FrancophonIA/ELRC3.0 huggingface dataset:
English: Enbrel 25 mg solution for injection in pre-filled syringe etanercept
Slovenian: Enbrel 25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku etanercept
English: Enbrel 25 mg powder and solvent for solution for injection
Slovenian: Enbrel 25 mg prašek in vehikel za raztopino za injiciranje
English: Adding solvent
Slovenian: Dodajanje vehikla
English: Enbrel 25 mg powder and solvent for solution for injection Etanercept
Slovenian: Enbrel 25 mg prašek in vehikel za raztopino za injiciranje etanercept
English: Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Slovenian: Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila Enbrel so navedena v navodilu za uporabo, poglavje 7 "NAVODILA ZA PRIPRAVO IN DAJANJE INJEKCIJE ZDRAVILA ENBREL".
English: Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, “INSTRUCTIONS FOR PREPARATION AND GIVING AN INJECTION OF ENBREL”.
Slovenian: Obsežna navodila za pripravo in aplikacijo rekonstituirane viale zdravila Enbrel so navedena v navodilu za uporabo, poglavje 7 "Navodila za pripravo in dajanje injekcije zdravila Enbrel".
English: Methotrexate Enbrel
Slovenian: --Zdravilo Enbrel
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake ''Uporabno do'' ali ''Upor.
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with Enbrel use.
Slovenian: Pri uporabi zdravila Enbrel so poročali o redkih primerih demielinizacije centralnega in zelo redkih primerih demielinizacije perifernega živčevja.
English: • Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Enbrel.
Slovenian: Hepatitis B: Če ste vi ali vaš otrok kdaj imeli hepatitis B, o tem obvestite zdravnika.
English: How to store Enbrel
Slovenian: Shranjevanje zdravila Enbrel
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE - EU/1/99/126/016-018 (50 mg Pre-filled Syringe)
Slovenian: BESEDILO NA NAPOLNJENI INJEKCIJSKI BRIZGI - EU/1/99/126/016-018 (50 mg napolnjena injekcijska brizga)
English: Setting up for an injection
Slovenian: Priprava na injiciranje
English: In this study, most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving Enbrel.
Slovenian: Toda celokupno so bili titri zmerno nižji in malo bolnikov je imelo dvakraten porast titrov v primerjavi z bolniki, ki niso dobivali zdravila Enbrel.
English: A 50 mg strength of Enbrel is available for doses of 50 mg.
Slovenian: Napolnjeni injekcijski peresnik Enbrel je na voljo v jakostih 25 mg in 50 mg.
English: Treatment with Enbrel may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Slovenian: Če je bolnik pozitiven na HBV, je pred uvedbo zdravljenja z zdravilom Enbrel priporočljivo posvetovanje z zdravnikom specialistom za zdravljenje hepatitisa B. Pri dajanju zdravila Enbrel bolnikom, ki so že bili okuženi s HBV, je potrebna previdnost.
English: You have been prescribed a 25 mg strength of Enbrel.
Slovenian: Predpisali so vam zdravilo Enbrel v jakosti 25 mg. Za 50 mg odmerek je na voljo zdravilo Enbrel jakosti 50 mg.
English: With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 11).
Slovenian: Nato potisnite bat tako, da počasi in enakomerno injicirate vso raztopino (glejte sliko 11).
English: Pre-filled pen (MYCLIC) containing a 25 mg pre-filled syringe of Enbrel.
Slovenian: 25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Napolnjen injekcijski peresnik (MYCLIC), ki vsebuje 25 mg napolnjeno injekcijsko brizgo zdravila Enbrel.
English: Do not shake the pen.
Slovenian: Peresnika ne stresajte.
English: 1 Enbrel vial
Slovenian: gumijasti zamašek viala
English: Infect ions and infestations
Slovenian: invazivnih glivičnih okužb.
English: Pre-filled pen (MYCLIC) containing a 50 mg pre-filled syringe of Enbrel.
Slovenian: 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Napolnjen injekcijski peresnik (MYCLIC), ki vsebuje 50 mg napolnjeno injekcijsko brizgo zdravila Enbrel.
English: Laboratory workers are also at risk.
Slovenian: Tveganju so izpostavljeni tudi laboratorijski delavci.
English: Of the 10 cases, 7 were in contacts, and 3 in contacts-of-contacts.
Slovenian: Od teh 10 primerov jih je bilo 7 med kontakti in 3 med kontakti kontaktov.
English: Duration of protection
Slovenian: Trajanje zaščite
English: What is Ebola?
Slovenian: Kaj je ebola?
English: n = Number of subjects contributing to the analysis.
Slovenian: n = število preiskovancev, ki so prispevali k analizi.
English: Proper hand washing methods are described below.
Slovenian: Pravilni načini umivanja rok so opisani spodaj.
