natgillin/translations-raw huggingface dataset:
Nogle bivirkninger er ikke almindelige (kan påvirke op til 1 ud af 100 patienter) - øget hudfølsomhed - tør i munden, ondt i halsen, sår i munden - smerter i brystet - smerter og hævede led (gigt) - øget appetit - opmærksomhedsforstyrrelse - kan ikke opnå eller opretholde rejsning - brystforstørrelse hos mænd - influenzalignende symptomer - lungebetændelse, bronkitis - urinvejsinfektion - herpes virus infektion - svamp i munden eller skeden - stivhed i muskler og led, hævede led - følelse af, at kropstemperaturen ændrer sig (inklusive svedeture, kuldefølelse) - følsomme tænder 
Some side effects are uncommon (may affect up to 1 in 100 people) - increased skin sensitivity - dry mouth, sore throat, mouth sores - breast pain - painful and swollen joints (gout) - increased appetite - attention disorder - inability to achieve or maintain an erection - breast enlargement in men - flu-like symptoms - pneumonia, bronchitis - urinary tract infection - herpes virus infection - oral or vaginal thrush - muscle and joint stiffness, joint swelling - feeling body temperature change (including feeling hot, feeling cold) - sensitive teeth
No Observed Effect Level (NOEL) for unge rotter anses for at være 6 mg/kg/dag baseret på en reduktion i kropsvægt hos begge køn og en forsinket preputial seperation hos hanrotter (som kan skyldes vægtreduktionen). 
Based on a reduction in body weight in both genders and a delayed preputial separation in males (which may be associated with the reduction in weight), the No-Observed-Effect-Level in juvenile rats was considered to be 6 mg/kg/day.
- 120 (3 pakninger med 40) hårde kapsler. 
- 120 (3 packs of 40) hard capsules.
Dosering til pædiatriske Philadelphiakromosom-positive CML-patienter Dosering til pædiatriske patienter er individuelt tilpasset og er baseret på kropsoverfladeareal (mg/m Den anbefalede dosis af nilotinib er 230 mg/m2 gange dagligt, afrundet til nærmeste 50 mg dosis (til en maksimal enkeltdosis på 400 mg) (se tabel 1). 
The recommended dose of nilotinib is 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg) (see Table 1).
De estimerede rater af patienter uden progression til accelereret fase eller blastkrise inklusive klonal evolution ved 72 måneder var henholdsvis 98,7 %, 97,9 % og 93,2 % (HR=0,1626 og stratificeret log-rank p=0,0009 mellem nilotinib 300 mg 2 gange dagligt og imatinib 1 gang dagligt, HR=0,2848 og stratificeret log-rank p=0,0085 mellem nilotinib 400 mg 2 gange dagligt og imatinib 1 gang dagligt). 
The estimated rates of patients free from progression to accelerated phase or blast crisis including clonal evolution at 72 months were 98.7%, 97.9% and 93.2%, respectively (HR=0.1626 and stratified log-rank p=0.0009 between nilotinib 300 mg twice daily and imatinib once daily, HR=0.2848 and stratified log-rank p=0.0085 between nilotinib 400 mg twice daily and imatinib once daily).
I alt 199 (35,2 %) af alle patienter var ikke evaluerbare for MMR ved 36 måneder (87 i nilotinib-gruppen, der fik 300 mg 2 gange dagligt og 112 i imatinib-gruppen) på grund af manglende/ikke evaluerbare PCR-vurderinger (n=17), atypiske transkriptioner ved baseline (n=7), eller ophør før 36-måneder (n=175). 
A total of 199 (35.2%) of all patients were not evaluable for MMR at 36 months (87 in the nilotinib 300 mg twice daily group and 112 in the imatinib group) due to missing/unevaluable PCR assessments (n=17), atypical transcripts at baseline (n=7), or discontinuation prior to the 36-month time point (n=175).
