natgillin/translations-raw huggingface dataset:
As with all injectable vaccines, the vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
Kot pri vseh cepivih, ki se injicirajo, je treba cepivo dajati previdno pri posameznikih s trombocitopenijo ali motnjo strjevanja krvi, saj lahko po intramuskularni aplikaciji pride do krvavitve.
Vaxelis will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Cepivo Vaxelis bo vašemu otroku injiciral zdravnik ali medicinska sestra, ki sta usposobljena za uporabo cepiv in za obravnavo vseh občasnih hudih alergijskih reakcij na injekcijo (glejte poglavje 4 Možni neželeni učinki).
Table 1: List of Adverse Reactions
Preglednica 1: Seznam neželenih učinkov
• Persistent crying lasting ≥3 hours, occurring within 48 hours of vaccination
• neutolažljiv jok, ki traja ≥ 3 ure in se pojavi v 48 urah po cepljenju;
Talk to your doctor, pharmacist or nurse before vaccination if your child:
Pred cepljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če (je) vaš otrok:
As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine (see section 4.3).
Kot pri vseh cepivih, ki se injicirajo, je treba zagotoviti ustrezno zdravljenje in nadzor, ki morata biti takoj na voljo v redkem primeru anafilaktične reakcije po cepljenju (glejte poglavje 4.3).
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Kot velja za vsa cepiva, zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah.
• episodes of shock-like state or paleness, floppy and unresponsive
• epizode šoku podobnega stanja ali bledica, mlahavost in neodzivnost.
After the first course of injections, your child will receive a booster dose, in accordance with local recommendations, at least 6 months after the last dose of the first course.
Po prvem cepljenju bo vaš otrok skladno z lokalnimi priporočili prejel obnovitveni odmerek vsaj 6 mesecev po zadnjem odmerku prvega cepljenja.
Aluminium phosphate and amorphous aluminium hydroxyphosphate sulphate are included in the vaccine as adjuvants.
Aluminijev fosfat in amorfni aluminijev hidroksifosfat sulfat sta dodana cepivu kot adjuvansa.
• has any problems with bleeding for a long time after minor cuts, or bruises easily.
• ima težave z dolgotrajnim krvavenjem po manjših urezninah ali je nagnjen k modricam.
Vaxelis should not be mixed with any other vaccine or other parenterally administered medicinal products.
Cepiva Vaxelis ni dovoljeno mešati z drugimi cepivi ali drugimi parenteralno apliciranimi zdravili.
The safety and efficacy of Vaxelis in infants less than 6 weeks of age have not been established.
Varnost in učinkovitost cepiva Vaxelis pri otrocih, mlajših od 6 tednov, nista bili dokazani.
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including Vaxelis, should be based on careful consideration of the potential benefits and possible risks.
Če se po prejemu predhodnega cepiva, ki vsebuje tetanusni toksoid, v 6 tednih razvije GuillainBarréjev sindrom, je potrebno odločitev o nadaljevanju cepljenja s cepivi, ki vsebujejo tetanusni toksoid, vključno s cepivom Vaxelis, skrbno pretehtati glede na morebitne koristi in tveganja.
As with other vaccines, administration of Vaxelis should be postponed in children suffering from moderate to severe acute disease, with or without fever.
Kot pri drugih cepivih je treba cepljenje s cepivom Vaxelis odložiti pri otrocih, ki trpijo za zmerno do hudo akutno boleznijo z ali brez povišane telesne temperature.
Interference with laboratory testing
Vpliv na rezultate laboratorijskih preiskav
Multipack of 50 (with blue box).
Skupno pakiranje po 50 (z modrim okencem).
The normal appearance of the vaccine is a uniform, cloudy, white to off-white suspension, which may settle down during storage.
Normalen videz cepiva je enakomerna, motna, bela ali skoraj bela suspenzija, ki se lahko med dolgotrajnim mirovanjem poleže.
Tetanus Toxoid not less than 40 IU
toksoid tetanusa ne manj kot 40 IU
The following adverse events have been reported with other vaccines containing the components or constituents of Vaxelis without regard to causality or frequency.
Naslednji neželeni učinki so bili opisani pri drugih cepivih, ki vsebujejo komponente ali sestavine cepiva Vaxelis, ne glede na vzročnost ali pogostost.
Non-clinical data reveal no special hazard for humans based on conventional studies.
Predklinični podatki na osnovi običajnih študij ne kažejo posebnega tveganja za človeka.
Vaxelis does not protect your child against diseases caused by other bacteria and viruses that may cause similar symptoms.
Cepivo Vaxelis vašega otroka ne ščiti pred boleznimi, ki jih povzročajo druge bakterije in virusi, ki imajo morda podobne simptome.
