natgillin/translations-raw huggingface dataset:
Den mediane PFS (95 % CI) var 12,5 måneder (7,26, 14,03) i panobinostat + bortezomib + dexamethason-armen og 4,7 måneder (3,71, 6,05) i placebo + bortezomib + dexamethason-armen [HR: 0,47 (0,31, 0,72)].
The median PFS (95% CI) was 12.5 months (7.26, 14.03) in the panobinostat + bortezomib + dexamethasone arm and 4.7 months (3.71, 6.05) in the placebo + bortezomib + and dexamethasone arm [HR: 0.47 (0.31, 0.72)].
Panobinostateksponering udløste desuden en øget ekspression af tumorsuppressorgenet p21CDKNIA (cyklinafhængig kinasehæmmer 1/p21)-gen, en vigtig mediator af G1-standsning ogdifferentiering.
In addition, increased expression of the tumour suppressor gene p21CDKNIA (cyclin dependent kinase inhibitor 1/p21) gene, a key mediator of G1 arrest and differentiation, was triggered with panobinostat exposure.
Placebo bortezomib og dexamethason N=74
Placebo bortezomib and dexamethasone N=74
PAN=panobinostat BTZ= bortezomib Dex = dexamethason
PAN=panobinostat BTZ= bortezomib Dex = dexamethasone
- medicin til behandling af hoste, som fx dextromethorphan.
- medicines used to treat cough, such as dextromethorphan.
Der var 33.3% patienter i panobinostat + bortezomib + dexamethason armen og 10,3% patienter i placebo + bortezomib + dexamethason armen, der fik trombocyttransfusion under behandling.
33.3% patients in the panobinostat + bortezomib + dexamethasone arm and 10.3% patients in the placebo + bortezomib + dexamethasone arm received platelet transfusions during treatment.
- medicin til behandling af brystkræft, som fx tamoxifen.
- medicines used to treat breast cancer, such as tamoxifen.
For patienter >75 år kan justering af startdosis eller af planen for kombinationsbehandlingens komponenter overvejes afhængig af patientens almentilstand og samtidige sygdomme (se pkt.
For patients >75 years of age, depending on the patient's general condition and concomitant diseases, an adjustment of the starting doses or schedule of the components of the combination regimen may be considered (see section 4.2).
Hjertetilfælde (oftest atrieflimren, takykardi, palpitation og sinustakykardi) blev rapporteret hos 17,6% af panobinostat + bortezomib + dexamethason-behandlede patienter versus 9,8% af placebo + bortezomib + dexamethason-behandlede patienter og synkope tilfælde blev rapporteret hos henholdsvis 6,0% versus 2,4%.
Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation and sinus tachycardia) were reported in 17.6% of panobinostat + bortezomib + dexamethasone-treated patients versus 9.8% of placebo + bortezomib + dexamethasone-treated patients and syncope events were reported in 6.0% versus 2.4%, respectively.
Uge 2 Dage
Week 2 Days
Virkningen af leverinsufficiens på farmakokinetikken af panobinostat blev evalueret i et fase I-forsøg hos 24 patienter med solide tumorer og varierende grader af leverinsufficiens.
The effect of hepatic impairment on the pharmacokinetics of panobinostat was evaluated in a phase I study, in 24 patients with solid tumours and with varying degrees of hepatic impairment.
• kraftig hovedpine, svaghedsfølelse eller lammelse i arme, ben eller ansigt, talebesvær, pludselig besvimelse (mulige tegn på problemer i nervesystemet, som fx blødning eller hævelse i kraniet eller hjernen)
• severe headache, feeling weak or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (potential signs of nervous system problems such as bleeding or swelling in the skull or brain)
Trombocytter 10 x 109/l
Platelets 10 x 109/l
Dosiseskalering fra 10 mg til 15 mg kan overvejes baseret på patientens tolerabilitet.
A dose escalation from 10 mg to 15 mg may be considered based on patient tolerability.
I denne undergruppe af patienter (N=147) var den mediane behandlingstid 4,5 måneder i panobinostat + bortezomib + dexamethason-armen og 4,8 måneder i placebo + bortezomib + dexamethason-armen.
