natgillin/translations-raw huggingface dataset:
Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made. 
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
• Circulation problems such as low or high blood pressure 
• težave s krvnim obtokom, na primer nizek ali visok krvni tlak,
• Tell your doctor before you are given Flixabi if you have or have ever had lymphoma (a type of blood cancer) or any other cancer. 
• Preden prejmete zdravilo Flixabi, povejte zdravniku, če imate ali ste imeli kdaj v preteklosti limfom (vrsta krvnega raka) oziroma katero koli drugo vrsto raka.
At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/mL, respectively. 
Po enkratnem odmerku 3, 5 ali 10 mg/kg so bile mediane vrednosti Cmax 77, 118 in
PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2) All nails cleared c 
PGA brez plakov (0) ali minimalni (1) PGA brez plakov (0), minimalni (1), ali blagi (2) Vsi nohti brez psoriatičnih sprememb c
Appropriate screening tests, e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply). 
Pri vseh bolnikih je treba opraviti ustrezne presejalne teste (npr. tuberkulinski kožni test, rentgensko slikanje prsnega koša in/ali test sproščanja interferona gama (v skladu z lokalnimi priporočili).
In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks. 
V tej študiji je bilo 150 bolnikov s srčnim popuščanjem stopnje III do IV po NYHA (iztisni delež levega ventrikla ≤ 35 %) zdravljenih s tremi infuzijami: infliksimab v odmerkih 5 mg/kg, 10 mg/kg ali s placebom več kot 6 tednov.
Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction. 
anafilaktična reakcija, lupusu podoben sindrom, serumska bolezen ali reakcija, podobna serumski bolezni redki:
• Children should receive recommended vaccinations before starting Flixabi treatment. 
• Otroci morajo prejeti priporočena cepljenja, preden se začnejo zdraviti z zdravilom Flixabi.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Flixabi and is positive for antibodies against double-stranded DNA, further treatment with Flixabi must not be given (see section 4.8). 
Če se po zdravljenju z zdravilom Flixabi pri bolniku pojavijo simptomi, ki kažejo na lupusu podoben sindrom, in je bolnik pozitiven na protitelesa proti dvojnoverižni DNA, ne sme več prejeti zdravila Flixabi (glejte poglavje 4.8).
While using Flixabi you should not receive live vaccines. 
Med uporabo zdravila Flixabi ne smete prejeti živih cepiv.
• A type of blood cancer (lymphoma) 
• vrsta krvnega raka (limfom),
When reconstitution and dilution are performed under aseptic conditions, Flixabi infusion solution can be used within 24 hours if stored at 2°C to 8°C. 
Če sta rekonstitucija in razredčenje opravljena v aseptičnih pogojih, smete infuzijsko raztopino zdravila Flixabi uporabiti v roku 24 ur, če je shranjena pri temperaturi od 2 °C do 8 °C.
• Pain. 
• bolečine.
Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura. 
agranulocitoza (vključno pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu), trombotična trombocitopenična purpura, pancitopenija, hemolitična anemija, idiopatska trombocitopenična purpura
• You will be monitored while you are given Flixabi and also for 1 to 2 hours afterwards. 
• Med prejemanjem zdravila Flixabi in še eno do dve uri po tem vas bodo spremljali.
• Reactions at the injection site such as pain, swelling, redness or itching 
• reakcije na mestu injiciranja, na primer bolečina, otekanje, pordelost ali srbenje,
By week 26, twenty weeks after the last induction dose, 30% of patients in the 5 mg/kg group and 13.8% of patients in the 3 mg/kg group were PASI 75 responders. 
Do 26. tedna, t. j. dvajset tednov po zadnjem uvodnem odmerku, je 30 % bolnikov iz skupine, ki je prejemala 5 mg/kg, in 13,8 % bolnikov iz skupine, ki je prejemala 3 mg/kg, imelo odziv PASI 75.
Patients with fistulising Crohn's disease with acute suppurative fistulas must not initiate Flixabi therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3). 
