.MINISTERUL SANATATII~I PROTECTIEI SOCIALE

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Cu privire la monitorizarea reacfiilor adverseale medicamentelor ~iallor produsefarmaceutice in Republica Moldova

In temeiul Legilor "Cu privire la medicamente" nr.1409 XIII din 17.12.97 ~i"Cu privire la activitatea farmaceutidi" nr. 1456-XII din 25.05.93 ~i in scopulorganizarii masurilor de farmacovigilenta in Republica Moldova.

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APROB:1. Instructiunea cu privire la monitorizarea reactiilor adverse ale medicamentelor ~i

altor produse farmaceutice (anexa 1).2. Fi~a-comunicare a reactiilor adverse ale medicamentelor ~i altor produse

farmaceutice (anexa 2).3. Fi~a-comunicare a reactiilor adverse ale medicamentelor ~i altor produse

farmaceutice "Pacientul comunica" (anexa 3).

0 R DON:1. Medicilor ~efi ai Institutiilor Medico-Sanitare Publice republicane ~i raionale,directorului Directiei Sanatatii a Consiliului Municipal Chi~inau, ~efului SectieiSanatatii a Primariei municipiului Balti, directorului Directiei Sanatatii a AsistenteiSociale UTA Gagauzia.1.1. A desemna in fiecare institutie medico-sanitara, timp de 1 luna de la data emiterii

prezentului ordin, persoane responsabile de problemele farmacovigilentei; ininstitutiile medicale in care activeaza farmacolog-clinician sau farmacist-clinician aceasta functie sa fie indeplinita de catre acesta.

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1.2. A asigura inregistrarea reactiilor adverse ale medicamentelor ~i altor produsefarmaceutice depistate la uti1izarea lor, cu comunicarea in mod ob1igatoriu inadresa sectiei "Autorizare medicamente, evaluare clinidi ~ifarmacovigilenta" aAgentiei Medicamentu1ui.

1.3. A asigura controlul prezentarii la timp a informatiei despre reactiile adverse alemedicamente10r ~i altor produse farmaceutice, depistate in institutie cuincluderea 10rin darea de seama anua1a.

2. Agentiei Medicamentului (director V. Verde~).2.1. A asigura organizarea activitatii de monitorizare a reactiilor adverse ale

medicamentelor ~i altor produse farmaceutice, depistate in institutiasubordonata.

2.2. A asigura informarea speciali~tilor din domeniul ocrotirii sanatatii desprereactiile adverse ale medicamente10r, problemele actuale referitoare lasiguranta remediilor medicamentoase ~i altor produse farmaceutice,actualitati ale farmacote'rapiei rationale prin modalitati diverse.

2.3. A propaga in randuri1e populatiei cuno~tinte referitoare la inofensivitateamedicamentelor ~ialtor produse farmaceutice.

2.4. A conlucra cu Centrul International de Farmacovigilenta al OMS (or.Uppsala, Suedia) ~i Centrele Nationale de Farmacovigi1enta din alte tari invederea monitorizarii reactii10r adverse ale medicamente10r ~i altor produsefarmaceutice ~ischimbului de informatie in domeniul farmacovigilentei.

2.5. A elabora ~iedita trimestrial un Bu1etinInformational pentru medici, dedicatproblemelor de farmacovigi1enta.

3. Acest ordin sa fie publicat in Monitorul Oficial al Repub1iciiMoldova.

4. De la data pub1icarii 1ui se abroga ordinu1 Ministerului Sanatatii din RepublicaMoldova nr.75 din 17.03.1999 "Cu privire la supravegherea ~i farmacovigi1entamedicamentelor in Republica Mo1dova".

5. Controlul executarii prevederilor prezentului ordin se atribuie viceministruluiD-lui Boris Golovin.

Ministru

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ANEXA nr.1

la ordinul MSPS nrA'1?din I'ct ()( Of;

Instructiune cu privire la monitorizarea reactiilor adverse alemedicamentelor ~iaItor produse farmaceutice

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1. Dispozipi generale1.1. Prezenta Instructiune este elaborata in corespundere cu prevederile Legilor "Cuprivire la medicamente" (nr.1409 XIII din 17.12.97), "Cu privire la activitateafarmaceutica" (nr.1456 XII din 25.05.93), "Cu privire la modificarea ~i completareaLegii cu privire la activitatea farmaceutica" (nr.1460 XIII din 28.01.98). Paralel aufost luate in consideratie alte acte normative, utilizate in practica internationala -Indrumarul Conferintei Intemationale pentru armonizarea cerintelor tehnice fata deautorizarea remediilor medicamentoase de uz uman (ICH) ~i Directiva ConsiliuluiComunitatii Economice Europene pe problemele farmacovigilentei .N2 75/319,inclusiv ~icompletarile la aceasta directiva.N283/570 ~i.N293/39.1.2. Prezenta Instructiune stabile~te cerintele de baza fata de colectarea datelor,necesare pentru realizarea supravegherii reactiilor adverse ale remediilormedicamentoase ~i altor produse farmaceutice, aparute la utilizarea lor in practicamedicala, inclusiv ~iunele cerinte pentru analiza ~tiintificaa acestor informatii.1.3. Supravegherea reactiilor adverse la medicamente ~i alte produse farmaceuticeeste efectuata de catre Agentia Medicamentului, in cadrul caruia activeaza sectia"Autorizare medicamente, evaluare clinica ~i farmacovigilenta", care are dreptsarcina sa inregistreze, sa examineze, sa valideze ~i sa evalueze sistematic reactiileadverse ale medicamentelor ~ialtor produse farmaceutice.

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2. Definirea principalelor nopuni2.1 Sistemul de farmacovigilenta - sistemul de stat creat pentru stocarea, evaluarea~tiintifica ~i controlul informatiei despre reactiile adverse ale medicamentelor ~i altorproduse farmaceutice, in scopul intreprinderii masurilor corespunzatoare la etapastudiilor clinice ~i la etapa utilizarii lor in practica medicala, conform legislatiei invIgoare.2.2 Reactie adversa - Organizatia Mondiala a Sanatatii (OMS) define~te prin aceastanotiune orice reactie la un medicament sau alt produs farmaceutic ce este daunatoare~i nedorita ~i apare la utilizarea lui in doze autorizate (doze terapeutice) pentruprofilaxia, diagnosticul ~itratamentul unor boli.2.3 Comunicari spontane - comunicari despre toate tipurile de reactii adverseaparute la utilizarea in practica a remediilor medicamentoase.2.4. Reactie adversa grava - orice reactie adversa periculoasa pentru viatapacientului aparuta la utilizarea medicamentului (independent de doza lui) sau altuiprodus farmaceutic ~i care necesita spitalizarea pacientului sau prelungireatermenului de spitalizare, poate cauza invalidizarea sau decesul pacientului, anomaliide dezvoltare a fatului, malformatii congenitale.2.5 Reactie adversa negrava - orice reactie adversa care nu corespunde criteriilordefinite pentru 0 reactie adversa grava.2.6 Criterii de imputabilitate - criteriile de cauzalitate a efectelor adverse, conformterminologiei scolii franceze de farmacovigilenta, care sunt recomandate de OMS ~i

