FrancophonIA/ELRC3.0 huggingface dataset:
English: What Foclivia is and what it is used for What you need to know before you receive Foclivia How Foclivia is given
Croatian: Što je Foclivia i za što se koristi Što trebate znati prije nego što primite Focliviju
English: In such cases, the side effects may be more intense).
Croatian: U takvim bi slučajevima nuspojave mogle biti pojačane).
English: MN results, similar to SRH results demonstrated strong immune response after completion of priming vaccination series in a population of elderly subjects.
Croatian: analize, slični rezultatima SRH analize, pokazali su snažan imunološki odgovor nakon dovršetka prve serije cijepljenja u populaciji starijih ispitanika.
English: What Foclivia looks like and contents of the pack
Croatian: Kako Foclivia izgleda i sadržaj pakiranja
English: Pandemic preparedness vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Croatian: Cjepiva spremna protiv pandemijske influence sadrže antigene influence koji su različiti od onih u trenutačno cirkulirajućim virusima influence.
English: Two doses of 7.5 micrograms were administered three weeks apart and a third dose 12 months following the first dose.
Croatian: Dvije doze od 7,5 mikrograma primijenjene su u razmaku od tri tjedna, a treća doza 12 mjeseci nakon prve doze.
English: The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
Croatian: Učestalost pojave simptoma primijećenih kod ispitanika starijih od 60 godina niža je od one kod populacije u dobi od 18 do 60 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 je gripa vrsta influence koja se javlja u intervalima koji variraju od manje od 10 godina do nekoliko desetljeća i brzo se širi diljem svijeta.
English: Foclivia can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Foclivia takes due account of the officially declared pandemic strain.
Croatian: Foclivia se može staviti u promet samo ako SZO/EU službeno proglasi pandemiju influence, pod uvjetom da nositelj odobrenja za stavljanje Foclivije u promet vodi računa o službeno proglašenom pandemijskom soju.
English: Although Foclivia in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Croatian: Iako Focetria u višedoznim spremnicima sadrži konzervans koji sprječava rast mikroorganizama, za smanjenje rizika od kontaminacije višedoznog spremnika prilikom izvlačenja svake pojedine doze odgovoran je korisnik.
English: These viral proteins are prepared from the strain of influenza virus that complies with the World Health Organisation recommendations and EU decision in an officially declared Pandemic situation.
Croatian: Ti virusni proteini pripremljeni su od soja virusa influence koji je u skladu s preporukama Svjetske zdravstvene organizacije i Odluke EU u službeno proglašenoj pandemijskoj situaciji.
English: Foclivia should not be given at the same time as other vaccines.
Croatian: Focliviju se ne smije davati istovremeno s drugim cjepivima.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Croatian: Ovo stanje može biti popraćeno s nekoliko neuroloških znakova poput prolazne smetnje vida, parestezije i toničko-kloničkih pokreta udova tijekom oporavka.
English: It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional,
Croatian: Široko je prihvaćeno da je djelovanje adjuvansa koje dovodi do povećane imunogenosti povezano s nešto većom učestalosti lokalnih reakcija (uglavnom blaga bol) u usporedbi s uobičajenim,
English: EU/1/09/577/001 1 prefilled syringe with needle EU/1/09/577/002 10 prefilled syringes with needle EU/1/09/577/005 1 prefilled syringe without needle EU/1/09/577/006 10 prefilled syringes without needle
Croatian: EU/1/09/577/001 1 napunjena štrcaljka s iglom EU/1/09/577/002 10 napunjenih štrcaljki s iglom EU/1/09/577/005 1 napunjena štrcaljka bez igle EU/1/09/577/006 10 napunjenih štrcaljki bez igle
English: The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove (EMA) će svake godine procjenjivati nove informacije o lijeku te će se ova uputa obnavljati prema potrebi.
English: The adjuvant includes also polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Croatian: Adjuvans također uključuje polisorbat 80 i sorbitan-trioleat u citratnom puferu (natrijev citrat, citratna kiselina).
