FrancophonIA/ELRC3.0 huggingface dataset:
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to
Slovenian: Kot posledica delovanja obeh zdravilnih učinkovin se koncentracija glukoze v krvi zniža, to pa prispeva k nadzoru nad sladkorno boleznijo tipa 2.
English: Avaglim is used in patients who cannot satisfactorily control their blood glucose (sugar) when using an adequate dose of a sulphonylurea (a type of antidiabetes medicine) on its own, and for whom metformin (another antidiabetes medicine) is
Slovenian: Zdravilo se uporablja pri bolnikih, pri katerih ravni glukoze (sladkorja) v krvi ni mogoče zadovoljivo uravnavati z ustreznim odmerkom sulfonilsečnine (vrste zdravila proti sladkorni bolezni), vzete samostojno, in za katere metformin (druga vrsta zdravila proti sladkorni bolezni) ni primeren.
English: The full EPAR for Avaglim can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Avaglim je na voljo tukaj.
English: How does Avaglim work?
Slovenian: Kako zdravilo Avaglim deluje?
English: It can be used in combination with a sulphonylurea when metformin is not suitable.
Slovenian: Kadar metformin ni primeren, se lahko uporablja v kombinaciji s sulfonilsečnino.
English: The full list is available in the Package Leaflet.
Slovenian: Za celoten seznam
English: Not known (frequency cannot be estimated from available data)
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: 1) including spontaneous reporting data
Slovenian: 1)Vključno s podatki iz spontanega poročanja
English: 1.4 You will also need following supplies that are not included in the kit:
Slovenian: 1.4 Potrebovali boste tudi naslednje pripomočke, ki niso priloženi v kompletu:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 2 April 2019
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM 2. april 2019
English: Table 25 Maintenance regimen
Slovenian: Preglednica 25 Vzdrževalni režim
English: Then release the pinched skin.
Slovenian: Nato spustite kožno gubo.
English: Idacio may be available in other presentations depending on the individual treatment needs.
Slovenian: Zdravilo Idacio je lahko na voljo v drugih oblikah, odvisno od individualnih potreb zdravljenja.
English: 1.3 Open the kit and take out all components and put them on a clean, dry, flat surface.
Slovenian: 1.3 Komplet odprite, vzemite ven vse pripomočke ter jih položite na čisto, suho, ravno površino.
English: Patients were allowed to continue on study medication beyond Week 78 until they had access to adalimumab.
Slovenian: Bolnikom je bilo dovoljeno prejemati zdravilo v preskušanju tudi po 78. tednu, dokler niso imeli dostopa do adalimumaba.
English: Travel/recurrent infection
Slovenian: Potovanja/ponavljajoče okužbe
English: You and your doctor should pay special attention to signs of infection while you are being treated with Idacio.
Slovenian: Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom Idacio.
English: • If you are over 65 years you may be more susceptible to infections while taking Idacio.
Slovenian: • Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Idacio.
English: NE = not estimable.
Slovenian: c NE = ni mogoče oceniti.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies 1) including spontaneous reporting data
Slovenian: *Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 **Vključno pri podaljšanih študijah brez placeba 1)Vključno s podatki iz spontanega poročanja
English: It can now be thrown away in the sharps container.
Slovenian: Sedaj jo lahko zavržete v zbiralnik za ostre predmete.
English: • When the syringe plunger has moved to the bottom and has stopped moving, continue holding it for 5 seconds.
Slovenian: • Ko se je bat premaknil do konca in se je prenehal premikati, držite injekcijski peresnik na mestu še 5 sekund.
English: Label area (Idacio, dose, expiration date)
Slovenian: Nalepka (Idacio, odmerek, rok uporabnosti)
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Slovenian: Opozorilna kartica za bolnika (za odrasle in otroke) vsebuje naslednje ključne podatke: - okužbe, vključno s tuberkulozo - rak - težave živčnega sistema - cepljenja
English: • Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
Slovenian: • sindrom Stevens-Johnson (življenjsko ogrožajoča reakcija z gripo podobnimi simptomi in mehurjastimi izpuščaji);
English: Idacio can also be given alone.
Slovenian: Zdravilo Idacio se lahko daje tudi samo.
