FrancophonIA/ELRC3.0 huggingface dataset:
English: • Kisplyx 4 mg hard capsule: yellowish red body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Danish: • Kisplyx 4 mg hård kapsel: gullig-rød underdel og en gullig-rød hætte, ca. 14,3 mm lang med ”Є” præget med sort blæk på hætten og ”LENV 4 mg” på underdelen.
English: Nongastrointestinal fistulak
Danish: Nedsat nyrefunktion
English: Malaise
Danish: Vægttab
English: Patients with end-stage renal disease were not studied, therefore the use of lenvatinib in these patients is not recommended.
Danish: Derfor anbefales lenvatinib ikke til disse patienter.
English: The median time to onset of proteinuria was 6.1 weeks (any grade) and 20.1 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Danish: Mediantiden til start af proteinuri var 6,1 uger (alle grader) og 20,1 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen.
English: The median time to onset of liver events was 6.7 weeks (any grade) and 14.2 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Danish: Mediantiden til start af leverrelaterede reaktioner var 6,7 uger (alle grader) og 14,2 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen.
English: Cardiac failure Electrocardiogram QT prolonged Ejection fraction decreased
Danish: Hjertesvigt QT-forlængelse i ekg Nedsat uddrivningsfraktion
English: 14 mg orally once daily One 10 mg capsule plus one 4 mg capsule
Danish: Én 10 mg kapsel plus to 4 mg kapsler
English: Cardiac dysfunction (see section 4.4)
Danish: Kardial dysfunktion (se pkt.
English: Palmar-plantar erythrodysaesthesia syndrome Palmar erythema Rash Alopecia
Danish: Palmoplantar erytrodysæstesisynd rom Erytem i håndfladen Udslæt Alopeci
English: In the RCC study (see section 5.1), haemorrhage was reported in 38.7% (8.1% were Grade ≥ 3) of patients in the lenvatinib plus everolimus-treated group.
Danish: 5.1) blev blødning rapporteret hos 38,7 % (8,1 % var grad ≥ 3) af patienterne i lenvatinib plus everolimus-gruppen.
English: Blood thyroid stimulating hormone increased (see section 4.4 Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction) (see section 4.4)
Danish: 4.4 Hæmning af suppression af thyreoideastimulerende hormon/thyreoideadysfunktion)
English: Optimal medical management (i.e. treatment or therapy) for nausea, vomiting, and diarrhoea should be initiated prior to any lenvatinib therapy interruption or dose reduction; however, gastrointestinal toxicity should be actively treated in order to reduce the risk of development of renal impairment or renal failure (see section 4.4 Renal failure and impairment).
Danish: Optimal behandling af kvalme, opkastning og diarré bør påbegyndes før enhver behandlingsafbrydelse eller reduktion af lenvatinibdosis.
English: In the RCC study (see section 5.1), hypocalcaemia was reported in 8.1% of patients in the lenvatinib plus everolimus-treated group (3.2% were Grade ≥ 3) and 4.0% of patients in the everolimus-treated group (none were Grade ≥ 3).
Danish: 5.1) blev hypokalcæmi rapporteret hos 8,1 % af patienterne i lenvatinib plus everolimus-gruppen (3,2 % var grad ≥ 3) og hos 4,0 % i everolimus-gruppen (ingen var grad ≥ 3).
English: Proteinuria has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Danish: Der er blevet rapporteret proteinuri hos patienter i behandling med lenvatinib, hvilket sædvanligvis opstod tidligt i behandlingsforløbet (se pkt.
English: Very common (may affect more than 1 in 10 people) • high or low blood pressure
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer)
English: What Kisplyx looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: What Kisplyx is and what it is used for What you need to know before you take Kisplyx How to take Kisplyx
Danish: Det skal du vide, før du begynder at tage Kisplyx Sådan skal du tage Kisplyx Bivirkninger
English: The following terms have been combined: a: Thrombocytopenia includes thrombocytopenia and decreased platelet count.
Danish: Trombocytopeni omfatter trombocytopeni og nedsat antal trombocytter.
English: In the RCC study (see section 5.1), proteinuria was reported in 30.6% of patients in the lenvatinib plus everolimus-treated group (8.1% were Grade ≥ 3) and 14.0% of patients in the everolimus-treated group (2.0% were Grade ≥3).
