natgillin/translations-raw huggingface dataset:
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 RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
Low Dose 20/10 mg eow N = 95 
Majhni odmerek 20/10 mg vsak drugi teden n = 95
COPD, or you are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you. 
Če imate KOPB ali če veliko kadite, se morate z zdravnikom posvetovati, ali je zdravljenje
There is no relevant use of adalimumab in children aged less than 4 years for this indication. 
Adalimumab ni namenjen za uporabo pri otrocih, starih manj kot 4 leta, za to indikacijo.
In controlled Phase 3 trials of adalimumab in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8 % of adalimumab-treated patients 
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s psoriazo s plaki in s trajanjem kontrolnega obdobja od 12 do 24 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 1,8 % bolnikov, zdravljenih z adalimumabom, in pri 1,8 % bolnikov v kontrolni skupini.
Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p < 0.001) in the adalimumab group (at week 48). 
Sprememba je bila (povprečje ± standardni odklon) 0,8 ± 2,5 v skupini s placebom (po 24 tednih) in 0,0 ± 1,9; (p < 0,001) v skupini z adalimumabom (po 48 tednih).
Cyltezo is contraindicated in moderate to severe heart failure (see section 4.3). 
Pri bolnikih z zmernim ali hudim srčnim popuščanjem je zdravilo Cyltezo kontraindicirano (glejte poglavje 4.3).
• shortness of breath; 
• predrtje črevesja;
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z
A 40 mg pre-filled syringe/pre-filled pen is available for patients to administer a full 40 mg dose. 
Za dajanje polnega 40 mg odmerka je bolnikom na voljo 40 mg napolnjena injekcijska
The recommended dose of Cyltezo is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later. 
Priporočeno odmerjanje zdravila Cyltezo je začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), čemur sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
Keep the pre-filled syringe/pre-filled pen in the outer carton in order to protect from light. 
Napolnjeno injekcijsko brizgo/napolnjeni injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
The recommended Cyltezo dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day). 
Priporočena shema odmerjanja zdravila Cyltezo pri odraslih bolnikih s hidradenitis suppurativa (HS) je 160 mg na 1. dan (apliciran v obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (apliciran v obliki dveh 40 mg injiciranj v enem dnevu).
• 1 pre-filled syringe (0.8 mL sterile solution) in a blister, with 2 alcohol pads. 
• 1 napolnjena injekcijska brizga (0,8 ml sterilne raztopine) v pretisnem omotu, z 2 alkoholnima
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Cyltezo cannot be excluded (see section 4.8). 
Tveganja za razvoj hepatospleničnega T-celičnega limfoma pri bolnikih, ki dobivajo zdravilo Cyltezo, ni mogoče
How to use Cyltezo 
Ne uporabljajte zdravila Cyltezo
In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of 
Pri odraslih bolnikih z uveitisom je uvajalni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil srednjo koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks 
Preglednica 20: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
Following subcutaneous administration of 40 mg of adalimumab every other week in adult non-radiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at week 68 was 
Po subkutanem apliciranju 40 mg adalimumaba vsak drugi teden odraslim bolnikom z neradiografskim aksialnim spondiloartritisom je bila povprečna (±SD) najmanjša koncentracija v stanju dinamičnega ravnovesja v 68. tednu 8,0 ± 4,6 μg/ml.
Efficacy Response in Placebo-Controlled Study nr-axSpA I 
Preglednica 14: Odziv učinkovitosti v s placebom kontrolirani študiji nr-axSpA I Dvojno slepa
No data are available on the secondary transmission of infection by live vaccines in 
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih z adalimumabom, ni.
In monotherapy, some patients who experience a decrease in their response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week. 
Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Cyltezo 40 mg vsak drugi teden, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden ali 80 mg vsak drugi teden.
The recommended dose of Cyltezo for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose. 
Priporočeni odmerek zdravila Cyltezo za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
In RA study III, where adalimumab treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score. 
V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 10).
If you are unsure, contact your doctor. 
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
If something goes wrong with the injection, do not use another Cyltezo pen. 
Če injiciranje ne poteka tako, kot bi bilo treba, ne uporabite drugega peresnika zdravila
Some patients who experience decrease in their response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg Cyltezo every week or 80 mg every other week. 
Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Cyltezo 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Cyltezo na 40 mg vsak teden ali 80 mg vsak drugi teden.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement 
Če se bolniku stanje po 12. tednih ne izboljša, je pred podaljšanjem zdravljenja na več kot 12 tednov potreben natančen ponoven premislek.
p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c. 
Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U.
The recommended dose of Cyltezo for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. 
Priporočeni začetni odmerek zdravila Cyltezo za odrasle bolnike z uveitisom je 80 mg, čemur sledi 40 mg odmerek vsak drugi teden, ki se ga začne dajati en teden po začetnem odmerku.
Your doctor may recommend temporary discontinuation of Cyltezo. 
Odločil se bo, ali lahko dobivate zdravilo Cyltezo.
4.3 Contraindications 
6.4 Posebna navodila za shranjevanje
The recommended Cyltezo induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day). 
Priporočena shema odmerjanja zdravila Cyltezo med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
Pulmonary embolism interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion 
tuberkulozo in oportunistične okužbe, kongestivno srčno popuščanje, demielinizirajoče
Room spinning sensation (vertigo) and vision disturbances may occur after taking Cyltezo. 
Po dajanju zdravila Cyltezo se lahko pojavita vrtoglavica (vertigo) in poslabšanje vida.
NAME OF THE MEDICINAL PRODUCT Cyltezo 40 mg solution for injection in pre-filled syringe Cyltezo 40 mg solution for injection in pre-filled pen 
Cyltezo 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Cyltezo 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
There is no relevant use of adalimumab in children aged less than 6 years for this indication. 
Adalimumab ni namenjen za uporabo pri otrocih, starih manj kot 6 let, za to indikacijo.
“Sharps” container (not included) 
Vsebnik za ostre predmete (ni priložen)
Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Cyltezo is 40 mg every other week. 
Otroci in mladostniki, starejši od 6 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Cyltezo je 40 mg vsak drugi teden.
• Discard Cyltezo pre-filled syringe into “sharps” container. 
• Napolnjeno injekcijsko brizgo zdravila Cyltezo vrzite v vsebnik za ostre predmete.
Cyltezo 40 mg solution for injection in pre-filled syringe Each 0.8 mL single dose pre-filled syringe contains 40 mg of adalimumab. 
Cyltezo 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
40 mg every week or 80 mg every other week 
10 mg vsak drugi teden 20 mg vsak drugi teden 20 mg vsak drugi teden 40 mg vsak drugi teden
Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Cyltezo is 40 mg every other week. 
Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Cyltezo je 40 mg vsak drugi teden.
EU/1/17/1240/008 
EU/1/17/1240/005 1 napolnjen injekcijski peresnik EU/1/17/1240/006 2 napolnjena injekcijska peresnika EU/1/17/1240/007 4 napolnjeni injekcijski peresniki EU/1/17/1240/008 6 napolnjenih injekcijskih peresnikov
If your doctor considers that methotrexate is inappropriate, 
Če vaš zdravnik meni, da metotreksat ni primeren, lahko zdravilo Cyltezo dobivate samo.
Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients) 
Preglednica 28: Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov) placebo adalimumab 40 mg vsak drugi teden
Cyltezo therapy should not be continued in patients failing to respond within this time period. 
Pri bolnikih, ki se v tem času ne odzovejo, zdravljenja z zdravilom Cyltezo ni priporočljivo nadaljevati.
• 1 pre-filled pen (0.8 mL sterile solution) in a blister, with 2 alcohol pads. 
• 1 napolnjen injekcijski peresnik (0,8 ml sterilne raztopine) v pretisnem omotu, z 2 alkoholnima
Ps Study I (REVEAL) - Efficacy Results at 16 Weeks 
Preglednica 17: Študija pri psoriazi I (REVEAL) - rezultati učinkovitosti po 16 tednih placebo n = 398 n (%)
Adalimumab treated patients showed statistically significant improvements at week 26 compared with 
Pri bolnikih, zdravljenih z adalimumabom, je prišlo do statistično značilnega izboljšanja dermatološkega indeksa kakovosti življenja (DLQI) po 26 tednih v primerjavi z placebom.
The combination of Cyltezo and anakinra is not recommended (see section 4.4 “Concurrent administration of 
Zato kombinacija adalimumaba in anakinre ni priporočljiva (glejte poglavje 4.5).
• severe rash, hives or other signs of allergic reaction; 
Poiščite urgentno zdravniško pomoč, če opazite kaj od naslednjega: • hud izpuščaj, koprivnico ali druge znake alergijske reakcije;
Cyltezo 40 mg solution for injection in pre-filled syringe 
Cyltezo 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
• You might get infections more easily while you are receiving Cyltezo treatment. 
• Med zdravljenjem z zdravilom Cyltezo se lahko poveča dovzetnost za okužbe.
