FrancophonIA/ELRC3.0 huggingface dataset:
English: After vaccination, you should consult a doctor if you or your child believe you might have a dengue infection, and develop any of the following symptoms: high fever, severe abdominal pain, persistent vomiting, rapid breathing, bleeding gums, tiredness, restlessness and blood in vomit.
Croatian: Obratite se liječniku nakon cijepljenja ako mislite da biste Vi ili Vaše dijete mogli imati infekciju virusom denge i ako se pojavi bilo koji od sljedećih simptoma: visoka vrućica, jaka bol u trbuhu,
English: How to use Dengvaxia
Croatian: Kako se primjenjuje Dengvaxia
English: Transfer the entire content of the pre-filled syringe into the vial containing the powder.
Croatian: 2. Prenesite sav sadržaj napunjene štrcaljke u bočicu s praškom.
English: STATEMENT OF ACTIVE SUBSTANCES After reconstitution, one dose (0.5 mL) contains 4.5 - 6.0 log10 CCID50 of each serotype of the chimeric yellow fever dengue virus (1, 2, 3 and 4) (live, attenuated).
Croatian: Nakon rekonstitucije, jedna doza (0,5 ml) sadrži 4,5 - 6,0 log10 CCID50 svakog serotipa kimeričkog virusa žute groznice/denge (1, 2, 3 i 4) (živi, atenuirani).
English: In subjects 2 to 8 years of age, with no previous dengue infection, long-term safety follow-up data showed an increased risk of dengue disease requiring hospitalisation including clinically severe dengue in vaccinated subjects as compared to non-vaccinated subjects.
Croatian: Podaci o dugoročnom praćenju sigurnosti u ispitanika u dobi od 2 do 8 godina koji prethodno nisu bili zaraženi virusom denge pokazali su povećan rizik od denga bolesti koja zahtijeva hospitalizaciju, uključujući klinički težak oblik denge, u cijepljenih ispitanika u odnosu na necijepljene.
English: • If you or your child get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: • Ako kod sebe ili svog djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: The post dose 3 GMTs in subjects 9 to 16 years of age in CYD14 and CYD15 are shown in the Table
Croatian: GMT-i nakon treće doze u ispitanika u dobi od 9 do 16 godina u ispitivanjima CYD14 i CYD15 prikazani su u Tablici 6.
English: Dengvaxia is reconstituted by transferring all of the solvent (0.9% sodium chloride solution) provided in the 5-dose vial with a dark gray flip-off cap into the 5-dose vial of freeze-dried powder with a medium brown flip-off cap, using a sterile syringe and needle.
Croatian: Dengvaxia se rekonstituira tako što se cijeli volumen otapala (otopina natrijeva klorida od 0,9%), koje dolazi u 5-doznoj bočici s tamnosivim flip-off zatvaračem, prenese u 5-doznu bočicu s liofiliziranim praškom zatvorenu smeđim flip-off zatvaračem, pri čemu se koristi sterilna štrcaljka i igla.
English: Dengvaxia is reconstituted by transferring all of the solvent (0.4% sodium chloride solution) provided in the blue-labelled pre-filled syringe into the vial of freeze-dried powder with a yellowish green flip-off cap.
Croatian: Dengvaxia se rekonstituira prenošenjem cijelog volumena otapala (otopina natrijeva klorida od 0,4%), koje dolazi u napunjenoj štrcaljki s plavom naljepnicom, u bočicu s liofiliziranim praškom zatvorenu žućkasto-zelenim flip-off zatvaračem.
English: Pooled * CYD14+CYD15+ CYD23
Croatian: Objedinjeni podaci* CYD14+CYD15+ CYD23
English: Uncommon: (may affect up to 1 in 100 people)
Croatian: Manje često: (mogu se javiti u do 1 na 100 osoba)
English: You must continue to protect yourself against mosquito bites even after vaccination.
Croatian: Čak i nakon cijepljenja morate se nastaviti štititi od uboda komaraca.