English: This should include data from ongoing studies, or actual use if applicable, of the pandemic preparedness strains and any safety data relevant to the adjuvant system.
Croatian: To treba uključivati podatke iz trenutačnih ispitivanja ili stvarne uporabe, ako je primjenjivo,,sojeva cjepiva spremnog protiv pandemijske influence i bilo koje podatke o sigurnosti povezane sa sustavom adjuvansa.
English: Fertility No fertility data are available.
Croatian: Plodnost Nema dostupnih podataka.
English: Regardless of age, reactogenicity was higher after the first dose than after the second vaccination.
Croatian: Bez obzira na dob, reaktogenost je bila viša nakon prve doze nego nakon drugog cijepljenja.
English: The European medicines Agency has deferred the obligation to submit the results of studies with Foclivia in one or more subsets of the paediatric populations in active immunisation against H5N1 subtype of Influenza A virus.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Foclivia u jednoj ili više podskupina pedijatrijske populacije u aktivnoj imunizaciji protiv podtipa H5N1 virusa influence A.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Croatian: Reakcija protutijela u pacijenata s endogenom ili jatrogenom imunosupresijom može biti nedostatna.
English: - Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Croatian: - Učestalost treba razmotriti nositelj odobrenja i (su)izvjestitelj svakih 6 mjeseci.
English: Important information about some of the ingredients of Foclivia Foclivia contains thiomersal
Croatian: Važne informacije o nekim sastojcima Foclivije Foclivia sadrži tiomersal
English: Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Foclivia with other H5N1 monovalent vaccines.
Croatian: Budući da se preporučuje druga doza, treba uzeti u obzir da ne postoje podaci o sigurnosti, imunogenosti ili djelotvornosti koji bi poduprli međusobnu zamjenjivost Foclivije i drugih monovalentnih cjepiva protiv virusa H5N1.
English: Foclivia contains Thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Croatian: Foclivia sadrži tiomersal kao konzervans i moguća je pojava alergijske reakcije.
English: Reactogenicity after a third dose, administered 12 months after the second dose, was higher than after both first and second dose.
Croatian: Reaktogenost nakon treće doze, primijenjene 12 mjeseci nakon druge doze, bila je viša nego nakon prve i druge doze.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Croatian: Sinkopa (nesvjestica) se može javiti kao posljedica ili čak prije bilo kakvog cijepljenja kao psihogeni odgovor na ubod iglom.
English: Some cases were observed in subjects with a history of epilepsy.
Croatian: Neki su slučajevi primijećeni kod osoba s anamnezom epilepsije.
English: Fainting can occur following, or even before, any needle injection.
Croatian: Nesvjestica se može javiti nakon, ili čak prije, bilo kakvog cijepljenja.
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Croatian: Kada se CHMP složi da „pojednostavljeni PSUR“ nije više potreban, potpuni PSUR koji obuhvaća razdoblje od zaključavanja baze zadnjeg rutinskog PSUR-a bit će predan unutar roka koji će dogovoriti s izvjestiteljem.
English: Keep this vaccine out of the sight and reach of children.
Croatian: Cjepivo čuvati izvan pogleda i dohvata djece.
English: Contents of the pack and other information What Foclivia contains
Croatian: Sadržaj pakiranja i druge informacije Što Foclivia sadrži
English: Syringes without needle are fitted with a Luer Lock system.
Croatian: Štrcaljke bez igle imaju Luer Lock sustav.
English: Foclivia is a milky-white liquid.
Croatian: Foclivia je mliječnobijela tekućina.
English: One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
Croatian: Jedna doza (0,5 ml) cjepiva sadrži najmanje 7,5 mikrograma hemaglutinina iz sljedećeg preporučenog soja virusa influence:
English: You should discuss with your doctor whether you should receive Foclivia.
Croatian: Savjetujte se s liječnikom o tome trebate li primiti cjepivo FOCLIVIA.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Croatian: Stavku 8. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:.
