natgillin/translations-raw huggingface dataset:
Excipients: sodium acetate, sodium chloride and water for injections.
SEZNAM POMOŽNIIH SNOVI Pomožne snovi so: natrijev acetat, natrijev klorid in voda za injekcije.
The most common adverse reactions belonged to the system organ classes Infections and infestations, reported in 14.4% of patients on Cimzia and 8.0% of patients on placebo, General disorders and administration site conditions, reported in 8.8% of patients on Cimzia and 7.4% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 7.0% of patients on Cimzia and 2.4% of patients on placebo.
Najpogostejše vrste neželenih učinkov so bile infekcijske in parazitske bolezni, ki so se pojavile pri 14,4 % bolnikov, ki so prejemali zdravilo Cimzia, in pri 8,0 % bolnikov, ki so prejemali placebo, splošne težave in spremembe na mestu aplikacije, ki so se pojavile pri 8,8 % bolnikov, ki so dobivali zdravilo Cimzia, in 7,4 % bolnikov, ki so prejemali placebo, ter bolezni kože in podkožja, ki so se pojavile pri 7,0 % bolnikov, ki so prejemali zdravilo Cimzia, in pri 2,4 % bolnikov, ki so prejemali placebo.
Operations or dental procedures - Talk to your doctor if you are going to have any operations or dental procedures.
Operativni in zobozdravstveni posegi Če ste naročeni na operativni ali zobozdravstveni poseg, o tem obvestite svojega zdravnika.
• This is followed by a maintenance dose of 200 mg every 2 weeks (from week 6) or 400 mg every 4 weeks (from week 8) as instructed by your physician.
• Sledi vzdrževalni odmerek 200 mg vsak drugi teden (po 6 tednih) ali 400 mg vsake 4 tedne (po 8
Excluding non-melanoma of the skin, 121 malignancies including 5 cases of lymphoma were observed in the Cimzia RA clinical trials in which a total of 4,049 patients were treated, representing 9,277 patient-years.
Če ne upštevamo nemelanomskega raka kože, so v okviru kliničnih študij za zdravilo Cimzia za revmatoidni artritis, v katerem je sodelovalo 4.049 bolnikov, opazili 121 malignih obolenj, vključno s 5 primeri limfoma, kar predstavlja 9,277 bolnikovih let.
Uncommo menstrual cycle and uterine bleeding disorders (including amenorrhea), breast disorders
občasni motnje menstrualnega cikla in materničnih krvavitev (vključno z amenorejo), obolenja dojk
• skin sloughing, blistering, hair texture disorder
• luščenje kože, vročinski izpuščaji, motnje v strukturi las
Common pyrexia, pain (any site), asthaenia, pruritus (any site), injection site reactions
Splošne težave in spremembe na mestu aplikacije pogosti pireksija, bolečina (na različnih mestih), astenija, pruritus (na različnih mestih), reakcije na mestu injiciranja
Axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis subpopulations)
Aksialni spondiloartritis (podskupine z neradiografskim aksialnim spondiloartritisom in ankilozirajočim spondilitisom)
Physical function response and health-related outcomes In PsA001 clinical trial, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI), in pain as assessed by the PAAP and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) as compared to placebo.
Odziv v obliki fizične funkcije in z zdravstvenim stanjem povezani izidi V kliničnem preskušanju PsA001 so v primerjavi s placebom bolniki, ki so se zdravili z zdravilom Cimzia, poročali o značilnih izboljšanjih telesnih funkcij, ocenjeno z indeksom nezmožnosti na osnovi vprašalnika za oceno zdravstvenega stanja (HAQ-DI - Health Assessment Questionnaire - Disability Index), značilnih izboljšanjih bolečine, ocenjeno sPAAP, in značilnih izboljšanjih glede utrujenosti, določeno z lestvico za ocenjevanje utrujenosti (FAS - Fatigue Assessment Scale).
(a) Cimzia all dosing regimen = data from Cimzia 200 mg administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 plus Cimzia 400 mg administered every 4 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (b) Results are from the randomized set (c) Wald p-values are quoted for the comparison of treatments using logistic regression with factors for treatment and region.
