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Description
PRODUCT DESCRIPTION:
Dactinomycin is a potent cytotoxic antibiotic used as part of essential chemotherapy regimens for pediatric and adult cancers.
It works by intercalating DNA strands and inhibiting RNA synthesis, making it vital in curative protocols for Wilms’ tumor, rhabdomyosarcoma, Ewing’s sarcoma, and gestational trophoblastic diseases.
This Pre-Filled Syringe (PFS) format ensures safety, precise dosing, and reduced risk of contamination during preparation—ideal for high-compliance oncology care centers and field hospitals.
Formulation & Presentation:
- Dosage Form: Aqueous Sterile Injectable (Sterile lyophilized or solution) – Pre Filled Syringe
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 500 MCG
- Route of Administration: Intravenous or as per clinical indication and severity. Reconstituted as per protocol (As per physician’s discretion or decision)
Therapeutic Indications:
- Wilms’ Tumor (in children)
- Rhabdomyosarcoma
- Ewing’s Sarcoma
- Gestational Trophoblastic Neoplasia (Choriocarcinoma)
- Testicular Cancer (as part of combination regimens)
Side Effects:
- COMMON:
- Nausea, vomiting
- Mucositis or stomatitis
- Bone marrow suppression (leukopenia)
- Fatigue
- Local injection site pain
- SERIOUS (RARE):
- Hepatotoxicity
- Severe bone marrow suppression
- Gastrointestinal perforation or hemorrhage
- Tissue necrosis if extravasation occurs
- Anaphylaxis or hypersensitivity reaction
- PRECAUTIONS:
- Administer under supervision of a qualified oncologist only
- Strictly avoid extravasation — use central line where possible
- Monitor CBC and liver function before each cycle
- Contraindicated during pregnancy and lactation
- Use caution in hepatic dysfunction and with concurrent radiotherapy
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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: Store between 2°C–8°C (Do not freeze). Requires cold-chain logistics. 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 and tertiary cancer care centers
- Government health agencies handling pediatric and reproductive cancers
- NGOs and Global Aid Missions in LATAM, Africa & South Asia
- Pharmaceutical importers seeking trusted, dossier-complete oncology injectables
- National tenders and programs focused on pediatric cancer protocols
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation for effective registration
- Trusted consortium network simplifying India’s pharma supply chain
- Multiple approved manufacturers for optimal country-specific sourcing
- Audited, compliant manufacturers across India
- Flexible branding, packaging & formulation options
- End-to-end logistics support with cold-chain capabilities
- Expertise in exporting specialty injectables & oncology drugs
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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