natgillin/translations-raw huggingface dataset:
Absorption og fordeling
Adsorption and distribution
• Patienter, der overholder alle kriterierne for CR undtagen normalisering af trombocyttal til > 100 x 109/l
• Patients who met all of the criteria for a CR except for recovery of platelet counts to > 100 x 10
Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
• DNA-polymerase α-hæmning, der afslutter DNA-kædens elongering og/eller DNAsyntese/reparation.
• DNA polymerase  inhibition resulting in termination of DNA chain elongation and/or DNA synthesis / repair.
De fleste af bivirkninger tilhørende hjerte organklassen blev indberettet inden for de første to cykler.
Most of the cardiac adverse events were reported in the first 2 cycles.
Hvis en patient bliver gravid under behandlingen med clofarabin, skal hun informeres om den mulige risiko for fostret.
If a patient becomes pregnant during treatment with clofarabine, they should be informed of the possible hazard to the foetus.
Patienter, der gennemgik transplantation under fortsat remission*
Patients who underwent transplant while in continued remission*
Histologisk dokumentation af leverpåvirkning sås hos hunde efter akut administration af høje doser, men det var heller ikke ledsaget af forandringer i serum-værdier.
Histological evidence of hepatic effects was seen in dogs following acute administration of high doses, but was also not accompanied by changes in serum chemistry.
Fortæl lægen, hvis du bruger anden medicin eller har gjort det for nyligt: - hjertemedicin; - medicin, der påvirker blodtrykket; - medicin, der påvirker lever eller nyrer; - andre lægemidler, også hvis der er tale om ikke-receptpligtige lægemidler.
Tell your doctor if you are using or have recently used: - medicines for heart disease; - any medicine that changes your blood pressure; - medicines that affect your liver or kidneys; - any other medicines including those obtained without a prescription.
På grund af muligheden for alvorlige bivirkninger under amning af spædbørn skal amningen dog indstilles før, under og efter behandling med Evoltra (se pkt.
However, because of the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued prior to, during and following treatment with Evoltra (see section 4.3).
Evoltra anvendes til at behandle børn (≥ 1 år) og unge i alderen op til 21 år med akut lymfoid leukæmi (ALL), når tidligere behandlinger ikke virkede eller er holdt op med at virke.
Evoltra is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
1 hætteglas 3 hætteglas 4 hætteglas 10 hætteglas 20 hætteglas
1 vial 3 vials 4 vials 10 vials 20 vials
Perikardiel ekssudation og pericarditis optrådte som bivirkning hos 9 % (10/115) af patienterne.
Pericardial effusion and pericarditis were reported as an adverse event in 9% (10/115) of patients.
CR * Remissionsvarighed vurderet på tidspunktet for transplantation ** Patient gennemgik transplantation efter alternativ behandling *** Patient gennemgik transplantation efter recidiv
CR * Duration of remission censored at the time of transplant ** Patient received a transplant following alternate therapy *** Patient received a transplant following relapse
37 Hollands Road Haverhill Suffolk
Genzyme Limited 37 Hollands Road Haverhill Suffolk
Evoltra indeholder det aktive stof clofarabin.
Evoltra contains the active substance clofarabine.
De fleste tilfælde af forhøjet ALAT og ASAT forekom inden for 10 dage efter administration af clofarabin og returnerede til ≤ grad 2 inden for 15 dage.
The majority of elevations in ALT and AST occurred within 10 days of clofarabine administration and returned to  grade 2 within 15 days.
Meget almindelig: Febril neutropeni Almindelig: Neutropeni
Very common: Febrile neutropaenia Common: Neutropaenia
Det svarer til 3,08 mmol (eller 70,77 mg) natrium, og der bør tages højde for dette hos patienter på diæt med kontrolleret natriumindhold.
This is equivalent to 3.08 mmol (or 70.77 mg) of sodium and should be taken into consideration for patients on a controlled sodium diet.
Evoltra må ikke blandes med eller administreres samtidig med andre lægemidler via det samme intravenøse drop (se pkt.
Evoltra must not be mixed with or concomitantly administered using the same intravenous line as other medicinal products (see section 6.2).
Hvis der ikke er tegn på persisterende leukæmi, anbefales det at reducere dosis til næste cyklus med 25 % i forhold til den forudgående dosis, efter at ANC atter er ≥0,75 x 109/l.
If persistent leukaemia is not evident, it is recommended that the dose for the next cycle be reduced by 25% of the previous dose following recovery of ANC to ≥ 0.75 × 10
Grænsen for udviklingstoksicitetsforsøg ansås at være 6 mg/m2/dag hos rotter og 1,2 mg/m2/dag hos kaniner.
