, deformations of adjacent tissues or impaired functions of the organs.
PHARMACOKINETICS

When applying Mardil Selen to the affected areas of the skin, absorption of active substances and their systemic effect on the body are not detected.

INDICATIONS

- external treatment of benign skin tumors (low-pigment and unpigmented nevi, papillomatous nevi, skin horn, seborrheic keratosis and other keratoses);

- external treatment of vascular benign neoplasms (senile hemangioma, angiokeratoma, angiomatous nevus);

- external treatment of benign skin formations of a viral origin (common warts, plantar warts, flat warts, papillomas);

- external treatment of non-metastasizing skin malignant tumors (basal cell carcinoma of the 1st degree).

DOSING MODE

Outwardly

Treatment of basal cell carcinoma .
Treatment is carried out on an outpatient basis, under the supervision of a doctor. The procedure does not require anesthesia. The preparation is applied with a thin wooden spatula or with the help of the attached glass capillary to the surface of formation previously degreased with 70% ethyl alcohol. The treatment is carried out by several applications at intervals of 1-2 min, taking 1-2 mm of apparently healthy skin, until dense whitish-gray coloration appears. Change in color of the tissue occurs within 2-3 minutes after application of the preparation. At the same time, the consistency of the neoplasm changes to a more dense one. The dose of the drug depends on the stage, clinical form and density of the tumor and can be up to 0.2 ml. The maximum daily dose is 0.2 ml. The standard course of therapy for basal cell cancer of Stage 1 includes 3-fold treatment of the tumor and is performed on days 1, 2 or 3 and 8 or 9 days. Additional, 4 applications Mardil Selen allowed after rejection of a mummified scab at the doctor's discretion. Around the neoplasm after the application of the drug Mardil Selen, a transient band of hyperemia and edema is observed, which passes 24-48 hours after the completion of the procedure. Any additional medical measures after the application of the drug is not required. The next day after the application the pathological focus is mummified, acquires a dark brown hue and sharply decreases in size. Mummified scab is separated only after complete epithelization spontaneously after 2-4 weeks. The healing takes place without complications, especially in the absence of secondary infection, leaving no significant scarring, scars and deformities of adjacent tissues or impaired functions of the organs.
Treatment of benign skin tumors, vascular benign neoplasms of the skin, benign skin formations of viral origin .
Treatment is carried out on an outpatient basis under the supervision of a physician. The standard procedure is performed once and does not require anesthesia. The preparation is applied with a thin wooden spatula or with the help of the attached glass capillary to the surface of formation previously degreased with 70% ethyl alcohol. The treatment is carried out by several applications at an interval of 1-2 minutes until the appearance of whitish-gray or grayish staining. Change in color of the tissue occurs within 2-3 minutes after application of the drug, in the presence of pronounced hyperkeratosis - within 5-7 minutes. At the same time, the consistency of the neoplasm changes to a more dense one. The dose of the drug depends on the type, size, density and severity of hyperkeratosis and can range from 0.02 ml to 0.2 ml. The maximum daily dose is 0.2 ml.
Around the neoplasm after application of the drug Mardil Selen, a transient band of hyperemia and edema is observed, which disappears without a trace 24-48 hours after the completion of the procedure.
Any additional medical measures after the application of the drug is not required. The next day after the application the pathological focus is mummified, acquires a dark brown hue and sharply decreases in size. Mummified scabs are separated only after complete epithelization spontaneously after 2-3 weeks. The healing takes place without complications, especially in the absence of secondary infection, leaving no significant scarring, scars and deformities of adjacent tissues or impaired functions of the organs.
In large neoplasms and tumors with severe hyperkeratosis, in case of their incomplete removal, it is possible to apply the drug again.

SIDE EFFECT

The use of the drug Mardil Selen can lead to a change in skin pigmentation and the formation of superficial cicatricial changes.
With the normal course of the process of epithelialization, the absence of secondary infection and the independent separation of mummified scabs, the probability of such consequences is small. There may be swelling of the tissues; very rarely, with individual sensitivity to the components of the drug, allergic reactions in the form of skin itching are possible.
CONTRAINDICATIONS

- malignant skin tumors prone to metastasis;

- pronounced tendency to form keloids;

- age up to 18 years;

- Pregnancy;

- lactation period;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation.

APPLICATION FOR CHILDREN

Contraindicated for children and adolescents under 18 years.

SPECIAL INSTRUCTIONS

Handle with care.

Before opening the vial should be shaken and move the solution, which got in the top of the bottle, to its bottom.
The opened vial should be in a strictly vertical position.
Mardil Selen contains acid in its composition.
Avoid getting the product on healthy skin or mucous membranes. If an accidental ingestion of Mardil Selen to a healthy skin or mucous membrane occurs, remove the drug as soon as possible with a cotton swab moistened with water. In the treatment of affected skin areas located near the eye area, special precautions should be observed. Avoid contact with eyes. If an accidental ingestion of Mardil Selen in the eyes occurs, rinse immediately with plenty of water and 1% sodium hydrogen carbonate solution, and then consult a doctor.
It is impossible to remove the mummified scab by scraping or using mechanical means.
The scab should separate from the healthy skin by itself, otherwise it may damage the processes of tissue healing and the formation of scars. Until complete healing of the skin is not recommended to swim in swimming pools and open water, and should avoid exposure to direct sunlight and ultraviolet radiation. On the day of treatment it is recommended to limit water procedures. It is desirable to avoid traumatization and contamination of the treated pathological focus to complete epithelialization.
Disposal of used vials: before discarding the vial, the rests of the drug should be washed off in running water.
Empty vial can be thrown into the garbage container.
OVERDOSE

If Mardil Selen is misused, to prevent damage to deeper layers of the skin, the preparation should be rinsed with running water.
Healing can occur independently without the use of additional drugs or with the use of wound healing drugs.
DRUG INTERACTION

The interaction of the drug Mardil Selen with other drugs of external action is not established.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep the drug in a dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life - 2 years.

Do not use the medicinal product after the expiration date indicated on the package.

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