FrancophonIA/ELRC3.0 huggingface dataset:
English: When the value zero is included, i.e. when the lower limit of the CI is <0, the efficacy is not considered statistically significant.
Croatian: Kada je uključena nulta vrijednost, odnosno kada je donja granica CI <0, djelotvornost se ne smatra statistički značajnom.
English: The total number of injections you will receive depends on your age at the time of the first injection.
Croatian: Ukupan broj injekcija koje ćete primiti ovisi o Vašoj dobi u trenutku primjene prve injekcije.
English: Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite ovo cjepivo jer sadrži Vama važne podatke.
English: Therefore tell the doctor or nurse if you or your child fainted with a previous injection.
Croatian: Stoga recite liječniku ili sestri ukoliko ste se Vi ili Vaše dijete onesvijestili prilikom prijašnjih injekcija.
English: Tell your doctor if you are taking, have recently taken, might take any other medicines, or have recently received any other vaccine.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, ili ako ste nedavno primili bilo koje drugo cjepivo.
English: For storage after first opening, see section 6.3.
Croatian: Za čuvanje nakon prvog otvaranja, vidjeti dio 6.3.
English: B-1330 Rixensart, Belgium
Croatian: B-1330 Rixensart, Belgija
English: However, do not drive or use any machines if you are feeling unwell.
Croatian: Međutim, nemojte upravljati vozilima i strojevima ako se ne osjećate dobro.
English: Use with hormonal contraceptive
Croatian: Primjena s hormonskom kontracepcijom
English: Immunization and schedule
Croatian: Imunizacija i raspored
English: HPV type
Croatian: HPV tip
English: Functional antibodies were not determined.
Croatian: Funkcionalna protutijela nisu određivana.
English: It is important that you follow the instructions of your doctor or nurse regarding return visits.
Croatian: Važno je da slijedite upute svog liječnika ili medicinske sestre u vezi ponovnog dolaska radi cijepljenja.
English: The vaccine should never be given into a vein.
Croatian: Cjepivo se nikada ne smije dati u venu.
English: In clinical studies, approximately 60% of women who received Cervarix used hormonal contraceptives.
Croatian: U kliničkim ispitivanjima, otprilike 60% žena koje su primile Cervarix koristilo je hormonske kontraceptive.
English: You will receive 2 injections:
Croatian: Primit ćete 2 injekcije:
English: 20 micrograms
Croatian: 20 mikrograma
English: The GMTs appeared to be lower in the HIV infected group (non overlapping 95% confidence interval).
Croatian: Činilo se da su GMT-i bili niži u HIV zaraženoj grupi (bez preklapanja 95% interval pouzdanosti).
English: In accordance with Article 114 of Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: Sukladno članku 114 Direktive 2001/83/EC, službeno puštanje serije lijeka u promet preuzet će državni laboratoriji ili laboratorij određen za tu svrhu.
English: However, the presence of a minor infection, such as a cold, is not a contraindication for immunisation.
Croatian: Međutim, prisutnost manje infekcije, poput prehlade, nije kontraindikacija za imunizaciju.
English: You will receive 3 injections:
Croatian: Primit ćete 3 injekcije:
English: EXP After first opening, use immediately or within 6 hours if stored in a refrigerator
Croatian: Nakon prvog otvaranja, upotrijebiti odmah ili unutar 6 sati ako je čuvano u hladnjaku.
English: • if you have a severe infection with a high temperature.
Croatian: • ako bolujete od teške infekcije praćene visokom temperaturom.
English: Cross protective efficacy
Croatian: Križna zaštitna djelotvornost
English: The majority of these reactions were of mild to moderate severity and were not long lasting.
Croatian: Većina ovih reakcija je bila blaga do umjerena po težini i kratkotrajna.
English: Duration of the immune response in women aged 26 years and older
Croatian: Trajanje imunološkog odgovora u žena u dobi od 26 godina i više
English: Immunogenicity in HIV infected women
Croatian: Imunogenost u žena zaraženih HIV-om
English: What Cervarix is and what it is used for
Croatian: Što je Cervarix i za što se koristi
English: It might be necessary to postpone the vaccination until recovery.
Croatian: Cijepljenje će možda trebati odgoditi do oporavka.
English: 50 micrograms
Croatian: 50 mikrograma
English: The need for a booster dose has not been established (see section 5.1).
Croatian: Potreba za dozom docjepljivanja nije utvrđena (vidjeti dio 5.1).
