natgillin/translations-raw huggingface dataset:
Undersøgelserne varede mellem seks og 52 uger, og det primære effektmål var ændringen i blodtrykket, som enten var det diastoliske blodtryk (blodtrykket i hvilefasen mellem to hjerteslag) eller det systoliske blodtryk (blodtrykket i hjertekamrenes sammentrækningsfase).
The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (‘diastolic') or when the chambers of the heart were contracting (‘systolic').
Undersøgelserne viste også, at når Enviage anvendes sammen med andre lægemidler (især hydrochlorthiazid), kan det mindske blodtrykket mere, end når disse lægemidler anvendes uden
The studies also showed that Enviage, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with the decreases produced by these medicines when they are taken without Enviage.
Den anbefalede dosis af Enviage er 150 mg én gang dagligt, anvendt enten alene eller sammen med anden medicin mod for højt blodtryk.
The recommended dose of Enviage is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Den fuldstændige liste over alle de indberettede bivirkninger ved Enviage fremgår af indlægssedlen.
For the full list of all side effects reported with Enviage, see the Package Leaflet.
I kombinationsundersøgelserne blev Enviage anvendt sammen med en angiotensinkonvertaseenzymhæmmer, ramipril, en angiotensinreceptorblokker (valsartan), en betablokker (atenolol), en kalciumkanalblokker (amlodipin) og et vanddrivende middel (hydrochlorthiazid).
Combination studies looked at Enviage used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Enviage bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for aliskiren eller andre af indholdsstofferne.
Enviage should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
I de fem undersøgelser, hvor Enviage blev anvendt alene og sammenlignet med placebo, fik patienter under 65 år i gennemsnit mindsket det diastoliske blodtryk med 9,0 mmHg efter otte ugers behandling med Enviage, 150 mg.
When the results of the five studies comparing Enviage taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Enviage, from an average of 99.4 mmHg at the start of the study.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) ENVIAGE
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ENVIAGE EPAR summary for the public
Hvilken fordel viser undersøgelserne, at der er ved Enviage?
What benefit has Enviage shown during the studies?
Tretten af undersøgelserne omfattede patienter med let til moderat hypertension.
Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension.
‘Essentiel' betyder, at
‘Essential' means that the hypertension has no obvious cause.
Enviage blev dels taget alene, dels i kombination med andre lægemidler og blev sammenlignet med andre lægemidler mod for højt blodtryk.
Enviage, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Hos patienter over 65 år og hos dem, der fik Enviage i større doser, blev blodtrykket sænket yderligere.
Larger falls were seen in patients aged 65 years or over and those taking higher doses of Enviage.
Udvalget anbefalede udstedelse af
The Committee recommended that Enviage be given marketing authorisation.
Det blokerer virkningen af enzymet renin, der i kroppen medvirker ved dannelsen af stoffet angiotensin I. Angiotensin I omdannes til hormonet angiotensin II, der virker stærkt sammentrækkende på blodkarrene.
It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Dette kan nedsætte de risici, der er forbundet med
This may reduce the risks associated with high blood pressure, such as having a stroke.
Yderligere oplysninger findes her:
Further information can be found here:
Virksomheden fremlagde oplysninger om forsøgsmodeller fra den videnskabelige litteratur.
The company provided data in experimental models from the scientific literature.
CHMP havde desuden betænkeligheder ved visse aspekter af fremstillingen og kvalitetskontrollen af lægemidlet.
The CHMP also had some concerns regarding some aspects of the manufacture and quality control of the medicine.
Den virksomhed, der har ansøgt om tilladelse, er Biovest Europe Ltd.
The company that applied for authorisation is Biovest Europe Ltd.
Den 24. april 2015 EMA/372529/2015 EMEA/H/C/002772
EMA/249530/2015 EMEA/H/C/002772
Hvad er Lympreva?
What is Lympreva?
