natgillin/translations-raw huggingface dataset:
Seponering
Coating
Seroquel Prolong 400 mg indeholder 400 mg quetiapin (som quetiapinfumarat).
Each tablet contains 400 mg quetiapine (as fumarate)
LÆGEMIDLETS NAVN Seroquel Prolong 50 mg depottabletter quetiapin
Seroquel XR 50 mg prolonged-release tablets quetiapine
INFORMATION I BRAILLE-SKRIFT Seroquel Prolong 50 mg
INFORMATION IN BRAILLE Seroquel XR 50 mg
Seroquel Prolong 150 mg indeholder 150 mg quetiapin (som quetiapinfumarat).
Each tablet contains 150 mg quetiapine (as fumarate)
Brug til børn og unge Børn og unge under 18 år må ikke anvende Seroquel.
Use in children and adolescents Seroquel should not be used by children and adolescents aged under 18 years.
Meget almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer):
Very Common side effects (may affect more than 1 in 10 people):
o Til behandling af major depressive episoder inden for bipolar lidelse.
For add-on treatment of major depressive episodes in MDD:
4.4, 4.8, 5.1 og 5.2.
The available evidence from placebo-controlled clinical trials is presented in sections 4.4, 4.8, 5.1 and 5.2.
Din læge vil fortælle dig hvornår).
Your doctor will decide on your starting dose.
60 depottabletter
60 prolonged-relaease tablets
medicinen virker.
It can affect the way the medicine works.
Dette sammendrag blev senest ajourført i 11-2014.
This summary was last updated in 11-2014.
Desuden har Trulicity den fordel, at det kun skal gives én gang om ugen.
In addition, Trulicity has the advantage of being given once a week.
Yderligere information fremgår af resuméet af risikostyringsplanen.
Further information can be found in the summary of the risk management plan.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Trulicity den 21. november 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Trulicity on 21 November 2014.
Der blev desuden taget hensyn til oplysninger fra en sjette undersøgelse, som blev forelagt mens ansøgningen var under behandling.
Information from a sixth study that was submitted during the procedure was also considered.
Trulicity dulaglutid
Trulicity dulaglutide
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Trulicity.
This is a summary of the European public assessment report (EPAR) for Trulicity.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Trulicity findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Trulicity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om Trulicity
Other information about Trulicity
Fordelene ved Trulicity er undersøgt i 5 hovedundersøgelser med over 4 500 patienter med type 2sukkersyge.
The benefits of Trulicity have been studied in 5 main studies involving over 4,500 patients with type 2 diabetes.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Trulicity overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Trulicity's benefits are greater than its risks and recommended that it be approved for use in the EU.
Hvad sikkerheden angår, bør man overvåge de langsigtede virkninger og sikkerheden hos sårbare grupper såsom patienter med høj alder. Der var imidlertid ingen områder, der gav anledning til større betænkelighed, og risiciene blev anset for at være de samme som med andre lægemidler i denne klasse.
With respect to safety, effects of longer term use and safety in vulnerable groups such as the very elderly would need to be monitored, but there were no specific areas of major concern and the risks were considered similar to those of other medicines in its class.
Dette blev anset for at have klinisk betydning, og fordelene viste sig at vedvare ved langtidsbehandling.
This was considered to be clinically meaningful and there was evidence that the benefits were maintained during long-term treatment.
Der er udarbejdet en risikostyringsplan for at sikre, at Trulicity anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Trulicity is used as safely as possible.
Lægemidlet var mere effektivt i ugentlige doser på 1,5 mg end 0,75 mg.
The medicine was more effective at weekly doses of 1.5 mg than 0.75 mg.
De hyppigste bivirkninger ved Trulicity (som kan forekomme hos op til 1 ud af 10 personer) er kvalme, opkastning og diarré.
The most common side effects with Trulicity (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting and diarrhoea.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trulicity?
What measures are being taken to ensure the safe and effective use of Trulicity?
Trulicity indeholder det aktive stof dulaglutid.
Trulicity contains the active substance dulaglutide.
Det aktive stof i Trulicity, dulaglutid, er en “GLP-1-receptoragonist”.
The active substance in Trulicity, dulaglutide, is a ‘GLP-1 receptor agonist'.
HbA1c er et mål for, hvor velreguleret blodsukkeret er.
HbA1c gives an indication of how well the blood glucose is controlled.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Trulicity, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trulicity, including the appropriate precautions to be followed by healthcare professionals and patients.
