FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the company that makes Daliresp will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Danish: Virksomheden, som fremstiller Daliresp, skal endvidere sikre, at der i alle EU-medlemsstater udleveres undervisningsmateriale, som indeholder oplysninger om lægemidlets bivirkninger, og hvordan det skal anvendes, til sundhedspersonale, som ordinerer dette lægemiddel.
English: The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Daliresp is appropriate for them.
Danish: Virksomheden skal desuden sørge for patientkort med oplysninger til patienterne om, hvad de skal fortælle deres læge om deres symptomer og tidligere sygdomme, for at lægen kan vurdere, om Daliresp er en hensigtsmæssig behandling for dem. Patientkortet skal indeholde et felt, hvor patienterne kan notere deres vægt.
English: Because patients taking Daliresp may lose weight, they are advised to weigh themselves on a regular basis.
Danish: Eftersom Daliresp kan forårsage vægttab, rådes patienter, der tager Daliresp, til at veje sig selv med jævne mellemrum.
English: What is Daliresp?
Danish: Hvad er Daliresp?
English: How has Daliresp been studied?
Danish: Hvordan blev Daliresp undersøgt?
English: What is Daliresp used for?
Danish: Hvad anvendes Daliresp til?
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
Danish: Daliresp anvendes til behandling af svær, kronisk obstruktiv lungesygdom (KOL) hos voksne patienter med kronisk bronkitis (langvarig betændelse i luftvejene), hvis KOL hyppigt blusser op. KOL er en langvarig sygdom, hvor luftvejene og luftsækkene i lungerne skades eller blokeres, hvilket kan give problemer med at ånde luften ind i og ud af lungerne.
English: What benefit has Daliresp shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Daliresp?
English: How is Daliresp used?
Danish: Hvordan anvendes Daliresp?
English: How does Daliresp work?
Danish: Hvordan virker Daliresp?
English: These side effects occurred in more than 1 in 4 patients.
Danish: Disse bivirkninger forekom hos mere end 1 ud af 4 patienter.
English: Further information on Braftovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Braftovi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This encourages cancers to develop by allowing uncontrolled division of cells.
Danish: Dette fremmer udviklingen af kræft gennem ukontrolleret deling af cellerne.
English: Braftovi is available as capsules (50 mg and 75 mg).
Danish: Braftovi fås som kapsler (50 mg og 75 mg).
English: As for all medicines, data on the use of Braftovi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Braftovi løbende overvåget.
English: Patients normally take 450 mg (six 75 mg capsules) once a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects.
Danish: Patienterne tager normalt 450 mg (seks kapsler a 75 mg) én gang dagligt, men kan få dosen reduceret, eller behandlingen midlertidigt stoppet, hvis de oplever generende bivirkninger.
English: The dose of the other medicine, binimetinib, may also be reduced but if binimetinib is stopped Braftovi must be stopped too.
Danish: Dosen af det andet lægemiddel, binimetinib, kan også reduceres, men hvis binimetinib stoppes, skal Braftovi også stoppes.
English: What measures are being taken to ensure the safe and effective use of Braftovi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Braftovi?
English: For the full list of side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger fremgår af indlægssedlen.
English: Treatment with Braftovi can last for as long as the patient is benefiting from it and does not have unacceptable side effects.
Danish: Behandlingen med Braftovi kan fortsættes så længe, som patienten har gavn af den og ikke oplever uacceptable bivirkninger.
English: For more information about using Braftovi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Braftovi se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency therefore decided that Braftovi's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Braftovi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Other information about Braftovi
Danish: Andre oplysninger om Braftovi
English: Side effects reported with Braftovi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Braftovi vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Up to 50% of patients with metastatic melanoma have a mutation in BRAF with the V600 mutation being the most common.
Danish: Op til 50 % af patienterne med metastaserende melanom har en mutation i BRAF, og V600-mutationen er den hyppigste.
English: The side effects seen with Braftovi are similar to those seen with other medicines in the same class and are considered manageable.
Danish: Bivirkningerne ved Braftovi, svarer til de bivirkninger, der er set ved andre lægemidler i samme klasse, og de anses for at være håndterbare.
English: Braftovi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in prescribing cancer medicines.
Danish: Braftovi udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i brug af kræftlægemidler.
English: An overview of Braftovi and why it is authorised in the EU
Danish: En oversigt over Braftovi, og hvorfor det er godkendt i EU
English: Why is Braftovi authorised in the EU?
Danish: Hvorfor blev Braftovi godkendt i EU?
English: Braftovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Danish: Braftovi er et lægemiddel til behandling af melanomer (hudkræft), der har spredt sig, eller som ikke kan fjernes ved operation.
English: What is Braftovi and what is it used for?
Danish: Hvad er Braftovi, og hvad anvendes det til?
