natgillin/translations-raw huggingface dataset:
Myokardieinfarkt, ventrikeltakykardi, atrieflimren, arytmi
Myocardial infarction, Ventricular tachycardia, Atrial fibrillation, Arrhythmia
Klinisk monitorering er indiceret, såvel under nehandling med induktoren som efter seponering, muligvis med dosisjustering af amlodipin.
Clinical monitoring is indicated, with possible dosage adjustment of amlodipine during the treatment with the inducer and after its withdrawal.
- Hvis du er allergisk over for andre ACE-hæmmere (såsom enalapril, captopril og ramipril) eller andre calciumkanalblokkere (såsom nifedipin, felodipin eller nimodipin) - Hvis du har haft et angioødem (symptomer såsom kløe, nældefeber, hvæsende åndedræt og hævelse af hænder, hals, mund eller øjenlåg), uanset om det var relateret til behandlingen med en ACE-hæmmer eller ikke - Hvis dit blodtryk er for lavt (alvorlig hypotension) - Hvis du har en forsnævring på aorta (aortastenose), på en hjerteklap (mitralstenose), en forøgelse af hjertemusklens tykkelse (hypertrofisk kardiomyopati) eller kardiogent chok
You must not take this medicine: - if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Lisonorm - if you are allergic to other ACE inhibitors (such as enalapril, captopril and ramipril) or other calcium channel blockers (such as nifedipine, felodipine or nimodipine) - if you have had an angioedema (symptoms such as itching, nettle rash, wheezing and swelling of the hands, throat, mouth or eyelids), related or not to treatment with an ACE-inhibitor - if your blood pressure is too low (severe hypotension) - if you have a narrowing of the aorta (aortic stenosis), of a heart valve (mitral stenosis), an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy) or cardiogenic shock (not enough blood supply to your tissues) - if you have unstable angina (except Prinzmetal's angina) - if you have suffered a heart attack (myocardial infarction) within the last 28 days - if you are pregnant or think you may be pregnant - if you are breast-feeding
Vertigo, paræstesi, smagsforstyrrelse
Uncommon Vertigo, Paraesthesia, Taste disturbance
Halveringstiden for amlodipin er forlænget hos patienter med nedsat leverfunktion.
The half-life of amlodipine is prolonged in patients with impaired liver function.
Hver tablet indeholder 10 mg lisinopril (som dihydrat) og 5 mg amlodipin (som besilat).
Each tablet contains 10 mg lisinopril (as dihydrate) and 5 mg amlodipine (as besilate).
• medicin til behandling af epilepsi (antikonvulsiva såsom carbamazepin, fenobarbital og fenytoin)
• anticonvulsants (such as carbamazepine, phenobarbital and phenytoin), used to treat epilepsy
Det reproduktive system og mammae:
Reproductive system and breast disorders
Synkope, tremor, smagsforvrængning, hypoæstesi, paræstesi
Syncope, Tremor, Taste perversion,
For at finde den optimale startdosis og vedligeholdelsesdosis til patienter med nyreinsufficiens, skal patienterne titreres individuelt med de enkelte indholdsstoffer i lisinopril og amlodipin.
To find the optimal starting dose and maintenance dose of patients with renal impairment, the patients should be individually titrated using the individual components of lisinopril and amlodipine.
For at finde den optimale vedligeholdelsesdosis til patienter med nyreinsufficiens skal patienterne titreres individuelt med de enkelte indholdsstoffer i lisinopril og amlodipin med nøje monitorering af nyrefunktionen.
To find the optimal maintenance dose of patients with renal impairment, the patients should individually be titrated using the individual components of lisinopril and amlodipine, with close monitoring of renal function.
Nedsat blodglukose (hypoglykæmi), bihulesmerter, hvæsende åndedræt, lungebetændelse, gul hud og/eller øjne (gulsot), betændelse i lever eller bugspytkirtel, alvorlige hudlidelser (symptomer på dette omfatter rødmen, blærer og afskalning), svedafsondring.
