natgillin/translations-raw huggingface dataset:
For administration, the instructions for use at the end of the package leaflet and in the user manual provided with the electromechanical injection device ava should be followed.
Pri uporabi je treba upoštevati navodila, ki so na koncu navodila za uporabo in v priročniku, ki je priložen k elektromehanski injekcijski napravi ava.
In all 3 studies, the PASI 75 response rate was significantly greater for Cimzia compared to placebo starting at Week 4.
V vseh 3 študijah je bila stopnja odziva PASI 75 od 4. tedna naprprej značilno večja za zdravilo Cimzia v primerjavi s placebom.
At week 12 significant inhibition of inflammatory signs in both sacroiliac joints and the spine was observed in the Cimzia-treated patients (all dose group), in the overall axial spondyloarthritis population as well as in the sub-populations of ankylosing spondylitis and non-radiographic axial spondyloarthritis.
Pomembno zmanjšanje znakov vnetja sakroiliakalnih sklepov in hrbtenice so opazili v 12. tednu pri bolnikih, ki so se zdravili z zdravilom Cimzia (skupina z vsemi odmerki), pri celotni populaciji z aksialnim spondiloartritisom in tudi v podpopulacijah z ankilozirajočim spondilitisom ter neradiografskim aksialnim spondiloartritisom.
Do not rub the injection site.
- Mesta injiciranja ne drgnite.
•If you need to have a second injection as prescribed by your doctor repeat the injection process starting at Step 2.
• Če je potrebna druga injekcija, ki jo je predpisal zdravnik, ponovite postopek injiciranja pri koraku 2.
At the end of this period the pre-filled syringes must be used or discarded.
Po koncu tega obdobja je treba napolnjene injekcijske brizge uporabiti ali zavreči.
The proportion of patients who discontinued treatment due to adverse events in the controlled clinical studies was 1.5% for patients treated with Cimzia and 1.4% for patients treated with placebo.
Delež bolnikov, ki so zdravljenje v nadzorovanih kliničnih študijah prekinili zaradi neželenih učinkov, je bil 1,5 % za bolnike, zdravljenje z zdravilom Cimzia, in 1,4 % za bolnike, zdravljene s placebom.
Common hepatitis (including hepatic enzyme increased) Uncommo hepatopathy (including cirrhosis), cholestasis, blood bilirubin increased
občasni hepatopatija (vključno s cirozo), holestaza, povečane vrednosti bilirubina v krvi
The efficacy and safety of Cimzia have been assessed in 2 randomised, placebo-controlled, doubleblind clinical trials in patients ≥ 18 years of age with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria, RA-I (RAPID 1) and RA-II (RAPID 2).
Učinkovitost in varnost zdravila Cimzia so ocenili v 2 dvojno slepih, randomiziranih, s placebom nadzorovanih študijah pri bolnikih, starih ≥ 18 let z aktivnim revmatoidnim artritisom, ki je opredeljen v skladu z merili ACR (American College of Rheumatology), RA-I (RAPID 1) in RA-II (RAPID 2).
Do not remove the needle cap. - “Medication accepted” is shown if it is correct.
- ˝Medication accepted˝ se prikaže, če je vse pravilno.
The majority of reported TNF-antagonist cases occurred in adolescent and young adult males with Crohn's disease or ulcerative colitis.
Večina bolnikov, zdravljenih z zaviralci TNF, pri katerih se je pojavil hepatosplenični limfom celic T, so bili mladostniki in mladi, odrasli moški s Crohnovo boleznijo ali ulceroznim kolitisom.
• Allow the medication to reach room temperature.
• Pred injiciranjem naj se zdravilo segreje na sobno temperaturo.
If your doctor has allowed you to self-inject and you accidentally inject Cimzia more frequently than prescribed, you should tell your doctor.
Če ste uporabili večji odmerek zdravila Cimzia, kot bi smeli Če vam je zdravnik dovolil, da si zdravilo injicirate sami in ste si zdravilo Cimzia po pomoti injicirali večkrat kot je predpisano, morate zdravnika o tem obvestiti.
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy with Cimzia tell your doctor immediately.
Če se med ali po zdravljenju pojavijo simptomi tuberkuloze (dalj časa trajajoč kašelj, izguba telesne mase, ravnodušnost, rahlo zvišana telesna temperatura) ali katere druge okužbe, se takoj posvetujte z zdravnikom.
