Bioprofarma Bagó relies on a PHARMACOVIGILANCE PROGRAM that encourages the exchange of information among patients, healthcare professionals and sanitary authorities by reporting the necessary information for the early detection of adverse and/or unexpected events coming from drugs being used during the extended stage of use thereof.
Bioprofarma Bagó thinks that the management of the safety of drugs is an essential requirement to prevent and minimize health problems in all patients.
What is an adverse event? (AE)
Any health adverse incident (such as disease, symptom, sign or abnormal result of laboratory) in a patient, temporarily associated with the use of a product of Bioprofarma Bagó, whether or not related thereto.
Why should I report the AEs?
Because it is our responsibility to determine the security of our products towards patients and healthcare professionals. Therefore, we comply with the requirements of the Regulatory Authorities (ANMAT) and licensors, we anticipate to foreseeable risks and we take the corresponding measures to prevent greater consequences.
The following may be considered AEs:
- Progression or worsening of an underlying disease
- Lack of efficacy
- Drug interactions
- Overdose or abuses
- Withdrawal or dependence symptoms
- Bad usage / accidental intake
- Intrauterine exposition
- Exposition through human milk
- Medication errors
- Presumed transmission of an infectious agent
- Off-label use
- Occupational exposition
- Quality deviations
What information is required to report an adverse event?
- An identifiable patient: initials, gender, age.
- Minimum description
- Products of Bioprofarma Bagó that are involved.
- Source of information or contact Source of information or contact.
IF YOU HAVEN’T GATHERED ALL THIS INFORMATION, PROVIDE WHAT YOU HAVE ALREADY GOT.
SEND THE REPORT WITHOUT DELAY.
Who should I send the information to?
Any AE must be reported to Pharmacovigilance Bioprofarma Bagó within 24 hours of being known (it doesn’t matter when the event in question has occurred).
- Working days from 9 am to 6 pm:
+ 54 (11) 4016 6200
- Mobile telephone out of business hours
Dr. Manuel Vilanova + 54 9 (11) 4089 9407