FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncontrolled neurologic disorder or uncontrolled epilepsy: pertussis vaccination should not be administered until treatment for the condition has been established, the condition has stabilised and the benefit clearly outweighs the risk.
Slovenian: Nenadzorovana nevrološka bolezen ali nenadzorovana epilepsija: cepiva proti oslovskemu kašlju ne smemo dati, dokler ni uvedeno zdravljenje za to bolezen, dokler se stanje ne stabilizira in je jasno, da koristi odtehtajo tveganja.
English: The presence of a minor illness and /or low grade fever does not constitute a contraindication.
Slovenian: Prisotnost blage bolezni in/ali rahlo povišane telesne temperature ne predstavljata kontraindikacije.
English: Paralysis of the muscles that control breathing and swallowing can be fatal.
Slovenian: Paraliza mišic, ki nadzorujejo dihanje in požiranje je lahko usodna.
English: • allergic reaction, serious allergic reaction (anaphylactic reaction)
Slovenian: • alergijska reakcija, huda alergijska reakcija (anafilaktična reakcija),
English: • low blood pressure causing dizziness or collapse.
Slovenian: • nizek krvni tlak, ki povzroči omotico ali kolaps.
English: The needle must be fitted firmly on to the pre-filled syringe, rotating it by a one-quarter turn.
Slovenian: Iglo je treba trdno pritrditi na napolnjeno injekcijsko brizgo, tako da jo obrnete za četrt obrata.
English: However,children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Vaxelis but the protection may not be as good as in children with ahealthyimmune system.
Slovenian: Vendar pa se otroke z dolgotrajnimi težavami zimunskim sistemom,kot jeokužbas HIV (AIDS),lahko cepi s cepivom Vaxelis, vendar zaščita morda ne bo tako dobra kot pri otrocih z zdravim imunskim sistemom.
English: Pack of 10 (without blue box).
Slovenian: Pakiranje po 10 (brez modrega okenca).
English: Immunocompromised children
Slovenian: Imunsko ogroženi otroci
English: Do not administer by intravascular, intradermal or subcutaneous injection.
Slovenian: Cepiva ne dajajte z intravaskularnim, intradermalnim ali subkutanim injiciranjem.
English: The immune responses to Vaxelis in these infants were generally similar to those of the overall study population.
Slovenian: Imunski odzivi na cepivo Vaxelis pri teh dojenčkih so v splošnem podobni kot pri celotni populaciji v preskušanju.
English: Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.
Slovenian: Cepljenje posameznikov s kronično imunsko pomanjkljivostjo, npr. z okužbo s HIV, je priporočeno, čeprav je odziv s protitelesi morda omejen.
English: • previously had Guillain-Barré syndrome (temporary loss of feeling and movement) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin).
Slovenian: • v preteklosti imel Guillain-Barréjev sindrom (začasno nezmožnost občutenja in gibanja) po prejemu cepiva, ki je vsebovalo tetanusni toksoid (inaktivirano obliko tetanusnega toksina).
English: Read all of this leaflet carefully before your child is vaccinated with this medicine because it contains important information for you.
Slovenian: Preden je vaš otrok cepljen s tem zdravilom natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: It causes severe coughing that may lead to problems with breathing.
Slovenian: Povzroči hud kašelj, ki lahko privede do težav z dihanjem.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKIH UČINKOVIN IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Your child will receive two or three injections given at least one month apart.
Slovenian: Vaš otrok bo prejel dve ali tri injekcije, z vsaj mesecem dni časovnega zamika.
English: A history of febrile convulsions, a family history of convulsions, or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Vaxelis.
Slovenian: Anamneza vročinskih krčev, družinska anamneza krčev ali sindroma nenadne smrti dojenčka (SIDSSudden Infant Death Syndrome) niso kontraindikacija za uporabo cepiva Vaxelis.
English: Sanofi Pasteur SA 1541 Avenue Marcel Mérieux 69280 Marcy l'Etoile France
Slovenian: Sanofi Pasteur SA 1541 Avenue Marcel Mérieux 69280 Marcy l'Etoile Francija
English: •is receivinga treatment (such as steroids, chemotherapy or radiotherapy) or has a disease that suppressesor weakensthe body's ability to fight infections.
Slovenian: •prejema zdravljenje (kot so steroidi, kemoterapija ali obsevanje) ali ima bolezen, ki zavira ali slabi sposobnost telesa za boj proti okužbam.
English: • swelling of the face or throat
Slovenian: • otekanje obraza ali grla;
English: It is important to follow the instructions from the doctor or nurse so that your child completes the course of injections.
Slovenian: Pomembno je, da sledite navodilom zdravnika ali medicinske sestre, tako da bo vaš otrok zaključil celotno shemo cepljenja.