English: Table 6: Immunogenicity for dengue seropositive subjects 9 to 16 years of age in CYD14 and CYD15 from endemic areas
Croatian: Tablica 6: Imunogenost kod ispitanika iz endemskih područja u dobi od 9 do 16 godina koji su bili seropozitivni na virus denge u ispitivanjima CYD14 i CYD15
English: 5D
Croatian: 5 doza 5 D
English: At the start of the CYD14 and CYD15 trials, dengue seroprevalence for the overall population at the trial sites ranged from 52.8%-81.1% in CYD14 (Asia-Pacific) and 55.7%-92.7% in CYD15 (Latin America).
Croatian: Na početku ispitivanja CYD14 i CYD15, seroprevalencija virusa denge u cjelokupnoj populaciji na ispitivačkim mjestima kretala se u rasponu od 52,8% do 81,1% u ispitivanju CYD14
English: CYD22 19 CYD28 66 CYD47 109
Croatian: CYD28 66
English: Paediatric data in subjects below 9 years of age, i.e., outside the age indication
Croatian: Podaci za djecu mlađu od 9 godina, tj. osobe izvan dobnog raspona za koji je cjepivo indicirano
English: If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: After reconstitution, use immediately.
Croatian: Primijeniti odmah nakon rekonstitucije.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČI
English: However, the extrapolated vaccine efficacy (1- Hazard Ratio), obtained from an exploratory analysis (pooled CYD14 + CYD15 + CYD23) over 25-month period after the first injection, is estimated at 89.2% (95% CI: 78.5; 94.6) for hospitalized VCD and 95.3% (95% CI: 68.9; 99.3) for severe VCD.
Croatian: Međutim, procjenjuje se da ekstrapolirana djelotvornost cjepiva (1-omjer hazarda), utemeljena na eksploracijskoj analizi podataka (objedinjeni podaci iz ispitivanja CYD14, CYD15 i CYD23) prikupljenih tijekom 25-mjesečnog razdoblja nakon prve injekcije iznosi 89,2% (95% CI: 78,5; 94,6) za VCD koji zahtijeva hospitalizaciju te 95,3% (95% CI: 68,9; 99,3) za teški VCD.
English: During a period of 6 years after the first injection, in subjects 9 years of age and above with previous dengue infection, the extrapolated vaccine efficacy (1-Hazard Ratio)*100 (obtained from an exploratory analysis) is estimated at 80 (95% CI: 69; 87) for hospitalized VCD and 84 (95% CI: 61; 94) for severe VCD.
Croatian: Procjenjuje se (na temelju eksploracijske analize) da ekstrapolirana djelotvornost cjepiva (1-omjer hazarda) *100 tijekom razdoblja od 6 godina nakon prve injekcije u ispitanika u dobi od 9 i više godina koji su prethodno bili zaraženi virusom denge iznosi 80 (95% CI: 69; 87) za VCD koji zahtijeva hospitalizaciju te 84 (95% CI: 61; 94) za teški VCD.
English: Reconstitution and handling of multidose presentation
Croatian: Rekonstitucija i rukovanje višedoznom formulacijom cjepiva
English: Immunisation should be carried out by subcutaneous (SC) injection preferably in the upper arm in the region of deltoid.
Croatian: Cjepivo treba primijeniti supkutanom injekcijom, najbolje u deltoidni mišić nadlaktice.
English: VE is calculated using density incidence (cases per 100 person-years at risk) * Pooled results of CYD14, 15 and 23 need to be interpreted cautiously because of differences in the Dengue confirmatory test and acute febrile illness definition between CYD14/15 and CYD23.
Croatian: *Djelotvornost cjepiva izračunavala se na temelju gustoće incidencije (broj slučajeva na 100 osoba-godina pod rizikom) *Objedinjene rezultate iz ispitivanja CYD14, CYD15 i CYD23 treba tumačiti uz oprez zbog razlika u pretragama kojima se potvrđivala denga i definicijama akutne febrilne bolesti u ispitivanjima CYD14/15 odnosno CYD23.
English: N=4972 N=20854
Croatian: N=4972
English: Or
Croatian: NI
English: • Powder (5 doses) in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene) + 2.5 mL of solvent in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene).
