FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Ninlaro will provide the final data from the main study on the effects of the medicine on overall survival.
Danish: Virksomheden, der markedsfører Ninlaro, vil fremskaffe endelige data fra hovedundersøgelsen om lægemidlets virkning på den samlede overlevelse.
English: Data from the main study indicate that Ninlaro improves patients' progression-free survival.
Danish: Data fra hovedundersøgelsen tydede på, at Ninlaro forbedrede patienternes progressionsfrie overlevelse.
English: Since Ninlaro has been granted a conditional approval, the company that markets Ninlaro will provide further data on the benefits of this medicine from other studies, including a study in patients who have not been treated before.
Danish: Da Ninlaro har fået en betinget godkendelse, vil virksomheden, der markedsfører Ninlaro, fremskaffe yderligere data om fordelene ved dette lægemiddel fra andre undersøgelser, herunder fra en undersøgelse af patienter, der ikke tidligere er blevet behandlet.
English: It is not intended to provide practical advice on how to use Ninlaro.
Danish: Det er ikke en praktisk vejledning i, hvordan Ninlaro bør anvendes.
English: The study compared Ninlaro with placebo (a dummy treatment), both taken together with lenalidomide and dexamethasone.
Danish: I undersøgelsen sammenlignedes Ninlaro med placebo (en uvirksom behandling), idet begge stoffer blev taget sammen med lenalidomid og dexamethason.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ninlaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Ninlaro findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In a subsequent similar study involving 115 patients, many with advanced disease, those receiving Ninlaro with lenalidomide and dexamethasone lived on average for 6.7 months without their disease getting worse compared with 4 months in those receiving placebo with lenalidomide and dexamethasone.
Danish: Af en efterfølgende lignende undersøgelse omfattende 115 patienter, mange af hvis sygdom var fremskreden, fremgik det, at de, der modtog Ninlaro med lenalidomid og dexamethason, levede i gennemsnit i 6,7 måneder, uden at deres sygdom forværredes, sammenlignet med fire måneder hos dem, der modtog placebo med lenalidomid og dexamethason.
English: Ninlaro can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.
Danish: Ninlaro udleveres kun efter recept, og behandlingen skal iværksættes og overvåges af en læge med erfaring i behandling af myelomatose.
English: What information is still awaited for Ninlaro?
Danish: Hvilke oplysninger afventes der stadig for Ninlaro?
English: What are the risks associated with Ninlaro?
Danish: Hvilke risici er der forbundet med Ninlaro?
English: For more information about treatment with Ninlaro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ninlaro, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Ninlaro is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow).
Danish: Ninlaro er et kræftlægemiddel, der anvendes til at behandle voksne patienter med myelomatose (en knoglemarvskræft).
English: For the full list of all side effects and restrictions with Ninlaro, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Ninlaro fremgår af indlægssedlen.
English: Ninlaro does not seem to significantly increase the frequency of serious side effects when added to lenalidomide and dexamethasone, and offers the convenience of patients being able to take the capsules at home.
Danish: Intet tyder på, at brug af Ninlaro sammen med lenalidomid og dexamethason øger hyppigheden af alvorlige bivirkninger i betydelig grad, og lægemidlet har den fordel, at patienterne kan tage kapslerne i deres hjem.
English: However, because of the uncertainty regarding the size of the improvement following a later analysis, further confirmatory data will need to be provided by the company that markets the medicine.
Danish: Da en efterfølgende analyse imidlertid har medført en vis usikkerhed med hensyn til omfanget af forbedringen, skal den virksomhed, der markedsfører lægemidlet, fremlægge yderligere bekræftende data.
English: Treatment may need to be stopped temporarily or the dose reduced if the patient has certain side effects.
Danish: Hvis patienten oplever visse bivirkninger, kan det være nødvendigt at afbryde behandlingen midlertidigt eller nedsætte dosis.
English: For practical information about using Ninlaro, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ninlaro, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Ninlaro used?
Danish: Hvordan anvendes Ninlaro?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ninlaro have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ninlaro.
English: How does Ninlaro work?
Danish: Hvordan virker Ninlaro?
English: What benefits of Ninlaro have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ninlaro?
English: A first analysis of the data indicated that Ninlaro is effective at prolonging the time patients live without their disease getting worse (progression-free survival): patients treated with Ninlaro lived for an average of 21 months without their disease getting worse compared with 15 months in patients given placebo.
