FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse events have been reported with other vaccines containing the components or constituents of Vaxelis without regard to causality or frequency.
Croatian: Sljedeće nuspojave prijavljene su s drugim cjepivima koja sadrže komponente ili sastojke cjepiva Vaxelis, bez obzira na uzročnu povezanost ili učestalost.
English: If there is anything you do not understand, ask your doctor, pharmacist or nurse to explain.
Croatian: Ako nešto ne razumijete u potpunosti, zamolite svog liječnika, ljekarnika ili medicinsku sestru da vam objasne.
English: Table 1: List of Adverse Reactions
Croatian: Tablica 1: Popis nuspojava
English: Co-administration of Vaxelis with other injectable vaccines must be carried out at separate injection sites and, preferably, separate limbs.
Croatian: Istodobna primjena cjepiva Vaxelis s drugim cjepivima koja se injiciraju mora se provesti na različitim mjestima injiciranja i, poželjno, na različitim ekstremitetima.
English: One dose (0.5 mL) contains:
Croatian: Jedna doza (0,5 ml) sadrži:
English: The primary vaccination schedules used in clinical studies were: 2, 4 months of age without hepatitis B vaccination at birth; 2, 3, 4 months of age without hepatitis B vaccination at birth; and 2, 4, 6 months of age with and without hepatitis B vaccination at birth.
Croatian: Rasporedi primarnog cijepljenja korišteni u kliničkim ispitivanjima bili su sljedeći: u dobi od 2 i 4 mjeseca bez cijepljenja protiv hepatitisa B pri porodu; u dobi od 2, 3 i 4 mjeseca bez cijepljenja protiv hepatitisa B pri porodu; i u dobi od 2, 4 i 6 mjeseci sa i bez cijepljenja protiv hepatitisa B pri porodu.
English: After a 2-dose or a 3-dose primary series vaccination with Vaxelis , a booster dose should be given at least 6 months after the last priming dose.
Croatian: Nakon primarnih serija cijepljenja s dvije ili tri doze cjepiva Vaxelis, docjepljivanje se treba primijeniti najmanje 6 mjeseci nakon posljednje primarne doze.
English: Antibody Thresholds
Croatian: Granična vrijednost antitijela
English: How to store Vaxelis
Croatian: Kako čuvati Vaxelis
English: Do not administer by intravascular, intradermal or subcutaneous injection.
Croatian: Ne primjenjujte Vaxelis intravaskularnom, intradermalnom ili supkutanom injekcijom.
English: Additional injections (booster)
Croatian: Dodatne injekcije (docjepljivanje)
English: First course of vaccination (primary vaccination)
Croatian: Prvi ciklus cijepljenja (primarno cijepljenje)
English: The recommended injection sites are the anterolateral area of the thigh (preferred site for infants under one year of age) or the deltoid muscle of the upper arm.
Croatian: Preporučena mjesta za injiciranje su antero-lateralno područje bedra (poželjno kod dojenčadi mlađe od godine dana) ili deltoidni mišić nadlaktice.
English: The vaccine may not prevent hepatitis B infection in such cases.
Croatian: U takvim slučajevima cjepivo možda neće spriječiti infekciju virusom hepatitisa B.
English: Vaxelis does not protect against disease caused by Haemophilus influenzae other than type b or by other microorganisms that cause invasive disease such as meningitis or sepsis, including N. meningitidis.
Croatian: Vaxelis ne štiti od bolesti prouzročenih bakterijom Haemophilus influenzae koja nije tip b ili ostalim mikroorganizmima koji uzrokuju invazivne bolesti poput meningitisa ili sepse, uključujući bakteriju N. meningitidis.