Croatian: • Prašak (5 doza) u bočici (staklo tipa I) s čepom (halobutil) i flip-off zatvaračem (aluminij, polipropilen) + 2,5 ml otapala u bočici (staklo tipa I) s čepom (halobutil) i flip-off zatvaračem
English: Dengvaxia should not be used in the context of dengue outbreak (sudden occurrence of disease) in non-endemic regions.
Croatian: Dengvaxia se ne smije primjenjivati u situacijama izbijanja denga groznice (iznenadne pojave bolesti)
English: Serotype 1
Croatian: Serotip 1
English: An association between levels of post-injection 3 geometric mean titres (GMTs) and the probability of the disease has been demonstrated in efficacy studies.
Croatian: U ispitivanjima djelotvornosti dokazana je veza između razina GMT-a nakon treće injekcije i vjerojatnosti razvoja bolesti.
English: The Vaccine Efficacy (VE) against symptomatic VCD during the 25-month period after the first injection, in subjects 9 to 16 years of age dengue seropositives at baseline and for the immunogenicity subset for pooled CYD14 + CYD15+CYD23, is estimated at 81.9% (95% CI: 67.2 ; 90.0).
Croatian: Procjenjuje se da djelotvornost cjepiva protiv simptomatskog VCD-a tijekom 25-mjesečnog razdoblja nakon prve injekcije u ispitanika u dobi od 9 do 16 godina koji su na početku ispitivanja bili seropozitivni na virus denge te u podskupini za ocjenu imunogenosti iz objedinjenih ispitivanja CYD14, CYD15 i CYD23 iznosi 81,9% (95% CI: 67,2; 90,0).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe with 2 separate needles.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Prašak (1 doza) u bočici + 0,5 ml otapala u napunjenoj štrcaljki s 2 zasebne igle.
English: • injection site warmth
Croatian: • toplina na mjestu injiciranja
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 Doses - 2.5 mL
Croatian: 5 doza - 2,5 ml 5 D
English: 2.2 Clinical efficacy data for subjects 9 to 16 years of age in endemic areas, dengue seropositive at baseline
Croatian: 2.2. Podaci o kliničkoj djelotvornosti za ispitanike u dobi od 9 do 16 godina u endemskim područjima koji su na početku ispitivanja bili seropozitivni na virus denge
English: Outbreaks
Croatian: EXP
English: After reconstitution, Dengvaxia is a clear, colourless liquid with the possible presence of white to translucent particles (of endogenous nature).
Croatian: bezbojna tekućina koja može sadržavati bijele do prozirne čestice (endogene prirode).
English: Allergic including anaphylactic reactions*
Croatian: Poremećaji imunološkog sustava vrlo rijetko alergijske reakcije, uključujući anafilaktičke reakcije*
English: Infections and infestations Rare
Croatian: Infekcije i infestacije rijetko infekcija gornjih dišnih putova
English: • are pregnant or breast-feeding.
Croatian: • ako ste trudni ili dojite
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Dengvaxia - Solvent in a pre-filled syringe (0.5 mL)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Dengvaxia - otapalo u napunjenoj štrcaljki (0,5 ml)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Dengvaxia - Powder (1 dose) in vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Dengvaxia - prašak (1 doza) u bočici
English: Pooled CYD14+CYD15
Croatian: Objedinjeni podaci CYD14+CYD15
English: Serotype 4
Croatian: Serotip 4
English: Table 5: VE against symptomatic VCD cases over the 12-month period starting from 28 days after the third injection due to any of the 4 serotypes in subjects 9 to 16 years (dengue seropositive at baseline).
Croatian: Tablica 5: Djelotvornost cjepiva protiv simptomatskih slučajeva VCD-a uzrokovanog bilo kojim od 4 serotipa tijekom 12-mjesečnog razdoblja koje je započelo 28 dana nakon treće injekcije u ispitanika u dobi od 9 do 16 godina (seropozitivnih na virus denge na početku ispitivanja)
English: • fever.
Croatian: • vrućica
English: Solvent:
Croatian: SN:
English: Adverse Events
Croatian: Slučajevi /
English: Use a sterile syringe and needle for the transfer of the solvent.
Croatian: Za prijenos otapala upotrijebite sterilnu štrcaljku i iglu.
