FrancophonIA/ELRC3.0 huggingface dataset:
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Slovenian: Blažja okužba, na primer prehlad, ne predstavlja ovire, toda pred cepljenjem se o tem kljub temu pogovorite s svojim zdravnikom.
English: Pharmaco-therapeutic group: Hepatitis vaccines, ATC code: J07BC20.
Slovenian: Farmakoterapevtska skupina: Cepiva proti hepatitisu, oznaka ATC: J07BC20
English: However, if you get any of these symptoms you should contact a doctor urgently.
Slovenian: Če se vam pojavijo kateri koli od teh simptomov, morate nujno poklicati zdravnika.
English: • Infection around the brain which may give severe headache with stiff neck and sensitivity to light (meningitis)
Slovenian: • okužba okrog možganov, ki lahko povzroči hud glavobol z otrdelim vratom in občutljivostjo na svetlobo (meningitis),
English: After a fourth dose given at month 12, the incidence of systemic and local adverse reactions was comparable to that seen after vaccination at 0, 7, 21 days.
Slovenian: Po četrtem odmerku prejetem v 12. mesecu, je pojavnost sistemskih in lokalnih neželenih reakcij primerljiva s tisto po cepljenju na 0, 7, 21 dan.
English: • Reduction in blood platelets, which increases risk of bleeding or bruising
Slovenian: • znižanje števila krvnih ploščic (trombocitov), ki zviša tveganje za krvavitev ali pojav modric
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 25 PRE-FILLED SYRINGES WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 25 PRE-FILLED SYRINGES WITH 25 NEEDLES
Slovenian: PODATKI NA ZUNANJI OVOJNINI 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ IGLE 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 25 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 1 IGLO 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 10 IGLAMI 25 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 25 IGLAMI
English: General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines.
Slovenian: Splošne napotke za poživitvena cepljenja se zato lahko povzame iz izkušenj z monovalentnimi cepivi.
English: The kinetics of antibody decline are also similar.
Slovenian: Tudi upadanje titra protiteles je podobno.
English: The vaccine should not be given (deep) into the skin or intramuscularly into the buttock because protection may be less.
Slovenian: Cepiva se ne sme injicirati (globoko) v kožo ali intramuskularno v zadnjico, saj je pri takšnem načinu dajanja zaščita lahko manjša.
English: One month after the fourth dose, all vaccinees demonstrated seroprotective levels of anti-HBs antibodies and were seropositive for anti-HAV antibodies.
Slovenian: En mesec po četrtem odmerku so imele vse cepljene osebe zaščitni nivo anti-HBs protiteles in so bile seropozitivne na anti-HAV protitelesa.
English: This study did not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/fetal development, parturition or post-natal development.
Slovenian: Ta študija ni pokazala neposrednih ali posrednih škodljivih vplivov na plodnost, brejost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
English: The remaining 2 doses will be given 7 days and 21 days after the first dose.
Slovenian: Preostala dva odmerka boste prejeli sedem in enaindvajset dni po prvem odmerku.
English: The HA virus is propagated in MRC5 human diploid cells.
Slovenian: HA virus je namnožen na humanih diploidnih celicah MRC5.
English: The remaining two doses will be given one month, and six months after the first dose.
Slovenian: Preostala dva odmerka boste prejeli en mesec in šest mesecev po prvem odmerku.
English: Your doctor may advise you to have a blood test after you have completed the course of vaccinations to check if you have made a satisfactory response.
Slovenian: Vaš zdravnik vam lahko svetuje, da po prejemu vseh predvidenih odmerkov cepiva opravite krvne preiskave, da bi tako ugotovil, če je odziv na cepljenje zadovoljiv.
English: It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Slovenian: Pričakujemo lahko, da pri osebah, ki prejemajo imunosupresivno zdravljenje, ali bolnikih z imunsko pomanjkljivostjo morda ne bo dosežen ustrezen imunski odgovor.
English: • you have previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases.
Slovenian: • ste kdaj imeli alergijsko reakcijo na katero koli drugo cepivo proti hepatitisu A ali hepatitisu B.
English: The vaccine should be re-suspended following the steps below.
Slovenian: Cepivo je treba pretresti upoštevajoč naslednje korake:
English: Subjects received an additional dose of the same vaccine(s) 48 months after the first dose of the primary vaccination course.
