FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Imunokompromitirani bolesnici koji nemaju kontraindikacije za cijepljenje ovim cjepivom (vidjeti dio 4.3) možda neće tako dobro odgovoriti kao imunokompetentni bolesnici, stoga neki od ovih bolesnika mogu dobiti ospice, zaušnjake ili rubeolu u slučaju kontakta, usprkos primjerenoj primjeni cjepiva.
English: 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.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Subacute sclerosing panencephalitis
Croatian: Subakutni sklerozirajući panencefalitis
English: Such infants should be revaccinated at 12 to 15 months of age.
Croatian: Tu dojenčad je potrebno docjepljivati u dobi od 12 do 15 mjeseci.
English: M-M-RVAXPRO can be administered to infants from 9 months of age under special circumstances (see sections 4.2, 4.4 and 5.1).
Croatian: U posebnim okolnostima M-M-RVAXPRO se može primijeniti dojenčadi u dobi od 9 mjeseci nadalje (vidjeti dijelove 4.2, 4.4 i 5.1).
English: • Inflammation of the retina (in the eye) with changes in sight.
Croatian: • upala mrežnice (u oku) s promjenama vida
English: M-M-RVAXPRO contains sorbitol.
Croatian: M-M-RVAXPRO sadrži sorbitol.
English: More than 400 million doses of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2003).
Croatian: Više od 400 milijuna doza prethodnog kombiniranog cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. distribuirano je širom svijeta (od 1978. do 2003.).
English: • Severe allergic reaction that may include difficulty in breathing, facial swelling, localised swelling, and swelling of the limbs.
Croatian: • teške alergijske reakcije koje mogu uključivati otežano disanje, oticanje lica, lokalizirano oticanje i oticanje udova
English: Females of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month, or according to doctor's recommendation, after they have been given the vaccine.
Croatian: Žene reproduktivne dobi moraju primijeniti odgovarajuće mjere opreza kako bi izbjegle trudnoću tijekom razdoblja od 1 mjeseca nakon cijepljenja ili prema preporuci liječnika.
English: This vaccine contains 14.5 mg of sorbitol as an excipient.
Croatian: Ovo cjepivo sadrži 14,5 mg sorbitola kao pomoćnu tvar.
English: Furthermore, pregnancy should be avoided for 1 month following vaccination (see section
Croatian: Osim toga, trudnoću treba izbjegavati 1 mjesec nakon cijepljenja (vidjeti dio 4.6).
English: Infants from 9 to 12 months of age vaccinated with a measles-containing vaccine during measles outbreaks or for other reasons may fail to respond to the vaccine due to the presence of circulating antibodies of maternal origin and/or immaturity of the immune system (see sections 4.2 and 5.1).
Croatian: Dojenčad u dobi od 9 do 12 mjeseci cijepljena cjepivom protiv morbila u vrijeme epidemije ili zbog nekog drugog razloga možda neće imati odgovor na cjepivo zbog prisutnosti cirkulirajućih majčinih antitijela i/ili zbog nezrelosti imunološkog sustava (vidjeti dijelove 4.2 i 5.1).
English: Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.
Croatian: Vi ili Vaše dijete primite ovo cjepivo jer sadrži Vama važne podatke.
English: 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.
Croatian: M-M-RVAXPRO se može dati osobama koje su bile u nedavnom doticaju (u prethodna 3 dana) s osobom oboljelom od morbila i mogu biti u fazi inkubacije bolesti.
English: 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.
Croatian: Rezultati retrospektivnog kliničkog ispitivanja provedenog u Američkim Centrima za kontrolu i prevenciju bolesti (US Centers for Disease Control and Prevention), ukazuju na to da je cjepivo protiv morbila općenito štitilo protiv SSPE jer je spriječilo morbile, kojima je svojstven rizik od SSPE.
English: • Cough; lung infection with or without fever.
Croatian: • kašalj; upala pluća sa ili bez vrućice
English: In addition, individuals who experienced thrombocytopenia with the first dose of M-M-RVAXPRO (or its component vaccines) may develop thrombocytopenia with repeat doses.
