FrancophonIA/ELRC3.0 huggingface dataset:
English: Protective antibodies against hepatitis B have been shown to persist for at least 3.5 years in more than 90% of children administered four doses of a combined vaccine containing the same HBs antigen as Infanrix Penta.
Slovenian: Zaščitna protitelesa proti hepatitisu B so dokazano prisotna vsaj še 3,5 leta pri več kot 90 % otrok, ki dobijo štiri odmerke kombiniranega cepiva z enakim antigenom HBs, kot ga vsebuje Infanrix Penta.
English: months N=554
Slovenian: mesecev n =554
English: • Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination;
Slovenian: • Kolaps ali šoku podobno stanje (hipotonična-hiporesponzivna epizoda) v 48 urah po cepljenju.
English: Important information about some of the ingredients of Infanrix Penta This vaccine contains neomycin and polymyxin (antibiotics).
Slovenian: Pomembne informacije o nekaterih sestavinah cepiva Infanrix Penta To cepivo vsebuje neomicin in polimiksin (antibiotika).
English: • Do not use Infanrix Penta after the expiry date which is stated on the carton.
Slovenian: • Cepiva Infanrix Penta ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: The other ingredients in Infanrix Penta are: sodium chloride (NaCl), medium 199 containing principally amino acids, mineral salts, vitamins and water for injections.
Slovenian: Druge sestavine cepiva Infanrix Penta so: natrijev klorid (NaCl), medij 199, ki vsebuje predvsem aminokisline, mineralne soli, vitamine in voda za injekcije.
English: As the immune response to pertussis antigens following Infanrix Penta administration is equivalent to that of Infanrix, the protective efficacy of the two vaccines is expected to be equivalent.
Slovenian: Ker je imunski odziv na antigen pertusisa po uporabi cepiva Infanrix Penta enak kot po uporabi cepiva Infanrix, je pričakovati, da bo zaščitni učinek obeh cepiv enak.
English: Wounds that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse manure or wood splinters in them.
Slovenian: Rane, ki se še posebno rade okužijo s tetanusom so opekline, zlomi, globoke rane ali rane onesnažene z zemljo, s prahom, konjskimi iztrebki ali lesenimi trskami.
English: 6.6 Special precautions for disposal and other handling Upon storage, a white deposit and clear supernatant may be observed.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Med shranjevanjem se lahko pojavi bela usedlina in bister supernatant.
English: Very rare: convulsions (with or without fever) Respiratory, thoracic and mediastinal disorders
Slovenian: Zelo redki: konvulzije (s povišano telesno temperaturo ali brez nje) Bolezni dihal, prsnega koša in mediastinalnega prostora
English: • your child has had problems of the nervous system within 7 days after previous vaccination with a vaccine against whooping cough.
Slovenian: • je imel težave z živčevjem v prvih 7 dneh po cepljenju s cepivom proti oslovskemu kašlju;
English: • If your child misses an injection which is due, it is important that you make another appointment.
Slovenian: • Če vaš otrok zamudi predvideni odmerek, je pomembno, da ga prenaročite.
English: • Whooping cough (Pertussis) - a highly infectious illness that affects the airways.
Slovenian: • Oslovski kašelj (pertusis) - zelo nalezljiva bolezen, ki prizadane dihalne poti.
English: • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
Slovenian: • pri zelo prezgodaj rojenih dojenčkih (28. teden nosečnosti ali prej) se lahko 2 do 3 dni po cepljenju pojavijo daljši presledki med dihi, kot je običajno,
English: Antibody levels were not different from what was observed in a parallel cohort administered 4 doses of monovalent hepatitis B vaccine.
Slovenian: Raven protiteles se ni razlikovala od ugotovljene v vzporedni kohorti, ki je dobila 4 odmerke monovalentnega cepiva proti hepatitisu B.
English: • Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination;
Slovenian: • Stalen, neutolažljiv jok, ki traja ≥ 3 ure in se pojavi v 48 urah po cepljenju.
English: • your child has a bleeding problem or bruises easily
Slovenian: • ima vaš otrok težave s krvavitvami ali hitrim nastankom modric;
English: The clinical protection of the pertussis component of Infanrix, against WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) was demonstrated in:
Slovenian: Klinično je bila zaščita pertusisne sestavine cepiva Infanrix proti značilnemu oslovskemu kašlju v skladu z definicijo WHO (napadi kašlja, ki trajajo ≥ 21 dni) prikazana v:
English: Infanrix Penta is a vaccine used to protect your child again five diseases:
Slovenian: Infanrix Penta je cepivo, ki vašega otroka lahko zaščiti pred petimi boleznimi:
English: The primary vaccination schedule consists of three doses of 0.5 ml (such as 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) or two doses (such as 3, 5 months).
