FrancophonIA/ELRC3.0 huggingface dataset:
English: The distribution of the card will also prompt dialogue on any new or changes in symptoms since the prior visit.
Slovenian: Izročitev opozorilne kartice za bolnika bo tudi spodbudila pogovor o pojavu kakršnihkoli novih simptomov ali o spremembi simptomov od prejšnjega obiska.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 June 2011
Slovenian: Datum prve odobritve: 17. junij 2011
English: Take all medicines as instructed by your doctor.
Slovenian: Redno jemljite vsa zdravila, ki vam jih je predpisal zdravnik.
English: It is likely that the increased susceptibility to opportunistic infections observed in juvenile rats is associated with the exposure to abatacept before development of memory responses.
Slovenian: Možno je, da je večja dovzetnost za oportunistične okužbe, opažena pri mladičih podgan, povezana z izpostavljenostjo abataceptu pred razvojem spominskega odziva.
English: Tests may show:
Slovenian: Preiskave lahko pokažejo:
English: Syringes are marked in units of 0.5 ml; therefore, the calculated dose should be rounded to the nearest 0.5 ml.
Slovenian: Injekcijske brizge imajo oznake v enotah po 0,5 ml, zato izračunani odmerek zaokrožite na najbližjih 0,5 ml.
English: If you stop treatment with NULOJIX for a long period of time, without taking any other medicines to prevent rejection, and then restart, it is not known if belatacept will have the same effect as before.
Slovenian: Če zdravljenje z zdravilom NULOJIX prekinete za daljši čas in med tem ne jemljete nobenega drugega zdravila za preprečevanje zavrnitve, ni znano, če bo po ponovnem začetku zdravljenja učinek belatacepta enak kot pred tem.
English: Pneumocystis pneumonia prophylaxis is recommended for at least 6 months following transplantation.
Slovenian: Profilaksa pnevmocistične pljučnice je priporočljiva še vsaj 6 mesecev po presaditvi.
English: Ciclosporin N= 476
Slovenian: ciklosporin n = 476
English: You might get symptoms that you might not be aware of yourself.
Slovenian: Med zdravljenjem se lahko pojavijo nekateri simptomi, ki jih sami morda ne boste opazili.
English: Infections and infestations Serious infections Viral infections
Slovenian: Infekcijske in parazitske bolezni Resne okužbe Virusne okužbe
English: The card will have your doctor's name and phone number and the date when you started treatment, your last treatment visit, and your next visit for treatment.
Slovenian: Zdravnik bo na kartonček vpisal svoje ime in priimek, telefonsko številko, datum začetka zdravljenja, datum zadnjega odmerka zdravila in datum naslednjega odmerka zdravila.
English: The recommended dose is based on your body weight (in kg) and will be calculated by a healthcare professional.
Slovenian: Priporočeni odmerek zdravila je odvisen od vaše telesne mase (v kg) in ga bo izračunal zdravstveni delavec.
English: CMV prophylaxis is recommended for at least 3 months after transplantation, particularly for patients at increased risk for CMV infection.
Slovenian: Profilaksa CMV je priporočljiva še vsaj 3 mesece po presaditvi, še posebej pri bolnikih z visokim tveganjem za okužbo s CMV.
English: PML is a rare, often rapidly progressive and fatal, opportunistic infection of the CNS that is caused by the John Cunningham (JC) virus.
Slovenian: Progresivna multifokalna levkoencefalopatija (PML) PML je redka, pogosto hitro napredujoča in usodna oportunistična okužba CŽS, ki jo povzroča virus John Cunningham (JC).
English: Approximately 80% of AR episodes occurred by Month 3 and were infrequent after Month 6.
Slovenian: Približno 80 % primerov akutne zavrnitve se je zgodilo do 3. meseca, po 6. mesecu pa so bile redke.
English: From week 4 after transplant, you will receive treatment with NULOJIX every 4 weeks.
Slovenian: Zdravilo NULOJIX boste od 4. tedna po presaditvi prejemali na vsake 4 tedne.
English: Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - U.S.A.
