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.
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