Decrease of blood glucose (hypoglycaemia), sinus pain wheezing, inflammation of the lungs, yellow skin and/or eyes (jaundice), inflammation of the liver or pancreas, severe skin disorders (symptoms of which include redness, blistering and peeling), sweating.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 10 mg lisinopril (som dihydrat) og 5 mg amlodipin (som besilat).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg lisinopril (as dihydrate) and 5 mg amlodipine (as besilate).
Intestinalt ødem er indberettet i sjældne tilfælde hos patienter behandlet med ACE-hæmmere.
Intestinal oedema has been reported rarely in patients treated with ACE inhibitors.
Brystsmerter, smerter, malaise, asteni
Chest pain, Pain, Malaise, Asthenia
Lisonorm er kun indiceret til patienter hvor den optimale vedligeholdelsesdosis af lisinopril og amlodipin er blevet titreret til henholdsvis 10 mg og 5 mg.
Lisonorm is indicated only for patients in whom the optimal maintenance dose of lisinopril and amlodipine has been titrated to 10 mg and 5 mg, respectively.
AN 69) membran og samtidig behandling med en ACE-hæmmer, derfor bør denne kombination undgås.
Anaphylactic shock has been reported in patients dialysed with polyacrylonitrile (e.g. AN 69) membrane and treated concomitantly with an ACE inhibitor, therefore, this combination must be avoided.
Cerebrovaskulær hændelse (se punkt 4.4), Raynaudfænomen
Orthostatic hypotension Flushing Uncommon Cerebrovascular accident (see section 4.4), Raynaud's phenomenon
I visse tilfælde var der intet forudgående facialt angioødem, og C-1 esteraseniveauerne var normale.
These patients presented with abdominal pain (with or without nausea and vomiting); in some cases there was no prior facial angioedema and C-1 esterase levels were normal.
Du må ikke smide medicin i afløbet, toilettet eller skraldespanden.
Medicines should not be disposed of via wastewater or household waste.
Hoste indberettes hyppigt ved brug af ACE-hæmmere.
Commonly, cough has been reported with the use of ACE inhibitors.
Lisonorm er kun indiceret til patienter med titreret optimal vedligeholdelsesdosis af lisinopril og amlodipin til henholdsvis 10 mg og 5 mg.
Lisonorm is indicated only for patients with titrated optimal maintenance dose of lisinopril and amlodipine of 10 mg and 5 mg, respectively.
• Overfølsomhed over for ét eller flere af hjælpestofferne.
• Hypersensitivity to any of the excipients.
Højere andel af angioødem ses hos farvede patienter end hos ikke-farvede patienter), ændring af farve (lys blå efterfulgt af rødmen) og/eller følelsesløshed eller prikken i fingre eller tæer (Raynaudfænomen), smagsforandring, træthed, følelse af søvnighed eller vanskelighed ved at falde i søvn, mærkelige drømme, hurtig puls, rindende næse, kvalme, mavepine eller fordøjelsesbesvær, hududslæt, kløe, impotens, træthed, muskelsvækkelse).
Mood changes, angioedema (hypersensitivity reaction with sudden swelling of the lips, face and neck, and occasionally of the feet and hands; higher rate of angioedema in black patients than in non-black patients), change of colour (pale blue followed by redness) and/or numbness or tingling in the fingers or toes (Raynaud's phenomenon), changes in the way things taste, fatigue, feeling sleepy or difficulty in going to sleep, strange dreams, rapid heartbeat, runny nose, nausea, stomach pain or indigestion, skin rash, itching, impotence, tiredness, muscle weakness).
LÆGEMIDLETS NAVN Lisonorm (se bilag I) 10/5 mg tabletter [Se Bilag I - Skal udfærdiges nationalt] lisinopril/amlodipin
NAME OF THE MEDICINAL PRODUCT Lisonorm (see Annex I) 10/5 mg tablets [See Annex I - To be completed nationally] lisinopril/amlodipine
Hovedpine, ødem (for eksempel hævede ankler), træthedsfølelse, søvnighed, utilpashed, svimmelhed, mavesmerter, palpitationer (en hurtigere eller uregelmæssig puls), kvalme, rødmen.