The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4
Kaže, da je tveganje odvisno od števila predhodnih odmerkov cepiva, ki vsebuje acelularno komponento proti oslovskemu kašlju, pri čemer je tveganje večje po 4. in 5. odmerku.
For adjuvants, see section 2.
Za seznam adjuvantov glejte poglavje 2.
The bacteria also make a toxin (poison) that can damage the heart, kidneys and nerves.
Bakterije tvorijo tudi toksin (strup), ki lahko poškoduje srce, ledvice in živce.
Bordetella pertussis antigens (Pertussis Toxoid/Filamentous Haemagglutinin/ Fimbriae types 2 and 3/Pertactin)
protitelesa Bordetella pertussis (toksoid oslovskega kašlja/ filamentozni hemaglutinin/fibrije tipa 2 in 3/pertaktin)
d- Premature infants
d- Nedonošeni dojenčki
• Vaxelis will only help to prevent these diseases caused by the bacteria and viruses targeted by the vaccine.
• Cepivo Vaxelis ščiti samo pred temi boleznimi, ki jih povzročajo bakterije in virusi, proti katerim je cepivo usmerjeno.
• Hepatitis B: caused by the hepatitis B virus.
• Hepatitis B: povzroča ga virus hepatitisa B. Povzroča oteklino (vnetje) jeter.
After approximately 4 years, the percentages of children with anti-pertussis antibodies above LLOQ were as follows: anti-PT 58.4%, anti-FHA 80.9%, anti-PRN 66.1% and anti-FIM 94.3%.
Po približno 4 letih je bil odstotek otrok s protitelesi proti bakteriji B. pertussis nad LLOQ naslednji: protitelesa proti PT 58,4 %, protitelesa proti FHA 80,9 %, protitelesa proti PRN 66,1 % in protitelesa proti FIM 94,3 %.
If your child misses a dose of Vaxelis
Če vaš otrok zamudi odmerek cepiva Vaxelis
First course of vaccination (primary vaccination)
Prvo cepljenje (osnovno cepljenje)
The bacteria make a toxin (poison) that causes spasms of the muscles, leading to inability to breathe and the possibility of suffocation.
Bakterije proizvajajo toksin (strup), ki povzroča mišične krče, kar privede do nezmožnosti dihanja in možnosti zadušitve.
Almost all fevers were mild or moderate (<39.5°C) and transient (duration of ≤2 days).
Skoraj vsi primeri povišane telesne temperature so bili blagi ali zmerni (<39,5 °C) in prehodni (trajanje ≤2 dni).
Tetanus Toxoid
toksoid tetanusa
The anterolateral aspect of the thigh is the preferred site for infants under one year of age.
Anterolateralni del stegna je najboljše mesto za dojenčke, mlajše od enega leta starosti.
Keep the vaccine in the outer carton in order to protect from light.
Cepivo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine.
Encefalopatija neznanega izvora, ki se je pojavila v 7 dneh po predhodnem cepljenju s cepivom proti oslovskemu kašlju.
Individuals with a history of febrile convulsions should be closely followed up as febrile convulsions may occur within 2 to 3 days post vaccination.
Posameznike z anamnezo vročinskih krčev je potrebno skrbno spremljati, saj se vročinski krči lahko pojavijo v 2 do 3 dneh po cepljenju.
Fimbriae Types 2 and 3 (FIM)
3 mikrogrami fimbrije tipa 2 in 3 (FIM)
• extensive swelling of the vaccinated limb
• močno otekanje cepljenega uda,
The recommended injection sites are the anterolateral aspect of the thigh or the deltoid region of the upper arm if there is adequate muscle mass.
Priporočeni mesti injiciranja sta anterolateralni del stegna oziroma deltoidni predel nadlakti, če je na voljo zadostna mišična masa.
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.
Cepivo Vaxelis ne ščiti pred boleznijo, ki jo povzroči Haemophilus influenzae drugih tipov, razen tipa b, ali drugi mikroorganizmi, ki povzročajo invazivno bolezen, kot je meningitis ali sepsa, vključno z N. meningitidis.
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
Kaj je zdravilo Vaxelis in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok prejel cepivo Vaxelis Kako uporabljati cepivo Vaxelis Možni neželeni učinki
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.
Programi osnovnega cepljenja, ki so jih uporabljali v kliničnih preskušanjih, so bili naslednji: starost 2 in 4 mesece brez cepljenja proti hepatitisu B ob rojstvu; starost 2, 3 in 4 mesece brez cepljenja proti hepatitisu B ob rojstvu; ter starost 2, 4 in 6 mesecev z in brez cepljenja proti hepatitisu B ob rojstvu.
• Convulsions with or without fever, occurring within 3 days of vaccination.
• konvulzije, s povišano telesno temperaturo ali brez nje, ki se pojavijo v 3 dneh po cepljenju.