English: • Very common side effects (may affect more than 1 in 10 people) are: decreased appetite irritability crying vomiting sleepiness or drowsiness fever (temperature 38°C or higher) pain, redness, swelling at the injection site
Croatian: • Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) su: smanjen apetit razdražljivost plač povraćanje pospanost ili omamljenost vrućica (temperatura od 38°C ili viša) bol, crvenilo, oticanje na mjestu injiciranja
English: Anti-diphtheria (≥ 0.01 IU/mL) Anti-tetanus (≥ 0.01 IU/mL) Anti-PT (vaccine response) Anti-FHA (vaccine response) Anti-PRN (vaccine response)
Croatian: Anti-difterija (≥ 0,01 IU/ml) Anti-tetanus (≥ 0,01 IU/ml) Anti-PT (serološki odgovor) Anti-FHA (serološki odgovor) Anti-PRN (serološki odgovor)
English: If any of the following events have occurred after administration of a pertussis-containing vaccine, the decision to administer further doses of a pertussis-containing vaccine should be carefully considered:
Croatian: Ako su nakon primjene cjepiva koje sadrži komponentu hripavca bili prisutni bilo koji sljedeći događaji, odluku o primjeni daljnjih doza cjepiva koje sadrži komponentu hripavca treba pažljivo razmotriti:
English: Suspension for injection 10 pre-filled syringes (0.5 ml) without needle
Croatian: Suspenzija za injekciju 10 napunjenih štrcaljki (0,5 ml) bez igle
English: Keep the vaccine in the outer carton in order to protect from light.
Croatian: Cjepivo držite u vanjskom pakiranju radi zaštite od svjetlosti.
English: Vaccine response: If pre-Dose 1 antibody concentration < lower limit of quantification (LLOQ), then the post-vaccination series antibody concentration was ≥ LLOQ; if pre-Dose 1 antibody concentration ≥ LLOQ, then the post-vaccination series antibody concentration was ≥ pre-Dose 1 levels.
Croatian: Serološki odgovor: Ako je koncentracija antitijela prije 1. doziranja bila < donje granice kvantifikacije (LLOQ), tada je koncentracija antitijela nakon serije cijepljenja bila ≥ LLOQ; ako je koncentracija antitijela prije 1. doziranja bila ≥ LLOQ, tada je koncentracija antitijela nakon serije cijepljenja bila ≥ razine prije 1. doziranja.
English: MCM Vaccine B.V., Robert Boyleweg 4, 2333 CG Leiden.
Croatian: MCM Vaccine B.V., Robert Boyleweg 4, 2333 CG Leiden, Nizozemska
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Croatian: Kada se serije primarne imunizacije primjenjuju u vrlo rano rođene dojenčadi (rođeni nakon ≤28 tjedana trudnoće), potrebno je uzeti u obzir potencijalni rizik od apneje i potrebu za praćenjem disanja tijekom 48 - 72 sata, a naročito u djece s prethodno utvrđenom poviješću nesazrijevanja dišnog sustava.
English: Did not receive hepatitis B vaccine at birth
Croatian: Nisu primili cjepivo protiv hepatitisa B pri porodu
English: • Uncommon side effects (may affect up to 1 in 100 people) are: rash warmth, rash at the injection site increased appetite stomach pain excessive sweating cough nasal congestion and runny nose paleness sleep disorders including inability to get adequate sleep restlessness swollen glands in the neck, armpit or groin feeling tired floppy
Croatian: • Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) su: osip toplina, osip na mjestu injiciranja povećan apetit bol u trbuhu pretjerano znojenje kašalj začepljen nos ili curenje nosa bljedilo poremećaji spavanja uključujući i nedostatak sna nemir natečeni čvorovi na vratu, pod pazuhom ili u preponama osjećaj umora mlohavost
English: The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B which are used during the manufacturing process (see section 4.3).
Croatian: Cjepivo može sadržavati tragove glutaraldehida, formaldehida, neomicina, streptomicina i polimiksina B, koji su korišteni u proizvodnom procesu (vidjeti dio 4.3).
English: Booster at 11-12 months, after primary doses at 2, 4, months
Croatian: Docjepljivanje u dobi od 11 -12 mjeseci, nakon primarnih doza u dobi od 2, 4 mjeseca
English: The bacteria make a toxin (poison) that causes spasms of the muscles, leading to inability to breathe and the possibility of suffocation.
