AUSTRALIA AND NEW ZEALAND SPECIFIC REPORT FORM FORADVERSE REACTION AND OTHER SAFETY INFORMATIONEMAIL: PV.ANZ@GUERBET.COM

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FAX: +61 2 8075 3033

ONLY DATA REPORTED BY THE REPORTERREPORTERFIRST NAME:HOSPITAL/ CENTER:LAST NAME:STREET:

PHONE:POSTAL CODE:EMAIL:

CITY:

DOES THE REPORTER ACCEPT TO BE RE-

STATE:CONTACTED BY GUERBET? YESHEALTHCARE PROFESSIONAL:YESNOQUALIFICATION: ------------------Select-------------------NO

COUNTRY: -------------------------Select-------------------------------

PATIENTAGE

LAST NAME FIRST NAME DATE OF BIRTH(Initial)(Initial)

AGE GROUP-Select-SEX

ETHNICITY-----Select-----------Select-----------Select------UNK

UNK

CM

PREGNANCYYESNOUNKNOWNIF YES, SPECIFY THE PERIOD OF EXPOSURE:
Weeks of amenorrhea

KG

Other:UNK

UNK

WEIGHT

HEIGHTLAST MENSTRUATION PERIOD DATE:

8/8/22
UNK

UNK

UNK

UNK

BREASTFEEDINGYESNOUNKNOWNPATIENT MEDICAL HISTORY (ALLERGY, CARDIOVASCULAR DISORDERS, KIDNEY DISEASE, SURGERY…):DISEASE TERMSTART DATECONTINUINGYesNoYesNoYesNoYesNo

PAST DISEASE

CAUSE OF DEATH

PREVIOUS EXAMINATION WITH A CONTRAST AGENT:PREVIOUS REACTION TO ANY OF THESE CONTRAST AGENT(S):YESNOIF YES, SPECIFY THE EXAMINATION TYPE:THE CONTRAST AGENT:YESNOIF YES, SPECIFY THE REACTION AND THE PRODUCT:ACTIONTAKEN WITHGUERBETPRODUCTINDICATION(S)INDICATION(PATHOLOGY)

OF
TREATMENTCTIRM…

TYPE OFEXAMINATIONDATE OFEXAMINATIONIONROUTE OFADMINISTRATBATCHNUMBER

VOLUMEGUERBETPRODUCTGUERBET PRODUCTMLML

1.

----Select----2.

----Select----3.

----Select----4.

----Select----5.

----Select----6.

----Select----7.

----Select----8.

----Select----*suspect : product that is suspected to have potentially triggered the occurrence of the reaction*concomitant : current treatment of the patient and other products that were administered during the same period

END DATE

TIME OFTREATMENTSTARTDATE ANDROUTE OFADMINISTRATION

SUSPECT*CONCOMIT
ANT*DOSE/FREQUENCYPRODUCTNAME(S)OTHER PRODUCTSYour personal data as a reporter (identity, contact details) and / or as a patient processed by Guerbet’s partner and its data processor Guerbet isnecessary to carry out your pharmacovigilance notification. The processing of your data is necessary to comply with the applicable laws and regulations(EU and worldwide) in the frame of pharmacovigilance. Those data may be transferred to the competent authorities in or outside the European Union.
Subject to statutory restrictions, you have a right to access or rectify your personal data, upon written request to dataprotection.officer@guerbet.com

AUSTRALIA AND NEW ZEALAND SPECIFIC REPORT FORM FOR ADVERSE
REACTION AND OTHER SAFETY INFORMATIONREACTION(S) AND/OR OTHER SAFETY INFORMATIONREACTION(S) AND/OR OTHER DATE AND
SAFETY INFORMATION **TIME OFONSET OF(DIAGNOSIS IF AVAILABLE)THE
REACTIONDATE ANDTIME OFREACTIONEND

OUTCOMEINTENSITYFATALNOT RECOVERED/NOT RESOLVEDRECOVERED/RESOLVEDRECOVERINGRECOVERED/MILD
MODERATE
SEVERERESOLVED WITHSEQUELAEUNKNOWNSERIOUSNESSNON-SERIOUS
SERIOUS- RESULTS IN DEATH- LIFE-THREATENING- NEW HOSPIT./HOSPIT.PROLONGATION- DISABILITY / INCAPACITY- CONGENITAL ANOMALY/BIRTH DEFECT- OTHER MEDICALLYIMPORTANT CONDITION- NO INFORMATION

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CAUSALRELATIONSHIPWITH GUERBETPRODUCTCORRECTIVE
TREATMENTNOT RELATEDUNLIKELY POSSIBLE
PROBABLEHIGHLY PROBABLENOT ASSESSABLE

