FrancophonIA/ELRC3.0 huggingface dataset:
English: Histological evaluation of colonic biopsies, obtained before and 4 weeks after administration of infliximab, revealed a substantial reduction in detectable TNFα.
Slovenian: Histološka preiskava biopsijskih vzorcev kolona, odvzetih pred uporabo infliksimaba in 4 tedne po njej, je pokazala znatno zmanjšanje merljivega TNFα.
English: Limited experience from re-treatment with one single infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Slovenian: Omejene izkušnje s ponovnim zdravljenjem z enim samim odmerkom infliksimaba pri psoriazi po časovnem presledku 20 tednov kažejo zmanjšano učinkovitost in večjo incidenco blagih do zmernih z infuzijo povezanih reakcij v primerjavi s prvotnim uvodnim režimom zdravljenja (glejte poglavje 5.1).
English: Children may receive some vaccines during treatment with Flixabi but should not receive live vaccines while using Flixabi.
Slovenian: Otroci lahko med zdravljenjem z zdravilom Flixabi prejmejo nekatera cepiva, vendar med uporabo zdravila Flixabi ne smejo prejeti živih cepiv.
English: • Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding
Slovenian: • možni znaki raka, vključno z, vendar ne omejeno na otekanje bezgavk, izgubo telesne mase, zvišano telesno temperaturo, nenavadnimi kožnimi vozliči, spremembami znamenj ali barve kože, ali nenavadne vaginalne krvavitve;
English: 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Slovenian: 1 Bolniki iz skupine s placebom so prejemali metotreksat, medtem ko so bolniki iz skupine z infliksimabom prejemali tako infliksimab kot metotreksat.
English: (furunculosis)
Slovenian: (plevritis),
English: The safety and efficacy of readministration after an infliximab-free interval of more than 16 weeks has not been established.
Slovenian: Varnost in učinkovitost ponovne uporabe zdravila Flixabi po premoru brez infliksimaba, daljšem od 16 tednov, še nista bili dokazani.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Flixabi treatment.
Slovenian: • Bolniki s KOPB in tisti, ki veliko kadijo, imajo lahko povečano tveganje za nastanek raka pri zdravljenju z zdravilom Flixabi.
English: • Abnormal tissue swelling or growth
Slovenian: • nenormalno otekanje ali rast tkiva,
English: Calculate the total volume of reconstituted Flixabi solution required.
Slovenian: Izračunajte celoten volumen potrebne rekonstituirane raztopine zdravila Flixabi.
English: Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Slovenian: Analiza populacijske farmakokinetike na podlagi podatkov, pridobljenih pri bolnikih z ulceroznim kolitisom (n = 60), Crohnovo boleznijo (N = 112), juvenilnim revmatoidnim artritisom (N = 117) in boleznijo Kawasaki (N = 16) v starostni skupini od 2 mesecev do 17 let, je pokazala, da je izpostavljenost infliksimabu nelinearno odvisna od telesne mase.
English: Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440).
Slovenian: Strukturne okvare sklepov (erozije in zožitev sklepne špranje) tako na rokah kot na stopalih so merili na podlagi spremembe skupnega rezultata po metodi van der Heijde, modificirani po Sharpu (0-440) glede na začetne vrednosti.
English: Due to its inhibition of TNFα, infliximab administered during pregnancy could affect normal immune responses in the newborn.
Slovenian: Ker infliksimab zavira TNFα, lahko pri uporabi v času nosečnosti vpliva na normalni imunski odziv novorojenčka.
English: • Infection of the skin due to a fungus
Slovenian: • okužba kože zaradi glivic,
English: Ask your doctor to record the type and date of last screening(s) for TB below:
Slovenian: Naročite zdravniku, naj zabeleži tip in datum zadnjega presejalnega(ih) testa(ov) za TBC: Test:
English: This patient reminder card contains important safety information that you need to be aware of before and during treatment with Flixabi.
Slovenian: Ta opozorilna kartica za bolnika vsebuje pomembne varnostne informacije, ki jih morate poznati, preden prejmete zdravilo Flixabi ter med zdravljenjem z njim.
