Gemcitabine Hydrochloride (Gemzar)

Trade Name : Gemzar

Eli Lilly and Company

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 200 mg/5mL

GEMCITABINE HYDROCHLORIDE Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Gemcitabine Hydrochloride (Gemzar) which is also known as Gemzar and Manufactured by Eli Lilly and Company. It is available in strength of 200 mg/5mL per ml. Read more

Gemcitabine Hydrochloride (Gemzar) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • GEMZAR is a nucleoside metabolic inhibitor indicated:n
  • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ()n
  • 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. ()n
  • in combination with cisplatin, for the treatment of non-small cell lung cancer. ()n
  • as a single agent for the treatment of pancreatic cancer. ()n
  • GEMZAR is for intravenous use only.n
  • Ovarian Cancer: 1000u00a0mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. ()n
  • Breast Cancer: 1250u00a0mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. ()n
  • Non-Small Cell Lung Cancer: 1000u00a0mg/m over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250u00a0mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. ()n
  • Pancreatic Cancer: 1000u00a0mg/m over 30 minutes once weekly for the first 7 weeks, then one week rest, then once weekly for 3 weeks of each 28-day cycle. ()n
  • For injection: 200 mg gemcitabine or 1 g gemcitabine as a sterile white to off-white lyophilized powder in a single-dose vial for reconstitution.n
  • For injection: 200 mg or 1 gram lyophilized powder in single-dose vials for reconstitution. ()n
  • GEMZAR is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis .n
  • Patients with a known hypersensitivity to gemcitabine. ()n
  • No data
  • Schedule-Dependent Toxicity: Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly. ()n
  • Myelosuppression: Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression. (, )n
  • Pulmonary Toxicity and Respiratory Failure: Discontinue GEMZAR for unexplained dyspnea or other evidence of severe pulmonary toxicity. ()n
  • Hemolytic Uremic Syndrome (HUS): Monitor renal function prior to initiation and during treatment. Discontinue GEMZAR for HUS or severe renal impairment. ()n
  • Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment. Discontinue GEMZAR for severe hepatic toxicity. ()n
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females and males of reproductive potential to use effective contraception. (, )n
  • Exacerbation of Radiation Therapy Toxicity: May cause severe and life-threatening toxicity when administered during or within 7 days of radiation therapy. ()n
  • Capillary Leak Syndrome: Discontinue GEMZAR. ()n
  • Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue GEMZAR. ()n
  • The following clinically significant adverse reactions are described elsewhere in the labeling:n
  • The most common adverse reactions for the single agent (u226520%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. ()n
  • Lactation: Advise not to breastfeed. ()n
  • There is no known antidote for overdoses of gemcitabine. Myelosuppression, paresthesias, and severe rash were the principal toxicities seen when a single dose as high as 5700u00a0mg/m was administered by intravenous infusion over 30 minutes every 2 weeks to several patients in a dose-escalation study. In the event of suspected overdose, monitor with appropriate blood counts and provide supportive therapy, as necessary.n
  • Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2u2032-deoxy-2u2032,2u2032-difluorocytidine monohydrochloride (u03b2-isomer) with the following structural formula:n
  • The empirical formula for gemcitabine hydrochloride is CHFNO u2022 HCl. It has a molecular weight of 299.66 g/mol.n
  • Gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.n
  • GEMZAR (gemcitabine) is a sterile white to off-white lyophilized powder and available as 200 mg and 1 g single-dose vials for intravenous use only. Each 200u00a0mg vial contains 200 mg gemcitabine (equivalent to 227.7 mg gemcitabine hydrochloride), 200 mg mannitol and 12.5 mg sodium acetate. Each 1 g vial contains 1 g gemcitabine (equivalent to 1.139 g gemcitabine hydrochloride), 1 g mannitol, and 62.5 mg sodium acetate. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.n
  • No data
  • Long-term animal studies to evaluate the carcinogenic potential of GEMZAR have not been conducted. Gemcitabine was mutagenic in an in vitro mouse lymphoma (L5178Y) assay and was clastogenic in an in vivo mouse micronucleus assay. Gemcitabine intraperitoneal doses of 0.5u00a0mg/kg/day [about 1/700 the 1000 mg/m clinical dose based on body surface area (BSA)] in male mice resulted in moderate to severe hypospermatogenesis, decreased fertility, and decreased implantations. In female mice, fertility was not affected but maternal toxicities were observed at 1.5u00a0mg/kg/day administered intravenously (about 1/200 the 1000 mg/m clinical dose based on BSA) and fetotoxicity or embryolethality was observed at 0.25u00a0mg/kg/day administered intravenously (about 1/1300 the 1000 mg/m clinical dose based on BSA).n
  • No data
  • No data
  • GEMZAR (gemcitabine) is a sterile white to off-white lyophilized powder available in single-dose vials individually packaged in a carton containing 200 mg or 1 g gemcitabine:n
  • GEMZAR is a cytotoxic drug. Follow applicable special handling and disposal procedures.n
  • Store at controlled room temperature 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F) [see USP Controlled Room Temperature].n
  • No data
  • PACKAGE CARTON u2013 Gemzar 200 mg carton 1ct
  • Single-Dose Vialn
  • VL7501n
  • Discard Unused Portionn
  • NDC 0002-7501-01n
  • GEMZARn
  • gemcitabine for injectionn
  • 200 mg/vialn
  • Rx onlyn
  • Must be reconstituted and further diluted
  • For Intravenous Use Onlyn
  • www.gemzar.comn
  • Lillyn
  • PACKAGE CARTON u2013 Gemzar 1 g carton 1ct
  • Single-Dose Vialn
  • VL7502n
  • Discard Unused Portionn
  • NDC 0002-7502-01n
  • GEMZARn
  • gemcitabine for injectionn
  • 1 g/vialn
  • Rx onlyn
  • Must be reconstituted and further diluted
  • For Intravenous Use Onlyn
  • www.gemzar.comn
  • Lillyn

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