FrancophonIA/ELRC3.0 huggingface dataset:
English: In subjects 9 to 16 years of age, the efficacy of Dengvaxia against symptomatic virologicallyconfirmed dengue (VCD) cases due to any of the 4 serotypes was demonstrated in all three studies, CYD14, CYD15 and CYD23 (see Table 3).
Croatian: Među ispitanicima u dobi od 9 do 16 godina, djelotvornost cjepiva Dengvaxia protiv simptomatske virološki potvrđene denge (VCD) uzrokovane bilo kojim od 4 serotipa virusa dokazana je u sva tri ispitivanja - CYD14, CYD15 i CYD23 (vidjeti Tablicu 3).
English: The GMTs post-dose 3 in subjects 18 to 45 years of age are shown in the Table 7
Croatian: GMT-i nakon treće doze u ispitanika u dobi od 18 do 45 godina prikazani su u Tablici 7.
English: A protective immune response with Dengvaxia may not be elicited in all vaccinees.
Croatian: Zaštitni imunosni odgovor nakon primjene cjepiva Dengvaxia možda se neće postići u svih cijepljenih osoba.
English: The GMTs levels depend on age and dengue serostatus at baseline.
Croatian: Razine GMT-a ovise o dobi i početnom serološkom statusu za virus denge.
English: SANOFI PASTEUR NVL 31-33 Quai Armand Barbès 69250 Neuville-sur-Saône France
Croatian: Sanofi Pasteur NVL 31-33 quai Armand Barbès 69250 Neuville-sur-Saône Francuska
English: Dengvaxia should not be used in the context of dengue outbreak in non-endemic regions.
Croatian: Dengvaxia se ne smije primjenjivati u situacijama izbijanja denge izvan endemskih područja.
English: There is limited amount of data from the use of Dengvaxia in pregnant women.
Croatian: Podaci o primjeni cjepiva Dengvaxia u trudnica su ograničeni.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Croatian: Nazivi i adrese proizvođača bioloških djelatnih tvari
English: • Sterile dose withdrawal has not been fully observed.
Croatian: • ako se nije u potpunosti pridržavalo sterilnog postupka uvlačenja doze
English: Dengvaxia is a live attenuated vaccine, therefore Dengvaxia is contraindicated during pregnancy (see section 4.3).
Croatian: Budući da je Dengvaxia živo atenuirano cjepivo, njegova je primjena kontraindicirana tijekom trudnoće (vidjeti dio 4.3).
English: The use of Dengvaxia should be in accordance with official recommendations.
Croatian: Cjepivo Dengvaxia treba primjenjivati u skladu sa službenim preporukama.
English: Your doctor will not use Dengvaxia until 4 weeks after you stop treatment.
Croatian: Liječnik će Vam dati cjepivo Dengvaxia tek nakon 4 tjedna od prestanka liječenja.
English: This increased risk was not observed in individuals who have been previously infected by dengue virus, where it was estimated that 16 hospitalized dengue cases or 4 severe dengue cases could be prevented per 1000 vaccinees with previous dengue infection during 6 years of follow up from the first injection.
Croatian: Taj povećan rizik nije primijećen u osoba koje su prethodno bile zaražene virusom denge, kod kojih je procijenjeno da bi se tijekom 6 godina praćenja nakon prve injekcije moglo spriječiti 16 slučajeva hospitalizacije zbog denge ili 4 slučaja teškog oblika denge na 1000 cijepljenika koji su prethodno bili zaraženi virusom denge.
English: Dengvaxia must be reconstituted prior to administration.
Croatian: Dengvaxia se prije primjene mora rekonstituirati.
English: • The other ingredients are: essential amino acids including Phenylalanine, non-essential amino acids, Arginine hydrochloride, Sucrose, Trehalose dihydrate, Sorbitol (E420), trometamol, urea, sodium chloride, water for injections.
Croatian: • Drugi sastojci su: esencijalne aminokiseline, uključujući fenilalanin; neesencijalne aminokiseline, argininklorid, saharoza, trehaloza dihidrat, sorbitol (E420), trometamol, urea, natrijev klorid, voda za injekcije.
