natgillin/translations-raw huggingface dataset:
EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Norvasc i Den Europæiske Union (EU). 
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).
Når calcium kommer ind i muskelcellerne i blodkarvæggene, forårsager det en sammentrækning. 
When calcium enter the cells in the muscles of blood vessel walls, this causes contraction.
Det er blevet anvendt til behandling af kardiovaskulære problemer såsom hypertension (højt blodtryk) og angina (brystsmerter, der skyldes problemer med blodtilførslen til hjertet). 
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).
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. 
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.
CHMP harmoniserede indikationerne og anbefalede, at Norvasc bliver anvendt til hypertension, kronisk stabil angina og vasospastisk angina eller Prinzmetals angina. 
The CHMP harmonised the indications, recommending that Norvasc be used for: hypertension, chronic stable angina and vasospastic or Prinzmetal's angina.
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). 
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.
Dermed sænkes blodtrykket for patienter med hypertension, og det bliver lettere for patienter med hjerteproblemer at pumpe blodet rundt i kroppen. 
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.
Dato for første markedsføringstilladelse: 10. marts 2004 Dato for seneste fornyelse: 10. marts 2009 
Date of first authorisation: 10 March 2004 Date of latest renewal: 10 March 2009
Alle patienter c 
All Patients c
Skadeligt for personer der lider af alkoholisme. 
Harmful for those suffering from alcoholism.
Resultaterne i AI-undergruppen er inkonklusive. 
The results in the AI subgroup are inconclusive.
Der var ingen statistisk signifikante forskelle for nogle af disse endepunkter imellem de to behandlingsgrupper. 
There were no statistically significant differences in any of these endpoints between the two treatment groups.
Denne lille undersøgelse viste ingen nye sikkerhedsmæssige forhold, men 5-års-data er endnu ikke tilgængelige. 
There were no new safety concerns arising from this small study, but 5-year data are yet not available.
Alle andre bivirkninger: 
All other side effects:
Type af estimat; behandlingssammenligning 
Type of estimate; treatment comparison
Voksne kvinder (inklusive ældre) 
Adult females (including Elderly)
Fulvestrant distribueres omfattende og hurtigt. 
Fulvestrant is subject to extensive and rapid distribution.
Fulvestrant elimineres primært i metaboliseret form. 
Fulvestrant is eliminated mainly in metabolised form.
Understøttende PFS-analyser var baseret på en uafhængig central radiologisk gennemgang. 
Supportive PFS analyses were based on an Independent Central Radiology Review.
• Risikostyringsprogram (RMP) 
Risk Management Plan (RMP)
Progressionsfri overlevelse var det primære endepunkt. 
Progression-free survival was the primary endpoint.
Patienter med det bedste objektive respons blandt dem med fuldkomment respons, delvist respons eller stabil sygdom ≥24 uger. 
Patients with a best objective response of complete response, partial response or stable disease ≥24 weeks.
Fulvestrant udviser ikke genotoksisk potentiale. 
Fulvestrant showed no genotoxic potential.
Hvis der sker en overdosering, anbefales symptomatisk, understøttende behandling. 
If overdose occurs, symptomatic supportive treatment is recommended.
Dette lægemiddel kan udgøre en risiko for vandmiljøet. 
This medicine may pose a risk to the aquatic environment.
Fulvestrant er stærkt bundet (99%) til plasma-proteiner. 
Fulvestrant is highly (99%) bound to plasma proteins.
Der blev observeret overensstemmende resultater på tværs af størstedelen af de præspecificerede undergrupper af patienter. 
Consistent results were observed across the majority of pre-specified patient subgroups.
Du må ikke anvende Faslodex hvis du er gravid. 
You must not use Faslodex if you are pregnant.
Du kan have behov for omgående lægebehandling, hvis du får en af følgende bivirkninger: 
You may need immediate medical treatment if you experience any of the following side effects:
Tid (måned) 
Time (Month)
*(31 % modenhed) - ikke endelig OS-analyse **for patienter med målbar sygdom 
*(31% maturity)-not final OS analysis **for patients with measurable disease
Omtrent 20 % af patienterne var præ-/perimenopausale. 
Approximately 20% of patients were pre/perimenopausal.
Denne bivirkning blev ikke observeret i de vigtigste kliniske studier (CONFIRM, FINDER 1, FINDER 2, NEWEST). 
The event was not observed in major clinical studies (CONFIRM, FINDER 1, FINDER 2, NEWEST).
Klinisk virkning og sikkerhed ved fremskreden brystkræft 
Clinical efficacy and safety in advanced breast cancer
*Responsresultater baseret på bekræftede og ubekræftede responser. 
*Response results based on confirmed and unconfirmed responses.
Effektresultaterne af FALCON-studiet er præsenteret i tabel 4 og figur 1. 
