VISIONBLUE- trypan blue injection, solution
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Patient Information

Patients should be advised that if a non-hydrated, hydrophilic acrylic intraocular lens (IOL) is inserted into their eye, it may absorb the dye and become stained.

Manufactured by

D.O.R.C. International b.v.

Scheijdelveweg 2

3214 VN Zuidland

The Netherlands

Distributed in the United States by

Dutch Ophthalmic, USA

10 Continental Drive, Bldg 1

Exeter, NH 03833, USA

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

US Patents 6,367,480 and 6,720,314

Copyright , 2012 Dutch Ophthalmic Research Center

1. Highlights Of Prescribing Information
2. Indications And Usage
3. Dosage And Administration
4. Dosage Forms And Strengths
5. Contraindications
6. Warnings And Precautions
7. Adverse Reactions
8. Use In Specific Populations
9. Visionblue 0.06% - Indications & Usage Section
10. Visionblue 0.06% - Dosage & Administration Section
11. Visionblue 0.06% - Dosage Forms & Strengths Section
12. Visionblue 0.06% - Contraindications Section
13. Visionblue 0.06% - Warnings And Precautions Section
14. Visionblue 0.06% - Adverse Reactions Section
15. Visionblue 0.06% - Use In Specific Populations Section
16. Visionblue 0.06% - Description Section
17. Visionblue 0.06% - Clinical Pharmacology Section
18. Visionblue 0.06% - Nonclinical Toxicology Section
19. Visionblue 0.06% - How Supplied Section
20. Visionblue 0.06% - Storage And Handling Section
21. Visionblue 0.06% - Package Label.principal Display Panel

Highlights Of Prescribing Information ⮝

VisionBlue 0.06% Trypan blue Ophthalmic Solution. These highlights do not include all the information needed to use VISIONBLUE 0.06% safely and effectively. see full prescribing information for VISIONBLUE 0.06%. VisionBlue (trypan blue ophthalmic solution) 0.06% Initial U.S. Approval: 2004

Indications And Usage ⮝

HIGHLIGHTS OF PRESCRIBING INFORMATION (1)

These highlights do not include all the information needed to use VISIONBLUE 0.06% safely and effectively. see full prescribing information for VISIONBLUE 0.06%. VisionBlue (trypan blue ophthalmic solution) 0.06% Initial U.S. Approval: 2004 (1)

(1)

VisionBlue 0.06% is an acid di-azo group dye indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens. (1)

Dosage And Administration ⮝

• Inject an air bubble into the anterior chamber;
• Carefully apply VisionBlue 0.06% onto the lens capsule;
• Remove all excess dye from the anterior chamber.

Dosage Forms And Strengths ⮝

VisionBlue (trypan blue ophthalmic solution) 0.06% 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 VisionBlue 0.06% should be removed from the eye immediately after staining. (5)

Adverse Reactions ⮝

Inadvertent staining of the posterior lens capsule and vitreous face. (6)

(6)

To report SUSPECTED ADVERSE REACTIONS contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (6)

Use In Specific Populations ⮝

Trypan blue should not be given to pregnant women. (7)

Revised: 12/2012

Visionblue 0.06% - Indications & Usage Section ⮝

VisionBlue 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.

Visionblue 0.06% - Dosage & Administration Section ⮝

Cataract surgery.

VisionBlue 0.06% is packaged in a 2.25 mL syringe to which a blunt cannula has to be attached.

After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of VisionBlue 0.06% by the aqeous. VisionBlue 0.06% is carefully applied onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule. The anterior chamber is then irrigated with balanced salt solution to remove all excess dye. An anterior capsulotomy can then be performed.

Visionblue 0.06% - Dosage Forms & Strengths Section ⮝

VisionBlue 0.06% is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.

Visionblue 0.06% - Contraindications Section ⮝

VisionBlue 0.06% 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.

Visionblue 0.06% - Warnings And Precautions Section ⮝

Excessive staining:

It is recommended that after injection all excess VisionBlue 0.06% is immediately removed from the eye by thorough irrigation of the anterior chamber.

Visionblue 0.06% - Adverse Reactions Section ⮝

Adverse reactions reported following use of VisionBlue 0.06% 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.

Visionblue 0.06% - Use In Specific Populations Section ⮝

VisionBlue 0.06% - 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 10,000- and 5,000-fold the maximum recommended human dose of 0.3 mg per injection based in a 60 kg person, assuming that the whole dose is completely absorbed. 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 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 10,000-fold the maximum recommended human daily dose of 0.3 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.

VisionBlue 0.06% - 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.

VisionBlue 0.06% - 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.

VisionBlue 0.06% - Geriatric use section

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

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). 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 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:

Visionblue 0.06% - Clinical Pharmacology Section ⮝

VisionBlue 0.06% - Mechanism of action section

VisionBlue 0.06% selectively stains connective tissue structures in the human eye such as the anterior lens capsule of the human crystalline lens.

VisionBlue 0.06% is intended to be applied directly on the anterior lens capsule, staining any portion of the capsule which comes in contact with the dye. Excess dye is washed out of the anterior chamber. The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the non-stained lens cortex and inner lens material.

Visionblue 0.06% - Nonclinical Toxicology Section ⮝

VisionBlue 0.06% - Carcinogenesis & Mutagenesis & Impairment of fertility section

Trypan blue is carcinogenic in rats. Wistar/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total does approximately 250,000-fold the maximum recommended human dose of 0.3 mg per injection in a 60 kg person, assuming total absorption).

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

Visionblue 0.06% - How Supplied Section ⮝

VisionBlue 0.06% is supplied as follows:

0.5 mL of VisionBlue 0.06% 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. Ten pouched products are packed in on distribution box.

Visionblue 0.06% - Storage And Handling Section ⮝

Store between 15-25 C (59-77 F). Protect form direct sunlight.

Visionblue 0.06% - Package Label.principal Display Panel ⮝

VISIONBLUE trypan blue injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68803-612 Route of Administration INTRAOCULAR, OPHTHALMIC

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRYPAN BLUE (UNII: I2ZWO3LS3M) (TRYPAN BLUE FREE ACID - UNII:768N7QO4KH) TRYPAN BLUE 0.3 mg in 0.5 mL

Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) 0.15 mg in 0.5 mL SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) 0.85 mg in 0.5 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 4.1 mg in 0.5 mL WATER (UNII: 059QF0KO0R) 0.5 mL in 0.5 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68803-612-10 10 in 1 CARTON 12/16/2014 1 1 in 1 POUCH 1 0.5 mL in 1 SYRINGE, GLASS; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021670 12/16/2004

Labeler - D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. (407522184)

Registrant - D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. (407522184)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmpur GmbH		340805167	manufacture(68803-612)

Revised: 12/2018 Document Id: 7c57aaf4-e1a1-d191-e053-2a91aa0a757a 34391-3 Set id: a44bc2ef-3d7f-4125-a7f7-c5969b1b4142 Version: 16 Effective Time: 20181206 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.