FrancophonIA/ELRC3.0 huggingface dataset:
English: 21 months 3 years 5 years
Croatian: 21 mjesec 3 godine 5 godina
English: There was no evidence of an increased rate of reactogenicity or change in the safety profile of the vaccines in either study.
Croatian: Nema dokaza povećane stope reaktogenosti ili promjene u sigurnosnom profilu cjepiva u oba ispitivanja.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1).
Croatian: Kao i s bilo kojim drugim cjepivom, zaštitni imunološki odgovor se možda neće postići u svih cijepljenih osoba (vidjeti dio 5.1).
English: Menveo was non-inferior on these endpoints for serogroup C (Table 2).
Croatian: Menveo je bio neinferioran u ovim ishodima za serogrupu C (Tablica 2).
English: Invert and shake the vial vigorously and then withdraw 0.5 ml of reconstituted product.
Croatian: Preokrenite i snažno protresite bočicu, a zatim izvucite 0,5 ml rekonstituiranog cjepiva.
English: Tell your doctor or nurse if you have experienced this kind of reaction previously.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako ste prije imali takvu vrstu reakcije.
English: Available data in children 2 to 23 months of age
Croatian: Dostupni podaci u djece u dobi od 2 do 23 mjeseca
English: Your doctor will tell you if you need an additional injection of Menveo.
Croatian: Liječnik će Vam reći trebate li dodatnu injekciju cjepiva Menveo.
English: Frequencies are defined as follows:
Croatian: Učestalosti su definirane na sljedeći način:
English: As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following administration of the vaccine.
Croatian: Kao i kod svih injekcijskih cjepiva, odgovarajuće liječenje i medicinski nadzor moraju uvijek biti lako dostupni u slučaju pojave rijetkog anafilaktičkog događaja nakon primjene cjepiva.
English: Your doctor or nurse will take care to ensure the vaccine is not given into a blood vessel and will make sure that it is injected into muscle and not into the skin.
Croatian: Vaš će liječnik ili medicinska sestra paziti da se cjepivo ne primijeni u krvnu žilu ili u kožu, već u mišić.
English: GMTs declined over time as expected but remained between 2- and 8-fold higher than prebooster values (Table 8).
Croatian: GMTs se smanjio tijekom vremena, kao što je bilo i očekivano, ali je ostao između 2- i 8-puta veći nego prije docjepljivanja (Tablica 8).
English: Although insufficient clinical data on the use of Menveo during breast-feeding are available, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant.
Croatian: Iako nisu dostupni dostatni klinički podaci o primjeni cjepiva Menveo tijekom dojenja, nije vjerojatno da će protutijela izlučena u mlijeku biti štetna kad ih dojenče proguta.
English: It is important that procedures are in place to avoid injury from fainting.
Croatian: Važno je poduzeti mjere radi sprječavanja ozljeda uslijed nesvjestice.
English: Immunogenicity was assessed in a subset of 150 subjects in each vaccine group.
Croatian: Imunogenost je procijenjena u podskupini od 150 ispitanika u svakoj od ispitivanih skupina.
English: However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
Croatian: Blaga vrućica ili infekcija gornjih dišnih puteva (primjerice prehlada) nisu razlog za odgađanje cijepljenja.
English: Currently available data are not sufficient to establish the efficacy of Menveo in children under 2 years of age.
Croatian: Trenutačno dostupni podaci nisu dovoljni da bi se utvrdila djelotvornost lijeka Menveo u djece mlađe od 2 godine.
English: Menveo will not protect against infections caused by any other serogroups of N. meningitidis not present in the vaccine.
Croatian: Menveo neće štititi protiv infekcija uzrokovanih drugim serogrupama N. meningitidis kojih nema u cjepivu.
English: The safety and efficacy of Menveo in children under 2 years of age has not yet been established.
Croatian: Sigurnost i djelotvornost cjepiva Menveo u djece mlađe od 2 godine još nisu ustanovljene.
English: As with other vaccines, Menveo should be postponed in individuals suffering from an acute severe febrile illness.
Croatian: Kao i kod drugih cjepiva, primjenu cjepiva Menveo treba odgoditi u bolesnika s akutnom teškom febrilnom bolešću.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: There are no data on the applicability of the vaccine for post-exposure prophylaxis.
Croatian: Nema podataka o primjenjivosti cjepiva za postekspozicijsku profilaksu.
English: In immunocompromised individuals, vaccination may not result in an appropriate protective antibody response.
Croatian: U imunokompromitiranih osoba cijepljenje možda neće uzrokovati odgovarajući zaštitni odgovor protutijela.