Pri bolnikih s fistulirajočo Crohnovo boleznijo z akutnimi gnojnimi fistulami ne smete uvesti terapije z zdravilom Flixabi, dokler ne izključite možnosti, da obstaja nekje vir okužbe, na primer absces (glejte poglavje 4.3).
Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebotreated patients (p=0.001). 
Dodatno so pri 55 % bolnikov zdravljenih z infliksimabom dosegli zapiranje vseh fistul, v primerjavi s 13 % bolnikov, ki so prejemali placebo (p = 0,001).
• Convulsions, nerve problems 
• epileptični krči, težave z živčevjem,
In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF 
V študijah ACT 1 in ACT 2 je infliksimab tudi izboljšal kakovost življenja bolnikov, kar je bilo potrjeno s statistično značilnim izboljšanjem rezultata vprašalnika za oceno vnetnih bolezni črevesja IBDQ, ki je specifičen za to bolezen, in z izboljšanjem rezultatov generične kratke ankete SF-36 s 36 postavkami.
In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNFα, crystalline deposits were observed on the lens capsule of some of the treated male mice. 
V 6-mesečni študiji toksičnosti pri ponavljajočih se odmerkih pri miših z uporabo istega analognega protitelesa proti mišjem TNFα so opažali kopičenje kristalov na lečni kapsuli nekaterih mišjih samcev, ki so prejemali zdravilo.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of Flixabi. 
Pri bolnikih, ki imajo več dejavnikov tveganja oziroma pomembne dejavnike tveganja za tuberkulozo in pri katerih je bil test na latentno tuberkulozo negativen, premislite, ali bi bilo treba pri njih pred uvedbo zdravila Flixabi najprej zdraviti tuberkulozo.
Patients should be closely monitored and Flixabi must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8). 
Zdravljenja z zdravilom Flixabi ne smete nadaljevati pri bolnikih, pri katerih se pojavijo ali poslabšajo simptomi srčnega popuščanja (glejte poglavji 4.3 in 4.8).
• Small red or purple spots caused by bleeding under the skin 
• majhne rdeče ali vijolične pike zaradi podkožnih krvavitev,
Week 30 
30. teden
Clinical response at week 8 was similar between those with or without concomitant immunomodulator use at baseline. 
Klinični odziv 8. teden je bil podoben med bolniki, ki so na začetku prejemali sočasno imunomodulator, in med tistimi, ki ga niso.
Placebo → Infliximab 5 mg/kg (at week 24) 
placebo → infliksimab 5 mg/kg (24 teden)
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ). 
Infliksimab je himerno človeško-glodavsko monoklonsko protitelo, ki se z veliko afiniteto veže tako na topne kot na transmembranske oblike TNFα, ne pa tudi na limfotoksin α (TNFβ).
Flixabi is produced in packs of 1, 2, 3, 4, or 5 vial(s). 
Zdravilo Flixabi je na voljo v pakiranjih s po 1, 2, 3, 4 ali 5 vial.
• Inflammation of the lining of the brain (meningitis) 
• vnetje možganskih ovojnic (meningitis),
If these medicines do not work well enough, you will be given Flixabi which you will take in combination with another medicine called methotrexate to: 
Če ta zdravila ne delujejo dovolj dobro, boste prejeli zdravilo Flixabi skupaj z zdravilom, imenovanim metotreksat, za:
Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution. 
Ker raztopina za infundiranje ne vsebuje konzervansa, priporočamo, da z dajanjem infuzije začnete čim prej, v roku 3 ur po rekonstituciji in redčenju.
Flixabi should be administered intravenously over a 2-hour period. 
Zdravilo Flixabi je treba dajati intravensko v času 2 ur.
Available data do not support further Flixabi treatment, in patients not responding within 6 weeks of the initial infusion. 
Podatki, ki so na voljo, ne govorijo v prid nadaljevanju zdravljenja zdravilom Flixabi pri bolnikih, ki se niso odzvali na zdravilo v roku 6 tednov po prvi infuziji.
Flixabi is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. 
Zdravilo Flixabi je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih bolnikih, ki so se nezadostno odzvali na konvencionalno terapijo.
Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1). 
Raziskave so pokazale, da infliksimab izboljšuje funkcijo sklepov pri bolnikih s psoriatičnim artritisom in zmanjšuje hitrost napredovanja okvare perifernih sklepov, ocenjene na podlagi rentgenskih slik pri bolnikih s poliartikularnimi simetričnimi podtipi bolezni (glejte poglavje 5.1).
Improvement from baseline in HAQ averaged over time from week 30 to week 54 
Izboljšanje z začetne vrednosti za HAQčasovno povprečje od 30. do 54. tedna c
• Tell your doctor before you are given Flixabi if you are a carrier of hepatitis B or have ever had it. 
• Preden prejmete zdravilo Flixabi, povejte zdravniku, če ste prenašalec hepatitisa B ali če ste ga imeli kdaj v preteklosti.
• Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems 
• znaki težav z živčevjem (vključno s težavami z očmi), na primer znaki možganske kapi (nenadna odrevenelost ali šibkost obraza, rok ali nog, predvsem na eni strani telesa; nenadna zmedenost, težave z govorom ali razumevanjem; težave z vidom na enem ali obeh očesih, težave s hojo, omotica, izguba ravnotežja ali koordinacije, ali hud glavobol), epileptični napadi, mravljinci/občutek odrevenelosti v katerem koli delu telesa ali šibkost rok ali nog, spremembe vida, na primer dvojni vid ali druge težave z očmi;
In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted. 
V obeh študijah je bilo dovoljeno sočasno jemanje stalnih odmerkov folne kisline, peroralnih kortikosteroidov (≤ 10 mg/dan) in/ali nesteroidnih protivnetnih zdravil (NSAID).
Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 
Preobčutljivost na učinkovino, druge glodavske beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
In psoriatic arthritis, short term treatment with infliximab reduced the number of T-cells and blood vessels in the synovium and psoriatic skin. 
Pri psoriatičnem artritisu je kratkotrajno zdravljenje z infliksimabom zmanjšalo število celic T in krvnih žil v sinovialni ovojnici in v psoriatično spremenjeni koži.
Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10). 
Učinkovitost in varnost infliksimaba so ocenjevali v dveh multicentričnih, dvojno slepih, s placebom nadzorovanih študijah pri bolnikih z aktivnim ankilozirajočim spondilitisom (Bathov indeks aktivnosti ankilozirajočega spondilitisa [BASDAI] ≥ 4 in indeks jakosti bolečin v hrbtenici ≥ 4 na lestvici od 1 do 10).
This includes multiple sclerosis, Guillain-Barre syndrome, if you have fits or have been diagnosed with ‘optic neuritis'. 
Guillain-Barréjev sindrom, če ste imeli napade krčev ali so vam diagnosticirali "optični nevritis".
Infusion reactions following re-administration of infliximab A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare. 
Z infuzijo povezane reakcije po ponovni uvedbi infliksimaba Pri bolnikih z zmerno do hudo psoriazo je bila načrtovana klinična študija za oceno učinkovitosti in varnosti dolgotrajnega vzdrževalnega zdravljenja v primerjavi s ponovno uporabo uvodne sheme zdravljenja z infliksimabom (največ štiri infuzije v 0., 2., 6. in 14. tednu) po izbruhu bolezni.
In rheumatoid arthritis clinical studies, the incidence of serious infections was greater in infliximab plus methotrexate-treated patients 65 years and older (11.3%) than in those under 65 years of age (4.6%). 
V kliničnih študijah revmatoidnega artritisa je bila pri bolnikih, ki so se zdravili z infliksimabom in metotreksatom ter so bili stari 65 let ali več, incidenca resnih okužb večja (11,3 %) kot pri tistih, ki so bili mlajši od 65 let (4,6 %).
