natgillin/translations-raw huggingface dataset:
• The 1st click indicates the injection has started. 
• 1. klik pomeni, da se je injiciranje začelo.
Moderate to severe heart failure (NYHA class III / IV) (see section 4.4). 
Zmerno do hudo srčno popuščanje (razred III/IV po NYHA) (glejte poglavje 4.4).
In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years. 
V obdobju pomarketinške uporabe od januarja 2003 do decembra 2010, pretežno pri bolnikih z revmatoidnim artritisom, je bil zabeleženi delež malignomov približno 2,7 na 1000 bolnikov-let zdravljenja.
It is recommended that you use an antiseptic wash daily on the affected areas. 
Priporočljivo je, da na prizadetih področjih vsak dan uporabite antiseptično čistilno tekočino.
3 defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post-Baseline visits 
3 definiran kot zaprtje vseh fistul, ki so bile prisotne ob začetku študije na vsaj 2 zaporednih obiskih po začetku
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Hefiya. 
Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Hefiya.
• There may be a small amount of blood at the injection site. 
• Na mestu injiciranja je lahko malo krvi.
Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB04 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB04.
These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes. 
Takšne okužbe se pri uporabnikih antagonistov TNF niso pojavljale vedno, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
Drop outs due to reasons other than treatment failure were censored at the time of dropping out. 
Prekinitve sodelovanja zaradi razlogov, ki niso bili posledica neuspeha zdravljenja so bile cenzurirane ob prekinitvi sodelovanja.
If you forget to give yourself an injection, you should inject the next dose of Hefiya as soon as you remember. 
Če pozabite dati injekcijo, si morate naslednji odmerek zdravila Hefiya injicirati, čim se spomnite.
Sarcoidosis1), vasculitis 
občasni sarkoidoza1), vaskulitis
The impact of longterm treatment with adalimumab on the development of autoimmune diseases is unknown. 
Vpliv dolgoročnega zdravljenja z adalimumabom na nastanek avtoimunskih bolezni ni znan.
The criteria determining treatment failure were worsening or sustained non-improvement in ocular inflammation, partial improvement with development of sustained ocular co-morbidities or worsening of ocular co-morbidities, non-permitted use of concomitant medications, and suspension of treatment for an extended period of time. 
Merila, s katerimi so določali neuspeh zdravljenja, so bili poslabšanje ali vztrajno neizboljšanje očesnega vnetja, delno izboljšanje z razvojem trajnih sočasnih očesnih bolezni ali poslabšanjem sočasnih očesnih bolezni, nedovoljena uporaba sočasnih zdravil ter prekinitev zdravljenja za daljše časovno obdobje.
Across all indications in clinical trials patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment. 
Bolniki z zvišanim ALT, ne glede na indikacijo v kliničnih preskušanjih, so bili asimptomatski in v večini primerov so bila zvišanja prehodna ter so izzvenela med nadaljnim zdravljenjem.
week 26 
26. teden
Psoriasis Study I (REVEAL) evaluated 1,212 patients within three treatment periods. 
Študija pri psoriazi I (REVEAL) je ocenila 1.212 bolnikov v treh obdobjih zdravljenja.
week 52 
52. teden
The proportions of subjects with PedACR50 / 70 / 90 at week 12 and week 24 were 90.3 % / 61.3 % / 38.7 % and 83.3 % / 73.3 % / 36.7 %, respectively. 
Deleži preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
What you need to know before you use Hefiya Do not use Hefiya 
Kaj morate vedeti, preden boste uporabili zdravilo Hefiya Ne uporabljajte zdravila Hefiya
Return the syringe and the package it came in to the pharmacy. 
Injekcijsko brizgo in ovojnino, v kateri ste jo dobili, vrnite v lekarno.
Treatment with Hefiya should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. 
Zdravljenja z zdravilom Hefiya se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab. 
Nekaterim bolnikom, ki so bili uspešno zdravljeni zaradi aktivne tuberkuloze, se je med terapijo z adalimumabom ponovno razvila tuberkuloza.