Antibody Thresholds
Mejne vrednosti protiteles
Your doctor will advise you whether your child should receive Vaxelis.
Zdravnik vam bo svetoval, ali naj vaš otrok prejme cepivo Vaxelis.
In a clinical study where Vaxelis was administered concomitantly with Prevenar 13 (PCV13) as a booster dose of both vaccines, fever ≥38.0°C was reported in 54.3% of children, compared to 33.1% to 40.7% of children during the primary series.
V kliničnem preskušanju, v katerem je bilo cepivo Vaxelis vbrizgano sočasno s cepivom Prevenar 13 (PCV13), oba v obnovitvenem odmerku, so o povišani telesni temperaturi ≥38,0 °C poročali pri 54,3 % otrok, v primerjavi s 33,1 % do 40,7 % otrok v osnovnem cepljenju.
Hypersensitivity (such as rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (such as urticaria, angioedema, edema, face edema, shock).
Preobčutljivost (kot so izpuščaj, koprivnica, dispneja, multiformni eritem), anafilaktične reakcije (kot so koprivnica, angioedem, edem, edem obraza, šok).
• Haemophilus influenzae type b infections (often just called Hib infections ): serious bacterial infections causing meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness.
• Okužbe s Haemophilusom influenzae tipa b (imenovane tudi okužbe s Hib): hude bakterijske okužbe, ki povzročajo meningitis (vnetje zunanje možganske ovojnice), kar lahko privede do poškodb možganov, gluhosti, epilepsije ali delne slepote.
• Fits (convulsions) with or without fever
• napadi krčev (konvulzije) z vročino ali brez nje,
Common (1/100 to <1/10)
( 1/100 do < 1/10)
• Poliomyelitis (often just called polio): caused by viruses that affect the nerves.
• Otroška paraliza (imenovana tudi poliomielitis): povzročajo jo virusi, ki prizadenejo živce.
Table 3: Seroprotection/Vaccine Response Rates One Month After Booster Vaccination
Preglednica 3: Stopnje serozaščite/odziva na cepljenje en mesec po obnovitvenem cepljenju
The safety of Vaxelis in children over 15 months of age has not been studied in clinical trials.
Varnost cepiva Vaxelis pri otrocih, starejših od 15 mescev, ni bila raziskana v kliničnih preskušanjih.
Poliovirus (Inactivated) Type 1 (Mahoney)
10 mikrogramov poliovirus (inaktiviran) tipa 1 (sev Mahoney)
Almost all fevers after primary and booster doses were mild or moderate (<39.5°C) and transient (duration of ≤2 days).
Skoraj vsi primeri povišane telesne temperature po osnovnih in obnovitvenih odmerkih so bili blagi ali zmerni (<39,5 °C) in prehodni (trajanje ≤2 dni).
N = 319-609 % N = 498-550 % N = 2455-2696
Trije odmerki 2., 4. mesec 2., 3., 4. mesec 2., 4., 6. mesec N = 319-609 % N = 498-550 % N = 2455-2696
In these infants, longer gaps than normal between breaths may occur for 2 to 3 days after vaccination.
Pri takšnih dojenčkih lahko pride do daljših premorov med vdihi, v 2 do 3 dneh po cepljenju.
History of an anaphylactic reaction after a previous administration of Vaxelis or a vaccine containing the same components or constituents.
Anamneza anafilaktične reakcije po predhodnem cepljenju s cepivom Vaxelis ali s cepivom, ki vsebuje enake komponente ali sestavine.
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B which are used during the manufacturing process (see section 4.3).
Cepivo lahko vsebuje sledove glutaraldehida, formaldehida, neomicina, streptomicina in polimiksina B, ki se uporabljajo med proizvodnim postopkom (glejte poglavje 4.3).
• has suffered from a severe reaction affecting the brain (encephalopathy) within 7 days of a prior dose of a pertussis vaccine (acellular or whole cell pertussis).
• imel hudo reakcijo na možganih (encefalopatija) v 7 dneh po predhodnem odmerku cepiva proti oslovskemu kašlju (brezceličen ali s celimi celicami);
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.
Cepivo Vaxelis ne ščiti pred okužbo s hepatitisom, ki ga povzročajo drugi agensi, kot so hepatitis A, hepatitis C in hepatitis E, ali drugi jetrni patogeni.
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.
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.
Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)
polisaharid bakterije Haemophilus influenzae tipa b (poliribozilribitol fosfat)
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).
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).
Your doctor will decide whether to give Vaxelis to your child.
Zdravnik bo presodil, ali bo vašemu otroku dal cepivo Vaxelis.
• has had shortness of breath or swelling of the face (anaphylactic reaction) after administration of a previous dose of Vaxelis.
