Product Description
[Product Name]
Trypan Blue Ophthalmic Solution
[Model and Specification]
0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2 mL, 1.3 mL, 1.4 mL,
1.5 mL, 1.6 mL, 1.7 mL, 1.8 mL, 1.9 mL, 2.0 mL, 3.0 mL
[Structure and Composition]
This product consists of trypan blue as the active ingredient, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, and water for injection. The product is sterilized by moist heat.
[Product Performance Indicators]
1. Appearance: Dark blue, clear liquid, free from visible foreign matter.
2. Filled Volume: Not less than 93% of the labeled volume.
3. pH Value: 6.0 – 8.0.
4. Osmolality: 260 – 340 mOsm/kg H₂O.
5. Active Ingredient Content: Nominal concentration of trypan blue is 0.60 mg/mL (±20%).
[Sterility]
The product is sterile.
[Intended Use]
This product is intended for staining the anterior capsule of the lens during ophthalmic surgery to enhance visualization of the capsule, thereby facilitating cataract procedures such as continuous curvilinear capsulorhexis.
[Directions for Use]
Draw 0.1 mL of Trypan Blue Ophthalmic Solution into a 1 mL sterile syringe, then draw 0.3 mL of sterile air.
After entering the anterior chamber through a side port incision, inject approximately 0.3 mL of sterile air to form an air bubble, followed by the injection of 0.1 mL of Trypan Blue Ophthalmic Solution onto the anterior capsule.
Adequate staining is achieved within approximately 3 seconds. Irrigate the anterior chamber thoroughly with balanced salt solution to remove excess dye, then inject an ophthalmic viscoelastic agent. Standard phacoemulsification surgery may then be performed.
[Precautions]
Do not use if the package is damaged.
The staining time shall not exceed 30 seconds.
For ophthalmic use only. Not for oral administration or any other use.
This product shall only be used by qualified ophthalmic surgeons.
Use the lowest effective concentration and minimize intraocular retention time.
[Contraindications]
This product is contraindicated in patients with known hypersensitivity to trypan blue.
The safety of this product in pregnant or lactating women has not been established.
[Packaging]
Neutral borosilicate glass vial.
[Storage and Transportation]
Store at room temperature in a dry, clean, well-ventilated place, protected from light.
Transport under normal conditions. Handle with care. Avoid impact, moisture, and direct sunlight.