FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time to onset of Grade 3 or 4 neutropenia was 29 to 33 days, and median time to resolution was 11 to 15 days.
Danish: Mediantiden til indtræden af neutropeni af grad 3 eller 4 var 29 til 33 dage, og mediantiden til bedring var 11 til 15 dage.
English: The efficacy and safety of Verzenios in combination with an aromatase inhibitor (anastrozole or letrozole) was evaluated in MONARCH 3, a randomised, double-blind, placebo-controlled phase 3 study in women with HR positive, HER2 negative locally advanced or metastatic breast cancer who had not received prior systemic therapy in this disease setting.
Danish: Virkningen og sikkerheden af Verzenios i kombination med en aromatasehæmmer (anastrozol eller letrozol) blev vurderet i MONARCH 3, et randomiseret, dobbeltblindet, placebokontrolleret fase 3studie med kvinder med lokalt fremskreden eller metastatisk HR-positiv, HER2-negativ brystcancer, som ikke havde fået forudgående systemisk behandling i dette sygdomsregi.
English: Objective response rateb [%] (95% CI) Complete response, (%) Partial response, (%)
Danish: Objektiv responsrateb [%] (95 % CI) Komplet respons, (%)
English: The median time to onset of Grade 3 or 4 ALT elevation was 57 to 61 days, and median time to resolution was 14 days.
Danish: Mediantiden til indtræden af ALAT-stigninger af grad 3 eller 4 var 57 til 61 dage, og mediantiden til bedring var 14 dage.
English: Package leaflet: Information for the patient Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets abemaciclib This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Verzenios 50 mg filmovertrukne tabletter Verzenios 100 mg filmovertrukne tabletter Verzenios 150 mg filmovertrukne tabletter abemaciclib Dette lægemiddel er underlagt supplerende overvågning.
English: CYP3A4 inducers
Danish: CYP3A4-induktorer
English: Dose modification is recommended for patients who develop ≥ Grade 2 diarrhoea (see section 4.2).
Danish: Det anbefales at justere dosis hos patienter, der får diarré ≥ grad 2 (se pkt.
English: In the event of an abemaciclib overdose, fatigue and diarrhoea may occur.
Danish: Træthed og diarré kan forekomme i tilfælde af overdosering af abemaciclib.
English: First dose adjustment
Danish: Første dosisjustering
English: Verzenios may: - reduce the number of your white blood cells, and you may be at greater risk of getting an infection.
Danish: - forårsage et fald i antallet af hvide blodlegemer og øge din risiko for at få en infektion.
English: Increases in ALT and AST were reported in patients receiving abemaciclib.
Danish: Der blev rapporteret om stigninger i ALAT og ASAT hos patienter, der fik abemaciclib.
English: 100 mg twice daily
Danish: 100 mg to gange dagligt
English: A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), race, geographic region, disease site, endocrine therapy resistance, presence of measurable disease, progesterone receptor status, and menopausal status.
Danish: herunder alder (<65 eller ≥65 år), race, geografisk region, sygdomssted, resistens over for endokrin behandling, tilstedeværelse af målbar sygdom, progesteronreceptorstatus og menopausal status.
English: The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 8 and Figure 2.
Danish: De primære effektresultater er opsummeret i tabel 8 og figur 2.
English: - The other ingredients in this medicine are:
Danish: Øvrige indholdsstoffer:
English: Grade 3
Danish: Grad 3
English: Median PFS was significantly prolonged in the Verzenios plus fulvestrant arm (HR of 0.553 [95% CI 0.449, 0.681]); median PFS was 16.4 months versus 9.3 months in the placebo plus fulvestrant arm.
Danish: Median-PFS blev signifikant forlænget i den arm, der fik Verzenios plus fulvestrant (HR på 0,553 [95% CI 0,449; 0,681]); median-PFS var 16,4 måneder versus 9,3 måneder i den arm, der fik placebo plus fulvestrant.
English: White, oval tablet of 6.6 x 12.0 mm, debossed with “Lilly” on one side and “100” on the other.