English: Transmission to animals and livestock
Slovenian: Prenos na živali in živino
English: Your healthcare worker might need to do another test.
Slovenian: Zdravstveni delavec bo morda moral narediti drug test.
English: Efficacy in children has not been assessed.
Slovenian: Učinkovitost pri otrocih ni bila ocenjena.
English: • Excessive sweating.
Slovenian: • prekomerno znojenje.
English: A progress report has to be included in the annual renewal application.
Slovenian: Poročilo o napredku mora biti vključeno v vlogi za letno podaljšanje.
English: This does not mean that you have Ebola.
Slovenian: To ne pomeni, da imate ebolo.
English: It reduces the number of germs on the hands and so reduces their spread from person to person.
Slovenian: Zmanjša število klic na rokah in tako zmanjša njihovo širjenje z ene osebe na drugo.
English: It is not known if it is safe and works in children and adolescents.
Slovenian: Ni znano, ali je za otroke in mladostnike varno in ali pri njih deluje.
English: Are in contact with vulnerable individuals
Slovenian: Če ste v stiku z ranljivimi osebami
English: If you or your child is under 18 years old, talk to your healthcare worker.
Slovenian: Če ste vi ali vaš otrok mlajši od 18 let, se posvetujte z zdravstvenim delavcem.
English: One dose (1 mL) contains:
Slovenian: En odmerek (1 ml) vsebuje:
English: A total of 1,197 healthy subjects 18 to 65 years of age were enrolled in the US, Canada, and Spain.
Slovenian: Vključenih je bilo skupaj 1.197 zdravih oseb, starih od 18 do 65 let, v ZDA, Kanadi in Španiji.
English: While in an area affected by Ebola, it is important to avoid the following:
Slovenian: Medtem ko ste na območju, ki ga je prizadela ebola, se morate izogibati naslednjemu:
English: Most side effects go away within a few days.
Slovenian: Večina neželenih učinkov mine v nekaj dneh.
English: The reasons for differences in arthritis reporting across trials are not known but may be due to differences in study populations or outcome reporting.
Slovenian: Razlogi za razlike v poročanju o artritisu med preskušanji niso znani, a morda gre za posledico razlik v študijskih populacijah ali razlik v poročanju o izidih.
English: • Ebola is not spread through the air, water or food.
Slovenian: • Ebola se ne širi po zraku, z vodo ali s hrano.
English: Impact to serological testing
Slovenian: Vpliv na serološko testiranje
English: 29 May 2020
Slovenian: 29. maj 2020
English: • babies who are less than 1 year old,
Slovenian: • dojenčki, mlajšimi od 1 leta starosti,
English: • Children <1 year of age.
Slovenian: • otroci, stari < 1 leto.
English: Have had allergic reactions to vaccines or medicines
Slovenian: Če ste imeli alergijske reakcije na cepiva ali zdravila
English: It is not known if Ervebo will harm you or your unborn baby.
Slovenian: Ni znano, ali cepivo Ervebo škoduje vam ali vašemu nerojenemu otroku.
English: The use of other Ebola control measures should therefore not be interrupted.
Slovenian: Uporabe drugih ukrepov za nadzor nad ebolo se zato ne sme prekiniti.
English: Serious side effects are rare.
Slovenian: Resni neželeni učinki so redki.
English: Do not thaw the vial in a refrigerator.
Slovenian: Viale ne odtajajte v hladilniku.
English: This exemption is subject to annual review and in any case ceases to be valid on 31 July 2022.
Slovenian: Ta izjema je predmet letnega pregleda in ne more biti daljša kot do 31. julija 2022.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega cepiva.
English: As there are limitations to available data, including the small number of cases, caution should be exercised in drawing conclusions.
Slovenian: Ker obstajajo omejitve glede razpoložljivih podatkov, ki vključujejo majhno število primerov, je pri sprejemanju odločitev potrebna previdnost.
English: Both may present compelling needs that should be considered before vaccination of the mother.
Slovenian: Oboje lahko predstavlja nujno potrebo in o tem je treba razmisliti pred cepljenjem matere.
English: No immune correlates of protection have been defined to date.
Slovenian: Imunološki korelati zaščite doslej niso bili opredeljeni.
English: Protocol 009
Slovenian: Protokol 009
English: High-risk individuals include:
Slovenian: Med osebami z velikim tveganjem so:
English: Get medical care right away if you have symptoms of an allergic reaction, which may include:
Slovenian: Nemudoma poiščite zdravniško pomoč, če se vam pojavijo simptomi alergijske reakcije, med katerimi so lahko:
English: The clinical relevance of the immunogenicity data is currently not known.
Slovenian: Klinični pomen teh podatkov o imunogenosti trenutno ni znan.
English: • you have HIV infection or AIDS,
Slovenian: • Če imate okužbo z virusom HIV ali imate aids,
English: Tell your healthcare worker if you are taking, have recently taken or might take any other medicines or vaccines.
Slovenian: Obvestite zdravstvenega delavca, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo ali cepivo.
English: The median age of consenting CCCs was 35 years old.
Slovenian: Mediana starost vključenih KKK je bila 35 let.
English: Vaccine virus RNA was mainly detected from Day 1 to Day 7.
Slovenian: RNA cepilnega virusa so v glavnem zaznali od 1. do 7. dne.
English: If your immune system is weak (which means your body is less able to fight off diseases), you might not be able to receive Ervebo.
Slovenian: Če imate šibek imunski sistem (to pomeni, da je vaše telo manj sposobno premagovati bolezni), morda ne boste mogli prejeti cepiva Ervebo.
English: The median durations reported were between 6 to 18 days.
Slovenian: Mediano trajanje je bilo med 6 do 18 dni.
English: Instructions on the handling of the vaccine before administration
Slovenian: Navodila za ravnanje s cepivom pred uporabo
English: Individuals 18 years of age or older: one dose (1 mL) (see section 5.1).
Slovenian: Osebe, stare 18 let ali več: 1 odmerek (1 ml) (glejte poglavje 5.1).
English: At the end of 14 days, the vaccine should be used or discarded.
Slovenian: Ob koncu 14-dnevnega obdobja je treba cepivo ali uporabiti ali zavreči.
English: The use of Ervebo should be in accordance with official recommendations.
Slovenian: Cepivo Ervebo je treba uporabljati v skladu z uradnimi priporočili.
English: Have a fever (high temperature)
Slovenian: Če imate zvišano telesno temperaturo (vročino)
English: To avoid unintended exposure to livestock, ensure medical waste and other cleaning materials do not come in contact with livestock.
Slovenian: Za preprečitev nenamerne izpostavljenosti živine je treba zagotoviti, da medicinski odpadki in drugi materiali za čiščenje ne pridejo v stik z živino.
English: Your healthcare worker will talk to you and then together you can decide if you should receive this vaccine.
Slovenian: Zdravstveni delavec se bo pogovoril z vami in skupaj se bosta odločila, ali naj prejmete cepivo.
English: 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:
Slovenian: 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:
English: • Avoid contact with blood and body fluids
Slovenian: • preprečevanjem stika s krvjo in telesnimi tekočinami
English: • Ervebo is a vaccine for adults who are 18 years of age and older.
Slovenian: • Cepivo Ervebo je cepivo za odrasle, stare 18 let ali več.
English: 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.
Slovenian: 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.
English: Washing your hands correctly is the most effective way to prevent the spread of dangerous germs, like Ebola virus.
Slovenian: Pravilno umivanje rok je najučinkovitejši način za preprečevanje širjenja nevarnih klic, kakršna je virus Ebola.
English: • swelling of the face, lips, tongue, or other parts of the body,
Slovenian: • oteklost obraza, ustnic, jezika ali drugih delov telesa,
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: For precautions regarding thawing, handling and disposal of the vaccine, see section 6.6.
Slovenian: Za previdnostne ukrepe glede odtajanja, ravnanja in odstranjevanja cepiva glejte poglavje 6.6.
English: Very common (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb):
English: • someone who may be pregnant or breast-feeding,
Slovenian: • žensko, ki je morda noseča ali doji,
English: See sections 4.4 and 6.6 for further information.
Slovenian: Za dodatne informacije glejte poglavji 4.4 in 6.6.
English: If feasible, the waste liquid from eye washes should be collected and decontaminated before discarding into the drain.
Slovenian: Če je izvedljivo, je treba odpadno tekočino po izpiranju oči zbrati in dekontaminirati, preden se jo zavrže med odplake.
English: • Pregnant or breast-feeding women (see section 4.6),
Slovenian: • nosečnice in doječe ženske (glejte poglavje 4.6),
English: 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.
Slovenian: Tudi zaradi pomanjkanja zanesljivih podatkov o izhodiščnih deležih nosečnosti in neonatalnih izidov v prizadetih regijah je kontekstualno ocenjevanje podatkov zahtevno.
English: Randomization was stopped after an interim analysis with a p=0.0036 that did not meet the prespecified alpha level of 0.0027.
Slovenian: Randomizacija je bila po vmesni analizi s p = 0,0036, ki ni ustrezala vnaprej določeni ravni alfa 0,0027, ustavljena.
English: 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.
Slovenian: Če prejmete cepivo in imate šibek imunski sistem, cepivo morda ne bo delovalo tako dobro kot pri ljudeh z normalnim imunskim sistemom.
English: 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).
Slovenian: 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).
English: • are allergic to Ervebo, rice, or any of the other ingredients of this vaccine (listed in section 6).
Slovenian: • če ste alergični na cepivo Ervebo, riž ali katero koli sestavino tega cepiva (navedeno v poglavju 6).
English: Protection against filovirus disease
Slovenian: Zaščita pred boleznimi, ki jih povzročajo filovirusi
English: A risk to the newborns/infants from breast-feeding by vaccinated mothers cannot be excluded.
Slovenian: Z dojenjem povezanega tveganja za novorojenčke/dojenčke cepljenih mater ni mogoče izključiti.
English: All subjects received a single dose of vaccine.
Slovenian: Vsi preiskovanci so prejeli enkraten odmerek cepiva.
English: 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.
Slovenian: 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.
English: Are in contact with farm animals
Slovenian: Če ste v stiku z domačimi živalmi
English: 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.
Slovenian: 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.
English: For precautions to be taken before administering the vaccine, see section 4.4.
Slovenian: Za previdnostne ukrepe, potrebne pred dajanjem cepiva, glejte poglavje 4.4.
English: Joint pain and swelling may last for weeks or months in some people.
Slovenian: Bolečine v sklepih in oteklost sklepov lahko pri nekaterih osebah trajajo več tednov ali mesecev.
English: • wheezing or trouble breathing,
Slovenian: • piskajoče dihanje ali težave z dihanjem,
English: • Current immunosuppressive therapy, including high doses of corticosteroid.
Slovenian: • Trenutno imunosupresivno zdravljenje, vključno z velikimi odmerki kortikosteroidov.
English: There are no data on fertility effects in humans.
Slovenian: Podatkov o vplivih na plodnost pri človeku ni.
English: • Immunocompromised individuals and individuals receiving immunosuppressive therapy (see section above),
Slovenian: • imunsko oslabele osebe in osebe, ki prejemajo imunosupresivno zdravljenje (glejte poglavje zgoraj),
English: You should follow safe sex practices until you know the virus is gone from the semen.
Slovenian: Upoštevati morate ukrepe za varno spolnost, dokler ne veste, da virusa v semenski tekočini ni več.
English: 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).
Slovenian: Učinkovitost cepiva je bila ugotovljena v obdobju ≥ 10 do ≤ 31 dni po cepljenju, toda trajanje zaščite ni znano (glejte poglavje 5.1).
English: 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.
Slovenian: 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.
English: • After thawing, the vaccine should be used immediately.
Slovenian: • Po odtajanju naj bi cepivo uporabili takoj.
English: 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.
Slovenian: Po cepljenju se lahko število določenih belih krvnih celic zmanjša pod normalno raven, vendar to ne povzroči bolezni in število se znova normalizira.
English: Protocol 011
Slovenian: Protokol 011
English: 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.
Slovenian: 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.
English: What Ervebo is and what it is used for
Slovenian: Kaj je cepivo Ervebo in za kaj ga uporabljamo
English: Samples taken from humans and animals for investigation of Ebola infection should be handled by trained staff and processed in suitably equipped laboratories.
Slovenian: S človeškimi in živalskimi vzorci, odvzetimi za preiskave okužbe z virusom Ebola, mora ravnati usposobljeno osebje in morajo biti obdelani v ustrezno opremljenih laboratorijih.
English: Arthralgia and arthritis
Slovenian: Artralgija in artritis
English: The majority of arthritis reactions were mild to moderate in severity.
Slovenian: Večina artritičnih reakcij je bila po izrazitosti blagih do zmernih.
English: Do not thaw the vial in a refrigerator as it is not guaranteed that the vial will thaw in less than 4 hours.
Slovenian: Viale ne odtajajte v hladilniku, ker ni zagotovljeno, da se bo viala odtajala v manj kot 4 urah.
English: 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.
Slovenian: 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.
English: In a biodistribution study conducted in non-human primates, vaccine virus RNA was detected in lymphoid organs up to 112 days post-vaccination.
Slovenian: V študiji biološke porazdelitve, izvedeni pri ne-humanih primatih, so RNA cepilnega virusa ugotovili v limfatičnih organih do 112 dni po cepljenju.
English: • Do not use this vaccine if you notice particles in the liquid.
Slovenian: • Cepiva ne uporabite, če v tekočini opazite delce.
English: No studies have looked at how other medicines or vaccines and Ervebo might interact with each other.
Slovenian: V nobeni študiji še niso preučili, kako lahko druga zdravila ali cepiva medsebojno delujejo s cepivom Ervebo.
English: CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: SKLEPNE UGOTOVITVE O PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: No cases of overdose have been reported.
Slovenian: Ni poročil o primerih prevelikega odmerjanja.
English: Clinical efficacy of Ervebo was assessed in Protocol 010.
Slovenian: Klinično učinkovitost cepiva Ervebo so ocenili v Protokolu 010.