English: • Viral infections such as herpes or flu
Slovenian: • virusne okužbe, na primer herpes ali gripa,
English: In Crohn's disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Slovenian: Pri Crohnovi bolezni je malo izkušenj s ponovno uporabo zdravila po ponovitvi znakov in simptomov bolezni, primerjalnih podatkov o razmerju med koristmi in tveganji drugih možnosti nadaljnjega zdravljenja pa ni.
English: • In case you have received Flixabi while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Slovenian: • Če ste med nosečnostjo prejeli zdravilo Flixabi, je pomembno, da o tem obvestite zdravnika vašega dojenčka, preden dojenček prejme katero koli cepivo.
English: • Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
Slovenian: • vneta jetra zaradi težav z imunskim sistemom (avtoimunski hepatitis),
English: Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving infliximab than in controls, both when infliximab was given as monotherapy and when it was used in combination with other immunosuppressive agents.
Slovenian: Zvišanje aminotransferaz (ALT pogosteje kot AST) so opažali pri večjem deležu bolnikov, ki so prejemali infliksimab, kot v kontrolni skupini, in sicer tako med dajanjem infliksimaba v monoterapiji kot pri njegovi uporabi v kombinaciji z drugimi imunosupresivnimi sredstvi.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C to 8°C for 24 hours.
Slovenian: Vendar, če je bila raztopina pripravljena v aseptičnih pogojih, jo lahko za 24 ur shranite v hladilniku pri temperaturi 2 °C do 8 °C.
English: • The doctor will decide your dose and how often you will be given Flixabi.
Slovenian: • Zdravnik bo določil odmerek zdravila Flixabi, ki ga boste prejemali, in kako pogosto ga boste prejemali.
English: • If you get any side effects, talk to your doctor.
Slovenian: • Če opazite kateri koli neželeni učinek, se morate posvetovati z zdravnikom.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind studies: SPIRIT and EXPRESS.
Slovenian: Učinkovitost infliksimaba so ocenjevali v dveh multicentričnih, randomiziranih, dvojno slepih študijah: SPIRIT in EXPRESS.
English: Patients who were randomised to the placebo maintenance group and then later crossed over to infliximab are included in the infliximab group in the ALT analysis.
Slovenian: Bolniki, ki so jih naključno razporedili v skupino za vzdrževalno zdravljenje s placebom in so potem prešli v skupino za zdravljenje z infliksimabom, so bili pri analizi ALT vključeni v skupino z infliksimabom.
English: At 38 weeks, 9 of 101 patients treated with infliximab (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
Slovenian: Po 38 tednih je umrlo 9 od 101 bolnikov, zdravljenih z infliksimabom (2 z odmerkom 5 mg/kg in 7 z odmerkom 10 mg/kg), v primerjavi z eno smrtjo pri 49 bolnikih, ki so prejemali placebo.
English: Ask your doctor to record the type and date of your last screening(s) for TB on the card.
Slovenian: Naročite zdravniku, naj zabeleži tip in datum zadnjega presejalnega testa(ov) za TBC na opozorilno kartico.
English: Use of TNF-blocking agents, including infliximab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.
Slovenian: Uporaba zaviralcev TNF, vključno z infliksimabom, je bila povezana s primeri novega pojava oz. poslabšanja kliničnih simptomov in/ali z rentgenskimi znaki demielinizirajoče bolezni osrednjega živčevja, vključno z multiplo sklerozo, in demielinizirajoče bolezni perifernega živčevja, vključno z Guillain-Barréjevim sindromom.
English: Patients who develop a new infection while undergoing treatment with Flixabi, should be monitored closely and undergo a complete diagnostic evaluation.
Slovenian: Tiste bolnike, pri katerih se med zdravljenjem z zdravilom Flixabi pojavi nova okužba, je treba natančno spremljati in pri njih opraviti celotni diagnostični postopek.
English: Use of anti-tuberculosis therapy should also be considered before the initiation of Flixabi in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Slovenian: O potrebi po predhodnem zdravljenju tuberkuloze premislite tudi, preden boste uvedli zdravilo Flixabi pri bolniku, ki ima latentno ali aktivno tuberkulozo v pretekli anamnezi in pri katerem ni mogoče zagotovo potrditi, da je prejel zadostno zdravljenje.
