FrancophonIA/ELRC3.0 huggingface dataset:
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR DIHYDROERGOCRYPTINE CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER TIL RELEVANTE AFSNIT INDLÆGSSEDDEL FOR PRODUKTER INDEHOLDENDE DIHYDROERGOCRYPTIN
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR BROMOCRIPTINE CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER TIL RELEVANTE AFSNIT INDLÆGSSEDDEL FOR PRODUKTER INDEHOLDENDE BROMOCRIPTIN
English: “Among patients on bromocriptine, particularly on long-term and high-dose treatment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis have occasionally been reported.
Danish: ”Pleural og perikardiel effusion, såvel som pleura- og lungefibrose, konstriktiv perikarditis og retroperitoneal fibrose, kan forekomme, specielt ved længerevarende og høj-dosis-behandling med bromocriptin.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR BROMOCRIPTINE CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER TIL RELEVANTE AFSNIT I PRODUKTRESUMÉ OG INDLÆGSSEDDEL FOR PRODUKTER INDEHOLDENDE BROMOCRIPTIN
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR LISURIDE CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER TIL RELEVANTE AFSNIT I PRODUKTRESUMÉ OG INDLÆGSSEDDEL FOR PRODUKTER INDEHOLDENDE LISURID
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR LISURIDE CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER TIL RELEVANTE AFSNIT INDLÆGSSEDDEL FOR PRODUKTER INDEHOLDENDE LISURID
English: 7 October 2011
Danish: 7. oktober 2011
English: European Commission issued a decision on 7 October 2011.
Danish: Europa-Kommissionen traf en afgørelse den 7. oktober 2011.
English: What is Norvasc?
Danish: Hvad er Norvasc?
English: Norvasc is authorised in the EU via national procedures.
Danish: Norvasc er godkendt i EU efter nationale procedurer.
English: Why was Norvasc reviewed?
Danish: Hvorfor blev Norvasc vurderet igen?
English: It blocks special channels on the surface of cells called calcium channels, through which calcium particles normally enter.
Danish: Det blokerer særlige kanaler på celleoverfladen kaldet calciumkanaler, som calciumpartiklerne normalt kommer ind igennem.
English: Dosing instructions were already harmonised in all EU countries, however, not all countries had dosing recommendations for Norvasc when used together with other medicines.
Danish: Doseringsvejledningerne var allerede blevet harmoniseret i alle EU-lande, men det var ikke alle lande, der havde doseringsvejledninger for Norvasc, når det blev anvendt sammen med andre lægemidler.
English: Norvasc is medicine that contains the active substance amlodipine.
Danish: Norvasc er et lægemiddel, der indeholder det aktive stof amlodipin.
English: Norvasc had been used to treat hypertension and angina in all EU countries.
Danish: Norvasc er blevet anvendt til behandling af hypertension og angina i alle EU-lande.
English: The CHMP also harmonised other sections of the SmPC including sections 4.5 (interaction with other medicinal products and other forms of interaction) and 5.1 (pharmacodynamic properties)
Danish: CHMP harmoniserede ligeledes andre punkter i produktresuméet, herunder punkt 4.5 (interaktion med andre lægemidler og andre former for interaktion) og punkt 5.1 (farmakodynamiske egenskaber).
English: Norvasc is also available in the EU under other trade names: Amlodipine Pfizer, Amlodipino, Amlor, Istin, Monopina, and Norvasc.
Danish: Norvasc markedsføres ligeledes i EU under andre særnavne: Amlodipine Pfizer, Amlodipino, Amlor, Istin, Monopina og Norvasc.
English: On 2 February 2011, Pfizer referred the matter to the CHMP in order to harmonise the SmPCs as well as to standardise the test used for examining the quality of Norvasc in the EU.
Danish: Den 2. februar 2011 indbragte Pfizer sagen for CHMP med henblik på en harmonisering af produktresuméerne og en standardisering af den test, der anvendes til at undersøge kvaliteten af Norvasc i EU.
English: A type of angina called vasospastic or Prinzmetal's angina was approved in all EU countries except Denmark and Sweden, while coronary artery disease was approved in Latvia and Romania.
Danish: Anvendelse til en type angina kaldet vasospastisk angina eller Prinzmetals angina blev godkendt i alle EU-lande undtagen Danmark og Sverige, mens koronararteriesygdom blev godkendt i Letland og Rumænien.
English: The European Medicines Agency has completed a review of Norvasc.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en vurdering af Norvasc.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Norvasc in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Norvasc i Den Europæiske Union (EU).