Danish: Hvid, oval tablet på 6,6 x 12,0 mm, der er præget med “Lilly” på den ene side og“100” på den anden side.
English: Other medicines and Verzenios
Danish: Brug af anden medicin sammen med Verzenios
English: Concomitant use of strong CYP3A4 inhibitors should be avoided.
Danish: Samtidig brug af stærke CYP3A4-hæmmere bør undgås.
English: Creatinine
Danish: Kreatinin
English: The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 7 and Figure 1.
Danish: De primære effektresultater er opsummeret i tabel 7 og figur 1.
English: Progression-free survival (PFS) was significantly prolonged in the Verzenios plus aromatase inhibitor (AI) arm, (Hazard Ratio [HR] of 0.540 [95% CI, 0.418 to 0.698]); median PFS was 28.18 months in the Verzenios plus AI arm and was 14.76 months in the placebo plus AI arm.
Danish: Den progressionsfri overlevelse (PFS) blev signifikant forlænget i den arm, der fik Verzenios plus aromatasehæmmer (AI), (hazard ratio [HR] på 0,540 [95 % CI, 0,418 til 0,698]); median-PFS var 28,18 måneder i den arm, der fik Verzenios plus AI, og 14,76 måneder i den arm, der fik placebo plus AI.
English: A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.481 [95% CI: 0.369, 0.627]), median PFS 14.7 months versus 6.5 months; in patients with bone-only disease (HR of 0.543 [95% CI: 0.355, 0.833]); patients with measurable disease (HR of 0.523 [95% CI: 0.412, 0.644]).
Danish: Der blev set en reduktion i risikoen for sygdomsprogression eller død hos patienter med visceral sygdom (HR på 0,481 [95 % CI: 0,369; 0,627], median-PFS 14,7 måneder versus 6,5 måneder); hos patienter med sygdom i knoglerne alene (HR på 0,543 [95 % CI: 0,355; 0,833]); patienter med målbar sygdom (HR på 0,523, [95 % CI: 0,412; 0,644]).
English: Grade 1
Danish: Grad 1
English: Before treatment initiation, absolute neutrophil counts (ANC) ≥1500/mm3, platelets ≥100,000/mm3, and haemoglobin ≥8 g/dL are recommended.
Danish: ≥1.500/mm3, trombocytter ≥100.000/mm3 og hæmoglobin ≥8 g/dl.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede)
English: Second dose adjustment
Danish: Anden dosisjustering
English: A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.567 [95% CI: 0.407, 0.789]), median PFS 21.6 months versus 14.0 months; in patients with bone-only disease (HR 0.565, [95% CI: 0.306, 1.044]); and in patients with measurable disease (HR 0.517, [95% CI: 0.392, 0.681]).
Danish: Der blev set en reduktion i risikoen for sygdomsprogression eller død hos patienter med visceral sygdom (HR på 0,567 [95 % CI: 0,407; 0,789]), median-PFS 21,6 måneder versus 14,0 måneder; hos patienter med sygdom i knoglerne alene (HR 0,565, [95 % CI: 0,306; 1,044]); og hos patienter med målbar sygdom (HR 0,517, [95 % CI: 0,392; 0,681]).
English: Yellow, oval tablet of 7.5 x 13.7 mm, debossed with “Lilly” on one side and “150” on the other.
Danish: Gul, oval tablet på 7,5 x 13,7 mm, der er præget med “Lilly” på den ene side og“150” på den anden side.
English: The median time to onset of Grade 3 or 4 AST elevation was 71 to 185 days, and median time to resolution was 13 to 15 days.
Danish: Mediantiden til indtræden af ASAT-stigninger af grad 3 eller 4 var 71 til 185 dage, og mediantiden til bedring var 13 til 15 dage.
English: Infections/infestations
Danish: Infektioner/parasitære sygdomme
English: No dose adjustments are necessary in patients with mild or moderate renal impairment.
Danish: Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med let eller moderat nyreinsufficiens.
English: Beige, oval tablet of 5.2 x 9.5 mm, debossed with “Lilly” on one side and “50” on the other.
