FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will decide the appropriate dose for your child.
Croatian: Vaš će liječnik donijeti odluku o dozi koja je prikladna za Vaše dijete.
English: The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Croatian: Znakovi pandemijske gripe slični su onima obične gripe, ali mogu biti ozbiljniji.
English: If this applies to you then your vaccination will be postponed until you are feeling better.
Croatian: Ako se ovo odnosi na Vas, cijepljenje će biti odgođeno dok se budete osjećali bolje.
English: Date and time of mixing:
Croatian: Datum i vrijeme miješanja:
English: In such cases, the Western blot method is negative.
Croatian: U takvim slučajevima tehnika Western blot daje negativne rezultate.
English: Loss of appetite
Croatian: gubitak apetita
English: >80 years
Croatian: >80 godina
English: Date of latest renewal: 28 November 2017
Croatian: Datum posljednje obnove odobrenja: 28. studenog 2017.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Croatian: Dokazana kemijska i fizikalna stabilnost u primjeni je 24 sata pri 25°C.
English: • if you have a serious infection with a high temperature (over 38°C).
Croatian: • ako imate ozbiljnu infekciju praćenu visokom temperaturom (iznad 38°C).
English: For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom cjepivu obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Do not have Prepandrix if any of the above apply to you.
Croatian: Nemojte primiti Prepandrix ako se bilo što od gore navedenoga odnosi na Vas.
English: 71 to 80 years
Croatian: 71 do 80 godina
English: Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Croatian: Pandemijska gripa je tip influence koja se pojavljuje u intervalima koji variraju od manje od 10 godina do više desetljeća.
English: When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Croatian: Kada osoba primi cjepivo, prirodni tjelesni obrambeni sustav (imunološki sustav) stvoriti će svoju vlastitu zaštitu (protutijela) od bolesti.
English: Tell the doctor requesting these tests that you have recently received Prepandrix.
Croatian: Recite liječniku koji zahtijeva navedene pretrage da ste nedavno primili Prepandrix.
English: A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Prepandrix.
Croatian: Manja infekcija poput prehlade ne bi trebala predstavljati problem, no liječnik će Vas savjetovati možete li se unatoč tome cijepiti cjepivom Prepandrix.
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Croatian: • ako ćete obavljati krvnu pretragu kojom se dokazuje infekcija određenim virusima.
English: As with all vaccines, Prepandrix may not fully protect all persons who are vaccinated.
Croatian: Kao i sa svim cjepivima, Prepandrix ne može u potpunosti pružiti zaštitu svim osobama koje su cijepljene.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove ili ako ste nedavno primili neko drugo cjepivo.
English: See sections 4.4, 4.8 and 5.1.
Croatian: Vidjeti dijelove 4.4, 4.8 i 5.1.
English: The safety and efficacy of Prepandrix in children aged less than 3 years and in children and adolescents aged 10 to 17 years have not been established.
Croatian: Sigurnost i djelotvornost cjepiva Prepandrix u djece mlađe od 3 godine te u djece i adolescenata u dobi od 10 do 17 godina nisu još ustanovljene.
English: None of the ingredients in the vaccine can cause flu.
Croatian: Ni jedan sastojak cjepiva ne može izazvati gripu.
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: The vaccine contains an ‘adjuvant' AS03.
Croatian: Cjepivo sadrži „adjuvans“ AS03.
English: See sections 4.4, 4.8 and 6.1.
Croatian: Vidjeti dijelove 4.4, 4.8 i 6.1.
English: • if you have problems with your immune system, since your response to the vaccine may then be poor.
Croatian: • ako imate problema s imunološkim sustavom, s obzirom da bi tada reakcija na cjepivo mogla biti slaba.
English: Alternative schedules
Croatian: Alternativni rasporedi
English: In particular, tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system.
Croatian: Osobito, obavijestite svog liječnika ili medicinsku sestru ako uzimate bilo kakvu terapiju (poput liječenja kortikosteroidima ili kemoterapije za karcinom) koja utječe na imunološki sustav.
English: Adjuvants are used to improve the body's response to the vaccine.
Croatian: Adjuvansi se koriste radi poboljšanja odgovora tijela na cjepivo.
English: Information from non-clinical studies:
Croatian: Podaci iz nekliničkih ispitivanja:
English: In the first few weeks after vaccination with Prepandrix the results of these tests may not be correct.
Croatian: U prvih nekoliko tjedana nakon cijepljenja cjepivom Prepandrix rezultati takvih pretraga mogu biti netočni.
English: It is important that procedures are in place to avoid injury from faints.
Croatian: Važno je postojanje utvrđene procedure kako bi se izbjegle ozljede prilikom nesvjestica.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive 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 što primite ovo cjepivo.
English: However, in the case this needle size would not be available, a 21-G needle might be used.
