natgillin/translations-raw huggingface dataset:
Irbesartan er en ”angiotensin II-receptorantagonist”, hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
Irbesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Irbesartan/hydrochlorothiazid
CoAprovel irbesartan / hydrochlorothiazide
De mest almindelige bivirkninger ved CoAprovel (der ses hos mellem 1 og 10 patienter ud af 100) er svimmelhed, kvalme eller opkastning, uregelmæssig vandladning, træthed, forhøjet indhold af urinkvælstof (BUN, et spaltningsprodukt af protein), kreatinin (et spaltningsprodukt af musklerne) og kreatininkinase (et enzym i musklerne).
The most common side effects with CoAprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
CoAprovel var mere effektivt end placebo (en virkningsløs behandling) og hydrochlorothiazid alene til at reducere det diastoliske blodtryk.
CoAprovel was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Hvilken risiko er der forbundet med CoAprovel?
What is the risk associated with CoAprovel?
Dosen af CoAprovel afhænger af den dosis af irbesartan eller hydrochlorothiazid, som patienten tog tidligere.
The dose of CoAprovel to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
CoAprovel i kombination med lægemidler, der indeholder aliskiren (som anvendes til behandling af essentiel hypertension), må ikke anvendes til patienter med diabetes eller moderat eller alvorlig nyresygdom.
CoAprovel in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Der skal udvises forsigtighed, når CoAprovel anvendes sammen med andre lægemidler, som kan påvirke indholdet af kalium i blodet.
Care must be taken when using CoAprovel with other medicines that have an effect on blood potassium levels.
CoAprovel kan bruges som tillægsbehandling til visse andre behandlinger mod hypertension.
CoAprovel may be added to some other treatments for hypertension.
CoAprovel må ikke anvendes til personer, som er overfølsomme (allergiske) over for irbesartan, hydrochlorothiazid, sulfonamider eller andre af indholdsstofferne.
CoAprovel must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Det fås som tabletter (150 mg eller 300 mg irbesartan og 12,5 mg hydrochlorothiazid; 300 mg irbesartan og 25 mg hydrochlorothiazid).
It is available as tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide).
Hvorfor blev CoAprovel godkendt?
Why has CoAprovel been approved?
CoAprovel anvendes til voksne med essentiel hypertension (forhøjet blodtryk), hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
CoAprovel is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
CoAprovel er et lægemiddel, der indeholder de to aktive stoffer irbesartan og hydrochlorothiazid.
CoAprovel is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
CoAprovel må heller ikke gives til patienter, som har svære lever-, nyre- eller galdeproblemer, for lavt indhold af kalium i blodet eller for højt indhold af kalcium i blodet.
CoAprovel must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Hvilken fordel viser undersøgelserne, at der er ved CoAprovel?
What benefit has CoAprovel shown during the studies?
CoAprovel indeholder to aktive stoffer, irbesartan og hydrochlorothiazid.
CoAprovel contains two active substances, irbesartan and hydrochlorothiazide.
Hvordan blev CoAprovel undersøgt?
How has CoAprovel been studied?
Hvad anvendes CoAprovel til?
What is CoAprovel used for?
Hvordan anvendes CoAprovel?
How is CoAprovel used?
Hvad er CoAprovel?
What is CoAprovel?
Hvordan virker CoAprovel?
How does CoAprovel work?
Kontakt vores pressemedarbejdere Monika Benstetter eller Martin Harvey
Contact our press officers Monika Benstetter or Martin Harvey
Lægen vil afgøre, om du bør skifte til anden behandling.
Your doctor will confirm whether you should change to another treatment.
Gennemgangen af ergotderivater blev indledt den 18. januar 2012 på anmodning af Frankrig i medfør af artikel 31 i direktiv 2001/83/EF.
The review of ergot derivatives was initiated on 18 January 2012 at the request of France, under Article 31 of Directive 2001/83/EC.
Sværhedsgraden af sådanne bivirkninger og deres potentielle fatale udfald blev understreget.
The severity of such adverse effects and their possible fatal outcome was underlined.