English: There was evidence of some suppression of antibody response to two of the three pertussis antigens.
Croatian: Utvrđena je određena supresija odgovora protutijela na dva od tri antigena pertusisa.
English: Post-marketing experience (all age groups)
Croatian: Nakon stavljanja na tržište (sve dobne skupine)
English: The hSBA was the original correlate of protection against meningococcal disease.
Croatian: hSBA izvorni je korelat zaštite protiv meningokokne bolesti.
English: For children (from 2 years of age), adolescents and adults: a single (0.5 ml) injection will be given.
Croatian: Za djecu (u dobi od 2 i više godina), adolescente i odrasle: primijenit će se jedna injekcija (0,5 ml).
English: Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection.
Croatian: Nesvjestica, osjećaj nesvjestice ili druge reakcije povezane sa stresom mogu se javiti kao odgovor na bilo koju injekciju iglom.
English: The list provided below presents adverse reactions reported in three pivotal and two supportive clinical trials per system organ class.
Croatian: Popis u nastavku prikazuje nuspojave prijavljene u tri pivotalna ispitivanja i dva suportivna klinička ispitivanja po klasifikaciji organskih sustava.
English: Long-term antibody persistence data following vaccination with Menveo are available up to 5 years after vaccination (see section 4.4 and 5.1).
Croatian: Podaci o dugotrajnoj postojanosti protutijela nakon cijepljenja cjepivom Menveo dostupni su do 5 godina nakon cijepljenja (vidjeti dijelove 4.4 i 5.1).
English: After reconstitution, the medicinal product should be used immediately.
Croatian: Nakon rekonstitucije, lijek treba primijeniti odmah.
English: Contents of the pack and other information What Menveo contains
Croatian: Sadržaj pakiranja i druge informacije Što sadrži Menveo
English: Not for intravascular, subcutaneous or intradermal injection.
Croatian: Nije za intravaskularnu, supkutanu ili intradermalnu injekciju.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 March 2010
Croatian: Datum prvog odobrenja: 15. ožujka 2010.
English: - receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab.
Croatian: - ako primate terapiju koja blokira dio imunološkog sustava koji se naziva aktivacija komplemenata, primjerice ekulizumab.
English: 5 micrograms
Croatian: 5 mikrograma
English: This vaccine contains a protein (called CRM197) from the bacteria that cause diphtheria.
Croatian: Ovo cjepivo sadrži protein (zvan CRM197) iz bakterije koja uzrokuje difteriju.
English: Your doctor will advise you if and when you should receive a booster dose.
Croatian: Vaš liječnik će Vas uputiti da li i kada trebate primiti dozu za docjepljivanje.
English: The other ingredients (excipients) are:
Croatian: Drugi sastojci (pomoćne tvari) su:
English: The characterization of the safety profile of Menveo in children 2 to 10 years of age is based on data from four clinical trials in which 3181 subjects received Menveo.
Croatian: Karakterizacija sigurnosnog profila cjepiva Menveo u djece u dobi od 2 do 10 godina temelji se na podacima iz četiri klinička ispitivanja u kojima je 3181 ispitanik primio Menveo.
English: The risk-benefit ratio for persons at risk of haematoma following intramuscular injection must be evaluated by health care professionals.
Croatian: Omjer koristi i rizika za osobe s rizikom od nastanka hematoma nakon intramuskularne injekcije treba procijeniti zdravstveni djelatnik.
English: For children 2 to 10 years of age, no data are available for evaluating safety and immunogenicity of other childhood vaccines when administered concomitantly with Menveo.
Croatian: Za djecu u dobi od 2 do 10 godina nisu dostupni podaci za procjenu sigurnosti i imunogenosti drugih cjepiva dječje dobi kad se primjenjuju istodobno sa cjepivom Menveo.
English: If you or your child received a dose of Menveo more than one year ago and remains at particular risk of exposure to meningococcal group A bacteria, consideration may be given to administering a booster dose to maintain protection.
Croatian: Ako ste Vi ili Vaše dijete primili dozu cjepiva Menveo prije više od godinu dana, a i dalje postoji rizik izlaganja bakteriji meningokokne grupe A, treba razmisliti o primanju doze za docjepljivanje kako biste zadržali jednaku razinu zaštite.
English: A randomised, observer-blind study was conducted in children 12 to 59 months of age in Finland and Poland (V59P7).
Croatian: Randomizirano, za ocjenitelja slijepo ispitivanje, provedeno je na djeci u dobi od 12 do 59 mjeseci u Finskoj i Poljskoj (V59P7).
