FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 film-coated tablets of Ebixa 15 mg
Croatian: 7 Ebixa 15 mg filmom obloženih tableta
English: H. Lundbeck A/S, Denmark Tel: + 45 36301311
Croatian: Lundbeck A/S, Denmark Tel: + 45 36301311
English: Week 2 (day 8-14) The patient should take 1 ml solution (10 mg) equivalent to two pump actuations per day for 7 days.
Croatian: Bolesnik treba uzimati 1 ml otopine (10 mg) istovjetno dvama pokretanjima pumpice dnevno, tijekom 7 dana.
English: H. Lundbeck A/S, Danija Tel: + 45 36301311
Croatian: Lundbeck A/S, Danija Tel: + 45 36301311
English: Ebixa film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings “1 0” on one side and “M M” on the other side.
Croatian: Ebixa filmom obložene tablete su blijedožute do žute boje, filmom obložene tablete ovalnog oblika s razdjelom crtom i ugraviranim oznakama “1 0” na jednoj strani te “M M” na drugoj strani.
English: Tablet coat for 10/20 mg film-coated tablets: Hypromellose
Croatian: Ovojnica tablete za 10 mg/20 mg filmom obložene tablete: hipromeloza makrogol 400 titanijev dioksid
English: Week 4 (day 22-28) The patient should take one 20 mg film-coated tablet per day (grey-red, oval-oblong) for 7 days.
Croatian: Bolesnik treba uzimati jednu filmom obloženu tabletu od 20 mg (sivo-crvenu, duguljasto ovalnu) dnevno tijekom 7 dana.
English: shortness of breath, high blood pressure and drug hypersensitivity
Croatian: Poremećaji imunološkog sustava često preosjetljivost na lijek
English: Ebixa 20 mg
Croatian: Ebixa 20 mg memantinklorid
English: 7 film-coated tablets of Ebixa 20 mg
Croatian: 7 Ebixa 20 mg filmom obloženih tableta
English: Week 3 (day 15-21) The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong) for 7 days.
Croatian: Bolesnik treba uzimati jednu filmom obloženu tabletu od 15 mg (sivo-narančastu, duguljasto ovalnu) dnevno tijekom 7 dana.
English: Hepatobiliary disorders
Croatian: oralna otopina
English: 7 film-coated tablets of Ebixa 10 mg
Croatian: 7 Ebixa 10 mg filmom obloženih tableta
English: Elevated liver function test
Croatian: Poremećaji jetre i žuči često povišeni rezultat testa jetrene funkcije nepoznato hepatitis
English: 2013/2014 season
Croatian: Sezona 2013/2014
English: This product contains genetically modified organisms (GMOs).
Croatian: Ovaj proizvod sadrži genetski modificirane organizme (GMO).
English: (See also, How Fluenz is given, in section 3).
Croatian: (Vidjeti također, Kako se Fluenz daje u dijelu 3).
English: Protect from light.
Croatian: Čuvati zaštićeno od svjetlosti.
English: In addition, an updated RMP should be submitted:
Croatian: Nadalje, nadopunjeni RMP treba dostaviti:
English: You do not need to actively inhale or sniff.
Croatian: Ne morate aktivno udisati ili šmrkati.
English: Pack size of 10.
Croatian: Veličina pakovanja od 10.
English: The vaccine targets three strains of influenza virus each year, following the annual recommendations by the World Health Organisation.
Croatian: Cjepivo je usmjereno protiv tri soja virusa gripe svake godine, u skladu s godišnjim preporukama Svjetske zdravstvene organizacije.
English: For signs of allergic reactions, see section 4 “Possible side effects”.
Croatian: Za znakove alergijske reakcije, vidjeti dio 4 „Moguće nuspojave“.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Croatian: Kad osoba primi cjepivo, imunološki sustav (prirodni obrambeni sustav tijela) proizvest će vlastitu zaštitu protiv virusa gripe.
English: The immune response to rubella vaccine was significantly altered.
Croatian: Imunološki odgovor na cjepivo protiv rubeole bio je znatno promijenjen.
English: Before use, the vaccine may be taken out of the refrigerator, without being replaced, for a maximum period of 12 hours at a temperature not above 25°C.
Croatian: Prije upotrebe, cjepivo se može izvaditi iz hladnjaka bez ponovnog vraćanja u hladnjak na najviše 12 sati pri temperature do 25°C.