In addition, at Week 16, Cimzia treatment was associated with a greater proportion of patients achieving a DLQI score of 0 or 1 (Cimzia 400 mg every 2 weeks, 45.5% and 50.6% respectively; Cimzia 200 mg every 2 weeks, 47.4% and 46.2% respectively, versus placebo, 5.9% and 8.2% respectively).
Poleg tega je bilo v 16. tednu zdravljenje z zdravilom Cimzia povezano z večjim deležem bolnikov, ki so dosegli rezultat DLQI 0 ali 1 (zdravilo Cimzia 400 mg vsaka 2 tedna, 45,5 % oz. 50,6 %; zdravilo Cimzia 200 mg vsaka 2 tedna, 47,4 % oz. 46,2 %, v primerjavi s placebom, 5,9 % oz. 8,2 %).
Carriers of HBV who require treatment with Cimzia should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Pri bolnikih, ki so prenašalci HBV in potrebujejo zdravljenje z zdravilom Cimzia, je treba v času zdravljenja z njimi in nekaj mesecev po njem skrbno spremljati znake in simptome aktivne okužbe s HBV.
Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:
Zdravilo Cimzia je namenjeno za zdravljenje hudega aktivnega aksialnega spondiloartritisa pri odraslih bolnikih, ki obsega:
• Remove the prefilled syringe from the dose tray by grasping the syringe body as shown in
• Napolnjeno injekcijsko brizgo odstranite s podstavka tako, da jo držite za telo, kot prikazuje Slika 2.
The efficacy and safety of 2 dose regimens (200 mg every 2 weeks and 400 mg every 4 weeks) of Cimzia versus placebo were assessed in an 18-week, open-label, run-in, and 16-week randomised, double-blind, placebo-controlled clinical trial in adult patients with active rheumatoid arthritis diagnosed according to the ACR criteria who had inadequate response to MTX.
Za zdravilo Cimzia so v primerjavi s placebom ocenjevali učinkovitost in varnost dveh režimov odmerjanja (200 mg vsaka 2 tedna in 400 mg vsake 4 tedne) v 18-tedenskem, odprtem, uvajalnem obdobju in v 16-tedenskem, randomiziranem, dvojno slepem, s placebom nadzorovanem kliničnem preskušanju pri odraslih bolnikih z aktivnim revmatoidnim artritisom, diagnosticiranim v skladu z merili ACR, ki so se nezadostno odzvali na MTX.
Clinical response at Week 16 and 48 The key results of CIMPASI-1 and CIMPASI-2 studies are presented in Table 11.
Kliničnih odziv v 16. in 48. tednu Ključni rezultati študij CIMPASI-1 in CIMPASI-2 so predstavljeni v Preglednici 11.
• axial spondyloarthritis (including ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
• aksialni spondiloartritis (vključno z ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za ankilozirajoči spondilitis),
- Do not inject in an area where the skin is reddened, bruised, or hard.
- Ne injicirajte v predelih, kjer je koža rdeča, poškodovana ali otrdela.
At baseline, 37 % and 41% of patients had high disease activity (ASDAS ≥2.1, ≤3.5) and 62% and 58% of patient had very high disease activity (ASDAS >3.5) in the CIMZIA group and placebo group respectively.
Na začetku študije je imelo 37 % in 41 % bolnikov zelo aktivno bolezen (ASDAS ≥ 2,1, ≤ 3,5) in 62 % ter 58 % bolnikov izjemno aktivno bolezen (ASDAS > 3,5) ločeno v skupini, ki je prejemala zdravilo CIMZIA, in skupini, ki je prejemala placebo.
The active substance is certolizumab pegol.
- Učinkovina je certolizumab pegol.
In AS001 clinical trial, at Week 12 ASAS20 responses were achieved by 58% of patients receiving Cimzia 200 mg every 2 weeks and 64% of patients receiving Cimzia 400 mg every 4 weeks as compared to 38% of patients receiving placebo (p<0.01).
V kliničnem preskušanju AS001 je v 12. tednu 58 % bolnikov, ki so prejemali zdravilo Cimzia 200 mg vsaka 2 tedna in 64 % bolnikov, ki so prejemali zdravilo Cimzia 400 mg vsake 4 tedne, doseglo odziv ASAS20 v primerjavi z 38 % bolnikov, ki so prejemali placebo (p < 0,01).
