natgillin/translations-raw huggingface dataset:
Ponatinib virker ved at blokere Bcr-Abl, der er et enzym af typen tyrosinkinase, som findes på visse receptorer på kræftcellers overflade, hvor det stimulerer cellerne til at dele sig ukontrolleret.
Ponatinib works by blocking a tyrosine kinase (an enzyme) called Bcr-Abl, which is found in some receptors on the surface of the cancer cells where it is involved in stimulating the cells to divide uncontrollably.
Patienter i behandling med Iclusig kan have øget risiko for blodpropper og tillukning af blodkar, hvilket kan have alvorlige følger såsom hjerteanfald eller slagtilfælde.
Patients treated with Iclusig may be at increased risk of developing blood clots and blockages in the blood vessels, which can have serious consequences (such as heart attacks or strokes).
Gennemgangen fulgte efter en vurdering af data fra kliniske undersøgelser, som viste, at blodpropper og blokering af arterier eller vener var hyppigere end iagttaget ved den oprindelige godkendelse af lægemidlet.
The review followed a previous assessment of clinical trial data which indicated that cases of blood clots and blockages in the arteries or veins were occurring at a higher rate than was observed at the time of the medicine's initial authorisation.
Gennemgangen blev først foretaget af Udvalget For Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
• Behandlingen med Iclusig vil sædvanligvis blive standset, hvis der ikke er tilstrækkelig virkning efter tre måneder, eller hvis du får hjerte-kar-problemer under behandlingen.
• Treatment with Iclusig will usually be stopped if there is insufficient beneficial response within three months, or if you develop heart or circulatory problems during treatment.
• Behandling med Iclusig bør seponeres, hvis der efter tre måneder ikke er fuldstændig hæmatologisk respons.
• Treatment with Iclusig should be stopped if a complete haematologic response has not occurred by three months.
Iclusig anvendes hos patienter, der ikke tåler eller ikke har virkning af dasatinib eller nilotinib (andre lægemidler til behandling af leukæmi) eller ikke er egnede til efterfølgende behandling med imatinib.
Iclusig is used in patients who cannot tolerate or do not respond to dasatinib or nilotinib (other medicines for the treatment of leukaemia) and for whom subsequent treatment with imatinib is not considered appropriate.
PRAC konsulterede desuden en ekspertgruppe i tumorlære (onkologi), før udvalget afgav sine anbefalinger, som efterfølgende fik tilslutning i den endelige udtalelse fra agenturets Udvalg for Lægemidler til Mennesker (CHMP).
The PRAC also sought the advice of a group of experts in oncology before finalising its recommendations, which have now been endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP) in its final opinion.
CHMP's udtalelse blev overgivet til EuropaKommissionen, som den 15. januar 2015 traf en retligt bindende beslutning med gyldighed i hele EU.
The CHMP opinion will be sent to the European Commission, which will issue a legally binding decision valid throughout the EU in due course.
Iclusig er godkendt til patienter med kronisk myeloid leukæmi (CML) og akut lymfoblastær leukæmi (ALL), som ikke kan få eller ikke tåler andre lægemidler af samme klasse (tyrosinkinasehæmmere).
Iclusig is authorised for use in patients with chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL) who cannot take or tolerate several other medicines of the same class (known as ‘tyrosine-kinase inhibitors').
Desuden anvendes det til patienter, der har genmutationen T315I og derfor ikke har virkning af imatinib, dasatinib eller nilotinib.
It is also used in patients who have a genetic mutation called ‘T315I mutation' which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
Der vil blive udført en dosisfastlæggelsesundersøgelse hos patienter med CML i kronisk fase til fastlæggelse af den optimale initialdosis og karakterisering af Iclusigs sikkerhed og virkning ved dosisreduktion efter opnåelse af væsentlig cytogenetisk respons.
A dose-ranging study will be conducted in patients with chronic phase CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reduction after achieving major cytogenetic response.
• Iclusig er et lægemiddel til behandling af leukæmi, der er en kræftform udgående fra de hvide blodlegemer.
• Iclusig is a medicine used for the treatment of leukaemia, a type of cancer that affects white blood cells.
Den virksomhed, der markedsfører Iclusig, skal udlevere informationsmateriale til sundhedspersoner med fremhævelse af de risici, for hvilke der anbefales overvågning og/eller dosisjustering, og med de foreliggende data om forholdet mellem dosis af Iclusig og risikoen for kartillukning.
The company that markets Iclusig will provide healthcare professionals with educational material highlighting important risks for which monitoring and/or dose adjustments are recommended and including available data on the relationship between dose of Iclusig and risk of blood vessel blockage.
Der planlægges desuden en undersøgelse af sikkerhed og fordele ved Iclusig med henblik på at fastslå, om lavere dosis af lægemidlet vil medføre lavere risiko for blodpropper eller kartillukning og stadig have gavnlig virkning hos patienter med kronisk myeloid leukæmi i kronisk fase.
A study on the safety and benefits of Iclusig is also planned, to help clarify if lower doses of the medicine would carry a lower risk of blood clots or blockages of the blood vessels while still having a beneficial effect in patients with chronic phase CML.
Det aktive stof i Iclusig, ponatinib, er et lægemiddel i gruppen tyrosinkinasehæmmere.
The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine-kinase inhibitors'.
Iclusig er et lægemiddel til behandling af voksne med følgende former for leukæmi (blodkræft udgående fra de hvide blodlegemer):
Iclusig is a medicine used to treat adults with the following types of leukaemia (cancer of the white blood cells):
I materialet beskrives desuden den foreliggende evidens om sikkerheden og virkningen af ponatinib ved dosisreduktion hos patienter med CML i kronisk fase, som har opnået væsentlig cytogenetisk respons.
The material will also provide the available evidence regarding the safety and efficacy of ponatinib when dose is reduced in patients with chronic phase CML who have achieved major cytogenetic response.
Produktinformationen er ført ajour med skærpede advarsler om risiciene ved Iclusig, og der er desuden indsat information til sundhedspersoner om den nyeste viden med henblik på eventuel dosisreduktion for patienter med kronisk myeloid leukæmi i kronisk fase, som har god virkning af behandlingen og kan være særlig udsat for kartillukning.
The product information will be updated with strengthened warnings about the risks with Iclusig, and to also provide healthcare professionals with the latest evidence in case they wish to consider reducing the dose of Iclusig in patients with ‘chronic phase' CML who are responding well to treatment, and who might be at particular risk of blood vessel blockage.
• Spørg lægen eller en anden sundhedsperson, hvis der er mere, du vil vide.
• If you have any questions or concerns, you should consult your doctor or another healthcare professional.
Den foreliggende dokumentation viser, at risikoen for kartillukning med Iclusig må forventes at afhænge af dosis, men dokumentationen er ikke tilstrækkelig til, at der formelt kan anbefales lavere doser af Iclusig.
The available evidence shows that the risk of blood vessel blockage with Iclusig is likely to be doserelated, however the data are insufficient to formally recommend the use of lower doses of Iclusig, and there is a risk that lower doses might not be as effective in all patients and in long-term treatment.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom hyppighed og sværhed af blodpropper eller tillukning af arterier eller vener og gennemgik den mulige mekanisme i disse bivirkninger.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 October 2014 EMA/641476/2014
Den 23. oktober 2014 afsluttede Det Europæiske Lægemiddelagentur (EMA) en gennemgang af fordelene og risiciene ved Iclusig (ponatinib), som er et lægemiddel til behandling af leukæmi (kræft udgående fra de hvide blodlegemer).
The European Medicines Agency (EMA) has concluded its review of the benefits and risks of Iclusig (ponatinib), a medicine used for the treatment of leukaemia (cancer of the white blood cells), and has recommended strengthened warnings in the product information aimed at minimising the risk of blood clots and blockages in the arteries.
Ved toksisk virkning af behandlingen bør dosisændring eller seponering overvejes.
Dose modifications or treatment interruption (temporary or permanent) should be considered to manage treatment toxicity.
CHMP's udtalelse blev overgivet til Europa-Kommissionen, som den 15. januar 2015 vedtog en retligt bindende beslutning.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final decision in due course.
De foreliggende data om sammenhæng mellem dosis-virkning og dosis-toksicitet er imidlertid ikke tilstrækkelige til, at dosisreduktion formelt kan anbefales.
• The risk of vascular occlusive events with Iclusig is likely to be dose-related; however, the currently available data on the dose-efficacy and dose-toxicity relationship are not sufficient to make a formal recommendation on dose reduction, and there is a risk that lower doses might have reduced efficacy.
• I produktresuméet er der indsat data om sikkerheden og virkningen ved dosisreduktion efter væsentlig cytogenetisk respons hos patienter med CML i kronisk fase.
• Safety and efficacy data concerning dose reduction following major cytogenetic response in chronic phase CML patients have been included in the SmPC, to provide information to the prescriber and to facilitate an individual assessment of the benefit-risk balance of Iclusig with regards to dose reduction.
Behandlingen fortsættes, indtil patienten ikke længere har fordel af den, eller bivirkningerne bliver uacceptable.
Treatment is continued until the patient no longer benefits from it or side effects become unacceptable.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cometriq den 21. marts 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Cometriq on 21 March 2014.
Udvalget bemærkede dog, at mange patienter havde behov for nedsat dosis, og udvalget anbefalede, at virksomheden undersøgte, om påbegyndelse af behandlingen med lavere doser stadig ville være effektiv, men give færre bivirkninger.
However, the Committee noted that many patients required reductions in their dose and recommended that the company should study whether starting at lower doses would still be effective but would have fewer side effects.
Bivirkningerne blev anset for at kunne behandles og var acceptable i sammenligning med de begrænsede andre behandlingsmuligheder.
The side effects were considered manageable and were acceptable, compared with the limited other treatment options available.
Patienten bør undgå at spise mindst to timer før og en time efter at have fået dosen af Cometriq.
Patients should not eat for at least two hours before and one hour after their dose of Cometriq.
Cometriq har fået en "betinget godkendelse".
Cometriq has been given ‘conditional approval'.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cometriq.
This is a summary of the European public assessment report (EPAR) for Cometriq.
Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet, som virksomheden skal fremskaffe.
This means that there is more evidence to come about the medicine, which the company is required to provide.
Den anbefalede dosis er 140 mg én gang dagligt, der tages som én 80-mg-kapsel og tre 20-mg-kapsler.
The recommended dose is 140 mg once a day, taken as one 80-mg and three 20-mg capsules.
Cometriq leveres som kapsler (20 og 80 mg).
Cometriq is available as capsules (20 and 80 mg).
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Cometriq opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cometriq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Der er udarbejdet en risikostyringsplan for at sikre, at Cometriq anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Cometriq is used as safely as possible.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom behandlingen.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom due to side effects, especially during the first eight weeks of therapy.
Da antallet af patienter med medullær thyroideacancer er lavt, betragtes sygdommen som "sjælden", og Cometriq blev udpeget som "lægemiddel til sjældne sygdomme" den 6. februar 2009.
Because the number of patients with medullary thyroid cancer is low, the disease is considered ‘rare', and Cometriq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 February
Cometriq blev givet én gang dagligt med en begyndelsesdosis på 140 mg (som om nødvendigt kunne nedsættes ved bivirkninger) og sammenlignet med placebo (en virkningsløs behandling).
Cometriq was given once a day in an initial dose of 140 mg (reduced if necessary due to side effects) and compared with placebo (a dummy treatment).
Andre oplysninger om Cometriq
Other information about Cometriq
Det anvendes til behandling af voksne med medullær thyroideacancer, en kræfttype, som udgår fra de celler i skjoldbruskkirtlen, der producerer hormonet calcitonin.
It is used to treat adults with medullary thyroid cancer, a type of cancer originating in the cells in the thyroid gland that produce the hormone calcitonin.
Cometriq er et kræftlægemiddel, der indeholder det aktive stof cabozantinib.
Cometriq is a cancer medicine that contains the active substance cabozantinib.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Cometriq findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cometriq udleveres kun efter recept, og behandlingen bør kun iværksættes af en læge med erfaring i brug af kræftmedicin.
Cometriq can only be obtained with a prescription and treatment should only be started by a doctor who has experience in using cancer medicines.
Da Cometriq har fået en betinget godkendelse, skal den virksomhed, der markedsfører Cometriq, fremlægge oplysninger fra en undersøgelse, der sammenligner sikkerheden og virkningen af forskellige doser af Cometriq og fordele heraf hos patienter, der ikke har RET-genmutationen, eller hos hvem kræftcellerne har forandringer i en anden familie af gener (RAS).
Since Cometriq has been granted a conditional approval, the company that markets Cometriq will provide information from a study comparing the safety and effectiveness of different doses of Cometriq, and its benefit in patients lacking the RET gene mutation or whose cancer has changes in another family of genes called RAS.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cometriq, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cometriq, including the appropriate precautions to be followed by healthcare professionals and patients.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cometriq?
What measures are being taken to ensure the safe and effective use of Cometriq?
Det aktive stof i Cometriq, cabozantinib, er en tyrosinkinasehæmmer.
The active substance in Cometriq, cabozantinib, is a tyrosine kinase inhibitor.
Cometriq anvendes, når kræften ikke kan fjernes ved operation og er fremskreden eller har bredt sig til andre dele af kroppen.
Cometriq is used when the cancer cannot be removed by surgery and has progressed or spread to other parts of the body.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Cometriq findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Hvis du ønsker yderligere oplysninger om behandling med Cometriq, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Cometriq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Cometriq er påvist at være effektivt i én hovedundersøgelse med 330 voksne med medullær thyroideacancer, der ikke kunne behandles med operation og var omfattende eller havde bredt sig til andre dele af kroppen.
Cometriq has been shown to be effective in one main study involving 330 adults with medullary thyroid cancer that could not be treated with surgery and was extensive or had spread to other parts of the body.
Hvad er Cometriq, og hvad anvendes det til?
What is Cometriq and what is it used for?
Hvorfor blev Cometriq godkendt?
Why is Cometriq approved?
Cometriq bør anvendes med forsigtighed hos patienter, der får andre lægemidler, som påvirker dets nedbrydning i kroppen.
Cometriq should be used with care in patients taking certain other medicines that affect the way it is broken down in the body.
Det er ikke en praktisk vejledning i, hvordan Cometriq bør anvendes.
It is not intended to provide practical advice on how to use Cometriq.
Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Cometriq fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Cometriq, see the package leaflet.
Hvilke oplysninger afventes der stadig for Cometriq?
What information is still awaited for Cometriq?
Hvilke risici er der forbundet med Cometriq?
What are the risks associated with Cometriq?
Ved at blokere virkningen af disse enzymer i kræftcellerne medvirker Cometriq til at begrænse kræftens vækst og spredning.
By blocking the activity of these receptors in cancer cells, the medicine reduces the growth and spread of the cancer.
Cometriq havde vist gavnlig virkning hos patienter med fremskreden, ikke-operationsegnet medullær thyroideacancer, for hvem der kun er få andre behandlingsmuligheder.
Cometriq had shown a benefit in patients with advanced medullary thyroid cancer unsuitable for surgery, who have few other treatment options.
Fordelene ved Cometriq er muligvis mindre for patienter, hvis kræftceller ikke har en mutation i genet RET ("re-arranged during transfection").
The benefits of Cometriq may be smaller for patients whose cancer does not have a mutation in a gene called the ‘re-arranged during transfection' (RET) gene, and this should be taken into account when deciding whether to start treatment.
