natgillin/translations-raw huggingface dataset:
Eklira Genuair did not increase the MACE risk in patients with COPD compared to placebo when added to current background therapy (hazard ratio (HR) 0.89; 95% CI: 0.64, 1.23). 
Zdravilo Eklira Genuair pri bolnikih s KOPB dodano trenutnemu osnovnemu zdravljenju v primerjavi s placebom ni povečalo tveganja za MACE (razmerje ogroženosti (HR-hazard ratio) 0,89; 95 % IZ: 0,64; 1,23).
Eklira Genuair 322 micrograms inhalation powder 
Eklira Genuair 322 mikrogramov/odmerek prašek za inhaliranje
Patients treated with Eklira Genuair showed a statistically significant reduction of 22% compared to placebo (rate ratio [RR] 0.78; 95% CI 0.68 to 0.89; p<0.001). 
Bolniki, zdravljeni z zdravilom Eklira Genuair, so imeli v primerjavi s placebom statistično značilno zmanjšanje za 22 % (razmerje deležev [RR-rate ratio] 0,78, 95 % IZ od 0,68 do 0,89, p < 0,001).
In addition, Eklira Genuair showed a statistically significant reduction of 35% in the rate of hospitalisations due to COPD exacerbations while on-treatment during the first year compared with placebo (RR 0.65; 95% CI 0.48 to 0.89; p=0.006). 
Poleg tega je zdravilo Eklira Genuair v prvem letu v primerjavi s placebom doseglo statistično značilno 35-odstotno zmanjšanje deleža sprejemov v bolnišnico zaradi poslabšanj KOPB med zdravljenjem (RR 0,65, 95 % IZ od 0,48 do 0,89, p = 0,006).
How to use Eklira Genuair 
Kako uporabljati zdravilo Eklira Genuair
EU/1/12/778/001 30 doses 
EU/1/12/778/001 30 odmerkov
EU/1/12/778/002 60 doses 
EU/1/12/778/002 60 odmerkov
What Eklira Genuair contains - The active substance is aclidinium bromide. 
Kaj vsebuje zdravilo Eklira Genuair - Učinkovina je aklidinij (v obliki aklidinijevega bromida).
What Eklira Genuair is used for 
Za kaj se zdravilo Eklira Genuair uporablja
Eklira Genuair 322 micrograms inhalation powder aclidinium (aclidinium bromide) 
Eklira Genuair 322 mikrogramov/odmerek prašek za inhaliranje aklidinij (aklidinijev bromid)
How to store Eklira Genuair 
Shranjevanje zdravila Eklira Genuair
Eklira Genuair 322 mcg inhalation powder aclidinium (aclidinium bromide) Inhalation use 
Eklira Genuair 322 mikrogramov/odmerek prašek za inhaliranje aklidinij (aklidinijev bromid) za inhaliranje
What Eklira Genuair is 
Kaj je zdravilo Eklira Genuair
at least 17 weeks. 
najmanj 17 tednov.
Use the entire vaccine mixture immediately after mixing. 
Uporabite celotno mešanico cepiv takoj po mešanju.
A mild and transient hyperthermia very commonly occurs on the day of vaccination. 
Blaga in prehodna hipertermija se zelo pogosto pojavi na dan cepljenja.
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009. 
Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe (ES) 470/2009.
* Relative potency (ELISA test) by comparison with a reference vaccine 
* relativna učinkovitost (preskus ELISA) v primerjavi z referenčnim cepivom
Adjuvant: Carbomer 
Dodatek: karbomer
Store and transport refrigerated (2 C-8 C). 
Shranjujte in prevažajte v hladilniku (2 C - 8 C).
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in plastenki po EXP.
Do not mix with any other veterinary medicinal product, except with Ingelvac MycoFLEX (not for use in pregnant or lactating pigs). 
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen s cepivom Ingelvac MycoFLEX (mešanica ni za uporabo pri brejih ali doječih svinjah).
