Lidaxing Perfluoropropane-albumin Microspheres for Injection

1. Indications and Usage
Echocardiography Enhancement:
Used to improve endocardial border definition and increase the accuracy of lesion identification and diagnosis for patients with unclear images on conventional transthoracic echocardiography.
2. Dosage and Administration
Route of Administration:
For Peripheral Intravenous Injection ONLY.
Recommended Dosage:
Standard Dose: 0.01 mL/kg.
Maximum Dose: If the initial effect is unsatisfactory, the dose may be increased to 0.02 mL/kg, but the total number of injections must not exceed 2.
Critical Administration Instructions:
Reconstitution: Inject 3 mL of 0.9% Sodium Chloride Injection into the vial. Insert a second air-venting needle to maintain constant pressure and prevent microsphere rupture. Gently roll the vial between palms for approximately 1 minute. Do not shake vigorously.
Injection Technique: Inject at a speed of approximately 1 mL/sec using a three-way stopcock, immediately followed by a 5-10 mL saline flush. The ultrasound examination must be performed simultaneously during injection.
Time Limit: The interval between mixing and injection must not exceed 1 minute.
3. Mechanism of Action
Acoustic Impedance Mismatch:
The microspheres consist of perfluoropropane gas encapsulated in a 1% human albumin shell.
Signal Enhancement:
Upon intravenous administration, these stable gas microcircuits scatter ultrasound waves much more strongly than blood cells alone, significantly enhancing the Doppler signal and clarifying the left ventricular cavity boundaries.
4. Safety and Warnings
Cardiovascular Contraindications:
Absolute Contraindications: Severe arrhythmias, New York Heart Association (NYHA) Class IV heart failure, severe pulmonary hypertension, pulmonary embolism, and asthma.
Relative Contraindications: Mitral valve stenosis and congenital heart disease with intracardiac shunts (microspheres may bypass pulmonary filtration and enter arterial circulation).
Respiratory Contraindications:
Strictly contraindicated in patients with severe pulmonary emphysema, pulmonary vasculitis, adult respiratory distress syndrome, or respiratory failure.
Hypersensitivity:
As it contains human albumin, hypersensitivity reactions are possible. Emergency medications (adrenaline, antihistamines, corticosteroids) must be available.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions:
Headache (5.4%), nausea and vomiting (4.3%), flushing or facial redness (3.6%), and dizziness (2.5%).
Other Reported Adverse Reactions:
Transient changes in heart rate and blood pressure, dyspnea, chest pain, injection site erythema, and hypersensitivity reactions.
6. Drug Interactions
Concomitant Medications:
Clinical data on drug interactions are currently lacking. No significant pharmacokinetic interactions are expected as the agent is physically trapped in the vascular compartment and exhaled unchanged.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Perfluoropropane gas encapsulated in 5% human albumin microspheres.
Appearance: White lyophilized cake or loose body. Upon reconstitution, it forms a milky white suspension.
Storage: Store in the original carton at 2°C to 8°C. Do not freeze. Protect from light.