natgillin/translations-raw huggingface dataset:
Kliniske data fra raske, voksne personer indikerer, at samtidig administration af en enkelt 100 mg VITRAKVI-dosis med itraconazol (en potent CYP3A-inhibitor og P-gp og BCRP-inhibitor) 200 mg en gang dagligt i 7 dage forhøjede larotrectinib Cmax og AUC hhv. 2,8 gange og 4,3 gange.
Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with itraconazole (a strong CYP3A inhibitor and P-gp and BCRP inhibitor) 200 mg once daily for 7 days increased larotrectinib Cmax and AUC by 2.8-fold and 4.3-fold, respectively.
In vitro-studier viser, at larotrectinib er helt opløseligt i hele pH-intervallet i mave-tarm-kanalen i de væskevoluminer, der er relevante for mave-tarmkanalen.
In vitro studies show that in liquid volumes relevant to the gastrointestinal (GI) tract larotrectinib is fully soluble over entire pH range of the GI tract.
75 mg 2 gange dagligt
75 mg twice daily
Hvis bivirkningen er væk inden for 4 uger, genoptag behandlingen ved den næste dosismodifikation.
Resume at the next dose modification if resolution occurs within 4 weeks.
Hver kapsel indeholder larotrectinibsulfat svarende til 100 mg larotrectinib.
Each capsule contains larotrectinib sulfate, equivalent to 100 mg of larotrectinib.
Hver kapsel indeholder larotrectinibsulfat svarende til 25 mg larotrectinib.
Each capsule contains larotrectinib sulfate, equivalent to 25 mg of larotrectinib.
Kvinder i den fertile alder skal bruge meget sikker kontraception under behandlingen med VITRAKVI og i mindst en måned efter behandlingsophør (se pkt.
Women of childbearing potential must use highly effective contraception while taking VITRAKVI and for at least one month after stopping treatment (see sections 4.5 and 4.6).
Kliniske data fra raske, voksne personer indikerer, at samtidig administration af en enkelt 100 mg VITRAKVI-dosis med en enkeltdosis på 600 mg rifampin (en P-gp og BCRP-inhibitor) forhøjede larotrectinib Cmax og AUC hhv. 1,8 gange og 1,7 gange.
Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with a single dose of 600 mg rifampin (a P-gp and BCRP inhibitor) increased larotrectinib Cmax and AUC by 1.8-fold and 1.7-fold, respectively.
Baseline-karakteristika for de poolede 93 patienter med solide tumorer med en NTRK-genfusion var følgende: medianalder på 41 år (interval 0,1-78 år), 30 % < 18 år og 70 % ≥ 18 år, 70 % hvide og 53 % mænd; og ECOG PS 0-1 (89 %) eller 2 (11 %).
Baseline characteristics for the pooled 93 patients with solid tumours with an NTRK gene fusion were as follows: median age 41 years (range 0.1-78 years); 30% < 18 years of age, and 70% ≥ 18 years;
Svimmelhed Paræstesi Gangbesvær
Dizziness Paraesthesia Gait disturbance
mikrotracer sammen med en 100 mg oral dosis, hvilket indikerer moderat fordeling i vævet fra plasma.
The mean volume of distribution of larotrectinib in healthy adult subjects was 48 L following intravenous administration of an IV microtracer in conjunction with a 100 mg oral dose, indicating moderate distribution into tissues from the plasma.
Methylparahydroxybenzoat (E 218) Citrusfrugtsmag
Propylene glycol (E 1520) Potassium sorbate (E 202) Methyl parahydroxybenzoate (E 218) Citrus fruit flavour
Spytkirtel (n = 3) GIST (n = 2)a NSCLC (n = 1)c Bløddelssarkom (n = 1) Thyroidea (n = 1)
NSCLC (n=1)c Soft tissue sarcoma (n=1) Thyroid (n=1)
50 mg 2 gange dagligt
50 mg twice daily
Pankreas (n = 1)
Bone sarcoma (n=1) Pancreas (n=1)
Tilbagehold eller seponer
Dose and formulation
Forhøjet alaninaminotransferase (ALAT)
Very common Alanine aminotransferase (ALT) increased
Anæmi Nedsat neutrofiltal (neutropeni) Nedsat leukocyttal (leukopeni)
Anaemia Neutrophil count decreased (Neutropenia) Leukocyte count decreased (Leukopenia)
50 mg/m2 2 gange dagligt
50 mg/m2 twice daily
25 mg/m2 2 gange dagligt
25 mg/m2 twice daily
Det skal du vide, før du begynder at tage VITRAKVI Sådan skal du tage VITRAKVI Bivirkninger
What VITRAKVI is and what it is used for What you need to know before you take VITRAKVI How to take VITRAKVI
Forhøjet alaninaminotrans ferase (ALAT) Forhøjet aspartataminotran sferase (ASAT) Vægtøgning (unormal vægtstigning) Forhøjet basisk fosfatase i blodet
Alanine aminotransferase (ALT) increased Aspartate aminotransferase (AST) increased Weight increased (Abnormal weight gain) Blood alkaline phosphatase increased
75 mg/m2 2 gange dagligt
75 mg/m2 twice daily
Nyfødt
Neonate
Hvis du har taget for meget VITRAKVI
If you take more VITRAKVI than you should
Forhøjet alaninaminotrans ferase (ALAT) Forhøjet aspartataminotran sferase (ASAT) Vægtøgning (unormal vægtstigning)
Alanine aminotransferase (ALT) increaseda Aspartate aminotransferase (AST) increased
Hver ml oral opløsning indeholder larotrectinibsulfat svarende til 20 mg larotrectinib.