English: Maintenance dose starting at week 4
Slovenian: Vzdrževalni odmerek bolnika z začetkom v 4. tednu
English: The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.
Slovenian: Ustrezni deleži bolnikov, ki niso imeli rentgenografskih znakov napredovanja, so bili 31,3 %, 23,7 % oz. 36,7 %.
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) 1),
Slovenian: pogosti poslabšanje ali pojav psoriaze (vključno s palmplantarno pustularno psoriazo)1),
English: Side effects may occur up to 4 months or more after the last Idacio injection.
Slovenian: Neželeni učinki se lahko pojavijo še 4 mesece ali več po zadnji injekciji zdravila Idacio.
English: Treatment with Idacio can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Slovenian: Zdravljenje z zdravilom Idacio se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
English: Warning: Do not use the vial if:
Slovenian: Opozorilo:Vialo ne uporabljajte, če:
English: 36.8% (14/38) 64.9% (24/37)b 43.3% (13/30) 71.4% (20/28)c
Slovenian: 36,8 % (14/38) 64,9 % (24/37)b 43,3 % (13/30)
English: Pulmonary fibrosis1)
Slovenian: redki pljučna fibroza1)
English: Your doctor may recommend temporarily stopping Idacio.
Slovenian: Vaš zdravnik bo morda priporočil začasno prenehanje uporabe zdravila Idacio.
English: If retreatment with Idacio is indicated, the above guidance on dose and treatment duration should be followed.
Slovenian: Če je indicirano vnovično zdravljenje z zdravilom Idacio, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljena.
English: • On rare occasions, treatment with Idacio could result in lupus-like syndrome.
Slovenian: • V redkih primerih lahko zdravljenje z zdravilom Idacio povzroči lupusu podoben sindrom.
English: • signs of skin cancer such as a bump or open sore that doesn't heal;
Slovenian: • znaki kožnega raka kot je bula ali odprta rana, ki se ne zaceli;
English: • unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;
Slovenian: • neobičajne okužbe (vključujejo tuberkulozo in druge okužbe, ki se pojavijo ob slabši telesni odpornosti na bolezen);
English: Before initiation of therapy with Idacio, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Slovenian: Pred začetkom zdravljenja z zdravilom Idacio je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
English: By attaching to TNFα, Idacio blocks its action and reduces the inflammation in these diseases.
Slovenian: Z vezavo na TNFα zdravilo Idacio zaustavi to aktivnost in zmanjša vnetje pri teh boleznih.
English: • After the needle is inserted, release the pinched skin.
Slovenian: • Ko je injekcijska igla vstavljena, izpustite kožno gubo.
English: What you need to know before you use Idacio Do not use Idacio - if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO IDACIO Ne uporabljajte zdravila Idacio - če ste alergični na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Figure S Warning: Call your healthcare - professional or pharmacist if:
Slovenian: Opozorilo: Pokličite svojega zdravstvenega delavca ali farmacevta, če:
English: 2-sided p value from log rank test.
Slovenian: b 2-stranska vrednost p testa log-rank.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje adalimumab za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom, za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
English: Your doctor may prescribe another strength of Idacio if your child needs a different dose.
Slovenian: Zdravnik lahko predpiše vašemu otroku drugo jakost zdravila Idacio, če vaš otrok potrebuje drugačen odmerek.
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Slovenian: Navidezna koncentracija adalimumaba v plazmi, ki doseže polovico največje verjetnosti Ped ACR 50 odziva (EC50) je bila 3 μg/ml (95% IZ: 1-6 μg/ml).
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Slovenian: Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in ICAM-1 z IC50 0,1-0,2 nM).
English: Other medicines and Idacio
Slovenian: Druga zdravila in zdravilo Idacio
English: Corticosteroids or other medicines that influence the immune system may be continued while using Idacio.
Slovenian: Kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, se lahko še nadalje uporabljajo ob uporabi zdravila Idacio.
English: Warning: Do not lift the pre-filled pen from the skin until the plunger has moved all the way down and all the liquid has been injected.
Slovenian: Opozorilo: Napolnjenega injekcijskega peresnika ne odmikajte od kože, dokler se ni bat premaknil do konca navzdol in je bila vsa tekočina injicirana.
