FrancophonIA/ELRC3.0 huggingface dataset:
English: It was observed that the frequency and severity of adverse reactions, in particular infection, myelosuppression (neutropenia) and hepatotoxicity, are increased when clofarabine is used in combination.
Danish: Det blev observeret, at frekvensen og bivirkningernes sværhedsgrad, især infektion, knoglemarvssuppression (neutropeni) og hepatotoksicitet, er øget, når clofarabin anvendes i kombinationsbehandling.
English: A total of 83% of patients experienced at least 1 infection after clofarabine treatment, including fungal, viral and bacterial infections (see section 4.4).
Danish: I alt 83 % af patienterne fik mindst 1 infektion efter behandling med clofarabin, herunder svampe-, virusog bakterieinfektioner (se pkt.
English: In addition, clofarabine possesses greater resistance to cellular degradation by adenosine deaminase and decreased susceptibility to phosphorolytic cleavage than other active substances in its class whilst the affinity of clofarabine triphosphate for DNA polymerase  and ribonucleotide reductase is similar to or greater than that of deoxyadenosine triphosphate.
Danish: Endvidere besidder clofarabin større modstandsevne over for cellulær nedbrydning af adenosindeaminase og mindre modtagelighed for phosphorolytisk spaltning end andre aktive stoffer i denne klasse, mens clofarabintriphosphats affinitet til DNA-polymerase α and ribonukleotidreduktase svarer til eller overstiger affiniteten til deoxyadenosintriphosphat.
English: The incidence of these toxicities was dependent on both the dose of clofarabine administered and the duration of treatment.
Danish: Incidencen af disse toksiciteter afhang af såvel den indgivne dosis clofarabin som behandlingsvarighed.
English: Dilute before use.
Danish: Skal fortyndes før brug.
English: Intravenous infusion of 52 mg/m clofarabine produced equivalent exposure across a wide range of weights.
Danish: Intravenøs infusion af clofarabin 52 mg/m2 gav samme eksponering inden for et stort vægtområde.
English: Your treatment with Evoltra has been prescribed by a qualified doctor experienced in treating leukaemia.
Danish: Behandling med Evoltra er ordineret til dig af en speciallæge med erfaring i behandling af leukæmi.
English: The MAH shall provide yearly updates on any new information concerning efficacy and safety of the product in paediatric patients with acute lymphoblastic leukaemia who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
Danish: MAH skal give årlige opdateringer om enhver ny information om produktets effekt og sikkerhed i pædiatriske patienter med akut lymphoblastisk leukæmi, der har tilbagefald eller er resistente efter at have modtaget mindst to tidligere regimer, og hvor der ikke er nogen anden behandlingsmulighed, der forventes at resultere i et varigt respons.
English: Plasma protein binding Serum albumin Elimination:  half-life of clofarabine
Danish: Plasmaproteinbinding Serum-albumin Elimination:
English: What Evoltra is and what it is used for What you need to know before you use Evoltra How to use Evoltra
Danish: Virkning og anvendelse Det skal du vide, før du begynder at få Evoltra Sådan får du Evoltra
English: Patients with ALL must not have been eligible for therapy of higher curative potential and must have been in second or subsequent relapse and/or refractory i.e. failed to achieve remission after at least two prior regimens.
Danish: Patienter med ALL måtte ikke være egnet til behandling med et større kurativt potentiale og skulle være nået til andet eller senere recidiv og/eller være refraktære, d.v.s. de havde ikke opnået remission efter mindst de sidste to regimer.
English: Evoltra is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
Danish: Evoltra er et potent antineoplastisk middel, som kan have betydelige hæmatologiske og ikkehæmatologiske bivirkninger (se pkt.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLGE OMSTÆNDIGHEDER
English: Patients who underwent transplant after alternative therapy or relapse*
Danish: Patienter, der gennemgik transplantation efter alternativ behandling eller recidiv*
English: The safety and efficacy of clofarabine were evaluated in a phase I, open-label, non-comparative, dose-escalation study in 25 paediatric patients with relapsed or refractory leukaemia (17 ALL; 8 AML) who had failed standard therapy or for whom no other therapy existed.