Croatian: Osim toga, osobe u kojih se razvila trombocitopenija pri primjeni prve doze cjepiva M-M-RVAXPRO (ili cjepiva s nekom od njegovih komponenata) mogu razviti trombocitopeniju na ponovljenu dozu.
English: Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems.
Croatian: Krvne diskrazije, leukemija, limfomi bilo koje vrste ili druge maligne neoplazme koje zahvaćaju krvotvorni i limfni sustav.
English: Due caution should be employed in administration of M-M-RVAXPRO to persons with individual or family history of convulsions, or a history of cerebral injury.
Croatian: Posebna pozornost potrebna je pri primjeni M-M-RVAXPRO u osoba s konvulzijama u osobnoj ili obiteljskoj anamnezi ili s ozljedama mozga u osobnoj anamnezi.
English: As with other vaccines, M-M-RVAXPRO may not completely protect all persons who are vaccinated.
Croatian: Kao ni druga cjepiva, ni M-M-RVAXPRO možda neće potpuno zaštititi sve cijepljene osobe.
English: M-M-RVAXPRO is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals from 12 months of age (see section 4.2).
Croatian: M-M-RVAXPRO je indiciran za istodobno cijepljenje protiv morbila, parotitisa i rubele u osoba u dobi od 12 mjeseci nadalje (vidjeti dio 4.2).
English: Fertility M-M-RVAXPRO has not been evaluated in fertility studies.
Croatian: Plodnost M-M-RVAXPRO nije procjenjivan u ispitivanjima plodnosti.
English: 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.
Croatian: Prethodno necijepljene osobe starije od 9 mjeseci koje su u dodiru s trudnicama podložnim infekciji trebale bi primiti cjepivo koje sadrži atenuirani virus rubele (kao što je M-M-RVAXPRO ili monovalentno cjepivo protiv rubele) kako bi se smanjio rizik od izlaganja trudnica rubeli.
English: No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis.
Croatian: Do sada nisu prijavljena ispitivanja utjecaja cjepiva protiv morbila u djece s neliječenom tuberkulozom.
English: These studies also established that seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.
Croatian: Ta su ispitivanja također utvrdila da se serokonverzija kao odgovor na cijepljenje protiv morbila, parotitisa i rubele podudarala sa zaštitom od ovih bolesti.
English: • Aseptic meningitis (fever, feeling sick, vomiting, headache, stiff neck, and sensitivity to light); swollen testicles; infection of the middle ear; inflamed salivary glands; atypical measles (described in patients who received a killed measles virus vaccine, usually given before 1975).
Croatian: • aseptički meningitis (vrućica, mučnina, povraćanje, glavobolja, ukočen vrat, i osjetljivost na svjetlo); oticanje testisa; infekcija srednjeg uha; upala žlijezda slinovnica; atipične ospice (opisane u osoba koje su primile cjepivo s mrtvim virusom ospica, većinom prije 1975.)
English: 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).
Croatian: M-M-RVAXPRO nije kontraindiciran u osoba koje se liječe topikalnim kortikosteroidima ili niskim dozama kortikosteroida za parenteralnu primjenu (npr. u profilaksi astme ili nadomjesnoj terapiji).
English: • Diarrhoea, vomiting.
Croatian: • proljev, povraćanje
English: • Joint pain and/or swelling (usually transient and rarely chronic); muscle pain.
Croatian: • bol i/ili oticanje zglobova (obično prolazni i rijetko kronični); bol u mišićima
English: What you need to know before you receive M-M-RVAXPRO
Croatian: Što morate znati prije nego što primite M-M-RVAXPRO
English: Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin.
Croatian: Cijepljenje se mora odgoditi najmanje 3 mjeseca nakon transfuzije krvi ili plazme ili primjene humanog serumskog imunoglobulina.
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.
Croatian: Artralgija i/ili artritis (obično prolazni i rijetko kronični) i polineuritis znakovi su infekcije divljim virusom rubele i razlikuju se po učestalosti i težini ovisno o dobi i spolu, s time da su najčešće i najteže u odraslih žena, a najrjeđe i najlakše u pretpubertetske djece.
