natgillin/translations-raw huggingface dataset:
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with SOLYMBIC. 
Povejte zdravniku, če vaš otrok prejema azatioprin ali 6-merkaptopurin sočasno z zdravilom SOLYMBIC.
The safety and efficacy of adalimumab in children aged 2-17 years have not yet been established. 
Varnost in učinkovitost adalimumaba pri otrocih starih 2-17 let nista bili dokazani.
MTX = methotrexate b P = 0.027, adalimumab 0.8 mg/kg versus MTX 
PGA: čisto/minimalno a MTX = methotrexate b P = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX c P = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
Make sure the medicine in the window is clear and colourless to slightly yellow. 
Prepričajte se, da je zdravilo v okencu bistro in brezbarvno do rahlo rumenkasto.
PGA: Clear/minimal a, b a p < 0.001 adalimumab versus placebo b p < 0.001 adalimumab versus methotrexate c p < 0.01 adalimumab versus placebo d p < 0.05 adalimumab versus methotrexate 
PGA: čisto/minimalno a, b a p < 0,001 adalimumab v primerjavi s placebom b p < 0,001 adalimumab v primerjavi z metotreksatom c p < 0,01 adalimumab v primerjavi s placebom d p < 0,05 adalimumab v primerjavi z metotreksatom
Table 2 SOLYMBIC dose in milligrams (mg) by weight for patients with paediatric psoriasis 
Odmerek zdravila SOLYMBIC v miligramih (mg) glede na telesno maso bolnikov s pediatrično psoriazo
Week 26 Clinical remission Clinical response Week 52 Clinical remission Clinical response * p value for standard dose versus low dose comparison 
26. teden Klinična remisija Klinični odziv 52. teden Klinična remisija Klinični odziv
Thirty-three (18%) of patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline. 
33 (18 %) bolnikov je bilo na začetku sočasno zdravljenih z modifikatorji bolezni ali protirevmatskimi zdravili in 146 (79 %) bolnikov z nesteroidnimi antirevmatiki.
Beyond 16 weeks, patients with inadequate response may benefit from an increase in dosing frequency to 40 mg every week. 
Od 16. tedna dalje bolnikom z nezadostnim odzivom na zdravljenje lahko koristi povečanje pogostnosti odmerjanja na 40 mg vsak teden.
After two further weeks, continue with a dose of 40 mg every week. 
Čez nadaljnja dva tedna nadaljujte z odmerkom 40 mg vsak teden.
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see table 5). 
V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z adalimumabom in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 5).
● Put the used SOLYMBIC syringe in a sharps disposal container immediately after use. 
● Uporabljeno brizgo zdravila SOLYMBIC nemudoma po injiciranju dajte v vsebnik za ostre odpadke.
Table 21 Paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission 
Študija Crohnove bolezni pri pediatričnih bolnikih: Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule
SOLYMBIC contains sodium 
Zdravilo SOLYMBIC vsebuje natrij
On a clean, well-lit work surface, place a new, pre-filled pen. 
Na čisto, dobro osvetljeno delovno površino položite nov napolnjen injekcijski peresnik.
Placebo/MTXadalimumab /MTX (95% confidence interval b) 
adalimumab /MTX 40 mg vsak drugi teden placebo/MTXadalimumab/ MTX (95 % interval zaupanja b)
SOLYMBIC is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy. 
Zdravilo SOLYMBIC je indicirano za zdravljenje aktivne zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih bolnikih, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje.
SOLYMBIC contains the active substance adalimumab, a selective immuno suppressive agent. 
Zdravilo SOLYMBIC vsebuje zdravilno učinkovino adalimumab, selektivni zaviralec imunskega sistema.
- Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given SOLYMBIC and during treatment with SOLYMBIC. 
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo SOLYMBIC in med zdravljenjem z zdravilom SOLYMBIC.
Erosion score JSN 
Celotna Sharpova ocena Ocena erozij Seštevek JSN
Sodium hydroxide (for pH adjustment) Water for injections 
Ledocet saharoza polisorbat 80 natrijev hidroksid (za prilagoditev pH) voda za injekcije
The combination of SOLYMBIC and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”). 
Kombinacija zdravila SOLYMBIC in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
If you become pregnant, you should consult your doctor. 
Če zanosite, se posvetujte s svojim zdravnikom.
Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection. 
Ledocet, saharoza, polisorbat 80, natrijev hidroksid in voda za injekcije.
It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with SOLYMBIC. 
Priporoča se, da med zdravljenjem z zdravilom SOLYMBIC bolnik vsakodmevno izpira HS lezije s topikalnim antiseptikom.
