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 im rechten Fuß aufsteigenen Myalgien, dann auch Beine ( ): Tendopathien an allen Sehnen an Armen und Beinen ( ): Tendon discomfort ] Myalgien weiteten sich auch auf beide Arme aus ( ): Sensibilitätsstörungen im rechten Fuß ( ): Sensory level abnormal ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: DA MO YR 42 DA MO YR (Year) Male Nach Ersteinnahme entwickelten sich nach Stunden Sensibilitätsstörungen im rechten Fuß mit dort aufsteigenen Myalgien. Diese weiteten sich im weiteren Verlauf auf beide Beine aus. Nach weiterer Einnahme am nächsten Tag Ausweitung auf beide Arme, was zum Abbruch der Medikation führte. Nach weiteren 48 Stunden entwickelten sich so starke Tendopathien an allen Sehnen an Armen und Beinen, dass nur noch minimale Belastung möglich, ohne dass Schäden an Muskeln und Sehnen entstehen. Dieser Zustand ist seither unverändert. Parallele Einahme von PPIs zum Antibiotikum. II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) Cipro 1A Pharma 250mg 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION Oral 17. INDICATION(S) FOR USE Throat infection DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 28-JAN-2016 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) Protonenpumpenhemmer (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? YES NO NA (cont.) 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 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...) Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End im rechten Fuß aufsteigenen Myalgien, dann auch Beine [MedDRA 18.1 PT ( ): 2 Day 29-JAN-2016 ( ): Tendopathien an allen Sehnen an Armen und Beinen [MedDRA 18.1 PT ( ): Tendon discomfort ] not recovered/not resolved JAN-2016 ( ): Tendon discomfort ] Myalgien weiteten sich auch auf beide Arme aus [MedDRA 18.1 PT ( ): 3 Day 30-JAN-2016 ( ): Sensibilitätsstörungen im rechten Fuß [MedDRA 18.1 PT ( ): Sensory level abnormal ] 2 Day 29-JAN-2016 ( ): Sensory level abnormal ] * 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 End Duration Dose * Route(s) of Administration Indication(s) Cipro 1A Pharma 250mg 28-JAN A: B: C: D: E: Oral Throat infection 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)

3 Report Page: 3 of 5 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 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) Protonenpumpenhemmer A: B: C: D: E: 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: 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 Protonenpumpenhemmer

4 Report Page: 4 of 5 Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM Parent Parent identification Date of birth Age LMP 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 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? DE-CADRBFARM Yes 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 88 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax

5 Report Page: 5 of 5 Telephone address pharmakovigilanz@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 80 Height (cm) 190 Last menstrual periode Text for relevant medical history and concurrent conditions Dauer der Behandlung: 2 0