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Procox

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Procox

  1. 1. yTBBPmB/ xw- SaMCCTHTCIIL PyKQBÇHl/ ITCJIH ; Poccen 511031121330112": 11.71.31. ? S OATQJAJ? B I/ IHCTPYKLII/ UI 5 no npnMeHeHnm HpoxoKca® np14 1-1eMaTo11o3ax 14 1<o1<u111114o3e y coõax (oprannsauna-paspaõomnk: KoMnaHm «Bayer Animal Health GmbH», FepMaHuH) LOBHII/ IE CBEILEHI/ Ifl 1. ToproBoe HaHMeHOBaHBe neKapcTBeHHoro npenapaTa: l'lpo1co1cc® (Procox®). Mexcnynaponnoe HenaTeHroBaHHoe HaBMeHoBaHue: 3Mo11enc14n 14 'romrpa3yp1411. 2. . TIeKapcTBeHHaa (popMa: cycr1e1-13ua 111151 opanbnoro np14Me11eH14a. HpoKoxc® B 1 M11 B KaqecTBe neñcrByromnx BemecTB conepxcnr 3Mo11er1c1411 - 0,9 Mr 14 Tonrpasypm - 18,0 Mr, a Ta1o1<e BCHOMOFaTCJIBHBIC BemecTBa: õyrunrnnpoxcnronyon - 0,9 Mr, cop6nHoBy1o Kncnory - 0,7 Mr, rnnuepnna 11146ere1~1aT - 31, 5 Mr 14 paqmBBpoBaHHoe nonconneqnoe Mac11o 11o - 1 M11. Ho BHemHeMy B1411y npenapaT npencraBnaer 0060171 cycne113111o or 6e11oro 11o xcenroro uBeTa. BB1r1yc1<a1oT HpOKOKC® pacqmcoBaHHmM no 7,5 M11 14 20 M11 Bo qmaKoHax TeMHoro cTe1<11a cooTBercTBymmeü BMecTnMocTB c no11143T1411eHoBB1M anarrrepoM 14 xpmmxoü, cBaõmeHHoñ npncnocoõneunem 111111 3au114TB1 0T nereü, yIIaKOBaHHBIC nomryuno B KapTOHHLIe 1copoõ1u4. 3. XpaHaT Hpoxoxc B saxpsrroü yna1<oB1<e npo143Bo1114Te11a, B cyxoM, 3a11114111e1111oM 0T HpJIMBlX conBeqHmx nyqeü Mecre, oT11e11BHo 0T nponyKroB nuranua 11 KOpMOB, 11p14 TeMnepaType 0T 0°C 11o 25°C. 4. CpOK 10111100114 11e1<apcTBeH11oro npenapaTa np14 co6111o11e111414 ycnoBBü xpanenw¡ B saxpmroñ ynaKoBKe npo143Bo1114Te1v1 - 3 ro11a co 11H11 npo143Bo11cTBa, nocne nepBoro BCKpLITI/ IH cpnaKoHa -10 He11e11B. 3anpe111aeTcs1 11p14MeBe1114e npenapara Hp0KOKC® no 11cTet1e111414 cpoxa ro1111ocT14. 5. l'lpo1co1cc® c11e11yeT xpaHmB B Mectax, Henocrynnmx 111111 nereü. 6. HencnonbaoBannuñ nexapcrBennmü npenapaT ymnnanpyro-r B cooTBercTB1414 c Tpe6oBaH14aM14 aaxonozxarenscrBa. ® II. CDAPMAKOJIOFI/ IÍIECKI/ IE CBOÍ/ ÍCTBA 7. l'Ipo1<o1<c oTHocHTcx 1< rpyrme KoM6141114poBaHHB1x npotusonapasnrapurax JleKapCTBeHHbIX npenapaToB. Bxo11s111114e B COCTaB npenapaTa neücTBywmne BCHICCTBa oõecneqnnamr em 11114po1<14ü cneKrp nporuBonapasnrapnoro 11eñcTB14z B omomennn Bo3õy1114Te11e171 BeMaTono3oB 11 Ko1<11141114o3a coõax. 3Mo11encv111 - nonycnnremuecxoe coe111111e1114e rpynnm nencunenmnoB, o611a11ae1' BB1pa›1<e11111,1M14 HeMaroBounnHmMn cBoücTBaMH. O1<a3B1Ba›1 cT14My1114py1o111ee neñcrsne 11a npec1411anr14t1ec1<14e 11a1croqn111BHB1e peuemopu, BBIBBIBaCT napa1114t1 14 r146e11B 11apa314Ta. Bqacpercmnen B oT1-1o111e1-11411 HCMaTOJI, napa314mpy1o1u14x y coõaK, B ®
