natgillin/translations-raw huggingface dataset:
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. 
Takšnega večjega tveganja pa niso opazili pri osebah, predhodno okuženih z dengo: pri teh ocenjujejo, da bi bilo mogoče med 6-letnim spremljanjem po prvi injekciji preprečiti 16 sprejemov v bolnišnico zaradi denge ali 4 hude primere denge na 1.000 cepljenih oseb, predhodno okuženih z dengo.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja o uporabi tega cepiva, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Danmark Sanofi A/S Tel: +45 4516 7000 
Danmark sanofi-aventis Denmark A/S Tel: +45 4516 7000
What you need to know before you or your child use Dengvaxia 
Kaj morate vedeti, preden boste vi ali vaš otrok uporabili cepivo Dengvaxia
Postinjection 3 GMT (95%CI) 
GMT po 3. injekciji (95 % IZ)
• If you or your child get any side effects, talk to your doctor, pharmacist or nurse. 
• Če vi ali vaš otrok opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Adverse reactions collected within 28 days after any injection during clinical studies from 9 to 45 years of age, on a reactogenicity subset of 1306 adults and 3067 children, and adverse reactions observed during commercial use are presented in Table 1 for children 9 to 17 years old and in Table 2 for adults 18 to 45 years old. 
Neželeni učinki, zabeleženi v 28 dneh po kateri koli injekciji v kliničnih študijah pri preiskovancih od 9. do 45. leta starosti (na podlagi podskupine za reaktogenost, ki je obsegala 1.306 odraslih in 3.067 otrok) ter neželeni učinki, opaženi po prihodu cepiva na trg, so prikazani v preglednici 1 za otroke od 9. do 17. leta in v preglednici 2 za odrasle od 18. do 45. leta starosti.
• muscle pain (myalgia) 
• bolečine v mišici (mialgija)
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). 
Učinkovitost cepiva proti simptomatskim primerom VPD v 12-mesečnem obdobju od 28 dni po tretji injekciji zaradi katerega koli od 4 serotipov je bila 40,5 % (95 % IZ: 22,7; 54,2) (skupaj CYD14 + CYD23).
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC (PROIZVAJALCI)BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
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). 
Od 2930 preiskovancev, starih od 9 do 16 let, v tej podskupini (približno 80 %), ki so bili izhodiščno seropozitivni za dengo, je 1.974 oseb prejelo cepivo (901 oseba v CYD14 in 1.073 v CYD15) in 956 oseb je prejelo placebo (444 v CYD14 in 512 v CYD15) (glejte tudi podpoglavje 3).
o That healthcare professionals have to document before vaccination the previous dengue infection, which has to be assessed by laboratory confirmed history of dengue or through serotesting; 
o zdravstveni delavci morajo pred cepljenjem dokumentirati predhodno okužbo z dengo, ki mora biti ugotovljena z laboratorijsko potrjeno anamnezo denge ali s serološkim testiranjem,
2.3 Clinical efficacy data for subjects 17 to 45 years of age in endemic areas 
2.3 Klinični podatki o učinkovitosti za osebe v starosti od 17 do 45 let na endemičnih območjih
Dengue disease results in symptoms including fever, headache, pain behind the eyes, muscle and joint pain, feeling sick (nausea), being sick (vomiting), swollen glands or skin rash. 
Bolezen povzroči simptome, med katerimi so zvišana telesna temperatura, glavobol, bolečine za očmi, bolečine v mišicah in sklepih, siljenje na bruhanje, bruhanje, otekle bezgavke in izpuščaj na koži.
Dengvaxia must be reconstituted prior to administration. 
Cepivo Dengvaxia je treba pred uporabo rekonstituirati.
Blood and lymphatic tissue disorders 
Bolezni krvi in limfatičnega sistema
Preinjection 1 GMT (95%CI) 
GMT pred 1. injekcijo (95 % IZ)
Reconstitution and handling of single-dose presentation 
Rekonstitucija in ravnanje z enoodmernim pakiranjem
Do not use Dengvaxia after the expiry date that is stated on the carton after EXP. 
Cepiva Dengvaxia ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti cepiva se izteče na zadnji dan navedenega meseca.
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. 
