FrancophonIA/ELRC3.0 huggingface dataset:
English: Use with hormonal contraceptives
Croatian: Primjena s hormonskim kontraceptivima
English: HIV infection was an exclusion criterion (see also section 4.4).
Croatian: HIV infekcija bila je isključni kriterij (također vidjeti dio 4.4).
English: Do not receive Silgard if:
Croatian: Nemojte primiti Silgard:
English: • First injection: at chosen date
Croatian: • Prva injekcija: na odabrani datum
English: At the end of this period Silgard should be used or discarded.
Croatian: Na kraju tog razdoblja, Silgard treba primijeniti ili baciti.
English: If you miss a scheduled injection, your doctor will decide when to give the missed dose.
Croatian: Propustite li dogovoreno cijepljenje, liječnik će odlučiti kada će Vam dati propuštenu dozu.
English: 20 micrograms 40 micrograms 40 micrograms 20 micrograms.
Croatian: 20 mikrograma 40 mikrograma 40 mikrograma 20 mikrograma.
English: Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 42°C.
Croatian: Podaci iz ispitivanja stabilnosti pokazuju da su komponente cjepiva stabilne 72 sata kad se čuvaju na temperaturi od 8°C do 42°C.
English: [Very Common (≥1/10); Common (≥1/100 to 1/10); Uncommon (≥1/1,000 to 1/100); Rare (≥1/10,000 to 1/1,000); Very Rare (1/10,000)]
Croatian: [vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000)]
English: What you need to know before you receive Silgard
Croatian: Što morate znati prije nego primite Silgard
English: These methods of administration are not recommended (see section 6.6).
Croatian: Takvi načini primjene se ne preporučuju (vidjeti dio 6.6).
English: If you are from 9 to and including 13 years of age
Croatian: Ako ste u dobi od 9 do uključujući i 13 godina
English: The primary time point analysis after 3 years did not reach statistical significance for all pre-specified endpoints.
Croatian: Analiza primarne vremenske točke nakon 3 godine nije pokazala statističku značajnost za sve unaprijed određene ishode.
English: The duration of protection against anal cancer is currently unknown.
Croatian: Trajanje zaštite protiv raka anusa trenutno nije poznato.
English: What Silgard is and what it is used for
Croatian: Što je Silgard i za što se koristi
English: Rare: urticaria.
Croatian: Rijetko: urtikarija.
English: It is important that you follow the instructions of your doctor or nurse regarding return visits for the follow-up doses.
Croatian: Važno je da slijedite upute liječnika ili medicinske sestre vezano uz ponovne posjete i cijepljenja narednim dozama.
English: 1 dose (0.5 ml) contains approximately:
Croatian: 1 doza (0,5 ml) približno sadrži:
English: A subset of individuals enrolled in the Phase III studies was followed up for a long-term period for safety, immunogenicity and effectiveness.
Croatian: Podskupina osoba uključenih u ispitivanja faze III bila je praćena tijekom dugotrajnog razdoblja zbog sigurnosti, imunogenosti i učinkovitosti.
English: * Post-Marketing adverse events (frequency cannot be estimated from the available data).
Croatian: * štetni događaji nakon stavljanja u promet (učestalost se ne može utvrditi iz dostupnih podataka).
English: The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity.
Croatian: Primijećene razlike bile su <10%, a u većine su ispitanika zabilježeni štetni događaji bili blagog do umjerenog intenziteta.
English: The safety and efficacy of Silgard in children below 9 years of age have not been established.
Croatian: Sigurnost i djelotvornost cjepiva Silgard u djece mlađe od 9 godina nisu ustanovljene.
English: What Silgard is and what it is used for What you need to know before you receive Silgard
Croatian: Što je Silgard i za što se koristi Što morate znati prije nego primite Silgard
English: These data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity.
Croatian: Ovi podaci o primjeni u trudnica (više od 1000 ishoda izloženih trudnoća) ne ukazuju na malformirajuću niti feto/neonatalnu toksičnost.
English: 20 micrograms
Croatian: 20 mikrograma.
English: • you or your child developed an allergic reaction after receiving a dose of Silgard.
