Agalsidase Alfa Concentrated Solution for Infusion

Effects and efficacy:
For long-term enzyme replacement therapy of Fabry disease (α-galactosidase A deficiency).
Usage and dosage:
This product should be used for treatment under the guidance of a physician who has experience in managing patients with Fabry disease or other genetic metabolic diseases. The dosage is 0.2 mg/kg body weight. Dilute this product with 100 ml of 9 mg/mL (0.9%) sodium chloride solution before administration. Use an intravenous infusion tube with an integral filter. The intravenous infusion time is greater than 40 minutes and the drug is administered once every week (every two weeks). Instructions for use: Do not administer this product to other drugs through the same intravenous infusion tube for intravenous infusion at the same time. Before administration, the solution should be visually inspected to observe particulate matter and solution discoloration. Since this product does not contain any preservatives or antibacterial agents, it is recommended to be used immediately after preparation and must be diluted under controlled and verified aseptic conditions and used as soon as possible after dilution; if it cannot be used immediately, the user is responsible for the storage time and conditions before use, and storage at 2-8°C is usually not more than 24 hours. Once diluted, the solution should be gently mixed without shaking; it is limited to one-time use, and any unused product or waste should be disposed of in accordance with local requirements.
Adverse reactions:
The most common adverse reactions are infusion-related reactions, most of which are mild, including chills, headache, nausea, fever, flushing and fatigue, which generally resolve on their own; severe infusion reactions occur occasionally, such as urticaria, angioedema with a tightening sensation in the throat, wheezing and swollen tongue, etc.
Drug contraindications:
Contraindicated if allergic to this product