FrancophonIA/ELRC3.0 huggingface dataset:
English: START was a randomised, multicentre, double-blind, 3-arm, parallel-group safety study.
Croatian: START je bilo randomizirano, multicentrično, dvostruko slijepo ispitivanje sigurnosti primjene u 3 paralelne skupine bolesnika.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including infliximab in the post-marketing setting.
Croatian: Zloćudne bolesti, neke sa smrtnim ishodom, prijavljene su u djece, adolescenata i mladih odraslih osoba (do 22 godine starosti) koji su liječeni blokatorima TNF-a (liječenje započeto u dobi
English: Pregnancy and breast-feeding, and fertility
Croatian: Trudnoća, dojenje i plodnost
English: The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Croatian: Sigurnost i djelotvornost lijeka pri ponovnoj primjeni nisu ustanovljene, osim kada se davao svakih 8 tjedana (vidjeti dijelove 4.4 i 4.8).
English: Date of Flixabi therapy initiation:
Croatian: Datum početka liječenja lijekom Flixabi: Sadašnji režim primjene lijeka:
English: Peripheral ischaemia, thrombophlebitis, haematoma.
Croatian: periferna ishemija, tromboflebitis, hematom
English: Under aseptic conditions, reconstitute each Flixabi vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Croatian: U aseptičkim uvjetima rekonstituirajte u svakoj bočici otopinu lijeka Flixabi s 10 ml vode za injekcije, koristeći štrcaljku s iglom promjera 21 G (0,8 mm) ili užom.
English: The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
Croatian: Sigurnost i djelotvornost infliksimaba nisu ispitivane u djece mlađe od 6 godina koja boluju od Crohnove bolesti.
English: Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54.
Croatian: Među bolesnicima koji su primali infliksimab i imali reakciju na infuziju u uvodnom razdoblju liječenja do 6. tjedna, njih je 27% imalo reakciju na infuziju i tijekom terapije održavanja od 7. do 54. tjedna.
English: At week 16, 47 placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
Croatian: U 16. je tjednu 47 bolesnika koji su primali placebo i u odnosu na početno stanje imali < 10% poboljšanja s obzirom na broj otečenih i bolnih zglobova prebačeno na uvodnu terapiju infliksimabom (prijevremeno povlačenje, engl. early escape).
English: If you are 65 or older,
Croatian: Taj je rizik veći ako imate 65 ili više godina.
English: In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with infliximab with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Croatian: Nadalje, nakon stavljanja lijeka u promet prijavljeni su slučajevi hepatospleničkog limfoma T-stanica u bolesnika liječenih infliksimabom, s time da se većina slučajeva javila u bolesnika s Crohnovom bolešću i ulceroznim kolitisom i to većinom u adolescenata i mlađih odraslih muškaraca (vidjeti dio 4.4).
English: • Side effect due to an infusion
Croatian: • nuspojava kao posljedica infuzije
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).
Croatian: Infliksimab je kimerično ljudsko-mišje monoklonsko protutijelo koje se vezuje velikim afinitetom za topive i transmembranske oblike faktora nekroze tumora alfa (TNFα), ali ne i za limfotoksin α (TNFβ).
English: Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and a reduction in the frequency of infusion reactions.
Croatian: Istodobna primjena imunomodulatora povezana je s nižom incidencijom protutijela na infliksimab i smanjenom učestalošću reakcija na infuziju.
English: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
Croatian: infekcija donjih dišnih puteva (npr. bronhitis, pneumonija), dispneja, epistaksa
English: Percentage of subjects in clinical response and in sustained clinical response Clinical response at week 8
Croatian: Postotak ispitanika s kliničkim odgovorom i održanim kliničkim odgovorom Klinički odgovor u 8. tjednua
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.
