natgillin/translations-raw huggingface dataset:
Dette inkluderer patienter med hypokalæmi eller hypomagnesiæmi, patienter med kongenit langt QT- syndrom, patienter der tager antiarytmika eller andre lægemidler, som medfører QT- forlængelse samt kumulative høje doser af anthracyclin.
These include patients with hypokalemia or hypomagnesemia, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicinal products or other medicinal products which lead to QT prolongation, and cumulative high dose anthracycline therapy.
Hypokalæmi eller hypomagnesiæmi skal korrigeres inden administration af dasatinib.
Hypokalemia or hypomagnesemia should be corrected prior to dasatinib administration.
Patienter med ukontrolleret eller betydelig kardiovaskulær sygdom inkluderedes ikke i kliniske forsøg.
Patients with uncontrolled or significant cardiovascular disease were not included in the clinical studies.
Lactose En daglig dosis på 100 mg af dette produkt indeholder 135 mg lactosemonohydrat, og en daglig dosis på 140 mg indeholder 189 mg lactosemonohydrat.
Lactose This medicinal product contains 135 mg of lactose monohydrate in a 100 mg daily dose and 189 mg of lactose monohydrate in a 140 mg daily dose.
Patienter med sjældne arvelige problemer med galactoseintolerans, Lapp- lactasemangel eller glucose - / galactose- malabsorption bør ikke tage dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Aktive substanser der kan øge plasmakoncentrationer af dasatinib In vitro forsøg tyder på, at dasatinib er et CYP3A4- substrat.
Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib is a CYP3A4 substrate.
Samtidig brug af dasatinib og lægemidler der er potente hæmmere af CYP3A4 (fx ketoconazol, itraconazol, erythromycin, clarithromycin, ritonavir, telithromycin) kan øge eksponeringen af dasatinib.
Concomitant use of dasatinib and medicinal products which potently inhibit CYP3A4 (e. g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin) may increase exposure to dasatinib.
Systemisk administration af potente CYP3A4- hæmmere anbefales derfor ikke til patienter, der får dasatinib.
Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended.
96% ved klinisk relevante koncentrationer, baseret på in vitro undersøgelser.
At clinically relevant concentrations, binding of dasatinib to plasma proteins is approximately 96% on the basis of in vitro experiments.
Der har ikke været udført undersøgelser for at evaluere dasatinibs interaktioner med andre proteinbundne lægemidler; potentialet for displacering og den kliniske relevans af dette er ukendt.
The potential for displacement and its clinical relevance are unknown.
Aktive substanser der kan reducere plasmakoncentration af dasatinib Når dasatinib administreredes efter 8 daglige aften- administrationer af 600 mg rifampicin, der er en potent CYP3A4- induktor, faldt AUC af dasatinib med 82%.
Active substances that may decrease dasatinib plasma concentrations When dasatinib was administered following 8 daily evening administrations of 600 mg rifampicin, a potent CYP3A4 inducer, the AUC of dasatinib was decreased by 82%.
Andre lægemidler, der inducerer CYP3A4- aktivitet (fx dexamethazon, phenytoin, carbamazepin, phenobarbital eller naturlægemidler, der indeholder Hypericum perforatum, også kendt som prikbladet perikum), kan også øge metabolismen og reducere plasmakoncentrationer af dasatinib.
John´s Wort) may also increase metabolism and decrease dasatinib plasma concentrations.
Samtidig brug af potente CYP3A4 - induktorer og dasatinib anbefales derfor ikke.
Therefore, concomitant use of potent CYP3A4 inducers with dasatinib is not recommended.
Til patienter med behov for rifampicin eller andre CYP3A4- induktorer bør der anvendes alternative lægemidler med mindre enzyminduktionspotentiale.
In patients in whom rifampicin or other CYP3A4 inducers are indicated, alternative medicinal products with less enzyme induction potential should be used.
Histamin- 2- antagonister og protonpumpe- hæmmere:
Histamine-2 antagonists and proton pump inhibitors:
Langvarig suppression af mavesyresekretion ved H2- antagonister eller protonpumpe- hæmmere (fx famotidin og omeprazol) vil sandsynligvis reducere eksponeringen af dasatinib.
Long-term suppression of gastric acid secretion by H2 antagonists or proton pump inhibitors (e. g. famotidine and omeprazole) is likely to reduce dasatinib exposure.
I et enkeltdosisforsøg med raske frivillige reduceredes ekponeringen af dasatinib med 61% efter administration af famotidin 10 timer inden indtagelse af enkeltdosis SPRYCEL.
In a single-dose study in healthy subjects, the administration of famotidine 10 hours prior to a single dose of SPRYCEL reduced dasatinib exposure by 61%.
4. 4).
The use of antacids should be considered in place of H2 antagonists or proton pump inhibitors in patients receiving SPRYCEL therapy (see section 4.4).
Ikke- kliniske data viser, at dasatinibs opløselighed er pH- afhængig.
Non-clinical data demonstrate that the solubility of dasatinib is pH-dependent.
Ved samtidig brug af aluminumhydroxid - / magnesiumhydroxidantacida og SPRYCEL hos raske frivillige reduceres AUC efter indtagelse af enkeltdosis SPRYCEL med 55% og Cmax med 58%.
In healthy subjects, the concomitant use of aluminium hydroxide/ magnesium hydroxide antacids with SPRYCEL reduced the AUC of a single dose of SPRYCEL by 55% and the Cmax by 58%.
4. 4).
Thus, antacids may be administered up to 2 hours prior to or 2 hours following SPRYCEL (see section 4.4).
Aktive stoffer, hvis plasmakoncentration kan ændres af dasatinib Samtidig brug af dasatinib og et CYP3A4- substrat kan øge eksponeringen af CYP3A4- substratet.
Active substances that may have their plasma concentrations altered by dasatinib Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate.
I et forsøg med raske frivillige øgede enkeltdosis på 100 mg dasatinib AUC og Cmax af simvastatin, der er et kendt CYP3A4- substrat, med henholdsvis 20 og 37%.
In a study in healthy subjects, a single 100 mg dose of dasatinib increased AUC and Cmax exposure to simvastatin, a known CYP3A4 substrate, by 20 and 37% respectively.
4. 4).
Therefore, CYP3A4 substrates known to have a narrow therapeutic index (e. g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine)) should be administered with caution in patients receiving dasatinib (see section 4.4).
In vitro data indikerer en mulig risiko for interaktioner med CYP2C8- substrater såsom glitazoner.
In vitro data indicate a potential risk for interaction with CYP2C8 substrates, such as glitazones.
Graviditet Der foreligger ikke tilstrækkelige data om brugen af dasatinib hos gravide kvinder.
Pregnancy There are no adequate data from the use of dasatinib in pregnant women.
SPRYCEL bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt.
SPRYCEL should not be used during pregnancy unless clearly necessary.
Hvis lægemidlet anvendes under graviditet, skal patienten informeres om den potentielle risiko for fostret.
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
6 Amning Der er utilstrækkelig/ begrænset information vedrørende udskillelse af dasatinib i human modermælk og brystmælk hos dyr.
6 Lactation There is insufficient/ limited information on the excretion of dasatinib in human or animal breast milk.
Fysisk- kemiske og tilgængelige farmakodynamiske/ toksikologiske data vedrørende dasatinib peger mod, at stoffet udskilles i modermælk, og det kan ikke udelukkes, at der er en risiko for det ammende barn.
Physico-chemical and available pharmacodynamic/ toxicological data on dasatinib point to excretion in breast milk and a risk to the suckling child cannot be excluded.
Fertilitet Dasatinibs effekt på sæd er ukendt, og såvel seksuelt aktive mænd som kvinder bør derfor anvende effektive antikonceptionsmetoder under behandling.
Fertility The effect of dasatinib on sperm is unknown, therefore both sexually active men and women should use effective methods of contraception during treatment.
Patienterne skal informeres om, at de kan opleve bivirkninger som fx svimmelhed og sløret syn under behandling med dasatinib.
Patients should be advised that they may experience undesirable effects such as dizziness or blurred vision during treatment with dasatinib.
De nedenfor beskrevne data afspejler 2. 182 patienters brug af SPRYCEL i kliniske forsøg (startdosis på 100 mg 1 gang dagligt, 140 mg 1 gang dagligt, 50 mg 2 gange dagligt eller 70 mg 2 gange dagligt).