English: Braftovi in combination with binimetinib can help prolong the time that these patients live without their disease getting worse.
Danish: Braftovi i kombination med binimetinib kan være med til at forlænge den tid, disse patienter lever uden sygdomsforværring.
English: The most common side effects with Braftovi and binimetinib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Danish: De hyppigste bivirkninger ved Braftovi og binimetinib, når de tages sammen ved den højeste anbefalede dosis, er træthed, kvalme, diarré, opkastning, nethindeløsning (et øjenproblem, der medfører dårligt syn), mavesmerter, ledsmerter, muskelsmerter og højt niveau af enzymet kreatinkinase (kan være tegn på muskelproblemer).
English: Braftovi is used in combination with another medicine, binimetinib (Mektovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Danish: Braftovi anvendes i kombination med et andet lægemiddel, binimetinib (Mektovi), og kun hos patienter, hvis kræftceller i deres gener har en specifik mutation (forandring), som kaldes BRAF V600.
English: A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Braftovi with binimetinib can prolong the length of time patients lived without their disease getting worse.
Danish: Et studie med 577 patienter med BRAF V600-muteret melanom, der havde spredt sig, eller som ikke kunne fjernes ved operation, viste, at Braftovi kombineret med binimetinib kan forlænge den tid, patienterne lever uden sygdomsforværring.
English: What are the risks associated with Braftovi?
Danish: Hvilke risici er der forbundet med Braftovi?
English: It contains the active substance encorafenib.
Danish: Braftovi indeholder det aktive stof encorafenib.
English: In melanoma tumours with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Danish: Melanomtumorer med BRAF V600-mutationen indeholder en unormal form af BRAF-proteinet, der aktiverer et andet protein, MEK, som medvirker til at stimulere celledeling.
English: The active substance in Braftovi, encorafenib, works by blocking the BRAF protein thereby stopping its activation by MEK and slowing down the growth and spread of the cancer.
Danish: Det aktive stof i Braftovi, encorafenib, virker ved at blokere BRAF-proteinet og dermed forhindre det i at blive aktiveret af MEK.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Braftovi 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 Braftovi.
English: This compared with over 9.5 months for patients who took encorafenib alone and just over 7 months for patients taking a different medicine called vemurafenib.
Danish: Patienter, der blev behandlet med denne lægemiddelkombination, levede i gennemsnit næsten 15 måneder uden sygdomsforværring, sammenholdt med 9,5 måneder for patienter, der tog encorafenib alene, og lidt over 7 måneder for patienter, der tog et andet lægemiddel kaldet vemurafenib.
English: How is Braftovi used?
Danish: Hvordan anvendes Braftovi?
English: What benefits of Braftovi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Braftovi?
English: How does Braftovi work?
Danish: Hvordan virker Braftovi?
English: Wash hands after use.
Danish: Vask hænder efter anvendelse.
English: Date of first authorisation: 23/07/2012 Date of latest renewal:
Danish: Dato for første godkendelse: 23/07/2012 Dato for seneste fornyelse:
English: Food increases the bioavailability to 80 to 90%.
Danish: Foder øger biotilgængeligheden til 80-90 %.
English: Lot {number}
Danish: Lot{nummer}
English: Each chewable tablet contains:
Danish: Hver tyggetablet indeholder:
English: EXP {month/year}
Danish: EXP {måneder/år}
English: This veterinary medicinal product does not require any special storage conditions.
Danish: Dette veterinærlægemiddel kræver ingen særlige opbevaringsforhold.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the bottle.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, som er anført på glasset.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu
English: The result is an improvement in heart function.
Danish: Resultatet er en forbedret hjertefunktion.
English: ATCvet code: QC09BA07.
Danish: ATCvet-kode: QC09BA07
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Holdbarhed af det veterinære lægemiddel i salgspakning: 2 år.
English: This is thought to be due to activation of feedback mechanisms without adverse clinical consequence.
Danish: Det menes at skyldes aktivering af feedback-mekanismer uden skadelige kliniske konsekvenser.
English: Steady-state conditions are reached by day 2.
Danish: Ligevægtsforhold indtræder på dag 2.
English: However, this very slight decrease was transient, the red cell mass remained within the normal range, and the finding was not considered to be of clinical importance.
Danish: Dette moderate fald var dog forbigående, mængden af røde blodceller forblev inden for normalniveauet og fundet ansås ikke for at have klinisk betydning.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Hvis du bemærker bivirkninger, også selvom de ikke er omtalt i denne indlægsseddel, eller du synes lægemidlet ikke har virket, bedes du kontakte din dyrlæge.
English: (spironolactonum)
Danish: (spironolactone)
English: OTHER INFORMATION Pack sizes
Danish: ANDRE OPLYSNINGER Pakningsstørrelser
English: Oral use.
Danish: Oral administration.
English: This fixed combination product should only be used in dogs which require both active substances to be administered concomitantly at this fixed dose.