Derfor var CHMP på daværende tidspunkt af den opfattelse, at fordelene ved Lympreva ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Lympreva did not outweigh its risks and recommended that it be refused marketing authorisation.
Det var meningen, at det skulle kunne fås som injektionsvæske, suspension, til indsprøjtning under huden.
It was to be available as a suspension for injection under the skin.
Virkningen blev hovedsagelig målt på, hvor længe patienten levede uden tilbagevenden af sygdommen, eller til patientens død.
The main measure of effectiveness was based on how long the patients lived without their cancer symptoms reappearing or until death.
CHMP fandt, at hovedundersøgelsen var tilrettelagt og udført på en måde, der ikke gav udvalget tilstrækkelig mulighed for at fastslå fordelene ved lægemidlet.
The CHMP considered that the way the main study was designed and carried out was inadequate to allow the Committee to establish the medicine's benefit.
Lympreva er et lægemiddel, der indeholder det aktive stof dasiprotimut-T.
Lympreva is a medicine that contains the active substance dasiprotimut-T.
Virksomheden fremlagde desuden resultaterne fra én hovedundersøgelse med i alt 177 voksne med follikulært lymfom, som havde haft virkning af den anerkendte induktionsbehandling PACE (prednison, doxorubicin, cyclophosphamid og etoposid) og var uden sygdomstegn.
The company also presented the results of one main study involving a total of 177 adults with follicular lymphoma who had responded to induction treatment with an established therapy known as PACE (prednisone, doxyrubicin, cyclophosphamide, and etoposide) and who had no sign of their disease.
Den 23. april 2015 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse om anbefaling af afslag på ansøgningen om markedsføringstilladelse for lægemidlet Lympreva, der er beregnet til behandling af patienter med follikulært non-Hodgkins lymfom.
On 23 April 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lympreva, intended for the treatment of patients with follicular non-Hodgkin's lymphoma.
Hvad forventedes Lympreva anvendt til?
What was Lympreva expected to be used for?
Afslag på ansøgningen om markedsføringstilladelse for Lympreva (dasiprotimut-T)
Refusal of the marketing authorisation for Lympreva (dasiprotimut-T)
Afslag på ansøgningen om markedsføringstilladelse for Lympreva (dasiprotimut-T) EMA/372529/2015
Refusal of the marketing authorisation for Lympreva (dasiprotimut-T) EMA/249530/2015
Det var hensigten, at det skulle anvendes i kombination med et andet lægemiddel kaldet granulocyt-makrofagkolonistimulerende faktor (GM-CSF).
It was expected to be used in combination with another medicine called granulocyte macrophage colony-stimulating factor (GM-CSF).
Patienterne fik enten Lympreva sammen med GM-CSF eller hæmocyanin med GM-CSF.
Patients were given either Lympreva together with GM-CSF, or haemocyanin with GM-CSF.
Lympreva skulle anvendes til patienter, hvis sygdomstegn var forsvundet efter en såkaldt induktionsbehandling, med henblik på at opretholde fuldstændigt fravær af symptomer på kræft.
Lympreva was expected to be given to patients whose signs of disease had disappeared following an ‘induction' treatment, to maintain the complete disappearance of symptoms of cancer.
Hvordan forventes Lympreva at virke?
How is Lympreva expected to work?
Når disse lymfomspecifikke proteiner injiceres i patientens krop, forventes de at stimulere visse dele af immunsystemet til at angribe og dræbe lymfomcellerne.
When injected into the patient's body, these lymphoma-specific proteins are expected to stimulate certain components of the immune system to attack and kill the lymphoma cells.
Lympreva blev udpeget som »lægemiddel til sjældne sygdomme« den 28. august 2006 til behandling af follikulært lymfom.
Lympreva was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 August 2006, for the treatment of follicular lymphoma.
Lympreva fremstilles til hver enkelt patient ved hjælp af en prøve af patientens egne lymfomceller.