English: Additional side effects in children and adolescents (from 9 to and including 17 years of age): Uncommon: (may affect up to 1 in 100 people)
Croatian: Dodatne nuspojave u djece i adolescenata (u dobi od 9 do uključivo 17 godina):
English: 2.4 Other paediatric data from efficacy studies in subjects 2 through 8 years of age, i.e., outside the age indication
Croatian: 2.4 Drugi podaci o pedijatrijskoj primjeni iz ispitivanja djelotvornosti provedenih u ispitanika u dobi od 2 do 8 godina, tj. izvan dobnog raspona za koji je cjepivo indicirano
English: No clinical efficacy study has been done in subjects from 17 to 45 years from endemic areas.
Croatian: Nije provedeno kliničko ispitivanje djelotvornosti u osoba u dobi od 17 do 45 godina koji žive u endemskim područjima.
English: The reactogenicity subset in subjects below 9 years of age includes 2960 subjects as follows: 1287 subjects below 2 years of age, 905 subjects between 2 and 5 years of age and 768 subjects between 6 and 8 years of age.
Croatian: 2960 osoba: 1287 ispitanika mlađih od 2 godine, 905 ispitanika u dobi od 2 do 5 godina i 768 ispitanika u dobi od 6 do 8 godina.
English: Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with prior dengue virus infection and living in endemic areas (see sections 4.2, 4.4 and 4.8).
Croatian: Dengvaxia je indicirana za sprječavanje bolesti denga uzrokovane virusom denge serotipa 1, 2, 3 i 4 u osoba u dobi od 9 do 45 godina koje su prethodno bile zaražene virusom denge i koje žive u endemskim područjima (vidjeti dijelove 4.2, 4.4 i 5.1).
English: • Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to injection with a needle.
Croatian: • Nakon ili čak prije bilo kojeg cijepljenja može doći do sinkope (nesvjestice) kao psihogenog odgovora na injekciju iglom.
English: Over a period of 6 years, in subjects with no previous dengue infection, the risk of severe dengue is increased by 2.41 fold (95% CI: 0.50; 11.75) in subjects 9 to 16 years of age vaccinated with Dengvaxia as compared to non-vaccinated subjects in the same age group.
Croatian: Tijekom razdoblja od 6 godina, među ispitanicima koji prethodno nisu bili zaraženi virusom denge rizik od teškog oblika denge bio je 2,41 puta veći (95% CI: 0,50; 11,75) u ispitanika u dobi od 9 do 16 godina koji su primili cjepivo Dengvaxia nego u necijepljenih ispitanika iz iste dobne skupine.
English: • swollen glands (lymphadenopathy)
Croatian: • otečene limfne žlijezde (limfadenopatija)
English: SANOFI PASTEUR Parc Industriel d'Incarville 27100 Val de Reuil France
Croatian: SANOFI PASTEUR Parc Industriel d'Incarville 27100 Val de Reuil Francuska ili
English: • Dengue seropositivity if the PRNT50 titre ≥ 10 [1/dil] (the lower limit of quantification,
Croatian: • ispitanik je bio seropozitivan na virus denge ako je PRNT50 titar iznosio ≥ 10 [1/dil] (donja granica kvantifikacije) za najmanje jedan serotip
English: A decrease in the GMTs against all 4 serotypes was observed one year after the third injection.
Croatian: Godinu dana nakon treće injekcije zabilježen je pad GMT-a za sva 4 serotipa.
English: Severe dengue can give you a high fever and any of the following: severe abdominal (belly) pain, persistent sickness (vomiting), rapid breathing, severe bleeding, bleeding in the stomach, bleeding gums, feeling tired, feeling restless, coma, having fits (seizures) and organ failure.
Croatian: Teška denga može uzrokovati visoku vrućicu i bilo što od sljedećega: jaku bol u trbuhu (abdomenu), dugotrajno povraćanje, ubrzano disanje, jako krvarenje, krvarenje u trbuhu,
English: Blood and lymphatic tissue disorders
Croatian: Poremećaji krvi i limfnog tkiva manje često limfadenopatija
English: In this case, your doctor will not use Dengvaxia until 4 weeks after you stop treatment.
Croatian: U tom će slučaju liječnik primijeniti cjepivo Dengvaxia tek 4 tjedna nakon prestanka liječenja.