English: When calcium enter the cells in the muscles of blood vessel walls, this causes contraction.
Danish: Når calcium kommer ind i muskelcellerne i blodkarvæggene, forårsager det en sammentrækning.
English: It has been used to treat cardiovascular problems such as hypertension (high blood pressure) and angina (chest pain caused by problems with the blood flow to the heart).
Danish: Det er blevet anvendt til behandling af kardiovaskulære problemer såsom hypertension (højt blodtryk) og angina (brystsmerter, der skyldes problemer med blodtilførslen til hjertet).
English: The CHMP harmonised the contraindication as follows: hypersensitivity (allergy) to dihydropyridine derivatives, amlodipine or to any of the excipients; severe hypotension (low blood pressure), shock (a steep fall in blood pressure), obstruction of the outflow tract of the left ventricle (a chamber in the heart) and patients with heart failure following a heart attack.
Danish: CHMP harmoniserede kontraindikationerne som følger: overfølsomhed (allergi) over for dihydropyridinderivater, amlodipin eller eller et af hjælpestofferne; svær hypotension (lavt blodtryk), chok (et brat fald i blodtrykket), obstruktion af outflow-kanalen fra venstre ventrikel (et hjertekammer) og patienter med hjertesvigt efter et hjerteanfald.
English: The CHMP harmonised the indications, recommending that Norvasc be used for: hypertension, chronic stable angina and vasospastic or Prinzmetal's angina.
Danish: CHMP harmoniserede indikationerne og anbefalede, at Norvasc bliver anvendt til hypertension, kronisk stabil angina og vasospastisk angina eller Prinzmetals angina.
English: The CHMP has recommended that no dose adjustments for Norvasc are required when used together with the following antihypertensive medicines: thiazide, beta blockers, and angiotensin-converting enzyme (ACE) inhibitors.
Danish: CHMP anbefalede, at dosisjusteringer for Norvasc ikke er påkrævet, når det anvendes sammen med følgende lægemidler mod hypertension: thiazid, betablokkere og angiotensinkonverterende enzymhæmmere (ACE-hæmmere).
English: By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thus lowering the blood pressure for patients with hypertension and helping to make it easier for patients with heart problems to pump blood around the body.
Danish: Dermed sænkes blodtrykket for patienter med hypertension, og det bliver lettere for patienter med hjerteproblemer at pumpe blodet rundt i kroppen.
English: Date of first authorisation: 10 March 2004 Date of latest renewal: 10 March 2009
Danish: Dato for første markedsføringstilladelse: 10. marts 2004 Dato for seneste fornyelse: 10. marts 2009
English: All Patients c
Danish: Alle patienter c
English: Harmful for those suffering from alcoholism.
Danish: Skadeligt for personer der lider af alkoholisme.
English: The results in the AI subgroup are inconclusive.
Danish: Resultaterne i AI-undergruppen er inkonklusive.
English: There were no statistically significant differences in any of these endpoints between the two treatment groups.
Danish: Der var ingen statistisk signifikante forskelle for nogle af disse endepunkter imellem de to behandlingsgrupper.
English: There were no new safety concerns arising from this small study, but 5-year data are yet not available.
Danish: Denne lille undersøgelse viste ingen nye sikkerhedsmæssige forhold, men 5-års-data er endnu ikke tilgængelige.
English: All other side effects:
Danish: Alle andre bivirkninger:
English: Type of estimate; treatment comparison
Danish: Type af estimat; behandlingssammenligning
English: Adult females (including Elderly)
Danish: Voksne kvinder (inklusive ældre)
English: Fulvestrant is subject to extensive and rapid distribution.
Danish: Fulvestrant distribueres omfattende og hurtigt.
English: Fulvestrant is eliminated mainly in metabolised form.
Danish: Fulvestrant elimineres primært i metaboliseret form.
English: Supportive PFS analyses were based on an Independent Central Radiology Review.
Danish: Understøttende PFS-analyser var baseret på en uafhængig central radiologisk gennemgang.
English: Risk Management Plan (RMP)
Danish: • Risikostyringsprogram (RMP)
English: Progression-free survival was the primary endpoint.
Danish: Progressionsfri overlevelse var det primære endepunkt.
English: Patients with a best objective response of complete response, partial response or stable disease ≥24 weeks.
Danish: Patienter med det bedste objektive respons blandt dem med fuldkomment respons, delvist respons eller stabil sygdom ≥24 uger.
English: Fulvestrant showed no genotoxic potential.
Danish: Fulvestrant udviser ikke genotoksisk potentiale.
English: If overdose occurs, symptomatic supportive treatment is recommended.
