Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
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Occupational Hazards<br />
The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia or<br />
hyperglycemia or, for example, as a result of visual impairment. This may constitute a risk in<br />
situations where these abilities are of special importance (e.g. driving a car or operating<br />
machinery).<br />
Patients should be advised to take precautions to avoid hypoglycemia whilst driving. This is<br />
particularly important in those who have reduced or absent awareness of the warning symptoms<br />
of hypoglycemia or have frequent episodes of hypoglycemia. It should be considered whether it<br />
is advisable to drive or operate machinery in these circumstances.<br />
ADVERSE REACTIONS<br />
Adverse Drug Reaction Overview<br />
Overall, clinical studies comparing APIDRA with short-acting <strong>insulin</strong>s did not demonstrate a<br />
difference in frequency of adverse events.<br />
The adverse events observed were those known in this pharmacological class and consequently<br />
common to <strong>insulin</strong>s.<br />
Body as a whole:<br />
Local Allergy<br />
As with other <strong>insulin</strong> therapy, local allergy in patient may occur as redness, itching, swelling, or<br />
hemorrhage. These minor reactions usually resolve in a few days to a few weeks. In some<br />
instances, these reactions may be related to factors other than <strong>insulin</strong>, such as irritants in a skin<br />
cleansing agent or poor injection technique.<br />
Systemic Allergy<br />
Less common, but potentially more serious, is generalized allergy to <strong>insulin</strong> (including <strong>insulin</strong><br />
<strong>glulisine</strong>), which may cause rash (including pruritus) over the whole body, shortness of breath,<br />
wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized<br />
allergy, including anaphylactic reactions, may be life threatening.<br />
Localized reactions and generalized myalgias have been reported with the use of m-cresol as an<br />
injectable excipient.<br />
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