FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation Holder Samsung Bioepis NL B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom Samsung Bioepis NL B.V.
English: • Feeling forgetful, irritable, confused, nervous
Slovenian: • občutek pozabljivosti, razdražljivosti, zmedenosti, živčnosti,
English: Tell your doctor if you are using or have recently used any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno s katerimi koli drugimi zdravili za zdravljenje Crohnove bolezni, ulceroznega kolitisa, revmatoidnega artritisa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze in z zdravili, ki se jih dobi brez recepta, kot so vitamini in rastlinski pripravki.
English: For more information about the safety of infliximab in elderly patients (see sections 4.4 and 4.8).
Slovenian: Za več informacij o varnosti infliksimaba pri starejših glejte poglavji 4.4 in 4.8.
English: What you need to know before you use Flixabi
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Flixabi
English: Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Slovenian: Infliksimab so preučevali le v kombinaciji z običajno imunosupresivno terapijo.
English: It should be noted that suppression of TNFα may mask symptoms of infection such as fever.
Slovenian: Treba je tudi poudariti, da lahko zaviranje TNFα prikrije simptome okužbe, npr. zvišano telesno temperaturo.
English: • Some children and teenage patients who have received TNF-blockers such as Flixabi have developed cancers, including unusual types, which sometimes resulted in death.
Slovenian: • Pri nekaterih otrocih in najstnikih, ki so prejemali zaviralce TNF, kot je zdravilo Flixabi, se je razvil rak, vključno z neobičajnimi oblikami, ki se je včasih končal s smrtnim izidom.
English: • Serious lung problems (such as interstitial lung disease)
Slovenian: • resne težave s pljuči (na primer intersticijska pljučna bolezen),
English: d p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Slovenian: d p = 0,030 in < 0,001 za terapevtski skupini, ki sta prejemali 3 mg/kg in 6 mg/kg v primerjavi s placebom + MTX
English: • Tell your surgeon or dentist that you are having treatment with Flixabi by showing them your patient reminder card.
Slovenian: • Obvestite kirurga ali zobozdravnika, da prejemate zdravilo Flixabi, in mu pokažite svojo opozorilno kartico za bolnika.
English: • Children and adults taking Flixabi may have an increased risk of developing lymphoma or another cancer.
Slovenian: • Otroci in odrasli, ki prejemajo zdravilo Flixabi, imajo lahko povečano tveganje za pojav limfoma ali katere druge vrste raka.
English: In all cases, infliximab treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Slovenian: V vseh primerih je bilo zdravljenje z infliksimabom ukinjeno in/ali so bolniku uvedli drugo zdravljenje, znaki in simptomi bolezni pa so izginili.
English: The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%].
Slovenian: Mediana dolžine spremljanja bolnikov je bila 0,8 let (incidenca 5,7 % [95 % IZ 2,65 %-10,6 %].
English: Of the infliximabtreated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.
Slovenian: Pri bolnikih, zdravljenih z infliksimabom, ki so prejeli najmanj eno skrajšano infuzijo, so se z infuzijo povezane reakcije pojavljale pri 15 % bolnikov, resne z infuzijo povezane reakcije pa pri 0,4 % bolnikov.
English: Administration of Flixabi 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.
Slovenian: Uporabo zdravila Flixabi prekinite, če se pri bolniku pojavi nova resna okužba ali sepsa, in mu uvedite ustrezno protimikrobno ali protiglivično terapijo, dokler ne bo okužba obvladana.
English: Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Slovenian: Psoriatični artritis je vnetna bolezen sklepov, ki jo običajno spremlja psoriaza.
English: Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
Slovenian: Zavrzite to zdravilo, če ga ne uporabite do zgodnejšega od obeh datumov, novega datuma izteka roka uporabnosti ali datuma izteka roka uporabnosti, natisnjenega na škatli.
English: Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).
Slovenian: Sorazmerno s povečanjem enkratnega odmerka infliksimaba 1, 3, 5, 10 ali 20 mg/kg v intravenski infuziji sta se povečali tudi največja koncentracija tega zdravila v serumu (Cmax) in površina pod krivuljo koncentracije po času (AUC).
English: In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant therapy.
Slovenian: Na splošno bolniki, pri katerih se je pojavilo zvišanje ALT in AST, niso imeli simptomov in nenormalni izvidi so se zmanjšali ali normalizirali bodisi z nadaljevanjem ali z ukinitvijo zdravljenja z infliksimabom ali pa ob prilagoditvi drugih sočasnih terapij.
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patientsyears (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Slovenian: Pri spremljanju dolgoročne varnosti infliksimaba do 5 let po kliničnih študijah, to pomeni pri skupaj 6.234 bolnikih x letih (3.210 bolnikov), pa so poročali o 5 primerih limfoma in 38 primerih nelimfomskih rakavih bolezni.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Flixabi treatment.