Danish: Hvis der sker en overdosering, anbefales symptomatisk, understøttende behandling.
English: This medicine may pose a risk to the aquatic environment.
Danish: Dette lægemiddel kan udgøre en risiko for vandmiljøet.
English: Fulvestrant is highly (99%) bound to plasma proteins.
Danish: Fulvestrant er stærkt bundet (99%) til plasma-proteiner.
English: Consistent results were observed across the majority of pre-specified patient subgroups.
Danish: Der blev observeret overensstemmende resultater på tværs af størstedelen af de præspecificerede undergrupper af patienter.
English: You must not use Faslodex if you are pregnant.
Danish: Du må ikke anvende Faslodex hvis du er gravid.
English: You may need immediate medical treatment if you experience any of the following side effects:
Danish: Du kan have behov for omgående lægebehandling, hvis du får en af følgende bivirkninger:
English: Time (Month)
Danish: Tid (måned)
English: *(31% maturity)-not final OS analysis **for patients with measurable disease
Danish: *(31 % modenhed) - ikke endelig OS-analyse **for patienter med målbar sygdom
English: Approximately 20% of patients were pre/perimenopausal.
Danish: Omtrent 20 % af patienterne var præ-/perimenopausale.
English: The event was not observed in major clinical studies (CONFIRM, FINDER 1, FINDER 2, NEWEST).
Danish: Denne bivirkning blev ikke observeret i de vigtigste kliniske studier (CONFIRM, FINDER 1, FINDER 2, NEWEST).
English: Clinical efficacy and safety in advanced breast cancer
Danish: Klinisk virkning og sikkerhed ved fremskreden brystkræft
English: *Response results based on confirmed and unconfirmed responses.
Danish: *Responsresultater baseret på bekræftede og ubekræftede responser.
English: The efficacy results of the FALCON study are presented in Table 4 and Figure 1.
Danish: Effektresultaterne af FALCON-studiet er præsenteret i tabel 4 og figur 1.
English: These occurred at exposure levels higher than in patients (Cmax >15 times) and are likely to be of limited significance for human safety at the clinical dose.
Danish: Disse forekom ved højere eksponeringsniveauer end ved patienter (Cmax >15 gange) og er sandsynligvis af begrænset betydning for human sikkerhed ved den kliniske dosis.
English: Crossover between treatment arms was not allowed.
Danish: Overkrydsning mellem behandlingsarmene var ikke tilladt.
English: No interaction studies were conducted on competitive protein binding.
Danish: Der er ikke udført interaktionsstudier med henblik på kompetitiv proteinbinding.
English: Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.
Danish: Østrogener, en type af kvindeligt kønshormon, kan i nogle tilfælde være involveret i væksten af brystkræft.
English: *Response endpoints based on confirmed and unconfirmed responses.
Danish: *Respons-endepunkter baseret på bekræftede og ubekræftede responser.
English: The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate.
Danish: Hyppigheden blev beregnet ved hjælp af den øvre grænse for 95% konfidensintervallet for punktestimatet.
English: Venous thromboembolism
Danish: Venøs thromboembolisme
English: OS is presented for the final survival analyses at 75% maturity.
Danish: OS vises for de endelige overlevelsesanalyser ved 75 % modenhed.
English: Progression-Free Survival Probability (%)
Danish: Sandsynlighed for progressionsfri overlevelse (%)
English: Effects on the postmenopausal endometrium
Danish: Virkning på postmenopausal endometrium
English: This is calculated as 3/560 (where 560 is the number of patients in the major clinical studies), which equates to a frequency category of ‘uncommon'.
Danish: Dette estimat beregnes som 3/560 (hvor 560 er antallet af patienter i de vigtigste kliniske studier), hvilket svarer til hyppighedskategorien ‘ikke almindelig'.
English: This section provides information based on all adverse reactions from clinical studies, post-marketing studies or spontaneous reports.
Danish: Dette afsnit giver information baseret på alle bivirkninger fra kliniske studier, post-marketing-studier eller rapporterede spontane bivirkninger.
English: Very low density lipoprotein (VLDL), low density lipoprotein (LDL), and high density lipoprotein (HDL) fractions are the major binding components.
Danish: Very low density lipoprotein (VLDL), low density lipoprotein (LDL) og high density lipoprotein (HDL) fraktioner er de primære bindende bestanddele.
English: , hepatitis f, elevated gamma-GT
Danish: , hepatitis f, forhøjet gamma-GT
English: Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
Danish: På grund af fulvestrants virkningsmekanisme, er der en potentiel risiko for osteoporose.
