SUSPECT ADVERSE REACTION REPORT

Transcription

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 DE DA MO YR ( ): Palpitations ] ( ): Extrasystoles ] ( ): Fear of death ] ( ): Insomnia ] ( ): Cardiac pain ] 59 DA MO YR (Year) Female Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Ich bin 59 Jahre alt und wiege 103 kg, habe keine chronischen Krankheiten, auch keine Psychosen. Ich nehme alle 3 Tage Ranitidin 300mg sowie Fexofenadin 180mg wegen chronischer Urtikaria (nicht sedierend). Ich bat meine Ärztin um ein nicht sedierendes Antidepressivum wegen leichter reaktiver Depression. Ich habe vorher noch nie ein Antidepressivum genommen. Sie verschrieb mir Bupropion Hexal 150mg, das war am Ich nahm einige male früh eine Tablette ein. Das Produkt treibt das Herz an, schlimmer als Kokain, ich bekomme den ganzen Tag Herzrasen, Extrasystolen, Todesängste, ich schlafe die ganze Nacht nicht, sitze bis 3 Uhr oder 5 Uhr wach, das Herzklopfen hält auch den ganzen nächsten Tag noch an, an dem ich dann um CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION 14. SUSPECT DRUG(S) (include generic name) Bupropion Hexal 150 mg II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE Reactive depression 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 09- III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) ranitidine 300 mg fexofenadin 180 mg (cont.) DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 ( ): Chronic urticaria ] Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 29- DATE OF THIS REPORT 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 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Uhr ins Bett falle und 12 Stunden schlafe. In einer Nacht hatte ich besonders schlimme Herzschmerzen und Extrasystolen, ich dachte, ich müsse sterben. An diesem Tag hatte ich einmalig eine Dosis Appetitzügler Alvalin 40mg/g (8 Tropfen) genommen. Ich kann auch nicht ausschließen, dass ich einige Gläser Bier oder Wein getrunken habe. Ich bin kein Alkoholiker. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT ( ): Palpitations ] ( ): Palpitations ] [MedDRA 20.0 PT ( ): Extrasystoles ] ( ): Extrasystoles ] [MedDRA 20.0 PT ( ): Fear of death ] ( ): Fear of death ] [MedDRA 20.0 PT ( ): Insomnia ] ( ): Insomnia ] [MedDRA 20.0 PT ( ): Angina pectoris ] ( ): Cardiac pain ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug *** 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 Duration Dose * Route(s) of Bupropion Hexal 150 mg 09-MAY A: C: D: E: Reactive depression

3 Report Page: 3 of 6 Cumulative dose number (to first reaction) C: Structure dosages number bupropion 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of alvalin 40mg/g MAY A: einmalige Einnahme C: 8Gtt drop(s) D: E: Appetite exaggerated Cumulative dose number (to first reaction) C: Structure dosages number cathine hydrochloride 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of

4 Report Page: 4 of 6 ranitidine 300 mg A: C: D: 1 E: 3Day Cululative dose number (to first reaction) C: Structure of separate dosages ranitidine 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of fexofenadin 180 mg A: C: D: E: Chronic urticaria

5 Report Page: 5 of 6 Cululative dose number (to first reaction) C: Structure of separate dosages fexofenadine 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 ( ): Chronic urticaria ] ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 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 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 91 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175

6 Report Page: 6 of 6 Country Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 103 Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions