natgillin/translations-raw huggingface dataset:
Dette gentages hver 21. dag.
Younger patients receive a lower dose (650 mg per square metre) given over one hour on five consecutive days, repeated every 21 days.
Denne doseringsplan kan også anvendes til patien - ter i alderen 16 til 21 år.
This schedule can also be used in patients aged 16 to 21 years.
Behandlingen skal standses, hvis der opstår alvorlige bivirkninger fra hjernen eller nervesystemet.
Treatment should be stopped if the patient develops serious side effects affecting the brain or nervous system.
Desuden bør de have passende væsketilførsel, hvis der er risiko for tumorlysis- syndrom (en komplika - tion, der skyldes nedbrydning af kræftceller).
Patients receiving Atriance should be monitored regularly for changes in blood counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Under behandlingen med Atriance bør patienter med nyreproblemer overvåges tæt for bivirkninger.
Patients who have problems with their kidneys should be closely monitored for side effects during Atriance treatment.
Atriance bør anvendes med forsigtighed hos patienter med leverproblemer.
Atriance should be used with caution in patients with liver problems.
Det aktive stof i Atriance, nelabarin, er et vævsgiftigt stof, dvs. det dræber celler, der deler sig, f. eks. kræftceller.
The active substance in Atriance, nelabarine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Det tilhører den gruppe kræftmidler, der kaldes antimetabolitter (stofskiftehæmmere).
It belongs to the group of anti-cancer medicines called ‘ antimetabolites’.
Derved griber den ind i virk - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ningen af de enzymer (dna- polymeraser), der medvirker ved dannelse af dna.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Nelarabine is converted within cells to an analogue of guanine, one of the fundamental chemicals that make up DNA.
Det får dna - produktionen til at standse, og dette bremser kræftcellernes vækst og formering.
In the body, this active analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases.
Da den aktive guanin - analog ophobes i T- cellerne og forbliver længere i disse celler, bremser Atriance vækst og formering af de celler, der optræder ved T- ALL og T- LBL.
As the active guanine analogue accumulates in T-cells and lasts longer in these cells, Atriance slows down the growth and multiplication of the cells involved in T-ALL and T-LBL.
Virkningerne af Atriance blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos menne - sker.
The effects of Atriance were first tested in experimental models before being studied in humans.
Atriance blev anvendt i to hovedundersøgelser af patienter med T- ALL og T- LBL, hos hvem en eller flere typer kræftbehandling var holdt op med at virke.
Atriance has been studied in two main studies of patients with T-ALL and T-LBL who had stopped responding to one or more previous anticancer treatments.
Den anden omfattede i alt 40 voksne og unge over 16 år.
The first study involved a total of 70 children and young adults aged below 21 years, and the second involved a total of 40 adults and adolescents aged over 16 years.
I begge undersøgelser blev pa - tienterne behandlet med Atriance, men dets virkninger blev ikke sammenlignet med virkningerne af andre lægemidler.
In both studies, the patients were treated with Atriance, but its effects were not compared with those of any other medicine.
Behandlingens virkning blev hovedsagelig bedømt på den andel af patienterne, der var fri for sygdomstegn og havde normale blodcelletal inden for en måned efter påbegyndelse af be - handlingen med Atriance.
The main measure of effectiveness was the proportion of patients who responded to treatment, defined as no evidence of disease and recovery of blood cell counts, within a month of starting Atriance treatment.
Hvilken fordel viser undersøgelserne, der er ved Atriance?
What benefit has Atriance shown during the studies?
Af de 39 børn og unge i den første undersøgelse, hos hvem mindst to andre lægemidler havde svigtet, viste fem (13%) fuldstændig re - spons på behandlingen efter en måned, dvs. de var fri for sygdomstegn og havde normale blodcelletal.
In the first study, among the 39 children and young adults who had failed two or more previous treatments, five (13%) had a complete response to treatment after a month, with no evidence of disease and normal blood counts.
Af de 28 voksne og unge i den anden undersøgelse, hos hvem mindst to andre behandlinger havde svigtet, viste fem (18%) fuldstændig respons.
In the second study, among the 28 adults and adolescents who had failed two or more previous treatments, five (18%) had a complete response to treatment.
I begge undersøgelser udviste en større del af patienter - ne delvis respons på behandlingen med Atriance og fik normale blodcelletal.