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Flixabi (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Slovenian: Skrajšane infuzije pri indikacijah za odrasle bolnike Pri skrbno izbranih odraslih bolnikih, ki so dobro prenesli vsaj 3 začetne 2-urne infuzije zdravila Flixabi (uvajalna faza zdravljenja) in so trenutno na vzdrževalnem zdravljenju, lahko razmislite o skrajšanju naslednjih infuzij, vendar ne na manj kot 1 uro.
English: Flixabi contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo Flixabi vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni “brez natrija”.
English: • Do not use this medicine if it is discoloured or if there are particles present.
Slovenian: • Ne uporabljajte tega zdravila, če opazite, da je raztopina spremenila barvo ali da vsebuje delce.
English: • Upper respiratory infections such as sinusitis
Slovenian: • okužbe zgornjih dihal, na primer sinusitis,
English: • If you received Flixabi during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: • Če ste v času nosečnosti prejemali zdravilo Flixabi, ima vaš dojenček lahko povečano tveganje za okužbe.
English: Before starting treatment with Flixabi, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Slovenian: Pred začetkom zdravljenja z zdravilom Flixabi morate vse bolnike pregledati in preiskati, da ugotovite morebitno aktivno ali neaktivno (latentno) tuberkulozo.
English: • You are allergic (hypersensitive) to proteins that come from mice.
Slovenian: • če ste alergični (preobčutljivi) na mišje proteine,
English: In clinical studies, mild or moderate elevations of ALT and AST have been observed in patients receiving infliximab without progression to severe hepatic injury.
Slovenian: V kliničnih preskušanjih so opažali blago ali zmerno zvišanje vrednosti ALT in AST pri bolnikih, ki so prejemali infliksimab, brez napredovanja motnje do hude jetrne poškodbe.
English: 2 Placebo patients in the 2 Phase III studies in Crohn's disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Slovenian: 2 V dveh preskušanjih tretje faze pri Crohnovi bolezni, ACCENT I in ACCENT II, so bolniki iz placebo skupine na začetku obeh študij prejeli začetni odmerek infliksimaba 5 mg/kg, v fazi vzdrževalnega zdravljenja pa so prejemali placebo.
English: • Swelling of small blood vessels (vasculitis)
Slovenian: • otekanje majhnih krvnih žil (vaskulitis),
English: • Fast heart beat (tachycardia) or palpitations
Slovenian: • hitro bitje srca (tahikardija) ali razbijanje (palpitacije),
English: After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
Slovenian: Po zdravljenju z infliksimabom se je pri bolnikih zmanjšala serumska koncentracija interlevkina 6 (IL-6) in C-reaktivnega proteina (CRP) in zvišal nivo hemoglobina pri bolnikih z revmatoidnim artritisom, ki imajo ta nivo sicer znižan, v primerjavi z izhodiščno vrednostjo.
English: Cases of tuberculosis, sometimes fatal, including miliary tuberculosis and tuberculosis with extrapulmonary location have been reported (see section 4.4).
Slovenian: Poročali so tudi o primerih tuberkuloze, včasih celo s smrtnim izidom, vključno z miliarno tuberkulozo in tuberkulozo izven pljuč (glejte poglavje 4.4).
English: In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year (see sections 4.4 and 4.8).
Slovenian: V kliničnih študijah so bile pozne preobčutljivostne reakcije občasne in so se pojavile po premoru brez prejemanja infliksimaba manj kot 1 leto (glejte poglavji 4.4 in 4.8).
English: • Tuberculosis
Slovenian: • tuberkuloza,
English: • Blood problems such as anaemia or low white blood cell count
Slovenian: • težave s krvjo kot na primer anemija ali nizko število belih krvnih celic,
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of Flixabi treatment should be carefully considered before initiation of Flixabi therapy.
Slovenian: Pri bolnikih, ki so živeli ali potovali v kraje, kjer so endemične invazivne glivične okužbe, kot so histoplazmoza, kokcidioidomikoza ali blastomikoza, je treba pred uvedbo zdravila Flixabi skrbno pretehtati koristi in tveganja zdravljenja z zdravilom Flixabi.
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Flixabi.
Slovenian: • Če zdravnik sumi, da je možno, da imate tuberkulozo, vas bo lahko zdravil z zdravili za tuberkulozo, preden boste začeli zdravljenje z zdravilom Flixabi.