Slovenian: Osebe so dobile dodaten odmerek enakega cepiva/enakih cepiv 48 mesecev po prvem odmerku primarnega cepljenja.
English: Side effects that may occur are the following:
Slovenian: Možni neželeni učinki so:
English: • Hepatitis A: Hepatitis A is an infectious disease, which can affect the liver.
Slovenian: • Hepatitis A: Hepatitis A je nalezljiva bolezen, ki prizadene jetra.
English: Long-term antibody persistence data following vaccination with Twinrix Adult are available up to 15 years after vaccination.
Slovenian: Na voljo so podatki o dolgotrajni prisotnosti protiteles po cepljenju s cepivom Twinrix za odrasle v trajanju do 15 let po cepljenju.
English: The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Slovenian: Cepivo ne bo preprečilo okužbe z drugimi povzročitelji, kot sta virus hepatitisa C in hepatitisa E, ali drugimi patogeni, ki lahko prizadenejo jetra.
English: If you miss a scheduled injection, talk to your doctor and arrange another visit.
Slovenian: Če ste izpustili odmerek ob dogovorjenem času, se pogovorite z zdravnikom in se dogovorite za naslednji obisk.
English: 6 months after the first dose
Slovenian: 12 mesecev po prvem odmerku
English: Anti-HBs antibody concentrations decreased as age and body mass index increased; they were also lower in male than in female subjects.
Slovenian: Koncentracije protiteles anti-HB so bile manjše tudi zaradi višje starosti in indeksa telesne mase, bile pa so sicer nižje pri moških kot pri ženskah.
English: Frequencies are reported as: Very common: ≥ 1/10 Common:
Slovenian: Pogostnost je navedena kot: Zelo pogosti:
English: The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Slovenian: Pred uporabo je treba cepivo vizualno pregledati glede morebitnih tujih delcev in/ali nenormalnega fizikalnega videza.
English: EU/1/96/020/001 - pack of 1 without needle EU/1/96/020/002 - pack of 10 without needle EU/1/96/020/003 - pack of 25 without needle EU/1/96/020/007 - pack of 1 with 1 needle EU/1/96/020/008 - pack of 10 with 10 needles EU/1/96/020/009 - pack of 25 with 25 needles
Slovenian: EU/1/96/020/001 - 1 napolnjena injekcijska brizga brez igle EU/1/96/020/002 - 10 napolnjenih injekcijskih brizg brez igle EU/1/96/020/003 - 25 napolnjenih injekcijskih brizg brez igle EU/1/96/020/007 - 1 napolnjena injekcijska brizga z 1 iglo EU/1/96/020/008 - 10 napolnjenih injekcijskih brizg z 10 iglami EU/1/96/020/009 - 25 napolnjenih injekcijskih brizg z 25 iglami
English: Hepatitis B surface antigen3,4
Slovenian: Površinski antigen virusa hepatitisa B3,4
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve redno posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: • Swelling of the face, mouth or throat (angioneurotic oedema)
Slovenian: • oteklina obraza, ust ali grla (angionevrotični edem),
English: The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage.
Slovenian: To bolezen povzroča virus hepatitisa A. Virus hepatitisa A se lahko z osebe na osebo prenaša s hrano in pijačo ali s plavanjem v vodi, onesnaženi s fekalijami.
English: 6.6 Special precautions for disposal and other handling Upon storage, a fine white deposit with a clear colourless layer above may be observed.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Med shranjevanjem se lahko pojavi fina bela usedlina in bister brezbarvni zgornji sloj.
English: A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with Twinrix Adult should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Adult therapy to the woman.
Slovenian: Pri odločanju o nadaljevanju/prekinitvi dojenja ali nadaljevanju/prekinitvi cepljenja s cepivom Twinrix za odrasle je treba upoštevati tako korist dojenja za otroka kot korist cepljenja s cepivom Twinrix za odrasle za mater.
English: The seroprotection rate against hepatitis B increased to 95.1% by three months after the first dose.
Slovenian: Stopnja zaščite proti hepatitisu B je porasla na 95,1 % v treh mesecih po prvem odmerku.
English: Twinrix Adult is available in packs of 1, 10, and 25 with or without needles.