• imel težave z dihanjem ali otekanje obraza (anafilaktično reakcijo) po predhodnem odmerku cepiva Vaxelis;
The immunogenicity of Vaxelis administered to children over 15 months of age has not been studied in clinical trials.
Imunogenost cepiva Vaxelis pri otrocih, starejših od 15 mesecev, ni bila raziskana v kliničnih preskušanjih.
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
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
Carton for prefilled syringe without needle, with one separate needle, with two separate needles.
Škatla za napolnjeno injekcijsko brizgo brez igle, z eno ločeno iglo, z dvema ločenima iglama.
Regarding PT and FIM, similar response rates and higher GMCs were observed both post-primary and post-booster in comparison to control vaccine.
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.
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.
Priporočeni mesti injiciranja sta anterolateralni predel stegna (najboljše mesto za dojenčke, mlajše od enega leta starosti) ali deltoidna mišica nadlakti.
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
Cepivo lahko vsebuje sledove glutaraldehida, formaldehida, neomicina, streptomicina ali polimiksina B.
Pertactin (PRN)
20 mikrogramov pertaktin (PRN)
Uncommon Sleep disorders including insomnia, restlessness
Psihiatrične motnje občasni motnje spanja, vključno z nespečnostjo, nemir
• Tetanus (often called lock jaw): caused by the tetanus bacteria entering a deep wound.
• Tetanus (imenovan tudi mrtvični krč): povzročajo bakterije tetanusa, ki vstopajo skozi globoko rano.
Premature infants
Nedonošeni dojenčki
Table 2: Seroprotection/Vaccine Response Rates One Month After the Primary Vaccination Series
Preglednica 2: Stopnja serozaščite/odziva na cepljenje en mesec po osnovnem cepljenju
What Vaxelis looks like and contents of the pack
Videz zdravila Vaxelis in vsebina pakiranja
Did not receive hepatitis B vaccine at birth
Brez cepljenja proti hepatitisu B ob rojstvu
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.
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.
Sodium phosphate Water for injections
Natrijev fosfat Voda za injiciranje
One dose (0.5 mL) contains:
En odmerek (0,5 ml) vsebuje:
• 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.
• 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;
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.
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.
The immunogenicity of the vaccine may be reduced by immunosuppressive treatment or immunodeficiency.
Imunosupresivno zdravljenje ali imunska pomanjkljivost lahko zmanjšata imunogenost cepiva.
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.
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.
LLOQ = 4EU/mL are for anti-PT, anti-PRN and anti-FIM; and LLOQ = 3EU/mL for anti-FHA
LLOQ = 4 EU/ml za protitelesa proti PT, protitelesa proti PRN in protitelesa proti FIM; ter LLOQ = 3 EU/ml za protitelesa proti FHA
Nervous system disorders Convulsion, febrile convulsion.
Bolezni živčevja Konvulzija, vročinski krči
Booster at 12 months after primary doses at 2, 3, 4 months
Obnovitveno cepljenje pri 12 mesecih po osnovnih odmerkih pri 2, 3, 4 mesecih
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.
Po osnovnem cepljenju z 2 ali 3 odmerki cepiva Vaxelis je treba obnovitveno cepljenje izvesti vsaj 6 mesecev po zadnjem osnovnem odmerku.
Co-administration of Vaxelis with other injectable vaccines must be carried out at separate injection sites and, preferably, separate limbs.
Sočasno cepljenje s cepivom Vaxelis in drugimi cepivi za injiciranje je treba izvesti na različnih vbodnih mestih ter po možnosti na različnih okončinah.
Pack size of 1 or 10 pre-filled syringes, without attached needle, with 1 separate needle or with 2 separate needles.
Pakiranje po 1 ali 10 napolnjenih injekcijskih brizg, brez nameščene injekcijske igle, z 1 ločeno iglo ali 2 ločenima iglama.
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.
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.
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).
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).
Vaxelis is for intramuscular injection only.
Cepivo Vaxelis je namenjeno le intramuskularnemu injiciranju.
• Pertussis (often called whooping cough): a highly infectious illness that affects the airways.
• Oslovski kašelj (imenovan tudi pertusis): zelo nalezljiva bolezen, ki prizadene dihalne poti.
Suspension for injection 10 pre-filled syringes (0.5 ml) without needle
Suspenzija za injiciranje 10 napolnjenih injekcijskih brizg (0,5 ml) brez injekcijske igle
If either is observed, discard the pre-filled syringe.
Če opazite kaj od omenjenega, napolnjeno injekcijsko brizgo zavrzite.
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.
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.
Diphtheria Toxoid not less than 20 IU
toksoid davice ne manj kot 20 IU
As a minimum, a dose of Hib vaccine must be administered.
Cepiti je treba vsaj z obnovitvenim odmerkom cepiva proti Hib.