MEMBRANEBLUE- trypan blue injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

TRYPAN BLUE (UNII: I2ZWO3LS3M) (TRYPAN BLUE FREE ACID - UNII:768N7QO4KH)

थमां उपलब्ध:

Dutch Ophthalmic Research Center (International) B.V.

INN (इंटरनेशनल नाम):

TRYPAN BLUE

रचना:

TRYPAN BLUE 0.75 mg in 0.5 mL

प्रशासन का मार्ग:

OPHTHALMIC

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. 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. Teratogenic Effects: Pregnancy Category C. Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. These doses are approximately 4,000- and 2,000-fold the maximum recommended human dose of 0.75 mg per injection based on a 60 kg person, assuming that the whole dose is completely absorved. Characteristic anomalies included neural tube, cardiovascular,

उत्पाद समीक्षा:

MembraneBlue™ 0.15% is supplied as follows: 0.5 mL of MembraneBlue™ 0.15% in a sterile single-use Luer Lok, 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.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

MEMBRANEBLUE- TRYPAN BLUE INJECTION, SOLUTION
DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
MEMBRANEBLUE™ 0.15% (TRYPAN BLUE OPHTHALMIC SOLUTION). THESE
HIGHLIGHTS DO NOT INCLUDE
ALL THE INFORMATION NEEDED TO USE MEMBRANEBLUE™ 0.15% SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MEMBRANEBLUE™ 0.15%. MEMBRANEBLUE™
0.15% (TRYPAN BLUE
OPHTHALMIC SOLUTION) INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
HIGHLIGHTS OF PRESCRIBING INFORMATION (1)
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MEMBRANEBLUE™ 0.15%
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MEMBRANEBLUE™ 0.15%.
MEMBRANEBLUE™ 0.15% (TRYPAN BLUE OPHTHALMIC SOLUTION) INITIAL U.S.
APPROVAL: 2004 (1)
(1)
For use as an aid in ophthalmic posterior surgery;
Facilitating removal of epiretinal tissue.
DOSAGE AND ADMINISTRATION
Prior to injection of MembraneBlue™ 0.15% perform a 'fluid-air
exchange'; Carefully apply
MembraneBlue™ 0.15% to epiretinal membranes using a blunt cannula;
Remove all excess dye; Or
Inject MembraneBlue™ 0.15% directly in a BSS filled - vitreous
cavity; Wait 30 seconds; Remove all
excess dye.
DOSAGE FORMS AND STRENGTHS
MembraneBlue™ 0.15% (trypan blue ophthalmic solution) in a volume of
0.5 mL. (3)
CONTRAINDICATIONS
Insertion of a non-hydrated (dry state), hydrophilic acrylic
intraocular lens (IOL). (4)
WARNINGS AND PRECAUTIONS
Excessive staining: Excess MembraneBlue™ 0.15% should be removed
from the eye immediately after
staining.
Priming of the syringe: 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
Discoloration of high water content hydrogen intraocular lenses;
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
USE IN SPECIFIC POPULATIONS
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