English: Insufficient clinical data on exposed pregnancies are available.
Croatian: Nema dovoljno kliničkih podataka o izloženosti u trudnoći.
English: Allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash and swelling of the hands, feet and ankles, loss of consciousness, very low blood pressure; fits (convulsions) including fits associated with fever; balance disorder; faint; infection of the skin at the injection site; injection site swelling, including extensive swelling of the injected limb.
Croatian: Alergijske reakcije koje mogu uključivati jako oticanje usnica, usta, grla (što može uzrokovati poteškoće kod gutanja), otežano disanje s piskanjem ili kašljom, osip i oticanje šaka, stopala i gležnjeva, gubitak svijesti, vrlo nizak krvni tlak; napadaje (konvulzije) uključujući napadaje povezane s vrućicom; poremećaj ravnoteže; nesvjesticu; infekciju kože na mjestu injiciranja; oticanje na mjestu injiciranja, uključujući prekomjerno oticanje injiciranog uda.
English: This may temporarily affect the ability to drive or use machines.
Croatian: To može privremeno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Menveo is given as an intramuscular injection, preferably into the deltoid muscle.
Croatian: Menveo se daje kao intramuskularna injekcija, po mogućnosti u deltoidni mišić.
English: How to use Menveo
Croatian: Kako primjenjivati Menveo
English: Pharmacotherapeutic group: Meningococcal vaccines, ATC code: J07AH08.
Croatian: Farmakoterapijska skupina: Cjepiva protiv meningokoka, ATK oznaka: J07AH08.
English: In the adolescent age group, the safety and tolerability of the vaccine was favourable relative to Tdap and did not substantially change with concomitant or sequential administration of other vaccines.
Croatian: U skupini adolescenata, sigurnost i podnošljivost cjepiva bile su povoljne u odnosu na Tdap i nisu se znatno mijenjale s istodobnom ili naknadnom primjenom drugih cjepiva.
English: Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.
Croatian: Vi ili Vaše dijete primite ovaj lijek jer sadrži Vama važne podatke.
English: Therefore, Menveo may be used during breast feeding.
Croatian: Stoga se Menveo može primjenjivati tijekom dojenja.
English: Persistence of immune response and booster response in adolescents
Croatian: Postojanost imunološkog odgovora i odgovora nakon docjepljivanja u adolescenata
English: The need for and timing of a booster dose in subjects previously vaccinated with Menveo is to be defined based on national recommendations.
Croatian: Potreba i vrijeme docjepljivanja ispitanika koji su prethodno cijepljeni cjepivom Menveo određuje se sukladno nacionalnim preporukama.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Menveo Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Your doctor or nurse will dispose of this medicine.
Croatian: Vaš liječnik ili medicinska sestra pobrinut će se za zbrinjavanje lijeka.
English: The clinical benefit of a 2-dose vaccination series in children 2 through 10 years of age is not known.
Croatian: Klinička korist serije cijepljenja s 2 doze u djece u dobi od 2 do 10 godina nije poznata.
English: Prior to injection, change the needle for one suitable for the administration.
Croatian: Prije injiciranja zamijenite iglu drugom koja je prikladna za primjenu.
English: Not known (cannot be estimated from the available data) Adverse reactions from clinical trials
Croatian: Vrlo rijetko: Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Uncommon (may affect up to 1 in 100 people): injection site itching
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): svrbež na mjestu injiciranja
English: One dose (0.5 ml of the reconstituted vaccine) contains: The active substances are: (Originally contained in the powder)
Croatian: Jedna doza (0,5 ml pripremljenog cjepiva) sadrži: Djelatne tvari su: (Izvorno sadržan u prašku)
English: Little is known about the effectiveness of Menveo when administered to individuals with weakened immunity due to the use of immunosuppressive medications, or HIV infection, and other possible causes.
Croatian: Učinkovitost cjepiva Menveo nije potpuno poznata kada se daje osobama s oslabljenim imunitetom, primjerice zbog upotrebe imunosupresivnih lijekova ili infekcije HIV-om ili ostalih mogućih razloga.
English: Pre-boo ster 7 days 28 days 100% 2 years
Croatian: Prije docjeplj ivanja 7 dana 28 dana 100% 2 godin e
English: Menveo's effect could be diminished when administered to individuals who are taking medicines that suppress the immune system.
Croatian: Učinak cjepiva Menveo može se smanjiti ako se primjenjuje u osoba koje uzimaju lijekove za supresiju imunološkog sustava.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: There are limited data in individuals aged 56-65 and there are no data in subjects aged older than 65 years.
