natgillin/translations-raw huggingface dataset:
In the overall population, the percentage of ASAS20 responders was clinically relevant and significantly higher for the Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks treatment groups compared to placebo group at every visit from Week 1 through Week 24 (p≤0.001 at each visit).
V celotni populaciji je bil delež odzivov ASAS20 klinično pomemben in značilno višji pri vsakem obisku od 1. tedna do 24. tedna (p ≤ 0,001 pri vsakem obisku) v skupini, ki je prejemala zdravilo Cimzia 200 mg vsaka 2 tedna in v skupini, ki je prejemala zdravilo Cimzia 400 mg vsake 4 tedne, v primerjavi s skupino, ki je prejemala placebo.
Etanercept 50 mg BiW N=170
Etanercept 50 mg dvakrat na teden n = 170
• gastrointestinal obstructions (blockages of the digestive system).
• obstrukcija prebavne poti (zapora prebavnega sistema)
Patients received loading doses of Cimzia 400 mg at weeks 0, 2, and 4 followed by Cimzia 200 mg every 2 weeks during the initial open label period.
Bolniki so prejemali polnilni odmerek zdravila Cimzia 400 mg na začetku zdravljenja, 2. in 4. teden, ki mu je sledilo 200 mg zdravila Cimzia vsaka 2 tedna med začetnim odprtim obdobjem.
Sustained remission* (DAS28(ESR) <2.6 at both Week 40 and Week 52) Sustained low disease activity (DAS28(ESR) ≤3.2 at both Week 40 and Week 52) *Primary endpoint of C-EARLY trial (to Week 52) Full analysis set, non-responder imputation for missing values.
Trajnejša manjša aktivnost bolezni (DAS28(ESR) ≤ 3,2 po 40 tednih in 52 tednih) * Primarni cilj preskušanja C-EARLY (do 52. tedna) Popolna analiza, imputacija manjkajočih podatkov za bolnike **Cimzia+MTX v primerjavi s placebo + MTX: p<0.001 p vrednost je bila ocenjena z logistično regresijskim modelom s faktorji za zdravljenje, področje in čas od diagnoze RA v izhodiščni vrednosti (≤ 4 mesecev v primerjavi z > 4 mesecev)
The 24-week double-blind, placebo-controlled treatment period of the study was followed by a 24week dose-blind treatment period, and a 156-week open-label treatment period.
24-tedenskemu dvojno slepemu, s placebom nadzorovanem obdobju zdravljenja je sledilo 24-tedensko za odmerek slepo obdobje in 156-tedensko obdobje odprtega zdravljenja.
What Cimzia is and for what it is used for What you need to know before you use Cimzia How to use Cimzia
Kaj je zdravilo Cimzia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Cimzia Kako uporabljati zdravilo Cimzia Možni neželeni učinki
• nausea
• krči
• bleeding or bruising
• krvavitve ali nastajanje modric
MTX should be continued during treatment with Cimzia where appropriate.
Po potrebi bolnik med zdravljenjem z zdravilom Cimzia še naprej prejema MTX.
Over the course of the entire study (up to 4 years of exposure), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 17.3% (8.7% had transient formation and an additional 8.7% had persistent formation of antibodies to Cimzia).
Tekom študije (do 4 let izpostavljenosti) je bil celotni delež bolnikov, pri katerih so odkrili protitelesa proti zdravilu Cimzia vsaj v enem primeru, 17,3 % (8,7 % je imelo prehoden nastanek protiteles in dodatnih 8,7 % je imelo vztrajno nastajanje protiteles proti zdravilu Cimzia).
Patients were randomized to receive placebo, or Cimzia 200 mg every 2 weeks (following a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4), or Cimzia 400 mg every 2 weeks up to Week 16, or etanercept 50 mg twice weekly, up to Week 12.
Bolniki so bili randomizirani za prejemanje placeba ali zdravila Cimzia 200 mg vsaka 2 tedna (po polnilnem odmerku zdravila Cimzia 400 mg na začetku zdravljenja, v drugem in četrtem tednu), ali zdravila Cimzia 400 mg vsaka 2 tedna do 16 tednov, ali etanercepta 50 mg dvakrat na teden do 12 tednov.
The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 9.1%.
Skupni odstotek bolnikov, ki so bili pozitivni na protitelesa in se jim je trajno zmanjševala koncentracija učinkovine v plazmi, je bil ocenjen na 9,1 %.