Each vial is closed with a chlorobutyl stopper and lacquered aluminium seal. 
Vsaka staklenica je zaprta s klorobutilnim zamaškom in lakirano aluminijasto zaporko.
Under experimental challenge conditions in which only seronegative animals were included, it was demonstrated that vaccination reduces mortality, clinical signs and lesions in lymphoid tissues associated with PCV2 related disease (PCVD). 
V pogojih eksperimentalne provokacije v katero so bile vključene samo seronegativne živalih je bilo dokazano, da cepljenje zmanjša smrtnost, klinične znake in poškodbe v limfnih tkivih, ki jih povzroča bolezen zaradi okužbe s PCV2 (PCVD).
Date of first authorisation: 24.05.2017 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 24.05.2017
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE, ČE STA RAZLIČNA
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALCI ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJ
Overdose (symptoms, emergency procedures, antidotes) Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section “Adverse reactions” have been observed. 
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Po dajanju 4-krat prevelikega odmerka cepiva niso zasledili nobenih drugih neželenih učinkov, kot tistih, ki so opisani v poglavju poglavju »Neželeni učinki«.
EU/2/17/208/001-008 
ŠTEVILKE DOVOLJENJA ZA PROMET EU/2/17/208/001-001
Interactions with other medicinal products and other forms of interaction Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Ingelvac MycoFLEX and administered at one injection site. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Na voljo so podatki o varnosti in učinkovitosti, ki dokazujejo, da lahko to cepivo zmešamo s cepivom Ingelvac MycoFLEX in ga uporabimo na istem injekcijskem mestu.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis. 
Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicini odločamo od primera od primera.
Ingelvac PCV FLEX suspension for injection for pigs 
Ingelvac PCV FLEX, suspenzija za injiciranje za prašiče
For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2). 
Za aktivno imunizacijo prašičev, ki od matere niso prejeli protiteles proti PCV2, od starosti 2 tednov dalje proti prašičjemu cirkovirusu tipa 2 (PCV2).
Each dose (1 ml) contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA En odmerek (1 ml) vsebuje:
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Ingelvac MycoFLEX and administered at one injection site. 
Na voljo so podatki o varnosti in učinkovitosti, ki dokazujejo, da lahko to cepivo zmešamo s cepivom Ingelvac MycoFLEX in ga uporabimo na istem injekcijskem mestu.
If needed, gently press the vaccine bottle of Ingelvac PCV FLEX to facilitate the transfer. 
Če je treba, previdno stisnite plastenko s cepivom Ingelvac PCV FLEX, da pospešite prenos.
Carbomer Sodium chloride Water for injections 
6.1 Seznam pomožnih snovi karbomer natrijev klorid voda za injekcije
D. CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
To ensure correct mixing follow the steps as described below: Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX. 
Da boste zagotovili pravilno mešanje, se ravnajte po teh navodilih: Povežite en konec igle za prenos s plastenko s cepivom, ki vsebuje Ingelvac MycoFLEX.
• Use the same volumes of Ingelvac PCV FLEX and Ingelvac MycoFLEX. 
• Uporabite enak volumen cepiv Ingelvac PCV FLEX in Ingelvac MycoFLEX.
When mixed with Ingelvac MycoFLEX the following recommendations should be followed: 
Kadar cepivo mešate s cepivom Ingelvac MycoFLEX, morate upoštevati naslednja priporočila:
Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccines for pigs ATCvet code: QI09AA07 
Farmakoterapevtska skupina: imunološka zdravila za prašiče (Suidae), inaktivirana virusna cepiva za prašiče
The PSURs for Ingelvac PCV FLEX shall be submitted at the same frequency as for Ingelvac CircoFLEX. 
Redna posodobljena poročila o varnosti zdravila (PSUR) se predložijo z enako pogostnostjo kot za cepivo Ingelvac CircoFLEX.