Croatian: U tom je ispitivanju 150 bolesnika s kroničnim zatajenjem srca NYHA stupnja III-IV (ejekcijska frakcija lijeve klijetke ≤ 35%) liječeno s 3 infuzije infliksimaba u dozi od 5 mg/kg odnosno 10 mg/kg ili je primalo placebo tijekom 6 tjedana.
English: 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.
Croatian: U oba je ispitivanja bila dopuštena istodobna primjena ustaljenih doza folatne kiseline, peroralnih kortikosteroida (≤ 10 mg na dan) i/ili nesteroidnih protuupalnih lijekova.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Flixabi.
Croatian: Ako niste sigurni odnosi li se nešto od navedenog na Vas, porazgovarajte sa svojim liječnikom ili ljekarnikom prije nego što primite Flixabi.
English: Ask your doctor to record the type and date of your last screening(s) for TB on the card.
Croatian: Zamolite liječnika da na ovu karticu upiše vrstu i datum zadnjeg testiranja na TBC.
English: In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year.
Croatian: U kliničkim su ispitivanjima reakcije kasne preosjetljivosti bile manje česte i javljale su se nakon što se infliksimab nije primjenjivao u razdoblju kraćem od godinu dana.
English: Available data suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval.
Croatian: Dostupni podaci ukazuju na povećanje rizika od razvoja reakcija kasne preosjetljivosti što je dulje razdoblje u kojemu se infliksimab ne primjenjuje.
English: If these medicines do not work well enough, you will be given Flixabi to:
Croatian: Ako ti lijekovi ne djeluju dovoljno dobro, dobit ćete Flixabi kako bi se:
English: Infliximab Maintenance (5 mg/kg) (n=96)
Croatian: Terapija održavanja infliksimabom (5 mg/kg) (n = 96)
English:  adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Croatian: • odraslih bolesnika s teškom, aktivnom i progresivnom bolešću, koji se prethodno nisu liječili metotreksatom ili drugim antireumatskim lijekovima koji modificiraju tijek bolesti.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Flixabi cannot be excluded (see section 4.8).
Croatian: Ne može se isključiti rizik od razvoja hepatospleničkog limfoma T-stanica u bolesnika koji se liječe lijekom Flixabi (vidjeti dio 4.8).
English: In the second clinical study (ASSERT), 279 patients were randomised to receive either placebo (Group 1, n=78) or 5 mg/kg infliximab (Group 2, n=201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
Croatian: U drugom kliničkom ispitivanju (ASSERT), 279 bolesnika randomizirano je u skupinu koja je primala placebo (skupina 1, n = 78) ili u skupinu koja je primala infliksimab u dozi od 5 mg/kg (skupina 2, n = 201) u 0., 2. i 6. tjednu, a zatim svakih 6 tjedana do ukupno 24 tjedna.
English: Week 50
Croatian: 50. tjedan
English: Maintenance treatment in moderately to severely active Crohn's disease in adults The efficacy of repeated infusions with infliximab was studied in a 1-year clinical study (ACCENT I).
Croatian: Terapija održavanja u umjerenoj do teškoj aktivnoj Crohnovoj bolesti u odraslih bolesnika Djelotvornost ponovljenih infuzija infliksimaba ispitivala se u jednogodišnjem kliničkom ispitivanju (ACCENT I).
English: Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab is not established, the risk and benefits of continued therapy to the individual patients should be carefully considered by the clinician.
Croatian: Budući da u bolesnika s novodijagnosticiranom displazijom koji su liječeni infliksimabom nije utvrđena mogućnost povećanog rizika od razvoja raka, kliničar treba pažljivo razmotriti rizik i koristi nastavka liječenja za svakog bolesnika.
English: • Tell your doctor before you are given Flixabi if you are a carrier of hepatitis B or have ever had it.
Croatian: • Prije nego počnete primati Flixabi, obavijestite svog liječnika ako ste nositelj virusa hepatitisa B ili ste ikad imali hepatitis B.
English: • Some patients receiving infliximab have developed serious liver problems.
