FrancophonIA/ELRC3.0 huggingface dataset:
English: Official batch release: in accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: Uradna sprostitev serije: v skladu s členom 114 Direktive 2001/83/ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: The 3-5-12 month schedule was not evaluated.
Slovenian: Shema 3., 5., 12. mesec ni bila ovrednotena.
English: Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Slovenian: Vsako neuporabljeno cepivo ali odpadni material je potrebno zavreči v skladu z lokalnimi predpisi.
English: For this reason, the vaccinee should remain under medical supervision for at least 30 minutes.
Slovenian: Zaradi tega mora biti otrok po cepljenju še vsaj 30 minut pod zdravniškim nadzorom.
English: The reconstituted vaccine is a homogeneous turbid white suspension.
Slovenian: Rekonstituirano cepivo je homogena motna bela suspenzija.
English: • if your child has a severe infection with a high temperature (over 38°C).
Slovenian: • če ima vaš otrok hudo okužbo z zvišano telesno temperaturo (nad 38 ºC).
English: In these cases, the vaccination will be postponed until your child has recovered.
Slovenian: V takšnih primerih se bo cepljenje odložilo dokler vaš otrok ne bo ozdravel.
English: Frequencies are reported as: Very common:
Slovenian: Pogostnost je prikazana kot: Zelo pogosti:
English: Signs of the disease may not be seen for 6 weeks to 6 months after infection.
Slovenian: Bolezenski znaki se lahko pojavijo šele 6 tednov do 6 mesecev po okužbi.
English: However the stability has been demonstrated for 8 hours at 25°C after reconstitution.
Slovenian: Po rekonstituciji je bila sicer dokazana 8-urna stabilnost pri temperaturi 25 ºC.
English: HIB infection also causes inflammation of the throat.
Slovenian: Okužba s HIB povzroči tudi vnetje grla.
English: The vaccine works by causing the body to produce its own protection (antibodies) against these infectious diseases.
Slovenian: Cepivo deluje tako, da v telesu spodbudi ustvarjanje lastne zaščite (protiteles) proti tem nalezljivim boleznim.
English: Other tests should be performed in order to confirm HIB infection during this period.
Slovenian: V tem času je za potrditev okužbe s HIB potrebno uporabiti druge teste.
English: In the following cases, your doctor can determine the right time and scheme of vaccination for your child. Tell your doctor:
Slovenian: V naslednjih primerih lahko vaš zdravnik določi ustrezen čas in shemo cepljenja za vašega otroka.
English: However, you should seek immediate treatment in any event.
Slovenian: V katerem koli primeru morate nemudoma poiskati zdravniško pomoč.
English: 4.7 Effects on ability to drive and use machines Not relevant.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Navedba smiselno ni potrebna.
English: If your child misses the visit scheduled for the second or third injection, talk to your doctor and arrange another visit as soon as possible.
Slovenian: Če vaš otrok ni prejel drugega ali tretjega odmerka po načrtovani shemi, se pogovorite z zdravnikom in dogovorite za drug obisk takoj, ko je to možno.
English: • Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause.
Slovenian: • Zvišana telesna temperatura ≥ 40,0 ºC v 48 urah, ki ji ni možno pripisati drugega vzroka.
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
Slovenian: • Kolaps ali šoku podobno stanje (hipotonična-hiporesponzivna epizoda) v 48 urah.
English: If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: But some people, particularly children, who may not have shown signs of the disease can remain infected.
Slovenian: Vendar pa posamezniki, predvsem otroci, lahko ne kažejo bolezenskih znakov, ostanejo pa okuženi.
English: Adverse reactions are listed below.
Slovenian: Neželene reakcije so navedene v nadaljevanju.
English: • if your child is taking any other medicine or has recently received any other vaccine.
Slovenian: • če vaš otrok dobiva katero koli drugo zdravilo ali pa je pred kratkim prejel katero koli drugo cepivo.
English: You will be informed by the doctor or nurse when you should come back for subsequent injections.
Slovenian: Zdravnik ali sestra vam bosta naročila, kdaj morate priti po naslednje odmerke.
English: • Induration (hard lump)
Slovenian: • induracija (čvrsta oteklina)
English: Any vaccine can have some side effects.
Slovenian: Katero koli cepivo ima lahko nekatere neželene učinke.
English: The doctor or nurse will give Quintanrix as an injection into the muscle.
Slovenian: Zdravnik ali medicinska sestra bo dal/dala cepivo Quintanrix v obliki injekcije v mišico.