Croatian: Ove bakterije proizvode toksin (otrov) koji uzrokuje grč mišića, što dovodi do poteškoća u disanju i mogućeg gušenja
English: Table 3: Seroprotection/Vaccine Response Rates One Month After Booster Vaccination
Croatian: Tablica 3: Stope serozaštite/odgovora na cjepivo mjesec dana nakon docjepljivanja
English: Vaccine response: If pre-Dose 1 antibody concentration < LLOQ, then post-booster antibody concentration should be ≥ LLOQ; If pre-Dose 1 antibody concentration ≥ LLOQ, then the post-booster antibody concentration should be ≥ pre
Croatian: Serološki odgovor: Ako je koncentracija antitijela prije 1. doziranja bila < LLOQ, tada koncentracija antitijela nakon docjepljivanja treba biti ≥ LLOQ; ako je koncentracija antitijela prije 1. doziranja bila ≥ LLOQ, tada koncentracija antitijela nakon docjepljivanja treba biti ≥ razine prije 1. doziranja.
English: Table 2: Seroprotection/Vaccine Response Rates One Month After the Primary Vaccination Series
Croatian: Tablica 2: Stope serozaštite/odgovora na cjepivo mjesec dana nakon serija primarnog cijepljenja
English: Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.
Croatian: Hripavac također može uzrokovati upale uha, dugotrajne upale prsnog koša (bronhitis), upale pluća (pneumonije), napadaje, oštećenja mozga pa čak i smrt.
English: Hypersensitivity (such as rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (such as urticaria, angioedema, edema, face edema, shock).
Croatian: Preosjetljivost (poput osipa, urtikarije, dispneje, multiformnog etirema), anafilaktička reakcija (poput urtikarije, angioedema, edema, edema lica, šoka).
English: Hepatitis B surface antigen
Croatian: Površinski antigen virusa hepatitisa B
English: • is allergic (hypersensitive) to Vaxelis vaccine or any diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines, to any ingredients listed in section 6, to neomycin, streptomycin or polymyxin B (antibiotics), glutaraldehyde or formaldehyde, as these substances are used during the manufacturing process.
Croatian: • je alergično (preosjetljivo) na cjepivo Vaxelis ili bilo koja druga cjepiva protiv difterije, tetanusa, hripavca, poliomijelitisa, hepatitisa B ili Hib-a, na neki drugi sastojak naveden u dijelu 6, na neomicin, streptomicin ili polimiksin B (antibiotici) te glutaraldehid ili formaldehid, jer se te tvari koriste tijekom procesa proizvodnje.
English: Long-term persistence of antibodies to pertussis antigens The persistence of pertussis antibodies was measured in children 4 or 5 years of age who had received Vaxelis at 2, 4 and 11-12 months of age.
Croatian: Dugoročna perzistencija antitijela na antigene hripavca Perzistencija antitijela na hripavac mjerena je u djece u dobi od 4 ili 5 godina koja su primila Vaxelis u dobi od 2, 4 i 11-12 mjeseci.
English: b- Tabulated list of adverse reactions
Croatian: b- Tablični prikaz nuspojava
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin, and polymyxin B).
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na tvari zaostale u tragovima (glutaraldehid, formaldehid, neomicin, streptomicin i polimiksin B).
English: Keep this vaccine out of the sight and reach of children.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece.
English: • Pertussis (often called whooping cough): a highly infectious illness that affects the airways.
Croatian: • Hripavac (često zvan magareći kašalj): vrlo zarazna bolest koja napada dišne puteve.
English: Suspension for injection Multipack: 50 (5 packs of 10) pre-filled syringes (0.5 mL) without needle
Croatian: Suspenzija za injekciju Višestruko pakiranje: 50 (5 pakiranja po 10) napunjenih štrcaljki (0,5 ml) bez igle
English: Where a dose of hepatitis B vaccine is given at birth, Vaxelis can be used for supplementary doses of hepatitis B vaccine from the age of 6 weeks.
Croatian: Kada je po rođenju primijenjena doza cjepiva protiv hepatitisa B, Vaxelis se može primijeniti kao dodatna doza cjepiva protiv hepatitisa B, počevši od 6. tjedna starosne dobi djeteta.
English: România Merck Sharp & Dohme Romania S.R.L.
Croatian: Merck Sharp & Dohme Romania S.R.L.
English: Prior to administration, the pre-filled syringe should be shaken gently in order to obtain a homogeneous, whitish, cloudy suspension.
