Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
PRODUCT MONOGRAPH<br />
APIDRA ®<br />
<strong>insulin</strong> <strong>glulisine</strong> (rDNA origin)<br />
Antidiabetic Agent<br />
Short-acting Recombinant Human Insulin Analogue<br />
PART I: HEALTH PROFESSIONAL INFORMATION<br />
SUMMARY PRODUCT INFORMATION<br />
Route of<br />
Administration<br />
Dosage Form /<br />
Strength<br />
Subcutaneous Solution for injection<br />
DESCRIPTION<br />
100 U/mL<br />
Clinically Relevant Nonmedicinal Ingredients<br />
m-cresol, trometamol, sodium chloride, polysorbate 20, water for injection,<br />
hydrochloric acid and sodium hydroxide (for pH adjustment)<br />
For a complete listing see Dosage Forms, Composition and Packaging<br />
section.<br />
APIDRA ® (<strong>insulin</strong> <strong>glulisine</strong> [rDNA origin]) is a recombinant human <strong>insulin</strong> analogue that is a<br />
rapid-acting, parenteral blood glucose-lowering agent. Insulin <strong>glulisine</strong> is produced by<br />
recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli<br />
(K12).<br />
Insulin <strong>glulisine</strong> differs from human <strong>insulin</strong> ∗ in that the amino acid asparagine at position B3 is<br />
replaced by lysine and the lysine in position B29 is replaced by glutamic acid (see<br />
PHARMACEUTICAL INFORMATION).<br />
∗ In some studies regular human <strong>insulin</strong> refers to short acting <strong>insulin</strong> marketed internationally.<br />
Page 3 of 61