SOLYMBIC is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. 
Zdravilo SOLYMBIC je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis (patients weighing either 23 to 28 kg or 47 kg and greater), Crohn's disease in adults and children, ulcerative colitis and non-infectious uveitis affecting the back of the eye. 
Zdravilo SOLYMBIC je namenjeno za zdravljenje revmatoidnega artritisa, artritisa, povezanega z entezitisom, pri otrocih, starih od 6 do 17 let, ankilozirajočega spondilitisa, aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis, psoriatičnega artritisa, luskavice (psoriaze), hidradenitis suppurativa, pediatrične luskavice (pri bolnikih, ki tehtajo ali od 23 do 28 kg ali 47 kg in več), Chronove bolezni pri odraslih in otrocih, ulceroznega kolitisa in neinfekcijskega uveitisa, ki prizadene zadnji del očesa.
Not known Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin) 
redki levkemija neznana pogostnost karcinom Merkelovih celic (nevroendokrini karcinom kože)
The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis 6 years of age and older is 24 mg/m² body surface area up to a maximum single dose of 40 mg adalimumab administered every other week via subcutaneous injection. 
Priporočeni odmerek zdravila SOLYMBIC pri bolnikih z artritisom, povezanim z entezitison, starih 6 let in več, je 24 mg/m telesne površine do največjega posamičnega odmerka 40 mg adalimumaba vsak drugi teden v subkutani injekciji.
SOLYMBIC reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate. 
Rentgensko slikanje je pokazalo, da zdravilo SOLYMBIC upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
You are advised to avoid becoming pregnant and must use adequate contraception while using SOLYMBIC and for at least 5 months after the last SOLYMBIC treatment. 
Priporočljivo je, da ne zanosite, zato morate med zdravljenjem z zdravilom SOLYMBIC in vsaj še 5 mesecev po zadnjem odmerku zdravila SOLYMBIC uporabljati ustrezno kontracepcijsko zaščito.
Table 17 Induction of clinical remission and response (percent of patients) 
Indukcija klinične remisije in odziva (odstotek bolnikov)
2-sided P value from log rank test. c NE = not estimable. 
2-stranska vrednost p testa log-rank.
For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of SOLYMBIC should be promptly discontinued. 
Če se bolniku pojavijo znaki ali simptomi, kot so npr. zvišana telesna temperatura, splošno slabo počutje, hujšanje, znojenje, kašelj, dispneja in/ali pljučni infiltrati ali druga sistemska bolezen (s spremljajočim šokom ali brez njega), je treba posumiti na invazivno glivično okužbo.
G. Hold the pinch. 
G. Držite kožno gubo.
SOLYMBIC is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies. 
Zdravilo SOLYMBIC je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo, kortikosteroidom in imunomodulatorjem, ali pri tistih, ki imajo intoleranco ali kontraindikacije za tako zdravljenje.
SOLYMBIC is used to treat hidradenitis suppurativa in adults. 
Zdravilo SOLYMBIC se uporablja za zdravljenje hidradenitis suppurativa pri odraslih.
This includes any possible side effects not listed in this leaflet. 
Posvetujte se tudi, če opazite neželene učinke, ki niso omenjeni v tem navodilu.
Adalimumab 40 mg every other week was assessed in 185 patients in one randomised, 12 week double-blind, placebo-controlled study in patients with active non-radiographic axial spondyloarthritis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs. 
Uporabo adalimumaba 40 mg vsak drugi teden so proučili v randomizirani, 12 tednov trajajoči, dvojno slepi, s placebom kontrolirani študiji pri 185 bolnikih z aktivnim ne-radiografskim aksialnim spondiloartritisom (srednja vrednost aktivnosti bolezni [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] je bila 6,4 pri bolnikih zdravljenih z adalimumabom in 6,5 pri bolnikih na placebu), ki so nezadostno reagirali na ali niso prenašali vsaj enega NSAID ali s kontraindikacijo za NSAID.
The recommended SOLYMBIC dose is 0.8 mg per kg body weight (up to a maximum of 40 mg per dose) administered subcutaneously weekly for the first two doses and every other week thereafter. 
Priporočeni odmerek zdravila SOLYMBIC je 0,8 mg na kilogram telesne mase (do največ 40 mg na odmerek), ki se ga v primeru prvih dveh odmerkov injicira subkutano enkrat na teden, nato pa vsak drugi teden.
Patients were randomised to receive either 24 mg/m body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks. 