English: Fluenz vaccine viruses are grown in chicken eggs.
Croatian: Virusi cjepiva Fluenz uzgojeni su u kokošjim jajima.
English: You can breathe normally while you are given Fluenz.
Croatian: Možete normalno disati dok primate Fluenz.
English: This is because of the risk of Reye's syndrome, a very rare but serious disease that can affect the brain and liver.
Croatian: To je zbog toga što postoji rizik od Reyeva sindroma, vrlo rijetke, ali teške bolesti koja može utjecati na mozak i jetru.
English: All strains regardless of match
Croatian: Svi sojevi bez obzira na podudarnost
English: What Fluenz is and what it is used for What you need to know before you are given Fluenz How Fluenz is given
Croatian: Što je Fluenz i za što se koristi Što morate znati prije nego počnete primati Fluenz Kako se Fluenz daje
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation)
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: What Fluenz is and what it is used for
Croatian: Što je Fluenz i za što se koristi
English: Y = years.
Croatian: G = godine.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 January 2011
Croatian: Datum prvog odobrenja: 27. siječnja 2011.
English: (24.6, 70.5)d fewer cases than injectable
Croatian: (24,6; 70,5)d manje slučajeva nego s cjepivom koje se ubrizgava
English: • if you are allergic to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of Fluenz (listed in section 6 “Contents of the pack and other information”).
Croatian: • ako ste alergični na jaja, proteine jajeta, gentamicin ili želatinu ili bilo koji drugi sastojak cjepiva Fluenz (naveden u dijelu 6 „Sadržaj pakovanja i dodatne informacije“).
English: What Fluenz looks like and contents of the pack
Croatian: Kako Fluenz izgleda i sadržaj pakovanja
English: Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine.
Croatian: c Prikazani podaci iz kliničkog ispitivanja D153-P504 odnose se na sudionike ispitivanja koji su primili dvije doze ispitivanog cjepiva.
English: Instructions for health professionals
Croatian: Upute za zdravstvene djelatnike
English: Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.
Croatian: Cijepljene osobe trebale bi pokušati izbjegavati bliski kontakt s teško imunokompromitiranim osobama kad god je to moguće (npr. osobama s presađenom koštanom srži koje trebaju izolaciju) tijekom 1 do 2 tjedna nakon cijepljenja.
English: What you need to know before you are given Fluenz
Croatian: Što morate znati prije nego počnete primati Fluenz
English: Fluenz is not recommended for women who are pregnant or are breast-feeding.
Croatian: Fluenz se ne preporučuje ženama koje su trudne ili doje.
English: The influenza virus strains in FLUENZ are (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Croatian: Sojevi virusa influence u cjepivu FLUENZ su (a) hladnoćom prilagođeni; (b) osjetljivi su na toplinu i (c) oslabljeni.
English: • It is recommended that Fluenz is not given at the same time as influenza-specific antiviral medicines.
Croatian: • Fluenz se ne preporučuje davati istodobno sa specifičnim antivirusnim lijekovima protiv gripe.
English: Other medicines, other vaccines and Fluenz
Croatian: Drugi lijekovi, druga cjepiva i Fluenz
English: Non-clinical data with FLUENZ 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 sa cjepivom FLUENZ ne ukazuju na poseban rizik za ljude na temelju konvencionalnih nekliničkih ispitivanja toksičnosti ponovljenih doza, reproduktivne i razvojne toksičnosti, lokalne podnošljivosti i neurovirulencije.
English: If the vaccine has not been used after this 12-hour period, it should be disposed of.
Croatian: Ako cjepivo nije primijenjeno nakon tog 12-satnog razdoblja, mora se zbrinuti u otpad.
English: Several studies against placebo have shown that FLUENZ may have some efficacy in adults.
Croatian: Nekoliko ispitivanja pokazalo je da FLUENZ u usporedbi s placebom može biti donekle djelotvoran kod odraslih.
English: He or she will decide if Fluenz is suitable for you.
Croatian: Oni će odlučiti je li Fluenz prikladno cjepivo za Vas.
English: • If you are pregnant, think you may be pregnant, plan to become pregnant soon or are breast feeding, tell your doctor, nurse or pharmacist before receiving this vaccine.