The efficacy results of the FALCON study are presented in Table 4 and Figure 1.
Disse forekom ved højere eksponeringsniveauer end ved patienter (Cmax >15 gange) og er sandsynligvis af begrænset betydning for human sikkerhed ved den kliniske dosis. 
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.
Overkrydsning mellem behandlingsarmene var ikke tilladt. 
Crossover between treatment arms was not allowed.
Der er ikke udført interaktionsstudier med henblik på kompetitiv proteinbinding. 
No interaction studies were conducted on competitive protein binding.
Østrogener, en type af kvindeligt kønshormon, kan i nogle tilfælde være involveret i væksten af brystkræft. 
Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.
*Respons-endepunkter baseret på bekræftede og ubekræftede responser. 
*Response endpoints based on confirmed and unconfirmed responses.
Hyppigheden blev beregnet ved hjælp af den øvre grænse for 95% konfidensintervallet for punktestimatet. 
The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate.
Venøs thromboembolisme 
Venous thromboembolism
OS vises for de endelige overlevelsesanalyser ved 75 % modenhed. 
OS is presented for the final survival analyses at 75% maturity.
Sandsynlighed for progressionsfri overlevelse (%) 
Progression-Free Survival Probability (%)
Virkning på postmenopausal endometrium 
Effects on the postmenopausal endometrium
Dette estimat beregnes som 3/560 (hvor 560 er antallet af patienter i de vigtigste kliniske studier), hvilket svarer til hyppighedskategorien ‘ikke almindelig'. 
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'.
Dette afsnit giver information baseret på alle bivirkninger fra kliniske studier, post-marketing-studier eller rapporterede spontane bivirkninger. 
This section provides information based on all adverse reactions from clinical studies, post-marketing studies or spontaneous reports.
Very low density lipoprotein (VLDL), low density lipoprotein (LDL) og high density lipoprotein (HDL) fraktioner er de primære bindende bestanddele. 
Very low density lipoprotein (VLDL), low density lipoprotein (LDL), and high density lipoprotein (HDL) fractions are the major binding components.
, hepatitis f, forhøjet gamma-GT 
, hepatitis f, elevated gamma-GT
På grund af fulvestrants virkningsmekanisme, er der en potentiel risiko for osteoporose. 
Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
ALAT=alanin aminotransferase; ASAT=aspartat aminotransferase; N/n=antal patienter Foretrukne Termer (PTs) er anført i henhold til MedDRA 17.1. 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients Preferred Terms (PTs) are listed according to MedDRA 17.1.
Frekvenskategorien er ikke den samme i de kombinerede sikkerhedsdatasæt og i FALCON. 
Frequency category differs between pooled safety dataset and FALCON.
Personalet har ansvar for den korrekte opbevaring, brug og destruktion af Faslodex. 
Your healthcare professional will be responsible for the correct storage, use and disposal of Faslodex.
Faslodex er ikke indiceret til brug hos børn. 
Faslodex is not indicated for use in children.
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). 
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).
• 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) 
• 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)
Virkningen af det kønshormonbindende globulin (SHBG) er ikke fastlagt. 
The role of sex hormone-binding globulin (SHBG) has not been determined.
Hænderne skal til enhver tid holdes bag ved kanylen under anvendelse og ved destruktion. 
Hands must remain behind the needle at all times during use and disposal.
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. 
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.
Effekt på knogle 
Effects on bone
Akut toksicitet for fulvestrant er lav. 
The acute toxicity of fulvestrant is low.
Den terminale halveringstid (t1/2) efter intramuskulær administration er bestemt af absorbtionshastigheden og blev estimeret til at være 50 dage. 
The terminal half-life (t1/2) after intramuscular administration is governed by the absorption rate and was estimated to be 50 days.
K-M median i måneder; hazard ratio 
K-M median in months; hazard ratio
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. 
Patients continued to receive assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Disse betragtninger anses derfor ikke for relevante for brugen af fulvestrant til postmenopausale kvinder med fremskreden brystkræft. 
Therefore these findings are not considered to be relevant to the use of fulvestrant in postmenopausal women with advanced breast cancer.
Det primære endepunkt for studiet var investigatorvurderet PFS evalueret ifølge RECIST 1.1. 
The primary endpoint of the study was investigator-assessed PFS evaluated according to RECIST 1.1.
Børn og unge Faslodex er ikke beregnet til børn og teenagere under 18 år. 
Children and adolescents Faslodex is not indicated in children and adolescents under 18 years.
Dette bør tages i betragtning, når Faslodex ordineres til risikopatienter. 
This should be taken into consideration when prescribing Faslodex to patients at risk.
Medianvarigheden af behandling med fulvestrant 500 mg på tværs af det poolede datasæt (inklusive ovennævnte studier plus FALCON) var 6,5 måneder. 
