natgillin/translations-raw huggingface dataset:
Samples taken from humans and animals for investigation of Ebola infection should be handled by trained staff and processed in suitably equipped laboratories. 
S človeškimi in živalskimi vzorci, odvzetimi za preiskave okužbe z virusom Ebola, mora ravnati usposobljeno osebje in morajo biti obdelani v ustrezno opremljenih laboratorijih.
Arthralgia and arthritis 
Artralgija in artritis
The majority of arthritis reactions were mild to moderate in severity. 
Večina artritičnih reakcij je bila po izrazitosti blagih do zmernih.
Do not thaw the vial in a refrigerator as it is not guaranteed that the vial will thaw in less than 4 hours. 
Viale ne odtajajte v hladilniku, ker ni zagotovljeno, da se bo viala odtajala v manj kot 4 urah.
In the Phase 1 study with the highest rate of arthritis, 6 of 24 patients (25%) who reported arthritis after vaccination had persistent joint symptoms two years after vaccination. 
V študiji 1. faze z največjim deležem primerov artritisa je imelo 6 od 24 bolnikov (25 %), ki so po cepljenju poročali o artritisu, trajajoče sklepne simptome še dve leti po cepljenju.
In a biodistribution study conducted in non-human primates, vaccine virus RNA was detected in lymphoid organs up to 112 days post-vaccination. 
V študiji biološke porazdelitve, izvedeni pri ne-humanih primatih, so RNA cepilnega virusa ugotovili v limfatičnih organih do 112 dni po cepljenju.
• Do not use this vaccine if you notice particles in the liquid. 
• Cepiva ne uporabite, če v tekočini opazite delce.
No studies have looked at how other medicines or vaccines and Ervebo might interact with each other. 
V nobeni študiji še niso preučili, kako lahko druga zdravila ali cepiva medsebojno delujejo s cepivom Ervebo.
CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
SKLEPNE UGOTOVITVE O PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
No cases of overdose have been reported. 
Ni poročil o primerih prevelikega odmerjanja.
Clinical efficacy of Ervebo was assessed in Protocol 010. 
Klinično učinkovitost cepiva Ervebo so ocenili v Protokolu 010.
Shedding of vaccine virus has been detected by PCR in urine or saliva in 19 out of 299 adult subjects and in skin vesicles in 4 out of 10 adult subjects. 
Izločanje ccepilnega virusa je bilo s PCR ugotovljeno v urinu ali slini pri 19 od 299 odraslih oseb ter v kožnih mehurčkih pri 4 od 10 odraslih oseb.
Vaccination should be postponed in subjects experiencing moderate or severe febrile illness. 
Cepljenje je treba odložiti pri osebah z zmerno ali hudo febrilno boleznijo.
Do not inject the vaccine intravascularly. 
Cepiva ne injicirajte intravaskularno.
Additional side effects in children and adolescents The vaccine has been studied in a small number of children and adolescents who were 6 to 17 years of age. 
Dodatni neželeni učinki pri otrocih in mladostnikih Cepivo so raziskali pri majhnem številu otrok in mladostnikov, starih od 6 do 17 let.
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Animal studies in female rats do not indicate harmful effects (see section 5.3). 
Študije na živalih pri podganjih samicah ne kažejo škodljivih učinkov (glejte poglavje 5.3).
This does not include individuals who are receiving topical, inhaled or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy). 
To ne velja za osebe, ki prejemajo lokalne, inhalacijske ali nizkoodmerne parenteralne kortikosteroide (npr. za profilakso astme ali za nadomestno zdravljenje).
Healthcare workers caring for patients with suspected or confirmed Ebola virus should apply extra infection control measures to prevent contact with the patient's blood and body fluids and contaminated surfaces or materials such as clothing and bedding. 
Zdravstveni delavci, ki skrbijo za bolnike s sumom na virus Ebola ali potrjenim virusom, morajo upoštevati dodatne ukrepe za nadzor okužbe, da bi preprečili stik z bolnikovo krvjo in telesnimi tekočinami ter s kontaminiranimi površinami ali materiali, na primer z oblačili in posteljnino.
