natgillin/translations-raw huggingface dataset:
Concomitant administration of adalimumab with other biologic DMARDs (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section 4.5). 
Sočasna uporaba adalimumaba z drugimi biološkimi DMARD (tj.anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi možnega povečanega tveganja za okužbe, vključno z resnimi okužbami, in drugih potencialnih farmakoloških interakcij (glejte poglavje 4.5).
Reduction in HS-related skin pain was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale. 
povezane s HS, so ocenili s pomočjo numerične ocenjevalne lestvice pri bolnikih, ki so imeli pri vključitvi v študijo izhodiščni rezultat 3 ali več na 11-stopenjski numerični ocenjevalni lestvici.
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, 
• znake in simptome, ki nakazujejo bolezni krvi, npr. dolgotrajno zvišana telesna temperatura,
c p = 0.083, adalimumab 0.8 mg / kg versus MTX 
c p = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
Adalimumab, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II. 
Uporabo adalimumaba 40 mg vsak drugi teden so pri bolnikih z zmernim do hudim aktivnim psoriatičnim artritisom proučili v dveh s placebom kontroliranih študijah, študijah pri psoriatičnem artritisu I in II.
• increased uric acid in the blood; 
• povečana sečna kislina v krvi;
MTX = methotrexate ** p < 0.01, adalimumab versus placebo 
MTX = metotreksat ** p < 0,01, adalimumab v prim.
• if you drop your pen, do not use it if it looks damaged, or if you dropped it with the cap removed. 
• če injekcijski peresnik spustite, ga ne uporabite, če je videti poškodovan ali če ste ga spustili z odstranjenim pokrovčkom;
MARKETING AUTHORISATION NUMBER(S) 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hefiya. 
Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom Hefiya prejmejo vsa cepljenja, predvidena za njihovo starost, če je le mogoče.
MTX = methotrexate b p = 0.027, adalimumab 0.8 mg / kg versus MTX 
MTX = metotreksat b p = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX
• systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung, 
• sistemski eritematozni lupus (bolezen imunskega sistema, vključno z vnetjem kože, srca, pljuč,
Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. 
Z rentgenskim slikanjem je bilo dokazano, da adalimumab upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
Subjects (n = 215, 54.7 %) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses. 
Preiskovanci (n = 215, 54,7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa so bili obravnavani kot neodzivni bolniki.
Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply). 
Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave (tj. tuberkulinski kožni test in rentgensko slikanje prsnih organov)
− The active substance is adalimumab. 
- Učinkovina je adalimumab.
In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist. 
Med obdobjem trženja so bili opisani primeri levkemije pri bolnikih, zdravljenih z antagonistom TNF.
The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.452.73) with RA and CD combined. 
Prilagojeno razmerje obetov (z ozirom na izhodiščne razlike) je bilo 1.10 (95 % interval zaupanja 0.45-2.73) z RA in CB skupaj.
The safety profile for patients with HS treated with adalimumab weekly was consistent with the known safety profile of adalimumab. 
Varnostni profil bolnikov s HS, ki so bili tedensko zdravljeni z adalimumabom, je v skladu z znanim varnostnim profilom adalimumaba.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
• Crohn's disease, 
• Crohnove bolezni,
The solution should be colourless to slightly yellowish as well as clear to slightly opalescent. 
Raztopina mora biti brezbarvna do rahlo rumenkasta ter bistra do rahlo opalescentna.
The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6 % (median percent change -88.9 %) in patients in the adalimumab group compared to -11.6 % (median percent change -50.0 %) in patients in the placebo group. 
Primarni opazovani dogodek je bil odstotek spremembe od izhodiščne vrednosti do 12. tedna v številu aktivnih sklepov z artritisom (oteklina, ki ni nastala zaradi deformacije ali sklepi z zmanjšano gibljivostjo ter bolečino in/ali občutljivostjo); slednji je bil dosežen s povprečnim zmanjšanjem za -62,6 % (mediana sprememba -88,9 %) pri skupini bolnikov, ki je prejemala adalimumab, v primerjavi z -11,6 % (mediana sprememba -50,0 %) v skupini bolnikov, ki je prejemala placebo.