Slovenian: Cepivo Twinrix za odrasle je na voljo v pakiranjih po 1, 10 in 25 z iglami ali brez njih.
English: Twinrix Adult is a vaccine used in adults and adolescents 16 years of age and above to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Slovenian: Twinrix za odrasle je cepivo, ki se uporablja pri odraslih in mladostnikih, starih 16 let in več, za preprečevanje dveh bolezni: hepatitisa A in hepatitisa B. Cepivo deluje tako, da spodbudi telo k proizvajanju lastne zaščite (protiteles) proti tema boleznima.
English: Specific humoral antibodies against hepatitis B were observed in 70% of the adults after the first dose and approximately 99% after the third dose.
Slovenian: Specifična humoralna protitelesa proti hepatitisu B so ugotovili pri 70 % odraslih po prvem odmerku in pri približno 99 % po tretjem odmerku.
English: While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection.
Slovenian: Škodljivega vpliva rekombinantnega površinskega antigena virusa hepatitisa B na nosečnost ali plod sicer ne pričakujemo, vendar kljub temu priporočamo, da se cepljenje odloži na čas po porodu, če matere ni treba nujno zaščititi pred okužbo z virusom hepatitisa B.
English: Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions
Slovenian: Bolezni živčevja encefalitis, encefalopatija, nevritis, nevropatija, paraliza, konvulzije
English: Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Adult on pregnancy or on the health of the fetus/newborn child.
Slovenian: Podatki o izidih nosečnosti, pridobljeni pri manjšem številu cepljenih nosečnic, ne kažejo na možnost škodljivih vplivov cepiva Twinrix za odrasle na nosečnost ali zdravje plodu/novorojenca.
English: Upon storage, a fine white deposit with a clear colourless layer above may be observed.
Slovenian: Med shranjevanjem se lahko pojavi fina bela usedlina in bister brezbarvni zgornji sloj.
English: • Degenerative disease of the brain (encephalopathy)
Slovenian: • degenerativna bolezen možganov (encefalopatija),
English: • Inflammation of some blood vessels (vasculitis)
Slovenian: • okužba nekaterih krvnih žil (vaskulitis),
English: The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.
Slovenian: Kinetika upadanja nivoja anti-HAV in anti-HBs protiteles je bila podobna kot pri monovalentnih cepivih.
English: In exceptional circumstances in adults, when travel is anticipated within one month or more after initiating the vaccination course, but where insufficient time is available to allow the standard 0, 1, 6 month schedule to be completed, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used.
Slovenian: V izjemnih okoliščinah, kadar je potovanje predvideno en mesec ali več po prvem odmerku cepiva in ni na voljo dovolj časa za standardno (0, 1, 6) shemo cepljenja, lahko pri odraslih uporabimo shemo treh zaporednih intramuskularnih injekcij, apliciranih na 0., 7. in 21. dan.
English: The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established; however some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
Slovenian: Pri zdravih osebah, ki so prejele celotno osnovno shemo cepljenja, ni potrebno poživitveno cepljenje s cepivom proti hepatitisu B. Kljub temu nekateri uradni programi cepljenja vsebujejo priporočilo za poživitveno cepljenje s cepivom proti hepatitisu B in ta priporočila je potrebno upoštevati.
English: For some categories of subjects or patients exposed to HBV (e.g; haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥ 10IU/l.
Slovenian: Pri nekaterih kategorijah oseb ali bolnikov, izpostavljenih HBV (npr. bolniki na hemodializi ali imunsko pomanjkljive osebe), je zaradi zagotovitve zaščitnega nivoja protiteles ≥ 10 i.e./l potrebna posebna previdnost.
English: • Loss of skin sensitivity to pain or touch (hypoaesthesia)
Slovenian: • zmanjšana občutljivost za bolečino ali dotik (hipestezija),
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Slovenian: Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, težave z dihanjem (zasoplost) in zatekanje obraza ali jezika.
English: What Twinrix Adult is and what it is used for What you need to know before you receive Twinrix Adult How Twinrix Adult is given
Slovenian: Kaj je cepivo Twinrix za odrasle in za kaj ga uporabljamo Kaj morate vedeti, preden boste cepljeni s cepivom Twinrix za odrasle Kako uporabljati cepivo Twinrix za odrasle
English: • you are allergic to: - the active substances or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - zdravilne učinkovine ali katero koli sestavino tega cepiva (navedeno v poglavju 6).
