Special precautions for disposal and other handling: Instructions for use: Inspect the TYSABRI vial for particles prior to dilution and administration. If particles are observed and/or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.
Use aseptic technique when preparing TYSABRI solution for intravenous (IV) infusion. Remove flip-off cap from the vial. Insert the syringe needle into the vial through the centre of the rubber stopper and remove 15 ml concentrate for solution for infusion.
Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection. Gently invert the TYSABRI solution to mix completely. Do not shake.
TYSABRI must not be mixed with other medicinal products or diluents.
Visually inspect the diluted medicinal product for particles or discolouration prior to administration. Do not use if it is discoloured or if foreign particles are seen.
The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution. If the diluted medicinal product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion.
The diluted solution is to be infused intravenously over 1 hour at a rate of approximately 2 ml/minute.
After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Each vial is for single-use only.
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Incompatibilities: TYSABRI must not be mixed with other medicinal products except those previously mentioned in Special precautions for disposal and other handling.