Danish: Clofarabins sikkerhed og effekt blev evalueret i et fase I, åbent, non-komparativt dosiseskaleringsstudie med 25 pædiatriske patienter med recidiverende eller refraktær leukæmi (17 ALL, 8 AML), som ikke havde opnået bedring med standardbehandling, eller som ikke kunne få anden behandling.
English: Type I glass vial with bromobutyl rubber stopper, polypropylene flip-off cap and aluminium overseal.
Danish: Hætteglas af type I-glas med brombutyl gummiprop, flip-off plombering af polypropylen og aluminiumsforsegling.
English: Other medicines and Evoltra
Danish: Brug af anden medicin sammen med Evoltra
English: In addition, clofarabine is unlikely to inhibit any of the major 5 human CYP isoforms (1A2, 2C9, 2C19, 2D6 and 3A4) or to induce 2 of these isoforms (1A2 and 3A4) at the plasma concentrations achieved following intravenous infusion of 52 mg/m2/day.
Danish: CYP-isoformer (1A2, 2C9, 2C19, 2D6 og 3A4) eller inducere 2 af disse isoformer (1A2 og 3A4) ved de plasma-koncentrationer, der opnås efter en intravenøs infusion af 52 mg/m2/dag.
English: The patients were enrolled into a single phase I (n = 12) or two phase II (n = 14 / n = 14) safety and efficacy studies, and received multiple doses of clofarabine by intravenous infusion (see section 5.1).
Danish: Disse patienter indgik i en enkelt fase I-undersøgelse (n = 12) eller to fase IIundersøgelser (n = 14 / n = 14) af sikkerhed og effekt, hvor de fik gentagne doser clofarabin som intravenøs infusion (se pkt.
English: The no-observable effect level for maternal toxicity in rats was 18 mg/m 2/day and in rabbits was more than
Danish: Det ikke-observerbare effektniveau for maternel toksicitet hos rotter var 18 mg/m2/dag, mens det hos kaniner var over 12 mg/m2/dag.
English: Tell your doctor if any of these apply to you.
Danish: Fortæl din læge, hvis et af disse punkter passer på dig.
English: Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide
Danish: Patienter, der tidligere har fået et hæmatopoietisk stamcelletransplantat (HSCT), kan have øget risiko for hepatotoksicitet, der tyder på veneokklusion (VOD), efter behandling med clofarabin (40 mg/m2), når det anvendes sammen med etoposid (100 mg/m2) og cyclophosphamid (440 mg/m2).
English: The liver is a potential target organ for clofarabine toxicity and 25.2% of patients experienced at least one hepato-biliary disorders adverse event (see sections 4.3 and 4.4).
Danish: Leveren er et potentielt organ for clofarabintoksicitet, og 25,2 % af patienterne oplevede mindst ét tilfælde af bivirkninger fra lever- og galdeveje (se pkt.
English: However, for patients with a body surface area > 0.38 m2, the contents of between 1 to 7 vials will be required to produce the recommended daily dosage of clofarabine.
Danish: Til en patient med legemsoverflade > 0,38 m2 vil der imidlertid være behov for at anvende indholdet fra 1-7 hætteglas til at fremstille den anbefalede døgndosis clofarabin.
English: Fifty percent of patients experienced at least one cardiac disorders adverse event.
Danish: 50 % af patienterne fik mindst én bivirkning tilhørende hjerte organklassen.
English: These effects included bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells in rats at exaggerated exposure levels (150 mg/m2/day), and cell degeneration of the epididymis and degeneration of the seminiferous epithelium in dogs at clinically relevant exposure levels (> 7.5 mg/m2/day clofarabine).
