FrancophonIA/ELRC3.0 huggingface dataset:
English: Upon removal from the freezer, the product should be marked with both the date that it was taken out of the freezer and also a new discard date (in place of the labelled expiry date).
Slovenian: Po odstranitvi iz zmrzovalnika je treba označiti datum, ko je bilo cepivo vzeto iz zmrzovalnika, in novi datum, ko je cepivo treba zavreči (na mesto označenega roka uporabnosti).
English: • Put the used plasters and bandages in a sealed container, if possible, and throw them away in the garbage bin to avoid having animals come into contact with the plasters and bandages.
Slovenian: • Uporabljene obliže in povoje dajte v zapečaten vsebnik, če je to mogoče, in jih zavrzite v koš za smeti, da preprečite, da bi živali prišle v stik z obliži in povoji.
English: It is given as a single injection (dose of 1 mL) in the top of your arm or the outside of your thigh.
Slovenian: Dobili ga boste v enkratni injekciji (1-ml odmerek) v nadlaket ali v zunanji del stegna.
English: There is no need to use antimicrobial soaps for washing hands.
Slovenian: Umivanje rok s protimikrobnimi mili ni potrebno.
English: Immunization of subjects with the vaccine results in an immune response and protection from Zaire Ebola Virus Disease (EVD).
Slovenian: Cepljenje preiskovancev s tem cepivom je povzročilo imunski odziv in zaščito pred boleznijo zaradi virusa Ebola Zaire.
English: There are limited amount of data (less than 300 pregnancy outcomes) from the use of Ervebo in pregnant women, or women who became pregnant after receiving the vaccine.
Slovenian: Podatkov o uporabi cepiva Ervebo pri nosečnicah in ženskah, ki so zanosile po prejetju cepiva, je malo (manj kot 300 izidov nosečnosti).
English: When Ervebo was administered to female rats, antibodies against the vaccine virus were detected in foetuses and offspring, likely due to trans-placental transfer during gestation and with the acquisition of maternal antibodies during lactation, respectively (see section 4.6).
Slovenian: Ko je bilo cepivo Ervebo uporabljeno pri podganjih samicah, so pri plodovih in mladičih ugotovili protitelesa proti cepilnemu virusu, verjetno zaradi prenosa maternalnih protiteles skozi placento med brejostjo (pri plodovih) oz. z dojenjem (pri mladičih) (glejte poglavje 4.6).
English: If you think you might have a weak immune system, ask your healthcare worker if you should receive this vaccine.
Slovenian: Če menite, da imate šibek imunski sistem, se v primeru predvidenega cepljenja s tem cepivom posvetujte z zdravstvenim delavcem.
English: The safety of Ervebo has not been established in pregnant women.
Slovenian: Varnost cepiva Ervebo pri nosečnicah ni dokazana.
English: Continue to follow your healthcare worker's recommendations to protect yourself from Ebola infection after you get this vaccine.
Slovenian: Po opravljenem cepljenju še naprej upoštevajte navodila zdravstvenega delavca, da se boste zaščitili pred okužbo z virusom Ebola.
English: Concurrent illness
Slovenian: Sočasne bolezni
English: Store and transport frozen at -80°C to -60°C.
Slovenian: Shranjujte in prevažajte zmrznjeno pri temperaturi od -80 °C do -60 °C.
English: The preferred injection site is the deltoid area of the non-dominant arm or in the higher anterolateral area of the thigh.
Slovenian: Najbolje ga je injicirati v deltoidni predel nedominantne roke ali v zgornji anterolateralni predel stegna.
English: The preferred site is the deltoid area of the non-dominant arm or in the higher anterolateral area of the thigh.
Slovenian: Najbolje ga je aplicirati v deltoidni predel nedominantne roke ali v zgornji anterolateralni predel stegna.
English: Vaccination with Ervebo does not eliminate the necessity of standard precautions when caring for patients with known or suspected Ebola disease.
Slovenian: Cepljenje s cepivom Ervebo ne odpravlja potrebe po običajnih previdnostnih ukrepih v primeru nege bolnikov za katere je znano, da imajo ebolo, ali pri katerih obstaja sum nanjo.