NI: ni izračunano (odsotnost primerov v cepljeni in kontrolni skupini ne omogoča niti izračuna UC niti IZ) *Združene (kumulativne) rezultate študij CYD14, CYD15 in CYD23 je treba tolmačiti previdno, ker so med CYD14/15 in CYD23 obstajale razlike v potrditvenem testu za dengo in v opredelitvi akutne febrilne bolezni.
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. 
Pediatrični podatki pri preiskovancih do 9. leta starosti, tj. zunaj starostne indikacije Podskupina za reaktogenost pri preiskovancih do 9. leta starosti je zajela 2.960 oseb: 1.287 mlajših od 2 let, 905 starih od 2 do 5 let in 768 starih od 6 do 8 let.
If you or your child have never been infected by dengue virus before vaccination, you may have an increased risk of a more serious dengue illness that may lead to hospitalisation if you are later bitten by a dengue-infected mosquito. 
Če vi ali vaš otrok pred cepljenjem niste bili nikoli okuženi z virusom denge, obstaja večja možnost, da boste zboleli za resnejšo obliko denge (in boste morda potrebovali zdravljenje v bolnišnici), če vas bo kdaj v prihodnje pičil z dengo okužen komar.
PHARMACEUTICAL FORM AND CONTENTS Powder (5 doses) in vial + 2.5 mL of solvent in vial Pack size of 5. 
FARMACEVTSKA OBLIKA IN VSEBINA Prašek (5 odmerkov) v viali + 2,5 ml vehikla v viali Velikost pakiranja po 5.
Individuals who have not been previously infected by dengue virus or for whom this information is unknown 
Osebe, ki predhodno niso bile okužene z virusom denge, ali pri katerih ni podatka o takšni okužbi Oseb, ki predhodno niso bile okužene z virusom denge, ali pri katerih podatka o takšni okužbi ni, se ne sme cepiti.
Immunisation should be carried out by subcutaneous (SC) injection preferably in the upper arm in the region of deltoid. 
Imunizacijo je treba opraviti s subkutanim (s.c.) injiciranjem, po možnosti v nadlaket v predelu deltoidne mišice.
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). 
Učinkovitost pri osebah, starih 9 let ali več so ocenili pri 17.230 prejemnikih cepiva Dengvaxia (3.316 oseb v CYD14 in 13.914 v CYD15) in 8.596 prejemnikih placeba (1.656 v CYD14 in 6.940 v CYD15).
Upper respiratory tract infection 
Okužba zgornjih dihal
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. 
Pri nekaterih ljudeh, ki pred cepljenjem niso bili okuženi z virusom denge, se lahko poveča možnost, da zbolijo za resnejšo obliko denge, zaradi katere je potreben sprejem v bolnišnico, če jih kdaj v prihodnje piči z dengo okužen komar.
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. 
Analize učinkovitosti raziskovanega cepiva glede na serološko stanje v zvezi z dengo, merjeno s testom PRNT50 (test nevtralizacije redukcije plaka) ob izhodišču (pred prvo injekcijo), so opravili v podskupini za imunogenost, ki je v CYD14 in CYD15 obsegala v vsaki po 2.000 preiskovancev in v CYD23 300 preiskovancev.
5D 
5 O
• 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). 
• Po rekonstituciji en odmerek (0,5 ml) vsebuje 4,5-6,0 log10 CCID50* vsakega serotipa himernega virusa rumene mrzlice denge** (1, 2, 3 in 4) (živ, oslabljen).
SANOFI PASTEUR NVL 31-33 Quai Armand Barbès 69250 Neuville-sur-Saône France 
SANOFI PASTEUR NVL 31-33 Quai Armand Barbès 69250 Neuville-sur-Saône Francija
The solvent (0.4% sodium chloride solution) is a limpid, colourless solution. 
Vehikel (0,4 % raztopina natrijevega klorida) je bistra, brezbarvna raztopina.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 Dose - 0.5 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek - 0,5 ml
Do not use Dengvaxia if you or your child 
Ne uporabljajte cepiva Dengvaxia, če za vas ali vašega otroka velja kaj od naslednjega
• injection site reactions: redness (erythema), bruising (haematoma), swelling, and itching 
• reakcije na mestu injiciranja: pordelost (eritem), podplutba (hematom), oteklost in srbenje
The solvent (0.9% sodium chloride solution) is a limpid, colourless solution. 
