‘YHATCTBO 3A TTAITHEHTOT 3 Be (orf 201) Tpes ynorpe6a ua szexor sHumaresHo npowwrajre ro ynarcrsoTo | Uysajre ro ynatersoro. MoxeGu xe Tpe6a aa ro npounrare MOBTOpHO. Axo Mare JonoaHHTesIHH npaulatsa, oGparere ce kaj Bammor seKap wan dbapmanent Osoj sek Bute npeniman Bam amsHo m He Tpe6a sa To ZaBaTe Ha ApyrH sa, GuAejKH Mowe 1a HM HAIUTETH /LYPH AKO HUBHHTe CHMMTOMH ce HCTH KaKO Bauiure. Ynarersoro 3a naunentor coapacu Ito npeacrasysa Broncho-Vaxom® i 3a urro ce ynorpe6ysa Lro Mopa a 3Haere, mpey a To ynorpe6ute Broncho-Vaxom® Kako 1a ro ynorpe6ysare Broncho-Vaxom® |. Monn Hecakann tejerea ‘Uysare u pox Ha yrrorpeba na Broncho-Vaxom® 6. Jlonomurennu uidopmanun BRONCHO-VAXOM® 7 mg kantcys1a, rspaa- 3a Bospacun BRONCHO-VAXOM® 3,5 mg xancy.ra, Tapaa - 3a nena JSInopuansnpan Gaxrepuenn ansat Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae u ozaenae, ‘Staphylococcus aureus, Streptococcus pyogenes u viridans, Neisseria catarrhalis * Axrupua cyneranunja : aHoduseupax ausar Ha Gaxrepunre Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae m ozaenae, Staphylococcus aureus, Streptococcus pyogenes u viridans, Neisseria catarrhalis Enna kaneya 3a sospacn coapxu 40 mg amoduzusar exenpaienten Ha 7 mg sModusHsHpan siusar Ha Gakrepit. Enna xancyza 3a nena compas 20 mg no*unusar exsuBamenten Ha 3,5 mg aHocbwnHsHpaH maT a Gaxtepin. + Tomoumnu cynerannu: cxpoS npesxosio reaupax, MarHesHyM, creapar, nponmsranar, Gessonen (F310), HapuyM rnyranar, Maron, (E421), xenaTH, mamHroTHH (E132), THTaHHYM smoxens (E171). Hocures wa ofo6pexmero 3a crasarbe Ha eK BO MpoMeT 3EPHH 100, Cxonje yx. Haponex post 6p.5/3-1 1000 Cxonje P. Maxenonja Tpowssomuren OM PHARMA 22, rue du Bois-du-Lan CH-1217 Meyrin 2 / Geneva Lsajuapuja 1, LITO MPEACTABYBA BRONCHO-VAXOM*® H 3A LITO CE YIIOTPEBYBA - ®apmanestcKa nosupana hopma: Kanicysna Tapa ~ Axtusia cyncranmiija: aModuamaupan sar unre Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella _pneum ae ‘My “o2aehge, Staphylococcus aureus, Sireptococeus pyogenes u viridans, Neisseria cat oN ~ Hann na siejerbo: Broncho-Vaxom®ee eee Broncho-Vaxom® ro norrknysa ox6pamGeHHoT cHcTeM Ha opraHH3MOT H ja 3ronemysa. ornopxocra nporHs HHheKuHHTe Ha MUTE naTHUITA, - TlaxyBase:30 Kancysit Bo nakyBarse. - Tepanestcki HHMKauHH:Broncho-Vaxom" kancyaute ce HaMeHETH 3a ynlorpeba Kaj: TOBTOPYBAuKH MHbexUNH Ha FopHUTe M AONHKTe AMUIKH NaTHUNTA cnpesypaise a rlopTopyBaibe Ha HiIpeKUKH Ha AMMIHHOT cHCTEM akyTeH H XpoHsieH GpoHXICTHC