English: Serotype 2
Croatian: Serotip 2
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 Dose - 0.5 mL
Croatian: 1 doza - 0,5 ml 1 D
English: Individuals who have not been previously infected by dengue virus or for whom this information is unknown
Croatian: do 8 godina koji prethodno nisu bili zaraženi virusom denge.
English: Serotype 3
Croatian: Serotip 3
English: The Vaccine Efficacy (VE) results according to the primary endpoint (symptomatic VCD cases occurring during the 12-month period starting from 28 days after the third injection) in subjects 9 to 16 years of age (any serostatus at baseline) are shown in Table 3 for studies CYD14, CYD15 and CYD23.
Croatian: Rezultati za djelotvornost cjepiva prema primarnoj mjeri ishoda (simptomatski slučajevi VCD-a koji su se javili tijekom 12-mjesečnog razdoblja koje je započelo 28 dana nakon treće injekcije) u ispitanika u dobi od 9 do 16 godina (neovisno o serološkom statusu na početku ispitivanja) prikazani su u Tablici 3 za ispitivanja CYD14, CYD15 i CYD23.
English: 2.1 Clinical efficacy data for subjects 9 to 16 years of age in endemic areas, any serostatus at baseline
Croatian: 2.1. Podaci o kliničkoj djelotvornosti za ispitanike u dobi od 9 do 16 godina u endemskim područjima, neovisno o serološkom statusu na početku ispitivanja
English: The Vaccine Efficacy (VE) results according to exploratory analysis of symptomatic VCD cases occurring during the 12-month period starting from 28 days after the third injection in subjects 9 to 16 years of age, seropositives at baseline are shown in Table 5 for the immunogenicity subset of studies CYD14, CYD15 and CYD23.
Croatian: Rezultati za djelotvornost cjepiva dobiveni eksploracijskom analizom simptomatskih slučajeva VCD-a koji su se javili tijekom 12-mjesečnog razdoblja koje je započelo 28 dana nakon treće injekcije u ispitanika u dobi od 9 do 16 godina koji su na početku ispitivanja bili seropozitivni prikazani su u Tablici 5 za podskupine ispitanika kod kojih se ocjenjivala imunogenost u ispitivanjima CYD14, CYD15 i CYD23.
English: (pruritus).
Croatian: bolešću).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva manje često osip generalizirani osip
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Dengvaxia - Powder (5 doses) in vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Dengvaxia - prašak (5 doza) u bočici
English: • rash (skin eruption)
Croatian: • osip (kožna erupcija) • bol u vratu
English: Injection site reactions (erythema, hematoma, swelling, pruritus)
Croatian: manje često reakcije na mjestu injiciranja (hematom, pruritus)
English: Special patient groups
Croatian: Posebne populacije
English: Table 3: VE against symptomatic VCD cases over the 12-month period starting from 28 days after the third injection due to any of the 4 serotypes in subjects 9 to 16 years (any serostatus at baseline).
Croatian: Tablica 3: Djelotvornost cjepiva protiv simptomatskih slučajeva VCD-a uzrokovanog bilo kojim od 4 serotipa tijekom 12-mjesečnog razdoblja koje je započelo 28 dana nakon treće injekcije u ispitanika u dobi od 9 do 16 godina (neovisno o serološkom statusu na početku ispitivanja)
English: NaCl (0.4%)
Croatian: Otapalo za rekonstituciju cjepiva Dengvaxia NaCl (0,4%)
English: NaCl (0.9%)
Croatian: Otapalo za rekonstituciju cjepiva Dengvaxia NaCl (0,9%)
English: Reconstitute Dengvaxia with the solvent provided.
Croatian: Dengvaxia se mora rekonstituirati s priloženim otapalom.
