FrancophonIA/ELRC3.0 huggingface dataset:
English: • feeling nervous
Slovenian: • občutek živčnosti,
English: • Fendrix helps your body to produce its own protection against the virus (antibodies).
Slovenian: • Cepivo Fendrix telesu pomaga ustvariti lastno zaščito proti virusu (protitelesa).
English: These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Slovenian: To so lahko lokalizirani ali razširjeni izpuščaji, ki lahko srbijo ali se razvijejo mehurji, oteklost oči in obraza, težave z dihanjem ali požiranjem, nenaden padec krvnega tlaka in izguba zavesti.
English: 1adjuvanted by AS04C containing: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
Slovenian: 1adjuvans AS04C, ki vsebuje: - 3-O-desacil-4'- monofosforil lipid A (MPL) 2
English: Before administration, the vaccine should be well shaken to obtain a slightly opaque, white suspension.
Slovenian: Pred aplikacijo je potrebno cepivo dobro pretresti, da nastane rahlo motna bela suspenzija.
English: • if you have any known allergies • if you have had any health problems after having a vaccine in the past.
Slovenian: • če ste kdaj v preteklosti imeli kakšne zdravstvene težave po cepljenjih.
English: In a reproductive toxicity study in animals which included post-natal follow-up until weaning (see section 5.3), no effect on the development of the pups was observed.
Slovenian: V študiji škodljivih vplivov na sposobnost razmnoževanja pri živalih, v katero je bilo vključeno tudi spremljanje mladičev do odstavitve (glejte poglavje 5.3), vplivi na postnatalni razvoj psičkov niso bili opaženi.
English: Because of the long incubation period of hepatitis B, it is possible that subjects could have been infected before the time of immunisation.
Slovenian: Zaradi dolge inkubacijske dobe hepatitisa B je možno, da so bile osebe okužene že pred cepljenjem.
English: Carriers of hepatitis B
Slovenian: Nosilci hepatitisa B
English: • Experience with hepatitis B vaccine:
Slovenian: • Izkušnje s cepivi proti hepatitisu B:
English: Contents of the pack and other information What Fendrix contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Fendrix
English: What you need to know before you receive Fendrix
Slovenian: Kaj morate vedeti, preden boste prejeli cepivo Fendrix
English: • Once you have had the first injection of Fendrix, the next injections need also to be Fendrix (not another sort of hepatitis B vaccine).
Slovenian: • Ko enkrat prejmete prvo injekcijo cepiva Fendrix, morajo biti tudi naslednje injekcije cepivo Fendrix (ne kakšna druga vrsta cepiva proti hepatitisu B).
English: Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Slovenian: Med shranjevanjem se lahko pojavi fina bela usedlina in bister brezbarven supernatant.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.
Slovenian: Za vse morebitne nadaljnje informacije o tem cepivu se lahko obrnete na predstavništvo imetnika dovoljenja za promet.
English: • severe headache with a stiff neck
Slovenian: • hud glavobol z otrplostjo vratu,
English: • Carriers of the virus are likely to get serious liver problems, such as “cirrhosis” or liver cancer.
Slovenian: • Pri nosilcih virusa obstaja verjetnost resnih težav z jetri, npr. ciroze ali raka jeter.
English: • The virus is found in body fluids such as in the vagina, blood, semen, or saliva (spit).
Slovenian: • Virus se nahaja v telesnih tekočinah, npr. v nožnici, krvi, spermi ali slini (izpljunku).
English: The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or other pathogens known to infect the liver.
Slovenian: Cepivo ne bo preprečilo okužb z drugimi povzročitelji, kot so virus hepatitisa A, virus hepatitisa C in virus hepatitisa E, ter z drugimi patogeni, ki okužijo jetra.
English: What Fendrix is and what it is used for What you need to know before you receive Fendrix How Fendrix is given
Slovenian: Kaj je cepivo Fendrix in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Fendrix Kako se uporablja cepivo Fendrix
English: There are no data from the use of Fendrix in pregnant women.
Slovenian: Ni podatkov o uporabi cepiva Fendrix pri nosečnicah.
English: Pharmacokinetic properties of Fendrix or MPL alone has not been studied in humans.
Slovenian: Farmkokinetične lastnosti cepiva Fendrix ali samega MPL pri ljudeh niso bile raziskane.
English: • Suspension for injection in a prefilled syringe.
Slovenian: • Suspenzija za injiciranje v napolnjeni injekcijski brizgi.
English: Fendrix should under no circumstances be administered intradermally or intravenously.
