Irinotecan Inj 40 MG/2 ML, 100 MG/5 ML Pre-Filled Syringe

Categories:Oncology, Topoisomerase I Inhibitor SKU: 00001-84

Description

PRODUCT DESCRIPTION:

Irinotecan is a semi-synthetic camptothecin derivative used extensively in the treatment of metastatic colorectal cancer and other solid tumors.

It functions by inhibiting DNA topoisomerase I, resulting in DNA damage and cell death in rapidly dividing tumor cells.

Offered in ready-to-administer pre-filled syringes, it enhances dosing accuracy and minimizes exposure risks in clinical settings.

Formulation & Presentation:

Dosage Form: Sterile Injectable
Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
Available Strengths:
- 40 MG/ 2ML
- 100 MG/ 5 ML
Route of Administration: Intravenous after dilution or as per clinical indication and severity. Reconstituted as per protocol Intravenous infusion. To be administered under supervision of a qualified oncologist or day-care oncology units. (As per physician’s discretion or decision) Administered as continuous infusion, typically as part of combination chemotherapy regimens

Therapeutic Indications:

Side Effects:

COMMON:
- Diarrhea (early and late-onset)
- Nausea and vomiting
- Myelosuppression (neutropenia)
- Abdominal cramping
- Alopecia
- Fatigue
SERIOUS (RARE):
- Severe neutropenic fever
- Life-threatening diarrhea
- Interstitial lung disease
- Anaphylaxis or hypersensitivity
- Hepatic dysfunction
PRECAUTIONS:
- Antidiarrheal support (loperamide) must be available during treatment
- Neutrophil counts must be monitored; delay or dose-reduce in neutropenia
- Use cautiously in patients with hepatic impairment
- Ensure adequate hydration during and post-infusion
- Administer only in oncology-trained healthcare settings

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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:
- Pre-Filled Syringes: Store below 2°C–8°C
- Lyophilized Injection: Store below 25°C
- Do not freeze. Requires cold-chain logistics. Protect from moisture and direct sunlight. Use strictly as per label guidelines.

Regulatory Status: WHO-GMP Compliant Manufacturing. COA, MSDS, Stability Data, Manufacturing Batch Record & Dossier Support available on request
Export Dossiers: Available in CTD/eCTD formats
Stability: Compliant
MOQ: Negotiable based on market & registration status
Export Options: Available for private label, institutional supply, or branded export

Hospital oncology departments requiring precision-based cytotoxic infusions
Government tenders procuring essential anti-cancer medications
NGOs and humanitarian agencies supporting cancer treatment access in low-income regions
Importers and distributors seeking reliable, ready-to-administer injectable oncology drugs
LATAM, Africa, and South Asia markets sourcing proven oncology APIs with strong supply chain support