FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Novaquin has been shown to have comparable quality and to be bioequivalent to Metacam.
Danish: Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Novaquin er af sammenlignelig kvalitet og er bioækvivalent med Metacam.
English: Therefore, the CVMP's view was that, as for Metacam, the benefits outweigh the identified risks.
Danish: Det var derfor CVMP's opfattelse, at fordelene opvejer de identificerede risici som for Metacam.
English: For more information about treatment with Novaquin, read the package leaflet (also part of the EPAR) or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Novaquin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din dyrlæge eller dit apotek.
English: Novaquin is a veterinary medicine used for the alleviation of inflammation and relief of pain and chronic musculoskeletal disorders (disorders affecting the muscle and bones) in horses.
Danish: Novaquin er et lægemiddel til heste, der anvendes til at mindske inflammation og lindre smerter og kroniske sygdomstilstande i muskler og knogler (muskuloskeletale sygdomstilstande).
English: Why is Novaquin approved?
Danish: Hvorfor er Novaquin blevet godkendt?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Novaquin, including the precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Novaquin, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Because Novaquin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Novaquin er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Novaquin is a generic medicine, studies in animals have been limited to tests to determine that it is bioequivalent to the reference medicine, Metacam.
Danish: Da Novaquin er et generisk lægemiddel, har dyreundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Metacam.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during inflammation) and fever, meloxicam reduces these signs of disease.
Danish: Prostaglandiner er stoffer, der udløser inflammation, smerter, væskeudskillelse fra blodkarrene under inflammation (ekssudation) og feber.
English: How is Novaquin used?
Danish: Hvordan anvendes Novaquin?
English: How has Novaquin been studied?
Danish: Hvordan er Novaquin blevet undersøgt?
English: For practical information about using Novaquin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer af eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Novaquin, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Novaquin work?
Danish: Hvordan virker Novaquin?
English: Medical treatment may be necessary.
Danish: Lægebehandling kan være nødvendig.
English: Frequency Preferred term
Danish: Hyppighed Foretrukken term
English: Morning Evening
Danish: Morgen Aften
English: Date of first authorisation: 27 September 2018
Danish: Dato for første markedsføringstilladelse: 27. september 2018
English: Patients should take the doses at approximately the same times every day.
Danish: Patienterne bør tage doserne på omtrent samme tidspunkt hver dag.
English: de la Industria, 30 28108 Alcobendas, Madrid Spain
Danish: de la Industria, 30 28108 Alcobendas, Madrid Spanien
English: Fatal events occurred in <1% of patients.
Danish: Letale hændelser forekom hos <1 % af patienterne.
English: Progression-free survival
Danish: Progressionsfri overlevelse
English: Diarrhoea can be associated with dehydration.
Danish: Diarré kan være forbundet med dehydrering.
English: Swallow the tablet whole with a glass of water.
Danish: Tabletterne skal synkes hele med et glas vand.
English: Keep the blister card intact
Danish: Hold blisterkortet intakt
English: Visceral crisis
Danish: Visceral krise
English: The dose can be taken with or without food.
Danish: Dosis kan tages med eller uden mad.
English: Like all medicines, this medicine can cause side-effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Drink plenty of fluids.
Danish: Drik rigelig væske.
English: There should, however, be close monitoring for signs of toxicity.
Danish: Der skal dog monitoreres nøje for tegn på toksicitet.
English: Verzenios is for oral use.
Danish: Verzenios er til oral anvendelse.
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: de la Industria 30, 28108 Alcobendas, Madrid, Spanien Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Febrile neutropenia was reported in 0.9% patients.
Danish: Febril neutropeni blev indberettet hos 0,9 % af patienterne.
English: Take Verzenios twice daily, at about the same time every day, preferably in the morning and evening, so there is enough medicine in your body all the time.
Danish: Tag Verzenios to gange dagligt på cirka samme tidspunkt hver dag, helst om morgenen og om aftenen, så der altid er tilstrækkelig medicin i din krop.
English: a NCI CTCAE ULN = upper limit of normal
Danish: a NCI CTCAE ULN = øvre normalgrænse
English: Not all the pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: These changes were not considered to be clinically relevant.
Danish: Disse forandringer blev ikke vurderet at være af klinisk relevans.
English: Toxicitya, b
Danish: Toksiciteta, b
English: - if you are allergic to abemaciclib or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for abemaciclib eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Resume at next lower dose.
Danish: Genoptag behandlingen med den næste lavere dosis.
English: General supportive care should be provided.
Danish: Der bør gives almen understøttende behandling.
English: See section 4 “Possible side effects”, and talk to your doctor if you have any symptoms.
Danish: Se afsnit 4 ”Bivirkninger”, og kontakt lægen, hvis du får nogen symptomer.
English: The majority of patients (96%) had metastatic disease at baseline.
Danish: De fleste patienter (96 %) havde metastatisk sygdom ved baseline.
English: Dose reduction is not required.
Danish: Det er ikke nødvendigt at reducere dosis.
English: Verzenios is not to be used in children and adolescents under 18 years of age.
Danish: Verzenios må ikke anvendes til børn og unge under 18 år.
English: Incidence was greatest during the first month of abemaciclib treatment and was lower subsequently.
Danish: Forekomsten var højest i den første måned af abemaciclibbehandlingen og faldt efterfølgende.
English: This was not considered to be clinically relevant.
Danish: Dette blev ikke vurderet at være af klinisk relevans.
English: These proteins are abnormally active in some cancer cells and make them grow out of control.
Danish: Disse proteiner er unormalt aktive i nogle kræftceller og får dem til at vokse ukontrolleret.
English: In a sub-population with locally advanced or metastatic disease that had not received prior endocrine therapy, the PFS was also consistent.
Danish: I en subpopulation med lokalt fremskreden eller metastatisk sygdom, som ikke havde fået forudgående endokrin behandling, var PFS også konsekvent.
English: Complete or partial recovery was observed for all target organs at the end of the 28-day recovery period.
Danish: Der blev set komplet eller delvis rekonvalescens af alle målorganer efter en rekonvalescensperiode på 28 dage.
English: Grade 3, recurrent; or Grade 4
Danish: Grad 3, tilbagevendende; eller grad 4
English: Avoid grapefruit or grapefruit juice while you are taking the medicine as they may increase the concentration of Verzenios in the blood.
Danish: Undgå at indtage grapefrugt og grapefrugtjuice, mens du tager dette lægemiddel, da det kan øge indholdet af Verzenios i blodet.
English: If you feel unusually tired or dizzy, take special care when driving or using machines.
Danish: Hvis du føler dig usædvanligt træt eller svimmel, skal du være ekstra forsigtig, når du fører motorkøretøj eller betjener maskiner.
English: Verzenios has minor influence on the ability to drive and use machines.
Danish: Verzenios påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: There are no data from the use of abemaciclib in pregnant women.
Danish: Der er ingen data fra anvendelse af abemaciclib til gravide kvinder.
English: You can take the tablets either with or without food, just avoid grapefruit and grapefruit juice (see section 2 “Verzenios with food and drink”).
Danish: Du kan tage tabletterne sammen med eller uden mad, du skal bare undgå grapefrugt og grapefrugtjuice (se afsnit 2 ”Brug af Verzenios sammen med mad og drikke”).
English: Therefore, abemaciclib can be taken with or without food.
Danish: Derfor kan abemaciclib tages sammen med eller uden mad.
English: It is currently unknown whether abemaciclib may reduce the effectiveness of systemically acting hormonal contraceptives.
Danish: Det er for nuværende ukendt, om abemaciclib kan reducere virkningen af hormonelle kontraceptiva med systemisk virkning.
English: Verzenios with food and drink
Danish: Brug af Verzenios sammen med mad og drikke
English: Frequency gradings are: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Danish: Hyppighedskategorierne er: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The effect of abemaciclib on the QTcF interval was evaluated in 144 patients with advanced cancer.
