Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.
From the official U.S. FDA label for gemcitabine (gemcitabine hydrochloride), the active ingredient registered with NAFDAC.
Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. …
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications ( 4 )] Schedule-Dependent Toxicity [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions ( 5.4 )] Hemolytic Uremic Syndrome [see Warnings and Precautions ( 5.5 )] Hepatic Toxicity [see Warnings and Precautions ( 5.6 )] Exacerbation of Radiation Therapy Toxicity [see Warnings and Precautions ( 5.8 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.9 )] Posterior Re …
Gemcitabine injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions ( 6.1 )] . Patients with a known hypersensitivity to gemcitabine. ( 4 )
Schedule-Dependent Toxicity: Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly. ( 5.1 ) Myelosuppression: Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression. ( 5.2 ) Severe Cutaneous Adverse Reactions (SCARs) Permanently discontinue gemcitabine injection if SCARs occur. ( 5.3 ) Pulmonary Toxicity and Respiratory Failure: Discontinue gemcitabine injection for unexplained dyspnea or other evidence of severe pulmonary toxicity. ( 5.4 ) Hemolytic Uremic Syndrome (HUS): Monitor renal function prior to initiation and during treatment. …
8.1 Pregnancy Risk Summary Based on animal data and its mechanism of action, gemcitabine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on the use of gemcitabine in pregnant women. In animal reproduction studies, gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see Data ) . …
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Gemcitabine Sandoz 10 mg/mL Concentrate Solution for Infusion contains Gemcitabine (Gemcitabine Hydrochloride) (10 mg/mL), as concentrate for solution for infusion, according to its NAFDAC registration record.
Yes. Gemcitabine Sandoz 10 mg/mL Concentrate Solution for Infusion is listed on the NAFDAC register under registration number B4-7108, and its registration is active as of 27 October 2026.
No WHO falsified or substandard medical product alert currently matches Gemcitabine Sandoz 10 mg/mL Concentrate Solution for Infusion in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number B4-7108, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless an (Summarised from the official U.S. FDA label for gemcitabine (gemcitabine hydrochloride). Always follow your doctor or pharmacist.)
Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.