English: Your doctor may recommend temporarily stopping Flixabi.
Slovenian: Zdravnik bo morda priporočil začasno prekinitev zdravljenja z zdravilom Flixabi.
English: Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: • Circulation problems such as low or high blood pressure
Slovenian: • težave s krvnim obtokom, na primer nizek ali visok krvni tlak,
English: • 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.
Slovenian: • Preden prejmete zdravilo Flixabi, povejte zdravniku, če imate ali ste imeli kdaj v preteklosti limfom (vrsta krvnega raka) oziroma katero koli drugo vrsto raka.
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/mL, respectively.
Slovenian: Po enkratnem odmerku 3, 5 ali 10 mg/kg so bile mediane vrednosti Cmax 77, 118 in
English: PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2) All nails cleared c
Slovenian: PGA brez plakov (0) ali minimalni (1) PGA brez plakov (0), minimalni (1), ali blagi (2) Vsi nohti brez psoriatičnih sprememb c
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Slovenian: anafilaktična reakcija, lupusu podoben sindrom, serumska bolezen ali reakcija, podobna serumski bolezni redki:
English: • Children should receive recommended vaccinations before starting Flixabi treatment.
Slovenian: • Otroci morajo prejeti priporočena cepljenja, preden se začnejo zdraviti z zdravilom Flixabi.
English: 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).
Slovenian: 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).
English: While using Flixabi you should not receive live vaccines.
Slovenian: Med uporabo zdravila Flixabi ne smete prejeti živih cepiv.
English: • A type of blood cancer (lymphoma)
Slovenian: • vrsta krvnega raka (limfom),
English: 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.
Slovenian: 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.
English: • Pain.
Slovenian: • bolečine.
English: Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura.
Slovenian: agranulocitoza (vključno pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu), trombotična trombocitopenična purpura, pancitopenija, hemolitična anemija, idiopatska trombocitopenična purpura
English: • You will be monitored while you are given Flixabi and also for 1 to 2 hours afterwards.
Slovenian: • Med prejemanjem zdravila Flixabi in še eno do dve uri po tem vas bodo spremljali.
English: • Reactions at the injection site such as pain, swelling, redness or itching
Slovenian: • reakcije na mestu injiciranja, na primer bolečina, otekanje, pordelost ali srbenje,
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebotreated patients (p=0.001).
Slovenian: Dodatno so pri 55 % bolnikov zdravljenih z infliksimabom dosegli zapiranje vseh fistul, v primerjavi s 13 % bolnikov, ki so prejemali placebo (p = 0,001).
English: • Convulsions, nerve problems
Slovenian: • epileptični krči, težave z živčevjem,
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: • Small red or purple spots caused by bleeding under the skin
Slovenian: • majhne rdeče ali vijolične pike zaradi podkožnih krvavitev,
English: Week 30
Slovenian: 30. teden
English: Clinical response at week 8 was similar between those with or without concomitant immunomodulator use at baseline.
Slovenian: Klinični odziv 8. teden je bil podoben med bolniki, ki so na začetku prejemali sočasno imunomodulator, in med tistimi, ki ga niso.
English: Placebo → Infliximab 5 mg/kg (at week 24)
Slovenian: placebo → infliksimab 5 mg/kg (24 teden)
English: 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).
Slovenian: 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).
English: Flixabi is produced in packs of 1, 2, 3, 4, or 5 vial(s).
Slovenian: Zdravilo Flixabi je na voljo v pakiranjih s po 1, 2, 3, 4 ali 5 vial.
English: • Inflammation of the lining of the brain (meningitis)
Slovenian: • vnetje možganskih ovojnic (meningitis),
English: 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:
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste prejeli zdravilo Flixabi skupaj z zdravilom, imenovanim metotreksat, za:
English: 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.
Slovenian: Ker raztopina za infundiranje ne vsebuje konzervansa, priporočamo, da z dajanjem infuzije začnete čim prej, v roku 3 ur po rekonstituciji in redčenju.
English: Flixabi should be administered intravenously over a 2-hour period.
Slovenian: Zdravilo Flixabi je treba dajati intravensko v času 2 ur.