What Flixabi looks like and contents of the pack 
Izgled zdravila Flixabi in vsebina pakiranja
Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT 
Preglednica 3 Učinki na ACR 20, strukturno okvaro sklepov in funkcijo sklepov v 54. tednu, študija ATTRACT
• Tell your doctor before you are given Flixabi if you have a lung disease called Chronic Obstructive Pulmonary Disease (COPD) or if you are a heavy smoker. 
• Preden prejmete zdravilo Flixabi, povejte zdravniku, če imate kronično obstruktivno pljučno bolezen (KOPB) ali če veliko kadite.
• Balance problems or feeling dizzy 
• težave z ravnotežjem ali občutek omotice,
Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for Csection (1.50, 1.14-1.96; p=0.0032), preterm birth (1.48, 1.05-2.09; p=0.024), small for gestational age (2.79, 1.54-5.04; p=0.0007), and low birth weight (2.03, 1.41-2.94; p=0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies). 
Na podlagi severnoevropske opazovalne študije so pri ženskah, ki so bile v nosečnosti izpostavljene infliksimabu (z ali brez imunomodulatorjev/kortikosteroidov, 270 nosečnosti), v primerjavi z ženskami, ki so bile izpostavljene samo imunomodulatorjem in/ali kortikosteroidom (6.460 nosečnosti), opazili zvečano tveganje (OR; 95 % IZ; vrednost p) za carski rez (1,50; 1,14 - 1,96; p = 0,0032), prezgodnji porod (1,48; 1,05 - 2,09; p = 0,024), majhnost glede na gestacijsko starost (2,79; 1,54 - 5,04; p = 0,0007) in nizko porodno težo (2,03; 1,41 - 2,94; p = 0,0002).
Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p < 0.001). 
Zdravljenje z infliksimabom je zmanjšalo hitrost napredovanja okvare perifernih sklepov v primerjavi s placebom v 24. tednu kot primarni končni rezultat, merjeno kot sprememba celotne vrednosti modificiranega rezultata vdH-S glede na stanje na začetku študije (v skupini za placebo je znašala srednja vrednost ± SD 0,82 ± 2,62, v primerjavi z0,70 ± 2,53 za skupino, ki je prejemala infliksimab; p < 0,001).
• Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever 
• znaki težav z jetri (vključno z okužbo s hepatitisom B, če ste imeli hepatitis B v preteklosti), na primer porumenelost kože ali oči, temno rjavo obarvan urin, bolečina a ali oteklina na zgornji desni strani želodčnega predela, bolečina v sklepih, kožni izpuščaji ali zvišana telesna temperatura;
In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy. 
V kliničnih študijah z uporabo enega ali več odmerkov infliksimaba od 1 do 20 mg/kg so protitelesa proti infliksimabu našli pri 14 % bolnikov, zdravljenih s katerim od zdravil za zaviranje imunske odzivnosti, ter pri 24 % bolnikov, ki niso prejemali tovrstnih zdravil.
Flixabi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. 
Zdravilo Flixabi je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih bolnikih v primeru nezadostnega odziva na predhodno zdravljenje s protirevmatičnimi zdravili DMARD.
Upon removal from refrigerated storage, Flixabi must not be returned to refrigerated storage. 
Ko zdravilo Flixabi vzamete iz hladilnika, v katerem je bilo shranjeno, ga ne smete shraniti nazaj v hladilnik.
Therefore, the combination of Flixabi and anakinra is not recommended. 
Kombiniranje zdravila Flixabi in anakinre torej ni priporočljivo.
Complement factor abnormal. 
nenormalna vrednost faktorja komplementa
• Tell your doctor if you have an infection even if it is a very minor one. 
• Zdravniku povejte, če imate kakršno koli, tudi najmanjšo okužbo.
Almost all patients had also received medicines containing azathioprine or 6mercaptopurine in addition to TNF-blockers. 
Skoraj vsi bolniki so poleg zaviralcev TNF prejeli tudi zdravila, ki vsebujejo azatioprin ali 6-merkaptopurin.
In this situation, Flixabi should be re-initiated as a single dose followed by the maintenance dose recommendations described above. 
