FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the results are uncertain due to limitations in the methods used for serum analyses of infliximab and antibodies against infliximab.
Slovenian: Ti izsledki pa so nezanesljivi zaradi pomanjkljivosti metod, uporabljenih za serumske analize infliksimaba in protiteles proti njemu.
English: In the REACH study, infections were reported in 56.3% of randomised subjects treated with infliximab.
Slovenian: V preskušanju REACH so o okužbah poročali pri 56,3 % randomiziranih preiskovancih, zdravljenih z infliksimabom.
English: If these medicines or treatments do not work well enough, you will be given Remicade to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ali terapije ne delujejo dovolj dobro, boste prejeli zdravilo Remicade za zmanjševanje znakov in simptomov bolezni.
English: Studies in mice deficient in TNF demonstrated no increase in tumours when challenged with known tumour initiators and/or promoters.
Slovenian: Študije pri miših s pomanjkanjem TNF niso pokazale povečanja pogostnosti tumorjev po provokaciji z znanimi sprožilci novih tumorjev in/ali spodbujevalci.
English: Every 6 to 8 weeks depending on your disease
Slovenian: 6 tednov po prvem odmerku nadaljnji odmerki vsakih 6 do 8 tednov, odvisno od vaše bolezni
English: The relative deficiency of TNF caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Slovenian: Relativno pomanjkanje TNF kot posledica anti-TNF terapije lahko sproži avtoimunski proces.
English: Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Slovenian: To zdravilo zavrzite, če ga ne uporabite do izteka novega roka uporabnosti ali roka uporabnosti, natisnjenega na škatli, kar nastopi prej.
English: Thereafter, all subjects continued on infliximab every 6 weeks to week 96.
Slovenian: Potem so vsi preiskovanci nadaljevali z jemanjem infliksimaba na vsakih 6 tednov, do 96. tedna.
English: List of allergies:
Slovenian: Alergije:
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis
Slovenian: • resne težave s kožo, na primer toksična epidermalna nekroliza, Stevens-Johnsonov sindrom in akutna generalizirana eksantematozna pustuloza
English: These skin reactions can be accompanied by fever.
Slovenian: Te kožne reakcije lahko spremlja zvišana telesna temperatura.
English: Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer.
Slovenian: Dosedanji podatki ne kažejo, da zdravljenje z infliksimabom vpliva na tveganje za nastanek displazije ali karcinoma kolona.
English: Invasive fungal infections may present as disseminated rather than localised disease, and antigen and antibody testing may be negative in some patients with active infection.
Slovenian: Invazivne glivične okužbe lahko namesto v obliki lokalizirane nastopajo v obliki diseminirane bolezni, poleg tega pa sta lahko pri nekaterih bolnikih z aktivno okužbo testa na antigen in protitelesa negativna.
English: ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
Slovenian: ≥ 90 % izboljšanje ≥ 75 % izboljšanje ≥ 50 % izboljšanje
English: At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive.
Slovenian: Ob zadnji oceni je bilo 57 % bolnikov, zdravljenih z infliksimabom, še vedno pozitivnih na anti-dsDNA.
English: Sustained response (clinical response at both week 8 and week 30)
Slovenian: Trajnejši odziv (klinični odziv tako v 8. tednu kot v 30. tednu)
English: If you have moderate to severe plaque psoriasis, you will first be given other medicines or treatments, such as phototherapy.
Slovenian: Če imate zmerno do hudo psoriazo s plaki, boste najprej prejeli druga zdravila ali drugo terapijo, npr. fototerapijo.
English: • New or worsening heart failure, slow heart rate
Slovenian: • novo nastalo srčno popuščanje ali poslabšanje srčnega popuščanja, počasen srčni utrip
English: • Tell your doctor straight away if you have signs of an infection.
Slovenian: • Zdravniku morate takoj povedati, če imate znake, ki kažejo na okužbo.
