CIOMS Report

CIOMS FORM
DE-BFARM-16116758
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH
DA
MO
YR
2a. AGE
13
(Year)
3. SEX
Male
4-6 REACTION ONSET
DA
MO
YR
02
04
2016
8-12 CHECK ALL
APPROPRIATE TO
ADVERSE REACTION
¨ PATIENT DIED
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
[ MedDRA 18.1 LLT (10002856): Anxiety attack ]
Kind erwacht mit Wahnvorstellungen vor imaginären Pflanzen die "schiessen" [ MedDRA 18.1 LLT
(10012260): Delusions ]
Case narrative including clinical course, therapeutic measures, outcome and additional relevant
information:
Bericht des Meldenden:
Nasenspray-Gabe zur Abschwellung der Schleimhaut abends kurz vor dem Einschlafen ca. 20 Uhr
bei fieberhaftem Infekt. Etwa 3 Stunden später (23 Uhr) erwacht Kind mit Wahnvorstellungen und
Angstattaken, fürchtet sich vor imaginären Pflanzen, die "schiessen". Die gleiche Situation
wiederholt sich gegen 5.20 Uhr. Kind konnte durch Zureden binnen 5 bis 10 Minuten beruhigt
werden. Am Morgen danach kann sich das Kind kaum noch an das Geschehen der Nacht erinnern.
Begleitende Medikation: Paracetamol 500 mg.
¨
INVOLVED OR
PROLONGED
INPATIENT
HOSPITALISATION
¨
INVOLVED
PERSISTENCE OR
SIGNIFICANT
DISABILITY OR
INCAPACITY
¨ LIFE THREATENING
¨
CONGENITAL
ANOMALY / BIRTH
DEFECT
¨
OTHER MEDICALLY
IMPORTANT
CONDITION
II. SUSPECT DRUG(S) INFORMATION
(cont.) 20. DID REACTION ABATE
14. SUSPECT DRUG(S) (include generic name)
AFTER STOPPING DRUG?
nasic fuer Kinder (batch: 407075)
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
Nasal
17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION?
¨ YES ¨ NO ¨ NA
Flu like symptoms
18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 02-APR-2016
III. CONCOMITANT DRUG(S) AND HISTORY
22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
(cont.)
paracetamol 500mg
23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.)
IV. SENDER INFORMATION
24a. NAME AND ADRESS OF SENDER
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
24b. MFR CONTROL NO.
DE-BFARM-16116758
24c. DATE RECEIVED BY
MANUFACTURER
06-APR-2016
DATE OF THIS REPORT
11-APR-2016
24d. REPORT SOURCE
¨ STUDY ¨ LITERATURE
¨ HEALTH PROFESSIONAL
25a. REPORT TYPE
þ INITIAL ¨FOLLOW UP ¨ FINAL
(Cont.) = Continuation on attached sheet(s)
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
DE-BFARM-16116758
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Reaction text as reported
MedDRA coding
11-APR-2016
Report Page:
2 of 4
(... continuation ...)
Outcome*
Term highlighted
Duration
Report Date:
Time interval 1**
Time interval 2*** Start date
Kind erwacht mit Wahnvorstellungen vor imaginären Pflanzen die "schiessen"
[MedDRA 18.1 PT (10012239):
Unknown
3 Hour
Delusion ]
End date
02-APR-2016
[ MedDRA 18.1 LLT
(10012260): Delusions ]
[MedDRA 18.1 PT (10002855):
Anxiety ]
Unknown
3 Hour
02-APR-2016
[ MedDRA 18.1 LLT
(10002856): Anxiety attack ]
* Outcome of reaction/event at the time of last observation
** Time interval between beginning of suspect drug administration and start of reaction/event
*** Time interval between last dose and start of reaction/event
Results of tests
Date
Test
Result
14. Suspect Drug(s) (including generic name)
Suspect Drug
and batch no.
Start
date
nasic fuer Kinder (batch:
407075)
02-APR2016
Unit
Identification of the country
where the drug was obtained
Duration
More inform.
available
Dose *
Route(s) of
Administration
Indication(s)
A:
B:
C:
D:
E:
Nasal
Flu like symptoms
Deutschland
Name of holder/applicant
Authorization/Application Number
Country of authorization/application
Pharmaceutical form (Dosage form)
Parent route of administration
(in case of a parent child/fetus report)
Gestation period at time of exposure
Time interval between beginning of drug
administration and start of reaction/event
Time interval between last dose
of drug and start of reaction/event
Action(s) taken with drug
Additional information on drug
Did reaction reappear after reintroduction?
Active drug substance name
Normal high
range
(... continuation ...)
End
date
* A: Dosage Text
B: Cumulative dose number (to first reaction)
C: Structure dosages number
D: Number of separate dosages
E: Number of units in the interval
Normal low
range
Deutschland
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
DE-BFARM-16116758
dexpanthenol
xylometazoline hydrochloride
22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction)
Concomitant Drug
and batch no.
Start
date
End
date
Duration
paracetamol 500mg
Dose *
A:
B:
C:
D:
E:
Deutschland
Identification of the country
where the drug was obtained
Name of holder/applicant
Authorization/Application Number
Country of authorization/application
Deutschland
Pharmaceutical form (Dosage form)
Parent route of administration
(in case of a parent child/fetus report)
Gestation period at time of exposure
Time interval between beginning of drug
administration and start of reaction/event
Time interval between last dose
of drug and start of reaction/event
Action(s) taken with drug
Additional information on drug
Did reaction reappear after reintroduction?
* A: Dosage Text
B: Cululative dose number (to first reaction)
C: Structure of separate dosages
D: Number of separate dosages
E: Number of units in the interval
Active drug substance name
paracetamol
ADMINISTRATIVE AND IDENTIFICATION INFORMATION
Safetyreportversion
1
Identification of the country where the
reaction/event occur
Deutschland
Serious
No
Date Format of receipt of the most recent
information for this report
20160406
Additional documents
No
List of documents held by sender
Does this case fulfill the local criteria for an
expedited report?
No
Regulatory authority's case report number
Other case identifiers in previous
transmissions
Yes
Report Date:
11-APR-2016
Report Page:
3 of 4
(... continuation ...)
Route(s) of
Administration
Indication(s)
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Was the case medically confirmed, if not
initially from health professional?
Continuation sheet for CIOMS report
DE-BFARM-16116758
Report Date:
11-APR-2016
Report Page:
4 of 4
No
Primary source(s) of information
Study name
Reporter postcode Reporter country
Qualification
04
Consumer or other
non health
professional
Deutschland
Literature reference(s)
SENDER INFORMATION (... continuation ...)
Type
Regulatory Authority
Organisation
BfArM
Department
Pharmakovigilanz
Street address
Kurt-Georg-Kiesinger-Allee 3
City
Bonn
Postcode
53175
Country
Deutschland
Fax
Telephone
E-mail address
[email protected]
PATIENT INFORMATION (... continuation ...)
Investigation number
Gestation period
Patient age group
Weight (kg)
Height (cm)
Last menstrual periode date
Text for relevant medical history and
concurrent conditions
Adolescent >12.Lj. bis einschl. 18.Lj.
Sponsor study number
Study type in which the
reaction(s)/event(s)
were observed