The data described below reflect exposure to SPRYCEL in 2,182 patients in clinical trials (starting dose 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily).
Af de 2. 182 behandlede patienter var 25% ≥ 65 år, mens 5% var ≥ 75 år.
Of the 2,182 patients treated, 25% were ≥ 65 years of age, while 5% were ≥ 75 years of age.
Gennemsnitlig behandlingsvarighed var 11 måneder (0, 03- 31 måneder).
The median duration of therapy was 11 months (range 0.03 -31 months).
De fleste SPRYCEL- behandlede patienter oplevede bivirkninger på et tidspunkt.
The majority of SPRYCEL-treated patients experienced adverse reactions at some time.
De fleste bivirkninger var af mild til moderat grad.
Most reactions were of mild-to-moderate grade.
Behandlingen seponeredes dog på grund af bivirkninger hos 11% af patienterne med CML i kronisk fase, 12% af patienterne med CML i accelereret fase, 15% af patienterne med CML i myeloid blastfase og 8% af patienterne med CML i lymfoid blastfase eller Ph+All.
Treatment was discontinued for adverse reactions in 11% of patients in chronic phase CML, 12% in accelerated phase CML, 15% in myeloid blast phase CML, and 8% in lymphoid blast phase CML or Ph+ ALL.
I Fase III- forsøget vedrørende dosisoptimering hos patienter med CML i kronisk fase, var antallet af patienter, der udgik på grund af bivirkninger lavere blandt de patienter der blev behandlet med 100 mg 1 gang dagligt end blandt de patienter der blev behandlet med 70 mg 2 gange dagligt (henholdsvis 3% og 11%).
In the Phase III dose-optimisation study in patients with chronic phase CML, the rate of discontinuation for adverse drug reaction was lower for patients treated with 100 mg once daily than for those treated with 70 mg twice daily (3% and 11%, respectively).
De fleste imatinib- intolerante patienter med CML i kronisk fase kunne tåle behandling med dasatinib.
The majority of imatinib-intolerant patients with chronic phase CML were able to tolerate treatment with dasatinib.
Alle 3 patienter fortsatte SPRYCEL- behandlingen efter dosisreduktion.
In the Phase II single-arm study in chronic phase CML, 3 of the 99 imatinib-intolerant patients had the same grade 3 or 4 non-hematological toxicity with SPRYCEL as they did with prior imatinib; all 3 patients continued SPRYCEL treatment after dose reduction.
De hyppigst indberettede bivirkninger var væskeretention (inklusiv pleural effusion), diarré, hovedpine, kvalme, udslæt, dyspnø, blødning, træthed, muskelskeletale smerter, infektion, opkastning, hoste, abdominal smerter og pyreksi (Tabel 3).
The most frequently reported adverse reactions were fluid retention (including pleural effusion), diarrhoea, headache, nausea, skin rash, dyspnoea, haemorrhage, fatigue, musculoskeletal pain, infection, vomiting, cough, abdominal pain and pyrexia (Table 3).
Hos 5% af patienterne blev der indberettet lægemiddelrelateret febril neutropeni.
Drug-related febrile neutropenia was reported in 5% of patients.
Diverse bivirkninger som fx pleural effusion, ascites, lungeødem og perikardiel effusion, med eller uden perifert ødem, kan kollektivt beskrives som “ væskeretention ”.
Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and pericardial effusion with or without superficial oedema may be collectively described as “ fluid retention”.
Brug af dasatinib er forbundet med væskeretention i svær grad hos 9% af patienterne.
The use of dasatinib is associated with fluid retention with severe cases in 9% of patients.
Hos henholdsvis 6% og 1% af patienterne blev der indberettet svær pleural og perikardiel effusion.
Severe pleural and pericardial effusion were reported in 6% and 1% of patients, respectively.
Svær ascites og generaliseret ødem blev hver især indberettet hos < 1%.
Severe ascites and generalised oedema were each reported in < 1%.
1% af patienterne oplevede svært ikke- kardiogent lungeødem.
One percent of patients experienced severe non-cardiogenic pulmonary oedema.
Understøttende tiltag, der omfattede diuretika eller kortvarig behandling med steroider, kuperede sædvanligvis væskeretentionshændelser.
