FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before receiving this vaccine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili medicinskoj sestri za savjet prije nego primite ovo cjepivo.
English: Visually inspect the suspension prior to administration.
Croatian: Vizualno pregledajte suspenziju prije primjene.
English: Tell the doctor requesting these tests that you have recently been given AFLUNOV.
Croatian: Recite liječniku koji zatraži te pretrage da ste nedavno primili AFLUNOV;
English: Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta ili ako ste nedavno primili bilo koje drugo cjepivo.
English: In the absence of compatibility trials, this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: Similar trends were observed for seroprotection rates in both studies.
Croatian: Slični trendovi primjećeni su za stope seroprotekcije u oba ispitivanja.
English: - Adjuvant MF59C.1:
Croatian: − Adjuvans MF59C.1:
English: A second dose of 0.5 ml should be given after an interval of at least 3 weeks.
Croatian: Drugu je dozu od 0,5 ml potrebno dati nakon intervala od najmanje 3 tjedna.
English: Immunogenicity was assessed in 182 subjects.
Croatian: Imunogenost je procijenjena u 182 ispitanika.
English: Contents of the pack and other information What AFLUNOV contains
Croatian: Sadržaj pakiranja i druge informacije Što AFLUNOV sadrži
English: Paediatric population The safety and efficacy of AFLUNOV in subjects under 18 years of age have not yet been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost cjepiva AFLUNOV u ispitanika mlađih od 18 godina nisu još ustanovljene.
English: The magnitude of immune response was lower in the group who received the 2nd dose 1 week later and higher in the groups with longer interval schedules.
Croatian: Magnituda imunološkog odgovora bila je niža u skupini koja je primila 2. dozu 1 tjedan kasnije, a viša u skupinama s rasporedom koji je imao duže intervale.
English: Cross reactivity data in adults
Croatian: Podaci o križnoj reaktivnosti u odraslih
English: Irrespective of antigen dose, almost all systemic reactions were reported on the day of vaccination (day 1) or during the 3 days immediately following.
Croatian: Bez obzira na dozu antigena, gotovo sve sistemske reakcije prijavljene su na dan cijepljenja (1. dan) ili tijekom sljedeća 3 dana.
English: Anti-HA antibody (SRH)
Croatian: Anti-HA protutijelo (SRH)
English: Tell your doctor if you have a weak immune system or an underlying long term medical problem.
Croatian: Obavijestite svog liječnika ako imate oslabljen imunosni sustav i neki već postojeći dugotrajni zdravstveni problem.
English: Vaccination is currently not recommended in this age group.
Croatian: Cijepljenje se trenutačno ne preporučuje u ovoj dobnoj skupini.
English: As with all vaccines, AFLUNOV may not fully protect all persons who are vaccinated.
Croatian: Kao i kod svih cjepiva, AFLUNOV možda neće potpuno zaštititi sve osobe koje su cijepljene.
English: • Neuritis (inflammation of nerves)
Croatian: • Neuritis (upala živaca)
English: If they persist, CONSULT YOUR DOCTOR.
Croatian: Ako potraju, OBRATITE SE SVOM LIJEČNIKU.
English: Talk to your doctor or nurse before having this vaccine
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite ovo cjepivo
English: These transitory false positive results may be due to IgM production in response to the vaccine.
Croatian: Ti prolazni lažno pozitivni rezultati mogu biti prouzročeni proizvodnjom IgM protutijela kao odgovor na cjepivo.
English: However, in immunocompromised subjects 18 through 60 years of age, slightly higher rates of nausea (13.0%) were reported.
Croatian: Međutim, u imunokompromitiranih ispitanika u dobi od 18 do 60 godina, prijavljena je nešto viša stopa mučnine (13,0%).
English: None of the ingredients in the vaccine can cause flu.
Croatian: Nijedan sastojak cjepiva ne može izazvati gripu.
English: Alternative vaccination schedules:
Croatian: Alternativni rasporedi cijepljenja:
English: In addition, higher rates of arthralgia (up to 23.3%) were reported in both adult and elderly subjects, who were immunocompromised or with underlying medical conditions.