Each mL of oral solution contains larotrectinib sulfate equivalent to 20 mg of larotrectinib.
Svimmelhed Paræstesi
Dizziness Paraesthesia
Hver ml oral opløsning indeholder larotrectinibsulfat, svarende til 20 mg larotrectinib.
Each mL of oral solution contains larotrectinib sulfate, equivalent to 20 mg of larotrectinib.
Almindelig Dysgeusi
Natural flavour
Forstoppelse
Excretion
SD Ikke relevant
SD, NE
Mave-tarm-kanalen Meget almindelig
Very common Fatigue Common
Forhøjet alaninaminotrans ferase (ALAT) Forhøjet aspartataminotran sferase (ASAT) Vægtøgning (unormal vægtstigning).
Alanine aminotransferase (ALT) increased Aspartate aminotransferase (AST) increased Weight increased (Abnormal weight gain)
Blindtarm
Appendixa
PD Ikke relevant
PD NA
Nedsatneutrofilta l (neutropeni) Nedsat leukocyttal (leukopeni)
Neutrophil count decreased (Neutropenia) Leukocyte count decreased (Leukopenia)
Sondediameter til standardtilførsler
Tube diameter for standard feeds
Nedsat neutrofiltal (neutropeni)a Nedsat leukocyttal (leukopeni)
Neutrophil count decreased (Neutropenia)a Leukocyte count decreased (Leukopenia)
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) b Vurdering af investigator ved hjælp af enten RANO eller RESIST v1.1 kriterier for primære CNS-tumorer (9 patienter).
b Investigator assessment using either RANO or RECIST v1.1 criteria for primary CNS tumours (9 patients).
Paræstesi Gangbesvær
Hepatic impairment
De fleste af disse bivirkninger var også hyppige hos børn.
Most of these side effects were also very common in children.
Atriance fik en markedsføringstilladelse med gyldighed i hele EU den 22. august 2007.
Atriance received a marketing authorisation valid throughout the EU on 22 August 2007.
Atriance er godkendt under "særlige omstændigheder".
Atriance has been authorised under ‘exceptional circumstances'.
Denne doseringsplan kan også anvendes hos patienter i alderen 16 til 21 år.
This schedule can also be used in patients aged 16 to 21 years.
Atriance (nelarabin)
Atriance (nelarabine)
Yderligere information om Atriance findes på agenturets websted under: https://www.ema.europa.eu/en/medicines/human/EPAR/atriance
Further information on Atriance can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/atriance
Det første studie omfattede 70 børn og unge under 21 år.
The first study involved 70 children and young adults below 21 years of age.
Behandlingen kan udsættes, hvis der forekommer andre bivirkninger.
Treatment may be delayed if other side effects occur.
Det skyldes, at det grundet sygdommens sjældenhed ikke har været muligt at indhente fyldestgørende oplysninger om Atriance.
This means that because the diseases are rare, it has not been possible to obtain complete information about Atriance.
Hvert år gennemgår agenturet alle nye oplysninger, der måtte foreligge, og ajourfører om nødvendigt denne oversigt.
Agency will review any new information that may become available and this overview will be updated as necessary.
Den anvendte dosis og hyppigheden af infusionerne afhænger af patientens alder og legemsoverflade (beregnet ud fra patientens højde og vægt).
The dose and frequency of infusion depend on the patient's age and body surface area (calculated using the patient's height and weight).
Som for alle lægemidler bliver data vedrørende brugen af Atriance løbende overvåget.
As for all medicines, data on the use of Atriance are continuously monitored.
