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Omega-3-Acid Ethyl Esters (Lovaza)

Trade Name : LOVAZA

GlaxoSmithKline LLC

CAPSULE, LIQUID FILLED

Strength 900 mg/1

OMEGA-3-ACID ETHYL ESTERS Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [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 Omega-3-Acid Ethyl Esters (Lovaza) which is also known as LOVAZA and Manufactured by GlaxoSmithKline LLC. It is available in strength of 900 mg/1 per ml. Read more

Omega-3-Acid Ethyl Esters (Lovaza) 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

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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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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
  • LOVAZA (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG).
  • Usage Considerations:
  • Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as betau00a0blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
  • Limitations of Use:
  • The effect of LOVAZA on the risk for pancreatitis has not been determined.
  • The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined.
  • LOVAZA is a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (u2265500 mg/dL) hypertriglyceridemia (HTG). ()
  • Limitations of Use:
  • The daily dose of LOVAZA is 4 grams per day. The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).
  • Patients should be advised to swallow LOVAZA capsules whole. Do not break open, crush, dissolve, or chew LOVAZA.
  • LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent, soft-gelatin capsules filled with light-yellow oil and bearing the designation u201cGS FH2u201d.
  • Capsules: 1 gram ()
  • LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA or any of its components.
  • LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA or any of its components. ()
  • No data
  • The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .
  • Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these trials has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of LOVAZA and concomitant anticoagulants. Patients receiving treatment with LOVAZA and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
  • Omega-3-acids may prolong bleeding time. Patients taking LOVAZA and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. ()
  • Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. ()
  • LOVAZA does not have any known drug abuse or withdrawal effects.
  • LOVAZA, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of LOVAZA contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA u2014 approximately 465 mg) and docosahexaenoic acid (DHA u2014 approximately 375 mg).
  • The empirical formula of EPA ethyl ester is CHO, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:
  • The empirical formula of DHA ethyl ester is CHO, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:
  • LOVAZA capsules also contain the following inactive ingredients: 4 mg u03b1-tocopherol (in a carrier of soybean oil), and gelatin, glycerol, and purified water (components of the capsule shell).
  • No data
  • In a rat carcinogenicity study with oral gavage doses of 100, 600, and 2,000 mg per kg per day, males were treated with omega-3-acid ethyl esters for 101 weeks and females for 89 weeks without an increased incidence of tumors (up to 5 times human systemic exposures following an oral dose of 4 grams per day based on a body surface area comparison). Standard lifetime carcinogenicity bioassays were not conducted in mice.
  • Omega-3-acid ethyl esters were not mutagenic or clastogenic with or without metabolic activation in the bacterial mutagenesis (Ames) test with and or in the chromosomal aberration assay in Chinese hamster V79 lung cells or human lymphocytes. Omega-3-acid ethyl esters were negative in the in vivo mouse micronucleus assay.
  • In a rat fertility study with oral gavage doses of 100, 600, and 2,000 mg per kg per day, males were treated for 10 weeks prior to mating and females were treated for 2 weeks prior to and throughout mating, gestation, and lactation. No adverse effect on fertility was observed at 2,000 mg per kg per day (5 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).
  • The effects of LOVAZA 4 grams per day were assessed in 2 randomized, placebo-controlled, double-blind, parallel-group trials of 84 adult subjects (42 on LOVAZA, 42 on placebo) with very high triglyceride levels. Subjects whose baseline triglyceride levels were between 500 and 2,000 mg per dL were enrolled in these 2 trials of 6 and 16 weeksu2019 duration. The median triglyceride and LDL-C levels in these subjects were 792 mg per dL and 100 mg per dL, respectively. Median high-density lipoprotein cholesterol (HDL-C) level was 23.0 mg per dL.
  • The changes in the major lipoprotein lipid parameters for the groups receiving LOVAZA or placebo are shown in .
  • LOVAZA 4 grams per day reduced median TG, VLDL-C, and non-HDL-C levels and increased median HDL-C from baseline relative to placebo. Treatment with LOVAZA to reduce very high TG levels may result in elevations in LDL-C and non-HDL-C in some individuals. Patients should be monitored to ensure that the LDL-C level does not increase excessively.
  • The effect of LOVAZA on the risk of pancreatitis has not been determined.
  • The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined.
  • LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram, transparent, soft-gelatin capsules filled with light-yellow oil and bearing the designation u201cGS FH2u201d.
  • Bottles of 120: NDC 0173-0884-08.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Information for Patients
  • Manufactured for:
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709n
  • Trademarks are owned by or licensed to the GSK group of companies.
  • u00a92019 GSK group of companies or its licensor.
  • LVZ:14PI
  • PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
  • _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _
  • This Patient Information has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: 4/2019
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0783-02
  • Lovazan
  • (omega-3-acid ethyl esters)
  • Capsules
  • R only
  • Swallow capsules whole.
  • Arrayn- 120 Capsules
  • Each capsule contains 1 gram omega-3-acid ethyl ester liquid concentrate consisting of at least 900 mg omega-3-acid ethyl esters.
  • Each capsule provides: Eicosapentaenoic acid (EPA) ethyl ester: 465 mg
  • Docosahexaenoic acid (DHA) ethyl ester: 375 mg
  • Usual Dosage
  • Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature]. Do not freeze.
  • Do not accept if seal on bottle opening is missing or broken.
  • Manufactured for:
  • GlaxoSmithKline
  • RTP, NC 27709
  • Made in Norway
  • Rev. 9/14
  • A127667
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0884-08
  • Arrayn- Lovazan
  • (omega-3-acid ethyl esters)
  • Arrayn- Capsules
  • R only
  • Swallow capsules whole.
  • Arrayn- 120 Capsules
  • Each capsule contains 1 gram omega-3-acid ethyl ester liquid concentrate consisting of at least 900 mg omega-3-acid ethyl esters.
  • Each capsule provides: Eicosapentaenoic acid (EPA) ethyl ester: 465 mg
  • Docosahexaenoic acid (DHA) ethyl ester: 375 mg
  • Usual Dosage
  • Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature]. Do not freeze.
  • Do not accept if membrane seal under cap is missing or broken.
  • Manufactured for:
  • GlaxoSmithKline
  • RTP, NC 27709
  • Made in Norway
  • Rev. 1/17
  • 10000000143675

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