(a) Cimzia vsi režimi odmerjanja = rezultati pri odmerjanju zdravila Cimzia 200 mg vsaka 2 tedna po prejemanju polnilnega odmerka 400 mg na začetku zdravljenja, drugi in četrti teden ter rezultati pri odmerjanju zdravila Cimzia 400 mg vsake 4 tedne po prejemanju polnilnega odmerka na začetku zdravljenja, drugi in četrti teden (b) Rezultati iz naključnega vzorca (c) Waldove p-vrednosti so citirane za primerjavo zdravljenj.
In the placebo+MTX group, 49.7% of patients experienced no radiographic progression (change in mTSS ≤0.5) at Week 52 compared to 70.3% in the Cimzia+MTX group (p<0.001).
V skupini, ki je v 52. tednu prejemala placebo in MTX je bilo 49,7 % bolnikov brez radiografske progresije (spremembe v mTSS ≤ 0,5), v skupini, ki je prejemala zdravilo Cimzia in MTX, je bilo 70,3 % bolnikov brez radiografske progresije.
Specific clinical trials have not been performed to assess the effect of renal impairment on the pharmacokinetics of certolizumab pegol or its PEG fraction.
Za oceno učinka motenj v delovanju ledvic na farmakokinetiko certolizumab pegola ali njegove frakcije PEG niso bile izvedene specifične klinične študije.
Paediatric malignancy
Maligna obolenja pri pediatrični populaciji
Uncommo electrolyte imbalance, dyslipidaemia, appetite disorders, weight change
Bolezni endokrinega sistema redki motnje v delovanju ščitnice občasni neravnovesje elektrolitov, dislipidemija, motnje apetita, sprememba telesne mase
• symptoms of blood disorders such as persistent fever, bruising, bleeding, paleness
• simptomi krvnih bolezni, kot so dalj časa trajajoča zvišana telesna temperatura, modrice,
Medication information chip 5.
b) Lestvica kategorije PGA 5.
• Push the plunger to inject solution.
• S potiskanjem bata vbrizgajte raztopino.
• Look at the expiry date on the medication and pack.
• Preverite rok uporabnosti na zdravilu in na pakiranju.
Please read the instructions at the end of this leaflet on how to inject Cimzia and in the user manual provided with the injection device ava.
Preberite navodila glede injiciranja zdravila Cimzia, ki so na koncu navodila za uporabo in v priročniku, ki je priložen k injekcijski napravi ava.
After Use • Do not re-use the cartridge
Po uporabi • Vložka ne uporabite ponovno.
Cimzia is used to treat moderate to severe plaque psoriasis.
Zdravilo Cimzia se uporablja za zdravljenje zmerne do hude psoriaze v plakih.
• Allow the pre-filled syringe to reach room temperature.
• Pred injiciranjem naj se napolnjena injekcijska brizga segreje na sobno temperaturo.
(pancytopaenia, anaemia, low platelet count, low white blood cell count)
krvavitve, bledica (pancitopenija, anemija, majhno število trombocitov, majhno število belih krvnih celic)
The total content (1 ml) of the pre-filled pen should be administered as a subcutaneous injection only.
Vsebino celega (1 ml) napolnjenega injekcijskega peresnika je treba aplicirati le v obliki subkutane injekcije.
Responders (achieved ACR 20) at week 16 were randomised at week 18 to Cimzia 200 mg every 2 weeks, Cimzia 400 mg every 4 weeks, or placebo in combination with MTX for an additional 16 weeks (total trial length: 34 weeks).
Bolniki, ki so se odzvali na zdravljenje (dosegli ACR 20) v 16. tednu, so od 18. tedna naprej nadaljnih 16 tednov naključno prejemali 200 mg zdravila Cimzia vsaka 2 tedna, 400 mg zdravila Cimzia vsake 4 tedne ali placebo v kombinaciji z MTX (celoten čas preskušanja: 34 tednov).
The efficacy and safety of Cimzia were assessed in one multicenter, randomized, double-blind, placebo-controlled trial (AS001) in 325 patients ≥18 years of age with adult-onset active axial spondyloarthritis for at least 3 months as defined by the Assessment of Spondyloarthritis International Society (ASAS) Classification Criteria for axial spondyloarthritis.
