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Administration of Replagal Infusion

Replagal is administered as a 40-minute intravenous infusion at an approved recommended dose of 0.2 mg/kg of body weight every other week.1

Click here to download a PDF on how to calculate the dose for Replagal

Replagal Vial
The package and vial may be different in your region.

Home Treatment Authorised (SmPC)

Preparing for Replagal infusion

The following instructions are based on the SmPC instructions for use, handling and disposal.1

1. Based on the patient’s weight, calculate the dose and number of vials

2. Collect the necessary equipment for infusion

Replagal infusion checklist

Replagal infusion syringe withdrawal3. Using a clean, non-touch technique, withdraw the required amount of Replagal from the vial into a sterile syringe

Replagal infusion bag dilution4. Transfer the dose into an infusion bag to dilute in 100 mL of 0.9% sodium chloride solution

Replagal infusion bag mixing5. Gently invert the infusion bag containing the diluted solution to ensure thorough mixture of the product and the diluent. DO NOT shake the solution

6. Before administration, inspect the solution for particles and discolouration; the solution should be clear and colourless. DO NOT use if the solution is discoloured, or if foreign particles are present

Replagal Infusion Intravenous Administration7. Administer the Replagal infusion solution as soon as possible after dilution using an intravenous line with an integral 0.2µm filter over a period of 40 minutes

8. DO NOT infuse Replagal concomitantly in the same intravenous lines with other agents

Store the concentrate in a refrigerator (2-8°C). Care must be taken to ensure the sterility of the prepared solution since Replagal does not contain any preservative or bacteriostatic agent. Stability in use has been demonstrated for 24 hours at 25°C. If not used immediately, storage would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Reference:
1. Replagal (agalsidase alfa), EMA Summary of Product Characteristics, August 2016. Available here.