FrancophonIA/ELRC3.0 huggingface dataset:
English: Focetria H1N1v may be co-administered with a non adjuvanted seasonal influenza vaccine.
Croatian: Focetria H1N1v smije se primijeniti istodobno s neadjuvantiranim cjepivom protiv sezonske influence.
English: Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Croatian: Nakon cijepljenja protiv influence, mogu se dobiti lažno pozitivni serološki rezultati testova metodom ELISA na protutijela na virus humane imunodeficijencije-1(HIV-1), virus hepatitisa C i naročito, HTLV-1.
English: Cardiac disorders Palpitation, tachycardia.
Croatian: Srčani poremećaji Palpitacije, tahikardija.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Elderly (>60 years)
Croatian: Starije osobe (>60 godina)
English: The safety profile of Focetria was similar to that of the H5N1 mock up vaccines.
Croatian: Sigurnosni profil Focetrie bio je sličan je onomu „mock-up“ cjepivima za H5N1.
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
Croatian: Neurološki poremećaji kao što je encefalomijelitis (upala središnjeg živčanog sustava) i vrsta paralize koja je poznata kao Guillain Barréov sindrom.
English: (Manufacturer responsible for monovalent pooled harvests, before final filtration): Novartis Vaccines and Diagnostics S.r.l.
Croatian: (Proizvođač odgovoran za monovalentne pulirane žetve, prije konačne filtracije): Novartis Vaccines and Diagnostics S.r.l.
English: 0.05 milligrams
Croatian: 0,05 miligrama
English: Elderly (>60 years):
Croatian: Starije osobe (>60 godina):
English: Pharmacotherapeutic group: Vaccines.
Croatian: Farmakoterapijska skupina: cjepiva.
English: Ready-to-use syringe, containing a single dose of 0.5 ml for injection:
Croatian: Štrcaljka spremna za uporabu koja sadrži jednokratnu dozu od 0,5 ml za injekciju:
English: Adverse reactions from clinical trials with the mock-up vaccine are listed below.
Croatian: Nuspojave iz kliničkih ispitivanja s „mock-up“ cjepivima navedene su u nastavku.
English: Gently shake the multidose vial each time before withdrawing a dose (0.5 ml) of the vaccine into a syringe.
Croatian: Lagano protresti višedoznu bočicu svaki put prije izvlačenja doze (0,5 ml) cjepiva u štrcaljku.
English: (Manufacturer responsible for final filtration of monovalent pooled harvest): Novartis Vaccines and Diagnostics S.r.l.
Croatian: (Proizvođač odgovoran za konačnu filtraciju monovalentne pulirane žetve): Novartis Vaccines and Diagnostics S.r.l.
English: In clinical trial 131 adults and 123 elderly were exposed to two doses of the 7.5 µg Focetria.
Croatian: U kliničkom su ispitivanju 131 odrasle i 123 starije osobe bile izložene s dvije doze Focetrie od 7,5 µg.
English: Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Croatian: Vrlo česte reakcije prijavljene u djece i adolescenata u dobi od 3 do 17 godina: Bol, otvrdnuće i eritem, malaksalost, mialgija, glavobolja i umor.
English: Novartis Vaccines and Diagnostics S.r.l.
Croatian: Novartis Vaccines and Diagnostics S.r.l. Loc.
English: Data on co-administration of Focetria H1N1v with a non-adjuvanted seasonal influenza subunit vaccine in healthy adults aged 18-60 years of age did not suggest any interference in the immune response to Focetria.
Croatian: Podaci o istodobnoj primjeni Focetrie H1N1v sa subjediničnim neadjuvantiranim cjepivom protiv sezonske influence u zdravih odraslih osoba u dobi od 18-60 godina starosti ne ukazuju na bilo kakvu interferenciju u imunološkom odgovoru na Focetriu.
English: Excipients: thiomersal
Croatian: Pomoćne tvari: tiomersal
English: Record date and time of the first dose withdrawal on the vial label.
Croatian: Na naljepnici bočice treba zabilježiti datum i vrijeme izvlačenja prve doze.