Slovenian: Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - ZDA
English: Reversible pharmacological effects consisted of minimal decreases in serum IgG and minimal to severe lymphoid depletion of germinal centers in the spleen and/or lymph nodes.
Slovenian: Reverzibilni farmakološki učinki so obsegali minimalno zmanjšanje koncentracije serumskih IgG in minimalno do hudo izgubo germinalnih limfatičnih centrov v vranici in/ali bezgavkah.
English: During the first month post-transplantation, 85% saturation of CD86 was maintained.
Slovenian: Med prvim mesecem po presaditvi se je zasičenost CD86 ohranila pri 85 %.
English: Any unused portion in the vials must be discarded in accordance with local requirements.
Slovenian: Neporabljeno vsebino vial morate zavreči v skladu z lokalnimi predpisi.
English: The viral status was not determined in the belatacept study but, as this virus is prevalent in monkeys, it was likely present in these monkeys as well.
Slovenian: V študiji z belataceptom virusnega statusa niso ugotavljali, ker pa je ta virus pri opicah zelo razširjen, je verjetno, da je bil prisoten tudi pri tej populaciji opic.
English: If you have not been exposed to EBV prior to your transplant
Slovenian: če pred presaditvijo še niste bili izpostavljeni virusu EBV.
English: Single doses up to 20 mg/kg have been administered without apparent toxic effect.
Slovenian: Pri aplikaciji enkratnih odmerkov do 20 mg/kg niso poročali o pojavu toksičnih učinkov.
English: Table 4: Infections occurring by treatment group (%)
Slovenian: Preglednica 4: Pojavnost okužb po skupinah zdravljenja (%)
English: Because of abatacept's similarity to belatacept in structure and mechanism of action and its higher activity in rodents, abatacept was used as a more active homolog for belatacept in rodents.
Slovenian: Ker je abatacept po strukturi in mehanizmu delovanja podoben belataceptu, njegova aktivnost pri glodavcih pa je večja, so abatacept pri glodavcih uporabili kot aktivnejši homolog od belatacepta.
English: Belatacept has a minor influence on the ability to drive and use machines since it may cause fatigue, malaise and/or nausea.
Slovenian: Belatacept ima blag vpliv na sposobnost vožnje in upravljanja s stroji, ker lahko povzroči utrujenost, splošno slabo počutje in/ali slabost.
English: If you have not been exposed to the Epstein-Barr virus (EBV) or are uncertain of previous exposure, you must not be treated with NULOJIX.
Slovenian: če niste bili izpostavljeni virusu Epstein-Barr (EBV) ali ne veste, če ste v preteklosti bili izpostavljeni, se z zdravilom NULOJIX ne smete zdraviti.
English: Tell your doctor immediately if you or your family notice any symptoms listed below:
Slovenian: Nemudoma obvestite zdravnika, če opazite ali kdo od družinskih članov pri vas opazi kateregakoli od naslednjih simptomov:
English: Studies in rats have shown excretion of belatacept in milk.
Slovenian: Študije pri podganah so pokazale, da se belatacept izloča v mleko.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with belatacept in one or more subsets of the paediatric population in renal transplantation (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z belataceptom za eno ali več skupin pediatrične populacije s presajeno ledvico (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Each pack of the medicine contains an alert card that should be given to the patient.
Slovenian: Vsakemu pakiranju zdravila je priložen opozorilni kartonček za bolnika.
English: Belatacept appears not to have any relevant direct effects on cytokine levels in liver transplant recipients or in healthy volunteers.
Slovenian: Belatacept nima nobenih pomembnih neposrednih učinkov na vrednosti citokinov pri bolnikih s presajenimi jetri ali pri zdravih prostovoljcih.
English: It is not known whether these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept or belatacept.
Slovenian: Ni znano, če te spremembe kažejo na tveganje za razvoj avtoimunskih bolezni pri človeku po in utero izpostavljenosti abataceptu ali belataceptu.
English: With NULOJIX treatment, this more often develops in the brain and can lead to death.
