Omanpharma



ADR Form (Ref SOP No. PV-GEN-003-00)ADVERSE DRUG REACTION REPORTING FORMOman Pharmaceutical Products Co. LLCPatient details: ??????? ??????Patient name or initial (Optional) ??? ?????? (???????)?Date of birth (day/month/year): ????? ??????? (???/???/???)Age (years): ????? (?????)?Sex ????? ?Male ????Female ????Weight (kg)????? (???) Height (cms) ????? (??)Country: ???????Medical Record No.: ??? ????? ?????Healthcare Institution: ?????? ?????Suspected Drug: ??????? ??????? ???The details information of suspected drug will be provided as per below table????????? ????????? ??????? ??????? ??? ????? ?????? ?????Brand name (Generic name) ????? ??????? (????? ??????)Daily dose ?????? ???????Indication(s) for use????? ????????? Route of administration ????? ?????????Therapy dates (from/ to)????? ?????? (??/ ???)Therapy duration ??? ?????? Batch number ??? ??????Concomitant drugs and history ??????? ???????? ? ???????Concomitant drugs and dates of administration (exclude those used to treat reaction) ??????? ???????? ? ????? ??????? (?????? ?? ??? ??????? ???? ????? ????? ???????)Other relevant medical history (e.g. 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.) ??? ??????? ???????? (????? ???? ????? ???????- ???????? ????????- ????? ???? ????? ???????- ????? ?????? ????? ???????)Reaction start date ????? ????? ???? ????? ???????Describe reaction(s) ??? ????? ??????? ?(Please Tick () in front of the appropriate option) (???? ??? ????? () ???? ?????? ???????)Is the ADR serious? ?? ????? ??????? ??????Yes ??? ?No ?? Seriousness of ADR????? ????? ??????? ?Patient died, if yes date ?? ???? ??????, ???? ????? ??????? ?Life threatening ??? ???? ?????? ?Permanent disability ????? ????? ?Hospitalization????? ?? ???????? ?Prolonged hospitalization more 24 hours ????? ?? ???????? ????? ?? 24 ???? ?Congenital anomaly ??? ???? ?? ?????? ?Required intervention to prevent Permanent impairment/ damage?????? ????? ???? ??????? ??????/ ??????Required Emergency Room (ER) visit ?????? ???? ??????? ?Other ???? Action Taken ??????? ???????Drug withdrawn ??? ?????? ?Dose reduced ????? ?????? ?Dose increased ????? ???????Dose not changed ??? ??????? ?? ?????? ?Unknown ??? ????? ?Not applicable ?? ????? Did Reaction abate after stopping drug??? ???? ????? ??? ????? ???????Yes ??? ?No ?? ?Not applicable ?? ????? Did Reaction re-appear after re-introduction of drug? ?? ??? ????? ??? ???? ??? ????? ??????? ?????? ??? ???????Yes ??? ?No ?? ?Not applicable ?? ????? Outcome of ADR ????? ????? ??????? ?Recovered, if yes date ?? ??????? ?? ???? ??????? ????, ???? ????? ??????? ?Recovering ?? ??? ??????? ?No improvement ?? ???? ???? ?Unknown ??? ????? ?Reporter Details ?????? ?????? Reporter name ??? ?????? ?Profession (Specialty)?????? (??????) ?Address ??????? ?Email ?????? ?????????? ?Phone / Mobile ??????/ ?????? ?Fax ???????Date of filling report ????? ?????????????? ?Signature ???????Manufacturer information??????? ???????Name and address of the manufacturer ??? ? ????? ??????? ?Date received by manufacturer ????? ??????? ?? ????????Report source ???? ????????Study ????? ?Literature ????? ??????Health professional ????? ??? ?Other ???? Report type ??? ??????? ?Initial ??????? ?Follow-up ?????? ?????? ???? ................
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