natgillin/translations-raw huggingface dataset:
In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p <0.001).
V študiji revmatoidnega artritisa IV je bil odziv 20 po ACR pri bolnikih, zdravljenih z adalimumabom in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
This study evaluated the efficacy of adalimumab 40 mg every other week/methotrexate combination therapy, adalimumab 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Ta študija je ocenila učinkovitost treh shem (kombinirano zdravljenje s 40 mg adalimumaba vsak drugi teden/metotreksatom, monoterapija s 40 mg adalimumaba vsak drugi teden in monoterapija z metotreksatom) za zmanjšanje znakov in simptomov ter hitrosti napredovanja sklepne okvare pri revmatoidnem artritisu v obdobju 104 tednov.
• Prepare the syringe by partially peeling the package open from the end closest to white plunger rod.
• Pripravite brizgo: delno odprite njeno ovojnino tako, da jo odlepite od konca, ki je najbližji belemu nosilcu bata.
Imraldi may be available as a vial, a pre-filled syringe and/or a pre-filled pen.
Zdravilo Imraldi je lahko na voljo kot viala, napolnjena injekcijska brizga in/ali napolnjen injekcijski peresnik.
TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Antagonisti tumorje nekrotizirajočega faktorja (TNF), z adalimumabom vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega živčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barréjevim sindromom.
Amongst those who responded at week 16 (n=144), the Paediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Med bolniki, ki so se odzvali 16. teden (n = 144), so se odzivi»Paediatric ACR« 30/50/70/90 v odprti podaljšani fazi ohranili do 6 let pri tistih, ki so ves čas študije dobivali adalimumab.
Should treatment be interrupted, Imraldi 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom Imraldi z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
Read all of this leaflet carefully before your child starts using this medicine because it contains important information.
Preden vaš otrok začne uporabljati to zdravilo, natančno preberite navodilo, ker vsebuje pomembne podatke!
Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and/or 12 did not receive further dose increases.
Bolnikom, ki so dobivali metotreksat in so 8. in/ali 12. teden dosegli odziv PASI ≥ 50, odmerka niso več povečevali.
Imraldi is used to treat
Zdravilo Imraldi se uporablja za zdravljenje
Imraldi 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Imraldi 40 mg raztopina za injiciranje v viali za enkratno uporabo (steklo tipa I), opremljeni z zamaški iz gume, folijami iz aluminija in tesnili "flip-off".
Imraldi is a biosimilar medicinal product.
Zdravilo Imraldi je podobno biološko zdravilo.
Alternatively, if a patient has stopped Imraldi and signs and symptoms of disease recur, Imraldi may be re-administered.
Če bolnik neha uporabljati zdravilo Imraldi, pa se znaki in simptomi bolezni ponovijo, je mogoče zdravilo Imraldi znova uvesti.
Hold the white plunger rod in and turn the vial and syringe upside down.
Držite beli nosilec bata in obrnite vialo in brizgo tako, da je viala zgoraj.
• Use one of the alcohol pads to wipe the vial stopper.
• Uporabite enega od alkoholnih zložencev in z njim obrišite zamašek viale.
Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Od 342 oseb, ki so bile od začetka randomizirane na monoterapijo z adalimumabom ali kombinirano zdravljenje z adalimumabom/metotreksatom in so bile vključene v odprto podaljšanje študije, je 171 bolnikov zaključilo 10-letno zdravljenje z adalimumabom.
A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used.
Za oceno so uporabili modificirani celotni seštevek po Sharpu (modified Total Sharp Score, mTSS), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).
If you have COPD, or you are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.
Če imate KOPB ali če veliko kadite, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNFα za vas primerno.
In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥3 × ULN occurred in 2.6 % (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
V preskušanju faze 3 z adalimumabom pri bolnikih s pediatrično Crohnovo boleznijo, kjer so ocenjevali učinkovitost in varnost dveh telesni masi prilagojenih vzdrževalnih režimov odmerjanja, ki sta sledila telesni masi prilagojenemu začetnemu zdravljenju do 52 tednov zdravljenja, so se pojavila zvišanja ALT ≥ 3 × ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
• As cases of tuberculosis have been reported in patients treated with Imraldi, your doctor will check your child for signs and symptoms of tuberculosis before starting Imraldi.