  2. 2. TOM 11140110 Toxocara canis ( nonoB03p011B1e, 1101101I0B03p011110 000611 14 1111111411101 L4), Uncinaria stenocephala (no110Bo3p011B10 000614), Ancylostoma caninum 14 Tríhurís vulpis (r1011oBo3p011BIe 0co614). T0111pa3yp1411 - np0143B0111100 1p14a31411o11a 0611a11a01 BB1pa›Ke11111,1M14 1<o1<11141114011111111B1Mu CBOÍÍCTBaMH. E1101<14py›1 111,1xa10111›111,1e tpepM0111L1 KOKIII/ IJII/ IÍ/ Í, 01<a31›1Bae1 11oBpe›1<11a1011100 11014013140 11a M1410xo1111p1414 11 r1p011ec0B1 11011011141 xnpa 1<01<11111114171, Hapymaa npouecc qmpMnpoBaHBa Ma1<p0raM01o111410B. 911111101011411011 B 011101110111414 Bcex BHy1p141<11010=111B1x 01mm¡ pa3B14114›1 11apa314114py1011114x y 006a1< 1<01<11141114171. 1100110 nepopanbnoro 33011011112 r1p0r1apa1a 311101101101411 6B101p0 BcacB1Ba01c51 B >1<011y11o1111o-1<141n0r1110M 1pa1cre, 11001141011 MaKcuManBHoñ K011110111pa111411 B KpOBH =10p03 2 qaca, r1po11111(a0r B 0pra11B1 14 11<a1114, 00311aBaa 11a14601100 551001040 1<011110111pa111414 B ›1<11p0Bo1'4 11<a1114, BB1B0111410a 143 0pra111431~1a B 110143Me11e11110ñ qaopMe 14 B B14110 r1411p01<c141114p0Ba1111B1x r1p0143B0n11B1x, rnaB11B1M o6pa3oM 0 (ÍICKaJII/ IHMH. Tompaaypnn, Me111101111o BCaCBIBíiSICB B ›1<0J1y11or111o-1<14111eq110M 1pa1cr0, oKa3B1Bae1 1<01<1114111401111111100 11014013140 11a 0111431401014 14 1101101114314010171 06o110t11<ax, BB1B011111c11 143 0pra11143Ma B 110143M011e11110í4 tpopMe 11 B1411e Me1a60111410B (oc110B110171 M01a6o11141 - 1o111pa3yp1111a cy11Bqao11) 0 q1e1<a1114s1MH 14 11ac114I1110 c M0t1o171. Hpo1<01<c® 110 0101101114 B03110ñ01B1v1 11a 0pra11143M 01110014101; K B0111001BaM «MaJTOOHaCHBIM» (4 1<11acc 0r1a011oc111 110 FOCT 12.l.0O7-76), 110 01<a3B1Ba01 M001110- pa311pa>1<a101110ro, 3M6p140101<014=1e01<0r0, 10pa10re11110r0, My1ar011110r0 14 ce110146141114314py101110r0 110ñ01B1451. l'Ipe11apa1 1o1<c14=1011 111111 pB16 14 11pyr14x r1111po614o111oB. III. HOPHZIOK HPI/ IMEHEHI/ IH 8. Hp01<o1<0 1121311003101 B3po0111›1M 006a1<aM 14 1110111<aM 0 2-11011011111010 Bo3pa01a 0 1101106110171 14 np0qn411a1<1w1001<0171 11011B10 11p14 11apa3141ap11B1x 1111Ba31451x, BBI3Bal-IHBIX He1ua1o11aM11 14 1<01<11111114aM11 c11011y1o11114x B14110B: ® 110Ma1011B1 (KpyFJIBIC I10pB14): - T oxocara canis (110110B03pe11B10 000614, HCHOJIOBOSpCJTBIC 000614, 1114111411104 L4); - Uncinaria stenocephala (nonoBo3p011B10 000614); - Ancylostoma caninum (110:10Bo3p0111›1e 000614); - T richuris vulpis (no110Bo3p011B10 000611); 1<o1<1114,11111: - Isospora ohioensis, Isospora burrowsi, Isospora neorívolt, Isospora canis. 9. Hp0114B01101<a3a11140M 1( 11p14M0110111410 11331101051 14111114B1411ya11111aB HOBLIHICHHaH 11yBc1B141e11B11001B >1<14B0111or0 1( 1<0M110110111aM np0r1apa1a, BB1pa›1<01111B10 11apy111e11m1 (byHKLmñ 1101101114 14/141114 11011010 H0 011e11y01 np14M011a1B Hp01<01<c® u10111<a1s1 Maccoü M01100 0,4 K1" 14 B B03pa010 11o 2 110110111, ÕepCMCHHLIM, a 1a1o1<0 1<0pMs1L1111M CaMKaM 110pBB10 11Be 1101101111 11a1<1a111414, U10111<aM 60610171110, 1<0111114, 111011114 11 po1101B01111B1x 110p011, B 0311314 0 14x r10BB1u101111o171 'íyBCTBHTCIIBI-IOCTbw 1( 3M01101101411y np14 11006xo11141u00114 npenapar npnM011a101 no11 K0111p0110M 110t1a1110r0 Be1ep1411ap110ro Bpaqa.