In this subset of patients (N=147), the median duration of treatment was 4.5 months in the panobinostat + bortezomib + dexamethasone arm and 4.8 months in the placebo + bortezomib + dexamethasone arm.
Overvej dosiseskalering op til 15 mg i efterfølgende cyklusser baseret på patient-tolerabilitet.
Consider dose escalation up to 15 mg in subsequent cycles based on patient tolerability.
• ophostning af blod, blodig væske, der siver ud af næsen (tegn på blødning i lungerne)
• coughing up blood, oozing of bloody fluid from the nose (signs of bleeding in the lungs)
Stærke inducere forventes at have en større virkning og kan nedsætte panobinostats effekt, hvorfor samtidig brug af stærke CYP3A4-inducere, herunder, men ikke begrænset til carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin og prikbladet perikon (Hypericum perforatum), skal undgås.
Strong inducers are expected to have greater effects, and may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided.
Jernoxid, sort (E172) Propylenglycol (E1520) Schellak-glasur
Iron oxide, black (E172) Propylene glycol (E1520) Shellac glaze
Den mediane OS var henholdsvis 40,3 måneder i panobinostat + bortezomib + dexamethason-armen og 35,8 måneder i placebo + bortezomib + dexamethason-armen (hazard ratio: 0,94 (95 % CI: 0,78; 1,14)).
The median OS was 40.3 months in the panobinostat + bortezomib + dexamethasone arm and 35.8 months in the placebo + bortezomib + dexamethasone arm (Hazard ratio: 0.94 (95% CI: 0.78, 1.14)).
• forhøjet mængde urinsyre i blodet
• increased blood level of uric acid
- hvis du bemærker et eller flere tegn på problemer med leveren.
- if you notice any signs of a liver problem.
Farydak 10 mg hårde kapsler Farydak 15 mg hårde kapsler Farydak 20 mg hårde kapsler
Farydak 10 mg hard capsules Farydak 15 mg hard capsules Farydak 20 mg hard capsules
Bortezomibdosis ved bedring til ≤ grad 1
Bortezomib dose on recovery to ≤ grade 1
- medicin til behandling af uregelmæssig hjerterytme, som fx amiodaron, disopyramid,
- medicines used to treat irregular heartbeat, such as amiodarone, disopyramide, procainamide,
Der blev rapporteret tilfælde af mild hypothyroidisme i patienter, der var behandlet med panobinostat + bortezomib + dexamethason i studiet D2308, og nogle patienter krævede behandling (se pkt.
Mild hypothyroidism was reported in patients treated with panobinostat + bortezomib + dexamethasone in Study D2308; some patients required treatment (see section 4.4).
Panobinostat øgede Cmax og AUC for dextromethorphan (et substrat for CYP2D6) henholdsvis 1,8 og 1,6 gange, og det kan ikke udelukkes, at effekten kan blive større med et mere sensitiv CYP2D6 substrat.
1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate.
Meget almindelig Pancytopeni, trombocytopeni, anæmi, leukopeni, neutropeni, lymfopeni
Very common Pancytopenia, thrombocytopenia, anaemia, leukopenia, neutropenia, lymphopenia
blev registreret hos 1,3 % af patienterne, og ændring fra baseline på >60 msek.
QTcF >480 and <500 msec was recorded in 1.3% of patients and change from baseline of >60 msec was observed in 0.8% of patients.
Tabel 8 Progressionsfri overlevelse hos patienter, der tidligere har modtaget mindst 2 forudgående behandlingsregimer, herunder med bortezomib og en immunmodulator
Table 8 Progression-free survival in patients who received at least two prior regimens including bortezomib and an immunomodulating agent
Behandling med panobinostat bør undgås hos patienter med nedsat leverfunktion, der samtidigt er i behandling med lægemidler, som er stærke CYP3A4-hæmmere, på grund af manglende erfaring og sikkerhedsdata i denne patientgruppe.
In patients with hepatic impairment receiving concomitant medicinal products which are strong CYP3A4 inhibitors, treatment with panobinostat should be avoided due to lack of experience and safety data in this patient population.
• mavesmerter, kvalme, diarré, opkastning, sort eller blodig afføring, forstoppelse, halsbrand,
• stomach or abdominal pain, nausea, diarrhoea, vomiting, black or bloody stools, constipation,
Trombocyttransfusioner kan være nødvendigt, hvis det er klinisk indiceret (se pkt.