Učinkovitost in varnost zdravila Cimzia so ocenili v multicentričnem, randomiziranem, dvojno slepem, s placebom nadzorovanim preskušanjem (AS001) pri 325 bolnikih, starih ≥ 18 let, s pojavom aktivnega aksialnega spondiloartritisa v zadnjih 3 mesecih, ki je bil določen po kriterijih ocene v spondiloartritičnem mednarodnem združenju (ASAS - Assessment of Spondyloarthritis International Society) za aksialni spondiloartritis.
879 400 mg (0,2,4 weeks) with MTX 200 mg every 2 weeks with MTX
879 400 mg (0,2,4 tedni) z MTX 200 mg vsak drugi teden z MTX
Physical function response and health-related outcomes In the AS001 clinical trial, Cimzia-treated patients reported significant improvements in physical function as assessed by the BASFI and in pain as assessed by the Total and Nocturnal Back Pain NRS scales as compared to placebo.
Odziv v obliki fizične funkcije in z zdravstvenim stanjem povezani izidi V primerjavi s placebom so bolniki pri AS001 kliničnem preskušanju, ki so se zdravili z zdravilom Cimzia, poročali o značilnih izboljšanjih telesnih funkcij, ocenjeno z BASFI, in značilnih izboljšanjih bolečine, ocenjeno s številčno lestvico (NRS) za celostno in nočno bolečino v križu.
• blood disorders
• obolenja krvi
Administration of Cimzia should be discontinued if a patient develops a new serious infection until the infection is controlled.
Če se pri bolniku pojavi nova resna okužba, moramo uporabo zdravila Cimzia prekiniti, dokler okužba ni pod nadzorom.
Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.
Rentgenske preiskave so pokazale, da zdravilo Cimzia v kombinaciji z MTX upočasni napredovanje poškodb sklepov in izboljša fizično funkcijo.
• Let go of the needle cap so that ava can push out the used medication.
• Spustite pokrovček igle, da bo naprava ava lahko izrinila ven uporabljen vložek.
The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 11.5%.
Celotni delež bolnikov, ki so bili pozitivni za protitelesa z vztrajnim zmanjšanjem plazemske koncentracije učinkovine, je bil ocenjen na 11,5 %.
• oral disorders including pain on swallowing
• obolenja ustne votline, vključno z bolečinami pri požiranju
*p<0.01, Cimzia vs placebo **p<0.001, Cimzia vs placebo ***p<0.001(nominal), Cimzia vs placebo
*p<0,01, zdravilo Cimzia v primerjavi s placebom **p<0,001, zdravilo Cimzia v primerjavi s placebom ***p<0,001(nominalno), zdravilo Cimzia v primerjavi s placebom Rezultati so iz naključnega niza.
Rare pericarditis, atrioventricular block Common hypertension Uncommo haemorrhage or bleeding (any site), hypercoagulation (including thrombophlebitis, pulmonary embolism), syncope, oedema (including peripheral, facial), ecchymoses (including haematoma, petechiae)
Srčne bolezni redke perikarditis, atrioventrikularni blok pogosti hipertenzija občasni krvavitev (na različnih mestih), hiperkoagulacija (vključno s tromboflebitisom in pljučno embolijo), sinkopa, edem (vključno s perifernim in facialnim edemom), ehimoze (vključno s hematomom in petehijami)
Antibody formation was associated with lowered drug plasma concentration.
Nastanek protiteles je bil povezan z znižano koncentracijo učinkovine v plazmi.
(On/Off button) for 1 second, or until the screen lights up and you hear sound - “Hello” is displayed for 2 seconds - this means ava is switched on.
- ˝Hello˝ se izpiše za 2 sekundi - to pomeni, da je naprava ava prižgana.