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code JO7CA10
Slovenian: Farmakoterapevtska skupina: Kombinacije bakterijskih in virusnih cepiv, Oznaka ATC: JO7CA10
English: Quintanrix is available in the following pack sizes:
Slovenian: Cepivo Quintanrix je na voljo v naslednjih velikostih pakiranja:
English: As Quintanrix is not intended for use in adults, information on the safety of the vaccine when used during pregnancy or lactation is not available.
Slovenian: Ker cepivo Quintanrix ni predvideno za uporabo pri odraslih, podatki o varnosti uporabe cepiva med nosečnostjo ali dojenjem niso na voljo.
English: In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti se rekonstituirano cepivo Quintanrix ne sme mešati z drugimi zdravili.
English: Inactivated Bordetella pertussis 2
Slovenian: Inaktivirana bakterija Bordetella pertussis2
English: The use of Quintanrix should be determined on the basis of official recommendations.
Slovenian: Cepivo Quintanrix je potrebno uporabljati na osnovi uradnih priporočil.
English: Since the capsular polysaccharide antigen is excreted in the urine a positive urine antigen test can be observed within 1-2 weeks following vaccination.
Slovenian: Ker se kapsularni polisaharidni antigen izloča z urinom, so rezultati testov za odkrivanje antigena v urinu od 1 do 2 tednov po cepljenju lahko pozitivni.
English: Powder and suspension for suspension for injection 1 Vial: Powder
Slovenian: Prašek in suspenzija za pripravo suspenzije za injiciranje 1 viala: prašek
English: As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.
Slovenian: Tako kot pri drugih cepivih, je potrebno odmerek cepiva odvzeti v striktnih aseptičnih pogojih in paziti, da ne pride do kontaminacije vsebine.
English: This may require separate administration of hepatitis B vaccine and should follow official recommendations.
Slovenian: Ukrepi lahko tako terjajo ločeno cepljenje s cepivom proti hepatitisu B, biti pa morajo v skladu z uradnimi priporočili.
English: • Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
Slovenian: • Stalen, neutolažljiv jok, ki traja ≥ 3 ure in se pojavi v 48 urah.
English: They may be extremely tired, and have dark urine, pale faces, yellowish skin and/or eyes (jaundice), and other signs of the disease possibly requiring hospitalisation.
Slovenian: Ti ljudje so lahko zelo utrujeni, imajo temen urin, svetlo blato, rumenkasto kožo in/ali oči (zlatenica) in druge bolezenske znake zaradi katerih je lahko potreben sprejem v bolnišnico.
English: not less than 30 International Units
Slovenian: ne manj kot 30 mednarodnih enot
English: Do not be alarmed by this list of possible side effects.
Slovenian: Naj vas ta seznam neželenih učinkov ne prestraši.
English: not less than 4 International Units
Slovenian: ne manj kot 4 mednarodne enote
English: Do not use after the expiry date stated on the pack.
Slovenian: Cepiva ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Your child will receive a total of three injections with an interval of at least one month between each one.
Slovenian: Vaš otrok bo prejel skupaj tri odmerke z vsaj enomesečnim vmesnim presledkom.
English: WHAT QUINTANRIX IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE CEPIVO QUINTANRIX IN ZA KAJ GA UPORABLJAMO
English: No preclinical safety testing with the vaccine has been conducted.
Slovenian: Predklinične študije o varnosti cepiva niso bile izvedene.
English: The primary vaccination schedule consists of three doses of 0.5 ml to be administered at intervals of at least 4 weeks within the first six months of life in accordance with local official recommendations.
Slovenian: Shema osnovnega cepljenja je sestavljena iz treh odmerkov po 0,5 ml, ki se jih v skladu z uradnimi lokalnimi priporočili daje v prvih šestih mesecih življenja.
English: Side effects that occurred during clinical trials with Quintanrix were as follows:
Slovenian: Neželeni učinki, ki so se pojavili med kliničnimi študijami s cepivom Quintanrix so bili naslednji:
English: • if after previously having Quintanrix or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse (floppiness) or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/fits with or without a high temperature within 3 days of vaccination
Slovenian: • če je imel vaš otrok kakršne koli težave po predhodnem cepljenju s cepivom Quintanrix ali drugim cepivom proti oslovskemu kašlju, še posebej: ♦ visoko telesno temperaturo (nad 40 ºC) v 48 urah po cepljenju, ♦ kolaps (ohlapnost) ali šoku podobno stanje v 48 urah po cepljenju, ♦ če je v 48 urah po cepljenju vztrajno in neutolažljivo jokal 3 ure ali dlje, ♦ epileptične napade/krče z ali brez zvišane telesne temperature v 3 dneh po cepljenju,
English: The DTPw-HBV component should be well shaken in order to obtain a homogeneous turbid white suspension and should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Slovenian: Komponento DTPw-HBV je potrebno dobro pretresti, da nastane homogena motna bela suspenzija, potrebno pa jo je tudi vizualno preveriti glede morebitne prisotnosti tujih delcev in/ali neobičajnega fizikalnega izgleda.
English: not less than 60 International Units
Slovenian: ne manj kot 60 mednarodnih enot
English: GlaxoSmithKline Biologicals S.A. 2100 Gödöllö, Táncsics Mihály út 82 Hungary
Slovenian: GlaxoSmithKline Biologicals S.A. 2100 Gödöllö, Táncsics Mihály út 82 Madžarska
English: • Diphtheria: Diphtheria mainly affects the airways and sometimes the skin.
Slovenian: • Davica: Davica v glavnem prizadene dihalne poti in včasih tudi kožo.
English: The seroprotection rates for anti-HBs (≥10 mlU/ml) observed with the 6, 10, 14 week schedule was lower as shown in the table below, but is unlikely to be clinically relevant due to the small sample size:
Slovenian: Odstotek serozaščite s proti-HBs ((≥ 10 i.e./ml) opažen pri shemi 6., 10., 14. teden je bil nižji od navedenega v preglednici v nadaljevanju, vendar pa je zaradi majhne velikosti vzorca malo verjetno, da bi to imelo klinični pomen:
English: There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Slovenian: V nekaterih okoliščinah, npr. v primeru visoke incidence oslovskega kašlja, lahko pričakovana korist cepljenja prevlada nad možnim tveganjem.
English: The active substances and other ingredients in Quintanrix are listed at the beginning of the leaflet.
Slovenian: Učinkovine in druge sestavine v cepivu Quintanrix so navedene na začetku navodila.
English: GlaxoSmithKline Biologicals S.A. 89 rue de I'Institut-1330 Rixensart Belgium
Slovenian: GlaxoSmithKline Biologicals S.A. 89 rue de I'Institut-1330 Rixensart Belgija
English: Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters.
Slovenian: Rane, ki so še posebej nagnjene k okužbi so opekline, zlomi, globoke rane ali rane onesnažene z zemljo, s prahom, konjskim gnojilom/z iztrebki ali lesenimi trskami.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator Do not freeze
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku.
English: When using a multidose vial, each 0.5 ml dose of the reconstituted suspension should be taken with a sterile needle and syringe.
Slovenian: Pri uporabi večodmerne viale je potrebno vsak odmerek po 0,5 ml odvzeti s sterilno iglo in brizgo.
English: Tetanus toxoid1
Slovenian: Tetanusni toksoid1
English: BEFORE YOUR CHILD RECEIVES QUINTANRIX
Slovenian: PREDEN VAŠ OTROK DOBI CEPIVO QUINTANRIX
English: These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Slovenian: Te se lahko pojavijo v obliki omejenih ali razširjenih, srbečih ali mehurčastih izpuščajev, otekline oči in obraza, težav pri dihanju ali požiranju, nenadnega padca krvnega tlaka ali izgube zavesti.
English: • Tetanus (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.
Slovenian: • Tetanus (mrtvični krč): Bakterije, povzročiteljice tetanusa vdrejo v telo skozi vreznine, opraskanine ali rane na koži.
English: What Quintanrix is and what it is used for Before your child receives Quintanrix How Quintanrix is given Possible side effects
Slovenian: Kaj je cepivo Quintanrix in za kaj ga uporabljamo Preden vaš otrok dobi cepivo Quintanrix Kako se cepivo Quintanrix daje Možni neželeni učinki
English: Important information about some of the ingredients of Quintanrix
Slovenian: Pomembne informacije o nekaterih sestavinah cepiva Quintanrix
English: HIV infection is not considered as a contraindication.
Slovenian: Okužba z virusom humane imunske pomanjkljivosti (HIV) ne velja za kontraindikacijo.
English: After the addition of the DTPw-HBV component to the HIB powder, the mixture should be well shaken until the powder is completely dissolved.
Slovenian: Po dodajanju komponente DTPw-HBV komponenti HIB v obliki praška, je potrebno mešanico dobro pretresti, da se prašek popolnoma raztopi.
English: • Convulsions with or without fever, occurring within 3 days.
Slovenian: • Krči z zvišano telesno temperaturo ali brez nje, ki so se pojavili v 3 dneh.