Administration of adalimumab without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1). 
Uporaba adalimumaba brez metotreksata je zvečala nastajanje protiteles, zvečala očistek in zmanjšala učinkovitost adalimumaba (glejte poglavje 5.1).
• If you are about to have surgery or dental procedures tell your doctor that you are taking Hefiya. 
• Če boste imeli kirurški poseg ali poseg na zobeh, povejte svojemu zdravniku, da jemljete zdravilo Hefiya.
• double vision; 
• dvojni vid;
• Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common. 
• Zdravniku povejte, če ste živeli na območju ali ste potovali v predele, kjer so pogoste glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. 
Luskavica v plakih lahko prizadene tudi nohte, ki postanejo krušljivi, zadebeljeni in se dvignejo od nohtne posteljice, kar je lahko boleče.
Patients who had been randomised to placebo in period A were assigned to receive placebo in period B. 
Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdobju B prejemali placebo.
Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive). 
Reaktivacijo hepatitisa B so opažali pri bolnikih, ki so dobivali antagonist TNF (vključno z adalimumabom) in ki so bili kronični nosilci virusa (tj. pozitivni na površinski antigen).
At week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 21). 
V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 21).
• ulcerative colitis and 
• ulceroznega kolitisa in
• Slowly release the plunger and allow the needle safety guard to automatically cover the exposed needle (see Figure K). 
• Počasi spuščajte bat in pustite, da varnostni ščitnik za iglo samodejno zapre izpostavljeno iglo (glejte sliko K).
Overall, 20 subjects were treated for 60 weeks or longer. 
Vsega skupaj je bilo 60 tednov ali več zdravljenih 20 preiskovancev.
Name and address of the manufacturer(s) of the biological active substance(s) 
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin)
10 6336 Langkampfen AUSTRIA 
10 6336 Langkampfen AVSTRIJA
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye. 
• otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1). 
Koristi in tveganja nadaljevanja zdravljenja z 40 mg vsak teden ali 80 mg vsak drugi teden je treba ponovno natančno pretehtati pri bolniku z nezadostnim odzivom na zdravljenje po povečanju odmerka (glejte poglavje 5.1).
• cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer); 
• rak, vključno z rakom, ki zajame limfni sistem (limfom) in melanomom (vrsta kožnega raka);
Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo-controlled AS study II of 82 adult patients with active ankylosing spondylitis. 
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri ankilozirajočem spondilitisu II pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
Children and adolescents with chronic non-infectious uveitis from 2 years of age 
Otroci in mladostniki s kroničnim neinfekcijskim uveitisom, starejši od 2 let
During the study, most subjects used concomitant MTX, with fewer reporting use of corticosteroids or NSAIDs. 
Med študijo je večina preiskovancev sočasno uporabljala metotreksat, manj pa jih je navedlo uporabo kortikosteroidov ali NSPVZ.
If active tuberculosis is diagnosed, Hefiya therapy must not be initiated (see section 4.3). 
Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Hefiya ne sme začeti (glejte poglavje 4.3).
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines. 
Med vzdrževalnim zdravljenjem, je mogoče kortikosteroide postopoma zmanjšati v skladu s smernicami za klinično prakso.
ASAS partial remission BASDAIb 50 
ASAS delno izboljšanje BASDAIb50
At week 12 and week 24, PedACR30 response was 93.5 % and 90.0 %, respectively, using the observed data approach. 
12. teden je bil odziv PedACR30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
The recommended adolescent HS dosing schedule is 40 mg every other week. 
Priporočena shema odmerjanja pri mladostnikih s HS je 40 mg vsak drugi teden.
Corticosteroid taper was permitted after week 8. 
Po 8. tednu je bilo dovoljeno postopno zmanjševanje kortikosteroida.
Hefiya treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hefiya is indicated. 
Zdravljenje z zdravilom Hefiya mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Hefiya indicirano.
Therefore, the combination of adalimumab and anakinra is not recommended (see section 4.5). 
Zato kombinacija adalimumaba in anakinre ni priporočljiva (glejte poglavje 4.5).
Ankylosing Spondylitis Disease Activity Score d partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits. 
d Delni zagon bolezni je določen kot ASDAS ≥ 1,3 vendar < 2,1 pri dveh zaporednih obiskih.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Hefiya in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. 
O uporabi protituberkuloznega profilaktičnega zdravljenja morate pred uvedbo zdravila Hefiya razmisliti tudi pri bolnikih s hudimi ali pomembnimi faktorji tveganja za tuberkulozo kljub negativnemu testu za tuberkulozo in pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
This includes any possible side effects not listed in this leaflet (see section 4). 
Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu (glejte poglavje 4).
Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn. 
Ker adalimumab zavira TNFα, bi njegova uporaba med nosečnostjo lahko okrnila normalne imunske odzive novorojenčka.
• unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered; 
• nenavadne okužbe (vključujejo tuberkulozo in druge okužbe, ki se pojavijo ob slabši telesni odpornosti na bolezen);
• non-infectious uveitis. 
• neinfekcijskega uveitisa
Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus. 
Zdravnik vas mora testirati na HBV. Adalimumab lahko pri nosilcih HBV reaktivira okužbo s tem virusom.
If you use more Hefiya than you should 
Če ste uporabili večji odmerek zdravila Hefiya, kot bi smeli
Patients on Hefiya may receive concurrent vaccinations, except for live vaccines. 
Bolniki, ki prejemajo zdravilo Hefiya, lahko sočasno dobijo cepiva, razen živih cepiv.
• mood swings (including depression); 
• spremenljivo razpoloženje (vključno z depresijo);
Efficacy results 
Rezultati učinkovitosti
• shortness of breath with exertion or upon lying down or swelling of the feet. 
• težko dihanje ob naporu ali med ležanjem ali otekanje nog.
Detailed instructions on how to inject Hefiya are provided in section 7, “Instructions for use”. 
Podrobna navodila za injiciranje zdravila Hefiya so navedena v poglavju 7, ''Navodila za uporabo''.
The active ingredient in Hefiya, adalimumab, is a monoclonal antibody. 
Učinkovina v zdravilu Hefiya, adalimumab, je monoklonsko protitelo.
• signs of skin cancer such as a bump or open sore that doesn't heal; 
• znake kožnega raka, kot sta bula ali odprta rana, ki se ne zaceli,
The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months. 
Varnost adalimumaba pri pediatričnih bolnikih s psoriazo v plakih je bila ocenjena za povprečno obdobje 13 mesecev.
If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Hefiya, and in accordance with local recommendations. 
Če ugotovite latentno tuberkulozo, morate pred uvedbo zdravila Hefiya začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
• Hefiya should only be used during a pregnancy if needed. 
• Zdravilo Hefiya se med nosečnostjo lahko uporablja samo, če je potrebno.
Throughout all 3 studies patients used topical antiseptic wash daily. 
Tekom vseh treh študij so bolniki dnevno uporabljali topikalno antiseptično čistilno tekočino.
Cases of worsening congestive heart failure have also been reported in patients receiving adalimumab. 
O primerih poslabšanja kongestivnega srčnega popuščanja so poročali pri bolnikih, ki so prejemali adalimumab.
The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study. 
Primarni opazovani dogodek kot merilo učinkovitosti je bil delež bolnikov brez ponovnega zagona bolezni do 68. tedna študije.
ACR responses were maintained in the open-label extension study for up to 136 weeks. 
Odziv po ACR se je v odprti nadaljevalni študiji ohranil do 136 tednov.
This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test). 
To bo vključevalo natančno zdravniško oceno vključno s poizvedbo o vašem zdravju v preteklosti in ustrezne preiskave (npr. rentgensko slikanje prsnih organov in tuberkulinski test).
Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response. 
Čeprav ni statistično značilno, je bilo pri večini bolnikov dokazano klinično izboljšanje sekundarnih opazovanih dogodkov, kot so število mest entezitisa, število občutljivih sklepov, število oteklih sklepov, odziv glede na merila Pediatric ARC 50 in Pediatric ARC 70.