In the open-label extension for RA study V, ACR response rates were maintained when followed for up to 10 years. 
V odprtem podaljšanju študije revmatoidnega artritisa V so se stopnje odzivov po ACR ohranile tudi do 10 let.
Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks). 
Bolniki, ki so v odprti fazi dosegli trajno remisijo za vsaj 12 tednov (N = 305) (ASDAS < 1,3 v 16., 20., 24. in 28. tednu), so bili nato randomizirani tako, da so prejemali bodisi nadaljevalno zdravljenje z adalimumabom 40 mg vsak drugi teden (N = 152) ali placebo (N = 153) dodatnih 40 tednov v dvojno slepem, s placebom kontroliranem obdobju (celotno trajanje študije 68 tednov).
Consequently, Hefiya can be used during breastfeeding.. 
Posledično se zdravilo Hefiya lahko uporablja med dojenjem.
If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. 
Če imate ankilozirajoči spondilitis ali aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis, boste najprej dobili druga zdravila.
Should treatment be interrupted, Hefiya 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1). 
Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom Hefiya z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis. 
Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih bolnikih s psoriazo v plakih.
• skin cancer; 
• kožni rak;
Physicians should exercise caution when considering the use of Hefiya in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications. 
Pri odločanju za uporabo zdravila Hefiya je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
a time to treatment failure at or after week 6 in study UV I 
Vrednostb čas do neuspeha zdravljenja v ali po 6. tednu v študiji UV I
Crohn's disease is an inflammatory disease of the gut. 
Crohnova bolezen je vnetna bolezen črevesa.
Figure J: lift the needle straight out 
Slika J: Potegnite iglo naravnost ven
Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab / methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment. 
Od 342 oseb, ki so bile od začetka randomizirane na monoterapijo z adalimumabom ali kombinirano zdravljenje z adalimumabom in metotreksatom in so bile vključene v odprto podaljšanje študije, je 171 bolnikov zaključilo 10-letno zdravljenje z adalimumabom.
What Hefiya looks like and contents of the pack 
Izgled zdravila Hefiya in vsebina pakiranja
Based on the observed data approach, 222 (80.4 %) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence. 
Na osnovi pristopa z opaženimi podatki je bilo 222 (80,4 %) bolnikov v remisiji (brez aktivnih vnetnih lezij, ocena celic sprednje očesne komore ≤ 0,5+, motnost steklovine ≤ 0,5+) ob sočasnem jemanju steroidov v odmerku 7,5 mg na dan in pa 184 bolnikov (66,7 %), ki so bili v remisiji in brez steroidov.
Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising antibodies in rodents. 
niti standardne ocene plodnosti ter poporodne toksičnosti, in sicer zato, ker ni ustreznih modelov za protitelo z omejeno navzkrižno reaktivnostjo z glodalskim TNF, in zaradi nastanka nevtralizirajočih protiteles pri glodalcih.
Muscle spasms (including blood creatine phosphokinase increased) 
Neželeni učinki pogosti mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more 
Mladostniki s hidradenitis suppurativa, stari od 12 do 17 let, ki tehtajo 30 kg ali več
In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see table 22). 
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu, je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden, kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden, ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 22).
All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Hefiya. 
Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo zdravila Hefiya pojavijo znaki ali simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away. 
Če dobite zvišano telesno temperaturo, ki ne mine, ali če se vam pojavljajo podplutbe, zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte s svojim zdravnikom.
• oedema (a build-up of fluid in the body which causes the affected tissue to swell); 
• edem (kopičenje tekočine v telesu, ki povzroči otekanje prizadetega tkiva);
Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD. 
Bolniki so morali biti neuspešno zdravljeni s konvencionalno terapijo (vključno s kortikosteroidom in/ali z imunomodulatorjem) zaradi Crohnove bolezni.