English: • Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Slovenian: • poslabšanje dermatomiozitisa (ki se kaže kot kožni izpuščaj, ki spremlja šibkost mišic)
English: • Serious lung problems (such as interstitial lung disease)
Slovenian: • resne težave s pljuči (na primer intersticijska pljučna bolezen)
English: Administration of Remicade should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Slovenian: Uporabo zdravila Remicade prekinite, če se pri bolniku pojavi nova resna okužba ali sepsa, in mu uvedite ustrezno protimikrobno ali protiglivično terapijo, dokler ne bo okužba obvladana.
English: Reconstitute and dilute before use.
Slovenian: Pred uporabo rekonstituirajte in razredčite.
English: • Tell your surgeon or dentist that you are having treatment with Remicade by showing them your patient reminder card.
Slovenian: • Obvestite kirurga ali zobozdravnika, da prejemate zdravilo Remicade in mu pokažite svojo opozorilno kartico za bolnika.
English: • Some children and teenage patients who have received TNF-blockers such as Remicade have developed cancers, including unusual types, which sometimes resulted in death.
Slovenian: • Pri nekaterih otrocih in najstnikih, ki so prejemali zaviralce TNF, kot je zdravilo Remicade, se je razvil rak, vključno z zelo neobičajnimi oblikami, ki se včasih končajo s smrtnim izidom.
English: Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Slovenian: Infliksimab je monoklonsko protitelo - vrsta beljakovine, ki se veže na določeno tarčo v telesu, imenovano TNF (tumorje nekrotizirajoči faktor) alfa.
English: Dosing continued for all patients through week 46.
Slovenian: Odmerjanje zdravila se je potem nadaljevalo do 46. tedna za vse bolnike.
English: In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%.
Slovenian: V enoletni študiji z večkratnimi infuzijami zdravila pri bolnikih s Crohnovo boleznijo (študija ACCENT I), je bila incidenca reakcij, podobnih serumski bolezni, 2,4 %.
English: Other medicines and Remicade
Slovenian: Druga zdravila in zdravilo Remicade
English: Tuberculosis (TB)
Slovenian: Tuberkuloza (TBC)
English: Placebo (week 16)
Slovenian: Placebo (16. teden)
English: Tell your doctor if you are using or have recently used any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Slovenian: Obvestite zdravnika, če jemljete ali ste pred kratkim jemali katero koli zdravilo, vključno s katerimi koli drugimi zdravili za zdravljenje Crohnove bolezni, ulceroznega kolitisa, revmatoidnega artritisa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze in z zdravili, ki se jih dobi brez recepta, kot so vitamini in rastlinski pripravki.
English: • Tell your doctor before you are given Remicade if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Slovenian: • Preden prejmete zdravilo Remicade, povejte zdravniku, če ste kdaj živeli v ali potovali po krajih, kjer so pogoste okužbe, imenovane histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: Currently available pharmacokinetic data are described in section 5.2 but no recommendation on a posology can be made in children younger than 6 years.
Slovenian: Trenutno razpoložljivi farmakokinetični podatki so opisani v poglavju 5.2, vendar ni mogoče podati priporočil za odmerjanje za otroke, mlajše od 6 let.
English: In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Slovenian: Zaradi izboljšanja sledljivosti bioloških zdravil morata biti jasno zabeležena lastniško ime in številka serije uporabljenega zdravila.
English: • Abnormal tissue swelling or growth
Slovenian: • nenormalno otekanje ali rast tkiva
English: • Collections of immune cells resulting from an inflammatory response (granulomatous lesions)
Slovenian: • kopičenje imunskih celic zaradi vnetnega odziva (granulomatozne lezije)
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Remicade treatment.
Slovenian: Ženske v rodni dobi morajo za preprečevanje nosečnosti razmisliti o uporabi ustrezne kontracepcije in z njo nadaljevati še najmanj 6 mesecev po zaključku zdravljenja z zdravilom Remicade.
English: In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of Remicade, or modification of concomitant therapy.
Slovenian: Na splošno bolniki, pri katerih se je pojavilo zvišanje ALT in AST, niso imeli simptomov in nenormalni izvidi so se zmanjšali ali normalizirali bodisi z nadaljevanjem ali z ukinitvijo zdravljenja z zdravilom Remicade, ali pa ob prilagoditvi drugih sočasnih terapij.
English: A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria: (1) evaluator's global assessment, (2) patient's global assessment, (3) functional/disability measure, (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
Slovenian: Zmanjšanje znakov in simptomov so opredelili kot najmanj 20 % izboljšanje (ACR 20) števila bolečih in oteklih sklepov ter 3 od naslednjih 5 meril: (1) zdravnikove splošne ocene, (2) bolnikove splošne ocene, (3) merila funkcionalne prizadetosti/neprizadetosti, (4) vizualne analogne lestvice bolečine in (5) hitrosti sedimentacije eritrocitov ali C-reaktivnega proteina.
English: • Liver problem that causes yellowing of the skin or eyes (jaundice)
Slovenian: • težave z jetri, ki povzročajo porumenelost kože ali oči (zlatenica)
English: Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Slovenian: Janssen Biologics B.V., Einsteinweg 101 2333 CB Leiden, Nizozemska
English: • Swelling of small blood vessels (vasculitis)
Slovenian: • otekanje majhnih krvnih žil (vaskulitis)
English: • Temporary loss of sight during or within 2 hours of infusion
Slovenian: • začasna izguba vida med infundiranjem ali v roku 2 ur po infundiranju
English: The effect of concomitant immunomodulator therapy was more profound in episodically-treated patients than in patients given maintenance therapy.
Slovenian: Učinek sočasne terapije z imunomodulatorji je bil močnejši pri občasno zdravljenih bolnikih kot pri tistih na vzdrževalni terapiji.
English: • Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Remicade.
Slovenian: • Zdravnik vam bo dal tudi opozorilno kartico za bolnika, na kateri so navedeni pomembnejši varnostni podatki, ki jih morate poznati, preden prejmete zdravilo Remicade in tudi med zdravljenjem z njim.
English: Instructions for use and handling - reconstitution, dilution and administration
Slovenian: Navodila za uporabo in ravnanje z zdravilom - rekonstitucija, redčenje in infundiranje
English: This patient reminder card contains important safety information that you need to be aware of before and during treatment with Remicade.
Slovenian: Ta opozorilna kartica za bolnika vsebuje pomembne varnostne informacije, ki jih morate poznati preden prejmete zdravilo Remicade ter med zdravljenjem z njim.
English: • Viral infections such as herpes or flu
Slovenian: • virusne okužbe, na primer herpes ali gripa
English: You may receive some vaccines during treatment with Remicade but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remicade because they may cause infections.
Slovenian: Med zdravljenjem z zdravilom Remicade lahko prejmete nekatera cepiva, vendar med uporabo zdravila Remicade ne smete prejeti živih cepiv (cepiv, ki vsebujejo žive, a oslabljene povzročitelje okužb), saj lahko le-ta povzročijo okužbo.
English: A response was observed within 2 weeks, with a maximum response at 4 weeks.
Slovenian: Klinični odziv na zdravljenje so ugotavljali v roku 2 tednov, največji odziv pa po 4 tednih.
English: A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
Slovenian: Skupaj 573 bolnikov z zmerno do hudo aktivno Crohnovo boleznijo (CDAI ≥ 220 ≤ 400) je prejelo enkratno infuzijo odmerka 5 mg/kg v tednu 0.
English: Remicade should be administered intravenously over a 2 hour period.
Slovenian: Zdravilo Remicade je treba dajati intravensko v času 2 ur.
English: In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
Slovenian: V preskušanju C0168T72 so bili najpogostejši neželeni učinki okužba zgornjih dihal, faringitis, bolečine v trebuhu, zvišana telesna temperatura in glavobol.
English: Rheumatoid arthritis The usual dose is 3 mg for every kg of body weight.
Slovenian: Revmatoidni artritis Običajni odmerek je 3 mg na kg telesne mase.
English: It is unknown whether infliximab is excreted in human milk or absorbed systemically after ingestion.
Slovenian: Ni znano, ali se infliksimab izloča v materino mleko pri človeku, niti ali se po zaužitju sistemsko absorbira.
English: • Infections due to a weakened immune system
Slovenian: • okužbe zaradi oslabljenega imunskega sistema
English: At 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Slovenian: Čez 102 tedna se je 49 preiskovancev še vedno zdravilo z infliksimabom in od tega jih je imelo 30 (61 %) odziv BASDAI 50.
English: Nine of these patients developed malignancies, including 1 lymphoma.
Slovenian: Devet od teh bolnikov je dobilo malignom, med njimi eden celo limfom.
English: The pharmacokinetics of infliximab in elderly patients has not been studied.
Slovenian: Farmakokinetike infliksimaba pri starejših bolnikih niso raziskovali.
English: Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Slovenian: Remicade je v kombinaciji z metotreksatom indiciran za zmanjšanje znakov in simptomov ter izboljšanje funkcije sklepov:
English: In all cases, Remicade treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Slovenian: V vseh primerih je bilo zdravljenje z zdravilom Remicade ukinjeno in/ali so bolniku uvedli drugo zdravljenje, znaki in simptomi bolezni pa so izginili.
English: • Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
Slovenian: • Zdravniku povejte, če imate hepatitis B ali če sumite, da ste nosilec virusa hepatitis B.
English: • Stomach pain, feeling sick
Slovenian: • želodčne bolečine, občutek slabosti
English: Discontinuation of immunomodulators and corticosteroid taper were permitted after week 0.
Slovenian: Prenehanje uporabe imunomodulatorjev in zmanjševanje odmerka kortikosteroidov sta bila dovoljena po tednu 0.
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease,
Slovenian: • resne težave z živčevjem, na primer transverzni mielitis, multipli sklerozi podobna bolezen,
English: Paediatric Crohn's disease (6 to 17 years)
Slovenian: Pediatrična Crohnova bolezen (6 do 17 let)
English: Remicade and Orencia should not be used together.
Slovenian: Zdravili Remicade in Orencia se ne smeta uporabljati skupaj.
English: The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess.
Slovenian: Najpogosteje prijavljene okužbe so bile okužbe zgornjih dihal in faringitis, medtem ko je bila najpogosteje prijavljena resna okužba absces.
English: Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).
Slovenian: Uporabite lahko le infuzijske komplete, opremljene z linijskim, sterilnim, nepirogenim filtrom, ki le malo veže beljakovine (velikost por 1,2 mikrometra ali manj).
English: There have been reports of active tuberculosis in patients receiving Remicade.
Slovenian: Bilo je nekaj poročil o aktivni tuberkulozi pri bolnikih, ki so prejemali zdravilo Remicade.
English: Clinical Remission
Slovenian: Klinična remisija
English: Remicade infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Slovenian: Infuzije zdravila Remicade morajo bolniku dajati kvalificirani zdravstveni delavci, ki so usposobljeni za ugotavljanje morebitnih težav pri infundiranju zdravil.
English: Table 2 Proportion of patients with increased ALT activity in clinical studies
Slovenian: Preglednica 2 Delež bolnikov s povišano vrednostjo ALT v kliničnih preskušanjih
English: Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Slovenian: Znaki vključujejo spremembe vida, šibkost v rokah in nogah, odrevenelost ali mravljinčenje v katerem koli delu telesa.
English: Name doctor:
Slovenian: Ime zdravnika:
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Slovenian: Pri spremljanju dolgoročne varnosti infliksimaba do 5 let po kliničnih študijah, to pomeni pri skupaj 6.234 bolnikih x letih (3.210 bolnikov), pa so poročali o 5 primerih limfoma in 38 primerih nelimfomskih rakavih bolezni.
English: Children may receive some vaccines during treatment with Remicade but should not receive live vaccines while using Remicade.
Slovenian: Otroci lahko med zdravljenjem z zdravilom Remicade prejmejo nekatera cepiva, vendar med uporabo zdravila Remicade ne smejo prejeti živih cepiv.
English: Remicade belongs to a group of medicines called ‘TNF blockers'.
Slovenian: Zdravilo Remicade spada v skupino zdravil, ki se imenujejo zaviralci TNF.
English: • Children should receive recommended vaccinations before starting Remicade treatment.
Slovenian: • Otroci morajo prejeti priporočena cepljenja, preden se začnejo zdraviti z zdravilom Remicade.
English: • Narrowed airway in the lungs, causing difficulty breathing
Slovenian: • zoženje dihalnih poti v pljučih, ki povzroča težave z dihanjem
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF) inhibitors, ATC code: L04AB02.
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNF), oznaka ATC: L04AB02.
English: In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed versus baseline.
Slovenian: Poleg tega so opazili statistično in klinično pomembno izboljšanje kakovosti življenja in dosežene višine otrok pa tudi bistveno zmanjšanje porabe kortikosteroidov v primerjavi z začetkom preskušanja.
English: It should be noted that suppression of TNF may mask symptoms of infection such as fever.
Slovenian: Treba je tudi poudariti, da lahko zaviranje TNF prikrije simptome okužbe, npr. zvišano telesno temperaturo.
English: Names and addresses of the manufacturer(s) of the biological active substance(s)
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
English: The usual dose is 5 mg for every kg of body weight.
Slovenian: Običajni odmerek je 5 mg na kg telesne mase.
English: Remicade should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Zdravilo Remicade morate uporabljati previdno pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA).
English: If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.
Slovenian: Če bolnik po daljšem obdobju ponovno prejme zdravilo Remicade, ga morate skrbno spremljati zaradi morebitnega pojava znakov in simptomov pozne preobčutljivosti.
English: TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Slovenian: TNF-alfa sodeluje v procesu vnetja v telesu, zato se z njegovim zaviranjem vnetje v telesu lahko zmanjša.
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leucopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Slovenian: O naslednjih neželenih učinkih so poročali pogosteje pri pediatričnih bolnikih s Crohnovo boleznijo v študiji REACH (glejte poglavje 5.1) kot pri odraslih bolnikih s Crohnovo boleznijo: anemija (10,7 %), kri v blatu (9,7 %), levkopenija (8,7 %), zardevanje (8,7 %), virusna okužba (7,8 %), nevtropenija (6,8 %), bakterijska okužba (5,8 %), alergijska reakcija dihal (5,8 %).
English: In post-marketing spontaneous reporting, infections are the most common serious adverse reaction.
Slovenian: V spontanih poročilih iz obdobja trženja so okužbe navedene kot najpogostejši resen neželeni učinek.
English: The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
Slovenian: Delež bolnikov z okužbami je bil v preskušanju C0168T72 podoben kot v študiji Crohnove bolezni pri pediatričnih bolnikih (REACH), a večji od deleža v študijah ulceroznega kolitisa pri odraslih bolnikih (ACT 1 in ACT 2).
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with Remicade at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Slovenian: V poskusnem kliničnem preskušanju pri bolnikih z zmerno do hudo KOPB, ki so bili bodisi aktivni kadilci ali bivši kadilci, je bilo 157 odraslih bolnikov zdravljenih z zdravilom Remicade v odmerkih, podobnih tistim, ki se uporabljajo pri revmatoidnem artritisu in pri Crohnovi bolezni.
English: Of the infliximab-treated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.
Slovenian: Pri bolnikih, zdravljenih z infliksimabom, ki so prejeli najmanj eno skrajšano infuzijo, so se z infuzijo povezane reakcije pojavljale pri 15 % bolnikov, resne z infuzijo povezane reakcije pa pri 0,4 % bolnikov.
English: The powder is a freeze-dried white pellet.
Slovenian: Prašek vsebuje liofilizirane bele pelete.
English: In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus Calmette-Guérin (BCG) infection has been reported following administration of BCG vaccine after birth.
Slovenian: Pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu, so poročali o smrtnem izidu zaradi razsejane okužbe s Calmette-Guerinovim bacilom (BCG) po cepljenju s cepivom BCG po rojstvu.