SUSPECT ADVERSE REACTION REPORT
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- Julius Hines
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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 ( ): Vitamin K ( ): Magnesium ( ): Acromegaly ] ( ): Haemorrhage ] ( ): Muscle cramps ] ( ): Vitamin A ( ): Vitamin D Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: DE stetiges Absinken der fettlöslichen Vitamine A und K, sowie Magnesiummangel ( Verbesserung durch orale Substitution ), Vitamin K :vermehrtes Auftreten von Blutungen, Magnesium : Muskelkrämpfe Ergänzende Angaben des Meldenden: DA MO YR 48 DA MO YR (Year) Female 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED þ 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) (cont.) Somatuline 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 90 Mg milligram(s) Subcutaneous 17. INDICATION(S) FOR USE Pituitary adenoma 18. THERAPY DATES (from/to) 19. THERAPY DURATION from NOV- to FEB Month III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) vitamin d 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 19.1 ( ): Crohn's disease ] Continuing: [ MedDRA 19.1 ( ): Strumectomy ] from 1999 Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 24-NOV-2016 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ 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...) Ich wurde von November bis Februar 2013 präoperativ mit Somatuline 90 mg vorbehandelt. Bereits nach der ersten Spritze kam es zu einem Absinken des Quickwertes. Die medikamentöse Behandlung wurde postoperativ dann erst wieder Ende 2013 mit 60 mg aufgenommen. Unter der Pausierung kam es zu einer Stabilisierung der genannten Werte (hauptsächlich K und D) Aufgrund der Crohnerkrankung wurde Vitamin D bereits langjährig mit 1000 I.E. substituiert, mittlerweise ist, seit der Somatuline Behandlung, eine Gabe von 2000 I.E. täglich erforderlich, um die Werte im Normbereich zu halten. Das Vitamin K-Defizit wird derzeit mit Konakion behandelt, wobei die Werte noch nicht konstant sind. Sender's comment: langjähriger Morbus Crohn mit Vitamin A + K und Magnesium bis zur Behandlung mit Somatuline unauffällig. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End [MedDRA 19.1 PT ( ): Vitamin A ( ): Vitamin A [MedDRA 19.1 PT ( ): Vitamin K ( ): Vitamin K [MedDRA 19.1 PT ( ): Magnesium ( ): Magnesium [MedDRA 19.1 PT ( ): Acromegaly ] ( ): Acromegaly ] [MedDRA 19.1 PT ( ): Haemorrhage ] ( ): Haemorrhage ] [MedDRA 19.1 PT ( ): Muscle spasms ] ( ): Muscle cramps ] [MedDRA 19.1 PT ( ): Vitamin D ( ): Vitamin D * 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
3 Report Page: 3 of 6 21-JAN-2013 Quick's test 61 % 13-DEC- Quick's test 64 % 17-APR-2013 Vitamin D 48,0 nmol/l 17-APR-2013 Carotene 97,00 µg/l 07-JUN-2016 Vitamin K 93 ng/l 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Somatuline NOV- FEB Month A: B: C: 90Mg milligram(s) D: E: Subcutaneous Pituitary adenoma 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 praeoperative Behandlung 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 lanreotide acetate Causality assessment Reaction Source Method Result [ MedDRA 19.1 ( ): Vitamin K [ MedDRA 19.1 ( ): Vitamin D [ MedDRA 19.1 ( ): Vitamin A [ MedDRA 19.1 ( ): Muscle cramps ] [ MedDRA 19.1 ( ):
4 Report Page: 4 of 6 Haemorrhage ] [ MedDRA 19.1 ( ): Acromegaly ] [ MedDRA 19.1 ( ): Magnesium 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) somatuline 2013 A: daily dose: 60 Mg milligram(s) every 5 Week B: C: 60Mg milligram(s) D: 1 E: 5Week Subcutaneous Pituitary adenoma 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 postoperative Behandlung Beginn Ende 2013 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 lanreotide 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) vitamin d A: B: C: 1000Iu international unit(s) D: E: Crohn's disease Identification of the country where the drug was obtained Name of holder/applicant
5 Report Page: 5 of 6 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 langjährige Behandlung 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 ergocalciferol 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.1 ( ): Crohn's disease ] [ MedDRA 19.1 ( ): Strumectomy ] 1999 Strumaresektion 1999 bei Knotenstruma 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 Yes No List of documents held by sender Yes
6 Report Page: 6 of 6 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 No 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 34 Consumer or other non health professional 34 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 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) 53 Height (cm) 166 Last menstrual periode Text for relevant medical history and concurrent conditions
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