  3. 3. 10. Hp0KOKC® np14Me1m1oT coõaKaM unmmnnyanbno nepopanbno, o1111o1<paTHo B M14H14Ma11BHoí4 'repaneBTnqecKoü no36 0,5 Mn/ Kr Maccm ›1<14BoTHoro (BKBI/ IBQJICHTHO 0,45 Mr aMonencnna 14 9 Mr ro111pa3yp1411a Ha 1 1<r Macca), c 11oMo111B1o 11111p1411a onaopaaonoro 14c11o11B3oBaH14a. l'Iepe11 np14MeHe1-114eM cycne113141o B0 qmaKoHe cnenyeT xopo11Io 13360111415. , E1111 oõecueqennn Heoõxommoñ , uo314poBK14 coõaKaM Maccoñ 11o 4 xr 14c11o11B3y1oT 111np1411B1 c rpanauueñ 0,1 M11, 111151 co6a1< Maccoñ õonee 4 Kr - c rpanauneñ 0,5 M11. OT1<pyT14B 1<p1›11111<y 14 BcTaB14B 11oc141< 111r1p1411a B ropnBnnKo qmakona, cnenyer Bamoumr, apnaxon 14 143B11e=4B cycnermno B OÕLCMC, paccqmaHHoM 14a Maccy xmBoTHoro, 3aTeM B03BpaTPITL qmaKoH B Bepmxanbnoe nonoxceune 14 TOJIBKO nocne 31010 143B11et1L 111r1p1411 14 3a1<pB1TB qmaKoH xpmnncoñ. Ha›1<14Mas1 1-1a 11op111eHB 11111p1411a, BBCCTPI 11e1<apcTBe11HB1ñ npenapar B poToBy1o HOJIOCTB co6a1<14. HoBTopHoe 14c11o11B3oBaH14e 11111p1411a He nonycxaerca, ero yT141114314py1oT c 6B1ToBB1M14 orxonaMn. PeKOMeHByeMBIe 110351 l'Ipo1<o1<ca B 3aB14c14MocT14 or Macca¡ co6a1<14 11p14Be11e11B1 B raõnnue: [[033, M11 Macca co6a1<14, I[o3a, M11 xr Macca co6a1c14, 1a" 0 íí É _í ; í : í , >l0 + 0,5 MJ'I Ha 1<a›1<111.1ñ UOCIIGIIYIOIIIHP¡ K1* MaCCBI HpOKOKC® HC yCTpaI-IXCT KJIHHI/ HCCKPIC CHMHTOMBI 1<o1<11141114o3a, B CBHSI/ I C STI/ IM HPI/ I Bupaxcenuux KJTHHPFICCKPIX r1p1431-1a1<ax saõoneBanm MHBOTHOMy , IIOIIOIIHHTCJIBHO Ha3Ha'-IaIOT CPCJICTBH CHMHTOMBTPIHCCKOÊ PI naroreuermecxoñ Tepan1414. B [ICIIHX 11pe11y HpCXUlCHI/ IX IIOBTOPHOFO SÉIPEDKCHPIX ? KHBOTHBIX HCOÕXOJII/ IMO HpOBeÃCHl/ IC CaHHTapHO-FI/ IFHCHI/ ILICCKIIIC MCPOIIPHHTPIH B MeCTaX PIX co11ep›1<a1114›1. ll. Hp14 nepeaoanpoBxe npenapara y ›1<14Bor1~1oro MO>KCT Ha6111o11aTBca yrBeTeHHoe cocToBHne, oT1<a3 OT 1<opMa, ›1<14111<14ñ cTy11, pBOTa. 12. OcoõeHHocTeñ 11e14cTB14a 11e1<apcTBe11Horo npenapaTa np14 1'1epBoM np14eMe 141114 r1p14 ero oTMeHe He BBmBneHo. 13. Hpenapar np14MeHx1oT coõaxaM o1111o1<paTHo. 111m 11ocT14›1<eH1411 Ma1<c14Ma11BHoro npotpunaxrnqecxoro sqnpercra 14 c1114›1<e1114s1 1<o1114r1ecTBa 00111401, BB111e11aeMB1x BO BHe111111o1o cpeny, B Heõnarononyquux 11o 1<o1<11141114o3y 11141oM11141<ax 3
