Bracco Accessories and devices Instructions For Use


What is Pharmacovigilance?
Pharmacovigilance is a system concerned with identifying, assessing, understanding and preventing adverse reactions as well as any other problems associated with taking medicines, with the aim to improve the treatment and safety of patients and better the public health.
In order to provide the most accurate information to doctors and consumers, it’s necessary to fully understand and continuously monitor the risk/benefit profile of medicines.
Bracco is responsible for collecting, processing and evaluating the information relative to the risk/benefit profile of its products, both commercially available and those currently in clinical development. Any problems that may arise are promptly communicated to healthcare professionals, patients and the proper authorities in accordance with current regulations.

What is an adverse reaction to medicines?
It’s a harmful and unintended consequence of the medicine’s use.
Adverse drug reactions may result either from correct use of the medicine, unauthorized use of the medicine or from medical personnel exposure. Unauthorized use includes, among others, overdose, improper use, abuse and medication errors.

How can you report an adverse drug reaction?
Voluntary reporting of suspected adverse reactions make up an important source of information for pharmacovigilance activities; so as to correctly assess the profile of the safety and efficacy of pharmaceuticals, any and all adverse reactions to medicines in the country are logged in a single database.
Any undesiderable event experienced during the course of treatment or diagnostic procedures must be immediately reported to the patient’s physician or pharmacist.

Different countries may have specific processes in place to handle reports of adverse reactions. To report an adverse reaction related to Bracco products, you can find specific contacts and information following the link: and selecting the page “contacts” of your country.

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All materials provided in this repository are for informational purposes only and are intended for healthcare professionals in compliance with Regulation (EU) 2017/745, Annex 1, Article 23.