English: Therefore the data indicate that Focetria may be co-administered with non adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Croatian: Stoga, podaci pokazuju da se Focetria može primijeniti istodobno s neadjuvantiranim cjepivima protiv sezonske influence (s injekcijama danim u suprotne udove).
English: Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Croatian: Poremećaji kože i potkožnog tkiva Opće kožne reakcije, uključujući pruritus, urtikariju ili nespecifičan osip; angioedem.
English: Prophylaxis of influenza caused by A(H1N1v) 2009 virus (see section 4.4).
Croatian: Profilaksa influence uzrokovane virusom A (H1N1v) 2009 (vidjeti dio 4.4).
English: Prophylaxis of influenza caused by A (H1N1v) 2009 virus (see section 4.4).
Croatian: Profilaksa influence uzrokovane virusom A(H1N1v) 2009 (vidjeti dio 4.4).
English: Pre-filled syringe:
Croatian: Napunjena štrcaljka:
English: A dose (0.5 ml) of the vaccine will be given.
Croatian: Primjenit će se jedna doza (0,5 ml) cjepiva.
English: • Studies in adults and elderly
Croatian: • Ispitivanja u odraslih i starijih osoba
English: Clinical studies with Focetria H1N1v currently provide:
Croatian: Iz kliničkih ispitivanja s Focetriom H1N1v trenutačno su dostupni:
English: Total N=117
Croatian: Ukupno n=117
English: Children aged 6 months to 35 months:
Croatian: Djeca u dobi od 6 mjeseci do 35 mjeseci:
English: Grounds recommending the variation to the terms of the Marketing Authorisation On the basis of the scientific conclusions for Focetria, the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing the active substance influenza vaccine h1n1v (surface antigen, inactivated, adjuvanted) is favourable subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za lijek Focetria, CHMP smatra da je omjer koristi i rizika lijeka koji sadrži djelatnu tvar cjepiva protiv influence H1N1v (površinski antigen, inaktivirano, adjuvantirano) povoljan, uz predložene izmjene informacija o lijeku.
English: Blood and lymphatic system disorders Lymphadenopathy.
Croatian: Poremećaji krvi i limfnog sustava Limfadenopatija.
English: Adults (18-60 years):
Croatian: Odrasli (18 do 60 godina):
English: Vasculitis with transient renal involvement and exudative erythema multiforme.
Croatian: Vaskulitis s prolaznim zahvaćanjem bubrega i eksudativni multiformni eritem.
English: Total N=66
Croatian: Ukupno n=66
English: Focetria should under no circumstances be administered intravascularly.
Croatian: Focetria se ni u kojem slučaju ne smije primijeniti intravaskularno.
English: PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe.
Croatian: OBLIK Suspenzija za injekciju u napunjenoj štrcaljki.
English: General side effects reported very commonly in the 6 months-35 months of age group per dose were irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Croatian: Općenite nuspojave prijavljene vrlo često u dobnoj skupini od 6-35 mjeseci po dozi bile su razdražljivost, neuobičajeno plakanje, pospanost, proljev i promjena u prehrambenim navikama.
English: Pain, hardening of the skin at the injection site, injection site redness, injection site swelling, pain at the site of injection, aching muscles, headache, sweating, fatigue, generally feeling unwell and shivering
Croatian: Bol, otvrdnuće kože na mjestu injekcije, crvenilo na mjestu injekcije, oticanje na mjestu injekcije, bol na mjestu injekcije, bol u mišićima, glavobolja, znojenje, umor, općenito loše osjećanje i drhtanje.
English: Very common reactions reported in 233 infants and toddlers 6 to 35 months of age: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Croatian: Vrlo česte reakcije prijavljene u 233 dojenčadi i male djece u dobi od 6 do 35 mjeseci: osjetljivost, eritem, razdražljivost, neuobičajeno plakanje, pospanost, proljev i promjene u prehrambenim navikama.
English: Infants (6 to 11 months of age)
Croatian: Dojenčad (u dobi od 6 do 11 mjeseci)
English: Children (3-8 years)
Croatian: Djeca (3-8 godina)
English: Total N=120
Croatian: Ukupno n=120
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA ZA ŠTRCALJKU
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 10-DOSE VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA ZA BOČICU S 10 DOZA
English: Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
Croatian: Otečeni limfni čvorovi, palpitacije, slabost, bol u udovima i kašalj.