Slovenian: Shema osnovnega cepljenja sestoji iz treh odmerkov po 0,5 ml (v 2., 3., 4. mesecu starosti; 3., 4., 5. mesecu starosti; 2., 4., 6. mesecu starosti) ali dveh odmerkov (v 3., 5. mesecu starosti).
English: months N= 326
Slovenian: mesecev n = 326
English: The holder of the marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Slovenian: Imetnik tega dovoljenja za promet z zdravilom mora obvestiti Evropsko Komisijo o načrtu trženja za
English: • Polio - a viral infection.
Slovenian: • Otroška paraliza- virusna okužba.
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 Infanrix Penta.
Slovenian: Anamneze vročinskih krčev družinske obremenjenosti z vročinskimi krči ali sindroma nenadne smrti dojenčka (SIDS-Sudden Infant Death Syndrome) ne uvrščamo med kontraindikacije za uporabo cepiva Infanrix Penta.
English: Pack sizes of 1, 10, 20 and 50 with or without needles.
Slovenian: Pakiranja po 1, 10, 20 in 50 injekcijskih brizg z injekcijskimi iglami ali brez njih.
English: Infanrix Penta should not be given if:
Slovenian: Vaš otrok cepiva Infanrix Penta ne sme prejeti, če:
English: • Infanrix Penta will be given as an injection into a muscle.
Slovenian: • Cepivo Infanrix Penta bo zdravnik dal v obliki injekcije v mišico.
English: • feeling nervous.
Slovenian: • občutek zaspanosti,
English: In the event of either being observed, discard the container.
Slovenian: Če opazite karkoli od tega, vsebnik zavrzite.
English: • Convulsions with or without fever, occurring within 3 days of vaccination.
Slovenian: • Krči z zvišano telesno temperaturo ali brez nje, ki so se pojavili v 3 dneh po cepljenju.
English: Where a dose of hepatitis B vaccine is given at birth, Infanrix Penta can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks.
Slovenian: Kadar otrok prejme prvi odmerek cepiva proti hepatitisu B ob rojstvu, lahko uporabimo cepivo Infanrix Penta kot nadomestilo za dodatne odmerke cepiva proti hepatitisu B od starosti šestih tednov dalje.
English: The virus is found in body fluids such as in the vagina, blood, semen, or spit (saliva) of infected people.
Slovenian: Pri okuženih ljudeh se virus nahaja v telesnih tekočinah, kot so kri, sperma, ali izpljunek (slina) ter v nožnici.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 20 PRE-FILLED SYRINGES WITHOUT NEEDLES 50 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 20 PRE-FILLED SYRINGES WITH 20 NEEDLES 50 PRE-FILLED SYRINGES WITH 50 NEEDLES
Slovenian: PODATKI NA ZUNANJI OVOJNINI 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ INJEKCIJSKE IGLE 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 20 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 50 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 1 IGLO 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 10 IGLAMI 20 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 20 IGLAMI 50 NAPOLNJENIH INJEKCIJSKIH BRIZG S 50 IGLAMI 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 2 IGLAMA 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 20 IGLAMI
English: If any of the following events are known to have occurred in temporal relation to receipt of pertussiscontaining vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:
Slovenian: Če je znano, da se je v določenem času po prejemu cepiva proti oslovskemu kašlju pojavil kateri koli izmed naslednjih neželenih učinkov, moramo temeljito pretehtati odločitev o dajanju nadaljnjih odmerkov cepiva s komponento proti oslovskemu kašlju:
English: • Infanrix Penta is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).
Slovenian: • Cepivo Infanrix Penta je bela, rahlo mlečna tekočina in je na voljo v napolnjeni injekcijski brizgi (0,5 ml).
English: Infanrix Penta is a turbid white suspension.
Slovenian: Cepivo Infanrix Penta je motna bela suspenzija.
English: As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix Penta with respect to the
Slovenian: Kot pri DTPa cepivu in kombiniranih cepivih, ki vsebujejo DTPa, so poročali o povečanem pojavu lokalnih reakcij in zvišane telesne temperature po aplikaciji obnovitvenega odmerka cepiva Infanrix Penta v primerjavi z osnovnim cepljenjem.
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with plunger stoppers (butyl).
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom iz butilne gume.
English: Infanrix Penta can be considered for the booster if the composition is in accordance with the official
Slovenian: Cepivo Infanrix Penta se lahko uporabi za obnovitveno cepljenje, če njegova sestava ustreza uradnim
English: Infanrix Penta, Suspension for injection
Slovenian: Infanrix Penta, suspenzija za injiciranje
English: * Children primed with acellular pertussis vaccines are more likely to experience swelling reactions after booster administration in comparison with children primed with whole cell vaccines.
Slovenian: * Pri otrocih, ki so bili osnovno cepljeni z acelularnim cepivom proti oslovskemu kašlju je verjetneje, da se bo po obnovitvenem cepljenju pojavila reakcija v obliki otekline kot pa pri otrocih, ki so bili osnovno cepljeni s cepivom proti oslovskemu kašlju, ki je vsebovalo celotno celico.
English: The DTPa-HBV-IPV suspension should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Slovenian: Preveriti morate videz suspenzije DTPa-HBV-IPV glede morebitne prisotnosti tujih delcev in/ali neobičajnega fizikalnega videza cepiva.
English: The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.
Slovenian: Drugačno shemo cepljenja (v 6., 10., 14. tednu starosti) se lahko uporabi le v primeru, če je bil otrok cepljen proti hepatitisu B že ob rojstvu.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Slovenian: Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor v redkih primerih anafilaktične reakcije, ki lahko sledi cepljenju.
English: Infanrix Penta should under no circumstances be administered intravascularly or intradermally.
Slovenian: Cepiva Infanrix Penta v nobenem primeru ne dajemo intravaskularno ali intradermalno.
English: The holder of marketing authorisation will submit 2-yearly PSURs.
Slovenian: Imetnik dovoljenja za promet bo redno predajal 2-letna posodobljena poročila o varnosti zdravila
English: WHAT INFANRIX PENTA IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE CEPIVO Infanrix Penta IN ZA KAJ GA UPORABLJAMO
English: • your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping
Slovenian: • je kdaj imel alergijsko reakcijo na katerokoli cepivo proti davici, tetanusu, oslovskemu kašlju,
English: Infanrix Penta will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus or poliovirus.
Slovenian: Cepivo Infanrix Penta ne prepreči bolezni, ki jih povzročijo drugi patogeni, ne pa Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virus hepatitisa B ali poliovirus.
English: (5 EL.U/ml) Anti-PRN (5 EL.U/ml) Anti-HBs (10 mIU/ml) † Anti-Polio type 1 (1/8 dilution) †
Slovenian: Anti-PRN (5 EL. e./ml) Anti-HBs (10 mi.e./ml) † Antipolio tip 1 (razredčenje 1/8) †
English: There is no relevant use of Infanrix Penta in children over 36 months.
Slovenian: Cepivo Infanrix Penta ni namenjeno za cepljenje otrok, starejših od 36 mesecev.
English: As with other vaccines, administration of Infanrix Penta should be postponed in subjects suffering from acute severe febrile illness.
Slovenian: Kot pri cepljenju z drugimi cepivi moramo cepljenje s cepivom Infanrix Penta odložiti pri otrocih, ki prebolevajo hudo akutno vročinsko bolezen.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: - a high temperature (over 40°C) within 48 hours of vaccination - a collapse or ‘shock-like' state within 48 hours of vaccination - persistent crying lasting 3 hours or more within 48 hours of vaccination - fits with or without a high temperature within 3 days of vaccination
Slovenian: • je po predhodnem cepljenju s cepivom Infanrix Penta ali drugim cepivom proti oslovskemu kašlju vaš otrok imel kakršnekoli težave, še posebej: - visoko telesno temperaturo (nad 40 ºC) v 48 urah po cepljenju; - kolaps ali »šoku podobno« stanje v 48 urah po cepljenju; - če je v 48 urah po cepljenju vztrajno in neutolažljivo jokal 3 ure ali dlje; - krče z ali brez zvišane telesne temperature v 3 dneh po cepljenju;
English: Based on data collected from secondary contacts in households where there was an index case with typical pertussis, the protective efficacy of the vaccine was 88.7%.
Slovenian: Na podlagi podatkov, zbranih po drugem obisku v gospodinjstvih, v katerih so imeli primer značilnega oslovskega kašlja, je bila učinkovitost zaščite, ki jo je nudilo cepivo,
English: In the event of either being observed, discard the vaccine.
Slovenian: Če opazite kar koli od tega, cepivo zavrzite.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web
Slovenian: Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila:
English: If you are not sure, talk to your doctor or pharmacist before your child is given Infanrix Penta.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom, preden bo vaš otrok cepljen s cepivom
English: • your child tends to have fits when they have a fever, or if there is a history of this in the family.
Slovenian: • je vaš otrok nagnjen h krčem, ko ima zvišano telesno temperaturo, ali pa so se ti pojavljali v
English: ND = not determined * in a subgroup of infants not administered hepatitis B vaccine at birth, 80.2% of subjects had antiHBs titres ≥ 10 mIU/ml † cut-off accepted as indicative of protection
Slovenian: * v podskupini otrok, ki ob rojstvu niso dobili cepiva proti hepatitisu B, jih je 80,2 % imelo titre anti
English: Hypersensitivity to the active substances or to any of the excipients or neomycin and polymyxin.
Slovenian: Preobčutljivost za učinkovine, katero koli pomožno snov cepiva, neomicin ali polimiksin.
English: Anti-Polio type 2 (1/8 dilution) †
Slovenian: Antipolio tip 2 (razredčenje 1/8) †
English: Infanrix Penta should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Slovenian: Otrokom s trombocitopenijo ali motnjami strjevanja krvi cepivo Infanrix Penta dajemo previdno, ker se pri njih po intramuskularnem injiciranju lahko pojavi krvavitev.
English: Anti-Polio type 3 (1/8 dilution) †
Slovenian: Antipolio tip 3 (razredčenje 1/8) †
English: After vaccination with 3 doses (e.g. 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose and preferably before 18
Slovenian: Po cepljenju s tremi odmerki cepiva Infanrix Penta (v 2., 3., 4. mesecu starosti; 3., 4., 5. mesecu starosti; 2., 4., 6. mesecu starosti) mora otrok prejeti obnovitveni odmerek cepiva najmanj 6 mesecev po cepljenju z zadnjim odmerkom iz osnovne sheme cepljenja, po možnosti preden dopolni
English: There are no data with regard to the efficacy and safety of simultaneous administration of Infanrix Penta and Measles-Mumps-Rubella vaccine.
Slovenian: O učinkovitosti in varnosti sočasnega dajanja cepiva Infanrix Penta ter cepiva proti ošpicam, mumpsu in rdečkam ni podatkov.
English: HIV infection is not considered as a contraindication.
Slovenian: Okužba z virusom humane imunske pomanjkljivosti (HIV) ne prištevamo h kontraindikacijam.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section
Slovenian: Kot velja za vsa cepiva, zaščitnega imunskega odziva ni vedno mogoče izzvati pri vseh cepljenih
English: After a vaccination with 2 doses (e.g. 3, 5 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose, preferably between 11 and 13 months of age.
Slovenian: Po cepljenju z dvema odmerkoma cepiva Infanrix Penta (v 3. in 5. mesecu starosti) mora otrok prejeti obnovitveni odmerek cepiva najmanj 6 mesecev po cepljenju z zadnjim odmerkom iz osnovne sheme cepljenja, po možnosti v starosti od 11 do 13 mesecev.
English: What Infanrix Penta looks like and contents of the pack
Slovenian: Izgled cepiva Infanrix Penta in vsebina pakiranja
English: • swelling larger than 5 cm or hard lump where the injection was given.
Slovenian: • zvišana telesna temperatura nad 39,5 °C, • več kot 5 cm velika oteklina ali trda bula na mestu injiciranja.
English: • your child is allergic (hypersensitive) to - Infanrix Penta, or any ingredients in Infanrix Penta (listed in Section 6) - neomycin or polymyxin (antibiotics).
Slovenian: - cepivo Infanrix Penta ali katerokoli sestavino cepiva Infanrix Penta (navedene v poglavju 6); - neomicin ali polimiksin (antibiotika).
English: Like all medicines, Infanrix Penta can cause side effects, although not everybody gets them.
Slovenian: Kot vsa cepiva ima lahko tudi cepivo Infanrix Penta neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
English: (Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1)
Slovenian: (toksoid1 Bordetella pertussis, filamentozni hemaglutinin1, pertaktin1) 25, 25, 8 mikrogramov
English: Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia),
Slovenian: Oslovski kašelj lahko povzroči vnetje ušes, vnetje v prsnem košu (bronhitis), ki je lahko dolgotrajno, vnetje pljuč (pljučnico), krče,
English: Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Slovenian: Cepivo Infanrix Penta je indicirano za osnovno in obnovitveno cepljenje otrok proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in otroški ohromelosti.
English: 8 D-antigen unit 32 D-antigen unit
Slovenian: 10 mikrogramov 40 D-antigenskih enot 8 D-antigenskih enot 32 D-antigenskih enot
English: Results obtained in the clinical studies for each of the components are summarised in the tables below: Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination months N= 55
Slovenian: Farmakoterapevtska skupina: Kombinacija bakterijskih in virusnih cepiv, oznaka ATC: J07CA12 Spodaj so v tabelah povzeti rezultati kliničnih študij za vsako izmed komponent: Odstotek preiskovancev, ki so imeli titre protiteles ≥ mejno vrednostjo preizkusa en mesec po osnovnem cepljenju s cepivom Infanrix Penta mesecev n = 55
English: Very common: fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain, redness Common: fever >39.5°C, local swelling at the injection site (> 50 mm)*, injection site reactions,
Slovenian: Pogosti: povišana telesna temperatura (> 39 °C), lokalna oteklina na mestu injiciranja (> 50 mm)*, reakcije na mestu injiciranja, vključno z zatrdlinoObčasni: difuzna oteklina okončine v katero je bilo cepivo injicirano, ki je včasih zajela tudi sosednji sklep*
English: Very common (these may occur with more than 1 in 10 doses of the vaccine)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 odmerkov cepiva)
English: 50 x 1 dose (0.5 ml) 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
Slovenian: 50 x 1 odmerek (0,5 ml) 1 napolnjena injekcijska brizga + 1 igla 1 odmerek (0,5 ml)
English: BEFORE YOUR CHILD RECEIVES INFANRIX PENTA
Slovenian: KAJ MORATE VEDETI, PREDEN BO VAŠ OTROK PREJEL CEPIVO Infanrix Penta
English: 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Slovenian: 10 napolnjenih injekcijskih brizg + 20 igel
English: As for any vaccination, the risk-benefit of immunising with Infanrix Penta or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
Slovenian: Pri dojenčku ali otroku pri katerem se je pojavilo novo hujše nevrološko obolenje ali pa je prišlo do njegovega poslabšanja je, tako kot pri vsakem cepljenju, treba skrbno presoditi o koristih in tveganjih, povezanih s cepljenjem ali z odložitvijo cepljenja s cepivom Infanrix Penta.
English: 0.5 milligrams Al3+ 0.2 milligrams Al3+
Slovenian: 0,5 miligramov Al3+ 0,2 miligramov Al3+
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Slovenian: Znaki preobčutljivostne reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in zatekanje
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 odmerkov cepiva)
English: However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 months schedule.
Slovenian: Vendar pa podatki kažejo tudi, da pri cepljenju po shemi (3-5-12 mesec) zaščita proti oslovskemu kašlju v starosti od 7 do 8 let lahko oslabi, kar kaže, da je pri otrocih, ki so bili cepljeni po tej shemi, v starosti od 5 do 7 let upravičeno cepljenje še z drugim obnovitvenim odmerkom cepiva.
English: Check with your doctor or pharmacist before your child is given this vaccine if:
Slovenian: Preden bo vaš otrok cepljen s tem cepivom, se posvetujte z zdravnikom ali s farmacevtom, če:
English: 25, 25, 8 micrograms 10 micrograms 40, 8, 32 DU
Slovenian: 10 mikrogramov 40, 8, 32 D-antigenskih enot
English: 0.2 milligrams Al3+
Slovenian: 0,2 miligramov Al3+
English: Booster vaccination during the second year of life following a three dose primary course N = 350
Slovenian: Odstotek preiskovancev, ki so imeli titre protiteles ≥ mejno vrednostjo preizkusa en mesec po obnovitvenem cepljenju s cepivom Infanrix Penta Obnovitveno cepljenje v drugem letu življenja po treh odmerkih osnovnega cepljenja n = 350
English: Infanrix Penta, Suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Slovenian: Infanrix Penta, suspenzija za injiciranje Adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju (brezcelično, pripravljeno iz antigenskih sestavin) (Pa), hepatitisu B (rekombinantno) (HBV) in otroški ohromelosti (inaktivirano) (IPV)