English: • if you are allergic to any of the active substances or any of the other ingredients of this vaccine (listed in section 6).
Croatian: • ako ste alergični na djelatne tvari ili neki drugi sastojak ovog cjepiva (naveden u dijelu 6).
English: Other medicines and Cervarix
Croatian: Drugi lijekovi i Cervarix
English: • if you have any disease which reduces your resistance to infection such as HIV infection.
Croatian: • ako bolujete od neke bolesti koja smanjuje Vašu otpornost na infekciju (npr. HIV infekciju)
English: For adjuvants, see section 2.
Croatian: Za adjuvanse, vidjeti dio 2.
English: The vaccine has not been shown to have a therapeutic effect.
Croatian: Cjepivo nije pokazalo terapijski učinak.
English: A minor infection such as a cold should not be a problem, but talk to the doctor first.
Croatian: Manja infekcija, poput prehlade, ne bi trebala predstavljati problem, ali najprije porazgovarajte s liječnikom.
English: However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.
Croatian: Međutim, neki od učinaka spomenutih u dijelu 4.8 'Nuspojave' mogu privremeno utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Cervarix is a turbid white suspension.
Croatian: Cervarix je mutna bijela suspenzija.
English: Age at the time of the first injection
Croatian: Dob u trenutku prve injekcije
English: These subjects were followed for serious adverse events over the entire study period.
Croatian: Pojava ozbiljnih štetnih događaja praćena je u tih ispitanica tijekom čitavog ispitivanja.
English: Case counting for the ATP cohort started on day 1 after the third dose of vaccine.
Croatian: Brojanje slučajeva za ATP kohortu počelo je na prvi dan, nakon treće doze cjepiva.
English: • fainting sometimes accompanied by shaking or stiffness.
Croatian: • nesvjestica ponekad praćena drhtanjem ili ukočenošću.
English: Evidence of Anamnestic (Immune Memory) Response
Croatian: Dokazi o anamnestičkom (imunološkom pamćenju) odgovoru
English: However, during the clinical development program, a total of 10,476 pregnancies were reported including 5,387 in women who had received Cervarix.
Croatian: Ipak, tijekom kliničkog razvojnog programa, zabilježeno je ukupno 10 476 trudnoća, među kojima je bilo 5387 žena koje su primile Cervarix.
English: It is important that procedures are in place to avoid injury from faints.
Croatian: Važno je da postoje utvrđene procedure kako bi se izbjegle ozljede prilikom nesvjestica.
English: Final analysis was performed at study conclusion, 7 years after 1st vaccination.
Croatian: Završna analiza napravljena je na kraju ispitivanja, 7 godina nakon prvog cijepljenja.
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100)
Croatian: Vrlo često (≥1/10) Često (≥1/100 i <1/10) Manje često (≥1/1000 i <1/100)
English: The most common adverse reaction observed after vaccine administration was injection site pain which occurred after 78% of all doses.
Croatian: Najčešća zabilježena nuspojava nakon primjene cjepiva bila je bol na mjestu injiciranja, koja se pojavila nakon 78% svih doza.
English: Specific studies of the vaccine in pregnant women were not conducted.
Croatian: Nisu provedena posebna ispitivanja cjepiva u trudnica.
English: The efficacy against CIN3 was only demonstrated for HPV-31 and there was no evidence of protection against AIS for any of the HPV types.
Croatian: Djelotvornost protiv CIN3 prikazana je samo za HPV-31 i nema dokaza o zaštiti protiv AIS za bilo koji od HPV tipova.
English: Unlike histopathological endpoints, virological endpoints are less confounded by multiple infections.
Croatian: Za razliku od histopatoloških ishoda, virološki ishodi manje su ometani višekratnim infekcijama.
English: Cervarix should be used in accordance with official guidelines.
Croatian: Cervarix treba primjenjivati u skladu sa službenim preporukama.
English: The study was not powered to assess efficacy against disease caused by individual HPV types.
Croatian: Ispitivanje nije imalo dovoljnu snagu da bi se procijenila djelotvornost protiv bolesti uzrokovane individualnim HPV tipovima.
English: The vaccine should be well shaken before use.
Croatian: Cjepivo treba dobro protresti prije primjene.
English: In clinical trials, oral contraceptives (e.g. the pill) did not reduce the protection obtained by Cervarix.
