danarti N 21 - pentaximi instr
danarti N 21 - pentaximi instr
danarti N 21 - pentaximi instr
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პრეპარატის გამოყენების ინსტრუქცია<br />
pentaqsimi<br />
PENTAXIM<br />
difteriis, tetanusis, yivanaxvelas (acelularuli, komponenturi),<br />
poliomielitis (inaqtivirebuli) vaqcina (adsorbirebuli) da<br />
HAEMOPHILUS INFLUENZAE tipi b (koniugirebuli) vaqcina<br />
fxvnili da gamxsneli saineqcio xsnarisaTvis Sevsebul SpricSi<br />
bavSvis vaqcinaciamde yuradRebiT gaecaniT am broSuras<br />
• vaqcinaciis cxrilis dasrulebamde SeinaxeT broSura, SesaZlebelia<br />
kvlav dagWirdeT;<br />
• yuradRebiT miyeviT eqimis an eqTanis rCevebs. damatebiTi<br />
informaciisaTvis mimarTeT Tqvens eqims an farmacevts.<br />
• darwmundiT , rom vaqcinaciis kursi mTlianad CautareT Tqvens Svils<br />
, winaaRmdeg SemTxvevaSi srulad daculi ver iqnebiT.<br />
• es vaqcina gamowerilia Tqveni SvilisTvis, ar gadasceT sxvas.<br />
Semadgenloba<br />
aqtiuri nivTierebebi<br />
difteriis toqsoidi . . . . . . . . .≥30 se<br />
tetanusis toqsoidi . . . . . . . . . .≥40 se<br />
Bordetella Pertussis antigenebi:<br />
toqsoidi . . . . . . . . . . . . . . . . . 25 mikrogrami<br />
filementuri hemaglutinini . . . . . 25 mikrogrami<br />
poliomielitis 1 tipis virusi (inaqtivirebuli) 40 DU*†<br />
poliomielitis 2 tipis virusi (inaqtivirebuli) 8 DU*†<br />
poliomielitis 3 tipis virusi (inaqtivirebuli) 32 DU*†<br />
Haemophilus Influenzae b tipis polisaqaridi . . . . . . . . . . . . 10 mikrogrami.<br />
koniugirebuli tetanusis cilasTan
*DU:D – antigenis erTeuli.<br />
erTi doza 0.5ml gaxsnis Semdeg<br />
† an eqvivalenturi antigenuri raodenoba - dadgenilia Sesabamisi<br />
imunoqimiuri meTodebiT.<br />
sxva ingredientebi<br />
saqaroza, trometamoli, aluminis hidroqsidi, henkinis garemo (romelic ar<br />
Seicavs wiTel fenols) ZmarmJava da/an natriumis hidroqsidi pH-is<br />
gasakontroleblad, formaldehidi, fenoqsieTanoli da saineqcio wyali.<br />
savaWro licenziis mflobeli<br />
sanofi pasteri s.a<br />
2 aveniu pont paster, 69007 lioni , safrangeTi<br />
1.ras warmoadgens pentaqsimi da risTvis gamoiyeneba<br />
pentaqsimi warmodgenilia fxvnilis da saineqcio suspenziis saxiT (0.5 ml<br />
Sevsebul SpricSi nemsiT an 0.5 ml Sevsebul SpricSi ori calcalke nemsiT<br />
–kolofSi 1).<br />
pentaqsimi gamoiyeneba 2 Tveze meti asakis bavSvebSi difteriis, tetanusis,<br />
yivanaxvelas, poliomielitis da haemophilus influenzae b tipis baqteriiT<br />
gamowveuli invaziuri infeqciebis (meningiti, sisxlis infeqciebi da a.S.)<br />
profilaqtikisaTvis.<br />
igi ar icavs sxva tipis haemophilus influenzae b –Ti gamowveuli infeqciebisa da<br />
sxva mikroorganizmebiT gamowveuli meningitis ganviTarebisagan.<br />
2. pentaqsimis gamoyenebamde<br />
ar gamoiyenoT pentaqsimi<br />
- Tu bavSvi alergiulia vaqcinis nebismieri komponentis an yivana xvelis<br />
(araujreduli an ujreduli yivana xevala) vaqcinis mimarT, aseve Tu imave
nivTierebis Semcveli vaqcinis ineqciis Semdeg aRiniSneba alergiuli<br />
reaqcia.<br />
- Tu bavSvi daavadebulia progresuli encefalopaTiiT (Tavis tvinis<br />
paTologiuri cvlileba)<br />
-Tu yivana xvelis (araujreduli an ujreduli yivanaxvela) wina vaqciniis<br />
Semdeg 7 dRis manZilze ganuviTarda encefalopaTia (Tavis tvinis<br />
paTologiuri cvlileba).<br />
-Tu bavSvs aReniSneba cxeleba an mwvave daavadeba (vaqcinacia unda<br />
gadaidos)<br />
gansakuTrebuli yuradRebiT gamoiyeneT pentaqsimi<br />
-ar SeiZleba vaqcinis Seyvana intravaskulurad (nemsi ar unda moxvdes<br />
sisxlZarRvSi) da kanSi.<br />
-Tu bavSvs aReniSneba Trombocitopenia , sisxlis Sededebis problemebi,<br />
radgan kunTSi Seyvanisas arsebobs sisxldenis riski.<br />
-Tu bavSvi alergiulia glutaraldehidis, neomicinis, streptomicinis da<br />
polimiqsin B-s mimarT, radgan aRniSnuli nivTierebebi gamoiyeneba<br />
warmoebis procesSi.<br />
- febriluri krunCxvebis arsebobisas, romelic ar iyo dakavSirebuli<br />
vaqcinis wina ineqciasTan, gansakuTrebiT mniSvnelovania temperaturis<br />
kontroli 48 saaTis ganmavlobaSi da regularulad sicxis sawinaaRmdego<br />
mkurnalobis Catareba 48 saaTis ganmavlobaSi.<br />
-Tu vaqcinaciis Semdeg aRiniSneba qvemoT mocemuli movlenebi (sifrTxilea<br />
saWiro yivanaxvelis Semcveli vaqcinis damatebiTi dozis miRebisas):<br />
• cxeleba ≥ 40ºC 48 saaTis ganmavlobaSi , romelic gamowveulia<br />
vaqciniT da ara sxva mizeziT.
• kolafsi an Sokis msgavsi mdgomareoba hipotonuri da hiporeaqtiuli<br />
epizodebiT (energiis daqveiTeba) vaqcinaciis Semdeg 48 saaTis<br />
ganmavlobaSi.<br />
• persistiuli tirili, romelic grZeldeba ≥ 3 saaTi vaqcinaciis Semdeg<br />
48 saaTis ganmavlobaSi.<br />
• krunCxvebi cxelebiT an mis gareSe vaqcinaciidan 3 dRis ganmavlobaSi<br />
-Tu bavSvs aReniSneboda/aReniSneba janmrTelobasTan dakavSirebuli<br />
problemebi an alergiuli reaqciebi, gansakuTrebiT ki pentaqsimis ineqciis<br />
Semdeg.<br />
-Tu tetanusis toqsoidis Semcveli vaqcinis (tetanusis sawinaaRmdego<br />
vaqcina) ineqciis Semdeg bavSvs aReniSna gien baris sindromi (paTologiuri<br />
mgrZnobeloba, dambla) an mxris nevriti (dambla, difuzuri tkivili xelis<br />
da mxaris areSi). aseT SemTxvevaSi eqimi Rebulobs gadawyvetilebas<br />
tetanusis toqsoidis Semcveli vaqcinis damatebiTi dozis miRebaze.<br />
- Tu haemophilus influenzae b tipis Semcveli vaqcinis ineqciis Semdeg bavSvs<br />
ganuviTarda qveda kidurebis SeSupeba aseT SemTxvevaSi ori vaqcinis<br />
difteriis, tetanusis, yivanaxvelas, poliomielitis da koniugirebuli<br />
haemophilus influenzae b tipis vaqcinis ineqcia xdeba or sxvadasxva adgilas da<br />
sxvadasxva dRes.<br />
- Tu bavSvs utardeboda imunosupresuli mkurnaloba an aqvs<br />
imunodeficituri daavadeba, aseT SemTxvevaSi vaqcinis Sedegad gamowveuli<br />
imunuri reaqcia SesaZlebelia daqveiTdes. aseT SemTxvevaSi<br />
rekomendirebulia mkurnalobis dasrulebamde vaqcinaciis gadadeba. Tumca<br />
qronikuli imunodeficitis dros, rogoric aris adamianis<br />
imunodeficituri virusi rekomendirebulia vaqcinaciis Catareba miuxedavad<br />
imisa rom SesaZlebelia antisxeulis reaqcia SezRuduli iyos.<br />
- pentaqsimi ar icavs sxva tipis haemophilus influenzae b –Ti stimulirebuli<br />
infeqciebisa da sxva mikroorganizmebiT gamowveuli meningitis<br />
ganviTarebisagan.
Semavseblebis sia cnobili efeqtiT: formaldehidi<br />
sxva wamlebTan urTierTqmedeba<br />
Tu pentaqsimTan erTad bavSvs unda Cautardes sxva acrac damatebiTi<br />
informaciisaTvis mimarTeT Tqvens eqims an farmacevts.<br />
gTxovT miawodoT Tqvens eqims informacia Tu bavSvi Rebulobs an<br />
Rebulobda sxva, maT Soris receptis gareSe gacemul medikamentebs.<br />
3. petaqsimis gamoyenebis meTodi<br />
dozireba<br />
vaqcinaciis rekomendirebuli sqema zogadad Semdegnairia: pirveli<br />
vaqcinacia tardeba 2 Tvis asakidan, 3 ineqciis saxiT. ineqciebs Soris<br />
intervali Seadgens erT an or Tves. busteruli ineqcia keTdeba 2 wlis<br />
asakSi.<br />
miRebis meTodi:<br />
Tu Sprics ar aqvs nemsi am SemTxvevaSi calke nemsi mWidroT unda<br />
miemagros Sprics erTi meoTxediT SemobrunebiT.<br />
suspenzia mzaddeba Semdegnairad: difteriis, tetanusis, aceluraluri<br />
yivanaxvelas da poliomileitis kombinirebuli vaqcina SehyavT haemophilus<br />
influenzae b tipis koniugirebuli vaqcinis fxvnilis Semcvel flakonSi.<br />
fxvnili unda SeinjRres manamde, sanam igi mTlianad ar gaixsneba.<br />
normaluria Tu suspenzias aqvs daburuli, moTeTro Seferiloba.<br />
vaqcina SehyavT xsnaris momzadebisTanave.<br />
vaqcina keTdeba intramuskulurad.<br />
ineqciis rekomendirebuli adgilia barZayis wina gverdiTi (antero-<br />
lateraluri ) mxare.<br />
pentaqsimi dozis gamotovebis SemTxvevaSi unda ecnobos mkurnal eqims.<br />
4. SesaZlebeli gverdiTi efeqtebi
iseve rogorc sxva samedicino preparatebis SemTxvevaSi, pentaqsimis<br />
gamoyenebisas SesaZlebelia gamovlindes gverdiTi movlenebi.<br />
yvelaze xSirad gavrcelebuli reaqciebia: gaRizianeba, ineqciis adgilze<br />
lokaluri reaqciebi, rogoric aris siwiTle da gamkvriveba 2 sm ze met<br />
adgilze. mocemuli simptomebi Cveulebriv aRiniSneba vaqcinaciidan 48<br />
saaTis ganmavlobaSi da grZledeba 48-72 saaTi. simptomebi spontanurad<br />
qreba, ar saWiroebs specialur mkurnalobas.<br />
fiqsirdeba Semdegi gverdiTi movlenebi:<br />
- eriTema, gamkvriveba, tkivili, siwiTle, SeSupeba ≥ 5 sm ineqciis adgilze,<br />
zogjer sicxe 40ºC temperaturaze zemoT.<br />
- faRaraTi, Rebineba<br />
- madis dakargva<br />
- Zili, krunCxvebi cxelebiT an cxelebis gareSe, hipotonuri da<br />
hiporeaqtiuli epizodebi (hipotonuri- energiis daqveiTeba – hiporeaqtiuli-<br />
cnobierebis daqveiTeba).<br />
- nerviuloba, gaRizianeba, uZiloba an Zilis problemebi, paTologiuri<br />
tirili, xangrZlivi tirili.<br />
- alergiis msgavsi simptomebi: gamonayari kanze, eriTema, urtikaria.<br />
garda amisa haemophilus influenzae b tipis komponentis Semcveli vaqcinis<br />
Seyvanis Semdeg iSviaT SemTxvevaSi SesaZlebelia gamovlindes qveda<br />
kidurebis SeSupeba. aRniSnul reaqcias zogjer Tan axlavs sicxe, tkivili<br />
da tirili. ar axlavs kardio respiratoruli simptomebi.<br />
potenciuri gverdiTi efeqtebi ( mag: ar aris aRniSuli pentaqsimis<br />
SemTxvevaSi Tumca aRiniSneba sxva vaqcinebis SemTxvevaSi, romlebic<br />
Seicaven pentaqsimis erT an ramdenime antigenur komponents)
- gien baris sindromi (paTologiuri mgrZnobeloba, dambla) an mxris<br />
nevriti (dambla, difuzuri tkivili xelis da mxris areSi) tetanusis<br />
Semcveli vaqcinis ineqciis Semdeg.<br />
- SeSupeba >5 sm, SesaZlebelia gavrceldes mTlianad kidurze<br />
acelularuli yivanaxvelis vaqcinis gamoyenebisas. es reaqcia Cveulebriv<br />
vlindeba vaqcinaciidan 24-74 saaTis ganmavlobaSi da qreba 3-5 dReSi. riski<br />
gacilebiT didia meoTxe da mexuTe dozis miRebis Semdeg.<br />
- naadrevad dabadebul CvilebSi (≤28 kvira) vaqcinaciidan 2-3 dRis Semdeg<br />
SesaZlebelia aRiniSnos sunTqis dros Cveulebrivze xangrZlivi Seyovneba.<br />
Tu SeniSnavT nebismier gverdiT movlenas, romelic ar aris aRwerili am<br />
broSuraSi mimarTeT eqims an farmacevts.<br />
5. pentaqsimis Senaxvis pirobebi<br />
SeinaxeT bavSvebisaTvis miuwvdomel adgilze.<br />
SeinaxeT macivarSi (2ºC-8 ºC). ar gayinoT.<br />
ar gamoiyenoT pentaqsimi Tu SeniSnavT uCveulo fers an ucxo nawilakebs.<br />
ar gamoiyenoT kolofze aRniSnuli vadis gasvlis Semdeg.<br />
vargisianobis vada: 3 weli<br />
broSuris damtkicebis TariRi: 04/2009<br />
afTiaqidan gacemis wesi: farmacevtuli produqtis jgufi II – gamoiyeneba<br />
eqimis daniSnulebiT.
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