FrancophonIA/ELRC3.0 huggingface dataset:
English: This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Croatian: Ovo cjepivo odgovara preporuci SZO i odluci EU za pandemiju.
English: Vaccine distribution report
Croatian: Izvješće o distribuciji cjepiva
English: - Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Croatian: - Periodičnost treba razmotriti nositelj odobrenja i (su)izvjestitelj svakih 6 mjeseci.
English: Day 42 a
Croatian: 42. dan a
English: 18 - 59 years
Croatian: 18 do 59 godina
English: Patients with chronic disease conditions
Croatian: Pacijenti s kroničnim bolestima
English: Format of the simplified PSUR
Croatian: Format pojednostavljenog PSUR-a
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01
Croatian: Farmakoterapijska skupina: Cjepiva protiv influence, ATK oznaka J07BB01
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Croatian: Podaci nakon cijepljenja trudnica različitim inaktiviranim neadjuvantiranim sezonskim cjepivima ne upućuju na malformacije ili fetalnu ili neonatalnu toksičnost.
English: You should be aware that the side effects may be intensified.
Croatian: Morate znati da bi se nuspojave mogle pojačati.
English: 21 days after 2nd dose
Croatian: 21 dan nakon 2.doze
English: 7.5 microgram**
Croatian: 7,5 mikrograma**
English: 3 - 8 years
Croatian: 3 - 8 godina
English: PT “Vaccination failure”.
Croatian: PT “Neuspjeh cijepljenja”.
English: Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Croatian: Mock-up cjepiva sadrže antigene influence koji su različiti od onih u trenutačno cirkulirajućim virusima influence.
English: This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up' strains.
Croatian: To treba uključivati podatke iz trenutačnih ispitivanja ili stvarne primjene „mock-up“
English: 9 - 17 years
Croatian: 9 - 17 godina
English: Prior to administration, visually inspect the suspension for any foreign particulate matter and/or abnormal physical appearance.
Croatian: Prije primjene vizualno pregledajte suspenziju kako biste provjerili sadrži li bilo kakve čestice i/ili je neuobičajena fizičkog izgleda.
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 i kod svih cjepiva koja se injiciraju, odgovarajući medicinski tretman i nadzor moraju uvijek biti dostupni za slučaj da nakon primjene cjepiva dođe do rijetke anafilaktičke reakcije.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove (EMA): http://www.ema.europa.eu/
English: • allergic reactions, including severe reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock.
Croatian: • alergijske reakcije, uključujući snažne reakcije koje dovode do opasnog smanjenja krvnog tlaka,
English: Some undesirable effects mentioned under section 4.8 such as dizziness and vertigo may affect the ability to drive or use machines.
Croatian: Neke od nuspojava spomenutih u dijelu 4.8, kao što su omaglica i vrtoglavica, mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom proizvodu dostupne su na web stranici Europske agencije za lijekove (EMA): http://www.ema.europa.eu/
English: If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can still be given but your response to the vaccine may be poor.
Croatian: Ako uzimate bilo kakve lijekove koji smanjuju imunitet na infekcije ili primate bilo kakvu drugu vrstu liječenja (kao što je radioterapija) koja utječe na imunološki sustav, CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER može se primijeniti, no odgovor na cjepivo mogao bi biti slab.
English: Infants, children, and adolescents
Croatian: Dojenčad, djeca i adolescenti
English: • abnormal, reduced sensation
Croatian: • neuobičajeni, smanjeni osjeti
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Croatian: Tijekom pandemije podnositelj će prikupiti podatke o kliničkoj sigurnosti i učinkovitosti pandemijskog cjepiva i predati te informacije CHMP-u na procjenu.
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: Dakle, zdravstveni djelatnici trebaju ocijeniti koristi i moguće rizike primjene cjepiva u osoba s trombocitopenijom ili nekim drugim poremećajem krvarenja koji mogu predstavljati kontraindikaciju za intramuskularnu primjenu, osim ako je moguća korist značajnija od rizika od krvarenja.
English: The results indicate an overall decline in antibody levels over time.
Croatian: Rezultati pokazuju smanjenje razina protutijela s vremenom.
English: Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Croatian: Podaci dobiveni s mock-up cjepivom podržat će strategiju cijepljenja koja će se vjerojatno koristiti za pandemijsko cjepivo: klinički podaci koji se odnose na imunogenost, sigurnost i reaktogenost dobiveni s mock-up cjepivom relevantni su za pandemijska cjepiva.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI ZA SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: However, in a pandemic situation, your doctor may recommend to give the vaccine.
Croatian: Međutim, liječnik će Vam, u pandemijskoj situaciji, možda preporučiti primanje cjepiva.
English: - CHMP report is circulated to the vaccine manufacturer on Day 55.
