Trombless^® (Gel) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

C05BA03 (Heparin sodium)

Active Substance

Heparin sodium

Dosage Form

Trombless^®

Gel for external use 1000 IU/1 g: tubes 10 g, 20 g, 30 g, 40 g or 50 g

Dosage Form, Packaging, and Composition

Gel for external use colorless or with a slight yellowish tint, transparent, with a specific odor.

	1 g
Heparin sodium	1000 IU*

Excipients: ethanol (ethyl alcohol) – 240 mg, methylparahydroxybenzoate (nipagin, methylparaben) – 1.2 mg, propylparahydroxybenzoate (nipasol, propylparaben) – 300 mcg, diethanolamine (2,2′-iminodiethanol) – up to 14 mg (to obtain a gel with pH from 7.5 to 8.7), carbomer (carbopol) – up to 15 mg, water (purified water) – up to 1 g.

* 8.33 mg with heparin activity of 120 IU/mg.

10 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
10 g – polyethylene tubes (1) – cardboard packs.
20 g – polyethylene tubes (1) – cardboard packs.
30 g – polyethylene tubes (1) – cardboard packs.
40 g – polyethylene tubes (1) – cardboard packs.
50 g – polyethylene tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antithrombotic action for topical use

Pharmacotherapeutic Group

Direct-acting anticoagulant for topical use

Pharmacological Action

Direct anticoagulant. It has anti-inflammatory, antiproliferative, anti-edematous, and analgesic effects. It reduces platelet aggregation, binds to antithrombin III, preventing the conversion of prothrombin to thrombin. It inhibits thrombin activity. It reduces hyaluronidase activity and increases the fibrinolytic properties of blood.

Trombless^® improves microcirculation and activates tissue metabolism, thereby accelerating the processes of resorption of hematomas and blood clots, ultimately restoring venous patency; clinically, this is accompanied by a pronounced analgesic and anti-inflammatory effect.

Pharmacokinetics

A small amount of heparin is absorbed from the skin surface into the systemic circulation. The C_max of the active substance in the blood is noted 8 hours after application. Heparin is excreted mainly in the urine. The T_1/2 is 12 hours.

Indications

Migrating phlebitis (including in chronic varicose disease and varicose ulcers);
Thrombophlebitis of superficial veins;
Local edema and aseptic infiltrates;
Complications arising after venous surgery;
Subcutaneous hematomas (including after phlebectomy);
Injuries, bruises of joints, tendons, muscle tissue.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
I80	Phlebitis and thrombophlebitis
I83.2	Varicose veins of lower extremities with ulcer and inflammation
I87.0	Postthrombotic syndrome
I87.2	Venous insufficiency (chronic) (peripheral)
T14.0	Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)

ICD-11 code	Indication
BD70.0	Superficial thrombophlebitis of lower extremities
BD70.Z	Superficial thrombophlebitis, unspecified
BD71.4	Deep vein thrombosis of lower extremity
BD74.Z	Chronic venous insufficiency of lower extremities, unspecified
BD7Z	Diseases of veins, unspecified
EH92	Dermatoses provoked by friction or mechanical impact
EH92.1	Blister due to friction
ND56.0	Superficial injury of unspecified body region

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the gel externally to intact skin over the affected area.

Use a dose of 3 to 10 cm of gel per application.

Apply with gentle rubbing motions until fully absorbed.

Repeat the application 1 to 3 times per day.

The frequency depends on the severity of the condition.

For the treatment of superficial thrombophlebitis, apply a thin layer along the inflamed vein.

For hematomas, bruises, and injuries, apply gel to the entire affected area.

In cases of hemorrhoidal vein thrombosis, do not apply directly.

Instead, apply the gel to a pad and use the pad on the affected area.

The duration of treatment is determined by the clinical response.

Discontinue use if skin hyperemia or signs of an allergic reaction occur.

Adverse Reactions

Local reactions: with prolonged use, skin hyperemia, allergic reactions are possible.

Contraindications

Ulcerative-necrotic, purulent processes on the skin;
Traumatic violation of the integrity of the skin;
Hypersensitivity to the components of the drug.

With caution increased tendency to bleeding, thrombocytopenia.

Use in Pregnancy and Lactation

The drug can be used during pregnancy and lactation if indicated.

Special Precautions

Trombless^® does not have a local irritant effect.

Overdose

Data on overdose of Trombless^® have not been provided.

Drug Interactions

Concomitant use of the drug with oral anticoagulants may cause an increase in prothrombin time.

Storage Conditions

List B. The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is available without a prescription.

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.

Medical Disclaimer