Hemostatic collagen sponge (Sponge) Instructions for Use

Marketing Authorization Holder

Belkozin – Luzhsky Plant, JSC (Russia)

ATC Code

B02BC07 (Collagen)

Active Substances

Collagen (BP British Pharmacopoeia)

Boric acid (Ph.Eur. European Pharmacopoeia)

Nitrofural (Rec.INN WHO registered)

Dosage Form

Hemostatic collagen sponge

Sponge 50×50 mm or 90×90 mm: sachet 1 pc.

Dosage Form, Packaging, and Composition

Sponge 50×50 mm or 90×90 mm.

1 pc. – double-layer polyethylene bags (1) – cardboard packs.

Clinical-Pharmacological Group

Hemostatic agent for topical application

Pharmacotherapeutic Group

Topical hemostatic agent

Pharmacological Action

Hemostatic agent for topical application, has antiseptic and adsorbing action, stimulates tissue regeneration.

The sponge left in the wound or cavity is completely absorbed.

Indications

• Capillary and parenchymal bleeding.
• Nosebleeds; bleeding from the sinuses of the dura mater; alveolar bleeding.
• Hemostasis during dental interventions; filling defects of parenchymal organs.
• Trophic ulcers; bedsores; skin lesions.
• Otitis.

ICD codes

Dosage Regimen

Apply topically to the bleeding surface or use for wound tamponade. Wait 3-5 minutes for the sponge to become saturated with blood and adhere tightly to the tissue.

In cases of continued bleeding, apply a second layer of the sponge. After hemostasis is achieved, secure the sponge in place with a U-shaped suture.

To enhance the hemostatic effect, pre-moisten the sponge with a thrombin solution before application.

Adverse Reactions

Monitor for local or systemic allergic reactions, including skin rash, itching, or swelling. Be aware of the potential for secondary infection at the application site, which may present with increased pain, redness, or purulent discharge.

Discontinue use immediately if any adverse reactions occur and seek appropriate medical attention.

Contraindications

• Hypersensitivity to collagen, boric acid, nitrofural, or any other component of the formulation.
• Arterial bleeding, as this product is not intended for controlling hemorrhage from arteries.

Drug Interactions

Concurrent use with thrombin solutions, when used for additional moistening of the sponge, results in an enhanced hemostatic effect.

No other clinically significant drug interactions have been reported for topical application.

Overdose

Overdose from topical application is unlikely. Systemic absorption of components is minimal when used as directed.

Excessive application may delay wound healing or increase the risk of local reactions. Remove excess material if necessary.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.