CIOMS FORM

DE-BFARM-17053675

SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS

1a. COUNTRY

DE

privacy

2. DATE OF BIRTH DA MO YR

2a. AGE

61 (Year)

3. SEX

4-6 REACTION ONSET DA MO YR

Female

7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)

8-1

2010 (cont.)

CHECK ALL APPROPRIATE TO ADVERSE REACTION

¨ PATIENT DIED

Todesangst [ MedDRA 19.1 LLT (10002855): Anxiety ] INVOLVED OR wandernde massive Gelenkschmerzen in Ellbogen, Fingern, Knien Fußgelenken [ MedDRA 19.1 PROLONGED LLT (10023222): Joint pain ] INPATIENT Dauerhafter extremer Schmerz in den Großzehengrundgelenken [ MedDRA 19.1 LLT (10033452): HOSPITALISATION Pain in toe ] INVOLVED reißende Schmerzen in den Achillessehnen [ MedDRA 19.1 LLT (10050471): Achilles tendon pain ] PERSISTENCE OR [ MedDRA 19.1 LLT (10061218): Inflammation ] SIGNIFICANT Instabilität des Fußbandapparates mit Neigung zu Bänderrissen [ MedDRA 19.1 LLT (10074599): DISABILITY OR Tendon discomfort ] INCAPACITY Instabilität des Fußbandapparates mit Neigung zu Brüchen [ MedDRA 19.1 LLT (10061728): LIFE THREATENING Bone lesion ] [ MedDRA 19.1 LLT (10012378): Depression ] CONGENITAL [ MedDRA 19.1 LLT (10016257): Fatigue extreme ] ANOMALY / BIRTH [ MedDRA 19.1 LLT (10072623): Avolition ] DEFECT [ MedDRA 19.1 LLT (10024461): Light headedness ] [ MedDRA 19.1 LLT (10004070): Balance difficulty ] OTHER MEDICALLY [ MedDRA 19.1 LLT (10027172): Memory disturbance ] IMPORTANT [ MedDRA 19.1 LLT (10010250): Concentration impairment ] CONDITION [ MedDRA 19.1 LLT (10029328): Neuropathy ] II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) 20. DID REACTION ABATE AFTER STOPPING DRUG? ciprobay

¨

þ ¨ ¨

¨

15. DAILY DOSE(S)

16. ROUTE(S) OF ADMINISTRATION

Oral 17. INDICATION(S) FOR USE

¨ YES ¨ NO ¨ NA 21. DID REACTION REAPPEAR AFTER REINTRODUCTION?

¨ YES ¨ NO ¨ NA

Urinary tract infection 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.)

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-17053675 24c. DATE RECEIVED BY MANUFACTURER

15-FEB-2017 DATE OF THIS REPORT

20-FEB-2017

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-17053675

7. + 13. Describe Reaction(s) (including relevant tests/lab data)

Report Date: Report Page:

20-FEB-2017 2 of 7

(... continuation ...)

Berührungsempfindlichkeit [ MedDRA 19.1 LLT (10000184): Abnormal touch sensation ] [ MedDRA 19.1 LLT (10028347): Muscle twitching ] Steifigkeit insbesondere der Füße und Finger [ MedDRA 19.1 LLT (10024509): Limbs stiffness ] Blasenschwäche [ MedDRA 19.1 LLT (10021643): Incontinence urinary ] Nierenschwäche [ MedDRA 19.1 LLT (10062237): Renal impairment ] [ MedDRA 19.1 LLT (10023432): Kidney pain ] [ MedDRA 19.1 LLT (10008531): Chills ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Direkt nach Einnahme von Levofloxacin: Schüttelfrost, Todesangst. Zeitversetzt nach Ciprofloxacin:wandernde massive Gelenkschmerzen in Ellbogen, Fingern, Knien Fußgelenken. Dauerhafter extremer Schmerz in den Großzehengrundgelenken,reißende Schmerzen in den Achillessehnen,Übergang zum Außenband mit Entzündungen. Instabilität des Fußbandapparates mit Neigung zu Brüchen und Bänderrissen. Depressionen und extreme Müdigkeit, Antriebslosigkeit, Schwindel, Gleichgewichtsstörungen, Gedächtnis- und Konzentrationsschwierigkeiten, Neuropathien/ Berührungsempfindlichkeit, Muskelzuckungen, Steifigkeit, insbesondere der Füße und Finger. Nieren- und Blasenschwäche, Nierenschmerzen. Alles in wechselhafter Intensität, jedoch dauerhaft vorhanden. Sender's comment: Keine Risikofaktoren,vor Gabe dieser Mittel kerngesund

Reaction text as reported MedDRA coding

Duration

[MedDRA 19.1 PT (10008531): 7 Year Chills ]

Outcome* Term highlighted

Time interval 1** Time interval 2*** Start date

End date

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

[ MedDRA 19.1 LLT (10008531): Chills ] Todesangst [MedDRA 19.1 PT (10002855): 7 Year Anxiety ] [ MedDRA 19.1 LLT (10002855): Anxiety ] wandernde massive Gelenkschmerzen in Ellbogen, Fingern, Knien Fußgelenken [MedDRA 19.1 PT (10003239): 7 Year Arthralgia ]

recovered/resolved with sequel

2010

[ MedDRA 19.1 LLT (10023222): Joint pain ] Dauerhafter extremer Schmerz in den Großzehengrundgelenken [MedDRA 19.1 PT (10033425): 7 Year Pain in extremity ]

