FrancophonIA/ELRC3.0 huggingface dataset:
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: Prema smjernicama CHMP-a za Sustave upravljanja rizicima za lijekove za humanu uporabu, dopunjeni RMP mora se podnijeti istodobno uz sljedeće Periodičko izvješće o neškodljivosti lijeka (PSUR).
English: Do not use Focetria after the expiry date which is stated on the carton and the label.
Croatian: Focetria se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici.
English: Clinical studies in which a version of Focetria containing HA derived from A/Vietnam/1194/2004 (H5N1) was administered at day 1 and at day 22 provide:
Croatian: Iz kliničkih ispitivanja u kojima je verzija Focetrie koja je sadržavala HA dobiven iz A/Vietnam/1194/2004 (H5N1) primijenjena 1. i 22. dana dostupni su:
English: Elderly: A dose (0.5 ml) of the vaccine and a second dose of 0.5 ml at least three weeks later.
Croatian: Starije osobe: Doza (0,5 ml) cjepiva i druga doza od 0,5 ml najmanje tri tjedna kasnije.
English: Immunogenicity data obtained at three weeks after one dose of Focetria H1N1v suggest that a single dose may be sufficient.
Croatian: Podaci o imunogenosti dobiveni tri tjedna nakon jedne doze Focetrie H1N1v ukazuju na mogućnost da je jednokratna doza dovoljna.
English: Systemic
Croatian: Sistemska
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 su stoga moguće reakcije senzibilizacije (vidjeti dio 4.4).
English: You should discuss with your doctor whether you should receive Focetria taking into consideration official recommendation based on post-marketing reported adverse events during second and third trimesters of pregnancy.
Croatian: S liječnikom se savjetujte o primanju Focetrie uzimajući u obzir službenu preporuku na temelju nuspojava prijavljenih nakon stavljanja lijeka u promet tijekom drugog i trećeg trimestra trudnoće.
English: Nervous system disorders Very common: headache Rare: convulsions
Croatian: Poremećaji živčanog sustava Vrlo često: glavobolja Rijetko: konvulzije
English: Vaccination is not currently recommended in this age group.
Croatian: Cijepljenje se trenutačno ne preporučuje za ovu dobnu skupinu.
English: The vaccine may be used during breast-feeding.
Croatian: Cjepivo se može primjenjivati tijekom dojenja.
English: It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Croatian: Široko je prihvaćeno da je učinak adjuvansa koje dovodi do povećane imunogenosti povezan s nešto višom stopom lokalnih reakcija (uglavnom blaga bol) u usporedbi s konvencionalnim, neadjuvantiranim cjepivima protiv influence.
English: Among the adolescents the very common events were: sweating, nausea and chills.
Croatian: Među adolescentima, vrlo česti događaji bili su: znojenje, mučnina i zimica.
English: One dose of 0.5 ml at an elected date.
Croatian: Jedna doza od 0,5 ml odabranog datuma.
English: Focetria contains
Croatian: Focetria sadrži
English: If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
Croatian: Ako se primjenjuje druga doza, treba napraviti razmak od najmanje tri tjedna između prve i druge doze.
English: • The MAH shall agree with Member States on the provision of a targeted communication to healthcare professionals which should address the following:
Croatian: • Nositelj odobrenja će s državama članicama dogovoriti pružanje ciljanih informacija zdravstvenim djelatnicima koje bi se trebale odnositi na sljedeće:
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Croatian: • Minimalni podaci koje treba prenijeti u sigurnosnom izvješću o pojedinom slučaju radi omogućavanja procjene i identifikacije cjepiva primijenjenog na svaku osobu uključuju zaštićeno ime, proizvođača cjepiva i broj serije.
English: Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
English: The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP
Croatian: Podnošenje PSUR-a za lijek trebalo bi pratiti šestomjesečni ciklus do drugačije dogovorenog od strane CHMP-a.
English: It is recommended that subjects who receive a first dose of Focetria, should complete the vaccination course with Focetria H1N1v (see section 4.4).
Croatian: Preporučuje se da osobe koje prime prvu dozu Focetrie završe shemu cijepljenja s Focetriom H1N1v (vidjeti dio 4.4).