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni, planirate imati dijete ili dojite obavijestite svog liječnika, medicinsku sestru ili ljekarnika prije nego primite ovo cjepivo.
English: The vaccine is unlikely to have an effect on the ability to drive and use machines.
Croatian: Nije vjerojatno da će cjepivo utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: FLUENZ has been administered to over 30,000 individuals in controlled clinical studies over multiple years, in various regions and using different vaccine strains.
Croatian: FLUENZ je bio primijenjen na više od 30 000 osoba u kontroliranim kliničkim ispitivanjima tijekom više godina, u različitim regijama te s različitim sojevima u cjepivu.
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 skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: The adverse reactions reported were similar to those seen with the recommended single dose of FLUENZ.
Croatian: Zabilježene su nuspojave bile slične onima koje su bile primijećene s preporučenom pojedinačnom dozom cjepiva FLUENZ.
English: • Do not give acetylsalicylic acid to children aged less than 18 years for 4 weeks after vaccination with Fluenz unless your doctor, nurse or pharmacist tells you otherwise.
Croatian: • Nemojte davati acetilsalicilnu kiselinu djeci mlađoj od 18 godina tijekom 4 tjedna nakon cijepljenja cjepivom Fluenz osim ako Vam liječnik, medicinska sestra ili ljekarnik ne preporuči drugačije.
English: No data exist regarding the safety of intranasal administration of FLUENZ in children with unrepaired craniofacial malformations.
Croatian: Ne postoje podaci o sigurnosti intranazalne primjene cjepiva FLUENZ u djece s nekorigiranim kraniofacijalnim malformacijama.
English: While animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, FLUENZ is not recommended during pregnancy.
Croatian: Iako ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na reprodukciju, ne preporučuje se koristiti FLUENZ tijekom trudnoće.
English: The following information is intended for medical or healthcare professionals only: Fluenz is for nasal use only.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima: Fluenz je namijenjen samo za primjenu u nos.
English: Please read the package leaflet for disposal of medicines no longer required.
Croatian: Molimo pročitajte uputu o lijeku za zbrinjavanje lijekova koji više nisu potrebni.
English: The most common adverse reaction observed in clinical studies was nasal congestion/rhinorrhoea.
Croatian: Najčešće nuspojave primijećene u kliničkim ispitivanjima bile su nazalna kongestija/rinoreja.
English: Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ukoliko osoba koju se cijepi uzima, nedavno je uzela ili bi mogla uzeti bilo koje druge lijekove.
English: The use of FLUENZ should be based on official recommendations.
Croatian: FLUENZ se smije upotrebljavati samo u skladu sa službenim preporukama.
English: • The recommended dose for children and adolescents is 0.2 ml Fluenz, administered as 0.1 ml in each nostril.
Croatian: • Preporučena doza za djecu i adolescente je 0,2 ml cjepiva Fluenz, primjenjene kao 0,1 ml u svaku nosnicu.
English: Follow your doctor, nurse or pharmacist's instructions about when your child should return for the second dose.
Croatian: Pridržavajte se uputa liječnika, medicinske sestre ili ljekarnika o tome kada bi se Vaše dijete moralo vratiti po drugu dozu cjepiva.
English: Age range as described in the protocol for the study.
Croatian: Dobni raspon kako je opisan u planu ispitivanja.
English: The suspension is colourless to pale yellow, clear to opalescent.
Croatian: Suspenzija je bezbojna do blijedo žuta, bistra do opalescentna.
English: • Refer to the FLUENZ administration diagram (Figure 1) for step-by-step administration instructions.
Croatian: • Pogledajte dijagram primjene cjepiva FLUENZ (slika 1) za upute o primjeni korak-po-korak.
English: However, based upon the potential for influenza antiviral agents to reduce the effectiveness of FLUENZ, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.
Croatian: Međutim, budući da antivirusni lijekovi protiv influence mogu smanjiti učinkovitost cjepiva FLUENZ, ne preporučuje se primijeniti cjepivo prije nego što protekne 48 sati od prestanka antivirusne terapije protiv influence.
English: Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03
Croatian: Farmakoterapijska skupina: cjepiva protiv influence, oslabljeni živi virus influence; ATK oznaka: J07BB03
English: Your doctor, nurse or pharmacist will decide if Fluenz can be given at the same time as other vaccines.
