FrancophonIA/ELRC3.0 huggingface dataset:
English: For fleas, the onset of efficacy is within 8 hours of attachment during the 28 day period after product administration.
Slovenian: Pri začne zdravilo delovati v 8 urah po pritrditvi, v obdobju 28 dni po dajanju zdravila.
English: For the treatment of tick infestations (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus).
Slovenian: Za zdravljenje infestacij s klopi (Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus in
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Ena tableta vsebuje:
English: Simparica 5 mg chewable tablets for dogs 1.3-2.5 kg Simparica 10 mg chewable tablets for dogs >2.5-5 kg Simparica 20 mg chewable tablets for dogs >5-10 kg Simparica 40 mg chewable tablets for dogs >10-20 kg Simparica 80 mg chewable tablets for dogs >20-40 kg Simparica 120 mg chewable tablets for dogs >40-60 kg
Slovenian: Simparica 5 mg žvečljive tablete za pse 1,3-2,5 kg Simparica 10 mg žvečljive tablete za pse >2,5-5 kg Simparica 20 mg žvečljive tablete za pse >5-10 kg Simparica 40 mg žvečljive tablete za pse >10-20 kg Simparica 80 mg žvečljive tablete za pse >20-40 kg Simparica 120 mg žvečljive tablete za pse >40-60 kg
English: Simparica 5 mg chewable tablets for dogs 1.3-2.5 kg Simparica 10 mg chewable tablets for dogs >2.5-5 kg Simparica 20 mg chewable tablets for dogs >5-10 kg Simparica 40 mg chewable tablets for dogs >10-20 kg Simparica 80 mg chewable tablets for dogs >20-40 kg Simparica 120 mg chewable tablets for dogs >40-60 kg sarolaner
Slovenian: Simparica 5 mg žvečljive tablete za pse 1,3-2,5 kg Simparica 10 mg žvečljive tablete za pse >2,5-5 kg Simparica 20 mg žvečljive tablete za pse >5-10 kg Simparica 40 mg žvečljive tablete za pse >10-20 kg Simparica 80 mg žvečljive tablete za pse >20-40 kg Simparica 120 mg žvečljive tablete za pse >40-60 kg sarolaner
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij Zoetis Belgium SA
English: Glucose, liquid (81.5% solids) Spray dried pork liver powder Hydrolysed vegetable protein Gelatin type A
Slovenian: 6.1 Seznam pomožnih snovi hipromeloza acetat sukcinat, srednje stopnje laktoza monohidrat natrijev karboksimetilškrob silicijev dioksid, koloidni, brezvodni magnezijev stearat koruzni škrob saharoza glukoza, tekoča (81,5 % trdne snovi) aroma svinjskih jeter, posušena z razprševanjem hidrolizirani rastlinski protein želatina, tip A pšenični kalčki kalcijev hidrogenfosfat, brezvodni
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B POGOJI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
English: To be supplied only on veterinary prescription.
Slovenian: PRETISNI OMOT IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: 250 tablets 30 tablets
Slovenian: 250 tablet 30 tablet
English: 80 mg, 25 mg 40 mg, 12.5 mg
Slovenian: 80 mg, 25 mg 40 mg, 12.5 mg tablete tablete peroralna uporaba peroralna uporaba steklenička (HDPE) pretisni omot (Alu/Alu)
English: • Need to ensure appropriate hydration of the patient
Slovenian: • potrebo po zagotovitvi primerne hidriranosti bolnika
English: • Contraindication in patients with creatinine clearance < 35 ml/min
Slovenian: • kontraindikacije pri bolnikih z očistkom kreatinina < 35 ml/min
English: The educational programme contains the following:
Slovenian: Izobraževalno gradivo vsebuje naslednje:
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da se izvajajo vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila kot so opisani v nadaljevanju:
English: • Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
Slovenian: • ključne znake in simptome resnih neželenih dogodkov • navodila o tem, kdaj je treba poiskati zdravniško pomoč
English: The Marketing Authorisation Holder (MAH) shall provide an educational programme targeting all physicians who are expected to prescribe/use Zoledronic acid Teva Pharma for the treatment of osteoporosis prior to the launch in Member States.
Slovenian: Imetnik dovoljenja za promet mora pred začetkom trženja v državah članicah zagotoviti, da bo izobraževalno gradivo razširil na vse zdravnike, ki bodo predvidoma predpisovali/uporabljali zdravilo Zoledronska kislina Teva Pharma za zdravljenje osteoporoze.