English: Recombinant human serum albumin, trometamol buffer, water for injections, hydrochloric acid, sodium hydroxide
Slovenian: rekombinantni humani serumski albumin, trometamolijev pufer, voda za injekcije, klorovodikova kislina, natrijev hidroksid
English: • Upon removal from the freezer, the product should be marked with both the date that it was taken out of the freezer and also a new discard date (in place of the labelled expiry date).
Slovenian: • Po odstranitvi iz zmrzovalnika je treba označiti datum, ko je bilo cepivo vzeto iz zmrzovalnika, in novi datum, ko je cepivo treba zavreči (na mesto označenega roka uporabnosti).
English: Immunocompromised individuals may not respond as well as immunocompetent individuals to Ervebo.
Slovenian: Imunsko oslabele osebe se lahko na cepivo Ervebo ne odzovejo tako dobro kot imunsko sposobne.
English: Dispose of contaminated bandages following institutional guidelines or WHO healthcare waste management policy.
Slovenian: Kontaminirane povoje zavrzite v skladu s smernicami v ustanovi ali politiko Svetovne zdravstvene organizacije za ravnanje z zdravstvenimi odpadki.
English: Arthralgia was generally reported in the first few days following vaccination, was mild to moderate in intensity, and resolved within one week after onset.
Slovenian: O artralgiji so na splošno poročali v prvih nekaj dneh po cepljenju, bila je blaga do zmerna in je minila v enem tednu po pojavu.
English: Ervebo might make you bleed or bruise where the vaccine is injected.
Slovenian: Cepivo Ervebo namreč lahko povzroči krvavitev ali podplutbo na mestu, kjer je injicirano.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: • Feeling tired,
Slovenian: • utrujenost
English: Ask your healthcare worker how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja cepiva, ki ga ne uporabljate več, se posvetujte z zdravstvenim delavcem.
English: 31 Jan 2020
Slovenian: 31. januar 2020
English: Transmission
Slovenian: Prenos
English: The clinical development program included four Phase 2/3 (Protocols 009-012) clinical trials.
Slovenian: Program kliničnega razvoja je obsegal štiri klinična preskušanja 2./3.
English: • Store and transport frozen at -80°C to -60°C.
Slovenian: • Shranjujte in prevažajte zamrznjeno pri temperaturi od -80 °C do -60 °C.
English: Ervebo consists of a live, attenuated recombinant vesicular stomatitis virus-based vector expressing the envelope glycoprotein gene of Zaire Ebola virus (rVSVΔG-ZEBOV-GP).
Slovenian: Cepivo Ervebo vsebuje živ, oslabljen vektor na podlagi rekombinantnega virusa vezikularnega stomatitisa, ki ima izražen gen za glikoprotein ovojnice virusa Ebola Zaire (rVSVΔG-ZEBOV-GP).
English: Ervebo administered to female rats had no effects on mating performance, fertility, or embryonic/foetal development.
Slovenian: Cepivo Ervebo, uporabljeno pri podganjih samicah, ni vplivalo na sposobnost parjenja, plodnost ali razvoj zarodka/ploda.
English: It is unknown whether the vaccine virus is secreted in human milk.
Slovenian: Ni znano, ali se cepilni virus izloča v materino mleko.
English: • Ervebo is given to protect you from getting Ebola virus disease caused by the Zaire Ebola virus,
Slovenian: • Cepivo Ervebo uporabljamo, da bi vas pomagalo zaščititi pred ebolo, ki jo povzroča virus Ebola
English: In some people joint pain and swelling may come back after initially going away.
Slovenian: Nekaterim osebam se lahko bolečine v sklepih in oteklost sklepov ponovijo, potem ko so že minile.
English: Summary of Geometric Mean Titers for the PRNT from Protocols 009, 011 and 012 Clinical Trials
Slovenian: Povzetek geometrične sredine titrov za PRNT iz kliničnih preskušanj Protokol 009, 011 in 012
English: • You can catch Ebola from blood and body fluids like urine, stools, saliva, vomit, sweat, breast milk, semen and vaginal fluids of people who are infected with Ebola virus.
