Pharmacovigilance form - AntibioticeAntibiotice

Patient’s initials:

No. F.O/REG. CONS*

GENDER*

AGE*

BIRTH DATE*

DATE WHEN THE ADVERSE EVENT WAS REPORTED/OCCURED*

DATE OF END OF REACTION/EVENT*

DURATION

Check the adequate box below:

THE ADVERSE REACTION DETERMINED:

the patient’s deathdisability/ significant or long-lasting incapacityjeopardized the patient’s lifeanomaly/ congenital malformationhospitalization/prolonged hospitalizationother medically important condition

DESCRIBE THE ADVERSE REACTION SUSPECTED:*

THE DRUG(S) (INCLUDING VACCINES) (TRADE NAME, MANUFACTURER):

DAILY DOSAGE*

ROUTE OF ADMINISTRATION*

LOT (RELATIVE TO THE VACCINE)*

BATCH (RELATIVE TO THE DRUG)*

FROM*

TO*

THE SUSPECTED MEDICATION WAS RECOMMENDED/INTENDED FOR:

OTHER MEDICINES AND SELF-MEDICATION

DAILY DOSAGE

ROUTE OF ADMINISTRATION

FROM

RECOMMENDED FOR:

ADVERSE REACTION TREATMENT

WAS THERE ANY RECOVERY AFTER THE ADVERSE REACTION?
YESNO

COMPLETE
YESNO

COMMENTS:

TRAUMAS
YESNO

COMMENTS:

WAS THE ADMINSTRATION OF THE SUSPECTED DRUG INTERRUPTED?
YESNO

WAS THE DOSAGE REDUCED?
YESNO

COMMENTS:

HOW DID THE ALLEGED ADVERSE REACTION DEVELOP?

RESUMING THE ADMINISTRATION OF THE SUSPECTED DRUG:
YESNO

COMMENTS:

OTHER COMMENTS (RELEVANT MEDICAL RECORD, ALLERGIES, MENTIONS OF
WHETHER THE PATIENT HAS PREVIOUSLY USED THE SUSPECTED DRUG)

FILLED IN BY*

SPECIALIZATION :*

PHONE no.:*

EMAIL:*

DATE:*

HEALTH UNIT ADDRESS:

* all fields are compulsory