natgillin/translations-raw huggingface dataset:
- if you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
- če imate hudo okužbo, vključno s tuberkulozo, sepso (zastrupitev krvi) ali drugo oportunistično okužbo (ponavadi okužba povezana z oslabljenim imunskim sistemom).
Should treatment be interrupted, Idacio 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom Idacio z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v 0,8 ml odmerku, kar v bistvu pomeni ‘‘brez natrija''.
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)).
Table 28 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)
3.4 Keep the vial and syringe vertical and slowly pull the prescribed dose.
3.4 Vialo in injekcijsko brizgo držite navpično in počasi potegnite bat ter brizgo napolnite s predpisanim odmerkom.
Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Uporaba živih cepiv (npr. BCG cepiva) pri dojenčkih, ki so bili izpostavljeni adalimumabu v maternici, ni priporočljiva še 5 mesecev po materini zadnji injekciji adalimumaba med nosečnostjo.
patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment.
Na splošno med bolniki, ki so prekinili študijo, jih je 18 % prekinilo študijo zaradi neželenih učinkov in 8 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
Fever, bruising, bleeding or looking pale
Vročina,podpludbe, krvavitev ali bledica
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9% for patients taking adalimumab and 5.4% for control treated patients.
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim delom študij, ki podpirajo vlogo za pridobitev dovoljenja za promet, je bil 5,9 % v skupini bolnikov, ki je prejemala adalimumab, in 5,4 % v kontrolni skupini bolnikov.
• symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
• znaki problemov z živčevjem kot je mravljinčenje; omrtvelost; dvojni vid ali šibkost rok ali nog;
6.4 Remove the needle from the skin, being careful to pull it out at the same angle that it was inserted.
6.4 Injekcijsko iglo izvlecite iz kože pod istim kotom, kot ste jo vstavili.
Idacio works by reducing this inflammation.
Zdravilo Idacio deluje tako, da zmanjša tako vnetje.
Idacio is a biosimilar medicinal product.
Zdravilo Idacio je biološko podobno zdravilo.
You should not take Idacio with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Zdravila Idacio ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept zaradi povečanega tveganja za resne okužbe.
• nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• bolezni živčevja (kot je vnetje vidnega živca v očeh in sindrom Guillain-Barré, to je stanje ki lahko povzroči šibkost mišic, nenormalna občutenja, mravljinčenje v rokah in zgornjem delu telesa);
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Idacio treatment.
Ženske v rodni dobi morajo premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom Idacio.
Alternatively, if a patient has stopped Idacio and signs and symptoms of disease recur, Idacio may be re-administered.
Če bolnik neha uporabljati zdravilo Idacio, pa se znaki in simptomi bolezni ponovijo, je alternativno mogoče zdravilo Idacio znova uvesti.
Idacio is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Zdravilo Idacio se uporablja za zdravljenje otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadane sprednji del očesa.
Thirty-three (18%) 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 NSAIDs.
If you receive Idacio while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Če prejemate zdravilo Idacio med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil okužbo do okoli pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
What Idacio is and what it is used for
KAJ JE ZDRAVILO IDACIO IN ZA KAJ GA UPORABLJAMO
Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Med bolniki, pri katerih je bilo zdravljenje z adalimumabom ukinjeno v 12. tednu v študijah HS-I in HS-II, se je po ponovni uvedbi adalimumaba 40 mg enkrat na teden raven kliničnega odziva (HiSCR) vrnila na podobno raven, kot so jo opazili pred ukinitvijo (56,0 %).
Table 29 Time to treatment failure in studies UV I and UV II
Preglednica 29 Čas do neuspeha zdravljenja v študijah UV I in UV II
In rheumatoid arthritis, methotrexate is continued while using Idacio.
Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila Idacio nadaljuje.
• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of contracting HBV.
• Zdravniku morate povedati, če je vaš otrok nosilec virusa hepatitisa B (HBV), če ima aktivno HBV okužbo ali če mislite, da bi se lahko nalezel HBV.
Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Zdravilo Idacio je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
• The name on the vial is not Idacio.
• Na nalepki ni imena Idacio.
Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (study HS-I).
Večja izboljšanja v 12. tednu glede na izhodiščno vrednost v primerjavi s placebom so bila prikazana v kakovosti življenja, povezani s koži specifičnim zdravjem, merjena z dermatološkim indeksom kakovosti življenja (“Dermatology life quality index” (DLQI), v študijah HS-I in HS-II), glede bolnikovega splošnega zadovoljstva z zdravljenjem z zdravilom, merjenim z vprašalnikom o zadovoljstvu z zdravljenjem z zdravilom (“Treatment Satisfaction Questionnaire - medication” (TSQM), v študijah HS-I in HS-II), in glede telesnega zdravja, merjenega s seštevkom telesnih komponent v vprašalniku SF-36 (“Short Form Health Survey" (SF 36) v študiji HS-I).
- if your child has a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
• če ima vaš otrok hudo okužbo, vključno s tuberkulozo, sepso (zastrupitev krvi) ali drugo oportunistično okužbo (ponavadi okužba povezana z oslabljenim imunskim sistemom).
If active tuberculosis is diagnosed, Idacio therapy must not be initiated (see section 4.3).
Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Idacio ne sme začeti (glejte poglavje
2.2 Check the label on the vial for Idacio and expiration date.
2.2 Preglejte nalepko in preverite, ali je na njej ime Idacio in če je rok uporabnosti že pretekel.
Idacio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Zdravilo Idacio se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri otrocih in mladostnikih, starih 2 do 17 let, in artritisa, povezanega z entezitisom pri otrocih in mladostnikih starih od 6 do 17 let.
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 a Of those receiving corticosteroids at baseline
Klinični odgovor pomeni znižanje ocene Mayo od začetka za ≥ 3 in ≥ 30 % ter znižanje podocene rektalne krvavitve [RBS] ≥ 1 ali absolutna RBS 0 ali 1; *p < 0,05 za parno primerjavo deležev med adalimumabom in placebom **p < 0,001 za parno primerjavo deležev med adalimumabom in placebom a Od tistih, ki so izhodiščno prejemali kortikosteroide
The recommended dose of Idacio 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 Idacio pri bolnikih z ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za AS in pri bolnikih s psoriatičnim artritisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
The combination of Idacio and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Kombinacija zdravila Idacio in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDs ali antagonistov TNF”).
Physicians should exercise caution when considering the use of Idacio in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Pri odločanju za uporabo zdravila Idacio je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
• The name on the syringe is not Idacio.
• na injekcijski brizgi ni imena Idacio.
INFORMATION IN BRAILLE Idacio 40 mg/0.8 mL
PODATKI V BRAILLOVI PISAVI Idacio 40 mg/0,8 ml
PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX c P=0.083, adalimumab 0.8 mg/kg versus MTX
PGA: čisto/minimalnoc a MTX = metotreksat 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
If you forget to use Idacio
Če ste pozabili uporabiti zdravilo Idacio
• neuropathy (nerve damage);
• nevropatija (poškodbe živčevja);
Tell your doctor if you are taking azathioprine or mercaptopurine with Idacio.
Povejte zdravniku, če jemljete azatioprin ali merkaptopurin sočasno z zdravilom Idacio.
What you need to know before your child uses Idacio 3.
KAJ MORATE VEDETI, PREDEN BO VAŠ OTROK UPORABIL ZDRAVILO IDACIO
Idacio 40 mg solution for injection in pre-filled syringe EU/1/19/1356/002
Idacio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/19/1356/002
The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Primarni opazovani dogodek je bil odstotek spremembe od izhodiščne vrednosti do 12. tedna v številu aktivnih sklepov z artritisom (oteklina, ki ni nastala zaradi deformacije ali sklepi z zmanjšano gibljivostjo ter bolečino in/ali občutljivostjo); slednji je bil dosežen s povprečnim zmanjšanjem za -62,6 % (mediana sprememba -88,9 %) pri skupini bolnikov, ki je prejemala adalimumab v primerjavi z -11,6 % (mediana sprememba -50,0 %) v skupini bolnikov, ki je prejemala placebo.