Cyltezo dose for paediatric patients with uveitis 
Preglednica 5: Odmerjanje zdravila Cyltezo pri pediatričnih bolnikih z uveitisom
Table 6: 
Slika 3:
Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome. 
V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od 3.441 bolnikov, zdravljenih z adalimumabom.
In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/mL during the induction period. 
Pri bolnikih z ulceroznim kolitisom doseže polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
Talk to your doctor or pharmacist before using Cyltezo Allergic reaction 
Pred začetkom uporabe zdravila Cyltezo se posvetujte z zdravnikom ali farmacevtom.
There is no relevant use of adalimumab in children aged less than 12 years in this indication. 
Adalimumab ni namenjen za uporabo pri otrocih, mlajših od 12 let, za to indikacijo.
Cyltezo is intended for the treatment of the inflammatory diseases described below: • Polyarticular juvenile idiopathic arthritis, 
Zdravilo Cyltezo je namenjeno za zdravljenje vnetnih bolezni, ki so opisane spodaj:
Preclinical data on postnatal toxicity of adalimumab are not available (see 
Predkliničnih podatkov o poporodni toksičnosti adalimumaba ni (glejte poglavje 5.3).
• facial oedema associated with allergic reactions; 
• artritisa, povezanega z entezitisom,
Cyltezo can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease. 
Zdravilo Cyltezo lahko zmanjša število vozličev in ognojkov, ki jih imate.
coccidioidomycosis or blastomycosis are endemic. 
nesteroidnih protivnetnih zdravil ali analgetikov.
• Do not inject through clothes. 
• Napolnjenih injekcijskih brizg NE vrzite med gospodinjske odpadke.
The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose. 
Običajni začetni odmerek za odrasle z luskavico (psoriazo) je 80 mg (dve 40 mg injekciji v enem dnevu), nato pa 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab. 
Pri bolnikih, zdravljenih z adalimumabom, je bil v redkih primerih med obdobjem trženja identificiran hepatosplenični T-celični limfom.
Continued therapy should be reconsidered in a patient not responding within this time period. 
Po 12 tednih je treba nadaljevanje zdravljenja pri bolniku, pri katerem v tem obdobju ni prišlo do
Placebo Adalimumab 40 mg Weekly 
placebo adalimumab
Anaphylaxis 
Imunosupresija
• sensation of heart beating rapidly; 
• občutek siljenja na bruhanje, bruhanje;
p-value p-value p-value p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. 
Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U.
• Do not rub the injection site. 
Stisnite mesto injiciranja
If these medicines do not work well enough, you will be given Cyltezo to reduce the signs and 
Če ta zdravila ne bodo delovala dovolj dobro, boste za zmanjšanje znakov in simptomov bolezni dobili zdravilo Cyltezo.
40 mg Adalimumab every week 
40 mg adalimumaba vsak teden n = 172
5) Clean injection site 
11) Zavrzite napolnjeno injekcijsko brizgo
Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus 
pogosti poslabšanje ali pojav psoriaze (vključno s palmplantarno pustularno psoriazo) urtikarija, modrice (vključno s purpuro), dermatitis (vključno z ekcemom), oniholiza, čezmerno znojenje, alopecija srbenje nočno potenje, brazgotinjenje multiformni eritem Stevens-Johnsonov sindrom angioedem kožni vaskulitis lihenoidna reakcija poslabšanje simptomov dermatomiozitisa mišično-skeletne bolečine mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
Traceability 
A. OZNAČEVANJE
Rare (may affect up to 1 in 1,000 people): • leukaemia (cancer affecting the blood and bone marrow); 
• levkemija (rak, ki prizadene kri in kostni mozeg);
• facial oedema; 
• kratka sapa;
In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: 
≥ 40 kg • 80 mg v 0. tednu in 40 mg v 2. tednu V primeru, ko je potreben hitrejši odgovor na zdravljenje, z zavedanjem, da je tveganje za pojav neželenih učinkov povečano ob uporabi večjega začetnega odmerka, se lahko uporabi odmerek:
ACR Responses in Placebo-Controlled Trials (Percent of Patients) RA Study II a** 
Preglednica 7: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov) Odziv
Diplopia 
adalimumab
Adalimumab 40 mg eow N = 80 
adalimumab 80/40 mg n = 75
RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks 40 mg adalimumab administered every other week 
Študija revmatoidnega artritisa I po 24 tednih, študija revmatoidnega artritisa II po 26 tednih in študija revmatoidnega p < 0,01, adalimumab v prim.