Croatian: • ako ste Vi ili Vaše dijete razvili alergijsku reakciju nakon primljene doze cjepiva Silgard
English: Impact on Biopsy and Definitive Therapy Procedures
Croatian: Utjecaj na biopsiju i konačne terapijske postupke
English: Evidence of Anamnestic (Immune Memory) Response
Croatian: Dokazi anamnestičkoga odgovora (imunološkog pamćenja)
English: However, these data are insufficient to recommend use of Silgard during pregnancy.
Croatian: Ipak, ovi podaci nisu dovoljni da se preporuči primjena cjepiva Silgard tijekom trudnoće.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove
English: Silgard is intended for adolescents and adults from 9 years of age onwards.
Croatian: Silgard je namijenjen adolescentima i odraslima od 9 godina starosti nadalje.
English: Talk to your doctor, pharmacist or nurse before vaccination if you or your child
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije cijepljenja ako Vi ili Vaše dijete:
English: What other important information should you or your child know about Silgard
Croatian: Što još važno Vi ili Vaše dijete morate znati o cjepivu Silgard
English: • has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia
Croatian: • imate poremećaj krvarenja (bolest zbog koje krvarite dulje nego li je normalno) kao što je hemofilija
English: Long-term follow-up studies are currently ongoing to determine the duration of protection (see
Croatian: Trenutno su u tijeku ispitivanja s dugotrajnim praćenjem kako bi se odredilo trajanje zaštite (vidjeti
English: For the 10 individual HPV types, statistical significance was only reached for HPV 31.
Croatian: Za 10 pojedinih tipova HPV-a, statistička značajnost utvrđena je jedino za HPV 31.
English: You should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Croatian: I dalje morate slijediti liječničke savjete vezane uz pretrage cervikalnog razmaza/Papa testa te preventivne i zaštitne mjere.
English: GMT- Geometric mean titre in mMU/ml (mMU = milli-Merck units)
Croatian: GMT - geometrijski srednji titar izražen u mMU/ml (mMU = mili-Merck jedinice)
English: Human Papillomavirus = HPV
Croatian: humani papilomavirus = HPV.
English: Results of individual studies support the results from the combined analysis.
Croatian: Rezultati pojedinačnih ispitivanja potvrđuju rezultate dobivene objedinjenom analizom.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Istraživanja na životinjama ne ukazuju na izravni ili neizravni učinak na reproduktivnu toksičnost (vidjeti dio 5.3).
English: Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Croatian: Budući da su ovi događaji prijavljeni na dobrovoljnoj osnovi iz populacije neodređene veličine, nije uvijek moguće sa sigurnošću procijeniti njihovu učestalost niti utvrditi uzročno-posljedičnu povezanost s izlaganjem cjepivu.
English: • you or your child is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Silgard (listed under “other ingredients”- see section 6).
Croatian: • ako ste Vi ili Vaše dijete alergični (preosjetljivi) na bilo koju djelatnu tvar ili neki drugi sastojak cjepiva Silgard (naveden pod "drugi sastojci" pogledajte dio 6.).
English: Few individuals (0.2%) discontinued due to adverse reactions.
Croatian: Nekoliko ispitanika (0,2%) je prekinulo ispitivanje zbog nuspojava.
English: Antibodies against all four HPV types were transferred to the offspring during gestation and possibly during lactation.
Croatian: Protutijela na sva četiri tipa HPV-a prenijela su se na mladunčad za vrijeme gestacije, a moguće i za vrijeme dojenja.
English: Silgard is intended to prevent these diseases.
Croatian: Silgard je namijenjen sprječavanju tih bolesti.
English: Silgard may not have an optimal effect if: • used with medicines that suppress the immune system.
Croatian: Djelovanje cjepiva Silgard možda neće biti optimalno ako: • se daje s lijekovima koji potiskuju djelovanje imunološkog sustava.
English: Table 1 also includes additional adverse events which have been spontaneously reported during the post-marketing use of Silgard worldwide.
Croatian: Tablica 1 također uključuje dodatne štetne događaje koji su bili spontano prijavljeni nakon stavljanja cjepiva Silgard u promet u svijetu.
English: Pharmacotherapeutic group: Viral Vaccine, ATC code: J07BM01
Croatian: Farmakoterapijska skupina: virusna cjepiva, ATK oznaka: J07BM01
English: • you or your child suffer from an illness with high fever.
Croatian: • ako Vi ili Vaše dijete patite od bolesti koju prati visoka tjelesna temperatura (vrućica).
English: What Silgard looks like and contents of the pack 1 dose of Silgard suspension for injection contains 0.5 ml.
Croatian: Kako Silgard izgleda i sadržaj pakiranja Jedna doza Silgard suspenzije za injekciju sadrži 0,5 ml.
English: Specific studies of the vaccine in pregnant women were not conducted.
Croatian: Nisu provedena posebna ispitivanja djelovanja cjepiva u trudnica.
English: n % of seropositive subjects
Croatian: % seropozitivnih ispitanika
English: All three doses should be given within a 1-year period.
Croatian: Sve tri doze moraju se primiti unutar godine dana.
English: • has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system.
Croatian: • imate oslabljen imunološki sustav, npr. zbog prirođenog nedostatka, infekcije HIV-om ili lijekova koji utječu na imunološki sustav
English: The results are summarised in Table 3.
Croatian: Rezultati ispitivanja sažeti su u Tablici 3.
English: Administer the entire dose as per standard protocol.
Croatian: Primijenite cijelu dozu prema standardnom protokolu.
English: • Second injection: 2 months after first injection
Croatian: • Druga injekcija: 2 mjeseca nakon prve injekcije
English: Longer term follow-up studies are ongoing to determine whether a booster dose is needed.
Croatian: U tijeku su dugoročna ispitivanja kojima se želi saznati je li potrebna doza docjepljivanja.
English: If you forget or are not able to go back to your doctor at the scheduled time, ask your doctor for advice.
Croatian: Zaboravite li ili propustite posjet liječniku u dogovoreno vrijeme, posavjetujte se sa svojim liječnikom.
English: The primary analysis was done in type-specific populations that required women to be negative for the type being analyzed, but who could be positive for other HPV types (96% of the overall population).
Croatian: Glavna je analiza provedena u populacijama s obzirom na određeni tip virusa, u kojima su žene morale imati negativne nalaze za analizirani tip, ali su mogle imati pozitivne nalaze za ostale tipove HPV-a (96% ukupne populacije).
English: Please tell your doctor or pharmacist if you or your child are taking or have taken recently any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vi ili Vaše dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Duration of protection of a 2-dose schedule of Silgard has not been established.
Croatian: Trajanje zaštite cijepljenja sa 2 doze cjepiva Silgard nije ustanovljeno.
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Croatian: Stoga, obavijestite liječnika ili medicinsku sestru ako ste se onesvijestili kod prijašnjih
English: The data on Silgard administered during pregnancy did not indicate any safety signal.
Croatian: Podaci o primjeni cjepiva Silgard za trajanja trudnoće nisu ukazali na bilo koji sigurnosni signal.
English: For any information about this medicinal product, please contact the local representative of the
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje
English: Name and address of the manufacturers of the biological active substances
Croatian: Nazivi i adrese proizvođača bioloških djelatnih tvari
English: The use of Silgard in adult women should take into consideration the variability of HPV type prevalence in different geographical areas.
Croatian: Prilikom primjene cjepiva Silgard u odraslih žena potrebno je uzeti u obzir razlike u prevalenciji tipova HPV-a na različitim geografskim područjima.
English: Silgard cannot cause the diseases it protects against.
Croatian: Silgard ne može prouzročiti bolesti od kojih Vas štiti.
English: Therefore Silgard can be used during breast-feeding.
Croatian: Silgard se stoga može koristiti tijekom dojenja.
English: Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, or other causes, may not respond to the vaccine.
Croatian: Pojedinci s oštećenim imunološkim odgovorom zbog primjene snažne imunosupresivne terapije, genetske mane ili iz drugih razloga, možda neće odgovoriti na cjepivo.
English: Therefore, it is important that the same vaccine should be prescribed for the whole dose regimen.
Croatian: Stoga je važno da se tijekom cijelog režima doziranja propisuje isto cjepivo.
English: As expected for women 24 to 45 years of age (Protocol 019), the observed antibody titres were lower than that seen in women 16 to 26 years.
Croatian: Kao što se i očekivalo u žena u dobi od 24 do 45 godina (Protokol 019), opaženi titri protutijela bili su niži od onih u žena u dobi od 16 do 26 godina.
