FrancophonIA/ELRC3.0 huggingface dataset:
English: The wording of this paragraph was amended as follows: “In subjects who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for three months or longer (up to 11 months) depending on the dose of human globulins administered because of the likelihood of vaccine failure due to passively acquired measles, mumps and rubella antibodies”.
Slovenian: Besedilo tega odstavka je bilo spremenjeno, kot sledi: „Pri posameznikih, ki so prejeli transfuzijo humanih gamaglobulinov ali krvi, je treba cepljenje prestaviti za tri mesece ali več (do 11 mesecev), odvisno od odmerka uporabljenih humanih globulinov, zaradi verjetnosti, da cepivo ne bo delovalo kot posledica pasivno pridobljenih protiteles proti ošpicam, mumpsu in rdečkam.“
English: If not given at the same time, an interval of at least one month is recommended between administration of PRIORIX and other live attenuated vaccines.
Slovenian: Če se cepiva ne dajo sočasno, se med cepljenjem s cepivom PRIORIX in drugimi živimi oslabljenimi cepivi priporoča vsaj enomesečni presledek.
English: Only in the event the child is confirmed or suspected to be immunodeficient, risks and benefits of vaccinating the mother should be evaluated (see section 4.3)”.
Slovenian: Samo če je imunska pomanjkljivost pri otroku potrjena ali pri sumu nanjo je treba oceniti razmerje med tveganji in koristmi pri cepljenju matere (glejte poglavje 4.3)“.
English: Vaccinees with a history of febrile convulsions should be closely followed-up.”
Slovenian: Cepljene osebe z anamnezo vročinskih krčev je treba skrbno spremljati.“
English: Transmission of the rubella vaccine virus to infants via breast milk as well as transplacental transmission has been documented without any evidence of clinical disease.”
Slovenian: Prenos virusa iz cepiva proti rdečkam na dojenčke z materinim mlekom in prenos prek placente je bil dokumentiran, vendar ni dokazov o klinični bolezni.“
English: The Advisory Committee on Immunization Practices (ACIP) shortened its recommended period in 2001 to avoid pregnancy after receipt of rubella-containing vaccine from 3 months to 28 days because no case of CRS had been identified among infants born to women who were vaccinated inadvertently against rubella within 3 months or early in pregnancy (Center for Disease Control and Prevention, 2001).
Slovenian: Svetovalni odbor za imunizacijo (ACIP - Advisory Committee on Immunization Practices) je priporočeno obdobje leta 2001 skrajšal, da prepreči nosečnost po cepljenju s cepivom, ki vsebuje rdečke, s 3 mesecev na 28 dni, saj med dojenčki, rojenimi ženskam, ki so jih v 3 mesecih ali zgodaj med nosečnostjo nehote cepili proti rdečkam, niso odkrili nobenega primera kongenitalnega sindroma rdečk (Center za nadzor in preprečevanje bolezni, 2001).
English: adapt the wording about HIV+ subjects and hypersensitivity to vaccine components to align with section 4.3.
Slovenian: prilagoditev besedila o posameznikih, okuženih z virusom HIV, in o preobčutljivosti na sestavine cepiva zaradi skladnosti s poglavjem 4.3,
English: The CHMP also noted that the contraindication for immune-depressed humans might need a general rewording in all MMR vaccines following the progress of science and the important knowledge of the immunology.
Slovenian: CHMP je pripomnil tudi, da bi bilo morda treba kontraindikacije za osebe s pomanjkljivim imunskim odzivom v celoti prenoviti za vsa cepiva MMR zaradi napredka znanosti in pomembnih imunoloških dognanj.
English: Based on the assessment of all data, the Marketing Authorisation Holder (MAH) proposed to align the indication of Priorix to children aged from 9 months old using the following wording: “PRIORIX is indicated for the active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella.”