Platelet transfusions may be required, if clinically indicated (see section 4.4).
Leverfunktionstests
Liver function tests
Antiemetisk medicin med en kendt risiko for QT-forlængelse, såsom dolasetron, granisetron, ondansetron og tropisetron, skal anvendes med forsigtighed (se pkt.
Anti-emetic medicinal products with a known risk of QT prolongation such as dolasetron, granisetron, ondansetron and tropisetron should be used with caution (see section 4.4).
Delvist respons
Adverse reaction
Grad 3 trods lægemidler mod diarré
Grade 3 despite anti-diarrhoeal medicinal product
Grad 4 trods lægemidler mod diarré
Grade 4 despite anti-diarrhoeal medicinal product
• stærkt nedsat urinmængde, hævede ben (tegn på et nyreproblem)
• severely decreased urine output, swelling of the legs (signs of a kidney problem)
Titandioxid (E171) Brilliant blue FCF (E133) Jernoxid, gul (E172)
Titanium dioxide (E171) Brilliant blue FCF (E133) Iron oxide, yellow (E172)
Hos patienter, der tager samtidige lægemidler, som er stærke CYP3A- og/eller Pgp-hæmmere, herunder, men ikke begrænset til ketoconazol, itraconazol, voriconazol, ritonavir, saquinavir, telithromycin, posaconazol og nefazodon, bør panobinostat-dosis nedsættes (se pkt.
In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, including, but not limited to, ketoconazole, itraconazole, voriconazole, ritonavir, saquinavir, telithromycin, posaconazole and nefazodone, the dose of panobinostat should be reduced (see section 4.2).
Træthed og asteni
Fatigue and asthenia
Andre mulige bivirkninger Fortæl det til lægen eller på apoteket, hvis nogle af disse bivirkninger bliver alvorlige.
Other possible side effects If any of the side effects below becomes severe, tell your doctor, or your pharmacist.
kortåndethed eller åndedrætsbesvær, smerte eller svie ved vandladning, overdreven vandladningstrang, blod i urinen (tegn på en infektion i lungerne eller urinvejene)
pain or burning feeling when passing urine, exaggerated sense of needing to pass urine, blood in urine (signs of an infection in the lungs or urinary tract)
Tabel 4 Anbefalede dosisændringer for gastrointestinal toksicitet Bivirkning Grad på behandlingsdagen
Table 4 Recommended dose modifications for gastrointestinal toxicity Adverse drug reaction
PFS baseret på full analysis set (FAS) var statistisk signifikant forskellig i de to behandlingsarme (stratificeret log-rank-test p<0,0001, med en estimeret risikoreduktion på 37 % i behandlingsarmen med panobinostat + bortezomib + dexamethason sammenlignet med behandlingsarmen med placebo + bortezomib + dexamethason (hazard ratio: 0,63 (95 % CI: 0,52; 0,76)), i den overordnede patientpopulation.
In the overall patient population PFS based on the full analysis set (FAS) was statistically significantly different between the treatment arms (stratified Log-rank test p<0.0001, with an estimated 37% risk reduction in the panobinostat + bortezomib + dexamethasone arm compared to the placebo + bortezomib + dexamethasone arm (Hazard ratio: 0.63 (95% CI: 0.52, 0.76)).
Lægemidler, hvis plasmakoncentrationer kan forøges af panobinostat
Agents whose plasma concentrations may be increased by panobinostat
Dødsfald under behandlingen, som ikke skyldtes forsøgets indikation (myelomatose), blev indberettet hos 6,8 % af de patienter, der fik panobinostat + bortezomib + dexamethason, versus 3,2 % af de patienter, der fik placebo + bortezomib + dexamethason.
On-treatment deaths not due to the study indication (multiple myeloma) were reported in 6.8% of panobinostat + bortezomib + dexamethasone-treated patients versus 3.2% of placebo + bortezomib + dexamethasone-treated patients.
Bortezomib-dosis ved bedring til grad 2 thrombocytopeni
Bortezomib dose on recovery to grade 2 thrombocytopenia
Panobinostatdosis ved bedring til ≤ grad 1
Panobinostat dose on recovery to ≤ grade 1
De erythropoietiske, myelopoietiske og lymfatiske systemer blev identificeret som primære målorganer for toksisitet efter administration af panobinostat hos rotter og hunde.
