FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are: - Purified water - Sucrose - Hydroxypropylbetadex - Glycerol (E 422) - Sorbitol (E 420) - Sodium citrate (E 331) - Sodium dihydrogen phosphate dihydrate (E 339) - Citric acid (E 330) - Propylene glycol (E 1520) - Potassium sorbate (E 202) - Methyl parahydroxybenzoate (E 218) - Citrus fruit flavour - Natural flavour
Danish: Øvrige indholdsstoffer: - Renset vand - Saccharose - Hydroxypropylbetadex - Glycerol (E 422) - Sorbitol (E 420) - Natriumcitrat (E 331) - Natriumdihydrogenphosphatdihydrat (E 339) - Citronsyre (E 330) - Propylenglycol (E 1520) - Kaliumsorbat (E 202) - Methylparahydroxybenzoat (E 218) - Citrusfrugtsmag - Naturlig smag
English: Parahydroxybenzoate: may cause allergic reactions (possibly delayed).
Danish: Parahydroxybenzoat: kan give allergiske reaktioner (kan optræde efter behandlingen).
English: EU/1/19/1385/003 - VITRAKVI 20 mg/mL oral solution
Danish: EU/1/19/1385/003 - VITRAKVI 20 mg/ml oral opløsning
English: In order to further confirm the appropriate dose recommended in paediatric patients, the MAH should submit an updated pop PK model based on additional PK sampling in patients aged 1 month to 6 years from study LOXO-TRK-15003 (SCOUT).
Danish: For yderligere at bekræfte den passende dosis hos pædiatriske patienter, skalindehaveren af markedsføringstilladelsen indsende en opdateret pop-PKmodel baseret på yderligere PK-prøveudtagning hos patienter i alderen 1 måned til 6 år fra LOXO-TRK-15003 (SCOUT)-studiet.
English: The area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of larotrectinib after a single dose in healthy adult subjects were dose proportional up to 400 mg and slightly greater than proportional at doses of 600 to 900 mg.
Danish: Arealet under kurven over plasmakoncentration mod tid (AUC) og den maksimale plasmakoncentration (Cmax) af larotrectinib efter en enkelt dosis hos raske, voksne personer var dosisproportional op til 400 mg, og lidt mere end proportional ved doser på 600 til 900 mg.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at gøre det.
English: In vitro studies indicate that larotrectinib induces CYP2B6.
Danish: In vitro studier indikerer, at larotrectinib inducerer CYP2B6.
English: Study 2 “NAVIGATE” NCT02576431
Danish: Studie 2“NAVIGATE” NCT02576431
English: Paediatric patients with body surface area less than 1.0 m2
Danish: Pædiatriske patienter med et legemsoverfladeareal på under 1,0 m2
English: In rats, severe toxicity (STD10) was observed at doses corresponding to 1- to 2-times the human AUC at the recommended clinical dose.
Danish: Hos rotter blev svær toksicitet (STD10) observeret ved doser svarende til 1 til 2 gange det humane AUC ved den anbefalede kliniske dosis.
English: In order to further confirm the histology-independent efficacy of larotrectinib and to investigate the primary and secondary resistance mechanisms, the MAH should submit a pooled analysis for the increased sample size including the final report of study LOXO-TRK-15002 (NAVIGATE).
Danish: For yderligere at bekræfte den histologiske uafhængige virkning af larotrectinib og for at undersøge de primære og sekundære resistensmekanismer, skal indehaveren af markedsføringstilladelsen indsende en samlet analyse af den øgede prøvestørrelse inklusiv den færdige rapport af LOXO-TRK-15002 (NAVIGATE)-studiet.
English: After the inhibitor has been discontinued for 3 to 5 elimination half-lives, VITRAKVI should be resumed at the dose taken prior to initiating the CYP3A4 inhibitor (see section 4.5).
Danish: Efter inhibitoren er blevet seponeret i 3 til 5 eliminationshalveringstider, bør VITRAKVI-dosen genoptages ved dosis fra, før der påbegyndtes en CYP3A4-inhibitor (se pkt.