Patients were then re-treated with adalimumab 0.8 mg / kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects). 
Bolniki so bili nato znova zdravljeni z adalimumabom v odmerku 0,8 mg/kg vsak drugi teden še nadaljnjih 16 tednov, pri čemer so bile opažene stopnje odziva podobne kot v prejšnjem dvojno slepem obdobju: odziv PASI 75 pri 78,9 % (15 od 19 oseb) in PGA čisto ali minimalno pri 52,6 % (10 od 19 oseb).
Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods. 
V študiji HS-I (PIONEER I) je bilo ocenjenih 307 v dveh obdobjih zdravljenja.
Amongst those who responded at week 16 (n = 144), the paediatric ACR 30 / 50 / 70 /90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study. 
Med bolniki, ki so se odzvali 16. teden (n = 144), so se odzivi »pediatric ACR« 30/50/70/90 v odprti podaljšani fazi ohranili do 6 let pri tistih, ki so ves čas študije dobivali adalimumab.
People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow). 
Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom in levkemijo (raka, ki prizadeneta krvne celice in kostni mozeg).
The mean (± SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥ 40 kg (160 / 80 mg) and 10.6 ± 6.1 µg / ml for patients < 40 kg (80 / 40 mg). 
Srednje (±SD) serumske koncentracije adalimumaba, dosežene v 4. tednu, so bile 15,7 ± 6,6 μg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6,1 μg/ml pri bolnikih < 40 kg (80/40 mg).
• Do not use the syringe if it is broken or the needle guard is activated. 
• Injekcijske brizge ne uporabite, če je poškodovana ali če je aktiviran ščitnik za iglo.
• ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12. 
• ≥ 40 kg: 40 mg vsak teden ali 80 mg vsak drugi teden Če se bolnik ne odzove na zdravljenje do 12. tedna, je potrebno skrbno premisliti o nadaljevanju zdravljenja.
Table 5. 
Preglednica 5.
In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis). 
V kontroliranih in odprtih študijah pri odraslih in otrocih z adalimumabom so poročali o resnih okužbah (vključno s smrtno nevarnimi okužbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidaza, aspergiloza in listerioza).
• pleural effusion (abnormal collection of fluid in the pleural space); 
• plevralna efuzija (nenormalno zbiranje tekočine v plevralnem prostoru);
The pivotal controlled studies involved 6,089 patients receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled period. 
ki podpirajo vlogo za pridobitev dovoljenja za promet, so vključevale 6089 bolnikov, ki so med kontroliranim obdobjem dobivali adalimumab, in 3801 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
Some of these hepatosplenic T-cell lymphomas with adalimumab have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease. 
Pri uporabi adalimumaba so se nekateri od hepatospleničnih limfomov celic T pojavili pri mladih odraslih bolnikih, ki so se sočasno zdravili z azatioprinom ali 6-merkaptopurinom, ki se uporabljata pri vnetni bolezni črevesa.
Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see table 29). 
Klinični odziv Rezultati iz obeh študij kažejo statistično značilno zmanjšanje tveganja za neuspeh zdravljenja pri bolnikih, ki so prejemali adalimumab, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 29).
If you stop using Hefiya 
Če ste prenehali uporabljati zdravilo Hefiya
• inflammation of the pancreas which causes severe pain in the abdomen and back; 
• vnetje trebušne slinavke, ki povzroča težjo bolečino v trebuhu in hrbtu;
If you are concerned with the appearance of the solution, then contact your pharmacist for assistance. 
Če vas skrbi videz raztopine, se po pomoč obrnite na farmacevta.
Adalimumab has not been studied in patients with hepatic or renal impairment. 
Adalimumaba niso proučili pri bolnikih z okvaro jeter ali ledvic.
• If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Hefiya. 
Demielinizirajoča bolezen • Če imate ali pa se pri vas razvija demielinizirajoča bolezen (bolezen, ki prizadene izolacijsko plast okrog živcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobivate zdravilo Hefiya.
