natgillin/translations-raw huggingface dataset:
Adverse reactions of the haematologic system, including medically significant cytopaenia (e.g. leukopaenia, pancytopaenia, thrombocytopaenia) have been reported with Cimzia (see section 4.8).
O neželenih hematoloških učinkih, vključno z medicinskega vidika pomembno citopenijo (levkopenija, pancitopenija, trombocitopenija), so poročali pri zdravljenju z zdravilom Cimzia (glejte poglavje 4.8).
The key results from the study are presented in table 4.
Ključni rezultati so predstavljeni v tabeli 4.
Cimzia is used to treat severe active ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis (sometimes referred to as non-radiographic axial spondyloarthritis).
Zdravilo Cimzia se uporablja za zdravljenje hudega aktivnega ankilozirajočega spondilitisa in aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis (včasih navedeno kot neradiografski aksialni spondiloartritis).
How to use Cimzia
Kako uporabljati zdravilo Cimzia
• respiratory disorders and inflammation (including asthma, shortness of breath, cough, blocked sinuses, pleurisy, or difficulty breathing)
• obolenja in vnetja dihal (vključno z astmo, kratko sapo, kašljem, zamašenimi sinusi, vnetjem rebrne mrene ali oteženo dihanje)
Cimzia treatment inhibited the radiographic progression compared with placebo treatment at Week 24 as measured by change from baseline in total mTSS Score (LS mean [±SE] score was 0.28 [±0.07] in the placebo group compared with 0.06 [±0.06] in the Cimzia all doses group; p=0.007).
Zdravljenje z zdravilom Cimzia je v primerjavi s placebom v 24. tednu zaviralo radiografsko potrjeno napredovanje bolezni, kar je bilo izmerjeno kot sprememba glede na izhodišče pri celotni oceni mTSS (srednja vrednost ocene LS [±SE] je bila 0,28 [±0,07] v placebo skupini v primerjavi z 0,06 [± 0,06] pri vseh skupinah, ki so se zdravile z zdravilom Cimzia; p=0.007).
Table 10 Key efficacy outcomes in PsA001 clinical trial (percent of patients) Response
Preglednica 10 Ključni rezultati glede učinkovitosti pri kliničnem preskušanju PsA001 (delež bolnikov)
• immune disorders such as sarcoidosis (rash, joint pain, fever), serum sickness, inflammation of the fat tissue, angioneurotic oedema (swelling of the lips, face, throat)
• obolenja imunskega sistema, kot so sarkoidoza (izpuščaj, bolečine v sklepih, zvišana telesna temperatura), serumska bolezen, vnetje maščobnega tkiva, angionevrotski edem (otekanje ustnic, obraza in grla)
Antibody positivity was associated with lowered drug plasma concentration and in some patients with reduced efficacy.
Pozitivnost na protitelesa je bila povezana z znižanimi koncentracijami zdravila v plazmi in pri nekaterih bolnikih z zmanjšano učinkovitostjo.
In a placebo-controlled clinical trial in patients with rheumatoid arthritis, similar antibody response between Cimzia and placebo treatment were observed when the pneumococcal polysaccharide vaccine and influenza vaccine were administered concurrently with Cimzia.
V klinični študiji, nadzorovani s placebom, pri bolnikih z revmatoidnim artritisom so opazili podoben odziv protiteles pri zdravljenju z zdravilom Cimzia in zdravljenju s placebom po apliciranju pnevmokoknega polisaharidnega cepiva in cepiva za gripo sočasno z zdravilom Cimzia.
An ANCOVA was fitted to the ranked change from baseline for each measure with region and treatment as factors and rank baseline as a covariate.
ANCOVA je bila prilagojena rangiranim spremembam glede na izhodiščno vrednost za vsako meritev, pri čemer sta bila regija in zdravilo faktorja, izhodiščna vrednost razvrstitve pa sospremenljivka.
The safety profile of Cimzia 400 mg every 2 weeks and Cimzia 200 mg every 2 weeks were generally similar.
Profila varnosti zdravila Cimzia 400 mg vsaka 2 tedna in zdravila Cimzia 200 mg vsaka 2 tedna sta bila načeloma podobna.
Rare skin exfoliation and desquamation, bullous conditions, hair texture disorder, Stevens-Johnson syndrome**, erythema multiforme**, lichenoid reactions
Bolezni kože in podkožja redki luščenje kože, bulozna obolenja, motnje v strukturi las, Stevens-Johnsonov sindrom**, multiformni eritem**, lihenoidne reakcije
• Do not re-use the syringe.
• Brizge ne uporabite ponovno.
Cimzia will usually be given to you by a specialist doctor or healthcare professional.
Zdravilo vam bo običajno dajal zdravnik specialist ali drug zdravstveni delavec.
• lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
• vnetni kožni izpuščaj (multiformni eritem) • lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah)
• benign (non-cancerous) tumours and cysts (including those of the skin)
• benigni (nerakavi) tumorji in ciste (vključno s kožnimi)
Inhibition of inflammation in Magnetic Resonance Imaging (MRI) In an imaging sub-study including 153 patients, signs of inflammation were assessed by MRI at week 12 and expressed as change from baseline in SPARCC (Spondyloarthritis Research Consortium of Canada) score for sacroiliac joints and ASspiMRI-a score in the Berlin modifications for the spine.
V podštudiji, ki je vključevala 153 bolnikov, so v 12. tednu z magnetno resonanco ocenjevali znake vnetja, izraženo kot sprememba od izhodišča po lestvici SPARCC (Kanadski raziskovalni konzorcij za spondiloartritis) za sakroiliakalne sklepe in po lestvici ASspiMRI-a iz Berlinske modifikacijske metode za hrbtenico.
However, no effect of age was observed in a population pharmacokinetic analysis in patients with rheumatoid arthritis in which 78 subjects (13.2% of the population) were aged 65 or greater and the oldest subject was aged 83 years.
Specifične klinične študije pri starejših bolnikih niso bile izvedene, vendar pa v populacijski farmakokinetični analizi bolnikov z revmatoidnim artritisom, v kateri je bilo 78 oseb (13,2 % populacije) starih 65 let in več, najstarejši pa 83 let, niso opazili učinka starosti na farmakokinetiko.
At Week 52, the percentage of patients achieving ASDAS inactive disease (ASDAS < 1.3) was 36.4 % for the Cimzia group compared to 11.8 % for the placebo group.
V 52. tednu je bil delež bolnikov, ki so dosegli neaktivno bolezen po kriteriju ASDAS (ASDAS < 1,3), 36,4 % v skupini, ki je prejemala zdravilo Cimzia, v primerjavi z 11,8 % za skupino, ki je prejemala placebo.
If latent (inactive) tuberculosis is diagnosed, you might be required to receive appropriate anti tuberculosis medicines before starting Cimzia.
Če je diagnosticirana latentna (neaktivna) oblika tuberkuloze, boste morali morda pred začetkom zdravljenja z zdravilom Cimzia jemati ustrezna zdravila za preprečevanje tuberkuloze.
The other ingredients are: sodium acetate, sodium chloride and water for injection (see “Cimzia contains sodium acetate and sodium chloride” in section 2).
- Pomožne snovi so: natrijev acetat, natrijev klorid in voda za injekcije (glejte ˝Zdravilo Cimzia vsebuje natrijev acetat in natrijev klorid˝ v poglavju 2).
Efficacy and safety of Cimzia in patients with PsA whose predominant symptoms were sacroiliitis or axial spondyloarthritis have not been separately analysed.
Učinkovitost in varnost zdravila Cimzia nista bili posebej analizirani pri bolnikih s psoriatičnim artritisom, pri katerih so bili prevladujoči simptomi sakroiliitis ali aksialni spondiloartritis.
• increased gastrointestinal motility
• povečana motiliteta prebavil
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age) in the post marketing setting.
Pri otrocih, mladostnikih in mladih odraslih (do 22 leta starosti), ki so se zdravili z zaviralci TNF (začetek zdravljenja pri starosti ≤ 18 let), so v obdobju trženja poročali o primerih malignih obolenj, nekaterih tudi smrtnih.
• eye and eyelid inflammation, vision disturbances, problems with tears
• vnetje oči in vek, motnje vida, težave s solzenjem
The observed ACR 20 response rate at this timepoint was 91%.The reduction (RA-I) from Baseline in DAS28 (ESR) also was significantly greater (p<0.001) at Week 52 (RA-I) and Week 24 (RA-II) compared to placebo and maintained through 2 years in the open-label extension trial to RA-I.
