FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 50 PRE-FILLED SYRINGES WITHOUT NEEDLES
Slovenian: PODATKI NA ZUNANJI OVOJNINI 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ IGLE 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 1 IGLO 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 10 IGLAMI 50 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL
English: AMBIRIX SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVASCULARLY.
Slovenian: CEPIVO AMBIRIX SE V NOBENEM PRIMERU NE SME APLICIRATI INTRAVASKULARNO.
English: Clinical trials involved the administration of 2029 doses of Ambirix to 1027 subjects from 1 year up to and including 15 years of age.
Slovenian: Klinična preskušanja so obsegala uporabo 2029 odmerkov cepiva Ambirix pri 1027 otrocih, starih od 1 leta do vključno 15 let.
English: What Ambirix is and what it is used for
Slovenian: Kaj je cepivo Ambirix in za kaj ga uporabljamo
English: • Ambirix is a white, slightly milky liquid presented in a glass 1 ml pre-filled syringe.
Slovenian: • Cepivo Ambirix je bela, rahlo mlečna tekočina v stekleni 1ml napolnjeni injekcijski brizgi.
English: • fainting • loss of skin sensitivity to pain or touch (hypoaesthesia)
Slovenian: • izguba občutljivosti kože za bolečino ali dotik (hipestezija).
English: Multiple sclerosis, encephalitis, encephalopathy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), myelitis, convulsions, paralysis, facial palsy, neuritis, optic neuritis, neuropathy
Slovenian: Multipla skleroza, encefalitis, encefalopatija,polinevritis, npr. Guillain-Barréjev sindrom (z ascendentno paralizo), mielitis, konvulzije, paraliza, paraliza obraza, nevritis, optični nevritis,
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator
Slovenian: Shranjujte v hladilniku
English: Psychiatric disorders Very common: irritability
Slovenian: Psihiatrične motnje Zelo pogosti: razdražljivost.
English: • disease mainly affecting the joints with pain and swelling (arthritis), muscular weakness
Slovenian: • bolezen, ki prizadene predvsem sklepe in povzroči bolečine in oteklost (artritis), mišična šibkost,
English: Ambirix has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo Ambirix nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: This difference is no longer present after the second dose of Ambirix (see section 5.1 for seroprotection rates).
Slovenian: Po prejemu drugega odmerka cepiva Ambirix pa ta razlika ni več prisotna (za odstotke serozaščite glejte poglavje 5.1).
English: • swelling of the face, mouth and throat (angioneurotic oedema)
Slovenian: • oteklost obraza, ust in žrela (angionevrotični edem),
English: What Ambirix is and what it is used for What you need to know before you receive Ambirix How Ambirix is given
Slovenian: Kaj je cepivo Ambirix in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Ambirix Kako uporabljati cepivo Ambirix
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of your face or tongue
Slovenian: Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in oteklino obraza ali jezika;
English: Adverse reactions reported are listed according to the following frequency: Very common:
Slovenian: Opisani neželeni učinki so navedeni z naslednjo pogostnostjo:
English: The virus is found in body fluids such as faeces, serum or saliva.
Slovenian: Virus se nahaja v telesnih tekočinah, kot so blato, serum ali slina.
English: It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Slovenian: Pri bolnikih, ki se zdravijo z zdravili za zaviranje imunske odzivnosti, ali bolnikih z imunsko pomanjkljivostjo se lahko pričakuje, da ne bo dosežen zadosten imunski odziv.
English: • Ambirix is available in packs of 1 and 10 pre-filled syringes (with or without needles) and in pack sizes of 50 pre-filled syringes without needles.
Slovenian: • Cepivo Ambirix je na voljo v pakiranjih po 1 in 10 napolnjenih injekcijskih brizg (z injekcijskimi iglami ali brez njih) ter v pakiranju po 50 napolnjenih injekcijskih brizg brez injekcijskih igel.
English: Ambirix contains neomycin and sodium
Slovenian: Cepivo Ambirix vsebuje neomicin in natrij
English: Concomitant administration of Ambirix and other vaccines than those listed above has not been studied.
Slovenian: Sočasno dajanje cepiva Ambirix in drugih cepiv, razen zgoraj navedenih, ni bilo raziskano.
English: The vaccine can be given after you have recovered.
Slovenian: Cepili se boste lahko, ko boste ozdraveli.
English: Ambirix can be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.