Lympreva is prepared individually for each patient from a sample of their own lymphoma cells.
Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Lympreva.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Lympreva.
Lægemidlet består af et protein fra patientens lymfomceller, som er bundet til et molekyle hæmocyanin og derved aktiverer immunsystemet mod lymfomcellerne.
The medicine is made up of a protein found in the patient's lymphoma cells, attached to a molecule called haemocyanin, which helps to activate the immune system against the lymphoma cells.
Desuden var det ikke påvist, at Lympreva var effektivt efter at patienterne havde fået den induktionsbehandling, der anvendes i dag (den såkaldte anti-CD20-behandling).
In addition, the effectiveness of Lympreva following induction treatment with the current standard of care (the so-called ‘anti-CD20' therapies) has not been demonstrated.
Det betyder, at dets struktur er beregnet til at stimulere patientens immunsystem (kroppens naturlige forsvar), så det angriber og dræber kræftcellerne.
Lympreva is a type of ‘cancer immunotherapy' medicine, a medicine designed to stimulate the patient's immune system (the body's natural defences) so that it attacks and kills the cancer cells.
Lympreva forventedes anvendt til behandling af voksne med follikulært non-Hodgkins lymfom.
Lympreva was expected to be used to treat adults with follicular non-Hodgkin's lymphoma, a cancer of a type of white blood cells called ‘B cells'.
antopsykotika, antiepileptika;
antipsychotics, antiepileptics;
Copalia HCT anbefales derfor ikke til denne population.
Therefore, Copalia HCT is not recommended in this population.
Du bør aldrig tage Copalia HCT igen.
You should never take Copalia HCT again.
Børn og unge Brug af Copalia HCT til børn og unge under 18 år frarådes.
Children and adolescents The use of Copalia HCT in children and adolescents under 18 years of age is not recommended.
Det er imidlertid vigtigt at tage i betragtning, at Copalia HCT kan øge den hypotensive virkning af andre antihypertensive stoffer.
However, it is important to take into account that Copalia HCT may increase the hypotensive effect of other antihypertensive agents.
Kutane lupus erythematosus-lignende reaktioner, reaktivering af kutan lupus erythematosus
Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus
Copalia HCT er blevet undersøgt i et dobbeltblindet, aktivt-kontrolleret studie hos hypertensive patienter.
Copalia HCT was studied in a double-blind, active controlled study in hypertensive patients.
Se også information under ovrskriften ”Tag ikke Copalia HCT”.
See also information under the heading “Do not take Copalia HCT”.
Doseringen af Copalia HCT skal baseres på doserne af de individuelle komponenter i kombinationen ved tidspunktet for omskiftningen.
The dose of Copalia HCT should be based on the doses of the individual components of the combination at the time of switching.
Copalia HCT frarådes i den tidlige periode af graviditeten og må ikke tages, når du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på dit barn, hvis det tages efter tredje graviditetsmåned.
Copalia HCT is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Inden skift til Copalia HCT skal patienter være kontrolleret på stabile doser af monokomponenterne taget på samme tid.
Before switching to Copalia HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Derfor anbefales tæt monitorering af lithium-koncentrationen i serum ved samtidig brug.
Therefore careful monitoring of serum lithium concentrations is recommended during concomitant use.
Den sædvanlige dosis af Copalia HCT er én tablet daglig.
The usual dose of Copalia HCT is one tablet per day.
Tag ikke Copalia HCT sammen med grapefrugt eller grapefrugtjuice.
Do not take Copalia HCT with grapefruit or grapefruit juice.
Den fulde blodtrykssænkende effekt blev opnået 2 uger efter, at patienterne fik den maksimale dosis af Copalia HCT.
The full blood pressure lowering effect was achieved 2 weeks after being on their maximal dose of Copalia HCT.
Dette kan være symptomer på øget tryk i øjet og kan opstå inden for timer eller en uge efter indtagelse af Copalia HCT.