English: M-M-RVAXPRO is available in packs of 1, 10 and 20, with or without needles.
Croatian: M-M-RVAXPRO je dostupan u pakiranjima od 1, 10 ili 20 s ili bez igala.
English: Encephalitis and Encephalopathy
Croatian: Encefalitis i encefalopatija
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.
Croatian: Rijetko je prijavljena primjena doza cjepiva M-M-RVAXPRO koje su bile više od preporučenih, a profil nuspojava bio je usporediv s onim zapaženim pri primjeni preporučene doze M-M-RVAXPRO.
English: M-M-RVAXPRO is given as follows:
Croatian: M-M-RVAXPRO se primjenjuje na sljedeći način:
English: Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Francuska
English: M-M-RVAXPRO is given to help protect you or your child against measles, mumps, and rubella.
Croatian: M-M-RVAXPRO se daje kako bi pomoglo zaštititi Vas ili Vaše dijete od morbila, parotitisa i rubele.
English: 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).
Croatian: Podaci o imunogenosti i sigurnosti pokazuju da se M-M-RVAXPRO može primjenjivati u dojenčadi u dobi od 9 do 12 mjeseci, u skladu sa službenim preporukama ili kad se rana zaštita smatra neophodnom (npr. u dječjem vrtiću, u vrijeme epidemije ili putovanja u područja s visokom prevalencijom morbila).
English: M-M-RVAXPRO is expected to have no or negligible influence on ability to drive and use machines.
Croatian: Očekuje se da M-M-RVAXPRO ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Immune globulin Immune globulin (IG) is not to be given concomitantly with M-M-RVAXPRO.
Croatian: Imunoglobulin Imunoglobulini (IG) se ne smiju davati istodobno s cjepivom M-M-RVAXPRO.
English: Measles (titre ≥255 mIU/mL)
Croatian: Morbili (titar ≥255 mIU/ml)
English: Only rarely have vaccine recipients developed chronic joint symptoms.
Croatian: Samo su u rijetkim slučajevima cijepljene osobe razvile kronične simptome zglobova.
English: In a clinical trial, 752 children received M-M-RVAXPRO, either intramuscularly or subcutaneously.
Croatian: U jednom je kliničkom ispitivanju 752 djece primilo M-M-RVAXPRO intramuskularno ili supkutano.
English: M-M-RVAXPRO should be given concomitantly at separate injection sites, or one month before or after administration of other live virus vaccines.
Croatian: M-M-RVAXPRO treba davati istodobno u različita mjesta primjene ili jedan mjesec prije ili poslije primjene drugih živih virusnih cjepiva.
English: Infants between 9 and 12 months of age:
Croatian: Dojenčad u dobi od 9 do 12 mjeseci:
English: If you have been told by your doctor that you or your child have an intolerance to some sugars, inform your doctor before you or your child receive this vaccine.
Croatian: Ako Vam je liječnik rekao da Vi ili Vaše dijete imate bolest tzv. nepodnošenja nekih šećera, prije nego što Vi ili Vaše dijete primite ovo cjepivo posavjetujte se sa svojim liječnikom.
English: 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.
Croatian: U tim je kliničkim ispitivanjima jedna injekcija cjepiva protiv morbila izazvala proizvodnju protutijela inhibicije hemaglutinacije (IH) u 95% osoba, proizvodnju neutralizirajućih protutijela na parotitis u 96%, a proizvodnju protutijela IH na rubelu u 99% osoba podložnih infekciji.
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).
Croatian: • svrbež; upala potkožnog masnog tkiva; crvene ili ljubičaste, ravne, sitne točkice pod kožom; otvrdnuti izdignuti dijelovi kože; ozbiljna bolest s pojavom čireva ili mjehura na koži, ustima, očima i/ili genitalijama (Steven-Johnsonov sindrom)
English: Transmission
Croatian: Prijenos
English: Rubella (titre ≥10 IU/mL)
Croatian: Rubela (titar ≥10 IU/ml)
English: Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25% ; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4).