1----Select----- ----Select---- -----------Select------------ ---------------Select-------------

2----Select----- ----Select---- -----------Select------------ ---------------Select-------------

3----Select----- ----Select---- -----------Select------------ ---------------Select-------------

4----Select----- ----Select---- -----------Select------------ ---------------Select-------------

5----Select----- ----Select---- -----------Select------------ ---------------Select-------------

6----Select----- ----Select---- -----------Select------------ ---------------Select-------------

7----Select----- ----Select---- -----------Select------------ ---------------Select-------------

8----Select----- ----Select---- -----------Select------------ ---------------Select-------------*corrective: treatment administered to treat the reaction(s)**OTHER SAFETY INFORMATION: UNEXPECTED BENEFICIAL EFFECT, QUALITY DEFECT WHEN THE PATIENT IS CONNECTED, SUSPICION OF TRANSMISSION OF INFECTIOUS AGENT, SUSPECTED FALSIFIEDPRODUCT, LACK OF EFFICACY, OCCUPATIONAL EXPOSURE, EXPOSURE DURING PREGNANCY OR BREASTFEEDING, OFF-LABEL USE, ABUSE, MISUSE, MEDICATION ERROR, OVERDOSE, DRUG INTERACTIONDIAGNOSIS (IF AVAILABLE):TIME TO ONSET OF THE FIRST REACTION AFTER DRUG ADMINISTRATION:----Select------DURATION:Seconds

DETAILED DESCRIPTION (DESCRIBE THE CLINICAL PICTURE, THE CHRONOLOGICAL COURSE OF THE EVENTS, THE TREATMENT AND OUTCOME):IF THE PATIENT HAS SEQUELAE, PLEASE SPECIFY:IF THE PATIENT DIED, PLEASE SPECIFY:DATE OF DEATH:THE CAUSE OF DEATH:WAS THE DEATH RELATED TO THE REACTION? YESNOYESNOWAS AN AUTOPSY PERFORMED?

UNKNOWNUNKNOWNIF YES, PLEASE ATTACH THE AUTOPSY REPORT AND SPECIFY THE DATE OF AUTOPSY:LABORATORY ANALYSES RESULTS, RADIOLOGY EXAMINATION OR OTHER RELEVANT INFORMATION(PLEASE ATTACH A COPY OF THE REPORT):LAB TEST NAMEDATERESULTSWERE ANY OF THE SUSPECT PRODUCT(S) STOPPED AFTER THEREACTION?
YESNONOT APPLICABLEIF YES, PLEASE SPECIFY WHICH PRODUCT(S):DID THE REACTION ABATE AFTER STOPPING A SUSPECT PRODUCT?

YESNONOT APPLICABLE
IF YES, PLEASE SPECIFY WHICH PRODUCT:WERE ANY OF THE SUSPECT PRODUCT(S) RE-INTRODUCED?

YESNONOT APPLICABLE
IF YES, PLEASE SPECIFY WHICH PRODUCT(S):DID THE REACTION REAPPEAR AFTER RE-INTRODUCTION?
YESNONOT APPLICABLE
IF YES, PLEASE SPECIFY WHICH PRODUCT(S):SIGNATURE OF THE REPORTER :WAS THE CASE REPORTED TO THE HEALTH AUTHORITY?
YESNOYour personal data as a reporter (identity, contact details) and / or as a patient processed by Guerbet’s partner and its data processor Guerbet isnecessary to carry out your pharmacovigilance notification. The processing of your data is necessary to comply with the applicable laws andregulations (EU and worldwide) in the frame of pharmacovigilance. Those data may be transferred to the competent authorities in or outside theEuropean Union. Subject to statutory restrictions, you have a right to access or rectify your personal data, upon written request todataprotection.officer@guerbet.com

AUSTRALIA AND NEW ZEALAND SPECIFIC REPORT FORM FOR ADVERSE
REACTION AND OTHER SAFETY INFORMATION

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LOCAL RESPONSIBLE PERSON FOR PHARMACOVIGILANCE (LRPPV)/ DEPUTY ASSESSMENTLOCAL REFERENCE NUMBER:DATE OF RECEIPT / AWARENESS DATE (DAY 0):

COMPLAINT REFERENCE:MEDICAL INFORMATION ENQUIRY REFERENCE:REPORT TYPE:FOLLOW-UP

INITIAL REPORTPOTENTIAL SIGNAL?
EMERGING SAFETY ISSUE?