English: • Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity
Slovenian: • kontraindikacije med nosečnostjo in dojenjem zaradi možne teratogenosti
English: • Need to measure serum creatinine before treatment with Zoledronic acid Teva Pharma
Slovenian: • potrebnost meritve kreatinina v serumu pred zdravljenjem z zdravilom Zoledronska kislina
English: • Contraindication in pregnancy and in breast-feeding women • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non
Slovenian: • kontraindikacije med nosečnostjo in dojenjem • potrebnost zadostnega nadomeščanja kalcija in vitamina D, ustrezne telesne dejavnosti in
English: The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authorities in Member States prior to distribution of the educational programme.
Slovenian: Imetnik dovoljenja za promet se mora pred distribucijo izobraževalnega gradiva glede vsebine in oblike gradiva ter načrta za komunikacijo dogovoriti s pristojnim nacionalnim organom.
English: The patient educational material should contain the following key messages:
Slovenian: Izobraževalno gradivo za bolnika mora vsebovati naslednje ključne sestavine:
English: The physician educational material should contain the following key messages:
Slovenian: Izobraževalno gradivo za zdravnika mora vsebovati naslednje ključne sestavine:
English: o Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non-smoking and healthy diet o Key signs and symptoms of serious adverse events o When to seek attention from the health care provider
Slovenian: • That all patients should be provided with the educational material and be counselled about: o potrebnost zadostnega nadomeščanja kalcija in vitamina D, ustrezne telesne dejavnosti in zdrave prehrane ter odsotnosti kajenja o ključne znake in simptome resnih neželenih dogodkov o navodila o tem, kdaj je treba poiskati zdravniško pomoč
English: • One-yearly dosing regime
Slovenian: • shemo odmerjanja enkrat letno
English: Further information on Orencia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/orencia.
Slovenian: Nadaljnje informacije o zdravilu Orencia so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/orencia.
English: Around three-quarters of the patients were also taking methotrexate.
Slovenian: Približno tri četrtine bolnikov je jemalo tudi metotreksat.
English: What measures are being taken to ensure the safe and effective use of Orencia?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Orencia?
English: Orencia received a marketing authorisation valid throughout the EU on 21 May 2007.
Slovenian: Za zdravilo Orencia je bilo 21. maja 2007 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: As for all medicines, data on the use of Orencia is continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Orencia stalno spremljajo.
English: The main measure of effectiveness was a reduction in symptoms of at least 20% after 24 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje simptomov za vsaj 20 % po 24 tednih zdravljenja.
English: The Agency decided that Orencia's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Agencija je zaključila, da so koristi zdravila Orencia večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: If Orencia has not worked within 6 months, the doctor should consider if treatment should continue.
Slovenian: Če zdravilo Orencia v šestih mesecih ni bilo učinkovito, mora zdravnik pretehtati, ali naj se zdravljenje nadaljuje.
English: The main measure of effectiveness was how long it was before the patient's disease flared up again.
Slovenian: Glavno merilo učinkovitosti je bil čas do ponovnega izbruha bolezni.
English: Other information about Orencia
Slovenian: Druge informacije o zdravilu Orencia
English: What benefits has Orencia have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Orencia izkazalo v študijah?
English: The dose depends on the patient's weight.
Slovenian: Odmerek je odvisen od bolnikove telesne mase.
English: Why is Orencia authorised in the EU?
Slovenian: Zakaj je zdravilo Orencia odobreno v EU?
English: What is Orencia and what is it used for?
Slovenian: Kaj je zdravilo Orencia in za kaj se uporablja?
English: T cells are activated when signal molecules attach to receptors on the cells.
Slovenian: Aktivirajo se, ko se signalne molekule vežejo na receptorje na celicah.
English: An overview of Orencia and why it is authorised in the EU
Slovenian: Pregled zdravila Orencia in zakaj je odobreno v EU
English: Side effects reported with Orencia are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Orencia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What are the risks associated with Orencia?
Slovenian: Kakšna tveganja so povezana z zdravilom Orencia?
English: In this case it should be followed by an injection under the skin the next day.
Slovenian: V tem primeru mora naslednji dan slediti injekcija v podkožje.
English: Orencia is a medicine that is often used in combination with methotrexate (a medicine that acts on the immune system) to treat the following diseases:
Slovenian: Orencia je zdravilo, ki se pogosto uporablja v kombinaciji z metotreksatom (zdravilom, ki učinkuje na imunski sistem) za zdravljenje naslednjih bolezni:
English: The main measures of effectiveness were the reduction in symptoms of arthritis after treatment, as well as physical function (the ability to carry out everyday tasks) and the amount of damage to the joints (assessed using X-rays).