Croatian: Vaš liječnik, medicinska sestra ili ljekarnik odlučit će može li se Fluenz dati istodobno s drugim cjepivima.
English: Children and adolescents from 24 months: 0.2 ml (administered as 0.1 ml per nostril).
Croatian: Djeca i adolescenti stariji od 24 mjeseca: 0,2 ml (primjenjuje se kao 0,1 ml po nosnici).
English: Like all medicines, Fluenz can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, lijek Fluenz može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: • Fluenz is administered as a divided dose in both nostrils as described below.
Croatian: • Fluenz se primjenjuje kao podijeljena doza u obje nosnice, kako je dolje opisano.
English: If influenza antiviral agents and FLUENZ are administered concomitantly, revaccination should be considered when appropriate.
Croatian: Ukoliko se antivirusni lijekovi protiv influence i FLUENZ primijene istodobno, potrebno je razmotriti ponovno cijepljenje kad to bude moguće.
English: • Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks.
Croatian: • Djeca koja nisu prethodno primala cjepivo protiv gripe primit će drugu, dodatnu dozu cjepiva nakon razdoblja od najmanje 4 tjedna.
English: Do not administer FLUENZ to infants and toddlers younger than 12 months.
Croatian: Ne primjenjujte FLUENZ kod dojenčadi i male djece mlađe od 12 mjeseci.
English: In studies of adults in which a high percentage of individuals had underlying chronic medical conditions, the safety profile of FLUENZ was comparable to the safety profile observed in individuals without these conditions.
Croatian: U ispitivanjima na odraslim osobama koje su u visokom postotku imale kroničnu bolest, sigurnosni profil cjepiva FLUENZ bio je usporediv sa sigurnosnim profilom zabilježenim kod osoba koje nisu imale te bolesti.
English: DO NOT INJECT FLUENZ.
Croatian: NEMOJTE UBRIZGAVATI FLUENZ.
English: However, a conclusion on clinical benefit of this vaccine in adults could not be made given that results observed in some studies versus injectable influenza vaccines were suggestive of a lower efficacy of FLUENZ.
Croatian: Međutim, ne može se donijeti zaključak o kliničkoj koristi ovog cjepiva kod odraslih s obzirom na to da su rezultati dobiveni u nekim ispitivanjima pokazali slabiju djelotvornost cjepiva FLUENZ u odnosu na cjepivo protiv influence koje se ubrizgava.
English: Therefore, as some viruses are excreted in human milk, FLUENZ should not be used during breastfeeding.
Croatian: Stoga, s obzirom na to da se neki virusi izlučuju u majčino mlijeko, FLUENZ se ne bi trebao primjenjivati tijekom dojenja.
English: FLUENZ'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 cjepiva FLUENZ u pedijatrijskoj populaciji prikupljeni su u 9 kontroliranih ispitivanja provedenih na više od 20 000 dojenčadi, male djece, djece i adolescenata tijekom 7 sezona influence.
English: MedImmune, LLC Lagelandseweg 78 6545 CG Nijmegen Netherlands
Croatian: MedImmune, LLC Lagelandseweg 78 6545 CG Nijmegen Nizozemska
English: There have been occasional reports of administration of twice the recommended dose of FLUENZ in the post-marketing setting.
Croatian: Povremeno je zabilježena primjena dvostruke preporučene doze cjepiva FLUENZ nakon stavljanja u promet.
English: The MAH shall perform 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 potrebne 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: Fluenz is a vaccine to prevent influenza (flu).
Croatian: Fluenz je cjepivo protiv influence (gripe).
English: Fluenz will be administered under the supervision of a doctor, nurse or pharmacist.
Croatian: Fluenz će Vam se dati pod nadzorom liječnika, medicinske sestre ili ljekarnika.
English: Manufacturer: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, Liverpool, L24 9JW, UK
Croatian: Proizvođač: MedImmune, UK Limited, Plot 6, Renaissance Way, Boulevard Industry Park, Speke, Liverpool, L24 9JW, Ujedinjeno Kraljevstvo (Velika Britanija)
English: Adverse reaction frequencies are reported as: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Very rare (< 1/10,000)
Croatian: Manje često (≥ 1/1000 i < 1/100) Vrlo rijetko (< 1/10 000)
English: Do not use Fluenz after the expiry date which is stated on the applicator label after the letters EXP.
