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II npep,nor :.. 'a'Ha rQf!.f!JHO yn.arcrso PRAZEP;jJyl 1.fiP14"6Ef1AM

I PRAZEPAM/nPA3EnAM
(prazepam)
I Ta6neTV1 OA 10 mg

I npeA ynoTpe6aTa Ha JleKOT BHHMaTeJlHO npO"tHTajTe ro ynaTCTBOTO.

• '-lysajre ro ynarcrsoro. Mo:>Ke6u Ke rpe6a ,aa ro npol.furare nosropHo

II • AKo uMare ,aononHurenHu npawatba, o6parere ce Kaj Bawuor ,aoKTop unu

cjJapM8L(8BT
• Osoj neK Bu e npenuwaH BaM nu'-IHO u He rpe6a ,aa UM ro ,aasare Ha ,apyru

-~
f1UL(8, 6u,aejKU MO:>Ke /1,8 UM H8l1JT8TU ,aypu 8KO HUBHUT8 CUMnTOMU ce UCTU
KaKo Bawure ·

I AKTusHa cyncraHLta eo nPA3EnAM Ta6nenne e npa3enaM .

EAHa Ta6neTa COAP)f(ll1 10 mg n pa3enaM.

I noMowHu cyncraHLtU so ra6nerure: MII1KPOKPII1CTanHa u.enyno3a, naKTo3a

MOHOX111ApaT, KpOCKapMeno3a HaTpll1yM, KOnOB111AOH, MarH93111YM CTeapaT, 6oja

I E 132.

naKyBal-ba: 5poj u ,aaryM.Ha

I peweHuero 38 npoMeT
KYT111ia co 20 Ta6neTII1 OA 10 mg (2 6nii1CTepa).

I ~ lAMe H aApeca Ha npOH3BOAHTeJ10T H HOCHTe11 Ha OA06peHHe 3a CTaBaH::te BO

I npoMeT:
A)J, JAKA 80 PaAOBII1W
npo1113BOAHa noKau,ll1ja: npaoMajcKa 6.6. CKonje

I Peny6n111Ka MaKeAOHII1ja

1. WTO npeTCTaeyea JleKOT nPA3EnAM H 3a WTO ce ynoTpe6yea

I npa3enaMOT cn·ara so rpynaTa Ha 6eH30A111ja3enii1HII1 co AonroTpajHo AejcTso.

l='oj 111Ma aHKCII10nii1TII14KO, Xll1nHOTII14KO, C9AaTII1BHO, M1110penaKCaHTHO 111
aHTII1KOHayn3111BHO AejcTso.

I 0CHOBHOTO A9jCTBO Ha npa3enaMOT e aHKCII10nii1TII14KOTO A9jCTBO- Cy36111Bal-be

Ha nCII1XII14KaTa HanHaTOCT 693 npeAII138111KyBal-be Ha COHnii1BOCT. npa3enaMOT ja
HOpManll13111pa acpeKTII1BHaTa peaKTII1BHOCT, cp11131114KaTa 111 nCII1XII14KaTa

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npep,nor -""£IIj8TpeWHO ynaT,t;.,TBQ PRAZEPAM I nPA3EnAM~.

Toj V1CTO TaKa ce KOpV1CTV1 V1 3a TpeTMaH Ha anCTV1H8Hl.lV1janeH CV1HAPOM KOj Ce

jasysa BO TeK Ha neKyBat-be Ha 3aBV1CHOCT OA anKOXOJl .

I 2. WTO Tpe6a Aa 3HaeTe npeA Aa ro 3eMeTe neKOT nPA3EnAM

•I HeMojTe Aa ro 3eMaTe neKOT nPA3EnAM :

• aKo ere aneprw1HV1 Ha npa3enaM V111V1 APYrV1 6eH30AV1ja3enV1HV1 V11ll-1 Ha
6111110 KOja OA COCTOjKl'!Te HaB9A9HV1 BO OBa ynaTCTBO,
• aKO l'!MaTe noKaYeH OY9H npl-1TV1COK (TeCHOarOJ19H rnayKOM) ,
• aKo l'!Mare rewKa pecnl'lparopHa l-1Hcycpl-1l.ll-1eHUl-1ja.