English: When this schedule is applied, a fourth dose is recommended 12 months after the first dose.
Slovenian: Kadar je uporabljena ta shema cepljenja, je priporočljivo dati še 4. odmerek cepiva 12 mesecev po aplikaciji prvega odmerka.
English: The severity and type of symptoms can vary.
Slovenian: Jakost in vrsta simptomov se od bolnika do bolnika lahko razlikujeta.
English: In the two clinical trials in which Twinrix Adult was administered at 0, 7, 21 days, overall solicited general and local symptoms were reported with the same categories of frequency as defined below.
Slovenian: V dveh kliničnih študijah, kjer so osebe prejele Twinrix za odrasle po pospešeni shemi (0, 7, 21 dan), so poročali o splošnih in lokalnih učinkih z isto kategorijo pogostnosti, kot je tu prikazano.
English: What Twinrix Adult is and what it is used for
Slovenian: Kaj je cepivo Twinrix za odrasle in za kaj ga uporabljamo
English: The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Slovenian: Virus hepatitisa B je prisoten v telesnih tekočinah, kot so kri, sperma, vaginalni izločki ali slina (izpljunek) okuženih ljudi.
English: Although the concomitant administration of Twinrix Adult and other vaccines has not specifically been studied, it is anticipated that, if different syringes and other injection sites are used, no interaction will be observed.
Slovenian: Čeprav hkratnega dajanja cepiva Twinrix za odrasle in drugih cepiv niso posebej preučevali, ob uporabi različnih injekcijskih brizg in pri injiciranju na različna mesta interakcija ni predvidena.
English: • you have a bleeding problem or bruise easily.
Slovenian: • imate težave s krvavitvami ali hitrim nastankom modric.
English: • Generally feeling unwell
Slovenian: • splošno slabo počutje.
English: In the event of either being observed, do not administer the vaccine.
Slovenian: Če opazite kar koli od navedenega, cepiva ne smete uporabiti.
English: HBsAg is produced by culture, in a selective medium, of genetically engineered yeast cells.
Slovenian: HBsAg je pridobljen z gensko tehnologijo na kulturi celic kvasovk v selektivnem mediju.
English: The doctor will give Twinrix Adult as an injection into your upper arm muscle.
Slovenian: Zdravnik vam bo dal cepivo Twinrix za odrasle v obliki injekcije v mišico nadlakti.
English: 1 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Slovenian: 1 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (butilna guma).
English: In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.
Slovenian: Pri bolnikih na hemodializi in osebah s slabšim imunskim odzivom po osnovnem cepljenju morda ne bo dosežen ustrezen titer protiteles antiHAV in anti-HBs, zato bodo tovrstni bolniki morda potrebovali dodatne odmerke cepiva.
English: • Purple or red brown spots visible through the skin (thrombocytopenic purpura)
Slovenian: • rdeče ali rdečerjave lise, ki se vidijo skozi kožo (trombocitopenična purpura),
English: In two long term clinical studies conducted in adults aged 17 years to 43 years, 56 subjects had evaluable tests 15 years after the primary vaccination with Twinrix Adult; the anti-HAV seropositivity rates were 100% in both studies and the anti-HBs seroprotection rates were 89.3% and 92.9%, respectively.
Slovenian: V dveh dolgotrajnih kliničnih raziskavah izvedenih pri odraslih osebah, starih od 17 do 43 let, so pri 56 osebah 15 let po primarnem cepljenju s cepivom Twinrix za odrasle s testi določili, da je bila antiHAV seropozitivnost 100% v obeh raziskavah, stopnji anti-HBs serološke zaščite pa sta bili 89,3% oziroma 92,9% glede na vsako reziskavo.
English: Hepatitis A virus (inactivated)1,2
Slovenian: Virus hepatitisa A (inaktivirani)1,2
English: In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 94% of the adults one month after the first dose and in 100% one month after the third dose (i.e. month 7).
Slovenian: V kliničnih študijah so specifična humoralna protitelesa proti hepatitisu A ugotovili pri približno 94 % odraslih oseb en mesec po aplikaciji prvega odmerka cepiva in pri 100 % oseb en mesec po aplikaciji tretjega odmerka (to je mesec 7).