(eosinofiler) i blodet - øget indhold i blodet af lipase eller amylase (funktionen af bugspytkirtlen) - øget indhold i blodet af bilirubin eller leverenzymer (leverfunktionen) - øget indhold af kreatinin eller urinstof (nyrefunktionen) i blodet - lavt eller højt indhold af insulin i blodet (hormon, der regulerer blodsukkeret) - lavt eller højt indhold af sukker eller højt fedt-indhold (herunder kolesterol) i blodet - øget indhold af parathyroideahormon (et hormon som regulerer indholdet af calcium og fosfor) i blodet - ændringer af proteiner (lavt antal af globuliner eller tilstedeværelse af paraprotein) i blodet - højt indhold af enzymer (alkalisk fosfatase, laktatdehydrogenase eller kreatininfosfokinase) i blodet - højt indhold af kalium, calcium, fosfor eller urinsyre i blodet - lavt indhold af magnesium, kalium, natrium, calcium eller fosfor i blodet 
During Tasigna treatment, you may also have some abnormal blood test results such as: low level of blood cells (white cells, red cells, platelets) or haemoglobin increase in the number of platelets or white cells, or specific types of white cells (eosinophils) in the blood high blood level of lipase or amylase (pancreas function) high blood level of bilirubin or liver enzymes (liver function) high blood level of creatinine or urea (kidney function) low or high blood level of insulin (a hormone regulating blood sugar level) low or high level of sugar, or high level of fats (including cholesterol) in the blood high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus level) change in blood proteins (low level of globulins or presence of paraprotein) high blood levels of enzymes (alkaline phosphatase, lactate dehydrogenase or creatine phosphokinase) high blood level of potassium, calcium, phosphorus or uric acid low blood level of magnesium, potassium, sodium, calcium, or phosphorus
Hvis kun CML-relaterede dødsfald tages i betragtning, var de estimerede rater for total overlevelse ved 72 måneder henholdsvis 97,7 %, 98,5 % og 93,9 % (HR=0,3694 og stratificeret log-rank p=0,0302 mellem nilotinib 300 mg 2 gange dagligt og imatinib, HR=0,2433 og stratificeret log-rank p=0,0061,mellem nilotinib 400 mg 2 gange dagligt og imatinib). 
Considering only CML-related deaths as events, the estimated rates of overall survival at 72 months were 97.7%, 98.5% and 93.9%, respectively (HR=0.3694 and stratified log-rank p=0.0302 between nilotinib 300 mg twice daily and imatinib, HR=0.2433 and stratified log-rank p=0.0061 between nilotinib 400 mg twice daily and imatinib).
(eosinofiler) i blodet - øget indhold i blodet af lipase eller amylase (funktionen af bugspytkirtlen) - øget indhold i blodet af bilirubin eller leverenzymer (leverfunktionen) - lavt eller højt indhold af insulin i blodet (hormon, der regulerer blodsukkeret) - lavt eller højt indhold af sukker eller højt fedt-indhold (herunder kolesterol) i blodet - øget indhold af parathyroideahormon (et hormon som regulerer indholdet af calcium og fosfor) i blodet - ændringer af proteiner (lavt antal af globuliner eller tilstedeværelse af paraprotein) i blodet - højt indhold af alkalisk fosfatase i blodet - højt indhold af kalium, calcium, fosfor eller unrinsyre i blodet - lavt indhold af kalium eller calcium i blodet 
During Tasigna treatment, you may also have some abnormal blood test results such as: - low level of blood cells (white cells, red cells, platelets) or haemoglobin - increase in the number of platelets or white cells, or specific types of white cells (eosinophils) in the blood - high blood level of lipase or amylase (pancreas function) - high blood level of bilirubin or liver enzymes (liver function) - low or high blood level of insulin (a hormone regulating blood sugar level) - low or high level of sugar, or high level of fats (including cholesterol) in the blood - high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus level) - change in blood proteins (low level of globulins or presence of paraprotein) - high blood level of alkaline phosphatase - high blood level of potassium, calcium, phosphorus or uric acid - low blood level of potassium or calcium
120 (3 pakninger med 40) hårde kapsler. 
120 (3 packs of 40) hard capsules.