Danish: 5.1) blev proteinuri rapporteret hos 30,6 % af patienterne i lenvatinib plus everolimus-gruppen (8,1 % var grad ≥ 3) og hos 14,0 % i everolimus-gruppen (2,0 % var grad ≥ 3).
English: In the RCC study (see section 5.1), diarrhoea was reported in 80.6% of patients in the lenvatinib plus everolimus-treated group (21.0% were Grade ≥ 3) and in 34.0% of patients in the everolimus-treated group (2.0% were Grade ≥ 3).
Danish: 5.1) blev diarré rapporteret hos 80,6 % i lenvatinib plus everolimus-gruppen (21,0 % var grad ≥ 3) og hos 34,0 % i everolimus-gruppen (2,0 % var grad ≥ 3).
English: A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
Danish: En gul underdel og en gullig-rød hætte, ca. 14,3 mm lang med ”Є” præget med sort blæk på hætten og”LENV 10 mg” på underdelen.
English: In the RCC study (see section 5.1), decreased ejection fraction/cardiac failure was reported in 4.8% of patients (3.2% were Grade ≥ 3) in the lenvatinib plus everolimus treated group, and 4.0% in the everolimus group (2.0% were Grade ≥ 3).
Danish: 5.1) blev der rapporteret nedsat uddrivningsfraktion/hjertesvigt hos 4,8 % af patienterne i lenvatinib plus everolimus-gruppen (3,2 % var grad ≥ 3) og hos 4,0 % i everolimusgruppen (2,0 % var grad ≥ 3).
English: For previously normotensive subjects, monotherapy with one of the classes of antihypertensive should be started when elevated BP is observed.
Danish: Ved observation af forhøjet blodtryk skal patienter, som tidligere var normotensive, starte med monoterapi med et antihypertensivum.
English: Hypertension has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Danish: Der er blevet rapporteret om hypertension, der sædvanligvis opstod tidligt i behandlingsforløbet, hos patienter i behandling med lenvatinib (se pkt.
English: In the case of bleeding, dose interruptions, adjustments, or discontinuation may be required (see Section 4.2, Table 2).
Danish: I tilfælde af blødning kan behandlingsafbrydelse, dosisjustering eller seponering være nødvendig (se pkt.
English: A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Danish: En gullig-rød underdel og en gullig-rød hætte, ca. 14,3 mm lang med ”Є” præget med sort blæk på hætten og ”LENV 4 mg” på underdelen.
English: Limited data are available on use in patients aged ≥75 years (see also section 4.8, Other special populations).
Danish: Justering af startdosis er ikke nødvendig på basis af alder. Der foreligger kun begrænsede data for patienter ≥ 75 år (se også pkt.
English: Renal failure j, †, ‡ Renal impairment‡ Blood creatinine increased Blood urea increased
Danish: Forhøjet kreatinin i blodet Forhøjet urinstof i blodet
English: Hypokalaemia Decreased appetite Weight decreased
Danish: Hypokaliæmi Appetitløshed
English: In the RCC study (see section 5.1), 1.6% of patients in the lenvatinib plus everolimus-treated group reported arterial thromboembolic events.
Danish: 5.1) blev der rapporteret arteriel tromboemboli hos 1,6 % af patienterne i lenvatinib plus everolimus-gruppen.
English: In the RCC study (see section 5.1), 1.6% of cases of perforated appendicitis (of Grade 3) occurred in the lenvatinib plus everolimus-treated group; there were no reports in the lenvatinib or everolimus groups.
Danish: 5.1) blev perforeret blindtarmsbetændelse (af grad 3) rapporteret hos 1,6 % af patienterne i lenvatinib plus everolimus-gruppen.
English: If patients have severe hepatic impairment, the initial dose of lenvatinib should be adjusted (see sections 4.2 and 5.2).
Danish: Initialdosis af lenvatinib skal justeres hos patienter med svært nedsat leverfunktion (se pkt.
English: Gastrointestinal disorders
Danish: Gastrointestinal perforation eller fisteldannelse
English: Breast-feeding (see section 4.6).
Danish: I RCC-studiet (se pkt.
English: With regard to safety, the Agency noted an acceptable safety profile.