English: Step 2 Wash your Hands
Slovenian: 2. korak Umijte si roke
English: In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
Slovenian: V primeru, ko je potreben hitrejši odgovor na zdravljenje, z teden zavedanjem, da je tveganje za pojav neželenih učinkov povečano ob uporabi večjega začetnega odmerka, se lahko uporabi odmerek:
English: The active ingredient in Idacio, adalimumab, is a monoclonal antibody.
Slovenian: Učinkovina v zdravilu Idacio, adalimumab, je monoklonsko protitelo.
English: Patients taking TNF-antagonists are more susceptible to serious infections.
Slovenian: Bolniki, ki uporabljajo antagoniste tumor nekrotizirajočega faktorja (TNF), so bolj dovzetni za resne okužbe.
English: Detailed instructions on how to inject Idacio are provided in section 7 ‘Instructions for use'.
Slovenian: Podrobnejše informacije kako injicirati zdravilo Idacio so opisane v poglavju 7 “Navodila za uporabo”.
English: cAnkylosing Spondylitis Disease Activity Score dPartial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Slovenian: Activity Score) d Delni zagon bolezni je določen kot ASDAS ≥ 1,3 vendar < 2,1 pri dveh zaporednih obiskih.
English: HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Slovenian: a RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
English: Idacio in combination with methotrexate, is indicated for:
Slovenian: Zdravilo Idacio je v kombinaciji z metotreksatom indicirano za:
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Treatment with Idacio should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Slovenian: Zdravljenja z zdravilom Idacio se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Idacio.
Slovenian: Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Idacio.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Idacio (see section 4.4).
Slovenian: Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Idacio posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
English: Idacio treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Idacio is indicated.
Slovenian: Zdravljenje z zdravilom Idacio mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Idacio indicirano.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Idacio in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Slovenian: O uporabi protituberkuloznega profilaktičnega zdravljenja morate pred uvedbo zdravila Idacio razmisliti tudi pri bolnikih s hudimi ali pomembnimi faktorji tveganja za tuberkulozo kljub negativnemu testu za tuberkulozo in pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
English: • With your other hand gently pinch skin (without squeezing) to avoid injecting into a muscle
Slovenian: • Z drugo roko nežno stisnite kožo (brez stiskanja), da bi preprečili injiciranje v mišico (Slika O).
English: These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Slovenian: Te okužbe so lahko bolj resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije ali druge nenavadne okužbe organizma in sepso (zastrupitev krvi).
English: • Children are not allowed to inject themselves and injection must be done by a trained adult.
Slovenian: • Otroci si zdravila ne smejo injicirati sami, temveč jim ga mora injekcirati usposobljena odrasla oseba.
English: Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Slovenian: Psoriaza v plakih lahko vpliva tudi na nohte, zaradi česar se le-ti lomijo, postanejo debelejši in se dvignejo od svojega ležišča, kar je lahko boleče.
English: In rare cases, these infections may be lifethreatening.
Slovenian: Te okužbe so lahko v redkih primerih smrtno nevarne.
English: Thus additional caution should be exercised in considering Idacio treatment of these patients (see section 4.8).
Slovenian: Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z zdravilom Idacio pri teh bolnikih (glejte poglavje 4.8).
English: Systemic infections (including sepsis, candidiasis and influenza),
Slovenian: pogosti sistemske okužbe (vključno s sepso, kandidiazo in gripo),
English: b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
Slovenian: b Bolniki, ki izpolnjujejo merila, določena v protokolu za izgubo odziva ali brez izboljšanja, so bili izključeni iz študij in so še šteli pod bolnike brez odgovora (“nonresponders”).
English: • Place your thumb above (not touching) the yellow injection button (Figure M).
Slovenian: • Palec držite nad (brez dotikanja) rumenim gumbom za injiciranje (Slika M).
English: 7.1 Now that you have completed your injection, update your record with:
Slovenian: 7.1 Po zaključenem injiciranju zabeležite podatke o:
English: In patients who develop HBV reactivation, Idacio should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Slovenian: Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila Idacio prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
English: Week 26 Week 52 1 p value for Standard Dose versus Low Dose comparison.
Slovenian: 26. teden 52. teden 1p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku.
