Solkoderm

General characteristics. Structure:

Nitric acid of 70   % 580,7 mg
Acetic acid of 99   % 41,1 mg
Oxalic acid dihydrate   of 57,4 mg
Lactic acid of 90   % 4,5 mg
Nitrate copper trihydrate   of 48,0 mkg
The water distilled   to 1, 0 ml
Description
Transparent colourless solution.

Pharmacological properties:

Solkoderm represents the solution containing concentrated acids and is intended for external use at treatment of high-quality superficial damages of skin.
At topical administration on affected areas of skin Solkoderm leads to direct intravital fixing with the subsequent mummification patholologically of the changed fabric with which drug enters contact.
Direct effect of drug is expressed in decolouration of skin with the advent of a characteristic pale gray or yellowish shade. The fabric devitalized after drug influence is dehydrated and in process of a mummifying gets dark brown coloring. The formed mummified scab spontaneously exfoliates several days later or weeks.

Pharmacokinetics. Combined effect on an affected area of skin of components of Solkoderm: nitric acid, copper nitrate and organic acids (acetic, milk, oxalic acids), - provides a bystry devitalization and fixing patholologically of the changed site of fabric which underwent treatment.
During therapy by Solkoderm any essential absorption of active agent through skin is not observed; in view of the minimum volumes of a therapeutic dose, it is possible not to be afraid system impact of drug on an organism.

Indications to use:

Solkoderm is intended only for external use at treatment of the following high-quality changes of skin:

- Verruca vulgaris (ordinary warts)
- Verruca plantaris (bottom warts)
- Condylomata acuminata (sharp-pointed condylomas)
- Naevus naevo-cellularis (the nevocellular nevus checked for high quality).

Route of administration and doses:

Solkoderm is intended only for external use; the procedure has to be carried out by the doctor or medical personnel under control of the doctor.
Before the procedure the area of an affected area of skin is processed by alcohol or ether. Solkoderm is applied directly on an affected area of skin. For putting drug on skin the special plastic applicator with the acute and stupid ends which is available in each packaging is used. The keen edge is used mainly for putting drug on affected areas of skin, small on the area; the blunt end is used for processing of the extensive centers of defeat.
As an alternative method of putting drug the enclosed glass capillary is used. The combined damages of leather of 2-3 cm2 can be also processed by means of a glass capillary. To fill with drug a glass capillary, it needs to be shipped for several minutes in Solkoderm's solution. It is necessary to observe extra care at application, avoiding drawing too large volumes of solution Solkoderm and damages of deep layers of fabric. It is necessary to apply so much solution how many it absorbs fabric of an affected area of skin.
Solkoderm is carefully applied on an affected area of skin with the plastic applicator or a glass capillary and then evenly distributed on the surface of the chosen site of skin at easy pressing by means of the plastic applicator before full penetration of solution into fabric. Within the next 3-5 minutes it is necessary to watch the changes happening on the processed site carefully: there is a decolouration of skin with the advent of a characteristic pale gray or yellowish shade. The procedure has to repeat until occurs the above-stated changes of coloring of skin.
When processing the keratosic warts the upper layer of a corneous layer should be removed previously.
Affected areas of skin with a diameter more than 10 mm are processed by Solkoderm only if it is established that only the upper layer of skin is patholologically modified.
In the presence of the numerous centers of damage of skin treatment by Solkoderm has to be carried out in several steps, with an interval approximately of 4 weeks. During each procedure no more than 2-3 centers of defeat with a total area no more than 2-3 cm2 can be processed.
During a procedure the moderate passing erythema and emergence of a white ischemic ring on healthy skin around a drug site of application can be observed. These phenomena are considered as normal and do not demand special treatment. In cases of emergence of pain treatment has to be immediately interrupted. Within several days after holding a procedure the processed site of skin gets a dark brown shade and dries up with an escharosis. In case of unsatisfactory mummification patholologically the changed fabric can carry out the repeated procedure in several days.
To promote fixing and mummification patholologically of the changed fabrics which underwent treatment, it is necessary to process affected areas 2-3 times a day the tampon moistened 70% with alcohol (especially after acceptance of a bathtub or after washing).

Use of drug during pregnancy and a lactation, at children and elderly people.