Zmanjšanje (RA-I) glede na izhodiščno vrednosti v DAS28 (ESR) je bilo v primerjavi s placebom prav tako pomembno večje (p<0,001) po 52 tednih (RA-I) oz. 24 tednih (RA-II) ter se je ohranjalo 2 leti v odprtem podaljšku študije RA-I.
Cimzia all dosing regimens(a) N=97
Cimzia vsi režimi odmerjanja(a) n = 97
In PsA001 clinical trial, inhibition of progression of structural damage was assessed radiographically and expressed as the change in modified total Sharp score (mTSS) and its components, the Erosion Score (ES) and Joint Space Narrowing score (JSN) at Week 24, compared to baseline.
V PsA001 kliničnem preskušanju so radiografsko ocenili zaviranje napredovanja strukturnih poškodb, izraženo kot razliko v modificirani celotni Sharpovi oceni (mTSS - modified total Sharp score) in njenih komponent, oceno erozije (ES - erosion score) in oceno zožitve sklepne špranje (JSN - joint space narrowing score) v 24. tednu v primerjavi z izhodiščnimi vrednostmi.
• spontaneous abortion.
• spontani splav
No trials have been conducted that include patients with a history of malignancy, or that continue treatment in patients who develop malignancy, while receiving Cimzia.
Nobene študije niso opravili pri bolnikih z malignimi obolenji v anamnezi ali pri bolnikih, ki so med zdravljenjem z zdravilom Cimzia razvili maligno obolenje in zdravljenje nadaljevali.
Clearance following subcutaneous dosing was estimated to be 21.0 ml/h in a rheumatoid arthritis population pharmacokinetic analysis, with an inter-subject variability of 30.8% (CV) and an interoccasion variability of 22.0%.
Očistek po subkutanem odmerjanju je bil v populacijski farmakokinetični analizi bolnikov z revmatoidnim artritisom ocenjen na 21,0 ml/h s 30,8 % variabilnostjo med preiskovanci (CV, coefficient of variation) in 22,0 % variabilnostjo med poskusi.
You should not receive certain (live) vaccines while using Cimzia.
Med zdravljenjem z zdravilom Cimzia nekaterih (živih) cepiv ne smete prejemati.
• Do not use the syringe if it has been dropped without its packaging.
• Injekcijske brizge ne smete uporabiti, če vam je padla in ni bila zapakirana.
• Methotrexate is continued while using Cimzia.
• Metotreksat bolniki med uporabo zdravila Cimzia jemljejo naprej.
If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor immediately.
Pri pojavu zvišane telesne temperature, ki ne mine, ter pri hitrem nastanku modric in krvavitev ali močni bledici nemudoma pokličite zdravnika.
Accordingly, certolizumab pegol is an antibody Fab' fragment conjugated with PEG in order to extend the terminal plasma elimination half-life of the Fab' to a value comparable with a whole antibody product.
Certolizumab pegol je fragment protitelesa Fab', ki je za podaljšanje razpolovne dobe končne plazemske eliminacije konjugiran s PEG.
Cimzia all dosing regimens(a) N=121
Cimzia vsi režimi odmerjanja(a) n = 121
On the basis of Phase II and Phase III clinical trial data in patients with rheumatoid arthritis, a population exposure-response relationship was established between average plasma concentration of certolizumab pegol during a dosing interval (Cavg) and efficacy (ACR 20 responder definition).
Razmerje med farmakokinetiko in farmakodinamiko Na podlagi podatkov iz kliničnih preskušanj faze II in faze III pri bolnikih z revmatoidnim artritisom, je bilo razmerje med izpostavljenostjo in odzivom ugotovljeno med povprečnimi koncentracijami certolizumab pegola v plazmi med intervalom odmerjanja (Cavg) in učinkovitostjo (definicija odzivne osebe ACR 20.
Cimzia solution for injection in a dose-dispenser cartridge (also referred to as “medication”) is intended for single-use in conjunction with the electromechanical injection device called ava.