I blr1AeTe noce6HO BHir1MaTenHir1 CO neKOT nPA3EnAM:

• aKo l'!Mare pecnV1paropHl-1 3a6onysat-ba,
• aKo V1Mare owrerysat-be Ha LlPHl'IOT AP06 ,
• aKo l'IMare owrerysat-be Ha 6y6pe3111re,
• aKO nOCTOV1 aHKCV103Ha COCTOj6a npOCJleAeHa CO AenpeCV1ja ,
• aKo l'IMare MV1jacreHV1ja rpas111c ,
• rpe6a Aa l-136erHysare 3eMat-be Ha 6ap6111rypar111 111 ApyrV1 AenpecopV1 Ha
LlHC Kora npV1Mare npa3enaM ,
• aKo 3eMare Apyrl'lneKOBl-1 (norneAHere so nornasl'lero 3eMatbe Ha
Apyrlr1 neKOBir1).
npa3enaMOT rpe6a nperna31ll-1BO Aa ce Aasa Kaj crap111 , l-13HeMowreHl-11ll-1l.la.
Kaj naul'!eHTl-1 KOl'IWTO npl'!MaaT npeKyMepHV1 A03111 BO nOAOJlr BpeMeHCKl-1
nepl'IOA MO>Ke Aa Ce nojaBV1 cpV13V1YKa 3aBV1CHOCT OA npa3enaM .
npeKV1Hysat-bero Ha repanl'ljara co npa3enaM rpe6a Aa 6l'!Ae nocreneHo, co
P6AYL.lV1pat-be Ha no3ara, noce6Ho Kaj OHV1e naul-1eHTV1 KOl-1 ro ynorpe6ysane
118KOT BO nOAOJlr BpeMeHCKV1 nepl'IOA 6111AejKl-1 HarJlOTO npeKl'IHyBat-be Ha
repan111jara MO>t<e Aa AOBeAe AO nojasa Ha anCTl-1H9Hl.ll-1janHV1 Cl-1MnTOMV1.

Be MOnii1Me Aa ce nocoserysare co AOKTOP 111 roraw Kora ropeHaBeAeHl'!Te

yKa>+<ysat-ba ce OAHecysane Ha Bac 6l-1110 Kora so Ml'!Haroro.

3eMatbe Ha neKOT co xpaHa 1r1n1r1 co n1.1janoK

neKor MO>+<e Aa ce 3eMa co 11111111 6e3 xpaHa.
Tpe6a Aa ce 11136erHysa KOH3yM111pat-be anKoxon AOAeKa ro 3eMar e osoj neK.

opeMeHOCT 1.1 AOetbe

Coaeryaajre ce co Bawuor p,oKTop unu cpapMau.esr npep, p,a 3eMere 6uno

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il npe/l,f!Or - BH8'[PeWHO ypaTf;TBO PRAZEPAM ! nPA3~nAM

B11111jaH111e ep3 cnoco6HocTa 3a eo3etbe Ha aeTOM0611111 11111111 paKyeatbe co

MaWII1HJ.1
np83en8M MO>Ke A8 np9AL-1381-1K8 COH111-1BOCT 1-1 80 T8KOB C11Y48j He Tpe68 A8
B031-1Te 1-1111-1 A8 p8KyB8Te co M8WL-1HI-1.

3eMatbe Ha APYrll1 neKOBII1 (Ha WTO Tpe6a Aa ce BH111Maea aKo ynoTpe6yeaTe

APYrll1 neKOB111)
Be MOflUMe 11.8 ro UHC/JOpMupare 88WUOT J].OKTOp UflU cpapMaLJ,eBT 8KO
3eMare, unu aKo Heo,aaMHa ere 3eMane 6uno KOj ,o.pyr neK, ,aypu u oHue Kou
He ce Ha neKapcKu peu,enr.
Be MOflUMe ,o.a UM8Te BO npe,O.BU,O. ,0.8K8 OBUe YK8)f(YB81-b8 M0)1(8T 11.8 Ce
o,o.Hecyaaar u Ha oHue npenaparu Kou wro ere ru 3eMane BO MUHaroro unu ie
ru 38M8Te BO U,O.HUH8.

