Apidra (insulin glulisine) - Sanofi Canada

local injection site reactions, contact your health
professional.
This is not a complete list of side effects. For any
unexpected effects while taking APIDRA, contact
your health professional.
HOW TO STORE IT
Unopened Vial:
Unopened APIDRA vials should be stored in a
refrigerator, between 2°C - 8°C. Keep APIDRA away
from direct heat and light. APIDRA should not be
stored in the freezer and should not be allowed to
freeze. If APIDRA freezes or overheats, discard it.
Opened (In Use) Vial:
The opened vial can be kept refrigerated or
unrefrigerated (15 - 25°C) for up to 28 days away
from direct heat and light, as long as the temperature
is not greater than 25°C. Opened APIDRA vials,
whether or not refrigerated, must be discarded after
28 days even if they contain insulin.
Opened APIDRA vials should not be stored in the
freezer and should not be allowed to freeze. If a vial
freezes or overheats, discard it.
Do not use a vial of APIDRA after the expiration
date stamped on the label or if it is cloudy or if you
see particles.
Infusion sets (when used with Continuous
Subcutaneous Insulin Infusion pump)
Infusion sets (reservoirs, tubing, and catheters) and
the APIDRA in the reservoir should be discarded
after no more than 48 hours of use or after exposure
to temperatures that exceed 37°C.
As with all medications and devices, keep out of
reach of children.
IMPORTANT: PLEASE READ
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions
associated with the use of health products to the
Canada Vigilance Program by one of the following 3
ways:
• Report online at:
www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form
and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting
Form and the adverse reaction reporting guidelines
are available on the MedEffect Canada Web site at
www.healthcanada.gc.ca/medeffect .
NOTE: Should you require information related to the
management of side effects, contact your health
professional. The Canada Vigilance Program does
not provide medical advice.
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