SOLCODERM 0.2 ml. 5 ampoules

Qualitative and quantitative composition
1 ml contains:
Nitric acid, 65% acetic acid, 98% Oxalic acid dihydrate Lactic acid trihydrate Mednonitraten


3. PHARMACEUTICAL FORM
625,2mg 41,5mg 57,4mg 4,5mg 48mg
Acid caustic solution for topical application

4. Clinical Features
4.1. Therapeutic indications

Solcoderm solution is indicated for the topical treatment of superficial benign skin lesions:
- Verruca vulgaris
- Verruca plantaris


4.2. Dosage / Route of administration
Solcoderm solution is designed exclusively for outdoor use and is applied only by a doctor or trained health care worker under the supervision of a physician.
The pack contains 1 respectively. 5 ampoules Solcoderm. Since the solution does not remain chemically stable after opening of the ampoule, in each application it is necessary to use a new ampoule. The ampoule is opened by breaking the highlighted part. Open ampoule can be placed upright in a plastic holder of the kit.
Area of skin to be treated is cleaned with alcohol or surgical spirit. Solcoderm solution is applied directly on the lesion. For this purpose the plastic applicator with a blunt and tapered end. The tapered portion of the applicator is used mostly for minor skin lesions, and the blunt end - for larger and / or stronger Callose lesions. Optionally, the solution can be applied using a glass pipette. Combined lesions of 2-3 sq. Cm may also be treated with a glass pipette. Care should be taken not to apply excessive amounts of the solution, as it may lead to lesions of the tissues beneath.
Solcoderm solution is carefully applied to the surface of damaged skin by the applicator / glass pipette and then rubbed with a plastic applicator by exerting gentle pressure until the solution completely penetrates the skin. In the next 3-5 minutes treated skin should be monitored to determine whether appears white, gray or yellow. The application is repeated as often as necessary, to give it color. Skin lesions adjacent to the mucous membrane or near the eyes should be treated with caution.
In highly Callose lesions would be better to remove part of the stratum corneum. Lesions with a diameter of more than 10 mm should be treated with Solcoderm solution only if the affected surface. If the required processing of large numbers of lesions, this must be done in several sessions, with an interval of about 4 weeks. No more than 2-3 lesions with a total area not exceeding 2-3 cm @ can be treated during a single session.
The emergence of low red and white, ischemic and slightly edematous ring around the treated area is normal and does not require special treatment. When feeling pain, treatment should be discontinued immediately. The first few days after treatment appears dark brown, drying the treated areas and the formation of a hard crust. In case of insufficient drying, treatment must be repeated after a few days.
To assist drying and crusting, the treated area was carefully treated with 70% alcohol 2 or 3 times a day, particularly after washing or bathing. The crust should not be removed by scratching or by other mechanical means. It must be allowed to fall from itself in order not to disturb the healing process and especially to avoid scarring. The complete healing of the lesion after about 2-4 months should avoid exposure to direct sunlight or UV radiation.


4.3.Protivopokazaniya:
Malignant skin tumors with a tendency to metastasis, especially malignant melanoma are stroko contraindicated for treatment with Solcoderm.
Solcoderm should not be used in patients with a known tendency to strongly pronounced scarring.
Solcoderm is not indicated for the treatment of freckles or keloids. Do not use in children under 5 years of age.


4.4. Special warnings and special precautions for use
Solcoderm solution should not be applied to inflamed areas. In pain, treatment should be discontinued immediately.
Attention! Treatment with Solcoderm without adequate measures (in excessive amounts) can cause acid burns and lesions of the underlying tissues. Special attention is required when applying the preparation to face, especially near the eyes. In case of a Solcoderm solution on healthy skin, it should immediately wash with a damp sponge. If part of the solution gets into the eyes should be washed thoroughly with water or a weak alkaline solution such as a 1% solution of sodium bicarbonate.
In case of a recent biopsy excision is recommended to wait 8-10 days before starting treatment with Solcoderm solution.
Skin lesions treated with other drugs must be handled with particular care.


4.5. Interactions
None known.

4.6. Pregnancy and lactation
Pregnancy - Category B: Reproduction studies in animals have not shown risks to the fetus. No controlled and documented studies in pregnant women. The advantages of treatment with Solcoderm solution should be well matched with the possible risk.

4.7. Effects on ability to drive and use machines
Because the drug is administered and acts locally, do not expect a similar effect.


4.8. adverse reactions
In case of incorrect application (especially in very large quantities) can damage tissue beneath the lesion.
It can often appear a feeling of slight burning sensation that lasts a few minutes. In the case of acute local reaction or itching, may be administered a steroid cream or ointment anesthetic.
It is possible to appear pigmentation and scarring, but if the healing process is proceeding normally and without infection and rind removed from itself, there is minimal risk.


4.9. overdose
In case of overdose, formed ulceration treated as a normal wound.


5. pharmacological properties
5.1. pharmacodynamics

Solcoderm solution is highly acidic with topical administration leads to immediate Devitalisation and subsequent mummification of pathological tissue. The action of Solcoderm solution is strictly limited in the area of treatment. Instant effect occurs with a white-gray to yellowish discoloration of the skin in the treated area. Devitalized tissue dries and through gradual mummification to dark brown. After a few days or weeks mummified division dropped spontaneously. Healing is quick and rarely seen complications such as secondary infections or extensive scarring.

5.2. pharmacokinetics
Acid ions and reduced nitrate solution Solcoderm cause rapid Devitalisation and fixation of the treated pathological tissues. In this procedure absorption shall be null and given the minimal therapeutic dose can not expect systemic effects.

5.3. Preclinical safety data
• Single dose toxicity topical application in the treatment of sheared fur on the back of rabbits with 1 cm2 area after 30 minutes was observed yellowish with a slight edema. After 24 hours started necrosis, and in isolated cases appeared limited in size erythema. From 3rd to 7th day necrosis ranged from degree of hemorrhagic infiltrates with smooth skin relief to distinct skin necrosis.

Double dose toxicity when used topically
In the treatment of sheared skin of rabbits with a diameter of 3 cm, three times at an interval of 48 hours after the first application appeared hyperemia around the treatment area. After the third application was observed a slight decrease in the elasticity of the surrounding area. Later appeared slight desquamation of the epithelium, and six days after the last application the treated area is no different from the surrounding skin.
When used properly, Solcoderm solution is considered safe. In topical application the amount of the absorbed substances is minimized.


6. PHARMACEUTICAL PARTICULARS
6.1. List of auxiliary agents
Distilled water

6.2. incompatibilities
no

6.3. Expiry date
3 years at room temperature (15-25 ° C).

6.4. Special storage conditions
Do not store above 25 ° C.
- Glass vial with a nominal capacity 1 ml, containing 0,2 ml solution


6.6. Instructions for Use
Solcoderm is strong (caustic) caustic agent and should be stored out of the reach of children. Do not use after the expiry date indicated on the package with EXP.
Disposal of empty bottles:
Do not throw directly.
Rinse beforehand with water in a closed stopper and then discarded.