FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who develop HBV reactivation, Hefiya should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Slovenian: Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila Hefiya prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
English: Patients treated with Hefiya should be given the Patient Reminder Card.
Slovenian: Bolniki, ki se zdravijo z zdravilom Hefiya, morajo dobiti opozorilno kartico za bolnika.
English: You should continue to inject Hefiya for as long as your doctor has told you.
Slovenian: Nadaljevati morate z injiciranjem zdravila Hefiya tako dolgo, kot vam je naročil zdravnik.
English: Following 3 years of adalimumab therapy, 75 % (301 / 402) continued to be in clinical remission per partial Mayo score.
Slovenian: Po 3 letih zdravljenja z adalimumabom jih je 75 % (301/402) ostalo v klinični remisiji po delni oceni Mayo.
English: Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
Slovenian: Takoj poiščite zdravniško pomoč, če opazite katere od naslednjih znakov alergijske reakcije ali srčnega popuščanja: • hud izpuščaj, koprivnico;
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10 % (60 % of patients) and BSA < 10 % and ≥ 5 % (40 % of patients)).
Slovenian: Adalimumab je pokazal terapevtsko korist pri bolnikih s psoriazo nohtov z različnim obsegom prizadetosti kože (telesna površina ≥ 10 % (60 % bolnikov) in telesna površina < 10 % in ≥ 5 % (40 % bolnikov)).
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Hefiya.
Slovenian: Povejte zdravniku, če prejemate azatioprin ali merkaptopurin sočasno z zdravilom Hefiya.
English: With the current knowledge, a possible risk for the development of lymphomas, leukaemia, and other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Slovenian: S sedanjim znanjem možnega tveganja za razvoj limfomov, levkemije in drugih malignomov pri bolnikih, zdravljenih z antagonistom TNF, ni mogoče izključiti.
English: Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an openlabel extension trial, where adalimumab was given for at least an additional 108 weeks.
Slovenian: Bolniki, ki so sodelovali v študijah psoriaze 2. in 3. faze, so bili lahko vključeni v odprto podaljšano preskušanje, v katerem so adalimumab prejemali vsaj še dodatnih 108 tednov.
English: HS study II
Slovenian: študija HS II
English: Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in study UV I, and for general vision and mental health in study UV II.
Slovenian: Številke so bile v korist adalimumaba za večino podrezultatov s statistično značilno povprečno razliko za splošni vid, očesno bolečino, vid na blizu, duševno zdravje in skupen rezultat v študiji UV I, ter za splošni vid in duševno zdravje v študiji UV II.
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Slovenian: PASI 75 in PGA čisto ali minimalno, sta se povečevali z zvečanjem koncentracije adalimumaba, obe s podobno navidezno EC50, za približno 4,5 μg/ml (95 % IZ 0,4-47,6 in 1,9-10,5).
English: • abnormal muscle breakdown;
Slovenian: • neobičajen razpad mišic;
English: Crohn's disease in adults and children
Slovenian: Crohnova bolezen pri odraslih in otrocih
English: Your doctor may recommend temporarily stopping Hefiya.
Slovenian: Vaš zdravnik bo morda priporočil začasno prenehanje uporabe zdravila Hefiya.
English: -56.2a a p < 0.001, adalimumab vs. placebo
Slovenian: -56,2a a p < 0,001, adalimumab v primerjavi s placebom
English: See “4.
Slovenian: Glejte točko “4.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Hefiya cannot be excluded (see section 4.8).
Slovenian: Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki dobivajo zdravilo Hefiya, ni mogoče izključiti (glejte poglavje 4.8).
English: Study nr-axSpA II
Slovenian: Študija nr-axSpA II
English: Results from the Short Form Health Survey (SF 36) for all doses / schedules of adalimumab in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Slovenian: Te izsledke podpirajo rezultati SF 36 (Short Form Health Survey) za vse odmerke/sheme adalimumaba v vseh štirih študijah, s statistično značilnim seštevkom PCS (Physical Component Summary) in statistično značilnima seštevkoma za področje bolečin in vitalnosti za odmerek 40 mg vsak drugi teden.
English: There were no distinct differences between adalimumab-treated and untreated women for the secondary endpoints spontaneous abortions, minor birth defects, preterm delivery, birth size and serious or opportunistic infections and no stillbirths or malignancies were reported.
Slovenian: Ni bilo opaznih razlik med nosečnicami, zdravljenimi z adalimumabom in nezdravljenimi glede sekundarnih opazovanih dogodkov, kot so spontani splavi, manjši defekti ob rojstvu, prezgodnji porodi, porodna velikost in resne ali oportunistične okužbe, prav tako ni bilo opisanih mrtvorojenosti ali malignosti.
