FrancophonIA/ELRC3.0 huggingface dataset:
English: CRPS is a chronic pain syndrome affecting a limb, while POTS is a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, as well as headache, aches and pains, nausea and fatigue.
Croatian: KRBS je kronični bolni sindrom koji pogađa ud, dok je SPOT stanje u kojem se brzina otkucaja srca povećava na abnormalnu razinu pri sjedenju ili ustajanju, zajedno sa simptomima kao što su vrtoglavica, nesvjestica i osjećaj slabosti te glavobolja, bolovi i smetnje, mučnina i umor.
English: • There are therefore no recommendations to change the way in which the vaccines are used and no changes have been made to the prescribing information for these vaccines.
Croatian: • Stoga ne postoje preporuke o izmjeni načina na koji se cjepiva primjenjuju te nisu unesene izmjene informacija o propisivanju tih cjepiva.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom account detailed information received from a number of patient groups that also highlighted the impact these syndromes can have on patients and families.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Use of these vaccines is expected to prevent many cases of cervical cancer as well as various other cancers and conditions caused by HPV.
Croatian: Očekuje se da će se primjenom tih cjepiva spriječiti brojni slučajevi raka grlića maternica te druge vrste raka i stanja koja uzrokuje HPV.
English: These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions.
Croatian: Cijepljenje se provodi u svrhu zaštite od raka grlića maternice te ostalih vrsta raka i stanja koja prethode razvoju raka, a povezana su s HPV-om.
English: In reaching its recommendations, it also consulted a group of leading experts in the field, and took into
Croatian: U donošenju svojih preporuka također se posavjetovao sa skupinom vodećih stručnjaka u ovom području i uzeo u obzir podrobne informacije koje je primio od više skupina bolesnika u kojima su također istaknuti mogući učinci tih sindroma na bolesnike i obitelji.
English: Vaccine
Croatian: Tel.
English: • There have been reports of two syndromes, CRPS and POTS, in girls who have been given HPV vaccines.
Croatian: • U djevojaka koje su cijepljene protiv HPV-a prijavljeni su slučajevi dvaju sindroma, KRBS-a i SPOTa.
English: Exposure was estimated at 171,000 infants per year.
Croatian: Izloženost je procijenjena na 171 000 dojenčadi godišnje.
English: Ask your pharmacist how to throw away vaccines you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: • Crying.
Croatian: • plač
English: Not known (Frequency cannot be estimated from the available data)*
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka)*
English: Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Croatian: Čak i u starijih žena (u dobi od 35-45 godina) te se reakcije općenito dobro podnose i rijetko ometaju uobičajene aktivnosti.
English: Symptoms may persist for a matter of months or on rare occasions for years.
Croatian: Simptomi mogu trajati i mjesecima, a u rijetkim prilikama i godinama.
English: All adverse reactions were evaluated in 1940 children.
Croatian: Sve nuspojave su se procjenjivale u 1940 djece.
English: The interval between 2 doses should be at least 4 weeks.
Croatian: Razmak između 2 doze treba biti najmanje 4 tjedna.
English: 71% of the reports (212 of 297) concerned crying with a time to onset of more than 24 hours.
Croatian: 71% prijava (212 od 297) odnosilo se na plač s vremenom nastupa duljim od 24 sata.
English: Active untreated tuberculosis.
Croatian: Aktivna neliječena tuberkuloza.
English: These data were reported based on more than 400 million doses distributed worldwide.
Croatian: Ti su podaci prijavljeni iz primjene više od 400 milijuna doza u cijelom svijetu.
English: Seroprotection rates [95% CI]
Croatian: stopa seroprotekcije [95% CI]
English: If, however, the vaccine is given a few days before exposure, substantial protection may be afforded.
Croatian: Međutim, ako se cjepivo primjeni nekoliko dana prije izlaganja, može se pružiti znatna zaštita.
English: Under special circumstances, it can be given from 9 months of age.
Croatian: U posebnim okolnostima, može se primijeniti od 9 mjeseci starosti.
English: The second dose is intended for individuals who did not respond to the first dose for any reason.