If you get Ebola, it can kill you. 
Če zbolite za ebolo, lahko zaradi nje umrete.
EU/1/19/1392/001 - pack of 10 
EU/1/19/1392/001 - pakiranje po 10
An immunogenicity sub-study included 508 subjects who were vaccinated and provided samples for the assessment of immunogenicity. 
V pod-študiji imunogenosti je bilo vključenih 508 oseb, ki so jih cepili in od njih pridobili vzorce za oceno imunogenosti.
Based on limited shedding in adults, the results of a toxicity study in non-human primates, and lack of horizontal transmission in pigs, the overall risk of Ervebo to human health and the environment is considered negligible. 
Na podlagi omejenega izločanja pri odraslih, rezultatov študije toksičnosti pri ne-humanih primatih in odsotnosti vodoravnega prenosa pri prašičih velja, da je celotno tveganje cepiva Ervebo za človeško zdravje in okolje zanemarljivo.
Other medicines and Ervebo 
Druga zdravila in cepivo Ervebo
Vaccination of contacts of Ebola cases should occur as soon as possible (see section 5.1). 
Osebe, ki so bile v stiku z osebami z ebolo, je treba cepiti čim prej (glejte poglavje 5.1).
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to rice protein listed in section 2. 
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali riževe beljakovine, navedene v poglavju 2.
It is also not known if it can pass to your baby through your breast milk. 
Prav tako ni znano, ali lahko z vašim mlekom preide v otrokovo telo.
Overall, the side effects in children and adolescents were similar to those in adults. 
Na splošno so neželeni učinki pri otrocih in mladostnikih podobni kot pri odraslih.
The safety, immunogenicity and efficacy of Ervebo in children aged 1 to 17 years have not yet been established (see sections 4.8 and 5.1). 
Varnost, imunogenost in učinkovitost cepiva Ervebo pri otrocih, starih od 1 do 17 let, še niso dokazane (glejte poglavji 4.8 in 5.1).
What you need to know before you receive Ervebo 
Kaj morate vedeti, preden boste prejeli cepivo Ervebo
Evaluation of the vaccine virus in animal milk has not been conducted. 
Ovrednotenja cepilnega virusa v mleku živali niso izvedli.
• Ebola is a serious disease caused by a virus. 
• Ebola je resna virusna bolezen.
See section 5.3. 
Glejte poglavje 5.3.
It is unknown whether concurrent administration of antiviral medication including interferons could impact vaccine virus replication and efficacy. 
Ni znano, ali lahko sočasna uporaba protivirusnih zdravil, vključno z interferoni, vpliva na replikacijo in učinkovitost cepilnega virusa.
Nevertheless considering the severity of EVD, vaccination should not be withheld when there is a clear risk of exposure to Ebola infection. 
Vendar pa glede na resnost ebole cepljenja ne smemo odložiti, kadar obstaja očitno tveganje izpostavljenosti okužbi z ebolo.
• Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated. 
• Družinska anamneza prirojene ali dedne imunske pomanjkljivosti, razen če je dokazana imunska sposobnost osebe, ki naj bi bila cepljena.
A CD4+ T-lymphocyte count threshold for use in asymptomatic HIV-positive individuals has not been established. 
Prag števila limfocitov T CD4+ za uporabo tega cepiva pri nesimptomatskih HIV-pozitivnih osebah ni ugotovljen.
This vaccine contains a trace amount of rice protein. 
Cepivo vsebuje riževe beljakovine v sledeh.
Viral shedding was observed more frequently in children and adolescents (28/39) compared to adults. 
Izločanje virusa so pogosteje opažali pri otrocih in mladostnikih (28/39) kot pri odraslih.
• Contact with semen from a man who had Ebola. 
• Stikom s semensko tekočino moškega, ki je imel ebolo.
• you have cancer or a blood problem that makes your immune system weak, 
• če imate raka ali kakšno krvno bolezen, zaradi katere imate šibek imunski sistem,
• A minor infection such as a cold should not be a problem but talk to your healthcare worker before receiving Ervebo. 
• Blage okužbe, kakršna je na primer prehlad, ne bi smele biti težava, vendar se posvetujte z zdravstvenim delavcem, preden prejmete cepivo Ervebo.
• Funeral or burial rituals that require handling the body of someone who died from Ebola. 
• Obredom pogreba ali pokopa, ki zahtevajo ravnanje s truplom osebe, umrle zaradi ebole.
Women of child-bearing potential should use an effective contraceptive method. 
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijsko metodo.
The MAH should complete master cell banks (MCB)/working cell bank (WCB) qualification to include also tests for specified viruses. 
Imetnik dovoljenja za promet s cepivom mora dopolniti kvalifikacijo glavnih celičnih bank (MCB - master cell banks)/delujočih celičnih bank (WCBworking cell bank), tako da vključi tudi teste za določene viruse.
Arthritis has been reported by subjects in clinical trials at a frequency that ranged from 0% in several protocols to 23.5% in one Phase 1 study. 
Pri preiskovancih v kliničnih preskušanjih so o artritisu poročali s pogostnostjo, ki je segala od 0 % v več protokolih do 23,5 % v eni študiji 1. faze.
In a Phase 1 trial in children 6 to 17 years of age (median age = 10), non-validated ELISA and Pseudovirion Neutralization Assay (PsVNA) results at Day 28 and Day 180 post-vaccination were similar to those observed in adults in the same study (see also sections 4.4 and 4.8). 
V preskušanju 1. faze pri otrocih, starih od 6 do 17 let (mediana starost = 10), so bili rezultati nevalidiranega testa ELISA in rezultati psevdovirionskega nevtralizacijskega preizkusa (PsVNA - Pseudovirion Neutralization Assay) 28 in 180 dni po cepljenju podobni kot pri odraslih v isti študiji (glejte tudi poglavji 4.4 in 4.8).
Intramuscular use Read the package leaflet before use. 
intramuskularna uporaba Pred uporabo preberite priloženo navodilo!
An ERA was conducted to determine the potential impact of this vaccine on human health and the environment. 
Izvedena je bila ocena tveganja za okolje (ERA - environmental risk assessment) za ugotovitev možnega vpliva tega cepiva na človeško zdravje in okolje.
Vaccine efficacy was 100% (unadjusted 95% CI: 63.5% to 100%; 95% CI adjusted for multiplicity: 14.4% to 100%) (0 cases in the immediate arm; 10 cases in 4 rings in the delayed arm). 
Učinkovitost cepiva je bila 100-odstotna (nekorigiran 95 % IZ: 63,5 % do 100 %; 95 % IZ korigiran za multiplikativnost: 14,4 % do 100 %) (0 primerov v skupini s takojšnim cepljenjem, 10 primerov v 4 krogih z odloženim cepljenjem).
Arthritis (arthritis, joint effusion, joint swelling, osteoarthritis, monoarthritis or polyarthritis) was generally reported within the first few weeks following vaccination. 
O artritisu (artritis, izliv v sklep, oteklost sklepa, osteoartritis, monoartritis ali poliartritis) so na splošno poročali v prvih nekaj tednih po cepljenju.
Testing for Ebola after you receive Ervebo 
Testiranje za ebolo, potem ko ste prejeli cepivo Ervebo
• Make sure your blood or body fluids do not come into close contact with farm animals for at least 6 weeks after you receive this vaccine. 
• Poskrbite, da s krvjo ali telesnimi tekočinami ne pridete v tesni stik z domačimi živalmi vsaj 6 tednov po tem, ko prejmete to cepivo.
• Do not use this medicine after the expiry date which is stated on the vial label and the outer carton after ‘EXP'. 
• Cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale in na škatli poleg oznake "EXP".
• you are taking certain medicines that make your immune system weak such as immunosuppressants or corticosteroids, 
• če jemljete določena zdravila, ki oslabijo imunski sistem, na primer imunosupresivna zdravila ali kortikosteroide,
Inadvertent transmission of vaccine virus to animals and livestock is also theoretically possible, see below. 
Teoretično je možen tudi nenameren prenos cepilnega virusa na živali in živino, glejte spodaj.
Ervebo is indicated for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus (see sections 4.2, 4.4 and 5.1). 
Cepivo Ervebo je indicirano za aktivno imunizacijo oseb, starih 18 let ali več, za zaščito pred ebolo, ki jo povzroča virus Ebola Zaire (glejte poglavja 4.2, 4.4 in 5.1).
The European Medicines Agency has deferred the obligation to submit the results of studies with Ervebo in one or more subsets of the paediatric population in prevention of Ebola disease (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom Ervebo za eno ali več podskupin pediatrične populacije za preprečevanje ebole (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
As a precautionary measure, it is preferable to avoid the use of Ervebo during pregnancy. 
Zaradi previdnosti se je uporabi cepiva Ervebo med nosečnostjo najbolje izogniti.
• Do not become pregnant for 2 months after you receive Ervebo. 
• Ne zanosite v 2 mesecih potem, ko prejmete cepivo Ervebo.
Tell your healthcare worker if in the 6 weeks after you receive Ervebo you might be in close contact with or in the same household as: 
Zdravstvenemu delavcu morate povedati, če boste v 6 tednih po cepljenju s cepivom Ervebo morda v tesnem stiku ali v istem gospodinjstvu skupaj z:
Anaphylaxis was reported very rarely (0.006%) in clinical trials. 
O anafilaksiji so v kliničnih preskušanjih poročali zelo redko (0,006 %).
Once thawed, the vaccine cannot be re-frozen. 
Ko je cepivo enkrat odtajano, se ga ne sme ponovno zamrzniti.
The relative contributions of innate, humoral and cell-mediated immunity to protection from Zaire Ebola virus are unknown. 
Sorazmerni prispevki prirojene, humoralne in celične imunosti k zaščiti pred virusom Ebola Zaire niso znani.
• Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia, and AIDS or symptomatic HIV infection. 
• Huda humoralna ali celična (primarna ali pridobljena) imunska pomanjkljivost, npr. huda kombinirana imunska pomanjkljivost, agamaglobulinemija, aids ali simptomatska okužba s HIV.
The vaccination may have to be delayed until your fever is gone. 
Cepljenje bo morda treba odložiti, dokler zvišana telesna temperatura ne mine.
• a member of your family has a weak immune system. 
• če ima kakšen član vaše družine šibek imunski sistem.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. 
Kot pri vseh cepivih za injiciranje morajo biti vedno na voljo ustrezne možnosti za zdravljenje in nadzor, če bi po cepljenju prišlo do anafilaktične reakcije.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your healthcare worker for advice before you receive this vaccine. 
• Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravstvenim delavcem, preden prejmete to cepivo.
Tell your healthcare worker that you have received Ervebo. 
Zdravstvenemu delavcu morate povedati, da ste prejeli cepivo Ervebo.
30 Oct 2020 
30. oktober 2020
Ervebo might not work as well if you get blood or blood products 3 months before or up to 1 month after vaccination. 
Cepivo Ervebo namreč morda ne bo delovalo enako dobro, če dobite kri ali krvne izdelke v 3 mesecih pred cepljenjem ali do 1 mesec po cepljenju.
The vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding or bruising may occur following an intramuscular administration in these individuals. 
Cepivo je treba previdno dajati osebam s trombocitopenijo ali kakršno koli drugo motnjo strjevanja krvi, ker se lahko pri takšnih osebah po intramuskularnem injiciranju pojavijo krvavitev ali podplutbe.
In view of the declared Public Health Emergency of International Concern and in order to ensure early supply this medicinal product is subject to a time-limited exemption allowing reliance on batch control testing conducted in the registered site(s) that are located in a third country. 
Zaradi razglasitve izrednih razmer mednarodnih razsežnosti na področju javnega zdravja in za zagotovitev zgodnje preskrbe je za to zdravilo na podlagi časovno omejene izjeme dovoljeno priznavanje kontrolnega testiranja serij, opravljenega na odobrenem (odobrenih) mestu (mestih) v tretji državi.
The final primary analysis was to assess efficacy against laboratory confirmed EVD by comparing incidence of cases occurring 10 to 31 days post-randomization for those vaccinated in the immediate vaccination rings versus incidence of cases for subjects who consented on Day 0 in the delayed vaccination rings. 
Namen primarne analize je bila ocena učinkovitosti proti laboratorijsko potrjeni eboli s primerjavo pojavnosti primerov, ki so se pojavili od 10 do 31 dni po randomizaciji med osebami v krogih takojšnjega cepljenja, s pojavnostjo primerov med osebami, na dan 0 vključenimi v kroge odloženega cepljenja.
Placebo Group 
Skupina s placebom
SOLUTION FOR INJECTION IN VIAL - PACK OF 10 
RAZTOPINA ZA INJICIRANJE V VIALI - PAKIRANJA PO 10
The median duration of arthritis across clinical trials in which arthritis was reported ranged from 2 days to 81.5 days (including duration of recurrent arthritis) with a maximum of 330 days. 
Mediano trajanje artritisa je bilo v tistih kliničnih preskušanjih, v katerih so o njem poročali, od 2 dni do 81,5 dneva (vključno s trajanjem ponovljenega artritisa) in največ 330 dni.
• Use of PPE (to block splashes or other contact with infected materials) 
• uporabo opreme za osebno zaščito (za preprečitev obrizganja in drugih stikov z okuženim materialom)
Immunogenicity testing has been performed in Protocol 009, Protocol 011 and Protocol 012, and includes the assessment of binding immunoglobulin G (IgG) specific to purified Kikwit ZEBOV GP by validated enzyme linked immunosorbent assay (GP-ELISA) as well as validated neutralization of vaccine virus by a plaque reduction neutralization test (PRNT). 
Testiranje imunogenosti so izvedli v Protokolu 009, Protokolu 011 in Protokolu 012; to testiranje vključuje oceno vezave imunoglobulina G (IgG), specifičnega za prečiščeni Kikwit ZEBOV GP, z validiranim encimskoimunskim testom (GP-ELISA) in validirano nevtralizacijo cepilnega virusa s testom PRNT (plaque reduction neutralization test).
Vaccination with Ervebo may not result in protection in all vaccinees. 
Cepljenje s cepivom Ervebo morda ne bo zaščitilo vseh cepljenih oseb.
If breakage/spillage were to occur, disinfectants such as aldehydes, alcohols and detergents are proven to reduce viral infection potential after only a few minutes. 
Če se viala razbije ali se cepivo polije, je dokazano, da dezinfekcijska sredstva (kot so aldehidi, alkoholi in detergenti) že po samo nekaj minutah zmanjšajo virusni infekcijski potencial.
Pack size of 10 vials. 
Velikost pakiranja z 10 vialami.
The active substance is a living Vesicular Stomatitis Virus. 
Učinkovina je živ virus vezikularnega stomatitisa.
Your healthcare worker may recommend that you receive this vaccine in an emergency involving the spread of Ebola virus disease. 
Zdravstveni delavec vam bo morda svetoval, da prejmete to cepivo v nujnih razmerah širjenja ebole.
As shown in Tables 2 and 3, the geometric mean titers (GMT) of GP-ELISA and PRNT increased from pre-vaccination to post-vaccination. 
Kot prikazujeta preglednici 2 in 3, so se geometrični srednji titri (GMT - geometric mean titers) GPELISA in PRNT po cepljenju povečali v primerjavi z vrednostmi pred cepljenjem.
As a precautionary measure, it is preferable to avoid the use of Ervebo in individuals with known immunocompromised conditions or receiving immunosuppressive therapy, including the following conditions: 
Zaradi previdnosti se je uporabi cepiva Ervebo najbolje izogniti pri osebah z znano imunsko oslabelostjo ali osebah, ki prejemajo imunosupresivno zdravljenje, vključno z naslednjimi stanji:
If you have any further questions on the use of this vaccine, ask your healthcare worker. 
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravstvenim delavcem.
When in close contact (within 1 metre) of patients with Ebola Virus Disease, healthcare workers should wear face protection (a face shield or a medical mask and goggles), a clean, non-sterile long-sleeved gown, and gloves (sterile gloves for some procedures). 
Zdravstveni delavci, ki so v tesnem stiku (znotraj 1 metra) z bolniki z ebolo, morajo nositi zaščito za obraz (obrazni ščitnik ali medicinsko masko in očala), čisto, nesterilno obleko z dolgimi rokavi in rokavice (sterilne rokavice za nekatere postopke).
Protocols 009 and 011 used gamma irradiation of specimens to reduce risk of wild-type Ebola virus infection of laboratory workers 
V protokolih 009 in 011 je bilo uporabljeno obsevanje vzorcev z žarki gama za zmanjšanje tveganja okužbe laboratorijskih delavcev z divjim tipom virusa Ebola.
• Safe injection practices 
• varne postopke injiciranja
• Ervebo is available in a pack of 10 vials. 
• Cepivo Ervebo je na voljo v pakiranjih, ki vsebujejo po 10 vial.
• someone who has a weak immune system. 
• osebo, ki ima šibek imunski sistem.
The presence of a minor infection should not result in deferral of vaccination. 
Prisotna blaga okužba ne sme biti vzrok za odložitev cepljenja.
The vaccine will not prevent disease caused by Filoviruses other than Zaire Ebola virus. 
To cepivo ne prepreči bolezni, ki jih povzročajo drugi filovirusi in ne virus Ebola Zaire.
The need for a booster dose has not been established. 
Potreba po obnovitvenem odmerku ni ugotovljena.
See description of selected adverse reactions. 
Glejte opis izbranih neželenih učinkov.
• Diseases of the blood such as leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems. 
• Krvne bolezni, na primer levkemija, katera koli vrsta limfoma ali druge maligne novotvorbe, ki vplivajo na krvotvorni in limfatični sistem.
Do not use alcohol-based hand sanitiser when hands are soiled with dirt, blood, or other body fluids. 
Ne uporabljajte sredstev za čiščenje rok na osnovi alkohola, če so roke onesnažene z umazanijo, krvjo ali drugimi telesnimi tekočinami.
In this trial, 8,673 adult subjects were enrolled and 8,651 with valid consents randomized to immediate (within 7 days of enrolment) or deferred (18 to 24 weeks after enrolment) vaccination with Ervebo. 
V to preskušanje je bilo vključenih 8.673 odraslih in 8.651 z veljavnimi soglasji so randomizirali na takojšnje (v 7 dneh po vključitvi) ali odloženo (od 18 do 24 tednov po vključitvi) cepljenje s cepivom Ervebo.
This leaflet was last revised in MM/YYYY 
Navodilo je bilo nazadnje revidirano dne MM. LLLL.
CI = Confidence interval; GMT = Geometric mean titer; PRNT = Plaque Reduction Neutralization Test *Protocol 011 from Month 9-12 
IZ = interval zaupanja, GMT = geometrični srednji titer, PRNT = nevtralizacijski test redukcije plakov *Protokol 011 od 9. do 12. meseca
Not applicable. 
ni relevantno
A decision must be made whether to discontinue breast-feeding or to abstain from Ervebo taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba ali za prenehanje dojenja ali za opustitev cepljenja s cepivom Ervebo, upoštevaje koristi dojenja za otroka in koristi cepljenja za žensko.
Clinical immunogenicity 
Klinična imunogenost
Table 1: Tabulated summary of adverse reactions considered related to vaccination MedDRA-System Organ Class Adverse Reactions 
Preglednica 1: Povzetek neželenih učinkov, ki veljajo za povezane s cepljenjem Organski sistem