• raised bilirubin measurement (liver blood test). 
• povečane vrednosti bilirubina (krvni test jetrne funkcije).
Not included in your carton are (see Figure B): 
Ni priloženo v škatli (glejte sliko B):
Your injection You must read this before injecting 
Injiciranje Nujno preberite pred injiciranjem
The conduct and results of these tests should be recorded on your Patient Reminder Card. 
Izvedbo in rezultate teh preiskav je treba zabeležiti na opozorilni kartici.
Rare 
Redki
Maintenance of remission and response rates are presented in table 24. 
Vzdrževanje remisije in deleže odziva prikazuje preglednica 24.
Patients treated with adalimumab usually experienced improvement in haematological signs of chronic inflammation. 
Bolnikom, zdravljenim z adalimumabom, so se ponavadi izboljšali hematološki znaki kroničnega vnetja.
If an alternate dose is required, other adalimumab products offering such an option should be used. 
Če je potreben drugačen odmerek, je treba uporabiti druga zdravila z adalimumabom, ki omogočajo to možnost.
Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3 % on placebo and 10 % on adalimumab. 
Med bolniki, pri katerih predhodno anti-TNF zdravljenje ni bilo uspešno, jih je 52. teden doseglo remisijo 3 % na placebu in 10 % na adalimumabu.
Thus additional caution should be exercised in considering Hefiya treatment of these patients (see section 4.8). 
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z zdravilom Hefiya pri teh bolnikih (glejte poglavje 4.8).
In patients who develop HBV reactivation, Hefiya should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. 
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila Hefiya prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
Patients treated with Hefiya should be given the Patient Reminder Card. 
Bolniki, ki se zdravijo z zdravilom Hefiya, morajo dobiti opozorilno kartico za bolnika.
You should continue to inject Hefiya for as long as your doctor has told you. 
Nadaljevati morate z injiciranjem zdravila Hefiya tako dolgo, kot vam je naročil zdravnik.
Following 3 years of adalimumab therapy, 75 % (301 / 402) continued to be in clinical remission per partial Mayo score. 
Po 3 letih zdravljenja z adalimumabom jih je 75 % (301/402) ostalo v klinični remisiji po delni oceni Mayo.
Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure: 
Takoj poiščite zdravniško pomoč, če opazite katere od naslednjih znakov alergijske reakcije ali srčnega popuščanja: • hud izpuščaj, koprivnico;
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)). 
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)).
Tell your doctor if you are taking azathioprine or mercaptopurine with Hefiya. 
Povejte zdravniku, če prejemate azatioprin ali merkaptopurin sočasno z zdravilom Hefiya.
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. 
S sedanjim znanjem možnega tveganja za razvoj limfomov, levkemije in drugih malignomov pri bolnikih, zdravljenih z antagonistom TNF, ni mogoče izključiti.
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. 
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.
HS study II 
študija HS II
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. 
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.
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). 
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).
• abnormal muscle breakdown; 
• neobičajen razpad mišic;
Crohn's disease in adults and children 
Crohnova bolezen pri odraslih in otrocih
Your doctor may recommend temporarily stopping Hefiya. 
Vaš zdravnik bo morda priporočil začasno prenehanje uporabe zdravila Hefiya.
-56.2a a p < 0.001, adalimumab vs. placebo 
-56,2a a p < 0,001, adalimumab v primerjavi s placebom
See “4. 
Glejte točko “4.
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Hefiya cannot be excluded (see section 4.8). 
Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki dobivajo zdravilo Hefiya, ni mogoče izključiti (glejte poglavje 4.8).
Study nr-axSpA II 
Študija nr-axSpA II
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. 
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.
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. 
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.
14 weeks a ped ACR 30/50/70 responses week 48 significantly greater than those of placebo-treated patients b p = 0.015 
Odzivi »ped ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo b p = 0,015
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. 
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.
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). 
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).
A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used. 
Score, mTSS), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).
• gallbladder inflammation, gallbladder stones; 
• vnetje žolčnika, žolčni kamni;