Vehikel (0,9 % raztopina natrijevega klorida) je bistra, brezbarvna raztopina.
After reconstitution with the solvent provided, Dengvaxia should be used immediately. 
Po rekonstituciji s priloženim vehiklom je treba cepivo Dengvaxia uporabiti takoj.
• Know you are allergic to the active substances or any of the other ingredients of Dengvaxia 
• Veste, da ste alergični na učinkovine ali katero koli sestavino cepiva Dengvaxia (navedene v poglavju 6).
An association between levels of post-injection 3 geometric mean titres (GMTs) and the probability of the disease has been demonstrated in efficacy studies. 
Študije učinkovitosti so dokazale povezanost med ravnjo geometrične sredine titrov (geometirc mean titer - GMT) po 3. injekciji in verjetnostjo bolezni.
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). 
Prenesite celotno vsebino viale z vehiklom (ki ima temnosivo snemno zaporko) v vialo, ki vsebuje prašek (in ima srednjerjavo snemno zaporko).
After mixing (reconstitution) with the solvent provided, the product should be used immediately. 
Po pripravi (rekonstituciji) s priloženim vehiklom je treba cepivo uporabiti v takoj.
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). 
Učinkovitost cepiva proti simptomatskim, hudim in hospitaliziranim primerom VPD v 25-mesečnem obdobju po prvi injekciji zaradi katerega koli serotipa (skupaj CYD14 + CYD23) je bila 42,2 % (95 % IZ: 30,6; 51,8), 45,1 (95 % IZ: 29,3; 76,7), 47,6 % (95 % IZ: 23,7; 64,0).
Use a sterile syringe and needle for the transfer of the solvent. 
Za prenos vehikla uporabite sterilno brizgo in iglo.
o The healthcare professionals should be aware that the test they use should have adequate performance in terms of specificity and cross-reactivity based on the local disease epidemiology. 
o zdravstveni delavci se morajo zavedati, da je treba uporabljati le teste, ki so na podlagi lokalne epidemiologije bolezni ustrezni glede specifičnosti in navzkrižne reaktivnosti,
Partially used vials must be kept between 2°C and 8°C (in a refrigerator) and protected from light. 
Delno uporabljene viale je treba shranjevati na temperaturi od 2 do 8 °C (v hladilniku) in zaščitene pred svetlobo.
3.1 Immunogenicity data for subjects 9 to 17 years of age in endemic areas 
Podatki o imunogenosti pri osebah v starosti od 9 do 17 let na endemičnih območjih
Pack size of 5 
Velikost pakiranja po 5
In paediatric population, fever has been observed with a higher frequency (very common) than in adults (common). 
Pediatrični podatki pri preiskovancih v starosti od 9 do 17 let V pediatrični populaciji je bila pogostnost zvišane telesne temperature večja (zelo pogosto) kot pri odraslih (pogosto).
• Dengvaxia must not be administered by intravascular injection under any circumstances. 
• Cepiva Dengvaxia se ne sme v nobenem primeru injicirati intravaskularno.
After reconstitution, Dengvaxia is a clear, colourless liquid with the possible presence of white to translucent particles (of endogenous nature). 
Po rekonstituciji je cepivo Dengvaxia bistra, brezbarvna tekočina, ki lahko vsebuje bele ali prosojne delce (endogenega izvora).
Dengvaxia is given by your doctor or nurse as an injection under the skin (subcutaneous injection) in the upper arm. 
Cepivo Dengvaxia vam bo injiciral zdravnik ali medicinska sestra s podkožno (subkutano) injekcijo v nadlaket.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 Doses - 2.5 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 5 odmerkov - 2,5 mL
Infections and infestations Rare 
Infekcijske in parazitske bolezni
• swollen glands (lymphadenopathy) 
• otekle bezgavke (limfadenopatija)
Uncommon: ≥ 1/1000 to < 1/100 Rare: ≥ 1/10 000 to < 1/1000 
Občasni: ≥ 1/1.000 do < 1/100
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
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. 
Pri otrocih od 2. do 8. leta, predhodno neokuženih z dengo, je dolgoročno spremljanje varnosti pokazalo večje tveganje za sprejem v bolnišnico zaradi denge, vključno s klinično hudo obliko denge, pri cepljenih osebah v primerjavi z necepljenimi.