English: Children aged less than 6 months:
Croatian: Djeca mlađa od 6 mjeseci:
English: • The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Croatian: • Nositelj odobrenja dogovorit će s državama članicama mjere koje omogućavaju identifikaciju i sljedivost cjepiva A/H1N1 primijenjenog svakom bolesniku radi smanjenja medikacijskih pogrešaka i pomaganja bolesnicima i zdravstvenim djelatnicima u prijavljivanju nuspojava.
English: Influenza vaccine, ATC Code: J07BB02
Croatian: Cjepivo protiv influence, ATK oznaka: J07BB02 Klinička djelotvornost i sigurnost
English: Non-clinical data obtained with the mock-up vaccine (MF59C.1-adjuvanted H5N1 vaccine) and with seasonal vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of efficacy, repeated dose toxicity, and reproductive and developmental toxicity.
Croatian: Neklinički podaci dobiveni s „mock-up“ cjepivom (cjepivo H5N1 adjuvantirano s MF59C.1) te sa sezonskim cjepivom koje sadrži adjuvans MF59C.1 ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja djelotvornosti, toksičnosti ponovljenih doza, reproduktivne i razvojne toksičnosti.
English: Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Croatian: Alergijske reakcije koje može pratiti nedostatak zraka, sipnja, oticanje grla ili koje dovode do opasnog sniženja krvnog tlaka koje, ako se ne liječi, može dovesti do šoka.
English: 7.5 micrograms** per 0.5 ml dose
Croatian: 7,5 mikrograma** po dozi od 0,5 ml
English: The MAH shall perform the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use CHMP.
Croatian: Nositelj odobrenja provodit će ispitivanja i dodatne farmakovigilancijske aktivnosti predviđene Farmakovigilancijskim planom, kako je dogovoreno RMP-om prikazanim u Modulu 1.8.2. odobrenja za stavljanje gotovog lijeka u promet te svim daljnjim dopunama RMP-a dogovorenim od strane Povjerenstva za humane lijekove CHMP.
English: These transitory false positive results may be due to IgM production in response to the vaccine.
Croatian: Ti prolazni lažno pozitivni rezultati mogu biti uzrokovani stvaranjem protutijela IgM kao odgovor na cjepivo.
English: • Clinical trials
Croatian: • Klinička ispitivanja
English: Based on the findings of an observational study conducted in >2000 pregnant women, reflecting the use of Focetria in pregnant women, influenza A (H1N1) vaccination with Focetria does not seem to be associated with an increased risk of adverse pregnancy outcomes, especially in the second or third trimesters of pregnancy.
Croatian: Na temelju rezultata opservacijskog ispitivanja provedenog na >2000 trudnica koje se odnosilo na upotrebu lijeka Focetria u trudnica, čini se da cijepljenje protiv influence A (H1N1) lijekom Focetria nije povezano s povećanim rizikom od štetnih ishoda trudnoće, naročito u drugom ili trećem tromjesečju trudnoće.
English: See section 4.4 for special warnings and special precautions for use.
Croatian: Vidjeti dio 4.4 za posebna upozorenja i mjere opreza pri uporabi.
English: Thiomersal:
Croatian: Tiomersal:
English: In the 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: This medicinal contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium free.
Croatian: Ovaj pripravak sadrži manje od 1 mmol natrija (23 mg) i manje od 1 mmol kalija (39 mg) po dozi od 0,5 ml, tj. ne sadrži natrij i kalij.
English: Any adverse reaction Local
Croatian: Bilo koja nuspojava Lokalna
English: There is a further immune response to a second dose of 0.5 ml administered after an interval of three weeks.
Croatian: Postoji dodatni imunološki odgovor na drugu dozu od 0,5 ml primijenjenu nakon razmaka od tri tjedna.
English: The side-effects are generally similar to those related to the seasonal flu vaccine.
Croatian: Nuspojave su uglavnom slične onima povezanima s cjepivom protiv sezonske gripe.
English: Although Focetria in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Croatian: Iako Focetria u višedoznim spremnicima sadrži konzervans koji inhibira rast mikroorganizama, za smanjenje rizika od kontaminacije višedozne bočice tijekom izvlačenja svake doze odgovoran je korisnik.