Croatian: Međutim, ako ta veličina igle nije na raspolaganju, može se upotrijebiti igla promjera 21-G.
English: Prepandrix is a vaccine for use in adults from 18 years old.
Croatian: Prepandrix je cjepivo za primjenu u odraslih osoba starijih od 18 godina.
English: • Allergic reactions leading to a dangerously low blood pressure.
Croatian: • alergijske reakcije koje mogu rezultirati opasno niskim krvnim tlakom.
English: • This will usually be in the upper arm.
Croatian: • To će obično biti u mišić nadlaktice.
English: • Other ingredients:
Croatian: • Drugi sastojci:
English: In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Croatian: Uz to, u postmarketinškom praćenju interpandemijskih trovalentnih cjepiva, prijavljene su sljedeće nuspojave:
English: • Serious stabbing or throbbing pain along one or more nerves
Croatian: • jaka probadajuća ili pulsirajuća bol uzduž jednog ili više živaca
English: What you need to know before you receive Prepandrix
Croatian: Što morate znati prije nego primite Prepandrix
English: Other medicines and Prepandrix
Croatian: Drugi lijekovi i Prepandrix
English: Other information
Croatian: Dodatne informacije
English: • The double injections will be given in opposite arms.
Croatian: • Dvostruke injekcije će se davati u suprotne ruke.
English: Available epidemiological data in adults aged over 20 years have indicated approximately 1 additional case per 100,000 vaccinated subjects.
Croatian: Dostupni epidemiološki podaci u odraslih osoba starijih od 20 godina pokazali su približno 1 dodatan slučaj na 100 000 cijepljenika.
English: At day 180, the seroprotection rate was 13%.
Croatian: Na 180. dan stopa seroprotekcije bila je 13%.
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom ili medicinskom sestrom prije nego primite ovo cjepivo.
English: Tell your doctor if you have any known allergies.
Croatian: Obavijestite liječnika o svojim poznatim alergijama.
English: The use of Prepandrix may be considered during pregnancy if this is thought to be necessary taking into account official recommendations.
Croatian: Može se razmotriti primjena cjepiva Prepandrix tijekom trudnoće, ako se smatra neophodnom, uzimajući u obzir službene preporuke.
English: • if you have a bleeding problem or you bruise easily.
Croatian: • ako imate problema s krvarenjem ili lako dobivate modrice.
English: anti-HA antibody
Croatian: anti-HA protutijelo
English: Prepandrix can still be given but your response to the vaccine may be poor.
Croatian: Još uvijek možete primiti Prepandrix, ali Vaša reakcija na cjepivo može biti slaba.
English: No case of overdose has been reported.
Croatian: Nije prijavljen slučaj predoziranja.
English: Your doctors know that this might happen and will have emergency treatment ready to use.
Croatian: Liječnici znaju da se to može dogoditi i imaju pribor za hitnu intervenciju spreman za uporabu.
English: Shivering NA=not available
Croatian: drhtanje ND=nije dostupno
English: OTHER Storage (2ºC-8ºC), do not freeze, protect from light
Croatian: Čuvati na temperaturi 2ºC-8ºC, ne zamrzavati, zaštititi od svjetlosti.
English: • Generalised skin reactions including urticaria (hives)
Croatian: • generalizirane kožne reakcije uključujući urtikariju (koprivnjaču)
English: It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Croatian: Namijenjeno je za primjenu prije ili tijekom sljedeće pandemije influence (gripe) kako bi se spriječila gripa uzrokovana virusom podtipa H5N1.
English: 3.75 micrograms**
Croatian: 3,75 mikrograma**
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude temeljem konvencionalnih ispitivanja sigurnosne farmakologije, akutne i toksičnosti ponovljenih doza, lokalne podnošljivosti, plodnosti ženki, embrio-fetalne i postnatalne toksičnosti (do kraja razdoblja laktacije).
English: 0, 6 months schedule (D-Pan-H5N1-012)
Croatian: režim 0, 6 mjeseci (D-Pan-H5N1-012)
English: After the addition of the adjuvant to the antigen, the mixture should be well shaken.
Croatian: Nakon dodavanja adjuvansa u antigen, mješavinu treba dobro protresti.
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 uključivati kožni osip sa svrbežom, nedostatak zraka i oticanje lica ili jezika.
English: • Adjuvant:
Croatian: • Adjuvans:
English: The first two injections should be given at the elected date and the two other injections should preferably be given 3 weeks after.
Croatian: Prve dvije injekcije trebate primiti odabranog datuma, a druge dvije bi trebali dobiti po mogućnosti 3 tjedna nakon toga.
English: Prepandrix should not be given:
Croatian: Prepandrix se ne smije primijeniti:
English: If a double dose is given, the injections should be given into opposite limbs.
Croatian: Ako se daje dvostruka doza, injekcije se moraju dati u suprotne udove.