Headache, oedema (for example ankle swelling), feeling tired, sleepiness, feeling sick, dizziness, abdominal pain, palpitations (a quicker or irregular heart beat), nausea, flushing.
Lisinopril kan fjernes fra det systemiske kredsløb ved hæmodialyse.
Lisinopril can be removed from the systemic circulation by haemodialysis.
Lisonorm og tilknyttede navne (se bilag I) 10 mg/5 mg tabletter [Se Bilag I - Udfyldes nationalt] Lisinopril/Amlodipin
Lisonorm and associated names (see Annex I) 10 mg/5mg tablets [See Annex I - To be completed nationally] Lisinopril/Amlodipine
Hvis hævelsen er begrænset til ansigt, læber og ekstremiteter, ophører den i reglen spontant.
Where swelling is confined to the face, lips and extremities, it usually resolves spontaneously; nevertheless, antihistamines may be useful in relieving symptoms.
Sjældent
Rare
Stemningsændring, søvnforstyrrelser
Uncommon Mood altered, Sleep disturbances
Delekærven er der, for at tabletten kan deles, så den er nemmere at sluge, ikke for at kunne dosere to halve tabletter.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
6.6 Særlige regler for destruktion
6.6 Special precautions for disposal No special requirements.
Meget sjældent Autoimmunsygdomme
Autoimmune disorders
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg lisinopril (som dihydrat) og 5 mg amlodipin (som besilat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg lisinopril (as dihydrate) and 5 mg amlodipine (as besilate).
Det forbedrer iltforsyningen til myokardiet både i intakte og i iskæmiske områder.
Amlodipine may dilate coronary vessels (arteries and arterioles); it improves oxygen supply to the myocardium both in intact and in ischaemic regions.
Hæmoglobin sænket, hæmatokrit ssænket Serumbilirubin forhøjet, hyponatræmi
Haemoglobin decreased, Haematocrit decreased Serum bilirubin increased, Hyponatraemia
Psykiske forstyrrelser
Mental disorders
Luftveje, thorax-og mediastinum
Respiratory, thoracic and mediastinal disorders
Blod- og lymfesystem Meget sjældent Knoglemarvsdepression, agranulocytose, leukopeni, neutropeni, trombocytopeni, hæmolytisk anæmi
Bone marrow depression, Agranulocytosis, Leucopenia, Neutropenia, Thrombocytopenia, Haemolytic anaemia Anaemia,
Opkastning, dyspepsi, ændrede afføringsvaner, mundtørhed
Vomiting, Dyspepsia, Altered bowel habits, Dry mouth
Det metaboliseres ikke i organismen og det udskilles uændret i urinen.
Lisinopril does not bind to plasma proteins other than ACE; it is not metabolized in the organism and is excreted unchanged in the urine.
SÅDAN OPBEVARER DU LISONORM
HOW TO STORE LISONORM
Farmakoterapeutisk gruppe: ACE-hæmmere og kalciumkanalblokkere.
Pharmacotherapeutic group: ACE inhibitors and calcium channel blockers, ATC code: not yet assigned.
Leverenzymer forhøjet
Hepatic enzymes increased
Denne indlægsseddel blev senest godkendt den (MM/ÅÅÅÅ) [Udfyldes nationalt]
This leaflet was last approved in {MM/YYYY}.
Artralgi, myalgi, muskelkramper, rygsmerter
Arthralgia, Myalgia, Muscle cramps, Back pain
Blodurea forhøjet, serumkreatinin forhøjet, hyperkalæmi, leverenzymer forhøjet
Uncommon Blood urea increased, Serum creatinine increased,
Ødem, træthed
Dizziness, Headache
Svimmelhed, hovedpine Somnolens, svimmelhed, hovedpine
muscle pains, headache, inflammation, fever)
Hvis du har taget for meget Lisonorm
If you take more Lisonorm than you should
SÅDAN SKAL DU TAGE LISINORM
HOW TO TAKE LISONORM
Natriumstivelsesglycolat (Type A)
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Cellulose, microcrystalline Sodium starch glycolate (Type A) Magnesium stearate
Halveringstiden for amlodipin er forlænget hos patienter leverinsufficiens.