Croatian: Druga je doza namijenjena pojedincima koji iz bilo kojeg razloga nisu imali odgovor na prvu dozu.
English: DO NOT INJECT INTRAVASCULARLY.
Croatian: NE INJICIRATI INTRAVASKULARNO.
English: A second dose may be administered at least 4 weeks after the first dose in accordance with official recommendation.
Croatian: Druga se doza može primijeniti najmanje 4 tjedna nakon prve doze u skladu sa službenim preporukama.
English: Current immunosuppressive therapy (including high doses of corticosteroids).
Croatian: Aktualna imunosupresivna terapija (uključujući visoke doze kortikosteroida).
English: Further doses should be administered according to your doctor's recommendation.
Croatian: Daljnje doze se primjenjuju prema preporuci Vašeg liječnika.
English: Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vi ili Vaše dijete uzimate ili ste nedavno uzeli bilo koje druge lijekove (ili primili druga cjepiva).
English: In 297 reports a clear time to onset could be determined.
Croatian: Za 297 prijava bilo je moguće odrediti točno vrijeme nastupa.
English: Aseptic meningitis
Croatian: Aseptički meningitis
English: • Fever (38.5°C or higher).
Croatian: • vrućica (38,5°C ili viša)
English: Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a >99% reduction in the incidence of each of the 3 targeted diseases.
Croatian: Široka primjena dvije doze prema kalendaru cijepljenja u Sjedinjenim Američkim Državama i zemljama poput Finske i Švedske dovela je do >99% smanjenja incidencije svake od te 3 ciljne bolesti.
English: Vaccination should be postponed during any illness with fever >38.5°C.
Croatian: Cijepljenje se mora odgoditi za vrijeme trajanja bilo koje bolesti s vrućicom >38,5°C.
English: Interference with laboratory tests: see section 4.5.
Croatian: Utjecaj na laboratorijske pretrage: vidjeti dio 4.5.
English: After reconstitution, one dose (0.5 ml) contains:
Croatian: Nakon rekonstitucije, jedna doza (0,5 ml) sadrži:
English: Women who intend to become pregnant should be advised to delay.
Croatian: Ženama koje namjeravaju zatrudnjeti potrebno je savjetovati da odgode trudnoću.
English: Do not throw away any vaccines via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: 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.
Croatian: Direktive 2001/83/EZ, službeno puštanje serije lijeka u promet preuzet će državni laboratoriji ili laboratorij određen za tu svrhu.
English: The antibodies help protect against infections caused by these viruses.
Croatian: Ta protutijela pomažu u zaštiti od zaraza uzrokovanih tim virusima.
English: Date of first authorisation: 11 May 2006 Date of latest renewal: 11 May 2011
Croatian: Datum prvog odobrenja: 11. svibnja 2006.
English: The vaccine may contain traces of recombinant human albumin (rHA).
Croatian: Cjepivo može sadržavati rekombinantni ljudski albumin (rHA) u tragovima.
English: Therefore, based on the aforementioned information the PRAC recommends a variation in section 4.8 to add “Crying” with the frequency “uncommon”.
Croatian: Stoga, temeljem prethodno navedenih informacija, PRAC preporučuje izmjenu dijela 4.8 SmPC-a dodavanjem nuspojave „plač“ s učestalošću „manje često“.
English: • Whenever the risk management system is modified , especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Do not freeze the reconstituted vaccine.
Croatian: Ne zamrzavajte rekonstituirano cjepivo.
English: • Bruising or bleeding more easily than normal.
Croatian: • stvaranje modrica ili krvarenje više nego obično
English: Non-pregnant adolescent and adult females
Croatian: Adolescentice i odrasle žene koje nisu trudne
English: In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: The majority of the crying occurred 6 to 10 days after vaccination.
Croatian: Većina nuspojava plača nastupila je 6 do 10 dana nakon cijepljenja.
English: Adverse reactions are ranked under headings of frequency using the following convention: [Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to ≤1/100); Not known (cannot be estimated from the available data)]
Croatian: Nuspojave su razvrstane prema učestalosti pojavljivanja, definiranoj kao: [vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i ≤1/100); nepoznato (ne može se procijeniti iz dostupnih podataka)]
English: If two needles are provided: use one needle to reconstitute the vaccine and the other for its administration to the person to be vaccinated.