Titandioxid (E 171) Jernoxid, gul (E 172) 
Titanium dioxide (E171) Yellow iron oxide (E172)
Nogle bivirkninger er almindelige (kan påvirke op til 1 ud af 10 patienter) - diarré, opkastning, mavesmerter, ubehag i maven efter måltider, luft i tarmene, hævelse eller opsvulmen af maven, forstoppelse - smerter i knoglerne, smerter i leddene, muskelspasmer, muskelsvaghed, smerter i armene eller benene, rygsmerter, smerte eller ubehag i siden af kroppen - infektioner i de øvre lufveje - tør hud, urenheder i huden, vorter, mindsket hudfølsomhed - tab af appetit, smagsforstyrrelser, vægtstigning - søvnløshed, angst, depression - natlige svedeture, stor svedafsondring 
Some side effects are common (may affect up to 1 in 10 people) - diarrhoea, vomiting, abdominal pain, stomach discomfort after meals, flatulence, swelling or bloating of the abdomen, constipation - bone pain, pain in joints, muscle spasms, muscle weakness, pain in extremity, back pain, pain or discomfort in the side of the body - upper respiratory tract infections - dry skin, acne, wart, decreased skin sensitivity - loss of appetite, disturbed sense of taste, weight increase - insomnia, anxiety, depression - night sweats, excessive sweating
Nogle bivirkninger er meget almindelige (kan påvirke mere end 1 ud af 10 patienter) - hovedpine - træthed - muskelsmerte - kløe, udslæt - kvalme - hårtab - muskelskeletale smerter, muskelsmerter, smerter i arme og/eller ben, ledsmerter, knoglesmerter og ryg smerter efter ophør med behandlingen med Tasigna langsommere vækst hos børn og unge 
Some side effects are very common (may affect more than 1 in 10 people) - headache - tiredness - muscle pain - itching, rash - nausea - hair loss - musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain upon discontinuing treatment with Tasigna - slowing of growth in children and adolescents
9/l og/eller trombocytter <10 x 10 
9/l and/or platelet counts <10 x 10
Nogle bivirkninger er almindelige (kan påvirke op til 1 ud af 10 patienter) - infektioner i de øvre lufveje - ubehag i maven efter måltider, luft i tarmene, hævelse eller opsvulmen af maven - smerter i knoglerne, smerter i leddene, muskelspasmer, muskelsvaghed - smerter inklusive rygsmerter, nakkesmerter og smerter i lemmerne, smerte eller ubehag i siden af kroppen - tør hud, urenheder i huden, vorte, mindsket hudfølsomhed, nældefeber - tab af appetit, smagsforstyrrelser, vægtstigning eller vægttab - søvnløshed, depression, angst - natlige svedeture, stor svedafsondring - generel utilpashed - forstyrrelser af stemmen - næseblod - hyppig vandladning 
Some side effects are common (may affect up to 1 in 10 people) - upper respiratory tract infections - stomach discomfort after meals, flatulence, swelling or bloating of the abdomen - bone pain, pain in joints, muscle spasms, muscle weakness - pain including back pain, neck pain and pain in extremity, pain or discomfort in the side of the body - dry skin, acne, wart, decreased skin sensitivity, hives - loss of appetite, disturbed sense of taste, weight decrease or increase - insomnia, depression, anxiety - night sweats, excessive sweating - generally feeling unwell - voice disorder - nose bleed - frequent urine output
De estimerede rater af patienter uden progression til accelereret fase eller blastkrise ved 72 måneder, var henholdsvis 99,3 %, 98,7 % og 95,2 % (HR=0,1599 og stratificeret log-rank p=0,0059 mellem nilotinib 300 mg 2 gange dagligt og imatinib 1 gang dagligt, HR=0,2457 og stratificeret log-rank p=0,0185 mellem nilotinib 400 mg 2 gange dagligt og imatinib 1 gang dagligt). 
The estimated rates of patients free from progression to accelerated phase or blast crisis at 72 months were 99.3%, 98.7% and 95.2%, respectively (HR=0.1599 and stratified log-rank p=0.0059 between nilotinib 300 mg twice daily and imatinib once daily, HR=0.2457 and stratified log-rank p=0.0185 between nilotinib 400 mg twice daily and imatinib once daily).