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se clasifidi reactiile adverse medicamentoase in 6 tipuri: reactie adversa sigura, pro-babila, posibila, improbabila, conditionataJneclasificata, neevaluabilaJneclasificabila.2.7 Reactie adversa sigura - eveniment clinic (inclusiv modificarile paracliniceaferente) care apare dupa administrarea medicamentului sau altui produs farmaceutic~i care nu poate fi explicat prin boli asociate sau prin terapii concomitente. Laintreruperea administrarii tabloul clinic regreseaza. Evenimentul trebuie sa fie binedefinit farmacologic sau fenomenologic, folosind, daca este nevoie, readministrarea(la readministrare reactia adversa apare din nou).2.8 Reacpe adversa probabila - evenimentclinic (inclusivmodificarileparacliniceaferente) care apare dupa administrarea medicamentului sau altui produs farmaceutic~i care este improbabil provocat de alte afectiuni sau alti factori (terapiiconcomitente), regreseaza dupa intreruperea administrarii. Readministrarea nu estenecesara.2.9 Reactie adversa posibila - eveniment clinic (inclusiv modificarile paracliniceaferente), posibillegat de administrarea medicamentului sau altui produs farmaceutic,dar care poate fi explicat ~iprin maladii asociate sau prin alti factori (alte tratamenteconcomitente, factori chimici "etc.). Informatiile despre raspunsul clinic laintreruperea administrarii pot sa lipseasca sau sa fie neclare.2.10 Reactie adversa improbabila - eveniment clinic (inclusiv modificarileparaclinice aferente), care apare intr-o relatie temporala neclara fata de administrareamedicamentului sau altui produs farmaceutic ~i care poate fi explicat ~i prin maladiiasociate sau prin alti factori (alte tratamente concomitente, factori chimici etc.)2.11 Reactie adversa conditionata/neclasificata: un eveniment clinic, cuprinzand ~imodificari paraclinice, raportat ca fiind efect advers, dar pentru care sunt esentialemai multe date in vederea evaluarii corecte sau informatiile sunt inca examinate.,

2.12 Reactie adversa neevaluabila/neclasificabila: un raport sugerand 0 reactieadversa, dar care nu poate fi judecat deoarece informatiile sunt insuficiente saucontradictorii ~inu pot fi suplimentate sau verificate.2.13 Reacpe adversa prevazuta - reactie adversa,caracterul~igradul de expresieal careia corespunde informatiei prezentate in instructiunea pentru utilizareaprodusului farmaceutic (pentru preparatele autorizate).2.14 Reacpe adversa neprevazuta - reactie adversa, caracterul ~i gradul de expresieal careia nu corespunde informatiei prezentate in instructiunea pentru utilizareaprodusului farmaceutic.2.15 Reactii de interactiune medicamentoasa - reactii, care apar pe fonuladministrarii a mai multor preparate medicamentoase ~isunt cauzate de interactiunilelor farmacodinamice ~i/saufarmacocinetice.2.16 Inofensivitatea (siguranta) remediilor medicamentoase - lipsa reactiiloradverse grave ~i neprevazute in cadrul studiilor clinice sau la utilizarea terapeutica aremediilor medicamentoase, ce corespund criteriului beneficiu/risc.2.17 Studii clinice suplimentare - studii lansate cu scop de a depista sau de aconfirma careva actiuni periculoase ale produsului farmaceutic la utilizarea lui inpractica medicala, care ar putea prezenta risc pentru sanatatea pacientilor. Acestestudii deseori implica necesitatea unor decizii corelate cu legislatia in vigoare.2.18 Certificat de inregistrare (autorizare) - document care permite utilizarea,importul ~ivanzarea medicamentului pe teritoriului Republicii Moldova.

~

2.4. CepbihHoe n060qHOe ,lXeiiCTBUe - mo60e He6narOnplUITHOe, onaCHoe ,lJ,n5I)IUI3HH n060qHOe ,lJ,eikTBHe, B03HHKaIOrn;ee npH Me,lJ,H:QHHCKOMnpHMeHeHHH

neKapcTBeHHoro Cpe,lJ,CTBa (He3aBHcHMo OT ,lJ,03bl), KOTopoe npHBO,lJ,HT K

rocnHTanH3a:QHH HnH YBenHqeHHIO cpoKa rocnHTanH3a:QHH, HHBanH,lJ,H3a:QHH,cMepTH

na:QHeHTa, Bbl3bIBaeT aHOManHH pa3BHTH5I nnO,lJ,a H BpmK,lJ,eHHble aHOManHH.

2.5. HecepbthHOe n060QHOe ,lXeiiCTBUe - mo60e n060qHOe ,lJ,eHCTBHe, He

OTBeqaIOrn;ee KpHTepH5IM, onpe,lJ,en5IeMbIM KaK cepbe3Hoe n060qHOe ,lJ,eHCTBHe.

2.6. KpuTepuu npUQUHHO-CJIe,lXCTBeHHoii CBH3U Me~y n060QHOii peaK...ueii U

npueMoM JIeKapCTBeHHoro Cpe,lXCTBa - cornaCHO onpe,lJ,eneHH5IM cppaH:QY3cKOH

IIIKonbI no cpapMaKOHa,lJ,30PY H peKOMeH,lJ,a:QH5IMB03, 3TH KpHTepHH onpe,lJ,en5IIOT 6BH,lJ,OB n060qHblX peaK:QHH neKapCTBeHHblX Cpe,lJ,CTB: ,lJ,OCTOBepHa5I n060QHa5I

peaK:QH5I (TIP), Bep05ITHa5I TIP, B03MO)l(Ha5I TIP, COMHHTenbHa5I TIP, ycnoBHa5I TIP,HeKnaccHcpH:QHpyeMa5I TIP.

2.7. ,l];ocToBepHaH n060QHaH peaK",uH - KnHHHQeCKHe np05IBneHH5I, KOTopble

BKnIOQaIOT H3MeHeHH5I na60paTopHbIX nOKa3aTeneH H B03HHKaIOT BO BpeM5I npHeMa

neKapcTBeHHoro Cpe,lJ,CTBa, HO He MorYT 6bITb 06'b5ICHeHbI HanHQHeM

conYTCTBYIOrn;HX 3a60neBaHHH H BnH5IHHeM ,lJ,pyrHx cpaKTopOB H XHMHQeCKHX

Bern;eCTB, KOTopble perpeCCl;ipy'IOT nocne OTMeHbl npHeMa neKapCTBeHHoro Cpe,lJ,CTBaH B03HHKaIOT npH era nOBTopHOM Ha3HaQeHHH.

2.8. BepoHTHaH n060QHaH peaK",UH - KnHHHQeCKHe np05IBneHH5I, KOTopble

BKnIOQaIOT H3MeHeHH5I na60paTopHbIx nOKa3aTeneH H B03HHKaIOT BO BpeM5I npHeMa

neKapcTBeHHoro Cpe,lJ,CTBa, HO Bp5I,lJ, nH HMeIOT OTHOIIIeHHe K conYTCTBYIOrn;HM

3a60neBaHH5IM HnH ,lJ,pyrHM cpaKTopaM, perpeCCHpYIOT nocne OTMeHbI

neKapCTBeHHoro Cpe,lJ,CTBa H npH nOBTopHOM Ha3HaQeHHH 3Toro neKapCTBeHHoro .

Cpe,lJ,CTBacpaKT HX nOBTopHoro B03HHKHOBeHH5IHeH3BeCTeH.

2.9. B03MO~HaH n060QHaH peaK",UH - KnHHHQeCKHe np05IBneHH5I, KOTopble

BKnIOQaIOT H3MeHeHH5I na60paTopHbIX nOKa3aTeneH H B03HHKaIOT BO BpeM5I npHeMa

neKapcTBeHHoro Cpe,lJ,CTBa,HO MorYT 6bITb 06'b5ICHeHbI HanHQHeM conYTCTBYIOrn;HX

3a60neBaHHH HnH npHeMOM ,lJ,pyrHx neKapCTBeHHblX Cpe,lJ,CTB HnH XHMHQeCKHX

Bern;eCTB H ,lJ,n5IKOTOpblX peaK:QH5I Ha OTMeHY neKapCTBeHHoro Cpe,lJ,CTBaHeH3BeCTHaHnH He5ICHa.

