natgillin/translations-raw huggingface dataset:
• Nødvendigheden af at informere patienterne om fødevarers effekt på Tasigna o Ikke at spise inden for 2 timer før og 1 time efter indtagelse af Tasigna o Nødvendigheden af at undgå fødevarer som grapejuice, der hæmmer CYP3A4- enzymer
• The need to inform patients about the effects of food on Tasigna o Not to eat within two hours before and one hour after taking Tasigna o The need to avoid foods such as grapefruit juice which inhibit CYP3A4 enzymes
Det leveres som lysegule kapsler (200 mg).
It is available as pale yellow capsules (200 mg).
Tasigna anvendes til behandling af voksne patienter med kronisk myeloid leukæmi (CML), en form for kræft i de hvide blodlegemer, hvor granulocytterne (en type hvide blodlegemer) begynder at vokse ukontrolleret.
Tasigna is used to treat adults with chronic myelogenous leukaemia (CML), a type of cancer of the white blood cells where granulocytes (a type of white blood cell) start growing out of control.
Det anvendes hos patienter med Philadelphia- kromosompositiv (Ph+) leukæmi, hvilket betyder, at nogle af patientens gener har byttet plads for at danne et særligt kromosom, det såkaldte Philadelphiakromosom.
It is used when the patient is ‘ Philadelphia chromosome positive’ (Ph+), which means that some of the patient ’ s genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
Tasigna anvendes i de “ kroniske ” og “ accelererede ” faser af CML.
Tasigna is used in the ‘ chronic’ and ‘ accelerated ’ phases of CML.
Der findes ingen tilgængelige oplysninger om dets virkning hos patienter, hvor sygdommen er i ” blastkrise ” (en anden fase af CML).
There is no information available on its effectiveness in patients whose disease is in ‘ blast crisis’ (another phase of CML).
Tasigna anvendes, når patienterne ikke kan tåle andre kræftmidler, herunder imatinib, eller når disse ikke virker.
Tasigna is used when patients cannot tolerate other treatments including imatinib (another anticancer medicine), or when their disease is not responding to them.
Da der kun findes få patienter med CML, blev Tasigna udpeget som ” lægemiddel til sjældne sygdomme ” den 26. maj 2006.
Because the number of patients with CML is low, the disease is considered ‘ rare’, and Tasigna was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 26 May 2006.
Den anbefalede dosis er to kapsler to gange dagligt, så længe patienten har fordel af behandlingen.
The recommended dose is two capsules twice a day, for as long as the patient continues to benefit.
12 timers mellemrum.
The two doses should be taken around 12 hours apart.
Der må ikke indtages mad i 2 timer før, dosen tages, og der må ikke indtages mad i mindst 1 time efter, at dosen er taget.
The capsules are swallowed whole with a glass of water, without eating anything for two hours before and one hour after each dose.
Hos patienter med svær leversygdom eller visse hjerteproblemer bør lægemidlet anvendes med forsigtighed.
It should be used with caution in patients who have severe problems with their liver or certain heart problems.
De nærmere oplysninger fremgår af produktresuméet, der også er en del af denne EPAR.
See the Summary of Product Characteristics (also part of the EPAR) for more information.
Dette enzym produceres af leukæmiceller og bevirker, at de formerer sig ukontrolleret.
(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 cells, and causes them to multiply uncontrollably.
Ved at blokere Bcr- Abl- kinase hjælper Tasigna med at kontrollere spredningen af leukæmiceller.
By blocking Bcr-Abl kinase, Tasigna helps to control the spread of leukaemia cells.
Virkningerne af Tasigna blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Tasigna were first tested in experimental models before being studied in humans.
Virkningen af Tasigna blev undersøgt i to hovedundersøgelser med i alt 439 patienter med CML, hvor imatinib ikke tolereredes eller ikke længere virkede på sygdommen.
The effectiveness of Tasigna was studied in two main studies involving a total of 439 patients with CML, who could not tolerate imatinib or whose disease had stopped responding to it.
Tasigna blev ikke sammenlignet med andre former for behandling.
Tasigna was not compared to any other treatment.
Den første undersøgelse omfattede i alt 320 patienter, som var i den kroniske fase af sygdommen, hvoraf tre fjerdedele ikke længere responderede på imatinib.
The first study included a total of 320 patients whose disease was in the ‘ chronic phase’, three quarters of whom had stopped responding to imatinib.
Behandlingens virkning blev hovedsagelig bedømt på, hvor mange af patienterne der havde opnået “ major cytogenetisk respons ” (andelen af patientens hvide blodlegemer, som indeholdt Philadelphiakromosomet, var faldet til under 35%).
Its main measure of effectiveness was the proportion of patients who had had a ‘ major cytogenetic response’ (the proportion of the patient’ s white blood cells that contained the Philadelphia chromosome had fallen to below 35%).
Den anden undersøgelse omfattede i alt 119 patienter, som var i den accelererede fase af sygdommen, hvoraf fire femtedele ikke længere responderede på imatinib.
The second study included a total of 119 patients whose disease was in the ‘ accelerated phase’, four fifths of whom had stopped responding to imatinib.
Den vigtigste målestok for virkningen var andelen af patienter, som havde vist “ hæmatologisk respons ” (antallet af hvide blodlegemer blev bragt tilbage til det normale).
Its main measure of effectiveness was the proportion of patients who had had a ‘ haematological response’ (a return to normal of the number of white cells in the blood).
11 måneder).
In the study of chronic phase CML, 156 (49%) of the 320 patients had a major cytogenetic response, after having received Tasigna for an average of 341 days (around eleven months).
I undersøgelsen af CML i accelereret fase viste 50 (42%) af de 119 patienter hæmatologisk respons efter at have fået Tasigna i gennemsnitligt 202 dage (ca. syv måneder).
In the study of accelerated phase CML, 50 (42%) of the 119 patients had a haematological response, after having received Tasigna for an average of 202 days (around seven months).
De hyppigste bivirkninger af Tasigna (som ses hos flere end 1 ud af 10 patienter) er trombocytopeni (lavt antal blodplader), neutropeni (lavt antal hvide blodlegemer), anæmi (lavt antal røde blodlegemer), hovedpine, kvalme, forstoppelse, diarré, udslæt, kløe, træthed og øget indhold af lipase i blodet (et enzym, der produceres af bugspytkirtlen).
The most common side effects with Tasigna (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), neutropenia (low white blood cell counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), constipation, diarrhoea, rash, pruritus (itching), fatigue (tiredness) and increased blood levels of lipase (an enzyme produced by the pancreas).
Den fuldstændige liste over alle de indberettede bivirkninger ved Tasigna fremgår af indlægssedlen.
For the full list of all side effects reported with Tasigna, see the Package Leaflet.
Tasigna bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for nilotinib eller andre af indholdsstofferne.
Tasigna should not be used in people who may be hypersensitive (allergic) to nilotinib or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at selvom Tasigna ikke var blevet direkte sammenlignet med andre typer behandling, var virkningen af lægemidlet blevet tilstrækkeligt påvist og svarede til virkningen af andre lægemidler i samme klasse.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, even though it was not directly compared to any other treatment, the effectiveness of Tasigna had been demonstrated sufficiently and was the same as that of another medicine in the same class.
Udvalget besluttede, at fordelene ved Tasigna er større end risiciene til behandling af voksne med Philadelphiakromosom positiv CML i kronisk eller accelereret fase, hvor forudgående behandling (herunder imatinib) ikke virker eller ikke tåles.
The Committee decided that Tasigna’ s benefits are greater than its risks for the treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Tasigna.
The Committee recommended that Tasigna be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre en risikofri anvendelse af Tasigna?
Which measures are being taken to ensure the safe use of Tasigna?
Det firma, der fremstiller Tasigna, sørger for, at der udleveres en informationspakke i hver enkelt medlemsstat til læger og farmaceuter, som skal ordinere og udlevere lægemidlet.
The company that makes Tasigna will provide an information pack in each Member State for doctors and pharmacists who will prescribe or dispense the medicine.
Andre oplysninger om Tasigna:
Other information about Tasigna:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tasigna til Novartis Europharm Limited den 19. november 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Tasigna to Novartis Europharm Limited on 19 November 2007.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Tasigna kan ses her.
The summary of opinion of the Committee for Orphan Medicinal Products for Tasigna is available here.
Den fuldstændige EPAR om Tasigna findes her.
The full EPAR for Tasigna can be found here.
Lægemiddelform
EU/ 1/ 07/ 422/ 001
Indgivelsesvej
Capsule, hard
Indhold (Koncentration)
Blister (PVC/ PVDC/ Al)
Paknings - størrelse
Blister (PA/ Al/ PVC/ Al)
EU/ 1/ 07/ 422/ 001 EU/ 1/ 07/ 422/ 002 EU/ 1/ 07/ 422/ 003 EU/ 1/ 07/ 422/ 004
EU/ 1/ 07/ 422/ 003
Tasigna Tasigna Tasigna Tasigna
Tasigna
200 mg 200 mg 200 mg 200 mg
200 mg
Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde
Capsule, hard
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Blister (PVC/ PVDC/ Al)
Blister (PVC/ PVDC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PVC/ PVDC/ Al) Blister (PA/ Al/ PVC/ Al)
Blister (PA/ Al/ PVC/ Al)
28 kapsler 28 kapsler 112 kapsler 112 kapsler
112 capsules
156, 11 mg per kapsel.
