Adverse reactions : תופעות לוואי

4.8   Undesirable effects

System organ classes  Frequency                              Undesirable effect Skin and subcutaneous Very common (≥1/10)                    long-lasting reaction, irritation caused tissue disorders                                             by the surgical tape Common (≥1/100 to <1/10)               transient hypopigmentation/hyperpigmentation
Uncommon       (≥1/1,000       to flare-up of dermatitis
<1/100)
Rare (≥1/10,000 to <1/1,000)        sensitisation


In extremely rare cases and only in relation to certain substances, anaphylactic reactions (systemic reaction, possibly with a life-threatening drop of blood pressure) have occurred. The allergy departments are for other reasons prepared to treat such incidences. Anaphylactic type reactions in relation to application of TRUE tests are not documented.


Irritation caused by the surgical tape adhesive disappears rapidly.

A positive test reaction usually disappears within 1-2 weeks. Long-term reactions are positive reactions, which persist for weeks or months.

Positive test reaction may leave an area of transient hypopigmentation/hyperpigmentation at application site.

A flare-up of dermatitis may be observed when testing during an active phase of dermatitis.

Sensitisation. See section 4.4 (special warnings and special precautions for use).
Reporting of suspected adverse reactions


Reporting suspected adverse reactions after authorisation 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://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.g ov.il