FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Oslovski kašelj lahko povzroči tudi vnetje ušes, okužbo dihal (bronhitis), ki lahko traja zelo dolgo, pljučno okužbo (pljučnico), napade krčev, poškodbe možganov in celo smrt.
English: Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)
Slovenian: polisaharid bakterije Haemophilus influenzae tipa b (poliribozilribitol fosfat)
English: Fever ≥39.5°C was observed in 3.7% of children (postbooster) and 0.2% to 0.8% of children (post-primary) receiving Vaxelis with PCV13 (see sections 4.4 and 4.5).
Slovenian: Telesno temperaturo ≥39,5 °C so opazili pri 3,7 % otrok (po obnovitvenem odmerku) in 0,2 do 0,8 % otrok (po osnovnem odmerku), ki so bili cepljeni s cepivom Vaxelis skupaj s PCV13 (glejte poglavji 4.4 in 4.5).
English: Your doctor will decide whether to give Vaxelis to your child.
Slovenian: Zdravnik bo presodil, ali bo vašemu otroku dal cepivo Vaxelis.
English: • has had shortness of breath or swelling of the face (anaphylactic reaction) after administration of a previous dose of Vaxelis.
Slovenian: • imel težave z dihanjem ali otekanje obraza (anafilaktično reakcijo) po predhodnem odmerku cepiva Vaxelis;
English: The immunogenicity of Vaxelis administered to children over 15 months of age has not been studied in clinical trials.
Slovenian: Imunogenost cepiva Vaxelis pri otrocih, starejših od 15 mesecev, ni bila raziskana v kliničnih preskušanjih.
English: Suspension for injection 1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with 1 needle 10 pre-filled syringes (0.5 ml) with 10 needles 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 20 needles
Slovenian: 1 napolnjena injekcijska brizga (0,5 ml) brez injekcijske igle 10 napolnjenih injekcijskih brizg (0,5 ml) brez injekcijske igle 1 napolnjena injekcijska brizga (0,5 ml) z 1 injekcijsko iglo 10 napolnjenih injekcijskih brizg (0,5 ml) z 10 injekcijskimi iglami 1 napolnjena injekcijska brizga (0,5 ml) z 2 injekcijskima iglama 10 napolnjenih injekcijskih brizg (0,5 ml) z 20 injekcijskimi iglami
English: Carton for prefilled syringe without needle, with one separate needle, with two separate needles.
Slovenian: Škatla za napolnjeno injekcijsko brizgo brez igle, z eno ločeno iglo, z dvema ločenima iglama.
English: Regarding PT and FIM, similar response rates and higher GMCs were observed both post-primary and post-booster in comparison to control vaccine.
Slovenian: Za PT in FIM so v primerjavi s kontrolnim cepivom opazili podobne stopnje odziva in višje geometrične sredine koncentracije protiteles tako po osnovnem kot po obnovitvenem cepljenju.
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.
Slovenian: Priporočeni mesti injiciranja sta anterolateralni predel stegna (najboljše mesto za dojenčke, mlajše od enega leta starosti) ali deltoidna mišica nadlakti.
English: The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
Slovenian: Cepivo lahko vsebuje sledove glutaraldehida, formaldehida, neomicina, streptomicina ali polimiksina B.
English: Pertactin (PRN)
Slovenian: 20 mikrogramov pertaktin (PRN)
English: Uncommon Sleep disorders including insomnia, restlessness
Slovenian: Psihiatrične motnje občasni motnje spanja, vključno z nespečnostjo, nemir
English: • Tetanus (often called lock jaw): caused by the tetanus bacteria entering a deep wound.
Slovenian: • Tetanus (imenovan tudi mrtvični krč): povzročajo bakterije tetanusa, ki vstopajo skozi globoko rano.
English: Premature infants
Slovenian: Nedonošeni dojenčki
English: MCM Vaccine B.V., Robert Boyleweg 4, 2333 CG Leiden.