Fluid retention events were typically managed by supportive care measures that include diuretics or short courses of steroids.
4. 4).
While the safety profile of SPRYCEL in the elderly population was similar to that in the younger population, patients aged 65 years and older are more likely to experience fluid retention events and should be monitored closely (see section 4.4).
4. 4).
Bleeding drug-related events, ranging from petechiae and epistaxis to severe gastrointestinal haemorrhage and CNS bleeding, were reported in patients taking SPRYCEL (see section 4.4).
7 disse var forbundet med trombocytopeni CTC- grad 4.
Severe CNS haemorrhage occurred in < 1% of patients; 8 cases were fatal and 5 of them were associated with CTC grade 4 thrombocytopenia.
Hos 4% af patienterne forekom der svær gastrointestinal blødning og krævede generelt afbrydelse af behandling og transfusioner.
Severe gastrointestinal haemorrhage occurred in 4% of patients and generally required treatment interruption and transfusions.
Hos 2% af patienterne forekom der andre svære blødninger.
Other severe haemorrhage occurred in 2%
De fleste blødningsrelaterede hændelser var typisk forbundet med svær trombocytopeni.
Most bleeding related events were typically associated with severe thrombocytopenia.
Behandling med SPRYCEL er forbundet med anæmi, neutropeni og trombocytopeni.
Treatment with SPRYCEL is associated with anaemia, neutropenia and thrombocytopenia.
4. 4).
Their occurrence is more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML (see section 4.4).
8 måneder) (Tabel 2a).
In the Phase III dose-optimisation study in patients with chronic phase CML (median duration of treatment approximately 8 months), the incidence of pleural effusion and congestive heart failure/ cardiac dysfunction was lower in patients treated with SPRYCEL 100 mg once daily than in those treated with SPRYCEL 70 mg twice daily (Table 2a).
Myelosuppression sås også mindre hyppigt med 100 mg 1 gang dagligt (se nedenstående Abnormaliteter ved laboratorieundersøgelser).
Myelosuppression was also reported less frequently with the 100 mg once daily (see Laboratory test abnormalities below).
Tabel 2a:
Table 2a:
Udvalgte bivirkninger der blev indberettet i Fase III- forsøg vedrørende dosisoptimering:
Selected Adverse Drug Reactions Reported in Phase III Dose-Optimisation Study:
CML i kronisk fase 100 mg 1 gang 140 mg 1 gang 50 mg 2 gange 70 mg 2 gange dagligt dagligt dagligt dagligt n = 166 n = 163 n = 166 n = 167 Alle Grad Alle Grad Alle Grad Alle Grad grader 3/ 4 grader 3/ 4 grader 3/ 4 grader 3/ 4
Chronic Phase CML 100 mg once daily 140 mg once daily 50 mg twice daily 70 mg twice daily n = 166 n = 163 n = 166 n = 167 All Grade All Grade All Grade All Grade Grades 3/ 4 Grades 3/ 4 Grades 3/ 4 Grades 3/ 4
Procentdel (%) af
Percent (%) of
patienter
Patients
Diarré Væskeretention Overfladisk ødem Pleuraeffusion Generaliseret ødem Kongestivt hjerte - svigt/ hjerte - insufficiens
Diarrhoea Fluid Retention Superficial Oedema Pleural Effusion Generalised oedema
24 21 14 7 2 0
24 21 14 7 2
1 1 0 1 0 0
1 1 0 1 0
23 26 12 15 2 1
23 26 12 15 2
2 4 1 3 0 1
2 4 1 3 0
24 22 13 11 1 1
24 22 13 11 1
2 2 0 2 0 1
2 2 0 2 0
22 28 14 16 1 3
22 28 14 16 1
4 4 0 1 0 2
4 4 0 1 0
Perikardieeffusion Lungeødem Pulmonær hypertension Blødning
Pericardial effusion Pulmonary oedema Pulmonary hypertension Haemorrhage
I Fase III- forsøget vedrørende dosisoptimering med patienter med CML i fremskreden fase og Ph+ ALL blev væskeretention indberettet (pleuraeffusion og perikardieeffusion) mindre hyppigt hos de patienter der blev behandlet med SPRYCEL 140 mg 1 gang dagligt, end hos de patienter der blev behandlet med 70 mg 2 gange dagligt (Tabel 2b).