Slovenian: Cepivo Ambirix se sme med nosečnostjo uporabiti le, če je nujno potrebno in če možne koristi odtehtajo možna tveganja za plod.
English: They may be very tired, and have dark urine, pale faeces, yellowish skin or eyes (jaundice).
Slovenian: Ti ljudje so lahko zelo utrujeni, imajo temen urin, svetlo blato, rumenkasto kožo ali oči (zlatenica).
English: It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Slovenian: Potreba po obnovitvenih odmerkih pri imunokompetentnih osebah, ki so se odzvale na cepljenje proti hepatitisu A, še ni popolnoma dokazana, ker je lahko zaščita v odsotnosti dokazljivih protiteles zagotovljena z imunskim spominom.
English: • This vaccine has been prescribed for you/your child only.
Slovenian: • Cepivo je bilo predpisano vam/vašemu otroku in ga ne smete dajati drugim.
English: • Ambirix helps the body to produce its own protection (antibodies) against these diseases.
Slovenian: Kako deluje cepivo Ambirix • Cepivo Ambirix telesu pomaga, da proizvede lastno zaščito (protitelesa) proti tema boleznima.
English: Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: V primeru, da opazite katerega koli od spodaj naštetih resnih neželenih učinkov, se nemudoma posvetujte z zdravnikom - lahko da boste potrebovali nujno medicinsko pomoč:
English: • purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
Slovenian: • vijoličaste ali rdeče vijoličaste bunčice na koži (lichen planus), resna oblika izpuščaja na koži (multiformni eritem),
English: The vaccine has not been tested in patients with an impaired immune system.
Slovenian: Pri bolnikih z oslabljenim imunskim sistemom cepivo ni bilo preizkušeno.
English: Read all of this leaflet carefully before you/your child starts receiving this vaccine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Read the package leaflet before use Intramuscular use Shake well before use
Slovenian: Intramuskularna uporaba Pred uporabo dobro pretresite
English: For some categories of subjects at risk of exposure to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure that a protective antibody level ≥ 10 mIU/ml is maintained.
Slovenian: Pri nekaterih skupinah oseb s tveganjem za okužbo s HBV (npr. bolniki na hemodializi ali bolniki z oslabljenim imunskim sistemom) je, da bi se zaščitni titer protiteles ≥ 10 i.e./l ohranil, treba upoštevati previdnostne ukrepe.
English: 6.4 Special precautions for storage Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: - It is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.
Slovenian: - Ambirix je priporočljivo dajati v okoliščinah, ki zagotavljajo dokončanje cepljenja z dvema odmerkoma.
English: Very rare: urticaria
Slovenian: Zelo redki: urtikarija.
English: The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.
Slovenian: Pričeto osnovno cepljenje je treba dokončati z istim cepivom.
English: Non-clinical data reveal no special hazard for humans based on general safety studies.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih študij varnosti ne kažejo posebnega tveganja za človeka.
English: Ambirix may need to be given at the same time as other vaccines for measles, mumps, rubella, diphtheria, tetanus, whooping cough (pertussis), poliomyelitis, Haemophilus influenzae type b or some types of treatments for hepatitis infections called “immunoglobulins”.
Slovenian: Cepivo Ambirix bo morda potrebno dati hkrati z drugimi cepivi proti ošpicam, mumpsu, rdečkam, davici, tetanusu, oslovskemu kašlju (pertusis), otroški paralizi, Haemophilusu influenzae tipa b ali nekaterim tipom zdravil za zdravljenje okužb s hepatitisom, imenovanih »imunoglobulini«.
English: The following adverse reactions were reported during post-marketing surveillance following vaccination with Ambirix.
Slovenian: Naslednje neželene učinke so zabeležili med postmarketinškim spremljanjem po cepljenju s cepivom
English: The most commonly reported adverse reactions following Ambirix administration are pain and fatigue occurring in an approximated per dose frequency of 50% and 30% respectively.
Slovenian: Najbolj pogosta neželena učinka, o katerih so poročali po uporabi cepiva Ambirix, sta bolečina in utrujenost, ki se pojavita s približno pogostnostjo na odmerek v 50 % prvi oziroma 30 % drugi neželeni učinek.
English: • Hepatitis B: Infection with the hepatitis B virus may cause the liver to become swollen (inflamed).
Slovenian: • Hepatitis B: Okužba z virusom hepatitisa B lahko povzroči oteklino jeter (vnetje).