• Hvis du ikke er sikker på, om du er omfattet, eller hvis du har spørgsmål, skal du tale med lægen eller apotekspersonalet.
• If you are unsure whether you are affected, or if you have any questions, speak with your doctor or pharmacist.
• De foreliggende data om virkning ved de beskrevne indikationer blev fundet meget begrænsede.
• The available efficacy data for the described indications were considered to be very limited.
Begrænsninger i brugen af lægemidler indeholdende ergotderivater
Restrictions on use of medicines containing ergot derivatives
• Patienter, der for øjeblikket er i behandling med disse lægemidler for nogen af ovennævnte indikationer, bør få behandlingen revideret ved en rutinemæssig (ikke hastende) lægekonsultation.
• Patients currently taking these medicines for any of the above indications should have their treatment reviewed at a routine (non-urgent) medical appointment.
Lægemiddelformer og de godkendte anvendelser, styrker og doser er forskellige i forskellige EU-lande.
The pharmaceutical forms and the approved indications, strengths and doses vary in different EU countries.
Den 27. juni 2013 anbefalede EMA's udvalg for lægemidler til mennesker (CHMP) begrænsninger i brugen af lægemidler indeholdende ergotderivater.
On 27 June 2013, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended restricting the use of medicines containing ergot derivatives.
På møder i den videnskabelige rådgivende gruppe i december 2012 og oktober 2013 blev der desuden ikke fundet evidens for, at der er terapeutisk behov for ergotderivater til de indikationer, som gennemgangen omfatter.
In addition, scientific advisory groups held in December 2012 and October 2013 did not consider there was evidence of a therapeutic need for ergot derivatives in the indications covered by the review.
Der var færre indberetninger af fibrotiske reaktioner med de øvrige ergotderivater.
There were fewer reports of fibrotic reactions with the other ergot derivatives.
Disse indikationer var ikke omfattet af CHMP's gennemgang; produkterne vil derfor fortsat være godkendt til anvendelse ved disse indikationer.
These indications were not included in the CHMP review; therefore these products will remain authorised and may continue to be used in those indications.
Den fornyede overvejelse sluttede den 24. oktober 2013 med, at udvalget fastholdt sine tidligere anbefalinger.
The re-examination concluded on 24 October 2013 with the Committee maintaining its previous recommendation, which will now be sent to the European Commission.
Gennemgangen blev indledt på grund af problemer konstateret af den franske lægemiddelstyrelse (ANSM) ved en national gennemgang af lægemiddelovervågning i 2011.
The review was initiated due to concerns identified by the French National Agency for the Safety of Medicine and Health Products (ANSM) in a national pharmacovigilance review in 2011.
Den 18. december 2013 EMA/27446/2014
25 October 2013 EMA/652753/2013
På anmodning af en fremstiller af lægemidler indeholdende dihydroergotoxin, som er et af ergotderivaterne, foretog CHMP et fornyet overvejelse af sin udtalelse om dette lægemiddel.
At the request of a manufacturer of medicines containing dihydroergotoxine, one of the ergot derivatives, the CHMP carried out a re-examination of its opinion on this medicine.
− Ortostatisk hypotension
− Orthostatic hypotension;
I EU har lægemidler indeholdende ergotderivater været godkendt ved nationale procedurer og har været markedsført under forskellige handelsnavne.
In the EU, medicines containing ergot derivatives have been authorised by national procedures and have been marketed under various trade names.
Patienterne var unge (gennemsnitsalder 41 år), og tiden til indsætten efter initiering af behandlingen med dihydroergotamin var kort (under to måneder, gennemsnit: 2 dage).
Patients were young (mean age 41 years-old), with a short time to onset after starting dihydroergotamine (less than 2 months, mean: 2 days).
Den franske lægemiddelstyrelse bad CHMP om at foretage en vurdering af forholdet mellem fordele og risici og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for disse lægemidler bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
The French medicines agency asked the CHMP to carry out an assessment of the benefit-risk balance and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the European Union.
• Tilfælde af ergotisme eller potentielt relaterede symptomer blev oftest indberettet med dihydroergotamin.
• Cases of ergotism or potentially related symptoms were most frequently reported with dihydroergotamine.
Fibrose kan være en alvorlig, undertiden dødelig sygdom, som ofte er vanskelig at diagnosticere på grund af sent indsættende symptomer, og sygdommen kan have uoprettelige følger.
Fibrosis can be a serious, sometimes fatal disease, which is often difficult to diagnose because of delayed symptoms and may be irreversible.
De vil fortsat være godkendt til disse indikationer.
They will remain authorised for use by patients in those indications.
Mere om lægemidlerne
More about the medicine
I betragtning af, at dokumentationen for disse lægemidlers fordele til disse indikationer er meget begrænset, konkluderede CHMP, at fordelene til de omhandlede indikationer ikke overstiger risikoen for fibrose og ergotisme.
benefits in these indications was very limited, the CHMP concluded that the benefits in the concerned indications did not outweigh the risk of fibrosis and ergotism.
Ergotderivater er stoffer, der udvindes af en gruppe svampe almindeligt kendt som ergot.
Ergot derivatives are substances derived from a group of fungi commonly known as ergot.
CHMP tog i betragtning, at det er vanskeligt at diagnosticere fibrose (som følge af forsinket indsætten af symptomer), og at fibrotiske reaktioner sandsynligvis underindberettes.
The CHMP noted the difficulty of diagnosing fibrosis (due to delayed onset of symptoms) and the probability of under-reporting of fibrotic reactions.
Lægemidler indeholdende ergotderivater har virkning på kredsløbet og har i årtier været anvendt til behandling af sygdomme med kredsløbsproblemer.
Medicines containing ergot derivatives have an effect on blood circulation and they have been used for decades to treat conditions involving circulatory problems.
• Fibrose blev oftest indberettet med dihydroergotamin, herunder retroperitoneal, kardial, pulmonal og pleural fibrose.
• Fibrosis was most frequently reported with dihydroergotamine, including retroperitoneal, cardiac, pulmonary and pleural fibrosis.
• Det er anerkendt, at ergotderivater er i stand til at inducere fibrose, navnlig af hjerteklapperne, gennem aktivering af serotoninerge receptorer, hvilket er udførligt beskrevet i litteraturen.
• Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis, through serotoninergic receptor activation, which is extensively described in the literature.
− Supplerende behandling af claudicatio intermittens ved symptomatisk perifer arteriel okklusiv sygdom (PAOD stadium II)
− Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II);
− Supplerende behandling af Raynauds syndrom
− Ancillary treatment of Raynaud's syndrome;
Disse lægemidler bør ikke længere bruges til behandling af forskellige sygdomme, der medfører kredsløbsproblemer eller problemer med hukommelse og følesans eller til forebyggelse af migræne, da risiciene er større end fordelene til disse indikationer.
These medicines should no longer be used to treat several conditions involving blood circulation problems or problems with memory and sensation, or to prevent migraine headaches, since the risks are greater than the benefits in these indications.
− Symptomatisk behandling af kronisk patologisk kognitiv og neurosensorisk funktionsnedsættelse hos ældre (bortset fra Alzheimers sygdom og anden form for demens)
− Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in the elderly (excluding Alzheimer's disease and other dementia);
CHMP bemærkede, at der ligger en plausibel mekanisme til grund for ergotderivaters evne til at medføre fibrose og ergotisme.
The CHMP noted that there is a plausible mechanism by which ergot-derivatives could cause fibrosis and ergotism.
CHMP's udtalelse følger efter en gennemgang af de foreliggende data om sikkerheden og virkningen af ergotderivater til ovennævnte indikationer, herunder kliniske undersøgelser, data efter markedsføring i Europa og den publicerede litteratur:
The CHMP opinion follows a review of available safety and efficacy data on ergot derivatives in the above indications, including clinical studies, post-marketing data in Europe and the published literature:
− Akutte retinopatier af vaskulær årsag
− Acute retinopathies of vascular origin;
Dette er baseret på en gennemgang af data, der viser, at lægemidlerne er forbundet med øget risiko for unormal bindevævsdannelse (fibrose), som kan beskadige organer og indre strukturer i kroppen, samt symptomer på ergotforgiftning (ergotisme) i form af spasmer og nedsat blodcirkulation.
