FrancophonIA/ELRC3.0 huggingface dataset:
English: In all situations described below, the benefit / risk balance of therapy should be very carefully considered.
Slovenian: V vseh spodaj opisanih okoliščinah je treba korist in tveganje zdravljenja z zdravilom Hefiya zelo natančno pretehtati.
English: These patients also had objective evidence of inflammation in the sacroiliac joints or spine on MRI or elevated hs-CRP.
Slovenian: Ti bolniki so imeli tudi objektivne znake vnetja sakroiliakalnih sklepov ali hrbtenice na MRI ali povišan hs-CRP.
English: One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Slovenian: Sto bolnikov (n = 100) iz študije Crohnove bolezni pri pediatričnih bolnikih je nadaljevalo v odprti dolgoročni podaljšani študiji.
English: • You may see a drop of liquid at the end of the needle.
Slovenian: • Na koncu igle lahko opazite kapljico tekočine.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in table 26.
Slovenian: Stopnja klinične remisije in kliničnega odziva (definiran kot zmanjšanje vrednosti PCDAI vsaj za 15 točk od začetne vrednosti) sta predstavljena v preglednici 26.
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Slovenian: Klinično remisijo (opredeljeno kot ocena Mayo ≤ 2 in nobena podocena > 1) so ocenili 8. teden.
English: 40 mg every other week in combination with methotrexate
Slovenian: 40 mg vsak drugi teden v kombinaciji z metotreksatom
English: Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Slovenian: Zaradi reakcij na injekcijskem mestu uporabe zdravila praviloma ni bilo treba prekiniti.
English: • Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Hefiya in case they cause infections.
Slovenian: • Določena cepiva lahko vsebujejo žive, vendar oslabljene oblike bakterij ali virusov, ki povzročajo bolezen, in teh cepiv se med zdravljenjem z zdravilom Hefiya ne sme uporabljati, da ne bi povzročila okužb.
English: Table 21 efficacy results at 12 weeks, HS studies I and II
Slovenian: Preglednica 21: rezultati učinkovitosti v 12. tednu, HS študiji I in II
English: If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.
Slovenian: Če imate KOPB ali če veliko kadite, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNFα za vas primerno.
English: Do not use this medicine after the expiry date which is stated on the label / blister / carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/pretisnem omotu/škatli poleg oznake “EXP”.
English: If you receive Hefiya while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Slovenian: Če prejemate zdravilo Hefiya med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
English: • Using a circular motion, clean the injection site with an alcohol wipe.
Slovenian: • S krožnim gibom obrišite mesto injiciranja z alkoholnim zložencem.
English: The highest dose level evaluated has been multiple intravenous doses of 10 mg / kg, which is approximately 15 times the recommended dose.
Slovenian: Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/kg, kar je približno 15-kraten priporočen odmerek.
English: Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25.
Slovenian: Izidi poročil bolnikov glede opravil, povezanih z vidom, so bili merjeni v obeh kliničnih študijah z uporabo vprašalnika NEI VFQ-25.
English: 48.9a percent change in total fingernail NAPSI (%)
Slovenian: 6,9 48,9a odstotek spremembe v celotnem indeksu NAPSI
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
Slovenian: • poslabšanje stanja, ki se imenuje dermatomiozitis (viden kot kožni izpuščaj, ki ga spremlja mišična šibkost).
English: • allergic reactions (including seasonal allergy);
Slovenian: • alergijske reakcije (vključno s sezonskimi alergijami);
English: Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Slovenian: Neinfekcijski uveitis je vnetna bolezen, ki prizadene določene dele očesa.
English: Your doctor may decide to stop treatment.
Slovenian: Morda se bo odločil, da vaše zdravljenje prekine.
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Slovenian: Z zdravjem povezano kakovost življenja in telesno funkcijo so ocenjevali s pomočjo vprašalnikov HAQ-S in SF-36.
English: Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by week 19.
Slovenian: Bolniki so bili kasneje deležni obveznega programa postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 19. tedna.
English: Approximately 40 % of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Slovenian: Pri približno 40 % bolnikih v študiji UC-II predhodno anti-TNF zdravljenje z infliksimabom ni bilo uspešno.
English: Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades).
Slovenian: Bolniki, ki so dosegli PASI 75 in PGA čisto ali minimalno, so bili z zdravljenja odpuščeni in spremljani do 36 tednov glede izgube nadzora nad boleznijo (tj. poslabšanje PGA za najmanj 2 stopnji).
English: Improvement in quality of life was measured up to week 156 (36 months) and improvement was maintained through that time.
Slovenian: Do 156. tedna (36. meseca) se je ocenjevalo izboljšanje kvalitete življenja, ki se je v tem času tudi ohranilo.
