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Nepafenac (Ilevro)

Trade Name : ILEVRO

Alcon Laboratories, Inc.

SUSPENSION

Strength 3 mg/mL

NEPAFENAC Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

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Product information is meant for

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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 Nepafenac (Ilevro) which is also known as ILEVRO and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 3 mg/mL per ml. Read more

Nepafenac (Ilevro) 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
  • ILEVRO 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery.
  • ILEVRO 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery .
  • One drop of ILEVRO 0.3% should be applied to the affected eye one-time-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. An additional drop should be administered 30 to 120 minutes prior to surgery. n
  • Sterile ophthalmic suspension 0.3%: 1.7 mL in a 4 mL bottle and 3 mL in a 4 mL bottle.
  • Sterile ophthalmic suspension 0.3%: 1.7 mL in a 4 mL bottle and 3 mL in a 4 mL bottle. n
  • ILEVRO 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDS). n
  • No data
  • Increased bleeding time due to interference with thrombocyte aggregation ()
  • Delayed healing ()
  • Corneal effects including keratitis ()
  • Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.
  • Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. ()n n n
  • No data
  • ILEVRO 0.3% is a sterile, topical, NSAID prodrug for ophthalmic use. Each mL of ILEVRO 0.3% contains 3 mg of nepafenac. Nepafenac is designated chemically as 2-amino-3-benzoylbenzeneacetamide with an empirical formula of C15H14N2O2. The structural formula of nepafenac is:n n
  • Nepafenac is a yellow crystalline powder. The molecular weight of nepafenac is 254.28 g/mol. ILEVRO 0.3% is supplied as a sterile, aqueous suspension with a pH approximately of 6.8.n The osmolality of ILEVRO 0.3% is approximately 300 mOsm/kg.n Each mL of ILEVRO 0.3% contains: nepafenac 0.3%. boric acid, propylene glycol, carbomer 974P, sodium chloride, guar gum, carboxymethylcellulose sodium, edetate disodium, benzalkonium chloride 0.005% (preservative), sodium hydroxide and/or hydrochloric acid to adjust pH and purified water, USP.
  • No data
  • Nepafenac has not been evaluated in long-term carcinogenicity studies. Increased chromosomal aberrations were observed in Chinese hamster ovary cells exposed to nepafenac suspension. Nepafenac was not mutagenic in the Ames assay or in the mouse lymphoma forward mutation assay. Oral doses up to 5000 mg/kg did not result in an increase in the formation of micronucleated polychromatic erythrocytes in the mouse micronucleus assay in the bone marrow of mice.n Nepafenac did not impair fertility when administered orally to male and female rats at 3 mg/kg.
  • In two double masked, randomized clinical trials in which patients were dosed daily beginning one day prior to cataract surgery, continued on the day of surgery and for the first two weeks of the postoperative period, ILEVRO 0.3% demonstrated superior clinical efficacy compared to its vehicle in treating postoperative pain and inflammation.n Treatment effect over vehicle for resolution of ocular pain occurred as early as Day 1 postsurgery. Treatment effect over vehicle for resolution of inflammation was significantly better than vehicle in both studies at Day 7 and Day 14 post-surgery.
  • nttttttAbbreviation: CI, confidence interval.n n/N is the ratio of those with complete resolution of anterior chamber cell and flare by the postoperative Day 14 visit over all randomized subjects. n Difference is Nepafenac ophthalmic suspension, 0.3% (n/N) u2013 vehicle. The 95% CI is derived using asymptotic approximation.
  • ILEVRO 0.3% is supplied in a white, oval, low density polyethylene DROP-TAINER dispenser with a natural low density polyethylene dispensing plug and gray polypropylene cap. The 1.7 mL fill is presented in an overwrap, which provides tamper evidence to the package. Tamper evidence for the 3 mL fill is provided with a shrink band around the closure and neck area of the package.
  • 1.7 mL in 4 mL bottleu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0065-1750-07
  • 3 mL in 4 mL bottleu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0065-1750-14
  • Storage:
  • Protect from light.
  • Slow or Delayed Healing
  • Inform the patient of the possibility that slow or delayed healing may occur while using NSAIDs .
  • Avoiding Contamination of the Product
  • Instruct the patient to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
  • Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.
  • Contact Lens Wear
  • ILEVRO 0.3% should not be administered while wearing contact lens .
  • Intercurrent Ocular Conditions
  • Advise the patient that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physicianu2019s advice concerning the continued use of the multi-dose container .
  • Concomitant Topical Ocular Therapy
  • If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart .
  • Shake Well Before Use
  • Patients should be instructed to shake well before each use .
  • ALCONn
  • Distributed by:Alcon Laboratories, Inc.Fort Worth, Texas 76134 USA
  • u00a92014, 2019 Novartis
  • *a trademark of Novartis
  • T2019-21
  • No data

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