NaCl (0.4%) 
UC (%)
Table 6: Immunogenicity for dengue seropositive subjects 9 to 16 years of age in CYD14 and CYD15 from endemic areas 
Preglednica 6: Imunogenost pri preiskovancih z endemičnih območij, starih od 9 do 16 let, v študijah CYD14 in CYD15
You must continue to protect yourself against mosquito bites even after vaccination. 
Tudi po cepljenju morate še naprej skrbeti za zaščito pred piki komarjev.
After reconstitution with the solvent provided, Dengvaxia is a clear, colourless liquid with the possible presence of white to translucent particles. 
Po rekonstituciji s priloženim vehiklom je cepivo Dengvaxia bistra, brezbarvna tekočina, ki lahko vsebuje bele ali prosojne delce.
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. 
Po pripravi (rekonstituciji) s priloženim vehiklom je treba cepivo uporabiti v 6 urah, če je shranjeno na temperaturi od 2 do 8 °C (tj. v hladilniku) in zaščiteno pred svetlobo.
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. 
Cepivo Dengvaxia je na voljo kot viala z enim odmerkom in vehikel v napolnjeni injekcijski brizgi z enim odmerkom (0,5 ml) z dvema ločenima iglama ali brez igle.
Store in a refrigerator (2°C to 8°C). 
Shranjujte v hladilniku (2 C do 8 C).
The post dose 3 GMTs in subjects 9 to 16 years of age in CYD14 and CYD15 are shown in the Table 
GMT po 3. odmerku pri osebah v starosti od 9 do 16 let v študijah CYD14 in CYD15 so prikazani v preglednici 6.
• injection site pain 
• bolečina na mestu injiciranja
Important information about the protection provided As with any vaccines, Dengvaxia may not protect everybody who has been vaccinated. 
Tako kot za vsa cepiva tudi za cepivo Dengvaxia velja, da ne zaščiti nujno vsake cepljene osebe.
MARKETING AUTHORISATION HOLDER 
Imetnik dovoljenja za promet:
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). 
Ocenjena učinkovitost cepiva (UC) proti simptomatski VPD med 25-mesečnim obdobjem po prvi injekciji pri osebah, izhodiščno seropozitivnih za dengo, starih od 9 do 16 let, in v podskupini za imunogenost za CYD14, CYD15 in CYD23 (kumulativno), znaša 81,9 % (95 % IZ: 67,2; 90,0).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Dengvaxia - Powder (5 doses) in vial + 2.5 mL of solvent in vial. 
PODATKI NA ZUNANJI OVOJNINI Cepivo Dengvaxia - prašek (5 odmerkov) v viali + 2,5 ml vehikla v viali.
Partially used multidose vials must be kept between 2°C and 8°C (i.e., in a refrigerator) and protected from light. 
Delno uporabljene viale z več odmerki je treba shranjevati na temperaturi od 2 do 8 °C (tj. v hladilniku) in zaščitene pred svetlobo.
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. 
Vendar je bila ocenjena ekstrapolirana učinkovitost cepiva (1 - razmerje ogroženosti) na podlagi eksplorativne analize (združene študije CYD14 + CYD15 + CYD23) med 25-mesečnim obdobjem po prvi injekciji 89,2 % (95 % IZ: 78,5; 94,6) za hospitalizirane primere VPD in 95,3 % (95 % IZ: 68,9; 99,3) za hude primere VPD.
3.2 Immunogenicity data for subjects 18 to 45 years of age in endemic areas 
Podatki o imunogenosti pri osebah v starosti od 18 do 45 let na endemičnih območjih
PHARMACEUTICAL FORM AND CONTENTS Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe with 2 separate needles Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe Pack size of 1 or 10 
FARMACEVTSKA OBLIKA IN VSEBINA Prašek (1 odmerek) in viali + 0,5 ml vehikla v napolnjeni injekcijski brizgi z dvema ločenima iglama Prašek (1 odmerek) in viali + 0,5 ml vehikla v napolnjeni injekcijski brizgi
CYD14 485 CYD15 1048 
CYD14 485 167
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. 
