FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you feel feverish, - if you have any illness or infection, - if you are having immunosuppressive therapy, e.g. corticosteroid treatment or chemotherapy for cancer, or if you have any condition which makes you prone to infections (immunodeficiency conditions).
Croatian: - ako se osjećate kao da imate vrućicu, - ako imate bilo koju bolest ili infekciju, - ako primate imunosupresijsku terapiju, npr. kortikosteroidnu terapiju ili kemoterapiju za rak,
English: Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Croatian: Imunizacija se treba provesti intramuskularnom injekcijom u deltoidni mišić ili anterolateralni dio bedara (ovisno o mišićnoj masi).
English: Induration and ecchymosis were very common reactions in toddlers but were less common in infants.
Croatian: Otvrdnuće i ekhimoza su bile česte reakcije kod male djece, ali manje česte kod dojenčadi.
English: Serologic responses obtained with the HI assay showed that 92% of subjects achieved seroprotection and 75% seroconverted after two 7.5 µg injections.
Croatian: Serološki odgovori dobiveni HI testom pokazali su da je 92% ispitanika ostvarilo serozaštitu, a 75% ih je serokonvertiralo nakon dviju injekcija od 7,5 µg.
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Croatian: Osim nuspojava prijavljenih u kliničkim ispitivanjima, sljedeće su prijavljene tijekom postmarketinškog praćenja Focetrie H1N1v:
English: Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Croatian: Poremećaji kože i potkožnog tkiva Generalizirane kožne reakcije, uključujući svrbež, urtikariju ili nespecifičan osip; angioedem.
English: Data obtained with a pandemic preparedness vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical efficacy and safety data obtained with pandemic preparednessvaccines are relevant for the pandemic vaccines.
Croatian: Podaci dobiveni nakon cijepljenja cjepivom spremnim protiv pandemijske influence podržat će strategiju cijepljenja koja će se vjerojatno koristiti za pandemijsko cjepivo: klinički podaci koji se odnose na djelotvornost i sigurnost dobiveni nakon cijepljenja cjepivima spremnima protiv pandemijske influence relevantni su za pandemijska cjepiva.
English: Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Croatian: Štetne događaje od posebnog interesa stratificirane prema vrsti izvješća (medicinski potvrđeno ili medicinski nepotvrđeno).
English: Adverse event(s) from post-marketing surveillance with the pandemic vaccine: not applicable.
Croatian: Štetni događaj(i) zabilježeni tijekom praćenja nakon stavljanja u promet pandemijskog cjepiva: nije primjenjivo.
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome.
Croatian: Neurološki poremećaji kao što su encefalomijelitis (upala središnjeg živčanog sustava), neuritis (upala živaca) i vrsta paralize koja se naziva Guillain Barréov sindrom.
English: Data in infants and toddlers 6-35 months of age suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Croatian: Podaci za dojenčad i malu djecu u dobi od 6-35 mjeseci ukazuju na nešto manju reaktogenost nakon druge doze, bez povećanja učestalosti vrućica.
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Croatian: Neke od nuspojava spomenute u dijelu 4. "Moguće nuspojave" mogu utjecati na sposobnost upravljanja vozilima ili rada na strojevima.
English: 10 x 10 doses 1 dose (0.5 ml)
Croatian: 10 x 10 doza 1 doza (0,5 ml)
English: ** geometric mean ratios of SRH
Croatian: ** omjeri srednje geometrijske vrijednosti SRH
English: Data in children and adolescents 3-17 years suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Croatian: Podaci dostupni za djecu i adolescente u dobi od 3 do 17 godina upućuju na nešto manju reaktogenost nakon druge doze, bez povećanja učestalosti vrućica.
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Croatian: Alergijske reakcije, anafilaksa uključujući dispneju, bronhospazam, laringealni edem, koje u rijetkim slučajevima dovode do šoka.
English: The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).
Croatian: Djelatni sastojci cjepiva su pročišćeni virusnim bjelančevinama (nazvani hemaglutinin i neuraminidaza).
English: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy
Croatian: Martino 53035 Monteriggioni (SI) Italija
English: A third (booster) dose of H5N1 vaccine combined with MF59C was administered 6 months onwards after the primary vaccination series.
Croatian: Treća (booster) doza H5N1 cjepiva kombiniranog s MF59C primijenjena je od 6 mjeseci nadalje nakon prve serije cijepljenja.
English: Dispose of in accordance with local requirements.
Croatian: Zbrinuti sukladno lokalnim zahtjevima.
