FrancophonIA/ELRC3.0 huggingface dataset:
English: In comparative studies, it was noted that the frequency of solicited adverse events following the administration of Twinrix Adult is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines.
Slovenian: V raziskavi, ki je primerjala pogostnost neželenih dogodkov po aplikaciji cepiva Twinrix za odrasle in po aplikaciji monovalentnih cepiv, so opazili, da se pogostnosti neželenih dogodkov, po katerih so bile cepljene osebe vprašane, med seboj ne razlikujejo.
English: • Low blood pressure
Slovenian: • izguba apetita, • nizek krvni tlak,
English: Twinrix Adult is not recommended for postexposure prophylaxis (e.g. needle stick injury).
Slovenian: Twinrix za odrasle ni priporočljiv za zaščito po predhodni izpostavljenosti (npr. po vbodu z iglo).
English: • Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
Slovenian: • hude alergijske reakcije (anafilaksija, anafilaktoidna reakcija in serumski bolezni podobna reakcija).
English: • Drooping eyelid and sagging muscles on one side of the face (facial palsy)
Slovenian: • povešena veka in mlahave mišice na eni strani obraza (paraliza obraza),
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Slovenian: 1Pridobljen na humanih diploidnih celicah (MRC-5) 2Adsorbiran na hidratirani aluminijev hidroksid
English: In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Adult can be given.
Slovenian: V okoliščinah, ko je zaželen poživitveni odmerek proti hepatitisu A in tudi proti hepatitisu B, se lahko uporabi cepivo Twinrix za odrasle.
English: Contents of the pack and other information What Twinrix Adult contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Twinrix za odrasle
English: A dose of 1.0 ml is recommended for adults and adolescents 16 years of age and above.
Slovenian: Za odrasle in mladostnike, stare 16 let in več, je priporočljiv odmerek 1,0 ml.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe 1 pre-filled syringe
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (1 ml)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intramuscular use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
English: EXPIRY DATE EXP: MM/YYYY
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: MM/LLLL
English: It is unknown whether Twinrix Adult is excreted in human breast milk.
Slovenian: Ni znano, če se cepivo Twinrix za odrasle izloča v materino mleko.
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: Še vedno ni popolnoma dognano, če imunsko kompetentne osebe, ki so se odzvale na cepljenje s cepivom proti hepatitisu A, potrebujejo poživitveni odmerek, saj kljub temu, da se protiteles ne zazna,
English: Influenza like illness, chills
Slovenian: redki gripi podobna bolezen, mrzlica
English: The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Slovenian: Titri anti-HBs in anti-HAV protiteles, opaženi po osnovnem cepljenju, so primerljivi z opažanji po cepljenju z monovalentnimi cepivi.
English: The safety profile presented below is based on a pooled analysis of events per dose from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule (n=5,683) or the accelerated 0, 7, 21 days schedule (n=320).
Slovenian: ki so bile cepljene po standardni shemi (0, 1, 6 mesec) (n=5,683) ali pospešeni shemi (0, 7, 21 dan) cepljenja (n=320).
English: Twinrix Adult should under no circumstances be administered intravascularly.
Slovenian: Cepiva Twinrix za odrasle se v nobenem primeru ne sme dajati v žilo.
English: Twinrix Adult confers immunity against HAV and HBV infection by inducing specific anti-HAV and anti-HBs antibodies.
Slovenian: Twinrix za odrasle omogoča imunost proti virusom hepatitisa A in hepatitisa B z indukcijo specifičnih anti-HAV in anti-HBs protiteles.
English: • Abnormal laboratory liver test results
Slovenian: • nenormalne vrednosti preiskav jetrne funkcije,
English: However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
Slovenian: ali hepatitisu B dani hkrati s specifičnimi imunoglobulini, ni bilo opaziti vpliva na serokonverzijo, čeprav so titri protiteles lahko nižji.
English: Angioneurotic oedema, lichen planus, erythema multiforme
Slovenian: Bolezni kože in podkožja angionevrotični edem, lichen planus, multiformni eritem
English: Twinrix Adult contains neomycin Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Slovenian: Obvestite zdravnika, če ste kdaj imeli alergijsko reakcijo na neomicin (antibiotik).