Croatian: Ako su priložene dvije igle: jednu iglu upotrijebite za rekonstituciju cjepiva, a drugu za primjenu cjepiva osobi koja će se cijepiti.
English: Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze ne bi trebali primiti ovo cjepivo.
English: This latency period appears to correspond with the time to onset of general malaise that often occurs after the MMR vaccination.
Croatian: Čini se da ovo razdoblje latencije odgovara vremenu do nastupa opće malaksalosti, koja često nastupa nakon cijepljenja MMR cjepivom.
English: Non-clinical studies have not been conducted.
Croatian: Nisu provedena neklinička ispitivanja lijeka.
English: Individuals 12 months of age or older:
Croatian: Osobe u dobi od 12 mjeseci i stariji:
English: The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults.
Croatian: Najpogodnija mjesta za primjenu injekcije su anterolateralno područje bedra u mlađe djece i deltoidno područje u starije djece, adolescenata i odraslih.
English: One dose is given at an elected date usually from 12 months of age.
Croatian: Daje se jedna doza na odabrani datum uglavnom od 12 mjeseci starosti nadalje.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primite ovo cjepivo.
English: In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12-20%), and the reactions tend to be more marked and of longer duration.
Croatian: U žena su stope incidencije artritisa i artralgije općenito više od onih u djece (12-20%), a reakcije su izraženije i dugotrajnije.
English: The conclusion of the MAH is not endorsed by the PRAC.
Croatian: Ovaj zaključak nositelja odobrenja nije podržan od strane PRAC-a.
English: Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
Croatian: Izlučivanje malih količina živog atenuiranog virusa rubele iz nosa ili grla bilo je prisutno u većine osjetljivih osoba 7 do 28 dana nakon cijepljenja.
English: Individuals 12 months or older should receive one dose at an elected date.
Croatian: Osobe od 12 mjeseci starosti nadalje trebaju primiti jednu dozu cjepiva na odabrani datum.
English: Like all vaccines and 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: In the infants with serological evidence of rubella infection, none had symptomatic disease.
Croatian: Niti jedno dojenče sa serološkim dokazom rubela infekcije nije imalo simptomatsku bolest.
English: Infants below 9 months of age:
Croatian: Dojenčad mlađa od 9 mjeseci:
English: No data on the efficacy and safety of M-M-RVAXPRO for use in children below 9 months of age are currently available.
Croatian: Trenutno nema dostupnih podataka o djelotvornosti i sigurnosti primjene cjepiva M-M-RVAXPRO u djece mlađe od 9 mjeseci.
English: Chronic arthritis
Croatian: Kronični artritis
English: The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Croatian: Profil sigurnosti primjene nakon primjene 1. i 2. doze cjepiva bio je općenito usporediv za kohorte svih dobnih skupina.
English: Pregnancy should be avoided for 1 month following vaccination.
Croatian: Trudnoću treba izbjegavati 1 mjesec nakon cijepljenja.
English: There is no evidence that measles vaccine can cause SSPE.
Croatian: Nema dokaza da cjepivo protiv morbila može prouzročiti SSPE.
English: After reconstitution, the vaccine should be used immediately; however, in-use stability has been demonstrated for 8 hours when refrigerated at 2°C-8°C.
Croatian: Nakon rekonstitucije, cjepivo se mora odmah primijeniti; međutim, dokazana stabilnost rekonstituiranog cjepiva u primjeni je 8 sati kada se čuva na hladnom pri temperaturi od 2°C - 8°C.
English: There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
Croatian: Nije dokazano da se takav virus može prenijeti na osobe podložne zarazi koje su u kontaktu sa cijepljenim osobama.
English: After vaccination with M-M-RVAXPRO, IG should not be given for 1 month, unless your doctor tells you otherwise.
Croatian: Nakon cijepljenja M-M-RVAXPRO cjepivom, IG se ne smije primijeniti sljedećih mjesec dana, osim ako Vam liječnik ne kaže suprotno.