Danish: Produktets faste kombination bør kun anvendes til hunde, som har behov for, at begge aktive stoffer administreres samtidigt i dette faste forhold.
English: Vomiting has been reported very rarely in spontaneous reports.
Danish: I meget sjældne tilfælde i spontane rapporter er der rapporteret opkastning.
English: Tres le Bois 22600 Loudeac France
Danish: Très le Bois 22600 Loudéac Frankrig
English: Therefore, the product should be used with caution with other veterinary medicinal products which induce, inhibit, or which are metabolised by these enzymes.
Danish: Produktet bør derfor anvendes med forsigtighed sammen med andre veterinære lægemidler, som inducerer, hæmmer eller metaboliseres af disse enzymer.
English: It also allowed a quicker improvement of cough and activity and a slower degradation of cough, heart sounds and appetite.
Danish: Det muliggjorde også en hurtigere forbedring af hoste og aktivitetsniveau og en langsommere forringelse af hjertelyde og appetit.
English: The tablets can be divided into equal halves.
Danish: Tabletten kan deles i halve.
English: In case of the accidental ingestion by a dog of many Cardalis chewable tablets, there is no specific antidote or treatment.
Danish: I tilfælde af en hunds utilsigtede indtagelse af mange Cardalis tyggetabletter er der ingen specifik antidot eller behandling.
English: A slight increase in aldosterone blood levels may be observed in animals on treatment.
Danish: En moderat forøgelse i aldosteron-blodniveauet kan observeres hos dyr, som behandles.
English: It is therefore recommended to induce vomiting, and then carry out gastric lavage (depending on the risk assessment) and monitor electrolytes.
Danish: Det anbefales at inducere vomitus samt at foretage lavage af ventriklen (afhængig af risikovurdering) og monitorere elektrolytter.
English: Overdose (symptoms, emergency procedures, antidotes)
Danish: Overdosering (symptomer, nødforanstaltninger, modgift)
English: Bodyweight (kg) of dog
Danish: Hundens vægt (kg)
English: This hypertrophy does not seem to be linked to any pathology and was observed to be reversible upon discontinuation of the treatment.
Danish: Denne hypertrofi synes ikke patologisk og er reversibel efter afbrydelse af behandlingen.
English: White plastic (HDPE) bottle with a child-resistant closure in a cardboard box.
Danish: Hvid plastglas (HDPE) med børnesikring i en kartonæske.
English: Artificial beef flavour Compressible sugar Crospovidone Magnesium stearate
Danish: Kunstig oksekødssmag Komprimerbart sukker Crospovidon
English: After oral administration of spironolactone to dogs, it was demonstrated that the three metabolites achieved levels of 32 to 49% of the administered dose.
Danish: Efter oral administration af spironolakton til hunde, er det vist, at de tre metabolitter når et niveau på 32 til 49 % af den administrerede dosis.
English: (benazeprilum HCl)
Danish: (benazepril HCl)
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: The bottles are fitted with childproof caps.
Danish: Glassene er udstyret med børnesikret lukning.
English: Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration.
Danish: Spironolakton nedsætter eliminationen af digoksin og hæver derved plasmakoncentrationen af digoksin.
English: Following oral administration of 2 to 4 mg/kg, absorption increases linearly over the range.
Danish: Efter oral administrering af 2 til 4 mg/kg øges absorptionen lineært inden for måleområdet.
English: Benazeprilat concentrations decline biphasically: the initial fast phase represents elimination of free drug, while the terminal phase reflects the release of benazeprilat that was bound to ACE, mainly in the tissues.
Danish: Benazeprilatkoncentrationerne aftager bifasisk: den initiale hurtige fase repræsenterer elimination af det ubundne lægemiddel, mens den terminale fase afspejler frigørelse af benazeprilat, som var bundet til ACE - især i væv.
English: Therefore, dogs treated concomitantly with an NSAID should be closely monitored and correctly hydrated.
Danish: Derfor skal hunde, som sideløbende behandles med NSAIDs, monitoreres tæt og have korrekt væsketilførsel.
English: The administration of deoxycorticosterone with the product may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
Danish: Administration af deoxykortikosteron sammen med produktet kan føre til en moderat reduktion af spironolaktons natriuretiske effekt (reduktion af natriumudskillelse i urinen).
English: Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could affect the metabolism of other substances utilizing these metabolic pathways.
Danish: Spironolakton kan forårsage både induktion og inhibition af cytokrom P450-enzymer, og kan derfor påvirke metabolismen af andre lægemidler, der metaboliseres på samme måde.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Al uanvendt medicin eller affald herfra skal bortskaffes i overensstemmelse med de lokale krav.
English: After the oral administration of radiolabelled spironolactone to the dog, 70% of the dose is recovered in faeces and 20% in the urine.