Danish: Beige, oval tablet på 5,2 x 9,5 mm, der er præget med “Lilly” på den ene side og“50” på den anden side.
English: • Film-coating: titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), macrogol 3350 (E1521), iron oxide yellow (E172) [50 mg and 150 mg tablets only], iron oxide red (E172) [50 mg tablets only].
Danish: • Filmovertræk: titandioxid (E171), talcum (E553b), polyvinylalkohol (E1203), macrogol 3350 (E1521), gul jernoxid (E172) [kun 50 mg og 150 mg tabletter], rød jernoxid (E172) [kun 50 mg tabletter].
English: 50 mg twice daily
Danish: 50 mg to gange dagligt
English: 150 mg twice daily
Danish: 150 mg to gange dagligt
English: Dose modification is recommended for patients who develop Grade 3 or 4 neutropenia (see section 4.2).
Danish: Det anbefales at justere dosis hos patienter, der udvikler neutropeni af grad 3 eller 4 (se pkt.
English: Duration of response [months] (95%CI)
Danish: Responsvarighed [måneder] (95 % CI)
English: Dose modification is recommended for patients who develop Grade 3 or 4 ALT or AST increase (see section 4.2).
Danish: Det anbefales at justere dosis hos patienter, der udvikler ALAT- eller ASAT-stigninger af grad 3 eller 4 (se pkt.
English: Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided.
Danish: Samtidig brug af stærke CYP3A4-hæmmere og abemaciclib bør undgås.
English: Verzenios plus aromatase inhibitor
Danish: Verzenios plus aromatasehæmmer
English: • Hair loss
Danish: • Hårtab
English: Objective response rateb [%] (95% CI)
Danish: Objektiv responsrateb [%] (95 % CI)
English: MONARCH 3: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Danish: MONARCH 3: Oversigt over effektdata (investigators vurdering, intent-to-treatpopulation)
English: Refer to Section 2 for more information on any of the possible effects listed above.
Danish: Du finder yderligere oplysninger om ovennævnte bivirkninger i afsnit 2.
English: Grade 2
Danish: Grad 2
English: MONARCH 2: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Danish: MONARCH 2: Kaplan-Meier-kurve over progressionsfri overlevelse (investigators vurdering, intent-to-treat-population)
English: Medicinal products that are substrates of transporters Abemaciclib and its major active metabolites inhibit the renal transporters organic cation transporter 2 (OCT2), multidrug and extrusion toxin protein (MATE1), and MATE2-K.
Danish: Abemaciclib og dets aktive hovedmetabolitter hæmmer de renale transportører organisk kationtransportør 2 (OCT2), multidrug and extrusion toxin protein (MATE1) og MATE2-K. In vivointeraktioner mellem abemaciclib og klinisk relevante substrater for disse transportører, såsom dofetilid eller kreatinin, kan forekomme (se pkt.
English: o Clarithromycin (antibiotic used to treat bacterial infections)
Danish: • lægemidler, der kan øge indholdet af Verzenios i blodet: o Clarithromycin (et antibiotikum, der anvendes til behandling af bakterieinfektioner)
English: Verzenios contains lactose
Danish: Verzenios indeholder lactose
English: MONARCH 3: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Danish: MONARCH 3: Kaplan-Meier-kurve over progressionsfri overlevelse (investigators vurdering, intent-to-treat-population)
English: MONARCH 2: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Danish: MONARCH 2: Oversigt over effektdata (investigators vurdering, intent-to-treatpopulation)
English: In particular, tell you doctor or pharmacist before taking Verzenios if you are taking the following:
Danish: Det er særligt vigtigt, at du fortæller det til lægen eller apotekspersonalet, hvis du tager nedenstående:
English: Lung infection was reported in patients receiving abemaciclib without concurrent neutropenia.
Danish: Der blev rapporteret om lungeinfektion uden samtidig neutropeni hos patienter, der fik abemaciclib.