Bolniki so bili randomizirani za prejemanje bodisi 24 mg/m telesne površine adalimumaba do največjega posamičnega odmerka 40 mg ali placebo vsak drugi teden, 12 tednov.
SOLYMBIC is administered by subcutaneous injection. 
Zdravilo SOLYMBIC se uporablja kot subkutana injekcija.
EU/1/16/1163/002 1 pack EU/1/16/1163/003 2 pack EU/1/16/1163/004 4 pack EU/1/16/1163/005 6 pack 
EU/1/16/1163/002 1 brizga EU/1/16/1163/003 2 brizgi EU/1/16/1163/004 4 brizge EU/1/16/1163/005 6 brizg
In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients. 
V kontroliranih preskušanjih z adalimumabom (začetni odmerek 80 mg v 0. tednu, ki mu sledi odmerek 40 mg vsak drugi teden z začetkom v 1. tednu) pri bolnikih z uveitisom do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih zdravljenih z adalimumabom in 105,0 dni pri bolnikih v kontrolni skupini, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 2,4 % bolnikov zdravljenih z adalimumabom in pri 2,4 % bolnikov v kontrolni skupini.
● Put the used pre-filled pen in a sharps disposal container immediately after use. 
● Uporabljen napolnjen injekcijski peresnik nemudoma po injiciranju dajte v vsebnik za ostre odpadke.
Sustained response Sustained remission Sustained mucosal healing 
Ohranjen odziv Ohranjena remisija Ohranjeno celjenje sluznice
Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with SOLYMBIC. 
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom SOLYMBIC ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje teže, nekoliko zvišano telesno temperaturo).
Pleural effusion 
Valj brizge
The administered dose is selected based on the patients' weight (table 2). 
Dani odmerek se določi glede na telesno maso bolnika (glejte preglednico 2).
In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week. 
Med monoterapijo lahko nekaterim bolnikom, ki se jim odziv na zdravilo zmanjša, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden.
EU/1/16/1163/006 1 pack EU/1/16/1163/007 2 pack EU/1/16/1163/008 4 pack EU/1/16/1163/009 6 pack 
EU/1/16/1163/006 1 peresnik EU/1/16/1163/007 2 peresnika EU/1/16/1163/008 4 peresniki EU/1/16/1163/009 6 peresnikov
Table 6 Radiographic mean changes over 12 months in RA study III 
Povprečne rentgenografske spremembe v 12 mesecih študije revmatoidnega artritisa III
System Organ Class Frequency Adverse Reaction Common 
Organski sistem Pogostnost
The usual dose regimen for Crohn's disease is 80 mg initially followed by 40 mg every other week two weeks later. 
Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg na začetku, čemur sledi 40 mg vsak drugi teden dva tedna kasneje.
If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your disease. 
Če se na ta zdravila ne boste dovolj dobro odzivali, boste prejeli zdravilo SOLYMBIC za zmanjšanje znakov in simptomov vaše bolezni.
malignancies. 
maligne bolezni.
Your doctor should test you for HBV. SOLYMBIC can cause reactivation of HBV in people who carry this virus. 
Zdravilo SOLYMBIC lahko pri nosilcih HBV povzroči reaktivacijo tega virusa.
It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating SOLYMBIC therapy. 
Za pediatrične bolnike je priporočljivo, da pred začetkom zdravljenja z zdravilom SOLYMBIC opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
Uncommon Pulmonary embolism Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis, 
astma, dispneja, kašelj pljučni embolizem intersticijska pljučna bolezen, kronična obstruktivna pljučna bolezen, pnevmonitis, plevralna efuzija pljučna fibroza
Enthesitis-related arthritis is an inflammatory disease of the joints. 
Artritis, povezan z entezitisom, je vnetna bolezen sklepov.
Adalimumab N = 51 
adalimuma b n = 51
Talk to your doctor or pharmacist before using SOLYMBIC: 
Pred začetkom uporabe zdravila SOLYMBIC se posvetujte s svojim zdravnikom ali s farmacevtom:
● The needle cover of the SOLYMBIC pre-filled syringe is made from dry natural rubber, which contains latex. 
● Pokrovček igle na napolnjeni injekcijski brizgi zdravila SOLYMBIC vsebuje suho naravno gumo, ki vsebuje lateks.
***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 
***,** Statistično značilno pri p < 0,001, < 0,01 za vse primerjave med adalimumabom in placebom po 2, 12 in 24 tednih a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis)
SOLYMBIC is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years. 
Zdravilo SOLYMBIC se uporablja za zdravljenje artritisa, povezanega z entezitisom, pri otrocih in mladostnikih, starih od 6 do 17 let.
Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last SOLYMBIC treatment. 
Ženske v rodni dobi/Kontracepcija pri moških in ženskah Ženske v rodni dobi morajo za preprečitev nosečnosti uporabljati ustrezno kontracepcijsko zaščito in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom SOLYMBIC.
SOLYMBIC is a clear and colourless to slightly yellow solution. 
Zdravilo SOLYMBIC je bistra in brezbarvna do rahlo rumena raztopina.
SOLYMBIC 20 mg syringe 
SOLYMBIC 20 mg brizga
Table 4 ACR responses in placebo-controlled trials (percent of patients) 
Preglednica 4: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov) Odziv
P value 
P vrednost
Hypokalaemia, Uric acid increased, Blood sodium abnormal, Hypocalcaemia, Hyperglycaemia, Hypophosphataemia, Dehydration 
Presnovne in prehranske motnje zvišanje lipidov hipokalemija, hiperurikemija, nenormalni nivo natrija v krvi, hipokalcemija, hiperglikemija, hipofosfotemija, dehidracija
Table 19 Maintenance regimen 
Vzdrževalni režim
SOLYMBIC is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. 
Zdravilo SOLYMBIC se uporablja za zdravljenje ankilozirajočega spondilitisa in aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis pri odraslih.
A single SOLYMBIC pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. 
Posamezno napolnjeno injekcijsko brizgo zdravila SOLYMBIC lahko shranite pri temperaturi do največ 25 ºC za obdobje do 14 dni.
SOLYMBIC is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. 
Zdravilo SOLYMBIC je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki se ne odzovejo zadostno na običajno zdravljenje, vključno s kortikosteroidi in 6merkaptopurinom (6-MP) ali azatioprinom (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
If you do not respond well enough to these medicines, you will be given SOLYMBIC to treat your rheumatoid arthritis. 
Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo SOLYMBIC.
Adalimumabb / MTX 
adalimumab / MTX
SOLYMBIC 20 mg solution for injection in pre-filled syringe EU/1/16/1163/001 - 1 pack 
SOLYMBIC 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/16/1163/001 - 1 brizga
The pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. 
Napolnjena injekcijska brizga ali napolnjen injekcijski peresnik se lahko shranjujeta pri temperaturi največ do 25ºC za obdobje do 14 dni.
The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex) (see section 4.4). 
Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa) (glejte poglavje 4.4).
ACR 20 Week 52 62.6% 54.4% 72.8% 0.013 < 0.001 0.043 Week 104 56.0% 49.3% 69.4% 0.002 < 0.001 0.140 ACR 50 Week 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Week 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 
ACR 20 6 mesecev 13,3 % 65,1 % 19,1 % 46,0 % 29,5 % 63,3 % 12 mesecev NP
SOLYMBIC may have a minor influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo SOLYMBIC ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and non-infectious uveitis affecting the back of the eye. 
Adalimumab se veže na specifično beljakovino (tumorje nekrotizirajoči faktor ali TNFα), ki je pri vnetnih boleznih, kakršne so revmatoidni artritis, artritis, povezan z entezitisom, ankilozirajoči spondilitis, aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis, psoriatični artritis, luskavica (psoriaza), hidradenitis suppurativa, Crohnova bolezen, ulcerozni kolitis in neinfekcijski uveitis, ki prizadene zadnji del očesa, prisoten v večji koncentraciji.
Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine 
* P < 0,05, ***P < 0,001, adalimumab v primerjavi s placebom a Med vsemi randomiziranimi bolniki b Med bolniki z izhodiščnim rezultatom 3 ali več pri ocenjevanju bolečine, povezane s hidradenitis suppurativa, po numerični ocenjevalni lestvici od 0 do 10; 0 = brez bolečin na koži, 10 = najhujša možna bolečina na koži
Carriers of HBV who require treatment with SOLYMBIC should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. 
Nosilce HBV, ki potrebujejo zdravljenje z zdravilom SOLYMBIC, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
Placebo N = 107 
Odziv placebo N = 107
K. Discard the used pre-filled pen and the yellow cap. 
K. Uporabljeni napolnjeni injekcijski peresnik in rumeni pokrovček igle odvrzite.
SOLYMBIC 40 mg solution for injection in pre-filled syringe EU/1/16/1163/002 - 1 pack 
SOLYMBIC 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/16/1163/002 - 1 brizga
SOLYMBIC is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. 
Zdravilo SOLYMBIC je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
Neoplasms benign, malignant and unspecified (including cysts and polyps)* 
Neželeni učinki novotvorbe (vključno s cistami in polipi)*