TissueBlue: Package Insert / Prescribing Info

Indications and Usage for TissueBlue

TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).

TissueBlue Dosage and Administration

TissueBlue 0.025% is carefully injected into the Balanced Salt Solution (BSS)-filled vitreous cavity using a blunt cannula attached to the pre-filled syringe, without allowing the cannula to contact the retina or allowing TissueBlue to get under the retina. Sufficient staining is expected within a few seconds. Following staining, all excess dye should be removed from the vitreous cavity.

Dosage Forms and Strengths

TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a clear, bright blue, single-dose ophthalmic solution supplied in 2.25 mL syringes pre-filled to a volume of 0.5 mL.

Contraindications

None

Warnings and Precautions

Excessive Staining
Excess TissueBlue 0.025% should be removed from the eye immediately after staining.

Use of the Syringe
Make sure the plunger moves smoothly before injecting the solution. Do not use the product if the plunger does not move smoothly to prime the cannula.

Adverse Reactions/Side Effects

Adverse reactions that have been reported in procedures that included the use of Brilliant Blue G Ophthalmic Solution have often been associated with the surgical procedure. These complications include retinal (retinal break, tear, hemorrhage, and detachment) and cataracts.

Use In Specific Populations

TissueBlue Description

TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is a sterile solution of BBG (a dye). Each mL of TissueBlue 0.025% contains BBG 0.25 mg, Polyethylene Glycol 40mg and Buffered Sodium Chloride solution (8.20 mg of sodium chloride, 3.10 mg sodium phosphate dibasic dodecahydrate, 0.30 mg sodium phosphate monobasic dihydrate, water for injection). The pH range of TissueBlue 0.025% Solution is between 7.3 and 7.6.

The drug substance BBG has the chemical name Brilliant Blue G, a molecular weight of 854.02 and has the following chemical structure:

Molecular formula: C 47H 48N 3NaO 7S 2

TissueBlue - Clinical Pharmacology

Nonclinical Toxicology

How is TissueBlue supplied

TissueBlue (Brilliant Blue G Ophthalmic Solution), 0.025% is supplied as 0.5 mL of Brilliant Blue G Ophthalmic Solution, 0.025% in a sterile, single-dose Luer Lok, 2.25 mL glass syringe, with a grey rubber plunger stopper and tip cap with polypropylene plunger rod in a pre-formed polypropylene blister pouch sealed with a Tyvek® lid.

NDC 68803-722-05 (One 0.5 mL syringe)
NDC 68803-722-25 (Carton of five 0.5 mL syringes)

Storage and Handling

TissueBlue 0.025% should be stored at 15°C to 25°C (59°F to 77°F). Protect from light, frost and moisture.

Rx Only

Distributed by:
Dutch Ophthalmic, USA
10 Continental Drive, Bldg 1
Exeter, NH 03833, USA
Phone: 800-75-DUTCH or 603-778-6929

Revision Date: 12/2019
Made in Germany
All trademarks are the property of their respective owners.

Package Label - 0.5 mL

TissueBlue

(Brilliant Blue G Ophthalmic Solution) 0.025%

Staining Solution for Ophthalmic Surgery

Protect from light, frost and moisture. Store at 15°C to 25°C (59°F to 77°F). Sterile.

Active ingredients/Ingrédient actif: Brilliant Blue G 0.025% Inactive ingredients/Ingrédients inactifs: Water for injection, Sodium chloride, Sodium phosphate dibasic dihydrate, Sodium phosphate monobasic dihydrate, Polyethylene Glycol.

NDC 68803-722-05 (One 0.5 mL syringe)
NDC 68803-722-25 (Carton of five 0.5 mL syringes)