English: N: number of subjects with available antibody titre for the relevant endpoint Dengue seropositive subjects are subjects with titres above or equal to LLOQ against at least one dengue serotype at baseline CI: Confidence Interval
Croatian: Ispitanici seropozitivni na virus denge su oni kojima je početni titar za najmanje jedan serotip virusa denge bio na donjoj granici kvantifikacije ili iznad nje CI: interval pouzdanosti
English: • generally feeling unwell (malaise)
Croatian: • bol u mišićima (mialgija) • opće loše osjećanje (malaksalost)
English: Very rare
Croatian: Mlađa djeca
English: Table 4: VE against symptomatic, Hospitalised or Severe VCD over the 25-month period after the first injection in subjects 9 to 16 years of age (any serostatus at baseline)
Croatian: Tablica 4: Djelotvornost cjepiva protiv simptomatskog VCD-a, VCD-a koji je zahtijevao hospitalizaciju ili teškog VCD-a tijekom 25-mjesečnog razdoblja nakon prve injekcije u ispitanika u dobi od 9 do 16 godina (neovisno o serološkom statusu na početku ispitivanja)
English: Attach a sterile needle to the pre-filled syringe for the transfer of the solvent.
Croatian: Za prijenos otapala pričvrstite sterilnu iglu na napunjenu štrcaljku.
English: The Vaccine Efficacy (VE) against symptomatic VCD, severe and hospitalised VCD during the 25month period after the first injection, which were secondary objectives, in subjects 9 to 16 years of age are shown in Table 4 for any serostatus at baseline for studies CYD14, CYD15 and CYD23.
Croatian: Rezultati za djelotvornost cjepiva protiv simptomatskog VCD-a, teškog VCD-a i VCD-a koji je zahtijevao hospitalizaciju tijekom 25-mjesečnog razdoblja nakon prve injekcije u ispitanika u dobi od 9 do 16 godina (neovisno o serološkom statusu na početku ispitivanja), što su bili sekundarni ciljevi, prikazana je u Tablici 4 za ispitivanja CYD14, CYD15 i CYD23.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Dengvaxia - Powder (5 doses) in vial + 2.5 mL of solvent in vial.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Prašak (5 doza) u bočici + 2,5 ml otapala u bočici.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Dengvaxia - Solvent in vial (2.5 mL)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Dengvaxia - otapalo u bočici (2,5 ml)
English: Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe.
Croatian: Prašak (1 doza) u bočici + 0,5 ml otapala u napunjenoj štrcaljki
English: Allergic including anaphylactic reactions* Nervous system disorders Very common Headache Uncommon
Croatian: Poremećaji živčanog sustava vrlo često glavobolja rijetko omaglica
English: Exploratory vaccine efficacy analyses according to dengue serostatus measured by plaque reduction neutralization test (PRNT50) at baseline (before the first injection) were performed in the immunogenicity subset of 2000 subjects each in CYD14 and CYD15 and 300 subjects in CYD23.
Croatian: PRNT50) na početku ispitivanja (prije prve injekcije), provedene su u podskupini za ocjenu imunogenosti, koju je činilo po 2000 ispitanika u ispitivanjima CYD14 i CYD15 te 300 ispitanika u ispitivanju CYD23.
English: Upper respiratory tract infection Nasopharyngitis
Croatian: Infekcije i infestacije manje često infekcija gornjih dišnih putova nazofaringitis
English: (listed in section 6).
Croatian: Tablicu 4).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for reconstitution of Dengvaxia
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: Essential amino acids including Phenylalanine Non-essential amino acids Arginine hydrochloride Sucrose
Croatian: esencijalne aminokiseline, uključujući fenilalanin neesencijalne aminokiseline argininklorid saharoza trehaloza dihidrat sorbitol (E420) trometamol urea
English: In subjects 9 through 16 years of age dengue seropositive at baseline (immunogenicity subset), one clinically severe VCD case and one WHO DHF VCD case was reported during the 25-month period after the first injection in the control group in each individual study (CYD14 and CYD15) versus none in the vaccine group.
Croatian: U svakom je ispitivanju (CYD14 i CYD15) tijekom 25-mjesečnog razdoblja nakon prve injekcije u ispitanika u dobi od 9 do 16 godina koji su na početku ispitivanja bili seropozitivni na virus denge (podskupina za ocjenu imunogenosti) prijavljen po jedan slučaj klinički teškog oblika VCD-a i jedan slučaj denga hemoragijske groznice prema kriterijima SZO-a u kontrolnoj skupini, dok u cijepljenoj skupini nije zabilježen nijedan slučaj.