Slovenian: Cepivo Fendrix se v nobenem primeru ne sme dajati intradermalno ali intravaskularno.
English: This is usually in your upper arm.
Slovenian: Ponavadi bo to mišica na nadlakti.
English: No increase in the reactogenicity was observed after the booster vaccination with respect to the primary vaccination.
Slovenian: Po obnovitvenem cepljenju ni bilo opažena povečana reaktogenost glede na osnovno cepljenje.
English: The most common adverse reactions reported were local reactions at the injection site.
Slovenian: Neželene reakicije, o katerih so najpogosteje poročali, so bile lokalne reakcije na mestu aplikacije.
English: In a large double-blind randomised comparative study, healthy subjects were enrolled to receive a three dose primary course of Fendrix (N= 713) or a commercially available hepatitis B vaccine (N= 238) at 0, 1, 2 months.
Slovenian: V veliko dvojno slepo randomizirano primerjalno študijo so bile vključene zdrave osebe, ki so med osnovnim cepljenjem prejele tri odmerke cepiva Fendrix (N = 713) ali komercialno dostopno cepivo proti hepatitisu (N = 238) po shemi 0, 1, 2 mesec.
English: As no data are available for the concomitant administration of this particular vaccine with other vaccines, an interval of 2 to 3 weeks should be respected.
Slovenian: Ker podatkov o sočasnem dajanju tega in drugih cepiv ni, je pri cepljenju potrebno upoštevati presledek 2 do 3 tednov.
English: • The other ingredients in Fendrix are: sodium chloride, water for injections.
Slovenian: • Pomožne snovi cepiva Fendrix so: natrijev klorid in voda za injekcije.
English: • If you miss an injection, talk to your doctor and arrange another visit.
Slovenian: Če ste izpustili odmerek • Če ste izpustili injekcijo, se posvetujte z zdravnikom in se dogovorite za drug obisk pri njem.
English: Vaccination with Fendrix induced more transient local symptoms as compared to the comparator vaccine, with pain at the injection site being the most frequently reported solicited local symptom.
Slovenian: V primerjavi s primerjalnim cepivom je cepljenje s cepivom Fendrix povzročilo bolj prehodne lokalne simptome, pri čemer so najpogosteje poročali o bolečini na mestu injiciranja kot lokalnem spontanem simptomu.
English: No fertility data are available.
Slovenian: Plodnost Podatkov o ploodnosti ni.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Slovenian: Možno je, tako kot pri kateremkoli drugem cepivu, da se zaščitni imunski odziv ne bo pojavil pri vseh cepljenih osebah.
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut - 1330 Rixensart Belgium
Slovenian: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut - 1330 Rixensart
English: • Fendrix is available in packs of 1 (with or without a separate needle) and in a pack size of 10 without needles.
Slovenian: • Cepivo Fendrix je na voljo v pakiranjih z 1 napolnjeno injekcijsko brizgo (z ločeno iglo ali brez nje) in v pakiranjih z 10 napolnjenimi injekcijskimi brizgami brez igel.
English: Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or use machines.
Slovenian: Na sposobnost vožnje ali upravljanje strojev lahko vplivajo nekateri neželeni učinki, ki so navedeni v poglavju 4.8.
English: How Fendrix is given How the vaccine is given
Slovenian: Kako uporabljati cepivo Fendrix Kako se cepivo daje
English: The reactogenicity profile of Fendrix in healthy subjects was generally comparable to that seen in prehaemodialysis and haemodialysis patients.
Slovenian: Reaktogeni profil cepiva Fendrix pri zdravih osebah je bil na splošno primerljiv s tistim pri predhemodializnih in hemodializnih bolnikih.
English: Primary immunisation:
Slovenian: Osnovno cepljenje:
English: • Fendrix is a white, milky suspension presented in a glass prefilled syringe (0.5 ml).
Slovenian: • Cepivo Fendrix je bela, mlečna suspenzija v stekleni napolnjeni injekcijski brizgi (0,5 ml).
English: The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/or change in physical appearance.
Slovenian: Pred in po tem, ko se cepivo pretrese, ga je potrebno vizualno pregledati glede morebitne prisotnosti tujih delcev in/ali spremenjenega fizikalnega videza.
English: Psychiatric disorders: Rare: nervousness
Slovenian: Psihiatrične motnje: Redki: živčnost
English: Healthy subjects
Slovenian: Zdrave osebe
English: Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects ≥ 15 years of age allowed to document the reactogenicity of the vaccine.
Slovenian: V kliničnih preskušanjih je bilo z 2.476 odmerki cepiva Fendrix cepljenih 82 predhemodializnih in hemodializnih bolnikov ter 713 zdravih oseb, ki so bile stare 15 let ali več, kar je omogočilo dokumentirati reaktogenost cepiva.
English: Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine.
Slovenian: Pričeto osnovno cepljenje po shemi 0, 1, 2 in 6 mesecev je potrebno dokončati s cepivom Fendrix in ne z drugimi komercialno dostopnimi cepivi proti hepatitisu B.
English: Fendrix induces specific humoral antibodies against HBsAg (anti-HBs antibodies).
Slovenian: Cepivo Fendrix sproži nastanek specifičnih humoralnih protiteles proti HBsAg (protiteles proti-HBs).
English: • feeling thirsty
Slovenian: • občutek žeje,
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium chloride
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
English: Immune system disorders: Rare: allergy
Slovenian: Bolezni imunskega sistema: Redki: alergija
English: As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines.
Slovenian: Ker so predhemodializni in hemodializni bolniki še posebej izpostavljeni okužbi s HBV, in ker je pri njih tveganje za kronično okužbo večje, je potrebno razmisliti o previdnostnih ukrepih, npr. cepljenje z obnovitvenim odmerkom, da bi tako zagotovili takšen zaščitni titer protiteles kot je definiran z nacionalnimi priporočili in smernicami.
English: If concomitant administration of specific hepatitis B immunoglobulin and Fendrix is required, these should be given at different injection sites.
Slovenian: Če je potrebno sočasno dajanje specifičnih imunoglobulinov proti hepatitisu B in cepiva Fendrix, je odmerka potrebno dati na različni mesti.
English: If you are not sure, talk to your doctor or pharmacist before having Fendrix.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom, preden prejmete cepivo Fendrix.
English: The following side effects may happen with this vaccine.
Slovenian: Med uporabo tega cepiva se lahko pojavijo naslednji neželeni učinki.
English: Fendrix has moderate influence on the ability to drive and use machine.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Cepivo Fendrix ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: However, in circumstances where exposure to HBV has recently occurred (e.g. stick with contaminated needle) and where simultaneous administration of Fendrix and a standard dose of HBIg is necessary, these should be given at separate injection sites.
Slovenian: V okoliščinah, kjer je pred kratkim prišlo do izpostavljenosti HBV (npr. vbod z okuženo iglo) in je potrebno sočasno cepljenje s cepivom Fendrix ter dajanje običajnega odmerka HBIg, je odmerek cepiva Fendrix in odmerek HBIg potrebno injicirati na različni mesti.
English: • The active substance in 1 dose (0.5 ml) of Fendrix is: Hepatitis B surface antigen 1, 2, 3
Slovenian: • Zdravilna učinkovina v 1 odmerku (0,5 ml) cepiva Fendrix je: površinski antigen virusa hepatitisa B 1, 2, 3
English: Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).
Slovenian: 4.1 Terapevtske indikacije Cepivo Fendrix je indicirano pri mladostnikih in odraslih, starejših od 15 let, za aktivno imunizacijo bolnikov z ledvično insuficienco (vključno s predhemodializnimi in hemodializnimi bolniki) proti okužbi z vsemi znanimi podtipi virusa hepatitisa B (HBV).
English: Fendrix should be injected intramuscularly in the deltoid region.
Slovenian: Cepivo Fendrix je potrebno injicirati intramuskularno v deltoidno mišico.
English: • numbness or weakness of the arms and legs (neuropathy), inflammation of nerves (neuritis), weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome), swelling or infection of the brain (encephalitis, encephalopathy).
Slovenian: • omrtvičenost ali šibkost rok in nog (nevropatija), vnetje živcev (nevritis), šibkost in paraliza udov, ki pogosto napreduje na prsni koš in obraz (Guillain-Barréjev sindrom),
English: What Fendrix looks like and contents of the pack
Slovenian: Izgled cepiva Fendrix in vsebina pakiranja
English: 0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without separate needle in a pack size of 1, or without needles in a pack size of 10.
Slovenian: 0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (butilna guma) s priloženo injekcijsko iglo ali brez v pakiranju po 1, ali brez priloženih injekcijskih igel v pakiranju po
English: FI.PT@gsk.com
Slovenian: gskcyprus@gsk.com
English: An anti-HBs antibody titre ≥ 10 mIU/ml correlates with protection to HBV infection.
Slovenian: Titer protiteles proti-HBs ≥10 i.e./l je v skladu z zaščito pred okužbo z virusom hepatitisa B.
English: • Fendrix may not protect you from being ill if you have already caught the hepatitis B virus.
Slovenian: • Cepivo Fendrix vas morda ne bo zaščitilo pred boleznijo, če ste že okuženi z virusom hepatitisa B.
English: • other reactions where the injection was given.
Slovenian: • druge reakcije na mestu injiciranja.
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa cepiva ima lahko tudi cepivo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Pre-haemodialysis and haemodialysis patients
Slovenian: Predhemodializni in hemodializni bolniki
English: EU/1/04/0299/003
Slovenian: EU/1/04/0299/001 EU/1/04/0299/002 EU/1/04/0299/003
English: Non-clinical data reveal no special hazard for humans based on conventional animal studies consisting of acute and repeated dose toxicity, cardiovascular and respiratory safety pharmacology and reproductive toxicity including pregnancy and peri and postnatal development of the pups till weaning (see section 4.6).
Slovenian: Predklinični podatki na osnovi običajnih študij na živalih (akutna toksičnost in toksičnost pri ponavljajočih se odmerkih, farmakološke varnosti za kardiovaskularni in respiratorni sistem in škodljivi vplivi na sposobnost razmnoževanja vključno z brejostjo in peri- ter postnatalnim razvojem psičkov do odstavitve) ne kažejo posebnega tveganja za človeka (glejte poglavje 4.6).
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before having Fendrix.
Slovenian: Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte z zdravnikom ali farmacevtom,
English: Frequencies are reported as: Very common: (≥1/10) Common:
Slovenian: Pogostnost je navedena kot: Zelo pogosti:
English: • Not all pack sizes may be marketed.
Slovenian: • Na trgu ni vseh navedenih pakiranj.
English: Fendrix can also be used as a booster after a course of a different type of hepatitis B vaccine.
Slovenian: Cepivo Fendrix je mogoče uporabiti tudi kot obnovitveno injekcijo po ciklusu drugačne vrste cepiva proti hepatitisu B.
English: Tell your doctor if you are taking, have recently taken, might take any other medicines or have recently received any other vaccine.
Slovenian: Druga zdravila in cepivo Fendrix Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo ali cepivo.
English: How Fendrix works
Slovenian: Kako deluje cepivo Fendrix
English: At month 36, 80.4% of these patients retained protective antibody levels (anti-HBs titres ≥ 10mIU/ml), as compared to 51.3% of patients who received a commercially available hepatitis B vaccine.
Slovenian: V 36. mesecu je 80,4 % omenjenih bolnikov še imelo zaščitni titer protiteles (titer proti-HBs ≥10 i.e./l) v primerjavi z 51,3 % bolnikov, ki so bili cepljeni s komercialno dostopnim cepivom proti hepatitisu B.
English: • patients having “haemo-dialysis”- where a “dialysis” machine removes waste products from the blood
Slovenian: • bolnike na hemodializi, pri kateri naprava za dializo odstrani odpadne snovi iz krvi, • bolnike, ki se bodo s hemodializo zdravili v prihodnje.
English: Vaccination during pregnancy should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the foetus.
Slovenian: Med nosečnostjo se lahko cepi le nosečnice, pri katerih pričakovane koristi cepljenja prevladajo nad možnim tveganjem za plod.
English: • Fendrix contains two things called “MPL” (a non-toxic purified fat derivative from bacteria) and
Slovenian: • Cepivo Fendrix vsebuje dve sestavini: ena se imenuje "MPL" (to je nestrupen, prečiščen maščobni izvleček bakterij), druga pa "aluminijev fosfat".
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITH SEPARATE NEEDLE 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES
Slovenian: 1 NAPOLNJENA INJEKCIJSKA BRIZGA S PRILOŽENO INJEKCIJSKO IGLO 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ INJEKCIJSKE IGLE 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ INJEKCIJSKE IGLE
English: Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being related or possibly related to vaccination have been categorised by frequency.
Slovenian: Neželene reakcije, o katerih so poročali v kliničnem preskušanju po osnovnem cepljenju s cepivom Fendrix in za katere se domneva, da so ali bi lahko bile povezane s cepljenjem, so bile razvrščene po pogostnosti.
English: Fendrix should not be given to subjects suffering from acute severe febrile illness.
Slovenian: S cepivom Fendrix se ne sme cepiti oseb, ki imajo hudo akutno vročinsko bolezen.
English: After completion of a four dose primary course (i.e at month 7), 90.9% of Fendrix recipients were seroprotected (≥ 10 mIU/ml) against hepatitis B, in comparison with 84.4% in a control group who received the commercially available hepatitis B vaccine.
Slovenian: Po zaključenem osnovnem cepljenju s štirimi odmerki cepiva (npr. v 7. mesecu) je bilo 90,9 % oseb, ki so bile cepljene s cepivom Fendrix serozaščitenih (≥10 i.e/l) pred okužbo z virusom hepatitisa B v primerjavi s 84,4 % oseb v kontrolni skupini, ki so bile cepljene s komercialno dostopnim cepivom proti hepatitisu B.
English: You may feel tired or get a headache after receiving Fendrix.
Slovenian: Potem, ko prejmete cepivo Fendrix, se lahko počutite utrujeni ali se vam pojavi glavobol.
English: No data on the concomitant administration of Fendrix and other vaccines or with specific hepatitis B immunoglobulin have been generated.
Slovenian: Podatki o sočasnem dajanju cepiva Fendrix in drugih cepiv ali specifičnih imunoglobulinov proti hepatitisu B niso bili pridobljeni.
English: Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
Slovenian: Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
English: The vaccine may not prevent hepatitis B infection in such cases.
Slovenian: V takšnih primerih je možno, da preventiva hepatitisa B ne bo uspešna.
English: Special posology recommendation for known or presumed exposure to HBV:
Slovenian: Posebna priporočila glede odmerjanja v primeru znane ali domnevne izpostavljenosti virusu hepatitisa B:
English: (≥1/100 to <1/10) Uncommon: (≥1/1,000 to <1/100)
Slovenian: (≥1/1.000 do<1/100)
English: Additionally, the following side effects have also been reported with other hepatitis B vaccines:
Slovenian: Poleg tega so bili z drugimi cepivi proti hepatitisu B opisani še naslednji neželeni učinki.
English: Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being at least possibly related to vaccination have been categorised by frequency.
Slovenian: Neželene reakcije, o katerih so poročali v kliničnem preskušanju po osnovnem cepljenju s cepivom Fendrix in za katere se domneva, da bi lahko bile povezane s cepljenjem, so bile razvrščene po pogostnosti.
English: Vaccination should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the infant.
Slovenian: Cepi se lahko le doječe matere, pri katerih pričakovane koristi cepljenja prevladajo nad možnim tveganjem za dojenega otroka.
English: In pre-haemodialysis and haemodialysis patients:
Slovenian: Predhemodializni in hemodializni bolniki:
English: These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases.
Slovenian: Opaženi so bili številni dejavniki, ki zmanjšujejo imunski odziv na cepiva proti hepatitisu B. Med te dejavnike spadajo višja starost, moški spol, debelost, kajenje, način uporabe in nekatere kronične osnovne bolezni.
English: The reactogenicity profile of Fendrix in a total of 82 pre-haemodialysis and haemodialysis patients was generally comparable to that seen in healthy subjects.
Slovenian: Pri vseh 82 predhemodializnih in hemodializnih bolnikih je bil reaktogeni profil na splošno primerljiv s tistim pri zdravih osebah.
English: Following widespread use of hepatitis B vaccines, in very rare cases, syncope, paralysis, neuropathy, neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, encephalopathy, meningitis and convulsions have been reported.
Slovenian: nevropatiji, nevritisu (vključno z Guillain-Barréjevim sindromom, optičnim nevritisem in multiplo sklerozo), encefalitisu, encefalopatiji, meningitisu in konvulzijah.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Intramuskularna uporaba
English: • if you are allergic to the active substance, or any of the other ingredients of this vaccine (listed in section 6).
Slovenian: Cepiva Fendrix ne smete prejeti: • če ste alergični na zdravilno učinkovino ali na katero koli sestavino tega cepiva (navedeno v poglavju 6).
English: The vaccine must not be used if any change in the appearance of the vaccine has taken place.
Slovenian: Če se opazi kakršnakoli sprememba v videzu, se cepivo ne sme uporabiti.
English: • red, raised skin rash
Slovenian: • nad nivo kože privzdignjen kožni izpuščaj,
English: There are no data from use of Fendrix during lactation.
Slovenian: Ni podatkov o uporabi cepiva Fendrix med dojenjem.
English: Fendrix should not be given to subjects with hypersensitivity after previous administration of other hepatitis B vaccines.
Slovenian: S cepivom Fendrix se ne sme cepiti oseb s preobčutljivostjo po predhodnem cepljenju z drugimi cepivi proti hepatitisu B.