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Gemcitabine Hydrochloride for Injection 1g
Composition:
Each vial contains:
- Gemcitabine Hydrochloride - 1g
- Excipients: None or specified buffering agents (if applicable)
Description:
Gemcitabine Hydrochloride is a nucleoside analog chemotherapy drug that inhibits DNA synthesis, leading to cell death in rapidly dividing tumor cells. It is used to treat various cancers, including non-small cell lung cancer (NSCLC), pancreatic cancer, breast cancer, ovarian cancer, and bladder cancer.
Indications:
- Non-Small Cell Lung Cancer (NSCLC) (alone or in combination with cisplatin)
- Pancreatic Cancer (first-line treatment for advanced/metastatic cases)
- Breast Cancer (in combination with paclitaxel for metastatic cases)
- Ovarian Cancer (with carboplatin for recurrent cases)
- Bladder Cancer (with cisplatin for locally advanced/metastatic cases)
Dosage & Administration:
Intravenous (IV) Infusion Only
- Standard dose: 1,000-1,250 mg/m² over 30 minutes, depending on cancer type
- Frequency: Once weekly or on specific days in a chemotherapy cycle
- Dilution: Reconstitute 1g vial with 25mL sterile saline (0.9% NaCl, non-preserved) to a concentration of 40mg/mL
Administration Guidelines:
- Do not administer as IV bolus (risk of increased toxicity)
- Monitor CBC counts before each dose
- Adjust dose in case of hematologic toxicity
Contraindications:
- Hypersensitivity to gemcitabine or any excipient
- Severe bone marrow suppression
- Pregnancy and lactation (unless benefits outweigh risks)
Precautions:
- Monitor blood cell counts regularly (risk of myelosuppression)
- Use with caution in patients with hepatic or renal impairment
- Avoid live vaccines during treatment
- Hydration recommended to prevent kidney toxicity
Adverse Reactions:
- Common: Fatigue, nausea, vomiting, fever, rash, anemia, leukopenia, thrombocytopenia
- Serious: Pulmonary toxicity, hepatotoxicity, renal toxicity, infusion reactions
Drug Interactions:
- Platinum-based chemotherapy (cisplatin, carboplatin): Increased hematologic toxicity
- Radiation therapy: Potential radiation recall syndrome
- Warfarin: Increased risk of bleeding (monitor INR closely)
Overdose & Management:
- Symptoms: Severe myelosuppression, liver/kidney dysfunction, bleeding
- Treatment: Supportive care, blood transfusions if needed, symptomatic management
Storage Conditions:
- Store at 15°C-30°C
- Reconstituted solution: Use immediately or within 24 hours if refrigerated
- Protect from light

