Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Skin disorders:
Very rarely (<1/10,000) allergic or irritation skin reactions have been reported with chlorhexidine, isopropyl alcohol and Sunset Yellow (E110) including: erythema, rash (e.g.
erythematous, papular, or maculopapular), pruritus and blisters or application site vesicles.
Other local symptoms have included skin burning sensation, pain and inflammation.
Frequency not known: dermatitis, eczema, urticaria, chemical burns in neonates.
Immune disorders: Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

The most commonly reported adverse reactions reported are associated with application site reactions. These were noted to occur most often within the area of application of the solution (i.e. at the prep site) and very rarely spread. The adverse reactions were often self-limiting in nature or resolved following treatment with topical steroids and / or antihistamines. The most commonly reported reactions were non-serious in nature and included application site rash, application site erythema, application site vesicles, application site pain and application site pruritus. Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Cases of anaphylactic reactions have been reported during anaesthesia.

Eye disorders
Frequency not known: Eye irritation, pain, hyperaemia, corneal erosion, epithelium defect/corneal injury, significant permanent visual impairment*.

*Cases of severe corneal erosion and permanent significant visual impairment due to inadvertent ocular exposure have been reported post-marketing, leading to some patients requiring corneal transplant (see section 4.4).

Description of selected adverse reactions
There have been isolated spontaneous reports of generalised allergic reactions potentially associated with ChloraPrep solution and have been reported during anaesthesia. In some cases the patient may have had a pre-existing sensitivity to chlorhexidine (see section 4.4).
This product may cause a severe allergic reaction. Symptoms may include wheezing/difficulty breathing, shock, facial swelling, hives, or rash. Use of ChloraPrep with Tint is contra-indicated where patients have shown previous hypersensitivity to chlorhexidine or isopropyl alcohol (see Section 4.3). If hypersensitivity or an allergic reaction occurs, stop use and seek medical help right away.

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://sideeffects.health.gov.il