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Patient detailsPatient name or initial (Optional) ………………………………….Date of birth ………………………………….Height ………………………………….Weight ………………………………….Health Institution: ………………………………….Medical Record No. : ………………………………….Age: ………………………………….Sex: …………………………………Country: …………………………………??????? ??????- ??? ?????? : ( ???????)....................................................- ????? ??????? : ...................................................- ????? : ................................................... - ????? : ...................................................- ?????? ????? : ................................................... - ??? ????? ????? : ...................................................- ????? : ...................................................- ????? : ...................................................- ?????? : ...................................................Suspected Drug: ???????????????????????????????????The details information of suspected drug will be provided as per below table ????????? ????????? ??????? ??????? ??? ???? ?????? ?????.Sr. noBrand name (Generic name)Daily doseIndication(s) for useRoute of administrationTherapy dates (from/ to)Therapy durationConcomitant drugs and history- ??????? ???????? ? ??????? Concomitant drugs and dates of administration (exclude those used to treat reaction) ??????? ???????? ? ????? ??????? (?????? ?? ??? ??????? ???? ????? ????? ???????)?Other relevant medical history (eg. Diagnostics, allergies, pregnancy with gestation age) ?? ????? ???? ????? (????: ?????, ??????, ???)Adverse Drug Reaction Description (including of event started, relevant tested/lab data, other relevant history and date of event disappeared, if applicable.)??? ??????? ???????? (????? ???? ????? ???????- ???????? ????????- ????? ???? ????? ???????- ????? ?????? ????? ???????)Describe reaction(s) ??? ????? ??????? ?Action Taken Drug withdrawn Dose reducedDose increased Dose not changedUnknown Not applicable Outcome of ADRecovered, if yes dateRecoveringNo improvementUnknownSeriousness of ADRPatient died, if yes dateLife threateningPermanent disabilityHospitalizationProlonged hospitalization more 24 hrCongenital anomalyRequired intervention to prevent Permanent impairment/ damageRequired Emergency Room (ER) visitOther Reporter DetailsReporter nameProfession (Specialty)AddressE-mail??????? ?????? - ??? ??????- ????? ?????? - ????? ?????? - ??? ??????? ?? ?????? - ??? ????? - ?? ????? ????? ????? ??????? - ?? ??????? ?? ???? ?????? ????? ???? ????? ???????- ?????? - ?? ???? ???? - ??? ?????????? ????? ??????? - ?? ???? ??????, ???? ????? ??????? - ??? ???? ??????- ????? ????? - ????? ?? ???????? - ????? ?? ???????? ????? ?? 24 ????- ??? ???? ?? ??????- ?????? ????? ???? ???????/ ?????- ?????? ???? ???????- ???? ?????? ?????? - ??? ?????? :- ?????? (??????)Phone / MobileFaxDateSignature- ?????? ?????????? :- ?????? / ?????? :- ?????? :- ??????? :- ??????? : - ??????? :5. Manufacturer informationName and address of the manufacturer- Date received by manufacturer- Date of this report - Report source -Study LiteratureHealth professional Other Report type - Initial Follow-up??????? ?????? - ??? ? ????? ?????? - ????? ??????? ?? ?????? - ????? ???????- ???? ??????? ????? ????? ????? ????? ???- ??? ??????? ??????? ?????? ???? ................
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