UC je izračunana glede na pogostost incidence (primerov na 100 oseb - izpostavljenost v letih) * Združene (kumulativne) rezultate študij CYD14, CYD15 in CYD23 je treba tolmačiti previdno, ker so med CYD14/15 in CYD23 obstajale razlike v potrditvenem testu za dengo in v opredelitvi akutne febrilne bolezni.
Dengvaxia is provided as a powder in a 5-dose vial and a solvent in a 5-dose vial (2.5 mL). 
Cepivo Dengvaxia je na voljo kot prašek v viali s 5 odmerki in vehikel v viali s 5 odmerki (2,5 ml).
*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. 
*Združene (kumulativne) rezultate študij CYD14, CYD15 in CYD23 je treba tolmačiti previdno, ker so med CYD14/15 in CYD23 obstajale razlike v potrditvenem testu za dengo in v opredelitvi akutne febrilne bolezni.
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). 
Po rekonstituciji vsebuje en odmerek (0,5 ml) 4,5-6,0 log10 CCID50 vsakega serotipa himernega virusa rumene mrzlice denge (1, 2, 3 in 4) (živo, oslabljeno).
What Dengvaxia looks like and contents of the pack Dengvaxia is a powder and solvent for suspension for injection. 
Cepivo Dengvaxia je prašek in vehikel za suspenzijo za injiciranje.
What is dengue and dengue disease? 
Kaj je vročica denga?
Oropharyngeal pain Cough 
Orofaringealna bolečina Kašelj
What Dengvaxia contains 
Kaj vsebuje cepivo Dengvaxia
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 Dose 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek
Dengvaxia must not be administered by intravascular injection under any circumstances. 
Cepiva Dengvaxia se ne sme v nobenem primeru injicirati intravaskularno.
VE % (95%CI) 
UC (%) (95 % IZ)
2.2 Clinical efficacy data for subjects 9 to 16 years of age in endemic areas, dengue seropositive at baseline 
2.2 Podatki o klinični učinkovitosti pri preiskovancih, starih od 9 do 16 let na endemičnih območjih, ki so bili izhodiščno seropozitivni za dengo
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. 
Pri osebah v starosti od 9 do 16 let, izhodiščno seropozitivnih za dengo (podskupina za imunogenost), so med 25-mesečnih obdobjem po prvi injekciji v vsaki posamezni študiji (CYD14 in CYD15) zabeležili en klinično hud primer VPD in en primer VPD po SZO HMD v kontrolni skupini; v cepljeni skupini takšnih primerov niso zabeležili.
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. 
V treh študijah učinkovitosti so v eksplorativni analizi dolgoročnega spremljanja po prvi injekciji pri cepljenih osebah, ki predhodno niso bile okužene z dengo, opažali večje tveganje za sprejem v bolnišnico zaradi denge, vključno s klinično hudo obliko denge (pretežno hemoragična vročica denga 1. ali 2. stopnje [SZO 1997]).
In vaccinees 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. 
Dolgoročno spremljanje varnosti je pri cepljenih otrocih, starih od 2 do 8 let, ki predhodno niso bili okuženi z dengo, pokazalo večje tveganje za obliko denge, ki zahteva sprejem v bolnišnico, vključno s klinično hudo obliko denge.
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. 
Med 6-letnim obdobjem po prvi injekciji je bila ocenjena ekstrapolirana učinkovitost cepiva (1razmerje ogroženosti)*100 (na podlagi eksplorativne analize) pri osebah, starih 9 let ali več in predhodno okuženih z dengo, 80 (95 % IZ: 69; 87) za hospitalizirane primere VPD in 84 (95 % IZ: 61; 94) za hude primere VPD.
Reconstitute Dengvaxia with the solvent provided. 
Cepivo Dengvaxia rekonstituirajte s priloženim vehiklom.
Powder and solvent for suspension for injection Prior to reconstitution, the vaccine is a white, homogenous, freeze-dried powder with possible retraction at the base (ring-shaped cake possible). 
Pred rekonstitucijo je cepivo bel, homogen, liofiliziran prašek z možnim sprimkom na spodnji strani (lahko v obliki obročaste pogače).
Uncommon: (may affect up to 1 in 100 people) 
Občasni: (pojavijo se lahko pri največ 1 od 100 oseb)
• injection site warmth 
• toplota na mestu injiciranja