English: Infantile fibrosarcoma (n=13)
Danish: Infantil fibrosarkom (n = 13)
English: These patients were required to have received prior standard therapy appropriate for their tumour type and stage of disease or who, in the opinion of the investigator, would have had to undergo radical surgery (such as limb amputation, facial resection, or paralysis causing procedure), or were unlikely to tolerate, or derive clinically meaningful benefit from available standard of care therapies in the advanced disease setting.
Danish: Disse patienter skulle have fået tidligere standardbehandling, der var relevant for deres tumortype og sygdomsstadie eller hvor det, efter investigatorens mening, var nødvendigt at gennemgå radikal kirurgi (såsom amputation af lemmer, resektion af ansigt eller indgreb, der forårsager paralyse), eller hvor det var usandsynligt, at de kunne tolerere eller drage klinisk meningsfyldt fordel fra den tilgængelige standardbehandling for fremskreden sygdom.
English: The majority of adverse reactions leading to dose reduction occurred in the first three months of treatment.
Danish: Hovedparten af bivirkningerne, der førte til dosisreduktion, opstod i løbet af de første 3 måneders behandling.
English: Withhold or permanently discontinue VITRAKVI based on the severity.
Danish: VITRAKVI permanent baseret på sværhedsgraden.
English: Ninety-seven percent of patients had received prior treatment for their cancer, defined as surgery, radiotherapy, or systemic therapy.
Danish: 97 procent af patienterne havde tidligere fået behandling for deres cancer, defineret som kirurgi, strålebehandling eller systemisk behandling.
English: - A suitable syringe should be used to administer VITRAKVI to the nasogastric feeding tube.
Danish: - Der skal bruges en egnet sprøjte til at administrere VITRAKVI til den nasogastriske sonde.
English: Majority of Grade 3 elevations were transient appearing in first or second month of treatment and resolving to Grade 1 by months 3-4.
Danish: Størstedelen af grad 3-forhøjelserne var forbigående, og opstod i første eller anden måned af behandlingerne og faldt til grad 1 efter 3-4 måneder.
English: In vitro studies indicate that larotrectinib does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations and is unlikely to affect clearance of substrates of these CYPs.
Danish: In vitro-studier indikerer, at larotrectinib ikke inhibere CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller CYP2D6 ved klinisk relevante koncentrationer, og at det ikke er sandsynligt, at det vil påvirke clearance af substrater for disse CYP'er.
English: - Fill the oral syringe with small amount of solution by pulling the plunger down, then push the plunger upwards to remove any bubbles.
Danish: - Fyld den orale sprøjte med en lille mængde opløsning ved at trække stemplet ned, og dernæst trykke stemplet op for at fjerne bobler.
English: Frequency Infants and toddlers (n=14)a
Danish: Hyppighed Spædbørn og småbørn (n=14)a
English: Women of childbearing potential / Contraception in males and females
Danish: Kvinder i den fertile alder/Kontraception hos mænd og kvinder
English: • Phase 1, open-label, dose escalation and expansion study; expansion phase required tumours with an NTRK gene fusion
Danish: • Fase 1, åbent, dosisoptrapnings- og forlængelsesstudie, forlængelsesfasen krævede tumorer med en NTRKgenfusion
English: - Turn the bottle the right way up and remove the oral syringe from the bottle adapter.
Danish: - Vend flasken den rigtige vej op, og fjern den orale sprøjte fra flaskeadapteren.
English: c Adolescents (12 to <18 years): no Grades 3 and 4 reactions were reported.
Danish: c Unge (12 til <18 år): Der blev ikke rapporteret grad 3 eller 4 bivirkninger.
English: Sodium citrate (E 331)
Danish: Natriumcitrat (E 331)
English: In the overall safety database (n=125), the maximum grade neurologic reaction observed was Grade 3 which was observed in three (2%) patients and included dizziness (one patient, <1%) and paraesthesia (two patients, 1.6%).
Danish: I den samlede sikkerhedsdatabase (n = 125) var den maksimale observerede grad af neurologisk reaktion grad 3, som blev observeret hos tre (2 %) af patienterne, og omfattede svimmelhed (en patient, <1%) og paræstesi (to patienter, 1,6%).
English: Exercise caution with concomitant use of CYP3A substrates with narrow therapeutic range (e.g. alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, or tacrolimus) in patients taking VITRAKVI.
Danish: Udvis forsigtighed ved samtidig anvendelse af CYP3A-substrater med et snævert terapeutisk interval (f.eks. alfentanil, ciclosporin, dihydroergotamin, ergotamin, fentanyl, pimozid, quinidin, sirolimus eller tacrolimus) hos patienter, der tager VITRAKVI.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse.
Danish: Hvis noget af det ovenstående gælder for dig (eller hvis du er i tvivl), skal du kontakte lægen, apotekspersonalet eller sygeplejersken.
English: One reported Grade 3 case each of Neutrophil count decreased (Neutropenia), Paraesthesia, Myalgia, Weight increased (Abnormal weight gain).
Danish: Der blev rapporteret ét tilfælde af grad 3 med nedsat neutrofiltal (neutropeni), paræstesi, myalgi, vægtstigning (unormal vægtforøgelse).
English: Larotrectinib was not teratogenic and embryotoxic when dosed daily during the period of organogenesis to pregnant rats and rabbits at maternotoxic doses, i.e. corresponding to 32-times (rats) and 16-times (rabbits) the human AUC at the recommended clinical dose.
Danish: Larotrectinib var ikke teratogent og embryotoksisk ved daglige doser i løbet af perioden med organogenese til drægtige rotter og kaniner ved maternotoksiske doser, dvs. svarende til 32 gange (rotter) og 16 gange (kaniner) den humane AUC ved den anbefalede kliniske dosis.
English: • Adult patients (≥ 18 years) with advanced solid tumours with an NTRK gene fusion
Danish: • Voksne patienter (≥ 18 år) med fremskredne solide tumorer med en NTRK-genfusion
English: VITRAKVI contains the active substance larotrectinib.
Danish: VITRAKVI indeholder det aktive stof larotrectinib.
English: Therefore, it cannot be excluded whether co-administration of larotrectinib with OATP1B1 substrates (e.g. valsartan, statins) may increase their exposure.
Danish: Det kan derfor ikke udelukkes, om samtidig administration af larotrectinib og OATP1B1-substrater (e.g. valsartan, statiner) kan forhøje deres eksponering.
English: An increase in larotrectinib Cmax and AUC0-inf, of 1.25 and 1.46-fold respectively was observed in renally impaired subjects versus those with normal renal function.
Danish: Der blev observeret en stigning i larotrectinib Cmax og AUC0-inf, på hhv. 1,25 og 1,46 gange hos personer med nedsat nyrefunktion versus personer med normal nyrefunktion.
English: Co-administration with strong CYP3A4 inhibitors If co-administration with a strong CYP3A4 inhibitor is necessary, the VITRAKVI dose should be reduced by 50%.
Danish: Samtidig administration med potente CYP3A4-inhibitore Hvis det er nødvendigt at administrere en potent CYP3A4-inhibitor samtidigt, bør VITRAKVI-dosen reduceres med 50 %.
English: No relevant systemic toxicity was observed in monkeys at doses which correspond to > 10-times the human AUC at the recommended clinical dose.
Danish: Der blev ikke observeret nogen relevant systemisk toksicitet hos aber ved doser, der svarer til > 10 gange den humane AUC ved den anbefalede kliniske dosis.
English: In vitro studies indicate that larotrectinib does not inhibit the transporters BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B3, BSEP, MATE1 and MATE2-K at clinically relevant concentrations and is unlikely to affect clearance of substrates of these transporters.
Danish: In vitro-studier indikerer, at larotrectinib ikke inhibere transporterne BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B3, BSEP, MATE1 og MATE2-K ved klinisk relevante koncentrationer, og at det ikke er sandsynligt, at det vil påvirke clearance af substrater for disse transportere.
English: As it is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives, women using systemically acting hormonal contraceptives should be advised to add a barrier method.
Danish: Eftersom det på nuværende tidspunkt er ukendt, om larotrectinib kan reducere virkningen af systemisk virkende hormonelle kontraceptiva, bør kvinder, der bruger systemisk virkende hormonelle kontraceptiva, rådes til at tilføje en barrieremetode.
