Lavenum^® (Gel) Instructions for Use

Marketing Authorization Holder

Pollo, LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Contact Information

POLLO LLC (Russia)

ATC Code

C05BA03 (Heparin sodium)

Active Substance

Heparin sodium (Rec.INN registered by WHO)

Dosage Form

Lavenum^®

Gel for external use 1000 IU/1 g: tubes 30 g, 50 g or 100 g

Dosage Form, Packaging, and Composition

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

	100 g
Heparin sodium	100,000 IU

Excipients: methylparahydroxybenzoate (nipagin or methylparaben) – 0.2 g, ethanol (rectified ethyl alcohol) – 24 g, carbomer (carbopol) – 1 g, trolamine (triethanolamine) – 0.85 g, lavender essential oil – 0.1 g, purified water – up to 100 g.

30 g – aluminum tubes (1) – cardboard boxes.
50 g – aluminum tubes (1) – cardboard boxes.
100 g – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

A drug with antithrombotic action for topical use

Pharmacotherapeutic Group

Angioprotectors; preparations for the treatment of varicose veins; heparins or heparinoids for topical application

Pharmacological Action

A direct-acting anticoagulant for external use from the group of medium molecular weight heparins. It has a moderate anti-inflammatory, anti-edematous, and antithrombotic effect.

It blocks the formation of thrombin, inhibits the activity of hyaluronidase, and activates the fibrinolytic properties of blood. Heparin, gradually released from the gel and penetrating through the skin, reduces the inflammatory process and exerts an antithrombotic effect, improves microcirculation, and activates tissue metabolism, thereby accelerating the resorption of hematomas and thrombi and reducing tissue swelling.

Pharmacokinetics

An insignificant amount of heparin is absorbed from the skin surface into the systemic circulation. The C_max of heparin in the blood is observed 8 hours after application. Heparin is eliminated primarily by the kidneys, T_1/2 is 12 hours.

Indications

Superficial vein thrombophlebitis;
Localized infiltrates and edema of soft tissues;
Injuries of tendons and joints;
Contusions of soft tissues and joints;
Subcutaneous hematomas (including hematomas in closed fractures of the bones of the upper and lower extremities and after phlebectomy in patients with varicose veins).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
I80.0	Phlebitis and thrombophlebitis of superficial vessels of lower extremities
R60.0	Localized edema
T14.0	Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.3	Dislocation, sprain and strain of joint and ligament of unspecified body region

ICD-11 code	Indication
BD70.0	Superficial thrombophlebitis of lower extremities
EH92	Dermatoses provoked by friction or mechanical impact
EH92.1	Blister due to friction
MG29.0	Localized edema
ND56.0	Superficial injury of unspecified body region
ND56.3	Dislocation, sprain or strain 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 only.

Apply a thin layer to the affected skin area.

Use a 3-5 cm length of gel for a skin area 3-5 cm in diameter.

Rub the gel into the skin gently until fully absorbed.

Apply the gel 1 to 3 times daily.

Continue treatment daily until inflammatory phenomena resolve.

The typical treatment duration is 3 to 7 days.

For courses longer than 7 days, consult a physician for evaluation.

Avoid application on open wounds, mucous membranes, or areas with ulcerative-necrotic changes.

Do not use the gel if you have local purulent processes.

Discontinue use if skin hyperemia or allergic reactions occur.

Adverse Reactions

Possible skin allergic reactions, skin hyperemia.

Contraindications

Ulcerative-necrotic skin changes at the sites of intended gel application;
Traumatic impairment of skin integrity;
Reduced blood clotting;
Thrombocytopenia;
Childhood (no experience of use);
Hypersensitivity to the components of the drug.

With caution the drug should be used in cases of increased vascular permeability.

Use in Pregnancy and Lactation

The drug can be used during pregnancy and breastfeeding if the intended benefit to the mother outweighs the potential risk to the fetus.

Pediatric Use

The use of the drug in children is contraindicated (no experience of use).

Special Precautions

It is not recommended to use Lavenum^® in cases of bleeding and in the presence of local purulent processes, as well as to apply it to open wounds or mucous membranes.

The use of the gel is not recommended for deep vein thrombosis.

Effect on the ability to drive vehicles and operate machinery

No data.

Overdose

Overdose is unlikely due to the low absorption of the gel components.

Drug Interactions

The drug Lavenum^® should not be prescribed externally simultaneously with NSAIDs, antibiotics of the tetracycline group, or antihistamines.

It is not recommended to mix the gel with other topical agents.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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