MEMBRANEBLUE .75 mg/.5mL
trypan blue · INJECTION, SOLUTION · Dutch Ophthalmic Research Center (International) B.V.
MEMBRANEBLUE is a injection, solution containing trypan blue at .75 mg/.5mL, taken intraocular. Manufactured by Dutch Ophthalmic Research Center (International) B.V..
Key Facts
- Brand Name
- MEMBRANEBLUE
- Generic Name
- trypan blue
- NDC Code (Product)
68803-672- Manufacturer
- Dutch Ophthalmic Research Center (International) B.V.
- Strength
- .75 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAOCULAR, OPHTHALMIC
- Marketing Status
- Application #
- NDA022278
- Marketing Start
- 02/20/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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
Dosage & Administration
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 inject…
Contraindications
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.
Adverse Reactions
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.
Frequently Asked Questions
What is MEMBRANEBLUE used for?
MEMBRANEBLUE contains trypan blue. It is a injection, solution taken intraocular. Consult your doctor for specific uses.
Is MEMBRANEBLUE a controlled substance?
MEMBRANEBLUE is not classified as a controlled substance by the DEA.
What is the generic name for MEMBRANEBLUE?
The generic name for MEMBRANEBLUE is trypan blue. There are 1 other brand versions of trypan blue.
What is the NDC code for MEMBRANEBLUE .75 mg/.5mL?
The NDC (National Drug Code) for MEMBRANEBLUE .75 mg/.5mL is 68803-672, listed by Dutch Ophthalmic Research Center (International) B.V..