Slovenian: Ženske v rodni dobi morajo za preprečevanje nosečnosti razmisliti o uporabi ustrezne kontracepcije in z njo nadaljevati še najmanj 6 mesecev po zaključku zdravljenja z zdravilom Flixabi.
English: Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8).
Slovenian: Bolniki z zmernim do hudim srčnim popuščanjem (razred III/IV po NYHA) (glejte poglavji 4.4 in 4.8).
English: • Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
Slovenian: • Pri nekaterih bolnikih, ki prejemajo infliksimab, so se pojavili simptomi bolezni imunskega sistema, imenovane lupus.
English: * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Slovenian: * Infliksimab je himerno človeško-glodavsko monoklonsko protitelo IgG1, pridobljeno iz celic jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
English: • Tell your doctor before you are given Flixabi if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Slovenian: • Preden prejmete zdravilo Flixabi, povejte zdravniku, če ste kdaj živeli v ali potovali po krajih, kjer so pogoste okužbe, imenovane histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: • Narrowed airway in the lungs, causing difficulty breathing
Slovenian: • zoženje dihalnih poti v pljučih, ki povzroča težave z dihanjem,
English:  adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Slovenian: • pri odraslih bolnikih s hudo, aktivno in progresivno boleznijo, ki še niso bili zdravljeni z metotreksatom ali drugimi protirevmatičnimi zdravili DMARD.
English: The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment.
Slovenian: Porazdelitveni volumen v stanju dinamičnega ravnovesja (mediana Vd od 3,0 do 4,1 litra) ni bil odvisen od danega odmerka, kar pomeni, da se infliksimab razporedi pretežno po žilnem razdelku.
English: • New or worsening heart failure, slow heart rate
Slovenian: • novo nastalo srčno popuščanje ali poslabšanje srčnega popuščanja, počasen srčni utrip,
English: Flixabi is available in packs containing 1, 2, 3, 4, and 5 vial(s).
Slovenian: Zdravilo Flixabi je na voljo v pakiranjih, ki vsebujejo po 1, 2, 3, 4 ali 5 vial.
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02.
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNFα), oznaka ATC: L04AB02.
English: Flixabi should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Zdravilo Flixabi morate uporabljati previdno pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA).
English: • Treat active Crohn's disease,
Slovenian: • zdravljenje aktivne Crohnove bolezni,
English: If these medicines or treatments do not work well enough, you will be given Flixabi to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ali terapije ne delujejo dovolj dobro, boste prejeli zdravilo Flixabi za zmanjševanje znakov in simptomov bolezni.
English: Viral infection (e.g. influenza, herpes virus infection).
Slovenian: virusna okužba (npr. gripa, okužba z virusom herpesa)
English: • Liver problem that causes yellowing of the skin or eyes (jaundice)
Slovenian: • težave z jetri, ki povzročajo porumenelost kože ali oči (zlatenica),
English: Placebo (week 24)
Slovenian: placebo (24. teden)
English: Flixabi works by selectively attaching to TNF alpha and blocking its action.
Slovenian: Zdravilo Flixabi deluje tako, da se selektivno veže na TNF-alfa in zavira njegovo delovanje.
English: • Talk to your doctor if you recently have had or are due to have a vaccine.
Slovenian: • Posvetujte se z zdravnikom, če ste bili pred kratkim cepljeni ali boste cepljeni.
English: • Stomach pain, feeling sick
Slovenian: • želodčne bolečine, občutek slabosti,
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Slovenian: V poskusnem kliničnem preskušanju pri bolnikih z zmerno do hudo KOPB, ki so bili bodisi aktivni kadilci ali bivši kadilci, je bilo 157 odraslih bolnikov zdravljenih z infliksimabom v odmerkih, podobnih tistim, ki se uporabljajo pri revmatoidnem artritisu in pri Crohnovi bolezni.
English: • That treatment with Flixabi may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Slovenian: • Da lahko zdravljenje z zdravilom Flixabi zveča tveganje za resne okužbe/sepso, oportunistične okužbe, tuberkulozo, reaktivacijo hepatitisa B in okužbo z BCG pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu, in kdaj poiskati zdravniško pomoč.
English: During Flixabi treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Slovenian: Med zdravljenjem z zdravilom Flixabi je treba optimizirati druge sočasne terapije, npr. s kortikosteroidi in zdravili za zaviranje imunske odzivnosti.
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis
Slovenian: • resne težave s kožo, na primer toksična epidermalna nekroliza, Stevens-Johnsonov sindrom in akutna generalizirana eksantematozna pustuloza,
English: Bacterial infections (e.g. sepsis, cellulitis, abscess).