Danish: Abemaciclibs indvirkning på QTcF-intervallet blev vurderet hos 144 patienter med fremskreden cancer.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR ATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Other side effects with Verzenios may include:
Danish: Andre bivirkninger ved Verzenios kan omfatte:
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og pakningen efter ”Exp”.
English: Management recommendations for non-haematologic toxicities (excluding diarrhoea and increased aminotransferases)
Danish: Anbefalinger vedrørende håndtering af ikke-hæmatologisk toksicitet (eksklusiv diarré og forhøjede aminotransferaser)
English: Contact your doctor immediately for any of the following: - Symptoms such as chills or fever.
Danish: Kontakt omgående lægen, hvis du oplever noget af nedenstående: - Symptomer såsom kulderystelser eller feber.
English: Specific animal studies to test abemaciclib for carcinogenic potential have not been performed.
Danish: Der er ikke udført specifikke dyrestudier med henblik på at undersøge abemaciclib for karcinogent potentiale.
English: Do not take a double dose to make up for the forgotten or vomited dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte eller opkastede dosis.
English: In animal studies, no effects on female reproductive organs were observed.
Danish: I dyreforsøg blev der ikke set nogen virkning på hunnernes reproduktionsorganer.
English: Objective response for patients with measurable diseasea
Danish: Objektivt respons hos patienter med målbar sygdoma
English: These could be a sign of low white blood cell counts (which may affect more than 1 in 10 people) and should be treated immediately.
Danish: Det kan være tegn på et lavt antal hvide blodlegemer (som kan forekomme hos flere end 1 ud af 10 behandlede) og bør behandles med det samme.
English: Tiredness and dizziness are very common side effects.
Danish: Træthed og svimmelhed er meget almindelige bivirkninger.
English: What your doctor will check before and during your treatment
Danish: Lægekontroller før og under behandlingen
English: You will have regular blood tests before and during treatment to check whether Verzenios affects your blood (white blood cells, red blood cells, platelets) or the concentration in your blood of enzymes from your liver.
Danish: Du skal have taget regelmæssige blodprøver før og under behandlingen for at kontrollere, om Verzenios påvirker dit blod (hvide blodlegemer, røde blodlegemer, blodplader), eller indholdet af leverenzymer i dit blod.
English: Age, gender, and body weight
Danish: Alder, køn og legemsvægt
English: Avoid grapefruit or grapefruit juice.
Danish: Grapefrugt og grapefrugtjuice bør undgås.
English: The primary target organ findings of potential relevance to humans included gastrointestinal and haematolymphopoietic organ effects in rats and dogs in studies up to 13 weeks duration.
Danish: De primære fund i målorganerne af potentiel relevans for mennesker omfattede gastrointestinale og hæmatolymfopoietiske organvirkninger hos rotter og hunde i studier af op til 13 ugers varighed.
English: Resume at next lower dose unless the dose was already reduced for the toxicity that led to the use of the growth factor.
Danish: Genoptag behandlingen med den næste lavere dosis, medmindre dosen allerede er reduceret på grund af den toksicitet, der førte til brug af vækstfaktoren.
English: The tablet should be swallowed whole (patients should not chew, crush, or split tablets before swallowing).
Danish: Tabletten skal synkes hel (patienterne må ikke tygge, knuse eller dele tabletterne, inden de synker dem).
English: - Painful swollen leg, chest pain, shortness of breath, rapid breathing or rapid heart rate as these can be signs of blood clots in the vein (which may affect up to 1 in 10 people).
Danish: - Smertefuld hævelse af benene, brystsmerter, stakåndethed, hurtig vejrtrækning eller hurtig puls, da det kan være tegn på blodpropper i venen (som kan forekomme hos op til 1 ud af 10 behandlede).
English: • Reduction in white blood cells, red blood cells, and blood platelets
Danish: • Fald i antallet af hvide blodlegemer, røde blodlegemer og blodplader
English: Discuss contraception with your doctor if there is any possibility that you may become pregnant.