English: In an exploratory analysis of the long-term follow up from the first injection in three efficacy studies, an increased risk of hospitalisation for dengue including clinically severe dengue (predominantly Dengue Haemorrhagic Fever grade 1 or 2 [WHO 1997]) has been observed in vaccinees with no previous dengue infection.
Croatian: U eksploracijskoj analizi podataka prikupljenih tijekom dugoročnog praćenja nakon prve injekcije u tri ispitivanja djelotvornosti opažen je povećan rizik od hospitalizacije zbog denge, uključujući klinički težak oblik bolesti (najčešće denga hemoragijsku groznicu 1. ili 2. stupnja [SZO 1997.]) u cijepljenika koji prethodno nisu bili zaraženi virusom denge.
English: The immunogenicity of the final formulation of the CYD dengue vaccine in adults aged 18 to 45 years in endemic areas was assessed in 3 studies conducted all in Asia-Pacific (CYD22 in Vietnam, CYD28 in Singapore and CYD47 in India).
Croatian: 18 do 45 godina u endemskim područjima ocjenjivala se u 3 ispitivanja provedena u azijsko-pacifičkoj regiji (CYD22 u Vijetnamu, CYD28 u Singapuru i CYD47 u Indiji).
English: Efficacy in subjects 9 years of age and older was assessed in 17 230 subjects who received Dengvaxia (3316 subjects in CYD14 and 13914 in CYD15) and 8596 subjects who received placebo (1656 in CYD14 and 6940 in CYD15).
Croatian: Djelotvornost u osoba u dobi od 9 i više godina ocjenjivala se kod 17 230 ispitanika koji su primili cjepivo Dengvaxia (3316 u ispitivanju CYD14 i 13 914 u ispitivanju CYD15) te 8596 ispitanika koji su primili placebo (1656 u ispitivanju CYD14 i 6940 u ispitivanju CYD15).
English: Previous dengue infection has to be assessed before vaccination by laboratory confirmed history of dengue or through an appropriately validated serological test (see section 4.4).
Croatian: Prije cijepljenja neophodno je utvrditi prethodnu infekciju virusom denge, temeljem laboratorijski potvrđene denge u anamnezi ili pravilno validiranog serološkog testa (vidjeti dio 4.4).
English: Reconstitution and handling of single-dose presentation
Croatian: Rekonstitucija i rukovanje jednodoznom formulacijom cjepiva
English: Fainting, and sometime falling, can occur (mostly in young people) following, or even before, any injection with a needle.
Croatian: Nakon ili čak prije bilo koje injekcije iglom može doći do nesvjestice, a ponekad i pada (najčešće u mladih ljudi).
English: Dengvaxia is given by your doctor or nurse as an injection under the skin (subcutaneous injection) in the upper arm.
Croatian: Cjepivo Dengvaxia dat će Vam liječnik ili medicinska sestra injekcijom pod kožu (supkutanom injekcijom) na nadlaktici.
English: Partially used vials must be kept between 2°C and 8°C (in a refrigerator) and protected from light.
Croatian: Djelomično iskorištene bočice moraju se čuvati na temperaturi od 2°C - 8°C (u hladnjaku), zaštićene od svjetlosti.
English: 3.3 Long-term persistence of antibodies
Croatian: Dugoročna postojanost protutijela
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to injection with a needle.
Croatian: Nakon ili čak prije bilo kojeg cijepljenja može doći do sinkope (nesvjestice) kao psihogenog odgovora na injekciju iglom.
English: How to store Dengvaxia
Croatian: Kako čuvati cjepivo Dengvaxia
English: Previous dengue infection has to be assessed by laboratory confirmed history of dengue or through serotesting according to official recommendations.
Croatian: Neophodno je utvrditi prethodnu infekciju virusom denge temeljem laboratorijski potvrđene denge u povijesti bolesti ili serološkim testiranjem u skladu sa službenim preporukama.
English: Keep Dengvaxia out of the sight and reach of children.
Croatian: Kako čuvati cjepivo Dengvaxia Cjepivo Dengvaxia čuvajte izvan pogleda i dohvata djece.
English: In the absence of documented prior dengue virus infection, previous infection has to be confirmed by serotesting before vaccination.