In the Phase III dose-optimisation study in patients with advanced phase CML and Ph+ ALL, fluid retention (pleural effusion and pericardial effusion) was reported less frequently in patients treated with SPRYCEL 140 mg once daily than in those treated with 70 mg twice daily (Table 2b).
8 Tabel 2b:
8 Table 2b:
Udvalgte bivirkninger der blev indberettet i Fase III- forsøg vedrørende dosisoptimering:
Selected Adverse Drug Reactions Reported in Phase Advanced Phase CML and Ph+ALL
CML i fremskreden fase og Ph+ALL 140 mg 1 gang dagligt 70 mg 2 gange dagligt n = 304 n = 305 Alle grader Grad 3/ 4 Alle grader Grad 3/ 4
140 mg once daily n = 304 All Grades Grade 3/ 4
Procentdel (%) af patienter
Percent (%) of Patients
Diarré Væskeretention Overfladisk ødem Pleuraeffusion Generaliseret ødem Kongestivt hjertesvigt / hjerteinsufficiens
Diarrhoea
27 26 12 16 1 1
27
3 27 5 34 < 1 16 4 23 0 2 0 2
3 27
3 9 1 6 1 1
3
Perikardieeffusion
Fluid Retention
0 4
34
1
9
Lungeødem Ascites Pulmonær hypertension Blødning
Pericardial effusion Pulmonary oedema Ascites Pulmonary hypertension
1 0 0
1 1 0 0
1 0 0
0 1 0 0
3 1 1
4 3 1 1
1 0 < 1
1 1 0 < 1
I kliniske forsøg anbefaledes det, at behandling med imatinib seponeredes mindst 7 dage inden påbegyndelse af behandling med SPRYCEL.
In clinical trials, it was recommended that treatment with imatinib be discontinued at least 7 days before starting treatment with SPRYCEL.
Følgende bivirkninger indberettedes hos patienter i kliniske forsøg med SPRYCEL.
The following adverse reactions were reported in patients in SPRYCEL clinical trials.
Disse reaktioner anføres efter organklasse og hyppigheden.
These reactions are presented by system organ class and by frequency.
Hyppigheden defineres som: meget almindelig (≥ 1/ 10); almindelig (≥ 1/ 100 til < 1/ 10); ikke almindelig (≥ 1/ 1. 000 til < 1/ 100); sjældne (≥ 1/ 10. 000 til < 1/ 1. 000).
Frequencies are defined as: 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).
Uønskede lægemiddelreaktioner, eksklusiv laboratorieabnormaliteter, som indberettedes hos ≥ 5% af patienter i kliniske forsøg med SPRYCEL vises i Tabel 3:
Adverse drug reactions, excluding laboratory abnormalities, that were reported in ≥ 5% of patients in SPRYCEL clinical trials are shown in Table 3:
Bivirkninger der blev indberettet hos ≥5% i kliniske forsøg
Adverse Drug Reactions (ADR) reported ≥ 5% in
Alle patienter (n= 2. 182) Procentdel (%) af patienter Alle grader Grad 3/ 4
All Patients (n= 2,182) Percent (%) of Patients
Blod og lymfesystem Almindelig: febril neutropeni Nervesystemet
Common: febrile neutropenia Nervous system disorders
Meget almindelig: hovedpine Almindelig: neuropati (inklusive perifer
Very common: headache Common: neuropathy (including
neuropati) Luftveje, thorax og mediastinum
peripheral neuropathy) Respiratory, thoracic and mediastinal disorders
Meget almindelige: pleuraeffusion,
Very common: pleural effusion, dyspnoea, cough Gastrointestinal disorders
25
25 21 10
6
6 4 < 1
dyspnø, hoste
Very common: diarrhoea, nausea, vomiting, abdominal pain
21 10
4 1 1 1
4 < 1
9
9 Mave- tarmkanalen Meget almindelige: diarré,
Common: gastrointestinal bleeding, mucosal inflammation (including
32
8
mucositis/ stomatitis),
mucositis/ stomatitis),
dyspepsi, abdominal udspiling Hud og subkutane væv
dyspepsia, abdominal distension Skin and subcutaneous tissue disorders a
Meget almindelig: udslæt
Very common: skin rash
Almindelig: pruritus Knogler, led, muskler og bindevæv
Common: pruritus Musculoskeletal and connective tissue disorders
Meget almindelig: muskelskeletale smerter
Very common: musculoskeletal pain Common: arthralgia,
myalgi Metabolisme og ernæring