Slovenian: MCM Vaccine B.V., Robert Boyleweg 4, 2333 CG Leiden, Nizozemska
English: Table 2: Seroprotection/Vaccine Response Rates One Month After the Primary Vaccination Series
Slovenian: Preglednica 2: Stopnja serozaščite/odziva na cepljenje en mesec po osnovnem cepljenju
English: What Vaxelis looks like and contents of the pack
Slovenian: Videz zdravila Vaxelis in vsebina pakiranja
English: Did not receive hepatitis B vaccine at birth
Slovenian: Brez cepljenja proti hepatitisu B ob rojstvu
English: The proportion of children seroprotected (anti-HBsAg ≥ 10 mIU/mL) after those vaccination schedules was 98.1% and 99.6%, respectively, and decreased to 65.7% and 70.2% approximately 4 years later.
Slovenian: Delež serozaščitenih otrok (anti-HbsAg ≥ 10 mi.e./ml) je bil 98,1 % po prvem programu cepljenja in 99,6 % po drugem programu cepljenja ter se je približno 4 leta kasneje znižal na 65,7 % po prvem programu cepljenja in na 70,2 % po drugem programu cepljenja.
English: Sodium phosphate Water for injections
Slovenian: Natrijev fosfat Voda za injiciranje
English: One dose (0.5 mL) contains:
Slovenian: En odmerek (0,5 ml) vsebuje:
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.
Slovenian: • alergičen (preobčutljiv) na cepivo Vaxelis ali katero koli cepivo, ki vsebuje davico, tetanus, oslovski kašelj, otroško paralizo, hepatitis B ali Hib, na katero koli sestavino, navedeno v poglavju 6, na neomicin, streptomicin ali polimiksin B (antibiotike), glutaraldehid ali formaldehid, saj se te snovi uporabljajo pri procesu izdelave cepiva;
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.
Slovenian: Odziv na cepljenje: Če je bila koncentracija protiteles pred 1. odmerkom < od spodnje meje kvantifikacije (LLOQ), potem je bila koncentracija protiteles po seriji odmerkov cepiva ≥ LLOQ; če je bila koncentracija protiteles pred 1. odmerkom ≥ LLOQ, potem je bila koncentracija po seriji odmerkov cepiva ≥ od ravni pred 1. odmerkom.
English: The immunogenicity of the vaccine may be reduced by immunosuppressive treatment or immunodeficiency.
Slovenian: Imunosupresivno zdravljenje ali imunska pomanjkljivost lahko zmanjšata imunogenost cepiva.
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.
Slovenian: Če je bil otrok cepljen proti hepatitisu B ob rojstvu, se cepivo Vaxelis lahko uporabi za dodatne odmerke cepiva proti hepatitisu B od starosti 6 tednov naprej.
English: LLOQ = 4EU/mL are for anti-PT, anti-PRN and anti-FIM; and LLOQ = 3EU/mL for anti-FHA
Slovenian: LLOQ = 4 EU/ml za protitelesa proti PT, protitelesa proti PRN in protitelesa proti FIM; ter LLOQ = 3 EU/ml za protitelesa proti FHA
English: Nervous system disorders Convulsion, febrile convulsion.
Slovenian: Bolezni živčevja Konvulzija, vročinski krči
English: Booster at 12 months after primary doses at 2, 3, 4 months
Slovenian: Obnovitveno cepljenje pri 12 mesecih po osnovnih odmerkih pri 2, 3, 4 mesecih
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.
Slovenian: Po osnovnem cepljenju z 2 ali 3 odmerki cepiva Vaxelis je treba obnovitveno cepljenje izvesti vsaj 6 mesecev po zadnjem osnovnem odmerku.
English: Co-administration of Vaxelis with other injectable vaccines must be carried out at separate injection sites and, preferably, separate limbs.
Slovenian: Sočasno cepljenje s cepivom Vaxelis in drugimi cepivi za injiciranje je treba izvesti na različnih vbodnih mestih ter po možnosti na različnih okončinah.
English: Pack size of 1 or 10 pre-filled syringes, without attached needle, with 1 separate needle or with 2 separate needles.
Slovenian: Pakiranje po 1 ali 10 napolnjenih injekcijskih brizg, brez nameščene injekcijske igle, z 1 ločeno iglo ali 2 ločenima iglama.
English: Vaxelis will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Slovenian: Cepivo Vaxelis preprečuje le bolezni, ki jih povzročajo patogeni Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virus hepatitisa B, poliovirus ali Haemophilus influenzae tipa b. Mogoče pa je pričakovati, da bo cepljenje preprečilo hepatitis D, saj se hepatitis D (ki ga povzroča agens delta) ne pojavi v odsotnosti okužbe s hepatitisom B.
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).
Slovenian: Preobčutljivost na učinkovine ali katero koli pomožno snov, ki je navedena v poglavju 6.1, ali na sledove ostankov (glutaraldehida, formaldehida, neomicina, streptomicina in polimiksina B).
English: Vaxelis is for intramuscular injection only.
Slovenian: Cepivo Vaxelis je namenjeno le intramuskularnemu injiciranju.
English: • Pertussis (often called whooping cough): a highly infectious illness that affects the airways.
Slovenian: • Oslovski kašelj (imenovan tudi pertusis): zelo nalezljiva bolezen, ki prizadene dihalne poti.
English: Suspension for injection 10 pre-filled syringes (0.5 ml) without needle
Slovenian: Suspenzija za injiciranje 10 napolnjenih injekcijskih brizg (0,5 ml) brez injekcijske igle
English: If either is observed, discard the pre-filled syringe.
Slovenian: Če opazite kaj od omenjenega, napolnjeno injekcijsko brizgo zavrzite.
English: Data from a clinical study indicate that, when Vaxelis is co-administered with pneumococcal conjugate vaccine (PCV13), the rate of fever is higher following the booster dose in the second year of life compared to the primary series.
Slovenian: Podatki iz klinične študije kažejo, da je pri sočasnem cepljenju s cepivom Vaxelis in konjugiranim pnevmokoknim cepivom (PCV13) pogostnost povišane telesne temperature višja po obnovitvenem odmerku v drugem letu življenja v primerjavi z osnovnim cepljenjem.
English: Diphtheria Toxoid not less than 20 IU
Slovenian: toksoid davice ne manj kot 20 IU
English: As a minimum, a dose of Hib vaccine must be administered.
Slovenian: Cepiti je treba vsaj z obnovitvenim odmerkom cepiva proti Hib.
English: Bordetella pertussis antigens Pertussis Toxoid (PT)
Slovenian: antigene bakterije Bordetelle pertussis toksoid oslovskega kašlja (PT)
English: Anti-PRP
Slovenian: PRP
English: The booster dose in clinical studies was given at 11-12 months after a 2-dose primary series, at 12 months of age after a 3-dose primary series (2, 3, 4 months), and at 15 months of age after a 3-dose primary series (2, 4, 6 months).
Slovenian: Obnovitveni odmerek je bil v kliničnih preskušanjih dan pri starosti 11 do 12 mesecev po osnovnem cepljenju z 2 odmerkoma, pri starosti 12 mesecev po osnovnem cepljenju s 3 odmerki (2., 3., 4. mesec), ter pri starosti 15 mesecev po osnovnem cepljenju s 3 odmerki (2., 4., 6. mesec).
English: 3 µg conjugated to meningococcal protein
Slovenian: 3 µg konjugiran na meningokonko beljakovino
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
Slovenian: • Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 cepljenih) so: zmanjšan apetit, razdražljivost, jok, bruhanje, zaspanost ali dremavost, vročina (38 °C ali več), bolečina, pordelost ali oteklina na mestu injiciranja.
English: Immunogenicity after primary series and booster doses
Slovenian: Imunogenost po osnovnem cepljenju in obnovitvenih odmerkih
English: Booster at 11-12 months, after primary doses at 2, 4, months
Slovenian: Obnovitveno cepljenje pri 11 do 12 mesecih po osnovnih odmerkih pri 2, 4 mesecih
English: If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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.
Slovenian: V takih primerih je treba cepljenje proti oslovskemu kašlju opustiti, cepljenje pa nadaljevati s cepivi proti davici, tetanusu, hepatitisu B, otroški paralizi in cepivi proti Hib.
English: The other ingredients are: Sodium phosphate, water for injections
Slovenian: Druge sestavine cepiva so: natrijev fosfat, voda za injiciranje.
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.
Slovenian: Pri aplikaciji osnovne serije imunizacije zelo prezgodaj rojenim dojenčkom (rojenim v 28. tednu gestacije ali prej), še zlasti tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati morebitno tveganje za apnejo in potrebo po spremljanju delovanja pljuč od 48 do 72 ur po cepljenju.