I Tpe68 A8 ce l-136e r Hysa l-1crospeMeHa ynorpe6a H8 np83en8M co :

• 8 HTI-1XI-1CT8MI-1HI-1L..I,I-1 ,
• c en8TL-1BI-1 ,

I •
•
Xl-1nHOTI-1L..I,L-1,
onwr1-1 8HeCT6TL-1U.L-1
3apaAL-1 noj8B8 Ha COHJ11-1BOCT 1-1111-1 peCn1-1p8TOpH8 1-1 K8PAI-10B8CKy118pH8

I nenpec1-1j8.
noro11eM1-1 A031-1 Ha np83en8M MO>K8T A8 ro noTeHu,L-1p88T nejcTBOTO H8
aHanreTL-1U.L-1Te 1-1 cenaTI-1BI-1Te .

I 3. KaKo Aa ce 3eMa neKOT

Crporo npu,o.p)f(yaajre ce KOH ynarcTBara Ha ,aoKTopor. /1,o3ure He cMeere ,aa

I ru MeHyaare unu neKyaal-bero ,aa ro npeKuHyaare 6e3 ,aa ce nocoaeryaare co

,O.OKTOp.
,llo31-1p81-bero e 1-1HAL-1BL-1AYa11HO. Boo61-1489H8 A038 38 rpeTMaH H8 8HKCI-103HOCT

I e 20-30 mg (2-3 Ta6Jl9TL-1) AH9BHO KaKO n08AL-1H94H8 ,[],038 H8B949p , 1-1111-1 80

noneneH!-1 A031-1 . K8j norewKI-1 cocroj 61-1 np83en8M MO>Ke na ce nasa no 60 mg
(6 Ta6118TL-1 ) AH8BHO .

I 38 Tp9TM8H Ha anCTI-1H8HL..I,I-1j8Jl9H CI-1H,IlpOM KOj Ce j8sysa BO T9K Ha JleKyBal-be

Ha 38BI-1CHOCT 0,[], 8JlKOXOJl Ce npenopa4yBa A03a OA 10 AO 20 mg (1-2
Ta6nen-1 ), 3 AO 4
naTI-1 Ha ASH.

I Kaj nocrap1r1 1r1 lr13HeMowreHI-1 n8U.Ir19HTir1 , rpeTM8HOT Tpe6a na 3ano4He co

AHSBHa ,[],038 OA 10- 15 mg (1 - 1 % T86Jl8Tir1).
npa3en8MOT Mo>Ke na ro nplr1Maar c8MO B03pacHI-1 HaA 18 rGAL-1Hir1.

Cne,aere ru uHcrpyKu,uure ocBeH aKo Bawuor ,aoKTop He au npenopaLfan

nOUH8Ky.

I He 3a6opaaajre ,aa ro 3eMere neKor.

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 AKO UMare 8n8'-laTOK p,eKa ecj:JeKTOT Ha fl8KOT e npeMHOry C/11fl8H /lffl/11 npeMHOTY
cna6, noco8ery8ajre ce co Bawuor p,oKrop unu cpapMau,e8r.

AKO CTe 3eMane noroneMa A03a OA neKOT OTKOflKY WTO Tpe6a

(npeA03'-1patbe):
AKo ere 3eManelynorpe6une noroneMa p,o3a op, neKor orKOnKy wm rpe6a
88/l,Haw rpe6a p,a ce noC088ry8are co Bawuor p,oKTop unu cj:JapMau,e8r.

Bo cnyYaj Ha np9A03~pat-be MO>K9 Aa ce nojae~ COHJl~BOCT,

36YH9TOCT, KOMa,
I pecn~paropHa ~ KapA~oeacKynapHa Aenpec~ja ,
cManysat-be Ha KPBH~or
np111r111coK. Bo cnyYaj Ha npeA03111pat-be co npa3enaM rpe6a Aa ce no6apa
neKapcKa noMow .

AKo cTe 3a6opaef.1ne Aa ro 3eMere neKOT nPA3EnAM:

3eMere ja nponywreHara ,a.o3a KOnKy wm e MOJKHO no6p3o.
I AKo e pel.f/IIC/11 p,ojp,eHo 8peMeTO 3a 3eMal-be Ha cne,a.Hara p,o3a, nol.feKajre
,a.o,a.eKa p,a p,ojp,e 8peMeTO 3a Mcrara /11 3eMere ja, a npecKOKHere ja

I nponywreHara p,o3a.
HeMojre p,a 3eMare 11.88 11.03/11 80 /IICTO 8peMe.