2.10. COMHUTeJIbHaHn060QHaH peaK",uH - KnHHHQeCKHe np05IBneHH5I, KOTopble

BKnIOQaIOT H3MeHeHH5I na60paTopHbIX nOKa3aTeneH, KOTopble B03HHKaIOT npH

OTCYTCTBHH QeTKOH CB5I3H co BpeMeHeM npHeMa neKapcTBeHHoro Cpe,lJ,CTBa.

TIpHQHHOH B03HHKHOBeHH5I 3TOH peaK:QHH MorYT 6bITb ,lJ,pyrHe cpaKTopbI (npHeM

,lJ,pyrHx neKapcTBeHHbIx Cpe,lJ,CTB, conYTcTBYIOrn;He 3a60neBaHH5I, XHMHQeCKHe

Bern;eCTBa H T.n.).

2.11. Y CJIOBHaH n060QHaH peaK",uH - KnHHHQeCKHe np05IBneHH5I, B TOM QHCne

H3MeHeHH5I na60paTopHblX nOKa3aTeneH, KOTopble OTHeceHbI K n060QHbIM

peaK:QH5IM, HO Tpe6yIOT nonYQeHH5I ,lJ,OnOnHHTenbHbIX ,lJ,aHHbIX ,lJ,n5ITOQHOH O:QeHKH.

2.12. HeKJIaCcucj)u...upyeMaH n060QHaH peaK",uH - C006rn;eHHe 0 npe,lJ,nOnaraeMoH .

n060QHOH peaK:QHH, KOTOPYIO Henb35I O:QeHHTb H3-3a He,lJ,OCTaTOQHOH HHcpopMa:QHH

HnH H3-3a HanHQH5I npoTHBOpeQHH B 3TOH HHcpopMa:QHH.

3. Modalitatea de raportare a reac{iilor adverse la medicamente sau alteproduse farmaceutice autorizate in Republica Moldova

3.1. Medicii ~i lucratorii medicali ai institutiilor medico-sanitare din RepublicaMoldova, indiferent de forma de proprietate, sunt obligati sa raporteze sectiei"Autorizare medicamente, evaluare clinica ~i farmacovigilenta" orice reactii adverseale medicamentelor sau altor produse farmaceutice utilizate in !Ma, completand fi~a-comunicare a reactiilor adverse ale medicamentelor ~i altor produse farmaceutice(anexa 2). Efectele adverse grave trebuie anuntate imediat sectiei "Autorizaremedicamente, evaluare clinica ~i farmacovigilenta" - timp de 48 ore de la debut, iarcelelalte efecte adverse - timp de 15 zile. Speciali~tii farmaciilor sunt obligati de acomunica reactiile adverse ale medicamentelor ~i altor produse farmaceutice,completand fi~a-comunicare a reactiilor adverse ale medicamentelor ~i altor produsefarmaceutice "Pacientul comunica" (anexa 3).3.2. Informatia despre reactiile adverse ale medicamentelor ~i altor produsefarmaceutice trebuie inregistrate de catre medic in documentatia medicala primara,cartela de ambulator, fi~a de observatie, fi~a statistica a persoanei externate dinstationar.,

3.3. Producatorii de medicamente/detinatorii certificatului de inregistrare (autorizare)sau reprezentantii lor oficiali sunt obligati sa supravegheze medicamentele noi peparcursul primilor 5 ani de la autorizare ~i sa prezinte sectiei "Autorizaremedicamente, evaluare clinica ~ifarmacovigilenta" informatii despre reactiile adversemedicamentoase la propriile medicamente autorizate in Republica Moldova.3.4. Sectia "Autorizare medicamente, evaluare clinica ~ifarmacovigilenta" efectueazaperiodic expertiza informatiilor prezentate pentru aprecierea sigurantei remediilormedicamentoase ~ialtor produse farmaceutice.3.5. In cazul depistarii reactiilor adverse necunoscute anterior, sectia "Autorizaremedicamente, evaluare clinica ~i farmacovigilenta" informeaza ComisiaMedicamentului ~i Ministerul Sanatatii ~i Protectiei Sociale despre acestea, invederea suspendarii sau retragerii autorizatiei preparatului pana la primirearezultatelor studiului clinic suplimentar ~i evaluarii specializate in scopul aprecieriisigurantei produsului farmaceutic.3.6. In baza informatiilor prezentate de sectia "Autorizare medicamente, evaluareclinica ~i farmacovigilenta", Ministerul Sanatatii ~i Protectiei Sociale decidesuspendarea sau retragerea autorizatiei medicamentului in Republica Moldova.Sectia "Autorizare medicamente, evaluare clinica ~i farmacovigilenta" anuntaproducatorii de medicamente ~i detinatorii certificatului de autorizare (saureprezentantii lor) despre decizia finala a Ministerului Sanatatii ~iProtectiei Sociale.3.7. Dupa aprecierea specializata a informatiei despre reactiile adverse alemedicamentelor ~i altor produse farmaceutice, secpa "Autorizare medicamente,evaluare clinica ~i farmacovigilenta" poate inainta Comisiei Medicamentuluipropuneri in vederea impunerii unor restrictii de utilizare a preparatului ~i anume:modificarea indicatiilor ~i contraindicatiilor incluse in instructiunile pentru utilizareapreparatului medicamentos. Sectia "Autorizare medicamente, evaluare clinica ~ifarmacovigilenta" anunta producatorii de medicamente/detinatorii certificatelor deautorizare (sau reprezentantilor oficiali) despre modificarile propuse.

2.13. npe~Bu~eHHaH n060QHaH peaK~uH - n060qHa5I peaKQM5I,xapaKTep HJIllCTeneHb BbIpa)KeHHOCTM KOTOpOH OTBeqaeT MMeIOrn;eHC5I MH<popMaQMM 0

JIeKapCTBeHHoM Cpe.IJ;CTBe B JIMCTKe-BKJIa.IJ;bIllIe WMJIM MHCTpYKQMM .IJ;JI5I

Me.IJ;MQMHCKoro npMMeHeHM5I JIeKapCTBeHHoro Cpe.IJ;CTBa (.IJ;JI5I pa3pellIeHHoro K

Me.IJ;MQMHCKOMYnpMMeHeHMIO JIeKapCTBeHHoro Cpe.IJ;CTBa).

2.14. Henpe~Bu~eHHaH n060QHaH peaK~uH - n060qHa5I peaKQM5I, xapaKTep MJIM

CTeneHb Bblpa)KeHHOCTM KOTOpOH He OTBeqaeT MMeIOrn;eHC5I MH<popMaQMM 0

JIeKapCTBeHHOM Cpe.IJ;CTBe B JIMCTKe-BKJIa.IJ;bIllIe WMJIM MHCTpYKQMM .IJ;JI5I

Me.IJ;MQMHCKoro npMMeHeHH5I JIeKapCTBeHHoro Cpe.IJ;CTBa (.IJ;JI5I pa3pellIeHHoro K

Me.IJ;MQMHCKOMYnpMMeHeHMIO JIeKapCTBeHHoro Cpe.IJ;CTBa).