Croatian: Prije primjene, napunjenu štrcaljku treba lagano protresti kako bi se dobila homogena, bjelkasta, mutna suspenzija.
English: Vaxelis should only be administered by intramuscular (IM) injection.
Croatian: Vaxelis treba primjenjivati samo intramuskularnom (i.m.) injekcijom.
English: 40 D antigen units
Croatian: 40 D-antigen jedinica
English: Uniform, cloudy, white to off-white suspension.
Croatian: Ujednačena, mutna, bijela do bjelkasta suspenzija.
English: Pack size of 1 or 10 pre-filled syringes, without attached needle, with 1 separate needle or with 2 separate needles.
Croatian: Veličina pakiranja od 1 ili 10 napunjenih štrcaljki, bez pričvršćene igle, s jednom ili dvije zasebne igle.
English: 8 D antigen units
Croatian: 8 D-antigen jedinica
English: Almost all fevers were mild or moderate (<39.5°C) and transient (duration of ≤2 days).
Croatian: Gotovo svi slučajevi vrućice bili su blagi ili umjereni (<39,5°C) te prolazni (trajali su ≤2 dana). (vidjeti dio 4.8).
English: Anti-diphtheria (≥ 0.1 IU/mL) Anti-tetanus (≥ 0.1 IU/mL) Anti-PT (vaccine response) Anti-FHA (vaccine response) Anti-PRN (vaccine response) Anti-FIM (vaccine response) Anti-Polio type 1 (≥ 1:8 dilution) Anti-Polio type 2 (≥ 1:8 dilution) Anti-Polio type 3 (≥ 1:8 dilution) Anti-HBs Ag (≥ 10 mIU/mL)
Croatian: Anti-difterija (≥ 0,1 IU/ml) Anti-tetanus (≥ 0,1 IU/ml) Anti-PT (serološki odgovor) Anti-FHA (serološki odgovor) Anti-PRN (serološki odgovor) Anti-FIM (serološki odgovor) Anti-Polio tip 1 (≥ 1:8 razrjeđenje) Anti-Polio tip 2 (≥ 1:8 razrjeđenje) Anti-Polio tip 3 (≥ 1:8 razrjeđenje) Anti-HBs Ag (≥ 10 IU/ml)
English: Vaxelis will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or by other liver pathogens.
Croatian: Vaxelis neće zaštititi od hepatitisa prouzročenog drugim patogenima poput virusa hepatitisa A, hepatitisa C i hepatitisa E ili drugih patogena koji napadaju jetru.
English: Carton for prefilled syringe without needle, with one separate needle, with two separate needles.
Croatian: Kutija s napunjenom štrcaljkom bez igle, s jednom zasebnom iglom, s dvije zasebne igle.
English: The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
Croatian: Cjepivo može sadržavati glutaraldehid, formaldehid, neomicin, streptomicin i polimiksin B u tragovima.
English: Booster at 12 months after primary doses at 2, 3, 4 months
Croatian: Docjepljivanje u dobi od 12 mjeseci, nakon primarnih doza u dobi od 2, 3, 4 mjeseca
English: The persistence of antibody to hepatitis B surface antigen (anti-HBsAg) was measured in children 4 or 5 years of age who had received Vaxelis either at 2, 4 and 11-12 months or at 2, 3, 4 and 12 months of age.
Croatian: Dugoročna perzistencija antitijela na površinski antigen hepatitisa B Perzistencija antitijela na površinski antigen hepatitisa B (anti-HBsAg) mjerena je u djece u dobi od 4 ili 5 godina koja su primila Vaxelis u dobi od 2, 4 i 11-12 mjeseci ili u dobi od 2, 3, 4 i 12 mjeseci.
English: The pre-filled syringe should be shaken gently in order to obtain a homogeneous, whitish, cloudy suspension.
Croatian: Prije primjene napunjenu štrcaljku treba lagano protresti kako bi se dobila homogena, bjelkasta, mutna suspenzija.