When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient years.
Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče in zaključene odprte nadaljevalne študije z medianim trajanjem približno 3,3 leta s 6427 bolniki in prek 26439 bolnikov-let zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 8,5 na 1000 bolnikov-let.
In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
V preskušanju faze 3 z adalimumabom pri bolnikih s pediatrično Crohnovo boleznijo, kjer so ocenjevali učinkovitost in varnost dveh telesni masi prilagojenih vzdrževalnih režimov odmerjanja, ki sta sledila telesni masi prilagojenemu začetnemu zdravljenju do 52 tednov zdravljenja, so se pojavila zvišanja ALT ≥ 3 x ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
Tell your doctor if your child is taking azathioprine or mercaptopurine with Idacio.
Povejte zdravniku, če vaš otrok prejema azatioprin ali merkaptopurin sočasno z zdravilom Idacio.
Myocardial infarction1), arrhythmia, congestive heart failure
pogosti tahikardija občasni miokardni infarkt1), aritmija, kongestivno srčno popuščanje redki zastoj srca
If your doctor considers that methotrexate is inappropriate, Idacio can be given alone.
Če vaš zdravnik meni, da metotreksat ni primeren, lahko zdravilo Idacio dobivate samo.
Leucopaenia (including neutropaenia and agranulocytosis), anaemia
zelo pogosti levkopenija (vključno z nevtropenijo in agranulocitozo), anemija
Keep this patient reminder card with you during your treatment and for 4 months after your (or your child's) last injection of Idacio.
To opozorilno kartico za bolnika imejte pri sebi med zdravljenjem in 4 mesece po vaši (ali otrokovi) zadnji injekciji zdravila Idacio.
Prescribers should exercise caution in considering the use of Idacio in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Idacio should be considered if any of these disorders develop.
Pri odločanju za uporabo zdravila Idacio pri bolnikih z že prej obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega ali perifernega živčevja je potrebna previdnost; če se razvije katera od teh bolezni, je treba razmisliti o prenehanju zdravljenja z zdravilom Idacio.
Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Idacio therapy and regularly during treatment to assess for pre- existing or developing central demyelinating disorders.
Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom Idacio in redno med zdravljenjem opravljati nevrološko oceno, da se oceni že obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega živčevja.
Idacio is intended for the treatment of the following inflammatory diseases:
Zdravilo Idacio je namenjeno za zdravljenje naslednjih vnetnih bolezni, opisanih spodaj:
A patient who requires surgery while on Idacio should be closely monitored for infections, and appropriate actions should be taken.
Bolnika, ki med zdravljenjem z zdravilom Idacio potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
Administration of Idacio should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Če se bolniku pojavi nova resna okužba ali sepsa, je treba uporabo zdravila Idacio prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
Each pack contains 1 vial (0.8 mL sterile solution), 1 sterile injection syringe, 1 sterile needle, 1 vial adaptor and 2 alcohol pads.
Eno pakiranje vsebuje 1 vialo (0,8 ml sterilne raztopine), 1 sterilno injekcijsko brizgo, 1 sterilno iglo, 1 adapter za vialo in 2 alkoholna zloženca.
ASASa,b 20 ASASa,b 40
ASASa,b20
Table 24 Time to treatment failure in studies UV I and UV II
Preglednica 24 Čas do neuspeha zdravljenja v študijah UV I in UV II
the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
• Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča antirevmatična zdravila, vključno z metotreksatom, ni zadosten.
Methotrexate should be continued during treatment with Idacio.
Med zdravljenjem z zdravilom Idacio je treba še naprej uporabljati metotreksat.
If you forget to give your child a Idacio injection, you should inject the Idacio dose as soon as you remember.
Če pozabite dati vašemu otroku injekcijo zdravila Idacio, mu morate odmerek zdravila Idacio injicirati, čim se spomnite.
If you stop using Idacio
Če ste prenehali uporabljati zdravilo Idacio
• symptoms of nerve root compression (including low back pain and leg pain);
• znaki stisnjenja živčnih korenin (vključno z bolečino v spodnjem delu hrbta in nogah);
What Idacio looks like and contents of the pack
Izgled zdravila Idacio in vsebina pakiranja
Idacio can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Zdravilo Idacio lahko upočasni napredovanje prizadetosti sklepnih hrustancev in kosti, ki jo povzroči bolezen, in izboljša telesno delovanje.
Step 8 Record your Injection
8. korak Zabeležite injiciranje
Of the 424 subjects included in the uncontrolled long-term extension of studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Od 424 bolnikov, ki so bili vključeni v nekontrolirani dolgoročni podaljšek študij UV I in UV II, je bilo 60 bolnikov neprimernih (npr. zaradi odstopanj ali zapletov, sekundarno ob diabetični retinopatiji zaradi kirurškega posega sive mrene ali vitrektomije) in so bili izključeni iz primarne analize učinkovitosti.
If your child takes Idacio the risk of getting lymphoma, leukaemia, or other cancers may increase.
Če vaš otrok uporablja zdravilo Idacio, se mu lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
Of the 424 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Od 424 bolnikov, ki so bili vključeni v nekontrolirani dolgoročni podaljšek študij UV I in UV II, je bilo 60 bolnikov neprimernih (npr.zaradi odstopanj ali zapletov, sekundarno ob diabetični retinopatiji zaradi kirurškega posega sive mrene ali vitrektomije) in so bili izključeni iz primarne analize učinkovitosti.
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
• imunske bolezni, ki lahko prizadenejo pljuča, kožo in limfne vozle (najpogosteje takšno stanje imenujemo sarkoidoze);
• In some patients the body may fail to produce enough of the blood cells that help your child's body fight off infections or help him/her to stop bleeding.
• Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki pomagajo pri premagovanju okužbe ali ustavitvi krvavitve.
the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
• Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso bili zdravljeni z metotreksatom.
Keep this patient reminder card with you or your child during treatment and for 4 months after your (or your child's) last injection of Idacio.
To opozorilno kartico za bolnika imejte pri sebi (ali jo naj ima pri sebi vaš otrok), med zdravljenjem in 4 mesece po vaši (ali otrokovi) zadnji injekciji zdravila Idacio.
TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Antagonisti TNF, z adalimumabom vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega živčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barré- jevim sindromom.
Put it on a clean flat surface.
Položite ga na čisto, ravno površino.
Figure A 1.3 Remove the box from the refrigerator (Figure B).
Slika A 1.3 Škatlo vzemite iz hladilnika (Slika B).
The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD combined.
Prilagojeno razmerje obetov (z ozirom na izhodiščne razlike) je bilo 1,10 (95 % interval zaupanja 0,45-2,73) z RA in CB skupaj.
• Hold the syringe firmly without moving it, at the same angle (Figure R).
• Injekcijsko brizgo držite trdno, ne da bi jo pri tem premikali ali spreminjali kot vboda (Slika R).
At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
V 16. tednu je statistično pomembno večji delež bolnikov, ki so prejemali adalimumab, doseglo PGA ‘'čisto'' ali ‘'skoraj čisto'' za dlani in/ali stopala, v primerjavi z bolniki, ki so prejemali placebo (30,6 % proti 4,3 %, v tem zaporedju [P = 0.014]).
5.4 Hold the syringe like a pencil with the pink needle safety cover pointing up
5.4 Injekcijsko iglo držite kot svinčnik, pri čemer je roza varovalo za injekcijsko iglo obrnjeno navzgor.