Croatian: • U nekih bolesnika koji primaju infliksimab razvile su se ozbiljne jetrene tegobe.
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.
Croatian: U skupini u kojoj su bili bolesnici koji nisu odgovorili na liječenje na odgovarajući način (skupina 2, n = 329) bilo je dozvoljeno postupno povećavati dozu sa 3 mg/kg na najviše 9 mg/kg u koracima od 1,5 mg/kg.
English: In all situations described below, the benefit/risk balance of Flixabi therapy should be very carefully considered.
Croatian: U svim situacijama opisanima u daljnjem tekstu potrebno je vrlo pažljivo odvagnuti omjer rizika i koristi liječenja lijekom Flixabi.
English: In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%.
Croatian: U jednogodišnjem kliničkom ispitivanju u kojemu se ispitivalo ponovljeno davanje infuzije bolesnicima s Crohnovom bolešću (ispitivanje ACCENT I), incidencija reakcija nalik serumskoj bolesti iznosila je
English: • 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
Croatian: • drugi problemi s kožom kao što su multiformni eritem, lihenoidne reakcije (crveno-ljubičasti kožni osip sa svrbežom i/ili bijelo-sive crte slične nitima na sluznici), mjehurići na koži i ljuštenje kože ili gnojni čirevi (furunkuloza)
English: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Flixabi with other agents.
Croatian: Nisu provedena ispitivanja fizikalno-biokemijske kompatibilnosti istodobne primjene lijeka Flixabi s drugim lijekovima.
English: The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Croatian: Sigurnost i djelotvornost infliksimaba ispitivane su u dva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja (ACT 1 i ACT 2) u odraslih bolesnika s umjerenim do teškim aktivnim ulceroznim kolitisom (Mayo bodovi 6 do 12; endoskopski ≥ 2), koji nisu odgovorili na konvencionalno liječenje na odgovarajući način [peroralne kortikosteroide, aminosalicilate i/ili imunomodulatore (6-MP, AZA)].
English: Flixabi contains the active substance infliximab.
Croatian: Flixabi sadrži djelatnu tvar infliksimab.
English: Ankylosing spondylitis Psoriatic arthritis Plaque psoriasis
Croatian: Ankilozantni spondilitis Psorijatični artritis
English: Table 5 Effects on response and remission rate, data from ACCENT I (week-2 responders)
Croatian: Učinci na stope odgovora i remisije, podaci iz ispitivanja ACCENT I (bolesnici s odgovorom u 2. tjednu)
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.
Croatian: • Prije nego počnete primati Flixabi, obavijestite liječnika ako bolujete ili ste bolovali od limfoma (vrsta raka krvi) ili neke druge vrste raka.
English: c a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Croatian: Prosječna vrijednost ± SDc a Kontrolna skupina = svi su bolesnici imali aktivni reumatoidni artritis usprkos liječenju ustaljenim dozama metotreksata tijekom 6 mjeseci prije uključenja u ispitivanje i trebali su nastaviti s uzimanjem istih doza tijekom čitavog ispitivanja.
English: Side effects may also occur after your treatment with Flixabi has stopped.
Croatian: Nuspojave se mogu pojaviti i nakon prestanka liječenja lijekom Flixabi.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind studies: SPIRIT and EXPRESS.
Croatian: Djelotvornost infliksimaba ispitivana je u dva multicentrična, randomizirana, dvostruko slijepa, klinička ispitivanja: SPIRIT i EXPRESS.
English: Patients treated with Flixabi should be given the patient reminder card.
Croatian: Bolesnici koji se liječe lijekom Flixabi moraju dobiti karticu s podsjetnikom za bolesnika.
English: Infections • Tell your doctor before you are given Flixabi if you have an infection even if it is a very minor one.
Croatian: • Prije nego što primite Flixabi, obavijestite svog liječnika ako imate neku infekciju, čak i ako je vrlo blaga.
