MEDICAL BILE PRESERVED

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHOLE MEDICATE CONSERVATA (CHOLE MEDICATE CONSERVATA)

Composition:

Active substance: bovine and porcine bile;

100 ml of solution contains: bovine and porcine bile – 88.85 ml;

Excipients: ethanol 96%, formalin, solution of furacilin in 70% alcohol (1:1500), perfume.

Pharmaceutical form. Topical solution.

Main physicochemical properties: yellowish-brown to dark brown liquid with a greenish tint, or light green to dark green liquid with a brownish tint, with a characteristic odor. The presence of lamellar or fine-grained sediment is permissible.

Pharmacotherapeutic group. Agents used locally for joint and muscular pain. ATC code M02AX10.

Pharmacological properties.

The drug exerts anti-inflammatory, analgesic, resorptive, and emulsifying effects.

Clinical characteristics.

Indications.

Spondyloarthroses and spondylarthritis, acute and chronic arthroses, arthritis, bursitis, tendovaginitis, secondary radiculitis, heel spurs. The drug can also be used for contusions, ligament and muscle strains, subcutaneous hematomas, conditions after bone fractures without soft tissue integrity disruption, phantom limb pain after amputation, and skin scar changes.

Contraindications.

Skin integrity impairment, inflammatory processes of the skin and subcutaneous tissue in the application area, skin abscesses, lymphadenitis, lymphangitis, tuberculosis.

Interaction with other medicinal products and other types of interactions.

There are no data regarding interactions with other medicinal products.

Special precautions.

When applying compresses, it is not allowed to use polyethylene, nylon or other synthetic materials.

In case of skin irritation caused by bile, if continued treatment is necessary, the application duration should be 6-10 hours per day. After removing the compress, wash the affected area with warm water and apply an inert ointment.

Use during pregnancy or breastfeeding.

There is no experience with the use of the drug during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

The drug should be used as part of a comprehensive therapy regimen together with other medicinal agents.

Apply externally (shake before use) as compresses. Soak 2–6 layers of gauze with bile, apply to the affected area, cover with a thin layer of cotton and waxed paper, and then secure with a light bandage. When the gauze dries, moisten it with water at room temperature and re-secure with a bandage. The duration of compress application is 24 hours. Replace compresses and the fixing bandage daily. Depending on the nature and severity of the disease, the treatment course lasts 6–30 days. Repeat courses may be administered after 1–2 months.

Children.

There is no experience with the use of the drug in the treatment of children.

Overdose.

There are no data on overdose with this drug.

Side effects.

Skin and subcutaneous tissue disorders: skin irritation. If pronounced skin reactions occur, discontinue use of the product. In such cases, the next application of the product is possible no earlier than 15–30 days after discontinuation.

Shelf life. 2 years 6 months.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Incompatibility. Not established.

Packaging. 250 ml in a bottle, 1 bottle per carton; 200 ml in a vial, 1 vial per carton; 100 ml in a vial or can, 1 vial or can per carton.

Prescription status. Over-the-counter.

Manufacturer. Limited liability company "Pharma Cherkasy", Ukraine.

Manufacturer's address.
14A Surikova Street, Cherkasy, Cherkasy region, 18007, Ukraine.

Marketing Authorization Holder. Private joint-stock company "Infuziya".

Address of the Marketing Authorization Holder.
21-A Moskovskyi Avenue, Kyiv, 04073, Ukraine.

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