natgillin/translations-raw huggingface dataset:
SPRYCEL 100 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, oval med “BMS 100” printet på den ene side og “852” på den anden.
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side.
SPRYCEL 80 mg filmovertrukne tabletter EU/1/06/363/013
SPRYCEL 80 mg film-coated tablets EU/1/06/363/013
Hvide til gråligt hvide, bikonvekse, runde filmovertrukne tabletter med "BMS 140" printet på den ene side og "857" på den anden.
White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side.
SPRYCEL 140 mg filmovertrukne tabletter EU/1/06/363/015
SPRYCEL 140 mg film-coated tablets EU/1/06/363/015
SPRYCEL 70 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, rund med “BMS” printet på den ene side og “524” på den anden.
SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “524” on the other side.
Medianbehandlingsvarighed med dasatinib var 3 måneder med 2% behandlet i > 24 måneder til dato.
Median duration of treatment on dasatinib was 3 months with 2% treated for > 24 months to date.
Gennemsnitstid fra diagnose til start af behandling var 82 måneder.
The median time from diagnosis to start of treatment was 82 months.
Medianbehandlingsvarighed med dasatinib var 14 måneder med 31% af patienterne behandlet i > 24 måneder til dato.
Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date.
Skade på blodkar kendt som trombotisk mikroangiopati (TMA), inklusive nedsat antal røde blodlegemer, nedsat antal blodplader og dannelse of blodpropper.
Disease of the kidneys with symptoms including oedema and abnormal laboratory test results such as protein in the urine and low protein level in the blood Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased red blood cell count, decreased platelets, and formation of blood clots
SPRYCEL 50 mg filmovertrukne tabletter EU/1/06/363/005
SPRYCEL 50 mg film-coated tablets EU/1/06/363/005
Responsrate (95% CI)
Response rate (95% CI)
Ikke kendt interstitiel lungesygdom Mave-tarm-kanalen
Not known interstitial lung disease
Hver filmovertrukket tablet indeholder 70 mg dasatinib (som monohydrat).
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Medianbehandlingsvarighed med dasatinib var 3,5 måneder med 12% af patienterne behandlet i > 24 måneder til dato.
Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date.
SPRYCEL 140 mg tabletter dasatinib
NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg tablets dasatinib
Hvide til gråligt hvide, bikonvekse, ovale filmovertrukne tabletter med "BMS 100" printet på den ene side og "852" på den anden.
White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side.
Hver filmovertrukket tablet indeholder 20 mg dasatinib (som monohydrat).
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
SPRYCEL 20 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 20 mg dasatinib (som monohydrat).
SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Pleuraeffusion
Pleural effusion
SPRYCEL 80 mg filmovertrukne tabletter
SPRYCEL 80 mg film-coated tablets
Perikardie-effusion
Breast-feeding
SPRYCEL 100 mg filmovertrukne tabletter EU/1/06/363/011
SPRYCEL 100 mg film-coated tablets EU/1/06/363/011
Tidligere fuldstændigt hæmatologisk respons (CHR) på
Prior complete haematologic response (CHR) to imatinib was
SPRYCEL 50 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 50 mg dasatinib (som monohydrat).
SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
SPRYCEL 70 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 70 mg dasatinib (som monohydrat).
SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
inden for 60 måneder (95% CI)
within 60 months (95% CI)
SPRYCEL 70 mg filmovertrukne tabletter dasatinib
SPRYCEL 70 mg film-coated tablets dasatinib
Hvide til gråligt hvide, bikonvekse, trekantede filmovertrukne tabletter med "BMS 80" printet på den ene side og "855" på den anden.
White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side.
Det reproduktive system og mammae Ikke almindelig gynækomasti, menstruationsforstyrrelser Almene symptomer og reaktioner på administrationsstedet
Reproductive system and breast disorders Uncommon gynecomastia, menstrual disorder General disorders and administration site conditions Very common peripheral oedemai, fatigue, pyrexia, face oedemaj
Ved år 3 p<0,0055
By 3 years 67%, p<.0055
MEDIAN (95% CI) HAZARD RATIO (95% CI)
HAZARD RATIO (95% CI)
SPRYCEL 80 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 80 mg dasatinib (som monohydrat).
SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Medianbehandlingsvarighed med dasatinib var 3 måneder med 7% af patienterne behandlet i > 24 måneder til dato.
Median duration of treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
4.2 i Produktresuméet for pulveret til oral suspension, forventes at give en eksponering, der er sammenlignelig med en tabletdosis på 60 mg/m2.
A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the tablet, in section 4.2, is expected to provide similar exposure to a tablet dose of 60 mg/m2.
SPRYCEL 100 mg filmovertrukne tabletter
SPRYCEL 100 mg film-coated tablets
Patienter, som får mere end den anbefalede dosis, skal monitoreres tæt for myelosuppression, eftersom dasatinib er forbundet med myelosuppression grad 3 eller 4 (se pkt.
Since dasatinib is associated with grade 3 or 4 myelosuppression (see section 4.4), patients who ingest more than the recommended dose should be closely monitored for myelosuppression and given appropriate supportive treatment.
SPRYCEL 20 mg filmovertrukne tabletter
SPRYCEL 20 mg film-coated tablets
Ikke kendt artrieflimren/hjerteflimren Vaskulære sygdomme
Not known atrial fibrillation/atrial flutter Vascular disorders
Hver filmovertrukket tablet indeholder 50 mg dasatinib (som monohydrat).
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
l Genital hævelse, ødem ved incisionsstedet, genitalt ødem, penilt ødem, penil hævelse, skrotalt ødem, hævelser på huden, hævede testikler, vulvovaginal hævelse.
l Genital swelling, incision site oedema, oedema genital, penile oedema, penile swelling, scrotal oedema, skin swelling, testicular swelling, vulvovaginal swelling.
Grad 3- eller 4-stigninger af aminotransferaser eller bilirubin blev indberettet hos 1% af patienterne med CML i kronisk fase (resistens eller intolerans over for imatinib).
Grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% of patients with chronic phase CML (resistant or intolerant to imatinib), but elevations were reported with an increased frequency of 1 to 7% of patients with advanced phase CML and Ph+ ALL.
Forekomsten af pleuraeffusion og kongestivt hjertesvigt/hjerteinsufficiens var lavere blandt de patienter, der blev behandlet med SPRYCEL 100 mg én gang dagligt, end blandt de patienter, der blev behandlet med SPRYCEL 70 mg 2 gange dagligt i fase III-studiet vedrørende dosisoptimering hos patienter med CML i kronisk fase og med resistens eller intolerans over for tidligere behandling med imatinib (medianbehandlingsvarigheden var 30 måneder).
In the Phase III dose-optimisation study in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy (median duration of treatment of 30 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.
SPRYCEL 50 mg filmovertrukne tabletter
SPRYCEL 50 mg film-coated tablets
Dosis (maksimum daglig dosis) Stardosis
Dose (maximum dose per day)
Vinsyre Trinatriumcitrat, vandfrit Natriumbenzoat (E211)
Tartaric acid Trisodium citrate anhydrous Sodium benzoate (E211) Silica hydrophobic colloidal Mixed berry flavour [containing benzyl alcohol, sulphur dioxide (E220)]
CHR (fremskreden CML/Ph+ ALL): WBC ≤ institutionel ULN, ANC ≥ 1.000/mm3, trombocytter ≥ 100.000/mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5%, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering.
CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
SPRYCEL 100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg dasatinib (som monohydrat).
SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
CHR: WBC ≤ institutionel ULN, ANC ≥ 1.000/mm3, trombocytter ≥ 100.000/mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5%, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering.
CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Ved år 3 p<0,0013
By 3 years 24%, p<.0013
Meget almindelig hududslæte
Rare diabetes mellitus
Neutropeni
Headache
EU/1/06/363/004 - 56 filmovertrukne tabletter (blistere) EU/1/06/363/007 - 60 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/001 - 60 filmovertrukne tabletter (flaske)
EU/1/06/363/004 - 56 film-coated tablets (blisters) EU/1/06/363/007 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/001 - 60 film-coated tablets (bottle)
SPRYCEL 50 mg filmovertrukne tabletter dasatinib
SPRYCEL 50 mg film-coated tablets dasatinib
EU/1/06/363/005 - 56 filmovertrukne tabletter (blistere) EU/1/06/363/008 - 60 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/002 - 60 filmovertrukne tabletter (flaske)
EU/1/06/363/005 - 56 film-coated tablets (blisters) EU/1/06/363/008 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/002 - 60 film-coated tablets (bottle)
Hvide til gråligt hvide, bikonvekse, ovale filmovertrukne tabletter med "BMS" printet på den ene side og "528" på den anden.
White to off-white, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side.
Hvide til gråligt hvide, bikonvekse, runde filmovertrukne tabletter med "BMS" printet på den ene side og "527" på den anden.
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side.
EU/1/06/363/006 - 56 filmovertrukne tabletter (blistere) EU/1/06/363/009 - 60 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/003 - 60 filmovertrukne tabletter (flaske)
EU/1/06/363/006 - 56 film-coated tablets (blisters) EU/1/06/363/009 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/003 - 60 film-coated tablets (bottle)
Ved år 4 p<0,0021
By 4 years 73%, p<.0021
CHR (kronisk CML): WBC ≤ institutionel ULN, trombocytter < 450.000/mm3, ingen blaster eller promyelocytter i perifert blod, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering.
CHR (chronic CML): WBC ≤ institutional ULN, platelets < 450,000/mm3, no blasts or promyelocytes in peripheral blood, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Ettrins dosisreduktion
One-level dose reduction
EU/1/06/363/015 - 30 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/014 - 30 filmovertrukne tabletter (flaske)
EU/1/06/363/015 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/014 - 30 film-coated tablets (bottle)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 140 mg dasatinib (som monohydrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
EU/1/06/363/011 - 30 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/010 - 30 filmovertrukne tabletter (flaske)
EU/1/06/363/011 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/010 - 30 film-coated tablets (bottle)
Hvide til gråligt hvide, bikonvekse, runde filmovertrukne tabletter med "BMS" printet på den ene side og "524" på den anden.
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "524" on the other side.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Bristol-Myers Squibb Pharma EEIG Plaza 254
Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
Systemisk administration af en potent CYP3A4-hæmmer frarådes derfor til patienter, der får dasatinib (se pkt.
Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended (see section 4.2).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 80 mg dasatinib (som monohydrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
21 patienter (1%) havde QTcF > 500 msek.
Twenty-one patients (1%) experienced a QTcF > 500 msec (see section 4.4).
Totrins dosisreduktion
Two-level dose reduction
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 100 mg dasatinib (som monohydrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
SPRYCEL 20 mg filmovertrukne tabletter dasatinib
SPRYCEL 20 mg film-coated tablets dasatinib
EU/1/06/363/013 - 30 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/012 - 30 filmovertrukne tabletter (flaske)
EU/1/06/363/013 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/012 - 30 film-coated tablets (bottle)
Under disse undersøgelser bør dosis af dasatinib reduceres eller behandlingen afbrydes i overensstemmelse med anbefalingerne for behandling af ikke-hæmatologiske bivirkninger (se pkt.
In accordance with recommendations for management of non-haematologic adverse reactions (see section 4.2) the dose of dasatinib should be reduced or therapy interrupted during this evaluation.
SPRYCEL 20 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, rund med “BMS” printet på den ene side og “527” på den anden.
What SPRYCEL looks like and contents of the pack SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “527” on the other side.
Ved alle post-dosis tidspunkter på dag 8 var medianændringerne fra baseline i QTcF-intervaller 4-6 msek., med tilhørende øvre 95% konfidensintervaller < 7 msek.
At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
2% af patienterne med CML i fremskreden fase oplevede andre grad 3 eller 4 blødninger.
Other grade 3 or 4 haemorrhage occurred in 2% of patients with advanced phase CML.
Tabel 2: Dosiseskaleringer for patienter med Ph+ CML-CP.
Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP
Virkning og anvendelse 2.
What SPRYCEL is and what it is used for 2.
SPRYCEL findes også som tabletter til brug hos voksne og børn fra 1 år og som vejer mere end 10 kg. Pulveret til oral suspension bør bruges til patienter, der vejer mindre end 10 kg og patienter, der ikke er i stand til at synke tabletter.