The median duration of fulvestrant 500 mg treatment across the pooled dataset (including the studies mentioned above plus FALCON) was 6.5 months.
Hos patienter der får Faslodex forventes en stigning i eksponering af denne størrelse at være veltolereret. 
In patients administered Faslodex, an increase in exposure of this magnitude is expected to be well tolerated.
Metabolismen af fulvestrant er ikke fuldstændig undersøgt men involverer kombinationer af en række mulige biotransformationsveje, analog til endogene steroider. 
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.
Udskillelsesvejen er primært via fæces, med mindre end 1% udskilt i urinen. 
The major route of excretion is via the faeces, with less than 1% being excreted in the urine.
Din læge eller sygeplejerske vil give dig Faslodex som en langsom intramuskulær injektion, én i hver balle. 
Your doctor or nurse will give you Faslodex as a slow intramuscular injection, one into each of your buttocks.
Yderligere effektmål (OR og TTR) vurderet i undergrupperne med patienter med eller uden visceral sygdom er angivet i tabel 6. 
Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 6.
% patienter med CB; absolut forskel i% 
% of patients with CB; absolute difference in
Farmakoterapeutisk klassifikation: Endokrin behandling, antiøstrogener, ATC-kode: L02BA03 
Pharmacotherapeutic group: Endocrine therapy, Antiestrogens, ATC code: L02BA03
Faslodex og andre formuleringer af fulvestrant var veltolererede hos de involverede dyrearter i flerdosis studier. 
Faslodex and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies.
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. 
The median time to death was 27.4 months for patients treated with Faslodex and 27.6 months for patients treated with anastrozole.
% patienter med OR; absolut forskel i% 
% of patients with OR; absolute difference in
Temperaturudsving uden for 2 °C - 8 °C skal begrænses. 
Temperature excursions outside 2°C - 8°C should be limited.
Se indlægssedlen for mere information. 
See the package leaflet for further information.
Nominel p-værdi uden foretagne justeringer for multiplicitet mellem de indledende samlede overlevelsesanalyser ved 50 % modenhed og de opdaterede overlevelsesanalyser ved 75 % modenhed. 
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.
Faslodex er indiceret: 
Faslodex is indicated:
• Unormale niveauer af leverenzymer (i blodprøver)* 
• Abnormal levels of liver enzymes (in blood tests)*
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. 
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.
Der er ingen tilgængelige data vedrørende endometrisk morfologi. 
No data are available regarding endometrial morphology.
Virkningsmekanismen hænger sammen med nedregulering af niveauet af østrogen receptor-protein. 
The mechanism of action is associated with downregulation of estrogen receptor protein levels.
Ved steady state er fulvestrant plasmakoncentrationer bibeholdt indenfor et relativt smalt koncentrationsområde med op til cirka 3 foldig difference mellem maksimale og trough koncentrationer. 
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.
Opkastning, diarré. 
Vomiting, diarrhoea
Efter administration af Faslodex langtidsvirkende intramuskulær injektion, absorberes fulvestrant langsomt, og maksimale plasmakoncentrationer (Cmax) opnås efter cirka 5 dage. 
After administration of Faslodex long-acting intramuscular injection, fulvestrant is slowly absorbed and maximum plasma concentrations (Cmax) are reached after about 5 days.
Der sås også en signifikant nedsat progesteron receptor-ekspression i overensstemmelse med en manglende intrinsic østrogen agonist effekt. 
There was also a significant decrease in progesterone receptor expression consistent with a lack of intrinsic estrogen agonist effects.
TTR*, median [måneder (interval)] 
TTR*, Median [months (range)]
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). 
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).
Febril neutropeni blev rapporteret hos 0,9 % af patienterne, der fik fulvestrant i kombination med palbociclib. 
Febrile neutropenia has been reported in 0.9% patients receiving fulvestrant in combination with palbociclib.
5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering. 
Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Der findes enkeltstående rapporter om overdosering med Faslodex hos mennesker. 
There are isolated reports of overdose with Faslodex in humans.
Injektionen skal administreres ifølge lokale retningslinjer for intramuskulær injektion af stort volumen. 
Administer the injection according to the local guidelines for performing large volume intramuscular injections.
ORR blev vurderet hos patienter, som kunne evalueres for respons ved baseline (dvs. dem med sygdom, som kunne måles ved baseline: 240 patienter i Faslodex 500 mg gruppen og 261 patienter i Faslodex 250 mg gruppen). 
ORR was assessed in patients who were evaluable for response at baseline (i.e. those with measurable disease at baseline: 240 patients in the Faslodex 500 mg group and 261 patients in the Faslodex 250 mg group).
Kvinder med svært nedsat leverfunktion, (Child-Pugh klasse C), blev ikke undersøgt. 
Women with severe hepatic impairment (Child-Pugh class C) were not evaluated.
