natgillin/translations-raw huggingface dataset:
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). 
Cepivo Dengvaxia je indicirano za preprečevanje vročice denga, ki jo povzroča virus denge serotipov 1, 2, 3 in 4, pri osebah od 9. do 45. leta starosti s predhodno okužbo z virusom denge in ki živijo na endemičnih območjih (glejte poglavja 4.2, 4.4 in 4.8).
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). 
Imunogenost končne oblike cepiva CYD proti dengi so pri odraslih v starosti od 18 do 45 let na endemičnih območjih ocenili v 3 študijah, ki so bile vse izvedene na azijsko-pacifiškem območju (CYD22 v Vietnamu, CYD28 v Singapurju in CYD47 v Indiji).
It is important that you or your child follow the instructions of your doctor, pharmacist or nurse regarding follow-up injection. 
Pomembno je, da vi ali vaš otrok glede nadaljnjih injekcij upoštevate navodila zdravnika, farmacevta ali medicinske sestre.
Before the administration of Dengvaxia, your doctor, pharmacist or nurse will check if you or your child have ever been infected by dengue virus, and will tell you if a serotesting has to be performed. 
Preden dobite cepivo Dengvaxia, bodo zdravnik, farmacevt ali medicinska sesta preverili, če ste bili vi ali vaš otrok že kdaj okuženi z virusom denge in vas opozorili, če bo potrebno serološko testiranje.
Animal studies did not indicate any direct or indirect harmful effects with respect to lactation. 
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih učinkov glede dojenja.
To avoid vaccination of false positives, only test methods with adequate performance in terms of specificity and cross-reactivity based on the local disease epidemiology should be used. 
Da cepljenja ne bi izvajali na podlagi lažno pozitivnih izvidov, je treba uporabljati le metode testiranja, ki so glede specifičnosti in navzkrižne reaktivnosti ustrezne ob upoštevanju lokalne epidemiologije bolezni.
For patients receiving treatment with immunoglobulins or blood products containing immunoglobulins, such as blood or plasma, it is recommended to wait for at least 6 weeks, and preferably for 3 months, following the end of treatment before administering Dengvaxia, in order to avoid neutralization of the attenuated viruses contained in the vaccine. 
Pri bolnikih, ki prejemajo zdravljenje z imunoglobulini ali izdelke iz krvi z imunoglobulini (npr. kri ali plazmo), je priporočljivo z uporabo cepiva Dengvaxia počakati minimalno 6 tednov oziroma bolj priporočljivo 3 mesece po koncu takšnega zdravljenja, da bi preprečili nevtralizacijo oslabljenih virusov v cepivu.
Table 1: Adverse reactions from Clinical Studies and reported during commercial use in children (9 to 17 years old) 
Preglednica 1: Neželeni učinki, zabeleženi v kliničnih študijah in med komercialno uporabo pri otrocih (9 do 17 let)
Non-clinical safety data revealed no special risks for humans based on a repeated-dose toxicity including assessment of local tolerance, and a developmental and reproductive toxicology program. 
Predklinični podatki o varnosti na osnovi študij toksičnosti pri ponavljajočih se odmerkih, vključno z oceno lokalne tolerance, ter toksičnih učinkov na razvoj in reprodukcijo ne kažejo posebnega tveganja za človeka.
If there is anything you do not understand, ask your doctor, pharmacist or nurse to explain. 
Če česa ne razumete, prosite zdravnika, farmacevta ali medicinsko sestro za pojasnilo.
Hospitalised and/or clinically severe dengue fever in long-term safety follow-up data 
c. Sprejemi v bolnišnico in/ali klinično huda vročica denga med dolgoročnim spremljanjem
To make sure that Dengvaxia is suitable for you or your child, it is important to tell your doctor, pharmacist or nurse if any of the points below apply to you or your child. 
Da se boste prepričali, ali je cepivo Dengvaxia primerno za vas ali vašega otroka, morate zdravniku, farmacevtu ali medicinski sestri povedati, če za vas ali vašega otroka velja kaj od spodaj naštetega.
It is recommended to continue personal protection measures against mosquito bites after vaccination. 
Tudi po cepljenju so še naprej priporočljivi osebni zaščitni ukrepi proti pikom komarjev.
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). 
Na začetku preskušanj CYD14 in CYD15 je seroprevalenca za celotno populacijo na mestih preskušanja znašala od 52,8 do 81,1 % v CYD14 (Azija-Pacifik) in od 55,7 do 92,7 % v CYD15 (Latinska Amerika).
What Dengvaxia is and what it is used for 
Kaj je cepivo Dengvaxia in za kaj ga uporabljamo
Dengvaxia is available in packs of 5 (vaccine and solvent vials provided in the same box). 
Cepivo Dengvaxia je na voljo v pakiranjih po 5 (viale s cepivom in vehiklom v isti škatli).
For injection, the syringe should be fitted with a new sterile needle. 
Za injiciranje je treba na brizgo namestiti novo sterilno iglo.
Dengvaxia should not be used in the context of dengue outbreak (sudden occurrence of disease) in non-endemic regions. 
Cepiva Dengvaxia se ne sme uporabljati v primeru izbruha denge (nenadnega pojava bolezni) na neendemičnih območjih.
Dengvaxia is a live attenuated vaccine, therefore Dengvaxia is contraindicated during pregnancy (see section 4.3). 
Cepivo Dengvaxia je živo, oslabljeno cepivo, zato je med nosečnostjo kontraindicirano (glejte poglavje 4.3).
Pharmacotherapeutic group: Vaccines, Viral vaccines, ATC code: J07BX/ Not Yet assigned 
oznaka ATC: J07BX/ še ni bila dodeljena
Table 2: Adverse reactions from Clinical Studies and reported during commercial use in adults (18 to 45 years old) 
Preglednica 2: Neželeni učinki, zabeleženi v kliničnih študijah in med komercialno uporabo pri odraslih (18 do 45 let)
• infections of the nose or throat (upper respiratory tract) 
• okužbe nosu ali žrela (okužbe zgornjih dihal)
For the primary endpoint, the incidence of symptomatic VCD cases occurring during the 12-month period from 28 days after the third injection was compared to the Control Group. 
Za primarni opazovani dogodek so pojavnost simptomatskih primerov VPD v 12-mesečnem obdobju od 28 dni po tretji injekciji primerjali s kontrolno skupino.
Fainting, and sometime falling, can occur (mostly in young people) following, or even before, any injection with a needle. 
Po injiciranju z iglo, včasih pa že pred tem, se lahko (večinoma pri mladih ljudeh) pojavi omedlevica, včasih s padcem.
N=4972 N=20854 
N = 4.972 N = 20.854 N = 25.826 N = 1.554
Reconstitution and handling of multidose presentation 
Rekonstitucija in ravnanje z opremo z več odmerki
• are taking a medicine that affects the immune system (such as high-dose corticosteroids or chemotherapy). 
• Jemljete zdravila, ki vplivajo na imunski sistem (na primer kemoterapije ali veliki odmerki kortikosteroidov).
Any unused product or waste material should be disposed of in accordance with local regulations. 
Vse neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
A protective immune response with Dengvaxia may not be elicited in all vaccinees. 
Zaščitni imunski odziv po uporabi cepiva Dengvaxia ni nujno dosežen pri vseh cepljenih osebah.
During clinical development, neutralizing antibody titres for each serotype were measured with the plaque reduction neutralization test (PRNT) and presented as geometric mean titres (GMTs). 
Med kliničnim razvojem so titre nevtralizirajočih protiteles za vsak serotip merili s testom PRNT (test nevtralizacije redukcije plaka) in jih prikazali kot geometirčne sredine titrov (GMT).
Four hospitalized VCD cases in CYD14 and two hospitalized VCD cases in CYD15 were reported in the control group versus none in the vaccine group. 
V kontrolni skupini so zabeležili štiri hospitalizirane primere VPD v CYD14 in dva hospitalizirana primera VPD v CYD15, v cepljeni skupini pa nobenega takšnega primera.
• Dengue seronegativity if the PRNT50 titre < the lower limit of quantification against any of the 
• Seronegativnost za dengo, če je bil titer PRNT50 < od spodnje meje kvantifikacije proti vsem 4
Solvent: sodium chloride (0.4%), water for injections. 
Vehikel: natrijev klorid (0,4 %), voda za injekcije.
The GMTs post-dose 3 in subjects 18 to 45 years of age are shown in the Table 7 
GMT po 3. odmerku pri osebah v starosti od 18 do 45 let so prikazani v preglednici 7.
In subjects below 2 years of age, the most frequently reported adverse reactions following any injection of Dengvaxia were fever, irritability, appetite lost, abnormal crying and injection site tenderness. 
Pri preiskovancih do 2. leta starosti so bili najpogosteje zabeleženi neželeni učinki po kateri koli injekciji cepiva Dengvaxia zvišana telesna temperatura, razdražljivost, izguba apetita, nenormalen jok in občutljivosti na mestu injiciranja.
