Betaferon (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Bayer, AG (Germany)

Manufactured By

Boehringer Ingelheim Pharma, KG (Germany)

Packaging and Quality Control Release

BAYER, AG (Germany)

ATC Code

L03AB08 (Interferon beta-1b)

Active Substance

Interferon beta-1b

Interferon beta-1b (USAN)

Dosage Form

Betaferon

Lyophilizate for the preparation of solution for subcutaneous administration 9.6 million IU: fl. 5 or 15 pcs. in a set with solvent or solvent, vial adapter with needle and alcohol wipes

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of solution for subcutaneous administration in the form of a white lyophilized mass; the supplied solvent is a clear, practically colorless solution; the prepared solution is from slightly opalescent to opalescent, colorless or light yellow in color.

1 ml of the prepared solution contains 0.25 mg (8 million IU) of recombinant interferon beta-1b (IFN-beta-1b).
1 ml of aqueous solvent for the preparation of injection solution contains 5.4 mg of sodium chloride.

Excipients : human albumin – 15 mg, mannitol – 15 mg.

Solvent sodium chloride solution 0.54% (1.2 ml).

9.6 million IU – type I glass vials (1) in a set with solvent (1.2 ml syringe), vial adapter with needle and alcohol wipes (2 pcs.) – cardboard packs with insert (5) – cardboard boxes with first opening control (perforation or sticker).
9.6 million IU – type I glass vials (1) in a set with solvent (syringe-ampoules), vial adapter with needle and alcohol wipes (2 pcs.) – cardboard packs with insert (15) – cardboard boxes with first opening control (perforation or sticker).

Clinical-Pharmacological Group

Interferon. A drug used for multiple sclerosis

Pharmacotherapeutic Groups

• Multiple sclerosis treatment agent
• Cytokine

Pharmacological Action

Interferon. It is a non-glycosylated form of human interferon beta, with serine at position 17. It inhibits virus replication, reduces the formation of gamma-interferon and activates the function of T-suppressors, thereby weakening the action of antibodies against the main components of myelin.

Indications

Relapsing-remitting multiple sclerosis to reduce the frequency and severity of disease exacerbations.

ICD codes

Dosage Regimen

Administer subcutaneously at a dose of 8 million IU.

Inject every other day.

Initiate therapy under medical supervision for proper injection technique and management of potential adverse reactions.

Prepare the solution for injection immediately prior to administration using the supplied solvent and components.

Rotate injection sites with each administration to minimize the risk of local reactions and lipoatrophy.

Continue treatment as long-term therapy.

Regularly monitor for the development of injection site reactions, including skin necrosis.

Routinely assess clinical status and perform laboratory monitoring, including complete blood count and liver function tests.

Adverse Reactions

Flu-like syndrome, depression, moderate leukopenia are possible; local – pain, hyperemia, rarely – thinning of subcutaneous fat, necrosis.

Contraindications

Hypersensitivity to interferons and albumin; pregnancy, breastfeeding period; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Use with caution in patients with decompensated liver disease.

Use in Renal Impairment

Use with caution in patients with severe renal failure.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

During treatment, peripheral blood counts, calcium levels, and plasma liver enzyme activity should be regularly monitored.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.