Patients originally randomized to placebo that achieved a PASI 50 response but not a PASI 75 response at Week 16 received Cimzia 200 mg every 2 weeks (with a loading dose of Cimzia 400 mg at Weeks 16, 18, and 20).
Bolniki, ki so bili prvotno randomizirani za placebo, in so v 16. tednu dosegli odziv PASI 50, ne pa tudi PASI 75, so prejemali zdravilo Cimzia 200 mg vsaka 2 tedna (s polnilnim odmerkom zdravila Cimzia 400 mg v 16., 18. in 20. tednu).
Key efficacy outcomes from the AS001 clinical trial are shown in Table -8.
Ključni rezultati glede učinkovitosti pri kliničnem preskušanju AS001 so prikazani v Preglednici 8.
This evaluation should include a detailed medical history for patients with a personal history of tuberculosis, with possible previous exposure to others with active tuberculosis, and with previous and/or current use of immunosuppressive therapy.
Pri bolnikih s tuberkulozo v osebni anamnezi ali z možno predhodno izpostavljenostjo bolnikom z aktivno tuberkulozo ter s predhodnim in/ali trenutnim zdravljenjem z imunosupresivi moramo v oceno vključiti podrobno anamnezo.
• After injection, immediately throw away the used syringe(s) in a special container as instructed by your doctor, nurse or pharmacist.
• Po injiciranju uporabljen vložek nemudoma zavrzite v poseben vsebnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
The efficacy and safety of Cimzia were assessed in two placebo-controlled studies (CIMPASI-1 and CIMPASI-2) and one placebo- and active-controlled study (CIMPACT) in patients ≥18 years of age with moderate to severe chronic plaque psoriasis for at least 6 months.
Varnost in učinkovitost zdravila Cimzia so ocenili v dveh s placebom nadzorovanih študijah (CIMPASI-1 in CIMPASI-2) in eni s placebom in učinkovino nadzorovani študiji (CIMPACT), pri bolnikih ≥18 let z zmerno do hudo, vsaj 6-mesečno kronično psoriazo v plakih.
In RA-I, structural joint damage was assessed radiographically and expressed as change in mTSS and its components, the erosion score and joint space narrowing (JSN) score, at Week 52, compared to baseline.
V okviru študije RA-I so radiološko vrednotili strukturne poškodbe sklepov in jih izrazili kot spremembo mTSS in njenih komponent, ocene erozije in ocene zožitve sklepne špranje (JSN) po 52. tednu v primerjavi z izhodiščno vrednostjo.
Do not use this medicine if the solution is discoloured, cloudy or if you can see particles in it.
Ne uporabljajte tega zdravila, če je raztopina obarvana, motna ali če vidite delce v njej.
• viral infections (including cold sores, shingles, and influenza)
• virusne okužbe (vključno s herpesom na ustnici, Herpesom zoster in gripo)
• signs of infection such as fever, malaise, wounds, dental problems, burning on urination
• znake okužbe, kot so zvišana telesna temperatura, slabost, rane, težave z zobmi, pekoč občutek ob uriniranju
Table12: Clinical response in CIMPACT study at Week 12 and Week 16 Week 12
Preglednica 12: Klinični odziv v študiji CIMPACT v 12. in 16. tednu 12. teden
Results are from the randomized set.Treatment Difference: Cimzia 200 mg-placebo, Cimzia 400 mgplacebo (and corresponding 95% CI and p-value) are estimated using a standard two-sided Wald asymptotic standard errors test. Non-responder Imputation (NRI) is used for patients who escaped therapy or had missing data.
Razlika med zdravljenima: zdravilo Cimzia 200 mg-placebo, zdravilo Cimzia 400 mg-placebo (in ustreza 95 % CI in p-vrednosti) je ocenjena z uporabo standardnega dvostranskega asimptotskega Waldovega testa.
These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Ti se lahko pojavijo kot rdečkaste pege v obliki tarče ali okrogli izpuščaji na trupu, pogosto z mehurčki na sredini, luščenje kože, razjede v ustih, žrelu, nosu, na spolovilih in očeh.
Mean decreases (improvements) in DLQI from baseline ranged from -8.9 to -11.1 with Cimzia 200 mg every 2 weeks, from -9.6 to -10.0 with Cimzia 400 mg every 2 weeks, versus -2.9 to -3.3 for placebo at Week 16.
Povprečna znižanja (izboljšave) indeksa DLQI v 16. tednu od izhodišča so bila od -8,9 do -11,1 z zdravilom Cimzia 200 mg vsaka 2 tedna, od -9,6 do -10,0 z zdravilom Cimzia 400 mg vsaka 2 tedna v primerjavi z -2,9 do -3,3 za placebo.
Uncommo sepsis (including multi-organ failure, septic shock), tuberculosis (including miliary, disseminated and extrapulmonary disease), fungal infections (includes opportunistic)
Infekcijske in parazitske bolezni občasni sepsa (vključno z odpovedjo več organov, septični šok), tuberkuloza (vključno z miliarno, diseminirano in ekstrapulmonalno boleznijo), glivične okužbe (vključno z oportunističnimi)
Contents of the pack and other information
Shranjevanje zdravila Cimzia Vsebina pakiranja in dodatne informacije
Cases of lymphoma occurred at an incidence rate of 0.05 per 100 patient-years and melanoma at an incidence rate of 0.08 per 100 patient-years with Cimzia in rheumatoid arthritis clinical trials (see section 4.4).
Limfom se je v okviru kliničnih študij za zdravilo Cimzia pri bolnikih z revmatoidnim artritisom pojavljal s stopnjo incidence 0,05 na 100 bolnikovih let, melanom pa s stopnjo 0,08 na 100 bolnikovih let (glejte poglavje 4,4).
• cardiac arrhythmia
• srčna aritmija
• Press the pre-filled pen firmly against the skin.
• Napolnjeni injekcijski peresnik čvrsto potisnite v kožo.
Uncommo anaemia, lymphadenopathy, thrombocytopaenia, thrombocytosis
občasni anemija, limfadenopatija, trombocitopenija, trombocitoza
Cimzia solution for injection in a dose-dispenser cartridge is intended for single-use in conjunction with the electromechanical injection device named ava.
Zdravilo Cimzia raztopina za injiciranje v odmernem vložku je namenjeno za enkratno uporabo skupaj z elektromehansko injekcijsko napravo, imenovana ava.
• Store ava in the storage case after use.
• Po uporabi shranite napravo ava v škatlo za shranjevanje.
The needle shield is styrene butadiene rubber which contains a derivative of natural rubber latex (see section 4.4).
Ščitnik igle je izdelan iz stiren-butadienske gume, ki vsebuje derivat naravnega lateksa (glejte poglavje 4.4).
- Do not remove the needle cap from the medication yet.
- Pokrovčka igle še ne odstranite z vložka.
Severe infections and neutropaenia were reported in clinical trials with concurrent use of anakinra (an interleukin-1 antagonist) or abatacept (a CD28 modulator) and another TNF-antagonist, etanercept, with no added benefit compared to TNF-antagonist therapy alone.
V kliničnih študijah so ob sočasni uporabi anakinre (antagonist interlevkina-1) ali abatacepta (modulatorja CD28) in drugega zaviralca TNF etanercepta opazili pojav resnih okužb in nevtropenije.
If your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inject the next dose of Cimzia as soon as you remember.
Če vam je zdravnik dovolil, da si zdravilo injicirate sami in ste si ga pozabili injicirati, si naslednji odmerek vbrizgajte takoj, ko je to mogoče.
The most common adverse reactions reported through Week 16 belonged to the system organ classes Infections and infestations, reported in 6.1% of patients on Cimzia and 7% of patients on placebo, General disorders and administration site conditions, reported in 4.1% of patients on Cimzia and 2.3% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 3.5% of patients on Cimzia and 2.8% of patients on placebo.
Najpogostejši neželeni učinki, o katerih so poročali do konca 16. tedna, so bili iz organskih sistemov Infekcijske in parazitske bolezni, o katerih so poročali pri 6,1 % bolnikov, zdravljenih z zdravilom Cimzia in 7 % bolnikov, zdravljenih s placebom, Splošne težave in spremembe na mestu aplikacije, o katerih so poročali pri 4,1 % bolnikov, zdravljenih z zdravilom Cimzia, in 2,3 % bolnikov, zdravljenih s placebom, in Bolezni kože in podkožja, o katerih so poročali pri 3,5 % bolnikov, zdravljenih z zdravilom Cimzia, in 2,8 % bolnikov, zdravljenih s placebom.
