FrancophonIA/ELRC3.0 huggingface dataset:
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature (25°C - 30°C).
Croatian: Pripremljeno cjepivo se može čuvati ili u hladnjaku (2°C-8°C) ili na sobnoj temperaturi (25°C-30°C).
English: It is recommended to equip the syringe with a 23-G needle.
Croatian: Preporučuje se primjena štrcaljke s iglom promjera 23G.
English: Ferrets immunized with the non adjuvanted H5N1 influenza vaccine were not protected from death and showed similar lung viral loads and degree of viral shedding in the upper respiratory tract as those exhibited by ferrets immunized with the adjuvant alone.
Croatian: Tvorovi koji su bili cijepljeni cjepivom protiv H5N1 influence bez adjuvansa nisu bili zaštićeni od smrti i u njih je nađena slična količina virusa u plućima i stupanj izlučivanja virusa u gornjim dišnim putevima kao i u tvorova cijepljenih samo adjuvansom.
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Croatian: Obavijestite stoga liječnika ili medicinsku sestru ako ste izgubili svijest prilikom primanja prethodne
English: Adverse reactions reported are listed according to the following frequency:
Croatian: Prijavljene nuspojave navedene su prema sljedećoj učestalosti:
English: The CHMP recommends that the terms of the Marketing Authorisation should be varied.
Croatian: CHMP preporučuje izmjenu uvjeta odobrenja za stavljanje lijeka u promet.
English: Control groups included ferrets immunized with adjuvant alone and non-adjuvanted vaccine (7.5 micrograms HA).
Croatian: Kontrolnu skupnu sačinjavali su tvorovi koji su cijepljeni samo adjuvansom i cjepivom bez adjuvansa (7,5 mikrograma HA).
English: • Diarrhoea, feeling sick
Croatian: • proljev, osjećaj mučnine
English: Persons previously vaccinated with one or two doses of AS03-containing vaccine containing HA derived from a different clade of the same subtype
Croatian: Osobe koje su ranije cijepljene s jednom ili dvije doze cjepiva koje sadrži AS03 i hemaglutinine (HA) dobivene iz različitih linija istog podtipa
English: Clinical data in children less than 6 years of age who received two doses of another Pandemic influenza vaccine (H5N1 manufactured in Dresden, Germany) indicate an increase in frequency of fever (axillary≥38°C) after the administration of the second dose.
Croatian: Klinički podaci u djece mlađe od 6 godina koja su primila dvije doze drugog Cjepiva protiv pandemijske influence (H5N1, proizvedeno u Dresdenu, Njemačka) ukazuju na povećanu učestalost vrućice (≥ 38ºC aksilarno) nakon primjene druge doze.
English: Pumarix contains sodium and potassium
Croatian: Pumarix sadrži natrij i kalij
English: Each vial should be shaken and inspected visually for any foreign particulate matter (other than the white sediments described above) and/or abnormal physical appearance.
Croatian: Svaku bočicu treba protresti i vizualno pregledati na prisutnost stranih čestica (osim ranije opisanog bijelog taloga ) i/ili promjenu fizičkog izgleda.
English: Conversely the combination of a range of doses of H5N1 antigen with AS03 adjuvant was able to protect against mortality and to reduce lung virus loads and viral shedding after intra-tracheal challenge with a homologous wild type H5N1 virus.
Croatian: Suprotno tome, kombinacija različitih raspona doza H5N1 antigena s AS03 adjuvansom pružila je zaštitu od smrtnog ishoda i smanjenje količine virusa u plućima, kao i izlučivanja virusa nakon intratrahealnog opterećenja homolognim divljim sojem H5N1 virusa.
English: Do not use the suspension and the emulsion after the expiry date which is stated on the carton.