Danish: En indledende analyse af dataene viste, at Ninlaro er effektivt til at forlænge patienternes overlevelse uden sygdomsforværring (progressionsfri overlevelse).
English: NR: not reached
Danish: NR: ikke nået
English: - Restart the feeding.
Danish: - Genstart ernæringen.
English: After first opening: 30 days.
Danish: Efter første åbning: 30 dage.
English: - you have sex with a woman able to become pregnant.
Danish: - du har sex med en kvinde, der kan blive gravid.
English: A partial response was observed in 1 patient.
Danish: Et delvist respons blev observeret hos 1 patient.
English: Median progression free survival had not been reached at the time of analysis.
Danish: Median progressionsfri overlevelse var ikke nået på analysetidspunktet.
English: PD: progressive disease
Danish: PD: progressiv sygdom
English: NA: not applicable due to small numbers or lack of response NE: not evaluable
Danish: NA: ikke relevant på grund af lille antal eller manglende respons NE: kan ikke evalueres
English: It may also help to shrink the cancer.
Danish: Det kan også hjælpe med at skrumpe kræfttumoren.
English: This could be symptoms of nervous system problems.
Danish: Det kan være symptomer på problemer med nervesystemet.
English: The studies were ongoing at the time of approval.
Danish: Studierne var i gang på godkendelsestidpunktet.
English: - This leaflet has been written as though the person taking the medicine is reading it.
Danish: - Denne indlægsseddel er skrevet som om personen, der tager lægemidlet, læser den.
English: Elderly There are limited data in elderly.
Danish: Der foreligger begrænsede data for ældre.
English: Ask your doctor about the best method of contraception for you.
Danish: Spørg lægen om den bedste præventionsmetode for dig.
English: It is important to take VITRAKVI for as long as your doctor tells you.
Danish: Det er vigtigt at tage VITRAKVI, så længe lægen beder dig om det.
English: Tests and checks
Danish: Prøver og kontroller
English: Taking VITRAKVI with food and drink
Danish: Brug af VITRAKVI sammen med mad og drikke
English: How much to take Adults (from 18 years)
Danish: Voksne (fra 18 år)
English: Your doctor may decide to lower the dose, or pause or stop the treatment.
Danish: Lægen kan beslutte sig for at sænke dosis, eller pause eller stoppe behandlingen.
English: Patients should take the next dose at the next scheduled time.
Danish: Patienterne bør tage den næste dosis på det næste planlagte tidspunkt.
English: A decrease in pregnancy rate was also reported despite normal mating at the high-dose level.
Danish: Der blev også rapporteret et fald i graviditetsraten på trods af normal parring ved det høje dosisniveau.
English: You should immediately contact your doctor if you experience any of the following serious side effects:
Danish: Du skal straks fortælle det til lægen, hvis du oplever nogle af de følgende alvorlige bivirkninger:
English: - Once the bottle is open, you must use your medicine within 30 days of opening.
Danish: - Når flasken er åben, skal du bruge lægemidlet inden for 30 dage efter åbning.
English: Due to the bitter taste, the capsule should not be opened, chewed or crushed.
Danish: På grund af den bitre smag, må kapslen ikke åbnes, tygges eller knuses.
English: NOTE: See exceptions regarding neonates and patients with fluid restrictions in the sub-point directly below.
Danish: Bemærk: Se undtagelser vedrørende nyfødte og patienter med væskebegrænsninger under punktet direkte nedenfor.
English: In the event of overdose, physicians should follow general supportive measures and treat symptomatically.
Danish: I tilfælde af overdosering bør læger initiere generelle støtteforanstaltninger og behandle symptomatisk.
English: - Your child's doctor will work out the right dose for your child based on their height and weight.
Danish: - Dit barns læge vil beregne den rette dosis for dit barn baseret på barnets højde og vægt.
English: Total number of patients (n)*
Danish: Totalt antal patienter (n)*
English: DOR: duration of response
Danish: DOR: Varighed af respons
English: If you are giving this medicine to your child, please replace “you” with “your child” throughout.
Danish: Hvis du giver lægemidlet til dit barn, skal du erstatte ”du” med ”dit barn” i hele indlægssedlen.
English: PK data is available only in 2 patients over 65 years.
