Tissueblue 0.025% - Indications & Usage Section
TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).
Tissueblue Injection, Solution
FDA Label NDC 68803-722
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by D.o.r.c. Dutch Ophthalmic Research Center (international) B.v. for the product Tissueblue (NDC 68803-722). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding tissueblue 0.025% - indications & usage section, tissueblue 0.025% - dosage & administration section, tissueblue 0.025% - dosage forms & strengths section, tissueblue 0.025% - contraindications section, tissueblue 0.025% - warnings and precautions section, tissueblue 0.025% - adverse reactions section, tissueblue 0.025% - pregnancy section, tissueblue 0.025% - lactation section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Tissueblue 0.025% - Dosage & Administration Section
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.
Tissueblue 0.025% - Dosage Forms & Strengths Section
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.
Tissueblue 0.025% - Contraindications Section
None
Tissueblue 0.025% - Warnings And Precautions Section
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.
Tissueblue 0.025% - Adverse Reactions Section
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.
Tissueblue 0.025% - Pregnancy Section
Risk Summary
There are no available data on the use of TissueBlue 0.025% in pregnant women to inform a drug associated risk. Systemic absorption of TissueBlue 0.025% in humans is expected to be negligible following intravitreal injection and subsequent removal of the drug at the completion of surgical procedures. Due to the negligible systemic exposure, it is not expected that maternal use of TissueBlue 0.025% will result in fetal exposure to the drug.
Adequate animal reproduction studies were not conducted with TissueBlue 0.025%.
Tissueblue 0.025% - Lactation Section
Risk Summary
No data are available regarding the presence of Brilliant Blue G in human milk after intraocular administration of TissueBlue 0.025%, or the effects on the breastfed infant or the effects on milk production. However, breastfeeding is not expected to result in exposure of the child to Brilliant Blue G due to the expected negligible systemic exposure of BBG in humans following intravitreal injection and subsequent removal of the drug at the completion of surgical procedures.
Tissueblue 0.025% - Pediatric Use Section
The safety and effectiveness of TissueBlue 0.025% in pediatric patients has not been established.
Tissueblue 0.025% - Geriatric Use Section
No overall differences in safety or effectiveness were observed between elderly and younger adult patients.
Tissueblue 0.025% - Description Section
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: C47H48N3NaO7S2
Chemical Structure Tissueblue (Tissueblue 01)
Tissueblue 0.025% - Mechanism Of Action Section
Brilliant Blue G has been shown to selectively stain the ILM, but not the epiretinal membrane nor the retina, making it easier to visualize the membrane for removal, although the exact mechanism of this selectivity has not been elucidated.
Tissueblue 0.025% - Nonclinical Toxicology Section
Studies to evaluate the potential for carcinogenicity or impairment of fertility of TissueBlue 0.025% have not been conducted.
Brilliant Blue G was not mutagenic in the Ames assay, the in vitro mouse lymphoma assay, or the in vivo rat micronucleus assay.
Tissueblue 0.025% - How Supplied Section
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)
Tissueblue 0.025% - Storage And Handling Section
TissueBlue 0.025% should be stored at 15°C to 25°C (59°F to 77°F). Protect from light, frost and moisture.
Other
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)
Tissuebluebox.jpg (Tissuebluebox)
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