Danish: Tal med din læge om prævention, hvis der er mulighed for, at du kan blive gravid.
English: Verzenios plus fulvestrant prolonged progression-free survival with neither a clinically meaningful or significant detriment to health-related quality of life.
Danish: Verzenios plus fulvestrant forlængede den progressionsfri overlevelse uden klinisk betydningsfuld eller signifikant negativ indvirkning på den helbredsrelaterede livskvalitet.
English: Verzenios is a cancer medicine containing the active substance abemaciclib.
Danish: Verzenios er et lægemiddel mod kræft, der indeholder det aktive stof abemaciclib.
English: Very common Alopecia
Danish: Meget almindelig Alopeci
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: If you have cough, fever and difficulty breathing or chest pain, this could be a sign of lung infection.
Danish: Hvis du har hoste, feber og svært ved at få vejret eller smerter i brystet, kan det være tegn på en lungeinfektion.
English: Serious infections such as lung infections can be life-threatening; - cause blood clots in the veins; - affect the way your liver works; - cause diarrhoea.
Danish: Alvorlige infektioner, såsom lungeinfektioner, kan være livstruende; - forårsage blodpropper i venerne; - påvirke din leverfunktion; - forårsage diarré.
English: In each treatment arm the majority of patients were white, and had not received chemotherapy for metastatic disease.
Danish: I begge behandlingsarme var størstedelen af patienterne hvide og havde ikke fået kemoterapi for metastatisk sygdom.
English: Verzenios should be taken continuously as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
Danish: Verzenios bør indtages kontinuerligt, så længe patienten opnår en klinisk fordel ved behandlingen, eller indtil der opstår uacceptabel toksicitet.
English: Toxicity a
Danish: Toksicitet a
English: Blocking the action of these proteins can slow down growth of cancer cells, shrink the tumour and delay progression of the cancer.
Danish: Blokeringen af disse proteiners virkning kan hæmme væksten af kræftceller, gøre knuden mindre og forsinke kræftens udvikling.
English: Serious or life-threatening infections are uncommon (may affect up to 1 in 100 people).
Danish: Alvorlige eller livstruende infektioner er ikke almindelige (kan forekomme hos op til 1 ud af 100 behandlede).
English: Verzenios therapy should be initiated and supervised by physicians experienced in the use of anti-cancer therapies.
Danish: Behandlingen med Verzenios bør iværksættes og overvåges af læger med erfaring i brug af lægemidler mod cancer.
English: Do not chew, crush or split the tablets before swallowing.
Danish: Du må ikke tygge, knuse eller dele tabletterne, før du synker dem.
English: It is given together with hormonal therapies, such as aromatase inhibitors or fulvestrant.
Danish: Det gives sammen med hormonbehandlinger, såsom aromatasehæmmere eller fulvestrant.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands.
Danish: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, Holland.
English: Very common Infectionsb
Danish: Meget almindelig Infektionerb
English: • Infections
Danish: • Infektioner
English: If you get certain side effects while you are taking Verzenios your doctor may lower your dose or stop treatment temporarily or permanently.
Danish: Hvis du får visse bivirkninger under behandlingen med Verzenios, vil lægen eventuelt nedsætte din dosis eller stoppe behandlingen midlertidigt eller permanent.
English: No large change (that is, >20 ms) in the QTcF interval was detected at the mean observed maximal steady state abemaciclib concentration following a therapeutic dosing schedule.
Danish: Der blev ikke påvist nogen større ændring (dvs. >20 ms) i QTcF-intervallet ved den observerede gennemsnitlige maksimale steady state-koncentration af abemaciclib efter en terapeutisk doseringsplan.
English: It is not known if Verzenios passes into breast milk.
Danish: Det vides ikke, om Verzenios går over i modermælken.
English: The most commonly occurring adverse reactions are diarrhoea, infections, neutropenia, anaemia, fatigue, nausea, vomiting and decreased appetite.