Slovenian: bakterijske okužbe (npr. sepsa, celulitis, absces)
English: There are insufficient data on the incidence of delayed hypersensitivity reactions after infliximab-free intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval (see section 4.4).
Slovenian: Podatki o incidenci poznih preobčutljivostnih reakcij po premoru brez infliksimaba, daljšem od enega leta, so nezadostni, vendar omejeni podatki iz kliničnih preskušanj kažejo povečano tveganje za pozno preobčutljivost pri povečevanju premora brez infliksimaba (glejte poglavje 4.4).
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon γ.
Slovenian: Analiza mononuklearnih celic iz lamine proprie, dobljenih z biopsijo črevesne sluznice, je pokazala, da zdravljenje z infliksimabom povzroči zmanjšanje števila celic, ki lahko tvorijo TNFα in interferon γ.
English: Further treatment with Flixabi must not be given if a patient develops a serious infection or sepsis.
Slovenian: Bolnika ne smete več zdraviti z zdravilom Flixabi, če razvije resno okužbo ali sepso.
English: Powder for concentrate for solution for infusion (powder for concentrate).
Slovenian: Prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat).
English: During clinical studies of infliximab across all approved indications the incidence of lymphoma in infliximab-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Slovenian: Med kliničnimi preskušanji infliksimaba za vse odobrene indikacije je bila pri bolnikih, zdravljenih z infliksimabom, incidenca limfoma višja od pričakovane za splošno populacijo, vendar se je limfom dejansko pojavljal redko.
English: Had treatment with any medicine containing infliximab before
Slovenian: Predhodno ste se že zdravili s katerim koli zdravilom, ki vsebuje infliksimab
English: Keratitis, periorbital oedema, hordeolum.
Slovenian: keratitis, periorbitalni edem, hordeolum redki:
English: In a Phase II study aimed at evaluating infliximab in CHF, higher incidence of mortality due to worsening of heart failure were seen in patients treated with infliximab, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
Slovenian: V študiji faze II, katere cilj je bil ovrednotiti infliksimab pri CHF, so pri bolnikih, zdravljenih z infliksimabom, ugotavljali večjo incidenco smrtnosti zaradi poslabšanja srčnega popuščanja, še posebej pri tistih, ki so prejemali večji odmerek 10 mg/kg (dvakrat več od največjega odobrenega odmerka).
English: Flixabi and Orencia should not be used together.
Slovenian: Zdravili Flixabi in Orencia se ne smeta uporabljati skupaj.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij za referenčno zdravilo, ki vsebuje infliksimab, za vse podskupine pediatrične populacije z revmatoidnim artritisom, juvenilnim idiopatskim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom, psoriazo in Crohnovo boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • Bacterial infections such as blood poisoning, abscess or infection of the skin (cellulitis)
Slovenian: • bakterijske okužbe, na primer zastrupitev krvi, absces ali okužba kože (celulitis),
English: Table 7 Effects on response rate, data from ACCENT II (week-14 responders)
Slovenian: Preglednica 7 Učinki na stopnjo odziva; podatki iz študije ACCENT II (bolniki z odzivom v 14. tednu)
English: • Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Flixabi.
Slovenian: • Zdravnik vam bo dal tudi opozorilno kartico za bolnika, na kateri so navedeni pomembnejši varnostni podatki, ki jih morate poznati, preden prejmete zdravilo Flixabi in tudi med zdravljenjem z njim.
English: In one of the study arms (group 2, n=329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Slovenian: V enem kraku študije (skupina 2, n = 329) so bolnikom z nezadostnim odzivom na zdravilo omogočili titracijo, t. j. povečevanje odmerka v korakih po 1,5 mg/kg, od 3 do največ 9 mg/kg.
English: Type 1 glass vial with a rubber stopper and aluminium crimp protected by a plastic cap.
Slovenian: Viala (steklo tipa 1) z gumijastim zamaškom in aluminijasto zaporko, zaščiteno s plastičnim pokrovčkom.
English: Your doctor will advise you what other medicines you must keep using while you are having Flixabi.
Slovenian: Zdravnik vam bo svetoval, katera zdravila morate še naprej jemati tudi med zdravljenjem z zdravilom Flixabi.
English: The combination of Flixabi with other biological therapeutics used to treat the same conditions as Flixabi, including anakinra and abatacept, is not recommended (see section 4.4).
Slovenian: Kombiniranje zdravila Flixabi z drugimi biološkimi zdravili za zdravljenje enakih bolezni kot z zdravilom Flixabi, vključno z anakinro in abataceptom, ni priporočljivo (glejte poglavje 4.4).
