FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with rheumatoid arthritis may not manifest typical symptoms of infection, including fever, due to their disease and concomitant medicinal products.
Slovenian: Zaradi svoje bolezni in sočasne uporabe drugih zdravil včasih bolniki z revmatoidnim artritisom nimajo tipičnih znakov okužbe, med drugim tudi zvišane telesne temperature.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: How Cimzia will be given
Slovenian: Kako vam bodo dali zdravilo Cimzia
English: 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.
Slovenian: 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.
English: Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), have been reported in patients treated with TNF-antagonists.
Slovenian: Pri bolnikih, zdravljenih z zaviralci TNF, so poročali o postmarketinških primerih hepatospleničnega limfoma celic T (HSTCL - hepatosplenic T-cell lymphoma).
English: 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.
Slovenian: 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.
English: 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%
Slovenian: 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 %.
English: Multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes.
Slovenian: Večkratno pakiranje z 10 (5 pakiranj po 2) odmernimi vložki in 10 (5 pakiranj po 2) alkoholnimi zloženci.
English: Common bacterial infections (including abscess), viral infections
Slovenian: Pogostnost Neželeni učinki pogosti bakterijske okužbe (vključno z abscesom), virusne okužbe (vključno s herpes zoster, papiloma virusom, gripo)
English: 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.
Slovenian: 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.
English: Rare blood uric acid increased
Slovenian: Preiskave redki povečane vrednosti sečne kisline v krvi
English: Cimzia 200 mg + MTX every 2 weeks N=70
Slovenian: Cimzia 200 mg + MTX vsaka 2 tedna n = 70
English: Cimzia may have a minor influence on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Cimzia lahko v manjši meri vpliva na vašo sposobnost upravljanja vozil in strojev.
English: • 1 pre-filled syringe with needle guard • 1 alcohol wipe
Slovenian: • 1 napolnjeno brizgo z varovalom za iglo
English: Please read the instructions at the end of this leaflet on how to inject Cimzia.
Slovenian: Preberite navodilo za injiciranje zdravila Cimzia na koncu tega navodila za uporabo.
English: 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.
Slovenian: Pri bolnikih, ki so imeli hudo preobčutljivostno reakcijo pri drugem zdravilu, ki zavira TNF, so podatki o uporabi zdravila Cimzia omejeni.
English: Rare sexual dysfunction
Slovenian: Trajnejša manjša aktivnost bolezni
English: Cimzia 200 mg + MTX every 2 weeks N=393
Slovenian: Cimzia 200 mg + MTX vsak drugi teden n = 393
English: Inhibition of radiographic progression was further maintained up to Week 216 for the patients who remained in the study.
Slovenian: Pri bolnikih, ki so ostali v študiji, je radiografsko ocenjeno zaviranje trajalo do 216. tedna.
English: Multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes.
Slovenian: Večkratno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi brizgami in 6 (3 pakiranja po 2) alkoholnimi zloženci.
English: Do not use the pre-filled pen if the solution is discoloured, cloudy or if you can see particles in it.
Slovenian: - Ne uporabite brizge, če je raztopina obarvana, motna ali če v njej vidite delce.
English: Allée de la Recherche 60 1070 Brussels Belgium
Slovenian: UCB Pharma S.A. Allée de la Recherche 60 1070 Bruselj Belgija
English: Cimzia will be given to you by a specialist doctor or healthcare professional.
Slovenian: O tehniki samoinjiciranja vas bo poučil zdravnik ali drug zdravstveni delavec.
English: Pack of 2 pre-filled syringes and 2 alcohol wipes.
Slovenian: Na voljo je pakiranje z 2 napolnjenima injekcijskima brizgama in 2 alkoholnima zložencema.
English: Figure 2 Figure 3
Slovenian: Slika 3
English: One ml dose-dispenser cartridge containing a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber).
Slovenian: En odmerni vložek vsebuje napolnjeno injekcijsko brizgo (steklo vrste I) z bromobutilnim gumijastim zamaškom in zaporko.
English: 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.
Slovenian: 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.