V tem primeru bolniku najprej ponovno uvedite zdravilo Flixabi v enkratnem odmerku, pozneje pa mu spet predpišite vzdrževalni odmerek zdravila v skladu s priporočili, ki so podana zgoraj.
Pregnancy and breast-feeding, and fertility 
Nosečnost, dojenje in plodnost
• Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), blisters and peeling skin, or boils 
• ostale težave s kožo, kot so multiformni eritem, lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah), mehurji na koži in luščenje kože, ali turi
In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses. 
V podskupini 90 odraslih bolnikov z revmatoidnim artritisom iz študije ASPIRE se je učinkovito dva-kratno zvišanje titrov protiteles pri polivalentnem pnevmokoknem cepivu pokazalo pri podobnem deležu bolnikov iz vsake zdravljene skupine (metotreksat in: placebo [n = 17], infliksimab v odmerku 3 mg/kg [n = 27] ali infliksimab v odmerku 6 mg/kg [n = 46]), kar kaže, da infliksimab ni motil od celic T neodvisnih humoralnih imunskih odgovorov.
• Ulcerative colitis. 
• ulcerozni kolitis.
Limited experience from re-treatment following disease flare by a re-induction regimen suggests a higher incidence of infusion reactions, including serious ones, when compared to 8-weekly maintenance treatment (see section 4.8). 
Omejene izkušnje s ponovnim zdravljenjem bolnikov zaradi novega izbruha bolezni, t. j. izkušnje s ponovno uporabo uvodne sheme, so pokazale večjo incidenco z infuzijo povezanih reakcij, vključno z resnimi z infuzijo povezanimi reakcijami, v primerjavi z 8-tedenskim vzdrževalnim zdravljenjem (glejte poglavje 4.8).
The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4). 
Med najresnejše, z uporabo zaviralcev TNF povezane neželene učinke zdravila, o katerih so poročali pri uporabi infliksimaba, sodijo reaktivacija HBV, kongestivno srčno popuščanje (CHF - congestive heart failure), resne okužbe (vključno s sepso, oportunističnimi okužbami in TB), serumska bolezen (zapoznele preobčutljivostne reakcije), hematološke reakcije, sistemski eritematozni lupus/lupusu podoben sindrom, demielinizirajoče bolezni, dogodki povezani z jetri ali žolčnikom, limfom, hepatosplenični limfom celic T (HSTCL), levkemija, karcinom Merklovih celic, melanom, pojav malignomov pri otrocih, sarkoidoza/sarkoidozi podobne reakcije, črevesni ali perianalni absces (pri Crohnovi bolezni) ter resne z infuzijo povezane reakcije (glejte poglavje 4.4).
• Some women being treated for rheumatoid arthritis with infliximab have developed cervical cancer. 
• Pri nekaterih ženskah z revmatoidnim artritisom, ki so se zdravile z infliksimabom, se je pojavil rak materničnega vratu.
• Your blood not supplying enough oxygen to your body, circulation problems such as narrowing of a blood vessel 
• nezadostna oskrba telesa s kisikom preko krvi, motnje pretoka kot na primer zoženje krvnih žil,
In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity. 
Študija razvojne toksičnosti, opravljena na miših z uporabo analognega protitelesa, ki selektivno zavira delovanje mišjega TNFα, ni pokazala znakov toksičnosti za mater, embriotoksičnosti ali teratogenosti.
≥ 75% improvement 
≥ 50 % izboljšanje
Do not dilute the reconstituted Flixabi solution with any other diluent. 
Rekonstituirane raztopine zdravila Flixabi ne redčite z nobeno drugo tekočino.
e HAQ = Health Assessment Questionnaire; greater values indicate less disability. 
e Vprašalnik za oceno zdravstvenega stanja (HAQ): višje vrednosti pomenijo manjšo okvaro funkcije.
Flixabi is not likely to affect your ability to drive or use tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Flixabi verjetno ne vpliva na vašo sposobnost vožnje in upravljanja orodij ali strojev.