Profetal^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Institute of New Medical Technologies CJS (Russia)

ATC Code

L04AX (Other immunosuppressants)

Active Substance

Human alpha-fetoprotein (Grouping name)

Dosage Forms

	Profetal®	Lyophilisate for the preparation of a solution for intravenous and intramuscular administration 75 mcg (1 dose): fl. 5 or 10 pcs.
		Lyophilisate for the preparation of a solution for intravenous and intramuscular administration 75 mcg (1 dose): amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of a solution for intravenous and intramuscular administration in the form of a powder or porous mass from white to grayish-white, hygroscopic.

Excipients : dextran (α-fetoprotein protein stabilizer).

Glass ampoules (5) – cardboard packs.
Glass ampoules (10) – cardboard packs.

Lyophilisate for the preparation of a solution for intravenous and intramuscular administration in the form of a powder or porous mass from white to grayish-white, hygroscopic.

Excipients : dextran (α-fetoprotein protein stabilizer).

Glass vials (5) – cardboard packs.
Glass vials (10) – cardboard packs.

Clinical-Pharmacological Group

Immunosuppressive drug

Pharmacotherapeutic Group

Immunomodulatory agent

Pharmacological Action

The drug is of natural origin with a wide spectrum of regulatory action. The properties of α-fetoprotein (the active substance of the drug) are due to its affinity for some key regulatory molecules in the body (including steroid hormones, prostaglandins, polyunsaturated fatty acids, extracellular matrix proteins). α-fetoprotein has antiestrogenic and immunosuppressive properties. As a transport protein, it carries bilirubin, fatty acids, and various drugs.

When used as part of complex therapy for nonspecific ulcerative colitis, Profetal^® helps reduce inflammatory-proliferative processes in the intestinal mucosa and allows reducing the doses of glucocorticosteroids.

When used as part of complex therapy for autoimmune thyroiditis (Hashimoto’s disease), the drug helps reduce the level of antibodies against thyroglobulin, restores the initially reduced level of T-cells (CD3+), increases the content of CD8+ T-lymphocytes, increases the initially reduced level of IgA and IgM, and increases the production of endogenous thyroxine and triiodothyronine.

When used as part of complex therapy for chronic occlusive vascular diseases, α-fetoprotein helps improve intravascular and tissue hemoperfusion and stimulates the healing of trophic ulcers. The use of the drug during endoprosthetics reduces the number of complications in the postoperative period. The effectiveness of the drug is due to the fact that α-fetoprotein is an inducer of endogenous prostaglandins E₁ and E₂, which relieve vascular spasms and block the development of autoimmune reactions.

Pharmacokinetics

Data on the pharmacokinetics of the drug Profetal^® have not been provided.

Indications

As part of complex therapy

• Nonspecific ulcerative colitis;
• Autoimmune thyroiditis (Hashimoto’s disease);
• Chronic occlusive vascular diseases (thromboangiitis, obliterating endarteritis, atherosclerosis, infectious-allergic arteritis).

ICD codes

Dosage Regimen

The drug is administered intramuscularly or intravenously. Immediately before use, the contents of the ampoule or vial are dissolved in 0.9% sodium chloride injection solution (5 ml – for intramuscular, 20 ml – for intravenous bolus injection, 200 ml – for intravenous drip infusion). The drug solution should be clear and colorless. The diluted drug should not be stored.

For intravenous bolus injection, the drug is recommended to be administered at a rate of 5 ml/min, for intravenous drip infusion – 60-100 drops/min.

For the treatment of nonspecific ulcerative colitis, the drug is administered intramuscularly or intravenously (bolus or drip) at a dose of 4 mcg/kg of body weight once a day for 30 days.

For autoimmune thyroiditis, Profetal^® is administered intramuscularly or intravenously (bolus) at a dose of 1 to 4 mcg/kg once a day for 30 days.

For occlusive vascular diseases, the drug is administered intramuscularly or intravenously (bolus or drip) at a dose of 2 mcg/kg once a day for 14-30 days.

Repeated courses of therapy are carried out according to indications with an interval of at least 30 days after the completion of the previous course.

Adverse Reactions

When used according to the indications and in recommended doses, reactions to the administration of the drug were not noted.

Contraindications

• Pregnancy;
• Lactation (breastfeeding);
• Hypersensitivity to blood components.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation.

Special Precautions

Complaints about the quality of the drug and packaging should be sent to the manufacturer’s address.

Overdose

Data on overdose of the drug Profetal^® have not been provided.

Drug Interactions

Data on drug interactions of the drug Profetal^® have not been provided.

Storage Conditions

The drug should be stored and transported in a dry place, protected from light and out of the reach of children, at a temperature from 2°C (35.6°F) to 8°C (46.4°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by 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.