CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200326 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Anaphylaxie Stufe II nach Ring und Messmer 1977 (10002218): Anaphylaxis ] (10042706): Swelling of tongue ] (10013968): Dyspnoea ] synkopale Kreislaufdysregulation (10009197): Circulatory instability ] palmare Kribbeldysaesthesien (10043876): Tingling ] Globusgefühl (10061549): Sensation of foreign body ] Reporter's comments: DE DA MO YR Hersteller des Novaminsulfon kann von der Patientin nicht genannt werden. 26 DA MO YR (Year) Female 14 05 2017 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) Novaminsulfon 55 mg 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "einmalige Einnahme" { 500 Mg milligram(s), 1 separate Oral dose } 17. INDICATION(S) FOR USE Headache 18. THERAPY DATES (from/to) 19. THERAPY DURATION from to III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) Belara 20. 21. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10001738): Allergy ] Continuing: Unknown 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 06-JUN-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17200326 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 5 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reaction text as reported MedDRA coding Duration Anaphylaxie Stufe II nach Ring und Messmer 1977 [MedDRA 20.0 PT (10002198): Anaphylactic reaction ] (10002218): Anaphylaxis ] Outcome* Term highlighted Time interval 1** Time interval 2*** Start End [MedDRA 20.0 PT (10042727): Swollen tongue ] (10042706): Swelling of tongue ] [MedDRA 20.0 PT (10013968): Dyspnoea ] (10013968): Dyspnoea ] synkopale Kreislaufdysregulation [MedDRA 20.0 PT (10007649): Cardiovascular disorder ] (10009197): Circulatory instability ] palmare Kribbeldysaesthesien [MedDRA 20.0 PT (10033775): Paraesthesia ] (10043876): Tingling ] Globusgefühl [MedDRA 20.0 PT (10061549): Sensation of foreign body ] (10061549): Sensation of foreign body ] * 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 Normal low range Normal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Novaminsulfon 55 mg 14-MAY- 14-MAY- 2017 2017 A: einmalige Einnahme B: C: 500Mg milligram(s) Oral Headache
Report Page: 3 of 5 D: 1 E: Identification of the country where the drug was obtained Name of holder/applicant Hersteller unbekannt 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 metamizole sodium Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10061549): Sensation of foreign body ] [ MedDRA 20.0 (10043876): Tingling ] [ MedDRA 20.0 (10042706): Swelling of tongue ] [ MedDRA 20.0 (10013968): Dyspnoea ] [ MedDRA 20.0 (10009197): Circulatory instability ] [ MedDRA 20.0 (10002218): Anaphylaxis ] 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...) Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Belara A: B: C: D: E: Contraception Identification of the country where the drug was obtained
Report Page: 4 of 5 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: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name ethinylestradiol chlormadinone acetate 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 20.0 (10001738): Allergy ] Unknown Allergie auf Duftstoffe ( Typ-IV-Sensibilisierung) 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 20170606 No 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? No
Report Page: 5 of 5 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 06 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 68 Height (cm) 160 Last menstrual periode Text for relevant medical history and concurrent conditions