Adverse reactions : תופעות לוואי

4.8     Undesirable Effects

In extremely rare cases local anaesthetic preparations have been associated with allergic reactions. Occasional local skin irritation may occur following the use of STUD 100.

Systemic adverse reactions to lidocaine are usually the result of high plasma concentrations due to high dosage, rapid absorption or may result from hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Such reactions involve excitatory and/or depressant actions on the CNS characterised by nervousness, dizziness, convulsions, unconsciousness and possible respiratory arrest. Cardiovascular reactions are depressant and may include hypotension, myocardial depression, bradycardia and possibly cardiac arrest.

The plasma lidocaine levels attained following application of STUD 100 at the maximum recommended dose are extremely low at about 25 times lower than the concentrations associated with systemic toxicity.

Reporting suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
.
 https://sideeffects.health.gov.il

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