English: 0.4 milligrams Al
Slovenian: 0,4 miligrama Al
English: • Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills
Slovenian: • gripi podobna bolezen, kot so visoka telesna temperatura, vneto grlo, smrkavost, kašelj in mrzlica.
English: • Inflammation of nerves (neuritis)
Slovenian: • vnetje živcev (nevritis),
English: Inspect the vaccine again: a. If the vaccine appears as a uniform hazy white suspension, it is ready to use - the appearance should not be clear.
Slovenian: a. če je cepivo enotna, motno bela suspenzija, je pripravljeno za uporabo - videz ne sme biti bister;
English: 0.05 milligrams Al3+
Slovenian: 0,05 miligrama Al3+
English: LIST OF EXCIPIENTS Sodium chloride Water for injections
Slovenian: SEZNAM POMOŽNIH SNOVI natrijev klorid voda za injekcije
English: Twinrix Adult is for intramuscular injection, preferably in the deltoid region.
Slovenian: Twinrix za odrasle se injicira intramuskularno, najbolje v deltoidni predel.
English: The standard primary course of vaccination with Twinrix Adult consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose.
Slovenian: Standardno osnovno cepljenje s cepivom Twinrix za odrasle sestoji iz treh odmerkov: prvi odmerek apliciramo na izbrani dan cepljenja, drugi odmerek sledi 1 mesec po prvem cepljenju in tretji odmerek 6 mesecev po prvem cepljenju.
English: (thrombocytopenia)
Slovenian: (trombocitopenija),
English: The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats.
Slovenian: Vpliv cepiva Twinrix za odrasle na embriofetalno, perinatalno in postnatalno preživetje ter razvoj so ovrednotili pri podganah.
English: Twinrix Adult has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Twinrix za odrasle nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: It is not known if Twinrix Adult passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.
Slovenian: Ni znano, če cepivo Twinrix za odrasle prehaja v materino mleko, vendar pa težav pri dojenih otrocih ne pričakujemo.
English: Seropositivity rates for anti-HAV antibodies were 100%, 99.5% and 100% at months 1, 2 and 3 after the initial dose.
Slovenian: Stopnja seropozitivnosti za anti-HAV protitelesa je bila 100 % en mesec, 99,5 % dva meseca in 100 % tri mesece po prvem odmerku.
English: • Hepatitis B: Hepatitis B is caused by the hepatitis B virus.
Slovenian: • Hepatitis B: Hepatitis B povzroča virus hepatitisa B. Jetra otečejo (vnetje).
English: However, exceptionally Twinrix Adult can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects (see section 4.2).
Slovenian: Izjemoma se Twinrix za odrasle lahko daje subkutano in sicer bolnikom s trombocitopenijo in bolnikom z motnjami strjevanja krvi, ker lahko pri njih po intramuskularnem injiciranju nastopi krvavitev (glejte poglavje 4.2).
English: 0.4 milligrams Al3+
Slovenian: 0,4 miligrama Al3+
English: 1 dose (1 ml)
Slovenian: (1 ml).
English: Other medicines and Twinrix Adult
Slovenian: Druga zdravila in cepivo Twinrix za odrasle
English: The seropositivity rate for anti-HAV antibodies after Twinrix Adult was 97% at both 7 and 48 months versus 99% and 93% after the GlaxoSmithKline Biologicals monovalent hepatitis A vaccine and 99% and 97% after another licensed monovalent hepatitis A vaccine.
Slovenian: Stopnja seropozitivnosti za protitelesa anti-HAV po dajanju cepiva Twinrix za odrasle je bila 97 % po 7 in po 48 mesecih, v primerjavi z 99 in 93 % po dajanju monovalentnega cepiva proti hepatitisu A izdelovalca GlaxoSmithKline Biologicals ter 99 in 97 % po dajanju nekega drugega monovalentnega cepiva proti hepitatisu A z dovoljenjem za promet.
English: Name and address of the manufacturer of the biological active substances
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine (učinkovin)
English: Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the paediatric formulation
Slovenian: Preiskave nenormalne vrednosti preiskav jetrne funkcije *se nanaša na splošne reakcije, ki se lahko pojavijo v kliničnih preskusih z cepivom za otroke