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Slovenian: Juvenilni idiopatski artritis, psoriatični artritis in ankilozirajoči spondilitis Varnost in učinkovitost infliksimaba pri otrocih in mladostnikih, mlajših od 18 let, za indikacije juvenilni idiopatski artritis, psoriatični artritis in ankilozirajoči spondilitis nista bili dokazani.
English: • Immune disorders that could affect the lungs, skin and lymph nodes (such as sarcoidosis)
Slovenian: • imunske bolezni, ki lahko prizadenejo pljuča, kožo in bezgavke (na primer sarkoidoza),
English: All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Slovenian: Pri vseh bolnikih z ulceroznim kolitisom, pri katerih obstaja povečano tveganje za displazijo ali karcinom kolona (na primer pri bolnikih z dolgotrajnim ulceroznim kolitisom ali primarnim sklerozantnim holangitisom), ter pri tistih, ki imajo displazijo ali karcinom kolona v pretekli anamnezi, morate redno opravljati presejalne teste za displazijo, tako pred zdravljenjem kot skozi celoten potek bolezni.
English: In the 3 mg/kg infliximab group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions).
Slovenian: V skupini, ki je infliksimab prejemala v odmerku 3 mg/kg, so imeli 4 od 60-tih bolnikov resno z infuzijo povezano reakcijo, pri 3 pa so poročali o možni anafilaktični reakciji (od tega sta 2 sodili med resne z infuzijo povezane reakcije).
English: Other medicines and Flixabi
Slovenian: Druga zdravila in zdravilo Flixabi
English: If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Flixabi should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Slovenian: Če se pojavi zlatenica in/ali zvišanje vrednosti ALT ≥ 5-kratno zgornjo mejo normale, prenehajte z uporabo zdravila Flixabi in temeljito raziščite vzroke za nenormalne izvide.
English: Efficacy and safety were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
Slovenian: Učinkovitost in varnost zdravila so ocenjevali v dveh multicentričnih, dvojno slepih in s placebom kontroliranih študijah pri bolnikih z aktivnim psoriatičnim artritisom.
English: You may receive some vaccines during treatment with Flixabi but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Flixabi because they may cause infections.
Slovenian: Med zdravljenjem z zdravilom Flixabi lahko prejmete nekatera cepiva, vendar med uporabo zdravila Flixabi ne smete prejeti živih cepiv (cepiv, ki vsebujejo žive, a oslabljene povzročitelje okužb), saj lahko le-ta povzročijo okužbo.
English: • Side effect due to an infusion
Slovenian: • neželeni učinek zaradi infuzije,
English: Flixabi infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Slovenian: Infuzije zdravila Flixabi morajo bolniku dajati kvalificirani zdravstveni delavci, ki so usposobljeni za ugotavljanje morebitnih težav pri infundiranju zdravil.
English: Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Slovenian: Za zmanjšanje tveganja za pojav z infuzijo povezanih reakcij lahko bolnikom že prej daste npr. antihistaminik, hidrokortizon in/ali paracetamol in upočasnite hitrost infundiranja, še posebej če so se z infuzijo povezane reakcije pojavile že kdaj prej (glejte poglavje 4.4).
English: Flixabi is a biosimilar medicinal product.
Slovenian: Zdravilo Flixabi je podobno biološko zdravilo.
English: Because of the nature of the adverse reactions seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα-blocking agents.
Slovenian: Glede na vrsto neželenih učinkov, ki so jih opažali pri kombinirani terapiji z etanerceptom in anakinro, lahko podobni toksični učinki nastopijo tudi kot posledica kombiniranja anakinre in drugih zaviralcev TNFα.
English: Flixabi treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Slovenian: Zdravljenje z zdravilom Flixabi mora uvesti in nadzorovati kvalificiran zdravnik, ki je izkušen v diagnostiki in zdravljenju revmatoidnega artritisa, vnetnih bolezni črevesa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze.
English: Cases of transient visual loss occurring during or within 2 hours of infliximab infusion have been reported.
Slovenian: Poročali so o primerih prehodne izgube vida, ki je nastopila med infundiranjem ali v roku 2 ur po prejemu infuzije infliksimaba.
English: Amnesia, agitation, confusion, somnolence, nervousness.
Slovenian: amnezija, vznemirjenost, zmedenost, zaspanost, živčnost redki:
English: Cases of TB have been reported in patients treated with Flixabi, even in patients who have already been treated with medicines for TB.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Flixabi, so poročali o primerih tuberkuloze, tudi pri bolnikih, ki so že bili zdravljeni z zdravili proti TBC.
English: Anaphylactic shock, vasculitis, sarcoid-like reaction.
Slovenian: anafilaktični šok, vaskulitis, sarkoidni podobna reakcija
English: The combination of Flixabi and abatacept is not recommended.
Slovenian: Kombiniranje zdravila Flixabi in abatacepta torej ni priporočljivo.