English: ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients Preferred Terms (PTs) are listed according to MedDRA 17.1.
Danish: ALAT=alanin aminotransferase; ASAT=aspartat aminotransferase; N/n=antal patienter Foretrukne Termer (PTs) er anført i henhold til MedDRA 17.1.
English: Frequency category differs between pooled safety dataset and FALCON.
Danish: Frekvenskategorien er ikke den samme i de kombinerede sikkerhedsdatasæt og i FALCON.
English: Your healthcare professional will be responsible for the correct storage, use and disposal of Faslodex.
Danish: Personalet har ansvar for den korrekte opbevaring, brug og destruktion af Faslodex.
English: Faslodex is not indicated for use in children.
Danish: Faslodex er ikke indiceret til brug hos børn.
English: Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100).
Danish: Frekvensopdelingen er defineret i henhold til følgende: Meget almindelig (≥1/10), Almindelig (≥1/100 til <1/10), Ikke almindelig (≥1/1.000 til <1/100).
English: • Sudden weakness, numbness, tingling, or loss of movement in your leg, especially on only one side of your body, sudden problems with walking or balance (peripheral neuropathy)
Danish: • Pludselig svaghed, følelsesløshed, snurren eller manglende bevægelse i benet, især kun i den ene side af kroppen, pludselige problemer med at gå eller med balancen (perifer neuropati)
English: The role of sex hormone-binding globulin (SHBG) has not been determined.
Danish: Virkningen af det kønshormonbindende globulin (SHBG) er ikke fastlagt.
English: Hands must remain behind the needle at all times during use and disposal.
Danish: Hænderne skal til enhver tid holdes bag ved kanylen under anvendelse og ved destruktion.
English: More than half (62%) had an ECOG PS of 0, 60% had visceral metastases, and 60% had received more than 1 prior hormonal regimen for their primary diagnosis.
Danish: Mere end halvdelen (62 %) havde en ECOG PS på 0, 60 % havde viscerale metastaser, og 60 % havde modtaget mere end 1 tidligere hormonbehandlingsforløb for den primære diagnose.
English: Effects on bone
Danish: Effekt på knogle
English: The acute toxicity of fulvestrant is low.
Danish: Akut toksicitet for fulvestrant er lav.
English: The terminal half-life (t1/2) after intramuscular administration is governed by the absorption rate and was estimated to be 50 days.
Danish: Den terminale halveringstid (t1/2) efter intramuskulær administration er bestemt af absorbtionshastigheden og blev estimeret til at være 50 dage.
English: K-M median in months; hazard ratio
Danish: K-M median i måneder; hazard ratio
English: Patients continued to receive assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Danish: Patienterne fortsatte med at få den tildelte behandling, indtil objektiv sygdomsprogression, symptomatisk forværring, uacceptabel toksicitet, dødsfald eller tilbagetrækning af informeret samtykke indtraf, hvad der end opstod først.
English: Therefore these findings are not considered to be relevant to the use of fulvestrant in postmenopausal women with advanced breast cancer.
Danish: Disse betragtninger anses derfor ikke for relevante for brugen af fulvestrant til postmenopausale kvinder med fremskreden brystkræft.
English: The primary endpoint of the study was investigator-assessed PFS evaluated according to RECIST 1.1.
Danish: Det primære endepunkt for studiet var investigatorvurderet PFS evalueret ifølge RECIST 1.1.
English: Children and adolescents Faslodex is not indicated in children and adolescents under 18 years.
Danish: Børn og unge Faslodex er ikke beregnet til børn og teenagere under 18 år.
English: This should be taken into consideration when prescribing Faslodex to patients at risk.
Danish: Dette bør tages i betragtning, når Faslodex ordineres til risikopatienter.
English: The median duration of fulvestrant 500 mg treatment across the pooled dataset (including the studies mentioned above plus FALCON) was 6.5 months.
Danish: Medianvarigheden af behandling med fulvestrant 500 mg på tværs af det poolede datasæt (inklusive ovennævnte studier plus FALCON) var 6,5 måneder.
English: In patients administered Faslodex, an increase in exposure of this magnitude is expected to be well tolerated.
Danish: Hos patienter der får Faslodex forventes en stigning i eksponering af denne størrelse at være veltolereret.
English: The metabolism of fulvestrant has not been fully evaluated, but involves combinations of a number of possible biotransformation pathways analogous to those of endogenous steroids.
Danish: Metabolismen af fulvestrant er ikke fuldstændig undersøgt men involverer kombinationer af en række mulige biotransformationsveje, analog til endogene steroider.
English: The major route of excretion is via the faeces, with less than 1% being excreted in the urine.
Danish: Udskillelsesvejen er primært via fæces, med mindre end 1% udskilt i urinen.
English: Your doctor or nurse will give you Faslodex as a slow intramuscular injection, one into each of your buttocks.
Danish: Din læge eller sygeplejerske vil give dig Faslodex som en langsom intramuskulær injektion, én i hver balle.
English: Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 6.
Danish: Yderligere effektmål (OR og TTR) vurderet i undergrupperne med patienter med eller uden visceral sygdom er angivet i tabel 6.
English: % of patients with CB; absolute difference in
Danish: % patienter med CB; absolut forskel i%
English: Pharmacotherapeutic group: Endocrine therapy, Antiestrogens, ATC code: L02BA03
Danish: Farmakoterapeutisk klassifikation: Endokrin behandling, antiøstrogener, ATC-kode: L02BA03
English: Faslodex and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies.
Danish: Faslodex og andre formuleringer af fulvestrant var veltolererede hos de involverede dyrearter i flerdosis studier.
English: The median time to death was 27.4 months for patients treated with Faslodex and 27.6 months for patients treated with anastrozole.
Danish: Den gennemsnitlige tid til død var 27,4 måneder for patienter i behandling med Faslodex og 27,6 måneder for patienter i behandling med anastrozol.
English: % of patients with OR; absolute difference in
Danish: % patienter med OR; absolut forskel i%
English: Temperature excursions outside 2°C - 8°C should be limited.
Danish: Temperaturudsving uden for 2 °C - 8 °C skal begrænses.
English: See the package leaflet for further information.
Danish: Se indlægssedlen for mere information.
English: Nominal p-value with no adjustments made for multiplicity between the initial overall survival analyses at 50% maturity and the updated survival analyses at 75% maturity.
Danish: Nominel p-værdi uden foretagne justeringer for multiplicitet mellem de indledende samlede overlevelsesanalyser ved 50 % modenhed og de opdaterede overlevelsesanalyser ved 75 % modenhed.
English: Faslodex is indicated:
Danish: Faslodex er indiceret:
English: • Abnormal levels of liver enzymes (in blood tests)*
Danish: • Unormale niveauer af leverenzymer (i blodprøver)*
English: Identified metabolites (includes 17-ketone, sulphone, 3-sulphate, 3- and 17-glucuronide metabolites) are either less active or exhibit similar activity to fulvestrant in antiestrogen models.
Danish: Identificerede metabolitter (inkluderer 17-keton, sulfon, 3 sulfat 3- og 17-glucoronid metabolitter) er enten mindre aktive eller viser tilsvarende aktivitet som fulvestrant i antiøstrogene modeller.
English: No data are available regarding endometrial morphology.
Danish: Der er ingen tilgængelige data vedrørende endometrisk morfologi.
English: The mechanism of action is associated with downregulation of estrogen receptor protein levels.
Danish: Virkningsmekanismen hænger sammen med nedregulering af niveauet af østrogen receptor-protein.
English: At steady state, fulvestrant plasma concentrations are maintained within a relatively narrow range with up to an approximately 3-fold difference between maximum and trough concentrations.
Danish: Ved steady state er fulvestrant plasmakoncentrationer bibeholdt indenfor et relativt smalt koncentrationsområde med op til cirka 3 foldig difference mellem maksimale og trough koncentrationer.
English: Vomiting, diarrhoea
Danish: Opkastning, diarré.
English: After administration of Faslodex long-acting intramuscular injection, fulvestrant is slowly absorbed and maximum plasma concentrations (Cmax) are reached after about 5 days.
Danish: Efter administration af Faslodex langtidsvirkende intramuskulær injektion, absorberes fulvestrant langsomt, og maksimale plasmakoncentrationer (Cmax) opnås efter cirka 5 dage.
English: There was also a significant decrease in progesterone receptor expression consistent with a lack of intrinsic estrogen agonist effects.
Danish: Der sås også en signifikant nedsat progesteron receptor-ekspression i overensstemmelse med en manglende intrinsic østrogen agonist effekt.
English: TTR*, Median [months (range)]
Danish: TTR*, median [måneder (interval)]
English: Patient-reported symptoms were assessed using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and its Breast Cancer Module (EORTC QLQ-BR23).
Danish: De patientrapporterede symptomer blev vurderet under anvendelse af EORTC (European Organization for Research and Treatment of Cancer)-spørgeskema om livskvalitet (QLQ)-C30 og brystkræftmodulet (EORTC QLQ-BR23).