English: • They will give Prepandrix as an injection into a muscle.
Croatian: • Oni će Vam dati Prepandrix injekcijom u mišić.
English: Prepandrix should be used in accordance with official guidance.
Croatian: Prepandrix se mora primjenjivati u skladu sa službenim preporukama.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Croatian: Kao što je slučaj sa svim injekcijskim cjepivima, uvijek treba imati odmah dostupno odgovarajuće medicinsko liječenje i nadzor za slučaj rijetke anafilaktičke reakcije nakon primjene cjepiva.
English: • From 80 years onwards: you may receive two double injections of Prepandrix.
Croatian: • Osobe starije od 80 godina: možda ćete primiti dvije dvostruke injekcije cjepiva Prepandrix.
English: Prepandrix consists of two containers:
Croatian: Prepandrix sadrži dva spremnika:
English: These data suggest that the excess risk tends to decline with increasing age at vaccination.
Croatian: Ovi podaci upućuju na to da se povećan rizik smanjuje kako se povećava dob pri cijepljenju.
English: 3.75 micrograms*
Croatian: 3,75 mikrograma*
English: The side effects listed below have happened in the days or weeks after vaccination with other vaccines given routinely every year to prevent flu.
Croatian: Niže navedene nuspojave su se pojavile nekoliko dana ili tjedana nakon cijepljenja s cjepivima koja se primjenjuju rutinski svake godine za sprječavanje gripe.
English: What Prepandrix is and what it is used for What you need to know before you receive Prepandrix How Prepandrix is given
Croatian: Što je Prepandrix i za što se koristi Što morate znati prije nego primite Prepandrix
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature (for a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Croatian: Prije miješanja dvije komponente, emulziju (adjuvans) i suspenziju (antigen) treba zagrijati na sobnu temperaturu (najmanje 15 minuta); svaku bočicu treba protresti i vizualno pregledati na prisutnost stranih čestica i/ili promjenu fizičkog izgleda.
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C.
Croatian: Pripremljeno cjepivo može se čuvati ili u hladnjaku (2°C - 8°C) ili na sobnoj temperaturi koja ne prelazi 25°C.
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Croatian: Zbog toga zdravstveni radnici trebaju procijeniti koristi i moguće rizike primjene cjepiva u osoba s trombocitopenijom ili drugim poremećajima s krvarenjem koji mogu biti kontraindikacija za primjenu intramuskularne injekcije, osim ako moguća korist nadilazi rizik od krvarenja.
English: A complete vaccination course with Prepandrix consists of two doses.
Croatian: Potpuni postupak cijepljenja cjepivom Prepandrix provodi se s dvije doze.
English: The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.
Croatian: Bočica koja sadrži adjuvans treba se držati u okomitom položaju gornjom stranom okrenuta prema dolje, kako bi se olakšalo izvlačenje cijelog sadržaja.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Croatian: Uz nju mogu se javiti razni neurološki znakovi poput prolaznog poremećaja vida, parestezija i toničko-kloničkih pokreta udova tijekom oporavka.
English: What Prepandrix is and what it is used for
Croatian: Što je Prepandrix i za što se koristi
English: If this is not treated it may lead to shock.
Croatian: Ako ih se ne liječi mogu dovesti do šoka.
English: It should be noted that the adverse reactions may be intensified.
Croatian: Treba uzeti u obzir da nuspojave mogu biti pojačane.
English: Animal studies with Prepandrix containing A/Vietnam/1194/2004 do not indicate reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama cjepiva Prepandrix koje sadrži A/Vietnam/1194/2004 nisu ukazala na reproduktivnu toksičnost (vidjeti dio 5.3).
English: If this is not treated, it may lead to shock.
Croatian: ako ih se ne liječi, mogu dovesti do šoka.
English: • From 18 years onwards: you will receive two doses of Prepandrix.
Croatian: • Osobe starije od 18 godina: primit ćete dvije doze cjepiva Prepandrix.
English: Prepandrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Croatian: Prepandrix sadrži tiomersal kao konzervans te postoji mogućnost da razvijete alergijsku reakciju na njega.
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Croatian: U nekih cijepljenih osoba možda neće biti postignut zaštitni imunološki odgovor (vidjeti dio 5.1).
English: The volume of the Prepandrix vial after mixing is at least 5 ml.
Croatian: Volumen cjepiva Prepandrix u bočici nakon miješanja iznosi najmanje 5 ml.
English: The requirements 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 web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentntnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenim na europskom internetskom portalu za lijekove.
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Croatian: Nakon cijepljenja protiv influence, zabilježeni su lažno pozitivni rezultati seroloških testova metodom ELISA za otkrivanje protutijela protiv virusa humane imunodeficijencije 1 (HIV-1), hepatitisa C i osobito HTLV-1.