English: What Dengvaxia contains
Croatian: Sadržaj pakiranja i druge informacije Što Dengvaxia sadrži
English: Dengvaxia, powder and solvent for suspension for injection in pre-filled syringe dengue tetravalent vaccine (live, attenuated)
Croatian: Dengvaxia, prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki četverovalentno cjepivo protiv denge (živo, atenuirano)
English: Dengvaxia, powder and solvent for suspension for injection in multidose containers dengue tetravalent vaccine (live, attenuated)
Croatian: Dengvaxia, prašak i otapalo za suspenziju za injekciju u višedoznim spremnicima četverovalentno cjepivo protiv denge (živo, atenuirano)
English: Cases / personyears VE % (95%CI)
Croatian: Djelotvornost cjepiva, % (95% CI)
English: PHARMACEUTICAL FORM AND CONTENTS Powder (5 doses) in vial + 2.5 mL of solvent in vial Pack size of 5.
Croatian: Prašak (5 doza) u bočici + 2,5 ml otapala u bočici.
English: What Dengvaxia is and what it is used for What you need to know before you or your child use Dengvaxia How to use Dengvaxia
Croatian: Vi ili Vaše dijete primite cjepivo Dengvaxia Kako se primjenjuje Dengvaxia
English: Trometamol
Croatian: • mučnina
English: Vaccine efficacy against symptomatic VCD cases over the 12-month period starting from 28 days after the third injection due to any of the 4 serotypes was 40.5% (95% CI: 22.7; 54.2) (pooled CYD14+CYD23).
Croatian: Djelotvornost cjepiva protiv simptomatskih slučajeva VCD-a uzrokovanog bilo kojim od 4 serotipa tijekom 12-mjesečnog razdoblja koje je započelo 28 dana nakon treće injekcije iznosila je 40,5%
English: Chimeric yellow fever dengue virus serotype 1 (live, attenuated)* ............ 4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 2 (live, attenuated)* ............ 4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 3 (live, attenuated)* ............ 4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 4 (live, attenuated)* ............ 4.5 - 6.0 log10 CCID50/dose**
Croatian: 4,5 - 6,0 log10 CCID50 po dozi** Kimerički virus žute groznice/denge serotipa 4 (živi, atenuirani) *......
English: • feeling dizzy
Croatian: • suha usta
English: Injection site pain Malaise
Croatian: otvrdnuće na mjestu injiciranja
English: Nausea Dry mouth
Croatian: Poremećaji probavnog sustava manje često mučnina suha usta
English: • Powder (1 dose) in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene) + 0.5 mL of solvent in pre-filled syringe (Type-I glass), with a plunger stopper (halobutyl) and a tip cap (elastomer).
Croatian: polipropilen) + 0,5 ml otapala u napunjenoj štrcaljki (staklo tipa I) s čepom klipa (halobutil) i zatvaračem vrha (elastomer).
English: • fatigue.
Croatian: • zimica
English: • injection site reactions: redness (erythema), bruising (haematoma), swelling, and itching
Croatian: Često: (mogu se javiti u do 1 na 10 osoba) • reakcije na mjestu injiciranja: crvenilo (eritem), modrice (hematom), oticanje i svrbež (pruritus)
English: What you need to know before you or your child use Dengvaxia
Croatian: Vi ili Vaše dijete primite cjepivo Dengvaxia
English: • Powder (1 dose) in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene) + 0.5 mL of solvent in a pre-filled syringe (Type-I glass), with a plunger stopper (halobutyl) and a tip cap (elastomer) with 2 separate needles.
Croatian: polipropilen) + 0,5 ml otapala u napunjenoj štrcaljki (staklo tipa I) s čepom klipa (halobutil) i zatvaračem vrha (elastomer) te 2 zasebne igle.
English: • chills
Croatian: • omaglica
English: • sore throat (oropharyngeal pain)
Croatian: • grlobolja (bol u usnoj šupljini i ždrijelu)
English: NAME OF THE MEDICINAL PRODUCT Dengvaxia, powder and solvent for suspension for injection in multidose containers dengue tetravalent vaccine (live, attenuated)
Croatian: Uputa o lijeku: Informacije za korisnika Dengvaxia, prašak i otapalo za suspenziju za injekciju u višedoznim spremnicima četverovalentno cjepivo protiv denge (živo, atenuirano)