Croatian: - Izvješće CHMP-a šalje se proizvođaču cjepiva 55. dan.
English: Only spontaneously reported data should be included in the S-PSUR.
Croatian: U S-PSUR je potrebno uključiti samo spontano prijavljene podatke.
English: - All tables will be based on generic and not product-specific data1.
Croatian: - Sve će se tablice temeljiti na generičkim podacima koji nisu specifični za pojedini lijek1.
English: 21 Days after
Croatian: 21 dan kasnije
English: Pandemic influenza vaccine should be used in accordance with official guidance.
Croatian: Cjepivo protiv pandemijske influence treba koristiti u skladu sa službenim preporukama.
English: Immunization should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Croatian: Imunizacija se provodi intramuskularnom injekcijom u deltoidni mišić ili anterolateralno područje bedra, ovisno o mišićnoj masi.
English: - Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.
Croatian: Osim tablice 1., sve će se tablice temeljiti na broju reakcija (prikazano na PT razini, razvrstano prema organskom sustavu [SOC] i nazivu visoke razine [HLT]), a ne broju slučajeva.
English: - Guillain-Barré syndrome:
Croatian: - Guillain-Barréov sindrom:
English: Clinically significant alterations in liver enzymes and calcium levels have not been seen to date in human clinical studies.
Croatian: Klinički značajne promjene razine jetrenih enzima i kalcija do danas nisu zabilježene u kliničkim ispitivanjima na ljudima.
English: Animal reproductive and developmental toxicity studies do not indicate direct or indirect harmful effects with respect to female fertility, pregnancy, embryonal/ foetal development parturition or post natal development.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti na životinjama ne upućuju na izravne ili neizravne štetne učinke s obzirom na plodnost ženki, trudnoću, embrionalni/fetalni razvoj, porod ili postnatalni razvoj.
English: If your are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice if you should receive PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet ako trebate primiti CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER.
English: The following serious adverse reactions have been reported from post-marketing surveillance with egg-derived interpandemic trivalent vaccines:
Croatian: Sljedeće su ozbiljne nuspojave zabilježene na temelju postmarketinškog praćenja interpandemijskih trovalentnih cjepiva uzgojenih na jajima:
English: Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation)
Croatian: Senzorni poremećaji (parestezija, dizestezija, hipoestezija, oralna dizestezija, dizgeuzija i osjećaj žarenja)
English: The European 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) svake će godine procjenjivati nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
English: There were fewer side effects after the second vaccination compared with the first.
Croatian: Manje je nuspojava zabilježeno nakon drugog cijepljenja u usporedbi s prvim cijepljenjem.
English: - S-PSUR submission to the Rapporteur and CHMP members on Day 45.
Croatian: - Predaja S-PSUR-a izvjestitelju i članovima Povjerenstva za humane lijekove (CHMP-a) 45. dan.
English: For further information, see section 5.1.
Croatian: Za dodatne informacije, vidjeti dio 5.1. 4.3 Kontraindikacije
English: After removing the syringe cap, attach the needle immediately and remove the needle shield prior to administration.
Croatian: Nakon što uklonite poklopac štrcaljke, odmah pričvrstite iglu i prije primjene skinite zaštitu za iglu.
English: It is used to prevent influenza (flu) in an officially declared pandemic.
Croatian: Koristi se za sprječavanje influence (gripe) u slučaju službeno proglašene pandemije.
English: The vaccine should be allowed to reach room temperature before use.
Croatian: Prije primjene cjepivo treba pustiti da dosegne sobnu temperaturu.
English: * MN titer ≥ 20
Croatian: * MN titar ≥ 20
English: Male fertility was not investigated in the reproductive and developmental toxicity studies, however there were no findings in the repeat-dose toxicity studies to indicate any vaccine-related changes to the tissues of the male reproductive tract.
Croatian: Plodnost mužjaka nije ispitivana u ispitivanjima reproduktivne i razvojne toksičnosti, međutim u ispitivanjima toksičnosti ponovljene doze ne postoje rezultati koji bi upućivali na bilo kakve promjene tkiva muškog reproduktivnog sustava vezane uz cjepivo.
English: The vaccine is available in a multidose container (see section 6.5 for the number of doses per vial).
Croatian: Cjepivo je dostupno u višedoznom spremniku (za broj doza po bočici, vidjeti dio 6.5.).
English: Immunogenicity in immunocompromised subjects (N=122) and in patients with chronic disease conditions (N=123)
Croatian: Imunogenost u imunokomprimiranih ispitanika (N=122) i u pacijenata s kroničnim bolestima (N=123)
English: Non-clinical studies demonstrated minor alterations in liver enzymes and calcium levels in a repeat dose toxicity study in rats.
Croatian: Neklinička ispitivanja pokazala su manje promjene razina jetrenih enzima i kalcija u ispitivanju toksičnosti ponovljene doze na štakorima.
English: Depending on and after implementation of vaccine when first pandemic will take place.
Croatian: Ovisno kad se prva pandemija dogodi i nakon implementacije cjepiva.
English: A 12 to 24 months heterologous booster has also been administered in a phase 3 study in immunocompromised subjects and patients with chronic disease conditions.
Croatian: Heterologni booster također je primijenjen nakon 12 mjeseci do 24 mjeseca u fazi 3 ispitivanja u imunokompromitiranih ispitanika i u pacijenata s kroničnim bolestima.
English: To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
Croatian: Radi pružanja konteksta za izvješće o sigurnosti, potrebno je uključiti sažetak distribucije cjepiva koje pruža pojedinosti o broju doza cjepiva distribuiranih u i) državama članicama EU-a za izvještajno razdoblje po broju serije,
English: In the clinical studies conducted in infants, children and adolescents, the incidence and nature of symptoms after the first and second vaccination were similar to those occurred in adults and older people.
Croatian: U kliničkim ispitivanjima provedenim na dojenčadi, djeci i adolescentima, učestalost i priroda simptoma nakon prvog i drugog cijepljenja bili su slični onima koji su se pojavili u odraslih osoba i starijoj populaciji.
English: Such reactions occurred both in patients with a history of multiple allergies and in patients with no known allergy.
Croatian: Takve su reakcije zabilježene kod pacijenata koji su već imali više različitih alergija kao i kod pacijenata bez poznatih alergija.
English: Prophylaxis of influenza in an officially declared pandemic situation.
Croatian: Prevencija influence u službeno proglašenoj pandemijskoj situaciji.
English: The vaccine is available in a single dose pre-filled syringe.
Croatian: Cjepivo je dostupno u jednodoznoj napunjenoj štrcaljki.
English: • reduced blood pressure, feeling faint (syncope)
Croatian: • snižen krvni tlak, gubitak svijesti (sinkopa)
English: The MAH shall perfom the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: Immunogenicity in adults aged 18 to 59 years (N=961) and in subjects aged 60 years and older (N=391)
Croatian: Imunogenost u odraslih osoba od 18 do 59 godina (N=961) i u ispitanika u dobi od 60 godina i više (N=391)
English: Somnolence Hypoaesthesia
Croatian: Somnolencija Hipoestezija
English: Product-specific data can be evaluated during signal work-up.
Croatian: Podaci specifični za pojedini lijek bit će procijenjeni tijekom obrade signala.
English: The incidence and nature of symptoms after the first and second vaccination were similar to those observed in the healthy adults and older subjects.
Croatian: Incidencija i priroda simptoma nakon prvog i drugog cijepljenja bili su slični onima opaženima kod zdravih odraslih i starijih ispitanika.
English: • pain in mouth and throat
Croatian: • bol u ustima i grlu
English: A second dose of vaccine should be given after an interval of at least 3 weeks.
Croatian: Drugu je dozu cjepiva potrebno dati nakon razdoblja od najmanje 3 tjedna.
English: The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older subjects.
Croatian: Sigurnosni profil u imunokompromitiranih ispitanika i pacijenata s kroničnim bolestima sličan je sigurnosnom profilu u zdravih odraslih i starijih ispitanika.
English: narrow SMQ “Non-infectious encephalitis”
Croatian: suženi SMQ “Neinfektivni encefalitis”
English: Strain A/Indonesia/05/2005
Croatian: Soj A/Indonesia/05/2005
English: • Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Croatian: • Nakon cijepljenja protiv influence, zabilježeni su lažno pozitivni rezultati seroloških testova primjenom ELISA metode za detekciju protutijela protiv virusa HIV1, hepatitisa
English: Adverse Reactions (Adults and Older People)
Croatian: Nuspojave (Odrasli i starije osobe)
English: From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following adverse reactions have been reported (the frequency of these adverse reactions is not known as it cannot be estimated from the available data):
Croatian: Na temelju postmarketinškog praćenja cjelovirionskog cjepiva protiv virusa H1N1 uzgojenog na Vero stanicama, zabilježene su sljedeće nuspojave (učestalost tih nuspojava nije poznata jer se ne može procijeniti iz dostupnih podataka):
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Croatian: Drugu je dozu od 0,5 ml potrebno dati nakon razdoblja od najmanje tri tjedna.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c)
English: Once the needle is attached, the vaccine must be administered immediately.
Croatian: Nakon što pričvrstite iglu, cjepivo se mora odmah primijeniti.
English: • if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine.
Croatian: • ako ste alergični na bilo koji sastojak ili ostatne tvari u tragovima (formaldehid, benzonazu, saharozu) koje cjepivo sadrži.