English: Disease flare criteria were defined as a worsening of ≥ 30 % from baseline in ≥ 3 of 6 paediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30 % in no more than 1 of the 6 criteria.
Slovenian: Merila zagona bolezni so bila opredeljena kot poslabšanje ≥ 3 od 6 osnovnih meril pediatric ACR za ≥ 30 % v primerjavi z izhodiščem, ≥ 2 aktivna sklepa in izboljšanje ne več kot 1 od 6 meril za > 30 %.
English: In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Slovenian: V raziskavi razvojne toksičnosti pri opicah ni bilo znakov maternalne toksičnosti, embriotoksičnosti ali teratogenosti.
English: The primary efficacy endpoint in both studies was ‘time to treatment failure'.
Slovenian: Primarni opazovani dogodek kot merilo učinkovitosti je bil v obeh študijah ‘čas do neuspeha zdravljenja'.
English: Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
Slovenian: Zdravljenje prek 12. tedna ni prineslo značilno več odzivov (glejte poglavje 4.2).
English: 36.8 % (14 / 38) 64.9 % (24 / 37)b 43.3 % (13 / 30) 71.4 % (20 / 28)c median time to disease flare
Slovenian: 36,8 % (14/38) 64,9 % (24/37)b 43,3 % (13/30) 71,4 % (20/28)c srednji čas do zagona bolezni
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Hefiya.
Slovenian: • Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom Hefiya preiskal glede znakov in simptomov tuberkuloze.
English: Special populations
Slovenian: Posebne populacije Starejši
English: Other medicines and Hefiya
Slovenian: Druga zdravila in zdravilo Hefiya
English: The corresponding proportions of patients with no radiographic progression were 31.3 %, 23.7 % and 36.7 % respectively.
Slovenian: Ustrezni deleži bolnikov, ki niso imeli rentgenografskih znakov napredovanja, so bili 31,3 %, 23,7 % oz. 36,7 %.
English: Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy.
Slovenian: Adalimumab lahko prehaja skozi placento v serum dojenčkov, ki so jih rodile ženske, zdravljene z adalimumabom med nosečnostjo.
English: Traceability
Slovenian: Sledljivost
English: b patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders.
Slovenian: b bolniki, ki izpolnjujejo merila, določena v protokolu za izgubo odziva ali brez izboljšanja, so bili izključeni iz študij in so še šteli pod bolnike brez odgovora (“nonresponders”).
English: Table 25 maintenance regimen patient weight low dose standard dose
Slovenian: Preglednica 25 vzdrževalni režim bolnikova telesna masa majhni odmerek standardni odmerek
English: Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Slovenian: Uporaba živih cepiv (npr. BCG cepiva) pri dojenčkih, ki so bili izpostavljeni adalimumabu in utero, ni priporočljiva še 5 mesecev po materini zadnji injekciji adalimumaba med nosečnostjo.
English: Consequently, these infants may be at increased risk for infection.
Slovenian: Posledično je lahko tveganje za okužbe pri teh dojenčkih večje.
English: primary analysis (ITT) placebo adalimumab time to treatment failure at or after week 2 in study UV II
Slovenian: primarna analiza (ITT) placebo adalimumab čas do neuspeha zdravljenja v ali po 2. tednu v študiji UV II
English: • The recommended injection site is the front of your thighs.
Slovenian: • Priporočeno mesto injiciranja je sprednji del stegen.
English: In Study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Slovenian: V študiji UV II so opazili statistično pomembne razlike samo za ostrino vida, toda tudi ostale komponente so bile glede številk v korist adalimumaba.
English: • Check the green indicator fills the window and has stopped moving (see Figure I).
Slovenian: • Preverite, da je zeleni kazalnik zapolnil okence in se je nehal premikati (glejte sliko I).
English: Treatment with Hefiya can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Slovenian: Zdravljenje z zdravilom Hefiya se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
English: b 2-sided p value from log rank test.
Slovenian: b 2-stranska vrednost p testa log-rank.
English: 6336 Langkampfen Austria
Slovenian: 6336 Langkampfen Avstrija
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje adalimumab, za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Among the patients who discontinued the study prior to week 78, 11 % discontinued due to adverse events, and 5 % due to insufficient response to adalimumab treatment.
Slovenian: Med bolniki, ki so prekinili študijo pred 78. tednom, jih je 11 % prekinilo študijo zaradi neželenih učinkov in 5 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
English: Table 29 time to treatment failure in studies UV I and UV II
Slovenian: Preglednica 29 čas do neuspeha zdravljenja v študijah UV I in UV II
English: • serious infections (including blood poisoning and influenza);
Slovenian: • resne okužbe (vključno z zastrupitvijo krvi in gripo);
English: • pain in the muscles.
Slovenian: • bolečina v mišicah.
English: This risk may increase if your lung function is reduced.
Slovenian: Tveganje je lahko večje, če imate zmanjšano delovanje pljuč.
English: • multiple sclerosis;
Slovenian: • multipla skleroza;
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Hefiya and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.
Slovenian: • Če imate alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Hefiya ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Slovenian: • Zdravniku povejte, če ste nosilec virusa hepatitisa B (HBV), če imate aktivno okužbo sHBV ali če mislite, da bi se lahko nalezli HBV.
English: Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Slovenian: Adalimumab je značilno zmanjšal tveganje za neuspeh zdravljenja za 75 % glede na placebo, kot prikazuje razmerje ogroženosti (HR = 0,25 [95 % IZ: 0,12, 0,49]).
English: The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Slovenian: Tarča adalimumaba je druga beljakovina, ki se imenuje tumorje nekrotizirajoči faktor (TNFα), ki je prisoten v povečanih koncentracijah pri zgoraj navedenih vnetnih boleznih.
English: Fertility Preclinical data on fertility effects of adalimumab are not available.
Slovenian: Predkliničnih podatkov o učinkih adalimumaba na plodnost ni na voljo.
English: Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Slovenian: Nastanek protiteles proti adalimumabu spremljata večji očistek in manjša učinkovitost adalimumaba.
English: Figure C: needle guard is not activated - the syringe is ready for use
Slovenian: Slika C: Ščitnik za iglo ni aktiviran - injekcijska brizga je pripravljena za uporabo
English: In RA study III, these improvements were maintained throughout 52 weeks.
Slovenian: V študiji revmatoidnega artritisa III so se ta izboljšanja ohranila 52 tednov.
English: Maintenance of clinical remission was evaluated in CD study III (CHARM).
Slovenian: Vzdrževanje klinične remisije je ocenjevala študija pri Crohnovi bolezni III (CHARM).
English: The patients improved following discontinuation of therapy.
Slovenian: Stanje bolnikov se je po prekinitvi zdravljenja izboljšalo.
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Slovenian: Če sumite na latentno tuberkulozo, se posvetujte z zdravnikom, ki ima izkušnje z zdravljenjem tuberkuloze.
English: Figure D: needle guard is activated - do not use o In this configuration the needle guard is
Slovenian: Slika D: Ščitnik za iglo je aktiviran - ne uporabite o V tej konfiguraciji ščitnik za iglo NI
English: Since exposure to adalimumab can be affected by body size, adolescents with higher body weight and inadequate response may benefit from receiving the recommended adult dose of 40 mg every week.
Slovenian: Ker lahko velikost telesa vpliva na izpostavljenost adalimumabu, lahko mladostnikom z večjo telesno maso in nezadostnim odzivom na zdravljenje koristi jemanje priporočenega odmerka za odrasle, 40 mg vsak teden.
English: • new onset or worsening of psoriasis;
Slovenian: • izpadanje las; • pojav ali poslabšanje psoriaze;
English: Of the 417 subjects included in the uncontrolled long-term extension of studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Slovenian: Od 417 bolnikov, ki so bili vključeni v nekontrolirani dolgoročni podaljšek študij UV I in UV II, je bilo 46 bolnikov neprimernih (npr. razvili so se zapleti, sekundarno ob diabetični retinopatiji zaradi kirurškega posega sive mrene ali vitrektomije) in so bili izključeni iz primarne analize učinkovitosti.
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Slovenian: Za kombinirano uporabo z drugimi imunomodulirajočimi zdravili razen metotreksata glejte poglavji 4.4 in 5.1.
English: Of the 371 remaining patients, 276 evaluable patients reached 78 weeks of open-label adalimumab treatment.
Slovenian: Od preostalih 371 bolnikov je 276 ovrednotenih bolnikov zaključilo 78-tedensko odprto zdravljenje z adalimumabom.
English: Some of those patients were also treated with the medicines azathioprine or mercaptopurine.
Slovenian: Nekateri od teh bolnikov so bili zdravljeni tudi z zdraviloma azatioprinom ali merkaptopurinom.
English: In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Slovenian: V študiji UC-II je zdravljenje z adalimumabom pripeljalo do izboljšanja rezultatov Vprašalnika o vnetni bolezni črevesa (IBDQ - Inflammatory Bowel Disease Questionaire).
English: A similar safety profile was observed during retreatment as before withdrawal.
Slovenian: Varnostne značilnosti so bile po ponovnem zdravljenju podobne kot pred prenehanjem uporabe.
English: adalimumab n = 274 (95 % confidence interval)
Slovenian: adalimumab n = 274 (95 % interval zaupanja)
English: If such a dose is required, other adalimumab medicines should be used.
Slovenian: Če je potreben tak odmerek, je treba uporabiti druga zdravila z adalimumabom.
English: Figure B: items not included in the carton See “4.
Slovenian: Slika B: Predmeti, ki niso priloženi v škatli Glejte točko ''4.
English: discontinued corticosteroids
Slovenian: prenehanje s kortikosteroidi
English: 10 6250 Kundl Austria
Slovenian: 10 6250 Kundl Avstrija
English: • Do not use if the safety seal has been broken
Slovenian: • Ne uporabite, če je varnostni pečat zlomljen.
English: By attaching to TNFα, Hefiya blocks its action and reduces the inflammation in these diseases.
Slovenian: Z vezavo na TNFα zdravilo Hefiya zavre njegovo delovanje in zmanjša vnetni proces pri teh boleznih.
English: This evaluation should include a detailed medical assessment of patient history of tuberculosis or possible previous exposure to people with active tuberculosis and previous and/or current immunosuppressive therapy.
Slovenian: Pregled mora obsegati podrobno zdravstveno oceno bolnikove anamneze tuberkuloze ali morebitnih predhodnih stikov z ljudmi z aktivno tuberkulozo ter predhodnega in/ali trenutnega imunosupresivnega zdravljenja.
English: Keep Hefiya and all medicines out of the reach of children.
Slovenian: Zdravilo Hefiya in vsa zdravila shranjujte nedosegljivo otrokom.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: • Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: RA study III also had a primary endpoint of changes in quality of life.
Slovenian: Študija revmatoidnega artritisa III je imela kot primarno končno točko tudi spremembe v kakovosti življenja.
English: • If you receive Hefiya during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: • Če prejmete zdravilo Hefiya med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček dobil okužbo.
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96 % of those in serum.
Slovenian: Koncentracije adalimumaba v sinovijski tekočini več bolnikov z revmatoidnim artritisom so bile od 31 do 96 % tistih v serumu.
English: Note: treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Slovenian: Opomba: Neuspeh zdravljenja v ali po 6. tednu (študija UV I) ali v ali po 2. tednu (študija UV II) je bil štet kot dogodek.
English: Serious infections
Slovenian: Resne okužbe
English: If you have ulcerative colitis you will first be given other medicines.
Slovenian: Če imate ulcerozni kolitis, boste najprej dobili druga zdravila.
English: • asthma;
Slovenian: • astma;
English: After doses of 0.5 mg / kg (~40 mg), clearances ranged from 11 to 15 ml / hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Slovenian: Po odmerkih 0,5 mg/kg (~40 mg) je bil očistek od 11 do 15 ml/uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze približno dva tedna.
English: Patients were permitted to be either disease-modifying, antirheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Slovenian: Bolniki so bili lahko bodisi naivni za imunomodulirajoča antirevmatična zdravila bodisi so ohranili svojo prejšnjo revmatološko terapijo pod pogojem, da je bila ta terapija stabilna vsaj 28 dni.
English: Hospitalisation or fatal outcomes associated with infections have been reported.
Slovenian: Opisane so bile hospitalizacije in smrti zaradi okužb.
English: Of those in clinical response at week 4, 48 % had been previously exposed to other TNF-antagonists.
Slovenian: Od tistih, ki so imeli 4. teden klinični odziv, jih je 48 % predhodno dobilo antagoniste TNF.
English: In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.
Slovenian: Na splošno so bili neželeni učinki pri pediatričnih bolnikih po pogostnosti in vrsti podobni neželenim učinkom, opaženih pri odraslih bolnikih.
English: Blood and the lymphatic system disorders*
Slovenian: Bolezni krvi in limfatičnega sistema*
English: Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Slovenian: Zdravljenje z adalimumabom 40 mg vsak teden statistično zmanjša tveganje za poslabšanje abscesov in fistul z izcedkom.
English: The potential risk with the combination of azathioprine or 6mercaptopurine and Hefiya should be carefully considered.
Slovenian: Potrebno je upoštevati potencialno tveganje pri sočasni uporabi azatioprina ali 6-merkaptopurina in zdravila Hefiya.
English: Contents of the pack and other information What Hefiya contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Hefiya
English: In CD study III, at week 4, 58 % (499 / 854) of patients were in clinical response and were assessed in the primary analysis.
Slovenian: V študiji pri Crohnovi bolezni III je imelo 4. teden klinični odziv 58 % (499/854) bolnikov; ti so bili ocenjeni v primarni analizi.
English: Before initiation of therapy with Hefiya, all patients must be evaluated for both active and inactive (“latent”) tuberculosis infection.
Slovenian: Pred začetkom zdravljenja z zdravilom Hefiya je vse bolnike treba pregledati glede aktivne in neaktivne (latentne) tuberkulozne okužbe.
English: RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Slovenian: V študijah III in V je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
English: ANNEX II
Slovenian: PRILOGA III