Nogle bivirkninger er meget almindelige (kan påvirke mere end 1 ud af 10 patienter) - diarré - hovedpine - træthed, mangel på energi - muskelsmerte - kløe, udslæt - kvalme - mavesmerter - forstoppelse - opkastning - hårtab - muskelskeletale smerter, muskelsmerter, smerter i arme og/eller ben, ledsmerter, knoglesmerter og rygsmerter efter ophør med behandlingen med Tasigna - langsommere vækst hos børn og unge 
Some side effects are very common (may affect more than 1 in 10 people) - diarrhoea - headache - tiredness, lack of energy - muscle pain - itching, rash - nausea - abdominal pain - constipation - vomiting - hair loss - musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain upon discontinuing treatment with Tasigna - slowing of growth in children and adolescents
Dosering til voksne Philadelphiakromosom-positive CML-patienter Den anbefalede dosis er: - 300 mg 2 gange dagligt til patienter med nydiagnosticeret CML i kronisk fase. 
Posology for Philadelphia chromosome positive CML adult patients The recommended dose is: - 300 mg twice daily in newly diagnosed patients with CML in the chronic phase, - 400 mg twice daily in patients with chronic or accelerated phase CML with resistance or intolerance to prior therapy.
Imatinib 400 mg 1 gang dagligt n=283 
Imatinib 400 mg once daily n=283
I fase III-studiet med patienter med nydiagnosticeret CML i kronisk fase, som behandledes med 300 mg imatinib to gange dagligt, var den gennemsnitlige ændring fra baseline i QTcF-intervallet ved steady state 6 msek. 
In the Phase III study in patients with newly diagnosed CML in chronic phase receiving 300 mg nilotinib twice daily, the change from baseline in mean time-averaged QTcF interval at steady state was 6 msec. No patient had a QTcF >480 msec. No episodes of torsade de pointes were observed.
Hvidt til gulligt pulver i hård gelatinekapsel med rød, uigennemsigtig øverste del og lysegul, uigennemsigtig nederste del, størrelse 4 med ”NVR/ABL” præget med sort på øverste del. Tasigna 200 mg hårde kapsler 
White to yellowish powder in hard gelatin capsule with red opaque cap and light yellow opaque body, size 4 with black radial imprint “NVR/ABL” on cap.
Øjenlågsødem, fotopsi, konjunktival blødning, hyperæmi (skleral, konjunktival, okulær) 
Eyelid oedema, photopsia, conjunctival haemorrhage, hyperaemia (scleral, conjunctival, ocular)
I alt 322 (38,1 %) af alle patienter var ikke evaluerbare for MMR efter 60 måneder (99 i nilotinib 300 mg to gange dagligt gruppen, 93 i nilotinib 400 mg to gange dagligt gruppen og 130 i imatinib-gruppen) på grund af manglende / ikke evaluerbare PCR-vurderinger (n=9), atypiske transkripter ved baseline (n=8) eller seponering forud for 60-måneders tidspunktet (n=305). 
A total of 322 (38.1%) of all patients were not evaluable for MMR at 60 months (99 in the nilotinib 300 mg twice daily group, 93 in the nilotinib 400 mg twice daily group and 130 in the imatinib group) due to missing/unevaluable PCR assessments (n=9), atypical transcripts at baseline (n=8) or discontinuation prior to the 60-month time point (n=305).
Delpakning af multipakning med 4 pakninger. 
Component of a multipack comprising 4 cartons.
Multipakning: 112 (4 pakninger med 28) hårde kapsler. 
Multipack: 112 (4 packs of 28) hard capsules.
10 % af patienterne seponerede Tasigna på grund af bivirkninger. 
Discontinuation due to adverse drug reactions was observed in 10% of patients.
• Multipakninger indeholdende 112 (4 pakninger med 28) hårde kapsler. 
• Multipacks containing 112 (4 packs of 28) hard capsules.
I alt 395 (46,7 %) af alle patienter var ikke evaluerbare for MMR efter 72 måneder (130 i nilotinib 300 mg to gange dagligt gruppen, 110 i nilotinib 400 mg to gange dagligt gruppen og 155 i imatinib-gruppen) på grund af manglende / ikke evaluerbare PCR-vurderinger (n=25), atypiske transkripter ved baseline (n=8) eller seponering forud for 72-måneders tidspunktet (n=362). 