Danish: Disse virkninger omfattede bilateral degeneration af epitel i tubuli seminiferi med retention af spermatider og atrofi af interstitielle celler hos rotter ved meget høje eksponeringsniveauer af clofarabin (150 mg/m2/dag), og celledegeneration i epididymis samt degeneration af epitel i tubuli seminiferi hos hunde ved klinisk relevant eksponeringsniveauer (> 7,5 mg/m2/dag).
English: • Complete disappearance of circulating blasts
Danish: • Blaster fuldstændig forsvundet fra kredsløb
English: (59%), febrile neutropaenia (35%), headache (24%), rash (21%), diarrhoea (20%), pruritus (20%), pyrexia (19%), palmar-plantar erythrodysaesthesia syndrome (15%), fatigue (14%), anxiety (12%), mucosal inflammation (11%), and flushing (11%).
Danish: De hyppigst rapporterede bivirkninger var kvalme (61 % af patienterne), opkastning (59 %), febril neutropeni (35 %), hovedpine (24 %), udslæt (21 %), diarre (20 %), pruritus (20 %), pyreksi (19 %), palmar-plantar erytrodysæstesi-syndrom (15 %), træthed (14 %), angst (12 %), slimhindeinflammation (11 %) og flushing (11 %).
English: Common: Hyperbilirubinaemia, jaundice, venoocclusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
Danish: Almindelig: Hyperbilirubinæmi, gulsot, veneokklusion, stigninger i alanin- (ALAT)* og aspartat- (ASAT)* aminotransferaser, leversvigt Ikke almindelig: Hepatitis
English: Increases in postimplantation loss, reduced foetal body weights and decreased litter sizes together with increases in the number of malformations (gross external, soft tissue) and skeletal alterations (including retarded ossification) were reported in rats receiving doses which produced approximately 2 to 3 fold the clinical exposure (54 mg/m2/day) and in rabbits receiving 12 mg/m 2/day clofarabine.
Danish: En øget forekomst af fostertab efter implantation, reduceret føtal legemsvægt og reduceret kuldstørrelse sammen med et øget antal misdannelser (store eksterne misdannelser, bløde væv) og skeletale forandringer (inklusive forsinket ossifikation) rapporteredes hos rotter, der fik clofarabin i doser, som svarede til ca. 2-3 gange den kliniske eksponering (54 mg/m2/dag), og hos kaniner, der fik 12 mg/m2/dag.
English: CRp = Complete Remission in the Absence of Total Platelet Recovery
Danish: CRp = Komplet remission uden fuldstændig normalisering af trombocyttal
English: Systemic inflammatory response syndrome (SIRS) or capillary leak syndrome SIRS, capillary leak syndrome (signs and symptoms of cytokine release, e.g., tachypnea, tachycardia, hypotension, pulmonary oedema) were reported as an adverse event in 5% (6/115) of paediatric patients (5 ALL, 1 AML) (see section 4.4).
Danish: Systemisk inflammatorisk responssyndrom (SIRS) eller kapillær lækage-syndrom SIRS, kapillær lækage-syndrom (tegn og symptomer på frigivelse af cytokiner, f.eks. takypnø, takykardi, hypotension, lungeødem) rapporteredes som bivirkninger hos 5 % (6/115) af de pædiatriske patienter (5 med ALL, 1 med AML) (se pkt.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2
Danish: Hvis det ikke anvendes umiddelbart, er brugeren ansvarlig for opbevaringstid og -betingelser før brug, som normalt ikke må overstige 24 timer ved 2ºC - 8ºC, med mindre fortynding har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: Before Evoltra is given to you, it will be diluted in a sodium chloride solution (salt and water).
Danish: Evoltra, bliver lægemidlet fortyndet i en saltvandsopløsning (natriumchlorid).
English: Very common: Flushing* Common: Hypotension*, capillary leak syndrome, haematoma
Danish: Meget almindelig: Flushing* Almindelig: Hypotension*, kapillær lækage-syndrom, hæmatom
English: The use of disposable gloves and protective garments is recommended when handling Evoltra.