In both studies, more patients had a partial response to Atriance treatment, with blood counts returning towards normal levels.
Hos voksne var de almindeligste bivirkninger (der sås hos flere end 1 ud af 10 patienter) infektion, nedsat antal hvide blodlegemer med eller uden feber, nedsat antal blodplader, nedsat antal røde blod - legemer, søvnighed, nervelidelser i arme og ben, nedsat følesans, unormale føleindtryk, svimmelhed, hovedpine, stakåndethed, hoste, diarré, opkastning, forstoppelse, kvalme, muskelsmerter, hævelse, feber, smerter, træthed og kraftesløshed.
The most common side effects with Atriance in adults (seen in more than 1 patient in 10) are infection, febrile neutropenia (low white blood cell counts with fever), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoesthesia (a reduced sense of touch), paresthesia (abnormal sensations), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), oedema (swelling), pyrexia (fever), pain, fatigue (tiredness) and asthenia (weakness).
De fleste af disse bivirkninger var også meget almindelige hos børn.
Most of these side effects were also seen very commonly in children.
Den fuldstændige liste over de indberettede bivirkninger ved Atriance fremgår af indlægs - sedlen.
For the full list of all side effects reported with Atriance, see the Package Leaflet.
Der er indberettet om svære bivirkninger fra hjernen og nervesystemet, herunder søvntendens, kram - per og nervelidelser i arme og ben med følelsesløshed, usædvanlige sanseindtryk, svaghed og tilmed lammelser.
Severe side effects affecting the brain and nervous system have been reported in patients taking Atriance, including somnolence, convulsions, and peripheral neuropathy causing numbness, unusual sensations, weakness and even paralysis.
Patienterne bør nøje overvåges for sådanne bivirkninger, og om nødvendigt bør behandlin - gen standses.
Patients should be monitored closely for these side effects and treatment stopped if necessary.
Atriance bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for nelarabin eller andre af indholdsstofferne.
Atriance should not be used in people who may be hypersensitive (allergic) to nelarabine or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at der på grund af det lille antal patienter med disse sygdomme kun foreligger begrænsede oplysninger, der støtter godkendelse af Atriance, men fandt, at lægemidlet kan give nogle patienter mulighed for at gå videre til knoglemarvs - transplantation, så deres overlevelsesmulighed øges.
The Committee for Medicinal Products for Human Use (CHMP) noted that, due to the small number of patients with these diseases, the information to support the approval of Atriance is limited, but it agreed that the medicine could allow some patients to go on to receive a bone marrow transplant, increasing their chances of survival.
Udvalget konkluderede derfor, at fordelene ved Atriance opvejer risiciene til behandling af patienter med T- ALL and T- LBL ved manglende virkning eller tilbagefald af sygdommen efter behandling med mindst to regimer med kemoterapi.
Therefore, the Committee decided that Atriance’ s benefits are greater than its risks for the treatment of patients with T-ALL and T-LBL whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Atriance.
The Committee recommended that Atriance be given marketing authorisation.
Atriance er godkendt under "særlige omstændigheder".
Atriance has been authorised under “ Exceptional Circumstances”.
Det betyder, at sygdommene er så sjældne, at der ikke har kunnet skaffes fuldstændige oplysninger om Atriance.
This means that because the diseases are rare, it has not been possible to obtain complete information about Atriance.
Det Europæiske Lægemiddelagen - tur (EMEA) vil årligt gennemgå alle nye oplysninger, der måtte blive til rådighed, og vil om nødven - digt ajourføre dette sammendrag.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Atriance til Glaxo Group Limited den 22. august 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Atriance to Glaxo Group Limited on 22 August 2007.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Atriance findes her.
The summary of opinion of the Committee for Orphan Medicinal Products for Atriance is available here.
Den fuldstændige EPAR for Atriance findes her.
The full EPAR for Atriance can be found here.
EU- nummer EU/ 1/ 07/ 403/ 001
EU Number EU/ 1/ 07/ 403/ 001
Særnavn Atriance
Invented name Atriance
Styrke 5 mg/ ml
Strength 5 mg/ ml
Lægemiddelform Infussionsvæske, opløsning
Pharmaceutical Form Solution for infusion
Indgivelsesvej Intravenøs anvendelse
Route of Administration Intravenous use
Emballage Hætteglas (glas)
Packaging vial (glass)
Indhold 50 ml
Content 50 ml
Paknings- størrelse 6 hætteglas
Package size 6 vials
Atriance 5 mg/ ml infusionsvæske, opløsning.