Infections - If you have had RECURRENT or OPPORTUNISTIC INFECTIONS or other conditions that increase the risk of infections (such as treatment with immunosuppressants, which are medicines that could reduce your ability to fight infections).
ki povečajo tveganje za okužbe (npr. zdravljenje z imunosupresivi, zdravili, ki lahko zmanjšajo obrambno sposobnost vašega organizma).
• inflammation of the nerves for hearing, seeing, or of the face, impaired coordination or balance
• vnetje slušnega, očesnega ali obraznega živca, motnje koordinacije ali ravnotežja
Vaccinations - Talk to your doctor if you have had, or are due to have a vaccine.
Cepljenja Obvestite svojega zdravnika, če ste bili nedavno cepljeni ali ste naročeni na cepljenje.
Cimzia was shown to neutralise membrane associated and soluble human TNFα in a dose-dependent manner.
Pokazali so, da zdravilo Cimzia v odvisnosti od odmerka nevtralizira membransko vezano in topno obliko humanega TNF-α.
The total content (1 ml) of the pre-filled syringe should be administered as a subcutaneous injection only.
Vsebino cele (1 ml) napolnjene injekcijske brizge je treba aplicirati le v obliki subkutane injekcije.
Uncommo visual disorder (including decreased vision), eye and eyelid inflammation, lacrimation disorder
Očesne bolezni občasni motnje vida (vključno s poslabšanim vidom), vnetje oči in vek, motnje solzenja
• prolonged coagulation (clotting) test times
• podaljšan čas pri testu koagulacije (strjevanja krvi)
If your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inject yourself as soon as you remember and contact your doctor for information.
Če vam je zdravnik dovolil, da si zdravilo injicirate sami in ste si ga pozabili injicirati, si naslednji odmerek vbrizgajte takoj, ko je to mogoče, in se posvetujte z zdravnikom.
One ml pre-filled pen (AutoClicks) containing a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
En ml napolnjenega injekcijskega peresnika (AutoClicks) vsebuje napolnjeno injekcijsko brizgo (steklo vrste I) z bromobutilnim gumijastim zamaškom in zaporko, ki vsebuje 200 mg certolizumab pegola.
In addition, uncommon cases of non-melanoma skin cancer have been observed in patients taking Cimzia.
Poleg tega so pri bolnikih, ki so jemali zdravilo Cimzia, občasno poročali o primerih nemelanomskega raka kože.
Comprehensive instructions for the preparation and administration of Cimzia in a dose-dispenser cartridge are given in the package leaflet and in the user manual provided with the electromechanical injection device ava.
Obsežna navodila za pripravo in uporabo zdravila Cimzia v obliki z odmernim vložkom so podana v navodilu za uporabo in priročniku za uporabo, ki je priložen k elektromehanski injekcijski napravi ava.
Injecting the solution subcutaneously which contains air bubbles is harmless.
Subkutano injiciranje raztopine, ki vsebuje mehurčke je neškodljivo.
Antibody formation was associated with lowered drug plasma concentration and in some patients, reduced efficacy.
Nastanek protiteles je bil povezan z znižano koncentracijo zdravila v plazmi, pri nekaterih bolnikih pa je imel za posledico zmanjšano učinkovitost.
If this occurs, you should stop using Cimzia.
Če se to zgodi, morate zdravljenje z zdravilom Cimzia nemudoma prekiniti.
The total content (1 ml) of the dose-dispenser cartridge should be administered using the electromechanical injection device ava for a subcutaneous injection only.
Celotno vsebino (1 ml) odmernega vložka je treba aplicirati z uporabo elektromehanske injekcijske naprave ava le v obliki subkutane injekcije.
Cimzia, which you will take in combination with methotrexate, is used to:
Zdravilo Cimzia v kombinaciji z metotreksatom se uporablja za:
Specific clinical trials have not been performed to assess the effect of hepatic impairment on the pharmacokinetics of certolizumab pegol.
Specifične klinične študije za oceno učinka motenj v delovanju jeter na farmakokinetiko certolizumab pegola niso bile izvedene.