Danish: De hyppigst forekommende bivirkninger er diarré, infektioner, neutropeni, anæmi, træthed, kvalme, opkastning og nedsat appetit.
English: Grade 3 or 4 a NCI CTCAE
Danish: Grad 3 eller 4 a NCI CTCAE
English: Alternatively, the abemaciclib dose may be reduced to 50 mg once daily or discontinued.
Danish: Alternativt kan abemaciclibdosis reduceres til 50 mg én gang dagligt eller seponeres.
English: Increased aminotransferases
Danish: Forhøjede aminotransferaser
English: Abemaciclib absorption is slow, with a Tmax of 8 hours and a mean absolute bioavailability of approximately 45 %.
Danish: Abemaciclib absorberes langsomt med en Tmax på 8 timer og en gennemsnitlig absolut biotilgængelighed på cirka 45 %.
English: No dose adjustment is necessary for patients treated with moderate or weak CYP3A4 inhibitors.
Danish: Dosisjustering er ikke nødvendig for patienter, som behandles med moderate eller svage CYP3A4 inhibitorer.
English: In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Danish: Hos præ- eller perimenopausale kvinder bør den endokrine behandling kombineres med en luteiniserende hormonfrigivende hormonagonist (LHRH-agonist).
English: a NCI Common Terminology Criteria for Adverse Events (CTCAE) b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3; Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3
Danish: a NCI Common Terminology Criteria for Adverse Events (CTCAE) b ANC: Grad 1: ANC < LLN - 1.500/mm3; Grad 2: ANC 1.000 - <1.500/mm3; Grad 3: ANC 500 - <1.000/mm3; Grad 4: ANC <500/mm3 LLN = nedre normalgrænse
English: You must tell your doctor if you become pregnant.
Danish: Kontakt lægen, hvis du bliver gravid.
English: Diarrhoea was the most commonly reported adverse reaction (see Table 6).
Danish: Diarré Diarré var den hyppigst indberettede bivirkning (se tabel 6).
English: Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Danish: b Infektioner omfatter alle foretrukne termer, der er en del af systemorganklassen infektioner og parasitære sygdomme.
English: In vitro, Rb-negative and Rb-depleted cancer cell lines are generally less sensitive to abemaciclib.
Danish: In vitro er Rb-negative og Rb-depleterede cancercellelinjer generelt mindre følsomme over for abemaciclib.
English: When and how to take Verzenios
Danish: Hvornår og hvordan du skal tage Verzenios
English: In the therapeutic dose range of 50-200 mg, the increase in plasma exposure (AUC) and Cmax is approximately dose proportional.
Danish: I det terapeutiske dosisinterval på 50-200 mg er stigningen i plasmaeksponeringen (AUC) og Cmax omtrent dosisproportionel.
English: Diarrhoea returned to baseline or lesser grade with supportive treatment such as loperamide and/or dose adjustment (see section 4.2).
Danish: Diarré vendte tilbage til baseline eller en lavere grad med understøttende behandling såsom loperamid og/eller dosisjustering (se pkt.
English: Effects in lung and skeletal muscle occurred only in rats at exposure levels approximately 2-fold higher than human exposure levels and effects in kidney occurred only in rats at exposure levels approximately 6fold higher than human exposure levels.
Danish: Virkninger på lunger og skeletmuskulatur forekom kun hos rotter ved eksponeringsniveauer, der var cirka 2 gange højere end eksponeringsniveauet hos mennesker, og virkninger på nyrerne forekom kun hos rotter ved eksponeringsniveauer, der var cirka 6 gange højere end eksponeringsniveauet hos mennesker.
English: Suspend abemaciclib dose for at least 48 hours after the last dose of blood cell growth factors was administered and until toxicity resolves to Grade 2 or less.
Danish: Afbryd doseringen af abemaciclib i mindst 48 timer efter administration af den sidste dosis blodlegeme-vækstfaktorer, og indtil toksiciteten bedres til grad 2 eller derunder.