English: Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Slabost mišića, bol u ekstremitetima.
English: Gently shake before use.
Croatian: Lagano protresti prije uporabe.
English: Very commonly reported reactions in both children and adolescents were pain, hardening of the skin at the injection site, injection site redness, generally feeling unwell, muscle ache, headache and fatigue.
Croatian: Vrlo često prijavljene reakcije u djece i u adolescenata bile su bol, otvrdnuće kože na mjestu injekcije, crvenilo na mjestu injekcije, općenito loše osjećanje, bol u mišićima, glavobolja i umor.
English: Muscoskeletal, connective tissue and bone disorders Very common: myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često: mialgija
English: Focetria can be given at the same time as non-adjuvanted seasonal influenza vaccines, with injections made into separate limbs.
Croatian: Focetria se može primijeniti u isto vrijeme s neadjuvantiranim cjepivima protiv sezonske influence, uz davanje injekcija u suprotne udove.
English: Headache, dizziness, drowsiness, fainting.
Croatian: Glavobolja, omaglica, omamljenost, nesvjestica.
English: Total N=70
Croatian: Ukupno n=70
English: METHOD OF ADMINISTRATION Gently shake before use.
Croatian: NAČIN PRIMJENE LIJEKA Lagano protresti prije uporabe.
English: Any adverse reaction
Croatian: Bilo koja nuspojava
English: 5.0 ml in 10-dose vial (type I glass) with stopper (halo-butyl rubber).
Croatian: 5,0 ml u bočici s 10 doza (staklo tipa I) s čepom (halobutilna guma).
English: Prior to administration, the withdrawn vaccine should be allowed to reach room temperature.
Croatian: Prije primjene cjepivo treba ostaviti da dosegne sobnu temperaturu.
English: 1 x single dose of 0.5 ml pre-filled syringe 10 x single dose of 0.5 ml pre-filled syringes
Croatian: 1 napunjena štrcaljka s jednokratnom dozom od 0,5 ml 10 napunjenih štrcaljki s jednokratnom dozom od 0,5 ml
English: Clinical trials with Focetria H1N1v
Croatian: Klinička ispitivanja s Focetriom H1N1v
English: Children and adolescents aged 3-17 years:
Croatian: Djeca i adolescenti u dobi 3-17 godina:
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Croatian: Ako se razmatra istodobna primjena s drugim cjepivom, cjepiva treba primijeniti u suprotne udove.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION
Croatian: Razlozi za preporuku izmjena uvjeta odobrenja za stavljanje lijeka u promet
English: Total N=57
Croatian: Ukupno n=57
English: Seroconversion or Significant Increase (95% CI) * measured by HI assay ** geometric mean ratios of HI
Croatian: Serokonverzija ili značajno povećanje (95% CI) *mjereno HI analizom **omjeri geometrijske srednje vrijednosti HI
English: • Safety and immunogenicity data in healthy children and adolescents aged from 6 months to 17 years and in adults, including the elderly
Croatian: • podaci o sigurnosti i imunogenosti u zdrave djece i adolescenata u dobi od 6 mjeseci do 17 godina te u odraslih, uključujući starije osobe Imunološki odgovor na Focetriu H1N1v
English: Total N=88
Croatian: Ukupno n=88
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 u djece i adolescenata u dobi od 3 do 17 godina ukazuju na blago smanjenje reaktogenosti nakon druge doze, bez povećanja u stopama vrućice.
English: Generalised skin reactions including itching, urticaria (hives), rash or swelling of the skin and mucous membranes.
Croatian: Opće kožne reakcije, uključujući svrbež, urtikariju (koprivnjaču), osip ili oticanje kože i sluznica.
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 6-35 mjeseci ukazuju na blago smanjenje reaktogenosti nakon druge doze, bez povećanja u stopama vrućice.
English: Data in children and adolescents suggest a slight decrease in reactogenicity after the second dose of the vaccine, with no increase in rates of fever.
