FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal insufficiency Patients with renal insufficiency requiring dialysis have not been studied in clinical trials.
Slovenian: V kliničnih preskušanjih niso raziskali uporabo zdravila pri bolnikih z insuficienco ledvic, ki potrebujejo dializno zdravljenje.
English: NovoThirteen should be inspected visually for extraneous (for any foreign) particulate matter and discoloration prior to administration.
Slovenian: Pripravljeno zdravilo NovoThirteen je treba pred injiciranjem pregledati za vsebnost tujih delcev ali obarvanj.
English: How to store NovoThirteen
Slovenian: Shranjevanje zdravila NovoThirteen
English: Patients with hepatic impairment have not been studied.
Slovenian: Okvara jeter Raziskave niso vključevale bolnikov z okvaro jeter.
English: Common (≥ 1/100 to < 1/10)
Slovenian: EU/1/12/775/001
English: FXIII containing products (the recommended dose of NovoThirteen is 35 IU/kg body weight
Slovenian: • opozorilo o razlikah v odmerjanju in koncentraciji med zdravilom NovoThirteen in drugimi zdravili, ki vsebujejo FXIII (Priporočeni odmerek zdravila NovoThirteen je 35 i.e./kg telesne mase enkrat na mesec v intravenski bolusni injekciji.
English: METHOD AND ROUTE OF ADMINISTRATION Intravenous use
Slovenian: za intravensko uporabo
English: The antibodies had no inhibitory activity, and the subject did not experience any adverse events or bleeding in association with these antibodies.
Slovenian: Prav tako v zvezi s temi protitelesi ni bilo neželenih učinkov ali krvavitev.
English: Injection site pain
Slovenian: Pogosti bolečina na mestu injiciranja
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Slovenian: Sestavina vehikla je voda za injekcije.
English: Solvent: Water for injections
Slovenian: Vehikel za NovoThirteen voda za injekcije
English: Preparing the solution
Slovenian: Priprava raztopine
English: Unscrew the vial adapter with the vial.
Slovenian: Odvijte nastavek za vialo skupaj z vialo.
English: Contact your doctor if you have injected more NovoThirteen than you have been instructed.
Slovenian: Če ste si injicirali več zdravila NovoThirteen, kot vam je bilo naročeno, se posvetujte z zdravnikom.
English: Do not pass it on to others.
Slovenian: Zdravila ne zamrzujte.
English: The diluted solution is a clear, colourless solution.
Slovenian: Razredčena raztopina je bistra in brezbarvna.
English: 2 years.
Slovenian: 2 ml/minuto.
English: L-histidine
Slovenian: Hagedornsvej 1
English: FXIII B-subunit deficiency is associated with a much reduced half-life of the administered pharmacologically active A-subunit.
Slovenian: Pri takšnih bolnikih je razpolovni čas injicirane farmakološko aktivne podenote A močno zmanjšan.
English: Date of first authorisation: 31 July 2013
Slovenian: Datum prve odobritve: 31. julij 2013
English: These symptoms may be a sign of a serious allergic reaction.
Slovenian: Ti simptomi so morda znaki resne alergijske reakcije.
English: Special population:
Slovenian: Posebna populacija:
English: Efficacy in animals
Slovenian: Učinkovitost pri živalih
English: Healthy 9 HIV 131
Slovenian: Zdravi 9 HIV 131
English: Therefore, dose intervals of less than 4 weeks should be avoided.
Slovenian: Zato se je treba intervalom odmerkov, krajšim od 4 tednov, izogniti.
English: In this case, your doctor will postpone the vaccination until you are feeling better.
Slovenian: V tem primeru bo zdravnik cepljenje prestavil na kasneje, ko se boste počutili bolje.
English: The use of this vaccine during pregnancy and breast-feeding is not recommended.
Slovenian: Uporaba tega cepiva med nosečnostjo ali dojenjem se ne priporoča.
English: Contact a doctor immediately, or go immediately to the emergency department of your nearest hospital if you experience any of the following symptoms:
Slovenian: Takoj se posvetujte z zdravnikom ali pojdite na urgentni oddelek najbližje bolnišnice, če se pojavi kateri od naslednjih simptomov:
English: Dispose of in accordance with local requirement.
Slovenian: Odstranite v skladu z lokalnimi zahtevami.
