natgillin/translations-raw huggingface dataset:
This being a conditional marketing authorisation and pursuant to Article 14-a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14-a(4) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
• Avoid contact with blood and body fluids
• preprečevanjem stika s krvjo in telesnimi tekočinami
• Ervebo is a vaccine for adults who are 18 years of age and older.
• Cepivo Ervebo je cepivo za odrasle, stare 18 let ali več.
Implementation of EU based batch control arrangements, including the necessary variations to the terms of the marketing authorisation, has to be completed by the 31 July 2022 at the latest, in line with the agreed plan for this transfer of testing.
Uveljavitev ureditve kontrole serij v EU, vključno s potrebnimi spremembami pogojev dovoljenja za promet, mora biti končana najpozneje do 31. julija 2022, v skladu z dogovorjenim načrtom za ta prenos testiranja.
Washing your hands correctly is the most effective way to prevent the spread of dangerous germs, like Ebola virus.
Pravilno umivanje rok je najučinkovitejši način za preprečevanje širjenja nevarnih klic, kakršna je virus Ebola.
• swelling of the face, lips, tongue, or other parts of the body,
• oteklost obraza, ustnic, jezika ali drugih delov telesa,
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Pogostnosti so navedene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega cepiva.
For precautions regarding thawing, handling and disposal of the vaccine, see section 6.6.
Za previdnostne ukrepe glede odtajanja, ravnanja in odstranjevanja cepiva glejte poglavje 6.6.
Very common (may affect more than 1 in 10 people):
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb):
• someone who may be pregnant or breast-feeding,
• žensko, ki je morda noseča ali doji,
See sections 4.4 and 6.6 for further information.
Za dodatne informacije glejte poglavji 4.4 in 6.6.
If feasible, the waste liquid from eye washes should be collected and decontaminated before discarding into the drain.
Če je izvedljivo, je treba odpadno tekočino po izpiranju oči zbrati in dekontaminirati, preden se jo zavrže med odplake.
• Pregnant or breast-feeding women (see section 4.6),
• nosečnice in doječe ženske (glejte poglavje 4.6),
Lack of reliable data on background rates of pregnancy and neonatal outcomes in the affected regions also makes a contextual assessment of the data challenging.
Tudi zaradi pomanjkanja zanesljivih podatkov o izhodiščnih deležih nosečnosti in neonatalnih izidov v prizadetih regijah je kontekstualno ocenjevanje podatkov zahtevno.
Randomization was stopped after an interim analysis with a p=0.0036 that did not meet the prespecified alpha level of 0.0027.
Randomizacija je bila po vmesni analizi s p = 0,0036, ki ni ustrezala vnaprej določeni ravni alfa 0,0027, ustavljena.
If you do get the vaccine and have a weak immune system, the vaccine may not work as well as in people with a normal immune system.
Če prejmete cepivo in imate šibek imunski sistem, cepivo morda ne bo delovalo tako dobro kot pri ljudeh z normalnim imunskim sistemom.
However, infectious virus was detected at Day 1 and persistent infectious virus was not detected at any subsequent timepoints measured (Days 56, 84 and 112).
Toda infektivni virus je bil zaznan na 1. dan in persistence infektivnega virusa niso zaznali ob nobenem poznejšem času merjenja (56., 84. in 112. dan).
• are allergic to Ervebo, rice, or any of the other ingredients of this vaccine (listed in section 6).
• če ste alergični na cepivo Ervebo, riž ali katero koli sestavino tega cepiva (navedeno v poglavju 6).
Protection against filovirus disease
Zaščita pred boleznimi, ki jih povzročajo filovirusi
A risk to the newborns/infants from breast-feeding by vaccinated mothers cannot be excluded.
Z dojenjem povezanega tveganja za novorojenčke/dojenčke cepljenih mater ni mogoče izključiti.
All subjects received a single dose of vaccine.
Vsi preiskovanci so prejeli enkraten odmerek cepiva.
Although the clinical relevance of the GPELISA GMT as well as seroresponse is currently not known, based on available data it is expected that vaccine efficacy would apply to subjects from Guinea, Liberia, Sierra Leone, the United States, Canada, Europe, or other parts of the world.
Klinični pomen GMT GP-ELISA in serološkega odziva trenutno sicer ni znan, toda na podlagi podatkov, ki so na voljo, je pričakovati, da učinkovitost cepiva velja za preiskovance v Gvineji, Liberiji, Sierra Leone, ZDA, Kanadi, Evropi ali drugih delih sveta.
Are in contact with farm animals
Če ste v stiku z domačimi živalmi
Efficacy data was obtained in Protocol 010 in Guinea and immunogenicity data was obtained in Protocol 009 in Liberia, Protocol 011 in Sierra Leone, and Protocol 012 in the United States, Canada, and Europe.
Podatki o učinkovitosti so bili v Protokolu 010 zbrani v Gvineji, podatki o imunogenosti pa v Protokolu 009 v Liberiji, v Protokolu 011 v Sierri Leone in v Protokolu 012 v ZDA, Kanadi in Evropi.
For precautions to be taken before administering the vaccine, see section 4.4.
Za previdnostne ukrepe, potrebne pred dajanjem cepiva, glejte poglavje 4.4.
Joint pain and swelling may last for weeks or months in some people.
Bolečine v sklepih in oteklost sklepov lahko pri nekaterih osebah trajajo več tednov ali mesecev.
• wheezing or trouble breathing,
• piskajoče dihanje ali težave z dihanjem,
• Current immunosuppressive therapy, including high doses of corticosteroid.
• Trenutno imunosupresivno zdravljenje, vključno z velikimi odmerki kortikosteroidov.
There are no data on fertility effects in humans.
Podatkov o vplivih na plodnost pri človeku ni.
• Immunocompromised individuals and individuals receiving immunosuppressive therapy (see section above),
• imunsko oslabele osebe in osebe, ki prejemajo imunosupresivno zdravljenje (glejte poglavje zgoraj),
You should follow safe sex practices until you know the virus is gone from the semen.
Upoštevati morate ukrepe za varno spolnost, dokler ne veste, da virusa v semenski tekočini ni več.
Vaccine efficacy has been established in the period ≥10 to ≤31 days after vaccination, however the duration of protection is not known (see section 5.1).
Učinkovitost cepiva je bila ugotovljena v obdobju ≥ 10 do ≤ 31 dni po cepljenju, toda trajanje zaščite ni znano (glejte poglavje 5.1).
In certain circumstances, where alternatives to breastfeeding are limited, the immediate need and health benefits to the infant should be taken into consideration and balanced with the mother's need for Ervebo.
V določenih okoliščinah, v katerih so alternative dojenju omejene, je treba upoštevati neposredno potrebo in zdravstvene koristi za dojenčka in jih pretehtati glede na materino potrebo po cepivu Ervebo.
• After thawing, the vaccine should be used immediately.
• Po odtajanju naj bi cepivo uporabili takoj.
Certain white blood cell counts can decrease below normal after vaccination but this decrease has not resulted in illness and the counts return to normal.
Po cepljenju se lahko število določenih belih krvnih celic zmanjša pod normalno raven, vendar to ne povzroči bolezni in število se znova normalizira.
Because this vaccine is based on VSV, a known pathogen in livestock (e.g. horses, cattle, pigs), the risk assessment included species that are relevant for the wild type (wt) VSV backbone of this vaccine.
Ker to cepivo temelji na VSV, ki je znan patogen za živino (npr. za konje, govedo, prašiče), je ocena tveganja vključila živalske vrste, ki so relevantne za osnovno zgradbo divjega tipa (wt) VSV tega cepiva.
What Ervebo is and what it is used for
Kaj je cepivo Ervebo in za kaj ga uporabljamo
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