Andre oplysninger om Atriance
Other information about Atriance
Blandt de, der ikke havde vist respons (28), viste fem (18 %) fuldstændig respons på behandlingen.
Of those whose cancer had not responded (28) five (18%) had a complete response to treatment.
Atriance indeholder det aktive stof nelarabin.
Atriance contains the active substance nelarabine.
Patienterne bør nøje overvåges for sådanne bivirkninger, og om nødvendigt bør behandlingen bringes til ophør.
Patients should be monitored closely for these side effects and treatment stopped if necessary.
I begge studier blev patienterne behandlet med Atriance, men dets virkninger blev ikke sammenlignet med virkningerne af andre lægemidler.
In both studies, the patients were treated with Atriance, but its effects were not compared with those of any other medicine.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Atriance opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Atriance's benefits are greater than its risks and it can be authorised for use in the EU.
De hyppigste bivirkninger ved Atriance hos voksne (som kan forekomme hos mere end 1 ud af 10 personer) er infektion, febril neutropeni (nedsat antal hvide blodlegemer og feber), neutropeni (nedsat antal hvide blodlegemer), thrombocytopeni (nedsat antal blodplader), anæmi (nedsat antal røde blodlegemer), somnolens (søvnighed), perifer neuropati (beskadigelse af nerverne i ekstremiteterne), hypoæstesi (nedsat følesans), paræstesi (prikkende og stikkende fornemmelse), svimmelhed, hovedpine, dyspnø (stakåndethed), hoste, diarré, opkastning, forstoppelse, kvalme, myalgi (muskelsmerter), ødemer (hævelse), perifere ødemer (hævelse af ankler og fødder), pyreksi (feber), smerter, træthed og kraftesløshed.
The most common side effects with Atriance in adults (which may affect more than 1 in 10 people) are infection, febrile neutropenia (low white blood cell counts with fever), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoaesthesia (a reduced sense of touch), paraesthesia (unusual sensations like pins and needles), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), oedema (swelling), peripheral oedema (swelling in ankles and feet), pyrexia (fever), pain, tiredness and weakness.
Behandlingen bør bringes til ophør, hvis der opstår alvorlige bivirkninger, som påvirker hjernen eller nervesystemet.
Treatment should be stopped if the patient develops serious side effects affecting the brain or nervous system.
Eftersom Atriance er godkendt under særlige omstændigheder, vil virksomheden, der markedsfører Atriance, fremlægge årlige opdateringer fra et studie af Atriances effektivitet og sikkerhed hos børn og unge voksne.
Since Atriance has been authorised under exceptional circumstances, the company that markets Atriance will provide yearly updates from a study on the effectiveness and safety of Atriance in children and young adults.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Atriance?
What measures are being taken to ensure the safe and effective use of Atriance?
En oversigt over Atriance, og hvorfor det er godkendt i EU
An overview of Atriance and why it is authorised in the EU
Det andet studie omfattede i alt 40 voksne og unge over 16 år.
In the second study, involving a total of 40 adults and adolescents above the age of 16.
Agenturet konstaterede, at der som følge af det beskedne antal patienter med disse sygdomme kun foreligger begrænsede oplysninger til støtte for godkendelsen af Atriance, men fandt, at lægemidlet kan give nogle patienter mulighed for at gå videre til knoglemarvstransplantation, hvorved deres overlevelsesmuligheder øges.
The Agency noted that, due to the small number of patients with these diseases, the information to support the authorisation of Atriance is limited, but it agreed that the medicine could allow some patients to go on to receive bone-marrow transplantation, increasing their chances of survival.
Dette forhindrer dannelsen af dna og forhaler således cellernes vækst og formering.
This stops the production of DNA and thus slows down the growth and multiplication of cells.
Hvorfor er Atriance godkendt i EU?
Why is Atriance authorised in the EU?
De indberettede bivirkninger ved Atriance vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Atriance are carefully evaluated and any necessary action taken to protect patients.
Atriance viste sig at være effektivt i to hovedstudier, der omfattede T-ALL- og T-LBL-patienter, hos hvem en eller flere tidligere kræftbehandlinger var holdt op med at virke.
Atriance was shown to be effective in two main studies involving patients with T-ALL and T-LBL whose cancer had stopped responding to one or more previous cancer treatments.
Hvad er Atriance, og hvad anvendes det til?
What is Atriance and what is it used for?
Patienter under 16 år får en mindre dosis på 650 mg pr. kvadratmeter, givet i løbet af én time i fem på hinanden følgende dage og gentaget hver 21. dag.
Patients aged under 16 years receive a dose of 650 mg per square metre given over one hour on five consecutive days, repeated every 21 days.