De hyppigste abnorme blodprøver var forhøjede leverenzymer, såsom aspartataminotransferase (AST), alaninaminotransferase (ALT) og alkalisk fosfatase (ALP), lavt antal hvide blodlegemer (lymfopeni eller neutropeni), lavt antal blodplader (trombocytopeni), lavt calciumindhold i blodet (hypocalcæmi), lavt fosfatindhold i blodet (hypofosfatæmi), lavt magnesiumniveau i blodet (hypomagnesiæmi), lavt kaliumindhold i blodet (hypokaliæmi) og forhøjet indhold af bilirubin, et nedbrydningsprodukt af røde blodlegemer (hyperbilirubinæmi).
The most common abnormal results in laboratory blood tests were increased liver enzymes such as aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP), low white cell counts (lymphopenia or neutropenia), thrombocytopenia (low blood-platelet counts), hypocalcaemia (low blood calcium levels), hypophosphataemia (low blood levels of phosphates), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels) and hyperbilirubinaemia (increased amounts of bilirubin, a breakdown product of red blood cells).
De hyppigste bivirkninger ved Cometriq (som optræder hos mere end 2 ud af 10 patienter) er diarré, hånd-fod-syndrom med udslæt og følelsesløshed af håndflader og fodsåler (palmart-plantart erytrodysæstesisyndrom), vægttab, nedsat appetit, kvalme, træthed, smagsforstyrrelser, ændret hårfarve, for højt blodtryk (hypertension), inflammation af slimhinderne, herunder mundslimhinden (stomatitis), forstoppelse, opkastning, svaghed og ændret stemme.
The most common side effects with Cometriq (which may affect more than 2 in 10 people) are diarrhoea, palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), loss of weight, loss of appetite, nausea (feeling sick), tiredness, taste disturbances, changes in hair colour, hypertension (high blood pressure), inflammation of the mucosa (moist tissue that lines certain body cavities) including stomatitis (inflammation of the lining of the mouth), constipation, vomiting, weakness, and changes in the sound of the voice.
Hvis du ønsker praktisk vejledning om anvendelsen af Cometriq, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Cometriq, patients should read the package leaflet or contact their doctor or pharmacist.
Det kan være nødvendigt at nedsætte dosis eller midlertidigt standse behandlingen på grund af bivirkninger, navnlig i de første otte uger af
The dose may need to be reduced or stopped temporarily
De alvorligste bivirkninger er lungebetændelse, inflammation af slimhinder, for lavt calciumindhold i blodet (hypokalcæmi), synkebesvær (dysfagi), væsketab (dehydrering), blodpropper i karrene til lungerne (lungeemboli) og for højt blodtryk (hypertension).
The most common serious side effects are pneumonia, inflammation of the mucosa, hypocalcaemia (low calcium levels in the blood), dysphagia (difficulty swallowing), dehydration, pulmonary embolism (blood clots in the vessels supplying the lungs), and hypertension.
Hos de patienter, der fik Cometriq, var dette 11,2 måneder, sammenlignet med 4,0 måneder hos dem, der fik placebo.
The main measure of effectiveness was progression-free survival (how long the patients lived before their disease got worse): in patients given Cometriq this was 11.2 months, compared with 4.0 months in those given placebo.
Hvordan anvendes Cometriq?
How is Cometriq used?
Disse enzymer findes i visse receptorer (såsom VEGF-, MET- og RETreceptorer) i kræftceller.
These enzymes can be found in certain receptors (such as VEGF, MET and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer.
Hvordan virker Cometriq?
How does Cometriq work?
Hvilke fordele viser undersøgelserne, at der er ved Cometriq?
What benefits of Cometriq have been shown in studies?
Medlemsland EU/EØS
Member State EU/EEA
Andre gavnlige virkninger på patienter med hensyn til andre systemorganklasser er ikke blevet påvist på en overbevisende måde.
Other beneficial effects on patients with regards to other system organ classes have not convincingly been shown.
Sibutramin blev tilladt i EU første gang i januar 1999.
In the EU sibutramine was first authorised in January 1999.