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Description
PRODUCT DESCRIPTION:
Amifostine is a cytoprotective adjuvant used to reduce the cumulative toxicity of chemotherapy and radiation therapy.
It is particularly effective in protecting normal tissues from the harmful effects of alkylating agents and platinum-based chemotherapies, without reducing the anti-tumor efficacy.
The Amifostine Injection 500 MG Pre-Filled Syringe is a ready-to-administer, sterile solution that offers accuracy, speed, and sterility—making it ideal for use in oncology centers and high-dependency units. Its pre-filled syringe format reduces preparation time and minimizes the risk of dosing errors.
Formulation & Presentation:
- Dosage Form: Injectable Solution – Pre Filled Syringe
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths: 500 MG of Amifostine Per Syringe
- Route of Administration: Intravenous Infusion Slow IV or as per clinical indication and severity (As per physician’s discretion or decision)
Therapeutic Indications:
- Protection against cumulative renal toxicity associated with cisplatin in patients undergoing chemotherapy
- Reduction of xerostomia (dry mouth) in patients receiving postoperative radiation therapy for head and neck cancer
- Used selectively for myeloprotection and neuroprotection in oncology
Side Effects:
- COMMON:
- Nausea and vomiting
- Hypotension (transient)
- Flushing or warm sensation
- Dizziness or fatigue
- SERIOUS (RARE):
- Severe hypotension requiring intervention
- Allergic reactions (rash, bronchospasm, anaphylaxis)
- Seizures
- Loss of consciousness (extremely rare)
- PRECAUTIONS:
- Administer under strict medical supervision in a controlled hospital setting
- Pre-hydration and blood pressure monitoring are essential
- Contraindicated in patients with unstable angina or recent cerebrovascular accident
- Antiemetic premedication recommended to prevent nausea/vomiting
- Not recommended during pregnancy or lactation unless absolutely necessary
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TECHNICAL INFORMATION
Product Specifications
- HSN Code: To be assigned per international classification standards & import jurisdiction
- Weight: Approx. 40g per Carton (With Packaging)
- Dimensions: (15 x 1 x 8 CMS)
- Shelf Life: 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications
- Storage: 2–8°C (Do not freeze). Cold-chain logistics required. Protect from moisture and direct sunlight. Use strictly as per label guidelines.
Regulatory Status & Supply Information
- Regulatory Status: WHO-GMP Compliant Manufacturing. Further certifications available on request
- Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
- Stability: Compliant
- MOQ: Negotiable, based on market & registration status
- Export Options: Available for private label, institutional supply, or branded export
Who Should Source This Product?
- Oncology Hospitals & Chemotherapy Centers using platinum-based regimens
- Tertiary Cancer Institutions & Radiation Therapy Units
- Government Oncology Programs & Public Health Procurement Bodies
- Humanitarian Health Missions & NGO-Supported Cancer Care Programs
- Pharmaceutical Distributors specializing in oncology support products and cold-chain injectables
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation for effective registration in global markets
- Trusted consortium network simplifying India’s pharma supply chain
- Multiple approved manufacturers matched to country-specific requirements
- Network of audited, compliant manufacturers across India
- Customizable branding, packaging & formulation flexibility
- End-to-end logistics coordination & support
- Deep expertise in exporting specialty injectables & regulated products
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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