Croatian: Teška humoralna ili stanična (primarna ili stečena) imunodeficijencija, npr. teška kombinirana imunodeficijencija, agamaglobulinemija i AIDS ili simptomatska HIV-infekcija ili dobno specifični postotak CD4+ T limfocita u djece mlađe od 12 mjeseci: CD4+ <25%; u djece između 12 i 35 mjeseci: CD4+ <20%; u djece između 36 i 59 mjeseci: CD4+ <15% (vidjeti dio 4.4).
English: It is recommended that the vaccine be administered immediately after reconstitution or stored in the refrigerator and used within 8 hours to minimize loss of potency.
Croatian: Preporučuje se primijeniti cjepivo odmah nakon rekonstitucije ili pohraniti u hladnjak i primijeniti u roku od 8 sati kako bi se smanjila mogućnost gubitka djelotvornosti.
English: History of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin (see sections 2, 4.4, and 6.1).
Croatian: Preosjetljivost na bilo koje cjepivo protiv morbila, parotitisa ili rubele ili neku od pomoćnih tvari, uključujući neomicin (vidjeti dijelove 2, 4.4 i 6.1).
English: What M-M-RVAXPRO is and what it is used for 2.
Croatian: Što je M-M-RVAXPRO i za što se koristi 2.
English: What M-M-RVAXPRO looks like and contents of the pack
Croatian: Kako M-M-RVAXPRO izgleda i sadržaj pakiranja
English: B. CONDITIONS OR RESTRICTION REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: There have been reports of SSPE in children who did not have a history of infection with wild-type measles but did receive measles vaccine.
Croatian: Prijavljeni su slučajevi SSPE u djece koja nisu imala u anamnezi infekciju divljim tipom virusa morbila, ali su primila cjepivo protiv morbila.
English: The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
Croatian: Cjepivo se injicira intramuskularno (i.m.) ili supkutano (s.c.).
English: 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).
Croatian: Kao i sa svim injekcijskim cjepivima, uvijek je potrebno osigurati odgovarajući medicinski tretman i nadzor cijepljene osobe, jer u rijetkim slučajevima nakon primjene cjepiva može nastupiti anafilaktička reakcija (vidjeti dio 4.8).
English: In the Full Analysis Set (vaccinated subjects regardless of their antibody titre at baseline), high seroprotection rates of >99% were elicited to mumps and rubella post-dose 2, regardless of the age of the vaccinee at the first dose.
Croatian: U analizi cjelokupnih podataka (cijepljene osobe bez obzira na njihov titar antitijela na početku), visoka stopa seroprotekcije od >99% je postignuta za parotitis i rubelu nakon 2. doze cjepiva, bez obzira na dob cjepljenika prilikom primanja prve doze cjepiva.
English: When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the measles, mumps, and rubella viruses.
Croatian: Nakon cijepljenja, imunološki sustav (prirodna obrana tijela) počne proizvoditi protutijela na viruse morbila, parotitisa i rubele.
English: • An illness consisting of muscle weakness, abnormal sensations, tingling in the arms, legs, and upper body (Guillain-Barré syndrome).
Croatian: • bolest u kojoj se javlja mišićna slabost, promijenjen osjet, osjećaj trnjenja u rukama, nogama i gornjem dijelu tijela (Guillain-Barréov sindrom)
English: Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Croatian: Nemojte primijeniti rekonstituirano cjepivo ako primijetite da sadrži čestice ili se izgled otapala, praška ili rekonstituiranog cjepiva razlikuje od gore opisanog.
English: 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.
Croatian: Premda se pokazalo da postoji uzročno-posljedični odnos između aseptičkog meningitisa i drugih sojeva cjepiva protiv parotitisa, nema dokaza koji bi povezivali aseptički meningitis s cjepivom protiv parotitisa koje sadrži soj Jeryl Lynn™.
English: In clinical trials, M-M-RVAXPRO was administered to 1965 children (see section 5.1), and the general safety profile was comparable to the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Croatian: U kliničkim ispitivanjima M-M-RVAXPRO je bio primijenjen u 1965 djece (vidjeti dio 5.1), a opći sigurnosni profil mogao se usporediti s prethodnim kombiniranim cjepivom protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc.
English: The seroprotection rates to measles, mumps, and rubella for the Full Analysis Set are given in Table 1.
Croatian: Stope seroprotekcije za virus morbila, parotitisa i rubele u analizi cjelokupnih podataka prikazani su u Tablici 1.
English: There is no conclusive evidence that vaccination of individuals recently exposed to wild-type mumps or wild-type rubella will provide protection.
Croatian: Nema uvjerljivih dokaza da cijepljenje može pružiti zaštitu osobama koje su nedavno bile izložene divljem tipu virusa parotitisa ili rubele.
English: Persons who are breast-feeding or intend to breast-feed should tell the doctor.
Croatian: Žene koje doje ili namjeravaju dojiti moraju o tome obavijestiti liječnika.
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.
Croatian: Primjena krvnih pripravaka koji sadrže protutijela na morbile, parotitis ili rubelu, uključujući pripravke imunoglobulina, mora se izbjegavati tijekom mjesec dana nakon cijepljenja dozom M-M-RVAXPRO, osim ako se to ne smatra neophodnim.
English: Dose 1 at 11 months / Dose 2 at 14 months N = 480
Croatian: 1. doza u dozi od 11 mjeseci / 2. doza u dobi od 14 mjeseci N = 480
English: * 50% cell culture infectious dose
Croatian: *infektivna doza za 50% kulture stanica
English: In addition and as previously underlined from the first of June 2010 until the fifth of February 2016, the Dutch Pharmacovigilance Center (Lareb) received 327 reports of MedDRA® Preferred Term (PT) ‘Crying' (preferred term) following immunization with the MMR vaccine.
Croatian: Lareb je u razdoblju od 1. lipnja 2010. do 5. veljače 2016. zaprimio 327 prijava za MedDRA-in preporučeni pojam „plač“ koji je uslijedio nakon imunizacije MMR cjepivom.
English: • Irritability.
Croatian: • razdražljivost
English: Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
Croatian: Kako bi se utvrdilo je li potrebno dati dodatne doze cjepiva, može se procijeniti serološki status.
English: M-M-RVAXPRO should not be given to pregnant females.
Croatian: M-M-RVAXPRO se ne smije primijeniti trudnicama.
English: Very common (may affect more than 1 in 10 vaccinees)
Croatian: Vrlo često (može se javiti u više od 1 na 10 cijepljenih osoba)
English: The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.
Croatian: Cjepivo se mora primijeniti supkutano u bolesnika s trombocitopenijom ili bilo kojim poremećajem koagulacije.
English: To reconstitute, use the solvent supplied.
Croatian: Za rekonstituciju koristite priloženo otapalo.
English: 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.
Croatian: Djelotvornost sastavnih cjepiva prethodnog kombiniranog cjepiva protiv morbila, parotitisa i rubele proizvođača Merck & Co., Inc. bila je utvrđena u nizu dvostruko slijepih kontroliranih terenskih ispitivanja, koja su pokazala visok stupanj zaštitne djelotvornosti koju su pružala pojedinačna cjepiva.
English: Detailed information on this vaccine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom cjepivu dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Individuals who require vaccination against measles can receive M-M-RVAXPRO regardless of their immune status to mumps or rubella if a monovalent measles vaccine is not readily available.
Croatian: Osobe koje je potrebno cijepiti protiv morbila mogu primiti M-M-RVAXPRO bez obzira na njihov imunološki status obzirom na parotitis ili rubelu, ako monovalentno cjepivo protiv morbila nije dostupno.
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.
Croatian: Rekonstituirano cjepivo ne smije se upotrijebiti ako primijetite da sadrži čestice ili da se izgled otapala, praška ili rekonstituiranog cjepiva razlikuje od gore opisanog.
English: Before reconstitution, the powder is a light yellow compact crystalline cake and the solvent is a clear colourless fluid.
Croatian: Prije rekonstitucije, prašak je svijetložuti kompaktni kristalični kolačić, a otapalo je bistra bezbojna tekućina.