YESYESCASE RECEIVED BY:SOURCE:UNKNOWNNONOUNKNOWNIF YES PLEASE SPECIFY THE REACTION:IF YES PLEASE SPECIFY THE REACTION:SOURCEON:SPONTANEOUS (HEALTHCARE PROFESSIONAL, PATIENT, OTHER)INVESTIGATOR-INITIATED STUDY, PLEASE SPECIFY THE STUDY TITLE:LITERATURE, PLEASE PROVIDE THE ARTICLE IN ENGLISHAUTHORITY, SPECIFY THE NAME OF THE AUTHORITY:EXPECTEDNESS(ACCORDING TO THE
REACTION(S) AND/OR OTHER SAFETYINFORMATION**123456LOCAL REFERENCESAFETY INFORMATION)EXPECTEDUNEXPECTEDNOT ASSESSABLE-------------Select-------------AUTHORITY REFERENCE NUMBER:SERIOUSNESSNON-SERIOUS
SERIOUS- RESULTS IN DEATH- LIFE-THREATENING- NEW HOSPIT./ HOSPIT.PROLONGATION- DISABILITY / INCAPACITY- CONGENITAL ANOMALY / BIRTH DEFECT- OTHER MEDICALLY IMPORTANT CONDITIONCAUSAL RELATIONSHIP
WITH THE GUERBETPRODUCTNOT RELATEDUNLIKELYPOSSIBLE
PROBABLEHIGHLY PROBABLENOT ASSESSABLE------------------------------Select-------------------------- ------------------------Select-----------------------------------Select-------------------------------------------Select-------------------------- ------------------------Select-----------------------------------Select-------------------------------------------Select-------------------------- ------------------------Select-----------------------------------Select-------------------------------------------Select-------------------------- ------------------------Select-----------------------------------Select-------------------------------------------Select-------------------------- ------------------------Select-----------------------------------Select-------------------------------------------Select-------------------------- ------------------------Select-----------------------------------Select------------------------------------------Select-------------------------- ------------------------Select---------------------7------------------------------Select-------------------------- ------------------------Select----------------------------------Select------------8**OTHER SAFETY INFORMATION: UNEXPECTED BENEFICIAL EFFECT, QUALITY DEFECT WHEN THE PATIENT IS CONNECTED, SUSPICION OF TRANSMISSION OF INFECTIOUS AGENT, SUSPECTED FALSIFIEDPRODUCT, LACK OF EFFICACY, OCCUPATIONAL EXPOSURE, EXPOSURE DURING PREGNANCY OR BREASTFEEDING, OFF-LABEL USE, ABUSE, MISUSE, MEDICATION ERROR, OVERDOSE, DRUG INTERACTION.

IF THE PRODUCT WAS NOT USED IN ACCORDANCE WITH THE TERMS OF THEMARKETING AUTHORIZATION (MA), SPECIFY IF IT WAS:
☐ INTENTIONAL☐ NOT INTENTIONAL☐ UNKNOWNIF USED OUTSIDE THE TERMS OF THE MA, SPECIFY IF IT WAS USED BY:☐ AN HEALTHCARE PROFESSIONAL☐ THE PATIENT☐ UNKNOWNMISSING INFORMATIONIS THE CASE INVALID? (ONE OF THE 4 MINIMUM CRITERIA IS MISSING: PATIENT, REPORTER, SUSPECT PRODUCT, REACTION OR OTHER SAFETYYES ☐ NO ☐WAS A FOLLOW-UP (FU) REQUESTED:YES ☐ NO ☐IF YES, PLEASE INDICATE BELOW THE REQUESTED INFORMATION:INFORMATION)

PATIENT☐ AGE / DATE OF BIRTH☐ SEX☐ MEDICAL HISTORY☐ CONCOMITANT TREATMENTS☐ OTHERCOMMENTSSUSPECT PRODUCT☐ GUERBET PRODUCT☐ DATE OF ADMINISTRATION☐ INDICATION☐ BATCH NUMBER☐ VOLUME☐ OTHERREACTION / OTHER INFO☐ REACTION DESCRIPTION☐ TIME TO ONSET☐ FINAL OUTCOME☐ SERIOUSNESS☐ CORRECTIVE TREATMENTS☐ OTHERREPORTER☐ PROFESSION / CATEGORY☐ CAUSALITY ASSESSMENT☐ CONTACT DETAILS☐ OTHERFORM COMPLETED BY (PARTNER):FIRST NAME:LAST NAME:DATE :Your personal data as a reporter (identity, contact details) and / or as a patient processed by Guerbet’s partner and its data processor Guerbet isnecessary to carry out your pharmacovigilance notification. The processing of your data is necessary to comply with the applicable laws andregulations (EU and worldwide) in the frame of pharmacovigilance. Those data may be transferred to the competent authorities in or outside theEuropean Union. Subject to statutory restrictions, you have a right to access or rectify your personal data, upon written request to
dataprotection.officer@guerbet.com