English: 20/20/5/3 µg
Slovenian: 20/20/5/3 µg površinsko protitelo hepatitisa B
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
Slovenian: Odziv na cepljenje: Če je bila koncentracija protiteles pred 1. odmerkom < LLOQ, potem bi morala biti koncentracija protiteles po obnovitvenem cepljenju ≥ LLOQ; če je bila koncentracija protiteles pred 1. odmerkom ≥ LLOQ, potem bi morala biti koncentracija protiteles po obnovitvenem cepljenju ≥ od ravni pred 1. odmerkom.
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
Slovenian: • Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 cepljenih) so: izpuščaj, občutek toplote, izpuščaj na mestu injiciranja, povečan apetit, bolečina v trebuhu, prekomerno znojenje, kašelj, zamašen nos in izcedek iz nosu, bledica, motnje spanja, vključno z nezmožnostjo, da bi se zadostno naspal, nemirnost, otekle bezgavke na vratu, pod pazduho ali v dimljah, občutek utrujenosti, mlahavost.
English: România Merck Sharp & Dohme Romania S.R.L.
Slovenian: Merck Sharp & Dohme Romania S.R.L.
English: Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination.
Slovenian: Zaradi dolge inkubacijske dobe hepatitisa B je mogoče, da je v času cepljenja že prisotna neprepoznana okužba s hepatitisom B. V takih primerih cepivo morda ne bo preprečilo okužbe s hepatitisom B.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema občasni limfadenopatija
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.
Slovenian: Dolgotrajna prisotnost protiteles proti antigenom pertusisa Prisotnost protiteles proti bakteriji B. pertussis so merili pri otrocih, starih 4 ali 5 let, ki so prejeli cepivo Vaxelis pri 2, 4 in 11-12 mesecih starosti.
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).
Slovenian: Cepivo Vaxelis (DTaP-HB-IPV-Hib) je indicirano za osnovno in obnovitveno cepljenje pri dojenčkih in malčkih od starosti 6 tednov naprej proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, otroški paralizi in invazivnim boleznim, ki jih povzroča Haemophilus influenzae tipa b (Hib).
English: 8 D antigen units
Slovenian: 8 enot antigena D
English: How to store Vaxelis
Slovenian: Kako dajemo cepivo Vaxelis
English: Robert Boyleweg 4 2333 CG Leiden.
Slovenian: Robert Boyleweg 4 2333 CG Leiden Nizozemska
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.
Slovenian: Dolgotrajna prisotnost protiteles proti površinskemu antigenu hepatitisa B Prisotnost protiteles proti površinskemu antigenu hepatitisa B (anti-HBsAg) so merili pri otrocih, starih 4 ali 5 let, ki so prejeli cepivo Vaxelis bodisi pri 2, 4 in 11-12 mesecih bodisi pri 2, 3, 4 in 12 mesecih starosti.
English: 40 D antigen units
Slovenian: 40 enot antigena D
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.
Slovenian: Vaxelis je cepivo, ki pomaga ščititi vašega otroka pred davico, tetanusom, oslovskim kašljem, hepatitisom B, otroško paralizo in hudimi boleznimi, ki jih povzroča Haemophilus influenzae tipa b. Vaxelis dajemo otrokom, starim od šest tednov naprej.
English: Vaxelis is provided as a suspension for injection in pre-filled syringe.
Slovenian: Cepivo Vaxelis je na voljo kot suspenzija za injiciranje v napolnjeni injekcijski brizgi.
English: 32 D antigen units
Slovenian: 32 enot antigena D
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:
Slovenian: Če se po cepljenju s cepivom s komponento proti oslovskemu kašlju pojavi kateri koli od naslednjih neželenih učinkov, je treba temeljito pretehtati odločitev o dajanju nadaljnjih odmerkov cepiva s komponento proti oslovskemu kašlju:
English: Suspension for injection Multipack: 50 (5 packs of 10) pre-filled syringes (0.5 mL) without needle
Slovenian: Suspenzija za injiciranje Skupno pakiranje: 50 (5 paketov po 10) napolnjenih injekcijskih brizg (0,5 ml) brez injekcijske igle
English: What Vaxelis contains
Slovenian: Kaj vsebuje zdravilo Vaxelis
English: Uncommon (1/1,000 to <1/100)
Slovenian: ( 1/1.000 do < 1/100)
English: 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al produced in yeast (Saccharomyces cerevisiae) by recombinant DNA technology produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method.