Zdravilo Cimzia raztopina za injiciranje v odmernem vložku (imenovano tudi ˝zdravilo˝) je namenjeno za enkratno uporabo skupaj z elektromehansko injekcijsko napravo ava.
Marketing Authorisation Holder UCB Pharma S.A.
Imetnik dovoljenja za promet UCB Pharma S.A.
Table 5 Changes over 12 months in RA-I Placebo + MTX N=199 Mean (SD)
Preglednica 5 Spremembe po 12 mesecih v študiji RA-I Placebo + MTX n = 199 Srednja vrednost (SD)
After proper training in the injection technique, patients may self-inject using the electromechanical injection device ava with the single-use dose-dispenser cartridge if their physician determines that it is appropriate and with medical follow-up as necessary.
Po ustreznem treningu tehnike injiciranja, si lahko bolniki zdravilo sami injicirajo z uporabo elektromehanske injekcijske naprave ava z enoodmernim vložkom, če zdravnik presodi, da je primerno, čemur sledi medicinsko spremljanje po potrebi.
A patient who requires surgery while on Cimzia should be closely monitored for infections, and appropriate actions should be taken.
Bolnika, pri katerem je med zdravljenjem z zdravilom Cimzia potreben operativni poseg, je potrebno pozorno spremljati zaradi možnosti pojava okužb in ustrezno ukrepati.
Cimzia 200 mg + MTXPlacebo +MTX Difference*
Cimzia 200 mg + MTXPlacebo + MTX Razlika*
There is limited experience with Cimzia in pregnant women.
Izkušnje z uporabo zdravila Cimzia med nosečnostjo so omejene.
Key efficacy outcomes from the PsA001 clinical trial are shown in Table10.
Ključni rezultati glede učinkovitosti pri kliničnem preskušanju PsA001 so prikazani v Preglednici 10.
Cartridge/Injection port
3. vložek/injektor
Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4, spinal pain ≥ 4 on a 0 to 10 Numerical Rating Scale (NRS) and increased CRP or current evidence of sacroiliitis on Magnetic Resonance Imaging (MRI).
Bolniki so imeli aktivno bolezen določeno z Bathovim indeksom bolezenske aktivnosti ankilozirajočega spondilitisa (BASDAI - Bath Ankylosing Spondylitis Disease Activity Index) ≥ 4, spinalno bolečino ≥ 4, ocenjeno s številčno lestvico (NRS) z vrednostmi od od 0 do 10, in zvišan CRP ali sakroiliitis, dokazan z magnetno resonanco (MRI).
• Use a piece of gauze, apply pressure over the injection site for a few seconds:
• S kosom gaze nekaj sekund pritiskajte na mesto injiciranja:
Cimzia-treated patients reported greater improvements compared to placebo in the Hospital Anxiety and Depression Scale (HADS)-D.
Bolniki, zdravljeni z zdravilom Cimzia, so v primerjavi s placebom poročali o o večjih izboljšanjih , izmerjeno z bolnišnično lestvico tesnobe in depresije HADS-D (Hospital Anxiety and Depression Scale).
• Stevens-Johnson syndrome (a serious skin condition which early symptoms include malaise,
• Stevens-Johnsonov sindrom (huda kožna bolezen, katere zgodnji znaki vključujejo slabo počutje, povišano telesno temperaturo, glavobol in izpuščaj)
Instructions for self-injecting Cimzia
Navodila za samoinjiciranje zdravila Cimzia
No data are available on the response to live vaccinations or the secondary transmission of infection by live vaccines in patients receiving Cimzia.
Pri bolnikih, ki prejemajo zdravilo Cimzia, ni na voljo podatkov o njihovih odzivih na živa cepiva ali sekundarni prenosljivosti okužb z živimi cepivi.
Cimzia all dosing regimens(a) N=218
Cimzia vsi režimi odmerjanja (a) n = 218
What Cimzia is and what it is used for What you need to know before you use Cimzia How Cimzia will be given Possible side effects
Kaj je zdravilo Cimzia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Cimzia Kako vam bodo dali zdravilo Cimzia Možni neželeni učinki
Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of a tuberculosis infection occur during or after therapy with Cimzia.