Croatian: Podaci za osobe u dobi od 56 do 65 godina su ograničeni, a za osobe starije od 65 godina nema podataka.
English: Very common: headache
Croatian: Vrlo često: glavobolja
English: The vaccine is usually given into the upper arm muscle (deltoid) for children (from 2 years of age), adolescents and adults.
Croatian: Cjepivo se obično primjenjuje u (deltoidni) mišić nadlaktice u djece (u dobi od 2 i više godina), adolescenata i odraslih.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml of the reconstituted vaccine) contains: (Originally contained in the powder)
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna doza (0,5 ml rekonstituiranog cjepiva) sadrži: (Izvorno sadržan u prašku)
English: In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.
Croatian: U slučaju prisutnosti bilo kakvih stranih čestica i/ili promjene izgleda, cjepivo zbrinite u otpad.
English: Anxiety‐related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see section 4.8 Undesirable effects).
Croatian: Reakcije povezane s anksioznošću, uključujući vazovagalne reakcije (sinkopa), hiperventilaciju ili reakcije povezane sa stresom, mogu se javiti u vezi s cijepljenjem kao psihogeni odgovor na injekciju iglom (vidjeti dio 4.8 Nuspojave).
English: Do not use this medicine after the expiry date which is stated on the outer carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju iza oznake „EXP“.
English: 2-5 years
Croatian: 2-5 godina
English: MenCWY Conjugate
Croatian: MenCWY konjugata.
English: These adverse reactions were:
Croatian: Te su nuspojave bile:
English: In laboratory animals, no adverse reactions were seen in vaccinated maternal rabbits or in their offspring through postnatal day 29.
Croatian: Prilikom ispitivanja na laboratorijskim životinjama nisu primijećene nuspojave u cijepljenih skotnih ženki kunića ili njihove mladunčadi do 29. dana postnatalne faze.
English: 7.1 to 12.5 micrograms
Croatian: 7,1 do 12,5 mikrograma
English: GSK Vaccines S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), Italy
Croatian: GSK Vaccines S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), Italija
English: The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe.
Croatian: Najčešće nuspojave prijavljene tijekom kliničkih ispitivanja obično su trajale jedan do dva dana i obično nisu bile teške.
English: Considering the severity of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y, pregnancy should not preclude vaccination when the risk of exposure is clearly defined.
Croatian: S obzirom na težinu invazivne meningokokne bolesti uzrokovane Neisseria meningitidis serogrupama A, C, W-135 i Y, trudnoća ne smije isključivati cijepljenje kad je rizik od izloženosti jasno utvrđen.
English: The immunogenicity of Menveo in children 2 to 23 months of age was evaluated in several studies.
Croatian: Imunogenost cjepiva Menveo u djece u dobi od 2 do 23 mjeseca procijenjena je u nekoliko ispitivanja.
English: Menveo does not protect against diphtheria.
Croatian: Menveo ne štiti od difterije.
English: Menveo has not been evaluated in persons with thrombocytopenia, bleeding disorders or that are receiving anticoagulant therapy, because of the risk of haematoma.
Croatian: Menveo nije ispitan u osoba s trombocitopenijom, poremećajima krvarenja ili u onih koji primaju terapiju antikoagulansima jer postoji rizik od hematoma.
English: Menveo will be given to you or your child by a doctor or nurse.
Croatian: Menveo će Vama ili Vašem djetetu injicirati liječnik ili medicinska sestra.
English: MARKETING AUTHORISATION NUMBERS EU/1/10/614/002
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/614/002
English: If an individual is expected to be at particular risk of exposure to Men A and received a dose of Menveo more than approximately one year previously, consideration may be given to administering a booster dose.
Croatian: Ako se očekuje da će pojedinac biti pod posebnim rizikom od izloženosti meningokoku A, a primio je dozu cjepiva Menveo prije otprilike godinu dana, potrebno je razmotriti docjepljivanje.
English: Keep the vials in the outer carton in order to protect from light.
Croatian: Bočice čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
English: 6-10 years
Croatian: 6 do 10 godina
English: Immunogenicity in children 2 to 10 years of age
Croatian: Imunogenost u djece u dobi od 2 do 10 godina
English: Not known: tonic convulsion, febrile convulsion, syncope Ear and labyrinth disorders
Croatian: Nepoznato: toničke konvulzije, febrilne konvulzije, sinkopa Poremećaji uha i labirinta:
English: Neisseria meningitidis serogroup A, C, W-135 and Y bacteria can cause serious and sometimes life-threatening infections such as meningitis and sepsis (blood poisoning).