Danish: Farmakokinetiske data foreligger kun for 2 patienter over 65 år.
English: • Paediatric patients ≥ 1 month to
Danish: • Pædiatriske patienter ≥ 1 måned til
English: This is because some medicines may affect the way VITRAKVI works or VITRAKVI may affect how other medicines work.
Danish: Dette skyldes, at nogle lægemidler kan påvirke den måde, VITRAKVI virker på, eller VITRAKVI kan påvirke den måde, andre lægemidler virker på.
English: This being a conditional marketing authorisation and pursuant to Article 14a of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14-a, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: two times a day.
Danish: to gange dagligt.
English: Larotrectinib crosses the placenta in both species.
Danish: Larotrectinib krydser placenta hos begge arter.
English: If this happens, do not drive, cycle or use any tools or machines.
Danish: Hvis dette sker, må du ikke cykle, føre motorkøretøj eller betjene værktøj eller maskiner.
English: Larotrectinib was administered to juvenile rats from postnatal day (PND) 7 to 70.
Danish: Larotrectinib blev administreret til juvenile rotter fra postnatal dag (PND) 7 til 70.
English: Pooled primary analysis set
Danish: Poolede primære analysesæt
English: See “VITRAKVI contains” in section 2 for more information.
Danish: Se ”VITRAKVI indeholder” i punkt 2 for yderligere oplysninger.
English: VITRAKVI may make you feel dizzy or tired.
Danish: VITRAKVI kan få dig til at blive svimmel eller træt.
English: This is because it may increase the amount of VITRAKVI in your body.
Danish: Dette skyldes, at det kan øge mængden af VITRAKVI i kroppen.
English: Neurologic reactions
Danish: Neurologiske reaktioner
English: The patient should be advised to swallow the capsule whole with a glass of water.
Danish: Patienten bør rådes til at sluge kapslen hel med et glas vand.
English: Dose limiting skin lesions were only seen in rats and were primarily responsible for mortality and morbidity.
Danish: Dosisbegrænsende hudlæsioner blev kun observeret hos rotter, og de var primært årsagen til mortalitet og morbiditet.
English: Your doctor will do blood tests before and during treatment to check the level of ALT and AST and check how well your liver is working.
Danish: Lægen vil tage blodprøver før og under behandlingen for at kontrollere niveauet af ALAT og ASAT, og undersøge hvor godt din lever virker.
English: Genotoxicity and carcinogenicity
Danish: Genotoksicitet og carcinogenicitet
English: Clinical relevance of this finding has not been established.
Danish: Den kliniske relevans af dette fund er ikke klarlagt.
English: - VITRAKVI can be taken with or without food.
Danish: - VITRAKVI kan tages sammen med eller uden mad.
English: Sorbitol: patients with hereditary fructose intolerance (HFI) should not take this medicinal product.
Danish: Sorbitol: patienter med arvelig fructoseintolerans (HFI) bør ikke tage dette lægemiddel.
English: - sucrose: it may be harmful to the teeth.
Danish: - saccharose: det kan være skadeligt for tænderne.
English: This may influence the ability to drive and use machines during this time period.
Danish: Det kan påvirke evnen til at føre motorkøretøj og betjene maskiner i dette tidsrum.
English: Do not stop taking this medicine without talking to your doctor first.
Danish: Du må ikke holde op med at tage dette lægemiddel, uden først at kontakte din læge.
English: The median change in tumour size in the pooled primary analysis set was a decrease of 66%.
Danish: Den mediane ændring i tumorstørrelse i det poolede primære analysesæt var et fald på 66 %.
English: Dosing in paediatric patients is based on body surface area (BSA).
Danish: Doseringen hos pædiatriske patienter er baseret på legemsoverfladearealet (body surface area, BSA).
English: Symptoms of overdose are not established.
Danish: Symptomerne på overdosering er ikke klarlagt.
English: Grades 3 and 4
Danish: Grad 3 og 4
English: - Along with this medicine you need a bottle adapter (28 mm diameter) and a syringe that can be used to give medicines by mouth.
Danish: - Til dette lægemiddel har du brug for en flaskeadapter (28 mm diameter) og en sprøjte, der kan bruges til at give lægemidlet gennem munden.
English: VITRAKVI is for oral use.
Danish: VITRAKVI er til oral anvendelse.