How to use Hefiya 
Kako uporabljati zdravilo Hefiya
Available data suggest that the clinical response is usually achieved within 2-8 weeks of treatment. 
Razpoložljivi podatki kažejo, da se klinični odziv po navadi doseže v 2-8 tednih zdravljenja.
• acid reflux disease; 
• bolezen refluksa kisline;
The safety and efficacy of adalimumab were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies. 
Varnost in učinkovitost adalimumaba so ocenili pri več kot 1500 bolnikih z zmerno do zelo aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih,
Hefiya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). 
Zdravilo Hefiya je v kombinaciji z metotreksatom indicirano za zdravljenje aktivnega poliartikularnega juvenilnega idiopatskega artritisa pri bolnikih od 2. leta starosti, ki se ne odzovejo ustrezno na eno ali več imunomodulirajočih antirevmatičnih zdravil.
The combination of adalimumab and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”). 
Kombinacija adalimumaba in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARD ali antagonistov TNF”).
The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7 %) in the adalimumab-treated women with RA and 5/74 (6.8 %) in the untreated women with RA (unadjusted OR 1.31, 95 % CI 0.38-4.52) and 16/152 (10.5 %) in the adalimumabtreated women with CD and 3/32 (9.4 %) in the untreated women with CD (unadjusted OR 1.14, 95 % CI 0.31-4.16). 
Razmerje nosečnosti, ki so se končale vsaj z enim živorojenim otrokom z večjim defektom ob rojstvu je bilo 6/69 (8,7 %) pri nosečnicah, zdravljenih z adalimumabom z RA, in 5/74 (6,8 %) pri nezdravljenih nosečnicah z RA (neprilagojeno razmerje obetov 1.31, 95 % interval zaupanja 0.38-4.52), ter 16/152 (10,5 %) pri nosečnicah, zdravljenih z adalimumabom s CB, in 3/32 (9,4 %) pri nezdravljenih nosečnicah s CB (neprilagojeno razmerje obetov 1.14, 95 % interval zaupanja 0.31-4.16).
In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6 % (5 / 192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline. 
V preskušanju faze 3 z adalimumabom pri bolnikih s pediatrično Crohnovo boleznijo, kjer so ocenjevali učinkovitost in varnost dveh telesni masi prilagojenih vzdrževalnih režimov odmerjanja, ki sta sledila telesni masi prilagojenemu začetnemu zdravljenju do 52 tednov zdravljenja, so se pojavila zvišanja ALT ≥ 3 x ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
Hefiya is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). 
Zdravilo Hefiya je indicirano za zdravljenje aktivne, zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih in mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp Score (see table 10). 
V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 10).
Figure 1: Kaplan-Meier Curves summarizing time to flare in study nr-axSpA II 
Slika 1: Kaplan-Meier-jeve krivulje povzemajo čas do ponovnega zagona bolezni v študiji nr-axSpA II
Do not remove the cap until you are ready to inject. 
Pokrovčka ne odstranjujte, dokler niste pripravljeni na injiciranje.
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class (SOC) and frequency in table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data). 
zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) (<1/10.000).
In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients. 
V kontroliranih delih kliničnih preizkušanj z antagonisti TNF je bilo opaženih več primerov malignomov, vključno z limfomi, tako pri bolnikih, ki so prejemali antagonist TNF, kot pri kontrolnih bolnikih.
• Keep the plunger fully pressed down while you carefully lift the needle straight out from the injection site and let go of your skin (see Figure J). 
• Bat držite v najnižjem položaju, iglo pa previdno potegnite naravnost ven iz mesta injiciranja in spustite kožo (glejte sliko J).
• neuropathy (nerve damage); 
• nevropatija (poškodba živcev);
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN). 
Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, študiji pri
If these medicines do not work well enough, you will be given Hefiya. 
Če ta zdravila ne bodo dovolj dobro delovala, boste dobili zdravilo Hefiya.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX) 
NOTRANJA ŠKATLA ZA VEČKRATNO PAKIRANJE (BREZ MODREGA OKVIRČKA)