FrancophonIA/ELRC3.0 huggingface dataset:
English: The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases (see section 4.8).
Slovenian: V takšnih primerih je treba pred odločitvijo za cepljenje skrbno ovrednotiti razmerje med morebitnim tveganjem in koristjo cepljenja (glejte poglavje 4.8).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for measles / mumps / rubella vaccines (live, attenuated), the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za cepiva proti ošpicam / mumpsu / rdečkam (živa, oslabljena) je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
Slovenian: Pri večini cepljenih, za rdečke dovzetnih posameznikov je 7 do 28 dni po cepljenju prišlo do izločanja majhnih količin živega oslabljenega virusa rdečk iz nosu ali grla.
English: Withdraw the entire content of the reconstituted vaccine vial into the same syringe and inject the entire volume.
Slovenian: Celotno vsebino povlecite v isto brizgo in injicirajte celotno količino.
English: Before reconstitution, the powder is a light yellow compact crystalline cake and the solvent is a clear colourless fluid.
Slovenian: Pred rekonstitucijo je prašek svetlo rumen kompakten kristalni skupek, vehikel pa je bistra, brezbarvna tekočina.
English: Rubella virus Wistar RA 27/3 strain (live attenuated)
Slovenian: Virus rdečk, sev Wistar RA 27/3 (živ, oslabljen)
English: After 2 doses, the seroprotection rates against measles were 98.1% when the first dose was given at 11 months compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective met).
Slovenian: Po 2 odmerkih so bile stopnje serozaščite proti ošpicam 98,1 %, če so s prvim odmerkom cepili v starosti 11 mesecev, v primerjavi z 98,9 %, če so s prvim odmerkom cepili v starosti 12 mesecev (neinferiornost je bila v študiji dokazana).
English: Furthermore, pregnancy should be avoided for 1 month following vaccination (see section
Slovenian: Poleg tega ženska ne sme zanositi 1 mesec po cepljenju (glejte poglavje 4.6).
English: Table 1: Seroprotection Rates to Measles, Mumps, and Rubella 6 Weeks Post-Dose 1 and 6 Weeks Post-Dose 2 of the quadrivalent measles, mumps, rubella and varicella vaccine manufactured by Merck & Co., Inc. - Full Analysis Set
Slovenian: Preglednica 1: Stopnje serozaščite proti ošpicam, mumpsu in rdečkam 6 tednov po 1. odmerku in 6 tednov po 2. odmerku štirivalentnega cepiva proti ošpicam, mumpsu, rdečkam in noricam izdelovalca Merck & Co., Inc. - Popolna analiza
English: †, Atypical measles, Epididymitis, Orchitis, Otitis media, Parotitis, Rhinitis, Subacute Sclerosing Panencephalitis
Slovenian: †, atipične ošpice, epididimitis, orhitis, vnetje srednjega ušesa, parotitis, rinitis, subakutni sklerozirajoči panencefalitis neznana pogostnost
English: This vaccine should be given subcutaneously to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Slovenian: Pri posameznikih s trombocitopenijo ali kakršnokoli drugo motnjo koagulacije je potrebno cepivo aplicirati subkutano, saj bi pri intramuskularni aplikaciji lahko prišlo do krvavitev.
English: Other medicines and M-M-RVAXPRO
Slovenian: Druga zdravila in cepivo M-M-RVAXPRO
English: Uncommon (may affect 1 to 10 in 1000 vaccinees)
Slovenian: Občasni (pojavijo se lahko pri 1 do 10 od 1.000 cepljenih oseb)
English: M-M-RVAXPRO is a vaccine containing measles, mumps, and rubella viruses that have been weakened.
Slovenian: M-M-RVAXPRO je cepivo, ki vsebuje oslabljene viruse ošpic, mumpsa in rdečk.
English: †, Encephalopathy
Slovenian: †, encefalopatija
English: M-M-RVAXPRO may be given with some routine childhood vaccines that may be due to be given at the same time.
Slovenian: Cepljenje s cepivom M-M-RVAXPRO se lahko opravi hkrati z nekaterimi običajnimi otroškimi cepljenji.
English: M-M-RVAXPRO powder for suspension for injection
Slovenian: M-M-RVAXPRO prašek za suspenzijo za injiciranje
English: After two doses, the seroprotection rates against measles were 94.6% when the first dose was given at 9 months compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective not met).
Slovenian: Po dveh odmerkih so bile stopnje serozaščite proti ošpicam 94,6 %, če so s prvim odmerkom cepili v starosti 9 mesecev, v primerjavi z 98,9 %, če so s prvim odmerkom cepili v starosti 12 mesecev (neinferiornost v študiji ni bila dokazana).
English: • Diarrhoea, vomiting.
Slovenian: • driska, bruhanje
English: Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues.
Slovenian: Povezan je bil z izolacijo persistentnega virusa in/ali virusnega antigena, izoliranega iz telesnih tkiv.
English: Do not use this vaccine after the expiry date which is stated on the outer carton after EXP.
Slovenian: Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake Uporabno do ali EXP. Rok uporabnosti cepiva se izteče na zadnji dan navedenega meseca.
English: • Seizures (fits) without fever; seizures (fits) with fever in children; walking unsteadily; dizziness; illnesses involving inflammation of the nervous system (brain and/or spinal cord).
Slovenian: • napadi krčev brez zvišane telesne temperature, napadi krčev z zvišano telesno temperaturo pri otrocih, nestabilna hoja, omotica, bolezni, ki vključujejo vnetje živčnega sistema (možganov in/ali hrbtenjače)
English: The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Slovenian: Pripravljenega cepiva ne smete uporabiti, če v njem opazite delce ali če se videz vehikla, praška ali pripravljenega cepiva razlikuje od prej opisanega.
English: Pregnancy Pregnant women should not be vaccinated with M-M-RVAXPRO.
Slovenian: Nosečnost Nosečnic se ne sme cepiti s cepivom M-M-RVAXPRO.
English: • Itching; inflammation of the fatty tissue under the skin; red or purple, flat, pinhead spots under the skin; hardened, raised area of the skin; serious illness with ulcers or blistering of the skin, mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Slovenian: • srbenje, vnetje maščobnega tkiva pod kožo, rdeč ali škrlaten, neprivzdignjen, za bucikino glavico velik izpuščaj pod kožo, privzdignjena zatrdlina na koži, huda bolezen z razjedami in mehurji na koži, v ustih, očeh in/ali na spolovilih (Stevens-Johnsonov sindrom)
English: Post-exposure vaccination
Slovenian: Poekspozicijsko cepljenje
English: Pregnancy.
Slovenian: Nosečnost.
English: Therefore, inadvertent vaccination of unknowingly pregnant women with measles-, mumps-, or rubella-containing vaccines should not be a reason for termination of pregnancy.
Slovenian: Cepljenje žensk s cepivi proti ošpicam, mumpsu ali rdečkam, ki niso vedele, da so noseče, zato ne sme biti razlog za prekinitev nosečnosti.
English: The MAH presented an analysis of reports with PT (preferred term) “Crying” From the data provided by the MAH “crying” was reported during clinical trials, post marketing source and literature report in paediatric population as an ADR.
Slovenian: Iz podatkov, ki jih je predložil MAH, je bil "jok" pri pediatrični populaciji poročan kot neželeni učinek med kliničnimi preskušanji, v virih po začetku trženja in v poročilih iz literature.
English: • Cough; lung infection with or without fever.
Slovenian: • kašelj, okužba pljuč z zvišano telesno temperaturo ali brez
English: M-M-RVAXPRO can also be used in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated persons older than 9 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella.
Slovenian: Cepivo M-M-RVAXPRO lahko uporabljamo tudi za cepljenje med izbruhom ošpic ali za cepljenje po izpostavljenosti ošpicam ter pri predhodno necepljenih osebah, starejših od 9 mesecev, ki so v stiku z nosečnico, dovzetno za okužbo, ter za osebe, verjetno dovzetne za mumps in rdečke.
English: What M-M-RVAXPRO looks like and contents of the pack
Slovenian: Izgled cepiva M-M-RVAXPRO in vsebina pakiranja
English: Based on clinical studies with the quadrivalent measles, mumps, rubella and varicella vaccine and with the previous formulation of the combined measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., M-M-RVAXPRO can be given simultaneously (but at separate injection sites) with Prevenar and/or hepatitis A vaccine.
Slovenian: Na podlagi kliničnih študij s štirivalentnim cepivom proti ošpicam, mumpsu, rdečkam in noricam ter s prejšnjo obliko kombiniranega cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc. se lahko cepivo M-M-RVAXPRO da sočasno s cepivom Prevenar in/ali cepivom proti hepatitisu
English: INSTRUCTIONS IN USE
Slovenian: NAVODILA ZA UPORABO
English: Pregnant women should not be vaccinated with M-M-RVAXPRO.
Slovenian: Nosečnic se ne sme cepiti s cepivom M-M-RVAXPRO.
English: The doctor will decide if M-M-RVAXPRO should be given.
Slovenian: Zdravnik se bo odločil, ali jih sme cepiti s cepivom M-M-RVAXPRO.
English: Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. is highly immunogenic and generally well tolerated.
Slovenian: Klinične študije pri 284 trojno seronegativnih otrocih, starih od 11 mesecev do 7 let, so pokazale veliko imunogenost in splošno dobro prenašanje prejšnje oblike cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc.
English: Rubella (titre ≥10 IU/mL)
Slovenian: Rdečke (titer ≥10 i.e./ml)
English: M-M-RVAXPRO should be given concomitantly at separate injection sites, or one month before or after administration of other live virus vaccines.
Slovenian: Cepivo M-M-RVAXPRO se lahko da sočasno z drugimi živimi cepivi, toda na drugo vbodno mesto, ali pa en mesec pred ali en mesec po cepljenju z drugimi živimi cepivi.
English: M-MRVAXPRO is not to be injected directly into any blood vessel.
Slovenian: Cepiva M-M-RVAXPRO se ne sme injicirati neposredno v katero koli žilo.
English: Blood and the lymphatic system disorders Regional lymphadenopathy, Thrombocytopenia
Slovenian: Bolezni krvi in limfatičnega sistema področna limfadenopatija, trombocitopenija neznana pogostnost
English: Studies have not been conducted with M-M-RVAXPRO in pregnant women.
Slovenian: Študij o cepljenju s cepivom M-M-RVAXPRO pri nosečnicah niso izvedli.
English: Store and transport refrigerated (2°C - 8°C).
Slovenian: Shranjujte in prevažajte na hladnem ( 2 °C - 8 °C).
English: Evaluation of immunogenicity and clinical efficacy A comparative study in 1279 subjects who received M-M-RVAXPRO or the previous formulation (manufactured with human serum albumin) of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrated similar immunogenicity and safety between the 2 products.
Slovenian: Primerjalna študija s 1279 osebami, ki so bile cepljene s cepivom M-M-RVAXPRO ali prejšnjo obliko cepiva (izdelano s humanim serumskim albuminom) proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc., je pokazala, da sta imunogenost in varnost teh 2 cepiv podobni.
English: Discard if reconstituted vaccine is not used within 8 hours.
Slovenian: Če pripravljenega cepiva ne uporabite v 8 urah, ga zavrzite.
English: The general safety profile of either administration routes were comparable, although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
Slovenian: Splošni profil varnosti po obeh načinih injiciranja je bil primerljiv, čeprav so bile reakcije na mestu vboda manj pogoste pri i.m.
English: Before mixing with the solvent, the powder is a light yellow compact crystalline cake.
Slovenian: Preden ga zmešamo z vehiklom, je prašek svetlo rumen kompakten kristalni skupek.
English: Immune globulin Immune globulin (IG) is not to be given concomitantly with M-M-RVAXPRO.
Slovenian: Imunoglobulini Sočasno s cepivom M-M-RVAXPRO ne dajajte imunoglobulinov (IG).
English: If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, or 4 to 6 weeks after vaccination with M-M-RVAXPRO.
Slovenian: Če je potreben tuberkulinski test, ga je treba opraviti kadar koli pred cepljenjem s cepivom M-M-RVAXPRO, hkrati z njim ali 4 do 6 tednov po njem.
English: Anaphylactoid reaction, Anaphylaxis and related phenomenon such as Angioneurotic oedema, Facial oedema, and Peripheral oedema
Slovenian: Bolezni imunskega sistema anafilaktoidna reakcija, anafilaksija in povezani pojavi, kot so angionevrotični edem, obrazni edem in periferni edem neznana pogostnost
English: Individuals likely to be susceptible to mumps and rubella M-M-RVAXPRO is preferred for vaccination of persons likely to be susceptible to mumps and rubella.
Slovenian: Posamezniki, ki so verjetno dovzetni za mumps in rdečke Pri cepljenju oseb, ki so verjetno dovzetne za mumps in rdečke, ima prednost cepivo M-M-RVAXPRO.
English: Evaluation of immunogenicity in children from 9 to 12 months of age at the time of first dose A clinical study was conducted with the quadrivalent measles, mumps, rubella and varicella vaccine manufactured by Merck & Co., Inc., administered with a 2-dose schedule, the doses being given 3 months apart in 1,620 healthy subjects from 9 to 12 months of age at the time of first dose.
Slovenian: Ocena imunogenosti pri otrocih, ki so bili ob prejetju prvega odmerka stari od 9 do 12 mesecev Pri 1.620 zdravih osebah, ki so bile ob prejetju prvega odmerka, stare od 9 do 12 mesecev, so izvedli klinično študijo s štirivalentnim cepivom proti ošpicam, mumpsu, rdečkam in noricam izdelovalca Merck & Co., Inc., s katerim so cepili v 2 odmerkih, v razmiku 3 mesecev.
English: Encephalitis and Encephalopathy
Slovenian: Encefalitis in encefalopatija
English: M-M-RVAXPRO powder for suspension for injection in pre-filled syringe
Slovenian: M-M-RVAXPRO prašek za suspenzijo za injiciranje v napolnjeni injekcijski brizgi
English: Administration of a higher than recommended dose of M-M-RVAXPRO was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of M-M-RVAXPRO.
Slovenian: Profil neželenih učinkov je bil primerljiv s tistim, opaženim pri priporočenem odmerku cepiva M-M-RVAXPRO.
English: In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
Slovenian: Pri hudo imunsko oslabljenih posameznikih, ki so jih pomotoma cepili s cepivom, ki vsebuje virus ošpic, so poročali o ošpičnem encefalitisu z inkluzijskimi telesci, pnevmonitisu in smrti, kot neposredni posledici razsejane okužbe s cepilnim virusom ošpic.
English: Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a >99% reduction in the incidence of each of the 3 targeted diseases.
Slovenian: Po svetu so med letoma 1978 in 2003 razdelili več kot 400 milijonov odmerkov cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc. Razširjena uporaba cepljenja z 2 odmerkoma v ZDA in državah, kot sta Finska in Švedska, je vodila v > 99-odstotno zmanjšanje pojavnosti vsake od teh 3 bolezni.
English: Individuals 12 months or older should receive one dose at an elected date.
Slovenian: V starosti nad 12 mesecev cepimo na izbrani dan z enim odmerkom cepiva.
English: Afebrile convulsions or seizures, Ataxia, Dizziness, Encephalitis
Slovenian: Bolezni živčevja nevročinski krči ali napadi, ataksija, vrtoglavica, encefalitis
English: Infections and infestations Nasopharyngitis, Upper respiratory tract infection or Viral infection
Slovenian: Infekcijske in parazitske bolezni nazofaringitis, okužba zgornjih dihal ali virusna okužba občasni aseptični meningitis
English: After reconstitution, the vaccine should be used immediately; however, in-use stability has been demonstrated for 8 hours when refrigerated at 2°C-8°C.
Slovenian: V primeru shranjevanja rekonstituiranega cepiva v hladilniku pri temperaturi od 2 C - 8 C je bila dokazana njegova 8-urna stabilnost.
English: Do not freeze the reconstituted vaccine.
Slovenian: Pripravljenega cepiva ne zamrzujte.
English: Inject the entire content of the pre-filled syringe into the vial containing the powder.
Slovenian: Izbrizgajte celotno vsebino iz napolnjene injekcijske brizge v vialo s praškom.
English: • Burning and/or stinging of short duration at the injection site; blisters and/or hives at the injection site.
Slovenian: • kratkotrajen pekoč občutek in/ali zbadanje na mestu injiciranja, mehurji in/ali koprivnica na mestu injiciranja
English: Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks' salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.
Slovenian: sorbitol, natrijev fosfat, kalijev fosfat, saharoza, hidrolizirana želatina, medij 199 s Hanksovimi solmi, MEM, natrijev L-glutamat, neomicin, fenol rdeče, natrijev hidrogenkarbonat, klorovodikova kislina, natrijev hidroksid in voda za injekcije
English: Store and transport refrigerated (2°C- 8°C).
Slovenian: Shranjujte in prevažajte na hladnem (2 °C - 8 ºC).
English: Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in prepubertal children.
Slovenian: Artralgija in/ali artritis (običajno prehodna in redko kronična) ter polinevritis so značilni za okužbo z divjim sevom rdečk.
English: • Inflammation of the retina (in the eye) with changes in sight.
Slovenian: • vnetje očesne mrežnice s spremembami vida
English: Inject the entire content of the syringe into the vial containing the powder.
Slovenian: Izbrizgajte celotno vsebino brizge v vialo s praškom.
English: - If you get any of the side effects, talk to your doctor of pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: There is no information to suggest that M-M-RVAXPRO affects the ability to drive or operate machinery.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni podatkov, ki bi kazali, da cepivo M-M-RVAXPRO vpliva na sposobnost vožnje ali upravljanja s stroji.
English: 1 Jeryl Lynn™ [Level B] strain (live, attenuated)……...…not less than 12.5x10 3 CCID50*
Slovenian: 1, sev Jeryl Lynn™ (nivo B) (živ, oslabljen) ...............najmanj 12,5 x 10 3 CCID50*
English: • Feeling sick (nausea).
Slovenian: • slabost (siljenje na bruhanje)
English: For use in measles outbreaks, or for post-exposure vaccination, or, for use in previously unvaccinated individuals older than 9 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella, see section 5.1.
Slovenian: Uporaba pri izbruhih ošpic ali za poekspozicijsko cepljenje (cepljenje po izpostavitvi bolezni) ali uporaba pri predhodno necepljenih posameznikih, starejših od 9 mesecev, ki so v stiku z nosečnicami, dovzetnimi za ošpice, ter osebah, ki so verjetno dovzetne za mumps in rdečke, je opisana v poglavju 5.1.
English: M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10
Slovenian: M-M-RVAXPRO - prašek v viali in vehikel v viali - pakiranje po 1, 10
English: Administration of measles, mumps, or rubella antibody-containing blood products, including immune globulin preparations, should be avoided within 1 month after a dose of M-M-RVAXPRO unless considered to be essential.
Slovenian: 1 mesec po cepljenju s cepivom M-M-RVAXPRO se je treba izogibati dajanju krvnih pripravkov, ki vsebujejo protitelesa proti ošpicam, mumpsu ali rdečkam, vključno s pripravki imunoglobulinov, razen če je to nujno potrebno.
English: Solvent for M-M-RVAXPRO
Slovenian: Vehikel za M-M-RVAXPRO
English: DO NOT INJECT INTRAVASCULARLY.
Slovenian: CEPIVA NE INJICIRAJTE V ŽILO.
English: Dose 1 at 9 months / Dose 2 at 12 months
Slovenian: 1. odmerek pri 9 mesecih / 2. odmerek pri 12 mesecih N = 527
English: In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported (see section 4.3); disseminated mumps and rubella vaccine virus infection has also been reported.
Slovenian: Pri hudo imunsko oslabljenih posameznikih, ki so jih pomotoma cepili s cepivom, ki vsebuje virus ošpic, so poročali o ošpičnem encefalitisu z inkluzijskimi telesci, pnevmonitisu in smrti kot neposredni posledici razsejane okužbe s cepilnim virusom ošpic (glejte poglavje 4.3).
English: • Nasal congestion and sore throat; upper respiratory tract infection or viral infection; runny nose.
Slovenian: • zamašen nos in vneto grlo, okužba v zgornjem delu dihal ali virusna okužba, izcedek iz nosu
English: Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.
Slovenian: Pri posameznikih s trombocitopenijo se lahko ta po cepljenju poslabša.
English: Powder: sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks' salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)
Slovenian: Prašek: sorbitol, natrijev fosfat, kalijev fosfat, saharoza, hidrolizirana želatina, medij 199 s Hanksovimi solmi, MEM, natrijev L-glutamat, neomicin, fenol rdeče, natrijev hidrogenkarbonat, klorovodikova kislina (za uravnavanje pH) in natrijev hidroksid (za uravnavanje pH)
English: Eye disorders Conjunctivitis, Retinitis
Slovenian: Očesne bolezni konjunktivitis, retinitis neznana pogostnost
English: 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: Pri bolnikih z oslabelo imunostjo, ki nimajo kontraindikacij za cepljenje s tem cepivom (glejte poglavje 4.3), odziv morda ne bo tako dober kot pri imunsko sposobnih bolnikih.
English: Side effect
Slovenian: Neželeni učinek
English: Panniculitis, Pruritus, Purpura, Skin induration, Stevens-Johnson syndrome
Slovenian: Bolezni kože in podkožja ošpicam podoben izpuščaj ali drug izpuščaj pogosti urtikarija občasni panikulitis, pruritus, purpura, zatrdlina kože, Stevens-Johnsonov sindrom neznana pogostnost
English: Read the package leaflet before use.
Slovenian: intramuskularna ali subkutana uporaba Pred uporabo preberite priloženo navodilo!
English: How to use M-M-RVAXPRO
Slovenian: Kako uporabljati cepivo M-M-RVAXPRO