FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor straightaway or seek urgent medical care if you experience any of the effects above.
Croatian: Odmah obavijestite liječnika ili potražite hitnu medicinsku pomoć ako dobijete bilo koju od gore navedenih nuspojava.
English: Geometric mean titer
Croatian: Geometrijsk a sredina titra
English: Additional data are provided from 289 adults enrolled in studies of vaccine candidates for an additional 7 influenza subtypes and from 240 adults and 259 children enrolled in studies of the monovalent 2009 H1N1 pandemic vaccine.
Croatian: Dodatni podaci dobiveni su od 289 odraslih osoba uključenih u ispitivanja potencijalnih cjepiva za dodatnih 7 podtipova influence i od 240 odraslih osoba i 259 djece uključenih u ispitivanja pandemijskog monovalentnog 2009 H1N1 cjepiva.
English: There was no evidence of significant maternal adverse outcomes in 138 pregnant women who had a record of receiving the seasonal T/LAIV vaccine in a US-based health insurance claims database.
Croatian: Nema dokaza o značajnim štetnim posljedicama po majku u 138 trudnica koje su, prema bazi podataka potraživanja od zdravstvenog osiguranja u SAD-u, primile sezonsko T/LAIV cjepivo.
English: The European Medicines Agency will review new information on this medicines at least every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će barem jednom godišnje procjenjivati nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
English: Children less than 12 months
Croatian: Djeca mlađa od 12 mjeseci
English: • Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever) to children for 4 weeks after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca unless your doctor, nurse or pharmacist tells you otherwise.
Croatian: • Nemojte davati acetilsalicilnu kiselinu (tvar prisutna u mnogim lijekovima koja se koristi za ublažavanje boli i snižavanje vrućice) djeci tijekom 4 tjedna nakon cijepljenja Pandemijskim cjepivom protiv influence H5N1 AstraZeneca osim ako Vam liječnik, medicinska sestra ili ljekarnik ne preporuči drugačije.
English: In clinical studies with the vaccine, most side effects were mild in nature and short-term.
Croatian: U kliničkim ispitivanjima s cjepivom, većina nuspojava bila je blage naravi i kratkog trajanja.
English: Wheezing in children below 24 months of age
Croatian: Piskanje pri disanju u djece mlađe od 24 mjeseca
English: Children and adolescents from 12 months to less than 18 years of age 0.2 ml (administered as 0.1 ml per nostril).
Croatian: Djeca i adolescenti u dobi od 12 mjeseci do manje od 18 godina 0,2 ml (primjenjuje se kao 0,1 ml po nosnici).
English: A total of 20 subjects (12 T/LAIV, 0.3%; 8 injectable influenza vaccine, 0.2%) were hospitalised in association with medically significant wheezing.
Croatian: Ukupno je 20 ispitanika (12 za T/LAIV, 0,3%; 8 za cjepivo protiv influence koje se injicira, 0,2%) bilo hospitalizirano zbog medicinski značajnog piskanja pri disanju.
English: Animal developmental toxicity studies conducted with T/LAIV and Fluenz Tetra do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Croatian: Ispitivanja razvojne toksičnosti na životinjama provedena s T/LAIV cjepivom i cjepivom Fluenz Tetra nisu ukazala na izravne ili neizravne štetne učinke u smislu reproduktivne toksičnosti.
English: Due to the association of Reye's syndrome with salicylates and wild-type influenza infection, healthcare providers should assess the potential risks of administering the vaccine with the potential benefits in a pandemic situation (see section 4.5).
Croatian: Zbog povezanosti Reyevog sindroma s primjenom salicilata i infekcijom virusom influence divljeg tipa, zdravstveni djelatnici moraju procijeniti potencijalne rizike i koristi primjene cjepiva u slučaju pandemije (vidjeti dio 4.5).
English: D153-P502 Europe 6 to 35 M
Croatian: D153-P502 Europa od 6 do 35 M
English: • if the child is less than 12 months of age.
Croatian: • ako je dijete mlađe od 12 mjeseci.
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 slučaju pandemije može biti prikladno primijeniti cjepivo, ako se osigura da su u slučaju potrebe odgovarajući uvjeti za oživljavanje odmah zadovoljeni.