English: 14 weeks a ped ACR 30/50/70 responses week 48 significantly greater than those of placebo-treated patients b p = 0.015
Slovenian: Odzivi »ped ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo b p = 0,015
English: Patients participating in Studies HS-I and HS-II were eligible to enrol into an open-label extension study in which adalimumab 40 mg was administered every week.
Slovenian: Bolniki, vključeni v študiji HS-I in HS-II, so bili primerni za vključitev v odprto podaljšano študijo, pri kateri so prejemali adalimumab 40 mg vsak teden.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Hefiya and is positive for antibodies against double-stranded DNA, further treatment with Hefiya should not be given (see section 4.8).
Slovenian: Če se bolniku po zdravljenju z zdravilom Hefiya pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja z zdravilom Hefiya ne sme nadaljevati (glejte poglavje 4.8).
English: A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used.
Slovenian: Score, mTSS), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).
English: • gallbladder inflammation, gallbladder stones;
Slovenian: • vnetje žolčnika, žolčni kamni;
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Hefiya.
Slovenian: V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem lahko še nadalje uporabljajo ob uporabi zdravila Hefiya.
English: • intestinal perforation (hole in the wall of the gut);
Slovenian: • intestinalna perforacija (luknja v črevesni steni);
English: Adalimumab was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Slovenian: Adalimumab so raziskali pri 9506 bolnikih v kontroliranih in odprtih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet in so trajala do 60 mesecev ali več.
English: Should treatment be interrupted, Hefiya may be re-introduced as appropriate.
Slovenian: Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom Hefiya znova uvesti, kakor je primerno.
English: Psoriasis
Slovenian: Psoriaza
English: What Hefiya is and what it is used for What you need to know before you use Hefiya How to use Hefiya
Slovenian: Kaj je zdravilo Hefiya in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Hefiya Kako uporabljati zdravilo Hefiya
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see tables 17 and 18).
Slovenian: V študijah pri psoriazi I in II je bil primarna končna točka delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 17 in 18).
English: All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Slovenian: Vse bolnike z ulceroznim kolitisom, ki imajo večje tveganje za displazijo ali karcinom kolona (npr. bolnike z dolgotrajnim ulceroznim kolitisom ali primarnim sklerozirajočim holangitisom), ali imajo anamnezo displazije ali karcinoma kolona, je treba pred zdravljenjem in redno med potekom bolezni presejalno pregledovati glede displazije.
English: In the open-label extension of RA Study III, the reduction in rate of progression of structural damage is maintained for 8 and 10 years in a subset of patients.
Slovenian: V odprtem podaljšanju študije revmatoidnega artritisa III se upočasnitev napredovanja strukturne prizadetosti sklepov ohrani vseskozi 8 in 10 let v tej podskupini bolnikov.
English: Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Slovenian: Študija nr-axSpA II je bila študija prenehanja zdravljenja pri bolnikih z aktivnim nr-axSpA, ki so med zdravljenjem z adalimumabom v odprti fazi zdravljenja dosegli remisijo.
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for controltreated patients.
Slovenian: Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim delom študij, ki podpirajo vlogo za pridobitev dovoljenja za promet, je bil 5,9 % v skupini, ki je prejemala adalimumab, in 5,4 % v kontrolni skupini.
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Slovenian: • jetrnovranični limfom celic T (redka oblika krvnega raka, ki je pogosto smrtna);
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Hefiya should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila Hefiya nemudoma prekiniti in uvesti ustrezno zdravljenje.
English: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during adalimumab trials in paediatric patients with Crohn's disease.
Slovenian: Poleg tega niso opazili nobenega malignoma tudi pri 192 pediatričnih bolnikih, ki so bili izpostavljeni 498,1 bolnikov-let med študijami z adalimumabom pri pediatričnih bolnikih s Crohnovo boleznijo.
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Slovenian: Odstotek bolnikov, zdravljenih z adalimumabom, ki so dosegli odziv 20, 50 in 70 po ACR, se je v študijah revmatoidnega artritisa I, II in III skladal.
English: • benign tumours;
Slovenian: • benigni tumorji;
English: • If you have an infection, including long-term or localised infection (for example leg ulcer), consult your doctor before starting Hefiya.
Slovenian: • Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Hefiya posvetujte s svojim zdravnikom.
English: week 24 week 36 a patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Slovenian: 24. teden 36. teden a bolniki z vsaj delnim odzivom na odmerek 40 mg adalimumaba po 12. tednih zdravljenja.
English: Worsening of symptoms of dermatomyositis1)
Slovenian: neznana pogostnost poslabšanje simptomov dermatomiozitisa1)
English: Vision related effects were not numerically in favour of adalimumab for colour vision in study UV I and for colour vision, peripheral vision and near vision in study UV II.
Slovenian: Učinki povezani z vidom niso bili v korist adalimumaba v primeru barvnega vida v študiji UV I in v primeru barvnega vida, perifernega vida in vida na blizu v študiji UV II.
English: Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg / day) at baseline to control their disease.
Slovenian: Študija UV II je ovrednotila 226 bolnikov z inaktivnim uveitisom, ki je že na začetku zahteval kronično zdravljenje s kortikosteroidi (prednizolon peroralno 10 do 35 mg/dan) za nadzor njihove bolezni.
English: Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Slovenian: Zdravilo Hefiya je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
English: a adalimumab / MTX 40 mg every other week placebo / MTXadalimumab / MTX (95 % confidence interval b)
Slovenian: placebo/MTXa adalimumab/MTX 40 mg vsak drugi teden placebo/MTXadalimumab/MTX (95 % interval zaupanjab)
English: • Do not store the syringes in extreme heat or cold.
Slovenian: • Injekcijskih brizg ne hranite na ekstremni vročini ali mrazu.
English: Hefiya contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Slovenian: Zdravilo Hefiya vsebuje učinkovino adalimumab, ki deluje na imunski sistem (obrambni mehanizem) telesa.
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg / kg / day or 10 mg / day maximum).
Slovenian: Bolniki so ostali na stabilnih odmerkih nesteroidnih protivnetnih zdravil in/ali prednizona (≤ 0,2 mg/kg/dan ali največ 10 mg/dan).
English: For the safety and health of you and others, the pens must never be re-used.
Slovenian: Zaradi varnosti in zdravja vas in drugih oseb injekcijskih peresnikov nikoli ne smete ponovno uporabiti.
English: If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
Slovenian: Če se vam med zdravljenjem ali po njem pojavijo novi predeli poškodovane kože, ali če se vam spremeni videz obstoječih sprememb ali poškodovanih predelov, morate to povedati zdravniku.
English: Check the green indicator fills the window (see Figure J):
Slovenian: Po injiciranju Preverite, da je zeleni kazalnik zapolnil okence (glejte sliko J):
English: response
Slovenian: odziv
English: Flare was defined as ASDAS ≥ 2.1 at two consecutive visits four weeks apart.
Slovenian: Ponovni zagon bolezni je bil opredeljen kot ASDAS ≥ 2,1 pri dveh zaporednih obiskih štiri tedne narazen.
English: Instructions for use
Slovenian: NAVODILA ZA UPORABO
English: The inflammation leads to a decrease of vision and / or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Slovenian: Vnetje povzroči poslabšanje vida in/ali prisotnost delcev v očesu (črnih pik ali koprenastih črt, ki se premikajo po vidnem polju).
English: Patients treated with adalimumab had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
Slovenian: Bolniki, zdravljeni z adalimumabom, so imeli statistično pomembno zmanjšanje tveganja novega izbruha bolezni v začetnih 12 tednih zdravljenja.
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: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
Slovenian: V klinični študiji z drugim antagonistom TNF so opažali poslabšanje kongestivnega srčnega popuščanja in večjo umrljivost zaradi kongestivnega srčnega popuščanja.
English: Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see Figure 2).
Slovenian: V obeh študijah je bil dokazan zgodnji in vzdrževan učinek adalimumaba na odstotek neuspeha zdravljenja proti placebu (glejte sliko 2).
English: • For a more comfortable injection, take the blister containing the syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes so that it reaches room temperature.
Slovenian: • Da bo injiciranje prijetnejše, vzemite pretisni omot, ki vsebuje injekcijsko brizgo, iz hladilnika in ga pustite zaprtega na delovni površini približno 15 do 30 minut, da se ogreje na sobno temperaturo.
English: Psoriasis Study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Slovenian: Študija pri psoriazi II (CHAMPION) je primerjala učinkovitost in varnost adalimumaba z metotreksatom in placebom pri 271 bolnikih.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin-specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Slovenian: Večje izboljšanje v 12. tednu so pokazali glede na izhodiščno vrednost v primerjavi s placebom glede z zdravjem povezane kakovosti življenja, specifične za kožo, merjene z dermatološkim indeksom kakovosti življenja (“Dermatology life quality index” (DLQI), v študijah HS-I in HS-II), glede bolnikovega splošnega zadovoljstva z zdravljenjem z zdravilom, merjenem z vprašalnikom o zadovoljstvu z zdravljenjem z zdravilom (“Treatment Satisfaction Questionnaire - medication” (TSQM), v študijah HS-I in HS-II), in glede telesnega zdravja, merjenega s seštevkom telesnih komponent v vprašalniku SF-36 (“Short Form Health Survey" (SF 36) v študiji HS-I).
English: Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
Slovenian: Nekaterim bolnikom, ki se ne odzovejo do 4. tedna, lahko koristi nadaljnje vzdrževalno zdravljenje do 12. tedna.
English: Clinical Response
Slovenian: Klinični odziv
English: If you take Hefiya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Slovenian: Če uporabljate zdravilo Hefiya, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
English: • never leave the syringe unattended where others might tamper with it.
Slovenian: • nikoli ne pustite injekcijske brizge brez nadzora tam, kjer bi lahko kdo posegal vanjo.
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Slovenian: • avtoimunski hepatitis (vnetje jeter, ki ga povzroči lastni imunski sistem);
English: Full instructions for use are given in the package leaflet, section 7, "Instructions for Use".
Slovenian: Celotna navodila za uporabo so navedena v navodilu za uporabo, poglavje 7, „Navodila za uporabo“.
English: ACR response
Slovenian: Odziv po ACR
English: No studies have been conducted that include patients with a history of malignancy or in whom treatment with adalimumab is continued following development of malignancy.
Slovenian: Študij, ki bi vključevale bolnike z anamnezo malignoma ali bolnike, pri katerih bi se zdravljenje z adalimumabom nadaljevalo po pojavu malignoma, ni bilo.
English: Juvenile idiopathic arthritis (JIA)
Slovenian: Juvenilni idiopatski artritis (JIA)
English: • throw away the used syringe right away after use.
Slovenian: • injekcijsko brizgo zavržete takoj po uporabi.
English: p-value total Sharp score c erosion score JSN
Slovenian: Pc celotna Sharpova ocena ocena erozij seštevek JSN
English: Table 17 Ps study I (REVEAL) - efficacy results at 16 weeks placebo N = 398 n (%)
Slovenian: Preglednica 17 študija pri psoriazi I (REVEAL) - rezultati učinkovitosti po 16 tednih placebo n = 398 n (%)
English: Patients who develop a new infection while undergoing treatment with Hefiya should be monitored closely and undergo a complete diagnostic evaluation.
Slovenian: Bolnike, pri katerih se med zdravljenjem z zdravilom Hefiya pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
English: Hidradenitis suppurativa in adults and adolescents
Slovenian: Hidradenitis suppurativa pri odraslih in mladostnikih
English: • Hold your pen at 90 degrees to the cleaned injection site (see Figure G).
Slovenian: • Injekcijski peresnik držite pod kotom 90 stopinj na očiščeno mesto injiciranja (glejte sliko G).
English: It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks.
Slovenian: Najpogosteje prizadene specifične predele kože, kot je predel pod prsmi, pod pazduhami, notranji del stegen, dimlje in zadnjico.
English: Hefiya is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Slovenian: Zdravilo Hefiya se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri otrocih in mladostnikih, starih 2 do 17 let in artritisa, povezanega z entezitisom pri otrocih in mladostnikih starih od 6 do 17 let.
English: Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab ***,**,* statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo.
Slovenian: i n = 84 placebo in adalimumab j n = 82 placebo in n = 85 adalimumab ***, **, * Statistično pomembno pri p < 0,001, < 0,01 in < 0,05, v tem zaporedju, za vse primerjave med adalimumabom in placebom.
English: Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Slovenian: Domneva se, da luskavico povzroči motnja v delovanju imunskega sistema, ki ima za posledico povečano nastajanje kožnih celic.
English: Hefiya 40 mg solution for injection in pre-filled pen EU/1/18/1287/004
Slovenian: Hefiya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/18/1287/004
English: After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after administration.
Slovenian: Absorpcija in porazdelitev Po subkutani uporabi enega samega 40 mg odmerka sta bili absorpcija in distribucija adalimumaba počasni in največja koncentracija v serumu je bila dosežena približno 5 dni po uporabi.
English: Patients should be tested for HBV infection before initiating treatment with Hefiya.
Slovenian: Bolnike je treba pred začetkom zdravljenja z zdravilom Hefiya testirati na okužbo s HBV.
English: It is important that you tell your baby's doctors and other health care professionals about your Hefiya use during your pregnancy so they can decide when your baby should receive any vaccine.
Slovenian: Zato je pomembno, da obvestite zdravnika vašega otroka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Hefiya, da se lahko odločijo, kdaj bo vaš otrok lahko prejel katerokoli cepivo.