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** 
Himerni virus rumene mrzlice denga - serotip 1 (živ, oslabljen)*........4,5-6,0 log10 CCID50/odmerek** Himerni virus rumene mrzlice denga - serotip 2 (živ, oslabljen)*.........4,5-6,0 log10 CCID50/odmerek** Himerni virus rumene mrzlice denga - serotip 3 (živ, oslabljen)*.........4,5-6,0 log10 CCID50/odmerek** Himerni virus rumene mrzlice denga - serotip 4 (živ, oslabljen)*.........4,5-6,0 log10 CCID50/odmerek**
• 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. 
• Druge sestavine so: esencialne aminokisline, vključno s fenilalaninom, neesencialne aminokisline, argininijev klorid, saharoza, trehaloza dihidrat, sorbitol (E420), trometamol, sečnina, natrijev klorid, voda za injekcije.
Sanofi-aventis AEBE Τηλ.+30 210 900 16 00 
Ελλάδα anofi-aventis AEBE Τηλ.+30 210 900 16 00
The solvent is a limpid, colourless solution. 
Vehikel je bistra, brezbarvna raztopina.
Solvent: sodium chloride (0.9%), water for injections. 
Vehikel: natrijev klorid (0,9 %), voda za injekcije.
In the Phase IIb study, a total of 4002 subjects aged 4 to 11 years were randomised to receive Dengvaxia or a control, regardless of previous dengue infection. 
V študiji faze IIb so skupno 4.002 oseb (v starosti od 4 do 11 let) randomizirali na prejemanje cepiva Dengvaxia ali kontrolnega pripravka, ne glede na predhodno okužbo z dengo.
2.4 Other paediatric data from efficacy studies in subjects 2 through 8 years of age, i.e., outside the age indication 
2.4 Drugi pediatrični podatki iz študij učinkovitosti pri preiskovancih od 2. do 8. leta starosti, tj. starostna skupina, za katero cepivo ni indicirano
In subjects 2 to 8 years of age, as compared to subjects above 9 years of age, injection site erythema and swelling were more frequently reported (frequency: very common), and additional adverse events were reported (frequency: uncommon): injection site haemorrhage, decreased appetite and vomiting. 
Pri otrocih od 2. do 8. leta so v primerjavi z otroki od 9. leta starosti pogosteje opažali eritem in oteklino ne mestu injiciranja (pogostnost: zelo pogosto), zabeležili pa so tudi dodatne neželene učinke (pogostnost: pogosti): krvavitev na mestu injiciranja, zmanjšanje apetita in bruhanje.
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. 
V obdobju 6 let se je pri osebah, ki predhodno niso bile okužene z dengo, tveganje za hudo dengo povečalo za 2,41-krat (95-odstotni IZ: 0,50; 11,75) pri osebah, starih od 9 do 16 let, cepljenih z cepivom Dengvaxia, v primerjavi z necepljenimi osebami v isti starostni skupini.
Animal studies did not indicate any harmful effects with respect to female fertility (see section 5.3). 
Študije na živalih niso pokazale škodljivih učinkov na plodnost samic (glejte poglavje 5.3).
In subjects 9 to 45 years of age, the most frequently reported reactions whatever the dengue serostatus prior to vaccination, were headache (54%), injection site pain (49%), malaise (44%), myalgia (43%), asthenia (34%), and fever (16%). 
Pri preiskovancih v starosti od 9 do 45 let so bili najpogosteje opisani neželeni učinki (ne glede na serološko stanje v zvezi z dengo pred cepljenjem) glavobol (54 %), bolečina na mestu injiciranja (49 %), splošno slabo počutje (44 %), mialgija (43 %), astenija (34 %) in zvišana telesna temperatura
After reconstitution with the solvent provided, Dengvaxia must be used within 6 hours. 
Po rekonstituciji s priloženim vehiklom je treba cepivo Dengvaxia uporabiti v 6 urah.
Appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following administration of the vaccine. 
Vedno morata biti na voljo ustrezna medicinska oskrba in osebje za nadzor za primer, da se po dajanju cepiva pojavi anafilaktična reakcija.
These data are inconclusive due to the low number of cases in the immunogenicity subset. 
Zaradi majhnega števila primerov v podskupini za imunogenost ti podatki ne dopuščajo sklepanja.
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. 
Huda oblika denge lahko povzroči močno zvišano telesno temperaturo in katerokoli od naslednjih težav: hude bolečine v trebuhu, stalno bruhanje, hitro dihanje, hudo krvavitev, krvavitev v želodcu, krvavitev iz dlesni, utrujenost, nemir, komo, napade krčev (podobne epileptičnim) in odpoved organov.
• Dengvaxia must not be mixed with other medicinal products in the same syringe. 
• Cepiva Dengvaxia se ne sme mešati z drugimi zdravili ali cepivi v isti brizgi.
There is very limited experience on dengue virus excretion via breast milk. 
Izkušenj z izločanjem virusa denge v materinem mleku je zelo malo.
• swelling of the face or throat 
• oteklost obraza ali žrela
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) 
Dodatni neželeni učinki pri otrocih in mladostnikih (od 9. do vključno 17. leta starosti):
Store in the outer carton in order to protect from light. 
Shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
After complete dissolution, a 0.5 mL dose of the reconstituted suspension is withdrawn into a sterile syringe. 
Potem, ko je povsem raztopljeno, je treba 0,5-ml odmerek rekonstituirane suspenzije potegniti v sterilno brizgo.
Your doctor will not use Dengvaxia until 4 weeks after you stop treatment. 
Zdravnik ne bo uporabil cepiva Dengvaxia prej kot 4 tedne po koncu takšnega zdravljenja.
Sanofi Pasteur Parc Industriel d'Incarville 27100 Val de Reuil France 
Sanofi Pasteur Parc Industriel d'Incarville 27100 Val de Reuil Francija
Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov proizvajalca (proizvajalcev) odgovornega (odgovornih) za sproščanje serij
Efficacy in subjects 2 to 8 years of age was assessed in 2443 subjects (1634 in vaccine group and 809 in control group) in phase IIb study and in 5300 subjects (3532 subjects in vaccine group and 1768 in control group) in the pivotal Phase III study (CYD14). 
Učinkovitost v starostni skupini od 2 do 8 let so ocenili pri 2.443 otrocih (1.634 v cepljeni skupini in 809 v kontrolni skupini) v študiji faze IIb ter pri 5.300 otrocih (3.532 v cepljeni skupini in 1.768 v kontrolni skupini) v ključni študiji III. faze (CYD14).
The powder is a white, homogenous, freeze-dried powder with possible retraction at the base (ringshaped cake possible). 
Prašek je bel, homogen, liofiliziran prašek z možnim sprimkom na spodnji strani (lahko v obliki obročaste pogače).
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). 
Pred cepljenjem je predhodno okužbo z dengo treba ugotoviti z laboratorijsko potrjeno anamnezo denge ali z ustrezno validiranim serološkim testiranjem (glejte poglavje 4.4).
In the absence of documented prior dengue virus infection, previous infection has to be confirmed by serotesting before vaccination. 
Če predhodna okužba z virusom denge ni dokumentirana, jo je treba pred cepljenjem potrditi s serološkim testiranjem.
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. 
Za osebe, stare 9 let ali več so ocenili, da bi se lahko zaradi cepljenja med 6-letnim spremljanjem, pojavilo približno 5 dodatnih hospitalizacij zaradi denge ali 3 dodatni primeri hude denge na 1.000 cepljenih oseb, predhodno neokuženih z dengo.
How to use Dengvaxia 
Kako uporabljati cepivo Dengvaxia
• medicines that affect your body's natural defences (immune system) such as high-dose corticosteroids or chemotherapy. 
• zdravila, ki vplivajo na naravno telesno obrambo (imunski sistem), na primer kemoterapija ali veliki odmerki kortikosteroidov.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to injection with a needle. 
Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica) kot psihološki odziv na injiciranje z iglo.
Vaccine efficacy was demonstrated for these endpoints in CYD14 and CYD15 (see Table 4). 
Učinkovitost cepiva glede teh dveh opazovanih dogodkov je bila dokazana v študijah CYD14 in CYD15 (glejte preglednico 4).
• hardening of skin at the injection site (injection site induration). 
• zatrdelost kože na mestu injiciranja.
Immunogenicity data available from studies in adults aged 18 to 45 years in endemic regions show that post-injection 3 GMTs against each serotype are generally higher in adults than in children and adolescents in CYD14 and CYD15. 
Podatki o imunogenosti, ki so na voljo iz študij CYD14 in CYD15 pri odraslih v starosti od 18 do 45 let na endemičnih območjih, kažejo, da so GMT po 3. injekciji proti vsakemu od serotipov pri odraslih višji kot pri otrocih in mladostnikih.
Powder: essential amino acids including Phenylalanine, non-essential amino acids, Arginine hydrochloride, sucrose, Trehalose dihydrate, Sorbitol, trometamol, urea. 
Prašek: esencialne aminokisline, vključno s fenilalaninom, neesencialne aminokisline, argininijev klorid, saharoza, trehaloza dihidrat, sorbitol, trometamol, sečnina.
Driving and using machines Dengvaxia has minor influence on the ability to drive and use machines. 
Cepivo Dengvaxia ima blag vpliv na sposobnost vožnje in upravljanja strojev.
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). 
Pri preiskovancih v starosti o 9 do 16 let je bila učinkovitost cepiva Dengvaxia proti simptomatski virološko potrjeni dengi (VPD) zaradi katerega koli od 4 serotipov dokazana v vseh treh študijahCYD14, CYD15 in CYD23 (glejte preglednico 3).
Overall, the same adverse reactions but at lower frequencies were observed in dengue seropositive subjects. 
Na splošno so pri osebah, seropozitivnih za dengo, opažali enake neželene učinke, a z manjšo pogostnostjo.
No clinical efficacy study has been done in subjects from 17 to 45 years from endemic areas. 
Kliničnih študij o učinkovitosti pri osebah v starosti od 17 do 45 let na endemičnih območjih niso izvedli.
• Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to injection with a needle. 
• Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa kot psihološki odziv na injiciranje z iglo.
In the two pivotal Phase III studies (CYD14 and CYD15), a total of approximately 31000 subjects aged 2 to 16 years were randomised to receive either Dengvaxia or placebo, regardless of previous dengue infection. 
V dveh ključnih študijah III. faze (CYD14 in CYD15) so skupno približno 31.000 preiskovancev (v starosti od 2 do 16 let) randomizirali na prejemanje cepiva Dengvaxia ali placeba , ne glede na predhodno okužbo z dengo.
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 
N: število preiskovancev, za katere je bil na voljo titer protiteles za posamezni primarni cilj študije Za dengo seropozitivne osebe so osebe, ki so imele izhodiščno titre na spodnji meji kvantifikacije ali nad njo proti vsaj enemu serotipu denge.
Also, considering that Dengvaxia is a live attenuated vaccine and that there is very limited experience from post marketing data with Dengvaxia in lactating women, the vaccine is contraindicated during lactation (see section 4.3). 
Ker je cepivo Dengvaxia živo oslabljeno cepivo in ker je izkušenj iz obdobja po prihodu cepiva Dengvaxia na trg pri doječih ženskah zelo malo, je le to med obdobjem dojenja kontraindicirano (glejte poglavje 4.3).
• If you forget or are not able to go back at the schedule time, ask your doctor, pharmacist or nurse for advice. 
• Če pozabite na injekcijo ali ponjo ne morete priti ob predvidenem času, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Previous dengue infection has to be assessed by laboratory confirmed history of dengue or through serotesting according to official recommendations. 
Predhodno okužbo z dengo je treba ugotoviti z laboratorijsko potrjeno anamnezo denge ali s serološkim testiranjem v skladu z lokalnimi uradnimi priporočili.
Upper respiratory tract infection Nasopharyngitis 
Okužba zgornjih dihal Nazofaringitis
Pack size of 5. 
Velikost pakiranja po 5.
Table 7: Immunogenicity for dengue seropositive subjects 18 to 45 years of age from endemic areas 
Preglednica 7: Imunogenost pri seropozitivnih dengo preiskovancih z endemičnih območij, starih od 18 do 45 let
Animal studies did not indicate any direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih učinkov glede vpliva na razmnoževanje (glejte poglavje 5.3).
No pharmacokinetic studies have been performed on Dengvaxia. 
S cepivom Dengvaxia niso izvedli farmakokinetičnih študij.
After reconstitution with the solvent provided, Dengvaxia must be kept in a refrigerator (2°C to 8°C) and must be used within 6 hours. 
Po rekonstituciji s priloženim vehiklom je treba cepivo Dengvaxia shranjevati v hladilniku (od 2 do 8 °C) in ga uporabiti v 6 urah.
• Immunisation should be carried out by subcutaneous (SC) injection preferably in the upper arm in the region of the deltoid. 
• Imunizacijo je treba opraviti s subkutanim (s.c.) injiciranjem, po možnosti v nadlaket v predelu deltoidne mišice.
Dengvaxia should not be used in the context of dengue outbreak in non-endemic regions. 
Cepiva Dengvaxia se ne sme uporabljati v primeru izbruha denge na neendemičnih območjih.
Very common: (may affect more than 1 in 10 people) 
Zelo pogosti: (pojavijo se lahko pri več kot 1 od 10 oseb)