natgillin/translations-raw huggingface dataset:
• DO NOT move, twist, or rotate the syringe during injection.
• Injekcijske brizge NE premikajte, sukajte ali vrtite med injiciranjem.
If your child's doctor has told you that your child has an intolerance to some sugars or if your child has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your child's doctor before you give your child this medicine.
Če vam je otrokov zdravnik povedal, da ima vaš otrok intoleranco za nekatere sladkorje, ali če je bila pri vašem otroku odkrita dedna intoleranca za fruktozo (HFI), redka genetska bolezen, pri kateri telo ne more razgraditi fruktoze, se posvetujte z otrokovim zdravnikom, preden otrok začne jemati to zdravilo.
• DO NOT wipe the needle or syringe.
• NE BRIŠITE igle ali brizge.
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies 1) including spontaneous reporting data
** Vključno pri odprtih podaljšanih študijah 1) Vključno s podatki iz spontanega poročanja
Each box contains 1 vial, 1 sterile injection syringe, 1 sterile needle, 1 sterile vial adapter and 2 alcohol pads.
Vsaka škatla vsebuje 1 vialo, 1 sterilno injekcijsko brizgo, 1 sterilno iglo, 1 sterilen adapter za vialo in 2 alkoholna zloženca.
The recommended dose of Hulio for patients with ankylosing spondylitis axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek zdravila Hulio pri bolnikih z ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza o AS in pri bolnikih s psoriatičnim artritisom je 40 mg adalimumaba, apliciranega v enkratni subkutani injekciji vsak drugi teden.
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 teh 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.
At week 4 patients were randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 56 weeks.
V 4. tednu so bolnike randomizirali na 40 mg vsak drugi teden, 40 mg vsak teden ali placebo; v celoti je študija trajala 56 tednov.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON - VIAL MULTIPACK (WITHOUT BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA - VEČKRATNO PAKIRANJE VIAL (BREZ MODREGA OKENCA)
Table 14: Efficacy Response in Placebo-Controlled Study nr-axSpA I
Preglednica 14: Odziv učinkovitosti v s placebom kontrolirani študiji nr-axSpA I
Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (<1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 19,7, izhodiščna PGA pa je segala od ''blage'' (< 1 %), ''zmerne'' (48 %) in ''hude'' (46 %) do ''zelo hude'' (6 %).
Maintenance of clinical remission was evaluated in CD Study III (CHARM).
Vzdrževanje klinične remisije so ovrednostili v študiji pri Crohnovi bolezni III (CHARM).
• respiratory tract infections (including cold, runny nose, sinus infection, throat infection,
• okužbe dihal (vključno s prehladom, izcedkom iz nosu, okužbo sinusov, okužbo grla, pljučnico);
Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Adalimumab 40 mg so vsak drugi teden ocenili v dveh randomiziranih, 24-tedenskih, dvojno slepih, s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa - Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6,3), ki se niso odzvali ustrezno na konvencionalno terapijo.
If you accidentally inject your child Hulio more frequently than you should, call your child's doctor or pharmacist and explain that your child has been given more than required.
Če ste uporabili večji odmerek zdravila Hulio, kot bi smeli Če otroku pomotoma injicirate zdravilo Hulio pogosteje, kot bi morali, se posvetujte z otrokovim zdravnikom ali farmacevtom in mu povejte, da je vaš otrok prejel večji odmerek, kot je potreben.
If you take Hulio the risk of getting lymphoma, leukaemia, or other cancers may increase.
Če uporabljate zdravilo Hulio, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
The safety and efficacy of adalimumab were assessed in over 1,500 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, dvojno slepih, s placebom kontroliranih študijah.
Hulio 40 mg injection adalimumab Subcutaneous use SC
Hulio 40 mg injekcija adalimumab subkutana uporaba s.c.
Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections
pogosti sistemske okužbe (vključno s sepso, kandidiazo in gripo), črevesne okužbe (vključno z virusnim gastroenteritisom), okužbe kože in mehkih tkiv (vključno z zanohtnico, celulitisom, impetigom, nekrotizirajočim fasciitisom in herpes zostrom), okužbe ušes, okužbe ustne votline (vključno s herpesom simpleksom, ustnim herpesom in okužbami zob), okužbe reproduktivnega trakta (vključno z vulvovaginalno mikotično okužbo), okužbe urinarnega trakta (vključno s pielonefritisom), glivične okužbe, okužbe sklepov občasni okužbe centralnega živčevja (vključno z virusnim meningitisom), oportunistične okužbe in tuberkuloza (vključno s kokcidioidomikozo, histoplazmozo in kompleksno okužbo z Mycobacterium avium), bakterijske okužbe, okužbe oči, divertikulitis1)
If you have questions, please ask your child's doctor.
Če imate vprašanja, se posvetujte z otrokovim zdravnikom.
In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Opravljena je bila analiza, v kateri so vse bolnike, ki so izpadli iz študije zaradi neželenih učinkov ali nezadostne učinkovitosti ali jim je bil povečan odmerek, obravnavali kot neodzivne; pri teh bolnikih sta bila po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov) delež odziva PASI 75 69,6 % in delež odziva PGA ''čisto'' ali ''minimalno'' 55,7 %.
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.
Sočasna uporaba adalimumaba z drugimi biološkimi antirevmatiki DMARD (tj. anakinra in abatacept) 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).
Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Adalimumab je bil ocenjen v multicentrični, randomizirani, dvojno slepi klinični študiji, ki je bila zasnovana za oceno učinkovitosti in varnosti indukcijskega in vzdrževalnega zdravljenja z odmerki, odvisnimi od telesne mase (< 40 kg ali ≥ 40 kg), pri 192 pediatričnih bolnikih med 6. in (vključno) 17. letom starosti z zmerno do hudo Crohnovo boleznijo (CD), definirano kot vrednost indeksa Pediatric Crohn's Disease Activity Index (PCDAI) > 30.
• 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 Hulio.
• Če imate ali pa se pri vas razvija demielinizirajoča bolezen (bolezen, ki prizadene izolacijsko plast okoli živcev), kot je multipla skleroza, bo zdravnik presodil, ali lahko prejmete oziroma tudi še nadalje dobivate zdravilo Hulio.
It is recommended that you use an antiseptic wash daily on the affected areas.
Priporočljivo je, da na prizadetih predelih vsak dan uporabite antiseptično čistilno sredstvo.
The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Varnost in učinkovitost večkratnih odmerkov adalimumaba so ocenili pri odraslih bolnikih z zmernim do hudo aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12 z endoskopsko podoceno od 2 do 3) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
Amongst those who responded (Pediatric ACR 30) at week 24 (n=27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Med tistimi, ki so se odzvali (Pediatric ACR 30) v 24. tednu (n = 27 od 30 bolnikov), se je odziv Pediatric ACR 30 v odprti podaljšani fazi ohranil do 60 tednov pri bolnikih, ki so med tem celotnim obdobjem prejemali adalimumab.
The second received 20 mg of adalimumab every week for 52 weeks.
Druga je 52 tednov vsak teden dobivala 20 mg adalimumaba.
Hulio 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 Hulio je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your child's doctor.
Če se vašemu otroku med zdravljenjem ali po njem pojavijo nova območja poškodovane kože ali če se spremeni videz obstoječih znamenj ali poškodovanih območij, morate to povedati otrokovemu zdravniku.
Among those, 86 patients (75.4%) had ACR 20 responses; 72 patients (63.2%) had ACR 50 responses; and 41 patients (36%) had ACR 70 responses.
Med temi je 86 bolnikov (75,4 %) imelo odziv 20 po ACR; 72 bolnikov (63,2 %) je imelo odziv 50 po ACR in 41 bolnikov (36 %) je imelo odziv 70 po ACR.
• If your child has or develops demyelinating disease (a disease that affects the insulating layer around the nerves), such as multiple sclerosis, your child's doctor will decide if he/she should receive or continue to receive Hulio.