AKYTHH HitbeRTHBH BAOWYBarba Ha cocrojGara Ha xpouuyeH OpouxuT ANTHHG, TOHIMAMTHC, apHATHTHe H AapMHTUTHe (BOCHAMEHME Ha KpajHMLUH, PEO H Tp-O ) punurruc, cinycuTHe H OTHTHC ( BOCTIasIEHHe Ha Hoc, eHHYCH MYBO) MuekuHH KOH He pearupaar Ha Tepanuja co axruGuoruun GakTeplickH KOMAHKANIN Ha BHPYCHM MHKhEKIUAN Ha JUMUHHTe NATHUITa, KAKO H Ha YBO, HOC H pao Broncho-Vaxom" 7 mg kancyamte ce HameHeTu 3a ynotpe6a Kaj Bospacuu, a Broncho-Vaxom® 3,5 mg Kancynure ce HameneTi 3a ynorpeGa Kaj jetta. 2. INTO MOPA JJA 3HAETE, IIPEJ{ JA FO YIOTPEBHTE BRONCHO-VAXOM® Hemojre aa ynorpe6ysate Broncho-Vaxom axo: © cre anepriunu (mpesyscrsurenHH ) Ha aKTHBHATA cyncTaHUa HIM HeKoja om HaseneHuTe NOMOUIHH cynicraHuN HaBeneHH * ako mate axyTHa upesna mibexumja Buaere noceGno punmareann co Broncho-Vaxom® ai © Bo MocHenHUTe 4 HenenH UMaTe MPHMeHO 2KUBa BAKUMNHA NpeKy yora Bo nepHonot on 4 Henemm npen H 4 HeneNH NocKe MpHMarbe Ha %KHBA BAKYHHA MpeKy yera ( nepopamHo ) He eMear a ce semaat Broncho-Vaxom” xancyaH. Mitbopmnpajre ro Baunor AOKTOP AKO BO HIMHNATHTe 4 HesIENM CTE BAKLIMHMPAHH CO °KHBA BAKUKHA HI HMATE TARMpAHO na MIpamare Bo cnemuute 4 Hees. © aoxomxy Bammot aoxrop Ba npenmiiaa apyrn steKoBH, ocoGeHo axrHGuoTHu, He IPECTAHYBajTe CO HMBHO 3aMarbe ‘© He ce mpentopayysa ynorpe6a Ha Broncho-Vaxom® Kaj neuta nomaan om 6 Mecetm nopanH NaspellOcT Ha HHBHHOT HMyHONOUIKH cHCTEM YnorpeSysaie co apyrH steKoBH Be mosmoe sia ro undopwmpate Bamor sekap wm dbapMattent aKo 3emate, HUI AKO HeojaMta cre semaiie Gw:10 Koj {PYF sek, AYPH M OHH KOH He ce Ha AeKapeKM peuent. He ce npujasenn nya Ha uxtepaxuuja Ha Broncho-Vaxom® xaneyaH co pyri s1eKoBH. Kaj wcTospemesa mpxMeta Ha nepopania BaKUMHa MAH AeKoBM KOH TH HaMasypaar on6pamGennte cum Ha opranitsMor ( MMyHOcynpecHBHH sAcKOBH ), e*bextor on Broncho-Vaxon® Kaneysinte Moxke a Gute HaMasien, Ynorep6a na Broncho-Vaxom® co xpana nm co mijaxox To cera we ce nosHarn uxTepaKuuH, Bpemenoer u xoeme Coeemyeajme ce co Bawuom aexap usu dapmayeem nped, cg eS a, a Semaré Broncho- coe Bauimor sekap Ke npoueni stan TpeGa Wa He TpeGa) Gpemeniocr n aoeHe.0 eT | Bpemenocm Hemojre sta semare Broncho-Vaxom® kantcy.1n Bo mpsitre tpi Meceust on Gpemenocra.CurypHara ‘ pena Ha Broncho-Vaxom® 3a speme Ha GpemeHocr He € noKaxKatta. oewe He e nosnaro jam HeKox nes10BH 07 080] eK Ce HSNA4YBAAT MpeKY MajxHHOTO MAeKO. Tlopaan toa Gpemenute xem M sOMAIKHTe Mowe na semaat Broncho-Vaxom® camo Bo nenky4irremHH cory4aH, Banjanne pps cnoco6wocra 