myalgia Metabolism and nutrition disorders
Almindelig: anoreksi Infektioner og parasitære sygdomme
Common: anorexia Infections and infestations
Almindelige: infektion (inklusive bakteriel, viral, mykotisk, non- specifik) Vaskulære sygdomme b
Very common: infection (including bacterial, viral, fungal, non-specific) Vascular disorders
Meget almindelig: blødning Almene symptomer og reaktioner på administrationsstedet c
Very common: haemorrhageb General disorders and administration site conditions
Meget almindelige: overfladisk ødem træthed, pyreksia Almindelige: smerter, asteni, brystsmerter a
Very common: superficial oedemac, fatigue, pyrexia Common: pain, asthenia, chest pain a
Inkluderer lægemiddeludslæt, erythem, erythema multiforme, erythrosis, eksfoliativt udslæt, svampeudslæt, generaliseret erythem, genitalt udslæt, varmeudslæt, milia, udslæt, erythematøst udslæt, follikulært udslæt, generaliseret udslæt, makulært udslæt, makulo- papuløst udslæt, papuløst udslæt, pruritisk udslæt, purulent udslæt, vesikulært udslæt, eksfolierende hud, hudirritation og urticaria vesiculosa. b Eksklusive gastrointestinal blødning og CNS- blødning; disse bivirkninger er indberettet under bivirkninger relateret til henholdsvis mave- tarmkanalen og nervesystemet. c Inkluderer aurikulær hævelse, konjunktivalt ødem, øjenødem, hævede øjne, øjenlågsødem, ansigtsødem, gravitationelt ødem, læbeødem, lokaliseret ødem, makulært ødem, genitalt ødem, mundødem, perifert ødem, orbitalt ødem, penilt ødem, periorbitalt ødem, pittingødem, scrotalt ødem, hævet ansigt og tungeødem.
Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, fungal rash, generalised erythema, genital rash, heat rash, milia, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, skin irritation, and urticaria vesiculosa. b Excludes gastrointestinal bleeding and CNS bleeding; these ADRs are reported under the gastrointestinal disorders system organ class and the nervous system disorders system organ class, respectively. c Includes auricular swelling, conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, gravitational oedema, lip oedema, localised oedema, macular oedema, oedema genital, oedema mouth, oedema peripheral, orbital oedema, penile oedema, periorbital oedema, pitting oedema, scrotal oedema, swelling face, and tongue oedema.
Følgende bivirkninger er indberettet hos patienter i kliniske forsøg med SPRYCEL med en hyppighed på < 5%:
The following adverse drug reactions were reported in patients in the SPRYCEL clinical trials at a frequency of < 5%:
Undersøgelser Almindelige: vægttab, vægtøgning Ikke almindelig: forhøjet blod- kreatinphosphokinase
Investigations Common: weight decreased, weight increased Uncommon: blood creatine phosphokinase increased
10 Hjerte Almindelige: kongestivt hjertesvigt/ hjerteinsufficiens, perikardieeffusion, arytmi (inklusive takykardi), palpitationer Ikke almindelige: myokardieinfarkt, perikarditis, ventrikulær arytmi (inklusive ventrikulær takykardi), angina pectoris, kardiomegali Sjældne: cor pulmonale, myokarditis, akut koronarsyndrom
Cardiac disorders Common: congestive heart failure/ cardiac dysfunction, pericardial effusion, arrhythmia (including tachycardia), palpitations Uncommon: myocardial infarction, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly Rare: cor pulmonale, myocarditis, acute coronary syndrome
Blod og lymfesystem Almindelige: pancytopeni Sjældne: “ pure red cell ” anæmi
Blood and lymphatic system disorders Common: pancytopenia Rare: aplasia pure red cell
Nervesystemet Almindelige: svimmelhed, dysgeusi, søvnighed Ikke almindelige:
10 Nervous system disorders Common: dizziness, dysgeusia, somnolence Uncommon: