FLAVIN H
Riboflavin Ophthalmic solution with Hypromellose
Sterile and Preservative-Free Solution
Flavin H is sterile, preservative-free ophthalmic solution of Riboflavin 0.1% in saline with Hypromellose. 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.
FEATURES
Sterile and Preservative-Free Solution: Ensuring patient safety and minimizing the risk of ocular infections, Flavin H is formulated as a sterile, preservative-free solution. This characteristic is particularly crucial in ophthalmic applications, where even minor contaminants can lead to severe complications.
Riboflavin 0.1% in Saline with Hypromellose: At the heart of Flavin H lies riboflavin, a potent photosensitizing agent essential for initiating the cross-linking process in corneal tissue. The inclusion of hypromellose further enhances the solution’s viscosity, facilitating its application and retention on the corneal surface during treatment.
Corneal Collagen Cross-Linking Treatment: Flavin H is specifically designed for use as a photosensitizing agent in corneal cross-linking therapy. This treatment modality is indicated for patients suffering from progressive corneal disorders such as keratoconus and corneal ectasia, aiming to strengthen and stabilize the corneal structure.
TECHNICAL SPECIFICATIONS
Composition: Each milliliter of Flavin H contains Riboflavin Sodium Phosphate BP (equivalent to base riboflavin) at a concentration of 0.1% w/v, along with Phosphate Buffer Saline in a quantity sufficient to maintain isotonicity, and Hypromellose at a concentration of 1.1% w/v.
Supply: Flavin H is supplied in ready-to-use single-use sterile Prefilled Syringes of 1.0 ml, accompanied by a sterile single-use Cannula for precise application.
INGREDIENTS
Riboflavin Sodium Phosphate BP: Riboflavin, also known as vitamin B2, is converted to its active form, riboflavin-5-phosphate, within the corneal stroma upon exposure to ultraviolet-A (UV-A) light. This activation initiates the cross-linking process, reinforcing the collagen fibers within the cornea.
Phosphate Buffer Saline: The presence of phosphate buffer saline ensures optimal pH and osmolarity levels, maintaining the stability and efficacy of the solution during storage and administration.
Hypromellose: Hypromellose, a cellulose derivative, serves as a viscosity-enhancing agent, prolonging the contact time of riboflavin with the corneal surface and facilitating its penetration into the stroma.
OPERATIONS
Flavin H finds its primary application in corneal collagen cross-linking procedures, offering a targeted therapeutic approach for the management of corneal disorders. The following conditions warrant the utilization of Flavin H in ophthalmic practice:
Keratoconus: Keratoconus is a progressive degenerative disorder characterized by thinning and protrusion of the cornea, leading to irregular astigmatism and visual distortion. Corneal collagen cross-linking procedures with Flavin H aims to halt the progression of keratoconus by strengthening the corneal structure and preventing further ectatic changes.
Corneal Ectasia: Corneal ectasia encompasses a spectrum of conditions marked by corneal thinning and distortion, often secondary to refractive surgeries such as LASIK. Flavin H-mediated corneal cross-linking offers a promising therapeutic option for stabilizing ectatic corneas and preserving visual function.
ADVANTAGES
Increased Corneal Stiffness: Corneal cross-linking with Flavin H induces a significant increase in corneal stiffness, particularly in the anterior 200-250 micrometers. This biomechanical reinforcement contributes to the stabilization of corneal shape and the prevention of further ectatic progression.
Targeted Cross-Linking Effects: Flavin H exhibits high UV-A absorption capacity, ensuring that cross-linking effects are predominantly confined to the anterior corneal layers. This selective targeting minimizes collateral damage to adjacent ocular structures, including the corneal endothelium, lens, and retina.
Osmolarity Maintenance: The presence of dextran in Flavin H aids in maintaining corneal osmolarity, thereby preventing excessive corneal swelling and edema during the cross-linking procedure. This ensures optimal corneal hydration and facilitates the penetration of riboflavin into the stromal matrix.
Non-Invasive Treatment Modality: Unlike traditional surgical interventions such as keratoplasty, Flavin H-mediated corneal cross-linking is minimally invasive and does not entail intraocular injections, sutures, or incisions. This reduces patient discomfort, accelerates visual recovery, and lowers the risk of surgical complications.
Cost-Effectiveness: Corneal cross-linking with Flavin H represents a cost-effective alternative to conventional surgical approaches for corneal disorders. The streamlined treatment protocol, coupled with the absence of complex surgical infrastructure, translates into reduced healthcare expenditures and enhanced accessibility for patients.
Advantages of Cross Linking Treatment with Flavin H
Causes an increase in corneal stiffness of the anterior 200-250 um
Cross- linking effects are directed to the anterior Cornea because of Flavin’s high UV-A absorption capacity. Thus Corneal Endothelium, Lens and Retina will be protected
Dextran in FLAVIN helps
Maintains the Osmolarity
Avoids corneal soaking and swelling during the treatment
Halts the progress and causes some regression.
No injection, no stitches & no incisions as in Keratoplasty
Quick & Easy treatment with low costs
TECHNICAL SPECIFICATIONS
| FLAVIN H | Riboflavin Ophthalmic Solution (0.1%) with Hypromellose |
| COMPOSITION | Each ml contains Riboflavin Sodium Phosphate BP (Equivalent to base Riboflavin)…………………….0.1% w/v Phoshpate Buffar Saline………………………………q. s. Hypromellose |
SUPPLY
Flavin H is supplied in ready to single use sterile Prefilled Syringe of 1.0 ml with sterile single use Cannula.
Flavin H can be supplied with filled volume of 3.0 ml for special orders.
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