These could be symptoms of an increase of pressure in your eye and can happen within hours to a week of taking Copalia HCT.
• medicin, som kan nedsætte mængden af natrium i dit blod, såsom antidepressiva,
• medicines that may reduce the amount of sodium in your blood, such as antidepressants,
Brug ikke pakninger med Copalia HCT, som er beskadiget eller viser tegn på at have været forsøgt åbnet.
Do not use any Copalia HCT pack that is damaged or shows signs of tampering.
Lægemidler som kan forårsage torsades de
Medicinal products that could induce torsades de pointes
Det er ikke relevant at anvende Copalia HCT hos den pædiatriske population (patienter under 18 år) til indikationenen essentiel hypertension.
There is no relevant use of Copalia HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Beskyt huden mod sollys og UVstråler, mens du tager Copalia HCT.
Protect your skin from sun exposure and UV rays while taking Copalia HCT.
Copalia HCT kan tages sammen med eller uden mad.
Copalia HCT can be taken with or without food.
Den anbefalede dosis af Copalia HCT er én tablet dagligt, som helst skal tages om morgenen.
The recommended dose of Copalia HCT is one tablet per day, to be taken preferably in the morning.
Der er ingen erfaringer med brug af Copalia HCT til gravide kvinder.
There is no experience on the use of Copalia HCT in pregnant women.
Hvis Copalia HCT anvendes under amning, bør dosis holdes så lav som muligt.
If Copalia HCT is used during breast-feeding, doses should be kept as low as possible.
Copalia HCT skal seponeres straks hos patienter, som udvikler angioødem, og behandlingen bør ikke genoptages.
Copalia HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered.
- Du kan tage Copalia HCT sammen med eller uden mad.
You can take Copalia HCT with or without food.
Derudover kan samtidig brug af Copalia HCT og NSAID føre til en forværring af nyrefunktionen og en stigning i serumkalium.
Furthermore, concomitant use of Copalia HCT and NSAIDs may lead to worsening of renal function and an increase in serum potassium.
Et statistisk signifikant større antal af patienterne opnåede blodtrykskontrol (<140/90 mmHg) med Copalia HCT (71 %) sammenlignet med hver af de tre tokombinationsbehandlinger (45-54 %) (p<0,0001).
Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Copalia HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).
På grund af risiko for hypokaliæmi bør hydrochlorthiazid gives med forsigtighed sammen med lægemidler, der kan pointes forårsage torsades de pointes især Klasse Ia og Klasse III antiarytmika og visse antipsykotika.
Due to the risk of hypokalaemia, hydrochlorothiazide should be administered with caution when associated with medicinal products that could induce torsades de pointes, in particular Class Ia and Class III antiarrhythmics and some antipsychotics.
Klinisk signifikant hypotension pga. overdosering af Copalia HCT kræver aktiv kardiovaskulær støttebehandling, inklusive hyppig monitorering af hjerte- og respirationsfunktionen, hævede ekstremiteter og opmærksomhed på cirkulerende blodvolumen eller urinproduktion.
Clinically significant hypotension due to Copalia HCT overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Da thiazider nedsætter den renale clearance, kan risikoen for lithium-toksicitet muligvis være yderligere øget med Copalia HCT.
Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Copalia HCT.
Copalia HCT skal anvendes med forsigtighed ved behandling af hypertension hos patienter med unilateral eller bilateral nyrearteriestenose eller stenose i en enkelt nyre, da blod-urea og serumkreatinin kan stige hos disse patienter.
Copalia HCT should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Farmakoterapeutisk klassifikation: Præparater der virker på renin-angiotensin systemet, angiotensin II-antagonister, andre kombinationer, ATC-kode: C09DX01.
Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists, other combinations, ATC code: C09DX01.
På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Copalia HCT til patienter, som kort tid forinden har modtaget nyretransplantation.
To date there is no experience of the safe use of Copalia HCT in patients who have had a recent kidney transplantation.
