SUSPECT ADVERSE REACTION REPORT

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1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR DA MO YR Female ( ): Nausea ] ( ): Abdominal cramps ] ( ): Diarrhoea ] ( ): Pain in hand ] ( ): Wrist pain ] ( ): Fingers stiffness ] ( ): Tendon pain ] ( ): Muscle pain ] starke Schmerzen linke Schulter ( ): Shoulder pain ] Schmerzen rechtes Knie ( ): Pain in knee ] Steifheit rechtes Knie ( ): Joint stiffness ] Schwellung der rechten Hand und Handballen ( ): Hand swelling ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Meldung aus der Bevölkerung Letzte Woche habe ich Cipro Basics 500mg verordnet bekommen. Einnahme 2x täglich eine Tablette. II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) Cipro Basics 500 mg 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 1000 Mg milligram(s) every Day" { 500 Mg Oral milligram(s), 2 in } 17. INDICATION(S) FOR USE DE 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) (cont.) INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? þ YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 21- DATE OF THIS REPORT 22-24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)

2 22- Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Nach dem ersten Tag bekam ich Übelkeit, Bauchkrämpfe und Diarrhoe. Am 2. Tag traten starke Schmerzen in der linken Hand und im Handgelenk, Fingersteifigkeit, Sehnen- und Muskelschmerzen und starke Schmerzen in der linken Schulter auf. Am nächsten Tag kamen Schmerzen in der rechten Hand und im rechten Handgelenk plus Schmerzen und Steifheit im rechten Knie dazu. Danach starke Schwellung der rechten Hand und des Hanballen. Schmerzmittel haben nicht gegen die Schmerzen geholfen. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date [MedDRA 19.1 PT ( ): Nausea ] ( ): Nausea ] [MedDRA 19.1 PT ( ): Abdominal pain ] ( ): Abdominal cramps ] [MedDRA 19.1 PT ( ): Diarrhoea ] ( ): Diarrhoea ] [MedDRA 19.1 PT ( ): Pain in extremity ] ( ): Pain in hand ] [MedDRA 19.1 PT ( ): Arthralgia ] ( ): Wrist pain ] [MedDRA 19.1 PT ( ): Musculoskeletal stiffness ] ( ): Fingers stiffness ] [MedDRA 19.1 PT ( ): Tendon pain ] ( ): Tendon pain ] [MedDRA 19.1 PT ( ): Myalgia ] ( ): Muscle pain ] starke Schmerzen linke Schulter [MedDRA 19.1 PT ( ): Musculoskeletal pain ] ( ): Shoulder pain ] Schmerzen rechtes Knie [MedDRA 19.1 PT ( ): 3 Day

3 22- Report Page: 3 of 5 Arthralgia ] ( ): Pain in knee ] Steifheit rechtes Knie [MedDRA 19.1 PT ( ): Joint stiffness ] 3 Day ( ): Joint stiffness ] Schwellung der rechten Hand und Handballen [MedDRA 19.1 PT ( ): Peripheral swelling ] ( ): Hand swelling ] * 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 Unit rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start date End date Duration Dose * Route(s) of Administration Indication(s) Cipro Basics 500 mg A: daily dose: 1000 Mg milligram(s) every Day B: C: 500Mg milligram(s) D: 2 E: 1Day Oral 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 Drug withdrawn Additional information on drug Did reaction reappear after reintroduction? NA * A: Dosage Text

4 22- Report Page: 4 of 5 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 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number Other case identifiers in previous transmissions Yes Was the case medically confirmed, if not initially from health professional? Primary source(s) of information Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax Telephone address uaw@bfarm.de

5 22- Report Page: 5 of 5 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

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