Brilliant Blue G: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 22, 2025🚩 Report this page

Brilliant Blue G

Active ingredient

Sold as TISSUEBLUE

CA Health Canada

Drug class: -
Availability: See label
Routes: Intravitreal
Markets covered: 1
Products on record: 1

Overview

Brilliant Blue G is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	1	March 22, 2025

CACanada· Health Canada

1 product

Uses

CAOfficial regulatory label· revised March 22, 2025[1]

1 Pediatrics Pediatrics (< 9 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

How to take

Sources & citations

[1]Health Canada (DPD) · 02510995 · revised March 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

1 Adverse Reaction Overview Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Adverse reactions that have been reported in procedures that included the use of TISSUEBLUE have been associated with the surgical procedure and not the drug.
These complications include retinal (retinal break, tear, hemorrhage, and detachment) events, cataract complications, cystoid macular edema and transient ocular hypertension. 2 Post-Market Adverse Reactions No adverse reactions have been reported for TISSUEBLUE marketed outside of Canada.

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

General • Excessive Staining - Excess TISSUEBLUE 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 solution.
Do not use the product if the plunger does not move smoothly after priming. 1 Pregnant Women There are no available data on the use of TISSUEBLUE in pregnant women to inform about a drug associated risk. Systemic absorption of TISSUEBLUE in humans is negligible following intravitreal injection followed by 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 will result in fetal exposure to the drug. Animal reproduction studies were not conducted with TISSUEBLUE. 2 Breast-feeding It is unknown if the drug is excreted in human milk.
Because many drugs are excreted in human milk, precaution should be exercised. 3 Pediatrics Pediatrics (< 9 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
25 mg/mL Brilliant Blue G Polyethylene glycol, Sodium chloride, Sodium phosphate dibasic dodecahydrate, Sodium phosphate monobasic dihydrate, Water for injection TissueBlue™ Solution - Product Monograph Page 5 of 11

This is not medical advice. Consult a qualified healthcare professional.