English: No antigenic latex protein has to date been detected in the removable needle cap of the Cimzia pre-filled pen.
Slovenian: Do danes v odstranljivem pokrovčku napolnjene injekcijske brizge zdravila Cimzia še niso odkrili antigene lateksove beljakovine.
English: Start/Pause button
Slovenian: Naprava za injiciranje: ava vklop/izklop gumb start/pavza gumb
English: 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).
Slovenian: 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.
English: INSTRUCTIONS FOR USE FOR CIMZIA INJECTION BY MEANS OF A PRE-FILLED SYRINGE
Slovenian: NAVODILA ZA UPORABO NAPOLNJENE INJEKCIJSKE BRIZGE Z VAROVALOM ZA IGLO ZDRAVILA CIMZIA
English: •Keep the container out of the sight and reach of children.
Slovenian: • Vsebnik shranjujte nedosegljivo otrokom.
English: Pack size of 2 dose-dispenser cartridges and 2 alcohol wipes.
Slovenian: Na voljo je pakiranje z 2 odmernima vložkoma in 2 alkoholnima zložencema.
English: Cimzia 200 mg solution for injection in pre-filled syringe Pre-filled syringe with needle guard certolizumab pegol
Slovenian: Cimzia 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi napolnjena injekcijska brizga z varovalom za iglo certolizumab pegol
English: Cimzia 200 mg + MTX every 2 weeks N=246
Slovenian: Cimzia 200 mg + MTX vsak drugi teden n = 246
English: 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.
Slovenian: Napolnjeni injekcijski peresniki se lahko shranjujejo pri sobni temperaturi (do 25 °C) največ 10 dni in zaščiteni pred svetlobo.
English: After the starting dose, the maintenance dose of Cimzia for adult patients with plaque psoriasis is 200 mg every 2 weeks.
Slovenian: Po začetnem odmerku je vzdrževalni odmerek zdravila Cimzia za odrasle bolnike s psoriazo v plakih 200 mg vsaka 2 tedna.
English: • Each new injection should be given on a separate site from the last injection site.
Slovenian: • Za vsako naslednjo injekcijo morate uporabiti drugo mesto.
English: 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.
Slovenian: Napolnjeni odmerni vložki se lahko shranjujejo pri sobni temperaturi (do 25 °C) največ 10 dni in zaščiteni pred svetlobo.
English: 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.
Slovenian: 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.
English: The needle shield inside the removable cap of the CIMZIA pre-filled syringe contains a derivative of natural rubber latex (see section 6.5).
Slovenian: Ščitnik igle znotraj odstranljivega pokrovčka odmernega vložka zdravila Cimzia vsebuje derivat naravnega lateksa (glejte poglavje 6.5).
English: Cimzia was studied in 409 patients with psoriatic arthritis in the PsA001 clinical study for up to 4 years which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 168-week open-label treatment period.
Slovenian: V klinični študiji PsA001, ki je vključevala 24-tedensko s placebom nadzorovano fazo, kateri je sledilo 24-tedensko za odmerek slepo obdobje in 168-tedensko obdobje odprtega zdravljenja so zdravilo Cimzia preučevali do 4 leta pri 409 bolnikih s psoriatičnim artritisom.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe 2 single-use pre-filled syringes with needle guard 2 alcohol wipes
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjeni injekcijski brizgi 2 napolnjeni injekcijski brizgi z varovalom za iglo za enkratno uporabo 2 alkoholna zloženca
English: Patients received a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 (for both treatment arms) or placebo followed by either Cimzia 200 mg every 2 weeks or 400 mg every 4 weeks or placebo every 2 weeks.
Slovenian: Bolniki so prejeli polnilni odmerek 400 mg zdravila Cimzia na začetku zdravljenja, 2. in 4. teden (v obeh krakih študije) ali placebo, kateremu je sledilo 200 mg zdravila Cimzia vsaka 2 tedna ali 400 mg vsake 4 tedne ali placebo vsaka 2 tedna.