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Croatian: O TOME SVOG LIJEČNIKA ILI MEDICINSKU SESTRU, jer cijepljenje možda neće biti preporučljivo ili će možda biti odgođeno.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Croatian: Cijepljenje se izvodi intramuskularnom injekcijom, najbolje u deltoidni mišić ili anterolateralni dio bedra (ovisno o mišićnoj masi).
English: Neurological disorders such as severe stabbing or throbbing pain along one or more nerves, tingling, fits, and neuritis (inflammation of nerves).
Croatian: Neurološki poremećaji poput jake probadajuće ili pulsirajuće boli duž jednog ili više živaca, trnci, napadaji i neuritis (upala živaca).
English: Postmarketing spontaneously reported adverse events, an interventional study and large observational studies do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Croatian: Spontano prijavljene nuspojave nakon stavljanja lijeka u promet, intervencijsko ispitivanje i velika opservacijska ispitivanja ne upućuju na izravne ili neizravne štetne učinke izloženosti lijeku Focetria na trudnoću.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the marketing authorisation, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav prikazan u Modulu 1.8.1 odobrenja za stavljanje gotovog lijeka u promet, ustrojen i funkcionalan prije stavljanja gotovog lijeka na tržište i dok god je lijek u uporabi.
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.
Croatian: Od cjepiva se može očekivati samo zaštita od influence uzrokovane sojevima poput A/California/07/2009 (H1N1)v.
English: • Studies in adults and elderly:
Croatian: • Ispitivanja u odraslih i starijih osoba:
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Croatian: Neurološki poremećaji poput neuralgije, parestezije, konvulzija i neuritisa.
English: Clinical data suggest that a single dose may be sufficient.
Croatian: Klinički podaci ukazuju na to da jednokratna doza može biti dovoljna.
English: H1N1v to healthy children and adolescents aged 6 months-17 years and to healthy adults,
Croatian: H1N1v u zdrave djece i adolescenata u dobi od 6 mjeseci-17 godina i zdravih odraslih osoba,
English: Immunogencity results with two doses of 7.5 µg Focetria H1N1v vaccine from the ongoing clinical trial in adults and elderly are shown below.
Croatian: Rezultati imunogenosti s dvije doze Focetrie H1N1v od 7,5 µg iz kliničkog ispitivanja koje je u tijeku u odraslih i starijih osoba prikazani su u nastavku.
English: The common reactions usually disappear within 1-2 days without treatment.
Croatian: Česte reakcije uglavnom nestaju unutar 1- 2 dana bez liječenja.
English: This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
Croatian: To može značiti da nositelj odobrenja osigurava naljepnice sa zaštićenim imenom i brojem serije uz svako pakovanje cjepiva.
English: Uncommon: influenza like illness
Croatian: Manje često: bolest nalik influenci
English: Fertility An animal study with H5N1 mock-up vaccine did not indicate reproductive toxicity (see section 5.3).
Croatian: Ispitivanje na životinjama cijepljenima „mock-up“ cjepivom H5N1 nije ukazalo na reproduktivnu toksičnost (vidjeti dio 5.3).
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Croatian: Nakon cijepljenja može doći do alergijskih reakcija koje u rijetkim slučajevima dovode do šoka.
English: Available clinical data suggest that a single dose may be sufficient.
Croatian: Dostupni klinički podaci ukazuju na to da jednokratna doza može biti dovoljna.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (5 ml)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA Višedozna bočica (5 ml)
English: 10 x 10 doses of 0.5 ml vaccine (5 ml)
Croatian: 10 x 10 doza cjepiva od 0,5 ml (5 ml)
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Croatian: Alergijske reakcije, anafilaksija uključujući dispneju, bronhospazam, edem grkljana koji u rijetkim slučajevima dovodi do šoka.
English: In clinical trials with different formulations (H5N3, H9N2 and H5N1) approximately 3400 subjects were exposed to the candidate vaccine.
Croatian: U kliničkim ispitivanjima s različitim formulacijama (H5N3, H9N2 i H5N1) približno 3 400 ispitanika bilo je izloženo ispitivanom cjepivu.
English: Some cases were observed in subjects with a history of epilepsy.
Croatian: Neki slučajevi primijećeni su u ispitanika s epilepsijom u anamnezi.
English: MF59C.1 is an oil/water emulsion containing 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg sorbitan trioleate in a citrate buffer.