English: P/LAIV H5N1 vaccine
Croatian: P/LAIV H5N1 cjepivo
English: The adverse reactions reported were similar to those seen with the recommended single dose of T/LAIV and Fluenz Tetra.
Croatian: Zabilježene su nuspojave bile slične onima koje su primijećene s preporučenom jednokratnom dozom T/LAIV cjepiva ili cjepiva Fluenz Tetra.
English: Data for Group 3, subjects initially vaccinated with an H7N3 P/LAIV are not shown.
Croatian: Podaci za Skupinu 3, ispitanici koji su početno cijepljeni s cjepivom H7N3 P/LAIV nisu prikazani.
English: The virus must infect and replicate in cells lining the nasopharynx of the vaccine recipient in order to induce protective immunity.
Croatian: Virus mora inficirati i razmnožavati se u stanicama sluznice nazofarinksa primatelja cjepiva kako bi potaknuo zaštitni imunitet.
English: In a pandemic situation, healthcare providers need to assess the potential benefits, alternatives, and risks of administering the vaccine to children and adolescents with significant clinical immunodeficiency due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
Croatian: U slučaju pandemije, zdravstveni djelatnici moraju procijeniti potencijalne koristi i rizike te alternative primjeni cjepiva u djece i adolescenata sa značajnom kliničkom imunodeficijencijom koja je posljedica bolesti ili imunosupresivnog liječenja poput: akutne i kronične leukemije; limfoma; simptomatske infekcije HIV-om; deficijencije stanične imunosti; i primjene visokih doza kortikosteroida.
English: The influenza strain used for the vaccine in an offically declared pandemic is recommended by the World Health Organisation.
Croatian: Soj virusa influence upotrijebljen za izradu cjepiva u slučaju službeno proglašene pandemije u skladu je s preporukama Svjetske zdravstvene organizacije.
English: Although safety in children and adolescents with mild to moderate asthma has been established for T/LAIV, data in children with other pulmonary diseases or with chronic cardiovascular, metabolic or renal diseases are limited.
Croatian: Iako za T/LAIV nije ustanovljena sigurnost u djece i adolescenata s blagom do umjerenom astmom, podaci u djece s drugim plućnim bolestima ili kroničnim kardiovaskularnim, metaboličkim ili bubrežnim bolestima su ograničeni.
English: Use of salicylates in children and adolescents for 4 weeks after vaccination should be avoided unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.
Croatian: Primjena salicilata u djece i adolescenata tijekom 4 tjedna nakon cijepljenja treba se izbjegavati, osim ako to nije medicinski indicirano, jer je nakon primjene salicilata tijekom infekcije divljim tipom virusa influence zabilježen Reyev sindrom.
English: Post-marketing experience with seasonal T/LAIV Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed.
Croatian: Iskustva nakon stavljanja sezonskog T/LAIV cjepiva u promet Zabilježeni su i vrlo rijetki slučajevi Gulliain-Barréovog sindroma i egzacerbacije simptoma Leighovog sindroma (mitohondrijska encefalomiopatija).
English: T/LAIV's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons.
Croatian: Podaci o djelotvornosti T/LAIV cjepiva prikupljeni su u 9 kontroliranih ispitivanja provedenih na više od 20 000 dojenčadi, male djece, djece i adolescenata tijekom 7 sezona influence.
English: P/LAIV priming dose
Croatian: P/LAIV cjepiva
English: Non-clinical data with the Pandemic influenza vaccine H5N1 AstraZeneca, and the seasonal vaccines T/LAIV and Fluenz Tetra reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance, and neurovirulence.
Croatian: Neklinički podaci s Pandemijskim cjepivom protiv influence H5N1 AstraZeneca i sezonskim cjepivima T/LAIV i Fluenz Tetra ne ukazuju na poseban rizik za ljude na temelju konvencionalnih nekliničkih ispitivanja toksičnosti ponovljenih doza, reproduktivne i razvojne toksičnosti, lokalne podnošljivosti i neurovirulencije.