The threshold for developmental toxicity was considered to be 6 mg/m 2/day in rats and 1.2 mg/m 2/day in rabbits.
Ikke anvendt produkt eller affald herfra bortskaffes i overensstemmelse med lokale regler.
Any unused product or waste material should be disposed of in accordance with local requirements.
Paasheuvelweg 25 1105 BP Amsterdam Holland
Paasheuvelweg 251105 BP Amsterdam The Netherlands Manufacturer
Administration begyndte med en dosis på 11,25 og eskalerede til 15, 30, 40, 52 og 70 mg/ m2/dag som intravenøs infusion i 5 dage hver 2.
Dosing commenced at 11.25 with escalation to 15, 30, 40, 52 and 70 mg/m2/day by intravenous infusion for 5 days every
De hyppigste hæmatologiske laboratorieanomalier, der blev observeret hos patienter, som blev behandlet med clofarabin, var anæmi (83,3 %; 95/114); leukopeni (87,7 %; 100/114); lymfopeni (82,3 %; 93/113), neutropeni (63,7 %; 72/113) og trombocytopeni (80,7 %; 92/114).
The most frequent haematological laboratory abnormalities observed in patients treated with clofarabine were anaemia (83.3%; 95/114); leucopaenia (87.7%; 100/114); lymphopaenia (82.3%; 93/113), neutropaenia (63.7%; 72/113), and thrombocytopaenia (80.7%; 92/114).The majority of these events were of grade  3.
Koncentrat til infusionsvæske, opløsning 20 mg/20 ml
Concentrate for solution for infusion 20 mg/20 ml
Hidtil er den højeste døgndosis administreret til mennesker 70 mg/m2 5 dage i træk (2 pædiatriske ALL-patienter).
To date, the highest daily dose administered to human beings is 70 mg/m for 5 consecutive days (2 paediatric ALL patients).
E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLGE OMSTÆNDIGHEDER
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Patienter, der ikke gennemgik transplantation
Patients who did not undergo transplant CR
Almindelig: Anoreksi, nedsat appetit, dehydrering Ikke kendt: hyponatriæmi
Common: Anorexia, decreased appetite, dehydration Frequency not known: hyponatremia
Opløsningen filtreres gennem et sterilt 0,2 µm sprøjtefilter og fortyndes så med 9 mg/ml (0,9 %) natriumchlorid til fortynding af infusionskoncentrat, så der opnås et samlet volumen som angivet i eksemplerne på tabellen nedenfor.
It should be filtered through a sterile 0.2 micrometre syringe filter and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
De foreliggende oplysninger er baseret på data fra kliniske forsøg, hvor 115 patienter (> 1 og ≤ 21 år) enten med ALL eller akut myeloid leukæmi (AML) fik mindst én dosis clofarabin i den anbefalede dosis på 52 mg/m2 dagligt x 5.
The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ≤ 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine at the recommended dose of 52 mg/m daily x 5.
Hvis du er forælder til et barn, som bliver behandlet med Evoltra, skal du fortælle lægen, hvis et af disse punkter passer på dit barn.
If you are the parent of a child who is being treated with Evoltra, tell the doctor if any of them apply to your child.
Det blev observeret, at frekvensen og bivirkningernes sværhedsgrad, især infektion, knoglemarvssuppression (neutropeni) og hepatotoksicitet, er øget, når clofarabin anvendes i kombinationsbehandling.
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.
I alt 83 % af patienterne fik mindst 1 infektion efter behandling med clofarabin, herunder svampe-, virusog bakterieinfektioner (se pkt.
A total of 83% of patients experienced at least 1 infection after clofarabine treatment, including fungal, viral and bacterial infections (see section 4.4).
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.
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.
Incidencen af disse toksiciteter afhang af såvel den indgivne dosis clofarabin som behandlingsvarighed.
The incidence of these toxicities was dependent on both the dose of clofarabine administered and the duration of treatment.
Skal fortyndes før brug.
Dilute before use.
Intravenøs infusion af clofarabin 52 mg/m2 gav samme eksponering inden for et stort vægtområde.
Intravenous infusion of 52 mg/m clofarabine produced equivalent exposure across a wide range of weights.
Behandling med Evoltra er ordineret til dig af en speciallæge med erfaring i behandling af leukæmi.
Your treatment with Evoltra has been prescribed by a qualified doctor experienced in treating leukaemia.
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.
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.