Atriance 5 mg/ ml solution for infusion
1 ml indeholder 1, 725 mg (75 mikromol) natrium.
Each ml contains 1.725 mg (75 micromols) of sodium.
Nelarabin er indiceret til behandling af patienter med T- celle akut lymfoblastær leukæmi (T- ALL) og T- celle lymfoblastær lymfom (T- LBL), hvor sygdommen ikke har responderet på, eller er recidiveret efter behandling med mindst to regimer af kemoterapi.
Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
På grund af små patientpopulationer i dette sygdomsstadie, er oplysningerne til støtte for indikationerne baseret på begrænsede data.
Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Nelarabin er kun til intravenøs anvendelse og må kun gives under overvågning af en læge, der har erfaring med anvendelse af cytotoksiske midler.
Nelarabine is for intravenous use only and must only be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Nelarabin skal ikke fortyndes før administration.
Nelarabine is not diluted prior to administration.
Den ønskede dosis nelarabin tilsættes i en infusionspose af polyvinylchlorid (PVC) eller ethylvinylacetat (EVA), eller i en glasbeholder og administreres som infusion over 2 timer til voksne patienter og som infusion over 1 time til børn.
The appropriate dose of nelarabine is transferred into polyvinylchloride (PVC) or ethyl vinyl acetate (EVA) infusion bags or glass containers and administered as a two-hour infusion in adult patients and as a one-hour infusion in paediatric patients.
4. 4 og 4. 8).
Complete blood counts including platelets must be monitored regularly (see sections 4.4 and 4.8).
Det anbefales, at patienter i behandling med nelarabin får intravenøs hydrering i henhold til normal medicinsk praksis for behandling af hyperurikæmi hos patienter med risiko for tumor- lysis- syndrom.
Patients receiving nelarabine are recommended to receive intravenous hydration according to standard medical practice for the management of hyperuricemia in patients at risk for tumour lysis syndrome.
4. 4)
For patients at risk of hyperuricemia, the use of allopurinol should be considered (see section 4.4).
2 Den anbefalede dosis nelarabin til voksne er 1500 mg/ m2 indgivet intravenøst over 2 timer på dag 1, 3 og 5 og gentaget hver 21. dag.
2 The recommended dose of nelarabine for adults is 1,500 mg/ m2 administered intravenously over two hours on days 1, 3 and 5 and repeated every 21 days.
Den anbefalede dosis nelarabin til børn er 650 mg/ m2 indgivet intravenøst over 1 time dagligt i 5 på hinanden følgende dage og gentaget hver 21. dag.
The recommended dose of nelarabine for children is 650 mg/ m2 administered intravenously over one hour daily for 5 consecutive days, repeated every 21 days.
I kliniske forsøg blev både 650 mg/ m2 og 1500 mg/ m2 anvendt til patienter i aldersgruppen 16 - 21 år.
In clinical studies, the 650 mg/ m2 and 1,500 mg/ m2 dose have both been used in patients in the age range 16 to 21 years.
Kun begrænsede klinisk- farmakologiske data er tilgængelige for patienter under 4 år.
Limited clinical pharmacology data are available for patients below the age of 4 years.
4. 4 og 5. 2).
Insufficient numbers of patients aged 65 years of age and older have been treated with nelarabine to determine whether they respond differently than younger patients (see sections 4.4 and 5.2).
5. 2 — Nedsat nyrefunktion).
Nelarabine and 9-β -D-arabinofuranosylguanine (ara-G) are partially renally excreted (see section 5.2 — Renal impairment).
Der er ikke tilstrækkelige data til, at fastslå en anbefalet dosisjustering til personer med kreatininclearance på under 50 ml/ min.
There are insufficient data to support a dose adjustment recommendation for patients with a renal clearance of creatinin Clcr less than 50 ml/ min.
Nedsat leverfunktion
Hepatic Impairment
NEUROLOGISKE BIVIRKNINGER Der er rapporteret alvorlige neurologiske hændelser ved brug af nelarabin.
NEUROLOGICAL ADVERSE EVENTS Severe neurological events have been reported with the use of nelarabine.
Disse hændelser inkluderer: ændret mental tilstand herunder svær somnolens, påvirkning af centralnervesystemet inkl. kramper og perifer neuropati fra følelsesløshed og paræstesi til motorisk svækkelse og paralyse.
These events have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis.
Der er rapporteret om hændelser med demyeliniserende lidelser og ascenderende perifer neuropati, der ligner Guillain- Barré syndrom
There have also been reports of events associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré Syndrome.
3 Disse hændelser har ikke altid været reversible efter seponering af nelarabin.
Full recovery from these events has not always occurred with cessation of nelarabine.
Det anbefales derfor på det kraftigste at overvåge nøje for neurologiske hændelser og at seponere nelarabin ved første tegn på neurologiske hændelser af NCI Common Toxicity Criteria grad 2 eller derover.
Therefore, close monitoring for neurological events is strongly recommended, and nelarabine must be discontinued at the first sign of neurological events of NCI CTCAE Grade 2 or greater.
Neurotoksicitet er den dosisbegrænsende toksicitet for nelarabin.
3 Neurotoxicity is the dose-limiting toxicity of nelarabine.
Almindelige tegn og symptomer på nelarabin- relateret neurotoksicitet omfatter: somnolens, konfusion, krampe, ataksi, paræstesi og hypoæstesi.
Common signs and symptoms of nelarabine-related neurotoxicity include somnolence, confusion, convulsions, ataxia, paraesthesias, and hypoesthesia.
4. 8).
Severe neurological toxicity can manifest as coma, status epilepticus, demyelination, or ascending neuropathy similar in appearance to Guillain-Barré syndrome (see section 4.8).
Patienter, der tidligere er blevet eller sideløbende bliver behandlet med intratekal kemoterapi eller tidligere har modtaget kraniospinal strålebehandling, har potentielt øget risiko for neurologiske bivirkninger (se pkt.
Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation are potentially at increased risk for neurological adverse events (see section 4.2
4. 2 - dosisjustering).
not recommended.
Leukopeni, trombocytopeni, anæmi og neutropeni (inkl. febril neutropeni) er blevet forbundet med nelarabin- behandling.
Leukopenia, thrombocytopenia, anaemia, and neutropenia, (including febrile neutropenia) have been associated with nelarabine therapy.
4. 2 og 4. 8).
Complete blood counts including platelets must be monitored regularly (see sections 4.2 and 4.8).
Det anbefales, at patienter i behandling med nelarabin får intravenøs hydrering i henhold til standard medicinsk praksis for behandling af hyperurikæmi hos patienter med risiko for tumor- lysis- syndrom.
Patients receiving nelarabine are recommended to receive intravenous hydration according to standard medical practice for the management of hyperuricemia in patients at risk of tumour lysis syndrome.
For patienter med risiko for hyperurikæmi bør det overvejes at anvende allopurinol.
For patients at risk of hyperuricemia, the use of allopurinol should be considered.
Antallet af patienter, som er over 65 år eller ældre i de kliniske forsøg med nelarabin er ikke tilstrækkeligt til at kunne fastslå, om de responderer anderledes end yngre patienter.
Clinical studies of nelarabine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
5. 3).
Nelarabine however, is known to be genotoxic to mammalian cells (see section 5.3).
Denne medicin indeholder 1, 725 mg/ ml (75 mmol) natrium.
This medicinal product contains 1.725 mg/ ml (75 mmol) of sodium.
Nelarabin og ara- G hæmmede ikke i signifikant grad aktiviteterne af de vigtigste levercytokrom P450 (CYP) - isoenzymer CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4 in vitro.
Nelarabine and ara-G did not significantly inhibit the activities of the major hepatic cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in vitro.
Samtidig administration kan reducere effekten af nelarabin og/ eller ændre bivirkningsprofilen for begge de aktive stoffer.
Concomitant administration may reduce the efficacy of nelarabine and/ or change the adverse event profile of either active substance.
Der foreligger ikke tilstrækkelige data om brugen af nelarabin hos gravide kvinder.
There are no adequate data from the use of nelarabine in pregnant women.
5. 3).
Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Den potentielle risiko for mennesker kendes ikke, men eksponering under graviditet vil sandsynligvis føre til abnormaliteter og misdannelser hos fosteret.
The potential risk in humans is unknown, however, exposure during pregnancy will likely lead to anomalies and malformations of the foetus.