Danish: Under håndtering af Evoltra anbefales brug af engangshandsker og beskyttelsestøj.
English: 9/l) and return to baseline organ function.
Danish: ≥ 0,75 × 109/l), og organfunktionen atter er som ved baseline.
English: Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis
Danish: Almindelig: Septisk shock*, sepsis, bakteriæmi, pneumoni, herpes zoster, herpes simplex, oral candidiasis Ikke kendt: C. difficile colitis
English: Patients with cardiac disease and those taking medicinal products known to affect blood pressure or cardiac function should be closely monitored during treatment with clofarabine (see sections 4.5 and 4.8).
Danish: Patienter med hjertesygdom eller patienter, som tager lægemidler, der er kendt for at påvirke blodtryk eller hjertefunktion, bør kontrolleres nøje under behandling med clofarabin (se pkt.
English: Children and adolescents (≥ 1 year old) The recommended dose in monotherapy is 52 mg/m of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Danish: Børn og unge (≥ 1 år) Den anbefalede dosis i monoterapi er 52 mg/m2 legemsoverflade og administreres som intravenøs infusion over 2 timer dagligt 5 dage i træk.
English: Sixty-four patients of 115 (55.7%) experienced at least one vascular disorders adverse event.
Danish: 64 patienter ud af 115 (55,7 %) fik mindst én vaskulær bivirkning.
English: Therefore, for patients with a body surface area ≤ 0.38 m2, the partial contents of a single vial will be required to produce the recommended daily dosage of clofarabine.
Danish: Til en patient med legemsoverflade ≤ 0,38 m2 skal der derfor kun anvendes en del af indholdet i et enkelt hætteglas til at fremstille den anbefalede døgndosis clofarabin.
English: However, the pharmacokinetics of clofarabine in adults with relapsed or refractory AML following administration of a single dose of 40 mg/m clofarabine by intravenous infusion over 1 hour were comparable to those described above in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of 52 mg/m clofarabine by intravenous infusion over 2 hours for 5 consecutive days.
Danish: Imidlertid blev clofarabins farmakokinetik hos voksne med recidiverende eller refraktær AML efter administration af en enkelt dosis clofarabin på 40 mg/ m2 givet som intravenøs infusion over 1 time sammenlignet med farmakokinetikken beskrevet ovenfor hos patienter mellem 2 og 19 år med recidiverende eller refraktær ALL eller AML efter administration af clofarabin 52 mg/m2 som intravenøs infusion over 2 timer 5 dage i træk.
English: Dose reduction for patients experiencing non-haematological toxicities Infectious events
Danish: Dosisreduktion hos patienter med ikke-hæmatologisk toksicitet:
English: Each vial contains 180 mg of salt (sodium chloride).
Danish: Et hætteglas indeholder 180 mg salt (natriumchlorid).
English: Evoltra 1 mg/ml concentrate for solution for infusion must be diluted prior to administration.
Danish: Evoltra 1 mg/ml koncentrat til infusion, opløsning, skal fortyndes før administration.
English: - if you have heart disease, or used to have it.
Danish: - hvis du har en leversygdom eller har haft; - hvis du har en hjertesygdom eller har haft.
English: Forty-one patients of 115 (35.7%) experienced at least one renal and urinary disorders adverse event.
Danish: 41 patienter ud af 115 (35,7 %) fik mindst én bivirkning fra nyrer eller urinveje.
English: Excipients: Sodium chloride and water for injections.
Danish: Hjælpestoffer: Natriumchlorid og vand til injektionsvæsker.