English: swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Slovenian: Znaki hude alergijske reakcije so lahko izpuščaji, ki so lahko srbeči ali mehurjasti, oteklina okrog oči in obraza, težave pri dihanju in požiranju, nenaden padec krvnega tlaka in izguba zavesti.
English: Alternatively, subjects primed with Twinrix Adult may be administered a booster dose of either of the monovalent vaccines.
Slovenian: Osebe, cepljene s cepivom Twinrix za odrasle, lahko prejmejo poživitveni odmerek posameznega monovalentnega cepiva.
English: The excretion of Twinrix Adult in milk has not been studied in animals.
Slovenian: Študije izločanja cepiva Twinrix za odrasle v mleko pri živalih niso bile izvedene.
English: Concentrations (GMC) increased by 179-fold (GMC of 7234 mIU/ml) indicative of an immune memory response.
Slovenian: (GMC 7.234 mi.e./ml), kar kaže na imunski spominski odziv.
English: If not, your doctor will advise you on the possible need to have extra doses.
Slovenian: Če odziv ni zadovoljiv, vam bo zdravnik morda svetoval cepljenje z dodatnimi odmerki.
English: In a clinical trial where Twinrix Adult was administered according to this schedule, 82% and 85% of vaccinees had seroprotective levels of anti-HBV antibodies at 1 and 5 weeks respectively following the third dose (i.e. at months 1 and 2 after the initial dose).
Slovenian: V klinični raziskavi so uporabili to shemo cepljenja in ugotovili, da je imelo 82 % cepljenih oseb zaščitni nivo anti-HBV protiteles v 1. tednu in 85 % cepljenih oseb v 5. tednu po aplikaciji tretjega odmerka (to je en in dva meseca po prvem odmerku).
English: • Swelling or infection of the brain (encephalitis)
Slovenian: • oteklost ali okužba možganov (encefalitis),
English: Each injection is given on a separate visit.
Slovenian: Ambulanto morate obiskati za vsak odmerek posebej.
English: Post-marketing surveillance
Slovenian: Izkušnje v obdobju trženja
English: Make sure you finish the complete vaccination course of three injections.
Slovenian: Preverite, če ste v okviru cepljenja prejeli vse tri predpisane odmerke.
English: Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness
Slovenian: Bolezni imunskega sistema anafilaksijske, alergijske reakcije vključno z anafilaktoidnimi reakcijami in serumski bolezni podobno stanje
English: Cases of overdose have been reported during post-marketing surveillance.
Slovenian: Med spremljanjem cepiva po pridobitvi dovoljenja za promet so poročali o primerih prevelikega odmerjanja.
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: Kot pri vseh drugih parenteralnih cepivih mora biti zaradi redke možnosti anafilaktične reakcije na voljo ustrezno zdravljenje in zagotovljeno opazovanje osebe po cepljenju.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema redki limfadenopatija
English: Side effects occurred very rarely during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines include:
Slovenian: Neželeni učinki se zelo redko pojavijo med kliničnimi študijami ali rutinskim cepljenjem s cepivom Twinrix ali enovalentnim cepivom proti hepatitisu A ali hepatitisu B.
English: As indicated in section 2, a poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Slovenian: Kot je opisano v poglavju 2, se slab odziv na cepivo, lahko tudi brez dosežene zaščite proti hepatitisu B, pojavi bolj pogosto pri starejših osebah, pogosteje pri moških kot pri ženskah, kadilcih,
English: • Numbness or weakness of the arms and legs (neuropathy), paralysis
Slovenian: • otrplost ali šibkost rok in nog (nevropatija), paraliza,
English: • Fourth dose:
Slovenian: • četrti odmerek:
English: A poor response to the vaccine, possibly without achieving protection against hepatitis B, has also been observed in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Slovenian: Pri osebah s prekomerno telesno maso so poročali o slabem odzivu na cepivo, tudi brez dosežene zaščite proti hepatitisu A. Slabši odziv na cepivo, tudi brez dosežene zaščite proti hepatitisu B, so opazili tudi pri starejših osebah, pogosteje pri moških kot pri ženskah, kadilcih, osebah s prekomerno telesno maso, osebah z dolgotrajnimi boleznimi ali osebah, ki jemljejo določena zdravila.