Nelarabins virkning på fertilitet hos mennesker kendes ikke.
The effect of nelarabine on fertility in humans is unknown.
Ud fra stoffets farmakologiske virkning er der risiko for bivirkninger i forbindelse med fertilitet.
Based on the pharmacological action of the compound, undesirable effects on fertility are possible.
Det vides ikke, om nelarabin eller dets metabolitter udskilles i modermælk.
It is unknown whether nelarabine or its metabolites are excreted in human breast milk.
Patienterne skal advares om, at denne sovetrang kan påvirke evnen til at udføre krævende opgaver som f. eks. at køre bil.
Patients must be cautioned that somnolence can affect performance of skilled tasks, such as driving.
Data fra kliniske forsøg
Clinical trial data
Data fra pivotale kliniske forsøg
Pivotal clinical trial data
103 voksne og 84 pædiatriske patienter.
The safety profile from pivotal clinical trials at the recommended doses of nelarabine in adults (1,500 mg/ m2) and children (650 mg/ m2) is based on data from 103 adults and 84 paediatric patients respectively.
De hyppigste bivirkninger var træthed, gastro- intestinale forstyrrelser, hæmatologiske forstyrrelser, respiratoriske forstyrrelser, forstyrrelser i nervesystemet og pyreksi.
The most frequently occurring adverse events were fatigue; gastrointestinal disorders; haematological disorders; respiratory disorders; nervous system disorders; and pyrexia.
4. 4).
Neurotoxicity is the dose limiting toxicity associated with nelarabine therapy (see section 4.4).
Følgende termer er anvendt til klassifikation af frekvenser:
The following convention has been utilised for the classification of frequency:
Meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 til < 1/ 10), ikke almindelig (≥ 1/ 1. 000 til < 1/ 100), sjælden (≥ 1/ 10. 000 til < 1/ 1. 000) og meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100), Rare (≥ 1/ 10,000 to < 1/ 1,000) and Very rare (< 1/ 10,000), not known (cannot be estimated from the available data)
5 Systemorganklasser MedDRA
MedDRA Preferred Term(s) Infections and infestations
Voksne (1500 mg/ m2) N = 103 (%)
Adults (1,500 mg/ m2) N=103 (%)
Børn (650 mg/ m2) N = 84 (%)
Children (650 mg/ m2) N=84 (%)
Der var en enkelt supplerende biopsirapport, der bekræftede progressiv multifokal leukoencefalopati i den voksne population.
There was a single additional report of biopsy confirmed progressive multifocal leukoencephalopathy in the adult population.
Der er rapporter om undertiden fatal opportunistisk infektion hos patienter i nelarabinbehandling.
There have been reports of sometimes fatal opportunistic infections in patients receiving nelarabine therapy.
Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Tumor- lysis- syndrom (se også data fra programmet for udleveringstilladelse og fra de ikke pivotale- forsøg)
Neoplasms benign and malignant (including cysts and polyps) Tumour lysis syndrome (see also Data from compassionate use programme and non-pivotal studies)
-
N/ A
Febril neutropeni Neutropeni Leukopeni Trombocytopeni Anæmi
Blood and lymphatic system disorders Febrile neutropenia Neutropenia Leukopenia Thrombocytopenia Anaemia
12 (12) Meget almindelig:
12 (12) Very common:
83 (81) Almindelig:
83(81) Common:
3 (3) Meget almindelig:
3 (3) Very common:
89 (86) Meget almindelig:
89 (86) Very common:
1 (1) Meget almindelig:
1(1) Very common:
79 (94) Meget almindelig:
79 (94) Very common:
32 (38) Meget almindelig:
32 (38) Very common:
74 (88) Meget almindelig:
74 (88) Very common:
Metabolisme og ernæring Hypoglykæmi Hypocalcæmi Hypomagnesiæmi Hypokaliæmi Anoreksi
Hypoglycaemia Hypocalcaemia Hypomagnesaemia Hypokalaemia Anorexia
- Almindelig:
N/ A Common:
3 (3) Almindelig:
3 (3) Common:
4 (4) Almindelig:
4 (4) Common:
5 (6) Almindelig:
5 (6) Common:
7 (8) Almindelig:
7 (8) Common:
5 (6) Meget almindelig:
5 (6) Very common:
9 (11) -
9 (11) N/ A