English: Treatment cycles should be repeated every 2 to 6 weeks (from the starting day of the previous cycle) following recovery of normal haematopoiesis (i.e. ANC ≥ 0.75 × 10
Danish: - 6. uge (beregnet fra første dag i den foregående cyklus), når normal hæmatopoiese er genoprettet (ANC
English: Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 2 710 54 00 (Belgique/Belgien)
Danish: Sanofi Belgium Tél/Tel: + 32 2 710 54 00 (Belgique/Belgien)
English: Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine
Danish: Forslag til fortynding baseret på den anbefalede dosering af 52 mg/m2/dag clofarabin Legemsoverflade (m2)
English: Twentythree patients out of 115 experienced a vascular disorder considered to be related to clofarabine, the most frequently reported being flushing (13 events; not serious) and hypotension (5 events; all of which were considered to be serious; see section 4.4).
Danish: 23 patienter ud af 115 fik en vaskulær bivirkning, der blev anset for at være relateret til clofarabin, hvoraf den hyppigst rapporterede var flushing (13 ikke alvorlige tilfælde) og hypotension (5 tilfælde, hvoraf alle ansås for alvorlig, se pkt.
English: The safety profile of clofarabine has not been established in patients with severe renal impairment or patients receiving renal replacement therapy (see section 4.3).
Danish: Clofarabins sikkerhedsprofil er ikke klarlagt hos patienter med svært nedsat nyreinsufficiens eller hos patienter, som er i dialyse (se afsnit 4.3).
English: Very common: Vomiting, nausea, diarrhoea Common: Mouth haemorrhage, gingival bleeding, haematemesis, abdominal pain, stomatitis, upper abdominal pain, proctalgia, mouth ulceration Frequency not known: Pancreatitis elevations in serum amylase and lipase, enterocolitis, neutropaenic colitis, caecitis
Danish: Meget almindelig: Opkastning, kvalme, diarre Almindelig: Blødning i munden, gingivalblødning, hæmostase, abdominalsmerter, stomatitisk, øvre abdominalsmerter, proktalgi, mundsår Ikke kendt: Pancreatitis, forhøjelser i serum-amylase oglipase, enterocolitis, neutropenisk colitis, caecitis
English: Uncommon side effects (may affect up to 1 in 100 people): - inflammation of the liver (hepatitis).
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter):
English: It is supplied in 20 ml glass vials.
Danish: Evoltra udleveres i 20 ml hætteglas.
English: Any patient who experiences a severe toxicity on a third occasion, a severe toxicity that does not recover within 14 days (see above for exclusions), or a life-threatening or disabling toxicity (US NCI CTC Grade 4 toxicity) should be withdrawn from treatment with clofarabine (see section 4.4).
Danish: Enhver patient, som for tredje gang oplever en alvorlig forgiftning, som ikke fortager sig i løbet af 14 dage (se undtagelserne ovenfor), eller en livstruende eller invaliderende forgiftning (grad 4-toksicitet ifølge NCI-CTC), skal stoppe behandling med clofarabin (se pkt.
English: Do not use Evoltra: - if you are allergic to clofarabine or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding (please read the section “Pregnancy and breast-feeding” below); - if you have severe kidney or liver problems.
Danish: - hvis du er allergisk (overfølsom) over for clofarabin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6); - hvis du ammer (se afsnittet 'Graviditet og amning');
English: breathlessness, cough; - vomiting blood, stomach ache, pain in the bottom; - bleeding inside the head, stomach, intestine or lungs, mouth or gums, mouth ulcers, inflamed mouth lining; - yellowing of the skin and eyes (also called jaundice), or other liver disorders; - bruising, hair loss, changes to skin colour, increased sweating, dry skin, or other skin problems; - pain in the chest wall or bones, neck or back pain, pain in limbs, muscles, or joints; - blood in urine; - failure of organs, pain, increased muscle tension, water retention and swelling in parts of the body, including the arms and legs, changes in mental state, feeling hot, cold or abnormal; - clofarabine may affect the levels of certain substances in the blood.