English: All infliximab b
Croatian: Ukupno infliksimab b
English: Flixabi and Kineret should not be used together.
Croatian: Flixabi i Kineret ne smiju se istodobno uzimati.
English: Endophthalmitis.
Croatian: endoftalmitis
English: If you are given too much Flixabi
Croatian: Ako primite previše lijeka Flixabi
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
Croatian: Primarna mjera ishoda bila je udio bolesnika koji su pokazali klinički odgovor, definiran kao ≥ 50%-tno smanjenje početnog broja fistula koje su se cijedile na lagani pritisak u najmanje dva uzastopna dolaska (u razmaku od 4 tjedna), bez povećanja doze lijekova za Crohnovu bolest ili kirurškog liječenja Crohnove bolesti.
English: Infliximab Maintenance 5 mg/kg (n=113) (p value)
Croatian: Terapija održavanja infliksimabom 5 mg/kg (n = 113) (p-vrijednost)
English: The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years.
Croatian: Sigurnost i djelotvornost infliksimaba nisu ispitivane u djece mlađe od 6 godina koja boluju od ulceroznog kolitisa.
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.
Croatian: Zbog prirode nuspojava primijećenih kod istodobne primjene etanercepta i anakinre, slična toksičnost mogla bi se javiti i kod istodobne primjene anakinre i nekog drugog inhibitora TNFα.
English: Infliximab + AZA Combination therapy
Croatian: Kombinirana terapija infliksimab + AZA
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established.
Croatian: Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog reumatoidnog artritisa nisu ustanovljene.
English: There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab.
Croatian: Nakon stavljanja lijeka u promet bilo je prijava pogoršanja zatajenja srca u bolesnika s ili bez utvrđenih precipitirajućih čimbenika koji su primali infliksimab.
English: In psoriatic arthritis, short term treatment with infliximab reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Croatian: U bolesnika s psorijatičnim artritisom kratkotrajno liječenje infliksimabom smanjilo je broj T-stanica i krvnih žila u sinovijalnoj membrani i koži zahvaćenoj psorijazom.
English: • More children taking Flixabi developed infections as compared to adults.
Croatian: • u djece koja su primala Flixabi infekcije su se javljale češće nego u odraslih
English: All patients received methotrexate (optimised to 20 mg/wk by week 8) and either placebo, 3 mg/kg or 6 mg/kg infliximab at weeks 0, 2, and 6 and every 8 weeks thereafter.
Croatian: Svi su bolesnici primili metotreksat (doza optimizirana na 20 mg tjedno do 8. tjedna) te ili placebo ili 3 mg/kg odnosno 6 mg/kg infliksimaba u 0., 2. i 6. tjednu ispitivanja, a zatim svakih 8 tjedana.
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.
Croatian: Nakon 38 tjedana umrlo je 9 od 101 bolesnika liječenog infliksimabom (dva koja su primala dozu od 5 mg/kg i sedmero koji su primali dozu od 10 mg/kg), dok je među 49 bolesnika koji su primali placebo zabilježen samo jedan smrtni slučaj.
English: Carriers of HBV who require treatment with Flixabi should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Croatian: Nositelje virusa hepatitisa B koji se moraju liječiti lijekom Flixabi treba pažljivo nadzirati za vrijeme i nekoliko mjeseci nakon završetka liječenja kako bi se uočili mogući znakovi i simptomi aktivne HBV infekcije.
English: • Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet.
Croatian: • Znakove srčanih problema kao što su nelagoda ili bol u prsnom košu, bol u ruci, bol u trbuhu, nedostatak zraka, tjeskoba, ošamućenost, omaglica, nesvjestica, znojenje, mučnina, povraćanje, podrhtavanje ili lupanje u prsnom košu, ubrzani ili usporeni otkucaji srca i/ili oticanje stopala.