This is based on a review of data showing an increased risk of fibrosis (formation of excess connective tissue that can damage organs and body structures) and ergotism (symptoms of ergot poisoning, such as spasms and obstructed blood circulation) with these medicines.
− Supplerende behandling af synsnedsættelse og synsfeltforstyrrelser af formodet vaskulær årsag
− Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin;
Visse ergotderivater har været anvendt til behandling af sygdomme, sædvanligvis hos ældre patienter, såsom blokering af kroppens store arterier (perifer arteriel okklusiv sygdom (PAOD)), der medfører smerter ved gang, og Raynauds syndrom (med blokering af blodtilførslen til lemmerne, sædvanligvis fingre og tæer) samt synsforstyrrelser på grund af kredsløbsproblemer.
Certain ergot derivatives have been used to treat conditions usually affecting elderly patients, such as peripheral arterial occlusive disease (PAOD, where the body's large arteries become obstructed) causing pain when walking, and Raynaud's syndrome (where the blood supply is blocked to the extremities, usually the fingers and toes), as well as eyesight disturbances due to blood circulation problems.
CHMP's gennemgang omfattede alle foreliggende data om fordele og risici ved ergotderivater, herunder data fra kliniske undersøgelser, indberetninger efter markedsføring og den publicerede litteratur.
In its review, the CHMP considered all available data on the benefits and risks of ergot derivatives, including data from clinical studies, post-marketing safety reports and the published literature.
• Lægemidler indeholdende ergotderivater kan have alvorlige bivirkninger i form af fibrose og ergotisme.
• Medicines containing substances known as ergot derivatives can have serious side effects, called fibrosis and ergotism.
Derfor bør de ikke længere anvendes i EU til behandling af en række sygdomme med kredsløbsproblemer (sædvanligvis hos ældre patienter), hukommelsesproblemer og nedsat følesans, eller til forebyggelse af migræne, da risiciene overstiger fordelene.
As a result, they should no longer be used in the EU to treat a number of conditions involving blood circulation problems (that usually affect elderly patients) or problems with memory and sensation, or to prevent migraine headaches, as the risks outweigh the benefits.
I nogle EU-lande er visse ergotderivater desuden godkendt til andre indikationer, der ikke er omfattet af CHMP's gennemgang, herunder andre kredsløbsforstyrrelser, behandling af demens (herunder Alzheimers sygdom) og behandling af akut migræne.
In some EU countries, certain ergot derivatives are also authorised for other indications not covered by the CHMP review, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
CHMP's gennemgang omfattede 5 ergotderivater: dihydroergocristin, dihydroergotamin, dihydroergotoxin, nicergolin og en kombination af dihydroergocryptin med koffein.
Five ergot derivatives were considered in the CHMP review: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline and the combination of dihydroergocryptine with caffeine.
De har desuden været anvendt til behandling af problemer med nedsat hukommelse og følesans (kronisk patologisk kognitiv og neurosensorisk funktionsnedsættelse) og til forebyggelse af migræne.
They have also been used for treating chronic pathological cognitive and neurosensorial impairment (problems with memory and sensation) and for preventing migraine headaches.
• Nogle ergotderivater er i visse EU medlemsstater godkendt til andre terapeutiske indikationer, herunder andre kredsløbsforstyrrelser, behandling af demens (herunder Alzheimers sygdom) og behandling af akut migræne.
• Some ergot derivatives are approved in some EU Member States for use in other therapeutic indications, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
• Der bør ikke længere ordineres lægemidler indeholdende dihydroergotamin, dihydroergotoxin, nicergolin eller en kombination af dihydroergocryptin med koffein til følgende indikationer:
• Healthcare professionals should stop prescribing medicines containing dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine, for any of the following indications:
Med de øvrige ergotderivater blev der desuden fundet adskillige tilfælde af ergotisme og potentielt ergotismerelaterede symptomer (herunder tilfælde med svære symptomer på perifer vasokonstriktion).