SPRYCEL is also available as tablets for use in adults and children from one year of age and weighing more than 10 kg.
Ved år 1 p<0,0001
By 1 year 46%, p<.0001
Retningslinjer for pædiatriske patienter med Ph+ ALL behandlet i kombination med kemoterapi kan ses i et særskilt afsnit efter tabellen.
Guidelines for dose modifications in paediatric patients with CML-CP are summarised in Table 3.Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the table.
Anæmi a Resultater fra fase 3-dosisoptimeringsstudie rapporteret ved studieopfølgning ved år 2. b CA180-034 studieresultater ved anbefalet startdosis på 100 mg én gang dagligt.
Pericardial effusion Pulmonary oedema Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported at the recommended starting dose of 140 mg once daily (n=304) population at 2 year final study follow up.
SPRYCEL 100 mg tabletter dasatinib
NAME OF THE MEDICINAL PRODUCT SPRYCEL 100 mg tablets dasatinib
Ved år 2 p<0,0001
By 2 years 64%, p<.0001
I fase III-dosisoptimeringsstudiet i CML i kronisk fase blev grad 3 og 4 forhøjelse i aminotransferaser eller bilirubin indberettet hos ≤ 1% af patienterne med ensartet lav forekomst i de 4 behandlingsgrupper.
grade 3 or 4 elevations of transaminases or bilirubin were reported in ≤ 1% of patients with similar low incidence in the four treatment groups.
Leverinsufficiens
PROPORTION RESPONDERS
Meget almindelig perifert ødemi, udmattelse, pyreksi, ansigtsødemj
Very common skin rashe Common alopecia, dermatitis (including eczema), pruritus, acne, dry skin, urticaria, hyperhidrosis
Hæmatologisk parameter
Gastrointestinal disorders
Meget almindelig hovedpine
Hepatic impairment
SPRYCEL 140 mg filmovertrukne tabletter dasatinib
NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg film-coated tablets dasatinib
SPRYCEL 80 mg tabletter dasatinib
NAME OF THE MEDICINAL PRODUCT SPRYCEL 80 mg tablets dasatinib
Fortæl det til din læge, hvis du ammer.
If you are breast-feeding, tell your doctor.
Lever- og nyreinsufficiens
Hepatic and renal impairment
Hydrofobisk silicacolloid
Blood and lymphatic system disorders
Tal med din læge, hvis du ikke er sikker på, at du kan køre.
Talk to your doctor if you are not sure you can drive.
• spredt sig til andre dele af kroppen eller ikke kan fjernes ved operation.
• spread to other parts of the body or cannot be removed by surgery.
Disse data viser, at virkningen af kombinationen ville være lavere hos disse patienter.
These data show that the efficacy of the combination would be lower in these patients.
specifikke inducere af disse enzymer er ikke blevet undersøgt og kan medføre et tab af effekt.
Specific inducers of these enzymes have not been studied and may result in a loss of efficacy.
Der er ingen specifik behandling for overdosering.
There is no specific treatment of overdose.
Synsnedsættelse var generelt reversibel.
Visual impairment was generally reversible.
Mektovi bør ikke anvendes til børn og unge under 18 år.
Mektovi is not recommended for children and adolescents under 18 years of age.
Mektovi kan tages sammen med mad eller mellem måltiderne.
Mektovi can be taken with food or between meals.
Gilberts syndrom
Gilbert's syndrome
Hyppighed (alle grader)
Frequency (All grades)
EU/1/18/1315/001 84 filmovertrukne tabletter EU/1/18/1315/002 168 filmovertrukne tabletter
EU/1/18/1315/001 84 film-coated tablets EU/1/18/1315/002 168 film-coated tablets
• en bestemt forandring (mutation) i et gen, der er ansvarligt for at producere et protein, der kaldes BRAF, og
• a particular change (mutation) in a gene responsible for producing a protein called BRAF, and
PVC/PVDC/Alu-blister indeholdende 12 tabletter.
PVC/PVDC/Alu blister containing 12 tablets.
Hver pakning indeholder enten 84 eller 168 tabletter.
Each pack contains either 84 or 168 tablets.
Rekruttering til Del 2 startede, efter at alle Del 1patienter var blevet randomiseret.
Enrolment in Part 2 started after all Part 1 patients were randomised.
Tabletterne skal synkes hele med vand.
The tablets are to be swallowed whole with water.
Mektovi er til oral anvendelse.
Mektovi is for oral use.
Den investigatorvurderede PFS (investigatorvurdering) var en understøttende analyse.
PFS as assessed by investigators (investigator assessment) was a supportive analysis.
Det er vigtigt, at du tager Mektovi, så længe lægen foreskriver det. Du må ikke stoppe behandlingen, medmindre lægen siger det.
It is important to take Mektovi for as long as your doctor prescribes it. Do not stop taking this medicine unless your doctor tells you to.
Der blev ikke set nogen overordnede forskelle i sikkerheden eller virkningen mellem ældre patienter (≥65) og yngre patienter.
No overall differences in safety or efficacy were observed between elderly patients (≥ 65) and younger patients.
Kontakt straks lægen, hvis du får en af følgende alvorlige bivirkninger for første gang, eller hvis den bliver værre (se også afsnit 2):
Tell your doctor immediately if you have any of the following serious side effects, either for the first time or if they get worse (see also section 2).
Hos mennesker er blod-plasma-ratioen 0,718.
In humans, the blood-to-plasma ratio is 0.718.
Efter oral administration absorberes binimetinib hurtigt med en median Tmax på 1,5 timer.
After oral administration, binimetinib is rapidly absorbed with a median Tmax of 1.5 hours.
Om nødvendigt vil lægen afbryde behandlingen midlertidigt eller stoppe den helt.
If necessary, your doctor may interrupt your treatment or stop it altogether.
Alder, legemsvægt
Age, body weight
Du vil også blive behandlet med et andet lægemiddel, encorafenib.
You will also receive treatment with another medicine, encorafenib.
Tabel 4 og figur 1 opsummerer PFS og andre effektresultater baseret på en central datagennemgang udført af en blindet uafhængig radiologikomité.
Table 4 and Figure 1 summarise the PFS and other efficacy results based on central review of the data by a blinded independent radiology committee.
I tilfælde af overdosering bør patienten have understøttende behandling med passende monitorering efter behov.
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Udover ovenstående alvorlige bivirkninger kan personer, der tager Mektovi og encorafenib sammen, også få følgende bivirkninger.
Besides the serious side effects mentioned above, people taking Mektovi and encorafenib together may also get the following side effects.
I den lille gruppe af patienter, der var ≥75 år (n=15), havde patienterne større sandsynlighed for at opleve alvorlige uønskede hændelser og uønskede hændelser, der førte til seponering af behandlingen.
In the small group of patients aged ≥ 75 years (n=15), patients were more likely to experience serious adverse events and adverse events leading to discontinuation of treatment.
Fortsæt så med at tage tabletterne på de normale tidspunkter.
Then continue taking your tablets at regular times as usual.
CI = konfidensinterval; CR = komplet respons; DCR = sygdomskontrolrate (CR+PR+SD+Non-CR/Non-PD; Non-CR/Non-PD gælder kun patienter uden en target-læsion, som ikke opnåede CR eller havde PD); HR = hazard ratio; NE = ikke-estimerbar; PFS = progressionsfri overlevelse; PR = delvist respons; SD = stabil sygdom.
CI = confidence interval; CR = complete response; DCR = disease control rate (CR+PR+SD+NonCR/Non-PD; Non-CR/Non-PD applies only to patients without a target lesion who did not achieve CR or have PD); HR = hazard ratio; NE = not estimable; PFS = progression-free survival; PR = partial response; SD = stable disease.
Hvis du får alvorlige bivirkninger (såsom hjerte-, øjen- eller hudproblemer), kan lægen nedsætte din dosis eller stoppe behandlingen midlertidigt eller permanent.
If you get serious side effects (such as heart, eye or skin problems) your doctor may lower the dose or stop treatment temporarily or permanently.
LVEF skal vurderes hver 2. uge
LVEF should be evaluated every 2 weeks.