English: Warning: Do not inject intravascularly or subcutaneously.
Croatian: Upozorenje: Ne injicirati intravaskularno ili supkutano.
English: Numbness or tingling sensations, involuntary muscle contractions or thrombocytopenia (reduction in the number of certain types of particles in the blood called plateles; a low number of these can result in excessive bruising or bleeding).
Croatian: Osjećaj obamrlosti ili trnjenja, nevoljne mišićne kontrakcije ili prolazna trombocitopenija (smanjen broj određenih stanica krvi koje se nazivaju trombociti; nizak broj trombocita u krvi može dovesti do prekomjernog nastajanja modrica i krvarenja).
English: Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci u ispitanika u dobi od 6 mjeseci do 18 godina opisani su u dijelu 5.1,
English: The vaccine may be used during lactation.
Croatian: Cjepivo se može koristiti tijekom dojenja.
English: Some side effects listed in Section 4.
Croatian: Neke od nuspojava spomenutih u dijelu 4.8.
English: Foclivia contains sodium and potassium
Croatian: Foclivia sadrži natrij i kalij
English: Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43 * In the absence of CHMP immunogenicity criteria for children, the CHMP immunogenicity criteria used to evaluate seasonal flu vaccines in adults were applied to the serological data obtained after vaccination of children.
Croatian: (95% CI) 43. dan do 1. dan Stopa serokonverzije (95% CI) 43. dan * U nedostatku kriterija CHMP-a koji se odnose na imunogenost djece, kriteriji CHMP-a koji se odnose na imunogenost upotrijebljeni za procjenu cjepiva protiv sezonske influence u odraslih osoba primijenjeni su na serološke podatke dobivene nakon cijepljenja djece.
English: Serologic responses obtained with the SRH assay showed that 100% of subjects achieved seroprotection and 100% seroconverted after two 7.5 µg injections.
Croatian: Serološki odgovori dobiveni SRH analizom pokazali su da je 100% ispitanika ostvarilo serozaštitu, a 100% ih je serokonvertiralo nakon dviju injekcija od 7,5 µg.
English: Data on a third dose (booster) administered 6 months after the first dose are limited (see sections 4.8 and 5.1).
Croatian: Podaci o trećoj dozi (boosteru) primijenjenoj 6 mjeseci nakon prve doze ograničeni su (vidjeti dijelove 4.8 i 5.1).
English: ° measured by HI assay ≥ 40
Croatian: ° izmjereno HI testom ≥40
English: From the clinical trials conducted with the pandemic preparedness adjuvanted H5N1 vaccine in adult and elderly (see section 5.1 for more information), most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Croatian: U kliničkim ispitivanjima provedenim s adjuvantiranim cjepivom spremnim protiv pandemijske influence H5N1 (vidjeti dio 5.1 za više informacija) većina reakcija bila je blage naravi, kratkog trajanja i kvalitativno slična onima koje izazivaju konvencionalna cjepiva protiv sezonske influence.
English: Of these subjects, 3618 subjects received the pandemic preparedness vaccine Foclivia (A/H5N1) (see section 5.1).
Croatian: Od tih ispitanika, 3618 ispitanika primilo je cjepivo spremno protiv pandemijske influence Foclivia (A/H5N1) (vidjeti dio 5.1).
English: - Other Ingredients:
Croatian: Drugi sastojci:
English: Data on a third dose (booster) administered 6 months after the first dose are limited (see sections 4.8 and 5.1)
Croatian: Podaci o trećoj dozi (boosteru) primijenjenoj 6 mjeseci nakon prve doze ograničeni su (vidjeti dijelove 4.8 i 5.1)
English: Second dose (21 days after first dose)
Croatian: Druga doza (21 dan nakon prve doze)
English: 0.66 milligrams
Croatian: 0,66 miligrama
English: In some cases the effects may also include raised temperature, malaise (generally feeling unwell), shivering,
Croatian: U nekim slučajevima nuspojave mogu uključivati povišenu temperaturu, slabost (općenito loše osjećanje),
English: 0.04 milligrams
Croatian: 0,04 miligrama
English: - Guillain-Barré narrow SMQ “Guillain-Barré syndrome”
Croatian: suženi SMQ “Vaskulitis” - Guillain-Barréov sindrom: suženi SMQ "Guillain-Barréov sindrom" - Demijelinizacija:
English: It is essentially sodium- and potassium-free.
Croatian: U osnovi je bez natrija i kalija.