Croatian: Suspenziju i emulziju se ne smije upotrijebiti nakon isteka roka valjanosti navedenom na pakovanju.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: Sukladno članku 114 Direktive 2001/83/EC, službeno puštanje serije lijeka u promet preuzet će
English: Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each
Croatian: Stoga se nakon svake doze preporučuje kontrola tjelesne temperature i provođenje mjera za njezino snižavanje (poput davanja paracetamola ili drugih lijekova
English: In addition, one group of six ferrets were immunized with vaccine candidate containing 3.75 µg H5N1 + full dose of AS03 and one control group included ferrets immunized with non-adjuvanted vaccine (3.75 micrograms HA).
Croatian: Uz to, jedna skupina od šest tvorova je imunizirana predloženim cjepivom koje je sadržavalo 3,75 µg H5N1 + punu dozu AS03, a jedna kontrolna skupina je uključivala tvorove imunizirane cjepivom bez adjuvansa (3,75 mikrograma HA).
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Croatian: Ako se razmatra istovremena primjena s drugim cjepivom, cijepljenje treba provesti na različitim udovima.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant
Croatian: Imunološki odgovor može biti oslabljen u bolesnika na imunosupresivnoj terapiji.
English: The per-dose frequency of local and general solicited adverse reactions observed in the groups of children who received two adult (0.5 ml) doses was higher than that observed in the groups of children who received two half adult (i.e. 0.25 ml) doses, except for redness in the 6-9 years of age group.
Croatian: Učestalost lokalnih i općih praćenih nuspojava po dozi zabilježena u skupinama djece koja su primila dvije doze cjepiva za odrasle (0,5 ml) bila je viša nego u skupinama djece koja su primila dva puta po pola doze cjepiva za odrasle (tj. 0,25 ml), osim crvenila u dobnoj skupini od 6 do 9 godina.
English: Immune response to A/Vietnam/1194/2004
Croatian: Imunološki odgovor na A/Vietnam/1194/2004
English: No post-marketing surveillance data are available following Pumarix administration.
Croatian: Nema podataka iz postmarketinškog praćenja nakon primjene cjepiva Pumarix.
English: In adults 18 to 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (80.5%), muscle aches (37.2%), fatigue (25.2%), headache (25.1%), joint pain
Croatian: U odraslih osoba od 18 do 64 godina najčešće prijavljene nuspojave nakon cijepljenja bile su: bol na mjestu injiciranja (80,5%), bolovi u mišićima (37,2%), umor (25,2%), glavobolja (25,1%), bol u
English: Common: nausea, diarrhoea
Croatian: Često: mučnina, proljev
English: It is best to see how Pumarix affects you before you try these activities.
Croatian: Prije započinjanja ovih radnji, najbolje je prvo provjeriti kako Pumarix djeluje na Vas.
English: 4.7 Effects on ability to drive and use machines Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive
Croatian: Pojedini učinci cjepiva navedeni u dijelu 4.8 "Nuspojave" mogu utjecati na sposobnost upravljanja
English: • Pain in the back or neck, stiff muscles, muscle spasms, pain in your leg or hand
Croatian: • bol u stražnjem dijelu vrata, ukočenost mišića, grčevi mišića, bol u nogama ili rukama.
English: Proportional reporting ratio (PRR), Information Component (IC) or the Empirical Bayesian Geometric Mean (EBMG)); this is not mandatory as all MAHs do not yet have this capability.
Croatian: Ako bude moguće, treba priložiti mjeru relativnog izvješćivanja o signalima za svaki prijavljeni PT (npr. omjer proporcionalnog izvješćivanja (PRR), informacijska komponenta (IC) ili empirijska Bayesova geometrijska srednja vrijednost (EBMG)); to nije obvezatno budući da svi nositelji
English: It is recommended to equip the syringe with a needle gauge not larger than 23
Croatian: Ne preporučuje se koristiti štrcaljku s iglom čiji je promjer veći od 23G.
English: 6.5 Nature and contents of container
Croatian: 6.5 Vrsta i sadržaj spremnika Jedno pakovanje sadrži:
English: Pumarix is not intended to be given at the same time as some other vaccines.
Croatian: Pumarix nije namijenjen istovremenoj primjeni s drugim cjepivima.
English: Day 180 N=353
Croatian: 180. dan N=353
English: Prior to administration, the two components should be mixed.
Croatian: Prije primjene, dvije navedene komponente trebaju se pomiješati.
English: Day 42 N=479
Croatian: 42. dan N=479
English: The administration of a second half adult or an adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in <6 year olds.
Croatian: Primjena druge polovice ili cijele doze za odrasle nije pojačala reaktogenost, osim za stope općih simptoma koje su bile veće nakon druge doze, osobito stope vrućice u djece mlađe od 6 godina.
English: A titre of 1:80 was achieved in 84.2% of subjects aged 18-60 years and in 92.6% of subjects aged >60 years.
Croatian: Titar od 1:80 postignut je u 84,2% ispitanika od 18 do 60 godina, te u 92,6% ispitanika starijih od 60 godina.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane u padajućem slijedu prema ozbiljnosti:
English: Taking into account the PRAC Assessment Report on the PSUR for Pumarix, the scientific conclusions of the PRAC are as follows:
Croatian: Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC) je na temelju ocjene Periodičkog izvješća o neškodljivosti (PSUR) za Pumarix donijelo sljedeće znanstvene zaključke:
English: At day 42 and six months after the second dose, the anti-HA antibody responses were as follows:
Croatian: Odgovori anti-HA protutijela 42. dana i šest mjeseci nakon primjene druge doze bili su sljedeći:
English: At day 42, 100% of subjects aged 18-60 years and 96.4% of subjects aged >60 years
Croatian: Četrdeset i drugog dana, 100% ispitanika od 18 do 60 godina, te 96,4%
English: In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Croatian: tijekom trajanja pandemije, resursi potrebni za detaljnu analizu periodičkih izvješća o neškodljivosti lijeka, u formatu koji je zadan u Volumenu 9a Propisa o lijekovima u Europskoj
English: Day 180 N=104
Croatian: 180. dan N=104
English: Grounds recommending the variation to the terms of the Marketing Authorisation
Croatian: Osnove za preporuku izmjene uvjeta odobrenja za stavljanje lijeka u promet
English: Clinical studies have evaluated the incidence of adverse reactions in approximately 4,500 subjects 18 years old and above who received Pumarix or placebo.
Croatian: Klinička ispitivanja procijenila su incidenciju nuspojava u oko 4500 osoba starijih od 18 godina koje
English: If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes)
Croatian: Ako se pripremljeno cjepivo čuva u hladnjaku, prije svake primjene treba pričekati da se zagrije na sobnu temperaturu (najmanje 15
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Croatian: Imunološki odgovor može biti nedostatan u bolesnika s endogenom ili jatrogenom imunosupresijom.
English: In subjects > 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (58.0%), muscle aches (19.7%), fatigue (13.5%), headache (12.4%) and joint pain
Croatian: U osoba starijih od 64 godine, najčešće prijavljene nuspojave nakon cijepljenja bile su: bol na mjestu injiciranja (58,0%), bolovi u mišićima (19,7%), umor (13,5%), glavobolja (12,4%) i bol u zglobovima
English: The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen.
Croatian: Cjepivo se priprema tako da se pomoću štrcaljke od 5 ml izvuče cijeli sadržaj bočice s adjuvansom i doda u bočicu s antigenom.
English: In other clinical studies where children 6 months to 17 years received a similar vaccine containing A/Indonesia/05/2005, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
Croatian: U drugim kliničkim ispitivanjima, u kojima su djeca u dobi od 6 mjeseci do 17 godina primila slično cjepivo koje je sadržavalo soj A/Indonesia/05/2005, primijećena je povećana učestalost nekih nuspojava (uključujući bol na mjestu injekcije, crvenilo i vrućicu) nakon primjene druge doze u djece
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Croatian: Europska agencija za lijekove će svake godine procjenjivati nove informacije o lijeku, te će se tekst
English: However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be
Croatian: Međutim, ako to bude nužno, drugo cjepivo će trebati primijeniti u drugu ruku.
English: Day 180 N=141
Croatian: 180. dan N=141
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Croatian: Cjepivo se primjenjuje intramuskularno, po mogućnosti u deltoidni mišić ili anterolateralni dio bedra
English: If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se svom liječniku ili
English: No fertility data are available.
Croatian: Nema podataka o utjecaju na plodnost.
English: Immune response to A/Indonesia/5/2005 Day 42 N=145
Croatian: Imunološki odgovor na sojeve A/Indonesia/5/2005 42. dan N=145
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION (ADJUVANT)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU PAKOVANJE OD 25 BOČICA S EMULZIJOM (ADJUVANS)
English: This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up' strains and any safety data relevant
Croatian: Ovo treba uključivati podatke iz ispitivanja koja su u tijeku, ili ako je primjenjivo iz stvarnih iskustava,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION (ANTIGEN)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU PAKOVANJE OD 50 BOČICA SA SUSPENZIJOM (ANTIGEN)
English: All subjects achieved a neutralising antibody titre of at least 1:80 against each of the two strains regardless of the HA type in the vaccine and the previous number of doses.
Croatian: Svi ispitanici postigli su titar neutralizirajućih protutijela od najmanje 1:80 prema svakom od dva soja, neovisno o
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Croatian: Taj adjuvans sadrži skvalen (10,69 miligrama), DL-α tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama).
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
English: They may also happen with Pumarix.
Croatian: One se mogu javiti i pri primjeni cjepiva Pumarix.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Croatian: Ovaj lijek sadrži tiomersal (organski spoj žive) kao konzervans, stoga može doći do reakcije
English: Fatal and/or life-threatening reactions - for each Preferred Term (PT), including the proportion of fatal reports
Croatian: Izvješće će sadržavati sljedeće tablice zbirnih podataka prema dogovorenim predlošcima: Smrtonosne i/ili životno ugrožavajuće nuspojave - za svaku preferirani naziv (PT), uključujući Neželjeni događaji od posebnog interesa (PT)
English: Also fever occurred more often in children aged 6-9 years compared to the children aged 3-5 years.
Croatian: Vrućica se također javljala češće u djece od 6 do
English: - Periodicity will be reviewed by the MAH and the (Co)Rapporteur at 3 monthly intervals.
Croatian: - Učestalost podnošenja izvješća revidirat će se u tromjesečnim intervalima od strane nositelja
English: In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing three different doses of H5N1 antigen (7.5, 3.8 and 1.9 µg of HA antigen) adjuvanted with the standard dose or half dose of AS03.
Croatian: U tom ispitivanju zaštite, tvorovi (šest tvorova/skupina) su cijepljeni intramuskularno predloženim cjepivom koje je sadržavalo tri različite doze antigena H5N1 (7,5; 3,8 i 1,9 µg HA antigena), sa standardnom dozom ili pola doze adjuvansa AS03.
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to
Croatian: Volumen dobiven nakon miješanja 1 bočice suspenzije (2,5 ml) i 1 bočice emulzije (2,5 ml) odgovara
English: Immune response against A/Indonesia/5/2005 (H5N1)
Croatian: Imunološki odgovor na soj A/Indonesia/5/2005 (H5N1) Odrasli
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 (H5N1):
Croatian: Imunološki odgovori križne reaktivnosti postignuti cjepivom s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog iz soja A/Indonesia/5/2005 (H5N1):
English: The vaccine should be administered in accordance with the recommended posology (see section 3.
Croatian: Cjepivo se treba davati sukladno preporučenom doziranju (vidjeti dio 3. ''Kako se primjenjuje Pumarix'').
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
Croatian: - dva pakovanja s 25 bočica (staklo tip I) od 2,5 ml emulzije s čepom (butil guma).