Croatian: U kliničkim ispitivanjima primjena oralnih kontraceptiva (npr. pilule) nije smanjila zaštitu postignutu cjepivom Cervarix.
English: A similar kinetic profile was observed with the neutralising antibodies.
Croatian: Sličan farmakokinetički profil je primijećen sa neutralizirajućim antitijelima.
English: In study 008, immunogenicity up to month 48 was similar to the response observed in study 001.
Croatian: U ispitivanju 008, imunogenost do 48. mjeseca slična je odgovoru zabilježenom u ispitivanju 001.
English: The GMTs were, however, lower in women above 25 years.
Croatian: Međutim, GMT-i bili su niži u žena starijih od 25 godina.
English: Cervarix may not have an optimal effect if used with medicines that suppress the immune system.
Croatian: Cervarix možda neće postići optimalan učinak ako se primjeni s lijekovima koji potiskuju imunološki sustav.
English: The TVC may approximate to the general population of women in the age range of 15-25 years.
Croatian: TVC se može aproksimirati na opću populaciju žena od 15 do 25 godina.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Croatian: To može biti popraćeno s nekoliko neuroloških znakova kao što su prolazne smetnje vida, parestezija i toničko-kloničke kretnje udova tijekom oporavka.
English: Cervarix is not likely to affect your ability to drive or use machines.
Croatian: Nije izgledno da će Cervarix utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: Cervarix does not protect against all HPV types.
Croatian: Cervarix ne štiti od svih HPV tipova.
English: Inclusion of this subset allowed assessment of prophylactic efficacy in a population that is thought to reflect a real-world setting, as adult women are the age group generally targeted for cervical screening.
Croatian: Uključivanje ove podskupine omogućilo je procjenu djelotvornosti profilakse u populaciji za koju se smatra da odražava stvarnu situaciju, jer su odrasle žene ona dobna skupina u kojoj se općenito ciljano provodi probir na karcinom cerviksa.
English: Other oncogenic HPV types can also cause ano-genital cancers (approximately 30%).
Croatian: Ostali onkogeni tipovi HPV-a mogu također uzrokovati anogenitalne karcinome (približno 30%).
English: Immunogenicity in males was assessed in 2 clinical trials HPV-011 (N=173) and HPV-040 (N=556).
Croatian: Imunogenost u osoba muškog spola ocjenjivala se u 2 klinička ispitivanja: HPV-011 (N=173) i HPV-040 (N=556).
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive or use machines have been performed.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
English: What you need to know before you receive Cervarix Cervarix should not be given:
Croatian: Što morate znati prije nego primite Cervarix Cervarix se ne smije dati:
English: When using a multidose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.
Croatian: Kod upotrebe višedozne bočice, svaku dozu od 0,5 ml potrebno je povući upotrebom sterilne igle i štrcaljke; oprez je potreban radi izbjegavanja kontaminacije spremnika.
English: As a precautionary measure, it is preferable to avoid the use of Cervarix during pregnancy.
Croatian: Kao mjera predostrožnosti, preporučuje se izbjegavati primjenu cjepiva Cervarix tijekom trudnoće.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na neposredne niti posredne štetne učinke na plodnost, trudnoću, embrionalni/fetalni razvoj, porod i poslijeporođajni razvoj (vidjeti dio 5.3).
English: • aching muscles, muscle tenderness or weakness (not caused by exercise)
Croatian: • tupa bol u mišićima, osjetljivost ili slabost u mišićima (koji nisu posljedica vježbanja)
English: The immune response after 2 doses in females aged 9 to 14 years was non-inferior to the response after 3 doses in women aged 15 to 25 years.
Croatian: Imunološki odgovor nakon 2 doze u djevojčica u dobi od 9 do 14 godina bio je neinferioran u odnosu na odgovor nakon 3 doze u žena između 15 i 25 godina.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Croatian: Znakovi alergijske reakcije mogu obuhvaćati kožni osip koji svrbi, nedostatak zraka i oticanje lica ili jezika.
English: No information exists about protection against persistent infection or precancerous lesions among HIV infected women.
Croatian: Nema informacija o zaštiti protiv perzistirajuće infekcije ili prekanceroznih lezija među ženama zaraženim HIV-om.
English: If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
Croatian: Ako zaboravite doći u dogovoreno vrijeme, posavjetujte se s liječnikom.
English: After first opening, immediate use is recommended.
Croatian: Preporučuje se primijeniti odmah nakon prvog otvaranja.
English: • upper respiratory tract infection (infection of the nose, throat or trachea)
Croatian: • infekcije gornjih dišnih puteva (infekcija nosa, grla ili dušnika)
English: Turbid white suspension.
Croatian: Mutna bijela suspenzija.
English: As with all vaccines, Cervarix may not fully protect all people who are vaccinated.
Croatian: Kao i sva cjepiva, Cervarix možda neće potpuno zaštititi sve koji se cijepe.
English: The limits of the confidence interval around the vaccine efficacy were calculated.
Croatian: Izračunate su granice intervala pouzdanosti oko djelotvornosti cjepiva.
English: The efficacy estimates are lower in the TVC as this cohort includes women with pre-existing infections/lesions, which are not expected to be impacted by Cervarix.
Croatian: Procjene djelotvornosti su niže u TVC jer ova kohorta uključuje žene s od prije postojećim infekcijama/lezijama na koje se ne očekuje da će Cervarix djelovati.
English: If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this vaccine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovo cjepivo.
English: Fainting can occur (mostly in adolescents) following, or even before, any needle injection.
Croatian: Nesvjestica se može pojaviti (uglavnom u adolescenata) nakon, ili čak prije, ikakvog uboda iglom.
English: If not used within 6 hours it should be discarded.
Croatian: Ako se ne iskoristi unutar 6 sati, treba ga zbrinuti u otpad.
English: In study HPV-020, conducted in South Africa, 22 HIV uninfected and 42 HIV infected subjects (WHO clinical stage 1; ATP cohort for immunogenicity) received Cervarix.
Croatian: U ispitivanju HPV-020 provedenom u Južnoj Africi, 22 ispitanice nezaražene HIV-om i 42 ispitanice zaražene HIV-om (WHO klinički stadij 1; ATP kohorta za imunogenost) primile su Cervarix.
English: When a female or a male individual is vaccinated with Cervarix, the immune system (the body's natural defence system) will make antibodies against HPV types 16 and 18.
Croatian: Kad se ženska ili muška osoba cijepi cjepivom Cervarix, imunološki će sustav (prirodni obrambeni sustav tijela) stvoriti protutijela protiv HPV tipova 16 i 18.
English: Anti-HBs geometric mean antibody concentrations were significantly lower on co-administration, but the clinical relevance of this observation is not known since the seroprotection rates remain unaffected.
Croatian: Anti-HBs geometrijska sredina koncentracija antitijela je bila značajno niža kod istodobne primjene, ali klinički značaj ove opservacije nije poznat jer stopa seroprotekcije ostaje nepromijenjena.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Croatian: Neklinički podaci ne otkrivaju posebnu opasnost za ljude na temelju konvencionalnih ispitivanja farmakološke sigurnosti, akutne i toksičnosti ponavljanih doza, lokalne podnošljivosti, fertiliteta, embrio-fetalne i postnatalne toksičnosti (sve do kraja razdoblja dojenja).
English: Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Croatian: Budući da virusu slične čestice ne sadrže virusnu DNA, one ne mogu inficirati stanicu, razmnožavati se niti uzrokovati bolest.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2007.
Croatian: Datum prvog odobrenja: 20. rujna 2007.
English: The clinical relevance of this observation is unknown.
Croatian: Klinički značaj ovih zapažanja nije poznat.
English: What Cervarix is and what it is used for What you need to know before you receive Cervarix How Cervarix is given
Croatian: Što je Cervarix i za što se koristi Što morate znati prije nego primite Cervarix Kako primjenjivati Cervarix
English: Except for asymptomatic human immunodeficiency virus (HIV) infected subjects for whom limited immunogenicity data are available (see section 5.1), there are no data on the use of Cervarix in subjects with impaired immune responsiveness such as patients receiving immunosuppressive treatment.
Croatian: Izuzev za asimptomatske osobe zaražene humanim virusom imunodeficijencije (HIV) za koje su dostupni ograničeni podaci o imunogenosti (vidjeti dio 5.1), nema podataka o primjeni cjepiva Cervarix u osoba s oštećenim imunološkim odgovorom kao što su bolesnice koje se liječe imunosupresivnim lijekovima.
English: Cervarix contains sodium chloride.
Croatian: Cervarix sadrži natrijev klorid
English: The analysis against the primary endpoint was confounded by multiple co-infections in the CIN2+ lesions.