Croatian: Podaci za djecu i adolescente ukazuju na nešto manju reaktogenost nakon druge doze cjepiva, bez povećanja u učestalosti vrućice.
English: Breast-feeding Focetria may be administered to lactating women.
Croatian: Dojenje Focetriom se smiju cijepiti žene koje doje.
English: “Possible side effects” may affect the ability to drive or use machines.
Croatian: Neki učinci spomenuti u dijelu 4. "Moguće nuspojave" mogu utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: Children (3 to 8 years of age)
Croatian: Djeca (3 do 8 godina)
English: Rare: anaphylaxis
Croatian: Rijetko: anafilaksija
English: The incidence of symptoms observed in subjects over 60 years of age was generally lower as compared to the 18-60 years old population.
Croatian: Incidencija simptoma opaženih u ispitanika starijih od 60 godina uglavnom je bila niža u usporedbi s populacijom u dobi od 18-60godina.
English: There are no data on co-administration of Focetria with other vaccines.
Croatian: Nema podataka o istodobnoj primjeni Focetrie s drugim cjepivima.
English: How to store FOCETRIA
Croatian: Kako čuvati Focetriu
English: How to store Focetria
Croatian: Kako čuvati FOCETRIU
English: Loc. Bellaria
Croatian: Bellaria
English: How FOCETRIA is given
Croatian: Kako se FOCETRIA primjenjuje
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE
Croatian: UVJETI ODOBRENJA C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
English: Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Croatian: Cjepivo protiv pandemijske influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano).
English: Via Fiorentina, 1 - Siena, Italy.
Croatian: Novartis Vaccines and Diagnostics S.r.l. - Via Fiorentina, 1 - Siena, Italija.
English: The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
Croatian: Incidencija simptoma primijećenih u ispitanika starijih od 60 godina bila je niža u usporedbi s populacijom u dobi od 18-60 godina.
English: Seronegative at baseline N=51
Croatian: Seronegativni na početku n=51
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of Focetria (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
Croatian: • ako ste već imali naglu, po život opasnu alergijsku reakciju na bilo koji sastojak Focetrie (oni su navedeni na kraju upute) ili na bilo koje tvari koje mogu biti prisutne u tragovima kako slijedi: jaja i pileći protein, ovalbumin, formaldehid, kanamicin i neomicin sulfat (antibiotici) i cetiltrimetilamonijev bromid (CTAB).
English: Seronegative at baseline N=46
Croatian: Seronegativni na početku n=46
English: GMR (95% CI) Seroconversion or Significant Increase (95% CI)
Croatian: Stopa serozaštite (95% CI) GMR (95% CI) Serokonverzija ili značajno povećanje (95% CI)
English: Adverse reactions in the week following vaccination from 80 infants 6-11 months old and 82 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
Croatian: U tjednu nakon cijepljenja za 80 dojenčadi u dobi 6-11 mjeseci i 82 male djece u dobi 12-35 mjeseci koji su primali formulaciju od 7,5 µg prijavljene su sljedeće nuspojave:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Focetria injection
Croatian: NAZIV GOTOVOG LIJEKA I PUT(EVI) PRIMJENE LIJEKA Focetria injekcija cjepivo protiv influence H1N1v
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE NALJEPNICA ZA ŠTRCALJKU
English: There is no information on administration of the vaccine Focetria with any other vaccines.
Croatian: Nema podataka o primjeni Focetrie s bilo kojim drugim cjepivima.
English: Very rare (<1/10,000).
Croatian: Manje često (≥1/1000 do <1/100), Rijetko (≥1/10 000 do <1/1000), Vrlo rijetko (<1/10 000).
English: Respiratory disorders Cough.
Croatian: Poremećaji dišnog sustava Kašalj.
English: Adverse reactions in the week following vaccination from 87 children 3-8 years old and 95 children and adolescents 9-17 years old, receiving the 7.5 µg formulation were reported as follows:
Croatian: U tjednu nakon cijepljenja za 87 djece u dobi 3-8 godina i 95 djece i adolescenata u dobi 9-17 godina koji su primali formulaciju od 7,5 µg prijavljene su sljedeće nuspojave:
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181
Croatian: Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)* soja: A/California/07/2009 (H1N1)- iz kojeg je izveden korišten soj NYMC X-181
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/385/001
English: Seronegative at baseline N=37
Croatian: Seronegativni na početku n=37
English: There are no data with Focetria using the subcutaneous route.