Danish: Hvad sikkerheden angår, bemærkede agenturet, at sikkerhedsprofilen var acceptabel.
English: Praluent received a marketing authorisation valid throughout the EU on 23 September 2015.
Danish: Praluent fik en markedsføringstilladelse med gyldighed i hele EU den 23. september 2015.
English: If the desired response is not achieved after 4 to 8 weeks of treatment, the doctor can increase or decrease the dose.
Danish: Hvis den ønskede virkning ikke er opnået efter 4-8 ugers behandling, kan lægen øge eller nedsætte dosissen.
English: Further information on Praluent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Praluent.
Danish: Yderligere information om Praluent findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Praluent.
English: As for all medicines, data on the use of Praluent are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Praluent løbende overvåget.
English: Some patients are required to be on a low fat diet.
Danish: Nogle patienter skal have fedtfattig kost.
English: Other information about Praluent
Danish: Andre oplysninger om Praluent
English: The usual starting dose is 75 mg every two weeks, but patients requiring bigger reductions of blood fat levels may start with 150 mg every two weeks or 300 mg every 4 weeks.
Danish: Den sædvanlige startdosis er 75 mg hver anden uge, men patienter, der har behov for større nedsættelse af blodets fedtindhold, kan begynde med 150 mg hver anden uge eller 300 mg hver fjerde uge.
English: What measures are being taken to ensure the safe and effective use of Praluent?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Praluent?
English: Patients or their carers can inject the medicine once they have been trained by a healthcare professional.
Danish: Patienten selv eller dennes omsorgsgiver kan injicere lægemidlet efter at være blevet instrueret heri af en sundhedsperson.
English: What is Praluent and what is it used for?
Danish: Hvad er Praluent, og hvad anvendes det til?
English: Side effects reported with Praluent are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Praluent vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Why is Praluent authorised in the EU?
Danish: Hvorfor er Praluent godkendt i EU?
English: The European Medicines Agency decided that Praluent's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Praluent opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: It contains the active substance alirocumab.
Danish: Det indeholder det aktive stof alirocumab.
English: An overview of Praluent and why it is authorised in the EU
Danish: En oversigt over Praluent, og hvorfor det er godkendt i EU
English: Praluent is used in combination with a statin or a statin and other fat-lowering medicines.
Danish: Praluent anvendes i kombination med et statin eller med et statin og andre fedtstofnedsættende lægemidler.
English: Praluent can also be used without a statin in patients who cannot take statins.
Danish: Praluent kan også anvendes uden et statin hos patienter, der ikke kan tåle statiner.
English: The most common side effects leading to treatment discontinuation were local injection site reactions.
Danish: De hyppigste bivirkninger, der medførte seponering, var lokale reaktioner på injektionsstedet.
English: What are the risks associated with Praluent?
Danish: Hvilke risici er der forbundet med Praluent?
English: For more information about using Praluent, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Praluent, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The active substance in Praluent, alirocumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific enzyme called PCSK9.
Danish: Det aktive stof i Praluent, alirocumab, er et monoklonalt antistof (en type protein), som er fremstillet, så det genkender og binder til et enzym kaldet PCSK9.
English: Alirocumab also helps to reduce other fatty substances from blood in patients with mixed dyslipidaemia.
Danish: Alirocumab er også med til at reducere indholdet af andre fedtstoffer i blodet hos patienter med blandet dyslipidæmi.
English: This enzyme attaches to cholesterol receptors on the surface of liver cells and causes these receptors to be absorbed and broken down inside the cells.
Danish: Dette enzym binder sig til kolesterolreceptorerne på overfladen af leverceller og bevirker, at disse receptorer absorberes og nedbrydes inde i cellerne.
English: The injection is given under the skin of the abdomen, thigh or upper arm.
Danish: Injektionen gives under huden på maven, låret eller overarmen.
English: In patients with atherosclerotic heart disease, Praluent reduced the number of cardiovascular events, in particular heart attacks and strokes.
Danish: Hos patienter med aterosklerotisk hjertesygdom mindskede Praluent antallet af hjerte-kar-hændelser, navnlig hjerteanfald og slagtilfælde.