Slovenian: Glavna merila učinkovitosti so bila zmanjšanje simptomov artritisa po zdravljenju, funkcijska zmogljivost (sposobnost izvajanja vsakodnevnih nalog) in obseg poškodb sklepov (ocenjen z rentgenskim pregledom).
English: Orencia was also shown to reduce symptoms of psoriatic arthritis.
Slovenian: Dokazano je bilo tudi, da zdravilo Orencia zmanjšuje simptome psoriatičnega artritisa.
English: By attaching to signal molecules called CD80 and CD86, abatacept stops them activating the T cells, helping to reduce the inflammation and other symptoms of the diseases.
Slovenian: Abatacept z vezavo na signalne molekule, imenovane CD80 in CD86, onemogoči aktivacijo celic T ter pripomore k zmanjšanju vnetja in drugih simptomov bolezni.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orencia have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Orencia upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: In around 60% of these patients the TNF alpha blocker had not worked well enough.
Slovenian: Pri približno 60 % bolnikov zaviralec TNF-alfa ni bil dovolj učinkovit.
English: When given by infusion into a vein, Orencia is given every 2 weeks for the first 3 doses, and then every 4 weeks.
Slovenian: Kadar se zdravilo Orencia daje z infundiranjem v veno, se prvi trije odmerki dajejo vsaka dva tedna, nato pa vsake štiri tedne.
English: For more information about using Orencia, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Orencia glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Subsequently, it is injected under the skin once a week.
Slovenian: V nadaljevanju se zdravilo injicira pod kožo enkrat tedensko.
English: Patients taking Orencia also had a greater improvement in physical function after six months.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Orencia, je bilo po šestih mesecih opaženo tudi večje izboljšanje funkcijske zmogljivosti.
English: All patients received Orencia for 4 months, after which the 122 whose condition had improved on Orencia were either switched to placebo or continued receiving Orencia.
Slovenian: Vsi bolniki so zdravilo Orencia prejemali štiri mesece, nato pa je 122 bolnikov, pri katerih se je stanje z zdravilom Orencia izboljšalo, prešlo na placebo ali pa so še naprej prejemali zdravilo Orencia.
English: Patients who receive Orencia are given a special alert card explaining that it must not be used in patients with certain infections and instructing patients to contact their doctor immediately if they develop an infection during treatment with Orencia.
Slovenian: Bolniki, ki prejemajo zdravilo Orencia, dobijo posebno opozorilno kartico, ki pojasnjuje, da se zdravilo ne sme uporabljati pri bolnikih z določenimi okužbami, ter bolnike opominja, naj nemudoma poiščejo zdravniško pomoč, če se pri njih med zdravljenjem pojavi okužba.
English: Children between 2 and 6 years should only use Orencia pre-filled syringes.
Slovenian: Pri otrocih, starih od dve do šest let, se lahko uporabijo samo napolnjene injekcijske brizge zdravila Orencia.
English: It is used in combination with methotrexate, or on its own in patients who cannot take methotrexate.
Slovenian: Uporablja se v kombinaciji z metotreksatom ali samostojno pri bolnikih, ki metotreksata ne morejo jemati;
English: The most common side effects with Orencia (seen in more than 1 patient in 10) are upper respiratory tract infections (nose and throat infection).
Slovenian: Najpogostejši neželeni učinki zdravila Orencia pri odraslih (ki so se pojavili pri več kot 1 bolniku od 10) so okužbe zgornjih dihal (okužbe nosu in grla).
English: The study included 259 patients who had previously been treated with a TNF alpha blocker.
Slovenian: Študija je vključevala 259 bolnikov, ki so se predhodno zdravili z zaviralcem TNF-alfa.
English: The first two studies included 991 patients in whom methotrexate had not worked well enough.
Slovenian: Prvi dve študiji sta vključevali 991 bolnikov, pri katerih metotreksat ni bil dovolj učinkovit.
English: • highly active and progressive rheumatoid arthritis, used in combination with methotrexate in adults who have not previously been treated with methotrexate;
Slovenian: • močno aktivnega in napredujočega revmatoidnega artritisa v kombinaciji z metotreksatom pri odraslih, ki se z njim predhodno niso zdravili;
English: Orencia must not be used in patients with severe and uncontrolled infections, such as sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) or ‘opportunistic' infections (infections seen in patients with a weakened immune system).
