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FLAVIN

Isotonic Riboflavin Ophthalmic Solution

Sterile and Preservative-free Solution

Flavin is a sterile, preservative-free ophthalmic solution containing Riboflavin 0.1% and Dextran in saline buffer for external ocular usage. They are used as a photo sensitizing agent in Corneal Collagen cross linking as a treatment for patients with Keratoconus and Corneal Ectasia in different corneal conditions.

eIFU Publication

Advantages of Cross Linking Treatment with Flavin

Safe & effective in the management of progressive keratoconus

Cumulative visual acuity of 20/40 or better in 30% of eyes

92% eyes had no change in CDVA at 12 months postoperatively

4% eyes gains 1 line of CDVA at 12 months postoperatively

62% eyes achieve refractive SE range of +/- 1D

26% eyes achieve refractive astigmatism with in +/- 1D

No or minimal corneal haze after 12 months

No significant difference in ECD in Post op as compared to Pre – op

No immediate or long term post op vision threatening complications

FEATURES

  • Safe and Effective Management: FLAVIN Ophthalmic Solution offers a safe and effective treatment option for managing progressive keratoconus and corneal ectasia. Its formulation is specifically designed to address the underlying causes of these conditions and provide stabilization of the cornea.
  • Sterile and Preservative-free Solution: FLAVIN is manufactured as a sterile and preservative-free ophthalmic solution. This feature is crucial as it minimizes the risk of contamination and adverse reactions, ensuring the safety of patients during ocular procedures.
  • Riboflavin and Dextran Composition: FLAVIN contains Riboflavin Sodium Phosphate BP and Dextran P500 in precise concentrations. Riboflavin acts as a photosensitizing agent, while Dextran serves as a stabilizing agent. This carefully balanced composition ensures the effectiveness of FLAVIN in corneal collagen cross-linking procedures.
  • Ready-to-Use Prefilled Syringe: FLAVIN is conveniently supplied in ready-to-use single-use sterile prefilled syringes. These syringes come in varying volumes (1.0 ml or 3.0 ml) and are accompanied by a sterile single-use cannula. This packaging format simplifies the administration process for healthcare providers and ensures sterility, reducing the risk of contamination.
  • Isotonicity: FLAVIN Isotonic Riboflavin Ophthalmic Solution is formulated with sterile phosphate buffer saline to achieve isotonicity, ensuring compatibility with ocular tissues and minimizing irritation upon administration.

TECHNICAL SPECIFICATIONS

  • Composition: Each milliliter contains Riboflavin Sodium Phosphate BP (equivalent to Riboflavin) at a concentration of 0.1% w/v, Dextran P500 at 20.0% w/v, and Sterile Phosphate Buffer Saline to achieve isotonicity.
  • Supply: FLAVIN is supplied in ready-to-use single-use sterile Prefilled Syringes of 1.0 ml or 3.0 ml, accompanied by a sterile single-use Cannula, ensuring convenience and sterility during administration.

INGREDIENTS

FLAVIN Isotonic Riboflavin Ophthalmic Solution includes Riboflavin Sodium Phosphate BP, equivalent to Riboflavin, at a concentration of 0.1% w/v. This active ingredient serves as a vital photosensitizing agent in Corneal Collagen Cross-linking procedures.

OPERATIONS

FLAVIN Isotonic Riboflavin Ophthalmic Solution is primarily utilized in Corneal Collagen Cross-linking procedures. This innovative treatment approach is employed in patients with conditions such as Keratoconus and Corneal Ectasia, where the cornea becomes progressively weaker and thinner. During Corneal Collagen Cross-linking procedures, FLAVIN is used as a photosensitizing agent, aiding in the strengthening and stabilization of the corneal collagen fibers.

ADVANTAGES

  • Safety and Efficacy: FLAVIN offers a safe and effective treatment option for patients with progressive keratoconus and corneal ectasia. FLAVIN Isotonic Riboflavin Ophthalmic Solution in Corneal Collagen Cross-linking procedures helps strengthen and stabilize the cornea, thereby halting or slowing disease progression.
  • Stability: FLAVIN treatment contributes to the stability of vision postoperatively. Patients maintain their corrected distance visual acuity at 12 months following treatment, indicating long-term stability in vision.
  • Positive Refractive Outcomes: FLAVIN treatment is associated with positive refractive outcomes. Many patients achieve desirable refractive outcomes, such as reduced refractive error and improved visual clarity.
  • Minimal Corneal Haze: FLAVIN treatment minimizes the occurrence of corneal haze post-treatment. Corneal haze can occur as a side effect of certain ocular procedures and can negatively impact visual clarity. By minimizing corneal haze, FLAVIN helps to ensure clear corneas and improved visual quality for patients.
  • Preservation of Endothelial Cell Density: FLAVIN treatment preserves endothelial cell density, which is essential for maintaining corneal health. The endothelial cells are responsible for regulating the fluid balance within the cornea, and preserving their density helps to ensure the long-term health and function of the cornea.
  • Reduced Risk of Complications: FLAVIN treatment is associated with a reduced risk of postoperative complications. Patients experience fewer immediate and long-term complications, leading to a smoother recovery process.
  • Minimally Invasive Procedure: FLAVIN-assisted treatment is minimally invasive compared to traditional surgical interventions for progressive keratoconus and corneal ectasia. This means that patients experience less trauma and discomfort during the procedure, leading to faster recovery times and improved patient satisfaction.

Technical Specifications

FlavinIsotonic Riboflavin Ophthalmic Solution (0.1%)
COMPOSITIONEach ml contains

Riboflavin Sodium Phosphate BP

(Equivalent to base Riboflavin)…………………….0.1% w/v

Dextran P500…………………………………………….20.0% w/v

Phoshpate Buffar Saline……………………………..q. s.

SUPPLY

Flavin is supplied in ready to single use sterile Prefilled Syringe of 1.0 ml / 3.0 ml with sterile single use Cannula.

SURGERY VIDEO

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Battig Treuhand AG
Obergrundstrasse 17,
6002, Luzern,
Switzerland

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