English: Healthy 200
Slovenian: Zdravi 200
English: Status to be reported annually within each annual reassessment application
Slovenian: O stanju se poroča letno v okviru vsake letne vloge o ponovni oceni
English: Seroconversion by ELISA and PRNT were as follows:
Slovenian: Serokonverzije po testih ELISA in PRNT so bile kot sledi:
English: Primary immunisation
Slovenian: Primarna imunizacija
English: Individuals with atopic dermatitis (AD)
Slovenian: Posamezniki z atopičnim dermatitisom (AD)
English: • You will receive one injection.
Slovenian: • Prejeli boste eno injekcijo.
English: • if you are ill with a high temperature.
Slovenian: • če ste bolni z močno povečano telesno temperaturo.
English: Adverse reactions from all clinical trials are listed according to the following frequency:
Slovenian: Neželeni učinki iz vseh kliničnih preskušanj so našteti v skladu z naslednjo pogostnostjo:
English: Tell your doctor or nurse if you are taking or have recently taken any other medicines or if you have recently received any other vaccine.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali katero koli drugo zdravilo ali pa ste bili pred kratkim cepljeni s katerim koli drugim cepivom.
English: This means that because of scientific reasons it has been impossible to get complete information on this medicine.
Slovenian: To pomeni, da iz znanstvenih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: Long-term immunogenicity in humans
Slovenian: Dolgoročna imunogenost pri ljudeh
English: If you are a pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask to your doctor for advice.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
English: Thaw at room temperature.
Slovenian: Odtajajte pri sobni temperaturi.
English: Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX
Slovenian: Farmakoterapevtska skupina: cepivo, druga virusna cepiva, oznaka ATC: J07BX
English: Expiry date depends on storage temperature.
Slovenian: Potek roka uporabnosti je odvisen od temperature shranjevanja.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: • if you have atopic dermatitis (see section 4).
Slovenian: • če imate atopični dermatitis (glejte poglavje 4).
English: Day 7/141
Slovenian: Dan 7/141
English: Pack size of 20.
Slovenian: Velikost pakiranja je 20.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Slovenian: Preden vas bodo cepili s tem cepivom natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: N/A5
Slovenian: n/r5
English: Healthy 61
Slovenian: Zdravi 61
English: The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor or nurse first.
Slovenian: Zaradi prisotnosti manjših okužb, na primer prehlada, cepljenja ni treba preložiti, vendar se kljub temu najprej pogovorite z zdravnikom ali medicinsko sestro.
English: You can be given this vaccine whether or not you have received smallpox vaccination in the past.
Slovenian: Cepivo lahko prejmete, ne glede na to, ali ste v preteklosti že prejeli cepivo proti črnim kozam ali ne.
English: • loss of appetite,
Slovenian: • izguba apetita
English: Most of them were mild to moderate in nature and resolved without any treatment within seven days.
Slovenian: Večinoma so bili blagi in so brez zdravljenja izzveneli v sedmih dneh.
English: Individuals with atopic dermatitis developed more local and general symptoms after vaccination (see section 4.8)
Slovenian: Pri posameznikih z atopičnim dermatitisom se je po cepljenju razvilo več lokalnih in splošnih simptomov (glejte poglavje 4.8).
English: Swirl the vial gently before use for at least 30 seconds.
Slovenian: Vialo pred uporabo nežno obračajte vsaj 30 sekund.
English: 0.5 ml suspension in a vial (Type I glass) with stopper (bromobutyl rubber).
Slovenian: 0,5 ml suspenzije v viali (steklo tipa I) z zamaškom (bromobutilna guma).
English: Active immunisation against smallpox in adults (see sections 4.4 and 5.1).
Slovenian: Aktivna imunizacija odraslih proti črnim kozam (glejte poglavji 4.4 in 5.1).
English: A dose of 0.5 ml is withdrawn into a syringe for injection.
Slovenian: Odmerek 0,5 ml se izvleče z injekcijsko brizgo za injiciranje.
English: • You will receive two injections.
Slovenian: • Prejeli boste dve injekciji.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte tudi poglavje 5.3).
English: Data have been generated in HIV infected individuals with CD4 counts ≥ 100 cells/µl and ≤ 750 cells/µl.
Slovenian: Za posameznike, okužene z virusom HIV s številom CD4 ≥ 100 celic/µl in ≤ 750 celic/µl so bili pridobljeni podatki.
English: Do not use this vaccine after the expiry date which is stated on the label after Exp.
Slovenian: Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do/EXP.
English: • If your immune system is weakened you will receive two injections with the second injection no less than 28 days after the first.
Slovenian: • Če je vaš imunski sistem oslabljen, boste prejeli dve injekcij, pri čemer boste drugo injekcijo prejeli najmanj 28 dni po prvi.
English: If you already have atopic dermatitis, you may experience more intense local skin reactions (such as redness, swelling and itching) and other general symptoms (such as headache, muscle pain, feeling sick or tired), as well as a flare-up or worsening of your skin condition.
Slovenian: Če že imate atopični dermatitis, bodo morda lokalne kožne reakcije (kot so rdečina, oteklina in srbenje) in drugi splošni simptomi (kot so glavobol, mišična bolečina, občutek slabosti ali utrujenosti) bolj izraziti, kožna bolezen pa se lahko razširi ali se poslabša.
English: Swirl gently before use.
Slovenian: Pred uporabo nežno obračajte.
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa cepiva ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Therefore, concomitant administration of IMVANEX with other vaccines should be avoided.
Slovenian: Zato se je treba sočasni uporabi cepiva IMVANEX z drugimi cepivi izogniti.
English: To ensure adequate monitoring of safety and/or effectiveness, the applicant should perform the following studies to collect data where IMVANEX is used as a prophylactic vaccine and/or use in case of re-emergence of circulating smallpox.
Slovenian: Za zagotovitev ustreznega spremljanja varnosti in/ali učinkovitosti bo predlagatelj izvedel naslednje študije z zbiranjem podatkov, v katerih se cepivo IMVANEX uporablja kot profilaktično cepivo in/ali v primeru ponovnega pojava črnih koz med prebivalstvom.
English: • swelling of the face and neck.
Slovenian: • oteklost obraza in vratu.
English: N Day 71
Slovenian: N Dan 71
English: Day 421
Slovenian: Dan 421
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Slovenian: Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004,
English: For instructions on administration, see section 6.6.
Slovenian: Za navodila glede dajanja cepiva glejte poglavje 6.6.
English: Gently swirl for at least 30 seconds.
Slovenian: Nežno obračajte vsaj 30 sekund.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT • Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: Trometamol Sodium chloride Water for injections
Slovenian: trometamol natrijev klorid voda za injekcije
English: Immunogenicity and attenuation of take of ACAM2000 in healthy subjects
Slovenian: Imunogenost in zmanjšanje uporabe cepiva ACAM2000 pri zdravnih posameznikih
English: This means that because of the lack of smallpox disease in the world it has not been possible to obtain complete information on this medicinal product.
Slovenian: To pomeni, da zaradi redkosti črnih koz v svetu ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: There are inadequate data to determine the appropriate timing of booster doses.
Slovenian: Podatki ne zadoščajo za določitev ustreznega časovnega obdobja za poživitvene odmerke.
English: The safety and efficacy of IMVANEX in children below 18 years have not been established.
Slovenian: Varnost in učinkovitost cepiva IMVANEX pri otrocih, starih do 18 let, nista bili dokazani.
English: IMVANEX is provided as a suspension for injection in a vial (0.5 ml).
Slovenian: Cepivo IMVANEX je na voljo kot suspenzija za injiciranje v viali (0,5 ml).
English: Lower immune response data have been observed in HIV infected individuals compared to healthy individuals (see section 5.1).
Slovenian: Pri posameznikih, okuženih z virusom HIV, so opazili podatke o nižjem imunskem odzivu, kot pri zdravih posameznikih (glejte poglavje 5.1).
English: *represents seropositivity rates
Slovenian: *predstavlja stopnje seropozitivnosti.
English: This vaccine contains trace residues of gentamicin (see section 4.3).
Slovenian: To cepivo vsebuje ostanke gentamicina v sledovih (glejte poglavje 4.3).
English: A protective immune response may not be elicited in all vaccinees.
Slovenian: Zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah.
English: • nerve disorder causing weakness, tingling or numbness,
Slovenian: • živčne motnje, ki povzročajo šibkost, ščemenje ali odrevenelost,
English: Day 281
Slovenian: Dan 281
English: Animal studies did not reveal any evidence of impaired female and male fertility.
Slovenian: Študije na živalih niso pokazale vplivov na plodnost pri samicah in samcih.
English: Do not re-freeze a vial once it has been thawed.
Slovenian: Odmrznjenih vial ne zamrzujte ponovno.
English: Other medicines or vaccines and IMVANEX
Slovenian: Druga zdravila ali cepiva in cepivo IMVANEX
English: Two doses of IMVANEX given at a 7-day interval showed lower immune responses and slightly more local reactogenicity than two doses given at a 28-day interval.
Slovenian: Dva odmerka cepiva IMVANEX, dana v 7-dnevnem intervalu, sta pokazala nižje imunske odzive in nekoliko večjo lokalno reaktogenost, kot dva odmerka, dana v 28-dnevnem intervalu.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or trace residues (chicken protein, benzonase and gentamicin).
Slovenian: Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali ostanke v sledovih (piščančje beljakovine, benzonazo in gentamicin).
English: However, your doctor will assess whether the possible benefit in terms of preventing smallpox would outweigh the potential risks of giving you this vaccine.
Slovenian: Vendar bo zdravnik ocenil, ali bi morebitna korist preprečevanja črnih koz odtehtala morebitna tveganja, povezana s cepljenjem.
English: If you have never been vaccinated against smallpox:
Slovenian: Če še nikoli niste bili cepljeni proti črnim kozam:
English: The following information is intended for healthcare professionals only: Instructions for preparation and administration of the vaccine:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: If a booster dose is considered necessary then a single dose of 0.5 ml should be administered.
Slovenian: Če se oceni, da je potreben poživitveni odmerek, je treba uporabiti en 0,5-ml odmerek.
English: It must not be injected into a blood vessel.
Slovenian: Cepiva se ne sme injicirati v krvno žilo.
English: IMVANEX may trigger local rashes or more widespread eruptions.
Slovenian: Cepivo IMVANEX lahko izzove lokalne izpuščaje ali bolj razširjene kožne izbruhe.
English: IMVANEX may not fully protect all people who are vaccinated.
Slovenian: Cepivo IMVANEX morda ne bo v celoti zaščitilo vseh cepljenih oseb.
English: • influenza like illness,
Slovenian: • šibkost • gripi podobna bolezen
English: • increase of cardiac laboratory values (like Troponin I ), liver enzyme increased, white blood cell count decreased, mean platelet volume decreased
Slovenian: • povečanje laboratorijskih vrednosti za srce (kot je troponin I), povečanje jetrnih encimov, zmanjšanje števila belih krvničk, znižanje povprečnega volumna trombocitov
English: ACAM2000 was administered via scarification.
Slovenian: Cepivo ACAM2000 so aplicirali s skarifikacijo.
English: This vaccine contains trace residues of gentamicin and benzonase.
Slovenian: Cepivo vsebuje ostanke gentamicina in benzonaze v sledovih.
English: • Make sure you complete the vaccination course of two injections.
Slovenian: • Cikel cepljenja z dvema injiciranjema morate zaključiti.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih udarnina
English: The European Medicines Agency has deferred the obligation to submit the results of studies with IMVANEX in all subsets of the paediatric population for prevention of smallpox infection by active immunisation against smallpox infection and disease (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom IMVANEX za vse podskupine pediatrične populacije za preprečevanje okužbe s črnimi kozami z aktivno imunizacijo proti okužbi s črnimi kozami ali bolezni črnih koz (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Immunocompromised patients (e.g. HIV infected, patients under immunosuppressive therapy) who have been previously vaccinated against smallpox should receive two booster doses.
Slovenian: Bolniki z oslabljenim imunskim odzivom (npr. bolniki, okuženi z virusom HIV, bolniki, ki se zdravijo z imunosupresivi), ki so bili predhodno cepljeni proti virusu črnih koz, morajo prejeti dve poživitveni cepljenji.
English: The most common adverse reactions observed in clinical trials were injection site reactions and common systemic reactions typical for vaccines which were mild to moderate in intensity and resolved without intervention within seven days following vaccination.
Slovenian: Najpogostejši neželeni učinki, ki so jih opazili med kliničnimi preskušanji, so bile reakcije na mestu injiciranja in pogoste sistemske reakcije, običajne za cepiva, ki so bile po intenzivnosti blage do zmerne in so v sedmih dneh po cepljenju izzvenele brez ukrepov.
English: Booster vaccination (individuals previously vaccinated against smallpox): There are inadequate data to determine the appropriate timing of booster doses.
Slovenian: Poživitveno cepljenje (posamezniki, ki so že bili cepljeni proti črnim kozam): Podatki ne zadoščajo za določitev ustreznega časovnega obdobja za poživitvene odmerke.
English: The concomitant administration of the vaccine with any immunoglobulin including Vaccinia Immune Globulin (VIG) has not been studied and should be avoided.
Slovenian: Sočasne uporabe cepiva s katerim koli imunoglobulinom, vključno z imunoglobulinom vakcinija (VIG = Vaccinia Immune Globulin), niso preučili, zato se ji je treba izogniti.
English: • if you have HIV infection or any other condition or treatment leading to a weakened immune system.
Slovenian: • če ste okuženi z virusom HIV ali imate drugo bolezen oz. se zdravite z zdravili, ki slabijo imunski sistem.
English: 7% of the individuals with AD in clinical trials with IMVANEX experienced a flare-up or worsening of their skin condition during the course of the trial.
Slovenian: 7 % posameznikov z AD je v kliničnih preskušanjih s cepivom IMVANEX v teku preskušanja doživelo izbruh ali poslabšanje kožne bolezni.
English: • swelling of the ankles, feet or fingers,
Slovenian: • oteklost gležnjev, stopal ali prstov
English: ELISA = enzyme-linked immunosorbent assay; GMT= geometric mean titre; N = number of subjects in the specific study group; PRNT = plaque reduction neutralisation test; SCR = seroconversion rate.
Slovenian: ELISA = encimsko imunski test (enzyme-linked immunosorbent assay); GMT= geometrični povprečni titer (geometric mean titre); N = število oseb v specifični študijski skupini; PRNT = nevtralizacijski test redukcije plakov (plaque reduction neutralisation test); SCR = stopnja serokonverzije (seroconversion rate).
English: A second dose of 0.5 ml should be administered no less than 28 days after the first dose.
Slovenian: Drugi odmerek 0,5 ml je treba dati vsaj 28 dni po prvem odmerku.
English: • sweating,
Slovenian: • znojenje
English: The most common side effects reported were at the site of injection.
Slovenian: Najpogosteje so poročali o neželenih učinkih na mestu injiciranja.
English: • influenza,
Slovenian: • gripa
English: What you need to know before you receive IMVANEX 3.
Slovenian: Kaj morate vedeti, preden boste dobili cepivo IMVANEX 3.
English: As seen with traditional smallpox vaccines, a significant reduction in both mortality and morbidity (viral load, weight loss, number of pox lesions, etc.) compared to non-vaccinated controls was demonstrated for NHP vaccinated with IMVANEX.
Slovenian: Kot pri tradicionalnih cepivih proti črnim kozam se je smrtnost in obolevnost (virusna obremenitev, izguba telesne mase, število lezij zaradi koz itd.) pri primatih, cepljenih s cepivom IMVANEX, močno zmanjšala v primerjavi z necepljeno kontrolno skupino.
English: There are limited data (less than 300 pregnancy outcomes) from the use of IMVANEX in pregnant women.
Slovenian: Podatki o uporabi cepiva IMVANEX pri nosečnicah so omejeni (manj kot 300 izidov nosečnosti).
English: If you have previously been vaccinated against smallpox:
Slovenian: Če ste predhodno že bili cepljeni proti črnim kozam:
English: Immunisation should be carried out by subcutaneous injection, preferably into the upper arm (deltoid).
Slovenian: Način uporabe Imunizacija se opravi s subkutanim injiciranjem, najbolje v nadlaket (v deltoidno mišico).
English: Events of rash after vaccination (related cases observed in 0.4% of subjects) with IMVANEX tend to occur within the first days after vaccination, are mild to moderate in intensity and usually resolve without sequelae.
Slovenian: Dogodki z izpuščajem po cepljenju (zadevne primere so opazili pri 0,4 % oseb) s cepivom IMVANEX se pojavljajo v prvih dneh po cepljenju, so po intenzivnosti blagi do zmerni in običajno izzvenijo brez posledic.
English: The Vaccinia-naïve study population included healthy individuals as well as individuals with HIV infection and AD who received 2 doses of IMVANEX 4 weeks apart.
Slovenian: Študijska populacija, ki še ni bila cepljena z virusom vakcinija, je vključevala tako zdrave posameznike kot tudi posameznike, okužene z virusom HIV, in posameznike z AD, ki so prejeli 2 odmerka cepiva IMVANEX v časovnem razmiku 4 tednov.
English: S+ % GMT S+ % GMT
Slovenian: S+ % GMT S+ % GMT S+ % GMT
English: Two clinical studies have demonstrated that IMVANEX is able to boost a pre-existing immunological memory response, induced by either licensed smallpox vaccines a long time ago or two years after IMVANEX.
Slovenian: Dve klinični študiji sta pokazali, da lahko cepivo IMVANEX poživi obstoječi imunski spominski odziv, ki so ga pred dlje časa izzvala bodisi odobrena cepiva proti črnim kozam ali cepivo IMVANEX dve leti po primarnem cepljenju.
English: • night sweats,
Slovenian: • nočno znojenje
English: Adverse Reactions Reported in Completed Clinical Trials with IMVANEX (N = 7,082 subjects)
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali v zaključenih kliničnih preskušanjih s cepivom IMVANEX (N = 7.082 oseb)