• nerve disorders in the extremities including symptoms of numbness, tingling, burning sensation,
• obolenja živcev v okončinah, vključno s simptomi omrtvičenosti, mravljinčenja, pekočim občutkom, omotičnostjo, tremorjem
Cimzia patients demonstrated significantly less radiographic progression than patients receiving placebo at Week 24 and Week 52 (see Table 5).
Pri bolnikih, ki so prejemali zdravilo Cimzia, je bil po 24. oziroma 52. tednu obseg napredovanja bistveno manjši kot pri bolnikih, ki so dobivali placebo (glejte preglednico 5).
After the starting dose, the recommended maintenance dose of Cimzia for adult patients with axial spondyloarthritis is 200 mg every 2 weeks or 400 mg every 4 weeks.
Po začetnem odmerku je priporočeni vzdrževalni odmerek zdravila Cimzia pri odraslih bolnikih z aksialnim spondiloartritisom 200 mg vsaka 2 tedna ali 400 mg vsake 4 tedne.
The following instructions explain how to inject Cimzia.
Navodila, ki so pred vami, opisujejo postopek injiciranja zdravila Cimzia.
Cases of congestive heart failure have also been reported in rheumatoid arthritis patients receiving Cimzia.
Pri bolnikih z revmatoidnim artritisom, ki so prejemali zdravilo Cimzia, so prav tako poročali o poslabšanjih kongestivnega srčnega popuščanja.
The overall percentage of patients with antibodies to Cimzia detectable on at least 1 occasion was 9.6% in RA placebo-controlled trials.
V s placebom nadzorovanih preskušanjih pri revmatoidnem artritisu je bil skupen odstotek bolnikov, pri katerih so bila vsaj ob eni priložnosti prisotna protitelesa, 9,6 %.
• Allow the AutoClicks pre filled pen(s) to reach room temperature.
• Pred injiciranjem naj se napolnjeni injekcijski peresnik AutoClicks segreje na sobno temperaturo.
• flu-like symptoms, chills, altered temperature perception, night sweats, flushing
• otekli limfni vozli • gripi podobni simptomi, mrzlica, spremembe v zaznavi temperature, nočno potenje, vročinski valovi
At week 12 and 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) were seen in the Cimzia-treated patients (nominal p-value p<0.01).
Pri bolnikih, ki so se zdravili z zdravilom Cimzia (nominalna p-vrednost p<0,01), so v 12. tednu in 24. tednu opazili izboljšanje v parametrih periferne aktivnosti pri psoriatičnem artritisu (npr. število oteklih sklepov, število bolečih/občutljivih sklepov, daktilitis in entezitis).
(difference between etanercept and Cimzia 200 mg every 2 weeks was 8.0%, 95% CI -2.9, 18.9, based on a pre-specified non-inferiority margin of 10%).
§ Zdravilo Cimzia 200 mg vsaka 2 tedna v primerjavi z etanerceptom 50 mg dvakrat na teden se je izkazalo za neinferiorno (razlika med etanerceptom in zdravilom Cimzia 200 mg vsaka 2 tedna je bila 8,0 %, 95 % IZ -2,9,, 18,9, na podlagi predhodno opredeljene meje neinferiornosti 10 %).
Medication level indicator 3.
1. končni pokrovček 2. indikator nivoja zdravila 3. brizga
At Week 52, patients treated with Cimzia showed a clinical meaningful improvement in the MASES compared to placebo (LS mean change from baseline -2.4; -0.2 respectively).
V 52. tednu so bolniki, zdravljeni z zdravilom Cimzia, pokazali klinično pomembno izboljšanje MASES v primerjavi s skupino, ki je prejemala placebo (sprememba povprečne razlike od začetne vrednosti je znašala -2,4 pri bolnikih, zdravljenih z zdravilom Cimzia in -0,2 pri bolnikih, ki so prejemali placebo).
The incidence rate of new cases of infections in placebo-controlled clinical trials in rheumatoid arthritis was 1.03 per patient-year for all Cimzia-treated patients and 0.92 per patient-year for placebotreated patients.
V s placebom nadzorovanih kliničnih študijah pri revmatoidnem artritisu je bila pri bolnikih, ki so prejemali zdravilo Cimzia, pogostnost novih okužb 1,03 na bolnikovo leto, pri bolnikih, ki so prejemali placebo, pa 0,92 na bolnikovo leto.
The efficacy and safety of Cimzia was assessed in DMARD-naïve adult patients with active RA in a randomized, placebo-controlled, double-blind clinical trial (C-EARLY).
Učinkovitost in varnost zdravila Cimzia so ocenili v randomiziranem, s placebom nadzorovanem, dvojno slepem kliničnem preskušanju (C-EARLY) pri odraslih bolnikih z aktivnim RA, ki se predhodno niso zdravili z antirevmatiki DMARD.
Allergic reactions - If you experience ALLERGIC REACTIONS such as chest tightness, wheezing, dizziness,
Alergijske reakcije - Če imate ALERGIJSKE REAKCIJE, kot so tiščanje v prsih, piskanje, omotičnost, otekanje ali izpuščaj, uporabo zdravila Cimzia prekinite in TAKOJ obvestite svojega zdravnika.
Cimzia is provided as a solution for injection in a ready to use pre-filled pen (AutoClicks).
Zdravilo Cimzia je raztopina za injiciranje v napolnjenem injekcijskem peresniku (AutoClicks) za takojšnjo uporabo.
Your doctor should test you for HBV before starting Cimzia.
Pred zdravljenjem z zdravilom Cimzia vas mora zdravnik testirati na okužbo s HBV.
• coughing
• kašelj
Response Placebo + MTX N=199
Placebo + MTX n = 199
In the CIMPACT study, among PASI 75 responders at Week 16 who received Cimzia 400 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 2 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (98.0%, 80.0%, and 36.0%, respectively).
V študiji CIMPACT je bil med odzivnimi osebami PASI 75 v 16. tednu, ki so prejemale zdravilo Cimzia 400 mg vsaka 2 tedna in so bile ponovno randomizirane za zdravilo Cimzia 400 mg vsaka 2 tedna, zdravilo 200 mg vsaka 2 tedna ali placebo, večji odstotek odzivnih oseb PASI 75 v 48. tednu v skupinah z zdravilom Cimzia v primerjavi s placebom (98,0 %; 80,0 % oz. 36,0 %).
Cimzia 200 mg + MTX N=393 Mean (SD)
Cimzia 200 mg + MTX n = 393 Srednja vrednost (SD)
Haematological reactions
Hematološki pojavi
Cimzia contains the active substance certolizumab pegol, a human antibody fragment.
Zdravilo Cimzia vsebuje učinkovino certolizumab pegol, ki je del humaniziranega protitelesa.
If you feel unsure about the injection process, please contact your doctor or pharmacist.
Če ste negotovi glede postopka injiciranja, se posvetujte z zdravnikom ali farmacevtom.
How Cimzia is given
Kako se daje zdravilo Cimzia
Rare nephropathy (including nephritis)
Bolezni sečil redki nefropatija (vključno z nefritisom)
§§ Cimzia 400 mg every 2 weeks versus etanercept 50 mg twice weekly demonstrated superiority
§§ Zdravilo Cimzia 400 mg vsaka 2 tedna v primerjavi z etanerceptom 50 mg dvakrat na teden se je izkazalo za superiorno (p < 0.05).
Over the course of the entire study (up to 192 weeks), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 9.6% (4.8% had transient formation and an additional 4.8% had persistent formation of antibodies to Cimzia).
Tekom študije (do 192 tednov) je bil celotni delež bolnikov, pri katerih so odkrili protitelesa proti zdravilu Cimzia vsaj v enem primeru, 9,6 % (4,8 % je imelo prehodno nastajanje protiteles in dodatnih 4,8 % je imelo vztrajno nastajanje protiteles proti zdravilu Cimzia).
Cimziaa 200 mg every 2 weeks N= 159
Cimziaa 200 mg vsaka 2 tedna N= 159
Among PASI75 responders at Week 16 who received Cimzia 200 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 4 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was also a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (88.6%, 79.5%, and 45.5%, respectively).
Tudi med odzivnimi osebami PASI 75 v 16. tednu, ki so prejemale zdravilo Cimzia 200 mg vsaka 2 tedna in so bile ponovno randomizirane za zdravilo Cimzia 400 mg vsake 4 tedne, zdravilo Cimzia 200 mg vsaka 2 tedna ali placebo, je bil večji odstotek odzivnih oseb PASI 75 v 48. tednu v skupini z zdravilom Cimzia v primerjavi s placebom (88,6 %; 79,5 % oz. 45,5 %).