English: • seizure
Slovenian: • omrtvičenost
English: How to store Cimzia
Slovenian: Shranjevanje zdravila Cimzia
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in a pre-filled pen (AutoClicks) 2 single-use AutoClicks pre-filled pens 2 alcohol wipes
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje v napolnjenem injekcijskem peresniku (AutoClicks) 2 napolnjena injekcijska peresnika AutoClicks za enkratno uporabo 2 alkoholna zloženca
English: • gastrointestinal stenosis (narrowing of part of the digestive system).
Slovenian: • stenoza prebavne cevi (zožitev dela prebavil)
English: • The starting dose for adults with plaque psoriasis is 400 mg every 2 weeks given at weeks 0, 2 and 4.
Slovenian: • Začetni odmerek za odrasle s psoriazo v plakih je 400 mg vsaka 2 tedna, ki ga bolniki prejmejo na začetku zdravljenja, po dveh in po štirih tednih.
English: Keep the pre-filled pen in the outer carton in order to protect from light.
Slovenian: Odmerni vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Do not bend the needle.
Slovenian: Ne odstranite pokrovčka igle.
English: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is 200 mg every 2 weeks.
Slovenian: Po začetnem odmerku je priporočeni vzdrževalni odmerek zdravila Cimzia pri odraslih bolnikih z revmatoidnim artritisom 200 mg vsaka 2 tedna.
English: • sensory abnormalities such as numbness, tingling, burning sensation
Slovenian: • motnje občutkov, kot so omrtvičenost, mravljinčenje, pekoč občutek
English: Non-radiographic axial spondyloarthritis (nr-axSpA) The efficacy and safety of Cimzia were assessed in a 52 weeks multicenter, randomized, double-blind, placebo-controlled study (AS0006) in 317 patients ≥18 years of age with adult-onset axial spondyloarthritis and back pain for at least 12 months.
Slovenian: Učinkovitost in varnost zdravila Cimzia sta bili ocenjeni v 52-tedenski multicentrični, randomizirani, dvojno slepi, s placebom nadzorovani študiji (AS0006) pri 317 bolnikih, starih ≥ 18 let, s pojavom aksialniega spondiloartritisa, nastalega v odrasli dobi, in bolečinami v križu vsaj 12 mesecev.
English: Solution for injection in pre-filled syringe 2 single-use pre-filled syringes 2 alcohol wipes
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi 2 napolnjeni injekcijski brizgi za enkratno uporabo 2 alkoholna zloženca
English: The proportion of patients who discontinued treatment due to adverse events during the controlled trials was 4.4% for patients treated with Cimzia and 2.7% for patients treated with placebo.
Slovenian: V okviru nadzorovanih študij je zaradi neželenih učinkov zdravljenje prekinilo 4,4 % bolnikov, ki so prejemali zdravilo Cimzia, in 2,7 % tistih, ki so dobivali placebo.
English: • plaque psoriasis
Slovenian: • psoriaza v plakih (luskavica).
English: Parameters
Slovenian: Odmerjanje
English: Patients were treated with a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4 (for both treatment arms) or placebo followed by either 200 mg of Cimzia every 2 weeks or 400 mg of Cimzia every 4 weeks or placebo.
Slovenian: Bolnike so zdravili s polnilnim odmerkom zdravila Cimzia 400 mg na začetku zdravljenja, po 2 in 4 tednih ali s placebom (v obeh krakih študije), kateremu je sledilo 200 mg zdravila Cimzia vsaka 2 tedna ali 400 mg zdravila Cimzia vsake 4 tedne, ali s placebom.
English: No antigenic latex protein has to date been detected in the removable needle cap of the Cimzia dose-dispenser cartridge.
Slovenian: Do danes v odstranljivem pokrovčku odmernega vložka zdravila Cimzia še niso odkrili antigene lateksove beljakovine.
English: The needle shield inside the removable cap of the CIMZIA pre-filled pen contains a derivative of natural rubber latex (see section 6.5).
Slovenian: Ščitnik igle znotraj odstranljivega pokrovčka napolnjene injekcijske brizge zdravila Cimzia vsebuje derivat naravnega lateksa (glejte poglavje 6.5).
