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Levoleucovorin (Levoleucovorin Calcium)

Trade Name : Levoleucovorin Calcium

Amneal Biosciences LLC

INJECTION, SOLUTION

Strength 10 mg/mL

LEVOLEUCOVORIN CALCIUM Folate Analog [EPC],Folic Acid [CS]

Delivery Process

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Product information is meant for

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Disclaimer

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 Levoleucovorin (Levoleucovorin Calcium) which is also known as Levoleucovorin Calcium and Manufactured by Amneal Biosciences LLC. It is available in strength of 10 mg/mL per ml. Read more

Levoleucovorin (Levoleucovorin Calcium) 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
  • Indication and Usage (1) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 01/2020Dosage and Administration (2) u00a0u00a0u00a0u00a0 01/2020Contraindications (4) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a001/2020Warning and Precautions (5) u00a0u00a0u00a0u00a0u00a0u00a0u00a0 01/2020
  • Indications and Usage () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 01/2020Dosage and Administration () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0 11/2020Contraindications () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 01/2020Warning and Precautions () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 01/2020
  • Levoleucovorin injection is indicated for:
  • Limitations of Use
  • Levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B, because of the risk of progression of neurologic manifestations despite hematologic remission.
  • Levoleucovorin injection is a folate analog indicated for:
  • Limitations of Use:
  • Levoleucovorin injection is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B, because of the risk of progression of neurologic manifestations despite hematologic remission. ()
  • Rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. ()
  • Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. ()
  • Treatment of adults with metastatic colorectal cancer in combination with fluorouracil. ()
  • For intravenous administration only. Do not administer intrathecally. ()
  • Rescue After High-Dose Methotrexate Therapy
  • Overdosage of Folic Acid Antagonists or Impaired Methotrexate Elimination
  • Metastatic Colorectal Cancer in Combination with Fluorouracil
  • No data
  • Injection: 175 mg/17.5 mL (10 mg/mL) in a single-dose vial. ()
  • Levoleucovorinu00a0injection is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid .
  • Patients who have had severe hypersensitivity reactions to leucovorin products, folic acid or folinic acid. ()
  • No data
  • Hypercalcemia:
  • Increased Gastrointestinal Toxicities with Fluorouracil:
  • Drug Interaction with Trimethoprim-Sulfamethoxazole:n- d,l
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • The most common adverse reactions (u226520%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue are stomatitis and vomiting. ()
  • The most common adverse reactions (>50%) in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer are stomatitis, diarrhea, and nausea ()
  • Antiepileptic Drugs
  • Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone and increase the frequency of seizures in susceptible children. It is not known whether folinic acid has the same effects; however, both folic and folinic acids share some common metabolic pathways. Monitor patients taking folinic acid in combination with antiepileptic drugs.
  • Fluorouracil
  • Leucovorin products increase the toxicity of fluorouracil. Do not initiate or continue therapy with levoleucovorin and fluorouracil in patients with symptoms of gastrointestinal toxicity until those symptoms have resolved. Monitor patients with diarrhea until the diarrhea has resolved, as rapid deterioration leading to death can occur n
  • Trimethoprim-Sulfamethoxazole
  • The concomitant use of -leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of jiroveci pneumonia in patients with HIV infection was associated with increased rates of treatment failure and morbidity in a placebo-controlled study .
  • No data
  • Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of -leucovorin. The chemical name of levoleucovorin calcium is calcium (6)-N-{4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl}--glutamate mixed hydrates. The molecular formula is CHCaNO u2022nHO (n = 3 to 6) and the molecular weight is 565.6 to 619.6. The molecular structure is:
  • Levoleucovorin injection, for intravenous use is supplied as a sterile clear yellow color solution of 175 mg levoleucovorin in 17.5 mL per single-dose vial. Each mL contains 10 mg levoleucovorin (equivalent to 10.8 mg levoleucovorin calcium) and 8.3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8.1 (6.5 to 8.5).
  • No data
  • No studies have been conducted to evaluate the potential of levoleucovorin for carcinogenesis, mutagenesis and impairment of fertility.
  • No data
  • Levoleucovorin injection is a sterile clear yellow color solution in a single-dose vial available as:
  • 175 mg/17.5 mL (10 mg/mL) solution:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1572-1
  • Store in refrigerator at 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F). Protect from light. Store in carton until contents are used.
  • Manufactured by:n Ahmedabad 382213, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 12-2020-02
  • NDC 70121-1572-1
  • Levoleucovorin Injection
  • Strength: 175 mg/ 17.5 mL (10 mg/ mL)n
  • Rx only
  • Amneal Pharmaceuticals LLC

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