English: ♦ Very common (more than 1 per 10 doses of vaccine):
Slovenian: ♦ Zelo pogosti (več kot 1 na 10 odmerkov cepiva):
English: Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events).
Slovenian: Pred cepljenjem je potrebno oceniti anamnezo (s poudarkom na predhodnih cepljenjih in morebitnih neželenih učinkih).
English: - The other ingredients in the vaccine are: lactose, thiomersal (preservative), sodium chloride and water for injections.
Slovenian: - Druge sestavine cepiva so: laktoza, tiomersal (konzervans), natrijev klorid in voda za injiciranje.
English: Seroprotection and vaccine response rates were similar for the three schedules used, with the exception of anti-HBs.
Slovenian: Serozaščita in odstotek odziva na cepivo je bil pri vseh treh uporabljenih shemah podoben, izjema so bila le protitelesa proti-HBs.
English: • if your child has previously had any allergic reaction to Quintanrix, or any ingredient contained in this vaccine.
Slovenian: • če je imel vaš otrok predhodno kakršno koli alergijsko (preobčutljivostno) reakcijo na cepivo Quintanrix ali na katero koli sestavino v tem cepivu.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore it is possible that sensitisation reactions may occur (see section 4.3).
Slovenian: To cepivo vsebuje kot konzervans tiomersal (organska živosrebrova spojina) in tako je možen pojav preobčutljivostnih reakcij (glejte poglavje 4.3).
English: This is a multidose container.
Slovenian: Vsebnik vsebuje več odmerkov.
English: • if your child has any known allergies.
Slovenian: • če ima vaš otrok katero koli znano alergijo (preobčutljivost).
English: The immune response after a three-dose primary vaccination course was evaluated in five trials: 297 infants were evaluated after vaccination at 6, 10 and 14 weeks of age, 685 after vaccination at 2, 4, and 6 months of age and 107 after vaccination at 3, 4 and 5 months of age.
Slovenian: Imunski odziv po osnovnem cepljenju s tremi odmerki cepiva je bil ovrednoten s petimi raziskavami: pri 297 otrocih, ki so bili cepljeni po shemi 6., 10. in 14 teden starosti, pri 685 otrocih, ki so bili cepljeni po shemi 2., 4. in 6. mesec starosti in pri 107 otrocih, ki so bili cepljeni po shemi 3., 4. in 5. mesec starosti.
English: Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.
Slovenian: Otroke, ki jih cepimo in imajo vročinske krče v anamnezi, je potrebno skrbno nadzirati, saj se takšni neželeni dogodki lahko pojavijo v 2 do 3 dneh po cepljenju.
English: There will be some type of serious complications such as: mental retardation, cerebral palsy, deafness, epilepsy or partial blindness.
Slovenian: Okužba lahko povzroči nekatere resne komplikacije kot so: mentalna zaostalost, paraliza možganov, gluhota, epilepsija in delna oslepelost.
English: Quintanrix was administered as a booster to 435 infants in the second year of life.
Slovenian: Obnovitveni odmerek cepiva Quintanrix je v drugem letu življenja prejelo 435 otrok.
English: 2adsorbed on aluminium phosphate
Slovenian: 2adsorbiran na aluminijev fosfat
English: • if your child experienced problems of the nervous system (such as repetitive fits, decrease of consciousness) within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease.
Slovenian: • če je imel vaš otrok težave z živčevjem (npr. ponavljajoči se krči, zmanjšana stopnja zavesti) v prvih 7 dneh po cepljenju s cepivom proti oslovskemu kašlju;
English: • Fever (more than 37.5°C)
Slovenian: • zvišana telesna temperatura (večja od 37,5 ºC)
English: 4.5 Interaction with other medicinal products and other forms of interaction In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate injection sites, during the same session.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pogosta praksa pri cepljenju otrok je, da se jih ob enkratnem obisku cepi z različnimi cepivi za injiciranje, ki se jih injicira na ločenih mestih.
English: • Pain, redness or swelling at the injection site
Slovenian: • bolečina, rdečina in oteklina na mestu injiciranja
English: If these events continue or become severe, tell your doctor.
Slovenian: Če ti neželeni učinki ne minejo ali postanejo hujši, obvestite svojega zdravnika.
English: Nervous system disorders: very common: drowsiness rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions
Slovenian: Bolezni živčevja: zelo pogosti: zaspanost redki: kolaps ali šoku podobno stanje (hipotonična-hiporesponzivna epizoda), konvulzije
English: Store in the original package in order to protect from light.
Slovenian: Za zagotovitev zaščite pred svetlobo shranjujte v originalni ovojnini.