English: • Multiple sclerosis, swelling of the spinal cord (myelitis)
Slovenian: • multipla skleroza, oteklost hrbtenjače (mielitis),
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Slovenian: Kot cepljenje s katerim koli cepivom lahko tudi cepljenje s cepivom Twinrix za odrasle ne izzove zaščitnega imunskega odgovora pri vseh cepljenih osebah.
English: Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
Slovenian: Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica), zlasti pri mladostnikih,
English: 1 pre-filled syringe + 1 needle 1 dose (1 ml)
Slovenian: 1 napolnjena injekcijska brizga + 1 igla 1 odmerek (1 ml)
English: • Pain and redness at the injection site
Slovenian: • bolečina in rdečina na mestu vboda,
English: The seroprotection rate against hepatitis B after the administration of Twinrix Adult was 92% and 56% at 7 and 48 months respectively, versus 80% and 43% after the GlaxoSmithKline Biologicals monovalent 20µg hepatitis B vaccine, and 71% and 31% after another licensed monovalent 10µg hepatitis B vaccine.
Slovenian: mesecih in 56 % po 48 mesecih, po dajanju monovalentnega 20 µg cepiva proti hepatitisu B izdelovalca GlaxoSmithKline Biologicals pa 80 in 43 % (po 7 in po 48 mesecih) ter 71 in 31 % po dajanju nekega drugega monovalentnega 10 µg cepiva proti hepatitisu B z dovoljenjem za promet.
English: 25 pre-filled syringes + 25 needles 25 x 1 dose (1 ml)
Slovenian: 25 napolnjenih injekcijskih brizg + 25 igel 25 x 1 odmerek (1 ml)
English: • Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme), hives
Slovenian: • škrlatne ali rdeče-škrlatne izbokline na koži (lihen planus), močan kožni izpuščaj
English: Twinrix Adult is a white, slightly milky liquid presented in a glass pre-filled syringe (1 ml).
Slovenian: Cepivo Twinrix za odrasle je bela, rahlo mlečna tekočina v stekleni napolnjeni injekcijski brizgi
English: Re-suspension of the vaccine to obtain a uniform hazy white suspension
Slovenian: Kako pretresti cepivo, da dobimo enotno, motno belo suspenzijo
English: Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Slovenian: Twinrix za odrasle se lahko izjemoma aplicira podkožno pri osebah s trombocitopenijo ali motnjami strjevanja krvi.
English: Adverse events reported following overdosage were similar to those reported with normal vaccine administration.
Slovenian: Neželeni učinki so bili podobni tistim po navadnem cepljenju.
English: The 0, 7 and 21 day primary schedule plus a fourth dose at month 12 is for use in exceptional circumstances in adults.
Slovenian: V izjemnih okoliščinah se pri odraslih lahko uporabi osnovno shemo cepljenja (0, 7. in 21.dan) z dodatnim četrtim odmerkom 12 mesecev po prvem odmerku.
English: • First dose:
Slovenian: • prvi odmerek:
English: • Fever equal to or greater than 37.5°C
Slovenian: • okužba zgornjih dihalnih poti, • zvišana telesna temperatura do 37.5°C ali višja.
English: Twinrix Adult can also be given as a total of three doses over 1 month.
Slovenian: 6 mesecev po prvem odmerku S cepivom Twinrix za odrasle ste lahko cepljeni tudi z vsemi tremi odmerki v enem mesecu.
English: - The active substances are: Hepatitis A virus (inactivated)1,2
Slovenian: 1 odmerek (1 ml) vsebuje: Virus hepatitisa A (inaktivirani)1,2
English: • Diarrhoea, nausea
Slovenian: • driska, siljenje na bruhanje,
English: Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Slovenian: 4.1 Terapevtske indikacije Cepivo Twinrix za odrasle je indicirano za uporabo pri neimunih odraslih in mladostnikih, starih 16 let in več, pri katerih obstaja tveganje za okužbo z virusom hepatitisa A in virusom hepatitisa B. 4.2 Odmerjanje in način uporabe
English: How to store Twinrix Adult
Slovenian: Kako uporabljati cepivo Twinrix za odrasle
English: When re-suspended, the vaccine will have a uniform hazy white appearance.
Slovenian: Pred uporabo je treba cepivo pretresti, da ponovno postane enotnega, motno belega videza.
English: PHARMACEUTICAL FORM Suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA suspenzija za injiciranje motna bela suspenzija
English: • Second dose:
Slovenian: • drugi odmerek:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Twinrix Adult, suspension for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Twinrix za odrasle suspenzija za injiciranje HAB cepivo i.m.