English: Table 1 T/LAIV efficacy in placebo controlled paediatric studies
Croatian: Tablica 1 Djelotvornost T/LAIV cjepiva u placebom kontroliranim pedijatrijskim ispitivanjima
English: The incidence of wheezing within 15 days after vaccination was lower in T/LAIV recipients relative to seasonal inactivated vaccine recipients (19.5% vs. 23.8%, P=0.02).
Croatian: Incidencija piskanja pri disanju u razdoblju od 15 dana nakon cijepljenja bila je niža u primatelja T/LAIV cjepiva u odnosu na primatelje sezonskog inaktiviranog cjepiva (19,5% prema 23,8%, P = 0,02).
English: Overall, the safety profile of T/LAIV in a limited number of subjects with mildly to moderately nonHIV related compromised immune function, asymptomatic or mildly symptomatic HIV infection, or cancer (solid tumors and haematological malignancies) was comparable to that in healthy individuals and does not indicate any untoward effect.
Croatian: Sveukupno, sigurnosni profil T/LAIV cjepiva na ograničenom broju ispitanika s blago do umjereno kompromitiranom funkcijom imunološkog sustava koja nije vezana uz HIV, te asimptomatskom ili blago simptomatskom infekcijom HIV-om ili rakom (solidni tumori i hematološke maligne bolesti), bio je usporediv s profilom u zdravih osoba i ne upućuje na neželjene učinke.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pandemic influenza vaccine H5N1 AstraZeneca in one or more subsets of the paediatric population in prevention of influenza infection.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja Pandemijskog cjepiva protiv influence H5N1 AstraZeneca u jednoj ili više podskupina pedijatrijske populacije za prevenciju infekcije virusom influence.
English: In addition, studies conducted with AstraZeneca's 2009 H1N1 pandemic LAIV and seasonal T/LAIV vaccine are also considered supportive because all these vaccines are manufactured using the same process, administered through the same route, and studied primarily in naïve individuals.
Croatian: Dodatno, ispitivanja provedena s AstraZeneca 2009 H1N1 pandemijskim živim atenuiranim cjepivom protiv influence (P/LAIV) i sezonskim T/LAIV cjepivom također se smatraju suportivnima jer se sva ova cjepiva proizvode koristeći isti proces, primjenjuju se istim putem i prvenstveno su ispitana u osoba koje prethodno nisu bile izložene lijeku.
English: In a surveillance study conducted by the US CDC (Griffin, et al, 2011) the effectiveness of the H1N1 pandemic LAIV vaccine in children 2 through 9 years of age was estimated at 81.9% (95% CI:13.6,
Croatian: U nadzornom ispitivanju koje je proveo Američki centar za kontrolu bolesti (Griffin, et al, 2011), procijenjeno je da djelotvornost pandemijskog H1N1 LAIV cjepiva u djece u dobi od 2 do 9 godina iznosi 81,9% (95% CI:13,6, 96,2).
English: Shedding of the H5N1 vaccine virus in adults was extremely limited.
Croatian: Izlučivanje cijepnog virusa H5N1 u odraslih bilo je izrazito ograničeno.
English: Do not use this vaccine after the expiry date which is stated on the applicator label after the letters EXP.
Croatian: Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici aplikatora iza oznake EXP.
English: The suspension is colourless to pale yellow, clear to opalescent.
Croatian: Suspenzija je bezbojna do blijedožuta, bistra do opalescentna.
English: The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff.
Croatian: Bolesnik može normalno disati tijekom primjene cjepiva - nema potrebe za aktivnim udisanjem ili ušmrkavanjem.
English: T/LAIV efficacy
Croatian: Djelotvornost T/LAIV cjepiva
English: For placebo recipients regardless of baseline serostatus, seroresponse rate was 6.3% on Days 15 and 29 and 14.5% on Day 57.
Croatian: Za primatelje placeba, neovisno o njihovom početnom sero-statusu, stopa sero-odgovora bila je 6.3% za 15. i 29. dan, te 14,5% za 57. dan.
English: • It is recommended that Pandemic influenza vaccine H5N1 AstraZeneca is not given at the same time as influenza-specific antiviral medicines such as oseltamivir and zanamivir.