The primary target organs of toxicity following administration of panobinostat in rats and dogs were identified as the erythropoietic, myelopoietic and lymphatic systems.
Respirationssvigt, rhonchi, hvæsende vejrtrækning, epistaxis
Respiratory failure, rales, wheezing, epistaxis
Dag 9
Day 9
Figur 2 Kaplan-Meier plot for progressionsfri overlevelse hos patienter med myelomatose, der tidligere har modtaget mindst 2 forudgående behandlingsregimer, herunder med bortezomib og en immunmodulator
Figure 2 Kaplan-Meier plot of progression-free survival in patients with multiple myeloma who received at least two prior regimens including bortezomib and an immunomodulatory agent
Poolede kliniske data fra over 500 patienter, der blev behandlet med panobinostat alene mod flere indikationer og med forskellige dosisniveauer, har vist, at forekomsten af CTC-grad 3 QTc-forlængelse (QTcF >500 msek.)
Pooled clinical data from over 500 patients treated with panobinostat alone in multiple indications and at different dose levels have shown that the incidence of CTC grade 3 QTc prolongation (QTcF >500 msec) was approximately 1% overall and 5% or more at a dose of 60 mg or higher; no episodes of torsades de pointes were observed.
Patienter med mild nedsat leverfunktion skal startes med panobinostat på en nedsat dosis på 15 mg under den første behandlingscyklus.
Patients with mild hepatic impairment should be started on panobinostat at a reduced dose of 15 mg during the first treatment cycle.
Patienter med moderat nedsat leverfunktion skal startes på panobinostat med en nedsat dosis på 10 mg under den første behandlingscyklus.
Patients with moderate hepatic impairment should be started on panobinostat at a reduced dose of 10 mg during the first treatment cycle.
>1,0 x ULN og
>1.0 x ULN and ≤1.5 x ULN
- medicin til behandling af depression, som fx nefazodon.
- medicines used to treat depression, such as nefazodone.
Blødning er blevet indberettet hos patienter, der var i behandling med panobinostat.
Haemorrhage has been reported in patients during treatment with panobinostat.
• generel utilpashed
• generally feeling unwell
Grad 2 trods lægemidler mod diarré
Diarrhoea Grade 2 despite anti-diarrhoeal medicinal product
- medicin til at behandle forhøjet blodtryk, som fx metoprolol eller nebivolol.
- medicines used to treat hypertension, such as metoprolol or nebivolol.
Lægemidler, hvis plasmaeksponering kan nedsættes af panobinostat
Agents whose plasma exposure can be decreased by panobinostat
• ukontrolleret eller signifikant hjertesygdom, herunder nylig myokardieinfarkt, kongestiv hjerteinsufficiens, ustabil angina pectoris eller klinisk signifikant bradykardi.
congestive heart failure, unstable angina or clinically significant bradycardia.
ved baseline) skal behandlingens start udsættes, indtil det gennemsnitlige førdosis-QTcF er vendt tilbage til <480 msek.
In the event of long QT interval prior to initiation of panobinostat (QTcF ≥480 msec at baseline), the start of treatment should be delayed until pre-dose average QTcF has returned to <480 msec.
Lægemidler, der forventes at nedsætte koncentrationen af panobinostat
Agents that are predicted to decrease panobinostat concentrations
Meget almindelig Svimmelhed, hovedpine Almindelig
Nervous system disorders Very common Dizziness, headache Common
Trombocytter <25 x 109/l
Grade 4 Platelets <25 x 109/l
Opfølgningens mediane varighed var 28,75 måneder i behandlingsarmen med panobinostat + bortezomib + dexamethason og 29,04 måneder i behandlingsarmen med placebo + bortezomib + dexamethason.
The median duration of follow-up was 28.75 months in the panobinostat + bortezomib + dexamethasone arm and 29.04 months in the placebo + bortezomib + dexamethasone arm.
Brug af anden medicin sammen med Farydak
Other medicines and Farydak
Kvinder i den fødedygtige alder, der tager panobinostat i kombination med bortezomib og dexamethason, skal anvende yderst effektiv kontraception i tre måneder efter behandlingsophør (se pkt.
Women of childbearing potential taking panobinostat in combination with bortezomib and dexamethasone must use highly effective contraception for three months after stopping treatment (see sections 4.5 and 4.6 and bortezomib and dexamethasone SmPC).
• vægtstigning, træthed, hårtab, muskelsvækkelse, kuldskærhed (tegn på en underaktiv skjoldbruskkirtel, hvilket kaldes hypothyroidisme)
• weight gain, feeling tired, hair loss, muscle weakness, feeling cold (signs of an underactive thyroid gland, which is known as hypothyroidism)
Der kræves dosisjusteringer i tilfælde af samtidig brug af stoffer, der kan øge plasmakoncentrationer af panobinostat såsom CYP3A4-hæmmere (se pkt.
In case of concomitant use of agents that may increase panobinostat plasma concentrations, such as strong CYP3A4 inhibitors, dose adjustment is required (see sections 4.5 and 4.2).
Hæmatologiske toksiske virkninger, der opstod under behandlingen, var trombocytopeni, anæmi, neutropeni og lymfopeni.
Treatment-emergent haematological toxicities included thrombocytopenia, anaemia, neutropenia and lymphopenia.
Midler, der kan øge plasmakoncentrationen af panobinostat
Agents that may increase panobinostat plasma concentrations
- Aktivt stof: panobinostat.
- The active substance of Farydak is panobinostat.
Titandioxid (E171) Jernoxid, rød (E172)
Titanium dioxide (E171) Iron oxide, red (E172)
ved dosis på 20 mg Farydak i det kliniske fase III-forsøg i kombination med bortezomib og dexamethason.
No episodes of QTcF prolongation >500 msec were reported with the dose of 20 mg Farydak in the phase III clinical study, in combination with bortezomib and dexamethasone.
Før behandling med panobinostat påbegyndes, skal der foretages en komplet blodtælling.
A complete blood cell count must be performed before initiating treatment with panobinostat.
• sprukne læber
• cracked, chapped lips
Sandsynligheden for at panobinostat øgede risikoen for føtal død og udvikling af skeletale anomalier forudsiges at være høj baseret på dyredata.
Based on animal data, the likelihood of panobinostat increasing the risk of foetal death and developmental skeletal abnormalities is predicted to be high.
- Hver Farydak 20 mg hård kapsel indeholder 20 mg panobinostat.
- Each Farydak 20 mg hard capsule contains 20 mg panobinostat.
Ikke almindelig Pulmonal hæmoragi, hæmoptyse
Pulmonary haemorrhage, haemoptysis
- Hver Farydak 15 mg hård kapsel indeholder 15 mg panobinostat.
- Each Farydak 15 mg hard capsule contains 15 mg panobinostat.
≤3,0 x ULN
Moderate >1.5 x ULN and ≤3.0 x ULN
Gastrointestinale symptomer
Gastrointestinal disorders
Så længe skal du tage Farydak
How long to take Farydak
Panobinostartdosis ved bedring til grad 2 thrombocytopeni
Panobinostat dose on recovery to grade 2 thrombocytopenia
Dag 6
Day 6
- medicin til behandling af alvorlige psykiske problemer, som fx risperidon.
- medicines used to treat severe mental health problems, such as risperidone.
• kulderystelser
• palpitations
Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
Check with your doctor or your pharmacist if you are not sure.
- medicin, der kan have en uønsket virkning på hjertet (kaldet QT-forlængelse), fx chloroquin,
- medicines that may have an unwanted effect on the heart (called QT prolongation), such as chloroquine, halofantrine, methadone, moxifloxacin, bepridil or pimozide.
Af hensyn til miljøet må du ikke smide medicinrester i afløbet eller toilettet.
- Do not throw away any medicines via wastewater.
Hypertension, hæmatom, ortostatisk hypotension Ikke almindelig Hæmoragisk shock
Hypertension, haematoma, orthostatic hypotension
o Anbefaling om at medbringe compliance-kortet til hvert besøg: dette afsnit minder patienten om at medbringe compliance-kortet til sundhedspersonalet ved hvert besøg.
o How to use the compliance card: this section provides a general overview on how to use the compliance card. o How to take medication according to the prescription: this section provides guidance on how to fill in the compliance card. o Recommendation to bring compliance card to each visit: this section reminds the patient to bring the compliance card to the HCP at each visit.