• Če vaš otrok ima ali pa se pri njem razvija demielinizirajoča bolezen (bolezen, ki prizadene izolacijsko plast okoli živcev), kot je multipla skleroza, bo otrokov zdravnik presodil, ali lahko prejme oziroma še nadalje dobiva zdravilo Hulio.
Hulio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Zdravilo Hulio je indicirano za zdravljenje hude kronične psoriaze v plakih pri otrocih in mladostnikih od 4. leta starosti, ki so se nanj neustrezno odzvali ali niso ustrezni kandidati za topikalno zdravljenje in fototerapije.
Hulio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.
Zdravilo Hulio je indicirano za zdravljenje neinfekcijskega intermediarnega, posteriornega uveitisa in panuveitisa pri odraslih bolnikih, ki se niso ustrezno odzvali na zdravljenje s kortikosteroidi, pri bolnikih s potrebo po zmanjšani uporabi kortikosteroidov ali pri bolnikih, pri katerih je zdravljenje s kortikosteroidi neprimerno.
a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
36. teden a Bolniki z vsaj delnim odzivom na odmerek 40 mg adalimumaba vsak teden po 12 tednih zdravljenja.
Hulio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Aksialni spondiloartritis brez radiografskega dokaza za AS Zdravilo Hulio je indicirano za zdravljenje odraslih s hudim aksialnim spondiloartritisom brez radiografskega dokaza o AS, toda z objektivnimi znaki vnetja s povišanimi vrednostmi CRP in/ali MRI, ki so nezadostno reagirali na ali ne prenašajo nesteroidnih protivnetnih zdravil.
Hulio is used to treat Crohn's disease in adults, and children aged 6 to 17 years.
Zdravilo Hulio se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do 17 let.
Step 6 - Pull plunger to dose + 0.1 ml Hold the syringe package and SLOWLY pull the white plunger to 0.1 ml beyond the prescribed dose (for example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Držite ovojnino brizge in POČASI potegnite beli bat ven tako, da je 0,1 ml preko predpisanega odmerka (če je npr. predpisani odmerek 0,5 ml, potegnite beli nosilec bata do 0,6 ml).
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 odstotkovnim zmanjšanjem za −62,6 % (mediana odstotkovna sprememba −88,9 %) pri skupini bolnikov, ki je prejemala adalimumab, v primerjavi z −11,6 % (mediana odstotkovna sprememba
Table 26: Paediatric CD Study PCDAI Clinical Remission and Response
Preglednica 26: Študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv
Your child should not take Hulio with medicines containing the active substances anakinra or abatacept.
Vaš otrok ne sme jemati zdravila Hulio z zdravili, ki vsebujejo učinkovini anakinro ali abatacept.
(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).
Hulio 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers (fluoropolymer-laminated butyl rubber), aluminium crimps and flip-off seals.
Zdravilo Hulio 40 mg raztopina za injiciranje v viali za enkratno uporabo (steklo tipa I) z gumijasto zaporko (butilna guma, prevlečena s fluoropolimerom), aluminijastim zamaškom in tesnilom ''flip-off''.
After 12 weeks of therapy, patients who had received adalimumab in period A were rerandomised in period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Po 12 tednih terapije so bolnike, ki so prejemali adalimumab v obdobju A, ponovno randomizirali v obdobju B v eno izmed treh skupin zdravljenja (adalimumab 40 mg vsak teden, adalimumab 40 mg vsak drugi teden ali placebo od 12. do 35. tedna).
On rare occasions, a specific and severe type of lymphoma has been observed in some patients taking adalimumab.
V redkih primerih so pri bolnikih, ki dobivajo adalimumab, opazili specifično in resno obliko limfoma.
Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Psoriatični artritis in aksialni spondiloartritis, vključno z ankiloznim spondilitisom Uporaba adalimumaba pri pediatrični populaciji za indikaciji ankilozni spondilitis in psoriatični artritis ni primerna.
Table 23: Maintenance of Clinical Remission and Response (Percent of Patients) Placebo
Preglednica 23: Vzdrževanje klinične remisije in odziva (odstotek bolnikov) placebo
If these medicines do not work well enough, patients will be given Hulio.