• thyroid disorders (goitre, tiredness, weight loss)
• motnje v delovanju ščitnice (golša, utrujenost, hujšanje)
The 24-week double-blind placebo controlled treatment period of the study was followed by a 24week dose-blind treatment period and an 168-week open-label treatment period.
24-tedenskemu dvojno slepemu, s placebom nadzorovanem obdobju zdravljenja je sledilo 24-tedensko za odmerek slepo obdobje in 168-tedensko obdobje odprtega zdravljenja.
Non-radiographic AxSpA
Neradiografski aksialni spondiloartritis (nr-axSpA)
Cimzia 200 mg + MTX N = 528 Mean (SD)
Cimzia 200 mg + MTX n = 528 Srednja vrednost (SD)
Rare suicide attempt, delirium, mental impairment Common headaches (including migraine), sensory abnormalities Uncommo peripheral neuropathies, dizziness, tremor
Psihiatrične motnje redki suicidalnost, delirij, duševne motnje pogosti glavobol (vključno z migreno), motnje zaznavanja
In the pivotal studies, for subjects who were ANA negative at baseline, 16.7% of those treated with Cimzia developed positive ANA titers, compared with 12.0% of subjects in the placebo group.
V pivotnih študijah so bila ob koncu zdravljenja pri bolnikih, ki so bili pred zdravljenjem negativni, prisotna antinuklearna protitelesa, in sicer pri 16,7 % bolnikov, ki so prejemali zdravilo Cimzia, in pri 12 % tistih, ki so prejemali placebo.
Cimzia-treated patients reported significant improvements in axial spondyloarthritis-related productivity at work and within household, as reported by the Work Productivity Survey as compared to placebo.
V primerjavi s placebom so bolniki z aksialnim spondiloartritisom, ki so se zdravili z zdravilom Cimzia, v študiji o produktivnosti pri delu poročali o značilnih izboljšanjih produktivnosti pri delu in v gospodinjstvu.
Injecting the solution subcutaneously with air bubbles is harmless.
Subkutano injiciranje raztopine z mehurčki ni škodljivo.
Comprehensive instructions for the preparation and administration of Cimzia in a pre-filled syringe are given in the package leaflet.
Obsežna navodila za pripravo in uporabo zdravila Cimzia v obliki napolnjene injekcijske brizge so podana v navodilu za uporabo.
Biological tests for tuberculosis screening should be considered before starting Cimzia treatment if there is any potential latent tuberculosis infection, regardless of BCG vaccination.
Če obstaja možnost latentne tuberkulozne okužbe kljub cepljenju proti tuberkulozi, je treba pred začetkom zdravljenja z zdravilom Cimzia razmisliti o bioloških testih za presejanje na prisotnost tuberkuloze.
Patients with rheumatoid arthritis may not manifest typical symptoms of infection, including fever, due to their disease and concomitant medicinal products.
Zaradi svoje bolezni in sočasne uporabe drugih zdravil včasih bolniki z revmatoidnim artritisom nimajo tipičnih znakov okužbe, med drugim tudi zvišane telesne temperature.
In both studies patients were randomized to receive placebo or Cimzia 200 mg every 2 weeks (following a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4) or Cimzia 400 mg every 2 weeks.
V obeh študijah so bolnike randomizirali za prejemanje placeba ali zdravila Cimzia 200 mg vsaka 2 tedna (po polnilnem odmerku zdravila Cimzia 400 mg na začetku zdravljenja, v 2. in 4. tednu) ali zdravila Cimzia 400 mg vsaka 2 tedna.
Patients on Cimzia 200 mg every 2 weeks were re-randomized to Cimzia 200 mg every 2 weeks, Cimzia 400 mg every 4 weeks or placebo.
Bolniki, ki so prejemali zdravilo Cimzia 200 mg vsaka 2 tedna, so bili ponovno randomizirani za zdravilo Cimzia 200 mg vsaka 2 tedna, zdravilo Cimzia 400 mg vsake 4 tedne ali placebo.
In 2 long-term (up to 5 years of exposure) open-label studies, the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 13% (8.4% of the overall patients had transient formation of antibodies and an additional 4.7% had persistent formation of antibodies to Cimzia).
V dveh dolgoročnih (do 5 let izpostavljenosti) odprtih študijah je bil procent vseh bolnikov s protitelesi proti zdravilu Cimzia, ki so jih izmerili vsaj enkrat, 13 % (8,4 % vseh bolnikov je imelo prehodno tvorbo protiteles in 4,7 % jih je imelo trajno tvorbo protiteles proti zdravilu Cimzia).
How Cimzia will be given
Kako vam bodo dali zdravilo Cimzia
No adverse effects were seen on maternal well-being or female fertility, embryo-foetal and peri- and post-natal reproductive indices in rats using a rodent antirat TNFα PEGylated Fab' (cTN3 PF) following sustained TNFα suppression.
Pri podganah pri uporabi glodalčjega pegiliranega Fab' proti podganjemu TNF-α (cTN3 PF) in podaljšanem zaviranju TNF-α niso opazili nobenih neželenih učinkov na dobro počutje mater ali na plodnost samic, embriofetalne, peri- in postnatalne reproduktivne indekse.
Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), have been reported in patients treated with TNF-antagonists.
Pri bolnikih, zdravljenih z zaviralci TNF, so poročali o postmarketinških primerih hepatospleničnega limfoma celic T (HSTCL - hepatosplenic T-cell lymphoma).
Patients were treated with placebo or a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 followed by 200 mg of Cimzia every 2 weeks.
Bolnike so zdravili s placebom ali s polnilnim odmerkom 400 mg zdravila Cimzia na začetku zdravljenja, 2. in 4. teden, čemur je sledilo 200 mg zdravila Cimzia vsaka 2 tedna.
Among patients who were PGA clear or almost clear at Week 16 and received Cimzia 400 mg every 2 weeks or Cimzia 200 mg every 2 weeks, the maintenance response rate at Week 48 were 85.9% and 84.3%
16. tednu brez ali skoraj brez PGA, in so prejemali zdravilo Cimzia 400 mg vsaka 2 tedna ali zdravilo Cimzia 200 mg vsaka 2 tedna, je bila stopnja vzdrževanja odziva v 48. tednu 85,9 % oz. 84,3 %.
Multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes.
Večkratno pakiranje z 10 (5 pakiranj po 2) odmernimi vložki in 10 (5 pakiranj po 2) alkoholnimi zloženci.
Common bacterial infections (including abscess), viral infections
Pogostnost Neželeni učinki pogosti bakterijske okužbe (vključno z abscesom), virusne okužbe (vključno s herpes zoster, papiloma virusom, gripo)
After proper training in injection technique, patients may self-inject using the pre-filled pen if their physician determines that it is appropriate and with medical follow-up as necessary.
Z uporabo napolnjenega injekcijskega peresnika si lahko bolniki zdravilo injicirajo sami, če so bili za to ustrezno usposobljeni ter če zdravnik meni, da je to primerno in bolnikovo zdravljenje po potrebi spremlja.
Rare blood uric acid increased
Preiskave redki povečane vrednosti sečne kisline v krvi
Cimzia 200 mg + MTX every 2 weeks N=70
Cimzia 200 mg + MTX vsaka 2 tedna n = 70
Cimzia may have a minor influence on your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Cimzia lahko v manjši meri vpliva na vašo sposobnost upravljanja vozil in strojev.
• 1 pre-filled syringe with needle guard • 1 alcohol wipe
• 1 napolnjeno brizgo z varovalom za iglo
Please read the instructions at the end of this leaflet on how to inject Cimzia.
Preberite navodilo za injiciranje zdravila Cimzia na koncu tega navodila za uporabo.
There are limited data on the use of Cimzia in patients who have experienced a severe hypersensitivity reaction towards another TNF-antagonist; in these patients caution is needed.
Pri bolnikih, ki so imeli hudo preobčutljivostno reakcijo pri drugem zdravilu, ki zavira TNF, so podatki o uporabi zdravila Cimzia omejeni.
Rare sexual dysfunction
Trajnejša manjša aktivnost bolezni
Cimzia 200 mg + MTX every 2 weeks N=393
Cimzia 200 mg + MTX vsak drugi teden n = 393
Inhibition of radiographic progression was further maintained up to Week 216 for the patients who remained in the study.
Pri bolnikih, ki so ostali v študiji, je radiografsko ocenjeno zaviranje trajalo do 216. tedna.
Multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes.
Večkratno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi brizgami in 6 (3 pakiranja po 2) alkoholnimi zloženci.
Do not use the pre-filled pen if the solution is discoloured, cloudy or if you can see particles in it.
- Ne uporabite brizge, če je raztopina obarvana, motna ali če v njej vidite delce.