The efficacy and safety of Cimzia were assessed in a multicentre, randomised, double-blind, placebo controlled clinical trial (PsA001) in 409 patients ≥ 18 years of age with adult-onset active psoriatic arthritis for at least 6 months as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
Učinkovitost in varnost zdravila Cimzia so ocenili v multicentričnem, randomiziranem, dvojno slepem, s placebom nadzorovanem kliničnem preskušanju (PsA001) pri 409 bolnikih, starih ≥ 18 let, s pojavom aktivnega psoriatičnega artritisa v zadnjih 6 mesecih, ki je bil določen po kriterijih ocene za psoriatični artritis (CASPAR).
If severe reactions occur, administration of Cimzia should be discontinued immediately and appropriate therapy instituted.
Če se te reakcije pojavijo, je treba zdravljenje z zdravilom Cimzia prekiniti in začeti z ustrezno terapijo.
In an integrated analysis of CIMPASI-1 and CIMPASI-2, among patients who were PASI 75 responders at Week 16 and received Cimzia 400 mg every 2 weeks or Cimzia 200 mg every other week, the maintenance response rates at Week 48 were 98.0% and 87.5%, respectively.
V integrirani analizi študije CIMPASI-1 in CIMPASI-2, so bile med bolniki, ki so imeli v 16. tednu odziv PASI 75, in so prejemali zdravilo Cimzia 400 mg vsaka 2 tedna ali zdravilo Cimzia 200 mg vsaki drugi teden, stopnje vzdrževanja odziva v 48. tednu 98,0 % oz. 87,5 %.
Patients had active disease as defined by the BASDAI ≥4, and spinal pain ≥4 on a 0 to 10 NRS.
Bolniki so imeli aktivno bolezen po indeksu BASDAI ≥ 4 in bolečino v križu ≥ 4, ocenjeno s številčno lestvico (NRS) z vrednostmi od 0 do 10.
Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics showed no effect on the pharmacokinetics of certolizumab pegol based on a population pharmacokinetics analysis.
Rezultati populacijske farmakokinetične analize niso pokazali vpliva sočasne uporabe metotreksata, kortikosteroidov, nesteroidnih protivnetnih zdravil (NSAID) in analgetikov na farmakokinetiko certolizumab pegola.
• lupus (immune/connective tissue disease) symptoms (joint pain, skin rashes, photosensitivity and fever)
• edem (otekanje obraza ali nog) • simptomi lupusa (imunska bolezen/ bolezen veznega tkiva) (bolečine v sklepih, kožni izpuščaj,
Suitable sites for injection would include the thigh or abdomen.
Med ustrezna mesta za injiciranje sodita stegno in trebuh.
• “Remove and save needle cap” is shown.
• Prikaže se ˝Remove and save needle cap˝ - Pokrovček igle odstranite samo takrat, ko ste pripravljeni na injiciranje.
Of the 138 patients randomised to Cimzia 200 mg every 2 weeks, 92, 68 and 48 had an ACR 20/50/70 response, at Week 48 respectively.
Od 138 bolnikov, ki je randomizirano prejemalo 200 mg zdravila Cimzia vsaka 2 tedna, jih je v 48. tednu 92 imelo odziv ACR 20, 68 odziv ACR 50 in 48 odziv ACR 70.
In both clinical trials, Cimzia-treated patients reported significantly greater improvements in the SF-36 Physical and Mental Component Summaries and all domain scores.
V obeh kliničnih študijah so pri bolnikih, ki so prejemali zdravilo Cimzia, na osnovi uporabe vprašalnika o splošnem zdravstvenem stanju SF-36 poročali o pomembnem izboljšanju rezultatov v vseh domenah.
Rare cholelithiasis Common rash Uncommo alopecia, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis) and related conditions, dermatitis and eczema, sweat gland disorder, skin ulcer, photosensitivity, acne, skin discolouration, dry skin, nail and nail bed disorders
Bolezni jeter, žolčnika in žolčevodov redki holelitiaza pogosti izpuščaj občasni alopecija, nov pojav ali poslabšanje psoriaze (vključno s palmoplantarno pustulozno psoriazo) in z njo povezani simptomi, dermatitis in ekcem, motnje žlez znojnic, razjede kože, fotosenzitivna reakcija, akne, razbarvanost kože, suha koža, motnje nohtov in nohtne posteljice
**Cimzia+MTX vs placebo+MTX: p<0.001 p value was estimated from a logistic regression model with factors for treatment, region, and time since RA diagnosis at Baseline (≤4 months vs >4 months)
* 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)
Cimzia-treated patients reported significant improvements in tiredness (fatigue) as reported by the BASDAI-fatigue item and in health-related quality of life as measured by the ankylosing spondylitis QoL (ASQoL) and the SF-36 Physical and Mental Component Summaries and all domain scores as compared to placebo.
