natgillin/translations-raw huggingface dataset:
Based on the review of the data at the time of the withdrawal, the CHMP had asked the company to provide clarification on some aspects of manufacturing, storage and plans to monitor safety and effectiveness of the medicine after authorisation. 
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge od družbe zahteval, naj pojasni določene vidike proizvodnje, shranjevanja in načrtov za spremljanje varnosti in učinkovitosti zdravila po izdaji dovoljenja za promet.
This prevents the cancer cells from growing and dividing, while normal cells are only slightly affected. 
To rakavim celicam prepreči rast in delitev, na normalne celice pa ima le malo vpliva.
This means that it was intended to be similar to a ‘reference medicine' already authorised in the European Union called Alimta. 
To pomeni, da naj bi bilo podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Alimta.
The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this product. 
Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe tega zdravila.
The active substance in both medicines, pemetrexed, is changed in the body into an active form that blocks enzymes needed to make genetic material (DNA and RNA). 
Zdravilna učinkovina v obeh zdravilih, pemetreksed, se v telesu spremeni v aktivno obliko, ki zavira encime, potrebne za izdelovanje genetskega materiala (DNK in RNK).
On 22 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pemetrexed (as ditromethamine) Hospira, for the treatment of malignant pleural mesothelioma and non-small-cell lung cancer. 
Družba Hospira UK Limited je 22. septembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Pemetreksed (v obliki ditrometamina) Hospira, namenjenim zdravljenju malignega plevralnega mezotelioma in nedrobnoceličnega pljučnega raka.
Pemetrexed (as ditromethamine) Hospira was expected to be used to treat two types of lung cancer: malignant pleural mesothelioma (a cancer of the lining of the lungs usually caused by exposure to asbestos) and advanced non-small-cell lung cancer of the kind known as ‘non-squamous'. 
Zdravilo Pemetreksed (v obliki ditrometamina) Hospira naj bi se uporabljalo za zdravljenje dveh vrst pljučnega raka: malignega plevralnega mezotelioma (raka pljučne sluznice, ki ga običajno povzroči izpostavljenost azbestu) in napredovalega nedrobnoceličnega pljučnega raka, znanega kot „neskvamozni“ tip.
Because Pemetrexed (as ditromethamine) Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine. 
Ker je bilo zdravilo Pemetreksed (v obliki ditrometamina) Hospira razvito kot generično zdravilo, je družba predstavila rezultate študij, ki dokazujejo kakovost zdravila.
The CHMP thought that the company could have addressed these questions and was of the provisional opinion that Pemetrexed (as ditromethamine) Hospira could have been approved for the treatment of malignant pleural mesothelioma and nonsmall-cell lung cancer. 
Menil je, da bi se lahko družba odzvala na ta vprašanja, in je zato začasno menil, da se lahko zdravilo Pemetreksed (v obliki ditrometamina) Hospira odobri za zdravljenje malignega plevralnega mezotelioma in nedrobnoceličnega pljučnega raka.
Pemetrexed (as ditromethamine) Hospira is a cancer medicine that contains the active substance pemetrexed. 
Pemetreksed (v obliki ditrometamina) Hospira je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino pemetreksed.
Pemetrexed (as ditromethamine) Hospira was developed as a ‘generic medicine'. 
Zdravilo Pemetreksed (v obliki ditrometamina) Hospira je bilo razvito kot „generično zdravilo“.
Pemetrexed (as ditromethamine) Hospira is expected to work in the same way as the reference medicine, Alimta. 
Zdravilo Pemetreksed (v obliki ditrometamina) Hospira naj bi delovalo enako kot referenčno zdravilo Alimta.
No further studies were carried out because Pemetrexed (as ditromethamine) Hospira is a generic medicine that is given by infusion into a vein and contains the same active substance as the reference medicine, Alimta. 
Ker je zdravilo Pemetreksed (v obliki ditrometamina) Hospira generično zdravilo, ki se daje z infundiranjem v veno in vsebuje enako zdravilno učinkovino kot referenčno zdravilo Alimta, niso bile opravljene nobene dodatne študije.
What is Pemetrexed (as ditromethamine) Hospira? 
Kaj je zdravilo Pemetreksed (v obliki ditrometamina) Hospira?
How does Pemetrexed (as ditromethamine) Hospira work? 
Kako zdravilo Pemetreksed (v obliki ditrometamina) Hospira deluje?
