CIOMS Report

CIOMS FORM
DE-BFARM-16083368
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH
DA
MO
YR
2a. AGE
87
(Year)
3. SEX
4-6 REACTION ONSET
DA
MO
YR
Male
8-12 CHECK ALL
APPROPRIATE TO
ADVERSE REACTION
¨ PATIENT DIED
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
massive Hautrötungen (wie Nesselsucht) am ganzen Körper [ MedDRA 18.1 LLT (10046735):
Urticaria ]
massive Hautrötungen (wie Nesselsucht) am ganzen Körper [ MedDRA 18.1 LLT (10040850):
Skin flushed ]
Unterlippe ist geschwollen [ MedDRA 18.1 LLT (10042723): Swollen lips ]
¨
INVOLVED OR
PROLONGED
INPATIENT
HOSPITALISATION
Case narrative including clinical course, therapeutic measures, outcome and additional relevant
information:
¨
INVOLVED
PERSISTENCE OR
SIGNIFICANT
DISABILITY OR
INCAPACITY
Meldender schreibt:
Ich schreibe im Auftrag meines Mannes, da er die feuchte Makuladegeneration hat und sehr, sehr
schlecht sehen kann. Mein Mann nimmt jeden Morgen 1/2 Tablette Bisoprolol AbZ von einer 5 mg
Tablette, um den Blutdruck niedrig zu halten. Doch die Nebenwirkungen ließen nicht lange auf sich
warten: Massive Hautrötungen (wie Nesselsucht!) am ganzen Körper. Es sieht schrecklcih aus.
Mein Mann war im Leben nie krank, er ist 87 Jahre alt, auch jetzt keine Schmerzen. Wir wohnen
seit drei Jahren hier, da begann diese Krankheit. Am früheren Wohnort konnte er die Tablette
vertragen. Ich meine da war es eine andere Hersteller Firma. Auch die Unterlippe ist geschwollen.
Drei Mal schmieren bringt nichts, keine Besserung, auch fünf Mal nichts.
¨ 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?
bisoprolol AbZ 5 mg Tabletten
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
"daily dose: 2.5 Mg milligram(s) every Day" { 2.5 Mg
milligram(s), 1 in 1 Day }
¨ YES ¨ NO ¨ NA
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION?
17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA
Hypertension
18. THERAPY DATES (from/to)
19. THERAPY DURATION
III. CONCOMITANT DRUG(S) AND HISTORY
22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.)
[ MedDRA 18.1 (10025409): Macular degeneration ]
(cont.)
Continuing: Yes
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-16083368
24c. DATE RECEIVED BY
MANUFACTURER
07-MAR-2016
DATE OF THIS REPORT
14-MAR-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-16083368
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Reaction text as reported
MedDRA coding
14-MAR-2016
Report Page:
2 of 4
(... continuation ...)
Outcome*
Term highlighted
Duration
Report Date:
Time interval 1**
Time interval 2*** Start date
End date
massive Hautrötungen (wie Nesselsucht) am ganzen Körper
[MedDRA 18.1 PT (10046735):
Unknown
Urticaria ]
[ MedDRA 18.1 LLT
(10046735): Urticaria ]
massive Hautrötungen (wie Nesselsucht) am ganzen Körper
[MedDRA 18.1 PT (10016825):
Unknown
Flushing ]
[ MedDRA 18.1 LLT
(10040850): Skin flushed ]
Unterlippe ist geschwollen
[MedDRA 18.1 PT (10024570):
Lip swelling ]
Unknown
[ MedDRA 18.1 LLT
(10042723): Swollen lips ]
* 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
Unit
Normal high
range
More inform.
available
(... continuation ...)
End
date
bisoprolol AbZ 5 mg Tabletten
Identification of the country
where the drug was obtained
Duration
Dose *
A: daily dose: 2.5
Mg milligram(s)
every Day
B:
C: 2.5Mg
milligram(s)
D: 1
E: 1Day
Deutschland
Name of holder/applicant
Authorization/Application Number
Country of authorization/application
Deutschland
Pharmaceutical form (Dosage form)
245 (Tablet)
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
Normal low
range
Route(s) of
Administration
Indication(s)
Hypertension
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
DE-BFARM-16083368
Report Date:
14-MAR-2016
Report Page:
3 of 4
Action(s) taken with drug
Additional information on drug
Did reaction reappear after reintroduction?
* 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
Active drug substance name
bisoprolol
23. Other relevant history
(... continuation ...)
Reactions, Symptoms and Events
Start date End date
[ MedDRA 18.1 (10025409): Macular degeneration ]
Continuing Comments
Yes
feuchte Makuladegeneration
Patient past drug therapy
Name of drug as reported
bisoprolol
Indication MedDRA code
Reactions MedDRA code
[ MedDRA 18.1 (10020772):
Hypertension ]
[ MedDRA 18.1 (10067483): No
adverse reaction ]
Start date End date
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
20160307
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
Was the case medically confirmed, if not
initially from health professional?
No
Primary source(s) of information
Study name
Reporter postcode Reporter country
Qualification
24
Consumer or other
non health
professional
Deutschland
Literature reference(s)
SENDER INFORMATION (... continuation ...)
Type
Regulatory Authority
Sponsor study number
Study type in which the
reaction(s)/event(s)
were observed
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
DE-BFARM-16083368
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
Elderly
>65.Lj.
Report Date:
14-MAR-2016
Report Page:
4 of 4