A total of 395 (46.7%) of all patients were not evaluable for MMR at 72 months (130 in the nilotinib 300 mg twice daily group, 110 in the nilotinib 400 mg twice daily group and 155 in the imatinib group) due to missing/unevaluable PCR assessments (n=25), atypical transcripts at baseline (n=8) or discontinuation prior to the 72-month time point (n=362).
PVC/PVDC/Alu [i karton] 40 hårde kapsler 
PVC/PVDC/Alu [in carton] 40 hard capsules
Nedsat uddrivningsfraktion, perikardiel effusion, perikarditis, diastolisk dysfunktion, ventresidig grenblok Vaskulære sygdomme Almindelig: 
Ejection fraction decrease, pericardial effusion, pericarditis, diastolic dysfunction, left bundle branch block
CML-AP n=137 Grad 3-4 
CMLAP n=137 Grade
De fleste af patienterne havde et langt forløb med CML med ekstensiv forudgående behandling med andre antineoplastiske stoffer, inkl. 
The majority of patients had a long history of CML that included extensive prior treatment with other antineoplastic agents, including imatinib, hydroxyurea, interferon, and some had even failed organ transplant (Table 11).
PVC/PVDC/Alu [i karton] 120 hårde kapsler 
PVC/PVDC/Alu [in carton] 120 hard capsules
CML-C P n=321 Grad 
CMLCP n=321 Grade
PVC/PVDC/Alu [i karton] 112 hårde kapsler 
PVC/PVDC/Alu [in carton] 112 hard capsules
Almindelig 6 
1 Common
BCR-ABL kinase-domæne-mutationstest skal udføres hos patienter, der ikke kan opretholde MMR 3 måneder efter genoptagelse af behandlingen. 
For patients who fail to achieve MMR after three months of treatment re-initiation, BCR-ABL kinase domain mutation testing should be performed.
Det kan overvejes at seponere behandling af egnede voksne Philadelphiakromosom-positive (Ph+) CML-patienter i kronisk fase, som er blevet behandlet med 300 mg nilotinib to gange dagligt i mindst 3 år, hvis et dybt molekylært respons har været opretholdt i mindst et år umiddelbart før seponering af behandlingen. 
Adult Philadelphia chromosome positive CML patients in chronic phase who have been treated with nilotinib as first-line therapy and who achieved a sustained deep molecular response (MR4.5) Discontinuation of treatment may be considered in eligible adult Philadelphia chromosome positive (Ph+) CML patients in chronic phase who have been treated with nilotinib at 300 mg twice daily for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately prior to discontinuation of therapy.
QTcF-øgning fra baseline på mere end 60 msek. 
QTcF increase from baseline exceeding 60 msec was observed in <1% of patients while on the study medicinal product.
- pædiatriske patienter med Philadelphiakromosom-positiv CML, i kronisk fase, som er resistent eller intolerant over for tidligere behandling, herunder imatinib. 
Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Det kan overvejes at seponere behandling af egnede voksne Philadelphiakromosom-positive (Ph+) CML-patienter i kronisk fase, som er blevet behandlet med nilotinib i mindst 3 år, hvis et dybt molekylært respons har været opretholdt i mindst et år umiddelbart før seponering af behandlingen. 
Adult Philadelphia chromosome positive CML patients in chronic phase who have achieved a sustained deep molecular response (MR 4.5) on nilotinib following prior imatinib therapy Discontinuation of treatment may be considered in eligible adult Philadelphia chromosome positive (Ph+) CML patients in chronic phase who have been treated with nilotinib for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately prior to discontinuation of therapy.
Ændringen i baseline i tid for det gennemsnitlige QTcF-interval ved steady-state var 6 msek. 
The change from baseline in mean time-averaged QTcF interval at steady state was 6 msec. No patient had an absolute QTcF >500 msec while on the study medicinal product.
PVC/PVDC/Alu [i folder] 112 hårde kapsler 
PVC/PVDC/Alu [in wallet] 112 hard capsules
Titandioxid (E 171) Jernoxid, rød (E 172) Jernoxid, gul (E 172) 
Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
I alt 305 (36,1 %) af alle patienter var ikke evaluerbare for MMR ved 48 måneder (98 i nilotinib-gruppen, der fik 300 mg 2 gange dagligt, 88 i nilotinib-gruppen, der fik 400 mg 2 gange dagligt, og 119 i imatinib-gruppen) på grund af manglende/ikke evaluerbare PCR-vurderinger (n=18), atypiske transkriptioner ved baseline (n=8) eller ophør før 48-måneder (n=279). 
