ADVICE ABOUT REPORTING * Report adverse experiences medications * Report Serious adverse events. An event is serious when the patient outcome is: © death * life-threatening (eal risk of dying) * hospitalization (ital or prolonged) ‘ dsabilly (significant, persistent or permanent) * congenital anomaly ‘required intervention to prevent permanent impairment or damage + Report even if: + youite not certain the product caused adverse event + you don't have al the details although point nos. 1,5, 8, 11, 20 & 22 (see reverse) are essentially required * Who can report: * any health care professional @octors including Dentists, Nurses, and Pharmacists). ‘* Where to report: « after completing, please return this form to the same Pharmacovigilance Centre from where you received © allst of country vide Pharmacovigilance Centres is available at www.cdsco.nic.in + inany case of doubt, you may send this form to the National Pharmacovigilance Centre at: Central Drugs Standard Control Organisation, Directorate General of Health Services, Ministry of Health & Family Weltare, Nirman Bhawan, New Delhi 110011 * What happens to the submitted information submitted: «= the information provided in this form is handled in strict confidence. Peripheral Pharmacovigllance ‘will forward this form to the Regional Pharmacovigilance Centres, where the causality analysis is carried out and the information is forwarded to the Zonal Pharmacovigilance Centres. Finally the data is statistically analysed and forwarded to the global Pharmacovigilance Database managed by WHO Uppsala Monitoring Center in Sweden. '* the data is periodically reviewed by the National Pharmacovigilance Advisory Committee constituted by the Ministry of Health and Family Welfare. The Committee is entrusted with responsibility to review the data and suggest any interventions that may be required. Adverse Drug Event For VOLUNTARY reporting of adverse drug events by health care professionals “CDscO- Central Drugs Standard Control Organisation Drsctoale Geneat Petr Series Mristy of Health & Family Woare, Government of India, Nirman Bhawan, New Delhi 110011 www.edsco.nic.in ATTENTION HEALTH CARE PROFESSIONALS “ oatélton-CDSCO_ Central Drugs Standard Control Organisation ‘Drectorate General of eth Sevces, Mistry of Health & Family Welfare, Government of naa, ‘Nimman Bhawan, Now Dall 110017 www.cdsco,nic. in Adverse Drug Event Reporting Form enna ‘patent | 2 Ageatinestewnt [ase DJF Cm a pe oo a = anew “sane + woot — het SEE 5 Oueores strated averse eer Report ‘ofl in by Pharmacoviiarco| centro rahi te form 11 Name (rand andor ‘peer name) (Label Sverst) | ‘Mandictr 7 Bowe oie red Tw scene “| {check all that apply) Daicabivy [°4. Diagnosis fr use emariendsatee wie canna 15. Event abated after use Den [lesen aamay * Stpparane eared a reauted ierveson to prevent #1 Dyes C1 ne §Bbteabie Cl esnaaenns irene = ba pospiaason— ints ptoged 2 Des Cre D88hrcate Dataset event staring wenn [7 Dates of event stopping mm fe tete jinn) exp.cae (threw) |!” Even reappeared ater * Doves re TDR tcate 7 Dae at 2 = 2 Dyes Coo Cease a Carconfant dal posal hry des Relong wl medcalon ‘hoaltemeds (eeu owe toate Wea even) D. Clinician (if not the reporter) 18, Name and Protessionl Ares Ron way rage Wows ET Tafa urea hava ty nena ns ere er ie ee 7 Sasa a Confident: The tan denis hetin sfc conhéonce | MRPESU [= Grwpn boo and protected to the fullest extent. Programme staff is not i Bebe i natadese Reveponees amy nresponee [> prs rawaaypa nay acme me {2 a request ffom the publle. Submission of a report dows not tmancstoes deca te acto” C1] El ueertciy Cattle Sorin tat eden posennel sv manainaurt Bsns orthe product caused or contributed tothe event.