English: The requirement for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Clinical Trials
Croatian: Klinička ispitivanja
English: In clinical studies, 57.5% of women aged 16 to 26 years and 31.2% of women aged 24 to 45 years who received Silgard used hormonal contraceptives during the vaccination period.
Croatian: U kliničkim ispitivanjima, 57,5% žena u dobi od 16 do 26 godina i 31,2% žena u dobi od 24 do 45 godina, cijepljenih cjepivom Silgard uzimalo je hormonske kontraceptive tijekom perioda cijepljenja.
English: CIN 3 and AIS have been accepted as immediate precursors of invasive cervical
Croatian: CIN 3 i AIS općenito se smatraju izravnim prethodnicima invazivnog raka vrata maternice.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u
English: EXP MM/YYYY
Croatian: EXP MM/GGGG
English: The vaccine should be used as supplied; no dilution or reconstitution is necessary.
Croatian: Cjepivo se mora primijeniti u dostavljenom obliku; nije ga potrebno razrjeđivati ili rekonstituirati.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery.
Croatian: Može biti popraćena s nekoliko neuroloških znakova kao što su prolazni poremećaj vida, parestezija i toničko/klonički pokreti udova tijekom razdoblja oporavka.
English: Seroconversion to all four antigens occurred in more than ninety-six percent of the subjects.
Croatian: Serokonverzija na sva 4 antigena javila se u više od 96% ispitanika.
English: Among 15,706 individuals who received Silgard and 13,617 individuals who received placebo, there were 39 cases of non-specific arthritis/arthropathy reported, 24 in the Silgard group and 15 in the placebo group.
Croatian: Unutar 15 706 ispitanika koji su primili Silgard te 13 617 ispitanika koji su primili placebo, prijavljeno je 39 slučajeva nespecifičnog artritisa/artropatije, 24 u Silgard skupini i 15 u placebo skupini.
English: Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives and rash have been reported.
Croatian: Zabilježene su alergijske reakcije koje mogu uključivati otežano disanje, piskanje pri disanju (bronhospazam), koprivnjaču i osip.
English: These adverse reactions usually were mild or moderate in intensity.
Croatian: Ove nuspojave su obično bile blagog do umjerenog intenziteta.
English: Since no vaccine is 100% effective and Silgard will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
Croatian: Budući da nijedno cjepivo nije 100% učinkovito, ni Silgard neće pružiti zaštitu od svih tipova HPV-a, ili od već postojećih HPV infekcija, rutinski pregled vrata maternice od ključne je važnosti i treba ga provoditi u skladu s lokalnim
English: Efficacy was measured starting after the Month 7 visit.
Croatian: Djelotvornost se počela mjeriti nakon posjeta u 7-om mjesecu ispitivanja.
English: No effects on male fertility were observed in rats (see section 5.3).
Croatian: Nije utvrđen učinak na plodnost mužjaka štakora (vidjeti dio 5.3).
English: Immune Responses to Silgard at 1 month post dose 3
Croatian: Imunološki odgovori na Silgard 1 mjesec nakon 3. doze
English: During clinical trials, dizziness was observed as a common adverse reaction in females.
Croatian: Za vrijeme kliničkih ispitivanja, omaglica je opažena kao česta nuspojava u žena.
English: - genital warts (condyloma acuminata) causally related to specific HPV types.
Croatian: - genitalnih bradavica (condylomata acuminata) prouzročenih posebnim tipovima HPV-a.
English: Safety and immunogenicity of the vaccine have been assessed in individuals aged from 7 to 12 years who are known to be infected with human immunodeficiency virus (HIV) (see section 5.1).
Croatian: Sigurnost i imunogenost cjepiva ocijenjena je u pojedinaca u dobi od 7 do 12 godina u kojih je prisutna infekcija virusom humane imunodeficijencije (HIV) (vidjeti dio 5.1).
English: In 7 clinical trials (6 placebo-controlled), individuals were administered Silgard or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
Croatian: U 7 kliničkih ispitivanja (6 placebom kontroliranih) ispitanici su primili Silgard odnosno placebo na dan uključenja u ispitivanje i otprilike 2 i 6 mjeseci nakon toga.