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with

2010

[ MedDRA 19.1 LLT (10033452): Pain in toe ] reißende Schmerzen in den Achillessehnen [MedDRA 19.1 PT (10066371): 7 Year Tendon pain ] [ MedDRA 19.1 LLT (10050471): Achilles tendon pain ] [MedDRA 19.1 PT (10061218): 7 Year

BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE

Inflammation ]

Continuation sheet for CIOMS report DE-BFARM-17053675

Report Date: Report Page:

sequel

[ MedDRA 19.1 LLT (10061218): Inflammation ] Instabilität des Fußbandapparates mit Neigung zu Bänderrissen [MedDRA 19.1 PT (10074599): 7 Year Tendon discomfort ]

recovered/resolved with sequel

2010

[ MedDRA 19.1 LLT (10074599): Tendon discomfort ] Instabilität des Fußbandapparates mit Neigung zu Brüchen [MedDRA 19.1 PT (10061728): 7 Year Bone lesion ]

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

[ MedDRA 19.1 LLT (10061728): Bone lesion ] [MedDRA 19.1 PT (10012378): 7 Year Depression ] [ MedDRA 19.1 LLT (10012378): Depression ] [MedDRA 19.1 PT (10016256): 7 Year Fatigue ] [ MedDRA 19.1 LLT (10016257): Fatigue extreme ] [MedDRA 19.1 PT (10002942): 7 Year Apathy ] [ MedDRA 19.1 LLT (10072623): Avolition ] [MedDRA 19.1 PT (10013573): 7 Year Dizziness ] [ MedDRA 19.1 LLT (10024461): Light headedness ] [MedDRA 19.1 PT (10049848): 7 Year Balance disorder ] [ MedDRA 19.1 LLT (10004070): Balance difficulty ] [MedDRA 19.1 PT (10027175): 7 Year Memory impairment ] [ MedDRA 19.1 LLT (10027172): Memory disturbance ] [MedDRA 19.1 PT (10013496): 7 Year Disturbance in attention ] [ MedDRA 19.1 LLT (10010250): Concentration impairment ] [MedDRA 19.1 PT (10029331): 7 Year Neuropathy peripheral ] [ MedDRA 19.1 LLT (10029328): Neuropathy ]

20-FEB-2017 3 of 7

BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE

Continuation sheet for CIOMS report Report Date: Report Page:

DE-BFARM-17053675

20-FEB-2017 4 of 7

Berührungsempfindlichkeit [MedDRA 19.1 PT (10033775): 7 Year Paraesthesia ]

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

recovered/resolved with sequel

2010

[ MedDRA 19.1 LLT (10000184): Abnormal touch sensation ] [MedDRA 19.1 PT (10028347): 7 Year Muscle twitching ] [ MedDRA 19.1 LLT (10028347): Muscle twitching ] Steifigkeit insbesondere der Füße und Finger [MedDRA 19.1 PT (10052904): 7 Year Musculoskeletal stiffness ] [ MedDRA 19.1 LLT (10024509): Limbs stiffness ] Blasenschwäche [MedDRA 19.1 PT (10046543): 7 Year Urinary incontinence ] [ MedDRA 19.1 LLT (10021643): Incontinence urinary ] Nierenschwäche [MedDRA 19.1 PT (10062237): 7 Year Renal impairment ] [ MedDRA 19.1 LLT (10062237): Renal impairment ] [MedDRA 19.1 PT (10038490): 7 Year Renal pain ] [ MedDRA 19.1 LLT (10023432): Kidney pain ] * 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

ciprobay

Identification of the country where the drug was obtained Name of holder/applicant

End date

Unit

Normal low range

Normal high range

More inform. available

(... continuation ...) Duration

Dose *

Route(s) of Administration

Indication(s)

A: B: C: D: E:

Oral

Urinary tract infection

BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE

Continuation sheet for CIOMS report Report Date: Report Page:

DE-BFARM-17053675

20-FEB-2017 5 of 7

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? * 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 ciprofloxacin hydrochloride 14. Suspect Drug(s) (including generic name) Suspect Drug and batch no.

Start date

(... continuation ...)

End date

levofloxacin

Identification of the country where the drug was obtained 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? * 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

Duration

Dose *

Route(s) of Administration

Indication(s)

A: B: C: D: E:

Oral

Urinary tract infection

BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE

Continuation sheet for CIOMS report Report Date: Report Page:

DE-BFARM-17053675

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Active drug substance name levofloxacin Report duplicates Duplicate source

Duplicate number

Paul-Ehrlich-Institut

DE-CADRBFARM-2017015596

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

Yes

Date Format of receipt of the most recent information for this report

20170215

Additional documents

No

List of documents held by sender Does this case fulfill the local criteria for an expedited report?

Yes

Regulatory authority's case report number

DE-CADRBFARM-2017015596

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

65

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

Sponsor study number

Study type in which the reaction(s)/event(s) were observed

BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE

Country

Continuation sheet for CIOMS report DE-BFARM-17053675 Deutschland

Fax Telephone E-mail address

[email protected]

PATIENT INFORMATION (... continuation ...) Investigation number Gestation period Patient age group

Adult

Weight (kg)

65

Height (cm)

174

Last menstrual periode date Text for relevant medical history and concurrent conditions

>18.Lj. bis einschl. 65.Lj.

Report Date: Report Page:

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