natgillin/translations-raw huggingface dataset:
Dengue is a viral infection which spreads through the bite of an infected Aedes mosquito.
Denga je virusna okužba, ki se prenaša s piki okuženih komarjev iz rodu Aedes.
Rare: (may affect up to 1 in 1000 people) • runny nose (rhinorrhea).
Redki: (pojavijo se lahko pri največ 1 od 1.000 oseb) • izcedek iz nosu (rinoreja).
For storage conditions after reconstitution of Dengvaxia, see section 6.3.
Za pogoje shranjevanja po rekonstituciji cepiva Dengvaxia glejte poglavje 6.3.
pharmacist or nurse for advice before using Dengvaxia.
farmacevtom ali medicinsko sestro, preden uporabite cepivo Dengvaxia.
• a mild to high fever or acute disease.
• imate blago do zelo zvišano telesno temperaturo ali kakšno akutno bolezen.
Women of childbearing potential have to use effective contraception during at least one month after each dose.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo vsaj en mesec po vsakem odmerku.
Transfer the entire content of the pre-filled syringe into the vial containing the powder.
Prenesite celotno vsebino napolnjene injekcijske brizge v vialo, ki vsebuje prašek.
• fatigue.
• utrujenost.
• Dengue seropositivity if the PRNT50 titre ≥ 10 [1/dil] (the lower limit of quantification,
• Seropozitivnost za dengo, če je bil titer PRNT50 ≥ 10 [1/razr] (spodnja meja kvantifikacije
More information on dengue and vaccination QR Code to be included + http://qr.sanofi.com/dengvaxia
Več informacij o dengi in cepljenju QR-koda, ki jo je treba vključiti + http://qr.sanofi.com/dengvaxia
Other medicines and Dengvaxia
Druga zdravila in cepivo Dengvaxia
Swirl gently until the powder is dissolved.
Rahlo vrtite, dokler ni prašek raztopljen.
Do not use Dengvaxia if you or your daughter are pregnant or breast-feeding.
Ne uporabljajte cepiva Dengvaxia, če ste vi ali vaša hči noseči ali dojite.
Women of childbearing potential have to use effective contraception during at least one month after each dose (see section 4.6).
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo vsaj še en mesec po vsakem odmerku tega cepiva (glejte poglavje 4.6).
Pack size of 1 or 10.
Velikost pakiranja po 1 ali 10.
• This vaccine has been prescribed for you or your child only.
• Cepivo je bilo predpisano vam ali vašemu otroku osebno in ga ne smete dajati drugim.
The suspension should be visually inspected prior to administration.
Suspenzijo je treba pred uporabo pregledati.
** Produced in Vero cells by recombinant DNA technology.
** Pridobljeno v celicah Vero s tehnologijo rekombinantne DNA.
Nausea Dry mouth
Navzea Suha usta
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
Kaj je cepivo Dengvaxia in za kaj ga uporabljamo Kaj morate vedeti, preden boste vi ali vaš otrok uporabili cepivo Dengvaxia Kako uporabljati cepivo Dengvaxia
Dengvaxia is given to adults, young people and children (from 9 to 45 years of age) with prior dengue virus infection and who live in endemic areas (also see sections 2 and 3).
Cepivo Dengvaxia je namenjeno odraslim, mladostnikom in otrokom (od 9. do 45. leta starosti) s predhodno okužbo z virusom denga in ki živijo na endemičnih območjih (glejte tudi poglavji 2 in 3).
**CCID50: 50% Cell Culture Infectious Dose.
**CCID50: 50 % infekcijski odmerek v celični kulturi (CCID - Cell Culture Infectious Dose).
*Produced in Vero cells by recombinant DNA technology.
*Pridobljen v celicah Vero s tehnologijo rekombinantne DNA.
Like all medicines, Dengvaxia can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi cepivo Dengvaxia neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Do not administer by intravascular injection.
Ne injicirajte intravaskularno.
Dengvaxia must not be mixed with any other vaccine or medicinal product.
Cepiva Dengvaxia se ne sme mešati z nobenimi drugimi cepivi ali zdravili.
After complete dissolution, a 0.5 mL dose of the reconstituted suspension is withdrawn into the same syringe.
Po popolni raztopitvi je treba 0,5 ml odmerek rekonstituirane suspenzije potegniti v isto brizgo.
Adverse reactions occurred within 3 days following vaccination except fever which appears within 14 days after the injection.
Neželeni učinki so se pojavili v 3 dneh po cepljenju; izjema je bila zvišana telesna temperatura, ki se je pojavila v 14 dneh po injiciranju.
Sanofi Pasteur 14 Espace Henry Vallée 69007 Lyon France
Sanofi Pasteur 14 Espace Henry Vallée 69007 Lyon Francija
For instructions on reconstitution of Dengvaxia before administration, see section 6.6.
Za navodila o rekonstituciji cepiva Dengvaxia pred uporabo glejte poglavje 6.6.
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.
Po cepljenju se morate posvetovati z zdravnikom, če menite, da ste se vi ali vaš otrok okužili z dengo in se vam pojavijo kateri od naslednjih simptomov: zelo zvišana telesna temperatura, hude bolečine v trebuhu, vztrajno bruhanje, hitro dihanje, krvavitev iz dlesni, utrujenost, nemir in kri v izbruhani vsebini.
Path to more information on dengue and vaccination by scanning the QR code included on the outer carton with a smartphone.
Več informacij o dengi in cepljenju je na voljo s skeniranjem QR kode na zunanji ovojnini s pametnim telefonom.
• As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following the administration of
• Tako kot velja za vsa cepiva za injiciranje, morata biti vedno takoj na voljo ustrezno medicinsko zdravljenje in nadzor za primer, da se po uporabi cepiva Dengvaxia pojavi anafilaktična reakcija.
Swirl gently until the powder is completely dissolved.
Rahlo vrtite, dokler ni prašek povsem raztopljen.
* CCID50: 50% Cell Culture Infectious Dose.
* CCID50: 50 % infekcijski odmerek v celični kulturi (CCID - Cell Culture Infectious Dose).
• pain or swelling of the nose or throat (nasopharyngitis)
• bolečine ali otekanje nosu ali grla (nazofaringitis)
You will not get Dengvaxia until you or your child have recovered.
Cepiva Dengvaxia ne boste prejeli, dokler vi (ali vaš otrok) ne okrevate.
Dengvaxia should not be administered to subjects receiving immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids within 4 weeks prior to vaccination (see section 4.3).
Cepiva Dengvaxia se ne sme dajati osebam, ki prejemajo imunosupresivna zdravila, na primer kemoterapijo ali velike odmerke kortikosteroidov v 4 tednih pred cepljenjem (glejte poglavje 4.3).
In the following Tables the dengue serostatus at baseline (before the first injection), was defined as:
V naslednjih preglednicah je bilo izhodiščno (pred prvo injekcijo) serološko stanje v zvezi z dengo opredeljeno kot:
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.