English: 6.6 Instructions for use and handling
Slovenian: 6.6 Navodila za pripravo in ravnanje z zdravilom
English: A fine needle can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least two minutes following administration.
Slovenian: Pri cepljenju je potrebno uporabiti tanko iglo in nato na mesto aplikacije trdno pritiskati (brez drgnjenja) najmanj dve minuti.
English: Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.
Slovenian: Bakterije lahko, vendar manj pogosto, okužijo tudi kri, srce, pljuča, kosti, sklepe in tkiva oči ter ust.
English: Quintanrix can be given to children who have received hepatitis B vaccine at birth.
Slovenian: S cepivom Quintanrix se lahko cepi otroke, ki so ob rojstvu prejeli cepivo proti hepatitisu B.
English: The booster dose should preferably be given at least 6 months after the last primary dose.
Slovenian: Otrok mora obnovitveni odmerek po možnosti prejeti vsaj 6 mesecev po zadnjem odmerku osnovnega cepljenja.
English: Thiomersal Sodium chloride Water for injections
Slovenian: laktoza tiomersal natrijev klorid voda za injiciranje
English: • Fever (more than 39°C)
Slovenian: • zvišana telesna temperatura (večja od 39 ºC)
English: The vaccine is reconstituted by withdrawing the contents of the vial containing the DTPw-HBV component by means of a syringe and by adding it to the vial containing the HIB powder.
Slovenian: Cepivo se rekonstituira tako, da se vsebina viale s komponento DTPw-HBV odvzame z brizgo in se doda viali s komponento HIB v obliki praška.
English: Not all pack sizes may be marketed.
Slovenian: Možno je, da na tržišču ni vseh navedenih pakiranj.
English: Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 2
Slovenian: Polisaharid bakterije Haemophilus influenzae tipa b (poliribozilribitol-fosfat)2
English: 6, 10, 14 weeks schedule N = 97
Slovenian: Shema 6., 10., 14. teden N = 97
English: ♦ Rare (less than 1 per 1000 but more than 1 per 10 000 doses of vaccine):
Slovenian: ♦ Redki (manj kot 1 na 1.000 vendar več kot 1 na 10.000 odmerkov cepiva):
English: Hypersensitivity to the active substances or to any of the excipients.
Slovenian: Preobčutljivost za aktivne sestavine ali katero koli pomožno snov cepiva.
English: As shown with other vaccines, the booster dose is potentially associated with an increased incidence of minor adverse events such as fever and local reactions.
Slovenian: Obnovitveni odmerek je, tako kot pri drugih cepivih, povezan s povečano pojavnostjo blažjih neželenih dogodkov, kot so povišana telesna temperatura in lokalne reakcije.
English: The following schedules have been studied in clinical trials: 2-4-6 months, 3-4-5 months and 6-10-14 weeks.
Slovenian: Med kliničnim preskušanjem so bile opravljene študije z naslednjimi shemami: 2., 4., 6. mesec; 3., 4., 5. mesec in 6., 10., 14. teden.
English: It is possible that your child will have no side effects from vaccination.
Slovenian: Možno je, da vaš otrok po cepljenju ne bo imel nikakršnih neželenih učinkov.
English: As with all injectable vaccines, there is an extremely small risk of allergic reactions.
Slovenian: Tako kot pri vseh cepivih za injiciranje, tudi pri tem obstaja izjemno majhno tveganje za pojav alergijskih (preobčutljivostnih) reakcij.
English: The vaccine will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C and hepatitis E virus.
Slovenian: Cepivo ne bo preprečilo okužb z drugimi patogeni, ki lahko prizadenejo jetra, npr. okužbe z virusom hepatitisa A, virusom hepatitisa C in virusom hepatitisa E.
English: Hepatitis B carriers are at risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer.
Slovenian: Pri klicenoscih virusa hepatitisa B obstaja tveganje za resne bolezni jeter kot sta ciroza (brazgotinjenje jeter) in rak jeter.
English: Data from clinical trials show that Quintanrix, when given as a booster dose in the second year of life, induces a greater than 10-fold increase in mean antibody titre with respect to prebooster levels for all vaccine components.
Slovenian: Vendar pa podatki iz kliničnih raziskav kažejo, da dajanje obnovitvenega odmerka cepiva Quintanrix v drugem letu življenja povzroči več kot 10-kratni porast srednjega titra protiteles proti vsem komponentam cepiva glede na vrednosti pred obnovitvenim cepljenjem.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem cepivu se lahko obrnete na predstavništvo imetnika dovoljenja za promet.