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Croatian: Neurološki poremećaji poput encefalomijelitisa, neuritisa i Guillain Barréovog sindroma.
English: After mixing: Use within 24 hours and do not store above 25°C.
Croatian: Nakon miješanja: primijeniti unutar 24 sata i ne čuvati na temperaturi iznad 25°C.
English: 4.7 Effects on ability to drive and use machines Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Pojedine nuspojave navedene u dijelu 4.8 „Nuspojave“ mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Croatian: Imunizacija se provodi intramuskularnom injekcijom, po mogućnosti u deltoidni mišić ili anterolateralni dio bedra (ovisno o mišićnoj masi).
English: • Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘GuillainBarré Syndrome'.
Croatian: • tegobe s mozgom i živcima poput upale središnjeg živčanog sustava (encefalomijelitis), upale živaca (neuritis) ili određene vrste paralize poznate kao „Guillain-Barréov sindrom“.
English: However, following two administrations of a double dose of vaccine, the seroprotection rate at day 42 was 75%.
Croatian: Međutim, nakon dvije primjene dvostruke doze cjepiva, stopa seroprotekcije 42. dana bila je 75%.
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Croatian: Obavijestite stoga liječnika ili medicinsku sestru ako ste izgubili svijest prilikom primanja prošle injekcije.
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Croatian: Podaci u trudnica cijepljenih različitim inaktiviranim sezonskim cjepivima bez adjuvansa ne ukazuju na malformacije niti na fetalni, odnosno neonatalni toksični učinak.
English: An AS03-containing vaccine containing HA from H1N1v has been administered to women in each trimester of pregnancy.
Croatian: Cjepivo koje sadrži AS03 i hemaglutinine iz H1N1v je primijenjeno u žena u svakom trimestru trudnoće.
English: If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Croatian: Djeca Ako Vaše dijete primi cjepivo, morate imati na umu da nuspojave mogu biti izraženije nakon primjene druge doze, osobito temperatura iznad 38ºC.
English: Immunisation should be postponed in subjects with a severe febrile illness or acute infection.
Croatian: Imunizaciju bolesnika s teškom febrilnom bolešću ili akutnim infekcijama treba odgoditi.
English: It is recommended to equip the syringe with a 23-G needle.
Croatian: Preporučuje se rabiti štrcaljku s iglom promjera 23-G.
English: They may also happen with Prepandrix.
Croatian: One se također mogu dogoditi s cjepivom Prepandrix.
English: There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Croatian: Nema podataka o primjeni AS03-adjuvantiranog cjepiva prije ili nakon drugih vrsta cjepiva protiv influence koja su namijenjena za primjenu prije ili tijekom pandemije.
English: Allergic reactions which may cause you to have dangerously low blood pressure.
Croatian: Alergijske reakcije Alergijske reakcije koje mogu rezultirati opasno niskim krvnim tlakom.
English: Instructions for mixing and administration of the vaccine:
Croatian: Upute za miješanje i primjenu cjepiva:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: Against A/Indonesia 21 days after boosting with A/Indonesia N=49
Croatian: protiv A/Indonesia 21 dan nakon docjepljivanja s A/Indonesia N=49
English: Special population:
Croatian: Posebne populacije bolesnika:
English: What Prepandrix looks like and contents of the pack
Croatian: Kako Prepandrix izgleda i sadržaj pakiranja
English: Half dose
Croatian: Pola doze
English: All subjects achieved a neutralising antibody titre of at least 1:80 against each of the two strains regardless of the HA type in the vaccine and the previous number of doses.
Croatian: Svi ispitanici postigli su titar neutralizirajućih protutijela od najmanje 1:80 prema svakom od dva soja, neovisno o tipu hemaglutinina u cjepivu ili o broju prethodnih doza.
English: However, in the event of an officially declared influenza pandemic, persons previously vaccinated with one or two doses of Prepandrix that contained HA antigen derived from a different clade of the same influenza subtype as the pandemic influenza strain may receive a single dose of Adjupanrix instead of two doses that are required in previously unvaccinated individuals.
Croatian: Međutim, u slučaju službeno proglašene pandemije influence, osobe koje su ranije cijepljene s jednom ili dvije doze cjepiva Prepandrix koje sadrži antigene hemaglutinina (HA) iz različitih linija (engl: clade) istog podtipa influence kao i virus pandemijske influence, mogu primiti jednu dozu cjepiva Adjupanrix umjesto dvije doze koje su potrebne u prethodno necijepljenih pojedinaca.
English: The vaccine should not be administered intravascularly.
Croatian: Cjepivo se ne smije primijeniti intravaskularno.
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, ovo cjepivo može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: Prepandrix should under no circumstances be administered intravascularly.
Croatian: Prepandrix se ni u kojim okolnostima ne smije primijeniti intravaskularno.