English: Bordetella pertussis antigens (Pertussis Toxoid/Filamentous Haemagglutinin/ Fimbriae types 2 and 3/Pertactin)
Croatian: Antigeni bakterije Bordetella pertussis (toksoid hripavca/filamentozni hemaglutinin/fimbrije, tip 2 and 3/pertaktin)
English: 32 D antigen units
Croatian: 32 D-antigen jedinica
English: • Common side effects (may affect up to 1 in 10 people) are: diarrhoea hard mass, lump (nodule) at the injection site bruising at the injection site
Croatian: • Česte nuspojave (mogu se javiti u do 1 na 10 osoba) su: proljev tvrda masa, kvržica (čvorić) na mjestu injiciranja stvaranje modrica na mjestu injiciranja
English: If either is observed, discard the pre-filled syringe.
Croatian: U slučaju uočavanja bilo čega navedenoga, napunjenu štrcaljku treba baciti.
English: Robert Boyleweg 4 2333 CG Leiden.
Croatian: Robert Boyleweg 4 2333 CG Leiden Nizozemska
English: 1 dose (0.5 ml) :
Croatian: 1 doza (0,5 ml):
English: General disorders and administration site conditions Extensive swelling of the vaccinated limb from the injection site beyond one or both joints, has been reported in children.
Croatian: U djece je prijavljeno opsežno oticanje cijepljenog ekstremiteta koje se proteže od mjesta injiciranja do preko jednog ili oba zgloba.
English: If your child experiences any of the following side effects, please tell your doctor, nurse or pharmacist.
Croatian: Ako Vaše dijete razvije bilo koju od sljedećih nuspojava, molimo obavijestite svog liječnika, medicinsku sestru ili ljekarnika.
English: If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Croatian: Ako imate dodatnih pitanja u vezi s primjenom ovog cjepiva, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, poliomyelitis, and Hib vaccines.
Croatian: U takvim se okolnostima mora prekinuti cijepljenje protiv hripavca i nastaviti shemu cijepljenja s cjepivima protiv difterije, tetanusa, hepatitisa B, poliomijelitisa i Hib-a.
English: Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
Croatian: Vaxelis (DTaP-HB-IPV-Hib) je indiciran za primarno cijepljenje i docjepljivanje dojenčadi i male djece s navršenih 6 tjedana života protiv difterije, tetanusa, hripavca, hepatitisa B, poliomijelitisa i invazivnih bolesti uzrokovanih bakterijom Haemophilus influenzae tipa b (Hib).
English: Intramuscular use.
Croatian: Intramuskularno.
English: What Vaxelis is and what it is used for What you need to know before Vaxelis is given to your child How to use Vaxelis
Croatian: Što je Vaxelis i za što se koristi Što morate znati prije nego
English: Carton for multipack containing 5 packs of 10 prefilled syringes without needle.
Croatian: Kutija za višestruko pakiranje s 5 pakiranja od 10 napunjenih štrcaljki bez igle.
English: Uncommon Injection site rash, injection site warmth, fatigue c- Description of selected adverse reactions
Croatian: Manje često osip na mjestu injiciranja, toplina na mjestu injiciranja, umor c- Opis odabranih nuspojava
English: Carton for prefilled syringes without needle.
Croatian: Kutija s napunjenim štrcaljkama bez igle.
English: Vaxelis does not protect your child against diseases caused by other bacteria and viruses that may cause similar symptoms.
Croatian: Vaše dijete od bolesti uzrokovanih drugim bakterijama i virusima, koje mogu imati slične simptome.
English: Vaxelis is for intramuscular injection only.
Croatian: Cjepivo Vaxelis namijenjeno je samo za intramuskularnu injekciju.
English: Uncommon (1/1,000 to <1/100)
Croatian: Manje često (1/1000 do <1/100) Rijetko
English: Other side effects not listed above have been reported with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines:
Croatian: Druge nuspojave koje nisu gore navedene, a prijavljene su za druga cjepiva protiv difterije, tetanusa, hripavca, poliomijelitisa, hepatitisa B ili Hib-a:
English: The anterolateral aspect of the thigh is the preferred site for infants under one year of age.
Croatian: Anterolateralno područje bedra preporučeno je mjesto za davanje injekcije u djece mlađe od godinu dana.
English: Excipients:
Croatian: Docjepljivanje:
English: Uncommon Rash, hyperhidrosis
Croatian: Manje često osip, hiperhidroza
English: Vaxelis is a vaccine, which helps to protect your child against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Vaxelis is given to children from the age of six weeks.