Når det blev anvendt alene hos patienter, der ikke tåler metformin, og når det blev anvendt hos patienter med høj alder (over 75 år), var forholdet mellem fordele og risici bedst ved den lavere dosis.
However, when used alone in patients who cannot take metformin, or when used in very elderly patients (aged over 75), the ratio of benefit to risk was greatest at the lower dose.
Hvorfor blev Trulicity godkendt?
Why is Trulicity approved?
Trulicity leveres som fyldte penne (0,75 mg og 1,5 mg), der indeholder en opløsning, som indsprøjtes under huden.
Trulicity is available as prefilled pens (0.75 mg and 1.5 mg) containing a solution to be injected under the skin.
Hvad er Trulicity, og hvad anvendes det til?
What is Trulicity and what is it used for?
Patienterne giver sig selv lægemidlet (efter passende instruktion) under huden på maven eller i låret.
Patients inject the medicine themselves (after suitable training) under the skin in the abdomen or thigh.
Når Trulicity indsprøjtes, føres dulaglutid frem til receptorerne i bugspytkirtlen og aktiverer dem.
When Trulicity is injected, dulaglutide reaches the receptors in the pancreas and activates them.
Efter 26 ugers behandling mindskede Trulicity HbA1c med mellem 0,71 og 1,59 procentpoint i den lavere dosis, og med mellem 0,78 og 1,64 procentpoint i den højere dosis.
After 26 weeks of treatment, Trulicity reduced HbA1c by between 0.71 and 1.59 percentage points at the lower dose, and by between 0.78 and 1.64 percentage points at the higher dose.
Patienternes gennemsnitlige HbA1c før behandlingen var mellem 7,6 og 8,5 %, og behandlingen varede i mindst 52 uger.
The patients' average HbA1c at baseline ranged from 7.6 to 8.5% and patients were treated for at least 52 weeks.
Den fuldstændige liste over bivirkninger og begrænsninger med Trulicity fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Trulicity, see the package leaflet.
Udvalget bemærkede, at lægemidlet har en væsentlig blodsukkerregulerende virkning af klinisk betydning, når det bruges sammen med andre lægemidler.
The Committee noted that the medicine produces a significant and clinically relevant effect in controlling blood glucose when used with other medicines.
Hvilke risici er der forbundet med Trulicity?
What are the risks associated with Trulicity?
Det er ikke en praktisk vejledning i, hvordan Trulicity bør anvendes.
It is not intended to provide practical advice on how to use Trulicity.
Trulicity var mere effektivt end metformin til at nedsætte indholdet af HbA1c, når det blev anvendt alene, og var mere effektivt end sukkersygelægemidlerne exenatid (indgivet to gange dagligt) og sitagliptin, og mindst lige så godt som insulin glargin, når det blev anvendt som tillægsbehandling til andre behandlinger.
Trulicity was more effective than metformin at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines exenatide (given twice daily) or sitagliptin, and at least as good as insulin glargine, when used as add-on to other treatments.
Hvis du ønsker yderligere oplysninger om behandling med Trulicity, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Trulicity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Virkningen blev hovedsagelig bedømt på ændringen i indholdet af glykosyleret hæmoglobin (HbA1c), dvs. den procentdel af blodets hæmoglobin, der er bundet til sukker.
The main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Trulicity kan anvendes som selvstændig behandling til patienter, hos hvem blodsukkeret ikke kan reguleres tilfredsstillende med diæt og motion alene, og som ikke må få metformin (et andet lægemiddel mod sukkersyge).
Trulicity can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine).
Dette bevirker udskillelse af insulin og er medvirkende til at nedsætte blodsukkeret og regulere type 2-sukkersygen.
This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
I undersøgelserne blev Trulicity sammenlignet med virkningsløs behandling (placebo) eller andre sukkersygelægemidler, enten alene eller som tillægsbehandling i forskellige kombinerede behandlinger.
In these studies Trulicity was compared with placebo (a dummy treatment) or with other diabetes medicines when used alone or as an add-on to various combination treatments.
Trulicity kan desuden anvendes som tillægsbehandling til andre lægemidler mod sukkersyge, også insulin, når disse lægemidler sammen med motion og diæt ikke giver tilfredsstillende regulering af blodsukkeret.
It can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Ved type 2-sukkersyge producerer bugspytkirtlen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet tilstrækkeligt.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Hvis du ønsker praktisk vejledning om anvendelsen af Trulicity, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Trulicity, patients should read the package leaflet or contact their doctor or pharmacist.
Ca. 51 % af dem, der fik den lavere dosis, og 60% af dem, der fik den højere dosis af Trulicity, nåede målværdien af HbA1c på under 7,0 %.