Slovenian: 50 mikrogramov adsorbiran na aluminijev fosfat (0,17 mg Al adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,15 mg Al pridobljen v celicah kvasovke (Saccharomyces cerevisiae) s tehnologijo rekombinantne DNK pridobljen v celicah Vero.
English: The pre-filled syringe should be shaken gently in order to obtain a homogeneous, whitish, cloudy suspension.
Slovenian: Napolnjeno injekcijsko brizgo je treba rahlo pretresti, da dobite homogeno, belkasto, motno suspenzijo.
English: Your doctoror nurse will assess the potential benefit offered by vaccination, once the condition is stabilized.
Slovenian: Zdravnik ali medicinska sestrabo ocenilamorebitne koristi cepljenja, ko se bolezen stabilizira;
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.
Slovenian: Pri otrocih so poročali o obsežnem otekanju cepljenih udov od mesta injiciranja prek enega ali obeh sklepov.
English: What you need to know before Vaxelis is given to your child
Slovenian: Kaj morate vedeti, preden bo vaš otrok prejel cepivo Vaxelis
English: Other side effects not listed above have been reported with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines:
Slovenian: O drugih neželenih učinkih, ki niso navedeni zgoraj, poročajo pri drugih cepivih, ki vsebujejo cepiva proti davici, tetanusu, oslovskemu kašlju, otroški paralizi, hepatitisu B ali Hib:
English: •suffers from any undiagnosed illness of the brain or epilepsy which is not controlled.
Slovenian: •imanediagnosticirano bolezenmožganov ali nenadzorovano epilepsijo.
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.
Slovenian: Cepivo Vaxelis se lahko daje istočasno z drugimi cepivi, kot so cepiva proti pnevmokokom, cepiva proti ošpicam, mumpsu, rdečkam in noricam (MMRV), cepiva proti rotavirusom ali cepiva proti meningokokom skupine C.
English: The following convention has been used for the classification of adverse reactions: Very common (1/10)
Slovenian: Neželeni učinki so razvrščeni po skupinah po naslednjem dogovoru: zelo pogosti pogosti
English: Hepatitis B surface antigen
Slovenian: 5 mikrogramov površinski antigen hepatitisa B
English: Intramuscular use.
Slovenian: intramuskularna uporaba Pred uporabo pretresite.
English: Filamentous Haemagglutinin (FHA)
Slovenian: 20 mikrogramov filamentozni hemaglutinin (FHA)
English: Vaxelis should only be administered by intramuscular (IM) injection.
Slovenian: Cepljenje s cepivom Vaxelis je treba opraviti z intramuskularno (i. m.) injekcijo.
English: Anti-FIM (vaccine response)
Slovenian: Protitelesa proti FHA (odziv na cepljenje)
English: (1/10,000 to <1/1,000) Very rare (<1/10,000)
Slovenian: (≥ 1/10.000 do < 1/1.000)
English: 1 dose (0.5 ml) :
Slovenian: 1 odmerek (0,5 ml):
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij MCM Vaccine B.V.
English: Apnoea in very premature infants (≤28 weeks of gestation).
Slovenian: Apneja pri zelo prezgodaj rojenih dojenčkih (v 28. tednu gestacije ali prej) (glejte poglavje 4.4).
English: Multipack of 5 packs of 10 pre-filled syringes with no needle.
Slovenian: Skupno pakiranje 5 paketov po 10 napolnjenih injekcijskih brizg brez injekcijskih igel.
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.
Slovenian: • po prejemu cepiva proti oslovskemu kašlju imel katerega koli izmed naslednjih neželenih učinkov, saj je treba temeljito pretehtati odločitev o dajanju nadaljnjih odmerkov cepiva, ki vsebuje oslovski kašelj: vročino 40,5 °C ali več v 48 urah, ki ni bila posledica drugega ugotovljenega vzroka, postal mlahav, ravnodušen ali nezavesten po predhodnem cepljenju, v 48 urah po cepljenju, neprekinjeno jokal in ga ni bilo mogoče potolažiti več kot 3 ure v 48 urah po cepljenju, napade krčev (konvulzije), z vročino ali brez nje, v treh dneh po cepljenju,
English: Two doses
Slovenian: Dva odmerka
English: Carton for prefilled syringes without needle.
Slovenian: Škatla za napolnjene injekcijske brizge brez injekcijske igle.