Trade Name: Linezolid

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, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 2 mg/mL

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.
  3. Read more
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  • Linezolid injection is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid injection 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 nn
  • Linezolid injection 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 ); Community-acquired pneumonia (n n n ); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (n n n ); Uncomplicated skin and skin structure infections (n n n ); Vancomycin-resistant n n n infections. (n n n )n n n n n
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid and other antibacterial drugs, linezolid injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (n n n )n nn
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  • Linezolid injection: 300 mL (600 mg linezolid) single-use, ready-to-use flexible plastic container in a foil laminate overwrap. The flexible plastic container and port are latex-free.
  • Injection: 600 mg linezolidu00a0 (3)
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  • Known hypersensitivity to linezolid or any of the other product components. (4.1); Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. (4.2)
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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
  • 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
  • Serotonin syndrome: Patients taking serotonergic antidepressants should receive linezolid 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
  • 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
  • Clostridium difficile
  • Potential interactions producing elevation of blood pressure: monitor blood pressure. (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
  • Most common adverse reactions (> 5% of adult and/or pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. (n n n )n nn
  • 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 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 3,000 mg/kg/day and 2,000 mg/kg/day, respectively.
  • Linezolid 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.
  • Its structural formula is:
  • Cn n n Hn n n FNn n n On n n M.W. 337.35n n n
  • Linezolid 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 ) content is 0.38 mg/mL (5 mEq per 300 mL flexible plastic container). pH adjusted to 4.8 with sodium hydroxide or hydrochloric acid.n nn
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  • Patients should be counseled that antibacterial drugs including linezolid should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When linezolid 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 linezolid or other antibacterial drugs in the future.
  • Patients should be advised that:
  • Manufactured for:
  • Made in Norway
  • 451296A
  • Issued: June 2015n n n n n n
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Linezolid 300 mL Bag Labeln n n NDCn n n n- Linezolid Injectionn n n 600 mg per 300 mL (2 mg per mL) n n n

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of LINEZOLID (Linezolid) which is also known as Linezolid and Manufactured by Fresenius Kabi Norge AS. It is available in strength of 2 mg/mL.

LINEZOLID (Linezolid) 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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