156.11 mg per capsule.
Hvidt til let gulligt pulver i lysegule uigennemsigtige hårde gelatinekapsler, størrelse 0 med ” NVR/ TKI ” præget med rødt.
White to slightly yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “ NVR/ TKI”.
Tasigna er indiceret til behandling af voksne patienter med kronisk og accelereret Philadelphiakromosompositiv myeloid leukæmi (CML), som er resistente eller intolerante overfor tidligere behandling, inkl. imatinib.
Tasigna is indicated for the treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib.
Den anbefalede dosis Tasigna er 400 mg to gange dagligt.
The recommended dose of Tasigna is 400 mg twice daily.
12 timers interval og må ikke indtages sammen med mad.
Tasigna should be taken twice daily approximately 12 hours apart and must not be taken with food.
Tasigna kan gives i kombination med hæmatopoietiske vækstfaktorer som erythropoietin eller granulocytkoloni- stimulerende faktor (G- CSF), hvis dette er klinisk indiceret.
Tasigna may be given in combination with haematopoietic growth factors such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) if clinically indicated.
Tasigna kan gives med hydroxyurea eller anagrelid, hvis dette er klinisk indiceret.
Tasigna may be given with hydroxyurea or anagrelide if clinically indicated.
Dosisjusteringer eller - ændringer Det kan være nødvendigt midlertidigt at ophøre med Tasigna og/ eller reducere dosis af Tasigna på grund af hæmatologiske toksiciteter (neutropeni, trombocytopeni), som ikke er relateret til den underliggende leukæmi (se tabel 1).
Dose adjustments or modifications Tasigna may need to be temporarily withheld and/ or dose reduced for haematological toxicities (neutropenia, thrombocytopenia) that are not related to underlying leukaemia (see Table 1).
2 Tabel 1
2 Table 1
ved 400 mg to gange dagligt
Chronic phase CML at 400 mg twice daily
trombocytter < 50 x 109/ l
ANC* < 1.0 x 109/ l and/ or platelet counts < 50 x 109/ l
Hvis tallene fortsat er lave, kan en dosisreduktion til 400 mg én gang dagligt være nødvendig.
If blood counts remain low, a dose reduction to 400 mg once daily may be required.
Accelereret fase CML ved 400 mg to gange dagligt
Accelerated phase CML at 400 mg twice daily
ANC * < 1, 0 x 109/ l og/ eller trombocytter < 50 x 109/ l
ANC* < 0.5 x 109/ l and/ or platelet counts < 10 x 109/ l
Stop Tasigna, og monitorér blodbillede.
Stop Tasigna, and monitor blood counts.
Genoptag behandling inden 2 uger ved tidligere dosis, hvis ANC > 1, 0 x 109/ l og/ eller trombocytter > 20 x 109/ l.
Resume within 2 weeks at prior dose if ANC > 1.0 x 109/ l and/ or platelets > 20 x 109/ l.
* ANC = absolut neutrofiltal
*ANC = absolute neutrophil count
Behandlingen kan genoptages ved 400 mg en gang dagligt, når toksiciteten er svundet.
If clinically significant moderate or severe non-haematological toxicity develops, dosing should be interrupted, and may be resumed at 400 mg once daily once the toxicity has resolved.
Hvis det er klinisk passende, bør det overvejes at sætte dosis til 400 mg to gange dagligt igen.
If clinically appropriate, re-escalation of the dose to 400 mg twice daily should be considered.
Forhøjede serumlipaseværdier:
Elevated serum lipase:
For grad 3- 4 serumlipasestigninger, skal dosis reduceres til 400 mg en gang dagligt eller seponeres.
For Grade 3-4 serum lipase elevations, doses should be reduced to 400 mg once daily or interrupted.
Serumlipaseniveauerne skal testes hver måned eller hvor det er klinisk relevant.
Serum lipase levels should be tested monthly or as clinically indicated.
Forhøjede billirubin og hepatiske transaminaserværdier:
Elevated bilirubin and hepatic transaminases:
For grad 3- 4 bilirubinstigninger, skal dosis reduceres til 400 mg en gang dagligt eller seponeres.
For Grade 3-4 bilirubin elevations, doses should be reduced to 400 mg once daily or interrupted.
5. 1).
Children and adolescents Tasigna is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 5.1).
Ældre patienter Cirka 30% af patienterne i kliniske studier var 65 år eller derover.
Elderly patients Approximately 30% of subjects in clinical studies were 65 years of age or over.
Der blev ikke observeret nogen større forskelle med hensyn til sikkerhed og virkning hos patienter ≥65 år sammenlignet med voksne i alderen 18- 65 år.
No major differences were observed for safety and efficacy in patients ≥ 65 years of age as compared to adults aged 18 to 65 years.
Patienter med nyreinsufficiens Der er ikke gennemført kliniske studier med patienter med nyreinsufficiens.
Patients with renal impairment Clinical studies have not been performed in patients with impaired renal function.
Da nilotinib og dets metabolitter ikke udskilles via nyrerne, forventes et fald i total- clearance ikke hos patienter med nyreinsufficiens.
Since nilotinib and its metabolites are not renally excreted, a decrease in total body clearance is not anticipated in patients with renal impairment.
Patienter med leverinsufficiens Tasigna er ikke undersøgt hos patienter med leverinsufficiens.
Patients with hepatic impairment Tasigna has not been investigated in patients with hepatic impairment.
4. 4).
Patients with hepatic impairment should be treated with caution (see section 4.4).
Hjertesygdomme I kliniske studier blev patienter med ukontrolleret eller væsentlig hjertesygdom (f. eks. nylig myokardieinfarkt, kronisk venstresidig hjerteinsufficiens, ustabil angina eller klinisk signifikant bradykardi) ekskluderet.
Cardiac disorders In clinical studies, patients with uncontrolled or significant cardiac disease (e. g. recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia) were excluded.
Forsigtighed bør udvises hos patienter med relevante hjertelidelser (se pkt 4. 4).
Caution should be exercised in patients with relevant cardiac disorders (see section 4.4).
Myelosuppression Behandling med Tasigna er associeret med (National Cancer Institute Common Toxicity Criteria grad 3- 4) trombocytopeni, neutropeni og anæmi.
Myelosuppression Treatment with Tasigna is associated with (National Cancer Institute Common Toxicity Criteria grade 3-4) thrombocytopenia, neutropenia and anaemia.
Forekomsten er hyppigere hos patienter med accelereret CML.
Occurrence is more frequent in patients with accelerated-phase CML.
4. 2).
Myelosuppression was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction (see section 4.2).
QT- forlængelse Afhængigt af koncentrationen kan Tasigna forlænge kardiel ventrikulær repolarisering som målt med QT- intervallet på overflade- EKG.
QT prolongation Tasigna has been shown to prolong cardiac ventricular repolarisation as measured by the QT interval on the surface ECG in a concentration-dependent manner.
I fase II- studiet med imatinib- resistente og intolerante patienter med kronisk og accelereret CML var den gennemsnitlige ændring fra baseline i QTcF- intervallet ved steady state henholdsvis 6 og 8 msek.
In the Phase II study in imatinib-resistant and intolerant CML patients in chronic and accelerated phase, the change from baseline in mean time-averaged QTcF interval at steady state was 6 and 8 msec, respectively.
Der blev observeret QTcF > 500 msek. hos < 1% af disse patienter.
QTcF of > 500 msec was observed in < 1% of these patients.
(CI ± 4 msek.).
In a healthy volunteer study with exposures that were comparable to the exposures observed in patients, the time-averaged mean placebo-subtracted QTcF change from baseline was 7 msec (CI ± 4 msec).
Ingen forsøgspersoner havde et QTcF > 450 msek.
No subject had a QTcF > 450 msec.
Signifikant forlængelse af QT- intervallet kan forekomme, når nilotinib uhensigtsmæssigt tages sammen med stærke CYP3A4- inhibitorer og/ eller lægemidler med kendt potentiale for at forlænge QT, og/ eller fødeindtag (se pkt 4. 5).
Significant prolongation of the QT interval may occur when nilotinib is inappropriately taken with strong CYP3A4 inhibitors and/ or medicinal products with a known potential to prolong QT, and/ or food (see section 4.5).
Forlængelse af QT- intervallet kan udsætte patienten for risikoen for fatalt udfald.
Prolongation of the QT interval may expose patients to the risk of fatal outcome.
Det gælder patienter:
Tasigna should be used with caution in patients who have or who are at significant risk of developing prolongation of QTc, such as those:
- med medfødt lang QT- forlængelse
- with congenital long QT prolongation
- med ukontrollerede eller væsentlige kardielle lidelser inklusive nylig myokardieinfarkt, kronisk
- with uncontrolled or significant cardiac disease including recent myocardial infarction,
venstresidig hjerteinsufficiens, ustabil angina eller klinisk signifikant bradykardi.
congestive heart failure, unstable angina or clinically significant bradycardia.
- som tager antiarytmika eller andre substanser, der kan føre til QT- forlængelse.
- taking anti-arrhythmic medicinal products or other substances that lead to QT prolongation.
Det er tilrådeligt at monitorere tæt om der er effekt på QT- intervallet, og et baseline- EKG er anbefalet før initiering af behandling med Tasigna og som indikeret klinisk.
Close monitoring for an effect on the QTc interval is advisable and a baseline ECG is recommended prior to initiating therapy with Tasigna and as clinically indicated.
Interaktioner med andre lægemidler Administration af Tasigna sammen med midler, som er stærke CYP3A4- hæmmere (herunder, men ikke begrænset til, ketoconazol, itraconazol, voriconazol, moxifloxacin, clarithromycin, telithromycin, ritonavir) bør undgås.
Interactions with other medicinal products The administration of Tasigna with agents that are strong CYP3A4 inhibitors (including, but not limited to, ketoconazole, itraconazole, voriconazole, moxifloxacin, clarithromycin, telithromycin, ritonavir) should be avoided.
4. 5).
Should treatment with any of these agents be required, it is recommended that therapy with Tasigna be interrupted if possible (see section 4.5).
4. 2, 4. 5 og 5. 2).
If transient interruption of treatment with Tasigna is not possible, close monitoring of the individual for prolongation of the QT interval is indicated (see sections 4.2, 4.5 and 5.2).
Samtidig anvendelse af Tasigna med lægemidler, som er potente inducere af CYP3A4 (f. eks. phenytoin, rifampicin, carbamazepin, phenobarbital og prikbladet perikum) kan sandsynligvis mindske eksponeringen for nilotinib i klinisk relevant udstrækning.
Concomitant use of Tasigna with medicinal products that are potent inducers of CYP3A4 (e. g. phenytoin, rifampicin, carbamazepine, phenobarbital and St.
Derfor bør alternative midler med mindre
John’ s Wort) is likely to reduce exposure to nilotinib to a clinically relevant extent.
4. 5).
Therefore, in patients receiving Tasigna, coadministration of alternative therapeutic agents with less potential for CYP3A4 induction should be selected (see section 4.5).
Syrepumpehæmning kan føre til nedsat eksponering for nilotinib.
Suppression of gastric acid secretion might result in lower exposure to nilotinib.
Derfor er samtidig anvendelse af antacida, H2- blokkere eller protonpumpehæmmere og Tasigna frarådet (se pkt.
Therefore, concomitant use of antacids, H2 blockers, or proton pump inhibitors with Tasigna is not recommended
4. 5).
4 (see section 4.5).
Effekt af mad Nilotinibs biotilgængelighed øges af mad.
Food effect The bioavailability of nilotinib is increased by food.
4. 2 og 4. 5) og skal tages 2 timer efter et måltid.
Tasigna should not be taken in conjunction with food (see sections 4.2 and 4.5) and should be taken 2 hours after a meal.
Grapejuice og andre madvarer, man ved hæmmer CYP3A4, bør undgås.
Grapefruit juice and other foods that are known to inhibit CYP3A4 should be avoided.
Nedsat leverfunktion Tasigna er ikke undersøgt hos patienter med leverinsufficiens.
Hepatic impairment Tasigna has not been investigated in patients with hepatic impairment.
Kliniske studier har ekskluderet patienter med alanin transaminase (ALAT) og/ eller aspartat transaminase (ASAT) > 2, 5 (eller > 5, hvis relateret til sygdom) gange den øvre normalgrænse og/ eller total bilirubin > 1, 5 gange den øvre normalgrænse.
Clinical studies have excluded patients with alanine transaminase (ALT) and/ or aspartate transaminase (AST) > 2.5 (or > 5, if related to disease) times the upper limit of the normal range and/ or total bilirubin > 1.5 times the upper limit of the normal range.
4, 2).
Patients with hepatic impairment might therefore have increased exposure to nilotinib and should be treated with caution (see section 4.2).
Serumlipase Der er observeret forhøjelser af serumlipase.
Serum lipase Elevation in serum lipase has been observed.
Lactose Tasigna- kapsler indeholder lactose.
Lactose Tasigna capsules contain lactose.
Patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption bør ikke anvende dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.