Apidra (insulin glulisine) - Sanofi Canada

PART III: CONSUMER INFORMATION
APIDRA ® VIALS
insulin glulisine (rDNA origin)
This leaflet is part III of a three-part “Product
Monograph” published when APIDRA was approved
for sale in Canada and is designed specifically for
Consumers. This leaflet is a summary and will not
tell you everything about APIDRA. Contact your
health professional if you have any questions about
the drug.
ABOUT THIS MEDICATION
What the medication is used for:
APIDRA [insulin glulisine (rDNA origin)] is an
antidiabetic agent (short-acting recombinant human
insulin analogue), used to reduce high blood sugar in
adults and children (6 years or older) with diabetes
mellitus.
What it does:
Insulin is a hormone produced by the pancreas, a
large gland that lies near the stomach. This hormone
is necessary for the body's correct use of food,
especially sugar. Diabetes occurs when the pancreas
does not make enough insulin to meet your body's
needs or when your body cannot use properly the
insulin you normally produce.
When your body does not make enough insulin, you
need an external source of insulin. That is why you
must take insulin injections. APIDRA is similar to
the insulin made by your body.
APIDRA has a rapid onset of action and a short
duration of about 4 hours. APIDRA should normally
be used with a longer-acting insulin to maintain
adequate blood sugar. APIDRA can also be used with
oral drugs to reduce blood sugar.
You have been instructed to test your blood and/or
your urine regularly for glucose (sugar); it is
especially important to test even more often when
changing insulins or dosing schedule. If your blood
tests consistently show above- or below-normal
glucose levels, or your urine tests consistently show
the presence of glucose, your diabetes is not properly
IMPORTANT: PLEASE READ
controlled and you must let your health professional
know.
When it should not be used:
You should not take APIDRA if you are allergic to
this drug or to any ingredient in the formulation or
component of the container.
What the medicinal ingredient is:
The active ingredient in APIDRA is insulin glulisine,
(rDNA origin).
What the nonmedicinal ingredients are:
The nonmedicinal ingredients are m-cresol,
polysorbate 20, sodium chloride, trometamol, water,
and hydrochloric acid and sodium hydroxide for pH
adjustment.
What dosage forms it comes in:
APIDRA is a solution for injection (100 U/mL)
available in the following package size:
10-mL vials
It is also available in:
-3-mL Cartridges, package of 5 (for use only with
ClikSTAR and Autopen 24 * )
-3-mL SoloSTAR (pre-filled disposable pen),
package of 5
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
• Hypoglycemia (low blood sugar) is the most
common adverse effect of insulin, including
APIDRA.
• Blood glucose (blood sugar) monitoring is
recommended for all patients with diabetes.
• Uncorrected hypoglycemic (low blood sugar) or
hyperglycemic (high blood sugar) reactions can
cause loss of consciousness, coma, or death.
• Any change of insulin should be made cautiously
*
Registered trade-mark of Owen Mumford Limited, used
under license.
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