Liniment balsamic (by o.v. vishnevsky)

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LINIMENTUM BALSAMICUM (BY O. V. VISHNEVSKY)

Composition:

Active substances: birch tar, xeroform;

1 g of liniment contains 0.03 g of birch tar, 0.03 g of xeroform;

Excipients: silicon dioxide colloidal anhydrous, castor oil.

Pharmaceutical form. Liniment.

Main physicochemical properties: liniment from light yellow to brown in color, with a specific odor. The liniment should be homogeneous in appearance.

Pharmacotherapeutic group.

Antiseptics and disinfectants. ATC code D08A X.

Pharmacological properties.

Pharmacodynamics.

The medicinal product has antiseptic properties. It exerts a mild irritant effect on tissue receptors and promotes acceleration of epidermal regeneration by normalizing tissue blood supply.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Local treatment of purulent-inflammatory processes (abscesses, boils), as well as infected wounds, trophic ulcers, pressure sores, frostbite, and burns.

Contraindications.

Hypersensitivity to the components of the drug, phenol and its derivatives.

Interaction with other medicinal products and other types of interactions.

When used simultaneously on the same areas of skin with other topical medicinal products, new compounds with unpredictable effects may form.

Safety precautions.

Prior to initiating treatment, consult a physician.

The liniment is intended for external use only. Before applying a dressing, the wound should be cleaned from necrotic tissues, blisters should be opened, and the wound should be rinsed with an antiseptic solution.

Avoid contact of the medicinal product with mucous membranes. After application of the liniment, hands should be thoroughly washed to prevent any residue from entering the eyes, nose, or mouth. In case of accidental contact with mucous membranes, rinse them with water and seek immediate medical advice.

Birch tar, an ingredient of the product, may increase sensitivity to sunlight; therefore, during summer, exposure to sunlight should be avoided while using this product.

If signs of the disease do not begin to resolve, or conversely, if the condition worsens, or if any adverse reactions occur, discontinue use of the product and consult a physician for further management.

Special precautions.

Use during pregnancy or breastfeeding.

During pregnancy and breastfeeding, the decision to use the medicinal product should be made by a physician, taking into account the benefit-risk ratio for the mother and the potential risk to the fetus or infant.

Ability to influence reaction rate while driving or operating machinery.

There is no information available regarding the potential effect of the medicinal product on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

Apply externally. For adults, apply a thin layer to affected skin areas 2–3 times daily, or apply a dressing consisting of 5–6 layers of gauze soaked in the medication. Secure the dressing and change it once every 2–3 days. Treatment duration ranges from 6 to 20 days and is determined by the physician depending on the course of the disease and patient's condition. Dressings should be continued until complete clearance of the infected skin area.

Children

The safety and efficacy of the medication in children have not been established.

Overdose

Possible manifestations of local allergic reactions (including rash, itching) may occur, requiring desensitizing therapy.

Treatment: in case of accidental ingestion of a large amount of the liniment, induce vomiting and seek medical advice immediately. Symptomatic therapy.

Side effects.

Allergic reactions (including hyperemia, itching, skin rashes, urticaria, swelling). Possible photosensitization reactions.

If any adverse reactions occur, discontinue use of the drug and consult a physician immediately for further treatment.

Shelf life.

5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

40 g in tubes.

40 g in a tube, 1 tube per pack.

Prescription status.

Over-the-counter.

Manufacturer.

JSC "FITOPHARM".

Manufacturer's address.

84500, Bakhmut, Sybirtseva St., 2, Donetsk region, Ukraine.

Marketing authorization holder.

JSC "FITOPHARM".

Address of the marketing authorization holder.

7, Verkhovnoyi Rady Ave., premises 18, 3rd floor, Kyiv, 02100, Ukraine.

INSTRUCTION

for medical use of medicinal product

BALM LINIMENT (BY A.V. VISHNEVSKY)

Composition:

Active ingredients: birch tar, xeroform;

1 g of liniment contains 0.03 g of birch tar, 0.03 g of xeroform;

Excipients: colloidal anhydrous silicon dioxide, ricinus oil.

Pharmaceutical form. Liniment.

Main physicochemical properties: liniment from light-yellow to brown in color, with a specific odor. The liniment should be homogeneous in appearance.

Pharmacotherapeutic group.
Antiseptics and disinfectants. ATC code D08A X.

Pharmacological properties.

Pharmacodynamics.

The medicinal product has antiseptic properties. It exerts a mild irritant effect on tissue receptors and promotes acceleration of epidermal regeneration by normalizing tissue blood supply.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Local treatment of purulent-inflammatory conditions (abscesses, furuncles), as well as infected wounds, trophic ulcers, pressure sores, frostbite, and burns.

Contraindications.

Hypersensitivity to the components of the drug, phenol, and its derivatives.

Interaction with other medicinal products and other forms of interaction.

When used simultaneously with other topical medicinal products on the same areas of skin, new compounds with unpredictable effects may form.

Special precautions for use.

Before starting treatment, consult a physician.

The liniment is intended for external use only. Before applying a dressing, the wound should be cleaned of necrotic tissue, blisters opened, and washed with an antiseptic solution.

Avoid contact of the medicinal product with mucous membranes. Hands should be thoroughly washed after application of the liniment to prevent accidental transfer of residual product into the eyes, nose, or mouth. In case of accidental contact with mucous membranes, rinse immediately with water and seek medical advice without delay.

Birch tar, an ingredient of the product, may increase sensitivity to sunlight; therefore, during summer, exposure to sunlight should be avoided while undergoing treatment with this product.

If symptoms do not begin to improve, or if the patient's condition worsens, or if any adverse reactions occur, discontinue use of the product and consult a physician for further management.

Use during pregnancy or breastfeeding.

During pregnancy and breastfeeding, the decision to use this product should be made by a physician, taking into account the benefit-risk ratio for the mother and the potential risk to the fetus or infant.

Ability to affect reaction speed when driving or operating machinery.

There is no information available regarding a possible effect of the product on reaction speed when driving or operating machinery.

Method of administration and dosage.

Apply externally. For adults, apply a thin layer to affected areas of the skin 2–3 times daily, or apply a dressing consisting of 5–6 layers of gauze soaked with the preparation. Secure the dressing and change it once every 2–3 days. The duration of treatment ranges from 6 to 20 days and is determined by the physician depending on the course of the disease and the patient's condition. Dressings should be continued until complete clearance of the infected skin area.

Children.

The safety and efficacy of the drug in children have not been established.

Overdose.

Possible manifestations of local allergic reactions (including rash, itching), which require desensitizing therapy.

Treatment: in case of accidental ingestion of a large amount of liniment, induce vomiting and seek medical advice. Symptomatic therapy.

Side effects.

Allergic reactions (including hyperemia, itching, skin rashes, urticaria, swelling). Photosensitization reactions are possible.

If any adverse reactions occur, discontinue use of the product and consult a physician for further treatment.

Shelf life.

5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

40 g in tubes. 40 g in tubes; 1 tube per carton.

Availability.

Over-the-counter (without prescription).

Manufacturer. JSC «FITOFARM»

(responsible for batch release, excluding batch control/testing).

Manufacturer's address.

17, Chumatska Street, Boryspil, Kyiv region, Ukraine, 08303.

Marketing authorization holder.

JSC «FITOFARM».

Address of the marketing authorization holder.

7, Verkhovnoi Rady Avenue, Kyiv, Ukraine, 02100, floor 3, room 18.