Croatian: Vaxelis je cjepivo koje pomaže u zaštiti Vašeg djeteta protiv difterije, tetanusa, hripavca, hepatitisa B, poliomijelitisa i teških oboljenja prouzročenih bakterijom Haemophilus influenzae tip b.
English: • has had any of the following events after receiving a vaccine against pertussis (whooping cough), as the decision to give further doses of pertussis containing vaccine will need to be carefully considered: had a fever of 40.5°C or above within 48 hours not due to another identifiable cause.
Croatian: • je nakon cijepljenja protiv hripavca imalo bilo koji od dolje navedenih događaja, jer će se u tom slučaju odluka o primjeni daljnjih doza cjepiva protiv hripavca morati pažljivo razmotriti: vrućica od 40,5 °C ili više unutar 48 sati kojoj se ne može ustanoviti drugi uzrok. bilo je mlohavo, nije reagiralo ili je palo u nesvijest u roku od 48 sati nakon prethodnog cijepljenja. neprekidno je plakalo i nije ga se moglo utješiti više od 3 sata unutar 48 sati nakon cijepljenja. imalo je napadaje (konvulzije) s ili bez vrućice unutar 3 dana nakon cijepljenja.
English: It causes the liver to become swollen (inflamed).
Croatian: Izaziva oticanje (upalu) jetre.
English: Vaxelis is provided as a suspension for injection in pre-filled syringe.
Croatian: Vaxelis je dostupan kao suspenzija za injekciju u napunjenoj štrcaljki.
English: Multipack of 5 packs of 10 pre-filled syringes with no needle.
Croatian: Višestruko pakiranje od 5 ili 10 napunjenih štrcaljki bez igle.
English: Do not use Vaxelis if your child:
Croatian: Vaše se dijete ne smije cijepiti cjepivom Vaxelis ako:
English: 3 micrograms
Croatian: 3 mikrograma
English: The active substances per dose (0.5 mL):
Croatian: Djelatne tvari po jednoj dozi (0,5 ml):
English: Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)
Croatian: Polisaharid bakterije Haemophilus influenzae tip b (poliribozilribitolfosfat)
English: Vaxelis may be administered simultaneously with pneumococcal polysaccharide conjugate vaccines, rotavirus vaccines, measles, mumps, rubella (MMR) and varicella containing vaccines and meningococcal C conjugate vaccines.
Croatian: Vaxelis se može primjenjivati istodobno s polisaharidnim konjugiranim cjepivom protiv pneumokoka, cjepivima protiv rotavirusa, ospica, zaušnjaka, rubele (MMR) i vodenih kozica te konjugiranih cjepiva protiv meningokoka grupe C.
English: How Vaxelis is given
Croatian: Kako se primjenjuje Vaxelis
English: Vaxelis can be given at the same time as other vaccines such as pneumococcal vaccines, measlesmumps-rubella-varicella (MMRV) vaccines, rotavirus vaccines or meningococcal C vaccines.
Croatian: Vaxelis se može davati istodobno s drugim cjepivima, kao što su cjepiva protiv pneumokoka, MMRV cjepiva protiv ospica, zaušnjaka, rubele i vodenih kozica, cjepiva protiv rotavirusa ili cjepiva protiv meningokoka grupe C.
English: • extensive swelling of the vaccinated limb
Croatian: • prekomjerno oticanje cijepljenog ekstremiteta
English: {Label - Prefilled Syringe}
Croatian: Naljepnica -napunjena štrcaljka
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet MCM Vaccine B.V.
English: • a rash
Croatian: • osip
English: Injection site bruising, injection site induration, injection site nodule
Croatian: Često stvaranje modrica na mjestu injiciranja, otvrdnuće na mjestu injiciranja, čvorić na mjestu injiciranja
English: Vaxelis suspension for injection in pre-filled syringe
Croatian: Vaxelis suspenzija za injekciju u napunjenoj štrcaljki
English: Uncommon Sleep disorders including insomnia, restlessness
Croatian: Manje često poremećaj spavanja uključujući nesanicu, nemir Poremećaji živčanog sustava Vrlo često somnolencija Manje često hipotonija