MEMBRANEBLUE

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.

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.

MembraneBlue (trypan blue ophthalmic solution) 0.15% is a clear, dark blue ophthalmic solution supplied in a 2.25 mL single-patient-use syringe filled to a volume of 0.5 mL.

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.

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.

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.

MembraneBlue™ (trypan blue ophthalmic solution) 0.15% is a sterile solution of trypan blue (an acid di-azo group dye) for intraocular ophthalmic use. MembraneBlue selectively stains epiretinal membranes during ophthalmic surgical vitrectomy procedures.

Each mL of MembraneBlue 0.15% contains: 1.5 mg trypan blue; 1.9 mg sodium mono-hydrogen orthophosphate (Na ₂HPO ₄•2H ₂O); 0.3 mg sodium di-hydrogen orthophosphate (NaH ₂PO ₄•2H ₂O); 8.2 mg sodium chloride (NaCl); and water for injection. 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 ₃₄H ₂₄N ₆Na ₄O ₁₄S ₄, and has the following chemical structure: Chemical structure MembraneBlue

Carinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Trypan blue is carcinogenic in rats. Wister/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (approximately 645-fold the maximum recommended human dose of 0.75 mg per injection in a 60 kg person based on BSA, assuming complete systemic absorption).

Mutagenesis
Trypan blue was mutagenic in the Ames test and caused DNA strand breaks in vitro.

MembraneBlue (trypan blue ophthalmic solution) 0.15% is a clear, dark blue ophthalmic solution supplied as follows:

0.5 mL of MembraneBlue 0.15% in a sterile single-patient-use Luer Lock, 2.25 mL glass syringe, grey rubber plunger stopper and tip cap with polypropylene plunger rod in a peel pouch. Five pouched products are packed in one distribution box.

NDC 68803-672-01 (One 0.5 mL syringe)
NDC 68803-672-05 (Carton of five 0.5 mL syringes)

Storage: Store between 15ºC to 25ºC (59ºF to 77ºF). Protect from direct sunlight. Single-patient-use. Discard unused portion.

Made in Germany

Distributed in the United States by

Dutch Ophthalmic, USA

10, Continental Drive, Bldg 1

Exeter, NH 03833, USA

Phone: 800-75-DUTCH or 603-778-6929

MembraneBlue - Box

MembraneBlue - labelling