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Croatian: Ovi prolazni, lažno pozitivni rezultati mogući su zbog stvaranja
English: Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Croatian: cjepivo protiv pandemijske influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Croatian: Dokazana kemijska i fizikalna stabilnost u
English: Redness
Croatian: Nuspojave
English: Excipient with known effect: the vaccine contains 5 micrograms thiomersal For the full list of excipients see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: cjepivo sadrži 5 mikrograma tiomersala.
English: Shake before use
Croatian: Protresti prije primjene
English: The per-dose frequency of adverse reactions was as follows:
Croatian: Odgovori na anti-HA protutijela bili su sljedeći:
English: Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
Croatian: Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
English: On the basis of the scientific conclusions for Pumarix, the CHMP is of the opinion that the benefitrisk balance of the medicinal product containing the active substance purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 is favourable subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za Pumarix, mišljenje je CHMP-a da je omjer koristi i rizika lijeka koji sadrži djelatnu tvar dijelove pročišćenog antigena inaktiviranog fragmentiranog viriona A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 povoljan pod uvjetom da se provedu predložene
English: Tel.: + 48 (22) 576 9000
Croatian: GSK Commercial Sp. z o.o. Tel.: + 48 (22) 576 9000
English: Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde and sodium
Croatian: Potreban je oprez prilikom primjene ovog cjepiva osobama s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na neku od pomoćnih tvari navedenih u dijelu 6.1, tiomersal i ostatne tvari (jaja i pileći proteini, ovalbumin, formaldehid i natrijev deoksikolat).
English: Full dose N=29
Croatian: Puna doza N=29
English: 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT)
Croatian: 3faktor serokonverzije (tj. omjer GMT vrijednosti nakon i prije cijepljenja)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts, such as: egg and chicken protein, ovalbumin, formaldehyde or sodium deoxycholate.
Croatian: • ako ste prije imali iznenadnu životno ugrožavajuću alergijsku reakciju na bilo koji sastojak ovog cjepiva (navedenih u dijelu 6) ili na bilo koju tvar koja može biti prisutna u tragovima, poput: jaja i pilećih proteina, ovalbumina, formaldehida ili natrijeva deoksikolata.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Croatian: Kao psihogeni odgovor na ubod iglom, nakon ili čak i prije bilo kojeg cijepljenja može doći do sinkope (gubitka svijesti).
English: The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate,
Croatian: Drugi sastojci su: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat,
English: Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Croatian: Neovisno o tome jesu li su prije šest mjeseci primili jednu ili dvije doze primovakcinacije, stopa seroprotekcije protiv A/Indonesia bio je >80% nakon doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004, a stope seroprotekcije protiv A/Vietnam bile su >90% nakon doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Indonesia/05/2005.
English: Pumarix may be used in lactating women.
Croatian: Dojenje Pumarix se može primjenjivati u dojilja.
English: In the consistency study (Q-Pan-H5N1-002), a 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was at day 42 achieved in 65.5% of subjects aged 18-60 years and in 24.1% of subjects over 60 years of age.
Croatian: U ispitivanju konzistencije (Q-Pan-H5N1-002) 42. dana postignut je četverostruki porast neutralizirajućih protutijela protiv soja A/Vietnam/1194/2004 u serumu 65,5% ispitanika od 18 do 60
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Croatian: RMP mora se podnijeti istovremeno uz sljedeće Periodičko izvješće o neškodljivosti lijeka (PSUR).
English: A titre of 1:80 was achieved in 95.7% of subjects at days 21 and 42 and in 85.1% at day 180.
Croatian: Dvadeset i prvog, te 42. dana, titar od 1:80 postignut je u 95,7% ispitanika, a 180.-ti dan u 85,1% ispitanika.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with antigen suspension before administration
Croatian: Emulziju prije primjene treba pomiješati isključivo sa suspenzijom antigena
English: The side effects listed below have happened with H1N1 AS03-containing vaccines.
Croatian: S H1N1 cjepivima koja sadrže AS03 zabilježene su niže navedene nuspojave.