CIOMS Report

CIOMS FORM
DE-BFARM-16041186
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS
1a. COUNTRY
privacy
DE
2. DATE OF BIRTH
DA
MO
YR
2a. AGE
43
(Year)
3. SEX
Female
4-6 REACTION ONSET
DA
MO
YR
05
02
2016
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
Kraftlosigkeit [ MedDRA 18.1 LLT (10011942): Debility ]
Magenkrämpfe [ MedDRA 18.1 LLT (10049901): Stomach cramps ]
[ MedDRA 18.1 LLT (10006792): Burning skin ]
erhebliche Übelkeit [ MedDRA 18.1 LLT (10028813): Nausea ]
[ MedDRA 18.1 LLT (10004226): Belly ache ]
Case narrative including clinical course, therapeutic measures, outcome and additional relevant
information:
Bericht des Meldenden:
Ca. 5 Minuten nach dem Einreiben der Haut trat ein heftiger Magenschmerz auf, begleitet von starken
Brennen der Haut und akuter Kraftlosigkeit. Diese krampfartigen Schmerzen gingen nach ca. 10
Minuten wieder zurück. Ebenso das Brennen. Die Bauchschmerzen verloren sich nicht ganz, dazu
kam aber erhebliche Übelkeit, die zwei Stunden anhielt.
Leichte Bauchschmerzen waren auch am nächsten Tag noch zu spüren.
Ebenso war auch die Kraftlosigkeit noch bis in die Nachmittagsstunden des Folgetags zu spüren.
8-12 CHECK ALL
APPROPRIATE TO
ADVERSE REACTION
¨ PATIENT DIED
¨
INVOLVED OR
PROLONGED
INPATIENT
HOSPITALISATION
¨
INVOLVED
PERSISTENCE OR
SIGNIFICANT
DISABILITY OR
INCAPACITY
¨ LIFE THREATENING
CONGENITAL
/ BIRTH
¨ ANOMALY
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?
kytta-balsam f
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
Topical
17. INDICATION(S) FOR USE
¨YES ¨NO ¨NA
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION?
¨YES ¨NO ¨NA
Neck tightness
18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 05-FEB-2016
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.)
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-16041186
24c. DATE RECEIVED BY
MANUFACTURER
08-FEB-2016
DATE OF THIS REPORT
09-FEB-2016
24d. REPORT SOURCE
¨ STUDY ¨LITERATURE
¨ HEALTH PROFESSIONAL
25a. REPORT TYPE
þINITIAL ¨FOLLOW UP ¨FINAL
(Cont.) = Continuation on attached sheet(s)
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date:
Report Page:
DE-BFARM-16041186
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Reaction text as reported
MedDRA coding
Kraftlosigkeit
[MedDRA 18.1 PT (10003549):
Asthenia ]
09-FEB-2016
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(... continuation ...)
Duration
Outcome*
Term highlighted
Time interval 1**
Time interval 2***
2 Day
recovered/resolved
5 Minute
05-FEB-2016
10 Minute
recovered/resolved
5 Minute
05-FEB-2016
10 Minute
recovered/resolved
5 Minute
05-FEB-2016
2 Hour
recovered/resolved
5 Minute
05-FEB-2016
2 Day
recovered/resolved
1 Day
05-FEB-2016
Start date
End date
06-FEB-2016
[ MedDRA 18.1 LLT (10011942):
Debility ]
Magenkrämpfe
[MedDRA 18.1 PT (10000087):
Abdominal pain upper ]
[ MedDRA 18.1 LLT (10049901):
Stomach cramps ]
[MedDRA 18.1 PT (10054786):
Skin burning sensation ]
[ MedDRA 18.1 LLT (10006792):
Burning skin ]
erhebliche Übelkeit
[MedDRA 18.1 PT (10028813):
Nausea ]
[ MedDRA 18.1 LLT (10028813):
Nausea ]
[MedDRA 18.1 PT (10000081):
Abdominal pain ]
06-FEB-2016
[ MedDRA 18.1 LLT (10004226):
Belly ache ]
* 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
kytta-balsam f
05-FEB2016
End
date
Unit
Normal low
range
Authorization/Application Number
Country of authorization/application
Pharmaceutical form (Dosage form)
Parent route of administration
(in case of a parent child/fetus report)
More inform.
available
(... continuation ...)
Duration
Dose *
Route(s) of
Administration
Indication(s)
A:
B:
C:
D:
E:
Topical
Neck tightness
Identification of the country
where the drug was obtained
Name of holder/applicant
Normal high
range
Merck Selbstmedikation GmbH
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date:
Report Page:
DE-BFARM-16041186
09-FEB-2016
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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: 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
methyl nicotinate
symphytum officinale
Report duplicates
Duplicate source
Duplicate number
Paul-Ehrlich-Institut
DE-CADRBFARM-2016011289
Parent
Parent identification
Date of birth
Age
LMP date
Weight(kg) Height(cm) Sex
Text for relevant medical history
and concurrent conditions
0
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
20160208
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
DE-CADRBFARM-2016011289
Other case identifiers in previous transmissions Yes
Was the case medically confirmed, if not
initially from health professional?
No
Primary source(s) of information
Study name
Reporter postcode
Reporter country
Qualification
Literature reference(s)
Sponsor study number
Study type in which the
reaction(s)/event(s)
were observed
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
83
Deutschland
Continuation sheet for CIOMS report
DE-BFARM-16041186
Consumer or other
non health
professional
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
pharmakovigilanz@bfarm.de
PATIENT INFORMATION (... continuation ...)
Investigation number
Gestation period
Patient age group
Adult
Weight (kg)
65
Height (cm)
175
>18.Lj. bis einschl. 65.Lj.
Last menstrual periode date
Text for relevant medical history and
concurrent conditions
bisher noch keine allergischen Reaktionen
Report Date:
Report Page:
09-FEB-2016
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