Hvis du ønsker mere information om anvendelsen af Atriance, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Atriance, see the package leaflet or contact your doctor or pharmacist.
Atriance fås kun på recept og gives ved drop i en vene under opsyn af en læge med erfaring i anvendelse af denne type lægemidler.
Atriance can only be obtained with a prescription and is given by drip into a vein under the supervision of a doctor who has experience in the use of thes type of medicine.
Der er også indberettet svære bivirkninger i hjernen eller nervesystemet hos patienter, som tager Atriance, herunder somnolens, krampeanfald og perifer neuropati, som giver følelsesløshed, usædvanlige sanseindtryk, kraftesløshed og tilmed lammelse.
Severe side effects affecting the brain and nervous system have also been reported in patients taking Atriance, including somnolence, convulsions, and peripheral neuropathy causing numbness, unusual sensations, weakness and even paralysis.
Det aktive stof i Atriance, nelarabin, er et cytotoksisk stof, dvs. et lægemiddel, der dræber celler, der deler sig, f.eks. kræftceller.
The active substance in Atriance, nelarabine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Hos voksne og hos unge i alderen 16 år og derover er den anbefalede startdosis 1.500 mg pr. kvadratmeter legemsoverflade, givet i løbet af to timer på dag 1, 3 og 5 og gentaget hver 21. dag.
In adults and adolescents aged 16 years and over, the recommended starting dose is 1,500 mg per square metre of body surface area, given over two hours on days one, three and five, repeated every 21 days.
Blandt de, der ikke viste respons på to eller flere tidligere behandlinger (39), viste fem (13 %) fuldstændig respons på behandlingen efter en måned, dvs. de var fri for sygdomstegn og havde normale blodtal.
Of those whose cancer had not responded to two or more previous treatments (39) five (13%) had a complete response to treatment after a month, with no evidence of disease and normal blood counts.
Atriance er et kræftlægemiddel, der anvendes til behandling af patienter med akut lymfoblastisk Tcelle-leukæmi (T-ALL) eller lymfoblastisk T-celle-lymfom (T-LBL).
Atriance is a cancer medicine used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
Hvilke oplysninger afventes der stadig for Atriance?
What information is still awaited for Atriance?
I kroppen går denne analog ind på guaninets plads og forstyrrer virkningen af de enzymer, der medvirker ved dannelsen af nyt dna, dna-polymeraser.
In the body, this analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases.
Da den aktive guaninanalog ophobes i T-cellerne og forbliver længere i disse celler, bremser Atriance væksten og formeringen af de celler, der optræder ved T-ALL og T-LBL.
Because the guanine analogue accumulates in Tcells and lasts longer in these cells, Atriance slows down the growth and multiplication of the cells involved in T-ALL and T-LBL.
Hvilke risici er der forbundet med Atriance?
What are the risks associated with Atriance?
Den fuldstændige liste over bivirkninger og begrænsninger ved Atriance fremgår af indlægssedlen.
For the full list of side effects and restrictions of Atriance, see the package leaflet.
I cellerne omdannes nelarabin til en guanin-analog, dvs. et stof, der ligner guanin, som er en af de grundlæggende kemiske byggesten i dna.
Nelarabine is converted within cells into an analogue of guanine, one of the fundamental chemicals that make up DNA.
I begge studier viste en større del af patienterne delvis respons på behandlingen med Atriance, med blodtal, der vendte tilbage til normalområdet, sammenlignet med patienter, der viste fuldstændig respons.
In both studies, compared to patients who had a complete response more patients had a partial response to Atriance treatment, with blood counts returning towards normal levels.
Atriance anvendes, når mindst to typer kemoterapi har været uden virkning eller ikke længere virker.
Atriance is used when the cancer has not responded to, or has stopped responding to, at least two types of chemotherapy.
Hvordan anvendes Atriance?
How is Atriance used?
Disse kræftformer skyldes uhæmmet vækst af T-lymfoblaster (en art umodne hvide blodlegemer).
These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly.
Ved T-LBL findes de hovedsagelig i lymfesystemet (i lymfeknuderne eller brislen).
In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland).
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Atriance.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atriance have been included in the summary of product characteristics and the package leaflet.
Hvordan virker Atriance?
How does Atriance work?
Desuden bør de have passende væsketilførsel, hvis der er risiko for tumorlysis-syndrom (en komplikation, der skyldes nedbrydningen af kræftceller).
Patients receiving Atriance should be monitored regularly for changes in blood cell counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Hvilke fordele viser studierne, at der er ved Atriance?
What benefits of Atriance have been shown in studies?
Prøv imidlertid at tage den på samme tidspunkt hver dag.