One dose (1 ml) contains: Porcine circovirus type 2 ORF2 protein Carbomer 1 mg. 
En odmerek (1 ml) vsebuje: beljakovina ORF2 prašičjega cirkovirusa tipa 2, karbomer 1 mg.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)
- After the transfer of the full content of Ingelvac PCV FLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac PCV FLEX. 
- Ko prenesete celotno vsebino plastenke cepiva Ingelvac PCV FLEX, odstranite z vsebnika iglo za prenos in prazno plastenko za cepivo Ingelvac PCV FLEX in ju zavrzite.
Carton of 10 ml, 50 ml, 100 ml, 250 ml bottles 
Škatla s plastenkami po 10 ml, 50 ml, 100 ml, 250 ml
One dose (1 ml): Porcine circovirus type 2 ORF2 protein Carbomer 
En odmerek (1 ml): beljakovina ORF2 prašičjega cirkovirusa tipa 2 karbomer
Active substance: Porcine circovirus type 2 ORF2 protein 
Učinkovina: beljakovina ORF2 prašičjega cirkovirusa tipa 2
PACKAGE LEAFLET: Ingelvac PCV FLEX suspension for injection for pigs 
NAVODILO ZA UPORABO Ingelvac PCV FLEX, suspenzija za injiciranje za prašiče
Name and address of the manufacturers responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein 
Ime in naslov proizvajalcev zdravila, odgovornih za sproščanje serij Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Porcine circovirus type 2 ORF2 protein: RP* 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine. 
NAVEDBA UČINKOVINE IN DRUGIH SESTAVIN En odmerek (1 ml) vsebuje: beljakovino ORF2 prašičjega cirkovirusa tipa 2 * relativna učinkovitost (preskus ELISA) v primerjavi z referenčnim cepivom Dodatek: karbomer 1 mg.
Pack sizes of 1 or 12 high density polyethylene bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses). 
Velikosti vsebujejo 1 ali 12 plastenk iz polietilena velike gostote, ki vsebujejo po 10 ml (10 odmerkov), 50 ml (50 odmerkov), 100 ml (100 odmerkov) ali 250 ml (250 odmerkov).
Pack sizes of 1 or 12 bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses). 
Pakiranja vsebujejo 1 ali 12 plastenk po 10 ml (10 odmerkov), 50 ml (50 odmerkov), 100 ml (100 odmerkov) ali 250 ml (250 odmerkov).
- Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac PCV FLEX. 
- Povežite drugi konec igle za prenos s plastenko s cepivom Ingelvac PCV FLEX.
- Transfer the Ingelvac PCV FLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX. 
- Prenesite vsebino plastenke s cepivom Ingelvac PCV FLEX v plastenko s cepivom Ingelvac MycoFLEX.
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
- občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
10 ml, 50 ml bottle 
plastenka po 10 ml, 50 ml
STATEMENT OF ACTIVE SUBSTANCE 
NAVEDBA UČINKOVIN
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju 4-krat prevelikega odmerka cepiva niso zasledili nobenih drugih neželenih učinkov, kot tistih, ki so opisani v poglavju 4.6.
Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Vetmedica Inc. 
Imetnik dovoljenja za promet z zdravilom in izdelovalec, odgovoren za sprostitev serije: Boehringer Ingelheim Vetmedica GmbH
EXPIRY DATE 
Brejost in laktacija
20 mg/g Transdermal ointment 
20 mg/g transdermalno mazilo mačke transdermalna uporaba tuba (aluminij)
1 tube Not applicable 
1 tuba
EU (MA) Number 
Priloga A
If you or your daughter: 
Če ste vi ali vaša hči:
Symptoms usually last for 2 to 7 days. 
Simptomi po navadi trajajo od 2 do 7 dni.
Other serious reactions 
Druge resne reakcije
• There is any suspicion that the partially used vial has been contaminated. 
• obstaja sum, da je delno uporabljena viala kontaminirana.
The recommended size of the needle to be used is 23G or 25G. 
Priporočena velikost igle za uporabo je 23G ali 25G.
• There is visible evidence of contamination, such as a change in appearance. 
• obstajajo vidni dokazi kontaminacije, npr. spremenjen videz.
The bridging of efficacy is based on above available data and overall results. 
Premostitev učinkovitosti temelji na zgornjih dostopnih podatkih in celotnih rezultatih.
Your doctor will carefully consider the risks and benefits of vaccination. 
Zdravnik bo skrbno pretehtal tveganja in koristi cepljenja.
Children and adults 9 to 45 years of age 
Otroci in odrasli v starosti od 9 do 45 let
• The first injection will be given at the chosen or scheduled date. 
• Prvi odmerek boste prejeli na izbrani ali načrtovani datum.
Endemic areas are areas where the disease has been continuously present among the people who live there and where outbreaks or epidemics have occurred. 
Endemična območja so območja, kjer je bolezen stalno prisotna med ljudmi, ki tam živijo, in kjer so se pojavili izbruhi ali epidemije.
Instructions for preparing the vaccine intended for medical and healthcare professionals are included at the end of the leaflet. 
Navodila za pripravo cepiva, ki so namenjena zdravnikom in zdravstvenim delavcem, so vključena na koncu tega navodila.
LLOQ), against at least one serotype. 
[LLOQ]) proti vsaj enemu serotipu.
Younger children Children less than 9 years of age must not receive the vaccine. 
Otroci, mlajši od 9 let, ne smejo dobiti tega cepiva.
Additional side effects in adults: 
Dodatni neželeni učinki pri odraslih:
This leaflet was last revised in [{MM/YYYY}]. 
Navodilo je bilo nazadnje revidirano dne [{MM/LLLL}].
A partially used multidose vial must be discarded immediately if: 
Delno uporabljeno vialo z več odmerki morate nemudoma zavreči, če:
This may be due to a genetic defect or HIV infection. 
To je lahko posledica genetske napake, ali okužbe z virusom HIV.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018 
Datum prve odobritve: 12 december 2018
The following side effects occurred during studies in children, young people and adults. 
Naslednji neželeni učinki so se v študijah pojavili pri otrocih, mladostnikih in odraslih.
It contains versions of these 4 varieties of the virus that have been weakened so that they cannot cause the disease. 
To cepivo vsebuje različice teh 4 vrst virusov, ki pa so oslabljeni, tako da ne morejo povzročiti bolezni.
Additional protection precautions 
Dodatni zaščitni ukrepi
Study N 
Študija N
This includes using insect repellents, wearing protective clothing, and using mosquito nets. 
To vključuje uporabo repelentov proti insektom, nošenje zaščitnih oblačil in uporabo mrež proti komarjem.
The powder and the solvent must be mixed together before use. 
Prašek in vehikel je treba pred uporabo zmešati skupaj.
You or your child will receive 3 injections of 0.5 mL - one every 6 months. 
Vi (ali vaš otrok) boste dobili 3 injekcije po 0,5 ml - eno na vsakih 6 mesecev.
After reconstitution, use immediately. 
Po rekonstituciji uporabite takoj.
2.5 Long-term protection 
2.5 Dolgotrajna zaščita
QUALITATIVE AND QUANTITATIVE COMPOSITION 
2 KAKOVOSTNA IN KOLIČINSKA SESTAVA
These figures may not be extrapolated to other regions with different seroprevalence and epidemiological situations. 
Teh števil se ne sme ekstrapolirati na druge regije z drugačno seroprevalenco in epidemiološkimi razmerami.
CYD22: Vietnam; CYD28: Singapore; CYD47: India; 
CYD22: Vietnam; CYD28: Singapur; CYD47: Indija
If any of these symptoms occur after leaving the place where you or your child received an injection, contact a doctor immediately: 
Če se kateri od teh simptomov pojavi potem, ko ste že zapustili prostor, kjer ste vi ali vaš otrok dobili injekcijo, se morate nemudoma posvetovati z zdravnikom:
Very rare: (<1/10 000) 
Zelo redki: (< 1/10.000)
A decrease in the GMTs against all 4 serotypes was observed one year after the third injection. 
Zmanjšanje GMT proti vsem 4 serotipom so opažali eno leto po tretji injekciji.
This increased risk may mainly begin during the third year following the first injection. 
To povečano tveganje se večinoma lahko začne v tretjem letu po prvi injekciji.
• have a weak immune system (the body's natural defences). 
• Imate šibek imunski sistem (naravno telesno obrambo).
After reconstitution, one dose (0.5 mL) contains: 
Po rekonstituciji en odmerek (0,5 ml) vsebuje:
Then, GMTs stabilize over the next 2 to 4 years and remain superior to pre-vaccination GMTs. 
GMT se stabilizirajo v naslednjih 2 do 4 letih in ostanejo višji od GMT pred cepljenjem.
• Individuals with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function. 
• Osebe s simptomatsko okužbo s HIV ali z asimptomatsko okužbo s HIV, ki jo spremljajo dokazi prizadetega imunskega delovanja.
The adverse reactions were usually mild to moderate in severity and of short duration (0 to 3 days). 
Neželeni učinki so bili ponavadi blagi do zmerni in kratkotrajni (od 0 do 3 dni).
Tell your doctor or pharmacist if you or your child are using, have recently used or might use any other vaccines or medicines. 
Obvestite svojega zdravnika ali farmacevta, če vi ali vaš otrok uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo cepivo ali zdravilo.
Dengue is not transmitted directly from personto-person. 
Denga se ne prenaša neposredno s človeka na človeka.
How the vaccine works 
Kako cepivo deluje
Most of the subjects were 9 to 17 years of age (n= 2810). 
Večina preiskovancev je bila starih od 9 do 17 let (n = 2.810).
Dengvaxia is available in packs of 1 or 10. 
Cepivo Dengvaxia je na voljo v pakiranjih po 1 ali 10.
You can also have dengue but show no symptoms (called "asymptomatic"). 
Dengo lahko imate tudi, ne da bi se vam pojavili kakšni simptomi (temu pravimo "asimptomatska bolezen").
CYD15: Brazil, Colombia, Honduras, Mexico, Puerto Rico. 
CYD15: Brazilija, Kolumbija, Honduras, Mehika, Portoriko.
• Pregnant women (see section 4.6). 
• Nosečnice (glejte poglavje 4.6).
No specific studies have been performed on fertility. 
Specifičnih študij o vplivu na plodnost niso izvedli.
• medicines called “immunoglobulins” or blood products containing immuno globulins, such as blood or plasma. 
• zdravila, imenovana "imunoglobulini", ali krvni izdelki, ki vsebujejo imunoglobuline, npr. kri ali plazma.
†The efficacy against hospitalised and severe VCD was not a primary objective and cut-off thresholds to define statistical significance were not pre-specified. 
†Učinkovitost proti hospitaliziranim in hudim primerom VPD ni bila primarni cilj in mejne vrednosti statistične značilnosti niso bile vnaprej določene.
Therefore, protection is expected in adults in endemics areas although the actual magnitude of efficacy relative to that observed in children and adolescents is unknown. 
Zato se na endemičnih področjih pri odraslih pričakuje zaščitno delovanje, čeprav dejanski obseg učinkovitosti v primerjavi s tistim, ki so ga opazili na otrocih in mladostnikih, ni znan.
Vaccination should be preceded by a review of the individual's medical history (in particular, previous vaccinations and possible adverse reactions which occurred after vaccination). 
Pred cepljenjem je treba preveriti posameznikovo zdravstveno anamnezo (še zlasti predhodna cepljenja in možne neželene reakcije po cepljenjih).
You should take precautions to prevent mosquito bites. 
Upoštevati morate previdnostne ukrepe za preprečitev pikov komarjev.
Person-years: sum of time-at-risk (in years) for the subjects during the study period. 
Oseba-leta: vsota časa izpostavljenosti tveganju (v letih) pri preiskovancih med obdobjem študije.
• Sterile dose withdrawal has not been fully observed. 
• ni bil v celoti upoštevan sterilen odvzem odmerka.
There are no safety, immunogenicity or efficacy data to support vaccination of individuals living in non-endemic areas and travelling to endemic areas, therefore vaccination of these individuals is not recommended. 
Podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi podpirali cepljenje oseb z neendemičnih območij, ki potujejo na endemična območja, ni, zato cepljenje takšnih oseb ni priporočljivo.
In particular, tell your doctor or pharmacist if you are taking any of the following: 
Še zlasti morate zdravnika ali farmacevta obvestiti, če jemljete katera od naslednjih zdravil:
The same information is also available on the following URL: http://qr.sanofi.com/dengvaxia 
Iste informacije so na voljo tudi na naslednjem URL: http://qr.sanofi.com/dengvaxia
Protection 
Zaščita
• ever fainted from an injection. 
• ste kdaj omedleli zaradi injekcije.
o That healthcare professionals should be aware of dengue early warning signs. 
o zdravstveni delavci morajo poznati zgodnje opozorilne znake denge.
3.3 Long-term persistence of antibodies 
3.3 Dolgoročna persistenca protiteles
Occasionally dengue can be severe enough for you to have to go to hospital and in rare cases it can cause death. 
Občasno je lahko denga tako huda, da je potrebno zdravljenje v bolnišnici, v redkih primerih lahko celo povzroči smrt.
These signs or symptoms (anaphylactic reactions) usually develop soon after the injection is given and while you or your child are still in the clinic or doctor's surgery. 
Ti znaki in simptomi (anafilaktična reakcija) se po navadi pojavijo kmalu po injekciji in medtem, ko ste vi ali vaš otrok še v ambulanti.
• blueness of the tongue or lips 
• pomodrelost jezika ali ustnic
Cases: number of subjects with at least one symptomatic virologically-confirmed dengue episode in the considered period. 
Primeri: število preiskovancev z vsaj eno simptomatsko, virološko potrjeno epizodo denge v obravnavanem obdobju.
The efficacy was assessed during an Active Phase of 25 months, in which surveillance was designed to maximize the detection of all symptomatic virologically-confirmed dengue (VCD) cases regardless of the severity. 
Učinkovitost so ocenili med aktivno 25-mesečno fazo, v kateri je bil nadzor načrtovan tako, da je zajel kar največje število vseh primerov simptomatske, virološko potrjene denge (VPD), ne glede na to, kako huda je bila.
Clinically severe VCD cases† 
Klinično hudi primeri VPD†
The Control Group in dengue studies was defined as subjects who received at least one injection of placebo or comparator vaccine. 
Kontrolna skupina v študijah denge so bili preiskovanci, ki so prejeli vsaj eno injekcijo placeba ali primerjalnega cepiva.
Available data are not sufficient to confirm the safety and efficacy in individuals previously infected by any dengue virus and younger than 9 years. 
Podatki, ki so na voljo, ne zadoščajo za potrditev varnosti in učinkovitosti cepiva pri otrocih, predhodno okuženih s katerim koli virusom denge, ki so mlajši od 9 let.
CYD14: Indonesia, Malaysia, the Philippines, Thailand, Vietnam. 
CYD14: Indonezija, Malezija, Filipini, Tajska, Vietnam.
• low blood pressure causing dizziness or fainting 
• nizek krvni tlak, ki povzroči omotico ali omedlevico
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. 
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov proizvajalca , odgovornega za sprostitev zadevne serije.