English: The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
Slovenian: Poročali so o naslednjih neželenih reakcijah po cepljenju s cepivom Twinrix ali z monovalentnima cepivoma proti hepatitisu A ali hepatitisu B izdelovalca GlaxoSmithKline: Infekcijske in parazitske bolezni meningitis
English: 12 months after the first dose Your doctor will advise on the possible need for extra doses, and future booster dosing.
Slovenian: Vaš zdravnik vam bo svetoval v primeru, da bi potrebovali dodatne odmerke cepiva in kasnejše poživitvene odmerke.
English: • Swollen glands in the neck armpit or groin (lymphadenopathy)
Slovenian: • povečane bezgavke na vratu, pod pazduho ali v dimljah (limfadenopatija),
English: Swelling at the injection site, injection site reactions (such as haematoma, pruritus and bruising), malaise Uncommon Fever (≥ 37.5°C) Rare
Slovenian: srbenje in pojav modric), občutek slabosti občasni zvišana telesna temperatura (≥ 37,5 °C)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE
English: Very rare (These may occur in up to 1 in 10,000 doses of the vaccine):
Slovenian: Zelo redki (ki se lahko pojavijo pri največ 1 od 10.000 odmerkov cepiva):
English: • Vomiting, stomach pain
Slovenian: • bruhanje, bolečine v trebuhu, • boleče mišice,
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (1 ml)
Slovenian: 10 napolnjenih injekcijskih brizg + 10 igel 10 x 1 odmerek (1 ml)
English: • Fits or seizures
Slovenian: • krči ali napadi krčev,
English: The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
Slovenian: V kliničnih preskušanjih vpliva cepiva Twinrix za odrasle na embriofetalno, perinatalno in postnatalno preživetje ter razvoj prospektivno niso ovrednotili.
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Slovenian: 3Pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae)
English: Adult achieved seroprotective levels of anti-HBV antibodies (≥ 10 mIU/ml) and Geometric Mean
Slovenian: En mesec po tem odmerku je 95 % oseb, cepljenih s cepivom Twinrix za odrasle, doseglo seroprotektivno koncentracijo protiteles anti-HBV (≥ 10 mi.e./ml), geometrijska srednja vrednost koncentracij (GMC - geometric mean concentrations) pa se je povečala za 179-krat
English: - The other ingredients in Twinrix Adult are: sodium chloride, water for injections.
Slovenian: 0,4 miligrama Al3+ - Pomožne snovi cepiva Twinrix za odrasle so: natrijev klorid in voda za injekcije.
English: Gastrointestinal symptoms, diarrhoea, nausea
Slovenian: Bolezni prebavil pogosti gastrointestinalni simptomi, driska, navzea občasni bruhanje, bolečine v trebuhu*
English: Rare (These may occur in up to 1 in 1,000 doses of the vaccine):
Slovenian: Redki (ki se lahko pojavijo pri največ 1 od 1000 odmerkov cepiva):
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artritis, mišična oslabelost
English: • Swelling, bruising or itching at the injection site
Slovenian: • oteklina, pojav modric ali srbenja na mestu vboda,
English: These consist of nausea (feeling sick), fever and aches and pains.
Slovenian: Kažejo se v obliki siljenja na bruhanje, povišane telesne temperature in bolečin.
English: No data on concomitant administration of Twinrix Adult with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Slovenian: Ni zbranih podatkov o sočasnem dajanju cepiva Twinrix za odrasle in specifičnih imunoglobulinov proti hepatitisu A ali hepatitisu B. Vsekakor pa, kadar sta bili monovalentni cepivi proti hepatitisu A
English: - Booster dose
Slovenian: - Poživitveni odmerek
English: Following widespread use of the monovalent hepatitis A and/or hepatitis B vaccines, the following undesirable events have additionally been reported in temporal association with vaccination: Nervous system disorders
Slovenian: Pri spremljanju množične uporabe monovalentnih cepiv proti hepatitisu A in/ali hepatitisu B so dodatno poročali o naslednjih neželenih učinkih, ki so bili časovno povezani s cepljenjem: Bolezni živčevja multipla skleroza, mielitis, ohromelost obraza, polinevritis, kot je Guillain-Barréjev sindrom (z ascendentno paralizo), optični nevritis
English: • Feeling of pins and needles (paraesthesia)
Slovenian: • občutek mravljinčenja (parestezija),
English: It is not known whether Twinrix Adult will prevent hepatitis A and hepatitis B in such cases.
Slovenian: Obstaja možnost, da so osebe v času cepljenja v inkubacijski dobi za hepatitis A ali hepatitis B. Ni znano, če Twinrix za odrasle v teh primerih prepreči bolezni.
English: Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Slovenian: Cepiva se ne daje intradermalno ali intramuskularno v glutealno mišico, ker je mogoče, da se na ta način ne doseže ustreznega imunskega odgovora.
English: • Third dose:
Slovenian: • tretji odmerek:
English: The most commonly reported adverse reactions following Twinrix Adult administration with the standard 0, 1, 6 month schedule are pain and redness occurring in a per dose frequency of 37.6% and 17.0% respectively.
Slovenian: mesecev sta bili najbolj pogosto poročani neželeni reakciji bolečina in rdečina s pogostnostjo 37,6 %
English: Twinrix Adult, Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Slovenian: Twinrix za odrasle suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
English: Thrombocytopenia, thrombocytopenic purpura
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija, trombocitopenična purpura
English: If not, you may not be fully protected against the diseases.
Slovenian: V kolikor jih niste, obstaja možnost, da niste v celoti zaščiteni proti hepatitisu A in hepatitisu B.
English: A fourth dose is recommended at 12 months.
Slovenian: Cepljenje s četrtim odmerkom je priporočljivo dvanajst mesecev po cepljenju s prvim odmerkom.
English: Uncommon Upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni občasni okužba zgornjih dihalnih poti
English: Tel: +372 667 6900 estonia@gsk.com
Slovenian: GlaxoSmithKline Eesti OÜ Tel: +372 667 6900 estonia@gsk.com
English: HAB vaccine
Slovenian: Žilne bolezni vaskulitis
English: Very common Pain and redness at the injection site, fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije takojšnja bolečina na mestu vboda
English: Common (These may occur in up to 1 in 10 doses of the vaccine):
Slovenian: Pogosti (ki se lahko pojavijo pri največ 1 od 10 odmerkov cepiva):
English: Uncommon Myalgia Rare
Slovenian: Žilne bolezni redki hipotenzija
English: 10 x 1 dose (1 ml)
Slovenian: 10 napolnjenih injekcijskih brizg 10 x 1 odmerek (1 ml)
English: 25 x 1 dose (1 ml)
Slovenian: 25 napolnjenih injekcijskih brizg 25 x 1 odmerek (1 ml)
English: Tlf: + 47 22 70 20 00
Slovenian: GlaxoSmithKline AS Tlf: + 47 22 70 20 00
English: Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Twinrix Adult.
Slovenian: Pri bolnikih, pri katerih obstaja tveganje, da po osnovni shemi cepljenja s cepivom Twinrix za odrasle ne bodo razvili ustrezne serozaščite, je potrebno razmišljati o serološkem testiranju.
English: ГлаксоСмитКлайн ЕООД Тел.
Slovenian: България ГлаксоСмитКлайн ЕООД
English: Vascular disorders
Slovenian: intramuskularna uporaba
English: Suspension for injection in pre-filled syringe.
Slovenian: kot psihološki odziv na injiciranje z iglo.
English: • Immediate injection site pain, stinging and burning feeling
Slovenian: • bolezen očesnih živcev (optični nevritis), • takojšnja bolečina na mestu vboda, občutek zbadanja in pekoč občutek.
English: NAME OF THE MEDICINAL PRODUCT Twinrix Adult, suspension for injection Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Slovenian: Twinrix za odrasle suspenzija za injiciranje cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
English: Decreased appetite
Slovenian: Presnovne in prehranske motnje redki zmanjšan apetit
English: • Tiredness
Slovenian: • srbečica,
English: The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.
Slovenian: Za vse odmerke osnovnega cepljenja je potrebno uporabiti isto cepivo.
English: Additional doses may need to be considered for persons who do not respond or have a suboptimal response to a course of vaccinations.
Slovenian: Bolniki z zmanjšanim odzivom na cepljenje ali brez bodo morda potrebovali dodatne odmerke.