However, try to take it at the same time each day.
Hyppighed ikke kendt (kan ikke vurderes ud fra tilgængelige data)
Frequency not known (cannot be estimated from the available data)
Ingen patient var ældre end 85 år.
No patient was older than 85 years.
En risiko for nyfødte/spædbørn kan ikke udelukkes.
A risk to newborns or infants cannot be excluded.
Tegnene på for lavt blodsukker kan være:
The signs of too low blood sugar may include:
Virkninger, der er forbundet med de to aktive stoffer, er beskrevet nedenfor.
Effects related to the individual active substances are described below.
Ingen særlige krav til bortskaffelse.
No special requirements for disposal.
For vægt er baseline-vægt også inkluderet.
For weight, baseline weight is also included.
Diæt og motion kan hjælpe din krop med at bruge blodsukkeret bedre.
Diet and exercise can help your body to use its blood sugar better.
Den systemiske eksponering for de enkelte metabolitter var mindre end 10 % af det samlede lægemiddelrelaterede materiale.
Systemic exposure of each metabolite was less than 10 % of total drug-related material.
Lægen kan beslutte at stoppe din behandling med dette lægemiddel midlertidigt eller permanent.
Your doctor may decide to temporarily or permanently stop your treatment with this medicine.
4.2, 4.4, 4.5 og 5.1 for tilgængelige data om undersøgte kombinationer)
(See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied)
• hvis du har type 1-diabetes (din krop danner ikke insulin).
• if you have type 1 diabetes (your body does not produce any insulin).
(herunder pyelonefritis og urosepsis)
(including pyelonephritis and urosepsis)
Du må ikke holde op med at tage dette lægemiddel uden først at have rådført dig med din læge.
Do not stop taking this medicine without first consulting your doctor.
Tabletterne bør synkes hele sammen med vand.
The tablets should be swallowed whole with water.
Advarsler og forsigtighedsregler Kontakt lægen, før du tager dette lægemiddel og under behandlingen:
Warnings and precautions Talk to your doctor, before taking this medicine, and during treatment:
Hvad du skal gøre, hvis du har glemt at tage en tablet, afhænger af, hvor lang tid der er til din næste dosis.
What to do if you forget to take a tablet depends on how long it is until your next dose:
I de kliniske studier blev patienterne behandlet op til 24 eller 52 uger.
In clinical trials, patients were treated for up to 24 or 52 weeks.
Den næste dosis skal tages på det sædvanlige tidspunkt.
The next dose should be taken at the usual time.
For FPG er baseline-FPG også inkluderet.
For FPG, baseline FPG is also included.
Din læge vil fortælle dig, hvordan du skal forholde dig ved for lavt blodsukker, og hvad du skal gøre, hvis du mærker et eller flere af ovenstående tegn.
Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Type 2-diabetes er en sygdom, der både skyldes dine gener og din livsstil.
Type 2 diabetes is a condition that comes from both your genes and your lifestyle.
Det sker ved at blokere et protein, der kaldes DPP-4.
It does this by blocking a protein called DPP-4.
• hvis du har alvorlige nyreproblemer.
• if you have serious kidney problems.
Derefter faldt plasmakoncentrationen på en bifasisk måde med en hurtig fordelingsfase og en relativt langsom terminalfase.
Thereafter, plasma concentrations declined in a biphasic manner with a rapid distribution phase and a relatively slow terminal phase.
Overordnet var den virkning på HbA1c-reduktion, der blev observeret ved uge 24, opretholdt ved uge 52.
Overall, the effects on HbA1c reduction observed at 24 weeks were sustained at week 52.
Den renale clearance ved steady state var ca. 70 ml/min.
Renal clearance at steady-state was approximately 70 mL/min.
• hvis du kaster op, har diarré eller får feber, eller hvis du ikke kan spise eller drikke.
• if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink.
Forekomsten af bekræftede hypoglykæmiske hændelser var lav (< 1,5 %).
The incidence of confirmed hypoglycaemic events was low (< 1,5 %).
Den kliniske relevans af dette fund forbliver usikker.
The clinical relevance of this finding remains uncertain.
Sikkerhedsdata fra dette studie var i overensstemmelse med den tidligere kendte sikkerhedsprofil af linagliptin.
Safety data from this study was in line with previous known safety profile of linagliptin.
Tabel 5 Behandlingens virkning, hvad angår det primære sammensatte endepunkt, endepunktets komponenter og mortalitet
Table 5 Treatment effect for the primary composite endpoint, its components and mortality
Virkningen af Glyxambi kan blive reduceret.
The effect of Glyxambi may be reduced.