Danish: skælven; - problemer med hørelsen; - væskeansamlinger omkring hjertet, hurtig hjertebanken; - lavt blodtryk, buler ved større blå mærker; - små punktformede blødninger, hurtig vejrtrækning, næseblod, åndedrætsbesvær, åndenød, hoste; - opkastning af blod, mavesmerter, smerter i endetarmen; - blødning i hjerne, mave, tarme eller lunger, mund eller tandkød, mundsår, betændelse i mundhulen; - gullig hud og øjne (gulsot) eller andre leversygdomme; - blå mærker, hårtab, forandringer i hudfarve, øget svedtendens, tør hud eller andre hudproblemer; - smerter i brystkasse eller knogler, hals- eller rygsmerter, smerter i arme og ben, muskler eller led; - blod i urinen; - organsvigt, smerter, øget muskelspænding, væskeophobning og hævelser i forskellige legemsdele inklusive arme og ben, forandringer i sindstilstand, varmefølelse, kulderystelser eller ubehag; - clofarabin kan påvirke koncentrationen af visse stoffer i blodet.
English: Common: Respiratory distress, epistaxis, dyspnoea, tachypnoea, cough
Danish: Almindelig: Respirationshæmning, epistaxis, dyspnø, takypnø, hoste
English: The diluted concentrate is chemically and physically stable for 3 days at 2
Danish: Det fortyndede koncentrat holder sig fysik og kemisk stabilt i 3 dage ved 2ºC - 8º C og ved stuetemperatur (op til 25º C).
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Spørg din læge, hvis du har yderligere spørgsmål om behandling med lægemidlet.
English: Common: Haematuria* Common: Renal failure, acute renal failure
Danish: Almindelig: Hæmaturi* Almindelig: Nyresvigt, akut nyresvigt
English: 9/l for more than 4 weeks from the start of the last cycle, it is recommended that the dose for the next cycle be reduced by 25%.
Danish: Til patienter, hos hvem ANC holder sig < 0,5 × 109/l i over 4 uger efter start på den forudgående cyklus, anbefales det at reducere dosis til næste cyklus med 25 %.
English: Puh/Tel: + 358 201 200 300
Danish: Sanofi Oy Puh/Tel: + 358 201 200 300
English: • The use of prophylactic steroids (e.g., 100 mg/m hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak.
Danish: • Anvendelse af profylaktiske steroider (f.eks. 100 mg hydrocortison/m2 på dag 1 til og med dag 3)
English: Neoplasms benign and malignant (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper) og immunsystemet
English: Disposal
Danish: Destruktion
English: Each vial of Evoltra contains 180 mg of sodium chloride.
Danish: Et hætteglas Evoltra indeholder 180 mg natriumchlorid.
English: How to store Evoltra
Danish: Sådan får du Evoltra
English: Evoltra may not be suitable for you: - if you have suffered a severe reaction after previously using this medicine; - if you have kidney disease, or used to have it; - if you have liver disease, or used to have it;
Danish: I så fald er Evoltra måske ikke det rette middel til dig: - hvis du har haft en alvorlig reaktion efter tidligere behandling med lægemidlet;
English: Common (may affect up to 1 in 10 people): - infections of the blood, pneumonia, shingles, implant infections, infections of the mouth such as thrush and cold sores; - changes in blood chemistry, changes in white blood cells; - allergic reactions; - feeling thirsty and producing darker or less urine than normal, decreased or loss of appetite,
Danish: - infektioner i blodet, lungebetændelse, helvedesild, infektioner omkring implantater, infektioner i munden såsom trøske og forkølelsessår; - forandringer i blodbilledet, forandringer i de hvide blodlegemer; - allergiske reaktioner; - tørst og mørkfarvet urin eller mindre urin end normalt, nedsat eller manglende appetit, vægttab; - ophidselse, irritabilitet eller rastløshed;
English: 28.8 l/h/m
Danish: 28,8 l/time/m2
English: Evoltra 1 mg/ml concentrate for solution for infusion
Danish: Evoltra 1 mg/ml koncentrat til infusionsvæske, opløsning
English: Evoltra 1 mg/ml concentrate for solution for infusion clofarabine
Danish: Evoltra 1 mg/ml koncentrat til infusionsvæske, opløsning clofarabin