A total of 305 (36.1%) of all patients were not evaluable for MMR at 48 months (98 in the nilotinib 300 mg twice daily group, 88 in the nilotinib 400 mg twice daily group and 119 in the imatinib group) due to missing/unevaluable PCR assessments (n=18), atypical transcripts at baseline (n=8), or discontinuation prior to the 48-month time point (n=279).
Muskuloskeletale smerter, lændesmerter 
Musculoskeletal stiffness, joint swelling
KARTON MED DELPAKNINGER 
INTERMEDIATE CARTON
laboratorieabnormaliteter), som rapporteres hos mindst 5 % af de voksne patienter i kliniske studier af Tasigna, som ligger til grund for de godkendte indikationer, er vist i tabel 3. 
Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the adult patients in Tasigna clinical studies that serve as the basis for the approved indications are shown in Table 3.
nældefeber, svampeinfektion på fødderne - fortykkede hudpletter med rød/sølvfarvet hud (tegn på psoriasis) - øget hudoverfølsomhed - blødning, ømme eller hævede gummer - næseblod - tør mund, ondt i halsen, sår i munden - hyppig vandladning - hæmorroider, bylder i endetarmen - betændelse i tarmene (enterocolitis) - herpes virus infektion - følelse af spændte bryster, kraftige menstruationer, hævelse af brystvorterne - spiseforstyrrelse, vægttab - forstørrelse af bryster hos mænd - symptomer på restless legs syndrom (en uimodståelig trang til at bevæge en del af kroppen, som regel benene, ledsaget af ubehagelige følelser) 
- increased skin sensitivity - bleeding, tender or enlarged gums - nose bleed - dry mouth, sore throat, mouth sores - frequent urine output - haemorrhoids, anal abscess - enterocolitis (inflammation of the bowel) - herpes virus infection - feeling of hardening in the breasts, heavy periods, nipple swelling - appetite disorder, weight decreased - breast enlargement in men - symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
Tasigna er indiceret til behandling af: - voksne og pædiatriske patienter med nydiagnosticeret Philadelphiakromosom-positiv kronisk myeloid leukæmi (CML) i kronisk fase. 
Tasigna is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib.
Eksfoliativt udslæt, medikamentelt udsæt, smerte i huden, ekkymose, hævet ansigt 
Exfoliative rash, drug eruption, skin pain, ecchymosis, swelling face
Febril neutropeni 
Renal impairment
PVC/PVDC/Alu [i karton] 28 hårde kapsler 
PVC/PVDC/Alu [in carton] 28 hard capsules
Øjenblødning, periorbitalt ødem, øjenkløe, konjunktivitis, tørre øjne (inklusive xeroftalmi) 
Eye haemorrhage, periorbital oedema, eye pruritus, conjunctivitis, dry eye (including xerophthalmia)
Kronisk CML n=321 
Chronic phase n=321
Ingen forsøgspersoner havde et QTcF >450 msek. 
No subject had a QTcF >450 msec. Additionally, no clinically relevant arrhythmias were observed during the conduct of the trial.
Brystspændinger, menorrhagi, hævede brystvorter Almene symptomer og reaktioner på administrationsstedet Almindelig: 
Breast induration, menorrhagia, nipple swelling General disorders and administration site conditions Common:
Multipakning: 112 (4 foldere med 28) hårde kapsler. 
Multipack: 112 (4 wallets of 28) hard capsules.
Pulmonal hypertension, pibende vejrtrækning, orofaryngeal smerte 
Pulmonary hypertension, wheezing, oropharyngeal pain Gastrointestinal disorders
Hvis den tidligere dosis var 400 mg 1 gang dagligt hos voksne patienter, eller 230 mg/m 
If the prior dose was 400 mg once daily in adult patients or 230 mg/m once daily in paediatric patients, treatment should be discontinued.