Arteritis i forskellige væv blev observeret hos nogle hunde efter kronisk dosering (12 måneder). 
Arteritis involving a range of different tissues was seen in some dogs after chronic (12 months) dosing.
Infektioner inkluderer alle PTs, som er inkluderet i systemorganklassen Infektioner og parasitære sygdomme. 
Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Fertilitet Faslodex' virkning på fertiliteten hos mennesker er ikke blevet undersøgt. 
Fertility The effects of Faslodex on fertility in humans has not been studied.
Kombineret analyse af begge studier viste, at 83% af patienterne, som fik Faslodex, progredierede i forhold til 85% af patienterne, der fik anastrozol. 
Combined analysis of both studies showed that 83% of patients who received Faslodex progressed, compared with 85% of patients who received anastrozole.
De sekundære endepunkter omfattede OR, CBR, OS, sikkerhed og tid indtil forværring (TTD) af smerter. 
Secondary endpoints included OR, CBR, OS, safety, and time-to-deterioration (TTD) in pain endpoint.
77 % af studiepopulationen havde østrogen receptor positiv brystkræft. 
Seventy seven percent (77%) of the study population had estrogen receptor positive breast cancer.
Der var en øget forekomst af foster variationer hos kaniner (forskydning bagud af bækkenringen og 27. præ-sakrale hvirvel). 
There was an increased incidence of foetal variations in rabbits (backwards displacement of the pelvic girdle and 27 pre-sacral vertebrae).
Grad ≥ 3 n (%) 
Grade ≥ 3 n (%)
For fuldstændig instruktion vedrørende administration af Faslodex og brugen af den beskyttede kanyle, se vedlagte instruktioner vedrørende administration. 
For full instructions on the administration of Faslodex and the use of the safety needle see enclosed, Instructions for administration.
Tabel 2 viser bivirkningerne fra PALOMA3. 
Table 2 reports the adverse reactions from PALOMA3.
• Parenterale væsker skal inspiceres visuelt for partikler og misfarvning forud for administration. 
• Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.
Kombinationsbehandling med palbociclib 
Combination therapy with palbociclib
PFS: Progressionsfri overlevelse; ORR: objektiv respons rate; OR: objektiv respons; CBR: klinisk gevinstrate; CB: klinisk gevinst; OS: overordnet overlevelse; K-M: Kaplan-Meier; CI: konfidensinterval; AI: Aromatasehæmmer; AE: Anti-østrogen. 
PFS:Progression-free survival; ORR:Objective response rate; OR:Objective response; CBR:Clinical benefit rate; CB:Clinical benefit; OS:Overall survival; K-M:Kaplan-Meier; CI:Confidence interval; AI:Aromatase inhibitor; AE:Antiestrogen.
Der var ingen rapporteringer om grad 4 neutropeni i fulvestrant + placebo-armen. 
There were no reports of Grade 4 neutropenia in the fulvestrant + placebo arm.
Det store tilsyneladende distributionsvolumen ved steady state (Vdss) på ca. 3-5 l/kg, tyder på, at distributionen fortrinsvis sker ekstravasculært. 
The large apparent volume of distribution at steady state (Vdss) of approximately 3 to 5 l/kg suggests that distribution is largely extravascular.
Præ-/perimenopausale kvinder modtog LHRH-agonisten goserelin. 
Pre/perimenopausal women received the LHRH agonist goserelin.
I alt 17,1 % af patienterne havde tidligere modtaget kemoterapi imod fremskreden sygdom; 84,2 % af patienterne havde målbar sygdom. 
A total of 17.1% of patients received a prior chemotherapy regimen for advanced disease; 84.2% of patients had measurable disease.
Tid indtil forværring blev præspecificeret som tiden mellem baseline og første forekomst af ≥10 points stigning fra baseline i score for smertesymptomer. 
Time-to-Deterioration was pre-specified as time between baseline and first occurrence of ≥10 points increase from baseline in pain symptom scores.
I intramuskulære flerdosis toksicitetsstudier med rotter og hunde var den antiøstrogene aktivitet af fulvestrant årsag til de fleste observerede virkninger, specielt i hunkønnenes reproduktionssystem, men også i andre organer, som hos begge køn er følsomme overfor hormoner. 
In toxicity studies with multiple intramuscular doses of fulvestrant in rats and dogs, the antiestrogenic activity of fulvestrant was responsible for most of the effects seen, particularly in the female reproductive system, but also in other organs sensitive to hormones in both sexes.
Denne undersøgelse, der forløb over 12 måneder og undersøgte en række MASendepunkter, viste en reduktion i hyppigheden af vaginalblødning samt en reduktion af knoglealderens fremadskriden. 
This 12-month study investigated a range of MAS endpoints and showed a reduction in the frequency of vaginal bleeding and a reduction in the rate of bone age advancement.