Allée de la Recherche 60 1070 Brussels Belgium
UCB Pharma S.A. Allée de la Recherche 60 1070 Bruselj Belgija
Cimzia will be given to you by a specialist doctor or healthcare professional.
O tehniki samoinjiciranja vas bo poučil zdravnik ali drug zdravstveni delavec.
Pack of 2 pre-filled syringes and 2 alcohol wipes.
Na voljo je pakiranje z 2 napolnjenima injekcijskima brizgama in 2 alkoholnima zložencema.
Figure 2 Figure 3
Slika 3
One ml dose-dispenser cartridge containing a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber).
En odmerni vložek vsebuje napolnjeno injekcijsko brizgo (steklo vrste I) z bromobutilnim gumijastim zamaškom in zaporko.
Patient on Cimzia 400 mg every 2 weeks were re-randomized to Cimzia 400 mg every 2 weeks, Cimzia 200 mg every 2 weeks, or placebo.
Bolniki, ki so prejemali zdravilo Cimzia 400 mg vsaka 2 tedna, so bili ponovno randomizirani za zdravilo Cimzia 400 mg vsaka 2 tedna, zdravilo Cimzia 200 mg vsaka 2 tedna ali placebo.
No antigenic latex protein has to date been detected in the removable needle cap of the Cimzia pre-filled pen.
Do danes v odstranljivem pokrovčku napolnjene injekcijske brizge zdravila Cimzia še niso odkrili antigene lateksove beljakovine.
Start/Pause button
Naprava za injiciranje: ava vklop/izklop gumb start/pavza gumb
The percentage of ACR 20 responders was clinically relevant for the Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks treatment groups compared to placebo group at every visit after baseline through Week 24 (nominal p≤0.001 at each visit).
Delež odzivov ACR 20 je bil klinično pomembnem pri vsakem obisku od začetka zdravljenja do 24. tedna (nominalni p ≤0,001 pri vsakem obisku) pri skupini, ki je prejemala 200 mg zdravila Cimzia vsaka 2 tedna, in skupini, ki je prejemala 400 mg zdravila Cimzia vsake 4 tedne, v primerjavi s placebom.
INSTRUCTIONS FOR USE FOR CIMZIA INJECTION BY MEANS OF A PRE-FILLED SYRINGE
NAVODILA ZA UPORABO NAPOLNJENE INJEKCIJSKE BRIZGE Z VAROVALOM ZA IGLO ZDRAVILA CIMZIA
•Keep the container out of the sight and reach of children.
• Vsebnik shranjujte nedosegljivo otrokom.
Pack size of 2 dose-dispenser cartridges and 2 alcohol wipes.
Na voljo je pakiranje z 2 odmernima vložkoma in 2 alkoholnima zložencema.
Cimzia 200 mg solution for injection in pre-filled syringe Pre-filled syringe with needle guard certolizumab pegol
Cimzia 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi napolnjena injekcijska brizga z varovalom za iglo certolizumab pegol
Cimzia 200 mg + MTX every 2 weeks N=246
Cimzia 200 mg + MTX vsak drugi teden n = 246
The pre-filled syringes may be stored at room temperature (up to 25°C) for a single period of maximum 10 days with protection from light.
Napolnjeni injekcijski peresniki se lahko shranjujejo pri sobni temperaturi (do 25 °C) največ 10 dni in zaščiteni pred svetlobo.
After the starting dose, the maintenance dose of Cimzia for adult patients with plaque psoriasis is 200 mg every 2 weeks.
Po začetnem odmerku je vzdrževalni odmerek zdravila Cimzia za odrasle bolnike s psoriazo v plakih 200 mg vsaka 2 tedna.
• Each new injection should be given on a separate site from the last injection site.
• Za vsako naslednjo injekcijo morate uporabiti drugo mesto.
The pre-filled pens may be stored at room temperature (up to 25°C) for a single period of maximum 10 days with protection from light.
Napolnjeni odmerni vložki se lahko shranjujejo pri sobni temperaturi (do 25 °C) največ 10 dni in zaščiteni pred svetlobo.
Physicians should exercise caution when considering the use of Cimzia in patients with a history of recurring or opportunistic infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Pri bolnikih s ponavljajočimi se okužbami ali oportunističnimi okužbami v anamnezi ali pri bolnikih s stanji, zaradi katerih so bolj dovzetni za okužbe, vključno s sočasno uporabo zdravil za zaviranje imunskega odziva, morajo biti zdravniki pri uporabi zdravila Cimzia previdni.