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih občasni poškodbe kože, upočasnjeno celjenje
English: • The starting dose for adults with rheumatoid arthritis is 400 mg given at weeks 0, 2 and 4.
Slovenian: • Začetni odmerek za odrasle z revmatoidnim artritisom je 400 mg, ki ga bolniki prejmejo na začetku zdravljenja, po dveh in po štirih tednih.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance Sandoz GmbH
Slovenian: Ime in naslov izdelovalcev biološke učinkovine
English: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with psoriatic arthritis is 200 mg every 2 weeks.
Slovenian: Po začetnem odmerku je priporočeni vzdrževalni odmerek zdravila Cimzia pri odraslih bolnikih s psoriatičnim artritisom 200 mg vsaka 2 tedna.
English: Improvements in physical function and HRQoL were maintained through 2 years in the open-label extension to RA-I. Cimzia-treated patients reported statistically significant improvements in the Work Productivity Survey compared to placebo.
Slovenian: Izboljšanje fizične funkcije in HRQoL se je ohranilo 2 leti v odprtem podaljšku klinične študije RA-I.
English: •two alcohol wipes (for cleansing the areas chosen for injection).
Slovenian: • dve napolnjeni injekcijski brizgi z raztopino, in • dva alkoholna zloženca (za čiščenje izbranega mesta injiciranja).
English: Discontinuation of Cimzia therapy should be considered in patients with confirmed significant haematological abnormalities.
Slovenian: Pri bolnikih s potrjenimi pomembnimi hematološkimi nenormalnostmi je treba razmisliti o prekinitvi zdravljenja z zdravilom Cimzia.
English: Responsea.
Slovenian: Odziv
English: Treatment regimen week 0 to 16 Cimzia 400 mg + MTX at week 0, 2 and 4, followed by
Slovenian: Cimzia 400 mg + MTX 0., 2. in 4. teden, nadaljevanje s Cimzia 200 mg + MTX vsaka 2 tedna randomiziran, dvojno slep režim zdravljenja od 18. do 34. tedna
English: • Look at the expiry date on the pre-filled pen and pack.
Slovenian: • Preverite rok uporabnosti na napolnjenem injekcijskem peresniku in na pakiranju.
English: • The starting dose for adults with psoriatic arthritis is 400 mg given at weeks 0, 2 and 4.
Slovenian: • Začetni odmerek za odrasle s psoriatičnim artritisom je 400 mg, ki ga bolniki prejmejo na začetku zdravljenja, po dveh in po štirih tednih.
English: • The Summary of Product Characteristics
Slovenian: • Povzetek glavnih značilnosti zdravila • Opozorilno kartico za bolnika
English: Patients should be given the special reminder card.
Slovenian: Bolniki, ki se zdravijo z zdravilom Cimzia, morajo prejeti posebno opozorilno kartico.
English: This will include a thorough medical history, a chest X-ray and a tuberculin test.
Slovenian: To vključuje temeljit pregled vaših predhodnih bolezni, rentgensko slikanje prsnega koša in tuberkulinski test. Izvedba teh testov mora biti zabeležena na vaši Opozorilni kartici za bolnika.
English: INSTRUCTIONS FOR USE FOR THE CIMZIA INJECTION BY MEANS OF A DOSEDISPENSER CARTRIDGE
Slovenian: NAVODILA ZA UPORABO INJEKCIJSKE BRIZGE Z ODMERNIM VLOŽKOM ZDRAVILA CIMZIA
English: Cimzia was studied in 325 patients with active axial spondyloarthritis (including ankylosing spondylitis and non-radiopraphic axial spondyloarthritis) in the AS001 clinical study for up to 4 years, which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 156-week open-label treatment period.
Slovenian: V klinični študiji AS001, ki je vključevala 24-tedensko s placebom nadzorovano fazo, kateri je sledilo 24-tedensko za odmerek slepo obdobje in 156-tedensko obdobje odprtega zdravljenja, so zdravilo Cimzia preučevali do 4 leta pri 325 bolnikih z aktivnim aksialnim spondiloartritisom (vključno z ankilozirajočim spondilitisom in neradiografskim aksialnim spondiloartritisom).
English: Uncommo anxiety and mood disorders (including associated symptoms)
Slovenian: Presnovne in prehranske motnje redki hemosideroza občasni tesnoba in nihanje razpoloženja (vključno s pripadajočimi simptomi)
English: Figure 1 1: Needle cap 2: Plunger head
Slovenian: 1: pokrovček igle 2: glava bata 3: aktivacijska nastavka za varovalo za iglo
English: Each pre-filled syringe contains 200 mg of certolizumab pegol in one ml.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 200 mg certolizumab pegola v enem mililitru.
English: Multipack containing 6 (3 packs of 2) dose-dispenser cartridge and 6 (3 packs of 2) alcohol wipes.
Slovenian: Večkratno pakiranje s 6 (3 pakiranja po 2) odmernimi vložki in 6 (3 pakiranja po 2) alkoholnimi zloženci.
English: Uncommo asthma and related symptoms, pleural effusion and symptoms, respiratory tract congestion and inflammation, cough
Slovenian: Žilne bolezni redki možganskožilni dogodek, arterioskleroza, Raynaudov sindrom, livedo reticularis telangiektazija občasni astma in z njo povezani simptomi, plevralni izliv in simptomi, zamašene dihalne poti in vnetje, kašelj
English: For subjects who were anti-dsDNA antibody negative at baseline, 2.2% of those treated with Cimzia developed positive anti-dsDNA antibody titers, compared with 1.0% of subjects in the placebo group.
Slovenian: Pri bolnikih, ki so bili pred zdravljenjem negativni, so se pojavila protitelesa proti dvovijačni DNA in sicer pri 2,2 % bolnikov, ki so prejemali zdravilo Cimzia, in pri 1,0% bolnikov, ki so dobivali placebo.
English: Frequency Adverse reactions symptoms, respiratory tract congestion and inflammation, cough mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora redki intersticijska pljučna bolezen, pnevmonitis
English: a) Cimzia 200 mg administered every 2 weeks preceded by a loading dose of 400 mg at Week 0, 2, 4. b) PGA 5 category scale.
Slovenian: a) Zdravilo Cimzia 200 mg, uporabljeno vsaka 2 tedna po polnilnem odmerku 400 mg na začetku zdravljenja, v 2., 4. tednu.
English: Do not use Cimzia after the expiry date which is stated on the pack and medication after EXP.
Slovenian: Zdravila Cimzia ne smete uporabljajte po datumu izteka roka uporabnosti, ki je naveden na pakiranju in podstavku z zdravilom poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 pre-filled syringes with needle guard and 2 alcohol wipes)
Slovenian: Zunanja škatla (za pakiranja z 2 napolnjenima injekcijskima brizgama z varovalom za iglo in 2 alkoholnima zložencema)
English: • arm or leg weakness
Slovenian: • izpuščaj ali srbenje
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 200 mg certolizumab pegol in one ml.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En odmerni vložek vsebuje 200 mg certolizumab pegola v enem mililitru.
English: • Do not shake the pre-filled pen.
Slovenian: • Napolnjenega injekcijskega peresnika ne stresajte.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/544/010
English: Cimzia 200 mg Q2W a) N=95
Slovenian: Cimzia(a)200 mg Q2W n = 90
English: Solution for injection in a pre-filled pen (AutoClicks) 2 single-use AutoClicks pre-filled pens 2 alcohol wipes.
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku (AutoClicks) 2 napolnjena injekcijska peresnika AutoClicks za enkratno uporabo 2 alkoholna zloženca
English: EU/1/09/544/006
Slovenian: EU/1/09/544/005 EU/1/09/544/006 EU/1/09/544/007
English: Severe hypersensitivity reactions have been reported rarely following Cimzia administration.
Slovenian: Pri uporabi zdravila Cimzia so pri bolnikih le redko poročali o hudih preobčutljivostnih reakcijah.