English: narrow SMQ “Non-infectious encephalitis”
Croatian: suženi SMQ “Neinfektivni encefalitis"
English: Adjuvant MF59C.1 containing: Squalene
Croatian: Adjuvans MF59C.1 koji sadrži:
English: Across all ages, low percentages of subjects reported fever.
Croatian: U svim dobnim skupinama, mali postoci ispitanika prijavili su vrućicu.
English: Postmarketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Croatian: Spontano prijavljeni slučajevi nakon stavljanja lijeka u promet i intervencijske studije ne ukazuju na izravne ili neizravne štetne učinke cijepljenja cjepivom Focetria u odnosu na trudnoću.
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Croatian: O TOME SVOG LIJEČNIKA ILI MEDICINSKU SESTRU jer cijepljenje možda neće biti preporučljivo ili će možda biti odgođeno.
English: There were fewer reactions after the second dose compared with the first.
Croatian: Nakon druge doze bilo je manje reakcija nego nakon prve.
English: Foclivia is a vaccine intended to be given to prevent influenza (flu) in an officially declared pandemic.
Croatian: Foclivia je cjepivo namijenjeno za primjenu radi sprječavanja influence (gripe) u službeno proglašenoj pandemiji.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)
Croatian: Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)* soja: A/Vietnam/1194/2004 (H5N1)
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Croatian: Adjuvans: MF59C.1 emulzija ulja u vodi koja sadrži skvalen, kao uljnu fazu, stabiliziran polisorbatom 80 i sorbitan-trioleatom u citratnom puferu (natrijev citrat, citratna kiselina).
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 mogu se dobiti lažno pozitivni rezultati seroloških testiranja metodom ELISA na protutijelo protiv virusa humane imunodeficijencije -1 (HIV-1), hepatitisa C i,
English: * measured by SRH assay ≥ 25 mm2
Croatian: * izmjereno SRH analizom ≥25 mm2
English: Prophylaxis of influenza in an officially declared pandemic situation.
Croatian: Profilaksa influence u službeno proglašenoj situaciji pandemije.
English: Foclivia should under no circumstances be administered intravascularly or subcutaneously.
Croatian: Foclivia se ni u kojim okolnostima ne smije primijeniti intravaskularno ili potkožno.
English: - The clock should start from the first Monday after shipment of the first batch of vaccine.
Croatian: • Učestalost podnošenja: - Vrijeme počinje teći od prvog ponedjeljka nakon otpreme prve serije cjepiva.
English: However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Croatian: Međutim, u pandemijskoj će situaciji možda biti potrebno dati cjepivo, pod uvjetom da su sredstva i prostorije za oživljavanje odmah dostupne u slučaju potrebe.
English: Do not use Foclivia after the expiry date which is stated on the carton and the label after EXP.
Croatian: Foclivia se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i naljepnici iza oznake „Rok valjanosti“ ili „EXP“.
English: Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Croatian: Vrlo česte reakcije prijavljene kod djece i adolescenata u dobi od 3 do 17 godina: Bol, otvrdnuće i eritem, slabost, mijalgija, glavobolja i umor.
English: This section describes the clinical experience with the H5N1 pandemic preparedness vaccines following a two-dose administration of 7.5 microgram.
Croatian: Ovaj dio opisuje kliničko iskustvo s cjepivima spremnima protiv pandemijske influence H5N1 nakon primjene dviju doza od 7,5 mikrograma.
English: This vaccine complies with the WHO recommendations and EU decision for the pandemic.
Croatian: Ovo cjepivo je u skladu s preporukama Svjetske zdravstvene organizacije (SZO) i Odlukom EU za pandemiju.
English: Like all medicines, Foclivia can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Foclivia može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: Data are available that suggest that multidose vials could be used up to a maximum of 72 hours after first withdrawal, although such pro-longed storage periods should not be the preferred option.
Croatian: Dostupni podaci ukazuju na mogućnost uporabe višedozne bočice u roku od najviše 72 sata nakon prvog izvlačenja, no takva produžena razdoblja čuvanja treba izbjegavati.
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) and exudative Stevens-Johnson syndrome (erythema multiforme).
Croatian: Vaskulitis (upala krvnih žila koja može prouzročiti kožni osip, bol u zglobovima i probleme s bubrezima) i eksudativni Stevens-Johnsonov sindrom (eritema multiforme).
English: One dose (0.5 ml) contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilised hen's eggs from healthy chicken flocks, and adjuvanted with MF59C.1, of strain:
Croatian: Jedna doza (0,5 ml) sadrži: Djelatni sastojci: Površinski antigeni virusa influence (hemaglutinin i neuraminidaza), umnoženi u oplođenim kokošjim jajima iz jata zdravih kokoši i adjuvantirani s MF59C.1, soja:
English: In some cases the effects may also include raised temperature, malaise (generally feeling unwell), shivering, tiredness, headache, sweating, pain in muscles and joints.
Croatian: U nekim slučajevima nuspojave mogu uključivati povišenu temperaturu, slabost (općenito loše osjećanje), tresavicu, umor, glavobolju, znojenje, bol u mišićima i zglobovima.
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: Stoga zdravstveni djelatnici moraju procijeniti koristi i moguće rizike primjene cjepiva kod osoba s trombocitopenijom ili bilo kojim poremećajem krvarenja zbog kojeg bi bila kontraindicirana injekcija u mišić, osim ako moguće koristi nadilaze rizik od krvarenja.
English: It is provided in a ready-to-use syringe, containing a single dose (0.5 ml) for injection, in box of 1 or 10, with or without needle.
Croatian: Isporučena je u štrcaljki spremnoj za uporabu koja sadrži jednostruku dozu (0,5 ml) za injekciju, u kutiji od 1 ili 10, sa ili bez igle.
English: Health care providers need to assess the benefits and potential risks of administering Foclivia vaccine to pregnant women, taking into consideration official recommendations.
Croatian: Liječnici trebaju procijeniti koristi i moguće rizike primjen cjepiva Foclivia kod trudnica, uzimajući u obzir službene preporuke.
English: CHMP immunogenicity criteria set for adults (18-60 years) were met both after the 1st and the 2nd dose in all the above age strata (both in the overall population and in the subset seronegative at baseline).
Croatian: CHMP kriteriji imunogenosti za odrasle (18-60 godina) su dosegnuti nakon prve i druge doze u svim navedenim dobnim skupinama (u ukupnoj populaciji kao i u podskupini koja je bila seronegativna u početku).
English: 9.75 milligrams
Croatian: 9,75 miligrama
English: Persistence of antibodies after primary vaccination in this population as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules as assessed by HI, SRH, and MN tests.
Croatian: Postojanost protutijela nakon prvog cijepljenja u ovoj populaciji procijenjena HI, SRH i MN testovima smanjila se s ½ na 1/5 njihove postvakcinacijske razine u 202. danu u usporedbi s 43. danom nakon dovršetka rasporeda prvog cijepljenja procijenjenog HI, SRH i MN testovima.
English: - S-PSUR submission to the Rapporteur and CHMP members on Day 45.
Croatian: - Podnošenje „pojednostavljenog PSUR-a“ izvjestitelju i članovima CHMP-a je 45. dan.
English: injection into the deltoid muscle
Croatian: i.m. injekcija u deltoidni mišić
English: The adjuvanted vaccine was also found to induce antibodies that cross-protected against the H5N1 strains isolated in 2003 and 2004, which exhibit some antigenic drift compared to the original strains.
Croatian: Također je utvrđeno da je adjuvantirano cjepivo izazvalo protutijela koja su stvorila ukriženu zaštitu protiv sojeva virusa H5N1 izoliranih 2003. i 2004. koji pokazuju antigenski pomak u odnosu na izvorne sojeve.
English: Compared to the antibody levels obtained at day 43 after completion of primary vaccination schedules, antibody levels at day 202 were reduced by 1/5 to 1/2 from their prior levels.
Croatian: U usporedbi s razinama protutijela dobivenim u 43. danu nakon dovršetka rasporeda prvog cijepljenja, razine protutijela u 202. danu smanjile su se za 1/5 do ½ u odnosu na prethodne vrijednosti.
English: In toddlers, erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Croatian: Eritem i pojačana osjetljivost bili su najčešće prijavljene izazvane lokalne reakcije u male djece; razdražljivost i neuobičajena plačljivost bile su najčešće prijavljene izazvane sistemske reakcije.
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: Sorbitan trioleate
Croatian: Sorbitantrioleat
English: AESIs will be defined as follows:
Croatian: Štetni događaji će biti definirani kako slijedi:
English: In children and adolescents pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
Croatian: Najčešće prijavljena izazvana lokalna reakcija u djece i adolescenata bila je bol, dok su umor i glavobolja bili najčešće prijavljene izazvane sistemske reakcije.
English: In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10.000 vaccinated pregnant women and their offspring compared with unvaccinated controls.
Croatian: Osim toga, dvije velike opservacijske studije za procjenjivanje sigurnosti cijepljenja cjepivom Focetria tijekom trudnoće nisu pokazale povećanje stope gestacijskog dijabetesa, preeklampsije, pobačaja, mrtvorođene djece, djece niske porođajne težine, prerano rođene djece, novorođenačke smrti i kongenitalnih malformacija kod gotovo 10 000 cijepljenih trudnica i njihovog potomstva uspoređeno s necijepljenom kontrolnom skupinom.
English: Serum samples were tested against the original H5N3 and also a number of H5N1 isolates.
Croatian: Uzorci seruma testirani su na izvorni virus H5N3 kao i na određen broj izolata virusa H5N1.
English: Non-clinical data obtained with Foclivia and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Croatian: Neklinički podaci dobiveni cjepivom Foclivia i sezonskim cjepivom protiv influence koje sadrži adjuvans MF59C.1 ne ukazuju na poseban hazard za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza, lokalne tolerancije, ženske plodnosti i reproduktivne i razvojne toksičnosti (do kraja razdoblja dojenja).
English: A protective response may not be elicited in all vaccine recipients (see section 5.1).
Croatian: Možda neće doći do zaštitnog imunološkog odgovora kod svih cijepljenih osoba (vidjeti dio 5.1).
English: Very common reactions reported in 146 infants and toddlers 6 to 35 months of age: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea, vomiting and change in eating habits.
Croatian: Vrlo česte reakcije prijavljene kod 146 dojenčadi i male djece u dobi od 6 do 35 mjeseci: Pojačana osjetljivost, eritem, razdražljivost, neuobičajena plačljivost, pospanost, proljev, povraćanje i promjena apetita.
English: 1 x single dose (0.5 ml) pre-filled syringe with needle 1 x single dose (0.5 ml) pre-filled syringe without needle 10 x single dose (0.5 ml) pre-filled syringes with needle 10 x single dose (0.5 ml) pre-filled syringe without needle
Croatian: 1x jednodozna napunjena štrcaljka (0,5 ml) s iglom 1 x jednodozna napunjena štrcaljka (0,5 ml) bez igle 10 x jednodozna napunjena štrcaljka (0,5 ml) s iglom 10 x jednodozna napunjena štrcaljka (0,5 ml) bez igle
English: Up to 50% of the elderly subjects immunised with H5N1 vaccine combined with MF59C were seroprotected at six months.
Croatian: Do 50% starijih ispitanika imuniziranih H5N1 cjepivom kombiniranim s MF59C imalo je serozaštitu šest mjeseci.
English: tiredness, headache, sweating, pain in muscles and joints.
Croatian: tresavicu, umor, glavobolju, znojenje, bol u mišićima i zglobovima.
English: °° geometric mean ratios of HI *** In V87P1: baseline not tested
Croatian: °° omjeri srednje geometrijske vrijednosti HI *** U V87P1: početna vrijednost nije testirana