Do not touch this area again before injection.
- Tega predela se ne dotikajte več, dokler si ne boste dali injekcije.
Patients who develop a new infection while undergoing treatment with Cimzia should be monitored closely.
Pozorno je treba spremljati bolnike, pri katerih se v času zdravljenja z zdravilom Cimzia razvije nova okužba.
- It is uncommon, but symptoms of a disease called lupus (for example persistent rash, fever, joint pain and tiredness) may occur.
- V redkih primerih se lahko razvijejo simptomi bolezni, ki se imenuje lupus (npr. dalj časa trajajoč izpuščaj, zvišana telesna temperatura, bolečina v sklepih in utrujenost).
If you are given too much Cimzia
Če ste prejeli večji odmerek zdravila Cimzia
• gastrointestinal cancer, melanoma
• rak prebavil, melanom
N/A: Not Applicable *Wald p-values for Cimzia 200 mg vs. placebo and Cimzia 400 mg vs. placebo comparisons are estimated from a logistic regression model with factors for treatment
*Waldove p-vrednosti za zdravilo Cimzia 200 mg v primerjavi s placebom in za zdravilo Cimzia 400 mg v primerjavi s placebom so ocenjene z logistično regresijo s faktorji za zdravljenje
For rheumatoid arthritis and psoriatic arthritis, MTX should be continued during treatment with Cimzia where appropriate.
Po potrebi bolnik z revmatoidnim artritisom in psoriatičnim artritisom med zdravljenjem z zdravilom Cimzia še naprej prejema MTX.
Use of anti-tuberculosis therapy should also be considered before the initiation of Cimzia in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and in patients who have significant risk factors for tuberculosis despite a negative test for latent tuberculosis.
Pri bolnikih z latentno ali aktivno tuberkulozo v osebni anamnezi, pri katerih ni mogoče potrditi ustreznega režima zdravljenja, in pri bolnikih, kjer so dejavniki tveganja za tuberkulozo kljub negativnim rezultatom testiranja za latentno tuberkulozo precejšnji, je treba pred uvedbo zdravljenja z zdravilom Cimzia razmisliti tudi o možnosti zdravljenja tuberkuloze.
The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 6.8%.
Celotni delež bolnikov, ki so bili pozitivni za protitelesa z vztrajnim zmanjšanjem plazemske koncentracije učinkovine, je bil ocenjen na 6,8 %.
- You may cover the injection site with a small adhesive bandage, if necessary.
- Če je potrebno lahko mesto injiciranja pokrijete z majhnim samolepilnim obližem.
Of the 135 patients randomised to Cimzia 400 mg every 4 weeks, 89, 62 and 41 patients had an ACR 20/50/70 response, respectively.
Od 135 bolnikov, ki so randomizirano prejemali 400 mg zdravila Cimzia 4 tedne, je 89 bolnikov imelo odziv ACR 20, 62 odziv ACR 50 in 41 odziv ACR 70.
Sodium acetate Sodium chloride Water for injections
6.1 Seznam pomožnih snovi natrijev acetat natrijev klorid voda za injekcije
• skin disorders such as new onset or worsening of psoriasis, inflammation of the skin (such as eczema), sweat gland disorders, ulcers, photosensitivity, acne, hair loss, discoloration, nail separation, dry skin and injuries
• kožna obolenja, kot so pojav ali poslabšanje luskavice, vnetje kože (kot je ekcem), motnje žlez znojnic, razjede, fotosenzitivnost, akne, izguba las, razbarvanost, odstopanje nohtov, suha koža in poškodbe
• enlarged spleen
• povečana vranica
There was no effect of gender on the pharmacokinetics of certolizumab pegol.
Učinka spola na farmakokinetiko certolizumab pegola niso opazili.
Table11: Clinical response in studies CIMPASI-1 and CIMPASI-2 at Week 16 and Week 48 Week 16
Preglednica 11: Klinični odziv v študijah CIMPASI-1 in CIMPASI-2 v 16. tednu in 48. tednu 16. teden
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists including certolizumab pegol (see section 4.8).
Pri bolnikih, ki so se zdravili z zaviralci TNF, vključno s certolizumab pegolom, so poročali o melanomu in karcinomu Merklovih celic (glejte poglavje 4.8).