Reproductive researches on animals showed lack of risk factor for a fruit. Researches on studying of possible influence of drug on an organism of pregnant women and nursing mothers were not conducted so far. It is only necessary to appoint treatment by Solkoderm in relation to this category of patients when the potential advantage of its use for mother surpasses possible risk for a fruit.
Concerning use of drug for children 5 years of restrictions are more senior is not present.
Concerning use of drug for patients of advanced age restrictions are not present.

Precautionary measures when using Solkoderm's.
1.
Solkoderm's use on the inflamed sites of skin is not allowed.

2.
In cases of emergence of pain treatment has to be immediately interrupted.

3.
Can lead use of too high doses of Solkoderm to developing of acid burns and damage of deep layers of fabric.

4.
Special precautionary measures should be observed when putting solution Solkoderm on the person, especially on the skin sites located about eyes.

5.
If there was an accidental hit of solution Solkoderm on healthy skin, it has to be immediately removed by means of the cotton plug moistened with water. If there was an accidental hit of solution Solkoderm in an eye, it is necessary to wash out urgently an eye by means of a large amount of water or by means of weak alkaline solution, for example - 1% of solution of sodium of bicarbonate. The solution drops Solkoderm which got on furniture or clothes need to be washed away water as Solkoderm is capable to destroy materials of which they are made.

6.
After a biopsy of an affected area of skin it is recommended to wait 8-10 days before starting treatment by solution Solkoderm.

7.
Extra care at treatment by Solkoderm of the high-quality new growths of skin which were exposed earlier to treatment other drugs, by other methods is required.

8.
Utilization of the used ampoules: before throwing out an ampoule, it is necessary to wash away the remains of solution in flowing water. The empty ampoule can be thrown out in a trash bin.

Features of use:

As solution Solkoderm is chemically unstable after opening of an ampoule, for each therapeutic procedure it is necessary to use a new ampoule.
Before opening an ampoule it is necessary to stir up and bring down the solution which got to an upper part of an ampoule down. The neck of an ampoule cracks on put risk. The opened ampoule has to be stored strictly vertically by fixing it in a special nest of planimetric packaging for ampoules.
At treatment of the affected areas of skin close to mucous membranes, including about eyes, it is necessary to observe special precautionary measures.
It is impossible to delete a scab with stripping or use of mechanical means. The scab has to disappear spontaneously, otherwise disturbance of processes of healing of fabrics and formation of hems is possible.

Before achievement of full healing of the defeat processed by Solkoderm (about 2-4 months after performing therapy) it is necessary to avoid influence of direct sunshine and ultraviolet radiation.

Side effects:

1. In cases of misuse of Solkoderm (use of too high doses) deep layers of fabric can be damaged.
2. Treatment using Solkoderm is often accompanied by emergence of short-term burning in a site of application of the drug proceeding, as a rule, within several minutes. At emergence of the expressed local irritation and a severe itch on adjacent sites of skin it is recommended to apply the cream containing steroid components, or the ointment having anesthetic effect.
3. Solkoderm's use can lead to change of a xanthopathy and formation of cicatricial fabric. However, provided that process of healing proceeds normally, is not followed by an infection, and the arisen scab disappears spontaneously, the risk of such undesirable influences is insignificant.

Interaction with other medicines:

Solkoderm's interaction with other medicines of local action is not established.

Contraindications:

1. Solkoderm's use is strictly contraindicated at the malignancies of skin inclined to innidiation, in particular, at a malignant melanoma.
2. Solkoderm should not be used at patients with the expressed tendency to formation of cicatricial fabric.
3. Solkoderm should not be used for emaculation and keloid hems.

Overdose:

The ulcer formed owing to overdose is exposed to treatment as a usual wound.

Storage conditions:

Drug should be stored at a temperature from + 8ºС to + 20ºС. To store in the place, unavailable to children! To handle care! Period of validity 2 years. Not to apply medicine after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

On 0,2 ml of solution in ampoules of colourless glass from an ampoule, risky for opening.
1 ampoule complete with a set of plastic applicators (1 piece) and glass capillaries (2 pieces) is located in a cardboard blister strip packaging.
Or 5 ampoules complete with a set of plastic applicators (5 pieces) and glass capillaries (10 pieces) are located in a blister strip packaging from transparent plastic, with a nest for the opened ampoule.
Planimetric packaging together with the application instruction invest in a cardboard pack.