English: Package leaflet: Information for the patient VITRAKVI 25 mg hard capsules VITRAKVI 100 mg hard capsules larotrectinib This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten VITRAKVI 25 mg hårde kapsler VITRAKVI 100 mg hårde kapsler larotrectinib Dette lægemiddel er underlagt supplerende overvågning.
English: Contraception in female and male
Danish: Kontraception hos kvinder og mænd
English: - Close the bottle with the original bottle cap (leaving the adapter in place).
Danish: - Luk flasken med det originale låg (lad adapteren blive på plads).
English: Other medicines and VITRAKVI
Danish: Brug af anden medicin sammen med VITRAKVI
English: Effect of CYP3A, P-gp and BCRP inhibitors on larotrectinib Larotrectinib is a substrate of cytochrome P450 (CYP) 3A, P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Danish: Virkning af CYP3A-, P-gp og BCRP-inhibitorer på larotrectinib Larotrectinib er et substrat for cytokrom P450 (CYP) 3A, P-glykoprotein (P-gp) og brystcancerresistensprotein (BCRP).
English: The recommended dose in adults is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs.
Danish: Den anbefalede dosis til voksne er 100 mg larotrectinib to gange dagligt, indtil sygdomsprogression, eller indtil der opstår uacceptabel toksicitet.
English: - Slowly depress the plunger, directing the liquid towards the inside cheek to allow for natural swallowing.
Danish: - Tryk langsomt stemplet ned, mens væskestrømmen er rettet mod indersiden af kinden, så den kan sluges naturligt.
English: All patients had received prior treatment for their cancer, defined as surgery, radiotherapy, or systemic therapy.
Danish: Alle patienterne havde tidligere fået behandling for deres cancer, defineret som kirurgi, strålebehandling eller systemisk behandling.
English: Transaminase elevations
Danish: Transaminaseforhøjelser
English: In healthy adult subjects, the AUC of larotrectinib in the oral solution formulation was similar to the capsule, with Cmax 36% higher with the oral solution formulation.
Danish: Hos raske, voksne personer svarede AUC af larotrectinib som oral opløsning til kapslen, med Cmax 36 % højere med den orale opløsning.
English: At the recommended dose of 100 mg taken twice daily, steady-state arithmetic mean (± standard deviation) Cmax and daily AUC in adults were 914 ± 445 ng/mL and 5410 ± 3813 ng*h/mL, respectively.
Danish: Ved den anbefalede dosis på 100 mg to gange dagligt, var steady-state aritmetiske gennemsnit (± standardafvigelse) Cmax og daglig AUC hos voksne hhv. 914 ± 445 ng/ml og 5410 ± 3813 ng*t/ml.
English: The benefit of VITRAKVI has been established in single arm trials encompassing a relatively small sample of patients whose tumours exhibit NTRK gene fusions.
Danish: Fordelen ved VITRAKVI er blevet klarlagt i studier med en enkelt arm, der omfatter en relativt lille prøve af patienter, hvis tumorer udviser NTRK-genfusioner.
English: It is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives.
Danish: Det vides på nuværende tidspunkt ikke, om larotrectinib kan reducere effektiviteten af systemisk virkende hormonelle kontraceptiva.
English: 100 mg once daily
Danish: 100 mg én gang dagligt
English: Co-administration of larotrectinib with CYP2C8, CYP2C9 or CYP2C19 substrates (e.g. repaglinide, warfarin, tolbutamide or omeprazole) may decrease their exposure.
Danish: Samtidig administration af larotrectinib med CYP2C8, CYP2C9 eller CYP2C19 substrater (f.eks. repaglinid, warfarin, tolbutamid eller omeprazol) kan reducere deres eksponering.
English: Grade 2 ALT and AST increases were observed in 9 (7%) and 6 (5%) of patients, respectively, and Grade 1 ALT and AST increases were observed in 26 (21%) and 28 (22%) of patients, respectively.
Danish: Der blev observeret grad 2 ALAT- og ASAT-forhøjelser hos hhv. 9 (7 %) og 6 (5 %) patienter, og grad 1 ALAT- og ASAT-forhøjelser blev observeret hos hhv. 26 (21 %) og 28 (22 %) af patienterne.
English: Grade 3 ALT and AST increases in 3 (2%) and 2 (2%) patients, respectively.
Danish: Der blev observeret grad 3 ALAT- og ASAT-forhøjelser hos hhv. 3 (2 %) og 2 (2 %) patienter.
English: Table 5: Pooled efficacy results in solid tumours including and excluding primary CNS tumours Efficacy parameter
Danish: Tabel 5: Poolede effektresultater i solide tumorer inklusiv og eksklusiv primære CNS tumorer Effektparameter
English: Fill the syringe with a small amount of solution by pulling the plunger down, then push the plunger upwards to remove any large bubbles that are in the syringe.
Danish: - Fyld sprøjten med en lille mængde opløsning ved at trække stemplet ned, og tryk så stemplet op for at fjerne alle store bobler fra sprøjten.
English: Indigo carmine aluminium lake (E 132) Titanium dioxide (E 171) Propylene glycol (E 1520) Dimeticone
Danish: Indigo carmine aluminium lake (E 132) Titandioxid (E 171) Propylenglycol (E 1520), Dimethicon
English: Capsule shell: - Gelatin - Titanium dioxide (E 171) Printing ink: - Shellac - Indigo carmine aluminium lake (E 132) - Titanium dioxide (E 171) - Propylene glycol (E 1520) - Dimeticone
Danish: Kapselskal: - Gelatine - Titandioxid (E 171) Trykfarve: - Shellac - Indigo carmine aluminium lake (E 132) - Titandioxid (E 171) - Propylenglycol (E 1520) - Dimethicon
English: Gastrointestinal stromal tumoura Bone sarcomaa Cholangiocarcinomaa
Danish: Gastrointestinal stromaltumora Knoglesarkoma Kolangiokarcinoma
English: Fertility studies with larotrectinib have not been conducted.
Danish: Der er ikke blevet udført fertilitetsstudier med larotrectinib.
English: The most common adverse drug reactions (≥ 20%) of VITRAKVI in order of decreasing frequency were fatigue (32%), increased ALT (31%), dizziness (30%), increased AST (29%), constipation (29%), nausea (26%), anaemia (24%), and vomiting (20%).
Danish: De mest almindeligt forekommende bivirkninger med VITRAKVI (≥ 20 %) præsenteret i rækkefølge efter faldende hyppighed var træthed (32 %), forhøjet ALAT (31 %), svimmelhed (30 %), forhøjet ASAT (29 %), forstoppelse (29 %), kvalme (26 %), anæmi (24 %) og opkastning (20 %).
English: Each carton contains one bottle of 56 hard capsules.
Danish: Hver karton indeholder en plastbeholder med 56 hårde kapsler.
English: Gender did not appear to influence larotrectinib pharmacokinetics to a clinically significant extent.
Danish: Køn påvirkede umiddelbart ikke farmakokinetikken for larotrectinib i et klinisk signifikant omfang.
English: Analysis in solid tumours including primary CNS tumours (n=102)a, b
Danish: Analyse i solide tumorer inklusiv primære CNS tumorer (n = 102)a, b
English: Following oral administration of a single 100 mg dose of radiolabeled larotrectinib to healthy adult subjects, unchanged larotrectinib (19%) and an O-glucuronide that is formed following loss of the hydroxypyrrolidine-urea moiety (26%) were the major circulating radioactive drug components.
Danish: Efter oral administration af en enkelt 100 mg dosis af radioaktivt mærket larotrectinib til raske, voksne personer, var et uændret larotrectinib (19 %) og O-glucuronid, der blev dannet efter tab af hydroxypyrrolidin-urea-delen (26 %), de primære radioaktive lægemiddelkomponenter i kredsløbet.
English: Each carton contains 1 child-resistant glass bottle containing 100 mL oral solution.
Danish: Hver karton indeholder 1 børnesikret glasflaske indeholdende 100 ml oral opløsning.
English: Co-administration of larotrectinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may decrease their exposure.
Danish: Samtidig administration af larotrectinib og CYP2B6-substrater (f.eks. bupropion, efavirenz) kan reducere eksponeringen.