English: In addition, the immunogenicity has also been evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123) following a 0, 21 day schedule.
Croatian: Nadalje, imunogenost je također procijenjena u ispitivanju faze 3 u specifičnim rizičnim skupinama imunokompromitiranih ispitanika (N=122) i pacijenata s kroničnim bolestima (N=123) nakon režima primjene 0. i 21. dana.
English: The vaccine should never be given into a blood vessel.
Croatian: Cjepivo se nikad ne smije dati u krvnu žilu.
English: The following side effects have been reported in clinical studies in adults and older people.
Croatian: Sljedeće su nuspojave zabilježene u kliničkim ispitivanjima u odraslih i starijih osoba.
English: - Vasculitis:
Croatian: - Vaskulitis:
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome Reporting of suspected adverse reactions
Croatian: Neurološki poremećaji, kao što je encefalomijelitis, neuritis i Guillain Barréov sindrom
English: Rare: neuralgia, transient thrombocytopenia
Croatian: Rijetko: neuralgija, prolazna trombocitopenija
English: Health care providers should carefully consider the potential risks and benefits for each specific patient before administering PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Croatian: Zdravstveni djelatnici trebaju pažljivo razmotriti moguće rizike i koristi za svakog pojedinog pacijenta prije primjene CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER.
English: Similar to the homologous challenge, vaccination against a heterologous challenge reduced virus burden, and reduced haematological (leukopenia) changes associated with highly pathogenic avian influenza infection.
Croatian: Slično homolognom izazovu, cijepljenje protiv heterolognog izazova smanjilo je virusnu opterećenost i hematološke (leukopenija) promjene povezane s iznimno patogenom infekcijom ptičjom gripom.
English: Sudden hearing loss
Croatian: Iznenadan gubitak sluha
English: However, if this cannot be avoided, the other vaccine should be injected into the other limb.
Croatian: Međutim, ako se to ne može izbjeći, drugo se cjepivo treba injicirati u različit ud.
English: However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Croatian: Međutim, ako je istovremena primjena s drugim cjepivom indicirana, imunizacija se provodi na različitim udovima.
English: narrow SMQ “Guillain-Barré syndrome”
Croatian: suženi SMQ “Guillain-Barréov sindrom”
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Croatian: suženi SMQ “Anafilaktička reakcija” i suženi SMQ “Angioedem”
English: The European Medicines Agency (EMA) will review any new information which may become available every year and this SmPC will be updated as necessary.
Croatian: Europska agencija za lijekove (EMA) procjenjivat će svaku novu informaciju o lijeku koja može biti dostupna svake godine te će se tekst Sažetka opisa svojstava lijeka ažurirati prema potrebi.
English: Allergic reactions, including sudden and life-threatening allergic reactions (anaphylaxis), have been reported with a similar H1N1 influenza vaccine (swine flu vaccine) given during a pandemic period.
Croatian: Alergijske reakcije, uključujući nagle i po život opasne alergijske reakcije (anafilaksija), prijavljene su nakon primjene sličnog cjepiva protiv influence H1N1 (cjepiva protiv svinjske gripe) tijekom razdoblja pandemije.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER takes due account of the officially declared pandemic strain.
Croatian: CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER može se staviti na tržište samo kada SZO/EU službeno proglase pandemiju influence, pod uvjetom da nositelj odobrenja za stavljanje lijeka u promet za CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER propisno uzme u obzir službeno proglašen soj pandemije.
English: Two studies have been performed using either the H5N1 A/Vietnam/1203/2004 or the A/Indonesia/05/2005 vaccine.
Croatian: Provedena su dva ispitivanja pomoću cjepiva H5N1 A/Vietnam/1203/2004 ili A/Indonesia/05/2005.
English: The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme.
Croatian: Nuspojave navedene u nastavku pojavile su se nakon primjene sličnog cjepiva protiv influence (Celvapan) u odraslih i djece tijekom cijepljenja protiv pandemijske gripe H1N1.
English: • conjunctivitis (an inflammation of the eye), eye irritation
Croatian: • konjunktivitis (upala oka), nadraženost oka
English: Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine demonstrated a high rate of seroconversion.
Croatian: Tvorovi cijepljeni dozom od 7,5 µg cjepiva A/Vietnam/1203/2004 pokazali su visoku stopu serokonverzije.
English: • sleep disorder
Croatian: • poremećaj spavanja
English: However, if this cannot be avoided, the immunoglobulins should be injected into the other limb.
Croatian: Međutim, ako se to ne može izbjeći, imunoglobulini se trebaju injicirati u različit ud.
English: The use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.
Croatian: Primjena CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER može se razmotriti tijekom trudnoće ako se to smatra potrebnim, uzevši u obzir službene preporuke.