Croatian: Nadalje, više stope artralgije (do 23,3%) zabilježene su i u odraslih i u starijih ispitanika koji su bili imunokompromitirani ili s postojećim medicinskim stanjem.
English: In addition, the side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent seasonal flu.
Croatian: Osim toga, niže navedene nuspojave pojavile su se u danima ili tjednima nakon cijepljenja cjepivima koja se rutinski daju svake godine radi sprječavanja sezonske gripe.
English: Date of first authorisation: 29 November 2010 Date of latest renewal: 17 July 2015
Croatian: Datum posljednje obnove odobrenja: 17. srpnja 2015.
English: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy.
Croatian: Martino 53035 Monteriggioni (SI) Italija.
English: Immunization shall be postponed in patients with febrile illness or acute infection.
Croatian: Imunizacija će se odgoditi u bolesnika s febrilnom bolešću ili akutnom infekcijom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
English: The percentages of subjects reporting local reactions were higher in the older age groups, mainly due to the higher reports for pain.
Croatian: Postoci ispitanika koji su prijavili lokalne reakcije bili su viši u starijim dobnim skupinama, uglavnom zbog većeg broja prijava boli.
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation 726/2004/EC will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Croatian: Tijekom pandemijske situacije, učestalost podnošenja periodičkih izvješća o neškodljivosti lijeka predviđena člankom 24. Uredbe 726/2004/EK neće biti primjerena za praćenje sigurnosti pandemijskog cjepiva za koje se očekuju visoke razine izlaganja u kratkom roku.
English: No data are available in children aged less than 6 months.
Croatian: Nema dostupnih podataka za djecu mlađu od 6 mjeseci.
English: What AFLUNOV is and what it is used for
Croatian: Što je AFLUNOV i za što se koristi
English: Other medicines and AFLUNOV
Croatian: Drugi lijekovi i AFLUNOV
English: The majority of these side effects usually disappear within 1-2 days without treatment.
Croatian: Većina ovih nuspojava uglavnom nestaje u roku od 1 do 2 dana bez liječenja.
English: In the elderly, the reported reactions increased with the third booster dose only when compared with the second dose.
Croatian: U starijih osoba prijavljene reakcije povećale su se s trećom booster dozom samo u usporedbi s drugom dozom.
English: Children from 6 months to 17 years of age
Croatian: Djeca u dobi od 6 mjeseci do 17 godina
English: * propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Croatian: * umnožen u oplođenim kokošjim jajima iz jata zdravih kokoši ** izraženo u mikrogramima hemaglutinina.
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 bilo kojem od navedenih slučajeva, OBAVIJESTITE SVOG LIJEČNIKA ILI MEDICINSKU SESTRU jer cijepljenje možda neće biti preporučljivo ili će ga možda biti potrebno odgoditi.
English: In the first few weeks after vaccination with AFLUNOV the results of these tests may not be correct.
Croatian: U prvih nekoliko tjedana nakon cijepljenja cjepivom AFLUNOV nalazi tih pretraga možda neće biti točni.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivosti bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
English: In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Croatian: U slučaju da primijetite bilo kakve čestice i/ili neuobičajen izgled, cjepivo treba baciti.
English: • Anaphylaxis (severe allergic reactions).
Croatian: • Anafilaksija (teške alergijske reakcije)
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Croatian: cijepljenje će vjerojatno biti odgođeno dok se ne budete osjećali bolje.
English: It is provided in a ready-to-use pre-filled syringe, containing a single dose of 0.5 ml for injection.
Croatian: Isporučena je u napunjenoj štrcaljki spremnoj za uporabu koja sadrži jednokratnu dozu od 0,5 ml za injekciju.
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 radnici moraju procijeniti koristi i moguće rizike primjene cjepiva u pojedinaca s trombocitopenijom ili bilo kojim poremećajem s krvarenjem zbog kojeg bi bila kontraindicirana intramuskularna injekcija, osim ako moguće koristi nadilaze rizik od krvarenja.
English: There is limited experience in elderly over 70 years of age.
Croatian: Postoji ograničeno iskustvo u osoba starijih od 70 godina.
English: Healthcare providers need to assess the benefit and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Croatian: Zdravstveni radnici trebaju procijeniti korist i moguće rizike davanja cjepiva trudnicama uzimajući u obzir službene preporuke.
English: However, the degree of protection that may be elicited to H5N1 strains of other clades is unknown (see section 5.1).
Croatian: Stupanj zaštite koji se postiže za sojeve H5N1 drugih klada nije poznat (vidjeti dio 5.1).
English: Efficacy against challenge with the heterologous virus A/Indonesia/5/2005 was also tested.
Croatian: Djelotvornost je također bila testirana pokusom s heterolognim virusom A/Indonesia/5/2005.
English: A study in rabbits did not indicate reproductive or developmental toxicity of AFLUNOV (see section 5.3).
Croatian: Ispitivanje na kunićima nije pokazalo reproduktivnu ili razvojnu toksičnost cjepiva AFLUNOV (vidjeti dio 5.3).
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate.
Croatian: Adjuvans: MF59C.1 emulzija ulja u vodi, koja sadrži skvalen kao uljnu fazu, stabilizirano polisorbatom 80 i sorbitan trioleatom.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Croatian: Imunološki odgovor može biti slabiji ako je bolesnik podvrgnut imunosupresijskoj terapiji.
English: Very commonly reported reactions in the 36 months to 17 years of age group were pain, headache and fatigue.
Croatian: Vrlo često reakcije prijavljene u dobnoj skupini od 36 mjeseci do 17 godina bile su bol, glavobolja i umor.
English: Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of AFLUNOV 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 cjepiva AFLUNOV i drugih monovalentnih H5N1 cjepiva.
English: What AFLUNOV looks like and contents of the pack
Croatian: Kako AFLUNOV izgleda i sadržaj pakiranja
English: Zoonotic influenza viruses occasionally infect humans, and can cause disease ranging from mild upper respiratory infection (fever and cough) to rapid progression to severe pneumonia, acute respiratory distress syndrome, shock and even death.
Croatian: Virusi zoonozne gripe ponekad inficiraju ljude i mogu izazvati bolest koja se kreće u rasponu od blage infekcije gornjih dišnih putova (vrućica i kašalj) do brzo napredujuće i teške upale pluća, sindroma akutnog respiratornog distresa, šoka pa čak i smrti.
English: Information from non-clinical studies
Croatian: Podaci iz nekliničkih ispitivanja
English: In a similar study, intranasal challenge was delayed until approximately 4 months after the second dose of vaccine was administered.
Croatian: U sličnom ispitivanju intranazalna primjena virusa bila je odgođena do otprilike 4 mjeseca nakon primjene druge doze cjepiva.
English: The vaccine should never be given into a vein.
Croatian: Cjepivo se nikad ne smije dati u krvnu žilu.
English: Adults years)*
Croatian: Odrasli godina)*
English: There were 3872 subjects 18-60 years of age, 365 subjects 61-70 years of age, and 89 subjects greater than 70 years of age.
Croatian: Bilo je 3872 ispitanika u dobi od 8 do 60 godina, 365 ispitanika u dobi od 61 do 70 godina i 89 ispitanika starijih od 70 godina.
English: Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako imate problema s krvarenjem ili ako lako dobijete modrice.
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: Nadalje, dva opsežna opservacijska ispitivanja dizajnirana kako bi ocijenila sigurnost izloženosti cjepivu Focetria u trudnoći, nisu pokazala poraz stopa gestacijskog dijabetesa, preeklampsije, pobačaja, mrtvorođenih, niske porođajne težine, prijevremenog poroda, smrti novorođenčadi i urođenih malformacija u skupini od gotovo 10 000 cijepljenih trudnica i njihovih potomaka u usporedbi s necijepljenim kontrolnim skupinama.
