NDC 68803-672 Membraneblue

Trypan Blue

NDC Product Code 68803-672

NDC 68803-672-05

Package Description: 5 POUCH in 1 CARTON > 1 SYRINGE, GLASS in 1 POUCH > .5 mL in 1 SYRINGE, GLASS

NDC Product Information

Membraneblue with NDC 68803-672 is a a human prescription drug product labeled by Dutch Ophthalmic Research Center (international) B.v.. The generic name of Membraneblue is trypan blue. The product's dosage form is injection, solution and is administered via intraocular; ophthalmic form.

Labeler Name: Dutch Ophthalmic Research Center (international) B.v.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Membraneblue Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TRYPAN BLUE .75 mg/.5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intraocular - Administration within the eye.
  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Diagnostic Dye - [EPC] (Established Pharmacologic Class)
  • Dyes - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dutch Ophthalmic Research Center (international) B.v.
Labeler Code: 68803
FDA Application Number: NDA022278 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-20-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Membraneblue Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

Membraneblue 0.15% - Dosage & Administration Section

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™ 0.15% perform a 'fluid-air exchange', i.e. filling the entire vitreous cavity with air, to prevent aqeous dilution of MembraneBlue™ 0.15%. MembraneBlue™ 0.15% is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlue™ 0.15% 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™ 0.15% 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™ 0.15% 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 0.15% - Dosage Forms & Strengths Section.

MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.

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.

Membraneblue 0.15% - Warnings And Precautions Section

Excessive staining:It is recommended that after inection all excess MembraneBlue™ 0.15% be immediately removed from the eye.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.

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.

Membraneblue 0.15% - Pregnancy Section.

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, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality, and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between the 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 4,000-fold maximum recommended human dose of 0.75 mg per injection, assuming total absorption). There are no adequate and well-controlled studies in pregnant women. Trypan blue should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Membraneblue 0.15% - Nursing Mothers Section

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trypan blue is administered to a nursing woman.

Membraneblue 0.15% - Pediatric Use Section.

The safety and effectiveness of trypan blue have been established in pediatric patients. use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients.

Membraneblue 0.15% - Geriatric Use.

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Membraneblue 0.15% - Description.

MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is a sterile solution of trypan blue (an acid di-azo group dye). MembraneBlue™ 0.15% 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:

Membraneblue 0.15% - Mechanism Of Action Section.

MembraneBlue™ 0.15% selectively stains membranes in the human eye during posterior surgery, such as epiretinal membranes (ERM) and Internal Limiting Membranes (ILM).

Membraneblue 0.15% - Nonclinical Toxicology Section.

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 (total dose approximately 100,000-fold the maximum recommended human dose of 0.75 mg per injection in a 60 kg person,assuming total absorption).

Membraneblue 0.15% - How Supplied Section.

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.

Membraneblue 0.15% - Storage And Handling Section.

MembraneBlue™ 0.15% is stored at 15 - 25°C (59 - 77°F). Protect from direct sunlight.

Other

Rx ONLYManufactured byD.O.R.C. international b.v.Scheijdelveweg 23214 VN ZuidlandThe NetherlandsDistributed in the United States byDutch Ophthalmic, USA10, Continental Drive, Bldg 1Exeter, NH 03833, USAPhone: 800-75-DUTCH or 603-778-6929US Patents 6,696,430 and 6,372,449Copyright ©, 2009 Dutch Ophthalmic Research Center

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