3a Boseibe Ha aBTOMOGHA HIM pakyBalbe co MaLNMHME Broncho-Vaxom® Hema snujaime sp3 crocoGHocTa 3a BOsee Ha ABTOMOGHA M paKyBaibe co Baxuu uupopmauun 3a neko cocrapiu KomnonenTH Ha Broncho-Vaxom® Onoj ex compan Harpy rayramar.Opa e TloceGHo BAKHO 3a JIMKA KOM ce Ha KOHTposIMpatia expaa co HaMavieHia KONHMIHHA Ha COM 3. KAKO JIA TO YIIOTPEBYBATE BRONCHO-VAXOM® Crporo mpuapxysajre ce KoH ynarcrsara Ha stekapor.Jlosire He cMeeTe ma rH MeHyBaTe HoH lekyBatbeTo s1a To mpekHHyBate Ge3 1a ce NocoBetysate co BallMoT s1eKap. Joxonky Baumor srexap ne Bu onpenna nontso nosupaite, cxeere ro ynaretsoro 3a yrorpena. BooSmuaca 03a ¢ no esa Karieys1a Ha JH. Bospacnu Jlevene na axyrim mibexninn a ammmnrre nataurra Eqwa xancysia Broncho-Vaxom® on 7 mg Wa jleH 80 TeK Ha 10 70 30 nocnenonaTemHH neHa, 10 Hcuesttynaise Ha cummTomure Ha GosiecTa, Bo ceanure 2 mecewa ce sea NO e/lHA KaNicysla Ha eH BO TeK Ha 10 nlocHenoBaTeHH seHa. Murepsanor nomefy Bara nepHona Tpe6a 1a 6xixe 20 eHa, Toxoaxy ¢ teomxonna ynorpesa ta anrrnOuoriun, ce MperlopayyBa HBHO 3eMatbe Ha MOYCTOK a srewersero. Toarorpajuo severe nan enperypare na nudexunja Esuia kancysta Broncho-Vaxom® on 7 mg Ha eH , Ha THaslHO BO TeK Ha 10 MlocnenoRaTeTHM jeHa cekoj Mece, 80 Tpaeme on 3 wecenm. MitepsazoT nomefy Bava nepwona Ha 3emame Ha Kaneyanre TpeGa sa Gute 20 steHa. Texepantio nenocHa ecpuxactoct on Broncho-Vaxom® 7 mg KancysmTe ce nocrurHysa aKo nesemeTo Tpae 3 Meceu, Aleua Jleveme na axyTan mnibexunn Ha je naTHUTTA Equa kancysia Broncho-Vaxom® on 3,5 mg Ha eH Ha ranHo, 10 HcvesHyBarbe Ha CHMMTOMHTE Ha GosecTa.no TeK Ha HajManky 10 mocaenonatemHH eH. Bo ceKoj om cremunTe 2 mecena ce ema M10 c/1Ha KaNleyiia Ha JeH BO Tek Ha 10 nocHtenoBaTeTHH jeHa. Mirepsasior nomery xBara epvona Ha 3eMaibe Ha KantcyauTe Tpe6a 7a Guze 20 nena. Joxoaxy € neonxonna ynorpeba ta axTHOMOTHIMH, Ce Npenopatyna HNIBHO SeMarbe Ha MOYETOK Ha STeHeRETO. Aoarorpajno aeseme nan cnpesysawse na mubexunja Eqna Kaneya Broncho-Vaxom® om 3,5 mg Ha jeH Ha riaaKo, Bo . steHa ceKoj Mecett , 80 TpaeHe Ha 3 Mee. | Tetepano uenocHa eukacnoct on Broncho-Vaxom* 3,5 mg Ké esereTo Tpae 3 MecentH.