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Durezol (Durezol)

Trade Name : DUREZOL

Alcon Laboratories, Inc.

EMULSION

Strength 0.5 mg/mL

DIFLUPREDNATE

Delivery Process

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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 Durezol (Durezol) which is also known as DUREZOL and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 0.5 mg/mL per ml. Read more

Durezol (Durezol) 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
  • DUREZOL is a topical corticosteroid that is indicated for:
  • The treatment of inflammation and pain associated with ocular surgery ()
  • The treatment of endogenous anterior uveitis ()
  • No data
  • For the treatment of inflammation and pain associated with ocular surgery instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response. ()
  • For the treatment of endogenous anterior uveitis, instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated. ()
  • DUREZOL contains 0.05% difluprednate as a sterile preserved emulsion for topical ophthalmic administration.
  • DUREZOL contains 0.05% difluprednate, as a sterile preserved ophthalmic emulsion for topical ophthalmic use only. ()
  • The use of DUREZOL, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures.
  • DUREZOL, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. ()
  • No data
  • The following serious reactions are found elsewhere in the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • DUREZOL (difluprednate ophthalmic emulsion) 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6u03b1,9difluoro-11u03b2,17,21-trihydroxypregna-1,4- diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula:
  • Difluprednate has a molecular weight of 508.56, and the empirical formula is CHFO.
  • Each mL of DUREZOL contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411u00a0mOsm/kg. PRESERVATIVE: sorbic acid 0.1%.
  • No data
  • No data
  • No data
  • DUREZOL (difluprednate ophthalmic emulsion) 0.05% is a sterile, aqueous topical ophthalmic emulsion supplied in an opaque plastic bottle with a controlled drop tip and a pink cap in the following sizes: n 5u00a0mL in au00a08u00a0mL bottle NDC 0065-9240-07
  • Storage and Handling
  • Store at 15u00b0C to 25u00b0C (59u00b0F to 77u00b0F). Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton.
  • Risk of Contamination
  • This product is sterile when packaged. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the emulsion.u00a0Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.
  • Risk of Secondary Infection
  • If pain develops, or if redness, itching, or inflammation becomes aggravated, advise patients to consult a physician.
  • Contact Lens Wear
  • DUREZOL should not be instilled while wearing contact lenses. Advise patients to remove contact lenses prior to instillation of DUREZOL. The preservative in DUREZOL may be absorbed by soft contact lenses.u00a0 Lenses may be reinserted after 10 minutes following administration of DUREZOL.
  • U.S. Pat.: www.alconpatents.comu00a92013, 2016 Novartisn Distributed by: Alcon LaboratoriesFort Worth, Texas 76134 USA
  • T2017-52April 2017
  • NDC 0065-9240-07n n n n n n n n n n n n

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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