4. Mo>t<Hif1 HecaKaH..., AejcTea

I KaKO /11 C/11Te fl8K0811, nPA3EnAM MOJKe p,a /liMa HeCaKaH/11 p,ejCT8a.

AKo ce cnyl.f/11 6Mno wm op, p,onyHa8ep,eHoTO, 88/l.Haw npecraHere ·co

I 38Mal-beTO Ha fl8KOT U 3a UCTOTO 88/l,HaW U388CT8T8 ro 8aW/110T P,OKTOp UflU
op,ere 80 ypreHTH..OTO op,p,eneHue 80 Haj6nMcKara 6onHuu,a:

I • oreKysat-be Ha pau,e, cranana, n111u,e, ycH~ ~n~ rpno wro MO>Ke Aa

npeA~3B~Ka rewKor~~ np~ ronrat-be ~n~ A~W~t-be ,

• ~c~n/er3aHTeMa .

I C111re os111e ce MHory cep~o3H~ HecaKaHIIl Aejcrea. AKo ce nojaear Kaj Bac, roa
noKa:>Kysa MHory cep~o3Ha anepr~cKa peaKu,~ja Ha neKor. Bo raKos cnyYaj B~
9 norpe6Ha ~THa M9AMLI,MHCKa nOMOW ~Jll-1 XOCnMTaJlM3au,~ja.

CMT9 OB~e MHOry C9pM03HM H9CaKaH~ A9jCTBa ce MHOry peTKM .

I AKo 3a6eneJKMre HeKou op, cne,a.H/1188 cuMnTOM/11, 88/l,Haw vt38ecrere ro

BaW/IIOT ,D.OKTOp Ufl/11 OP,eTe 80 ypreHTHOTO OP,/1,8fl8Hl18 80 Haj6n/11CKara
6onHuu,a:

I • AenpecMja,
• Ae3opMeHrau,~ja,
• 36yH9TOCT,

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npetJnOr - fj,jj8Tpel11HO yn8TCTBO PfS!'-ZEPAM I nPA3EnAM

C1-ne os111e ce cep11103HII1 HecaKaHII1 ,uejcTBa, 3a KOII1 e norpe6Ha 111THa

MeA111L1,111HCKa nOMOW.

Cep11103HII1Te HecaKaHII1 Aejcrsa ce peTKII1.

U3aecrere ro Bawuor JJ.OKTop aKo 3a6eneJKure:

• COHJ1111BOCT 111 3rDJ18M8Ha ce,uau,111ja,
• rnaso6onKa ,
• sprornas111ua,
• MaJ1aKCaJ10CT,
• ore>+<HaT rosop,
• cysa ycra,
• CTOMa4HII1 np06J18MII1,
• cpu,e6111el-be,
• rpenepel-be Ha HeKoja rpyna Ha MYCKynll1.
C111re os111e ce cna6111 HecaKaHII1 .uejcrsa.

AKo 386eneJKure 6uno K8KBU HeC8K8HU JJ.ejcra8 Kou He ce cnoMeHaru ao OB8

yn8rcrao, Be MonuMe 11.8 ro uHcfJopMupare B8wuor JJ.OKTOP unu cpapM8Uear.

5. "'yeatbe Ha neKoT
na ce 4yBa Ha TeMneparypa AO 25° C, 3aWTII1T8HO OA CB8TJ1111Ha.
flEKOT AA CE "'YBA HA MECTA HEAOCTAnH~ 3A AEUA!

PoK Ha ynoTpe6a
fleKor He cMee P.a ce ynorpe6yaa no JJ.8TyMor Ha ucreKor H8 poKor H8
ynorpe68 wro e H8BeJJ.eH H8 KyTUj8ra u H8 6nucrepor.

Ha~I.1H Ha 1.13AaBatbe Ha 118KOT

n eKor ce 1113,uasa caMo sp3 ocHosa Ha peuem.

AaryM Ha nocneAHa pee1.1 31.1ja Ha eHarpewHOTo ynarcreo

8H8TpeWHOTO ynaTCTBO e OP,06peHO H8 .. .... ....... ...... .... ..... .

CKonje, cpespyap111, 2008 r.