Several cases of ergotism or symptoms potentially related to ergotism (including severe cases of symptoms of constriction of peripheral blood vessels) were also identified with the other ergot derivatives.
I nogle EU medlemsstater er ergotderivater desuden godkendt til andre anvendelser såsom behandling af demens, herunder Alzheimers sygdom, og behandling (men ikke forebyggelse) af akut migræne.
In some EU Member States, ergot derivatives are also authorised for other indications such as treatment of dementia, including Alzheimer's disease, and treatment (as opposed to prevention) of acute migraine headache.
• Hvis du tager et lægemiddel, der indeholder et af følgende stoffer, skal du få tid hos lægen til en ikke-hastende konsultation: dihydroergocristin, dihydroergotamin, dihydroergotoxin, nicergolin eller en kombination af dihydroergocryptin med koffein.
• You should make a non-urgent appointment with your doctor if you are taking a medicine containing any of these substances: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine.
De iagttagne forskelle i indberetningshyppigheden af fibrotiske reaktioner kan forklares dels af de forskellige ergotderivaters forskellige affinitet for serotoninerge receptorer, dels de anvendte terapeutiske doser.
The varying affinity for serotoninergic receptors of the different ergot derivatives, and the therapeutic doses used, may explain the differences observed in reporting frequencies for the fibrotic reactions.
Markedsføringstilladelserne vil blive ophævet i hele EU for ergotderivater, der kun er godkendt til disse sygdomme.
Ergot derivatives that are only indicated for these conditions will have their marketing authorisations suspended across the EU.
Europa-Kommissionen vedtog CHMP's udtalelse for dihydroergocristin, dihydroergotamin, nicergolin og dihydroergocryptin den 27. september 2013, og CHMP's udtalelse for dihydroergotoxin den 18. december 2013.
The European Commission has already endorsed the CHMP opinion for 4 other ergot derivatives (dihydroergocristine, dihydroergotamine, nicergoline dihydroergocryptine), adopting a final legally binding decision on 27 September 2013.
CHMP's anbefalinger blev forelagt Europa-Kommissionen, som har godkendt dem og truffet en endelig bindende beslutning med gyldighed i hele EU.
The CHMP opinion on dihydroergotoxine will now be forwarded to the European Commission, which will issue a final decision in due course.
1 hætteglas + 1 fyldt injektionssprøjte + 2 kanyler + 2 spritsvampe
1 vial + 1 pre-filled syringe + 2 injection needles + 2 alcohol swabs
1 hætteglas + 1 fyldte injektionssprøjter + 14 kanyler + 14 spritsvampe
7 vials + 7 pre-filled syringes + 14 injection needles + 14 alcohol swabs
Særnavn Styrke Lægemiddelform Indgivelsesvej
Strength Pharmaceutical form Route of administration
Det fås som tabletter (500 mg) og kapsler (250 mg).
It is available as tablets (500 mg) and capsules (250 mg).
Andre oplysninger om Myclausen:
Other information about Myclausen:
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Myclausen.
This document is a summary of the European public assessment report (EPAR) for Myclausen.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Myclausen den 7. oktober 2010.
The European Commission granted a marketing authorisation valid throughout the EU for Myclausen on 7 October 2010.
Hos børn mellem to og 18 år beregnes dosis af Myclausen på baggrund af barnets højde og vægt.
In children aged between two and 18 years, the dose of Myclausen is calculated depending on height and weight.
Den fuldstændige EPAR for Myclausen findes på EMA's websted på ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Myclausen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Det anvendes sammen med ciclosporin og kortikosteroider (andre lægemidler, der bruges til at forhindre organafstødning).
It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Det betyder, at Myclausen er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Cellcept.
This means that Myclausen is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cellcept.
Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Myclausen.
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 Myclausen.
Behandling med Myclausen skal påbegyndes og fortsættes af en transplantationsspecialist.
Myclausen treatment should be initiated and maintained by a qualified transplant specialist.