About 51% of those given the lower dose and 60% of patients given the higher dose of Trulicity achieved a target HbA1c below 7.0% and this was generally more than the proportion achieving this target with alternative treatments.
Trulicity er lægemiddel mod sukkersyge, der bruges til regulering af blodsukkeret hos voksne med type 2-sukkersyge.
Trulicity is a diabetes medicine used in adults with type 2 diabetes to control their blood glucose (sugar) level.
Hvilke fordele viser undersøgelserne, at der er ved Trulicity?
What benefits of Trulicity have been shown in studies?
Hvordan virker Trulicity?
How does Trulicity work?
Den anbefalede dosis er 0,75 mg, der indsprøjtes én gang om ugen, når lægemidlet bruges alene, og 1,5 mg én gang om ugen, når det bruges i kombination med andre lægemidler mod sukkersyge.
The recommended dose is 0.75 mg injected once a week when used on its own, and 1.5 mg once a week in combination with other diabetes medicines (although doctors may begin with the lower dose in patients at potentially greater risk such as those aged over 75).
Hvordan anvendes Trulicity?
How is Trulicity used?
Når Trulicity anvendes i kombination med sukkersygelægemidler af typen sulfonylurinstof eller insulin, kan det være nødvendigt at sænke dosis af det pågældende sulfonylurinstof eller insulin for at undgå for lavt blodsukker (hypoglykæmi).
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom with a type of diabetes medicine called a sulphonylurea or with insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Det virker ved at bindes til receptorerne for glucagonlignende peptid 1 (GLP-1).
It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Oral anvendelse flaske (PET)
Oral suspension Oral use bottle (PET)
340 ml (0,5 mg/ml)
0.5 mg/ml
1 flaske + 2 sprøjter + 1 adapter til flasken
340 ml (0.5 mg/ml) 1 bottle + 2 syringes + 1 bottle adapter
Der blev foreslået risikominimeringsforanstaltninger for de kendte risici.
Risk minimisation measures were proposed for the known risks.
Resultatet af en revurdering i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF
Outcome of re-examination of procedure under Article 29(4) of Directive 2001/83/EC
Virksomheden har anmodet om en revurdering af den oprindelige udtalelse.
The company requested a re-examination of the initial opinion.
Hvorfor blev Alcover vurderet igen?
Why were Alcover granules reviewed?
Alcover-syrup fås i Østrig og Italien.
Alcover syrup is available in Austria and Italy.
andre medlemsstater (de "berørte medlemsstater", her Danmark, Finland, Frankrig, Irland, Holland, Polen, Portugal, Spanien, Sverige og Det Forenede Kongerige).
(the ‘concerned Member States', in this instance Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom).
Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Østrig) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i
This is a procedure where one Member State (the ‘reference Member State', in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid nationally as well as in other Member States
CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som vedtog en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater den 18.12.2017.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 18/12/2017.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Alcover-granulat ikke opvejer risiciene, og at der ikke kan udstedes markedsføringstilladelse i Østrig eller i følgende EU-medlemsstater: Danmark, Finland, Frankrig, Irland, Nederlandene, Polen, Portugal, Spanien, Sverige og Det Forenede Kongerige.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Alcover granules did not outweigh their risks, and the marketing authorisation could not be granted in Austria or in the following Member States of the EU: Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom.
Den 22. juni 2017 gennemførte Det Europæiske Lægemiddelagentur (EMA) en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Alcover-granulat.
On 22 June 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Alcover granules.
På grundlag af de aktuelt tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at de indsendte data til støtte for markedsføringstilladelsen for Alcover-granulat var utilstrækkelige og af utilstrækkelig kvalitet til at påvise, at lægemidlet ville være effektivt i de ansøgte indikationer.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted in support of the marketing authorisation application for Alcover granules were insufficient and of inadequate quality to demonstrate that the medicine would be effective in the proposed uses.
Debrégeas & Associés Pharma indsendte en ansøgning om markedsføringstilladelse for Alcovergranulat til den østrigske lægemiddelstyrelse med henblik på en decentral procedure.
Debrégeas & Associés Pharma submitted a marketing authorisation application for Alcover granules to the Austrian medicines regulatory agency for a decentralised procedure.
Begrundelsen for indbringelsen var adskillige medlemsstaters betænkeligheder ved, at fordelene ved Alcover-granulat ikke var tydeligt påvist, og at der var forskellige risici, bl.a. risiko for afhængighed, misbrug og bivirkninger.