Slovenian: Zdravilo Orencia se ne sme uporabljati pri bolnikih s hudimi nenadzorovanimi okužbami, kot so npr. sepsa (pri kateri bakterije in njihovi toksini krožijo v krvi in povzročajo poškodbe organov) ali oportunistične okužbe (opažene pri bolnikih z oslabljenim imunskim sistemom).
English: Orencia contains the active substance abatacept.
Slovenian: Zdravilo Orencia vsebuje učinkovino abatacept.
English: The Agency also concluded that Orencia could be a valuable option in the treatment of polyarticular juvenile idiopathic arthritis.
Slovenian: Zaključila je tudi, da bi lahko bilo zdravilo Orencia pomembna možnost zdravljenja poliartikularnega juvenilnega idiopatskega artritisa.
English: The European Medicines Agency concluded that Orencia had a modest anti-inflammatory effect in rheumatoid arthritis and, in combination with methotrexate, it reduced the worsening of joint damage and improved physical function.
Slovenian: Evropska agencija za zdravila je zaključila, da ima zdravilo Orencia zmeren protivnetni učinek pri revmatoidnem artritisu in da v kombinaciji z metotreksatom zmanjša poslabšanje poškodb sklepov in izboljša funkcijsko zmogljivost.
English: In the fourth study, Orencia in combination with methotrexate was compared with Orencia alone and methotrexate alone in 351 adults who had not been treated with methotrexate (or with any biologic agents such as TNF alpha blockers), but may have been on other medicines for management of rheumatoid arthritis.
Slovenian: V četrti študiji so zdravilo Orencia v kombinaciji z metotreksatom primerjali z zdravilom Orencia, ki se daje samostojno, pri 351 odraslih, ki predhodno niso bili zdravljeni z metotreksatom (ali s katerimi drugimi biološkimi učinkovinami, kot so zaviralci TNF-alfa), so pa morda jemali druga zdravila za obvladovanje revmatoidnega artritisa.
English: In rheumatoid arthritis, if the patient is receiving Orencia for the first time, the first dose can be given by infusion.
Slovenian: Če bolnik pri revmatoidnem artritisu prejme zdravilo Orencia prvič, se prvi odmerek lahko da z infundiranjem.
English: Orencia can only be obtained with a prescription, and treatment with it should be started and supervised by a specialised doctor with experience in the diagnosis and treatment of rheumatoid arthritis or polyarticular juvenile idiopathic arthritis.
Slovenian: Predpisovanje in izdaja zdravila Orencia je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa ali juvenilnega idiopatskega artritisa.
English: After being trained and with the agreement of their doctor, patients or carers may inject the medicine themselves.
Slovenian: Bolniki ali njihovi negovalci lahko po opravljenem usposabljanju in s soglasjem zdravnika zdravilo injicirajo sami.
English: The study also led to similar improvements in symptoms to those seen with Orencia given into a vein in adults and children.
Slovenian: V študiji so bile ugotovljene tudi podobne izboljšave na področju simptomov kot pri zdravilu Orencia, kadar se daje v veno pri odraslih in otrocih.
English: Four main studies involving a total of 1,733 adults found Orencia effective in rheumatoid arthritis.
Slovenian: V štirih glavnih študijah, ki so vključevale skupaj 1 733 odraslih, so ugotovili, da je zdravilo Orencia učinkovito pri revmatoidnem artritisu.
English: The third study included 391 patients in whom TNF blockers had not worked well enough.
Slovenian: Tretja študija je vključevala 391 bolnikov, pri katerih zaviralci TNF niso bili dovolj učinkoviti.
English: • moderate to severe active polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), in adolescents and children from 2 years of age in whom other medicines have not worked well enough.
Slovenian: • zmernega do hudega aktivnega poliartikularnega juvenilnega idiopatskega artritisa (redke otroške bolezni, ki povzroča vnetje številnih sklepov) pri mladostnikih in otrocih od drugega leta dalje, pri katerih druga zdravila niso bila dovolj učinkovita.
English: Orencia is available as a powder that is made up into a solution for infusion (drip) into a vein and as a solution for injection under the skin in pre-filled syringes and pre-filled pens.
Slovenian: Zdravilo Orencia je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno in kot raztopina za injiciranje v podkožje v napolnjenih injekcijskih brizgah in napolnjenih peresnikih.
English: How does Orencia work?
Slovenian: Kako zdravilo Orencia deluje?