English: • a degenerative disease of the brain (encephalopathy)
Slovenian: • degenerativna možganska bolezen (encefalopatija),
English: In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given.
Slovenian: V okoliščinah, ko je zaželen obnovitveni odmerek cepiva proti hepatitisu A in/ali hepatitisu B, se lahko cepi z monovalentnim ali s kombiniranim cepivom.
English: In 2 comparative trials in subjects aged 1-15 years, the incidences of local and general solicited symptoms after a two dose regimen of Ambirix was overall similar to that seen with the three dose combined vaccine containing 360 ELISA Units of HAV and 10 µg of HBsAg.
Slovenian: V 2 primerjalnih preskušanjih pri otrocih, starih od 1 do 15 let, so bile incidence lokalnih in splošnih nespontano evidentiranih simptomov po shemi z dvema odmerkoma cepiva Ambirix v celoti podobne kot po uporabi treh odmerkov kombiniranega cepiva, ki je vsebovalo 360 ELISA-enot HAV in 10 µg HBsAg.
English: - Hepatitis A virus (inactivated) 1,2
Slovenian: -Virus hepatitisa A (inaktivirani)1,2
English: Rare: arthralgia
Slovenian: Redki: artralgija.
English: • paralysis, drooping eyelid and sagging muscles on one side of the face (facial palsy)
Slovenian: • paraliza, spuščena veka in mlahave mišice na eni strani obraza (paraliza obraza),
English: However, it is sometimes caught in other ways, such as by swimming in water that has sewage in it or from another infected person.
Slovenian: Do okužbe običajno pride s hrano ali pijačo, ki vsebuje virus, lahko pa se prenaša tudi na druge načine, na primer s plavanjem v vodi, ki je onesnažena s fekalijami ali preko okužene osebe.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Slovenian: Sprejeta je utemeljitev, da Braillova pisava ni potrebna
English: • If you have any further questions, ask your doctor, nurse or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Smith Kline & French Portuguesa - Produtos Farmacêuticos, Lda.
Slovenian: Portugal Smith Kline & French Portuguesa - Produtos
English: Immune system disorders Allergic reactions including mimicking serum sickness, angioneurotic oedema
Slovenian: Alergijske reakcije, vključno s takšnimi, ki so podobne serumski bolezni, angionevrotični edem.
English: Ambirix should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Slovenian: Cepivo Ambirix se sme med obdobjem dojenja uporabiti le, če možne koristi odtehtajo možna tveganja.
English: 1 dose (1 ml)
Slovenian: 1 odmerek (1 ml)
English: In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
Slovenian: Pri bolnikih na hemodializi in osebah z oslabljenim imunskim sistemom je možno, da po zaključku osnovnega cepljenja niso doseženi primerni titri protiteles anti-HAV in anti-HBs.
English: The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects aged 1-11 years or 12-15 years at the time of the first dose were 77.3% and 85.9%, respectively.
Slovenian: Delež protiteles anti-HBs ≥10 mi.e./ml je bil pri osebah, starih ob prvem cepljenju od 1 do 11 let ali 12 do 15 let, ob tem času 77,3 % pri prvih in 85,9 % pri drugih.
English: • generally feeling unwell
Slovenian: • splošno slabo počutje,
English: EXPIRY DATE EXP: MM/YYYY
Slovenian: EXP: MM/LLLL
English: What Ambirix looks like and contents of the pack
Slovenian: Izgled cepiva Ambirix in vsebina pakiranja
English: Adverse reactions reported following overdosage were similar to those reported with normal vaccine administration.
Slovenian: opisani po prevelikem odmerjanju, so bili podobni kot po normalni uporabi cepiva.
English: The safety and immunogenicity of Ambirix administered as a booster dose following a two dose primary course have not been evaluated.
Slovenian: Varnost in imunogenost obnovitvenega odmerka cepiva Ambirix, danega po že prejetih dveh odmerkih v času osnovnega cepljenja, nista bili ovrednoteni.
English: - Hepatitis B surface antigen 3,4
Slovenian: -Površinski antigen virusa hepatitisa B3,4
English: They are called hepatitis B “carriers” and can still infect other people throughout their lives.
Slovenian: Imenujejo se klicenosci virusa hepatitisa B in lahko ves čas življenja prenašajo virus hepatitisa B na druge.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reactions following the administration of the vaccine.
Slovenian: Tako kot pri vseh cepivih za injiciranje je zaradi možnih redkih primerov anafilaktične reakcije po aplikaciji treba vedno razpolagati s takojšnjim ustreznim zdravljenjem in nadzorom.
English: However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins there was no effect on seroconversion rates.
Slovenian: Kljub temu pa sočasno dajanje monovalentnih cepiv proti hepatitisu A in hepatitisu B ter specifičnih imunoglobulinov ni vplivalo na odstotek serokonverzije.
English: The holder of marketing authorisation will continue to submit annual PSURs.
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Imetnik dovoljenja za promet z zdravilom bo periodična poročila o varnosti zdravila (PSUR) še naprej predajal letno.
English: Ambirix confers immunity against HAV and HBV infection by inducing specific anti-HAV and antiHBs antibodies.
Slovenian: Mehanizem delovanja Ambirix zagotavlja imunost proti okužbi s HAV in HBV tako, da inducira tvorbo specifičnih anti
English: In both studies, subjects received either a two dose schedule of Ambirix or a three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
Slovenian: V obeh študijah so osebe prejele bodisi cepivo Ambirix po shemi dveh odmerkov bodisi tri odmerke kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
English: In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i.e month 7).
Slovenian: V kliničnih študijah, v katere so bile vključene osebe, stare od 1 do vključno 15 let, je bil en mesec po prejemu prvega odmerka odstotek seropozitivnosti za protitelesa anti-HAV 99,1 %, po prejemu drugega odmerka čez 6 mesecev (npr. 7. mesec) pa 100 %.
English: • inflammation of the nerves (neuritis)
Slovenian: • vnetje živcev (nevritis),
English: • disease of the nerves of the eyes (optic neuritis)
Slovenian: • bolezen vidnega živca (optični nevritis),
English: • swelling or infection of the brain (encephalitis)
Slovenian: • otekanje ali okužba možganov (encefalitis),
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 okužb z drugimi povzročitelji, kot sta virus hepatitisa C in virus hepatitisa E,
English: • immediate injection site pain, stinging and burning feeling
Slovenian: • takojšnja bolečina na mestu vboda, občutek zbadanja in pekoč občutek,
English: If you are taking medicines that affect your body's immune response, you can still have Ambirix if this is thought to be necessary.
Slovenian: Če jemljete zdravila, ki vplivajo na imunski odziv, lahko kljub temu prejmete cepivo Ambirix, če se zdi to potrebno, vendar cepivo morda ne bo delovalo popolnoma.
English: Following widespread use of either GlaxoSmithKline's combined hepatitis A and hepatitis B vaccines or the monovalent hepatitis A and/or hepatitis B vaccines, the following adverse reactions have additionally been reported.
Slovenian: Po široki uporabi kombiniranih cepiv družbe GlaxoSmithKline proti hepatitisu A in hepatitisu B ali njenih monovalentnih cepiv proti hepatitisu A in/ali hepatitisu B so bili dodatno opisani naslednji neželeni učinki.
English: • Hepatitis A: Infection with the hepatitis A virus may cause the liver to become swollen (inflamed).
Slovenian: • Hepatitis A: Okužba z virusom hepatitisa A lahko povzroči oteklino jeter (vnetje).
English: Blood and lymphatic system disorders Thrombocytopenic purpura, thrombocytopenia
Slovenian: Bolezni krvi in limfatičnega sistema Trombocitopenična purpura, trombocitopenija.
English: Infections and infestations Meningitis
Slovenian: Infekcijske in parazitske bolezni Meningitis.
English: A dose of 1.0 ml is recommended for subjects from 1 year up to and including 15 years of age.
Slovenian: Priporočen odmerek za od 1 do vključno 15 let stare osebe je 1,0 ml.
English: Concomitant vaccines should always be administered at separate injection sites and preferably into different limbs.
Slovenian: V primeru sočasnega dajanja je cepiva potrebno vedno aplicirati na ločena mesta, najboljše v drugo okončino.
English: After a few days they may be very tired, and have dark urine, pale faeces, yellowish skin or eyes (jaundice).
Slovenian: Po nekaj dneh so lahko zelo utrujeni, imajo temen urin, svetlo blato,
English: LIST OF EXCIPIENTS Sodium chloride Water for injections
Slovenian: natrijev klorid voda za injiciranje
English: Talk to your doctor, nurse or pharmacist before having Ambirix if:
Slovenian: Posvetujte se z zdravnikom, medicinsko sestro ali farmacevtom, preden se cepite s cepivom Ambirix,
English: In subjects aged 12-15 years at primary vaccination the anti-HAV and anti-HBs antibody concentrations were comparable between groups that had received Ambirix or a 3-dose regimen of the combined vaccine (content as described above).
Slovenian: Koncentracije protiteles anti-HAV in anti-HBs so bile pri osebah, starih ob prvem cepljenju od 12-15 let, primerljive s skupino, ki je prejela cepivo Ambirix, in skupino, ki je prejela 3 odmerke kombiniranega cepiva (vsebnost je opisana zgoraj).
English: Nervous system disorders Syncope or vasovagal responses to injection, localised hypoaesthesia
Slovenian: Sinkopa ali vazovagalni odziv na injekcijo, omejena hipestezija.
English: If you are not sure, talk to your doctor, nurse or pharmacist before having Ambirix.
Slovenian: Če niste prepričani, se pogovorite z zdravnikom, medicinsko sestro ali farmacevtom, preden se cepite s cepivom Ambirix.
English: Pack sizes of 1 and 10 pre-filled syringes with or without needles and pack size of 50 pre-filled syringes without needles.
Slovenian: Velikost pakiranja: po 1 in 10 napolnjenih injekcijskih brizg z injekcijskimi iglami ali brez njih ter po 50 napolnjenih injekcijskih brizg brez injekcijskih igel.
English: It is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit).
Slovenian: Virus se nahaja v telesnih tekočinah, kot so kri, sperma, nožnični izločki ali slina (izpljunki).
English: If any of the above apply (or you are not sure), talk to your doctor, nurse or pharmacist before having Ambirix.
Slovenian: Če za vas velja karkoli od zgoraj naštetega (oziroma ste negotovi), se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom pred cepljenjem s cepivom Ambirix.
English: This leaflet was last revised in {month YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
English: 1-5 yrs old
Slovenian: 1-5 let
English: Carriers are also at risk of serious liver problems, such as scarring (cirrhosis) or liver cancer.
Slovenian: Pri klicenoscih virusa hepatitisa B obstaja tveganje za resne težave z jetri, kot sta brazgotinjenje jeter (ciroza) in rak jeter.
English: When the first dose of Ambirix was administered concomitantly with a booster dose of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with the first dose of a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory.
Slovenian: Če se je prvi odmerek cepiva Ambirix dal sočasno z obnovitvenim odmerkom mešanega cepiva proti davici, tetanusu, oslovskemu kašlju - acelularno, otroški ohromelosti - inaktivirano in Haemophilusu influenzae tipa b (DTPa-IPV+Hib) ali s prvim odmerkom mešanega cepiva proti ošpicam, mumpsu in rdečkam v drugem letu življenja, so bili imunski odzivi na vse antigene zadovoljivi.
English: • inflammation of some blood vessels (vasculitis)
Slovenian: • vnetje nekaterih žil (vaskulitis),
English: • flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
Slovenian: • gripi podobni simptomi, npr. zvišana telesna temperatura, vnetje žrela, izcedek iz nosu,
English: What you need to know before you receive Ambirix
Slovenian: Kaj morate vedeti, preden boste prejeli cepivo Ambirix Cepiva Ambirix ne smete prejeti:
English: Seropositivity rates for anti-HBs antibodies were 74.2% one month after the first dose and 100% after the second dose given at month 6 (i.e. month 7).
Slovenian: En mesec po prejemu prvega odmerka je bil odstotek seropozitivnosti za protitelesa anti-HBs 74,2 %, po prejemu drugega odmerka čez 6 mesecev (npr. 7. mesec) pa 100 %.
English: • reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia),
Slovenian: • zmanjšanje števila krvnih ploščic, ki poveča tveganje za krvavitve ali podplutbe (trombocitopenija), vijoličaste ali rdečerjave pike, vidne skozi kožo (trombocitopenična purpura).
English: At 6 years following the initiation of a 0, 6 month or a 0, 12 month schedule of Ambirix in children aged 12-15 years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody.
Slovenian: 6 let po cepljenju otrok, starih od 12 do 15 let, s cepivom Ambirix po shemi 0., 6. mesec ali 0., 12. mesec so vse osebe ohranile ≥15 mi.e./ml protiteles anti-HAV.