English: Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets
Danish: Verzenios 50 mg filmovertrukne tabletter Verzenios 100 mg filmovertrukne tabletter Verzenios 150 mg filmovertrukne tabletter
English: Grade 2 that persists or recurs after resuming the same dose despite maximal supportive measures
Danish: Vedvarende eller tilbagevendende grad 2 efter genoptagelse af den samme dosis til trods for maksimale understøttende tiltag Afbryd doseringen, indtil toksiciteten bedres til grad 1 eller derunder.
English: Concomitant use of inducers of CYP3A4
Danish: Samtidig brug af CYP3A4-induktorer
English: If you miss a dose of Verzenios
Danish: Hvis du har taget for meget Verzenios
English: Suspend dose until toxicity resolves to Grade 2 or less.
Danish: Afbryd doseringen, indtil toksiciteten bedres til grad 2 eller derunder.
English: Abemaciclib is metabolised in the liver.
Danish: Abemaciclib metaboliseres i leveren.
English: - Verzenios 150 mg film-coated tablets are yellow, oval tablets debossed with “Lilly” on one side and “150” on the other.
Danish: - Verzenios 150 mg filmovertrukne tabletter er gule, ovale tabletter, der er præget med “Lilly” på den ene side og “150” på den anden side.
English: No dose adjustment required.
Danish: Det er ikke nødvendigt at justere dosis.
English: At the first sign of diarrhoea, start treatment with antidiarrhoeal agents, such as loperamide.
Danish: Påbegynd behandling med midler mod diarré, såsom loperamid, ved det første tegn på diarré.
English: Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00
Danish: Tlf: + 47 22 88 18 00
English: Independent radiographic review, number of events (%) Median [months] (95% CI)
Danish: Uafhængig radiografisk gennemgang, antal hændelser (%)
English: 0.246, 0.698); in patients who were progesterone receptor negative, the HR was 0.509 (95% CI: 0.325,
Danish: Hos præ-/perimenopausale patienter var hazard ratio 0,415 (95 % CI: 0,246; 0,698); hos patienter, der var progesteronreceptornegative, var HR 0,509 (95 % CI:
English: Verzenios 100 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b)
Danish: Verzenios 100 mg filmovertruktne tabletter polyvinylalkohol (E1203) titandioxid (E171) macrogol (E1521) talcum (E553b)
English: - Verzenios 50 mg film-coated tablets are beige, oval tablets debossed with “Lilly” on one side and “50” on the other.
Danish: - Verzenios 50 mg filmovertrukne tabletter er beige, ovale tabletter, der er præget med “Lilly” på den ene side og “50” på den anden side.
English: Sun.
Danish: Søn.
English: Please refer to the Summary of Product Characteristics of the endocrine therapy combination partner for the recommended posology.
Danish: Se den anbefalede dosering af den endokrine behandling i produktresuméet for det pågældende lægemiddel.
English: Posology
Danish: Filmovertræk
English: EU/1/18/1307/001 EU/1/18/1307/002 EU/1/18/1307/003 EU/1/18/1307/004 EU/1/18/1307/005 EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009 EU/1/18/1307/010 EU/1/18/1307/011 EU/1/18/1307/012 EU/1/18/1307/013 EU/1/18/1307/014 EU/1/18/1307/015
Danish: EU/1/18/1307/001 EU/1/18/1307/002 EU/1/18/1307/003 EU/1/18/1307/004 EU/1/18/1307/005 EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009 EU/1/18/1307/010
English: - Verzenios 100 mg film-coated tablets are white, oval tablets debossed with “Lilly” on one side and “100” on the other.
Danish: - Verzenios 100 mg filmovertrukne tabletter er hvide, ovale tabletter, der er præget med “Lilly” på den ene side og “100” på den anden side.
English: EU/1/18/1307/016 EU/1/18/1307/017 EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021
Danish: EU/1/18/1307/011 EU/1/18/1307/012 EU/1/18/1307/013 EU/1/18/1307/014 EU/1/18/1307/015 EU/1/18/1307/016 EU/1/18/1307/017 EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021
English: Suspend dose until toxicity resolves to Grade 1 or less.
Danish: Afbryd doseringen, indtil toksiciteten bedres til grad 1 eller derunder.