Bolniki, ki so se zdravili z zdravilom Cimzia, so poročali o značilnih izboljšanjih glede utrujenosti, ocenjeno z BASDAI indeksom-parameter utrujenost, in značilnih izboljšanjih kakovosti življenja v povezavi z zdravjem, ocenjeno z indeksom QoL za ankilozirajoči spondilitis (ASQoL) in na podlagi ocene telesne in duševne komponente SF-36.
NA = not available *p≤0.05, Cimzia vs placebo **p<0.001, Cimzia vs placebo
NA = ni na voljo *p≤ 0,05, zdravilo Cimzia v primerjavi s placebom **p<0,001, zdravilo Cimzia v primerjavi s placebom
Uncommo cardiomyopathies (including heart failure), ischaemic coronary artery disorders, arrhythmias (including atrial fibrillation), palpitations
Ušesne bolezni, vključno z motnjami labirinta občasni tinitus, vertigo občasni kardiomiopatije (vključno s srčnim popuščanjem), ishemična obolenja koronarnih arterij, aritmije (vključno z atrijsko fibrilacijo), palpitacije
- Do not touch the area again before injecting.
- Pred injiciranjem se tega predela ne dotikajte več.
982 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
982 400 mg (0,2,4 tedni) z MTX 200 mg ali 400 mg vsak drugi teden z MTX
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cimzia 200 mg injection certolizumab pegol
IME ZDRAVILA IN POT(I) UPORABE Cimzia 200 mg injekcija certolizumab pegol s.c.
All patients received Cimzia in both the dose-blind and openlabel follow-up periods.
Vsi bolniki so v za odmerek slepem obdobju in v obdobju odprtega zdravljenja prejemali zdravilo Cimzia.
N/A (a) Cimzia administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (b) Cimzia administered every 4 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (c) In subjects with at least 3% psoriasis BSA at Baseline
N/A (a) Odmerjanje zdravila Cimzia vsaka 2 tedna po prejemanju polnilnega odmerka 400 mg na začetku zdravljenja, drugi in četrti teden (b) Odmerjanje zdravila Cimzia vsake 4 tedne po prejemanju polnilnega odmerka 400 mg na začetku zdravljenja, drugi in četrti teden (c) Bolniki, ki so imeli v izhodišču najmanj 3 % telesne površine prizadete s psoriazo
- You can change this speed using the “scroll wheel” on the side of your ava.
• Prikazana je trenutna hitrost injiciranja (hitrost pretok zdravila) - To hitrost lahko spreminjate z uporabo˝koleščka˝ob strani naprave ava.
Statistically significantly greater ACR 20 and ACR 50 responses were achieved from Week 1 and Week 2, respectively, in both clinical trials compared to placebo.
V primerjavi s placebom so bili v obeh kliničnih študijah doseženi statistično pomembnejši odzivi ACR 20 in ACR 50 po 1 oziroma 2 tednih.
619 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
619 400 mg (0,2,4 tedni) z MTX 200 mg ali 400 mg vsak drugi teden z MTX
• If you feel unsure about the injection process, contact your doctor or pharmacist.
• Če ste negotovi glede postopka injiciranja, se posvetujte z zdravnikom ali farmacevtom.
- If the seal(s) is missing or broken - do not use and contact your pharmacist.
• Če manjka pečat ali če je zlomljen - ne uporabljajte in se posvetujte s farmacevtom.
Keep this Patient Reminder Card with you.
Opozorilno kartico za bolnika hranite pri sebi.
One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
Ena napolnjena injekcijska brizga (steklo vrste I) z bromobutilnim gumijastim zamaškom in zaporko, ki vsebuje 200 mg certolizumab pegola.
Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia.
Pri bolnikih, ki so se zdravili z zdravilom Cimzia, so v redkih primerih poročali o nevroloških obolenjih, vključno z obolenji s konvulzijami, nevritisom in periferno nevropatijo.
* Cimzia vs placebo: p< 0.0001.
* Zdravilo Cimzia v primerjavi s placebom: p < 0,0001.
PGA clear or almost clear b) 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.
Ocena PGA brez ali skoraj čisto brez b) a) Zdravilo Cimzia 200 mg, uporabljeno vsaka 2 tedna po polnilnem odmerku 400 mg na začetku zdravljenja, v 2., 4. tednu.
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment.
Pri bolnikih, pri katerih v prvih 12 tednih zdravljenja ni terapevtskega učinka, je treba odločitev o nadaljevanju zdravljenja ponovno skrbno pretehtati.
Certolizumab pegol is a recombinant, humanised antibody Fab' fragment against tumour necrosis factor alpha (TNFα) expressed in Escherichia coli and conjugated to polyethylene glycol (PEG).
Certolizumab pegol je fragment Fab' rekombinantnega, humaniziranega protitelesa proti tumorje nekrotizirajočem faktorju alfa (TNF-α).
- One or two pre-filled syringe(s), depending on your prescribed dose - One or two alcohol wipe(s)
◦ eno ali dve napolnjeni injekcijski brizgi, odvisno od predpisanega odmerka ◦ en ali dva alkoholna zloženca
• Remove the needle cap from the needle by pulling off in a straight line.
• Z igle odstranite pokrovček tako, da ga potegnete naravnost.
Serious infections, including sepsis and tuberculosis (including miliary, disseminated and extrapulmonary disease), and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) have been reported in patients receiving Cimzia.
Pri bolnikih, ki so prejemali zdravilo Cimzia, so poročali o pojavu resnih okužb, tuberkuloze (vključno z miliarno, diseminirano in ekstrapulmonalno obliko) in oportunističnih okužb (na primer histoplazmoza, nokardije, kandidiaza), ki so bile v nekaterih primerih smrtne.
Cimzia 400 mg + MTX every 4 weeks N=69
Cimzia 400 mg + MTX vsake 4 tedne n = 69
• heart problems including weakened heart muscle, heart failure, heart attack, chest discomfort or chest pressure, abnormal heart rhythm including irregular heart beats
tiščanje ali pritisk v prsih, motnje srčnega ritma, vključno z nepravilnim srčnim utripom
Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Cimzia (see section 4.8).
Po prejemanju zdravila Cimzia se lahko pojavi omotičnost (vključno z vertigom, motnjami vida in utrujenostjo) (glejte poglavje 4.8).
If the seal(s) is missing or broken - do not use and contact your pharmacist.
- Če manjka pečat ali če je zlomljen - ne uporabljajte in se posvetujte s farmacevtom.
Physical function response and health-related outcomes In RA-I and RA-II, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) from Week 1 through to the end of the studies compared to placebo.
Odziv v obliki fizične funkcije in z zdravstvenim stanjem povezani izidi V študijah RA-I in RA-II je bilo v primerjavi s placebom od 1. tedna do konca študij opaziti pomembno izboljšanje fizične funkcije, ki so jo pri bolnikih, ki so dobivali zdravila Cimzia, ovrednotili z indeksom nezmožnosti na osnovi vprašalnika za oceno zdravstvenega stanja (Health Assessment Questionnaire - Disability Index (HAQ-DI)), ter utrujenosti po lestvici FAS.
However, do not inject in an area where the skin is reddened, bruised, or hard.
Vendar pa si zdravila ne injicirajte v predel kože, ki je pordel, podplut ali otrdel.
Patients had ≥ 9 swollen and tender joints each and had active RA for at least 6 months prior to baseline.
V najmanj 9 primerih so bolniki imeli otečene in boleče sklepe ter aktivni revmatoidni artritis vsaj 6 mesecev pred začetkom zdravljenja.
The pre-filled syringe contains 200 mg of certolizumab pegol.
Napolnjena injekcijska brizga vsebuje 200 mg certolizumab pegola.