Croatian: Ako prethodna infekcija virusom denge nije dokumentirana, neophodno ju je prije cijepljenja potvrditi serološkim testiranjem.
English: For some people who have not been infected by dengue before vaccination, there may be an increased risk of getting a more serious dengue illness requiring hospitalisation if they become bitten by a dengue-infected mosquito later.
Croatian: U nekih osoba koje prije cijepljenja nisu bile zaražene virusom denge može postojati povećan rizik od razvoja ozbiljnije denga bolesti koja zahtijeva bolničko liječenje ako ih kasnije ubode komarac zaražen virusom denge.
English: Overall, the same adverse reactions but at lower frequencies were observed in dengue seropositive subjects.
Croatian: Sveukupno su iste nuspojave opažene i u ispitanika seropozitivnih na virus denge, ali uz manju učestalost.
English: Individuals who have not been previously infected by dengue virus or for whom this information is unknown should not be vaccinated because an increased risk of hospitalisation for dengue and clinically severe dengue (predominantly grade 1 or 2 Dengue Hemorrhagic Fever) has been observed in these individuals during the long-term follow up of clinical trials (see Section 4.8).
Croatian: Osobe koje prethodno nisu bile zaražene virusom denge ili za koje taj podatak nije poznat Cjepivo se ne smije primijeniti u osoba koje prethodno nisu bile zaražene virusom denge ili za koje taj podatak nije poznat jer je u tih osoba tijekom dugoročnog praćenja u sklopu kliničkih ispitivanja opažen povećan rizik od hospitalizacije zbog denge i klinički težak oblik bolesti (najčešće denga hemoragijska groznica 1. ili 2. stupnja) (vidjeti dio 4.8).
English: Table 2: Adverse reactions from Clinical Studies and reported during commercial use in adults (18 to 45 years old)
Croatian: Tablica 2: Nuspojave opažene u kliničkim ispitivanjima i nuspojave prijavljene nakon stavljanja cjepiva na tržište u odraslih (18 - 45 godina) Klasifikacija organskih sustava
English: Of the 2930 subjects 9 to 16 years old in this subset (approximately 80%) who were dengue seropositive at baseline, 1974 subjects received the vaccine (901 subjects in CYD14 and 1073 in CYD15) and 956 subjects received placebo (444 in CYD14 and 512 in CYD15) (see also subsection 3).
Croatian: Od 2930 ispitanika u dobi od 9 do 16 godina u toj podskupini (približno 80%) koji su na početku ispitivanja bili seropozitivni na virus denge, 1974 ispitanika primila su cjepivo (901 u ispitivanju CYD14 i 1073 u ispitivanju CYD15), a njih 956 placebo (444 u ispitivanju CYD14 i 512 u ispitivanju CYD15) (vidjeti i odlomak 3).
English: Vaccine efficacy was demonstrated for these endpoints in CYD14 and CYD15 (see Table 4).
Croatian: Djelotvornost cjepiva za te mjere ishoda dokazana je u ispitivanjima CYD14 i CYD15 (vidjeti
English: After mixing (reconstitution) with the solvent provided, the product must be used within 6 hours if stored between 2°C and 8°C (i.e., in a refrigerator) and protected from light.
Croatian: Nakon miješanja (rekonstitucije) s priloženim otapalom, cjepivo se mora primijeniti unutar 6 sati ako se čuva na temperaturi od 2°C - 8°C (tj. u hladnjaku) i zaštićeno od svjetlosti.
English: • Immunisation should be carried out by subcutaneous (SC) injection preferably in the upper arm in the region of the deltoid.
Croatian: • Cjepivo treba primijeniti supkutanom (s.c.) injekcijom, najbolje u deltoidni mišić nadlaktice.
English: In subjects 9 years of age or older, it was estimated that during a 6 year follow-up about 5 additional hospitalized dengue cases or 3 additional severe dengue cases per 1000 vaccinees with no previous dengue infection could occur following vaccination.
Croatian: Procijenjeno je da bi tijekom 6 godina praćenja nakon cijepljenja u ispitanika u dobi od 9 ili više godina moglo doći do približno 5 dodatnih slučajeva hospitalizacije zbog denge ili 3 dodatna slučaja teškog oblika denge na 1000 cijepljenika koji prethodno nisu bili zaraženi virusom denge.