  4. 4. (11p141o1ax) Hp01<01<c® 14e11e11B14or0 Bospacra. 14. Ho601414B1x 51B11e14141f1 14 001102040111111 y ›1<14B01111›1x np11 r1p14Me14e141414 Hpoxoxca B co01Be1c1B1414 c Hac-roxmeñ 1414c1py1<1114e171, 1<a1< 11paB14110, 14e 11aõ111011ae1c11. Y 11e1<010pB1x coõax B03M0>KHLI 14apy111e1114a pa6011.1 ›1<e11y110t111o-1<14111e|1110r0 1pa1cra 01041110414 c1y11, pBora), x01opB1e 14c11e3a1o1 caM011po113B011B11o 14 14e 1pe6y1o1 11p14Me14e1111a 11e1<apc113e1111B1x cpe11c1B. 15. l'Ip01<01<c® 14e c11e11ye1 11p14Me14x1B c0BMec1140 c 14BepMe1<11114oM 14 11pyr11M14 Ma1<p011141<111411ec1<11M11 11a1<1014aM11, a 1a101<e c 3p111poM141114H0M, 11pe1111113011o14oM 14 11141010c11op1414aM11, Bc11e11c1B11e 130311401111010 B3a14M1-1or0 yc1411e1414a 101<c14t1ec1<oro 11e171c1B14›1. CJIClIyCT 14a311aI1a1B BCCM BHOBL IIOCTYIIPIBIIIHM ? KHBOTHLIM C 2- 16. Hp01<o1<c® 14e r1pe1114a314at1e14 111m 11p14Me14e1411s1 11po11y1<111B11L1M11 ›1<11B0114B1M. IV. MEPbI JTI/ IIIHOÍ/ Í IIPOdJI/ IJIAKTI/ IKI/ I 17. IIp11 paõ01e c Hp01<o1<c0M c11e11ye1 coõ111o11a1B 0611111e 11paB1111a 11144110171 r14r11e1-1B1 14 'rex14141c14 6e30r1ac11oc114, 11pe11ycMor1pe14HB1e 11p11 pa601e c 11e1<apc1Be1411B1M14 cpe11c1BaM14. Bo BpeMa pa601B1 3ar1pe111ae1cs1 1<yp1111›, 111415 11 11p141414Ma1B r114111y. Ho o1<o14=1a111114 pa601B1py1<11 cne11ye1 1111a1e11B110 3511111411. py1<14 c MBmoM. 18. Hp11 c11yt1añ140M 1<o111a1cre 11e1<apc1Be14140ro 11pe11apa1a c Koxceü 141111 c1111311c1B1M11 060J10I11caM11 111a3, 11x 11e0õx01111Mo 11p0MB11B 6o11B11114M 1<o111411ec1BoM 3011141. H1011aM c r1111ep=1yBc1B141e11B140c1B1o 1< 1<oM11014e141aM 11pe11apa1a c11e11ye1 113õera11. 11ps1M0r0 1<o141a1<1a c r1pe11apa1oM Hp01<o1<c®. B cnyqae 110›1BJ1e1414s1 a1111epr1411ec1<14x pea1<1111171 141111 r1p11 c11y=1añ14oM 11011a11a111111 nper1apa1a B oprannaM qe11oBe1<a c11e11ye1 14eMe1111e14110 06pa1141Bcs1 B Me1111111414c1<0e yqpemzzenne (r1p11 ceõe 11Me1B 1111c1py1<11141o 110 r1p14Me14e11141o 11pe11apa1a 141111 31111<e11<y). 19. HycTBIe q›11a1<o14r.1 113-11011 11e1<apc1Be14140r0 11penapa1a 11 111r1p1411B13a11pe111ae1cs1 14c11o11B3oBa11. 111111 õmonmx 11e11eñ, 01414 1101111e›1<a1 y11411143a111414 c 6B11oBB1M14 01x011aM11. 20. 0pra14143a1114a-11po14313o11111e11B 1<oMr1a1111B «Bayer Animal Health GmbH»; KVP Pharma + Veterinaer Produkte GmbH; Projensdorfer str. 324, D-24106 Kiel (FepMaHm). I/ I14c1py1u111a paapaõorana 1<0M11a1111ei4 «Bayer Animal Health GmbH» (Kaiser- Wilhelm-Allee 50, 51373, Germany) c0BMec111o c 3AO «Baüep» (123022, MOCKBa, B. Tpexr0p1-1B1ü nep. , 11.1, c1p. l) . Pe1<0Me14110Ba14o 1( per14c1pa111114 B Poccuñcxoñ <De11epa111411 CDFBY «BFHKI/ I» HoMep per14c1pa111401-1140ro y110c1oBepeH14a

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