English: Syncope (fainting), sometimes associated with falling, can occur following, or even before, any vaccination, especially in adolescents as a psychogenic response to the needle injection.
Croatian: Sinkopa (nesvjestica) ponekad povezana s padom može uslijediti nakon, ili čak i prije svakog cijepljenja, osobito u adolescenata kao psihogeni odgovor na ubod iglom.
English: Like all vaccines and medicines, Silgard can cause side effects, although not everybody gets them.
Croatian: Kao i sva cjepiva i lijekovi, Silgard može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: There was no evidence of protection from disease caused by vaccine HPV types for which women were PCR positive at day 1.
Croatian: Nije bilo dokaza o zaštiti od bolesti prouzročene tipovima HPV-a sadržanim u cjepivu na koje su žene bile PCR pozitivne 1-og dana ispitivanja.
English: Silgard is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Croatian: Silgard je namijenjen samo za profilaktičku primjenu i ne djeluje na aktivne HPV infekcije ili klinički razvijenu bolest.
English: Persistence of Immune Response of Silgard
Croatian: Trajnost imunološkog odgovora na Silgard
English: Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.
Croatian: Vrlo rijetko (manje od 1 na 10 000 osoba) je zabilježeno otežano disanje (bronhospazam).
English: At 36 month follow-up, the GMT in girls (2 doses, n = 86) remained non-inferior to the GMT in women (3 doses, n = 86) for all 4 HPV types.
Croatian: Nakon 36 mjeseci praćenja, GMT u djevojčica (2 doze, n=86) ostao je neinferioran GMT-u u žena (3 doze, n=86) za sva 4 tipa HPV-a.
English: There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Silgard and placebo treated individuals.
Croatian: Nije bilo značajnih razlika u vrsti anomalija ili udjelu trudnoća s nepovoljnim ishodom između pojedinaca koji su primili Silgard i koji su primili placebo.
English: The clinical relevance of the lower response is unknown.
Croatian: Klinička značajnost slabijeg odgovora nije poznata.
English: During the clinical development program, 3,819 women (vaccine = 1,894 vs. placebo = 1,925) reported at least one pregnancy.
Croatian: Tijekom programa kliničkog razvoja, 3819 žena (1894 cijepljenih naspram 1925 na placebu) prijavilo je barem jednu trudnoću.
English: Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
Croatian: Stoga treba nastaviti primjenjivati odgovarajuću zaštitu od spolno prenosivih bolesti.
English: This vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Croatian: Cjepivo treba oprezno primjenjivati u osoba s trombocitopenijom odnosno bilo kojim poremećajem u zgrušavanju krvi, budući da intramuskularna primjena cjepiva u ovih osoba može dovesti do
English: This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of Silgard (see section 4.8).
Croatian: Nalaz se temelji na rezultatima kliničkog ispitivanja u kojem se kombinirano dTap-IPV cjepivo primijenilo istodobno s prvom dozom cjepiva Silgard (vidjeti dio 4.8).
English: The vaccine also produces type-specific antibodies in 9- to 15-year-old children and adolescents.
Croatian: Cjepivo također potiče nastanak protutijela specifičnih na tip virusa u djece i adolescenata u dobi od 9 do 15 godina.
English: Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
Croatian: Ispitivanja toksičnosti pojedinačne doze, ponovljenih doza i lokalne podnošljivosti nisu ukazala na poseban rizik za ljude.
English: Silgard will not protect against every type of Human Papillomavirus.
Croatian: Silgard Vas neće zaštititi od svih tipova ljudskog papilomavirusa.
English: % Efficacy (95%CI)
Croatian: % Djelotvornosti (95%CI)
English: Silgard may be given to women who are breast-feeding or intend to breast-feed.
Croatian: Cjepivom Silgard mogu se cijepiti žene koje doje ili namjeravaju dojiti.
English: As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Croatian: Kao i sa svim cjepivima koja se injiciraju uvijek je potrebno osigurati odgovarajući liječnički tretman u slučaju rijetkih anafilaktičkih reakcija nakon primjene cjepiva.
English: Silgard will not protect against other diseases that are not caused by Human Papillomavirus.
Croatian: Silgard ne štiti od drugih bolesti koje ne uzrokuje ljudski papilomavirus.