English: 1D
Croatian: 1 doza 1 D
English: Important information about the protection provided As with any vaccines, Dengvaxia may not protect everybody who has been vaccinated.
Croatian: Kao i sva cjepiva, Dengvaxia možda neće zaštititi sve cijepljene osobe.
English: After complete dissolution, a 0.5 mL dose of the reconstituted suspension is withdrawn into the same syringe.
Croatian: Nakon što se prašak potpuno otopi, u istu štrcaljku treba uvući dozu rekonstituirane suspenzije od 0,5 ml.
English: • 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 the following Tables the dengue serostatus at baseline (before the first injection), was defined as:
Croatian: U tablicama koje slijede, serološki status za virus denge na početku ispitivanja (prije prve injekcije)
English: CYD22: Vietnam; CYD28: Singapore; CYD47: India;
Croatian: CYD22: Vijetnam; CYD28: Singapur; CYD47: Indija Posredno zaključivanje o djelotvornosti temelji se na prethodno navedenim dostupnim podacima i sveukupnim rezultatima.
English: Dengvaxia is provided as a powder in a 5-dose vial and a solvent in a 5-dose vial (2.5 mL).
Croatian: Dengvaxia dolazi u obliku praška u 5-doznoj bočici i otapala u 5-doznoj bočici (2,5 ml).
English: Powder: essential amino acids including Phenylalanine, non-essential amino acids, Arginine hydrochloride, sucrose, Trehalose dihydrate, Sorbitol, trometamol, urea.
Croatian: Prašak: esencijalne aminokiseline, uključujući fenilalanin; neesencijalne aminokiseline, argininklorid, saharoza, trehaloza dihidrat, sorbitol, trometamol, urea.
English: CYD14 485 CYD15 1048
Croatian: CYD14 485
English: • Dengvaxia must not be administered by intravascular injection under any circumstances.
Croatian: • Dengvaxia se ni u kom slučaju ne smije primijeniti intravaskularnom injekcijom.
English: A new sterile syringe and needle should be used for withdrawal of each of the 5 doses.
Croatian: Za uvlačenje svake od 5 doza mora se upotrijebiti nova sterilna štrcaljka i igla.
English: Table 1: Adverse reactions from Clinical Studies and reported during commercial use in children (9 to 17 years old)
Croatian: Tablica 1: Nuspojave opažene u kliničkim ispitivanjima i nuspojave prijavljene nakon stavljanja cjepiva na tržište u djece (9 - 17 godina) Klasifikacija organskih sustava
English: 3.1 Immunogenicity data for subjects 9 to 17 years of age in endemic areas
Croatian: Podaci o imunogenosti za ispitanike u dobi od 9 do 17 godina u endemskim područjima
English: Preinjection 1 GMT (95%CI)
Croatian: GMT prije 1. injekcije (95% CI)
English: • Know you are allergic to the active substances or any of the other ingredients of Dengvaxia
Croatian: • ako znate da ste alergični na djelatnu tvar ili neki drugi sastojak cjepiva Dengvaxia (naveden u dijelu 6.)
English: 2.3 Clinical efficacy data for subjects 17 to 45 years of age in endemic areas
Croatian: 2.3 Podaci o kliničkoj djelotvornosti za ispitanike u dobi od 17 do 45 godina u endemskim područjima
English: Paediatric data in subjects 9 to 17 years of age
Croatian: Pedijatrijska populacija Podaci za djecu i adolescente u dobi od 9 do 17 godina
English: Dengvaxia is provided as a powder in a single-dose vial and a solvent in single-dose pre-filled syringe (0.5 mL) with 2 separate needles or with no needle.
Croatian: Dengvaxia dolazi u obliku praška u jednodoznoj bočici i otapala u jednodoznoj napunjenoj štrcaljki (0,5 ml) s 2 zasebne igle ili bez igala.
English: After complete dissolution, a 0.5 mL dose of the reconstituted suspension is withdrawn into a sterile syringe.
Croatian: Nakon što se prašak potpuno otopi, u sterilnu štrcaljku treba uvući dozu rekonstituirane suspenzije od 0,5 ml.
English: There is very limited experience on dengue virus excretion via breast milk.
Croatian: Podaci o izlučivanju virusa denge u majčino mlijeko vrlo su ograničeni.
English: Postinjection 3 GMT (95%CI)
Croatian: GMT nakon 3. injekcije (95% CI)
English: After mixing (reconstitution) with the solvent provided, the product should be used immediately.
Croatian: Nakon miješanja (rekonstitucije) s priloženim otapalom, cjepivo se mora primijeniti odmah.
English: NC: Not computed (the absence of cases in vaccine and control group does not permit to calculate VE nor CI) *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: NI: nije izračunato (djelotvornost cjepiva i CI ne mogu se izračunati zbog izostanka slučajeva u cijepljenoj i kontrolnoj skupini) *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: • hardening of skin at the injection site (injection site induration).
Croatian: • otvrdnuće kože na mjestu injiciranja
English: Immune system disorders Very rare
Croatian: Poremećaji probavnog sustava rijetko mučnina
English: The solvent (0.9% sodium chloride solution) is a limpid, colourless solution.
Croatian: Otapalo (otopina natrijeva klorida od 0,9%) je bistra, bezbojna otopina.
English: VE % (95%CI)
Croatian: (95% CI)
English: The solvent (0.4% sodium chloride solution) is a limpid, colourless solution.
Croatian: Otapalo (otopina natrijeva klorida od 0,4%) je bistra, bezbojna otopina.
English: Vaccine Efficacy against symptomatic, severe and hospitalized VCD during the 25-month period after the first injection due to any serotype (pooled CYD14+CYD23), was respectively 42.2% (95% CI: 30.6; 51.8), 45.1% (95% CI: 29.3; 76.7), 47.6% (95% CI: 23.7; 64.0).
Croatian: Djelotvornost cjepiva protiv simptomatskog VCD-a, teškog VCD-a i VCD-a koji je zahtijevao hospitalizaciju uzrokovanog bilo kojim serotipom tijekom 25-mjesečnog razdoblja nakon prve injekcije (objedinjeni podaci iz ispitivanja CYD14 i CYD23) iznosila je 42,2% (95% CI: 30,6; 51,8), 45,1% (95% CI: 29,3; 76,7) odnosno 47,6% (95% CI: 23,7; 64,0).
English: Dengvaxia must not be administered by intravascular injection under any circumstances.
Croatian: Dengvaxia se ni u kom slučaju ne smije primijeniti intravaskularnom injekcijom.
English: • Dengue seronegativity if the PRNT50 titre < the lower limit of quantification against any of the
Croatian: • ispitanik je bio seronegativan ako je PRNT50 titar bio ispod donje granice kvantifikacije za sva 4 serotipa
English: What Dengvaxia looks like and contents of the pack Dengvaxia is a powder and solvent for suspension for injection.
Croatian: Dengvaxia je prašak i otapalo za suspenziju za injekciju.
English: *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: *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: In this case, your doctor will not use Dengvaxia until 6 weeks, and preferably not for 3 months after you stop treatment.
Croatian: U tom će slučaju liječnik primijeniti cjepivo Dengvaxia tek 6 tjedana nakon prestanka liječenja, a po mogućnosti tek nakon 3 mjeseca.
English: Transfer the entire content of the solvent vial (with a dark gray flip-off cap) into the vial containing the powder (medium brown flip-off cap).
Croatian: Prenesite sav sadržaj bočice s otapalom (koja ima tamnosivi flip-off zatvarač) u bočicu s praškom (koja ima smeđi flip-off zatvarač).
English: You will not get Dengvaxia until you or your child have recovered.
Croatian: Dengvaxia se neće primijeniti dok se Vi ili
English: After reconstitution with the solvent provided, Dengvaxia should be used immediately.
Croatian: 3 godine Nakon rekonstitucije s priloženim otapalom, cjepivo Dengvaxia treba primijeniti odmah.
English: Table 7: Immunogenicity for dengue seropositive subjects 18 to 45 years of age from endemic areas
Croatian: Tablica 7: Imunogenost kod ispitanika iz endemskih područja u dobi od 18 do 45 godina koji su bili seropozitivni na virus denge
English: 4.7 Effects on ability to drive and use machines Dengvaxia has minor influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima