FA Dye Fluorescein Sodium Injection SDV 10% 5mL (10/Pack)

Fluorescein Sodium 10% Injection, 10 x 5 mL Single-Dose Vials — Nexus Pharmaceuticals Active ingredients Fluorescein sodium 10% (100 mg/mL), 500 mg per 5 mL Dosage form Sterile injectable solution, preservative-free Route Intravenous Size 5 mL single-dose vial, 10 vials per pack Manufacturer Nexus Pharmaceuticals, LLC NDC 14789-122-05 Indications and Usage Indicated as a diagnostic aid in fluorescein angiography or angioscopy of the retina and iris vasculature. Dosage and Administration For adults, the usual dose of Fluorescein Injection 10% is 5 mL (500 mg) administered intravenously. For pediatric patients, the dose is calculated based on body weight at approximately 7.7 mg/kg. Do not mix or dilute with other solutions or drugs. Warnings and Precautions Serious hypersensitivity and anaphylactic reactions, including rare deaths, may occur; appropriate resuscitation equipment and trained personnel should be readily available. Extravasation should be avoided, as it may cause significant local tissue injury. Patients with a history of hypersensitivity to fluorescein may be at increased risk of reaction. Fluorescein may cause temporary yellow discoloration of the skin and a bright yellow discoloration of the urine. Exercise caution in patients with a history of allergy or bronchial asthma. Contraindications Contraindicated in patients with known hypersensitivity to fluorescein sodium or any component of the formulation. Adverse Reactions Common adverse reactions include nausea, headache, gastrointestinal distress, vomiting, and dizziness. Hypersensitivity reactions, including urticaria, hypotension, bronchospasm, and anaphylaxis, may occur. Temporary yellow discoloration of the skin and urine is also expected following administration. Storage and Handling Store at 20°C to 25°C (68°F to 77°F) in accordance with USP Controlled Room Temperature requirements. Protect from freezing. How Supplied Fluorescein Injection, USP 10% is supplied as a sterile, preservative-free solution containing 500 mg/5 mL (100 mg/mL) in 5 mL single-dose glass vials, with 10 vials per carton. NDC 14789-122-05. Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details. If you have any questions related to DSCSA compliance, transaction history, regulatory data or quality assurance, please contact our team at compliance@dryeyerescue.com for more information.