English: Praluent has been studied in 10 main studies involving over 5,000 adult patients with hypercholesterolaemia (including patients with heterozygous familial disease) and mixed dyslipidaemia.
Danish: Praluent er blevet undersøgt i 10 hovedstudier med over 5.000 voksne patienter med hyperkolesterolæmi (herunder patienter med heterozygot arvelig sygdom) og blandet dyslipidæmi.
English: Before starting treatment with Praluent, other causes of excess cholesterol and abnormal fat levels in the blood should be excluded.
Danish: Før påbegyndelse af behandlingen med Praluent bør andre årsager til forhøjet kolesterol og unormalt fedtindhold i blodet udelukkes.
English: In a study involving over 18,000 patients who had established heart disease, less than 10% of patients given Praluent had a cardiovascular event (meaning death, heart attack, stroke, chest pain due to problems with the blood flow to the heart leading to hospitalisation) during the study compared with over 11% of patients given placebo.
Danish: I et studie med deltagelse af mere end 18.000 patienter, som havde fået konstateret hjertesygdom, oplevede under 10 % af de patienter, der fik Praluent, en hjerte-kar-hændelse (dvs. død, hjerteanfald, slagtilfælde, brystsmerter forårsaget af problemer med blodgennemstrømningen til hjertet, med indlæggelse til følge) i løbet af studiet, sammenlignet med over 11 % af de patienter, der fik placebo.
English: These studies showed that when Praluent was given on top of a statin it led to a substantial reduction in blood levels of LDL-cholesterol (between 39 and 62% more than placebo) after 6 months of treatment.
Danish: Af disse studier fremgik det, at når Praluent blev givet som tillægsbehandling til et statin, medførte det en væsentlig mindskelse af blodets indhold af LDL-kolesterol (mellem 39 og 62 % mere end placebo) efter 6 måneders behandling.
English: It is also used to reduce the risk of heart problems and strokes in patients who have atherosclerotic cardiovascular disease (heart problems such as heart attack, stroke or other problems of the circulatory system caused by fatty deposits build up in the walls of the arteries).
Danish: Det anvendes også til at mindske risikoen for hjerteproblemer og slagtilfælde hos patienter med aterosklerotisk hjerte-kar-sygdom (hjerteproblemer såsom hjerteanfald, slagtilfælde eller andre kredsløbsproblemer forårsaget af fedtdepoter, der ophobes i arterievæggene).
English: The most common side effects with Praluent (which may affect up to1 in 10 people) are injection site reactions such as pain and redness, problems affecting the nose and throat such as colds, and itching.
Danish: De hyppigste bivirkninger ved Praluent (som kan forekomme hos op til 1 ud af 10 personer) er reaktioner på injektionsstedet i form af smerter og rødme, problemer med næse og hals såsom forkølelse, og kløe.
English: Praluent is available as a solution for injection in a pre-filled syringe or pre-filled pen (75 and 150 mg).
Danish: Praluent findes som injektionsvæske, opløsning, i fyldte injektionssprøjter eller fyldte penne (75 og 150 mg).
English: By attaching and blocking PCSK9, Praluent prevents the receptors from being broken down inside cells and therefore increases the number of these receptors on the cell surface, where they can attach to LDL-cholesterol and remove it from the bloodstream.
Danish: Ved at bindes til og blokere PCSK9 forhindrer Praluent receptorerne i at blive nedbrudt inde i cellerne og øger derfor antallet af dem på celleoverfladen, hvor de kan bindes til LDL-kolesterol og fjerne dette fra blodbanen.
English: It is used to reduce fat levels in adults with primary hypercholesterolaemia (high levels of blood cholesterol without an identifiable cause, often resulting from the person's genetic makeup) and mixed dyslipidaemia (abnormal levels of different fats in the blood, including cholesterol).
Danish: Det anvendes til at reducere fedtindholdet hos voksne med primær hyperkolesterolæmi (højt kolesterol i blodet uden en identificerbar årsag, ofte som følge af personens genetiske sammensætning) og blandet dyslipidæmi (abnormt indhold af forskellige fedtstoffer i blodet, herunder kolesterol).
English: This helps to reduce the amount of LDL-cholesterol in the blood.
Danish: Dette bidrager til at nedsætte LDLkolesterolmængden i blodet.