Croatian: Analiza za primarni ishod ometana je višestrukim dodatnim infekcijama u CIN2+ lezijama.
English: There is no evidence that the use of hormonal contraceptives has an impact on the efficacy of Cervarix.
Croatian: Nema dokaza koji bi ukazivali da primjena hormonskih kontraceptiva utječe na djelotvornost cjepiva Cervarix.
English: 1Human Papillomavirus = HPV 2adjuvanted by AS04 containing:
Croatian: 1humani papilomavirus = HPV 2 s adjuvansom AS04, koji sadrži:
English: Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risks.
Croatian: Cervarix se smije primijeniti tijekom dojenja samo ukoliko moguća prednost nakon cijepljenja nadilazi moguće rizike.
English: 4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant
Croatian: 4L1 protein u obliku neinfektivnih virusima sličnih čestica proizveden tehnologijom rekombinantne
English: The vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Croatian: Cjepivo je namijenjeno samo za profilaktičku primjenu i nema utjecaja na aktivne HPV infekcije ili utvrđenu kliničku bolest.
English: Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
Croatian: Do sinkope (nesvjestice) može doći nakon ili čak prije bilo kojeg cijepljenja posebno u adolescenata kao psihogeni odgovor na injekciju s iglom.
English: Persistence of Immune Response to Cervarix
Croatian: Postojanost imunološkog odgovora na Cervarix
English: Frequencies are reported as:
Croatian: Učestalost pojavljivanja navodi se kao:
English: Not known* Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema
Croatian: Poremećaji imunološkog sustava nepoznato* alergijske reakcije (uključujući anafilaktičke i anafilaktoidne reakcije), angioedem
English: When Cervarix is given for the first dose, it is recommended that Cervarix (and not another vaccine against HPV) be given for the complete vaccination course.
Croatian: Ako dobijete prvu dozu cjepiva Cervarix, preporučuje se da se Cervarix (a ne neko drugo cjepivo protiv HPV-a) daje tijekom cijelog ciklusa cijepljenja.
English: Immunogenicity in males aged 10 to 18 years
Croatian: Imunogenost u osoba muškog spola u dobi od 10 do 18 godina
English: Control
Croatian: Kontrola
English: This cohort included women with normal or low-grade cytology at baseline and excluded only women with high-grade cytology (0.5% of the total population).
Croatian: Ova je kohorta uključivala žene sa normalnim ili citološkim nalazom niskog stupnja na početku ispitivanja, a isključila samo žene s citološkim nalazom visokog stupnja (0,5% cjelokupne populacije).
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovo cjepivo može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Control (N = 7,305)
Croatian: Kontrola (N = 7305)
English: Warnings and precautions Talk to your doctor or pharmacist before you are given Cervarix
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primite Cervarix
English: As with other vaccines administered intramuscularly, Cervarix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Croatian: Kao i druga cjepiva koja se primjenjuju intramuskularno, Cervarix treba primijeniti uz oprez u osoba s trombocitopenijom ili bilo kojim poremećajem zgrušavanja krvi jer u tih osoba može doći do krvarenja nakon intramuskularne primjene.
English: The effect on breast-fed infants of the administration of Cervarix to their mothers has not been evaluated in clinical studies.
Croatian: Učinak primjene cjepiva Cervarix na dojenčad prilikom cijepljenja njihovih majki nije bio ocijenjen u kliničkim ispitivanjima.
English: Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
Croatian: Zbog toga je nužno nastaviti s provođenjem mjera opreza od spolno prenosivih bolesti.
English: The immunogenicity induced by three doses of Cervarix has been evaluated in 5,465 female subjects from 9 to 55 years of age and over 800 male subjects aged 10 to 18 years.
Croatian: Imunogenost inducirana primjenom tri doze cjepiva Cervarix procijenjena je u 5465 ispitanica ženskog spola u dobi od 9 do 55 godina i više od 800 ispitanika muškog spola u dobi od 10 do 18 godina.
English: Although vaccination may protect you against cervical cancer, it is not a substitute for regular cervical screening.
Croatian: Iako Vas cijepljenje može zaštititi od raka vrata maternice, ono nije zamjena za redovite preglede vrata maternice.
English: On the basis of these immunogenicity data, the efficacy of Cervarix is inferred from 9 to 14 years of age.
Croatian: Na temelju ovih podataka o imunogenosti, proizlazi da je Cervarix djelotvoran i u dobnoj skupini od 9 do 14 godina.