— —— Tenepaano Jlevewero sanownysa co sewamse Ha Broncho-Vaxom® kaneymm on 3,5 mg (nena) ua 7 mg ( sospacii ) 80 Tex Ha 30 neHa Kaj aKYTHH MIKpeKUNH M Ce MponOwKyBa YurTe BO ABA epnoma oft to 10 jena Bo cnemHHTe 2 Meceuta. Tomefy aBara nepvona Ha samamwe Ha KancysHTe Mopa aa nwa miTepsan o7 20 neHa Kora He Ce SeMaaT Karicy.tHtTe Hawun ua ynompeba Kancyaute ce seMaat Ha npaseH 2KeayAHHK, eneH Yac Mpen NojaOK, co TeyHocT ( Bona wal, ‘onoilieH cox, miteKo HTH. ). JloKosIKY He Moxere Jia ja nporostTate, Karicysara Moxe Jia ce OTBOPH uM Hejausiara compskuHa sla ce 3eMe CO Te¥HOCT, KAILA HJIK HeMITO CIMYHO. Ako ere semate norotema jt03a 0x Broncho-Vaxom' orKosiky mrro tpe6a ‘Ako cme semane nozoreua dosa 00 Broncho-Vaxom® omKoaxy wumo mpe6a, seduau mpeGa da ce nocosemysame co Bauuom nekap uiu drapmayesm. He e nosHato aH BHCOKH 103M 0 TeKOT MODKAT fla HOBENAT NO TeUIKH HecaKaHH nejcrBa. No cera He ce onMINaHH cnysaH Ha HHTOKCHKauja co Broncho-Vaxom® Axo cre sa6opaniite a semere Broncho-Vaxom® Bemere ja 103ara BEAHAM! H MPOAOMKETE CO 3eMarbE KAKO ITO € MponuulaHO. Ho, ako € cKOpO BpeMe 3a HORA s103a, He ja 3ewajre saGopanenara s103a TYKY MpoOKeTe Co HOpMasIHHOT pHtTaM Ha semarbe. He semajme deojna do3a 3a da ja nadomecmume nponywmenama dosa. Kora aa npecranere co 3emaise Ha Broncho-Vaxom® Baumor nexap ke oapenu Kosky os1ro Mopare sta semare Broncho-Vaxom* Kantcy.ts Hemojre Hukoram camu a ja mpekuHere Tepanujara 11H a ja sromemuTe 203aTa. Axo mpepao mpecranere co 3emarse Ha Broncho-Vaxom® Kancyau, ebexTOT Ha se¥eIe Koj ce MOCTHTHyBa CO KOHTHHYMpaHo 3eMaibe Ha KarIcyaHTe MpeMa YnaTcTBOTO 3a OsMPAKe, HEMa Ja Ce nocrurHe. Fpea sia mpecraitete co semaibe Ha Kanicyaute Broncho-Vaxom® , nocosetysajre ce co Bauinor slexap. 4. MOXKHH HECAKAHH JIESJCTBA Broncho-Vaxom" kancymure ce nlonwecyBaat 06p0, HO KAKO M citTe steKoBHK H Broncho-Vaxom" kafleysiuTe Moxke ja HMaaT HecakaHH JlejcTBa, MaKO Kaj MoroseM Jes ON MALMeHTHTe He ce janysaar, Uecrorara na 1 cakannTe aejeTBa KOH ce japHiTe Bo Tex Ha KAMMHIKIITe cTyAHH GHIA 3-4%. Muory ect wecakann nejeTa Tlosexe on I nanment on 10 ‘Wectar necaxanit nejeTBa 1-10 nanwenr on 100 Tlowanky weet Hecakann nejerBa 1-10 nauseata on 1000 Perk niacakann nejerBa 1-10 nraunenta on 10000 Muory perk Hecaxanm nejersa Tlomanxy om I mannent on 10000 axaysysajkn 3 HSONHPAHH Cay4aH ecru necakann nejersa: npoams, rapoGomka Tomasky vecri Hecaxanit ejcrea:GonKu Bo cromaKor, HanpasHero rpaG;c Bulla, MasHHH, Tloppakatse, OCHTI, er3aHTeM Ht ypTukapHja, OTexKHATO JUIAKE, Kal Perku Hacakani slejersa: noKavena Teslecka TeMmepatypa, aepr 4—_— Muory perku Hecaxann nejcrsa: nypnypa, orexsaro auauieme, aneprija. Vsoampanu caywan: sackyauTue, MAMONaTcKa TpoMGouMToneHuja, ypuKapuja, renepansupana ersautema, Quincke-on elem, aHTMOHeYpOTCKH efleM, TelIKH AapTpanrMH, BNOMIyBaRme