English: Table 3: Adverse drug reactions reported in TRK fusion-positive paediatric cancer patients treated with VITRAKVI at recommended dose (n=37); all Grades System organ class
Danish: Table 3: Bivirkninger rapporteret hos TRK-fusionspositive pædiatriske cancerpatienter behandlet med VITRAKVI ved den anbefalede dosis (n = 37); alle grader Systemorganklasse
English: The 200 mg dose corresponds to a peak exposure (Cmax) similar to that observed with larotrectinib 100 mg BID at steady state.
Danish: 200 mg dosis svarer til en maksimal eksponering (Cmax), der er lig den observerede eksponering ved steady state med larotrectinib 100 mg to gange dagligt.
English: The majority of ALT and AST increases occurred in the first 3 months of treatment.
Danish: De fleste ALAT- og ASAT-forhøjelser opstod i løbet af de første 3 måneders behandling.
English: The adverse reactions of vomiting (35% versus 14% in adults), leucocyte count decrease (22% versus 9% in adults), neutrophil count decrease (30% versus 7% in adults), blood alkaline phosphatase increased (14% versus 2% in adults) and transaminase elevations (ALT 41% versus 27% in adults and AST 35% versus 26% in adults) were more frequent in paediatric patients compared to adults.
Danish: Bivirkningerne opkastning (35 % versus 14 % hos voksne), reduktion i leukocyttal (22 % versus 9 % hos voksne), reduktion i neutrofiltal (30 % versus 7 % hos voksne), forhøjet basisk fosfatase i blodet (14% versus 2% hos voksne) og transaminaseforhøjelser (ALAT 41 % versus 27 % hos voksne, og ASAT 35 % versus 26 % hos voksne) var hyppigere hos pædiatriske patienter, sammenlignet med voksne.
English: Larotrectinib had no adverse effect on haemodynamic parameters and ECG intervals in telemetered monkeys at exposures (Cmax) which are approximately 6-fold the human therapeutic exposures.
Danish: Larotrectinib havde ingen bivirkning på hæmodynamiske parametre og EKGintervaller hos aber i telemetri ved eksponeringer (Cmax), som var ca. 6 gange de humane terapeutiske eksponeringer.
English: As a precautionary measure, it is preferable to avoid the use of VITRAKVI during pregnancy.
Danish: For en sikkerheds skyld bør VITRAKVI undgås under graviditeten.
English: Common Blood alkaline phosphatase increased a Infant/toddlers (28 days to 23 months): one Grade 4 Neutrophil count decreased (Neutropenia) reaction reported.
Danish: Almindelig Forhøjet basisk fosfatase i blodet a Spædbørn/småbørn (28 dage til 23 måneder): Der blev rapporteret én bivirkning med nedsat neutrofiltal (Neutropeni) i grad 4.
English: VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, - who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and - who have no satisfactory treatment options (see sections 4.4 and 5.1).
Danish: VITRAKVI som monoterapi er indiceret til behandling af voksne og pædiatriske patienter med solide tumorer, der udviser en neurotrofisk tyrosinreceptorkinase (NTRK)-genfusion, - som har en sygdom, der er lokalt avanceret, metastatisk eller hvor kirurgisk resektion sandsynligvis fører til svær morbiditet, og - som ikke har nogen tilfredsstillende behandlingsmuligheder (se pkt.
English: Third
Danish: Tredje
English: Effects of other agents on larotrectinib
Danish: Virkning af andre stoffer på larotrectinib
English: Larotrectinib had no effect on respiratory function in rats; at exposures (Cmax) at least 8-times the human therapeutic exposure.
Danish: Larotrectinib påvirkede ikke åndedrætsfunktionen hos rotter ved eksponeringer (Cmax), der var mindst 8 gange den terapeutiske eksponering hos mennesker.
English: Turn the bottle the right way up and take the syringe out of the adapter.
Danish: - Vend flasken den rigtige vej op, og fjern sprøjten fra adapteren.
English: Tube length (cm)
Danish: Sondelængde (cm)
English: In the paediatric sub-population (n=28), the ORR was 82%.
Danish: I den pædiatriske delpopulation (n = 28) var ORR