Trade Name: Zyvox

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Fresenius Kabi Norge As

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 600 mg/300mL

Storage and handling

LINEZOLID Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • ZYVOX is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. ZYVOX is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [n n n n n n ].n nn n nn
  • ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (n n n n n n ); Community-acquired pneumonia (n n n n n n ); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (n n n n n n ); Uncomplicated skin and skin structure infections (n n n n n n ); Vancomycin-resistant n n n n n n infections. (n n n n n n )n nn n nn
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX formulations and other antibacterial drugs, ZYVOX should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (n n n n n n )n nn n nn
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  • ZYVOX I.V. Injection: 300-mL (600 mg linezolid) single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free.
  • Injection: 600 mg linezolid. (n n n n n n ) n n n n n n
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  • Known hypersensitivity to linezolid or any of the other product components. (n n n n n n ); Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. (n n n n n n )n n n n n n
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  • Myelosuppression: Monitor complete blood counts weekly. Consider discontinuation in patients who develop or have worsening myelosuppression. (n n n n n n ) n n n n n n
  • Peripheral and optic neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. (n n n n n n )n n n n n n
  • Serotonin syndrome: Patients taking serotonergic antidepressants should receive ZYVOX only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. (n n n n n n )n n n n n n
  • A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. (n n n n n n ) n n n n n n
  • Clostridium difficile
  • Potential interactions producing elevation of blood pressure: monitor blood pressure. (n n n n n n )n n n n n n
  • Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. (n n n n n n )n n n n n n
  • Most common adverse reactions (>5% of adult and/or pediatric patients treated with ZYVOX) include: diarrhea, vomiting, headache, nausea, and anemia. (n n n n n n ) n nn n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or n n n n n n n
  • Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. (n n n n n n , n n n n n n , n n n n n n , n n n n n n , n n n n n n )n nn n nn
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  • In the event of overdosage, supportive care is advised, with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination of linezolid. In a Phase 1 clinical trial, approximately 30% of a dose of linezolid was removed during a 3-hour hemodialysis session beginning 3 hours after the dose of linezolid was administered. Data are not available for removal of linezolid with peritoneal dialysis or hemoperfusion. Clinical signs of acute toxicity in animals were decreased activity and ataxia in rats and vomiting and tremors in dogs treated with 3000 mg/kg/day and 2000 mg/kg/day, respectively.
  • ZYVOX I.V. Injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide.
  • The empirical formula is Cn n n n n n Hn n n n n n FNn n n n n n On n n n n n . Its molecular weight is 337.35, and its chemical structure is represented below:n nn n nn
  • ZYVOX I.V. Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are sodium citrate, citric acid, and dextrose in an aqueous vehicle for intravenous administration. The sodium (Nan n n n n n ) content is 0.38 mg/mL (5 mEq/300-mL bag).n nn n nn
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  • ZYVOX I.V. Injection is available in single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free. The infusion bags are available in the following package sizes:
  • Store at 25u00baC (77u00baF). Protect from light. It is recommended that the infusion bags be kept in the overwrap until ready to use. Each overwrap contains a peel-off label. Apply the peel-off label to the infusion bag for barcode scanning before use. Protect infusion bags from freezing.
  • Patients should be counseled that antibacterial drugs including ZYVOX should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ZYVOX is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ZYVOX or other antibacterial drugs in the future.
  • Patients should be advised that:
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • Distributed byn n n n n n Pharmacia & Upjohn Con n n n n n Division of Pfizer Incn n n n n n NY, NY 10017n nn n nn
  • PREMIERProRxn n n n n n is a registered trademark of Premier Healthcare Alliance, L.P., used under license.n nn n nn
  • LAB-0739-5.0
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of LINEZOLID (Zyvox) which is also known as Zyvox and Manufactured by Fresenius Kabi Norge As. It is available in strength of 600 mg/300mL.

LINEZOLID (Zyvox) 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.

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