Croatian: Nema podataka o supkutanoj primjeni Focetrie.
English: The other ingredients are: thiomersal (multidose vial only), sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Croatian: Drugi sastojci su: tiomersal (samo kod višedozne bočice), natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev hidrogenfosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citratna kiselina i voda za injekcije.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva Često: znojenje
English: Seronegative at baseline N=48
Croatian: Seronegativni na početku n=48
English: Cough.
Croatian: Loc.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10-DOSE VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE NALJEPNICA ZA BOČICU S 10 DOZA
English: The vaccine should be allowed to reach room temperature before use.
Croatian: Prije uporabe cjepivo treba ostaviti da dosegne sobnu temperaturu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/07/385/004
English: Fever ≥ 38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C
Croatian: Vrućica ≥38°C do 38,9°C Vrućica 39°C do 39,9°C Vrućica ≥ 40° C
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 274 to 1700 (N=57) and an increase in GMT from 162 to 1399 in children who were seronegative at baseline (N=37).
Croatian: Podaci o odgovorima na drugu dozu primijenjenu nakon razmaka od tri tjedna pokazali su povećanje ukupnog GMT-a s 274 na 1700 (n=57) i povećanje GMT-a sa 162 na 1399 u djece koja su bila seronegativna na početku (n=37).
English: The vaccine should not be administered intravascularly.
Croatian: Cjepivo se ne smije primijeniti u krvnu žilu.
English: Seroprotection rate (95% CI)
Croatian: Stopa serozaštite (95% CI) GMR (95% CI)
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 793 to 1065 (N=88) and an increase in GMT from 522 to 870 in children who were seronegative at baseline (N=51).
Croatian: Podaci o odgovorima na drugu dozu primijenjenu nakon razmaka od tri tjedna pokazali su povećanje ukupnog GMT-a sa 793 na 1065 (n=88) kao i povećanje GMT-a s 522 na 870 u djece koja su bila seronegativna na početku (n=51).
English: Seronegative at baseline N=45
Croatian: Seronegativni na početku n=45
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, water for injections.
Croatian: Natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev hidrogenfosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citratna kiselina, voda za injekcije.
English: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, thiomersal, water for injections.
Croatian: Natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev hidrogenfosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citratna kiselina, tiomersal, voda za injekcije.
English: Talk to your doctor or nurse before receiving Focetria
Croatian: Prije primanja Focetrie razgovarajte s liječnikom ili medicinskom sestrom.
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal (only for the multidose vial presentation), to egg and, chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
Croatian: • ako ste imali bilo koju alergijsku reakciju osim nagle, po život opasne alergijske reakcije na bilo koji sastojak cjepiva, na tiomersal (samo za oblik višedozne bočice), na jaja, pileći protein, ovalbumin, formaldehid, kanamicin i neomicin sulfat (antibiotici) ili cetiltrimetilamonijev bromid (CTAB). (pogledajte dio 6. Dodatne informacije).
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
Croatian: Anamneza anafilaktičke (tj. po život opasne) reakcije na bilo koji sastojak ovog cjepiva ili na ostatne tvari u tragovima (jaja i pileći proteini, ovalbumin, kanamicin i neomicin sulfat, formaldehid i cetiltrimetilamonijev bromid (CTAB)).
English: Focetria suspension for injection Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Croatian: Focetria suspenzija za injekciju cjepivo protiv influence H1N1v (površinski antigen, inaktivirano, adjuvantirano)
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 319 to 702 (N=70) and an increase in GMT from 247 to 726 in children who were seronegative at baseline (N=48).
Croatian: Podaci o odgovorima na drugu dozu primijenjenu nakon razmaka od tri tjedna pokazali su povećanje ukupnog GMT-a s 319 na 702 (n=70) kao i povećanje GMT-a s 247 na 726 u djece koja su bila seronegativna na početku (n=48).
English: - If any of the side effects gets serious, talk to your doctor.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.