English: Some studies looked at Praluent taken on its own, while others studied Praluent in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins.
Danish: I nogle af studierne blev Praluent anvendt alene, mens det i andre blev undersøgt i kombination med andre fedtstofsænkende lægemidler, bl.a. hos patienter på den maksimalt anbefalede dosis af statiner.
English: How is Praluent used?
Danish: Hvordan anvendes Praluent?
English: These receptors control blood levels of cholesterol, especially LDLcholesterol, by removing it from the bloodstream.
Danish: Disse receptorer regulerer blodets indhold af kolesterol, navnlig LDLkolesterol, ved at fjerne det fra blodbanen.
English: Some studies compared Praluent with placebo (a dummy treatment) and others to another medicine for hypercholesterolaemia (ezetimibe).
Danish: I nogle af studierne blev Praluent sammenlignet med placebo (en uvirksom behandling), i andre blev det sammenlignet med et andet lægemiddel mod hyperkolesterolæmi (ezetimibe).
English: The Agency noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, including patients on maximum recommended doses of statins or those intolerant to them, treatment with Praluent led to a significant reduction in LDLcholesterol levels, which is a known risk factor for cardiovascular (affecting the heart and blood vessels) disease.
Danish: Agenturet bemærkede, at i alle studierne hos patienter med primær hyperkolesterolæmi og blandet dyslipidæmi, herunder patienter, der fik den maksimalt anbefalede dosis af statiner eller ikke tålte den, medførte behandling med Praluent en signifikant reduktion af indholdet af LDL-kolesterol, som er en kendt risikofaktor for hjerte-kar-sygdomme (kardiovaskulære sygdomme).
English: Therefore, Praluent has been approved for use in patients who do not adequately respond to the maximum tolerated dose of statins or who cannot be given statins.
Danish: Praluent er derfor godkendt til anvendelse hos patienter, hos hvem den maksimalt tålte dosis af statiner ikke virker, eller som ikke må få statiner.
English: Praluent is a medicine for lowering levels of fat in the blood.
Danish: Praluent er et lægemiddel beregnet til at sænke fedtindholdet i blodet.
English: When given on top of standard treatment or on its own, Praluent produced a 24 to 36% greater reduction in blood levels of LDL-cholesterol than ezetimibe.
Danish: Når Praluent blev givet som tillægsbehandling til standardbehandling eller alene, medførte det en 24-36 % større reduktion af blodets indhold af LDL-kolesterol end ezetimibe.
English: Atherosclerotic heart disease
Danish: Aterosklerotisk hjertesygdom
English: What benefits of Praluent have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Praluent?
English: The dose of Praluent is adjusted based on the levels of fats in blood and response to the medicine.
Danish: Dosissen af Praluent justeres efter fedtindholdet i blodet og responsen på lægemidlet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Praluent have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Praluent.
English: How does Praluent work?
Danish: Hvordan virker Praluent?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rapiscan on 6 September 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rapiscan den 6. september 2010.
English: Rapiscan should only be used once within any 24-hour period.
Danish: Rapiscan må kun anvendes en gang inden for en periode på 24 timer.
English: The full EPAR for Rapiscan can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rapiscan findes på agenturets websted under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: It is used in adult patients (aged 18 years or over) who are unable to exercise enough for a stress test.
Danish: Det anvendes til voksne patienter (i alderen 18 år og derover), som ikke kan motionere tilstrækkeligt til en stresstest.
English: This is a summary of the European public assessment report (EPAR) for Rapiscan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rapiscan.
English: The ‘agreement rates' between the first and second scans were similar regardless of which of the two medicines were used for the second scan.
Danish: "Overensstemmelsesprocenterne" mellem den første og den anden scanning var de samme, uanset hvilket af de to lægemidler der blev anvendt i anden scanning.
English: A risk management plan has been developed to ensure that Rapiscan is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Rapiscan anvendes så sikkert som muligt.
English: Other information about Rapiscan:
Danish: Andre oplysninger om Rapiscan:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rapiscan.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Rapiscan skal anvendes.
English: Rapiscan must only be used in a hospital that has equipment for resuscitation and monitoring the patient.
Danish: Rapiscan må udelukkende anvendes i på et hospital, som har udstyr til genoplivning og overvågning af patienten.