English: • Alteration in sense of taste
Danish: • Smagsforstyrrelser
English: If you take too many tablets, or if someone else takes your medicine, contact a doctor or hospital for advice.
Danish: Kontakt lægen eller skadestuen for at få rådgivning, hvis du har taget for mange tabletter, eller hvis en anden har taget din medicin.
English: Each film-coated tablet contains 42 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 42 mg lactose (som monohydrat).
English: Each film-coated tablet contains 28 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 28 mg lactose (som monohydrat).
English: Pruritus Rash Common Dry skin
Danish: Almindelig Tør hud
English: • Dizziness
Danish: • Udslæt
English: Each film-coated tablet contains 100 mg abemaciclib.
Danish: Hver filmovertrukken tablet indeholder 100 mg abemaciclib.
English: Very common Diarrhoea Vomiting Nausea
Danish: Meget almindelig Diarré
English: Each film-coated tablet contains 50 mg abemaciclib.
Danish: Hver filmovertrukken tablet indeholder 50 mg abemaciclib.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du har lactoseintolerans.
English: Developmental toxicity
Danish: Udviklingstoksicitet
English: Each film-coated tablet contains 14 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 14 mg lactose (som monohydrat).
English: Each film-coated tablet contains 150 mg abemaciclib.
Danish: Hver filmovertrukken tablet indeholder 150 mg abemaciclib.
English: • Muscular weakness
Danish: • Muskelsvaghed
English: If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced (see section 4.2), followed by careful monitoring of toxicity.
Danish: Hvis samtidig administration af stærke CYP3A4-hæmmere er nødvendig, bør abemaciclibdosis reduceres (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 150 MG FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 150 MG FILMOVERTRUKNE TABLETTER
English: CYP3A4 inhibitors
Danish: CYP3A4-hæmmere
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 100 MG FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 100 MG FILMOVERTRUKNE TABLETTER
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 50 MG FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 50 MG FILMOVERTRUKNE TABLETTER
English: Verzenios 150 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172)
Danish: Verzenios 150 mg filmovertruktne tabletter polyvinylalkohol (E1203) titandioxid (E171) macrogol (E1521) talcum (E553b) gul jernoxid (E172)
English: • Verzenios 150 mg film-coated tablet: each tablet contains 150 mg abemaciclib.
Danish: • Verzenios 150 mg filmovertrukne tabletter: hver tablet indeholder 150 mg abemaciclib.
English: Verzenios 150 mg film-coated tablets
Danish: Verzenios 150 mg filmovertrukne tabletter
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER UDLØBSDATO
English: Verzenios 50 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172) iron oxide red (E172)
Danish: Verzenios 50 mg filmovertruktne tabletter polyvinylalkohol (E1203) titandioxid (E171) macrogol (E1521) talcum (E553b) gul jernoxid (E172) rød jernoxid (E172)
English: Verzenios 50 mg film-coated tablets
Danish: Verzenios 50 mg filmovertrukne tabletter
English: Verzenios 100 mg film-coated tablets
Danish: Verzenios 100 mg filmovertrukne tabletter
English: • Verzenios 100 mg film-coated tablet: each tablet contains 100 mg abemaciclib.
Danish: • Verzenios 100 mg filmovertrukne tabletter: hver tablet indeholder 100 mg abemaciclib.
English: Verzenios 100 mg film-coated tablets Each film-coated tablet contains 100 mg abemaciclib.
Danish: Verzenios 100 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 100 mg abemaciclib.
English: Verzenios 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib.
Danish: Verzenios 150 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 150 mg abemaciclib.
English: Verzenios 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib.
Danish: Verzenios 50 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 50 mg abemaciclib.
English: What Verzenios is and what it is used for What you need to know before you take Verzenios How to take Verzenios
Danish: Det skal du vide, før du begynder at tage Verzenios Sådan skal du tage Verzenios Bivirkninger
English: • Verzenios 50 mg film-coated tablet: each tablet contains 50 mg abemaciclib.
Danish: • Verzenios 50 mg filmovertrukne tabletter: hver tablet indeholder 50 mg abemaciclib.
English: Verzenios 100 mg tablets abemaciclib
Danish: Verzenios 100 mg tabletter abemaciclib
English: EU/1/18/1307/007 (14 film-coated tablets) EU/1/18/1307/008 (168 film-coated tablets) EU/1/18/1307/009 (28 x 1 film-coated tablets) EU/1/18/1307/014 (28 film-coated tablets) EU/1/18/1307/015 (56 film-coated tablets) EU/1/18/1307/020 (42 film-coated tablets) EU/1/18/1307/021 (70 film-coated tablets)
Danish: EU/1/18/1307/007 (14 filmovertrukne tabletter) EU/1/18/1307/008 (168 filmovertrukne tabletter) EU/1/18/1307/009 (28 x 1 filmovertrukne tabletter) EU/1/18/1307/014 (28 filmovertrukne tabletter) EU/1/18/1307/015 (56 filmovertrukne tabletter) EU/1/18/1307/020 (42 filmovertrukne tabletter) EU/1/18/1307/021 (70 filmovertrukne tabletter)
English: EU/1/18/1307/004 (14 film-coated tablets) EU/1/18/1307/005 (168 film-coated tablets) EU/1/18/1307/006 (28 x 1 film-coated tablets) EU/1/18/1307/012 (28 film-coated tablets) EU/1/18/1307/013 (56 film-coated tablets) EU/1/18/1307/018 (42 film-coated tablets) EU/1/18/1307/019 (70 film-coated tablets)
Danish: EU/1/18/1307/004 (14 filmovertrukne tabletter) EU/1/18/1307/005 (168 filmovertrukne tabletter) EU/1/18/1307/006 (28 x 1 filmovertrukne tabletter) EU/1/18/1307/012 (28 filmovertrukne tabletter) EU/1/18/1307/013 (56 filmovertrukne tabletter) EU/1/18/1307/018 (42 filmovertrukne tabletter) EU/1/18/1307/019 (70 filmovertrukne tabletter)
English: EU/1/18/1307/001 (14 film-coated tablets) EU/1/18/1307/002 (168 film-coated tablets) EU/1/18/1307/003 (28 x 1 film-coated tablets) EU/1/18/1307/010 (28 film-coated tablets) EU/1/18/1307/011 (56 film-coated tablets) EU/1/18/1307/016 (42 film-coated tablets) EU/1/18/1307/017 (70 film-coated tablets)
Danish: EU/1/18/1307/001 (14 filmovertrukne tabletter) EU/1/18/1307/002 (168 filmovertrukne tabletter) EU/1/18/1307/003 (28 x 1 filmovertrukne tabletter) EU/1/18/1307/010 (28 filmovertrukne tabletter) EU/1/18/1307/011 (56 filmovertrukne tabletter) EU/1/18/1307/016 (42 filmovertrukne tabletter) EU/1/18/1307/017 (70 filmovertrukne tabletter)
English: Verzenios 150 mg tablets abemaciclib
Danish: Verzenios 150 mg tabletter abemaciclib
English: • Tiredness
Danish: • Mundtørhed
English: Abemaciclib in combination with letrozole, anastrozole, or fulvestrant.
Danish: Meget almindelig Forhøjet alanin-aminotransferase Forhøjet aspartat-aminotransferase a Abemaciclib i kombination med letrozol, anastrozol eller fulvestrant.
English: Verzenios 50 mg tablets abemaciclib
Danish: Verzenios 50 mg tabletter abemaciclib
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER CARD FOR 150 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP KALENDERBLISTERKORT TIL 150 MG FILMOVERTRUKNE TABLETTER
English: Verzenios 150 mg film-coated tablets abemaciclib
Danish: Verzenios 150 mg filmovertrukne tabletter abemaciclib
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER FOR 150 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET ENKELTDOSISBLISTER TIL 150 MG FILMOVERTRUKNE TABLETTER
English: Venous thromboembolism
Danish: Almindelig Venøs tromboembolic