TRYPAN BLUE: 24 Adverse Event Reports & Safety Profile

VisionBlue 0.06% - Description section VisionBlue® (trypan blue ophthalmic solution) 0.06% is a sterile solution of trypan blue (an acid di-azo group dye) for intraocular ophtalmic use. VisionBlue® 0.06% is a selective tissue staining agent for use as a medical aid in ophthalmic surgery. Each mL of VisionBlue® 0.06% contains: 0.6 mg trypan blue; 1.9 mg sodium mono-hydrogen orthophosphate (Na 2 HPO 4 ·2H 2 O); 0.3 mg sodium di-hydrogen orthophosphate (NaH 2 PO 4 ·2H 2 O); 8.2 mg sodium chloride (NaCl); and water for injection. Sodium hydroxide may be used to adjust pH. The pH is 7.3 – 7.6. The osmolality is 257-314 mOsm/kg. The drug substance trypan blue has the chemical name 3,3’-[(3,3’-dimethyl-4,4’-biphenylylene) bis (azo)] bis (5-amino-4-hydroxy-2,7-naphthalenedisulfonic acid) tetra sodium salt, a molecular weight of 960.8, a molecular formula of C 34 H 24 N 6 Na 4 O 14 S 4 , and has the following chemical structure: Chemical structure VisionBlue

MembraneBlue 0.15% - Indications & Usage Section MembraneBlue™ 0.15% is indicated for use as an aid in ophthalmic surgery by staining the epiretinal membranes during ophthalmic surgical vitrectomy procedures, facilitating removal of the tissue in adults and pediatric patients. These highlights do not include all the information needed to use MEMBRANEBLUE™ safely and effectively. See full prescribing information for MEMBRANEBLUE. MEMBRANEBLUE (trypan blue ophthalmic solution) 0.15%, for intraocular ophthalmic use Initial U.S. Approval: 2004 MembraneBlue is a diagnostic dye indicated for use as an aid in ophthalmic posterior surgery by staining the epiretinal membranes during ophthalmic surgical vitrectomy procedures, facilitating removal of epiretinal tissue in adults and pediatric patients

MembraneBlue 0.15% - Dosage & administration section MembraneBlue 0.15% is packaged in a single-patient-use syringe filled to a volume of 0.5 mL. Make sure the plunger moves smoothly before use. Prime the syringe prior to use by retracting the plunger before injecting the fluid. Alternatively, twist the plunger into the stopper in a clockwise motion until tight. Once tight, continue turning the plunger in a clockwise motion until the stopper rotates freely within the syringe, two or three rotations. The syringe is now primed and suitable for injection. Before injection of MembraneBlue perform a “fluid-air exchange” (i.e., filling the entire vitreous cavity with air, to prevent aqueous dilution of MembraneBlue). MembraneBlue is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlue syringe, without allowing the cannula to contact or damage the retina. Sufficient staining is expected on contact with the membrane. All excess dye should be removed from the vitreous cavity before performing an air-fluid exchange, to prevent unnecessary spreading of the dye. MembraneBlue can also be injected directly in a BSS filled vitreous cavity (instead of injecting under air). Clinical use demonstrated that, after complete vitreous and posterior hyaloid removal, sufficient staining is achieved after 30 seconds of application under BSS. MembraneBlue is intended to be applied directly on the areas where membranes could be present, staining any portion of the membrane which comes in contact with the dye. The dye does not penetrate the membrane. Prior to injection of MembraneBlue, perform a “fluid-air exchange” (i.e., fill the entire vitreous cavity with air). Carefully apply MembraneBlue to epiretinal membranes using a blunt cannula and remove all excess dye. OR Inject MembraneBlue directly in a BSS filled-vitreous cavity.

Wait

30 seconds and remove all excess dye. (2)

MembraneBlue 0.15% - Contraindications section. MembraneBlue 0.15% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye. The dye may be absorbed by the IOL and stain it. Insertion of a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL). MembraneBlue may be absorbed by the IOL and stain it.

MembraneBlue 0.15% - Adverse reactions section Adverse reactions reported following use of MembraneBlue 0.15% include discoloration of high water content hydrogen intraocular lenses [see Contraindications] and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week. Most common adverse reactions include discoloration of high water content hydrogen intraocular lenses and inadvertent staining of the posterior lens capsule and vitreous face. To report SUSPECTED ADVERSE REACTIONS contact Dutch Ophthalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

MembraneBlue 0.15% - Warnings and precautions section Excessive Staining Excess MembraneBlue 0.15% should be immediately removed from the eye after staining. Priming of the Syringe To make sure the plunger moves smoothly before use, first retract the plunger or twist the plunger in a clockwise motion before injecting the fluid.

Excessive

Staining: Excess MembraneBlue 0.15% should be immediately removed from the eye after staining. Priming of the Syringe: To make sure the plunger moves smoothly before use, first retract the plunger or twist the plunger in a clockwise motion before injecting the fluid.