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sairuojin human interferon α1b for injection chronic hepatitis b and c 10μg 20μg 30μg 40μg 50μg 60μg

Description

 Indication & Scope

SaiRuoJin® Human Interferon α1b for Injection is indicated for the treatment of multiple viral infectious diseases and specific malignant tumors in adults and eligible pediatric patients. Approved viral indications include chronic hepatitis B, chronic hepatitis C, herpes zoster, condyloma acuminatum, epidemic hemorrhagic fever, and respiratory syncytial virus pneumonia in children.

  • Mechanism: Recombinant human interferon α1b is a broad-spectrum endogenous cytokine biologic. It binds specifically to interferon receptors on human cell membranes, inducing intracellular synthesis of multiple antiviral proteins to block viral transcription, replication, and assembly. It also inhibits abnormal proliferation of tumor cells, regulates body immune cell function, enhances macrophage and lymphocyte antiviral and anti-tumor activity, and suppresses inflammatory overreaction during viral infection.
  • Drug class: Recombinant human cytokine biologic agent; broad-spectrum antiviral interferon; anti-proliferative and immunomodulatory therapeutic drug.
  • Clinical use: Long-term standardized intervention for chronic viral hepatitis B and C to inhibit viral replication and delay liver fibrosis progression. It provides targeted treatment for skin and systemic herpes viral diseases, controls hematological malignancies and solid tumors via anti-proliferative effects, and acts as immune adjuvant therapy for severe recurrent viral infections unresponsive to conventional antiviral drugs.
Specification
Generic Name Human Interferon α1b for Injection
Brand Name SaiRuoJin
Ingredient Human Interferon α1b
Dosage Form Injection
Package 10μg*10 vials/box;

20μg*10 vials/box;

30μg*10 vials/box;

40μg*10 vials/box;

50μg*10 vials/box;

60μg*10 vials/box;

Conditions Treated Chronic hepatitis B and chronic hepatitis C with active viral replication; cutaneous and systemic herpes virus infectious diseases; specific hematological tumors including hairy cell leukemia and chronic myeloid leukemia; partial solid tumors including malignant melanoma and lymphoma
Taboos Severe hypersensitivity to human interferon α1b, human albumin, or any injection excipients; severe decompensated liver cirrhosis; severe cardiac insufficiency; uncontrolled autoimmune diseases; pregnant and breastfeeding women; patients with severe myelosuppression before treatment
Place of origin China
Prescription type Prescription-only
Storage Conditions Unopened lyophilized powder vials must be stored at 2°C–8°C under refrigeration, protected from direct sunlight, high temperature and repeated freezing and thawing. Reconstituted solution should be used immediately
Manufacturer KeXing Biopharmaceutical Co., Ltd.
Registration Authority National Medical Products Administration (NMPA), China
Approval number S10960058; S20033034; S10960059; S20033039; S10970070; S20033035
Approval Date Mar 11, 2025; Mar 12, 2025; Mar 13, 2025
Shelf Life 24 months

How to use ?

Recommended Dose: For chronic hepatitis B and C: 30–50 μg per injection, administered once daily for the first month, then changed to once every other day for a total treatment course of 6–12 months. For hairy cell leukemia: 30–50 μg once daily via subcutaneous injection for more than 6 consecutive months. For condyloma acuminatum: 10–50 μg injected locally at lesion base once every other day for 3–6 weeks.

 

Time: Injection can be performed at any fixed time of the day, independent of meal status. Maintain fixed dosing intervals for long-term treatment courses.

 

Instructions for use: Reconstitute lyophilized powder completely with matched sterile water for injection before use. Administer via subcutaneous or intramuscular injection; perform local lesion basal injection for cutaneous warts. Monitor routine blood cell count, liver function and thyroid function regularly throughout treatment. Discontinue dosing immediately if severe flu-like symptoms or severe myelosuppression occurs. Adjust dose or suspend treatment according to adverse reaction severity.

 

Interaction: Concurrent immunosuppressants reduce interferon-mediated immune activation and weaken antiviral and anti-tumor efficacy. Combined with antiviral nucleoside analogs produces synergistic viral suppression effect. Concurrent myelosuppressive drugs increase leukopenia and thrombocytopenia risk, requiring close hematological monitoring.

 

Side effects:

1. Common mild to moderate adverse reactions: influenza-like symptoms including fever, fatigue, myalgia, headache and chills, mild injection site redness and swelling, transient mild leukopenia.

2. Severe rare adverse reactions: severe persistent myelosuppression, severe liver function damage, aggravated autoimmune diseases, severe allergic anaphylaxis, severe cardiac arrhythmia.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What dual core therapeutic effects does Human Interferon α1b for Injection provide compared with common oral antiviral drugs?

Human Interferon α1b for Injection delivers both direct broad-spectrum viral replication inhibition and indirect immune regulation effects, while ordinary antiviral drugs only suppress viral activity without improving the body’s own antiviral immune function.

Why do patients need regular blood and liver function tests during long-term Human Interferon α1b for Injection treatment for chronic hepatitis?

Long-term interferon therapy may cause transient leukopenia and mild liver enzyme fluctuation; regular monitoring helps adjust dosage timely to avoid irreversible myelosuppression and liver injury.

Which patient groups are strictly prohibited from using Human Interferon α1b for Injection for antiviral or anti-tumor treatment?

Pregnant and breastfeeding women, patients with severe liver and cardiac insufficiency, uncontrolled autoimmune diseases, and severe drug hypersensitivity patients cannot receive this medication.

How should patients manage common flu-like fever and fatigue side effects after Human Interferon α1b for Injection?

Mild fever and fatigue are normal early treatment reactions that gradually relieve with continued medication; adequate rest and hydration are recommended, and severe persistent symptoms require medical dose adjustment.

SaiRuoJin® | Human Interferon α1b for Injection | Chronic Hepatitis B and C | DengYueRX

INN: Human Interferon α1b for Injection
Indications: Chronic Hepatitis B and C
Dosage Form: Injection
Strength: 50μg/vial

Original price was: $9.78.Current price is: $8.31.

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