English: Lower FHA, PRN, IPV1 and IPV3 immune responses were observed after a 2-dose primary schedule (2, 4 months), although the clinical relevance of these data remain uncertain.
Slovenian: Nižje stopnje imunskega odziva na FHA, PRN, IPV1 in IPV3 so opazili pri programu osnovnega cepljenja z 2 odmerkoma (2., 4. mesec), vendar klinični pomen teh podatkov ostaja negotov.
English: Very Common Decreased appetite Uncommon Increased appetite
Slovenian: Presnovne in prehranske motnje zelo pogosti zmanjšan apetit občasni povečan apetit
English: Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed using sensitive tests, for at least 30 days following vaccination.
Slovenian: Ker se kapsularni polisaharidni antigen Hib izloča v urin, se lahko pri občutljivih testih v obdobju vsaj 30 dni po cepljenju pojavi pozitiven izvid urinskega testa.
English: • Diphtheria: a bacterial infection that usually first affects the throat, causing pain and swelling which can lead to suffocation.
Slovenian: • Davica: bakterijska okužba, ki običajno najprej prizadene grlo in ki povzroča bolečino in oteklino, ki lahko privede do zadušitve.
English: Poliovirus (Inactivated) Types 1/2/3
Slovenian: 10 µg poliovirus (inaktiviran) tipa 1/2/3
English: • has an uncontrolled condition or severe illness affecting the brain and nervous system (uncontrolled neurologic disorder) or uncontrolled epilepsy.
Slovenian: • ima nenadzorovano stanje ali hudo bolezen, ki prizadene možgane in živčevje (nenadzorovano nevrološko bolezen), ali nenadzorovano epilepsijo.
English: Your doctor or nurse will inject Vaxelis into your child's thigh (in infants from the age of 6 weeks) or arm (in children older than one year).
Slovenian: Zdravnik ali medicinska sestra bosta injicirala cepivo Vaxelis v otrokovo stegno (pri dojenčkih od starosti 6 tednov) ali v roko (pri otrocih, starejših od enega leta).
English: The suspension should be visually inspected, prior to administration, for foreign particulate matter and/or variation of physical appearance.
Slovenian: Suspenzijo je potrebno pred uporabo vizualno pregledati glede tujih delcev in/ali neobičajnega fizikalnega videza.
English: The primary vaccination schedule consists of two or three doses, with an interval of at least 1 month between doses, and may be given from 6 weeks of age, in accordance with the official recommendations.
Slovenian: Program osnovnega cepljenja je sestavljen iz dveh ali treh odmerkov z vsaj 1-mesečnim premorom med odmerki in se ga lahko daje pri starosti od 6 tednov naprej skladno z uradnimi priporočili.
English: Anti-HBs Ag (≥ 10 IU/mL)
Slovenian: Protitelesa proti HBs Ag (≥ 10 i.e./ml)
English: • has a moderate to severe acute disease, with or without fever (e.g. sore throat, cough, cold or flu).
Slovenian: • ima zmerno do hudo akutno bolezen z ali brez vročine (npr. vneto grlo, kašelj, prehlad ali gripo).
English: Type 3 (Saukett)
Slovenian: tipa 3 (sev Saukett)
English: If your child misses a scheduled injection, it is important that you discuss with your doctor or nurse who will decide when to give the missed dose.
Slovenian: Če vaš otrok zamudi predvideni odmerek, je pomembno, da se pogovorite z zdravnikom ali medicinsko sestro, ki bosta določila, kdaj naj otrok prejme izpuščeni odmerek.
English: What is Vaxelis and what it is used for
Slovenian: Kaj je zdravilo Vaxelis in za kaj ga uporabljamo
English: Pertussis response rates were similar to the control vaccine for all pertussis antigens after the booster dose.
Slovenian: Stopnje odziva za oslovski kašelj so bile podobne kot pri kontrolnem cepivu za vse antigene pertusisa po obnovitvenem odmerku.
English: ≥ 20 IU
Slovenian: ≥ 20 i.e.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Table 1: List of Adverse Reactions
Slovenian: Preglednica 1: Seznam neželenih učinkov
English: • Persistent crying lasting ≥3 hours, occurring within 48 hours of vaccination
Slovenian: • neutolažljiv jok, ki traja ≥ 3 ure in se pojavi v 48 urah po cepljenju;
English: Talk to your doctor, pharmacist or nurse before vaccination if your child:
Slovenian: Pred cepljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če (je) vaš otrok:
English: 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).
Slovenian: 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).
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Slovenian: Kot velja za vsa cepiva, zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah.
English: • episodes of shock-like state or paleness, floppy and unresponsive
Slovenian: • epizode šoku podobnega stanja ali bledica, mlahavost in neodzivnost.
English: 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.
Slovenian: Po prvem cepljenju bo vaš otrok skladno z lokalnimi priporočili prejel obnovitveni odmerek vsaj 6 mesecev po zadnjem odmerku prvega cepljenja.
English: Aluminium phosphate and amorphous aluminium hydroxyphosphate sulphate are included in the vaccine as adjuvants.
Slovenian: Aluminijev fosfat in amorfni aluminijev hidroksifosfat sulfat sta dodana cepivu kot adjuvansa.
English: • has any problems with bleeding for a long time after minor cuts, or bruises easily.
Slovenian: • ima težave z dolgotrajnim krvavenjem po manjših urezninah ali je nagnjen k modricam.
English: Vaxelis should not be mixed with any other vaccine or other parenterally administered medicinal products.
Slovenian: Cepiva Vaxelis ni dovoljeno mešati z drugimi cepivi ali drugimi parenteralno apliciranimi zdravili.
English: The safety and efficacy of Vaxelis in infants less than 6 weeks of age have not been established.
Slovenian: Varnost in učinkovitost cepiva Vaxelis pri otrocih, mlajših od 6 tednov, nista bili dokazani.
English: 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.
Slovenian: 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.
English: As with other vaccines, administration of Vaxelis should be postponed in children suffering from moderate to severe acute disease, with or without fever.
Slovenian: 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.
English: Interference with laboratory testing
Slovenian: Vpliv na rezultate laboratorijskih preiskav
English: Multipack of 50 (with blue box).
Slovenian: Skupno pakiranje po 50 (z modrim okencem).
English: The normal appearance of the vaccine is a uniform, cloudy, white to off-white suspension, which may settle down during storage.
Slovenian: Normalen videz cepiva je enakomerna, motna, bela ali skoraj bela suspenzija, ki se lahko med dolgotrajnim mirovanjem poleže.
English: Tetanus Toxoid not less than 40 IU
Slovenian: toksoid tetanusa ne manj kot 40 IU
English: The following adverse events have been reported with other vaccines containing the components or constituents of Vaxelis without regard to causality or frequency.
Slovenian: Naslednji neželeni učinki so bili opisani pri drugih cepivih, ki vsebujejo komponente ali sestavine cepiva Vaxelis, ne glede na vzročnost ali pogostost.
English: Non-clinical data reveal no special hazard for humans based on conventional studies.
Slovenian: Predklinični podatki na osnovi običajnih študij ne kažejo posebnega tveganja za človeka.
English: Vaxelis does not protect your child against diseases caused by other bacteria and viruses that may cause similar symptoms.
Slovenian: Cepivo Vaxelis vašega otroka ne ščiti pred boleznimi, ki jih povzročajo druge bakterije in virusi, ki imajo morda podobne simptome.
English: The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4
Slovenian: 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.
English: For adjuvants, see section 2.
Slovenian: Za seznam adjuvantov glejte poglavje 2.
English: The bacteria also make a toxin (poison) that can damage the heart, kidneys and nerves.
Slovenian: Bakterije tvorijo tudi toksin (strup), ki lahko poškoduje srce, ledvice in živce.
English: Bordetella pertussis antigens (Pertussis Toxoid/Filamentous Haemagglutinin/ Fimbriae types 2 and 3/Pertactin)
Slovenian: protitelesa Bordetella pertussis (toksoid oslovskega kašlja/ filamentozni hemaglutinin/fibrije tipa 2 in 3/pertaktin)
English: d- Premature infants
Slovenian: d- Nedonošeni dojenčki
English: • Vaxelis will only help to prevent these diseases caused by the bacteria and viruses targeted by the vaccine.
Slovenian: • Cepivo Vaxelis ščiti samo pred temi boleznimi, ki jih povzročajo bakterije in virusi, proti katerim je cepivo usmerjeno.
English: • Hepatitis B: caused by the hepatitis B virus.
Slovenian: • Hepatitis B: povzroča ga virus hepatitisa B. Povzroča oteklino (vnetje) jeter.
English: 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%.
Slovenian: 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 %.
English: If your child misses a dose of Vaxelis
Slovenian: Če vaš otrok zamudi odmerek cepiva Vaxelis
English: First course of vaccination (primary vaccination)
Slovenian: Prvo cepljenje (osnovno cepljenje)
English: The bacteria make a toxin (poison) that causes spasms of the muscles, leading to inability to breathe and the possibility of suffocation.
Slovenian: Bakterije proizvajajo toksin (strup), ki povzroča mišične krče, kar privede do nezmožnosti dihanja in možnosti zadušitve.
English: Almost all fevers were mild or moderate (<39.5°C) and transient (duration of ≤2 days).
Slovenian: Skoraj vsi primeri povišane telesne temperature so bili blagi ali zmerni (<39,5 °C) in prehodni (trajanje ≤2 dni).
English: Tetanus Toxoid
Slovenian: toksoid tetanusa
English: The anterolateral aspect of the thigh is the preferred site for infants under one year of age.
Slovenian: Anterolateralni del stegna je najboljše mesto za dojenčke, mlajše od enega leta starosti.
English: Keep the vaccine in the outer carton in order to protect from light.
Slovenian: Cepivo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine.
Slovenian: Encefalopatija neznanega izvora, ki se je pojavila v 7 dneh po predhodnem cepljenju s cepivom proti oslovskemu kašlju.
English: Individuals with a history of febrile convulsions should be closely followed up as febrile convulsions may occur within 2 to 3 days post vaccination.
Slovenian: Posameznike z anamnezo vročinskih krčev je potrebno skrbno spremljati, saj se vročinski krči lahko pojavijo v 2 do 3 dneh po cepljenju.
English: Fimbriae Types 2 and 3 (FIM)
Slovenian: 3 mikrogrami fimbrije tipa 2 in 3 (FIM)
English: • extensive swelling of the vaccinated limb
Slovenian: • močno otekanje cepljenega uda,
English: 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.
Slovenian: Priporočeni mesti injiciranja sta anterolateralni del stegna oziroma deltoidni predel nadlakti, če je na voljo zadostna mišična masa.
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.
Slovenian: 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.
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
Slovenian: 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
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.
Slovenian: 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.
English: • Convulsions with or without fever, occurring within 3 days of vaccination.
Slovenian: • konvulzije, s povišano telesno temperaturo ali brez nje, ki se pojavijo v 3 dneh po cepljenju.
English: Canada
Slovenian: Kanada
English: Antibody Thresholds
Slovenian: Mejne vrednosti protiteles
English: Your doctor will advise you whether your child should receive Vaxelis.
Slovenian: Zdravnik vam bo svetoval, ali naj vaš otrok prejme cepivo Vaxelis.
English: 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.
Slovenian: 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.
English: Hypersensitivity (such as rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (such as urticaria, angioedema, edema, face edema, shock).
Slovenian: Preobčutljivost (kot so izpuščaj, koprivnica, dispneja, multiformni eritem), anafilaktične reakcije (kot so koprivnica, angioedem, edem, edem obraza, šok).
English: • 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.
Slovenian: • 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.
English: • Fits (convulsions) with or without fever
Slovenian: • napadi krčev (konvulzije) z vročino ali brez nje,
English: Common (1/100 to <1/10)
Slovenian: ( 1/100 do < 1/10)
English: • Poliomyelitis (often just called polio): caused by viruses that affect the nerves.
Slovenian: • Otroška paraliza (imenovana tudi poliomielitis): povzročajo jo virusi, ki prizadenejo živce.
English: Table 3: Seroprotection/Vaccine Response Rates One Month After Booster Vaccination
Slovenian: Preglednica 3: Stopnje serozaščite/odziva na cepljenje en mesec po obnovitvenem cepljenju
English: The safety of Vaxelis in children over 15 months of age has not been studied in clinical trials.
Slovenian: Varnost cepiva Vaxelis pri otrocih, starejših od 15 mescev, ni bila raziskana v kliničnih preskušanjih.
English: Poliovirus (Inactivated) Type 1 (Mahoney)
Slovenian: 10 mikrogramov poliovirus (inaktiviran) tipa 1 (sev Mahoney)
English: Almost all fevers after primary and booster doses were mild or moderate (<39.5°C) and transient (duration of ≤2 days).
Slovenian: Skoraj vsi primeri povišane telesne temperature po osnovnih in obnovitvenih odmerkih so bili blagi ali zmerni (<39,5 °C) in prehodni (trajanje ≤2 dni).
English: N = 319-609 % N = 498-550 % N = 2455-2696
Slovenian: Trije odmerki 2., 4. mesec 2., 3., 4. mesec 2., 4., 6. mesec N = 319-609 % N = 498-550 % N = 2455-2696
English: In these infants, longer gaps than normal between breaths may occur for 2 to 3 days after vaccination.
Slovenian: Pri takšnih dojenčkih lahko pride do daljših premorov med vdihi, v 2 do 3 dneh po cepljenju.
English: History of an anaphylactic reaction after a previous administration of Vaxelis or a vaccine containing the same components or constituents.
Slovenian: Anamneza anafilaktične reakcije po predhodnem cepljenju s cepivom Vaxelis ali s cepivom, ki vsebuje enake komponente ali sestavine.
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).
Slovenian: Cepivo lahko vsebuje sledove glutaraldehida, formaldehida, neomicina, streptomicina in polimiksina B, ki se uporabljajo med proizvodnim postopkom (glejte poglavje 4.3).
English: • 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).
Slovenian: • imel hudo reakcijo na možganih (encefalopatija) v 7 dneh po predhodnem odmerku cepiva proti oslovskemu kašlju (brezceličen ali s celimi celicami);
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.
Slovenian: 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.