The recommended Cyltezo dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 
Priporočeni odmerek zdravila Cyltezo je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30 % plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions ** p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions 
Klinični odgovor pomeni znižanje ocene Mayo od začetka za ≥ 3 in ≥ 30 % ter znižanje podocene rektalne krvavitve [RBS]
• 4 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 4 alcohol pads. 
• 4 napolnjene injekcijske brizge (0,8 ml sterilne raztopine), vsaka v svojem pretisnem omotu, s
• inflammations. 
• hepatitis;
Hospitalisation rates 
Celjenje sluznice
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction. 
Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekcijia v enem dnevu).
• inflammation of the skin (such as eczema); • breaking of finger nails and toe nails; 
• vnetje kože (kot je ekcem);
• 6 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 6 alcohol pads. 
• 6 napolnjenih injekcijskih brizg (0,8 ml sterilne raztopine), vsaka v svojem pretisnem omotu, s
Keep the syringes in the outer carton in order to protect from light. 
Injekcijske brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Keep the pre-filled syringe in the outer carton in order to protect from light. 
Napolnjene injekcijske peresnike shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Liver failure 
Bat igle
Table 10: 
Preglednica 11:
- Keep this leaflet. 
Pokrovčka ne sučite.
Package leaflet: Information for the patient Cyltezo 40 mg solution for injection in pre-filled syringe Adalimumab 
Navodilo za uporabo Cyltezo 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
There is no relevant use of adalimumab in patients aged less than 2 years for this indication. 
Pri bolnikih, starih manj kot 2 leti, adalimumab za to indikacijo ni namenjen.
What Cyltezo is and what it is used for 2. 
Kaj je zdravilo Cyltezo in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Cyltezo
Adalimumab 0.8 mg/kg eow N = 38 
adalimumab 0,8 mg/kg vsak drugi teden n = 38
Headache 
Konica
Patients treated with adalimumab usually experienced improvement in haematological signs of chronic inflammation. 
Z adalimumabom zdravljenim bolnikom so se ponavadi izboljšali
Mean steady-state trough levels of approximately 7 μg/mL were observed in Crohn's disease patients who received a maintenance dose of 40 mg adalimumab every other week. 
Pri bolnikih s Crohnovo boleznijo, ki so dobivali vzdrževalni odmerek 40 mg adalimumaba vsak drugi teden, so ugotovili najmanjšo koncentracijo v stanju dinamičnega ravnovesja približno 7 µg/ml.
2) Inspect pen 
6) Odstranite pokrovček
Continued therapy should be carefully reconsidered in a patient not responding within this time period. 
Pri bolniku, ki se v tem času ne odzove na zdravljenje je treba ponovno razmisliti o nadaljevanju zdravljenja.
Age over 65 years 
13 do 17 let
• 2 pre-filled syringes (0.8 mL sterile solution), each in a blister, with 2 alcohol pads. 
• 2 napolnjeni injekcijski brizgi (0,8 ml sterilne raztopine), vsaka v svojem pretisnem omotu, z
• erythema multiforme (inflammatory skin rash); 
• edem obraza povezan z alergijskimi reakcijami; • multiformni eritem (vnetje kožnega izpuščaja);
Aortic aneurysm, vascular arterial occlusion, thrombophlebitis 
Psoriatični artritis in aksialni spondiloartritis, vključno z ankiloznim spondilitisom
Muscle spasms (including blood creatine phosphokinase increased) 
Bolezni kože in podkožja zelo pogosti izpuščaj (vključno z eksfoliativnim izpuščajem)
p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test 
Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann
Endpoint 
ASDAS
Adults with non-infectious uveitis 
Neinfekcijski uveitis pri odraslih in otrocih
- if you have blood in your urine that your doctor has not checked. 
če imate kri v urinu, ki ga zdravnik ni preiskal.
- if you have or have ever had bladder cancer. 
če imate ali ste kdaj imeli raka sečnega mehurja.
Your doctor will check whether Glustin is working 3 to 6 months after you start taking it. 
Zdravnik bo preveril ali zdravilo Glustin deluje, 3 do 6 mesecev po tem, ko začnete jemati zdravilo.
Date of first authorisation: 11/10/2000 Date of latest renewal: 31/08/2010 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 11. oktober 2000 Datum zadnjega podaljšanja: 31. avgust 2010
not known not known not known not known not known 
neznana neznana neznana neznana
Approximately half of the study population had at least two of the cardiovascular history entry criteria. 
Približno polovica populacije, vključene v študijo, je ustrezala vsaj dvema vstopnima kriterijema kardiovaskularne anamneze.