Slovenian: • Ebole se lahko nalezete preko krvi in telesnih tekočin, na primer urina, blata, sline, izbruhane vsebine, znoja, materinega mleka, semenske tekočine in nožničnih izločkov žensk, okuženih z virusom Ebola.
English: Pregnant and breast-feeding women
Slovenian: Nosečnice in doječe ženske
English: This product contains genetically modified organisms.
Slovenian: To zdravilo vsebuje gensko spremenjene organizme.
English: The other excipients are recombinant human serum albumin, trometamol buffer, water for injections, hydrochloric acid, sodium hydroxide.
Slovenian: Druge sestavine cepiva so rekombinantni humani serumski albumin, trometamolijev pufer, voda za injekcije, klorovodikova kislina, natrijev hidroksid.
English: CI = Confidence interval; GP-ELISA = Anti-Glycoprotein Human Enzyme-Linked Immunosorbent Assay (EU/mL); GMT = Geometric mean titer *Protocol 011 from Month 9-12
Slovenian: IZ = interval zaupanja, GP-ELISA = antiglikoproteinski humani encimskoimunski test (E.e./ml), GMT = geometrični srednji titer.
English: Put the used plasters and bandages in a sealed container, if possible, and throw them in the waste bin to to make sure that people with a weak immune system or animals do not come into contact with the plasters and bandages.
Slovenian: Uporabljene obliže in povoje dajte v zapečaten vsebnik, če je to mogoče, in jih zavrzite v koš za smeti, da zagotovite, da osebe s šibkim imunskim sistemom ali živali ne pridejo v stik z obliži in povoji.
English: • Keep the vial in the outer carton in order to protect from light.
Slovenian: • Viale shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: When Ervebo is administered to female rats, antibodies against the vaccine virus were detected in offspring, likely due to acquisition of maternal antibodies via placental transfer during gestation and via lactation.
Slovenian: Če je bilo cepivo Ervebo uporabljeno pri podganjih samicah, so pri mladičih ugotovili protitelesa proti cepilnemu virusu, verjetno zaradi pridobitve maternalnih protiteles skozi placento med brejostjo in z dojenjem.
English: The most common systemic adverse reactions reported following vaccination with Ervebo were headache (36.9%), pyrexia (34.3%), myalgia (32.5%), fatigue (18.5%), arthralgia (17.1%), nausea
Slovenian: Najpogostejši sistemski neželeni učinki, o katerih so poročali po cepljenju s cepivom Ervebo, so bili glavobol (36,9 %), zvišana telesna temperatura (34,3 %), mialgija (32,5 %), utrujenost (18,5 %), artralgija (17,1 %), navzea (8,0 %), mrzlica (6,3 %), artritis (3,7 %), izpuščaj (3,6 %), hiperhidroza (3,2 %) in bolečina v trebuhu (1,4 %).
English: No data are available for administration via the subcutaneous or intradermal routes.
Slovenian: Podatkov o subkutanem ali intradermalnem apliciranju ni.
English: live, attenuated) ≥72 million pfu Recombinant Vesicular Stomatitis Virus (rVSV) strain Indiana with a deletion of the VSV envelope glycoprotein (G) replaced with the Zaire Ebola Virus (ZEBOV) Kikwit 1995 strain surface glycoprotein (GP) Produced in Vero cells.
Slovenian: , z živimi oslabljenimi virusi) ≥ 72 milijonov pfu rekombinantni virus vezikularnega stomatitisa (rVSV) seva Indiana z delecijo glikoproteina (G) ovojnice VSV in njegovo nadomestitvijo s površinskim glikoproteinom (GP) virusa Ebola Zaire (ZEBOV - Zaire Ebola Virus) seva Kikwit 1995 pridobljeno v celicah Vero pfu = plakotvorne enote
English: Discard the vaccine if it is not used by the end of 14 days.
Slovenian: Če cepiva ne uporabite v 14 dneh, ga zavrzite.
English: The thawed vial should then be gently inverted several times prior to withdrawal with the syringe.
Slovenian: Odtajano vialo je treba pred odvzemom cepiva z brizgo večkrat previdno obrniti.
English: The vaccine virus RNA was detected in a skin vesicle at 12 days post-vaccination in one of the four subjects.
Slovenian: Pri enem od štirih preiskovancev so virusno RNA zaznali v kožnih mehurčkih 12 dni po cepljenju.
English: Protocol 012 Combined Consistency Lots Group
Slovenian: Združena skupina konsistenčnih serij
English: The MAH should provide additional data to confirm that the finished product (FP) process is properly validated.
Slovenian: Imetnik dovoljenja za promet s cepivom mora predložiti dodatne podatke, ki potrjujejo, da je postopek izdelave gotovega zdravila ustrezno validiran.
English: • generalized itching, redness, flushing or itchy bumps on the skin.
Slovenian: • po vsem telesu prisotno srbenje, pordelost, zardevanje ali srbeče bulice na koži.
English: Individuals administered Ervebo should not donate blood for at least 6 weeks post-vaccination.
Slovenian: Osebe, ki prejmejo cepivo Ervebo, vsaj 6 tednov po cepljenju ne smejo darovati krvi.
English: Cover the vaccination injection site or any vesicles with an adequate bandage (e.g. any adhesive bandage or gauze and tape) that provides a physical barrier to protect against direct contact (see sections 4.4 and 5.3).
Slovenian: Mesto injiciranja ali kakršne koli mehurčke na koži prekrijte z ustreznim povojem (npr. s kakršnim koli obližem ali gazo in trakom), ki zagotavlja fizično pregrado za zaščito pred neposrednim stikom (glejte poglavji 4.4 in 5.3).
English: Cover the vaccination site or any vesicles with an adequate bandage (e.g. any adhesive bandage or gauze and tape) that provides a physical barrier to protect against direct contact with vesicle fluid (see section 4.2).
Slovenian: Mesto cepljenja ali kakršne koli mehurčke na koži pokrijte z ustreznim povojem (npr. s kakršnim koli obližem ali gazo in trakom), ki zagotavlja fizično pregrado za zaščito pred neposrednim stikom s tekočino mehurčkov (glejte poglavje 4.2).
English: Talk to your healthcare worker before you receive Ervebo if you:
Slovenian: Preden prejmete cepivo Ervebo, se posvetujte z zdravstvenim delavcem, če:
English: Discard the vaccine if particulates are present.
Slovenian: Če so prisotni delci, cepivo zavrzite.
English: Cover the injection site with gauze or bandage (e.g. any adhesive bandage or gauze and tape) that provides a physical barrier to protect against direct contact with vesicle fluid.
Slovenian: Mesto injiciranja pokrijte z gazo ali povojem (npr. s kakršnim koli obližem ali gazo in trakom), ki zagotavlja fizično pregrado za zaščito pred neposrednim stikom s tekočino mehurčka.
English: High Dose Group
Slovenian: Skupina z velikim odmerkom
English: Standard precautions when caring for patients with known or suspected Ebola disease
Slovenian: Običajni previdnostni ukrepi pri oskrbi bolnikov, za katere je znano, da imajo ebolo, ali pri katerih obstaja sum nanjo
English: • Stomach pain,
Slovenian: • bolečine v trebuhu
English: Put the used plasters and bandages in a sealed container, if possible, and throw them away in the garbage bin to avoid having people with a weak immune system come into contact with the plasters and bandages.
Slovenian: Uporabljene obliže in povoje dajte v zapečaten vsebnik, če je to mogoče, in jih zavrzite v koš za smeti, da osebe s šibkim imunskim sistemom ne pridejo v stik z obliži in povoji.
English: • Any unused vaccine or waste material should be disposed of in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste, as appropriate.
Slovenian: • Neuporabljeno cepivo ali odpadni material zavrzite v skladu s smernicami, ki v ustanovi veljajo za odpadke z genetsko spremenjenimi organizmi ali za biološko nevarne odpadke, kot je ustrezno.
English: Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP
Slovenian: cepivo proti virusu Ebola Zaire (rVSVΔG-ZEBOV-GP
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: • Headache,
Slovenian: • glavobol
English: • Use alcohol-based hand sanitiser when hands are not dirty.
Slovenian: • Če roke niso umazane, uporabite sredstvo za čiščenje rok na osnovi alkohola.
English: Solution for injection The solution is a colourless to slightly brownish-yellow liquid.
Slovenian: raztopina za injiciranje Raztopina je brezbarvna do rahlo rjavorumena tekočina.
English: • You may test positive for Ebola virus after you receive Ervebo.
Slovenian: • Potem ko ste prejeli cepivo Ervebo, imate lahko pozitiven izvid testa za ebolo.
English: • Contact with blood and body fluids (such as urine, faeces, saliva, sweat, vomit, breast milk,
Slovenian: • Stiku s krvjo in telesnimi tekočinami (na primer z urinom, blatom, slino, znojem, izbruhano vsebino, materinim mlekom, semensko in nožnično tekočino).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih in vpliva na sposobnost razmnioževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Individuals who develop vesicular rash after receiving the vaccine should cover the vesicles until they heal.
Slovenian: Osebe, ki se jim po cepljenju pojavi vezikularen izpuščaj, morajo mehurčke pokrivati, dokler se ne pozdravijo.
English: How to store Ervebo
Slovenian: Kako boste prejeli cepivo Ervebo
English: This vaccine will not protect you against the other types of Ebola virus.
Slovenian: Zaire, vrsta virusa Ebola.To cepivo vas ne bo zaščitilo pred drugimi vrstami virusov Ebola.
English: Vaccine recipients should attempt to avoid exposure of livestock to blood and bodily fluids for at least 6 weeks following vaccination.
Slovenian: Prejemniki cepiva naj se vsaj 6 tednov po cepljenju poskusijo izogibati izpostavljanju živine krvi in telesnim tekočinam.
English: In a small number of subjects, the vaccine virus was recovered from joint effusion samples, suggestive of a virally-mediated process postvaccination.
Slovenian: Pri majhnem številu preiskovancev so v vzorcih sklepnega izliva našli cepilni virus; to kaže na virusno pogojeno dogajanje po cepljenju.
English: • If you get any side effects, talk to your healthcare worker.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravstvenim delavcem.
English: Vaccine recipients should avoid close contact with and exposure of high-risk individuals to blood and bodily fluids for at least 6 weeks following vaccination.
Slovenian: Prejemniki cepiva naj se vsaj 6 tednov po cepljenju izogibajo tesnemu stiku z osebami, ki imajo veliko tveganje, in izpostavljanju takšnih oseb krvi ali telesnim tekočinam.
English: Water for injections Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Slovenian: 6.1 Seznam pomožnih snovi rekombinantni humani serumski albumin trometamolijev pufer voda za injekcije klorovodikova kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH)
English: • Safe burial practices
Slovenian: • varnimi postopki pokopa
English: Protocol 011 named Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was a Phase 2/3 randomized open-label trial which evaluated safety and immunogenicity of Ervebo in adults ≥18 years of age working in healthcare facilities or on frontline activities related to the Ebola response in Sierra Leone.
Slovenian: faze, ki je ovrednotilo varnost in imunogenost cepiva Ervebo pri odraslih, starih ≥ 18 let, ki so delali v zdravstvenih ustanovah ali so sodelovali v frontnih dejavnostih, povezanih z odzivom na ebolo v Sierri Leone.
English: Anaphylactic reaction
Slovenian: anafilaktična reakcija zelo redki
English: Any unused vaccine or waste material should be disposed in compliance with the institutional guidelines for genetically modified organisms or biohazardous waste, as appropriate.
Slovenian: Neuporabljeno cepivo ali odpadni material zavrzite v skladu s smernicami, ki v ustanovi veljajo za odpadke z genetsko spremenjenimi organizmi ali za biološko nevarne odpadke, kot je ustrezno.
English: Transient decrease in white blood cells
Slovenian: Prehodno zmanjšanje števila levkocitov
English: Have a bleeding disorder or bruise easily
Slovenian: Če imate kakšno motnjo strjevanja krvi ali ste nagnjeni k podplutbam
English: • Ervebo is a colourless to slightly brownish-yellow liquid.
Slovenian: • Cepivo Ervebo je brezbarvna do rahlo rjavorumena tekočina.
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine, ATC code: J07BX02
Slovenian: Oznaka ATC: J07BX02
English: Do not receive Ervebo if you:
Slovenian: Cepiva Ervebo ne smete prejeti:
English: clusters) vaccinated in the immediate arm and 1,429 subjects (46 clusters) eligible and consented on Day 0 in the delayed arm.
Slovenian: Končna primarna analiza je zajela 2.108 oseb (51 gruč) iz skupine s takojšnjim cepljenjem in 1.429 oseb (46 gruč), ki so bile na dan 0 primerne in so dale soglasje za vključitev v študijo, iz skupine z odloženim cepljenjem.
English: Ervebo should be administered by the intramuscular (IM) route.
Slovenian: Cepivo Ervebo mora biti injicirano intramuskularno (i.m.)
English: What Ervebo contains
Slovenian: Kaj vsebuje cepivo Ervebo
English: After thawing, the vaccine should be used immediately; however, in-use stability data have demonstrated that once thawed, the vaccine can be stored for up to 14 days at 2°C to 8°C prior to use.
Slovenian: Vendar pa so podatki o stabilnosti med uporabo pokazali, da je mogoče po odtajanju cepivo pred uporabo shranjevati do 14 dni pri temperaturi od 2 do 8 °C.
English: • Ervebo should be administered intramuscularly.
Slovenian: • Cepivo Ervebo injicirajte intramuskularno.
English: Ervebo solution for injection rVSVΔG-ZEBOV-GP, live IM
Slovenian: Ervebo raztopina za injiciranje rVSVΔG-ZEBOV-GP, z živimi virusi i.m.
English: • If you get a rash where the skin is broken after receiving Ervebo, cover it until it heals.
Slovenian: • Če se vam po prejetju cepiva Ervebo na poškodovani koži pojavi izpuščaj, ga pokrijte, dokler se ne pozdravi.
English: Immunocompromised individuals
Slovenian: Imunsko oslabeli bolniki
English: Thrombocytopenia and coagulation disorders
Slovenian: Trombocitopenija in motnje strjevanja krvi
English: If you get any side effects, talk to your healthcare worker.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravstvenim delavcem.
English: If you get a rash where the skin is broken after receiving Ervebo, cover it until it heals.
Slovenian: Če se vam po prejetju cepiva Ervebo na poškodovani koži pojavi izpuščaj, ga pokrijte, dokler se ne pozdravi.
English: Ervebo solution for injection Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live)
Slovenian: Ervebo raztopina za injiciranje cepivo proti virusu Ebola Zaire (rVSVΔG-ZEBOV-GP, z živimi virusi)
English: This is because you could pass the vaccine to them through your body fluids.
Slovenian: Viruse iz cepiva bi namreč na takšno osebo lahko prenesli s svojimi telesnimi tekočinami.
English: • If you might be in close contact with, or in the same household as someone who may be pregnant or breast-feeding during the 6 weeks after you receive Ervebo, tell your healthcare worker.
Slovenian: • Zdravstvenemu delavcu morate povedati, če boste v 6 tednih po cepljenju s cepivom Ervebo morda v tesnem stiku ali v istem gospodinjstvu z osebo, ki je morda noseča ali doji.
English: The MAH should provide additional data to confirm that the active substance (AS) process is properly validated.
Slovenian: Imetnik dovoljenja za promet s cepivom mora predložiti dodatne podatke, ki potrjujejo, da je postopek izdelave učinkovine ustrezno validiran.
English: • Withdraw the entire content of the vaccine from the vial using a sterile needle and syringe.
Slovenian: • S sterilno iglo in injekcijsko brizgo iz viale izvlecite celotno vsebino cepiva.
English: • Contact with bats, apes and monkeys or with blood, fluids and raw meat prepared from these animals (bushmeat) or meat from an unknown source.
Slovenian: tekočinami in surovim mesom teh živali in z mesom neznanega izvora.
English: • Fever,
Slovenian: • mrzlica
English: • Withdraw the entire content of Ervebo from the vial using a sterile needle and syringe.
Slovenian: • S sterilno iglo in injekcijsko brizgo iz viale izvlecite celotno vsebino cepiva Ervebo.
English: Month 12* GMT (n) [95% CI]
Slovenian: 12. mesec* GMT (n) [95 % IZ]