English: urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia1),
Slovenian: urtikarija, modrice (vključno s purpuro), dermatitis (vključno z ekcemom), oniholiza, čezmerno znojenje, alopecija1),
English: Table 6 Undesirable effects
Slovenian: Preglednica 6 Neželeni učinki
English: INFORMATION IN BRAILLE Idacio 40 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Idacio 40 mg
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Idacio should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila Idacio nemudoma prekiniti in uvesti ustrezno zdravljenje.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Idacio and is positive for antibodies against double-stranded DNA, further treatment with Idacio should not be given (see section 4.8).
Slovenian: Če se bolniku po zdravljenju z zdravilom Idacio pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja z zdravilom Idacio ne sme nadaljevati (glejte poglavje 4.8).
English: • any issue you had
Slovenian: • kakršnihkoli težavah,
English: Note : images for illustration purposes only
Slovenian: Opomba: Slike so namenjene zgolj slikovni ponazoritvi
English: Figure B 1.4 Check the expiration date on the side of the box (Figure C).
Slovenian: Slika B 1.4 Preverite rok uporabnosti, ki je odtisnjen na strani škatle (Slika C).
English: Overall, among the patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment.
Slovenian: Na splošno med bolniki, ki so prekinili študijo , jih je 18 % prekinilo študijo zaradi neželenih učinkov in 8 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
English: • an alcohol pad (included in the box)
Slovenian: • zloženec, navlažen z alkoholom (priložen v škatli),
English: 6.2 Pinch the skin
Slovenian: 6.2 Naredite kožno gubo
English: Should treatment be interrupted, Idacio may be re-introduced as appropriate.
Slovenian: Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom Idacio znova uvesti, kakor je primerno.
English: • Do not use the Idacio pre-filled syringe if it has been dropped or crushed, as the pre-filled syringe may be broken even if you cannot see the break.
Slovenian: • Zdravila Idacio napolnjena injekcijska brizga ne uporabljajte, če vam je padlo iz rok ali je bila brizga strta, saj je lahko injekcijska brizga poškodovana, tudi če ne vidite razpok.
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Slovenian: Učinkovitost adalimumaba za zdravljenje mladostnikov s HS je napovedana na podlagi dokazane učinkovitosti in razmerja med izpostavljenostjo in odzivom pri odraslih bolnikih s HS ter verjetnosti, da so potek bolezni, patofiziologija in učinek zdravila bistveno podobni kot pri odraslih bolnikih pri enaki ravni izpostavljenosti.
English: People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow).
Slovenian: Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom in levkemijo (vrsto raka, ki prizadene krvne celice in kostni mozeg).
English: • In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding.
Slovenian: • Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki premagujejo okužbe ali pomagajo zaustaviti krvavitve.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Slovenian: Naslednji seznam neželenih učinkov je osnovan na izkušnjah iz kliničnih preskušanj in iz obdobja trženja zdravila in jih razvršča po organskih sistemih in pogostnosti v preglednici 6, spodaj: 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) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) (<1/10.000).
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Idacio cannot be excluded (see section 4.8).
Slovenian: Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki dobivajo zdravilo Idacio, ni mogoče izključiti (glejte poglavje 4.8).
English: In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
Slovenian: V redkih primerih, zlasti če uporabljate druga zdravila, ki zavirajo imunski sistem, je reaktivacija HBV okužbe lahko smrtno nevarna.
English: 4.2 Choose a different site (at least 2.5 centimeters away from the previous injection site) each time to reduce redness, irritation or other skin problems.
Slovenian: 4.2 Vsakič izberite drugo mesto (ki je vsaj 2,5 centimetra oddaljeno od prejšnjega), da bi zmanjšali pordelost, draženje in druge težave s kožo.
English: During treatment with Idacio, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Slovenian: Med zdravljenjem z zdravilom Idacio je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
English: Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Slovenian: Zdravilo Idacio se lahko uporablja kot monoterapija v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
English: Taking these results into consideration, Idacio is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Slovenian: Z upoštevanjem teh ugotovitev je zdravilo Idacio priporočljivo uporabljati v kombinaciji z metotreksatom, kot monoterapijo pa pri bolnikih, za katere uporaba metotreksata ni primerna (glejte poglavje 4.2).