English: Data defining exposure in small children (1 month to <6 years of age) at the recommended dose is limited (n=33).
Danish: Data, der definerer eksponeringen hos små børn (1 måned til < 6 år) ved den anbefalede dosis, er begrænset (n = 33).
English: Embryotoxicity / Teratogenicity
Danish: Embryotoksicitet/teratogenicitet
English: The only other kinase activity occurred at 100-fold higher concentrations.
Danish: Den eneste anden kinaseaktivitet forekom ved koncentrationer, der var 100 gange højere.
English: The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as determined by a blinded independent review committee (BIRC).
Danish: De vigtigste målinger af virkningsudfald var samlet responsrate (ORR) og varighed af respons (DOR), bedømt af en blindet uafhængig bedømmelseskomité (BIRC).
English: Breasta, c
Danish: Brysta,c
English: Treatment with VITRAKVI should be initiated by physicians experienced in the administration of anticancer therapies.
Danish: Behandling med VITRAKVI skal påbegyndes af læger med erfaring i administration af behandlinger mod cancer.
English: Important information about some of the ingredients
Danish: Vigtig information om nogle af indholdsstofferne
English: An oral solution of VITRAKVI is available for patients who cannot swallow the capsules.
Danish: En oral opløsning af VITRAKVI er tilgængelig for patienter, der ikke kan sluge kapslerne.
English: The overall incidence was 30% for dizziness, 10% for paraesthesia and 3% for gait disturbance.
Danish: Den samlede forekomst var 30 % for svimmelhed, 10 % for paræstesi og 3 % for gangbesvær.
English: The adverse drug reactions are classified according to the System Organ Class.
Danish: Bivirkningerne er klassificeret i henhold til systemorganklasse.
English: Systemic toxicity was assessed in studies with daily oral administration up to 3 months in rats and monkeys.
Danish: Den systemiske toksicitet blev vurderet i forsøg med daglig oral administration i op til 3 måneder hos rotter og aber.
English: Eighty-eight percent (88%) [95% CI: 81, 95] of patients treated were alive one year after the start of therapy.
Danish: 88 % [95 % CI: 81; 95] af de behandlede patienter var i live et år efter behandlingsstart.
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette lægemiddel inden for 6 måneder efter godkendelsen.
English: a Grade 4 reactions were reported
Danish: a Grad 4 bivirkninger blev rapporteret
English: Frequency groups are defined by the following convention: very common (≥ 1/10); common (≥ 1/100
Danish: Hyppighedsgrupperne er defineret ved følgende konvention: meget almindelig (≥ 1/10), almindelig
English: VITRAKVI should be permanently discontinued in patients who are unable to tolerate VITRAKVI after three dose modifications.
Danish: VITRAKVI bør seponeres permanent hos patienter, som ikke kan tolerere VITRAKVI efter tre dosismodifikationer.
English: - Swallow the VITRAKVI capsules whole with a glass of water.
Danish: - Slug VITRAKVI-kapslerne hele sammen med et stort glas vand.
English: Contains: sucrose, E 420, E 1520, E 218.
Danish: Indeholder: saccharose, E 420, E 218, E 1520.
English: The blood-to-plasma concentration ratio was approximately 0.9.
Danish: Forholdet med koncentrationen i blod og plasma var ca. 0,9.
English: Partial response (PR)
Danish: Delvist respons (partial response, PR)
English: The safety profile in elderly patients (≥ 65 years) is consistent with that seen in younger patients (< 65 years).
Danish: Sikkerhedsprofilen hos ældre patienter (≥ 65 år) er i overensstemmelse med, hvad der blev set hos yngre patienter (< 65 år).
English: For paediatric patients older than 12 years of age, the recommended dose is likely to give similar Cmax and AUC as observed in adults.
Danish: Til pædiatriske patienter over 12 år vil den anbefalede dosis sandsynligvis give samme Cmax og AUC, som observeret hos voksne.
English: In addition, larotrectinib had no effect on spermatogenesis in rats.
Danish: Desuden havde larotrectinib ingen virkning på spermatogenesen hos rotter.
English: It is unknown whether larotrectinib/metabolites are excreted in human milk.
Danish: Det er ukendt, om larotrectinib/metabolitter udskilles i human mælk.
