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Replagal

Replagal Caution For Usage

agalsidase alfa

Manufacturer:

Takeda

Distributor:

Zuellig
Full Prescribing Info
Caution For Usage
Incompatibilities: In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: Calculate the dose and number of Replagal vials needed.
Any dose change should occur only at the direction of the treating physician.
Dilute the total volume of Replagal concentrate required in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion. Care must be taken to ensure the sterility of the prepared solutions since Replagal does not contain any preservative or bacteriostatic agent; aseptic technique must be observed.
Once diluted, the solution should be mixed gently but not shaken.
Since no preservative is present, it is recommended that administration is started as soon as possible after dilution (see Shelf life under Storage).
The solution should be inspected visually for particulate matter and discolouration prior to administration.
For single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
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