English: The general safety profile of either administration routes were comparable, although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
Croatian: Oba puta primjene imala su usporediv opći sigurnosni profil, premda su reakcije na mjestu primjene bile manje česte u skupini cijepljenoj i.m. (15,8%) nego u skupini cijepljenoj s.c. (25,8%).
English: This vaccine contains a trace amount of neomycin.
Croatian: Ovo cjepivo sadrži neomicin u tragovima.
English: It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.
Croatian: Važno je da se za svaku osobu koja se cijepi koristi posebna sterilna štrcaljka i igla, kako bi se spriječio prijenos infektivnih čestica s jedne osobe na drugu.
English: An additional dose with a measles-containing vaccine should be considered according to official recommendations (see sections 4.4 and 5.1).
Croatian: Dodatna doza cjepiva koje sadrži morbile treba se razmotriti u skladu sa službenim preporukama (vidjeti dijelove 4.4 i 5.1).
English: Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination.
Croatian: Neki od tih slučajeva mogli su biti posljedica neprepoznatih ospica u prvoj godini života ili cijepljenja protiv morbila.
English: • Feeling sick (nausea).
Croatian: • osjećaj bolesti (mučnina)
English: Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours after exposure.
Croatian: Cijepljenje osoba izloženih divljem tipu virusa morbila može pružiti djelomičnu zaštitu ako se cjepivo primijeni u roku od 72 sata nakon izlaganja.
English: Valence (seropro tection level)
Croatian: Valencija (razina seroprotekcije)
English: Time point
Croatian: Vremenska točka
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Croatian: Proizvođač odgovoran za puštanje serije lijeka u promet: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN Haarlem, Nizozemska
English: When completely reconstituted, the vaccine is a clear yellow liquid.
Croatian: Potpuno rekonstituirano cjepivo je bistra žuta tekućina.
English: Arthralgia and/or arthritis
Croatian: Artralgija i/ili artritis
English: In these clinical studies, it was demonstrated that the immune responses were unaffected and that the overall safety profiles of the administered vaccines were similar.
Croatian: Ta su klinička ispitivanja pokazala da imunološki odgovor nije bio izmijenjen i da su cjepiva imala sličan opći sigurnosni profil.
English: The most common adverse reactions reported with the use of M-M-RVAXPRO were: fever (38.5°C or higher); injection site reactions including pain, swelling and erythema.
Croatian: Najčešće nuspojave prijavljene nakon primjene cjepiva M-M-RVAXPRO bile su: vrućica (38,5°C ili viša); reakcije na mjestu injekcije uključujući bol, oticanje i eritem.
English: In comparison to the first dose, a second dose of M-M-RVAXPRO is not associated with an increase in the incidence and severity of clinical symptoms including those suggestive of hypersensitivity reaction.
Croatian: U usporedbi s prvom dozom, druga doza cjepiva M-M-RVAXPRO nije povezana s povećanom incidencijom i težinom kliničkih simptoma uključujući one koji bi mogli ukazivati na reakciju preosjetljivosti.
English: Pharmacotherapeutic group: Viral vaccine, ATC code J07BD52
Croatian: Farmakoterapijska skupina: virusno cjepivo, ATK oznaka: J07BD52
English: M-M-RVAXPRO is available in packs of 1 and 10.
Croatian: M-M-RVAXPRO je dostupan u pakiranjima od 1 ili 10.
English: Although a theoretical risk cannot be excluded, no cases of congenital rubella syndrome have been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with a rubella-containing vaccine.
Croatian: Iako se ne može isključiti teoretski rizik, nije prijavljen nijedan slučaj sindroma kongenitalne rubeole na više od 3500 žena podložnih zarazi koje su, ne znajući da su u ranoj fazi trudnoće, bile cijepljene cjepivom koje je sadržavalo rubelu.
English: Although M-M-RVAXPRO contains live viruses, they are too weak to cause measles, mumps, or rubella in healthy people.
Croatian: Premda M-M-RVAXPRO sadrži žive viruse, oni su preslabi da bi izazvali morbile, parotitis ili rubelu u zdravih osoba.
English: The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or immune globulin (known as IG).
Croatian: Liječnik može odgoditi cijepljenje za najmanje 3 mjeseca nakon transfuzije krvi ili plazme ili imunoglobulina (poznatih kao IG).
English: Keep the vial of powder in the outer carton in order to protect from light.
Croatian: Bočicu s praškom čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: The physician should be alert to the temperature elevation that may occur following vaccination (see section 4.8).
Croatian: Liječnik treba voditi brigu o mogućem porastu temperature koji se može javiti nakon cijepljenja (vidjeti dio 4.8).
English: Withdraw the entire content of the reconstituted vaccine vial into the same syringe and inject the entire volume.
Croatian: Izvucite cijeli sadržaj rekonstituiranog cjepiva iz bočice u istu štrcaljku i injicirajte cijeli volumen.
English: In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women.
Croatian: U adolescentica je incidencija reakcija u sredini, između one u djece i one u žena.
English: Close monitoring is recommended following vaccination for the early signs of such reactions.
Croatian: Preporučuje se pažljivo pratiti takve osobe nakon cijepljenja, kako bi se prepoznali rani znakovi tih reakcija.
English: It is not known whether M-M-RVAXPRO can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
Croatian: Nije poznato može li M-M-RVAXPRO prouzročiti oštećenja fetusa kad se primjenjuje u trudnica i može li utjecati na reproduktivnu sposobnost.
English: The vaccine contains 14.5 mg of sorbitol.
Croatian: Ovo cjepivo sadrži 14,5 mg sorbitola.
English: Adults and adolescents with a history of allergies may potentially be at increased risk of anaphylaxis or anaphylactoid reactions.
Croatian: Odrasli i adolescenti s alergijama u anamnezi mogu imati povišen rizik od anafilaktične ili anafilaktoidne reakcije.
English: The vaccine may be administered to persons 12 months of age or older.
Croatian: Cjepivo se može primijeniti osobama od 12 mjeseci starosti nadalje.
English: Reconstitution instructions intended for medical and healthcare professionals are included at the end of the package leaflet.
Croatian: Upute za pripremu namijenjene zdravstvenim radnicima nalaze se na kraju ove upute o lijeku.
English: Following vaccination in children, reactions in joints are generally uncommon (0-3%) and of brief duration.
Croatian: U djece su nakon cijepljenja reakcije u zglobovima općenito manje česte (0-3%) i kratkotrajne.
English: M-M-RVAXPRO is to be used on the basis of official recommendations.
Croatian: Primjena M-M-RVAXPRO treba se temeljiti na službenim preporukama.
English: • Headache; fainting; nerve disorders which can cause weakness, tingling, or numbness; eye nerve disturbances.
Croatian: • glavobolja; nesvjestica; živčani poremećaj koji može uzrokovati slabost, osjećaj trnjenja ili obamrlost; smetnje očnog živca
English: Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues.
Croatian: Kronični artritis je bio povezan sa zarazom divljim tipom virusa rubele i povezuje se s perzistentnim virusom i/ili virusnim antigenom koji se može izolirati iz tkiva.
English: Currently no specific studies have been conducted on the concomitant use of M-M-RVAXPRO and other vaccines.
Croatian: Do danas nisu provedena posebna ispitivanja istodobne primjene M-M-RVAXPRO i drugih cjepiva.
English: Also, if the person who is to be vaccinated has already been exposed to the measles, mumps, or rubella virus but is not yet ill, M-M-RVAXPRO may not be able to prevent the illness from appearing.
Croatian: Također, ako je osoba koja će se cijepiti već bila izložena virusu morbila, parotitisa ili rubele, ali se još nije razboljela, M-M-RVAXPRO možda neće spriječiti pojavu bolesti.
English: Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (asymptomatic HIV patients, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Croatian: Cijepljenje se može uzeti u obzir u bolesnika s određenim imunodeficijencijama kod kojih su koristi veće od rizika (asimptomatski bolesnici s HIV-om, deficijencije podklase IgG, prirođena neutropenija, kronična granulomatozna bolest i bolesti deficijencije komplementa).