Če ta zdravila ne delujejo dovolj dobro, bodo bolniki prejeli zdravilo Hulio.
o DO NOT use the pen if the medication is not near the Fill Marker.
◦ Injekcijskega peresnika NE uporabljajte, če zdravilo ni v bližini oznake napolnjenosti.
Tell your child's doctor immediately if your child gets symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
Otrokovemu zdravniku takoj povejte, če se pri vašem otroku pojavijo simptomi, kot so spremembe vida, šibkost rok ali nog ali pa odrevenelost ali mravljinčenje v katerem koli delu telesa.
Push the plunger rod all the way down.
Nosilec bata potisnite do konca dol.
In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with adalimumab compared to placebo.
Rezultati obsežnejše študije AS I pri 315 bolnikih so pri bolnikih, ki so dobivali adalimumab, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
b 2-sided P value from log rank test. c NE = not estimable.
b 2-stranska vrednost P testa log-rank.
RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
V študiji revmatoidnega artritisa III je bilo ocenjenih 619 bolnikov z zmerno do zelo aktivnim revmatoidnim artritisom, starih ≥ 18 let, ki se niso učinkovito odzvali na odmerke metotreksata od 12,5 do 25 mg ali niso prenašali 10 mg metotreksata vsak teden.
In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 17 and 18).
V študijah psoriaze I in II je bila primarna končna točka delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 17 in 18).
• any infection (including tuberculosis, blood poisoning, influenza, cellulitis, shingles, ear infections, tooth infections, cold sores, reproductive tract infections, urinary tract infection,
• vse okužbe (vključno s tuberkulozo, zastrupitvijo krvi, gripo, celulitisom, pasovcem, okužbami ušes, okužbami zob, herpesom, okužbami reproduktivnih organov, okužbami sečil, glivičnimi okužbami, okužbami sklepov);
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 × ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Najpogosteje poročani neželeni učinki so okužbe (kot so nazofaringitis, okužbe zgornjih dihal in sinusitis), reakcije na mestu injiciranja (eritem, srbenje, hemoragija, bolečina ali otekanje), glavobol in mišično-skeletne bolečine.
Exposure-response relationships between adalimumab concentration and efficacy in paediatric patients with severe chronic plaque psoriasis were established for PASI 75 and PGA clear or minimal, respectively.
Razmerji med izpostavljenostjo in odzivom med koncentracijo adalimumaba in učinkovitostjo pri pediatričnih bolnikih s hudo kronično psoriazo v plakih sta bili določeni za PASI 75 (PASI - Psoriasis Area and Severity Index) in za PGA (PGA - Physician's Global Assessment) čisto ali minimalno.
In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
V študijah revmatoidnega artritisa I-IV so z adalimumabom zdravljeni bolniki v primerjavi s prejemniki placeba dosegli statistično značilna odziva 20 in 50 po ACR že en do dva tedna po začetku zdravljenja.
Hulio is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Zdravilo Hulio se uporablja za zdravljenje hidradenitis suppurativa pri mladostnikih, starejših od 12 let.
Medication
Zdravilo
• Once syringe is firmly attached to the needle, remove the clear needle packaging.
• Ko je brizga trdno nameščena na iglo, odstranite prozorno ovojnino igle.
Placebo / MTXc n=200
placebo/M TXc n = 200
Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of the body.
Zdravniku takoj povejte, če se pri vas pojavijo simptomi, kot so spremembe vida, šibkost rok ali nog ali pa odrevenelost ali mravljinčenje v katerem koli delu telesa.
Adalimumabb/ MTXc n=207
adalimumabb/M TXc n = 207
Table 16: Ps Study IV Efficacy Results at 16, 26 and 52 weeks Endpoint
Preglednica 16: Študija psoriaze IV - rezultati učinkovitosti po 16, 26 in 52 tednih Končna točka
There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitislike psoriatic arthropathy due to the small number of patients studied.
Zaradi majhnega števila proučevanih bolnikov ni dovolj dokazov o učinkovitosti adalimumaba pri bolnikih s psoriatično artropatijo, podobno ankilozirajočemu spondilitisu.