Ha cunmroxtne 07, Churg-Strauss-o8 cHHapom, Taxnkapanja, 4yBCTHO Ha cnaGOCT. Tlojasara wa peymarcH GoskH Ha srs0G0BHTE, eHAOKApAMTHe M rnOMepysoHedpuTHe € MHOry Mallky BepojaTia H He e 3aGenexaHa mx 3emarse Ha Broncho-Vaxom® xancysm. HonaTounte on HecaKanitre nejeTHa MOcme CTaBarBe Ha eKOT BO NPOMET BO HIMHHaTHTe 5 TONMHM YKaKYBaaT Ha MHory perka ojana ta ope cocToj6u ( momasia o7 0,001%) Kaj naneHTH KOM semane Broncho- Vaxom” kancysm (o6paGorenn ce okoky 20 MiMIMOHH maNHeHTH ). Tpedynpedyeane Ako TeiIKOTHHTe CO BapelbeTO HH ApyrHTe MpoGneMH Co CHCTeMOT 3a Baperbe HoTpaaT HajMasiky 2 aeHa, seaHa npeKHHeTe co semaibe Ha sleKoT Broncho-Vaxom® Kanicyam # KOHCy.THpajre ce co Bauunor stexap. AKO ce nojanar TeuIKH KoxkH mMpoMerH ( ypruxapyja ) HH BO cay¥aj Ha pecnuparopan npo6semu (ancrHea), BeaHal mpeKuHeTe co semaive Ha sleKoT Broncho-Vaxom? xancyH H Koncy.rrHpajte ce co Baumor eKap, Onnejkn wore na cratyba 3Gop 3a aslepricka peaxiHja. Ako saBenexcume 6uro Kaku necaxanu dejcmea Kou He ce chomenamu 60 06a ynamemso, Be soaume da 20 unbopmupame Bawuom nexap uau dbapmayeem. 5. UYBAIbE H POK HA YIIOTPEBA HA BRONCHO-VAXOM® Flexor ce 4ysa wa Temmeparypa 10 25°C, Bo opHrMHaTHO naKyBarbe. JIEKOT CE 4YBA HA MECTA HEJJOCTATIHH 3A JEUA! Pox Ha ynorpesa Jlexor He emee a ce ynorpeSysa no aryMor Ha HcTeKOT Ha PoKOT Ha ynorpeGa urTo € HaBeseH Ha mlaKyBarbero, He ro yriorpe6ysajre siekor ako cre saGeslearte Sian Ha OMITeTyBarbe HATH APyTH NPOMeH Haun na naaapanbe a aeKot JlexoT ce w3q1aBa camo Ha nexapcKs penent (P). Bpoj m xatym Ha ox0Gpenuero 3a nyurrame 1a nexor no mpomeT Alarys a nocaeana pesnsnja Ha BHaTpeMHoTO ynaTcTBO Mapr 2011 6. JONOJHMTEHK HH®OPMALMEL Kako wsraeaaaar Broncho-Vaxom® kaneyamre m Kako ce nakynani Broncho-Vaxom® 7 mg xanlcyni, ce KaNcyaM TepaH co cHHa HenposHpHa Kana H cHHO HenposHpHO Teo HaMeHETH 3a Mepopartia yrorpea. Broncho-Vaxom* 3,5 mg xancysm, ce KancynH TSpaH co ch HenposHpHo Teno, HaMeHeTH 3a Tlepopasma ynoTpeGa. Tlaxynaitn ce no 30 xancymu (3 PVC/PVDCI//AI Gaucrepa ), Bo X Snénposupid cxana Hn Geno a fm 2%. % Eo Ey Hauun a YHMUITYBaIe Ha eKOTJleKor He eee sta ce Hesppsia Bo oABON HIM AOMaeH ona. Koneyatupajre ce co Bawnor cbapMauest Kako Aa ro ncdpaure s1eKoT Koj Beke Hema na Bu e noTpeGen. Mepkure ke MomorHar 3a SalITHTa Ha OKONMHATA, Axo Bu ce norpeGun zonommurenunt mxbop MonUMe KOHTaKTHpajTe CO HOCHTENOT Ha O06) 3EPMH 100, Cxonje yal, Haponen pout 6p.5/3-1 1000 Cxonje P| Ten 023 115 600 (Makesounja’ era