Biopin^® (Ointment) Instructions for Use

Marketing Authorization Holder

Biopin Pharma, LLC (Russia)

Contact Information

Biopin Pharma LLC (Russia)

ATC Code

D11AX (Other drugs used in dermatology)

Dosage Forms

	Biopin®	Ointment for external use 5%: tubes 40 g, 50 g or 100 g, jars 30 g, 40 g or 50 g
		Ointment for external use 10%: tubes 40 g, 50 g or 100 g, jars 30 g, 40 g or 50 g
		Ointment for external use 20%: tubes 40 g, 50 g or 100 g, jars 30 g, 40 g or 50 g

Dosage Form, Packaging, and Composition

Ointment for external use 5% from light yellow to dark yellow in color with a faint odor of pine resin and beeswax.

Excipients: beeswax, edible rendered pork fat, refined olive oil.

30 g – dark glass jars (1) – cardboard packs.
40 g – polypropylene jars (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
40 g – dark glass jars (1) – cardboard packs.
50 g – dark glass jars (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.

Ointment for external use 10% from light yellow to dark yellow in color with a faint odor of pine resin and beeswax.

Excipients: beeswax, edible rendered pork fat, refined olive oil.

30 g – dark glass jars (1) – cardboard packs.
40 g – polypropylene jars (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
40 g – dark glass jars (1) – cardboard packs.
50 g – dark glass jars (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.

Ointment for external use 20% from light yellow to dark yellow in color with a faint odor of pine resin and beeswax.

Excipients: beeswax, edible rendered pork fat, refined olive oil.

30 g – dark glass jars (1) – cardboard packs.
40 g – dark glass jars (1) – cardboard packs.
40 g – polypropylene jars (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – dark glass jars (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory, analgesic, and locally irritant action

Pharmacotherapeutic Group

Local irritant of plant origin

Pharmacological Action

An antiseptic drug. The drug has antimicrobial, anti-inflammatory, wound-healing, and immunomodulatory effects.

Active against gram-positive bacteria Staphylococcus aureus, Streptococcus pyogenes; gram-negative bacteria Escherichia coli, Pseudomonas aeroginosa.

Moderately active against fungi.

The drug affects redox processes and activates low-molecular-weight components of the cell’s antioxidant system. It increases the phagocytic index and phagocytic number indicators, characterizing the number of phagocytic cells per 1 leukocyte. The drug enhances the functional activity of human blood neutrophilic leukocytes and increases the production of tumor necrosis factor.

The drug has an inhibitory effect on the level of primary products of lipid peroxidation, diene conjugates, and malondialdehyde.

Pharmacokinetics

Data on the pharmacokinetics of Biopin^® are not available.

Indications

Biopin^® 5%

• Clean and infected burns of all degrees;
• Trophic ulcers with moderate exudation;
• Long-term non-healing post-traumatic wounds without purulent process;
• Bedsores with a small amount of wound discharge;
• Atopic dermatitis;
• Eczema;
• Ichthyosis;
• Keratoderma;
• Cracks of the palms, plantar surface of the feet;
• Herpes at the initial erythematous stage.

Biopin^® 10%

• Postoperative and post-traumatic wounds in the granulation stage (bedsores, trophic ulcers);
• Purulent-inflammatory diseases of the skin and subcutaneous tissue in the infiltration stage (pyoderma /staphylococcal, streptococcal, atypical/);
• Allergic dermatitis;
• Psoriasis;
• Seborrhea;
• Herpes;
• Acne;
• Circumscribed neurodermatitis;
• Dermatomycoses.

Biopin^® 20%

Used for inflammatory diseases of soft tissues and joints, traumatic injuries of the musculoskeletal system, for diseases of the peripheral nervous system accompanied by pain syndrome and limited microcirculation disorders

• Osteochondrosis with neurological manifestations;
• Osteoarthritis;
• Myositis;
• Myalgia;
• Neuralgia;
• Tunnel neuropathy;
• Arthrosis;
• Arthritis;
• Polyarthritis;
• Arthralgia;
• Spondylitis;
• Psoriatic arthritis.

ICD codes

Dosage Regimen

Biopin^® 5%

Before applying the ointment, the wound derivative should be mechanically removed, followed by washing the wound surface, after which sterile gauze napkins with the ointment are applied. Dressing changes are performed daily or every other day depending on the degree of saturation of the napkins with wound discharge.

The dose of the drug depends on the size of the wound surface and is 2-5 g for a wound area of 5×5 cm. For extensive wounds and good tolerance, larger amounts of the ointment may be used, but not more than 100 g.

After removing the dressing, a small amount of wax remains on the skin around the wound, which serves as a kind of protective barrier for healthy areas of the skin from the damaging effects of wound discharge, which is especially important in the treatment of intestinal fistulas, extensive trophic ulcers, and post-traumatic wounds.

Treatment should be continued until the signs of inflammation have completely and persistently disappeared.

Biopin^® 10%

Before applying the ointment, the wound derivative should be mechanically removed, followed by washing the wound surface, after which sterile gauze napkins with the ointment are applied. Dressing changes are performed every 1-2 days (so as not to injure the granulation tissue and epithelial cells).

For dermatoses, the ointment is used as part of complex therapy. The ointment is applied in a thin layer to the affected areas of the skin 2-3 times/day after treating the skin with an antiseptic.

For herpes, after treatment with acyclovir, the ointment is applied in a thin layer 3-4 times/day.

For psoriasis, the ointment is used 2 times/day as part of complex therapy. The ointment is not used for progressive exudative processes.

For the prevention and treatment of mycosis of the feet and hands to accelerate healing in the area of the nail bed after onychectomy, resolve edema, and restore microcirculation in tissues, the ointment on sterile gauze napkins is additionally prescribed along with antifungal therapy.

The dose of the drug depends on the size of the wound surface and is 2-5 g for a wound area of 5×5 cm. For extensive wounds and good tolerance, larger amounts of the ointment may be used, but not more than 100 g.

After removing the dressing, a small amount of wax remains on the skin around the wound, which serves as a kind of protective barrier for healthy areas of the skin from the damaging effects of wound discharge.

Treatment should be continued until the signs of inflammation have completely and persistently disappeared.

Biopin^® 20%

For the treatment of inflammatory and post-traumatic diseases of the musculoskeletal system and peripheral nervous system, the ointment is applied in a thin layer (approximately 1 cm) onto a dense cotton fabric, which is applied overnight to the affected area.

For the treatment of osteochondrosis, myositis, neuralgia, the ointment is rubbed along the spine and painful muscles. The course of treatment is 7-14 procedures. For severe osteochondrosis, traditional treatment methods are additionally used.

For the treatment of psoriatic arthritis, the ointment is applied 2 times/day for 6-7 days using bandages.

The drug consumption is 2-5 g. For extensive surfaces and good tolerance of the drug, a larger amount of the drug may be used.

Treatment should be continued until a stable therapeutic effect is achieved.

Adverse Reactions

Local reactions redness, burning, itching (in case of increased individual sensitivity).

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

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

Special Precautions

If a pronounced local reaction develops, the use of the ointment should be discontinued and the affected surface should be treated with a 40% solution of ethyl alcohol or water with soap.

It should be taken into account that specific antibiotic therapy and physiotherapeutic treatment increase the effectiveness of the drug.

Overdose

There have been no reports of overdose with Biopin^® to date.

Drug Interactions

Clinically significant drug interactions of Biopin^® with other medicinal products have not been established.

Storage Conditions

The drug should be stored in a dry place protected from light at a temperature from 10°C (50°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 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.