Nyresvigt, hæmaturi, urininkontinens
Renal failure, haematuria, urinary incontinence
- hvis du har mave-tarmproblemer, fx diarré, kvalme eller opkastning.
- if you have gastrointestinal problems such as diarrhoea, nausea or vomiting.
Det bør overvejes at foretage dosiseskalering fra 15 mg til 20 mg baseret på patient-tolerabilitet.
A dose escalation from 15 mg to 20 mg may be considered based on patient tolerability.
• diarré, mavesmerter, feber (tegn på tyktarmsbetændelse)
• diarrhoea, abdominal pain, fever (signs of an inflamed colon)
- Hver Farydak 10 mg hård kapsel indeholder 10 mg panobinostat.
- Each Farydak 10 mg hard capsule contains 10 mg panobinostat.
Tabel 9: Responsrater hos patienter med myelomatose, der tidligere har modtaget mindst 2 behandlingsregimer, herunder med bortezomib og en immunmodulator.
Table 9 Response rates in patients with multiple myeloma who received at least two prior regimens including bortezomib and an immunomodulatory agent
Meget almindelig Infektion i øvre luftveje, pneumoni Almindelig
Infections and infestations Very common Upper respiratory tract infection, pneumonia
appetitløshed, smerter i højre side af maven, mørk eller brun urin, blødning eller blå mærker lettere end normalt (tegn på et leverproblem)
• feeling tired, itching, yellowing of the skin and whites of the eyes, nausea or vomiting, loss of appetite, pain on the right side of your stomach, dark or brown urine, bleeding or bruising more easily than normal (signs of a liver problem)
Udelad dosis Genoptag med samme dosis
Omit dose Resume at same dose
Panobinostat-dosis ved bedring til neutropeni, grad 2
Panobinostat dose on recovery to grade 2 neutropenia
Det endokrine system Almindelig
Endocrine disorders
Thyroidfunktionstest
Thyroid function tests
Meget almindelig Vægttab Almindelig
Very common Weight decreased Common
og understøttende pleje gives efter behov i tilfælde af overdosering.
Cardiac monitoring and assessment of electrolytes and platelet counts should be undertaken and supportive care given as necessary in the event of overdose.
Der er hyppigt observeret, ofte svær, trombocytopeni på baggrund af myelomatosens patogenese og den velkendte hæmatotoksicitet af panobinostat og dets kombinationsstof bortezomib.
Due to the nature of multiple myeloma and the known haematotoxicity for panobinostat and its combination agent bortezomib, thrombocytopenia, often severe, has been frequently observed.
- Perikum, et naturlægemiddel, til at behandle depression.
- St. John's wort, a herbal medicine used to treat depression.
• mavesmerter, diarré, oppustet eller udspilet mave (tegn på en betændt maveslimhinde)
• abdominal pain, diarrhoea, swelling or bloating of the abdomen (signs of inflamed stomach lining)
Udelad dosis Genoptag med nedsat dosis
Omit dose Resume at reduced dose
Blodcelletællinger
Blood cell counts
- Til mænd, der tager Farydak
- For men taking Farydak
Sådan skal du tage Farydak
How to take Farydak
12 kapsler
Capsule shell
SGOT = serum glutamin-oksalsyre-transaminase (forhøjet ASAT); ASAT = aspartataminotransferase ULN = upper limit of the normal range (øvre normalgrænse) * Baseret på NCI-CTEP-klassificering
SGOT = serum glutamic oxaloacetic transaminase; AST = aspartate aminotransferase
Øvrige indholdsstoffer: magnesiumstearat, mannitol, mikrokrystallinsk cellulose, pregelatineret stivelse, gelatine, titandioxid (E171), brilliant blue FCF (E133), gul jernoxid (E172), sort jernoxid (E172), propylenglycol (E1520), shellak-glasur.
The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
20 mg i efterfølgende cyklusser baseret på patient-tolerabilitet.
Consider dose escalation up to 20 mg in subsequent cycles based on patient tolerability.