2.15. PeaK~uu B3auMo~eHcTBuH - peaKQMM,KOTopbIe B03HMKaIOTHa <pOHenpMeMa .

HeCKOJIbKMX JIeKapCTBeHHbIX Cpe.IJ;CTB M 5IBJI5IIOTC5I CJIe.IJ;CTBMeM MX B3aMMO.IJ;eHCTBM5I B

<papMaKO.IJ;MHaMMqeCKOH M/MJIM <papMaKOKMHeTMqeCKOH <pa3ax.

2.16. Be30naCHOCTb (6e3Bpe~HocTb) JIeKapCTBeHHoro cpe~CTBa - OTCYTCTBMe

cepbe3HbIX M Henpe.IJ;BM.IJ;eHHbIX n060qHbIX peaKQMH npM KJIMHMqeCKMX MCnbITaHM5IX

MJIM Me.IJ;MQMHCKOM npMMeHeHMM JIeKapCTBeHHoro Cpe.IJ;CTBa, COOTBeTCTBYIOrn;MX

KpMTepMIO nOJIb3a/pMCK.

2.17. ,ZI:onOJIHUTeJIbHbIe kJIHHUQeCKUe UCCJIe~OBaHUH - 3TO MCCJIe.IJ;OBaHM5I,

KOTopble npOBOMTC5I C QeJIbIO nO.IJ;TBep)K.IJ;eHH5I M BbI5IBJIeHM5I JII06bIX onaCHbIX

CBOHCTB JIeKapCTBeHHoro Cpe.IJ;CTBa npM era Me.IJ;MQMHCKOM npMMeHeHMM,

YBeJIMqMBaIOrn;Me pMCK .IJ;JI5I 3.IJ;OpOBb5I qeJIOBeKa M HY)K.IJ;aIOrn;MeC5I B npMH5ITMM

pellIeHMH B COOTBeTCTBMM C .IJ;eHCTBYIOrn;MM 3aKOHO.IJ;aTeJIbCTBOM.

2.18. PerucTpa~uoHHoe Y~OCTOBepeHue (cBu~eTeJIbCTBo) - .IJ;OKYMeHT, KOTOpbIH

BbI.IJ;aeTC5I 3a5IBMTeJIIO M 5IBJI5IeTC5I pa3pellIeHMeM .IJ;JI5I Me.IJ;MQMHCKoro npMMeHeHM5I,

BB03a M npO.IJ;a)KM JIeKapCTBeHHoro Cpe.IJ;CTBa B Pecny6JIMKe MOJI.IJ;OBa.

3. IIopRooK npeOOCma6JleHlUI uHfjJopMal{UU 0 no6011HbIX peaKl{lUIX

JleKapCm6eHHbIX cpeocm6 U opyzux fjJapMal{e6mUllecKux npenapamo6,

paJpemeHHbIX K MeOul{UHCKOMY npwueHeHUIO 6 Pecny6JlUKe MOJlOO6a

3.1. BpaqM M Me.IJ;MQMHCKHepa60THMKH Bcex yqpe)K)J;eHMH 3.IJ;paBOOXpaHeHH5I

Pecny6JIMKH MOJI.IJ;OBa,He3aBMCMMOOT <pOpMc06CTBeHHOCTM,065I3aHbI npe.IJ;OCTaBJI5ITb

OT.IJ;eJIY perMCTpaQMM JIeKapCTB, KJIMHMqeCKOH OQeHKM M <papMaKOHa.IJ;30pa

MH<popMaQMIO 0 JII06bIX n060QHbIX .IJ;eHCTBH5IX JIeKapCTBeHHbIX Cpe.IJ;CTB, KOTopble

npMMeH5IIOTC5IHa TeppMTopMM Pecny6JIMKH MOJI.IJ;OBa,3anOJIH5I5IKapTy-co06rn;eHMe 0

n060QHbIX peaKQM5IX JIeKapCTBeHHbIX Cpe.IJ;CTB M .IJ;PyrMx <papMaQeBTMQeCKMX

npenapaTOB (npMJIO)KeHMe N22). Bce cepbe3Hble n060QHble peaKQMM .IJ;OJI)KHbI6bITb

C006rn;eHbI OT.IJ;eJIY perMCTpaQMM JIeKapCTB, KJIMHMQeCKOH OQeHKM M

<papMaKOHa.IJ;30pa B TeQeHMe 48 QaCOB nOCJIe B03HMKHOBeHH5I,a OCTaJIbHble n060QHbIe

peaKIIMM - B TeQeHMe 15 .IJ;HeH. CneIJ;HaJIMCTbI anTeK 065I3aHbI M3Bern;aTb OT.IJ;eJIY

perMCTpaQMM JIeKapCTB, KJIMHMQeCKOH OQeHKM M <papMaKOHa.IJ;30pa 060 Bcex

n060QHbIX peaKQH5IX Ha JIeKapCTBeHHble Cpe.IJ;CTBa,3anOJIH5I5I KapTy-co06rn;eHMe 0

n060QHbIX peaKIIH5IX JIeKapCTBeHHbIX Cpe.IJ;CTB M .IJ;pyrMx <papMaQeBTMQeCKMX

npenapaTOB.IJ;JI5I naQMeHTa (npMJIO)KeHMeN23).

3.8. Aspectele problematice referitoare la utilizarea terapeutidi a preparatuluimedicamentos In cazul survenirii reactiilor adverse la utilizarea lui terapeutidi suntsolutionate de Ministerul Sanatatii ~iProtectiei Sociale al Republicii Moldova.

r"

4. Sursele de colectare a injorma(iei despre reac(iile adverse alemedicamentelor ~ialtor produse jarmaceutice.

Schimbulinjorma(ionaL4.1. Informatia despre reactiile adverse ale medicamentelor ~i altor produsefarmaceutice este receptionata de catre sectia "Autorizare medicamente, evaluareclinica ~ifarmacovigilenta" a Agentiei Medicamentului de la:a) medicii ~i farmaci~tii tuturor institutiilor medico-sanitare, indiferent de forma deproprietate;b) producatorii / detinatorii certificatului de autorizare sau reprezentantii lor oficiali~c) reprezentantii organizatiilor intemationale (OMS - Organizatia Mondiala aSanatatii, CE - Comunitatea Europeana) etc.;d) sursele informationale medicaIe~i publicatiile ~tiintifice;e) organizatiile ob~te~ti,care reprezinta interesele consumatorilor de medicamente ~ia cetatenilor la general;f) comisiile de etica pentru studiul clinic al medicamentelor.4.2. Sectia "Autorizare medicamente, evaluare clinica ~i farmacovigilenta"receptioneaza informatiile despre reactiile adverse ale medicamentelor ~i altorproduse farmaceutice, le sistematizeaza, analizeaza conform definitiilor existente(Prezentate suplimentar In p.2), apoi elaboreaza operativ reviuri analitice,recomandari metodice pentru medici, farmaci~ti, investigatori, producatori demedicamente, propuneri pentru Comisia Medicamentului ~i Ministerul Sanatatii ~iProtectiei Sociale In vederea solutionarii unor probleme pentru asigurareainofensivitatii medicamentelor.,

4.3. Rapoartele despre reactiile adverse grave suspectate sectia "Autorizaremedicamente, evaluare clinica ~i farmacovigilenta" a Agentiei Medicamentului leprezinta Comisiei Medicamentului care adopta deciziile corespunzatoare, informandprompt Ministerul Sanatatii ~i Protectiei Sociale. La necesitate, se va prezenta unraport similar reprezentantei OMS In Republica Moldova.

~

ANEXA Nr. 2la ordinul MSPS nr._din -

Fl$A-COMUNICAREDESPRE REACTllLE ADVERSE ALE MEDICAMENTELOR $1 ALTOR PRODUSE FARMACEUTICE

(se va sublinia varianta dispunsului acceptat)

3.2. I1HCPOPMaQillO 0 n060q}ThIX ~eHCTBIDIX JIeKapCTBeHHoro Cpe~CTBa M ~pyrMx

cpapMaQeBTMqeCKMX npenapaTOB Bpaq ~OJDKeH3aHOCMTbB nepBwrnyK> ~OKYMeHTaQInO,

aM6YJIaTOpHyro KapTY, MCTOpmO 60JIe3HM, CTaTMCTH:qeCKyroKapTY BbI6bITlliI naQMeHTa

M3CTaQMOHapa.

3.3. IIpOM3Bo~TemflBJI~eJIbQbI perncTpaQMoHHoro CB~eTeJIbCTBa (MJIM MX

ynOJIHOMOqeHHbIe npe~cTaBMTeJIM) JIeKapCTBeHHoro cpe~CTBa, pa3perneHHoro K

Me~MQMHCKOMY npMMeHeHInO, o6R3aHbI npe~OCTaBJI}lTb OT~eJIY perMCTpaQMM

JIeKapCTB, KJIMHMqeCKOH OQeHKM M cpapMaKOHa~30pa MHcpOpMaQInO 0 mo60M

n060~OM ~eHCTBMMJIeKapCTBeHHOrO cpe~CTBa, Ha IIpOTIDKeHMMnepBbIX 5 JIeT nOCJIe

no~eHlliI perncTpaQMoHHoro CB~eTeJIbCTBa.

3.4. OT~eJI perMCTpaQMM JIeKapCTB, KJIMHMqeCKOH OQeHKM M cpapMaKOHa~30pa

npOBO~MT 3KcnepTM3Y npe~OCTaBJIeHHbIX MaTepMaJIOB ~JI}I OQeHKM 6e30naCHOCTM

JIeKapCTBeHHbIX cpe~CTB.

3.5. B c~ae BbrnBJIeHlliI HeM3BeCTHOHpaHee no6o~oH peaKQMM, OT~eJIperMCTpaQMM JIeKapCTB, KJIMHMqeCKOH OQeHKM M cpapMaKOHa~30pa BHOCMTPa3JIMqHbIe

npeMO:>KeHlliI Ha 3ace~aHMM KOMMCCMMno JIeKapCTBaM AreHTCTBa no JIeKapCTBaM M B

M3C3 Pecny6JIMKM MOJI~OBa, ~JI}I npMH}lTlliI perneHlliI 0 nOJIHOM MJIM BpeMeHHOM .>: ..

3anpeTe Me~QMHCKoro IIpMMeHeHlliI 3Toro JIeKapCTBeHHoro cpe~CTBa ~O nO~eHM}I

pe3YJIbTaTOB ~OnOJIHMTeJIbHOrO KJIMHMqeCKOrO MCCJIe~OBaHlliI M CneQMaJIM3MpOBaHHOH

OQeHKM C QeJIbIO nO~TBep~eHlliI MJIM OTCYTCTBlliI onaCHbIX CBOHCTB JIeKapCTBeHHoro

cpe~CTBa.

3.6. Ha OCHOBaHMMBHeceHHbIX OT~eJIOM perMcTpaQMM JIeKapCTB, KJIMHMqeCKOH

OQeHKMM cpapMaKOHa~30pa npe~JIO:>KeHMH,M3C3 Pecny6JIMKM MOJI~OBa npMHMMaeT

perneHMe 0 nOJIHOM MJIM BpeMeHHOM 3anpem;eHMM Me~MQMHCKoro npMMeHeHM}I

JIeKapCTBeHHoro cpe~CTBa. 0 perneHMM M3C3 Pecny6JIMKM MOMOBa OT~eJI

perMCTpaQMM JIeKapCTB, KJIMHMqeCKOH OQeHKM M cpapMaKOHa~30pa M3Bem;aeT

npOM3BO~MTenJUBJI~eJIbQa pernCTpaQMOHHoro CBM~eTeJIbCTBa (MJIM era

ynOJIHOMOqeHHOrO npe~cTaBMTeJI}l).

3.7. IIo pe3YJIbTaTaM cneQMaJIM3MpOBaHHoH OQeHKM MHcpopMaQMM 0 no6o~bIX

peaKQM}lx OT~eJIOM perMcTpaQMM JIeKapCTB, KJIMHMqeCKOH OQeHKM M

cpapMaKOHa~30pa MO~ 6bITb npeMO:>KeHbI orpaHH:qeHlliI OTHOCMTeJIbHO

Me~MHCKOrO npMMeHeHlliI JIeKapCTBeHHoro cpe~CTBa, a MMeHHO: M3MeHeHlliI

nOKa3aHMH M npOTMBOnOKa3aHMH, YTOqHeHlliI, KOTopbIe BHOCRTCRB MHCTpYKQMIOno

Me~MQMHCKOMY npMMeHeHMIO JIeKapCTBeHHoro cpe~CTBa. 0 npeMO:>KeHHbIX

M3MeHeHIDIX OT~eJI perMCTpaQMM JIeKapCTB, KJIMHH:qeCKOH OQeHKM M

cpapMaKOHa~30pa M3Bem;aeT npOM3BO~MTenJUBJI~eJIbQa perMCTpaQMOHHoro

y~OCTOBepeHlliI (MJIMera ynOJIHOMOqeHHOrO npe~cTaBMTeJI}l).

3.8. CnopHbIe BonpOCbI OTHOCMTeJIbHOMe~MQMHCKOrOnpMMeHeHlliI JIeKapCTBeHHoro

cpe~cTBa npM BbrnBJIeHMM n060qHbIX peaKQMii/~eHcTBMii, KOTopbIe B03HMKaIOT B

npoQecce era Me~MQMHCKOrOnpMMeHeHlliI, paCCMaTpMBaIOTCRB M3C3 Pecny6JIMKMMOJI~OBa.

1. Institutia medicala ..........................Adresa """"""""" ... ...... ......................Serviciul (sectia) ...............................Medicul care a Iacut observatia Telefonul...............................Pacientul (nume, prenume) Nr. fi~eide observatie..............Data internarii Data externarii (pentru pacientii externati) .................................Diagnosticul clinic (de baza, concomitent, complicatii): """"""''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''

2.

3.4.

5........................................................................................................................................................................................."""""""""""""""""""""""""""..................................................................................................................................Istoricul bolii: ................................."""""""""""""""""""""""""""...................................................................................................................................

""""""""""""""""""""""""""".......................

.........................................................................................................................................................................................

.........................................................................................................................................................................................

.........................................................................................................................................................................................

........................................................................................................................................................................................

~

6. Varsta Masa corporala Sexul: M 0 pO7. Originea etnica a pacientului: europeoida 0 negroida 0 mongoloida 0 asiatica 0 araba 08. Debutul efectului advers la medicament: """"'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' (data, luna, anul)9. Data finalizarii efectului advers (daca se cunoa~te): .............................................................................................10. Descrierea efectului advers la medicament (sau la 0 anumita combinatie de medicamente) - debutul,

localizarea, simptomele: .............................................................................................................................................................................................................................................................................................................................................................................................""""""""""""""""""""""""""".................................................................................................................................Severitatea efectului advers:

11. Evolutia efectului advers:0 Vindecare Iara sechele (urmari);0 Vindecare cu sechele (urmari);0 In curs de evolutie;0 Decesul pacientului in rezultatul administrarii medicamentului;0 Decesul -medicamentul a putut contribui la aceasta, sau medicamentul, posibil, a cauzat decesul;0 Decesul - nu este legat de administrarea medicamentului;0 Decesul - cauza decesului nu este clara.

12. Medicamentul (sau medicamentele. combinatiil

U~oara0 Medie 0 Grava 0

".-...

di tat d d fectului ad

Apreciati rolul preparatului suspectat (sau al preparatelor) in aparitia efectului advers:0 cert/sigur (reaqie adversa sigura)0 probabil (reactie adversa probabila)0 posibil (reactie adversa posibiIa)0 putin probabil/dubioasa (reactie adversa improbabiIa)0 conditionat/neclasificat (reactie adversa conditionata/neclasificata)0 neclasificabil/neevaluabil (reactie adversa neevaluabila/neclasificabila)0 e suspecta in producerea efectului advers interactiunea dintre 2 sau mai multe preparate medicamentoase

13. Medicatia concomitenta (nu vor fi enumerate preparatele care au fost indicate pentru coreqia efectului advers):

-- -

<1) Inceputul Sfaritul)(<j tij)(<j "8 --- .tJ administrarii administrarii Maladia sauN .... c<j.- '"

Denumirea produsului, forma 'i:: <1) <1).-'S preparatului preparatului procesul patologic,0.. S .s. )tij

farmaceutica, producatorul, 0 <1) . .tJ 's (dataJlunaJanul) (dataJlunaJanul) care a servit drept-> .::! '2

"'0..::!

utara, seria preparatului cu data 'S u "'0.- c<j

indicatie pentruc<j .9 S <1) Cand nu sunt cunoscute datelefabricarii N c<j ...."'O "'0

administrarea0 N [c<j c<j exacte, se va indica termenul deQ 0 '-" <1)preparatuluiQ "8 administrare a preparatului pana laU

debutul efectului advers

D N S-a determinat repetarea sau

Suspendarea preparatului a fost urmata regresarea A U agravarea efectului advers la DA NU

efectului advers? administrarea repetata a preparatului?

Nu seNu se tie

tie

~

/'

4. HCmOltllUKU nOJlyltellWl U oOMella ullfjJopMal{ueii 0 nOOOltllblXpeaKl{URX/()eiicmoURX JleKapCmoellllblx cpe()cmo U ()pyzux

ljJapMal{eOmUlteCKUX npenapamoo4.1. l1H<pOpMaU;IuI 0 n060qHbIX peaK[(IDIx/.n;eHcTBIDIx JIeKapCTBeHHbIx cpe.n;CTB

nocTynaeT B OT.n;eJI penICTpa[(lIlI JIeKapCTB, KJIlIHlIqeCKOH O[(eHKlI II

<papMaKoHa.n;30pa OT:. BpaqeH II <papMa[(eBTOB Bcex Me.n;lI[(lIHCKlIXyqpe)l()J;eHlIH Pecny6JIlIKlI MOJI.n;OBa,

He3aBlIClIMO OT <pOpM co6CTBeHHOCTlI;

. npolI3Bo.n;lITeJIelllBJIa.n;eJIb[(eB peraCTpa[(lIOHHOro CBlI.n;eTeJIbCTBa lIJIlI lIX

ynOJIHOMOqeHHbIX npe.n;CTaBlITeJIeH;

. ynOJIHOMOqeHHbIX Me)l()J;yHapo.n;HbIX opraHlI3a[(lIH (B03 - BceMlIpHa5I

opraHlI3a[(IDI 3.n;paBooxpaHeHIDI, EC - EBponeHCKoe COO6I[(eCTBOII T. n.);

. Me.n;lI[(lIHCKlIX lIH<popMa[(lIOHHbIX lICTOqHlIKOB II HayqHbIx lI3.n;aHlIH;

. 06I[(eCTBeHHbIX opraHlI3a[(lIH, KOTopbIe npe.n;CTaBmnoT lIHTepeCbI nOTpe6lITeJIeH

JIeKapCTBeHHbIX cpe.n;CTB, a TaIOKe rpa)l()J;aH;

. KOMlICClIlI no BonpocaM 3TlIKlI (BO BpeM5I KJIlIHlIqeCKlIXlIcnbITaHlIHJIeKapCTBeHHbIX cpe.n;CTB). "

4.2. OT.n;eJI perlICTpa[(lIlI JIeKapCTB, KJIlIHlIqeCKOH O[(eHKlI II <papMaKoHa.n;30pa

nOJIyqaeT lIH<popMa[(IIIO 0 n060qHbIX peaK[(IDIxI.n;eHcTBlI5IX JIeKapCTBeHHbIx cpe.n;cTB II

.n;pyrlIx <papMa[(eBTlIqeCKlIX npenapaToB, clIcTeMaTlI3lIpyeT, aHaJIlI3lIpyeT

COOTBeTCTBeHHO C onpe.n;eJIeHIDIMlI, KOTopbIe npe.n;cTaBJIeHbI B nyHKTe 2 .n;aHHoH

I1HCTpYK[(lIlI, II rOTOBlIT lIH<popMa[(lIOHHbIe COO6I[(eHIDI, aHaJIlITlIqeCKlIe 0630pbI, ,

3Kcnpecc-lIH<popMa[(lIIO, MeTo.n;lfqeCKlIe peKOMeH,D;a[(lIlI .n;JI5I BpaqeH, <papMa[(eBTOB,

lICCJIe.n;oBaTeJIeH, npolI3Bo.n;lITeJIelll BJIa.n;eJIb[(eB perlIcTpa[(lIOHHbIX CBlI.n;eTeJIbCTB;

npe.n;JIO)KeHIDI B KOMlICClIIO no JIeKapCTBaM II M3C3 Pecny6JIlIKlI MOJI.n;oBa .n;JI5I

nplIH5ITIDI cooTBeTcTByIOI[(lIX perneHlIH II Mep.

4.3. O~eTbI 0 no.n;03peBaeMbIX cepbe3HbIX n060qHbIX peaK[(IDIX OT.n;eJI perlICTpa[(lIlI

JIeKapCTB, KJIlIHlIqeCKOH O[(eHKlI II <papMaKoHa.n;30pa HanpaBJI5IeT B KOMlICClIIO no

JIeKapCTBaM .n;JI5InplIH5ITIDI COOTBeTCTByIOI[(lIX perneHlIH, 0 KOTOpbIX lI3BeI[(aeTC5I M3C3

Pecny6JIlIKlI MOJI,D;OBa. IIplI Heo6xo.n;lIMOCTlI npe.n;OCTaBJI5IeTC5I COOTBeTCTByIOI[(35I

lIH<popMa[(IDIB B03 qepe3 6IOpO B03 B Pecny6JIlIKe MOJI.n;oBa.

0 putin probabil/dubioasa (reactie adversa improbabila)0 conditionat/necIasificat (reactie adversa conditionata/necIasificata)0 necIasificabiVneevaluabil (reactie adversa neevaluabila/necIasificabila)0 e suspecta in producerea efectului advers interactiunea dintre 2 sau mai multe preparate medicamentoase

13.Medicatiaconcomitenta(nu vorfi enumerateoreDaratelecareau fost indicateDentrucorectiaefectuluiad '

14. Date din anamneza (maladii, stari alergice, alergie medicamentoasa in trecut, afectiuni renale sau hepatice, sarcina,lactatie, regimuri alimentare speciale, deprinderi daunatoare, expuneri la radiatia ionizanta etc.):

,......."""""'"''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''............................................................................................................................

,,-..""''''''''''''''''''''''''''''','''''''''''''''''''''''''''''''''' , "........

, ,: , ... .,.....................

15. Masurile de corectie a efectului advers:0 Anularea preparatului medicamentos0 Reducerea dozei preparatului medicamentos0 Terapie medicamentoasa suplimentara pentru ameliorarea efectului advers aparut, enumerati masurile efectuate ~imedicamentele administrate: ...........................................................................................................................................................................................................

, , ,....................................................

0 Faracorectie0 Anularea terapiei concomitente (indicati ce medicamente au fost anulate): .......................................................................

,.......

, ,...............................................................................

16. Date suplimentare referitoare la efectul advers (cIinice, paracIinice, concentratia medicamentului in sange ~i tesuturi,datele autopsiei in cazul decesului pacientului). Descrieti modificarile patologice, indicand in paranteze valorile normei:

,........................................................................................, ,...........................

, ,

--- , ""'"'''''''''''.'''''''''''''''''''''''''''''''''''''''''''''''''''''''''.................................................17.'"Alte informatii despre preparatul medicamentos suspectat de producerea efectului advers sau despre efectul advers:. A primit bolnavul acest preparat medicamentos anterior? Da Nu Nu se ~tie. A prezentat pacientul reactii identice sau diferite la acest produs? Da Nu Nu se ~tie

Daca Da, atunci indicati ce fel de reactii? "..............................................................................................".................................

......................................................................................................................................................................................................

...................................................................................................................................................................................................... A manifestat pacientul reactii adverse similare la alte medicamente? Da Nu Nu se ~tieDaca Da, atunci la ce medicamente au aparut aceste reactii: ..............................................................................................

""""""""""""""''''''''''''''''''''''''''''''''........................................................................................................................................... A avut bolnavul reactii adverse asemanatoare, care nu au fost cauzate de administrarea medicamentelor?Da Nu Nu se ~tie

Au putut oare alti factori sa influenteze aparitia ~i evolutia efectului advers descris (maladii cronice, de sistem, depen-denta medicamentoasa, factori ai mediului ambiant, radiatia ionizanta, consumul de substante chimice toxice, alergie)?Da Nu Nu se ~tieDaca Da, atunci enumerati: ..................................................................................................................................................

.

,........................................................................................................................

18. Statutul preparatului:0 Preparat autorizat in Republica Moldova. 0 Preparat destinat studiilor cIinice

19. Data indeplinirii fi~eide comunicare: ..........................................................................................................................20. Medicul care a inregistrat efectul advers: N.P. Semnatura: "21. Validareacomunicariide catre ~efulde sectie: ,I I

Expediati fi~a-comunicare la adresa: Sectia "Autorizare medicamente, evaluare clinidi ~i farmacovigilenta"2028 or. Chi~inau, str. Korolenko 2/1, Agentia Medicamentului.Tel.: 73-R7-R6: Tel/fax: 73-70-02: e-mail: nharmacovi!!ilance(@front.ru

. /

>rn "--'Inceputul administrarii

Sfaritul administrarii Maladia sauN ro .- (1)

'1: (1) .-Denumirea Q. .) (1)

preparatuluipreparatului (daca medicatia procesul patologic,

0 [) 'G t;"d.j:! continua,se va lasaspatiu

preparatului i > .-'- ro. (data/luna/anu!) care a servit dreptU"dl: (1) I: liber)

forma farmaceutica ro (1) 0'- "a'S indicatie pentru.....- 8N """d U"d Cand nu sunt cunoscute datele exacte, se va indica0 administrarea

0 8.ro ro'--' termenul de administrare a preparatului preparatului

1.

TIpHJIO)I{eHHeN22

KAPTA-COO/iI1l.EHHE K npHKa3Y M3C3 N2_0T-

0 nOOO'lHbIX peaKu,URX JleKapCm6eHHbIX CpeOCm6 U opyzux papMau,e6mU'leCKUX npenapam06

(OTMeTHTb npaBHJIbHbIH BapHaHT OTBeTa)

Ha3BaHHe Y'lpe)l{)],eHIUI 3)],paBOOXpaHeHHH ....................................................................................................................

AJ],pec ...............................................OT)],eJIeHHe. . .. . ........

Bpa'I, KOTOpbIHnpOBO)],HJIHa6JI1O)],eHHe TeJIe<jJOH...............................

TIaIIHeHT (HMH, <jJaMHJIIUI) N2 HCTOpHH 60JIe3HH ................,1J;aTa nOCTYnJIeHIUI B CTal\HOHap ,1J;aTa BbIllHCKH (eCJIH H3BeCTHO) ........................................KnHHH'IeCKHH )],Ham03 (OCHOBHOH,OCJIO)l{HeHIUI,COnyTcTByromHH) ..........

2.3.4.

5.........................................................................................................................................................................................

........................................................................................................................................................................................

AHaMHe3 3a6oJIeBaHIUI ................................, """"""""""""""""""""""""""".......................

.........................................................................................................................................................................................

.........................................................................................................................................................................................

.........................................................................................................................................................................................6. B03pacT naIIHeHTa Bec TIOJI: M 0 )I{ 07. 3THH'IeCKOenpOHCXO)l{)],eHHe:eBponeHcKoe 0 HerpoH)],HoeD MOHrOJIOH)],HOe0 a3HaTCKoe0 apa6cKoeD8. Ha'IaJIo n060'IHOH peaKIIHH: ()],eHb,MeCHl\,ro)],)9. OKOH'IaHHen060'IHOH peaKIIHH(eCJIHH3BecTHo): ()],eHb,MeCHl\,ro)],)10. OnHcaHHen060'IHOHpeaKl\HH- Ha'IaJIO, JIOKaJIH3al\IUI, CHMnTOMbI: ...............................................

...........................................................................................................................................................................

.........................................................................................................................................................................................

'."""'.""""""""""""""""""""""...............................................................................TH)I{eCTbn060'IHOH peaKIIHH: nerKaH 0 Cpe)],HeH TH)I{eCTH 0

11. TIoCJIe)],cTBHen060'IHOH peaKl\HH(Heo6xo)],HMoenO)],'IepKHYTb):0 BbI3)],opOBJIeHHe6e3 nOCJIe)],cTBHH;0 BbI3)],opOBJIeHHe C nOCJIe)],CTBIUIMH;

0 B npol\ecce pa3BHTIUI;0 CMepTbB pe3YJIbTaTenpHeMa JIeKapCTBeHHorocpe)],cTBa;0 CMepTb, B03MO)l{HO,CBH3aHaC npHeMoMJIeKapCTBeHHorocpe)],cTBa;0 CMepTb He CBH3aHa C npHeMOM JIeKapCTBa;

0 TIpH'IHHa CMepTH HeH3BeCTHa.

TH)I{eJIaH n060'IHaH peaKl\IUI 0

Onpe)],eJIHTe pOJIb nO)],03peBaeMoro npenapaTa (HJIH npenapaTOB) B B03HHKHOBeHHH

0 )],OCTOBepHaHn060'IHaH peaKl\IUI

0 BepOHTHaH n060'IHaH peaKl\IUI

0 B03MO)l{HaHn060'IHaH peaKl\IUI

0 COMHHTeJIbHaHn060'IHaH peaKl\IUI

0 YCJIOBHaHn060'IHaH peaKl\IUI

0 n060'IHaH peaKl\IUI, KOTOpaHHe no)],)],aeTCHKJIaCCH<jJHKal\HH

0 peaKIIHH B3aHMo)],eHcTBIUI2 HJIH HeCKOJIbKHXJIeKapCTBeHHblx cpe)],cTB

n060'IHOH peaKl\HH:

lL. l1HQJopMal\IUI 0 nO)],03peBaeMOM JIeKapCTBeHHOMC e)],CTBeHJIHJIeKapCTBeHHbIX cpe)],CTBax:

ro Ha'IaJIo 3aBepmeHHeM ro ro ga BBe)],eHIUI BBe)],eHHH0 ;:;:I::[ M = TIoKa3aHHH K

Ha3BaHHe npenapaTa,0 (1) (1)I::[ :si I::[ npenapaTa npenapaTa

npHMeHeHHlO<jJapMal\eBTH'IeCKaH <jJopMa,

0.. (1)()],eHb, MeCHl\, ()],eHb, MeCHl\,t::

0 = ro npenapaTa,npOH3BO)],HTeJIb, CTPaHa, [;j :r E-< \0 ro)],) ro)],) KJIHHH'IeCKHH0.. 0 0 0cepIUI H CpOK rO)],HOCTH 0 E-< E-< U Kor)],a HeH3BeCTHbI TO'IHble )],aHHbIe,= u 0 )],HarH03I::[ U ro t::

0 ::r u YKa)l{HTeCpOKnpHeMa npenapaTa )],0B03HHKHOBeHIUIn060'IHOH peaKl\HH

D H 3aMe'IeHO JIH nOBTopeHHe n060'IHOH

A E peaKl\HH nOCJIe nOBTopHoro DA HET

COnpOBO)l{)],aeTcHJIH OTMeHa npenapaTa HC'Ie3HOBeHHeM T Ha3Ha'IeHIUI npenapaTa?

n060'IHOH peaKl\HH? HeH3-

BeCT- HeH3BeCTHO

HO

ANEXA 3la ordinul MSPS nr din

Pacientul

comunidi

COMUNICARE DESPRE EFECTELE ADVERSE ALE MEDICAMENTELOR,

~I ALTOR PRODUSE FARMACEUTICE (KILEN'S FORM)Data

Sexul.0

0

Varsta (ani, luni)Ora;;ul ,................................Raionul Gude!) "...............................Tara ,................................................

MF

Comunicarea a fost primiti'i de la:0 Pacientul sau utilizatorul preparatului medicamentos0 Ruda pacientului0 Medic0 Farmacist

0 Alta specificare ...................

Preparatul medicamentos: ;...............................................................Doza ;;iregimul de administrare: ........Preparatul a fost prescris pentru tratamentul urmatoarei maladii (sau sHiripatologice): ......................

.................................................................................Durata administrarii: (zile)Inceputul administrarii preparatului: (data)Sfar;;ituladministrarii preparatului: (data)

Vreau sa comunic despre urmatoarele efecte adverse(nedorite) la preparat

care au aparut

In timpul Dupaadministrarii administrarea

preparatului preparatului0 0 ..............0 0 .............

0 0 "

.. .... ............

.

Alte preparate medicamentoase, administrate concomitent: ................................................................................................

.....................

.....................

Alte maladii asociate (sau stari patologice), care nu au fost enumerate mai sus: """""""""''''''''''''''''

.......................

.............................

A comunicat reactia: N.P " Tel:.......................................................Adresa: " .. ....

Expediati comunicarea la adresa: Sectia "Autorizare medicamente, evaluare clinica ~ifarmacovigilenta", MD-2028 or. Chi~inau, str. Korolenko 2/1, Agentia Medicamentului.Tel.: 73-87-86; Tellfax: 73-70-02; e-mail: pharmacovigilance@front.ru

13. ConyTCTB)'lOru:Me JIeKapCTBeHHbIe cpe~cTBa (3a MCKJIIO'IeHMeMJIeKapCTBeHHbIx cpe~cTB, Ha3Ha'leHHbIX C D:eJIblO60'lHOH neaKuMM)

14. ,IWyrMe ~aHHbIe aHaMHe3a (3a6oJIeBaHlliI, aJIJIeprlliI, IIe'leHO'lHO-IIO'le'lHaH ~MC<PYHKD:lliI,6epeMeHHocTb, Bpe~HbIeIIpMBbI'IKH, TOKCH'leCKHeXMMH'leCKMeBeru:eCTBa, HOHM3MpYIOru:eeM3JIY'leHHe M~p.)

""""""""""""""""""""""""""".........................................................................................

"""""""""""""""""""""""""""""""""""""""""""""""""""""".........................................................................................

"""""""""""""""""""""""""""...............................................................................................................................................15.CIIOco6bI KOppeKD:HMIIo60'lHOH peaKD:MH:

0 OTMeHaIIO~03peBaeMoro JIeKapCTBeHlloro cpe~CTBa

0 CHll)!(eHMe ~03bI IIO~03peBaeMoro JIeKapCTBeHHoro cpe~CTBa

0 Me~MKaMeHT03HaH TepaIIlliI IIo60'lHOH peaKD:HM(KaKHe JIeKapCTBeHHbIe cpe~CTBa MCIIOJIb30BaJIHCb) ........................................................................................................................................................................................................................."""""""""""""""""""""""""""...............................................................................................................................................00

Ee3 KOppeKD:MM

OTMeHa conyTcTB)'lOru:eH JIeKapCTBeHHOH TepaIIHH (KaKMe JIeKapCTBeHHbIe cpe~CTBa OTMeHeHbI)..................................

""""""""""""""""""""""""""'" """""""""""""""""""""""""""..................................

.....................................................................................................................................................................................................

16. )J;OIIOJIHMTeJIbHbIe~aHHbIe, CBH3aHHbIe C IIo6o'lHOH peaKD:HeH (KJIMHH'leCKMe,JIa60paTopHbIe, peHTreHOJIOrH'leCKMe

HCCJIe~OBaHlliI M ~aHHbIe aYTOIICMM, BKJIJO'IaH oIIpe~eJIeHMe KOHD:eHTpaD:MM JIeKapCTBeHHoro cpe~CTBa B KpOBWTKaHHX,

eCJIH TaKOBbIe eCTb). IIpMBe~MTe IIaTOJIOrH'leCKMe H3MeHeHlliI M IIOKa3aTeJIM HOpMbI M ~aTbI B cKo6Kax):....................................................................................................................................................................................................."""""""""""""""""""""""""""..............................................................................................................................................."""""""""""""""""""""""""""""""""""""""""""""""""""""".........................................................................................

17. HH<popMaD:lliI,KOTOpaHMMeeTOTHorneHHeKIIo~o3peBaeMoMYJIeKapCTBeHHoMYcpe~CTBYMIIo60'lHOHpeaKD:HM:. IIpMHMMaJIJIH 60JIbHOH IIO~03peBaeMoe JIeKapCTBeHHoe cpe~CTBO paHbrne?)J;a HeT HeH3BecTHO. EbillH JIH Y 60JIbHOrO IIo~o6HbIe HJIH ~pyrHe IIo60'lHbIe peaKD:HM, CBH3aHHbIe C IIpMeMOM ~aHHoro JIeKapCTBeHHorocpe~CTBa? )J;a HeT HeM3BeCTHO

ECJIM)J;a, TO KaKMe IIo6o'lHbIe peaKD:MM?............................................................................................................................

.....................................................................................................................................................................................................

.....................................................................................................................................................................................................

......................................................................................................................................................................................................EbillH JIM Y 60JIbHOrO IIo~o6HbIe KJIMHH'leCKMe IIpOHBJIeHlliI IIo60'lHOH peaKD:MM K ~pyrMM JIeKapCTBeHHblMcpe~CTBaM? )J;a HeT HeM3BecTHoECJIM )J;a, TO K KaKMM JIeKapCTBeHHbIM cpe~CTBaM: .............................................................................................................

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