• Ker so bili pri bolnikih, zdravljenih z zdravilom Imraldi, opisani primeri tuberkuloze, bo zdravnik pred začetkom zdravljenja z zdravilom Imraldi vašega otroka preiskal glede znakov in simptomov tuberkuloze.
What you need to know before you use Imraldi 3.
Kaj morate vedeti, preden boste uporabili zdravilo Imraldi 3.
• sensation disorders such as tingling, prickling or numbness;
• motnje v občutenju, kot so ščemenje, zbadanje ali omrtvelost;
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Preiskovanci (n = 215, 54,7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faze pa so bili obravnavani kot neodzivni bolniki.
The decision to stop using Imraldi should be discussed with your child's doctor.
O odločitvi, da bi prenehali uporabljati zdravilo Imraldi, se morate posvetovati z zdravnikom svojega otroka.
A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p<0.001) (Figure 1).
Pri večjem deležu bolnikov, ki so prejemali zdravilo adalimumab, v dvojno slepem obdobju ni prišlo do ponovnega zagona bolezni v primerjavi s tistimi, ki so prejemali placebo (70,4 % v primerjavi s 47,1 %, p < 0,001) (slika 1).
Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects).
Bolniki so bili nato znova zdravljeni z adalimumabom v odmerku 0,8 mg/kg vsak drugi teden še nadaljnjih 16 tednov, pri čemer so bile opažene stopnje odziva podobne kot v prejšnjem dvojno slepem obdobju: odziv PASI 75 pri 78,9 % (15 od 19 oseb) in PGA čisto ali minimalno pri 52,6 % (10 od 19 oseb).
- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
- Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata.
Imraldi can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Zdravilo Imraldi se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), kortikosteroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili.
• Push the white plunger rod gently into the syringe until the syringe contains the prescribed amount of liquid.
• Beli nosilec bata previdno potiskajte v brizgo, dokler brizga ne vsebuje predpisane količine tekočine.
No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab.
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih,
Clean your injection site with an alcohol pad.
Mesto injiciranja očistite z alkoholnim zložencem.
• Before you inject, ask your doctor or nurse to show you how to use your pre-filled pen.
• Pred injiciranjem prosite zdravnika ali medicinsko sestro, da vam pokažeta, kako uporabljati napolnjen injekcijski peresnik.
• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems);
• sistemski eritematozni lupus (vključno z vnetjem kože, srca, pljuč, sklepov in drugih organskih sistemov);
Place your pre-filled syringe and alcohol pads on a clean, dry surface.
Napolnjeno injekcijsko brizgo in alkoholna zloženca položite na čisto, suho površino.
Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk).
Opomba: P# = placebo (število dogodkov/število rizičnih preiskovancev); A# = adalimumab (število dogodkov/število rizičnih preiskovancev).
• oedema (a build up of fluid in the body which causes the affected tissue to swell);
• edem (kopičenje tekočine v telesu, ki povzroči otekanje prizadetega tkiva);
Lupus-like syndrome
Sindrom, podoben lupusu
If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for your child.
Če ima vaš otrok KOPB ali če veliko kadi, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNFα za primerno za vašega otroka.
• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of contracting HBV.
• Zdravniku morate povedati, če je vaš otrok nosilec virusa hepatitisa B (HBV), če ima aktivno okužbo s HBV ali če mislite, da bi se lahko nalezel HBV.
Very common Injection site reaction (including injection site erythema) Common
zelo pogosti reakcija na mestu injiciranja (vključno z eritemom na mestu injiciranja)
If you don't know the amount, STOP HERE and contact your doctor for further instruction.
TUKAJ USTAVITE in kontaktirajte otrokovega zdravnika za nadaljnja navodila.
It is very important that you tell your doctor if your child has ever had tuberculosis, or if he/she has been in close contact with someone who has had tuberculosis.
Zelo pomembno je, da zdravniku poveste, če je vaš otrok kadarkoli imel tuberkulozo ali bil v tesnem stiku s kom, ki jo je imel.
The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥40 kg (160/80 mg) and 10.6±6.1 µg/ml for patients <40 kg (80/40 mg).
Povprečne (±SD) serumske koncentracije adalimumaba, dosežene v 4. tednu, so bile 15,7 ± 6,6 μg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6,1 μg/ml pri bolnikih < 40 kg (80/40 mg).
• When you are sure the adapter is attached to the vial, lift off the package from the vial adapter.
• Ko ste prepričani, da je adapter nameščen na vialo, z njega snemite njegovo ovojnino.
5) Injecting Imraldi
5) Injiciranje zdravila Imraldi
• It is important that you tell your baby's doctors and other health care professionals about your Imraldi use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
• Pomembno je, da obvestite zdravnika vašega dojenčka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Imraldi, preden bo vaš dojenček prejel katerokoli cepivo (za več informacij o cepljenju glejte poglavje "Opozorila in previdnostni ukrepi").
Vial storage
Shranjevanje viale
Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration.
Po uporabi adalimumaba se je zmanjšala tudi serumska raven matriksnih metaloproteinaz (MMP 1 in MMP 3), ki povzročajo remodeliranje tkiva, odgovorno za uničenje hrustanca.
• Keeping the syringe up, insert the syringe tip into the yellow syringe connector and twist the syringe as indicated by the arrow in the picture until firm.
• Držite brizgo pokonci, vstavite konico igle v rumeni konektor za iglo in zasučite brizgo, kot kaže puščica na sliki, dokler ni trdno nameščena.
CI 95% for HR
IZ 95 %
• Prepare the needle by partially peeling the package open from the end closest to the yellow syringe connector.
• Pripravite iglo: delno odprite njeno ovojnino tako, da jo odlepite od konca, ki je najbližji rumenemu konektorju za brizgo.
You may see an air bubble, and that is okay.
Morda boste opazili zračni mehurček.
Packs of:
Pakiranja po:
Usually, Imraldi is used with methotrexate.
Zdravilo Imraldi ponavadi uporabljamo z metotreksatom.
If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your Imraldi provider for a replacement.
Če beli nosilec bata potegnete popolnoma iz brizge, brizgo zavrzite in se z dobaviteljem zdravila
Physicians should exercise caution when considering the use of Imraldi in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Pri odločanju za uporabo zdravila Imraldi je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
Administration of Imraldi should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Če se bolniku pojavi nova resna okužba ali sepsa, je treba uporabo zdravila Imraldi prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
It is important that you tell your baby's doctors and other health care professionals about your Imraldi use during your pregnancy so they can decide when your baby should receive any vaccine.
Zato je pomembno, da obvestite zdravnika vašega otroka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Imraldi, da se lahko odločijo, kdaj bo vaš otrok lahko prejel katerokoli cepivo.
• Push the white plunger rod all the way back in to push the liquid medication back into the vial.
• Potisnite beli nosilec bata do konca nazaj, da boste tekoče zdravilo potisnili nazaj v vialo.
RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
V študiji revmatoidnega artritisa III je bilo ocenjeno 619 bolnikov z zmerno do zelo aktivnim revmatoidnim artritisom, starih ≥ 18 let, ki se niso učinkovito odzvali na odmerke metotreksata od 12,5 do 25 mg ali niso prenašali 10 mg metotreksata vsak teden.
• fatty liver (build up of fat in liver cells);
• zamaščenost jeter (kopičenje maščobe v jetrnih celicah);
• lupus-like syndrome;
• sindrom, podoben lupusu;
In RA studies I-IV, adalimumab -treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
V študijah revmatoidnega artritisa I-IV so z adalimumabom zdravljeni bolniki v primerjavi s prejemniki placeba dosegli statistično značilen odziv 20 in 50 po ACR že en do dva tedna po začetku zdravljenja.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se obrnite na zdravnika, preden boste vzeli to zdravilo.
The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9 %) in patients in the adalimumab group compared to -11.6% (median percent change -50.0 %) in patients in the placebo group.
Primarni opazovani dogodek je bil odstotek spremembe od izhodiščne vrednosti do 12. tedna v številu aktivnih sklepov z artritisom (oteklina, ki ni nastala zaradi deformacije, ali sklepi z zmanjšano gibljivostjo ter bolečino in/ali občutljivostjo); slednji je bil dosežen s povprečnim zmanjšanjem za -62,6 % (mediana sprememba -88,9 %) pri skupini bolnikov, ki je prejemala adalimumab, v primerjavi z -11,6 % (mediana sprememba -50,0 %) v skupini bolnikov, ki je prejemala placebo.
Double-Blind Response at Week 12
Odziv v 12. tednu
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Devetinsedemdeset (20,1 %) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9,4 %) bolnikov pa glukokortikoide.
Never reuse a syringe.
Injekcijske brizge nikoli ne smete ponovno uporabiti.
Imraldi is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Zdravilo Imraldi je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
DO NOT put the clear needle cap back on the needle.
NE NAMEŠČAJTE prozornega pokrovčka igle nazaj na iglo.
- This medicine has been prescribed for your child only.
- Zdravilo je bilo predpisano vašemu otroku osebno in ga ne smete dajati drugim.
Rates of discontinuation of corticosteroids or immunomodulators are presented in Table 27.
Stopnja prenehanja zdravljenja s kortikosteroidi ali imunomodulatorji je predstavljena v preglednici 27.
No ALT elevations ≥3 × ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years.
Zvišanja ALT ≥ 3 × ULN se niso pojavila v preskušanju faze 3 z adalimumabom pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 2 do < 4 leta.
The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient-years.
Ugotovljeni delež nemelanomskih kožnih rakov je približno 9,6 na 1.000 bolnikov-let, ugotovljeni delež limfomov pa približno 1,3 na 1.000 bolnikov-let.
Adult Uveitis
Uveitis pri odraslih
After you push the plunger all the way down, the needle will retract to help prevent needle stick injury.
Ko potisnete bat povsem navzdol, se bo injekcijska igla pomaknila navznoter, kar pomaga preprečiti nehoten vbod.
Total Sharp Score
Celotna Sharpova ocena
Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
Skupno je bilo 6 let ali več zdravljenih 19 preiskovancev, od tega 11 iz izhodiščne starostne skupine od 4 do 12 let in 8 iz izhodiščne starostne skupine od 13 do 17 let.
For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5±5.6 μg/ml for the Standard Dose group and 3.5±2.2 μg/ml for the Low Dose group.
Pri bolnikih, ki so ostali na njihovi randomizirani terapiji, so bile povprečne najmanjše koncentracije adalimumaba v 52. tednu 9,5 ± 5,6 μg/ml v skupini s standardnim odmerkom in 3,5 ± 2,2 μg/ml v skupini z majhnim odmerkom.
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for >=90 daysa
Klinična remisija Klinični odziv (CR-100) Bolniki v remisiji brez steroidov ≥ 90 dnia
Available data suggest that the clinical response is usually achieved within 2-8 weeks of treatment.
Podatki, ki so na voljo, kažejo, da je klinični odziv po navadi dosežen v 2-8 tednih zdravljenja.
• Keep the special container out of the sight and reach of children at all times.
• Ta poseben vsebnik shranjujte ves čas nedosegljivo otrokom.
If your child takes Imraldi the risk of getting lymphoma, leukaemia, or other cancers may increase.
Če vaš otrok jemlje zdravilo Imraldi, se mu lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye
• otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
The pivotal controlled studies involved 6,089 patients receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled period.
Kontrolirane študije, ki podpirajo vlogo za pridobitev dovoljenja za promet, so vključevale 6.089 bolnikov, ki so med kontroliranim obdobjem dobivali adalimumab, in 3.801 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
• Do not give Imraldi to children with polyarticular juvenile idiopathic arthritis below the age of
• Zdravila Imraldi ne smete dati otroku s poliartikularnim juvenilnim idiopatskim artritisom, če je star manj kot 2 leti.
A patient who requires surgery while on Imraldi should be closely monitored for infections, and appropriate actions should be taken.
Bolnika, ki med zdravljenjem z zdravilom Imraldi potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
There is no button on your pre-filled pen.
Na vašem napolnjenem injekcijskem peresniku ni gumba.
In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab therapy through week 156.
Pri odprtih podaljšanih študijah se je pri zdravljenju z adalimumabom izboljšanje znakov in simptomov ohranjalo do 156. tedna.
• Pull the needle package off, but DO NOT remove the clear needle cap.
• Snemite ovojnino igle, vendar NE ODSTRANITE prozornega pokrovčka igle.
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin) Biogen Inc.
Table 28 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov)