FrancophonIA/ELRC3.0 huggingface dataset:
English: Use a 5 mL syringe with 0.2 mL marks for doses of 1 mL or more.
Danish: Brug en 5 ml sprøjte med inddelinger på 0,2 ml til doser på 1 ml eller mere.
English: The active substance is larotrectinib.
Danish: Aktivt stof: larotrectinib.
English: Slowly press the plunger in.
Danish: Tryk langsomt stemplet ned.
English: The most common tumour types represented were soft tissue sarcoma (23%), salivary gland tumour (18%), infantile fibrosarcoma (14%), thyroid cancer (11%), lung and melanoma cancer (8% for each), and colon cancer (6%).
Danish: spytkirteltumor (18 %), infantil fibrosarkom (14 %), thyroideacancer (11 %), lunge- og melanomcancer (8 % for hver) og koloncancer (6 %).
English: Based on population pharmacokinetic analyses exposure (Cmax and AUC) in paediatric patients (1 month to <3 months of age) at the recommended dose of 100 mg/m2 with a maximum of 100 mg BID was 3-fold higher than in adults (≥18 years of age) given the dose of 100 mg BID.
Danish: Baseret på populationsfarmakokinetiske analyser er eksponering (Cmax og AUC) hos pædiatriske patienter (1 måned til <3 måneder) ved den anbefalede dosis på 100 mg/m2 med maksimalt 100 mg to gange dagligt var tre gange højere end eksponeringen hos voksne (≥18 år), der fik en dosis på 100 mg to gange dagligt.
English: Nasogastric feeding tube - Use a suitable nasogastric feeding tube.
Danish: Nasogastrisk sonde - Brug en egnet naso-gastrisk sonde.
English: Patients with Grade 2 ALT and/or AST increases, should be followed with serial laboratory evaluations every one to two weeks after the observation of Grade 2 toxicity until resolved to establish whether a dose interruption or reduction is required.
Danish: For at fastlægge om det er nødvendigt at afbryde eller reducere en dosis, bør patienter med grad 2 ALAT- og/eller ASAT-forhøjelser følges med laboratorieundersøgelser i serie hver eller hver anden uge efter observation af grad 2-toksicitet, indtil grad 2-toksicitet går væk.
English: - For doses below 1 mL a 1 mL oral syringe should be used.
Danish: - For doser under 1 ml bør der anvendes en 1 ml oral sprøjte.
English: - VITRAKVI 25 mg is supplied as white opaque hard gelatine capsule, (18 mm long x 6 mm wide), with blue printing of BAYER-cross and “LARO 25 mg” on the body of the capsule - VITRAKVI 100 mg is supplied as white opaque hard gelatine capsule, (22 mm long x 7 mm wide), with blue printing of BAYER-cross and “LARO 100 mg” on the body of the capsule
Danish: - VITRAKVI 25 mg leveres som en hvid, uigennemsigtig hård gelatinekapsel, (18 mm lang x 6 mm bred), med et blåt printet BAYER-kors og ”LARO 25 mg” på kapslens underdel - VITRAKVI 100 mg leveres som en hvid, uigennemsigtig hård gelatinekapsel, (22 mm lang x 7 mm bred), med et blåt printet BAYER-kors og ”LARO 100 mg” på kapslens underdel
English: Press the bottle cap and turn it anti-clockwise to open the bottle.
Danish: - Tryk på flaskens låg og drej den mod uret for at åbne flasken.
English: VITRAKVI 20 mg/mL oral solution larotrectinib
Danish: VITRAKVI 20 mg/ml oral opløsning larotrectinib
English: • Adult and paediatric patients ≥ 12 years with advanced solid tumours with an NTRK gene fusion
Danish: • Voksne og pædiatriske patienter ≥ 12 år med fremskredne solide tumorer med en NTRK-genfusion
English: Amber glass (type III) bottle with a child-resistant polypropylene (PP) cap with a polyethylene (PE) seal liner.
Danish: Ravfarvet glasflaske (type III) med med et børnesikret låg af polypropylen (PP) med et lag af polyethylen (PE)-forsegling.
English: Weight increased (Abnormal weight gain)
Danish: Vægtøgning (unormal vægtøgning)
English: If necessary, VITRAKVI may be administered via a nasogastric feeding tube.
Danish: Hvis det er nødvendigt, kan VITRAKVI administreres gennem en næsesonde.
English: VITRAKVI is available as a capsule and oral solution formulation.
Danish: VITRAKVI fås som en kapsel og som oral opløsning.
English: ALT and AST increases leading to dose modifications occurred in 7 (6%) patients and 6 (5%) patients, respectively (see section 4.4).
Danish: ALAT- og ASAT-forhøjelser, der førte til dosismodifikationer, opstod hos hhv. 7 (6 %) patienter og 6 (5 %) patienter (se pkt.
English: - VITRAKVI should be permanently discontinued if an adverse reaction does not resolve within
Danish: - VITRAKVI bør seponeres permanent, hvis bivirkningen ikke går væk inden for 4 uger.
English: Put the bottle adapter into the bottle neck and make sure it is well fixed.
Danish: - Sæt flaskeadapteren på flaskehalsen, og sørg for, at den sidder godt fast.
English: - less than 1 mmol (or 23 mg) of sodium per 5 mL, that is to say essentially ‘sodium free'.
Danish: - mindre end 1 mmol (eller 23 mg) natrium pr. 5 ml, dvs. det er i det væsentlige natrium-frit - 1,6 mg propylenglycol i 1 ml.
English: Elderly No dose adjustment is recommended in elderly patients (see section 5.2).
Danish: Ældre Ingen dosisjustering er anbefalet hos ældre patienter (se pkt.
English: - Insert the bottle adapter into the bottle neck and ensure it is well fixed.
Danish: - Indsæt flaskeadapteren i flaskehalsen, og sørg for, at den sidder godt fast.
English: High density polyethylene (HDPE)-bottles with a child-resistant polypropylene (PP) cap with a polyethylene (PE) heat seal layer.
Danish: Højdensitets-polyethylen (HDPE)-plastbeholder med et børnesikret låg af polypropylen (PP) med et varmeforseglende lag af polyethylen.
English: The recommended dose in paediatric patients is 100 mg/m2 larotrectinib twice daily with a maximum of 100 mg per dose until disease progression or until unacceptable toxicity occurs.
Danish: Den anbefalede dosis hos pædiatriske patienter er 100 mg/m2 larotrectinib to gange dagligt med maksimalt 100 mg pr. dosis, indtil sygdomsprogression, eller indtil der opstår uacceptabel toksicitet.
English: You should avoid getting pregnant while taking this medicine.
Danish: Du skal undgå at blive gravid, mens du tager VITRAKVI.
English: The highest reported grade was Grade 3 for adverse reactions anaemia, weight increased, fatigue, increased AST, dizziness, paraesthesia, nausea, myalgia, and leukocyte count decreased.
Danish: Den højeste rapporterede grad for bivirkningerne anæmi, vægtøgning, træthed, forhøjet ASAT, svimmelhed, paræstesi, kvalme, myalgi og nedsat leukocyttal var grad 3.
English: Tumour types included in efficacy analysis n
Danish: Dosis og formulering Tumortyper inkluderet i virkningsanalysen n
English: Use a 1 mL syringe with 0.1 mL marks for doses less than 1 mL.
Danish: Brug en 1 ml sprøjte med inddelinger på 0,1 ml til doser mindre end 1 ml.
English: - Open the bottle: press the bottle cap and turn it counter clockwise.
Danish: - Åbn flasken: tryk ned på flaskens låg og drej mod uret.
English: These resultant novel chimeric oncogenic proteins are aberrantly expressed, driving constitutive kinase activity subsequently activating downstream cell signalling pathways involved in cell proliferation and survival leading to TRK fusion-positive cancer.
Danish: Disse dannede nye kimeriske onkogene proteiner, der er atypisk udtrykt, fører til konstitutiv kinaseaktivitet, som efterfølgende aktiverer downstreams signaleringsveje i cellen, der er involveret i celledeling ogoverlevelse, hvilket fører til TRK fusionspositiv cancer.
English: The fraction excreted as unchanged drug in urine was 29% following IV microtracer dose, indicating that direct renal excretion accounted for 29% of total clearance.
Danish: microtracer-dosis, hvilket indikerer, at direkte nyreudskillelse udgør 29 % af total clearance.
English: ALT and AST increase were reported in patients receiving larotrectinib (see section 4.8).
Danish: Der blev rapporteret ALAT- og ASAT-forhøjelser hos patienter, der fik larotrectinib (se pkt.
English: How VITRAKVI works
Danish: Sådan virker VITRAKVI
English: tacrolimus - a medicine used to treat an abnormal heart rhythm called quinidine - medicines used to treat migraines called dihydroergotamine, ergotamine - a medicine used to treat long-term pain called fentanyl - a medicine used to control involuntary movements or sounds called pimozide - a medicine to help you stop smoking called bupropion - medicines to reduce blood sugar levels called repaglinide, tolbutamide - a medicine that prevents blood clots called warfarin - a medicine used to reduce the amount of acid produced in the stomach called omeprazole - a medicine used to help control high blood pressure called valsartan - a group of medicines used to help lower cholesterol called statins - hormonal medicines used for contraception, see section “contraception - for men and women”
Danish: phenobarbital - et naturlægemiddel, der anvendes til at behandle depression, kaldetperikon - et lægemiddel, der anvendes til at behandle tuberkulose, kaldet rifampicin - et lægemiddel, der anvendes som stærk smertelindring, kaldet alfentanil - lægemidler, der anvendes til at forhindre organafstødning efter en organtransplantation, kaldet ciclosporin, sirolimus, tacrolimus - et lægemiddel, der anvendes til at behandle unormal hjerterytme, kaldet quinidin - lægemidler, der anvendes til at behandle migræne, kaldet dihydroergotamin, ergotamin - et lægemiddel, der anvendes til at behandle langvarige smerter, kaldet fentanyl - et lægemiddel, der anvendes til at kontrollere ufrivillige bevægelser eller lyde, kaldet pimozid - et lægemiddel, der hjælper dig med at holde op med at ryge, som kaldes bupropion - lægemidler, der sænker blodsukkeret, kaldet repaglinid, tolbutamid - et lægemiddel, der er blodfortyndende, kaldet warfarin - et lægemiddel, der anvendes til at mindske mængden af mavesyre, kaldet omeprazolet lægemiddel, der anvendes til at hjælpe med at kontrollere højt blodtryk, kaldet valsartan - en gruppe af lægemidler, der anvendes til at hjælpe med at sænke kolesetrol, kaldet statiner - hormonelle lægemidler, der anvendes til prævention, se punkt ”prævention - for mænd og kvinder” nedenfor.
English: Soft tissue sarcoma (n=11) Primary CNS (n=5) Bone sarcoma (n=1) Congenital mesoblastic nephroma (n=1) Melanoma (n=1)
Danish: Bløddelssarkom (n = 11) Primær CNS (n = 5) Knoglesarkom (n = 1) Medfødt mesoblastisk nefrom (n = 1) Melanom (n = 1)
English: For volumes of 1 mL and higher use a 5 mL oral syringe with 0.2 mL graduation.
Danish: For volumener på 1 ml og derover anvendes en 5 ml oral sprøjte med gradueringer på 0,2 ml.
English: Patients enrolled to Study 2 (“NAVIGATE”) were required to have TRK fusion-positive cancer.
Danish: Patienterne skulle have TRK-fusionspositiv cancer for at indgå i studie 2 (”NAVIGATE”).
English: For volumes less than 1 mL use a 1 mL oral syringe with 0.1 mL graduation.
Danish: For volumener under 1 ml anvendes en 1 ml oral sprøjte med gradueringer på 0,1 ml.
English: clarithromycin, telithromycin, troleandomycin - a medicine used to treat Cushing's syndrome called ketoconazole - medicines used to treat HIV infection called atazanavir, indinavir, nelfinavir, ritonavir,
Danish: voriconazol, clarithromycin, telithromycin, troleandomycin - et lægemiddel, der anvendes til at behandle Cushings syndrom, kaldet ketoconazol - lægemidler, der anvendes til at behandle HIV-infektion, kaldet atazanavir, indinavir, nelfinavir,
English: - For doses of 1 mL and higher a 5 mL oral syringe should be used.
Danish: - For doser på 1 ml og derover bør der anvendes en 5 ml oral sprøjte.
English: Clinical data in healthy adult subjects indicate that co-administration of VITRAKVI (100 mg twice daily for 10 days) increased the Cmax and AUC of oral midazolam 1.7-fold compared to midazolam alone, suggesting that larotrectinib is a weak inhibitor of CYP3A.
Danish: Kliniske data hos raske, voksne personer indikerer, at samtidig administration af VITRAKVI (100 mg to gange dagligt i 10 dage) forhøjede Cmax og AUC for oralt midazolam 1,7 gange, sammenlignet med midazolam alene, hvilket tyder på, at larotrectinib er en svag inhibitor af CYP3A.
English: ≥ 12 months Range (months)
Danish: ≥ 12 måneder
English: - The maximum recommended dose is 100 mg (5 mL), two times a day.
Danish: - Den maksimale anbefalede dosis er 100 mg (5 ml)to gange dagligt.
English: Larotrectinib had no neurobehavioural findings in adult animals (rats, mice, cynomolgus monkeys) at exposure (Cmax) at least 7-fold higher than the human exposure.
Danish: Der var ingen neuroadfærdsmæssige fund hos voksne dyr (rotter, mus, cynomolgusaber) ved eksponering (Cmax) mindst 7 gange højere end den humane eksponering.
English: How to take VITRAKVI
Danish: Sådan skal du tage VITRAKVI
English: Analysis in solid tumours excluding primary CNS tumours (n=93)a
Danish: Analyse i solide tumorer eksklusiv primære CNStumorer (n = 93)a
English: Hydroxypropylbetadex
Danish: Hydroxypropylbetadex Glycerol (E 422)
English: A pharmacokinetic study was conducted in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, and in healthy adult control subjects with normal hepatic function matched for age, body mass index and sex. All subjects received a single 100 mg dose of larotrectinib.
Danish: Der blev udført et farmakokinetisk studie hos personer med let (Child-Pugh A), moderat (Child-Pugh B) og svært (Child-Pugh C) nedsat leverfunktion, og hos raske, voksne kontrolpersoner med normal leverfunktion, matchet for alder, kropsmasseindex og køn.
English: An increase in larotrectinib AUC0-inf was observed in subjects with mild, moderate and severe hepatic impairment of 1.3, 2 and 3.2-fold respectively versus those with normal hepatic function.
Danish: Der blev observeret en øget AUC0-inf hos personer med let, moderat og svært nedsat leverfunktion, hhv. 1,3, 2 og 3,2 gange versus personer med normal leverfunktion.
English: - The recommended dose of VITRAKVI is 100 mg (5 mL), two times a day.
Danish: - Den anbefalede dosis af VITRAKVI er 100 mg (5 ml), to gange dagligt.
English: Women of reproductive potential should be advised to use highly effective contraception during treatment with VITRAKVI and for at least one month after the final dose.
Danish: Kvinder med reproduktionspotentiale skal rådes til at bruge meget sikker kontraception under behandlingen med VITRAKVI og i mindst en måned efter den sidste dosis.
English: - The recommended dose of VITRAKVI is 100 mg (1 capsule of 100 mg or 4 capsules of 25 mg),
Danish: - Den maksimale anbefalede dosis er 100 mg (1 kapsel med 100 mg eller 4 kapsler med 25 mg),
English: VITRAKVI 100 mg hard capsules larotrectinib
Danish: VITRAKVI 100 mg hårde kapsler larotrectinib
English: Pancreasa
Danish: Pankreasa
English: Renal impairment No dose adjustment is required for patients with renal impairment (see section 5.2).
Danish: Nedsat nyrefunktion Ingen dosisjustering er nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: VITRAKVI 25 mg hard capsules larotrectinib
Danish: VITRAKVI 25 mg hårde kapsler larotrectinib
English: Following oral administration of 100 mg radiolabeled larotrectinib to healthy adult subjects, 58% of the administered radioactivity was recovered in faeces and 39% was recovered in urine and when an IV microtracer dose was given in conjunction with a 100 mg oral dose of larotrectinib, 35% of the administered radioactivity was recovered in faeces and 53% was recovered in urine.
Danish: Efter oral administration af 100 mg radioaktivt mærket larotrectinib til raske, voksne personer blev 58 % af den administrerede radioaktivitet genfundet i fæces, og 39 % blev genfundet i urinen, og når en i.v.
English: Effects of larotrectinib on other agents
Danish: Virkning af larotrectinib på andre stoffer
English: Aspartate aminotransferase (AST) increased
Danish: Forhøjet aspartataminotransferase (ASAT)
English: Co-administration of VITRAKVI with strong CYP3A inhibitors, P-gp and BCRP inhibitors (e.g. atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole or grapefruit) may increase larotrectinib plasma concentrations (see section 4.2).
Danish: Samtidig administration af VITRAKVI og potente CYP3A-inhibitorer, P-gp- og BCRP-inhibitorer (f.eks. atazanavir, clarithromycin, indinavir, itraconazol, ketoconazol, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazol eller grapefrugt) kan øge plasmakoncentrationen af larotrectinib (se pkt.
English: Salivary gland (n=3) GIST (n=2)a
Danish: Primær CNS (n = 4) GIST (n = 2)a
English: VITRAKVI 20 mg/mL oral solution
Danish: VITRAKVI 20 mg/ml oral opløsning
English: ANNEX IV CONCLUSION ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: BILAG IV KONKLUSIONER VEDRØRENDE UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER BETINGEDE OMSTÆNDIGHEDER
English: Baseline characteristics for the 9 patients with primary CNS tumours with an NTRK gene fusion assessed by investigator were as follows: median age 12 years (range 2-79 years); 6 patients < 18 years of age, and 3 patients ≥ 18 years, and 8 patients white and 5 patients male; and ECOG PS 0-1 (8 patients), or 2 (1 patient).
Danish: Baseline-karakteristika for de 9 patienter med primære CNS-tumorer med en NTRK-genfusion som blev vurderet af investoren, var følgende: medianalder på 12 år (interval 2-79 år), 6 patienter < 18 år og 3 % ≥ 18 år, og 8 patienter var hvide og 5 patienter var mænd; og ECOG PS 0-1 (8 patienter) eller 2 (1 patient).
English: Mean clearance (CL) of larotrectinib was approximately 34 L/h following intravenous administration of an IV microtracer in conjunction with a 100 mg oral dose of VITRAKVI.
Danish: Gennemsnitlig clearance (CL) af larotrectinib var ca. 34 l/t efter intravenøs administration af en i.v.
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Very common (may affect more than 1 in 10 people): - you may look pale and feel your heart pumping, which could be symptoms of low red blood cells (anaemia) - flu like symptoms including fever, which could be symptoms of low white blood cells
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer): - du kan se bleg ud og føle, at dit hjerte banker, hvilket kan være symptomer på et lavt antal røde blodlegemer (anæmi) - influenzalignende symptomer, herunder feber, hvilket kan være symptomer på et lavt antal hvide blodlegemer (neutropeni, leukopeni) - kvalme eller opkastning - forstoppelse - muskelsmerter (myalgi) - muskelsvaghed - træthedsfølelse - forøget mængde leverenzymer i blodprøver - vægtøgning.
English: VITRAKVI 25 mg hard capsules VITRAKVI 100 mg hard capsules
Danish: VITRAKVI 25 mg hårde kapsler VITRAKVI 100 mg hårde kapsler
English: In 3-months toxicity studies, larotrectinib had no histological effect on the male reproductive organs in rats and monkeys at the highest tested doses corresponding to approximately 7-times (male rats) and 10-times (male monkeys) the human AUC at the recommended clinical dose.
Danish: I 3-måneders toksicitetsstudier havde larotrectinib ingen histologisk virkning på hannernes reproduktionsorganer hos rotter og aber ved de højeste testede doser svarende til ca. 7 gange (hanrotter) og 10 gange (hanaber) den humane AUC ved den anbefalede kliniske dosis.
English: A pharmacokinetic study was conducted in subjects with end stage renal disease requiring dialysis, and in healthy adult control subjects with normal renal function matched for age, body mass index and sex. All subjects received a single 100 mg dose of larotrectinib.
Danish: Der blev udført et farmakokinetiske studie hos personer med nyresygdom i slutstadiet, som havde behov for dialyse, og hos raske, voksne kontrolpersoner med normal nyrefunktion, matchet for alder, kropsmasseindeks og køn.
English: Effect of CYP3A and P-gp inducers on larotrectinib Co-administration of VITRAKVI with strong or moderate CYP3A and P-gp inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or St. John's Wort) may decrease larotrectinib plasma concentrations and should be avoided (see section 4.4).
Danish: Virkning af CYP3A- og P-gp-induktorer på larotrectinib Samtidig administration af VITRAKVI og potente eller moderate CYP3A og P-gp induktorer (f.eks. carbamazepin, phenobarbital, phenytoin, rifabutin, rifampin eller perikon) kan nedsætte plasmakoncentrationerne af larotrectinib og bør undgås (se pkt.
English: NR: not reached + denotes ongoing a Independent review committee analysis by RECIST v1.1 for solid tumours except primary CNS tumours (93 patients).
Danish: NR: ikke nået; + benævner igangværende a Analyse foretaget af uafhængig bedømmelseskomité (Independent Review Committee) af RESIST v1.1 for solide tumorer bortset fra primære CNS-tumorer (93 patienter) bVurdering af investigator ved hjælp af enten RANO eller RESIST v1.1 kriterier for primære CNS-tumorer (9 patienter).
English: Table 2: Adverse drug reactions reported in TRK fusion-positive cancer patients treated with VITRAKVI at recommended dose (n=125)
Danish: Tabel 2: Bivirkninger rapporteret hos TRK-fusionspositive cancerpatienter behandlet med VITRAKVI ved den anbefalede dosis (n = 125) Systemorganklasse Hyppighed Alle grader
English: No effects on female reproductive organs were seen in the 3-months toxicity studies in rats and monkeys at doses corresponding to approximately 3-times (female rats) and 17-times (female monkeys) the human AUC at the recommended clinical dose.
Danish: Der blev ikke observeret nogen virkninger på hunnernes reproduktionsorganer i de 3-måneders toksicitetsforsøg hos rotter og aber ved doser, der svarede til ca. 3 gange (hunrotter) og 17 gange (hunaber) den humane AUC ved den anbefalede kliniske dosis.
English: Males of reproductive potential with a non-pregnant woman partner of child-bearing potential should be advised to use highly effective contraception during treatment with VITRAKVI and for at least one month after the final dose.
Danish: Mænd med reproduktionspotentiale med en kvindelig partner i den fertile alder, som ikke er gravid, bør rådes til at bruge meget sikker kontraception under behandlingen med VITRAKVI og i mindst en måned efter den sidste dosis.
English: Soft tissue sarcomaa Salivary glanda Infantile fibrosarcomaa Thyroida
Danish: Bløddelssarkoma Spytkirtela Infantilt fibrosarkoma Thyroideaa Primære CNSb
English: glioblastoma and astrocytoma) with investigator tumour response assessment a GIST: gastrointestinal stromal tumour b brain metastases observed in one thyroid, one NSCLC, and one SCLC patient c NSCLC: non-small cell lung cancer d SCLC: small cell lung cancer
Danish: * består af 93 patienter med IRC-tumorrespons og 9 patienter med primære CNS-tumorer (herunder gliom, glioblastom og astrocytom) med investigator bedømt tumorrespons a GIST: gastrointestinal stromal tumor b hjernemetastaser observeret hos en thyroidea-, en NSCLC- og en SCLC-patient c NSCLC: ikke-småcellet lungecancer d SCLC: småcellet lungecancer
English: White opaque hard gelatine capsule, size 0 (22 mm long x 7 mm wide), with blue printing of BAYER-cross and “LARO 100 mg” on body of capsule.
Danish: Hvid, uigennemsigtig, hård gelatinekapsel, størrelse 0 (22 mm lang x 7 mm bred), med ”BAYER”-kors præget i blåt og “LARO 100 mg” på kapslens underdel.
English: Conditional approval
Danish: Betingede omstændigheder
English: Each VITRAKVI 25 mg capsule contains 25 mg of larotrectinib (as sulfate).
Danish: Hver VITRAKVI 25 mg kapsel indeholder 25 mg larotrectinib (som sulfat).
English: Each VITRAKVI 100 mg capsule contains 100 mg of larotrectinib (as sulfate).
Danish: Hver VITRAKVI 100 mg kapsel indeholder 100 mg larotrectinib (som sulfat).
English: White opaque hard gelatine capsule, size 2 (18 mm long x 6 mm wide), with blue printing of BAYER-cross and “LARO 25 mg” on body of capsule.
Danish: Hvid, uigennemsigtig, hård gelatinekapsel, størrelse 2 (18 mm lang x 6 mm bred), med ”BAYER”-kors præget i blåt og “LARO 25 mg” på kapslens underdel.
English: Doses up to 200 mg once or twice daily (25 mg, 100 mg capsules or 20 mg/mL oral solution)
Danish: Doser på op til 200 mg en eller to gange dagligt (25 mg, 100 mg kapsler eller 20 mg/ml oral opløsning)
English: Each mL of oral solution contains 20 mg of larotrectinib (as sulfate).
Danish: Hver ml oral opløsning indeholder 20 mg larotrectinib (som sulfat).