English: Any Other Adverse Event
Croatian: Bilo koja druga nuspojava
English: However, in a pandemic situation, it may be appropriate for you to be vaccinated with AFLUNOV provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Croatian: Međutim, u pandemijskoj će situaciji možda biti potrebno da se cijepite cjepivom AFLUNOV, pod uvjetom da je odgovarajuće liječenje odmah dostupno u slučaju alergijske reakcije.
English: Pharmacotherapeutic group: Influenza vaccine ATC Code J07BB02.
Croatian: Farmakoterapijska skupina: Cjepivo protiv influence, ATK oznaka: J07BB02.
English: Any unused vaccine and waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteno cjepivo i otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
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, nedostatak zraka i oticanje lica ili jezika.
English: Immunogenicity was assessed in a subset (n=197) of subjects .
Croatian: Imunogenost je procijenjena u podskupini (N=197) ispitanika.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Croatian: Liječnici su svjesni te mogućnosti, zbog čega imaju sve spremno za hitno liječenje u takvim slučajevima.
English: Non-clinical data obtained with AFLUNOV 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 AFLUNOV i sezonskim cjepivom protiv influence koje sadrži adjuvans MF59C.1 ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza, lokalne podnošljivosti, ženske plodnosti i reproduktivne i razvojne toksičnosti (do kraja razdoblja dojenja).
English: Since AFLUNOV is expected not to be used in an emergency situation, its administration during pregnancy might be deferred as a precautionary approach.
Croatian: Budući da se ne očekuje primjena cjepiva AFLUNOV u hitnoj situaciji, njegova primjena tijekom trudnoće može se odgoditi kao mjera opreza.
English: In such cases, you should be aware that the side effects may be more intense.
Croatian: U takvim slučajevima morate biti svjesni da bi nuspojave mogle biti pojačane.
English: Viral shedding and viral titres in lungs were also reduced, suggesting that vaccination may reduce the risk of viral transmission.
Croatian: Smanjeno je i izlučivanje virusa i titar virusa u plućima, što upućuje na to da cijepljenje može smanjiti rizik od transmisije virusa.
English: • in the presence of immune deficiencies AFLUNOV may be administered but a protective immune response may not be elicited.
Croatian: • u prisutnosti imunodeficijencije AFLUNOV se može primijeniti, no možda neće doći do zaštitnog imunološkog odgovora;
English: Across all ages, low percentages of subjects reported fever.
Croatian: U svim dobnim skupinama mali postoci ispitanika prijavili su vrućicu.
English: The side effects listed below have occurred with AFLUNOV in clinical studies in adults, including the elderly:
Croatian: Niže navedene nuspojave pojavile su se s cjepivom AFLUNOV u kliničkim ispitivanjima u odraslih, uključujući starije osobe:
English: Adults and elderly (18 years of age and above):
Croatian: Odrasli i starije osobe (18 godina naviše):
English: In consequence, as soon as the pandemic is declared and the zoonotic vaccine is used, the Marketing Authorisation Holder (MAH) shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the “CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context” (EMEA/49993/2008), and any subsequent update.
Croatian: Zbog toga će, čim se proglasi pandemija i upotrijebi cjepivo protiv zoonozne influence, nositelj odobrenja podnositi češća pojednostavljena periodička izvješća o neškodljivosti lijeka u formatu i s učestalosti koji su definirani u "Preporukama CHMP-a za Glavni plan upravljanja rizicima za cjepiva protiv influence pripremljena od virusa koji mogu uzrokovati pandemiju, a namijenjena su za primjenu izvan konteksta glavnog dosjea" (EMEA/49993/2008), te sve daljnje dopune plana.
English: • Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Croatian: • Alergijske reakcije koje može pratiti nedostatak zraka, zviždanje u plućima (pri disanju), oticanje grla ili one koje dovode do opasnog smanjenja krvnog tlaka koje, ako se ne liječi, može dovesti do šoka.
English: Nausea, aching joints, diarrhoea and loss of appetite were reported very commonly in this population.
Croatian: Mučnina, bol u zglobovima, proljev i gubitak apetita zabilježeni su vrlo često u toj populaciji.
English: Blood and lymphatic system disorders Thrombocytopenia (in some cases reversible platelet counts less than 5000 mm3).
Croatian: Poremećaji krvi i limfnog sustava Trombocitopenija (u nekim slučajevima broj trombocita reverzibilno se spustio na manje od 5000 mm³)
English: Like all medicines, AFLUNOV can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, AFLUNOV može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with AFLUNOV in one or more subsets of the paediatric population in active immunisation against H5N1 subtype of Influenza A virus.
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja cjepiva AFLUNOV u jednoj ili više podskupina pedijatrijske populacije u aktivnoj imunizaciji protiv podtipa H5N1 virusa influence A.
English: These side effects usually disappear within 1-2 days without treatment.
Croatian: Ove nuspojave nestaju u roku od 1 do 2 dana bez liječenja.
English: Healthy N=62
Croatian: Zdravi N=62
English: Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate machinery.
Croatian: Neke od nuspojava spomenutih u dijelu 4.8. mogu utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Healthy N=57
Croatian: Zdravi N=57
English: Persistence of antibodies after primary vaccination in this population was assessed by hemagglutination inhibition (HI), SRH, and MN assays.
Croatian: Postojanost protutijela nakon primarnog cijepljenja u ovoj populaciji procijenjena je na temelju inhibicije hemaglutinacije (HI), SRH i MN analiza.
English: • Swollen lymph nodes, palpitations (irregular or forceful heart beat), tachycardia (faster than normal heart beat), weakness, pain in the extremities, cough and asthenia (unusual weakness).
Croatian: • Otečeni limfni čvorovi, palpitacije (nepravilni ili jaki otkucaji srca), tahikardija (otkucaji srca brži nego što je to normalno), slabost, bol u udovima, kašalj i astenija (neuobičajena slabost)
English: • swelling, pain and redness at the injection site extending to more than 10 cm and lasting more than one week (Injection site cellulitis-like reaction)
Croatian: • Oteknuće, bol i crvenilo na mjestu injekcije koje se proširuje preko 10 cm i traje duže od jednog tjedna (reakcija nalik celulitisu na mjestu injekcije)
English: Consistent with the data observed by trial for solicited reactions, there was a general trend towards decreased reports of local reactions after the second vaccination compared with the first injection.
Croatian: U skladu s podacima dobivenim ispitivanjem izazvanih reakcija, zabilježen je opći trend smanjivanja broja prijavljenih lokalnih reakcija nakon drugog cijepljenja u usporedbi s prvom dozom.
English: Two doses of vaccine protected 92% of animals, and a single dose of vaccine protected 50% of animals against challenge with the A/Indonesia/5/2005 virus.
Croatian: Dvije doze cjepiva zaštitile su 92% životinja, a samo jedna doza cjepiva zaštitila je 50% životinja od postvakcinacijske provokacije virusom A/Indonesia/5/2005.
English: AFLUNOV contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium-free.
Croatian: AFLUNOV sadrži manje od 1 mmol natrija (23 mg) i manje od 1 mmol kalija (39 mg) po dozi od 0,5 ml, tj. zanemarive količine natrija i kalija.
English: What AFLUNOV is and what it is used for What you need to know before you receive AFLUNOV How AFLUNOV is given
Croatian: Što je AFLUNOV i za što se koristi Što morate znati prije nego primite AFLUNOV
English: The incidence of adverse reactions has been evaluated in seven clinical trials in healthy subjects involving over 4300 adults and elderly receiving AFLUNOV (at least 7.5 µg HA, adjuvanted).
Croatian: Incidencija nuspojava procijenjena je u sedam kliničkih ispitivanja sa zdravim odraslim ispitanicima u koja je bilo uključeno više od 4300 odraslih osoba i osoba starije dobi koje su primile AFLUNOV (najmanje 7,5 µg HA, adjuvantirano).