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henlius trastuzumab for injection 150mg per vial package

Description

 Indication & Scope

Trastuzumab for Injection (Henlius®)is a humanized monoclonal antibody targeting HER2. It binds selectively to the HER2 protein on tumor cells, inhibits HER2-mediated cell proliferation, induces antibody-dependent cellular cytotoxicity, and suppresses tumor growth and metastasis of HER2-overexpressing cancers.

  • Mechanism
    Target and block HER2 receptors, inhibit tumor cell proliferation, induce immune-mediated tumor cell death
  • Drug class
    Anti-tumor Monoclonal Antibody / HER2 Targeted Therapeutic
  • Clinical use
    Treatment of HER2-positive breast cancer and HER2-positive metastatic gastric cancer
Specification
Generic Name Trastuzumab for Injection
Brand Name Henlius®
Ingredient Trastuzumab
Dosage Form Injection
Package 150mg/vial
Conditions Treated HER2-positive early breast cancer, metastatic breast cancer; HER2-positive metastatic gastric adenocarcinoma and gastroesophageal junction adenocarcinoma
Taboos Hypersensitivity to trastuzumab or any excipients of the formulation
Place of origin Shanghai,China
Priscription Type Prescription Drug,Class B Medicare
Storage Conditions Store at 2℃-8℃, protected from light, do not freeze, avoid shaking
Manufacturer Shanghai Henlius Biotech, Inc.
Registration Authority National Medical Products Administration (NMPA)
Approval number S20200019
Date of Revision May 10, 2022
Shelf Life 36 months

How to use ?

Recommended Dose: 3-week regimen: initial loading dose 8mg/kg, followed by 6mg/kg every 3 weeks; weekly regimen: initial loading dose 4mg/kg, followed by 2mg/kg weekly, administered by intravenous infusion under physician supervision

 

Time: First infusion over 90 minutes; subsequent infusions may be shortened to 30 minutes if tolerated; do not give as rapid IV push

 

Interaction: Risk of cardiac toxicity when combined with anthracyclines; monitor cardiac function closely; do not mix with glucose solution

 

Side effects: Cardiac dysfunction, infusion reactions (fever, chills, dyspnea), diarrhea, asthenia, infection, interstitial lung disease, embryo-fetal toxicity

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

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

Must patients receive HER2 testing before use?

Yes, it is only indicated for confirmed HER2-positive patients.

What is the main serious adverse reaction of Trastuzumab for Injection to monitor?

Cardiac dysfunction (heart failure), severe infusion reactions and interstitial lung disease.

Can this medicine be given by rapid intravenous push?

No, it must be administered by slow intravenous infusion only.

Can pregnant women use trastuzumab?

Not recommended unless the benefit outweighs risk; effective contraception is required during treatment and for 7 months after the last dose.

Henlius® | Trastuzumab for Injection | Breast Cancer and Gastric Adenocarcinoma | DengYueRX

INN: Trastuzumab
Indications: Breast Cancer and Gastric Adenocarcinoma
Dosage Form: Injection
Strength: 150mg/Vial

Original price was: $425.55.Current price is: $361.71.

Low MOQ

WHO-GMP

Worldwide Delivery

Compliance and Regulatory Documents

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