Croatian: • Ne preporučuje se davati Pandemijsko cjepivo protiv influence H5N1 AstraZeneca istodobno sa specifičnim antivirusnim lijekovima protiv gripe kao što su oseltamivir i zanamivir.
English: Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.
Croatian: Profilaksa influence u slučaju službeno proglašene pandemije u djece i adolescenata u dobi od 12 mjeseci do manje od 18 godina.
English: There are a moderate amount of data from the use of T/LAIV and the seasonal Fluenz Tetra vaccine in pregnant women.
Croatian: Postoji ograničena količina podataka o primjeni T/LAIV cjepiva i sezonskog cjepiva Fluenz Tetra u trudnica.
English: In more than 300 case reports in the AstraZeneca safety database of vaccine administration in pregnant women, no unusual patterns of pregnancy complications or foetal outcomes were observed.
Croatian: U bazi sigurnosnih podataka tvrtke AstraZeneca u više od 300 prijava slučajeva primjene cjepiva u trudnica nisu zabilježeni neuobičajeni oblici komplikacija u trudnoći ili fetalnih ishoda.
English: In an active-controlled clinical study (MI-CP111) conducted with T/LAIV in comparison to the injectable influenza trivalent vaccine, an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants 6-11 months of age (6.1% T/LAIV versus 2.6% injectable influenza vaccine).
Croatian: U aktivno kontroliranom kliničkom ispitivanju (MI-CP111), u kojem je T/LAIV cjepivo uspoređeno s trovalentnim cjepivom protiv influence koje se injicira, zamijećena je povećana stopa hospitalizacija (iz bilo kojeg razloga) dojenčadi u dobi od 6 do 11 mjeseci tijekom 180 dana nakon posljednje doze cjepiva (6,1% za T/LAIV naspram 2,6% za cjepivo protiv influence koje se injicira).
English: Similarly from the VAERS, in 113 reports of pregnant women who had received AstraZeneca's (H1N1) 2009 Monovalent Vaccine Live, Intranasal, no unusual patterns of pregnancy complications or foetal outcomes were observed.
Croatian: Slično podacima iz VAERS-a, u izvještajima za 113 trudnica koje su primile AstraZeneca 2009 monovalentno živo cjepivo (H1N1) za intranazalnu primjenu, nisu zabilježeni neuobičajeni oblici komplikacija u trudnoći ili fetalnih ishoda.
English: For the H7N9 P/LAIV, 8 of 14 individuals who received a single dose of vaccine and 13 of 16 individuals who received two doses of vaccine developed strong antibody responses; peak titers were again seen by Day 14.
Croatian: Za P/LAIV H7N9 cjepivo, 8 od 14 ispitanika koji su primili jednokratnu dozu cjepiva i 13 od 16 ispitanika koji su primili dvije doze cjepiva su razvili snažan odgovor antitijela; vršne vrijednosti titra ponovno su zabilježene do 14. dana.
English: Similar responses were seen with P/LAIV H7N7- and H7N9-primed subjects who developed vigorous antibody responses to the corresponding wild-type viruses upon subsequent exposure to the inactivated vaccine from the same subtype.
Croatian: Slični odgovori zamijećeni su i u ispitanika primarno cijepljenih P/LAIV H7N7 i H7N9 cjepivima koji su razvili snažan odgovor antitijela na odgovarajuće divlje tipove virusa nakon naknadne izloženosti inaktiviranom cjepivu istog virusnog podtipa.
English: Clinical study CIR 277 assessed whether prior recipients of pandemic live attenuated influenza H5N1 vaccines were primed or established long-lasting immunity that could be detected following the subsequent administration of an inactivated H5N1 vaccine.
Croatian: Kliničko ispitivanje CIR 277 procijenilo je jesu li prethodni primatelji pandemijskog živog atenuiranog cjepiva H5N1 bili primarno imunizirani ili su uspostavili dugotrajnu imunost koja se može detektirati nakon naknadne primjene inaktiviranog H5N1 cjepiva.
English: In clinical studies, the safety profile of Pandemic influenza vaccine H5N1 AstraZeneca was comparable to the safety profile of the seasonal vaccines T/LAIV and Fluenz Tetra (see section 5.1 for more information).
Croatian: U kliničkim ispitivanjima, sigurnosni profil Pandemijskog cjepiva protiv influence H5N1 AstraZeneca bio je usporediv sa sigurnosnim profilom sezonskih cjepiva T/LAIV i Fluenz Tetra (za više informacija vidjeti dio 5.1).
English: In a study (D153-P515) of children 6 to 17 years of age with asthma (seasonal T/LAIV: n=1,114, seasonal injectable influenza vaccine: n=1,115), there were no significant differences between treatment groups in the incidence of asthma exacerbations, mean peak expiratory flow rate, asthma symptom scores, or night-time awakening scores.
Croatian: U ispitivanju (D153-P515) djece s astmom u dobi od 6 do 17 godina (sezonsko T/LAIV cjepivo: n=1114; sezonsko cjepivo protiv influence koje se injicira: n=1115) između skupina bolesnika nije bilo značajne razlike u incidenciji egzacerbacije astme, srednjoj vrijednosti brzine vršnog ekspiratornog protoka, zbroju bodova simptoma astme, ili zbroju bodova noćnih buđenja.
English: T/LAIV has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Croatian: T/LAIV cjepivo je pokazalo superiornost u 3 aktivno kontrolirana ispitivanja u odnosu na cjepivo protiv influence koje se injiciralo.
English: For children regardless of baseline serostatus, seroresponse rates after receipt of monovalent vaccine were 7.8% and 11.1% for Days 15 and 29, respectively, and 32.0% on Day 57.
Croatian: Neovisno o njihovom početnom sero-statusu, za djecu su stope sero-odgovora nakon primanja monovalentnog cjepiva bile 7,8% za 15. dan odnosno 11,1% za 29. dan, te 32,0% za 57. dan.
English: The most common adverse reactions observed in clinical studies conducted with the Pandemic influenza vaccine H5N1 AstraZeneca in healthy adults was headache (25.4%) and upper respiratory infection (10.2%).
Croatian: Najčešće nuspojave zamijećene u kliničkim ispitivanjima provedenima s Pandemijskim cjepivom protiv influence H5N1 AstraZeneca u zdravih ispitanika bile su glavobolja (25,4%) i infekcije gornjih dišnih puteva (10,2%).
English: The study enrolled 69 subjects in 5 groups: Group 1 enrolled 11 subjects who had previously received 2 doses of the A/Vietnam/1203/2004 H5N1 pandemic live attenuated influenza vaccine (P/LAIV) in 2006-2007; Group 2 enrolled 10 subjects who had previously received 2 doses of the A/Hong Kong/213/2003 H5N1 P/LAIV in 2007; Group 3 enrolled 8 subjects who had previously received 2 doses of the A/British Columbia/CN-6/2004 H7N3 P/LAIV in 2010 (as a P/LAIV control group); Groups 4 and 5 each enrolled 20 subjects who had not been previously vaccinated with LAIV and were influenza H5 naïve.
Croatian: Ispitivanje je uključivalo 69 ispitanika u 5 skupina: Skupina 1 uključivala je 11 ispitanika koji su prethodno primili 2 doze pandemijskog živog atenuiranog cjepiva protiv influence (P/LAIV) H5N1 soja A/Vietnam/1203/2004 od 2006. do 2007. godine; Skupina 2 uključivala je 10 ispitanika koji su prethodno primili 2 doze pandemijskog živog atenuiranog cjepiva protiv influence(P/LAIV) H5N1 soja A/Hong Kong/213/2003 u 2007. godini; Skupina 3 uključivala je 8 ispitanika koji su prethodno primili 2 doze pandemijskog živog atenuiranog cjepiva protiv influence (P/LAIV) H7N3 soja A/British Columbia/CN-6/2004 u 2010. godini (kao P/LAIV kontrolna skupina); Skupine 4 i 5 uključivale su svaka po 20 ispitanika koji nisu prethodno cijepljeni živim atenuiranim cjepivom i koji nisu prethodno bili izloženi influenci H5.
English: Post-marketing data from occasional inadvertent gestational use of the seasonal vaccines offer some reassurance.