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) var et studie, der skulle undersøge fordelen ved at tilføje aliskiren til standardbehandling med en ACE-hæmmer eller en ARB hos patienter med type 2-diabetes mellitus og kronisk nyresygdom, kardiovaskulær sygdom eller begge.
ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE inhibitor or an ARB in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Copalia HCT skal seponeres, hvis der udvikles hyperkalcæmi under behandlingen.
Copalia HCT should be discontinued if hypercalcaemia develops during treatment.
Absorptionshastigheden og absorptionsfraktionen af amlodipin, valsartan og hydrochlorthiazid fra Copalia HCT er de samme, som når de administreres som individuelle doseringer.
The rate and extent of absorption of amlodipine, valsartan and hydrochlorothiazide from Copalia HCT are the same as when administered as individual dosage forms.
Hvis du holder op med at tage Copalia HCT, kan det resultere i, at din sygdom bliver værre.
Stopping your treatment with Copalia HCT may cause your disease to get worse.
D-vitamin og calciumsalte
Vitamin D and calcium salts
Normalt vil din læge råde dig til at stoppe med at tage Copalia HCT, inden du bliver gravid, eller så snart du har konstateret, at du er gravid.
Your doctor will normally advise you to stop taking Copalia HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Copalia HCT.
Kontakt lægen eller apotekspersonalet, før du tager Copalia HCT - hvis du har et lavt niveau af kalium eller magnesium i blodet (med eller uden symptomer som fx muskelsvaghed, muskelkramper, unormal hjerterytme).
Talk to your doctor or pharmacist before taking Copalia HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
Hvis du får disse symptomer, skal du stoppe med at tage Copalia HCT og kontakte din læge med det samme.
If you get these symptoms, stop taking Copalia HCT and contact your doctor straight away.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Copalia HCT i alle undergrupper af den pædiatriske population med essentiel hypertension (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Copalia HCT in all subsets of the paediatric population in essential hypertension (see section 4.2 for information on paediatric use).
Copalia HCT er tilgængelig i pakninger, der indeholder 14, 28, 30, 56, 90, 98 eller 280 filmovertrukne tabletter, i multipakninger med 280 tabletter (bestående af 4 kartoner, der hver indeholder 70 tabletter eller 20 kartoner, der hver indeholder 14 tabletter), og i hospitalspakninger med 56, 98 eller 280 tabletter i perforerede enkeltdosis-blistere.
Copalia HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single perforated dose blisters.
Hvis der opstår lysfølsomhedsreaktioner under behandlingen med Copalia HCT, anbefales det at seponere behandlingen.
If photosensitivity reaction occurs during treatment with Copalia HCT, it is recommended to stop the treatment.
Hos patienter med alvorligt hjertesvigt, hvis nyrefunktion afhænger af renin-angiotensin-aldosteron-systemets aktivitet, er behandling med ACEhæmmere og angiotensin-receptorantagonister blevet forbundet med oliguri og/eller progressiv azotæmi og (sjældent) med akut nyresvigt og/eller død.
In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotaemia and (rarely) with acute renal failure and/or death.
I prækliniske studier foretaget i adskillige dyrearter med amlodipin, valsartan, hydrochlorthiazid, valsartan/hydrochlorthiazid, amlodipin/valsartan og amlodipin/valsartan/hydrochlorthiazid (Copalia HCT), var der ikke bevis for systemisk toksicitet eller toksicitet i målorganet, der skadelig kunne påvirke udviklingen af Copalia HCT til kliniske studier med mennesker.
In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Copalia HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Copalia HCT for clinical use in humans.
De indberettede bivirkninger med Copalia HCT eller en af dens tre aktive stoffer (amlodipin, valsartan og hydrochlorthiazid) er anført nedenfor og kan forekomme ved brug af Copalia HCT.
The side effects reported with Copalia HCT or one of its three active substances (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur with the use of Copalia HCT.