English: Infliximab Maintenance 10 mg/kg (n=112) (p value)
Croatian: Terapija održavanja infliksimabom 10 mg/kg (n = 112) (p-vrijednost)
English: The following side effects have been observed with infliximab:
Croatian: Kod primjene infliksimaba opažene su sljedeće nuspojave:
English: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Croatian: edem pluća, bronhospazam, pleuritis, pleuralni izljev
English: It is recommended that therapeutic infectious agents not be given concurrently with Flixabi (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena terapijskih infektivnih agensa istodobno s lijekom Flixabi (vidjeti dio 4.4).
English: Abdominal pain, nausea.
Croatian: bol u abdomenu, mučnina
English: Hypotension, hypertension, ecchymosis, hot flush, flushing.
Croatian: hipotenzija, hipertenzija, ekhimoza, navala vrućine, navale crvenila
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.
Croatian: U kliničkim ispitivanjima opažen je blagi do umjereni porast vrijednosti ALT-a i AST-a u bolesnika koji su primali infliksimab, ali nije došlo do razvoja teškog oštećenja jetre.
English: Overall, a higher proportion of patients receiving infliximab monotherapy experienced an infusion-related reaction compared to patients receiving infliximab with concomitant immunomodulators.
Croatian: Sveukupno je reakciju povezanu s infuzijom imao veći udio bolesnika koji su primali infliksimab kao monoterapiju u odnosu na bolesnike koji su primali infliksimab istodobno s imunomodulatorima.
English: • Slow down the damage in your joints,
Croatian: • usporilo oštećenje zglobova
English: • Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly and flaky skin
Croatian: • problemi s kožom kao što su mjehurići, bradavice, neprirodna boja kože ili pigmentacija, oticanje usana, zadebljanje kože ili crvena, ljuskava i perutava koža
English: It is recommended that therapeutic infectious agents not be given concurrently with Flixabi.
Croatian: Ne preporučuje se primjenjivati terapijske infektivne agense istodobno s lijekom Flixabi.
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Croatian: Udio bolesnika koji su mogli prestati uzimati kortikosteroide i pritom ostati u kliničkoj remisiji bio je veći u zbirnoj skupini bolesnika liječenih infliksimabom u odnosu na skupinu koja je primala placebo, kako u 30. tjednu (22,3% naspram 7,2%, p < 0,001, zbirni podaci iz ispitivanja ACT 1 i ACT 2) tako i u 54. tjednu (21,0% naspram 8,9%, p = 0,022, podaci iz ispitivanja ACT 1).
English: 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.
Croatian: Provedeno je kliničko ispitivanje bolesnika s umjerenom do teškom psorijazom kako bi se ocijenile djelotvornost i sigurnost dugotrajne terapije održavanja u odnosu na ponovno davanje uvodnog režima liječenja infliksimabom (najviše četiri infuzije u 0., 2., 6. i 14. tjednu) nakon ponovnog izbijanja bolesti.
English: Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20, respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Croatian: Bolesnici su kao uvodnu terapiju primili 3 doze infliksimaba u dozi od 3 mg/kg (u 0., 2. i 6. tjednu) ili 6 mg/kg (u 14., 16. i 20. tjednu), a nakon toga se provodila terapija održavanja svakih 8 tjedana, u kombinaciji s metotreksatom.
English: The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p < 0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Croatian: Udio bolesnika kojima je sluznica zacijelila u 26. tjednu bio je značajno veći u skupini koja je primala infliksimab + AZA (43,9%, p < 0,001) i skupini koja je primala monoterapiju infliksimabom (30,1%, p = 0,023) nego u skupini koja je primala monoterapiju AZA (16,5%).
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Flixabi.
Croatian: Razrjeđivanje se može provesti tako da se iz 250-mililitarske staklene boce ili vrećice za infuziju s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju izvuče volumen jednak volumenu rekonstituirane otopine lijeka Flixabi.