What was Pemetrexed (as ditromethamine) Hospira expected to be used for? 
Za kaj naj bi se zdravilo Pemetreksed (v obliki ditrometamina) Hospira uporabljalo?
Patients should not use more than one capsule in a day. 
Bolniki ne smejo vzeti več kot eno kapsulo na dan.
The recommended dose is one capsule once a day at the same time each day. 
Priporočeni odmerek je ena kapsula na dan vedno ob istem času.
Further information on Enurev Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Enurev Breezhaler so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
After 12 weeks of treatment, Enurev Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study. 
Po dvanajstih tednih zdravljenja se je z jemanjem zdravila Enurev Breezhaler v prvi študiji FEV1 povečal za 97 ml več kot pri placebu, v drugi študiji pa za 108 ml.
The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment. 
Prav tako je ugotovila, da se zaradi uporabe zdravila enkrat na dan bolniki lažje držijo zdravljenja.
Therefore, the Agency decided that Enurev Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU. 
Zato je agencija zaključila, da so koristi zdravila Enurev Breezhaler večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Enurev Breezhaler (glycopyrronium bromide) EMA/326865/2018 
Enurev Breezhaler(glikopironijev bromid) EMA/326865/2018
The most common side effects with Enurev Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting). 
Najpogostejši neželeni učinki zdravila Enurev Breezhaler (opaženi pri več kot 1 bolniku od 100) so suha usta, nazofaringitis (vnetje nosu in grla), nespečnost, bolečine v mišicah in kosteh ter gastroenteritis (driska in bruhanje).
This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs. 
To pomeni, da širi dihalne poti, tako da zavira muskarinske receptorje (tarče) v mišičnih celicah v pljučih.
Enurev Breezhaler capsules, which contain a powder for inhalation, are only used with the Enurev Breezhaler inhaler and must not be swallowed. 
Kapsule zdravila Enurev Breezhaler, ki vsebujejo prašek za inhaliranje, se uporabljajo samo z inhalatorjem Enurev Breezhaler in se ne smejo pogoltniti.
Enurev Breezhaler received a marketing authorisation valid throughout the EU on 28 September 2012. 
Za zdravilo Enurev Breezhaler je bilo 28. septembra 2012 izdano dovoljenje za promet, veljavno po vsej EU.
the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second). 
V obeh študijah je bilo glavno merilo učinkovitosti sprememba forsiranega ekspiracijskega volumna (FEV1 - največje količine zraka, ki jo oseba lahko izdihne v eni sekundi) pri bolnikih.
The European Medicines Agency noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD. 
Evropska agencija za zdravila je ugotovila, da je imelo zdravilo Enurev Breezhaler skromne, vendar koristne učinke za bolnike pri izboljšanju delovanja pljuč ter da je izboljšalo tudi simptome KOPB.
What measures are being taken to ensure the safe and effective use of Enurev Breezhaler? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Enurev Breezhaler?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enurev Breezhaler have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Enurev Breezhaler upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about using Enurev Breezhaler, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Enurev Breezhaler glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Enurev Breezhaler are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Enurev Breezhaler, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule. 
Bolnik vzame odmerek tako, da položi kapsulo v inhalator in skozi usta vdihne prašek, ki ga vsebuje kapsula.
As for all medicines, data on the use of Enurev Breezhaler are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Enurev Breezhaler stalno spremljajo.
Enurev Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD. 
Zdravilo Enurev Breezhaler se je izkazalo za učinkovitejše od placeba (zdravila brez učinkovine) pri lajšanju simptomov KOPB v dveh glavnih študijah pri 1 888 bolnikih s to boleznijo.
Enurev Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. 
Enurev Breezhaler je zdravilo, ki se uporablja za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
Enurev Breezhaler is used for maintenance (regular) treatment. 
Zdravilo Enurev Breezhaler se uporablja za vzdrževalno (redno) zdravljenje.
In addition, there were no major safety concerns with Enurev Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines. 
Poleg tega pri zdravilu Enurev Breezhaler ni večjih pomislekov glede varnosti, ker so njegovi neželeni učinki podobni kot pri drugih antagonistih muskarinskih receptorjev.
An overview of Enurev Breezhaler and why it is authorised in the EU 
Pregled zdravila Enurev Breezhaler in zakaj je odobreno v EU
Enurev Breezhaler (glycopyrronium bromide) 
Enurev Breezhaler(glikopironijev bromid)
Other information about Enurev Breezhaler 
Druge informacije o zdravilu Enurev Breezhaler
Why is Enurev Breezhaler authorised in the EU? 