English: Oral syringe - Use a suitable oral syringe with CE marking and bottle adapter (28 mm diameter) if applicable.
Danish: Oral sprøjte - Anvend en egnet oral sprøjte med CE-mærke og en flaskeadapter (28 mm diameter), hvis det er relevant.
English: For all Grade 2 adverse reactions, continued dosing may be appropriate, though close monitoring to ensure no worsening of the toxicity is advised.
Danish: For alle grad 2-bivirkninger kan en fortsat dosering være hensigtsmæssig, hvor en nøje overvågning anbefales for at sikre, at toksiciteten ikke forværres.
English: - Do not take the medicine if the bottle or bottle cap looks damaged or like it has leaked.
Danish: - Tag ikke lægemidlet, hvis flasken eller låget på flasken ser beskadiget ud, eller det ser ud til at have lækket.
English: - Do not use this medicine if you notice that capsules look damaged.
Danish: - Brug ikke lægemidlet, hvis du bemærker skader på kapslerne.
English: - Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og flasken efter EXP.
English: Table 7: Recommended tube dimensions per age group Patient
Danish: Tabel 7: Anbefalede sondedimensioner pr. aldersgruppe Patient
English: Neonates and children with fluid restrictions may require minimal flushing volume of 0.5 to 1 mL or flushing with air to deliver VITRAKVI.
Danish: Nyfødte og børn med væskerestriktioner kan kræve et minimalt skyllevolumen på 0,5 til 1 ml eller skylning med luft for at tilføre VITRAKVI.
English: Lunga Melanomaa Colona
Danish: Lungea Melanoma Kolona
English: If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment.
Danish: Hvis du kan blive gravid, skal din læge udføre en graviditetstest, før du starter behandligen.
English: • Phase 2 multinational, open label, tumour “basket” study
Danish: • Fase 2 multinationalt, åbent, tumor”basket”-studie
English: Time to first response (median, months)
Danish: Tid til første respons (median,
English: None of these adverse reactions led to treatment discontinuation.
Danish: Ingen af disse bivirkninger førte til, at behandlingen blev seponeret.
English: Do not take a double dose to make up for a forgotten dose or if you vomit after taking this medicine.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis, eller hvis du kaster op, efter du har taget dette lægemiddel.
English: % with duration ≥ 6 months % with duration ≥ 12 months
Danish: % med varighed ≥ 6 måneder % med varighed ≥ 12 måneder
English: Median time on treatment for the overall safety population was 7.4 months (range: 0.03 to 40.7).
Danish: Mediantiden for behandlingen hos den samlede sikkerhedspopulation var 7,4 måneder (interval: 0,03 til 40,7).
English: The ORR in the total population may not reflect the expected response in a specific tumour type.
Danish: ORR i den samlede befolkning afspejler måske ikke den forventede respons i en specifik tumortype.
English: Contraception - for men and women
Danish: Prævention - for mænd og kvinder
English: If you use hormonal contraceptives, you should also use a barrier method, such as a condom.
Danish: Hvis du bruger hormonel prævention, skal du også bruge en barrieremetode, f.eks et kondom.
English: If your doctor has told you that you or your child have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you or your child take or receive this medicine.
Danish: Hvis din læge har fortalt dig, at du eller dit barn har intolerance over for nogle sukkerarter, eller hvis du er blevet diagnosticeret med arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, hvor en person ikke kan nedbryde fructose, skal du tale med din læge, før du eller dit barn tager eller får dette lægemiddel.
English: Acquired resistance mutations after progression on TRK inhibitors have been observed.
Danish: Der er observeret erhvervede resistensmutationer efter progression af TRK-inhibitorer.
English: - 22 mg sorbitol in 1 mL.
Danish: - 22 mg sorbitol pr. 1 ml.
English: In the adult sub-population (n=65), the ORR was 68%.
Danish: I den voksne delpopulation (n = 65) var ORR 68 %.
English: The outer diameter of the nasogastric feeding tube should be selected based on the patient characteristics.
Danish: Den ydre diameter på den nasogastriske sonde skal vælges baseret på patientkarakteristika.
English: Of these, 77% had received prior systemic therapy with a median of 1 prior systemic treatment regimen.
Danish: Ud af disse havde 77 % tidligere fået systemisk behandling med en median på 1 tidligere systemisk behandlingsprogram.