Croatian: MF59C.1 je emulzija ulja u vodi koja sadrži 9,75 mg skvalena, 1,175 polisorbata 80 i 1,175 mg sorbitantrioleata u citratnom puferu.
English: Focetria is a vaccine to prevent influenza (flu) caused by A(H1N1v) 2009 virus.
Croatian: Focetria je cjepivo za sprječavanje influence (gripe) uzrokovane virusom A(H1N1v) 2009.
English: Warning: Do not inject intravascularly.
Croatian: Upozorenje: Ne primjenjivati u krvnu žilu.
English: Infants 6-11 months
Croatian: Dojenčad 6-11 mjeseci
English: 1.175 milligrams
Croatian: 1,175 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 koji svrbi, nedostatak zraka i oticanje lica ili jezika.
English: This vaccine in a multi-dose vial contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Croatian: Ovo cjepivo u višedoznoj bočici sadrži tiomersal kao konzervans i moguća je pojava alergijske reakcije.
English: Paediatric population Children and adolescents 6 months to 17 years of age
Croatian: Pedijatrijska populacija Djeca i adolescenti u dobi od 6 mjeseci do 17 godina
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer.
Croatian: Adjuvans: MF59C.1 emulzija ulja u vodi koja sadrži skvalen, kao uljnu fazu, stabiliziran polisorbatom 80 i sorbitantrioleatom u citratnom puferu.
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems), exudative erythema multiforme.
Croatian: Vaskulitis (upala krvnih žila koja može uzrokovati kožne osipe, bol u zglobovima i probleme s bubrezima), eksudativni multiformni eritem.
English: Additional information is available from the studies conducted with a vaccine similar in composition to Focetria but containing antigen derived from H5N1 viruses.
Croatian: Dodatne informacije dostupne su iz ispitivanja provedenih s cjepivom sastava sličnog Focetriji no koje sadrži antigen dobiven iz H5N1 virusa.
English: What Focetria contains
Croatian: Što Focetria sadrži
English: The multidose vial should preferably be used within 24 hours after first withdrawal.
Croatian: Poželjno je iskoristiti višedoznu bočicu unutar 24 sata nakon prvog izvlačenja.
English: Common: arthralgia
Croatian: Često: artralgija
English: A second dose of vaccine should be given after an interval of at least three weeks.
Croatian: Drugu dozu cjepiva treba primijeniti nakon razmaka od najmanje tri tjedna.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Croatian: Stvaranje protutijela u osoba s endogenom ili jatrogenom imunosupresijom može biti nedostatno.
English: 1.175 milligrams sorbitan trioleate
Croatian: 1,175 miligrama sorbitantrioleat
English: Therefore, the relevant SmPC wording currently stating the limited availability of clinical data in pregnant women, is recommended to be changed to reflect the newly available information.
Croatian: Stoga se preporučuje da se odgovarajući tekst u Sažetku opisa svojstava lijeka koji trenutno spominje ograničenu dostupnost kliničkih podataka u trudnica izmijeni kako bi odražavao novodostupne informacije.
English: Rare: Transient thrombocytopenia.
Croatian: Rijetko: Prolazna trombocitopenija.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription.
Croatian: • UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I UPORABU LIJEKA ZADANI NOSITELJU ODOBRENJA
English: Immunisation should be postponed in patients with severe febrile illness or acute infection.
Croatian: Cijepljenje osoba s teškom febrilnom bolešću ili onih s akutnom infekcijom treba odgoditi.
English: These side effects usually disappear within 1-2 days without treatment.
Croatian: Ove nuspojave uglavnom nestaju unutar 1-2 dana bez liječenja.
English: Common (1/100 to <1/10)
Croatian: Često (≥1/100 do <1/10)
English: Children and Adolescents (9-17 years)
Croatian: Djeca i adolescenti (9-17 godina)
English: 21 days after 2nd dose (day 43)
Croatian: 21 dan nakon 2. doze (43. dan)
English: 21 days after 1st dose(day 22)
Croatian: 21 dan nakon 1. doze (22. dan)
English: Common (affects 1 to 10 users in 100): Bruising of the skin at the injection site, fever and nausea
Croatian: Često (pogađa 1 do 10 korisnika na 100): Stvaranje modrica na koži na mjestu injekcije, vrućica i mučnina
English: Uncommon (affects 1 to 10 users in 1,000): Flu like symptoms
Croatian: Manje često (pogađa 1 do 10 korisnika na 1000): Simptomi nalik gripi
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection.