Slovenian: Na podlagi ocene vseh podatkov je imetnik dovoljenja za promet z zdravilom predlagal uskladitev indikacije za cepivo Priorix za otroke, stare 9 mesecev in več, z uporabo naslednjega besedila: „Cepivo PRIORIX je indicirano za aktivno imunizacijo otrok, starih 9 mesecev ali več, mladostnikov in odraslih proti ošpicam, mumpsu in rdečkam.“
English: Moreover, in the reference note for encephalitis the MAH was asked to add the risk of encephalitis after mumps infection, “mumps: 2-4 in 1000 cases”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil naprošen tudi, da v opombo s sklicem na encefalitis doda tveganje encefalitisa po okužbi z mumpsom; „mumps: 2-4 od 1 000 primerov“.
English: In general, the MAH proposed a harmonised text drafted mainly using as basis the one approved in the MRP procedure with some amendments.
Slovenian: Imetnik dovoljenja za promet z zdravilom na splošno predlaga usklajeno besedilo, ki temelji na besedilu, odobrenem v postopku z medsebojnim priznavanjem, z nekaterimi spremembami.
English: The MAH was asked to consider adding a specific overview of immunogenicity assessment in infants vaccinated at an age below 12 months, with month-specific figures if available, for a first dose, as well as an overview of the assessment of an early second dose.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil naprošen, da razmisli o vključitvi specifičnega pregleda ocene imunogenosti pri otrocih, cepljenih pri starosti pod 12 mesecev, s številkami po mesecih, če so na voljo, za prvi odmerek, in s pregledom ocene zgodnjega drugega odmerka.
English: In summary, the CHMP supported the proposal of the MAH which was “Humoral or cellular immune deficiency (primary or acquired), including hypogammaglobulinaemia, dysgammaglobulinaemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage <25%”.
Slovenian: Če povzamemo, CHMP podpira predlog imetnika dovoljenja za promet z zdravilom, ki je bil „Humoralna ali celična (primarna ali pridobljena) imunska pomanjkljivost, vključno s hipogamaglobulinemijo, disgamaglobulinemijo in aidsom, simptomatska okužba z virusom HIV ali starostno specifični odstotek CD4+ T-limfocitov < 25 %“.
English: MMR-associated thrombocytopenia is rare and generally self-limited.
Slovenian: Trombocitopenija, povezana z MMR, je redka in običajno samoomejujoča.
English: The CHMP noted that for the majority of clinical trials investigating co-administration of Priorix with other vaccines no CSRs are available but only literature references.
Slovenian: CHMP je ugotovil, da za večino kliničnih preskušanj, v katerih preučujejo sočasno uporabo cepiva Priorix z drugimi cepivi, ni na voljo poročil klinične študije, temveč samo navedbe literature.
English: The theoretical maximum risk for CRS after administration of the vaccine at 1.6%, is much lower than the risk of major non-CRS induced congenital defects during pregnancy (Bozzo et al., 2011).
Slovenian: Teoretično največje tveganje za KSR po uporabi cepiva znaša 1,6 %, kar je veliko manjše kot tveganje velikih prirojenih okvar, ki jih med nosečnostjo povzročijo drugi vzroki, ki ne vključujejo KSR (Bozzo et al., 2011).
English: This was endorsed by the CHMP.
Slovenian: CHMP je stavek odobril.
English: In addition as there was one inconsistency with the package leaflet the MAH was asked to add “atypical mild or attenuated measles” in section 4.8 under infections and infestations.
Slovenian: Poleg tega je bila v navodilu za uporabo ena nedoslednost, zato je bil imetnik dovoljenja za promet z zdravilom naprošen, da doda „neobičajno blage ali oslabljene ošpice“ v poglavju 4.8 pod infekcijske in parazitske bolezni.
English: Though available data in the literature highlight a valuable perspective with regard to the overall risk of vaccine exposure at various stages of pregnancy, the theoretical risk, and because it is impossible to prove that the risk is zero, the MAH proposed that known pregnancy remains a contraindication to administration of rubella-containing vaccine.
Slovenian: Čeprav razpoložljivi podatki iz literature osvetljujejo dragocen vidik glede splošnega tveganja izpostavljenosti cepivu v različnih obdobjih nosečnosti, je zaradi teoretičnega tveganja in ker je nemogoče dokazati, da je tveganje ničto, imetnik dovoljenja za promet z zdravilom predlagal, da ostane znana nosečnost še naprej kontraindikacija za uporabo cepiva, ki vsebuje virus rdečk.
English: In order to get more insight in possible harm of MMR vaccination during pregnancy or pre-conception the CHMP asked from the MAH to provide evidence from enhanced surveillance and controlled studies that focus on risk of spontaneous abortion in women susceptible to measles, mumps and/or rubella, risk of malformation and congenital rubella syndrome (CRS) in offspring of such women, follow-up data up to 1 year age of children born from rubella susceptible women.
Slovenian: Zaradi boljšega vpogleda v možno škodo, ki jo lahko cepivo MMR povzroči med nosečnostjo ali pred spočetjem, je CHMP imetnika dovoljenja za promet z zdravilom zaprosil za dokaze o povečanem spremljanju in kontroliranih študijah, ki se osredotočajo na tveganje spontanega splava pri ženskah, dovzetnih za ošpice, mumps in/ali rdečke, tveganje malformacij in kongenitalnega sindroma rdečk (KSR) pri potomcih teh žensk, in podatke o spremljanju do 1 leto po rojstvu za otroke žensk, dovzetnih za rdečke.
English: The CHMP agreed that the list of adverse reactions reported from clinical trials and post marketing experience was appropriately reflected in the proposed harmonized SmPC.
Slovenian: CHMP se je strinjal, da je seznam neželenih učinkov, o katerih so poročali iz kliničnih preskušanj in iz izkušenj v obdobju trženja zdravila, ustrezno naveden v predlaganem usklajenem povzetku glavnih značilnosti zdravila.
English: The MAH replaced the seroconversion rates and stated data from children below 12 months of age are yet to come as a study is currently being conducted.
Slovenian: Imetnik dovoljenja za promet z zdravilom je stopnje serokonverzije zamenjal in navedel, da bodo podatki za otroke, stare manj kot 12 mesecev, kmalu na voljo, saj študija trenutno poteka.
English: Vaccination of breastfeeding women with measles, mumps or rubella vaccines has not been related with any safety problem for the women or their infants, although there is limited experience with Priorix during breastfeeding.
Slovenian: Cepljenje nosečnic s cepivi proti ošpicam, mumpsu ali rdečkam ni povezano s kakršnim koli tveganjem za varnost za ženske ali njihove dojenčke, čeprav so izkušnje s cepivom Priorix med dojenjem omejene.
English: The intramuscular route of administration was initially investigated in a small number of subjects (N=40) with seroconversion rates of 96.7%, 97.5% and 100% against measles, mumps and rubella, respectively.
Slovenian: Intramuskularna pot dajanja je bila uvodoma raziskana pri majhnem številu oseb (n = 40) s stopnjo serokonverzije 96,7 % proti ošpicam, 97,5 % proti mumpsu in 100 % proti rdečkam.
English: Mumps vaccine efficacy has also been suggested to be lower in high-transmission settings (Brockhoff 2004).
Slovenian: Kaže tudi, da je učinkovitost cepiva proti mumpsu manjša v okolju, kjer je možnost okužbe velika (Brockhoff 2004).
English: However foetal damage has not been documented when measles, mumps and rubella vaccines have been given to women who were unknowingly in early stages of pregnancy”.
Slovenian: Vendar pa škodljivih učinkov za plod pri dajanju cepiv proti ošpicam, mumpsu in rdečkam ženskam, ki niso vedele, da so v zgodnji fazi nosečnosti, niso dokumentirali“.
English: The CHMP recommended reordering of some of the statements and adding subtitles to clearly distinguish each precaution (i.e. thrombocytopenia, immunocompromised patients, and transmission).
Slovenian: CHMP je priporočil spremembo vrstnega reda nekaterih navedb in dodatne podnaslove za jasnejšo razmejitev previdnostnih ukrepov (tj. trombocitopenija, imunokompromitirani bolniki in prenos).
English: The CHMP was of the opinion that the statement on subjects with humoral and cellular deficiency was appropriate and in line with the approved contraindication of other MMR vaccines.
Slovenian: CHMP je bil mnenja, da je navedba o osebah s humoralno ali celično imunsko pomanjkljivostjo primerna in v skladu z odobreno kontraindikacijo za druga cepiva MMR.
English: The purpose of this Art 30 referral is to harmonise the SmPC across EU member states for Priorix and associated names.
Slovenian: Napotitev v skladu s členom 30 je namenjena uskladitvi povzetkov glavnih značilnosti zdravila Priorix in povezanih imen v državah članicah EU.
English: The CHMP noted that there are no theoretical risks of vaccination during breastfeeding.
Slovenian: CHMP je ugotovil, da s cepljenjem med dojenjem ni povezano teoretično tveganje.
English: However, since new and very complex childhood vaccines are under development it was recommended to list vaccines applicable for co-administration rather than to give a general statement on co-administration with other vaccines.
Slovenian: Vendar pa so v razvoju nova, zelo kompleksna cepiva za otroke, zato se priporoča navedba vseh cepiv, ki jih je mogoče uporabiti sočasno, ne pa splošna navedba o sočasni uporabi drugih cepiv.
English: In conclusion, the CHMP was of the opinion that the statement of “pregnancy” as a contraindication was in line with the approved contraindication of other MMR vaccines.
Slovenian: Zato je CHMP menil, da je navedba „nosečnosti“ kot kontraindikacije v skladu z odobreno kontraindikacijo za druga cepiva MMR.
English: For patients with thrombocytopenia or any coagulation disorder subcutaneous administration is recommended and thus a statement has been included.
Slovenian: Za bolnike s trombocitopenijo ali motnjo koagulacije se priporoča subkutano dajanje, kar je bilo prav tako vključeno v besedilo.
English: Systematic reviews on the safety, immunogenicity and efficacy of measles vaccination in children infected with HIV revealed that attenuated measles vaccine virus can caused severe complications or fatal disease in severely immunosuppressed HIV-infected patients.
Slovenian: Sistematski pregledi varnosti, imunogenosti in učinkovitosti cepiva proti ošpicam pri otrocih, okuženih z virusom HIV, so pokazali, da lahko oslabljen virus cepiva proti ošpicam povzroči hude zaplete ali smrtno bolezen pri bolnikih, okuženih z virusom HIV, ki imajo zelo oslabljen imunski sistem.
English: The MAH was however asked to consider restructuring section 4.8 in accordance with the SmPC guideline to provide clear and readily accessible information (summary of the safety profile, tabulated list of adverse reactions, description of selected adverse reactions).
Slovenian: Vendar je bil imetnik dovoljenja za promet z zdravilom naprošen, da razmisli o preoblikovanju poglavja 4.8 v skladu s smernicami za povzetek glavnih značilnosti zdravila, z namenom izboljšati jasnost in dostopnost informacij (povzetek varnostnega profila, seznam neželenih učinkov v obliki preglednice, opis izbranih neželenih učinkov).
English: The WHO classification of HIV-related disease in adults and children published in 2006 states the following: “Immunological criteria for diagnosing advanced HIV in a child younger than five years of age with severe HIV infection: %CD4+ <25 among those younger than 12 months %CD4+ <20 among those aged 12-35 months %CD4+ <15 among those aged 36-59 months”
Slovenian: V svoji razvrstitvi bolezni, povezanih z virusom HIV, pri odraslih in otrocih, objavljeni leta 2006, SZO navaja naslednje: „Imunološki kriteriji za diagnosticiranje napredovale okužbe z virusom HIV pri otrocih, mlajših od pet let, s hudo okužbo z virusom HIV: % CD4+ < 25 med otrocii, mlajšimi od 12 mesecev % CD4+ < 20 med otroci, starimi od 12 do 35 mesecev % CD4+ < 15 med otroci, starimi od 36 do 59 mesecev“ Obstajajo tudi poročila o ošpičnem encefalitisu z inkluzijskimi telesci po cepljenju MMR pri otrocih s primarno imunodeficienco in disgamaglobulinemijo (glejte Bitnun et al. 1999 Clin.
English: More recently Priorix has been coadministered with Haemophilus influenzae type b (Hib) and meningococcal C conjugate vaccines as well as with concomitant co-administration with hepatitis A inactivated vaccine and pneumoccocal 7-valent conjugate vaccine.
Slovenian: Nedavno so cepivo Priorix uporabili sočasno s cepivom proti Haemophilusu influenzae tipa b (Hib) in konjugiranim cepivom proti meningokokom ter sočasno in hkrati z inaktiviranim cepivom proti hepatitisu A in konjugiranim 7-valentnim cepivom proti pnevmokokom.
English: Section 4.5 - Interactions with other medicinal products and other forms of interaction Clinical studies demonstrated that Priorix can be administered concomitantly with live attenuated varicella vaccine, DTPa-IPV and combined hepatitis A/B vaccine (Marshall et al., 2006; Stuck et al., 2002; Usonis et al., 2005; Wellington and Goa, 2003).
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Klinične študije so pokazale, da se lahko cepivo Priorix daje sočasno s cepivom proti noricam, ki vsebuje živ oslabljen virus, DTPa-IPV in kombiniranim cepivom proti hepatitisu A/B (Marshall et al., 2006; Stuck et al., 2002; Usonis et al., 2005; Wellington and Goa, 2003).
English: The final agreed wording is: “PRIORIX can be given simultaneously (but at separate injection sites) with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hepatitis A vaccine (HAV), Meningococcal serotype C conjugated vaccine (MenC), varicella zoster vaccine (VZV), oral polio vaccine (OPV) and 10-valent pneumococcal conjugate vaccine in accordance with local recommendations.
Slovenian: Dogovorjeno je bilo naslednje končno besedilo: „Cepivo PRIORIX se lahko daje sočasno (vendar na različna mesta injiciranja) s katerim koli od naslednjim monovalentnih ali kombiniranih cepiv [vključno s heksavalentnimi cepivi (DTPa-HBVIPV/Hib)]: cepivom proti davici, tetanusu in brezcelično cepivo proti oslovskemu kašlju (DTPa), cepivom proti Haemophilus influenzae tipa b (Hib), inaktiviranim cepivom proti otroški ohromelosti (IPV), cepivom proti hepatitisu B (HBV), cepivom proti hepatitisu A (HAV), konjugiranim cepivom proti meningokokom serološke skupine C (MenC), cepivom proti virusu herpesa zostra (VZV), peroralnim cepivom proti otroški ohromelosti (OPV) in 10-valentnim konjugiranim cepivom proti pnevmokokom v skladu z lokalnimi priporočili.
English: Priorix is a combined freeze-dried measles (M), mumps (M), and rubella (R) vaccine (live) preparation.
Slovenian: Cepivo Priorix je kombinirano (živo) cepivo proti ošpicam (M), mumpsu (M) in rdečkam (R), sušeno z zamrzovanjem.
English: The risk for measles vaccination (enhancement of spontaneous abortion of stillbirth) is indicated to be unknown.
Slovenian: Navedeno je, da je tveganje, povezano s cepljenjem proti ošpicam (spontani splav ali mrtvorojenost), neznano .
English: So, there were no Priorix-specific data on mumps effectiveness and the general comments proposed by the MAH were endorsed by the CHMP.
Slovenian: Podatkov o učinkovitosti proti mumpsu, specifičnih za cepivo Priorix, torej ni bilo, zato je odbor CHMP odobril splošne opombe, ki jih je predlagal imetnik dovoljenja za promet z zdravilom.
English: According to the SmPC guideline, the text should not include reference to other medicinal products, so the MAH proposed to delete reference on the result of comparative studies that were present in the SmPC of some MSs.
Slovenian: V skladu s smernicami za povzetek glavnih značilnosti zdravila besedilo ne sme vključevati sklicev na druga zdravila, zato je imetnik dovoljenja za promet z zdravilom predlagal, da se sklic na rezultate primerjalnih študij, prisoten v povzetkih glavnih značilnosti zdravila nekaterih držav članic, briše.
English: These patients should be vaccinated with caution and preferably using subcutaneous route”.
Slovenian: Pri cepljenju teh bolnikov je potrebna previdnost, priporoča pa se subkutani način cepljenja“.
English: Review of pharmacovigiliance and published data does not indicate a risk of CRS in inadvertently vaccinated women, who are pregnant or conceived shortly after vaccination with Priorix.
Slovenian: Pregled farmakovigilančnih podatkov in objavljenih podatkov ne kaže na tveganje KSR pri nenamerno cepljenih ženskah, ki so noseče ali zanosijo kmalu po cepljenju s cepivom Priorix.
English: The data set provided by the MAH was generated by post-marketing data from the MAH's safety database and data from recent published literature about MMR vaccination in pregnant women.
Slovenian: Niz podatkov, ki jih je imetnik dovoljenja za promet z zdravilom predložil, je nastal iz podatkov v obdobju trženja cepiva iz zbirke podatkov o varnosti zdravila, ki jo vodi imetnik dovoljenja za promet, in iz novejših objavljenih podatkov iz literature o cepljenju nosečnic s cepivom MMR.
English: The MAH amended the corresponding part accordingly and also added another sentence to reflect the documented transplacental transmission.
Slovenian: Imetnik dovoljenja za promet z zdravilom je zadevni del ustrezno spremenil in dodal še en stavek o dokumentiranem prenosu prek placente.
English: The final agreed wording is: “Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients, therefore some of these patients may acquire measles, mumps or rubella in case of contact, despite appropriate vaccine administration.
Slovenian: Dogovorjeno je bilo naslednje končno besedilo: „Imunokompromitirani bolniki, pri katerih ni kontraindikacije za to cepivo (glejte poglavje 4.3), se morda ne bodo odzvali tako dobro kot imunokompetentni bolniki, zato se lahko kljub ustreznemu cepljenju ti bolniki ob stiku nalezejo ošpic, mumpsa ali rdečk.
English: The MAH implemented all comments made by the CHMP and the final agreed wording was: “There is limited experience with PRIORIX during breast-feeding.
Slovenian: Imetnik dovoljenja za promet z zdravilom je vse opombe odbora CHMP upošteval in dogovorjeno je bilo končno besedilo: „Izkušnje z uporabo cepiva PRIORIX med dojenjem so omejene.
English: Pharyngeal excretion of the rubella and measles virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day.
Slovenian: Znano je, da se virusa rdečk in ošpic iz grla izločata približno 7 do 28 dni po cepljenju, pri čemer je izločanje največje okoli 11. dneva.
English: In HIV infected children with no evidence of immunosuppression measles vaccine has been safe and the risk of vaccine induced virus disease is very low.
Slovenian: Pri otrocih, okuženih z virusom HIV, ki niso kazali znakov imunosupresije, je bila uporaba cepiva proti ošpicam varna, tveganje za virusno obolenje, sproženo s cepivom, pa zelo majhno.
English: In patients with existing thrombocytopenia or a history of thrombocytopenia after measles, mumps or rubella vaccination the risk-benefit of administering PRIORIX should be carefully evaluated.
Slovenian: Pri bolnikih z obstoječo trombocitopenijo ali trombocitopenijo v anamnezi po cepljenju proti ošpicam, mumpsu ali rdečkam je treba razmerje med koristmi in tveganji uporabe cepiva PRIORIX skrbno oceniti.
English: The major divergence in the approved SmPCs relates to the administration of Priorix in HIVinfected subjects.
Slovenian: Največje razhajanje v odobrenih povzetkih glavnih značilnosti zdravila se nanaša na uporabo cepiva Priorix pri osebah, okuženih z virusom HIV.
English: The data from spontaneous reports and the pregnancy registry have not indicated a safety concern with respect to spontaneous abortion or congenital malformations related to the inadvertent administration of Priorix in pregnant women.
Slovenian: Podatki iz spontanih poročil in registra nosečnosti ne kažejo na varnostno tveganje za pojav spontanih splavov ali prirojenih malformacij, povezanih z nenamerno uporabo cepiva Priorix pri nosečnicah.
English: The attenuated virus strain in the current rubella vaccine can rarely infect the foetus and there is no evidence that foetal infection with the vaccine virus is harmful.
Slovenian: Oslabljeni sev virusa v obstoječem cepivu proti rdečkam le redko okuži plod, dokazov o škodljivem vplivu okužbe plodu z virusom cepiva pa ni.