Croatian: Fluenz se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici aplikatora nakon oznake EXP.
English: How Fluenz is given
Croatian: Kako se Fluenz daje
English: Name and address of the manufacturers of the biological active substance(s)
Croatian: Naziv i adresa proizvođača biološke(ih) djelatne(ih) tvari
English: Table 1 FLUENZ Efficacy in Placebo Controlled Paediatric Studies
Croatian: Tablica 1: Djelotvornost cjepiva FLUENZ u placebom kontroliranim pedijatrijskim ispitivanjima
English: Safety data regarding use of FLUENZ have been compiled from over 28,500 children and adolescents 2 to 17 years of age from clinical studies and over 52,500 children and adolescents from post-authorisation safety studies.
Croatian: Podaci o sigurnosti primjene cjepiva FLUENZ prikupljeni su iz kliničkih ispitivanja na više od 28 500 djece i adolescenata u dobi od 2 do 17 godina te iz ispitivanja sigurnosti primjene nakon stavljanja cjepiva u promet na više od 52 500 djece i adolescenata.
English: As with most vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of FLUENZ.
Croatian: Kao i kod primjene većine cjepiva, potrebno je uvijek imati spremne odgovarajuće lijekove i nadzirati bolesnika u slučaju anafilaktičke reakcije nakon primjene cjepiva FLUENZ.
English: Fluenz will be given as a spray in each nostril.
Croatian: Fluenz se daje kao sprej u svaku nosnicu.
English: Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
Croatian: Djeca i adolescenti mlađi od 18 godina koji primaju terapiju salicilatima zbog povezanosti Reyevog sindroma s primjenom salicilata i infekcijom divljim tipom virusa influence.
English: Additional experience has occurred with marketed use of this vaccine.
Croatian: Dodatna su iskustva stečena uporabom cjepiva nakon njegova stavljanja u promet.
English: 5 single-use nasal applicators (0.2 ml each) Store in a refrigerator.
Croatian: 5 aplikatora za nos za jednokratnu uporabu (0,2 ml svaki) Čuvati u hladnjaku.
English: It is not recommended to administer FLUENZ to infants and toddlers 12-23 months of age.
Croatian: Ne preporučuje se primjenjivati FLUENZ kod dojenčadi i male djece u dobi od 12 do 23 mjeseca.
English: 6545 CG Nijmegen Netherlands (Tel) +31 24 371 7310
Croatian: 6545 CG Nijmegen Nizozemska (Tel) +31 24 371 7310
English: FLUENZ should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies.
Croatian: FLUENZ ne treba davati djeci i adolescentima s teškom astmom ili prisutnim piskanjem pri disanju, jer se u tih osoba nisu provela odgovarajuća klinička ispitivanja.
English: However, this alteration might not be of clinical relevance with the two dose immunisation schedule of the rubella vaccine.
Croatian: Međutim, ta promjena možda nije klinički značajna s obzirom na to da se cjepivo protiv rubeole daje u dvije doze.
English: FLUENZ is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
Croatian: Primjena cjepiva FLUENZ nije kontraindicirana kod osoba s asimptomatskom HIV infekcijom ili onih koji primaju topikalne/inhalacijske kortikosteroide ili niske doze sistemskih kortikosteroida ili u onih koji primaju kortikosteroide kao nadomjesnu terapiju, npr. kod insuficijencije nadbubrežne žlijezde.
English: Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Fluenz.
Croatian: Pitajte svog liječnika, medicinsku sestru ili ljekarnika za dodatne informacije o mogućim nuspojavama cjepiva Fluenz.
English: e The primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).
Croatian: Primarni cirkulirajući soj bio je po antigenima različit od soja H3N2 koji je bio prisutan u cjepivu; djelotvornost naspram nepodudarnog soja A/H3N2 iznosila je 85,9% (95% CI: 75,3; 91,9).
English: A/Victoria/361/2011 (H3N2)-like strain (A/Texas/50/2012, MEDI 237514)
Croatian: A/Victoria/361/2011 (H3N2) kao soj (A/Texas/50/2012, MEDI 237514)
English: An updated RMP shall be submitted annually until renewal.
Croatian: Dopunjeni plan upravljanja rizikom podnosi se svake godine do obnove.