Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
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Opened APIDRA SoloSTAR should not be stored in the freezer and should not be allowed to<br />
freeze. If APIDRA SoloSTAR freezes discard it.<br />
As with all medications and devices, keep out of reach of children.<br />
Infusion sets:<br />
Infusion sets (reservoirs, tubing, and catheters) and the APIDRA in the reservoir should be<br />
discarded after no more than 2 days of use or after exposure to temperatures that exceed 37°C.<br />
SPECIAL HANDLING INSTRUCTIONS<br />
See also PART III: CONSUMER INFORMATION, and refer patients to the APIDRA<br />
Information for the Patient circular for APIDRA VIAL, APIDRA CARTRIDGE and APIDRA<br />
SoloSTAR for additional information. Refer patients to the User Manual for ClikSTAR, Autopen<br />
24 and APIDRA SoloSTAR for additional information on use of the pens.<br />
DOSAGE FORMS, COMPOSITION AND PACKAGING<br />
The vials, cartridges and SoloSTAR contain a sterile solution of <strong>insulin</strong> <strong>glulisine</strong> for use as an<br />
injection. APIDRA [Insulin Glulisine (rDNA origin)] consists of <strong>insulin</strong> <strong>glulisine</strong> dissolved in a<br />
clear aqueous solution.<br />
Each milliliter of APIDRA contains <strong>insulin</strong> <strong>glulisine</strong> 100 units. It also contains excipients: mcresol,<br />
trometamol, sodium chloride, polysorbate 20, and water for injection. APIDRA has a pH<br />
of approximately 7.3 and is adjusted by addition of aqueous solutions of hydrochloric acid and<br />
sodium hydroxide.<br />
APIDRA [<strong>insulin</strong> <strong>glulisine</strong> (rDNA origin)] 100 units per mL is available in the following<br />
package sizes:<br />
• 10-mL vials<br />
• 3-mL cartridges package of 5, for use with ClikSTAR and Autopen 24.<br />
• 3-mL APIDRA SoloSTAR (pre-filled disposable pen), package of 5<br />
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