GEMCITABINE 200 mg 10mL vial

Pyrimidine Antimetabolite – Antineoplastic Chemotherapy

ATC Code: L01BC05 | Prescription Only | Cytotoxic

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Product Description:

Gemcitabine is a nucleoside analog of deoxycytidine belonging to the antimetabolite class of chemotherapeutic agents. It is cell cycle–specific, primarily acting during the S-phase by being incorporated into DNA strands and inhibiting DNA synthesis, leading to programmed cell death. After intracellular phosphorylation, its active diphosphate and triphosphate forms inhibit ribonucleotide reductase and DNA polymerase, respectively. Gemcitabine is widely used for the treatment of solid tumors, particularly those of the pancreas, lung, bladder, breast, and ovary. The 200 mg vial presentation is suitable for low-to-moderate dose regimens, especially in weight-based protocols, palliative settings, or combination chemotherapy schedules.  

Available Presentation:

• Strength: 200 mg per vial
• Formulation: Lyophilized powder for reconstitution
• Packaging: Single-use glass vial in individual carton
• Reconstitution: 5 mL yields full solubilization of 200 mg active ingredient (non-preserved)
• Route of Administration: Intravenous infusion (short or prolonged)
• Storage Conditions: Store below 25°C; protect from moisture and light; reconstituted solution stable for limited hours as per product insert

Uses:

• Monotherapy or in combination regimens for advanced or metastatic cancers
• Used in both first-line and second-line protocols
• Commonly administered with cisplatin, carboplatin, or paclitaxel depending on tumor type
• Suitable for neoadjuvant, adjuvant, or palliative chemotherapy regimens

Indications:

• Pancreatic cancer: Locally advanced or metastatic adenocarcinoma
• Non-small cell lung cancer (NSCLC): First-line therapy in combination with platinum agents
• Bladder cancer: Locally advanced or metastatic, alone or with cisplatin
• Breast cancer: Metastatic breast cancer following anthracycline failure
• Ovarian cancer: Recurrent epithelial ovarian carcinoma, in combination with carboplatin
• Investigational/off-label use in cervical cancer, biliary tract cancers, and thymomas

Regulatory and Safety Profile:

• ATC Code: L01BC05
• Pharmacologic Class: Antimetabolite / Pyrimidine Analog
• Pregnancy Category: D – Known teratogen; contraindicated unless essential
• Common Adverse Effects: Myelosuppression (leukopenia, neutropenia, thrombocytopenia), nausea, fatigue, flu-like symptoms, liver enzyme elevation
• Serious Risks: Hemolytic-uremic syndrome (HUS), pulmonary toxicity (interstitial pneumonitis), capillary leak syndrome, renal toxicity
• Contraindications: Hypersensitivity to gemcitabine or excipients; severe myelosuppression
• Monitoring Parameters: CBC with differential, liver function tests, renal profile, pulmonary symptoms

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