|
Biomedica |
PHARMACOVIGILANCE |
|
Biomedica |
PHARMACOVIGILANCE |
The health-care professionals involved
in the prescription of Biomedica Foscama's
products, that should become
aware of suspected adverse reactions to the patient is kindly requested
to report, at any moment, at the:
|
PHARMACOVIGILANCE SERVICE +39 0775 802 1 |
The following minimun information should be reported:
|
1. |
specific adverse event (description and date of appearance) |
|
2. |
suspected substance/medicinal product (trade name) |
|
3. |
seriousness (see below for definition) |
|
4. |
patient's identification (initials, age and sex) |
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5. |
reporter's identification (name, initials, address, qualification and telephone number) |
|
6. |
indication for which the products has been administered |
|
7. |
concomitant medications |
An Adverse Drug Reaction's is considered serious if it fall into one or more of the following categories:
|
a) |
death |
| b) | life-threatening |
| c) | results in or prolongs hospitalisation |
| d) | results in temporary or persistent disability |
| e) | congenital anomalies |
| f) | medically relevant event |
| g) | event which requires medical intervent or surgery |
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