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če se med ali po zdravljenju z zdravilom Cimzia pojavijo znaki/simptomi (npr. dalj časa trajajoč kašelj, hujšanje/izguba telesne mase, nekoliko zvišana telesna temperatura, ravnodušnost), ki kažejo na okužbo s tuberkulozo.
The dosedispenser cartridge is to be used with the electromechanical injection device ava.
Odmerni vložek je treba uporabljati z elektromehansko injekcijsko napravo ava.
Do NOT use Cimzia: - If you are ALLERGIC (hypersensitive) to certolizumab pegol or any of the other ingredients of this medicine (listed in section 6) - If you have a severe infection, including active TUBERCULOSIS (TB).
NE uporabljajte zdravila Cimzia - če ste ALERGIČNI na (preobčutljivi za) certolizumab pegol ali katero koli sestavino tega zdravila (navedeno v poglavju 6) - če imate resno okužbo, vključno z aktivno TUBERKULOZO (TB) - če imate zmerno ali hudo SRČNO POPUŠČANJE; pomembno je, da zdravniku poveste, če ste imeli ali imate resno srčno obolenje
Uncommo blood and lymphatic system malignancies (including lymphoma and leukaemia), solid organ tumours, nonmelanoma skin cancers, pre-cancerous lesions (including oral leukoplakia, melanocytic nevus), benign tumours and cysts (including skin papilloma)
občasni maligna obolenja krvi in limfatičnega sistema (vključno z limfomom in levkemijo), tumorji čvrstih organov, nemelanomni tipi kožnega raka, predrakave tvorbe (vključno z oralno levkoplakijo in melanocitnim nevusom), benigni tumorji in ciste (vključno s kožnim papilonom)
Patients in the Cimzia+MTX group had a greater reduction from baseline in DAS 28 (ESR) compared with the placebo+MTX group observed as early as Week 2 and continued through Week 52 (p<0.001 at each visit).
Bolniki, ki so prejemali zdravilo Cimzia in MTX, so imeli večje zmanjšanje vrednosti DAS 28 (ESR) glede na izhodiščno vrednost v primerjavi s skupino, ki je prejemala placebo in MTX, v obdobju od 2. tedna do 52. tedna (p < 0,001 pri vsakem obisku).
Adverse reactions based primarily on experience from the placebo-controlled clinical trials and postmarketing cases at least possibly related to Cimzia are listed in Table 1 below, according to frequency and system organ class.
Neželeni učinki, ki primarno temeljijo na izkušnjah iz s placebom nadzorovanih kliničnih preskušanj in primerih iz obdobja trženja zdravila za katere obstaja možnost, da so povezani z zdravilom Cimzia, so navedeni spodaj v preglednici 1 glede na pogostnosti in organske sisteme.
Similar results were achieved in both the ankylosing spondylitis and non-radiographic axial spondyloarthritis subpopulations.
Podobni rezultati so bili dobljeni pri podpopulaciji z ankilozirajočim spondilitisom in neradiografskim aksialnim spondiloartritisom.
• If you need to have a second injection as prescribed by your doctor repeat the injection process starting at Step 2.
• Če potrebujete drugo injekcijo, ki vam jo je predpisal zdravnik, ponovite postopek injiciranja pri koraku 2.
Carcinogenicity studies have not been performed with certolizumab pegol.
Pri certolizumab pegolu študije karcinogenosti niso bile izvedene.
There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Pri bolnikih z revmatoidnim artritisom, pri katerih je vnetno obolenje dolgotrajno in visoko aktivno, obstaja povečano tveganje za limfom in levkemijo, kar zaplete oceno tveganja.
• This is followed by a maintenance dose of 200 mg every 2 weeks, or 400 mg every 2 weeks as instructed by your physician.
• Temu sledi vzdrževalni odmerek 200 mg vsaka 2 tedna ali 400 mg vsaka 2 tedna po navodilih zdravnika.
Skin sensor (the skin sensor detects when the injection port is fully in contact with your skin).
4. senzor kože (senzor kože zazna, kdaj je injektor popolnoma v stiku z vašo kožo) 5. kolešček (za prilagoditev hitrosti injiciranja) 6. podatkovni zaslon
The following instructions explain how to use the pre-filled pen (AutoClicks) to inject Cimzia.
Navodila, ki so pred vami, opisujejo postopek uporabe napolnjenega injekcijskega peresnika (AutoClicks) za injiciranja zdravila Cimzia.
Other aPTT assays may be affected as well.
Zdravilo lahko vpliva tudi na druge teste aPTT.
• shortness of breath with exertion or upon lying down or swelling of the feet (heart failure)
• kratka sapa ob fizičnem naporu ali v ležečem položaju, ali otekanje stopal (srčno popuščanje)
At the end of this period the dose-dispenser cartridges must be used or discarded.
Po koncu tega obdobja je treba odmerne vložke uporabiti ali zavreči.
Caution should be exercised when considering TNF-antagonist therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy.
Posebna previdnost je potrebna, kadar razmišljamo o zdravljenju z zaviralci TNF pri bolnikih, ki imajo v anamnezi maligno obolenje ali pri bolnikih, ki so razvili maligno obolenje med zdravljenjem.
Tell your doctor before treatment with Cimzia if any of the following applies to you:
Pred zdravljenjem z zdravilom Cimzia zdravniku povejte, če opazite karkoli od spodaj navedenega:
The recommended starting dose of Cimzia for adult patients is 400 mg (given as 2 subcutaneous injections of 200 mg each) at weeks 0, 2 and 4.
Priporočeni začetni odmerek zdravila Cimzia za odrasle bolnike je 400 mg (apliciran kot dve subkutani injekciji po 200 mg) na začetku zdravljenja, po 2 in 4 tednih.
Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs.
Odrasli s hudim aktivnim ankilozirajočim spondilitisom brez radiografskega dokaza za AS, z objektivnimi znaki vnetja, kot je zvišana koncentracija C-reaktivnega proteina (CRP) in/ali magnetno resonanco (MRI), pri katerih je bil odziv na NSAID neustrezen.
In the placebo-controlled rheumatoid arthritis clinical trials, 5.8% of patients treated with Cimzia developed injection site reactions such as erythema, itching, haematoma, pain, swelling or bruising, compared to 4.8% of patients receiving placebo.
V s placebom nadzorovanih kliničnih študijah za revmatoidni artritis je pri 5.8 % bolnikov, ki so se zdravili z zdravilom Cimzia, prišlo do reakcij na mestu injiciranja, kot so (eritem, srbenje, hematom, bolečina, otekanje ali modrice), v skupini, ki je prejemala placebo, pa je bilo takih bolnikov 4,8 %.
Table 7 ACR response in DoseFlex clinical trial at week 34
Preglednica 7 Odziv ACR v 34. tednu DoseFlex kliničnega preskušanja Režim zdravljenja od 0. do 16. tedna
Cimzia was studied in 4,049 patients with rheumatoid arthritis in controlled and open label trials for up to 92 months.
Zdravilo Cimzia je v okviru nadzorovanih in odprtih kliničnih študij do 92 mesecev prejemalo 4049 bolnikov z revmatoidnim artritisom.
There is no experience with Cimzia in combination with DMARDs other than MTX.
Z zdravilom Cimzia v kombinaciji z antirevmatiki DMARD, z izjemo MTX, ni izkušenj.
• bump or open sore that doesn't heal
• bule in odprte rane, ki se ne celijo
The ACR 20 endpoint was achieved for both Cimzia 200 mg every 2 weeks and 400 mg every 4 weeks.
ACR 20 je bil dosežen pri obeh odmerjanjih zdravila Cimzia, pri 200 mg vsaka 2 tedna kot tudi pri 400 mg vsake 4 tedne.
It is recommended that the conduct of these tests should be recorded in the patient's reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Predpisovalci zdravila se morajo zavedati tveganja lažno negativnih rezultatov tuberkulinskega kožnega testa, posebej pri bolnikih, ki so hudo bolni ali imajo oslabljen imunski sistem.
At Weeks 12 and 24, the percentage of subjects with an ASAS40 response was greater in the Cimzia-treated groups compared to placebo.
V 12. tednu in 24. tednu je bil delež bolnikov z odzivom ASAS40 večji v skupini, ki je prejemala zdravilo Cimzia, kot v skupini, ki je prejemala placebo.
Below is a diagram of the pre-filled syringe with needle guard.
Spodaj je shema napolnjene injekcijske brizge z varovalom za iglo.