Croatian: OBLIK I SADRŽAJ Suspenzija za injekciju.
English: Further, data from vaccinations with seasonal interpandemic inactivated trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Croatian: Nadalje, podaci dobiveni nakon cijepljenja trudnica sezonskim interpandemijskim inaktiviranim trovalentnim cjepivima ne upućuju na to da su se štetni ishodi za fetus i majku mogli pripisati cjepivu.
English: Rare (affects 1 to 10 users in 10,000): Convulsion, eye swelling and anaphylaxis
Croatian: Rijetko (pogađa 1 do 10 korisnika na 10 000): Konvulzije, oticanje oka i anafilaksija
English: In addition, from Post-marketing surveillance with seasonal trivalent vaccines in all age groups and with the MF59 adjuvanted seasonal trivalent vaccine with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), licensed for use in elderly subjects above 65 years of age, the following adverse events have been reported:
Croatian: Osim toga, iz postmarketinškog praćenja sezonskih trovalentnih cjepiva u svim dobnim skupinama i sezonskog adjuvantiranog trovalentnog cjepiva MF59 sastava sličnog Focetriji (površinski antigen, inaktivirano, adjuvantirano s MF59C.1), odobreno za primjenu u starijih ispitanika u dobi iznad 65 godina, prijavljeni su sljedeći štetni događaji:
English: It should be noted that the adverse reactions may be intensified.
Croatian: Mora se napomenuti da se nuspojave mogu pojačati.
English: Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C (36° and 46° F).
Croatian: Između uporaba vratite višedoznu bočicu u preporučene uvjete čuvanja između 2 ° i 8 °C.
English: When Focetria is given for the first dose, it is recommended that Focetria (and not another vaccine against H1N1v) be given for the complete vaccination course.
Croatian: Kada se Focetria primjenjuje kao prva doza, preporučuje se završiti shemu cijepljenja Focetriom (a ne drugim cjepivom protiv H1N1v).
English: It is provided in: - a ready-to-use syringe, containing a single dose of 0.5 ml for injection; - vial containing ten doses of 0.5 ml each for injection.
Croatian: Dostupna je u: - štrcaljki spremnoj za uporabu koja sadrži jednokratnu dozu od 0,5 ml za injekciju; - bočici koja sadrži deset doza od po 0,5 ml za injekciju.
English: Children 12-35 months
Croatian: Djeca (12-35 mjeseci)
English: Quantities are expressed per 0.5 ml vaccine dose.
Croatian: Količine su izražene po dozi cjepiva od 0,5 ml.
English: Vial containing ten doses (0.5 ml each) for injection:
Croatian: Bočica koja sadrži deset doza (svaka od 0,5 ml) za injekciju:
English: Very common: pain, induration and erythema, myalgia, headache, sweating, malaise and fatigue
Croatian: Vrlo često: bol, otvrdnuće i eritem, mialgija, glavobolja, znojenje, malaksalost i umor
English: The same study demonstrated that previous administration of adjuvanted or unadjuvanted seasonal influenza vaccines to adults and elderly does not interfere with the immune response to Focetria.
Croatian: Isto je ispitivanje pokazalo da prethodna primjena adjuvantiranog ili neadjuvantiranog cjepiva protiv sezonske influence u odraslih i starijih osoba ne interferira s imunološkim odgovorom na Focetriu.
English: Cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria.
Croatian: Slučajevi konvulzija uz vrućicu ili bez nje prijavljeni su u ispitanika cijepljenih Focetriom.
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Croatian: Neki od učinaka spomenutih u dijelu 4.8 "Nuspojave" mogu utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: Headache, dizziness, somnolence, syncope.
Croatian: Glavobolja, omaglica, somnolencija, sinkopa.
English: Neurological disorders, such as encephalomyelitis and Guillain Barré syndrome.
Croatian: Neurološki poremećaji kao što su encefalomijelitis i Guillain Barréov sindrom.
English: Adults and elderly
Croatian: Odrasle i starije osobe