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Vinorelbine (Vinorelbine)

Trade Name : Vinorelbine

Sagent Pharmaceuticals

INJECTION, SOLUTION

Strength 10 mg/mL

VINORELBINE TARTRATE Vinca Alkaloid [EPC],Vinca Alkaloids [CS]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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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 Vinorelbine (Vinorelbine) which is also known as Vinorelbine and Manufactured by Sagent Pharmaceuticals. It is available in strength of 10 mg/mL per ml. Read more

Vinorelbine (Vinorelbine) 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
  • WARNING: MYELOSUPPRESSION
  • See full prescribing information for complete boxed warning.
  • Severe myelosuppression resulting in serious infection, septic shock, and death can occur ().
  • Decrease the dose or withhold vinorelbine in accord with recommended dose modifications ().
  • Vinorelbine Injection is indicated:n
  • Vinorelbine Injection is a vinca alkaloid indicated:n
  • In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) ()n
  • As a single agent for first-line treatment of patients with metastatic NSCLC ()n
  • No data
  • In combination with cisplatin: 25 to 30 mg/m as an intravenous injection or infusion once weekly ()n
  • Single agent: 30 mg/m as intravenously once a week ()n
  • Adjust dose in patients with decreased neutrophil counts or elevated serum total bilirubin ()n
  • Vinorelbine Injection, USP: 1 mL (10 mg per 1 mL) and 5 mL (50 mg per 5 mL) clear colorless to pale yellow solution in single-dose vial.n
  • Vinorelbine Injection: 10 mg per 1 mL and 50 mg per 5 mL in single-dose vial ()n
  • Nonen
  • Nonen
  • No data
  • Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment ()n
  • Severe constipation and bowel obstruction, including necrosis and perforation, occur. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus ()n
  • Extravasation can result in severe tissue injury, local tissue necrosis and/or thrombophlebitis. Immediately stop vinorelbine and institute recommended management procedures ()n
  • Neurologic Toxicity: Severe sensory and motor neuropathies occur. Monitor patients for new or worsening signs and symptoms of neuropathy. Discontinue for Grade 2 or greater neuropathy ()n
  • Pulmonary toxicity and respiratory failure occur. Interrupt vinorelbine in patients who develop unexplained dyspnea or have any evidence of pulmonary toxicity. Permanently discontinue for confirmed interstitial pneumonitis or ARDS ()n
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception (, , )n
  • The following clinically significant adverse reactions are described elsewhere in the labeling:n
  • Most common adverse reactions (incidence u2265 20%) are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy ()n n
  • Exercise caution in patients concurrently taking drugs known to inhibit CYP3A. Concurrent administration of vinorelbine with a CYP3A inhibitor may cause an earlier onset and/or an increased severity of adverse reactions.n
  • Inhibitors of CYP3A4: May cause earlier onset and/or increased severity of adverse reactions ()n
  • No data
  • Lactation: Advise not to breastfeed ()n
  • There is no known antidote for overdoses of vinorelbine. Overdoses involving quantities up to 10 times the recommended dose (30 mg/m) have been reported. The adverse reactions described were consistent with those listed in the section, including paralytic ileus, stomatitis and esophagitis. Bone marrow aplasia, sepsis and paresis have also been reported. Fatalities have occurred following overdose of vinorelbine. If overdosage occurs, general supportive measures together with appropriate blood transfusions, growth factors and antibiotics should be instituted as deemed necessary by the physician.n
  • Vinorelbine Injection, USP contains vinorelbine, a semi-synthetic vinca alkaloid. The molecular formula for vinorelbine tartrate is CHNOu20222CHO It has a molecular weight of 1079.11. The structural formula is as follows:n
  • Vinorelbine tartrate is a white to light yellow amorphous powder. It is easily soluble in water, very soluble in methanol and practically insoluble in hexane.n
  • Vinorelbine Injection, USP is a sterile nonpyrogenic aqueous solution for intravenous use. Each milliliter of solution contains 10 mg vinorelbine equivalent to 13.85 mg vinorelbine tartrate in Water for Injection, USP. The pH of Vinorelbine Injection, USP is approximately 3.5.n
  • No data
  • The carcinogenic potential of vinorelbine has not been studied. Vinorelbine has been shown to affect chromosome number and possibly structure (polyploidy in bone marrow cells from Chinese hamsters and a positive micronucleus test in mice). It was not mutagenic in the Ames test and gave inconclusive results in the mouse lymphoma TK Locus assay.n
  • Vinorelbine did not affect fertility to a statistically significant extent when administered to rats on either a once-weekly (9 mg/m, approximately one third the human dose) or alternate-day schedule (4.2 mg/m, approximately 0.14 times the human recommended dose) prior to and during mating. In male rats, administration of vinorelbine twice weekly for 13 or 26 weeks at dose levels of 2.1 and 7.2 mg/m (approximately 0.07 and 0.24 times the recommended human dose), respectively, resulted in decreased spermatogenesis and prostate/seminal vesicle secretion.n
  • No data
  • No data
  • Vinorelbine Injection, USP is supplied as follows:n
  • Vinorelbine Injection, USP is a clear, colorless to pale yellow aqueous solution.n
  • Storage Conditionsn
  • Do not freeze. Protect from light.
  • Unopened vials of Vinorelbine Injection, USP are stable at 25u00b0C (77u00b0F) for up to 72 hours.n
  • Vinorelbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.n
  • Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
  • No data
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Vial Labeln
  • NDC 25021-204-01n
  • Vinorelbine Injection, USPn
  • 10 mg per mLn
  • Rx onlyn
  • 1 mL Single-Use Vialn
  • Must Be Dilutedn
  • For Intravenous Use Onlyn
  • Caution: Cytotoxic Agentn

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

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Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

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Clinical Trials Supply

Clinical Trials Supply

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