FURACILIN-TERNOFARM

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FURACILIN-TERNOPHARM (FURACILIN-TERNOPHARM)

Composition:

Active substance: nitrofurazone (nitrofural);

One sachet (0.94 g of powder) contains nitrofurazone (nitrofural) — 20 mg;

Excipients: sodium chloride, povidone.

Pharmaceutical form. Powder for preparation of a solution for external use.

Main physicochemical properties: yellow powder.

Pharmacotherapeutic group. Antiseptics and disinfectants. ATC code D08AF01.

Pharmacological properties.

Pharmacodynamics. Nitrofurale belongs to antibacterial agents. It is a potent antiseptic active against staphylococci, streptococci, dysentery and coliform bacilli, salmonella, and causative agents of gas gangrene. It promotes granulation and wound healing processes. The mechanism of action of the drug is associated with its ability to reduce the nitro group to an amino group, disrupt DNA function, and inhibit microbial cellular respiration.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

For mouth and throat rinsing, purulent wounds, pressure sores, ulcerative lesions, second- and third-degree burns, osteomyelitis, pleural empyema, chronic suppurative otitis, anaerobic infections.

Contraindications.

Hypersensitivity to the drug and to other nitrofuran derivatives, allergic dermatoses.

Interaction with other medicinal products and other forms of interaction.

Not studied.

Special precautions for use.

The medicinal product is intended for topical use only!

Use during pregnancy or breastfeeding.

There is no experience with the use of the medicinal product during pregnancy or breastfeeding; therefore, it should not be used during these periods.

Ability to affect reaction speed when driving or operating machinery.

Not studied.

Administration and Dosage.

The medicinal product "Furacilin-Ternofarm" is intended for topical use as an aqueous 0.02% (1:5000) solution. To prepare the aqueous solution, dissolve the contents of 1 sachet (0.94 g of powder) in 100 mL of isotonic sodium chloride solution or distilled water (for faster dissolution, use hot water). After dissolution, cool the solution to room temperature.

Mouth and throat rinsing: dissolve 1 sachet (0.94 g of powder) in 100 mL of hot water.

Repeat rinsing as directed by a physician. The duration of treatment depends on the form and severity of the disease, concomitant therapy, and the therapeutic effect achieved, and is determined individually by the physician.

For purulent wounds, pressure ulcers, ulcerative lesions, second- and third-degree burns, and for preparing granulating surfaces prior to skin grafting or secondary suturing, irrigate the wound with the aqueous solution of the medicinal product "Furacilin-Ternofarm" and apply moist dressings.

After surgery for osteomyelitis, irrigate the cavities with the aqueous solution of the medicinal product "Furacilin-Ternofarm", then apply a moist dressing.

In cases of empyema of the pleura, aspirate the pus and irrigate the pleural cavity using standard methods. Then introduce 20–100 mL of the aqueous solution of the medicinal product into the pleural cavity.

In anaerobic infections, after standard surgical intervention, treat the wound with the medicinal product "Furacilin-Ternofarm".

For chronic suppurative otitis, apply 8–10 drops of the aqueous solution of the medicinal product "Furacilin-Ternofarm" onto a cotton swab or a wick and insert into the external auditory canal twice daily. Prior to use, warm the solution to body temperature.

Children. There is no experience with the use of this medicinal product in children; therefore, it should not be used in this patient population.

Overdose.

When large doses of the medicinal product are used, adverse reactions may be intensified.

Side effects.

The medicinal product "Furacilin-Ternopharm" is generally well tolerated when applied externally. Occasionally, dermatitis may occur; when used for mouth rinsing — irritation of the oral mucosa, which requires temporary discontinuation of the medicinal product.

In individual cases, the following adverse reactions may occur during use of the medicinal product:

From the immune system: allergic reactions, including pruritus, hyperemia, skin rashes; very rarely — angioneurotic edema.

Reporting of adverse reactions after medicinal product registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of this medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 4 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

Powder 0.94 g in sachets; 30 sachets per cardboard pack.

Supply category. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Address of manufacturer and location of its business activities / applicant's address.

4 Fabrychna St., Ternopil, 46010, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua