natgillin/translations-raw huggingface dataset:
Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities. 
Tudi starejše ženske (stare 35 do 45 let) te neželene učinke večinoma dobro prenašajo in le redko jih motijo pri običajnih dejavnostih.
The vaccine may contain traces of recombinant human albumin (rHA). 
Cepivo lahko v sledeh vsebuje rekombinantni humani albumin (rHA).
Such infants should be revaccinated at 12 to 15 months of age. 
Te dojenčke je treba ponovno cepiti v starosti od 12 do 15 mesecev.
Seroprotection rates [95% CI] 
Stopnje serozaščite [95-odstotni IZ]
71% of the reports (212 of 297) concerned crying with a time to onset of more than 24 hours. 
71 % poročil (212 od 297) se je nanašalo na začetek joka več kot 24 urah po cepljenju.
The majority of the crying occurred 6 to 10 days after vaccination. 
Večina primerov joka se je pojavila 6 do 10 dni po cepljenju.
The conclusion of the MAH is not endorsed by the PRAC. 
Sklep MAH ni bil podprt s strani odbora PRAC.
The safety profile post-dose 1 and 2 was generally comparable for all age cohorts. 
Profil varnosti po 1. in 2. odmerku je bil v splošnem primerljiv za vse starostne skupine.
Aseptic meningitis 
Aseptični meningitis
Current immunosuppressive therapy (including high doses of corticosteroids). 
Trenutno imunosupresivno zdravljenje (vključno z velikimi odmerki kortikosteroidov).
Therefore, based on the aforementioned information the PRAC recommends a variation in section 4.8 to add “Crying” with the frequency “uncommon”. 
Na podlagi zgoraj navedenih informacij odbor PRAC priporoča spremembo v poglavju 4.8 z dodatkom izraza "jok" s pogostnostjo "občasni".
After reconstitution, one dose (0.5 ml) contains: 
Po pripravi cepiva en odmerek (0,5 ml) vsebuje:
Non-pregnant adolescent and adult females 
Mladostnice in odrasle ženske, ki niso noseče
If, however, the vaccine is given a few days before exposure, substantial protection may be afforded. 
Če je posameznik cepljen nekaj dni pred izpostavitvijo, je možna precejšnja zaščita.
This latency period appears to correspond with the time to onset of general malaise that often occurs after the MMR vaccination. 
To latentno obdobje ustreza času do nastopa splošnega slabega počutja, ki se pogosto pojavi po cepljenju s cepivom MMR.
Adverse reactions are ranked under headings of frequency using the following convention: [Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to ≤1/100); Not known (cannot be estimated from the available data)] 
Neželeni učinki so razvrščeni po pogostnosti v skladu z naslednjim dogovorom: [Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do ≤ 1/100), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)]
• Whenever the risk management system is modified , especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Patients with rare hereditary problems of fructose intolerance should not take this vaccine. 
Bolniki z redko dedno intoleranco za fruktozo ne smejo prejeti tega cepiva.
In these clinical studies, it was demonstrated that the immune responses were unaffected and that the overall safety profiles of the administered vaccines were similar. 
V teh kliničnih študijah se je pokazalo, da se imunski odziv ni spremenil in da so bili celotni varnostni profili prejetih cepiv podobni.
Vaccination should be postponed during any illness with fever >38.5°C. 
Cepljenje je treba odložiti pri katerikoli bolezni z zvišano telesno temperaturo > 38,5 C.
Close monitoring is recommended following vaccination for the early signs of such reactions. 
Po cepljenju je priporočeno pozorno spremljanje možnih zgodnjih znakov teh reakcij.
In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products. 
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination. 
Vzrok nekaterih od teh primerov bi lahko bile neprepoznane ošpice v prvem letu življenja ali morda cepljenje proti ošpicam.
Further doses should be administered according to your doctor's recommendation. 
Nadaljnja cepljenja je treba opraviti v skladu s priporočili zdravnika.
It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another. 
Pomembno je, da za vsakega bolnika uporabite drugo sterilno brizgo in iglo, da preprečite prenos okužb z ene osebe na drugo.
Non-clinical studies have not been conducted. 
Predklinične študije niso bile izvedene.
Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines). 
Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete ali ste pred kratkim prejeli katero koli drugo zdravilo (ali drugo cepivo).
Individuals 12 months of age or older: 
Posamezniki, stari 12 mesecev ali več:
Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed. 
Ovrednotiti je treba serološki status, da ugotovimo, ali je ponovno cepljenje potrebno ali ne.
The second dose is intended for individuals who did not respond to the first dose for any reason. 
Drugi odmerek je namenjen posameznikom, pri katerih po prvem cepljenju iz kakršnegakoli vzroka ni prišlo do odziva.
No data on the efficacy and safety of M-M-RVAXPRO for use in children below 9 months of age are currently available. 
Podatkov o učinkovitosti in varnosti cepiva M-M-RVAXPRO za uporabo pri otrocih, mlajših od 9 mesecev, trenutno ni na voljo.
There is no evidence that measles vaccine can cause SSPE. 
Ni dokazov, da bi cepivo proti ošpicam lahko povzročilo SSPE.
Infants below 9 months of age: 
Dojenčki, mlajši od 9 mesecev:
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. 
V skladu s členom 114 Derektive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. 
Ni potrjenih dokazov, ki bi kazali, da se tak virus prenaša na osebe, dovzetne za rdečke, ki so v stiku s cepljenimi posamezniki.
Under special circumstances, it can be given from 9 months of age. 
V posebnih primerih se lahko cepi od starosti 9 mesecev dalje.
All adverse reactions were evaluated in 1940 children. 
Vse neželene učinke so ocenili pri 1.940 otrocih.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2.of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis. 
Doslej niso poročali o študijah o vplivu cepiv proti ošpicam na otroke z nezdravljeno tuberkulozo.
One dose is given at an elected date usually from 12 months of age. 
Na izbrani dan se cepi z enim odmerkom, običajno od starosti 12 mesecev dalje.
You or your child should be monitored closely for measles, mumps, and rubella because vaccination may be less effective than for uninfected persons (see section Do not use M-M-RVAXPRO). 
Vas ali vašega otroka je treba skrbno spremljati zaradi ošpic, mumpsa in rdečk, ker je lahko cepljenje manj učinkovito kot pri neokuženih osebah (glejte poglavje Ne uporabljajte cepiva M-M-RVAXPRO).
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh osebah.
• Fever (38.5°C or higher). 
• zvišana telesna temperatura (38,5 ºC ali več)
In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12-20%), and the reactions tend to be more marked and of longer duration. 
Pri ženskah so pojavne stopnje artritisa in artralgije na splošno višje kot pri otrocih (12 do 20 %), neželeni učinki pa so izrazitejši in vztrajajo dalj časa.
Time point 
Časovna točka
Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours after exposure. 
Cepljenje posameznikov, ki so bili izpostavljeni divjemu sevu ošpic, lahko v določeni meri ščiti pred boleznijo, če ga je mogoče izvesti v 72 urah po izpostavitvi.
Following vaccination in children, reactions in joints are generally uncommon (0-3%) and of brief duration. 
Po cepljenju otrok so neželeni učinki v sklepih večinoma občasni (0 do 3 %) in kratkotrajni.
Pharmacotherapeutic group: Viral vaccine, ATC code J07BD52 
Farmakoterapevtska skupina: virusna cepiva; oznaka ATC: J07BD52
not less than 1 x10 
najmanj 1 x 10
In comparison to the first dose, a second dose of M-M-RVAXPRO is not associated with an increase in the incidence and severity of clinical symptoms including those suggestive of hypersensitivity reaction. 
V primerjavi s prvim odmerkom drugi odmerek cepiva M-M-RVAXPRO ni povezan s povečano pojavnostjo in jakostjo kliničnih simptomov, vključno s tistimi, ki nakazujejo preobčutljivostno reakcijo.
Adults and adolescents with a history of allergies may potentially be at increased risk of anaphylaxis or anaphylactoid reactions. 
Odrasli in mladostniki z anamnezo alergij imajo lahko večje tveganje za nastanek anafilaktičnih ali anafilaktoidnih reakcij.
Although a theoretical risk cannot be excluded, no cases of congenital rubella syndrome have been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with a rubella-containing vaccine. 
Teoretičnega tveganja sicer ni mogoče izključiti, vendar pa ni bilo nobenih poročil o primerih sindroma prirojenih rdečk pri več kot 3500 dovzetnih ženskah, ki so bile cepljene s cepivom proti rdečkam in niso vedele, da so v zgodnji fazi nosečnosti.
Women who intend to become pregnant should be advised to delay. 
Ženskam, ki načrtujejo zanositev, je treba svetovati naj z zanositvijo počakajo.
• Bruising or bleeding more easily than normal. 
• modrice ali krvavitve, do katerih pride prej kot običajno
An additional dose with a measles-containing vaccine should be considered according to official recommendations (see sections 4.4 and 5.1). 
Cepljenje z dodatnim odmerkom cepiva, ki vsebuje virus ošpic, se mora opraviti glede na uradna priporočila (glejte poglavji 4.4 in 5.1).
The vaccine contains 14.5 mg of sorbitol. 
Cepivo vsebuje 14,5 mg sorbitola.
produced in WI-38 human diploid lung fibroblasts. 
Pridobljen iz humanih diploidnih pljučnih (WI-38) fibroblastov.
Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands 
Izdelovalec zdravila, odgovoren za sproščanje serije: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Nizozemska
If two needles are provided: use one needle to reconstitute the vaccine and the other for its administration to the person to be vaccinated. 
Če sta priloženi dve igli: eno uporabite za pripravo cepiva, drugo pa za injiciranje cepiva.
Persons who are breast-feeding or intend to breast-feed should tell the doctor. 
Ženske, ki dojijo ali nameravajo dojiti, morajo to povedati zdravniku.
b. Tabulated list of adverse reactions 
b. Tabelarični seznam neželenih učinkov
Infants between 9 and 12 months of age: 
Dojenčki, stari od 9 do 12 mesecev:
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8). 
Kot pri vseh cepivih za injiciranje morajo vedno biti na voljo ustrezne možnosti za zdravljenje, če bi po cepljenju prišlo do sicer redke anafilaktične reakcije (glejte poglavje 4.8).
12.5x10 
najmanj 12,5 x 10
The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided. 
Cepivo je prašek za suspenzijo za injiciranje v enoodmerni viali, ki ga je treba zmešati s priloženim vehiklom.
Do not throw away any vaccines via wastewater or household waste. 
Cepiva ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
The MAH concluded that the review of both clinical trial and post-marketing data (including the EudraVigilance Data Analysis System (EVDAS)) for MMR, as well as a review of the literature, has not provided evidence to suggest a causal relationship for MMR and crying and therefore, a label update is not warranted at this time. 
MAH je sklenil, da pregled podatkov iz kliničnih preskušanj in iz obdobja po začetku trženja cepiva MMR (vključno s sistemom za analizo podatkov EudraVigilance (EVDAS)) in pregled literature ni zagotovil dokazov, ki bi kazali na vzročno povezavo med cepivom MMR in jokom, zato posodobitev označevanja v tem trenutku ni upravičena.
These patients should be monitored carefully for signs of measles, parotitis, and rubella. 
Te bolnike je treba pozorno spremljati glede znakov ošpic, parotitisa in rdečk.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden boste cepljeni s tem cepivom.
M-M-RVAXPRO contains sorbitol. 
Cepivo M-M-RVAXPRO vsebuje sorbitol.
This vaccine contains a trace amount of neomycin. 
Cepivo v sledeh vsebuje neomicin.
There is no conclusive evidence that vaccination of individuals recently exposed to wild-type mumps or wild-type rubella will provide protection. 
Ni dokončnih dokazov, da cepljenje posameznikov, nedavno izpostavljenih divjemu sevu mumpsa ali rdečk, ščiti pred boleznijo.
Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (asymptomatic HIV patients, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases). 
Cepljenje lahko pride v poštev pri bolnikih z določenimi imunskimi pomanjkljivostmi, kadar koristi odtehtajo tveganja (bolniki z asimptomatsko okužbo s HIV, pomanjkljivost IgG podrazreda, prirojena nevtropenija, kronična granulomatozna bolezen in bolezni z okvaro komplementa).
For precautions to be taken before handling or administering the medicinal product, and for instructions on reconstitution of the medicinal product before administration, see section 6.6. 
Za previdnostne ukrepe, potrebne pred ravnanjem s cepivom ali dajanjem cepiva in za navodila glede rekonstitucije cepiva pred dajanjem glejte poglavje 6.6.
Mumps (titre ≥10 ELISA Ab units/mL) 
Mumps (titer ≥10 ELISA Ab enot/ml)
Very common (may affect more than 1 in 10 vaccinees) 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 cepljenih oseb)
Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis. 
Čeprav je bila dokazana vzročna povezava med drugimi vrstami cepiva proti mumpsu in aseptičnim meningitisom, ni dokazov o povezavi cepiva proti mumpsu Jeryl Lynn™ z aseptičnim meningitisom.
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the package leaflet. 
Navodila za pripravo, namenjena zdravstvenemu osebju, so navedena na koncu navodila za uporabo.
Mumps virus 
Virus mumpsa
Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you. 
Preden boste vi ali vaš otrok cepljeni, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6). 
Zato prenos s tesnim osebnim stikom, ki je teoretično možen, ne velja za bistveno tveganje; dokumentirali pa so prenos cepilnega virusa rdečk na dojenčke z materinim mlekom, brez kliničnih znakov bolezni (glejte poglavje 4.6).
The results of a retrospective case-controlled study conducted by the US Centers for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent risk of SSPE. 
Rezultati retrospektivne študije primerov in kontrol (case-control study), ki so jo izvedli v Centrih za kontrolo in preprečevanje bolezni (Centers for Disease Control and Prevention) v ZDA, kažejo, da je skupni učinek cepljenja proti ošpicam zaščita pred SSPE, ker preprečuje ošpice in tveganje za SSPE ob njih.
Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin. 
Cepljenje je treba odložiti za vsaj 3 mesece po transfuziji krvi ali plazme ali po prejemu humanih serumskih imunoglobulinov.
In the infants with serological evidence of rubella infection, none had symptomatic disease. 
Med dojenčki s serološko dokazano okužbo z rdečkami se simptomatska bolezen ni razvila pri nobenem.
The most common adverse reactions reported with the use of M-M-RVAXPRO were: fever (38.5°C or higher); injection site reactions including pain, swelling and erythema. 
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi cepiva M-M-RVAXPRO, so bili: zvišana telesna temperatura (38,5 °C ali več); reakcije na mestu injiciranja, ki vključujejo bolečino, otekanje in eritem.
Immunogenicity and safety data show that M-M-RVAXPRO can be administered to infants between 9 and 12 months of age, in accordance with official recommendations or when an early protection is considered necessary (e.g., day-care, outbreak situations, or travel to a region with high prevalence of measles). 
Podatki o imunogenosti in varnosti kažejo, da se s cepivom M-M-RVAXPRO lahko cepi dojenčke, stare od 9 do 12 mesecev, v skladu z uradnimi priporočili ali kadar je nujna zgodnja zaščita (npr. če hodijo v vrtec, v primeru izbruha bolezni ali potovanja na področje z visoko prevalenco ošpic).
Once the vaccine has been mixed with the solvent supplied, it should be either used immediately or stored in the refrigerator and used within 8 hours. 
Ko je cepivo zmešano s priloženim vehiklom, ga je treba uporabiti takoj ali pa shraniti v hladilnik in uporabiti v 8 urah.
• Severe allergic reaction that may include difficulty in breathing, facial swelling, localised swelling, and swelling of the limbs. 
• huda alergijska reakcija, ki lahko vključuje oteženo dihanje, otekanje obraza, lokalizirano otekanje in otekanje okončin
Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems. 
Krvne diskrazije, levkemija, katerakoli vrsta limfoma ali druge maligne novotvorbe, ki vplivajo na hematopoetski in limfatični sistem.
Ask your pharmacist how to throw away vaccines you no longer use. 
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Currently no specific studies have been conducted on the concomitant use of M-M-RVAXPRO and other vaccines. 
Na splošno specifičnih študij o sočasnem cepljenju s cepivom M-M-RVAXPRO in z drugimi cepivi niso izvedli.
In these studies, a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralising antibodies in 96%, and rubella HI antibodies in 99% of susceptible persons. 
V teh študijah je eno cepljenje induciralo protitelesa HI (protitelesa, ki zavirajo hemaglutinacijo) proti ošpicam pri 95 %, nevtralizirajoča protitelesa proti mumpsu pri 96 % in protitelesa HI proti rdečkam pri 99 % dovzetnih oseb.
The physician should be alert to the temperature elevation that may occur following vaccination (see section 4.8). 
Zdravnik mora biti pozoren na morebitno zvišanje telesne temperature po cepljenju (glejte poglavje 4.8).
Although M-M-RVAXPRO contains live viruses, they are too weak to cause measles, mumps, or rubella in healthy people. 
Čeprav cepivo M-M-RVAXPRO vsebuje žive viruse, so ti prešibki, da bi povzročili ošpice, mumps ali rdečke pri zdravih ljudeh.
Previously unvaccinated individuals older than 9 months who are in contact with susceptible pregnant women should receive live attenuated rubella-containing vaccine (such as M-M-RVAXPRO or a monovalent rubella vaccine) to reduce the risk of exposure of the pregnant woman. 
Predhodno necepljeni posamezniki, starejši od 9 mesecev, ki so v stiku z dovzetnimi nosečnicami, naj bi bili cepljeni s cepivom, ki vsebuje oslabljeno živo cepivo proti rdečkam (kot je cepivo M-M-RVAXPRO ali enovalentno cepivo proti rdečkam), da se tako zmanjša tveganje izpostavitve nosečnice.
M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy). 
Cepivo M-M-RVAXPRO ni kontraindicirano pri posameznikih, ki prejemajo topične kortikosteroide ali majhne odmerke parenteralnih kortikosteroidov (npr. za preprečevanje astme ali kot nadomestno zdravljenje).
The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults. 
Najprimernejše mesto za injiciranje pri mlajših otrocih je anterolateralno področje stegna, pri starejših otrocih, mladostnikih in odraslih pa deltoidno področje nadlakti.
The efficacy of the components of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. was established in a series of double-blind controlled field trials, which demonstrated a high degree of protective efficacy afforded by the individual vaccine components. 
Učinkovitost komponent prejšnje oblike cepiva proti ošpicam, mumpsu in rdečkam izdelovalca Merck & Co., Inc. je bila dokazana v seriji dvojno slepih, nadzorovanih področnih študij, ki so dokazale visoko stopnjo učinkovitosti zaščite posameznih komponent cepiva.
It is not known whether M-M-RVAXPRO can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. 
Ni znano, ali lahko cepivo M-M-RVAXPRO škoduje plodu, če z njim cepimo nosečnico, in ali vpliva na sposobnost razmnoževanja.
Subacute sclerosing panencephalitis 
Subakutni sklerozirajoči panencefalitis
M-M-RVAXPRO is available in packs of 1 and 10. 
Cepivo M-M-RVAXPRO je na voljo v pakiranjih po 1 in 10.
M-M-RVAXPRO can be given to persons who have been in recent (within 3 days) contact with a case of measles and may be incubating the disease. 
S cepivom M-M-RVAXPRO se sme cepiti osebe, ki so bile pred nedavnim (v zadnjih 3 dneh) v stiku z bolnikom z ošpicami in so lahko v obdobju inkubacije.