Croatian: Podaci nakon stavljanja cjepiva u promet vezani uz povremenu nehotičnu primjenu sezonskih cjepiva u trudnoći su donekle ohrabrujući.
English: The influenza virus strain in Pandemic influenza vaccine H5N1 AstraZeneca is (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Croatian: Soj virusa influence u Pandemijskom cjepivu protiv influence H5N1 AstraZeneca je (a) prilagođen na hladnoću; (b) osjetljiv na temperaturu i (c) atenuiran.
English: Your doctor, nurse or pharmacist will decide if Pandemic influenza vaccine H5N1 AstraZeneca can be given at the same time as other vaccines.
Croatian: Vaš liječnik, medicinska sestra ili ljekarnik odlučit će može li se Pandemijsko cjepivo protiv influence H5N1 AstraZeneca dati istodobno s drugim cjepivima.
English: In a study (AV010) of children and adolescents 9 to 17 years of age with moderate to severe asthma (seasonal T/LAIV: n=24, placebo: n=24), the primary safety criterion, change in percent predicted forced expiratory volume in 1 second (FEV1) measured before and after vaccination, did not differ between treatment arms.
Croatian: U ispitivanju (AV010) djece i adolescenata s umjerenom do teškom astmom u dobi od 9 do 17 godina (sezonsko T/LAIV cjepivo: n=24; placebo: n=24) primarni kriterij sigurnosti, promjena u postotku predviđenog forsiranog ekspiratornog volumena u prvoj sekundi (FEV1) izmjerenog prije i nakon cijepljenja, nije se razlikovala između liječenih skupina.
English: The safety of seasonal live attenuated influenza vaccine (LAIV) in children with severe asthma and active wheezing has not been adequately studied.
Croatian: Sigurnost sezonskog živog atenuiranog cjepiva protiv influence (LAIV, od engl. live attenuated influenza vaccine) nije odgovarajuće ispitana u djece s teškom astmom i aktivnim piskanjem pri disanju.
English: Seven of 11 (64%) subjects in Group 1 (ca A/Vietnam/1204/2004 [H5N1]) had ≥4-fold rises in HAI antibody titer by Day 7 following receipt of the inactivated vaccine, with a geometric mean titer (GMT) of 165 and a titer range of 20 to 1280 in responders.
Croatian: Sedam od 11 (64%) ispitanika u Skupini 1 (ca A/Vietnam/1204/2004 [H5N1]) imalo je ≥ 4-struko povećanje u titru HAI antitijela do 7. dana, nakon što su primili inaktivirano cjepivo, uz vrijednost geometrijske sredine titra (engl. geometric mean titer, GMT) od 165 i raspon titra od 20 do 1280 u osoba koje su imale odgovor na cijepljenje.
English: Clinical studies have evaluated the incidence of adverse reactions in 59 adults from 18 to 49 years of age receiving at least one dose of Pandemic influenza vaccine H5N1 AstraZeneca.
Croatian: Klinička ispitivanja procijenila su incidenciju nuspojava u 59 odraslih osoba u dobi od 18 do 49 godina u kojih je primijenjena najmanje jedna doza Pandemijskog cjepiva protiv influence H5N1 AstraZeneca.
English: This section describes the clinical experience observed in three pivotal studies conducted with the Pandemic influenza vaccine H5N1 AstraZeneca in adults.
Croatian: Ovaj dio opisuje kliničko iskustvo iz tri pivotalna ispitivanja provedena s Pandemijskim cjepivom protiv influence H5N1 AstraZeneca u odraslih osoba.
English: • Do not use Pandemic influenza vaccine H5N1 AstraZeneca if the expiry date has passed or if the sprayer appears damaged, for example, if the plunger is loose or displaced from the sprayer or if there are any signs of leakage.
Croatian: • Nemojte primjenjivati pandemijsko cjepivo protiv influence H5N1 AstraZeneca ako je istekao rok valjanosti ili ako Vam se čini da je raspršivač oštećen, na primjer ako klip nije dobro pričvršćen ili se ne nalazi u raspršivaču ili ako postoje bilo kakvi znakova curenja.