English: In a phase II clinical trial (Study V87P6) safety of a pandemic preparedness adjuvanted H5N1 vaccine was evaluated in children and adolescent (see section 5.1 for more information).
Croatian: U fazi II kliničkog ispitivanja (Studija V87P6) sigurnost adjuvantiranog cjepiva spremnog protiv pandemijske influence H5N1 je procijenjena u djece i odraslih (vidjeti dio 5.1 za više informacija).
English: Excipients: Thiomersal
Croatian: Tiomersal
English: Vasculitis with transient renal involvement and exudative erythema multiforme.
Croatian: Vaskulitis s prolaznim zahvaćanjem bubrega i eksudativni eritema multiforme.
English: Pregnancy No data have been generated with Foclivia in pregnant women.
Croatian: Nema podataka o primjeni Foclivije u trudnica.
English: A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle).
Croatian: Doza (0,5 ml) cjepiva injicira se u nadlakticu (deltoidni mišić).
English: nonadjuvanted influenza vaccines.
Croatian: neadjuvantiranim cjepivima protiv influence.
English: After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below*.
Croatian: 2. cijepljenja (43. dan) sve dobne skupine (tj. 6-35 mjeseci, 3-8 godina i 9-17 godina) postigle su visoke razine protutijela na virus (A/Vietnam/1194/2004), što je procijenjeno SRH i HI testovima i prikazano u tablici u nastavku*.
English: H5N1 adjuvanted vaccine
Croatian: adjuvantirano cjepivo protiv virusa H5N1
English: Once the tip cap is removed, attach a needle to the syringe by screwing it on in a clockwise direction until it locks.
Croatian: Nakon što ste kapicu skinuli, nataknite iglu na štrcaljku tako da je zakrećete u smjeru kazaljke na satu sve dok ne bude čvrsto pričvršćena.
English: Breast-feeding The vaccine may be used during lactation.
Croatian: Dojenje Cjepivo se može koristiti tijekom dojenja.
English: Skin and subcutaneous tissue disorders Common (>1/100, <1/10): sweating
Croatian: Poremećaji kože i potkožnog tkiva Često (>1/100 i <1/10): znojenje
English: Warnings and precautions Talk to your doctor or nurse before having this vaccine:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije primanja ovog cjepiva:
English: In two dose finding studies 78 adults received an adjuvanted pandemic preparednessvaccine (H5N3 or H9N2).
Croatian: U dva ispitivanja s ciljem određivanja učinkovite doze 78 odraslih osoba primilo je adjuvantirano cjepivo spremno protiv pandemijske influence (H5N3 ili H9N2).
English: Foclivia was evaluated in adults (18 to 60 years old) and elderly (over 60 years old) following a 1, 22 day primary vaccination schedule.
Croatian: Foclivia je procijenjena u odraslih osoba (u dobi od 18 do 60 godina) i starijih osoba (starijih od 60 godina) slijedeći raspored primarnog cijepljenja na 1. dan, pa 22. dana.
English: Redness, swelling, pain at the site of injection, bruising, hardening of the skin injection site.
Croatian: Crvenilo, oteknuće, bol na mjestu injekcije, modrice, otvrdnuće kože na mjestu injekcije.
English: Generalised skin reactions including itching, bumps on the skin or a non-specific rash.
Croatian: Generalizirane kožne reakcije, uključujući svrbež, kvržice na koži ili nespecifičan osip.
English: The incidence of adverse reactions was evaluated in four clinical trials with different influenza strains and formulations (H5N3, H9N2 and H5N1); 3696 adults and elderly subjects were exposed.
Croatian: Nuspojave iz kliničkih ispitivanja u odraslih i starijih osoba (od 18 godina naviše) Učestalost nuspojava procijenjena je u četiri klinička ispitivanja s različitim sojevima influence i formulacijama (H5N3, H9N2 i H5N1); cijepljeno je 3696 odraslih i starijih ispitanika.
English: Some cross-protection was observed against related H5N1 virus variants in clinical trials (see section 5.1).
Croatian: U kliničkim je ispitivanjima primijećena ukrižena zaštita protiv srodnih varijanata virusa H5N1 (vidjeti dio 5.1).
English: Safety data after the first and second dose in children and adolescents with a similar pandemic vaccine (Focetria H1N1v) suggest a comparable safety profile with that reported for the aH5N1 pandemic preparedness vaccine formulation (Foclivia).
Croatian: Podaci o sigurnosti primjene nakon prve i druge doze sličnog pandemijskog cjepiva (Focetria H1N1v) kod djece i adolescenata upućuju na sigurnosni profil usporediv s onime dobivenim za formulaciju cjepiva spremnog protiv pandemijske influence aH5N1 (Foclivia).
English: 5 ml vial containing 10 doses (0.5 ml/dose)
Croatian: Bočica od 5 ml koja sadrži deset doza (0,5 ml po dozi)
English: When using a pre-filled syringe without needle supplied with a Luer Lock system, remove the tip cap by unscrewing it in a counter-clockwise direction.
Croatian: Kada se koriste napunjene štrcaljke s Luer Lock sustavom bez igle, skinite kapicu s vrška štrcaljke tako da je zakrenete u smjeru suprotnom od kazaljki na satu.
English: Cross reactivity
Croatian: Ukrižena reaktivnost
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 pa je moguća reakcija senzibilizacije
English: Common (>1/100, <1/10): headache
Croatian: Često (>1/100 i <1/10): glavobolja
English: Adverse reactions from clinical trial in adults and elderly (above 18 years old)
Croatian: Sažetak profila sigurnosti Odrasli i starije osobe (u dobi iznad 18 godina)
English: Record date and time of the first dose withdrawal on the vial label.
Croatian: Na naljepnicu bočice treba zabilježiti datum i vrijeme izvlačenja prve doze.
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Croatian: Neurološki poremećaji poput neuralgije, parestezije,
English: In another clinical trial (Phase III) (Study V87P13), 2693 healthy adults were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart.
Croatian: U drugo kliničko ispitivanje (Faza III) (Studija V87P13) uključene su 2693 zdrave odrasle osobe koje su primile dvije doze cjepiva koje sadrži virus H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/doza adjuvantirano) primijenjene u razmaku od tri tjedna.
English: Package leaflet: Information for the user Foclivia suspension for injection
Croatian: Uputa o lijeku: Informacije za korisnika Foclivia suspenzija za injekciju
English: Muscoskeletal, connective tissue and bone disorders Common (>1/100, <1/10): arthralgia and myalgia
Croatian: Poremećaji mišićno-koštanog sustava, vezivnog tkiva i kostiju Često (>1/100 i <1/10): artralgija i mijalgija
English: Once the needle is locked in place, remove the needle protector and administer the vaccine
Croatian: Nakon što je igla čvrsto pričvršćena na svoje mjesto, skinite štitnik s igle i primijenite cjepivo.
English: Two doses of vaccine with H5N3 (A/Duck/Singapore/97) strain at 3 different dosages (7.5, 15 and 30 µg HA/dose) were administered three weeks apart.
Croatian: Dvije doze cjepiva s virusom soja H5N3 (A/Duck/Singapore/97) u 3 različita doziranja (7,5, 15 i 30 µg HA/doza) primijenjene su u razmaku od tri tjedna.
English: Adverse reactions in the week following vaccination with Focetria H1N1v from 73 infants 6-11 months old and 73 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
Croatian: U tjednu nakon cijepljenja cjepivom Focetria H1N1v za 73 dojenčadi u dobi od 6 do 11 mjeseci i 73 male djece u dobi od 12 do 35 mjeseci koji su primili pripravak od 7,5 µg prijavljene su sljedeće nuspojave:
English: Study V87P1 Adults Booster (6 months after 2nd dose
Croatian: Studija V87P1 odrasli booster (6 mjeseci nakon 2. doze)
English: Adverse reactions in the week following vaccination with Focetria H1N1v from 77 children 3-8 years old and 80 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
Croatian: U tjednu nakon cijepljenja cjepivom Focetria H1N1v za 77 djece u dobi od 3 do 8 godina i 80 djece i adolescenata u dobi od 9 do 17 godina koji su primili pripravak od 7,5 µg prijavljene su sljedeće nuspojave:
English: Adverse reactions from clinical trials with the pandemic preparedness vaccine Foclivia are listed below.
Croatian: Nuspojave iz kliničkih ispitivanja s cjepivom spremnim protiv pandemijske influence Foclivia navedene su u nastavku.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE AND 1-DOSE VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA ŠTRCALJKU I 1-DOZNU BOČICU
English: An overview for all spontaneous cases per country, stratified according to type of report (medically confirmed or non-medically confirmed) and seriousness, for the period covered by the report and cumulatively.
Croatian: Pregled svih spontanih slučajeva po državi, razvrstanih prema vrsti izvješća (medicinski potvrđeno ili medicinski nepotvrđeno) i ozbiljnosti, za razdoblje obuhvaćeno izvješćem i skupno.
English: How to store Foclivia
Croatian: Kako čuvati FOCLIVIJU
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event
Croatian: Vrućica ≥38°C (≥40°C)
English: Persistence of antibodies after primary vaccination in this population was assessed by Hemagglutination Inhibition (HI), SRH, and MN assays.
Croatian: Postojanost protutijela nakon prvog cijepljenja u ovoj populaciji procijenjena je testom inhibicije hemaglutinacije (HI) te SRH i MN testovima.
English: 7.5 micrograms haemagglutinin
Croatian: 7,5 mikrograma hemaglutinina
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine
Croatian: Također možete prijaviti izravno putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: What you need to know before you receive Foclivia Foclivia should not be given if you:
Croatian: Focliviju se ne smije primiti ako ste:
English: Safety data are available, however, in pregnant women exposed to Focetria (an H1N1 pandemic vaccine similar to Foclivia) which contains the same amount of MF59C.1 as Foclivia.
Croatian: Sigurnosni podaci dostupni su, međutim, za trudnice cijepljenje cjepivom Focetria (H1N1 pandemijsko cjepivo slično cjepivu Foclivia) koje sadrži istu količinu adjuvansa MF59C.1 kao Foclivia.
English: The seroprotection rate and seroconversion rate measured by HI assay and the seroconversion factor expressed as geometric mean ratio of HI for anti-HA antibody to H1N1 after administration of one and two 7.5 µg doses of Focetria was evaluated in 70 children and adolescents (9-17 years), 60 children (3-8 years), 58 children (12-35 months) and 49 infants (6-11 months).
Croatian: Stupanj serozaštite, stupanj serokonverzije izmjereni HI testom i čimbenik serokonverzije izražen kao koeficijent geometrijske sredine HI za anti-HA protutijelo na H1N1 nakon primjene jedne ili dviju doza od 7,5 µg Focetrie je procijenjen u 70 djece i adolescenata (9-17 godina), 60 djece (3-8 godina), 58 djece (12-35 mjeseci) te 49 dojenčadi (6-11 mjeseci).
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: - Izuzev tablice 1., sve će se tablice temeljiti na broju reakcija (predstavljeno na PT razini,
English: Warnings and precautions Talk to your doctor or nurse before having this vaccine.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije primanja ovog cjepiva
English: It is provided in a vial containing ten doses (0.5 ml each) for injection.
Croatian: Isporučena je u bočici koja sadrži deset doza (0,5 ml svaka) za injekciju.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I)
English: “Possible side effects” may affect your ability to drive or use tools or machines.
Croatian: "Nuspojave" mogu utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: A clinical trial (study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 471 children from 6 months to 17 years of age.
Croatian: Kliničko ispitivanje (studija V87P6) provedeno je s cjepivom protiv virusa H5N1 u kombinaciji s adjuvansom MF59C.1 na 471 djetetu u dobi od 6 mjeseci do 17 godina.
English: Study V87P1 Elderly Booster (6 months after 2nd dos e)
Croatian: Studija V87P1 starije osobe booster (6 mjeseci nakon 2. doze)
English: The vaccine should not be administered intravascularly or subcutaneously.
Croatian: Cjepivo se ne smije primijeniti intravaskularno ili supkutano.
English: A Phase II clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults.
Croatian: Kliničko ispitivanje Faze II (Studija V87P1) provedeno je s cjepivom protiv virusa H5N1 u kombinaciji s adjuvansom MF59C.1 u 312 zdravih odraslih osoba.
English: Cardiac disorders Palpitation, tachycardia.
Croatian: Palpitacija, tahikardija.
English: • Post-marketing surveillance
Croatian: • Praćenje nakon stavljanja lijeka u promet
English: MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Croatian: Rezultati MN testiranja na virus A/Vietnam/1194/2004 ukazuju na stopu serozaštite od 99% (95%CI: 94-100), stopu serokonverzije u rasponu od 97% (95%CI): 91-99) do 99% (95%CI: 96-100) i GMR u rasponu od 29 (95%CI: 25-35) do 50 (95%CI: 44-58).
English: (see section 4.8).
Croatian: (vidjeti dio 4.4).
English: Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C. The multidose vial should preferably be used within 24 hours after first withdrawal.
Croatian: Između uporaba vratite višedoznu bočicu na preporučene uvjete čuvanja između 2 °C i 8 °C.