Slovenian: Pri zdravljenju z zdravilom NULOJIX le-ta pogosteje prizadene možgane in se lahko konča s smrtjo.
English: Based on population pharmacokinetic analysis of 944 renal transplant patients up to 1 year posttransplant, the pharmacokinetics of belatacept were similar at different time periods post-transplant.
Slovenian: Na osnovi podatkov analize populacijske farmakokinetike, izvedene pri 944 bolnikih s presajeno ledvico do 1 leta po presaditvi, je bila farmakokinetika belatacepta v različnih časovnih obdobjih po presaditvi podobna.
English: There was one case of PML reported (Study 1) in the ciclosporin group at 82 months post-transplant (more than 56 days after discontinuing therapy).
Slovenian: V skupini zdravljenja s ciklosporinom (Študija 1) so poročali o enem primeru PML 82 mesecev po presaditvi (več kot 56 dni po prekinitvi zdravljenja).
English: Of the 6 PTLD cases in the LI regimen, 3 involved the CNS and were fatal.
Slovenian: Od 6 primerov PTLB pri MI režimu, so 3 prizadeli CŽS in so se končali s smrtjo.
English: In 153 patients assessed for antibodies at least 56 days (approximately 7 half-lives) after discontinuation of belatacept, an additional 10 (6.5%) developed antibodies.
Slovenian: Pri 153 bolnikih, ki so bili na protitelesa ovrednoteni vsaj 56 dni (približno 7 razpolovnih časov) po prekinitvi zdravljenja z belataceptom, so protitelesa odkrili še pri dodatnih 10 bolnikih (6,5 %).
English: PML often leads to severe disability or death.
Slovenian: Progresivna multifokalna levkoencefalopatija pogosto povzroči hudo invalidnost ali smrt.
English: Nine of 14 cases of PTLD in belatacept-treated patients were located in the CNS; within the observation period, 8 of 14 cases were fatal (6 of the fatal cases involved the CNS).
Slovenian: Pri bolnikih, ki so se zdravili z belataceptom, je PTLB v 9 od 14 primerov prizadela CŽS, znotraj opazovalnega obdobja se je 8 od 14 primerov končalo s smrtjo (v 6 smrtnih primerih je bil prizadet CŽS).
English: Treatment should be prescribed and supervised by specialist physicians experienced in the management of immunosuppressive therapy and of renal transplant patients.
Slovenian: Zdravljenje mora predpisati in nadzirati zdravnik specialist, ki ima izkušnje z vodenjem imunosupresivnega zdravljenja in bolnikov s presajeno ledvico.
English: Gently mix the infusion container.
Slovenian: Infuzijski vsebnik nežno premešajte.
English: Activated T cells are the predominant mediators of immunologic response to the transplanted kidney.
Slovenian: Aktivirani limfociti T so poglaviten posrednik imunskega odziva po presaditvi ledvice.
English: Therapeutic monitoring of belatacept is not required.
Slovenian: Spremljanje terapevtskih koncentracij belatacepta ni potrebno.
English: It is unknown whether belatacept is excreted in human milk (see section 5.3).
Slovenian: Ni znano, če se belatacept izloča v materino mleko (glejte poglavje 5.3).
English: Table 5: Key efficacy outcomes at years 1 and 3 Study 1: living and standard criteria deceased donors
Slovenian: Preglednica 5: Ključni izidi učinkovitosti po 1. in 3. letu zdravljenja Študija 1: živi ali umrli darovalci (standardni kriteriji za darovalca)
English: Patients with high PRA often require increased immunosuppression.
Slovenian: Pri bolnikih z visoko vrednostjo PRA je pogosto potrebna močnejša imunosupresija.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/694/001
English: NULOJIX weakens the body's ability to fight infections.
Slovenian: Zdravilo NULOJIX zmanjša sposobnost telesa za obrambo pred okužbami.
English: **Median follow-up for PTLD for pooled studies is 1,199 days for MI, 1,206 days for LI, and 1,139 days for ciclosporin.
Slovenian: **Mediani čas spremljanja za PTLB za združene študije je 1.199 dni za BI režim, 1.206 dni za MI režim in 1.139 dni za ciklosporin.
English: Anti-belatacept antibody development was not associated with altered clearance of belatacept.
Slovenian: Pojavnost protiteles proti belataceptu ni bila povezana s spremembo očistka belatacepta.
English: Early diagnosis and treatment may mitigate the impact of PML.
Slovenian: Z zgodnjim odkritjem in zdravljenjem se potek PML lahko ublaži.
English: Belatacept has less activity in rodents than abatacept, a fusion protein that differs from belatacept by two amino acids in the CD80/86 binding domains.
Slovenian: Aktivnost belatacepta pri glodavcih je manjša od aktivnosti abatacepta, fuzijskega proteina, ki se od belatacepta razlikuje v dveh aminokislinah na CD80/86 vezavnih domenah.
English: Do not store any unused portion of the solution for infusion for reuse.
Slovenian: Neporabljene raztopine za infundiranje ne shranjujte za ponovno uporabo.
English: There are no data on use of belatacept and effect on fertility in humans.
Slovenian: O uporabi belatacepta in vplivu na plodnost pri človeku ni podatkov.
English: By Year 3 recurrent AR was similar across groups (< 3%) and subclinical AR identified on the 1 year protocol biopsy was 5% in both groups.
Slovenian: Do 3. leta je bila ponovitev akutne zavrnitve podobna v vseh skupinah (< 3 %), subklinična akutna zavrnitev, odkrita z biopsijo po protokolu po 1 letu, pa je bila v obeh skupinah 5 %.
English: The recommended dose is based on patient body weight (kg).
Slovenian: Priporočeni odmerek je odvisen od telesne mase bolnika (kg).
English: Treatment with NULOJIX will be prescribed and supervised by a specialist in kidney transplantation.
Slovenian: Zdravljenje z zdravilom NULOJIX bo predpisal in nadziral zdravnik specialist s področja presaditve ledvic.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA28.
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, Zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA28.
English: Study 1 and 2: Phase 3 studies in renal transplant recipients The safety and efficacy of belatacept as part of an immunosuppressive regimen following renal transplantation were assessed in two randomised, partially-blinded, multicenter, 3 year studies with the primary endpoint specified at Year 1.
Slovenian: Študija 1 in 2: Študiji 3. faze pri bolnikih s presajeno ledvico Varnost in učinkovitost belatacepta v sklopu režima imunosupresivnega zdravljenja po presaditvi ledvice sta bili ovrednoteni z dvema randomiziranima, deloma slepima, multicentričnima 3-letnima študijama, s primarnim opazovanim dogodkom, določenim v prvem letu.
English: 2 vials 2 syringes
Slovenian: 2 viali 2 injekcijski brizgi
English: However, immunogenicity rate normalised for duration of exposure was consistent at 2.0 to 2.1 per 100 patient years among the three studies.
Slovenian: Vendar pa je bil v teh treh študijah delež imunogenosti, normaliziran za trajanje izpostavljenosti, konsistenten pri 2,0 do 2,1 na 100 bolniških let.
English: The higher calculated GFR observed in belatacept-treated patients relative to ciclosporin-treated patients during the first 3 years was maintained over the long-term extension period.
Slovenian: Višja izračunana vrednost GFR, opažena med prvimi 3 leti zdravljenja pri bolnikih, ki so se zdravili z belataceptom, v primerjavi z bolniki, ki so se zdravili s ciklosporinom, se je v času dolgoročnega podaljšanega obdobja ohranila.
English: New Onset Diabetes Mellitus and Blood Pressure
Slovenian: Novo nastala sladkorna bolezen in krvni tlak
English: Fungal infections Tuberculosis
Slovenian: Glivične okužbe Tuberkuloza
English: NULOJIX Patient Alert Card
Slovenian: NULOJIX - Opozorilna kartica za bolnika
English: Wear protective clothing and use a sunscreen with a high protection factor.
Slovenian: Nosite zaščitna oblačila in uporabljajte varovalna sredstva za zaščito kože pred soncem z visokim zaščitnim faktorjem.
English: PML is usually diagnosed by brain imaging, including magnetic resonance imaging (MRI) or computed tomography (CT) scan, and cerebrospinal fluid (CSF) testing for JC viral DNA by polymerase chain reaction (PCR).
Slovenian: PML se običajno diagnosticira s slikovno preiskavo možganov, vključno z magnetno resonanco (MR) ali računalniško tomografijo (CT) in testiranjem cerebrospinalne tekočine na prisotnost DNA virusa JC s polimerazno verižno reakcijo (PCR).
English: There is no data available in patients with hepatic impairment.
Slovenian: Podatki pri bolnikih z okvaro jeter niso na voljo.
English: People who use NULOJIX have a higher risk of getting certain other types of cancer, especially skin cancer.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom NULOJIX, obstaja večje tveganje za pojav nekaterih oblik raka, še posebej kožnega raka.
English: You are being treated with a potent medicine that suppresses the immune system.
Slovenian: Predpisano vam je bilo zdravljenje z močnim zdravilom, ki deluje zaviralno na imunski sistem.
English: The diluted solution must be administered as an intravenous infusion at a relatively constant rate over 30 minutes.
Slovenian: Razredčeno raztopino je treba dati v obliki 30-minutne intravenske infuzije z relativno konstantno hitrostjo.
English: Method of administration NULOJIX is for intravenous use only.
Slovenian: Način uporabe Zdravilo NULOJIX je namenjeno le za intravensko uporabo.
English: Population pharmacokinetic analyses in renal transplant patients revealed that there was a trend toward higher clearance of belatacept with increasing body weight.
Slovenian: Analiza populacijske farmakokinetike pri bolnikih s presajeno ledvico je pokazala, da obstaja tendenca k večanju očistka belatacepta z večanjem telesne mase.
English: In the individual studies, the percentage of patients with antibodies ranged from 4.5% and 5.2% in the Phase 3 studies to 11.8% in the long-term extension of the Phase 2 study.
Slovenian: V posameznih študijah 3. faze se je odstotek bolnikov s protitelesi gibal v razponu od 4,5 % do 5,2 %, v dolgotrajnem podaljšku študije 2. faze pa do 11,8 %.
English: Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.
Slovenian: Bolniki s presajeno ledvico, ki so seronegativni za virus Epstein-Barr (EBV) ali pa njihovo serološko stanje ni znano.
English: Elderly patients No dose adjustment is required (see sections 5.1 and 5.2).
Slovenian: Starostniki Prilagajanje odmerka ni potrebno (glejte poglavji 5.1 in 5.2).
English: Adverse reactions resulting in interruption or discontinuation of belatacept in ≥ 1% of patients up to Year 3 were renal vein thrombosis and CMV infection.
Slovenian: Neželena učinka, zaradi katerih je bilo treba zdravljenje z belataceptom do 3. leta prekiniti ali opustiti pri ≥ 1 % bolnikov, sta bila tromboza ledvične vene in okužba s CMV.
English: This increased avidity provides a level of immunosuppression that is necessary for preventing immune-mediated allograft failure and dysfunction.
Slovenian: Ta večja vezavna afiniteta zagotavlja nivo imunosupresije, ki je potreben za preprečevanje imunsko pogojene odpovedi in okvare alogenskega presadka.
English: Belatacept MI N= 477
Slovenian: belatacept BI n = 477
English: Infusion of the first dose should be given in the immediate preoperative period or during surgery, but before completion of the transplant vascular anastomoses.
Slovenian: Bolnik mora prvi odmerek prejeti neposredno pred operacijo ali med operacijo samo, vendar pa pred vzpostavitvijo žilnih anastomoz presadka.
English: Belatacept is a fusion protein that is not expected to be metabolised by the cytochrome P450 enzymes (CYPs) and UDP-glucuronosyltransferases (UGTs).
Slovenian: Belatacept je fuzijska beljakovina, za katero se ne pričakuje, da bi se presnavljala z encimi citokroma P450 (CYP) ali UDP-glukuronozil-transferazami (UGT).
English: This should be taken into consideration when treating patients on a controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija.
English: Every 4 weeks (± 3 days), starting at the end of week 16 after transplantation
Slovenian: Vsake 4 tedne (± 3 dni), s pričetkom konec 16. tedna po presaditvi
English: During clinical studies, there was no dose modification of belatacept for a change in body weight of less than 10%.
Slovenian: V kliničnih študijah odmerka belatacepta spremembam telesne mase za manj kot 10 % niso prilagajali.
English: In this study, 543 patients were enrolled, randomised, and transplanted; 184 to belatacept MI, 175 to belatacept LI, and 184 to ciclosporin.
Slovenian: V to študijo je bilo vključenih 543 bolnikov, pri katerih je bila opravljena presaditev in so bili randomizirani: 184 na BI režim zdravljenja z belataceptom, 175 na MI režim zdravljenja z belataceptom in 184 na ciklosporin.
English: In this study, 666 patients were enrolled, randomised, and transplanted; 219 to belatacept MI, 226 to belatacept LI, and 221 to ciclosporin.
Slovenian: V to študijo je bilo vključenih 666 bolnikov, pri katerih je bila opravljena presaditev in so bili randomizirani: 219 na BI režim zdravljenja z belataceptom, 226 na MI režim zdravljenja z belataceptom in 221 na ciklosporin.
English: Therefore, during treatment with belatacept, vaccinations may be less effective although this has not been studied in clinical trials.
Slovenian: Med zdravljenjem z belataceptom je učinkovitost cepljenja lahko manjša, vendar v kliničnih študijah tega niso raziskovali.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Slovenian: Preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).
English: The increased incidence of lymphomas and mammary tumours observed in mice treated with abatacept may have been associated with decreased control of murine leukaemia virus and mouse mammary tumour virus, respectively, in the presence of long-term immunomodulation.
Slovenian: Večja pojavnost limfomov in tumorjev mlečne žleze pri miših, ki so prejemale abatacept, je lahko povezana z zmanjšanim nadzorom virusa mišje levkemije in virusa mišjega tumorja mlečne žleze v prisotnosti dolgotrajnega spreminjanja imunske odzivnosti.
English: Lymphocyte Depleting Therapies and MPA: As the total burden of immunosuppression is a risk factor for malignancies and opportunistic infections, higher than the recommended doses of concomitant immunosuppressive agents should be avoided.
Slovenian: Zdravljenje z uničenjem limfocitov in mikofenolno kislino: Ker je skupno breme imunosupresije dejavnik tveganja za razvoj novotvorb in oportunističnih okužb, se je treba izogibati sočasni uporabi imunosupresivnih zdravil v odmerkih, ki so večji od priporočenih.
English: Study 2: Recipients of Extended Criteria Donor Kidneys Extended criteria donors were defined as deceased donors with at least one of the following: (1) donor age ≥ 60 years; (2) donor age ≥ 50 years and other donor comorbidities (≥ 2 of the following: stroke, hypertension, serum creatinine > 1.5 mg/dl); (3) donation after cardiac death or (4) anticipated cold ischemia time of ≥ 24 hours.
Slovenian: Študija 2: Prejemniki ledvice po razširjenih kriterijih za darovani organ Razširjeni kriteriji darovani organ opredeljujejo kot organ umrlega darovalca, pri katerem je izpolnjen vsaj eden od naslednjih kriterijev: (1) starost darovalca ≥ 60 let; (2) starost darovalca ≥ 50 let in prisotnost drugih sočasnih bolezni (dve ali več od naslednjih: možganska kap, hipertenzija, vrednost serumskega kreatinina > 1,5 mg/dl); (3) darovanje po srčni smrti ali (4) pričakovani čas hladne ishemije ≥ 24 ur.
English: The use of live vaccines should be avoided (see section 4.4).
Slovenian: Izogibati se je treba uporabi živih cepiv (glejte poglavje 4.4).