English: A further study in 219 children with polyarticular juvenile idiopathic arthritis aged 2 to 17 years showed that Orencia given by injection under the skin produced expected levels of active substance in the blood based on data with Orencia given into a vein for other conditions.
Slovenian: V dodatni študiji pri 219 otrocih s poliartikularnim juvenilnim idiopatskim artritisom, starih od 2 do 17 let, je bilo dokazano, da so z injiciranjem zdravila Orencia pod kožo v krvi nastale pričakovane ravni učinkovine na podlagi podatkov o zdravilu Orencia, ki se je infundiralo v veno pri drugih obolenjih.
English: • psoriatic arthritis (arthritis combined with psoriasis, a condition causing red, scaly patches on the skin) in adults in whom treatment with other medicines, including methotrexate, has not worked well enough.
Slovenian: • psoriaznega artritisa (artritisa v kombinaciji s psoriazo, tj. obolenjem, ki povzroča rdeče, luskaste zaplate na koži) pri odraslih, pri katerih zdravljenje z drugimi zdravili, vključno z metotreksatom, ni bilo dovolj učinkovito.
English: In addition, a study involving around 1,370 patients with rheumatoid arthritis found similar benefit for both Orencia given by injection under the skin and Orencia given by infusion.
Slovenian: Poleg tega so v študiji, ki je vključevala okrog 1 370 bolnikov z revmatoidnim artritisom, ugotovili podobne koristi pri zdravilu Orencia, ki se daje s podkožno injekcijo, in zdravilu Orencia, ki se daje z infundiranjem.
English: • moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints) in adults using it in combination with methotrexate when other medicines including methotrexate or a ‘tumour necrosis factor (TNF) blocker' have not worked well enough;
Slovenian: • zmernega do hudega aktivnega revmatoidnega artritisa (bolezni imunskega sistema, ki povzroča poškodbe in vnetje sklepov) pri odraslih, ki ga uporabljajo v kombinaciji z metotreksatom, kadar druga zdravila, vključno z metotreksatom ali „zaviralcem tumorje nekrotizirajočega faktorja (TNF)“, niso bila dovolj učinkovita;
English: When injected under the skin, Orencia is given once a week.
Slovenian: Kadar se zdravilo Orencia injicira v podkožje, se daje enkrat na teden.
English: How is Orencia used?
Slovenian: Kako se zdravilo Orencia uporablja?
English: In another study involving 170 patients with psoriatic arthritis, Orencia given by infusion at the recommended dose reduced symptoms by at least 20% after 24 weeks in over 47% of the patients (19 out of 40) compared with 19% of the patients (8 out of 42) who received placebo.
Slovenian: V drugi študiji, ki je vključevala 170 bolnikov s psoriatičnim artritisom, je zdravilo Orencia, ki so ga dajali z infundiranjem v priporočenem odmerku, po 24 tednih zmanjšalo simptome za vsaj 20 % pri več kot 47 % (19 od 40) bolnikov v primerjavi z 19 % (8 od 42) bolnikov, ki so prejemali placebo.
English: In polyarticular juvenile idiopathic arthritis, Orencia infusion was found effective in one main study involving patients aged between 6 and 17 years whose previous treatment had not worked.
Slovenian: Pri poliartikularnem juvenilnem idiopatskem artritisu so v eni glavni študiji, ki je vključevala bolnike, stare od 6 do 17 let, pri katerih predhodno zdravljenje ni bilo uspešno, ugotovili, da je infuzija zdravila Orencia učinkovita.
English: Orencia given by injection under the skin reduced symptoms in 39% of the patients (84 out of 213) compared with 22% of the patients (47 out of 211) who received placebo.
Slovenian: Zdravilo Orencia, ki so ga dajali s podkožno injekcijo, je zmanjšalo simptome pri 39 % (84 od 213) bolnikov v primerjavi z 22 % (47 od 211) bolnikov, ki so prejemali placebo.
English: In the first study, symptoms of the disease were reduced in 61% (70 out of 115) of the patients adding the recommended dose of Orencia to methotrexate for 6 months, compared with 35% (42 out of 119) of the patients adding placebo (a dummy treatment).
Slovenian: V prvi študiji so se simptomi bolezni zmanjšali pri 61 % (70 od 115) bolnikov, ki so šest mesecev metotreksatu dodajali priporočeni odmerek zdravila Orencia, v primerjavi s 35 % (42 od 119) bolnikov, ki so dodajali placebo (zdravilo brez učinkovine).