TISSUEBLUE

5 mL) in each syringe to stain the ILM. 2 Administration  TISSUEBLUE is carefully injected into the BSS-filled vitreous cavity using a blunt cannula attached to the syringe, without allowing the cannula to contact or damage 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.  Do not use product if solution shows haziness, particulate matter, discolouration, or leakage.

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.

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

TISSUEBLUE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.