Zakaj je bilo zdravilo Enurev Breezhaler odobreno v EU?
What is Enurev Breezhaler and what is it used for? 
Kaj je zdravilo Enurev Breezhaler in za kaj se uporablja?
What benefits of Enurev Breezhaler have been shown in studies? 
Kakšne koristi je zdravilo Enurev Breezhaler izkazalo v študijah?
The active substance in Enurev Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist. 
Učinkovina v zdravilu Enurev Breezhaler, glikopironijev bromid, je antagonist muskarinskih receptorjev.
For the full list of side effects and restrictions with Enurev Breezhaler, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Enurev Breezhaler glejte navodilo za uporabo.
What are the risks associated with Enurev Breezhaler? 
Kakšna tveganja so povezana z zdravilom Enurev Breezhaler?
Enurev Breezhaler contains the active substance glycopyrronium bromide. 
Zdravilo Enurev Breezhaler vsebuje učinkovino glikopironijev bromid.
How is Enurev Breezhaler used? 
Kako se zdravilo Enurev Breezhaler uporablja?
This helps to keep the airways open and allows the patient to breathe more easily. 
Ti nadzirajo krčenje mišic, ob vdihu glikopironijevega bromida pa se mišice dihalnih poti sprostijo, kar pripomore, da ostanejo dihalne poti odprte, in bolniku omogoča, da lažje diha.
How does Enurev Breezhaler work? 
Kako zdravilo Enurev Breezhaler deluje?
Enurev Breezhaler can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila Enurev Breezhaler je le na recept.
Cartridge (glass) 3 ml (3.5 mg/ml) 1 cartridge 
3 ml (3,5 mg/ml) 1 injekcijski vložek
Route of administration Immediate Packaging 
Pot uporabe Stična ovojnina
Film-coated tablet Oral use 
2,5 mg filmsko obložena tableta peroralna uporaba
Strength Pharmaceutical form 
(Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
5mg 
2 tableti
There is no need to rush your injection - 5 minutes gives you enough time. 
Ni treba hiteti - 5 minut je dovolj časa.
Your doctor can provide advice. 
Zdravnik vam lahko svetuje.
For each injection you will need: 
Za vsako injiciranje boste potrebovali:
For all indications 
Za vse indikacije
• ringing in the ears 
• zvonenje v ušesih
- Certain vaccinations may cause infections. 
- Določena cepljenja lahko povzročijo okužbe.
• Wash your hands thoroughly. 
• Temeljito si umijte roke.
The value of these data to the evaluation of human risk may be limited. 
Vrednost teh podatkov za ovrednotenje tveganja pri ljudeh je lahko omejena.
The time left is shown on screen. 
Čas, ki je še na voljo, je prikazan na zaslonu.
The C-EARLY trial met its primary and key secondary endpoints. 
Preskušanje C-EARLY je izpolnilo svoje primarne in ključne sekundarne cilje.
The clinical significance of this is unknown. 
Klinični pomen tega ni poznan.
These data are reasonably in agreement with observed data. 
Ti podatki se v razumni meri skladajo z dobljenimi podatki.
- If you have ever had an allergic reaction to latex. 
- Če ste kdaj imeli alergijsko reakcijo na lateks.
• improve your physical function and performance of daily tasks. 
• izboljšanje vaše telesne funkcije in opravljanja vsakodnevnih nalog.
Approximately half the cases were lymphomas. 
Približno polovica teh primerov so bili limfomi.
The device is provided separately. 
Naprava je na voljo ločeno.
CH-1630 Bulle Switzerland 
CH-1630 Bulle Švica
Please read the instructions carefully and follow them step by step. 
Natančno jih preberite in jim sledite korak za korakom.
- Try to relax as this will make the injection more comfortable. 
- Poskusite se sprostiti, ker bo tako injiciranje bolj udobno.
As this medecine is being given by your doctor or nurse, it is unlikely that you will be given too much. 
Ker vam bo to zdravilo dal zdravnik ali medicinska sestra, je malo verjetno, da ga boste prejeli preveč.
(d) Full Analysis Set 
(d) celotna analiza
At this time, the injection will be complete. 
V tem času bo injiciranje zaključeno.
- Repeat the injection process starting at Step 2. 
- Ponovite postopek injiciranja tako, da začnete pri koraku 2.
Percentage response based upon number of subjects contributing data (n) to that endpoint and time point which may differ from N 
Odziv v odstotkih na osnovi števila posameznikov, ki so prispevali podatke (n) za ta cilj in čas, ki se lahko razlikuje od N.
Paediatric population (< 18 years old) 
Pediatrični bolniki (< 18 let)
ASAS 40 was a secondary endpoint. 
ASAS 40 je bil opredeljen kot sekundarni cilj.
The CIMPACT study evaluated 559 patients. 
V študiji CIMPACT so ocenili 559 bolnikov.
Do not inject until the skin is dry. 
- Ne injicirajte dokler se koža ne posuši.
PASI 90 at Week 16 was a key secondary endpoint in all 3 studies. 
PASI 90 v 16. tednu je bil ključen sekundarni opazovani dogodek v vseh 3 študijah.
Study objectives 
Cilji študije
* Hodges-Lehmann point estimate of shift and 95% asymptotic (Moses) confidence interval. 
* Hodges-Lehmann točka ocene razlike in 95 % asimptotski (Moses) interval zaupanja.
- In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. 
- Pri nekaterih bolnikih telo morda ne proizvaja dovolj krvnih celic, ki telesu pomagajo v boju proti okužbam ali pomagajo ustaviti krvavitve.
Antibodies are proteins that specifically recognise and bind to other proteins. 
Protitelesa so beljakovine, ki specifično prepoznavajo druge beljakovine in se nanje vežejo.
This will take 30 minutes. 
To bo trajalo 30 minut.
Results are from the Randomized Set. 
Rezultati so iz randomiziranega niza.
Concomitant use with other biologics 
Sočasna uporaba drugih bioloških zdravil
• feeling faint, including loss of consciousness 
• občutek šibkosti, vključno z izgubo zavesti
This can take up to 15 seconds. 
To lahko traja tudi do 15 sekund.
• antibody directed against normal tissue 
• protitelesa usmerjena proti normalnemu tkivu
There is no evidence of an increased risk of infections with continued exposure over time. 
Ni dokazov za povečano tveganje okužb z nadaljevanjem izpostavljenosti dalj časa.
Some cases have had a fatal outcome. 
V nekaterih primerih je bil izid smrten.
Frequency categories are defined as follows: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1000 to < 1/100); Rare (≥ 1/10,000 to < 1/1000); Very rare (< 1/10,000), not known (cannot be estimated from the available data). 
Kategorije pogostnosti so: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10,000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Quality of life / Patient reported outcomes 
Kakovost življenja / izidi po navedbi bolnikov
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. 
Zelo pomembno je, da zdravniku poveste, če ste kdaj imeli tuberkulozo ali ste bili v tesnem stiku z osebo, ki je imela tuberkulozo.
The terminal elimination phase half-life (t1/2) was approximately 14 days for all doses tested. 
Končna razpolovna doba faze eliminacije (t1/2) je bila pri vseh preskušenih odmerkih približno 14 dni.
You may see air bubbles - this is normal. 
- Vidite lahko zračne mehurčke - to je povsem normalno.
This will take 30 to 45 minutes. 
To bo trajalo 30-45 minut.
In vitro functional studies of human vacuolated macrophages indicated all functions tested were retained. 
In vitro funkcijske študije humanih vakuoliziranih makrofagov so pokazale, da so se vse testirane funkcije ohranile.
This will make sure you are giving the injection correctly. 
Tako bo zagotovljeno, da boste injicirali pravilno.
- The medication contains 1ml of Cimzia and is not completely full - this is normal. 
- Vložek vsebuje 1 ml zdravila Cimzia in ni povsem poln - to je normalno.
Component of a multipack, cannot be sold separately 
Sestavni del večkratnega pakiranja; ni za posamično prodajo
In rare occasions tuberculosis can develop during therapy even if you have received preventive treatment for tuberculosis. 
V redkih primerih se lahko tuberkuloza razvije tudi med zdravljenjem, čeprav ste prejeli preventivno zdravljenje za tuberkulozo.
• Once ava is placed firmly against your skin “When ready press > once” is shown. 
• Ko je ava nameščena tesno k vaši koži, se prikaže ˝When ready press > once˝.
Handle with care!” and “Please replace needle cap” are shown until the needle cap is put back on. 
Handle with care!” in “Please replace needle cap” sta prikazani, dokler pokrovčka igle ne namestite nazaj.
87.7% of patients received concomitant NSAIDs. 
87,7 % bolnikov je sočasno prejemalo NSAID.
OTHER SPECIAL WARNING(S), IF NECESSARY For healthcare professionals only. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Samo za zdravstveno osebje.
The maximum duration of the study was 204 weeks. 
Najdaljše trajanje študije je bilo 204 tednov.
• Take your thumb off the plunger head. 
• Palec umaknite z glave bata.
Studies in rats indicated that > 90% of the administered PEG was eliminated in 3 months following a single dose, with the urine being the main route of excretion. 
Študije pri podganah so pokazale, da se je > 90% apliciranega PEG v 3 mesecih po enkratnem odmerku izločilo z urinom, ki predstavlja glavno pot izločanja.
• The messages “Needle uncapped! 
• Sporočili “Needle uncapped!
The pH of the solution is approximately 4.7. 
pH raztopine je približno 4,7.
Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer. 
Priporočljive so periodične preiskave kože še posebej pri bolnikih z dejavniki tveganja za nastanek kožnega raka.
• feeling weak or tired 
• občutek šibkosti ali utrujenost
Please remove from skin" - you can then remove ava from you skin. 
Please remove from skin˝ - napravo ava lahko sedaj odstranite s kože.
All patients had a history of heavy smoking. 
Vsi bolniki so bili v preteklosti hudi kadilci.
This medicinal product is for single use only. 
Zdravilo je namenjeno samo enkratni uporabi.
Check that the red “medication level indicator” is at the top of the cartridge. 
Preverite, da je rdeči ˝indikator nivoja zdravila˝ na vrhu vložka.
You can inject yourself or the injection can be given by someone else (caregiver). 
Injicirate si lahko sami ali pa vam lahko da injekcijo kdo drug (skrbnik)
Radiographic set with linear extrapolation. 
Radiografski prikaz z linearno ekstrapolacijo.
Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks. 
Pri nekaterih bolnikih z začetnim delnim odzivom se lahko stanje z nadaljevanjem zdravljenja po 16 tednih izboljša.
• AutoClicks pre-filled pen is designed to work accurately and safely. 
• Napolnjeni injekcijski peresnik AutoClicks je oblikovan tako, da deluje natančno in varno.
If your doctor says you can inject yourself, you need to be fully trained first. 
Če vaš zdravnik meni, da si lahko injicirate sami, morate biti najprej v celoti usposobljeni.
• swollen face, hands, feet (angioedema) 
• otečen obraz, roke, stopala (angioedem)
The pivotal non-clinical safety studies were conducted in the cynomolgus monkey. 
Ključne neklinične študije varnosti so izvedli pri opici Cynomolgus.
The physician should discuss with the patient which injection presentation option is the most appropriate. 
Zdravnik se mora z bolnikom pogovoriti, katera oblika injiciranja je najprimernejša.
Response rates and p-values based on a logistic regression model. 
Stopnje odziva in vrednosti p na podlagi logističnega regresijskega modela.
• azoospermia (lack of sperm production). 
• azoospermija (odsotnost spermijev v spermi)
• after 16 weeks if you have plaque psoriasis. 
• po 16 tednih, če imate psoriazo v plakih.
•The needle safety device will not activate unless the entire dose is given. 
• Varnostni mehanizem igle se ne bo sprožil, če ni bil apliciran celoten odmerek.
• You must also carefully read the full instructions in the ava User Manual. 
• Natančno morate prebrati celotna navodila v ava Priročniku za uporabo.
These 3 groups were well balanced with regards to clinical response following the active run-in period (ACR 20: 83-84% at week 18). 
Te 3 skupine so bile dobro uravnotežene glede kliničnega odziva po aktivnem začetnem uvajalnem obdobju (ACR 20: 83-84 % v 18. tednu).
RA-I (52 weeks) 
RA-I (52 tednov)
Responses were maintained through Weeks 52 (RA-I) and 24 (RA-II). 
Odzivi so se ohranili do 52. tedna (RA-I) in do 24. tedna (RA-II).
Study AS0006, performed in subjects without radiographic signs of inflammation in the SI joints, confirmed the effect previously demonstrated in this subgroup in the AS001 study. 
Študija AS0006, ki je bila izvedena pri osebah brez radiografskih znakov vnetja v sakroiliakalnih sklepih, je potrdila učinek, ki je bil predhodno dokazan v tej podskupini v študiji AS001.