The grounds for the referral were concerns raised by several Member States that the benefits of Alcover granules were not clearly demonstrated and there were various risks including the risk of dependence, misuse and side effects.
Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en revurdering af udtalelsen og bekræftede den 12. oktober 2017, at der ikke kunne udstedes en markedsføringstilladelse.
After reviewing the grounds for this request, the CHMP re-examined the opinion and confirmed on 12 October 2017 that the marketing authorisation could not be granted.
Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den østrigske lægemiddelstyrelse indbragte den 22. december 2016 sagen for CHMP med henblik på voldgift.
However, the Member States were not able to reach an agreement and the Austrian medicines regulatory agency referred the matter to the CHMP for arbitration on 22 December 2016.
Efter revurderingen bekræftede CHMP sin oprindelige udtalelse om, at der ikke kunne udstedes markedsføringstilladelse.
After re-examination, the CHMP confirmed its initial opinion that the marketing authorisation could not be granted.
Denne beslutning vedrører kun markedsføringstilladelsen for Alcover-granulat og påvirker ikke Alcoversyrup.
This decision only concerns the marketing authorisation application for Alcover granules and does not affect Alcover syrup.
Det aktive stof i Alcover-granulat, natriumoxybat, binder til receptorer (mål) på nervecellerne i hjernen og i rygmarven for et stof, der hedder gammaaminobutansyre (GABA), og som reducerer nervecellernes aktivitet.
The active substance in Alcover granules, sodium oxybate, attaches to receptors (targets) on nerve cells of the brain and spinal cord for a substance called gammaaminobutyric acid (GABA), leading to a calming of the activity of these cells.
Hvad er Alcover-granulat?
What are Alcover granules?
Alcover-granulat er et lægemiddel, der forventedes anvendt til at behandle akutte alkoholabstinenser og til at understøtte mellemlang til langvarig afholdenhed hos alkoholafhængige voksne med et meget højt forbrug af alkohol.
Alcover granules are a medicine that was expected to be used to treat acute alcohol withdrawal syndrome and to support medium to long-term abstinence in alcohol-dependent adults with a very high level of alcohol consumption.
Eftersom lægemidlet er rettet mod disse receptorer på samme måde som alkohol, skulle Alcover-granulatet anvendes til at behandle symptomerne ved at stoppe alkoholforbruget hos alkoholafhængige patienter, herunder uro, rysten og søvnproblemer, og til at understøtte fortsat afholdenhed.
Since it targets these receptors in the same way as alcohol, Alcover granules were to be used to treat the effects of stopping alcohol use in alcohol-dependent patients, including agitation, tremor (shaking) and problems sleeping, and to support continued abstinence.
Spørgsmål og svar om Alcover-granulat (natriumoxybat 750, 1 250 og 1 750 mg)
Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)
Spørgsmål og svar om Alcover-granulat (natriumoxybat 750, 1 250 og 1 750 mg) EMA/816779/2017
Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) EMA/833763/2017
CHMP fandt imidlertid, at der ikke kunne udstedes markedsføringstilladelse i referencemedlemsstaten og de berørte medlemsstater, eftersom fordelene ved Alcover-granulat ikke var tydeligt påvist.
However, the CHMP concluded that, since the benefits of Alcover granules were not clearly demonstrated, the marketing authorisation could not be granted in the reference and concerned Member States.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Imprida den 17. januar 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Imprida on 17 January 2007.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Imprida.
This is a summary of the European public assessment report (EPAR) for Imprida.
Den fuldstændige EPAR for Imprida findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Imprida can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Imprida tages oralt som en tablet en gang dagligt med vand.
Imprida is taken by mouth as one tablet once a day with some water.
Andre oplysninger om Imprida
Other information about Imprida
Imprida amlodipin/valsartan
Imprida amlodipine / valsartan
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Imprida skal anvendes.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Imprida.
Hvis du ønsker yderligere oplysninger om behandling med Imprida, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Imprida, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
CHMP besluttede, at fordelene ved Imprida opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Imprida.
The CHMP decided that Imprida's benefits are greater than its risks and recommended that it be given marketing authorisation.
Begge er lægemidler mod forhøjet blodtryk, og begge har hver for sig været på markedet i Den Europæiske Union (EU) siden midten af
Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s.
Ved at nedsætte blodtrykket mindskes de risici, som er forbundet med forhøjet blodtryk, såsom slagtilfælde.
By lowering the blood pressure, the risks associated with by high blood pressure, such as having a stroke, are reduced.
Hvilken risiko er der forbundet med Imprida?
What is the risk associated with Imprida?