Croatian: Bakterija Neisseria meningitidis serogrupe A, C, W-135 i Y može uzrokovati ozbiljne i katkada po život opasne infekcije, kao što su meningitis i sepsa (trovanje krvi).
English: Serum bactericidal activity (SBA) was measured using human serum as the source of exogenous complement (hSBA).
Croatian: Baktericidna aktivnost seruma (SBA) izmjerena je primjenom humanog seruma kao izvora egzogenog komplementa (hSBA).
English: Powder and solution for solution for injection (powder and solution for injection).
Croatian: Prašak i otopina za otopinu za injekciju (prašak i otopina za injekciju).
English: Immunogenicity was evaluated in randomised, multicenter, active controlled clinical trials that enrolled children (2-10 years of age), adolescents (11-18 years of age), adults (19-55 years of age) and older adults (56-65 years of age).
Croatian: Imunogenost je procijenjena u randomiziranim, multicentričnim, aktivno kontroliranim kliničkim ispitivanjima koja su uključivala djecu (u dobi od 2 do 10 godina), adolescente (u dobi od 11 do 18 godina), odrasle (u dobi od 19 do 55 godina) i starije odrasle osobe (u dobi od 56 do 65 godina).
English: A significant increase in the hSBA GMTs against all four serogroups was also observed at 7 and 28 days after the booster dose (Table 8).
Croatian: Primijećeno je znatno povećanje hSBA GMTs protiv sve četiri serogrupe 7 do 28 dana nakon docjepljivanja (Tablica 8).
English: The most common adverse reactions during the clinical trials generally persisted for one to two days and were not severe.
Croatian: Najčešće nuspojave tijekom kliničkih ispitivanja obično su trajale jedan do dva dana i nisu bile teške.
English: Five doses (10 vials) per package.
Croatian: Pet doza (10 bočica) po pakiranju.
English: A small decline was observed in percentages of subjects with hSBA ≥ 1:8 against serogroup A, although percentages were still high (77% to 79%).
Croatian: Primijećeno je malo smanjenje postotka u ispitanika s hSBA ≥ 1:8 protiv serogrupe A, iako su postotci i dalje bili visoki (77% do 79%).
English: Menveo may be given at the same time as other vaccinations but any other injected vaccines should preferably be given into a different arm from the site of the Menveo injection.
Croatian: Menveo se smije davati istodobno s drugim cjepivima, no poželjno je da se sva druga cjepiva daju u drugu ruku od one u koju je ubrizgano cjepivo Menveo.
English: Among Menveo recipients, 58.9%, 16.4%, 21.3% and 3.4% were in the 11-18 year, 19-34 year, 35-55 year and 56-65 year age groups, respectively.
Croatian: Među osobama koje su primile Menveo 58,9% je bilo u dobi od 11 do 18 godina, 16,4% u dobi od 19 do 34 godine, 21,3% u dobi od 35 do 55 godina i 3,4% u dobi od 56 do 65 godina.
English: Pack size of one dose (2 vials) or five doses (10 vials).
Croatian: Veličina pakiranja: jedna doza (2 bočice) ili pet doza (10 bočica).
English: Powder in vial (type I glass) with a stopper (butyl rubber with fluoropolymer coated surface) and solution in vial (type I glass) with a stopper (butyl rubber).
Croatian: Prašak u bočici (staklo tipa I) s čepom (butilna guma obložena fluoropolimerom) i otopina u bočici (staklo tipa I) s čepom (butilna guma).
English: Overall 3464 subjects aged 2 to10 years were exposed to Menveo in completed clinical trials.
Croatian: Djeca u dobi od 2 do 10 godina Sveukupno je 3464 ispitanika u dobi od 2 do 10 godina bilo izloženo cjepivu Menveo u završenim kliničkim ispitivanjima.
English: Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose.
Croatian: Sasvim je normalno da u bočici nakon izvlačenja doze ostane mala količina tekućine.
English: Please tell your doctor if you have received a previous injection with Menveo or another meningococcal vaccine.
Croatian: Obavijestite svog liječnika ako ste već primili injekciju cjepiva Menveo ili nekog drugog cjepiva protiv meningokoka.
English: 21 months
Croatian: 12 mjeseci
English: The efficacy of Menveo has been inferred by measuring the production of serogroup-specific anti-capsular antibodies with bactericidal activity.
Croatian: Djelotvornost cjepiva Menveo dokazana je mjerenjem stvaranja antikapsularnih protutijela specifičnih za serogrupu koja su posjedovala baktericidnu aktivnost.