Danish: Efter oral administration af radioaktivt mærket spironolakton til hunde blev 70 % af dosis genfundet i fæces og 20 % i urinen.
English: Secretion of aldosterone can also be stimulated by factors other than Angiotensin-II, notably K+ increase or ACTH.
Danish: Sekretionen af aldosteron kan også stimuleres af andre faktorer end Angiotensin II især af kaliumforøgelse eller ACTH.
English: Lactose monohydrate Cellulose microcrystalline Povidone K30
Danish: Laktosemonohydrat Cellulose, mikrokrystallinsk Povidon K30
English: Do not use in dogs intended or used for breeding.
Danish: Bør ikke anvendes til dyr, der anvendes eller påtænkes anvendt til avl.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
English: Do not administer in conjunction with Non Steroidal Anti-Inflammatory Drugs (NSAIDs) to dogs with renal insufficiency.
Danish: Bør ikke anvendes sammen med nonsteroide antiinflammatoriske stoffer (NSAID) til hunde med renal insufficiens.
English: The product causes a long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity (>80%) persisting 24 hours after dosing.
Danish: Produktet forårsager en langvarig hæmning af aktiviteten af ACE i plasma hos hunde med mere end 95% hæmning ved maksimalt niveau og vedvarende signifikant aktivitet (> 80%) 24 timer efter tildelingen.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forsigtighedsregler der skal træffes af personer, der administrerer lægemidlet til dyr
English: 4.11 Withdrawal period(s)
Danish: 4.11 Tilbageholdelsestid(er)
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, ACE inhibitors, combinations.
Danish: Farmakoterapeutisk gruppe: Stoffer med virkning på renin-angiotensin systemet, ACE-hæmmere, kombinationer.
English: Pack sizes of 30 or 90 tablets.
Danish: Pakningstørrelse: 30 eller 90 tabletter.
English: Unchanged benazepril and hydrophilic metabolites account for the remainder.
Danish: Uforandret benazepril og hydrofile metabolitter udgør resten.
English: In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
Danish: I det kardio-vaskulære system, forebygger spironolakton de nedbrydende effekter af aldosteron.
English: The concomitant use of NSAIDs with this veterinary medicinal product may reduce its antihypertensive effect, its natriuretic effect and increase the level of serum potassium.
Danish: Samtidig brug af NSAIDs med veterinærlægemiddelet kan reducere dets antihypertensive og natriuretiske effekt og øge serumniveauet af kalium.
English: Symptomatic treatment, e.g., fluid therapy, should also be provided.
Danish: Symptomatisk behandling som f.eks. væsketerapi bør ligeledes indledes.
English: The association of spironolactone and benazepril is beneficial as both act on the renin-angiotensinaldosterone system (RAAS) but at different levels along the cascade.
Danish: Kombinationen af spironolakton og benazepril HCl er gavnlig, da begge påvirker renin-angiotensinaldosteron-systemet (RAAS) men på forskellige niveauer i kaskaden.
English: Therefore, to achieve a more complete inhibition of the deleterious effects of RAAS overactivity which occurs with heart failure, it is recommended to use aldosterone antagonists, such as spironolactone, concomitantly with ACE inhibitors to block specifically the activity of aldosterone (regardless of the source), through competitive antagonism on mineralocorticoid receptors.
Danish: For at opnå en mere fuldstændig hæmning af de ødelæggende virkninger af RAAS-overaktivitet, som opstår ved hjerteinsufficiens, kan det derfor anbefales at anvende aldosteron-antagonister som spironolakton sideløbende med ACE-hæmmere for specifikt at blokere aldosteron (uanset kilde) via kompetitiv antagonisme på mineralkortikoidreceptorer.
English: Spironolactone is mainly excreted via its metabolites.
Danish: Spironolakton udskilles hovedsageligt via dets metabolitter.
English: Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme (ACE), thus preventing the conversion of inactive angiotensin I to active angiotensin II.
Danish: Benazeprilat er en højst potent og selektiv hæmmer af det angiotensinkonverterende enzym (ACE) og forhindrer således omdannelsen af inaktiv angiotensin I til aktiv angiotensin II.
English: In experimental models in dogs, it was shown that long term therapy with an aldosterone antagonist prevents progressive left ventricle dysfunction and attenuates left ventricle remodelling in dogs with chronic heart failure.
Danish: I eksperimentelle hundemodeller blev det påvist, at langtidsterapi med en aldosteron-antagonist forhindrer den progressive dysfunktion af den venstre ventrikel og bremser remodelleringen af venstre ventrikel hos hunde med kronisk hjertesvigt.
English: Therefore, it blocks effects mediated by angiotensin II, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney.
Danish: Derfor blokerer det de virkninger, der medieres af angiotensin II bl.a. vasokonstriktion af både vener og arterier og nyrernes tilbageholdelse af natrium og vand.