Plasmaproteinbinding Serum-albumin Elimination:
Plasma protein binding Serum albumin Elimination:  half-life of clofarabine
Virkning og anvendelse Det skal du vide, før du begynder at få Evoltra Sådan får du Evoltra
What Evoltra is and what it is used for What you need to know before you use Evoltra How to use Evoltra
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.
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.
Evoltra er et potent antineoplastisk middel, som kan have betydelige hæmatologiske og ikkehæmatologiske bivirkninger (se pkt.
Evoltra is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLGE OMSTÆNDIGHEDER
SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Patienter, der gennemgik transplantation efter alternativ behandling eller recidiv*
Patients who underwent transplant after alternative therapy or relapse*
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.
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.
Hætteglas af type I-glas med brombutyl gummiprop, flip-off plombering af polypropylen og aluminiumsforsegling.
Type I glass vial with bromobutyl rubber stopper, polypropylene flip-off cap and aluminium overseal.
Brug af anden medicin sammen med Evoltra
Other medicines and Evoltra
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.
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.
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.
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).
Det ikke-observerbare effektniveau for maternel toksicitet hos rotter var 18 mg/m2/dag, mens det hos kaniner var over 12 mg/m2/dag.
The no-observable effect level for maternal toxicity in rats was 18 mg/m 2/day and in rabbits was more than
Fortæl din læge, hvis et af disse punkter passer på dig.
Tell your doctor if any of these apply to you.
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).
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
Leveren er et potentielt organ for clofarabintoksicitet, og 25,2 % af patienterne oplevede mindst ét tilfælde af bivirkninger fra lever- og galdeveje (se pkt.
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).
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.
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.
50 % af patienterne fik mindst én bivirkning tilhørende hjerte organklassen.
Fifty percent of patients experienced at least one cardiac disorders adverse event.
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).
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).
• Blaster fuldstændig forsvundet fra kredsløb
• Complete disappearance of circulating blasts
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 %).
(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%).
Almindelig: Hyperbilirubinæmi, gulsot, veneokklusion, stigninger i alanin- (ALAT)* og aspartat- (ASAT)* aminotransferaser, leversvigt Ikke almindelig: Hepatitis
Common: Hyperbilirubinaemia, jaundice, venoocclusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
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.
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.
CRp = Komplet remission uden fuldstændig normalisering af trombocyttal
CRp = Complete Remission in the Absence of Total Platelet Recovery
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.
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).
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.
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
Evoltra, bliver lægemidlet fortyndet i en saltvandsopløsning (natriumchlorid).
Before Evoltra is given to you, it will be diluted in a sodium chloride solution (salt and water).
Meget almindelig: Flushing* Almindelig: Hypotension*, kapillær lækage-syndrom, hæmatom
Very common: Flushing* Common: Hypotension*, capillary leak syndrome, haematoma
Under håndtering af Evoltra anbefales brug af engangshandsker og beskyttelsestøj.
The use of disposable gloves and protective garments is recommended when handling Evoltra.
≥ 0,75 × 109/l), og organfunktionen atter er som ved baseline.
9/l) and return to baseline organ function.
Almindelig: Septisk shock*, sepsis, bakteriæmi, pneumoni, herpes zoster, herpes simplex, oral candidiasis Ikke kendt: C. difficile colitis
Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis
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.
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).
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.
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.
64 patienter ud af 115 (55,7 %) fik mindst én vaskulær bivirkning.
Sixty-four patients of 115 (55.7%) experienced at least one vascular disorders adverse event.
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.
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.
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.
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.
Dosisreduktion hos patienter med ikke-hæmatologisk toksicitet:
Dose reduction for patients experiencing non-haematological toxicities Infectious events
Et hætteglas indeholder 180 mg salt (natriumchlorid).
Each vial contains 180 mg of salt (sodium chloride).
Evoltra 1 mg/ml koncentrat til infusion, opløsning, skal fortyndes før administration.
Evoltra 1 mg/ml concentrate for solution for infusion must be diluted prior to administration.
- hvis du har en leversygdom eller har haft; - hvis du har en hjertesygdom eller har haft.
- if you have heart disease, or used to have it.
41 patienter ud af 115 (35,7 %) fik mindst én bivirkning fra nyrer eller urinveje.
Forty-one patients of 115 (35.7%) experienced at least one renal and urinary disorders adverse event.
Hjælpestoffer: Natriumchlorid og vand til injektionsvæsker.
Excipients: Sodium chloride and water for injections.
- 6. uge (beregnet fra første dag i den foregående cyklus), når normal hæmatopoiese er genoprettet (ANC
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
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Forslag til fortynding baseret på den anbefalede dosering af 52 mg/m2/dag clofarabin Legemsoverflade (m2)
Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine