natgillin/translations-raw huggingface dataset:
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)
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.