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AstraZeneca

Yervoy
ipilimumab

Package leaflet: Information for the user


YERVOY 5 mg/ml concentrate for solution for infusion

ipilimumab


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


Tell your doctor immediately if you get any of these side effects.

Do not try to treat your symptoms with other medicines.


Other side effects that have been reported (frequency not known) with ipilimumab in combination include:


Flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection at the end of the infusion.


Storage conditions and shelf life:

Unopened vial

YERVOY must be stored in a refrigerator (2°C to 8°C). The vials must be kept in the original package in order to protect from light. YERVOY should not be frozen.


Do not use YERVOY after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.


YERVOY infusion

From a microbiological point of view, once opened, the medicine should be infused or diluted and infused immediately. The chemical and physical in-use stability of the undiluted or diluted infusion solution (between 1 and 4 mg/ml) has been demonstrated for 24 hours at room temperature (20°C

to 25°C) or when refrigerated (2°C to 8°C). If not used immediately, the infusion solution (undiluted or diluted) must be used within 24 hours when stored either under refrigeration (2°C to 8°C) or at room temperature (20°C to 25°C). Other in-use storage time and conditions are the responsibility of the user.


Disposal:

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.