The half-life of amlodipine is prolonged in patients with hepatic impairment.
Patienterne bør nøje monitoreres for at kontrollere, at den ønskede virkning opnås.
Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors; patients should be carefully monitored to confirm that the desired effect is being obtained.
Fortæl din læge eller tandlæge, at du tager Lisonorm, før du får en lokalbedøvelse eller fuldbedøvelse,
Tell your doctor or dentist that you are taking
(NSAID'er) såsom acetylsalicylsyre)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (used to treat for arthritis,
Øre- og labyrint-lidelser
Ear and labyrinth disorders Uncommon
Mikrokrystallinsk cellulose
Blood and lymphatic system disorders
Desensibilisering over for bi-/hvepsegift
Oliguria/Anuria
Hyperkalæmi:
Hyperkalaemia
Mavesmerter, kvalme
Abdominal pain, Nausea
Metabolisme - og ernæring Meget sjældent Hypoglykæmi
Metabolism and nutrition disorders
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE LISINORM
BEFORE YOU TAKE LISONORM
- Spørg lægen eller farmaceuten på apoteket, hvis der er mere, du vil vide.
You should check with your doctor or pharmacist if you are not sure.
Lisonorm er kun indiceret til patienter, hvor den optimale vedligeholdelsesdosis af lisinopril og amlodipin er blevet titreret til henholdsvis 10 mg og 5 mg. Nyrefunktionen samt serum-kalium og -natriumniveauerne skal monitoreres under behandling med Lisonorm.
Lisonorm is indicated only for patients in whom the optimal maintenance dose of lisinopril and amlodipine has been titrated to 10 mg and 5 mg, respectively (see section 4.4).
Vaskulære sygdomme:
Vascular disorders
Rhinitis
Gynaecomastia
BEGRUNDELSER
GROUNDS
De to politikker følger de samme principper.
Both policies follow the same principles.
Medlemmerne stillede ikke yderligere spørgsmål.
Members did not raise additional questions.
Fra vision til virkelighed
From vision to reality
Der blev afholdt et antal møder med interessenterne.
A number of meetings with stakeholders took place.
Dette bliver agenturets syvende udvalg.
This will be the seventh committee of the Agency.
• Det europæiske innovationsprojekt om aktiv og sund ældning.
• European Innovation Partnership on Active and Healthy Ageing.
Agenturets kerneaktiviteter er fortsat agenturets overordnede prioritet.
The Agency's core activities remain the overall priority for the Agency.
Det bør sikres nøje, at omfanget ikke udvides uberettiget.
Care should be taken not to extend the scope unjustifiably.
Dette punkt blev slettet.
The agenda point was cancelled.
Dette begreb understreges i arbejdsprogrammet og vil blive mere fremtrædende i de kommende år.
This concept is emphasised in the work programme and will become more prominent in future years.
(Den vil blive fremlagt sammen med medicineret foder i en samlet pakke i 2012.)
(It will be presented with medicated feed in a package in 2012.)
Budgettet er 10,1 mio. euro lavere end det foreløbige budgetforslag, der blev vedtaget i marts 2010.
The budget is €10.1 million lower than the preliminary draft budget adopted in March 2010.
Den tidligere bebudede dato (den 24. februar 2011) er blevet annulleret.
The earlier announced date of 24 February 2011 has been cancelled.)
Punkt 6 (budget 2011) blev ændret fra "til godkendelse" til "til vedtagelse".
Point 6 (budget 2011) was changed from ‘for endorsement' to ‘for adoption'.
De påviste fejl var ikke systematiske, og der er blevet etableret en kontrolmekanisme, som skal styrke proceduren.
The detected mistakes were not systematic and a control mechanism has been established to reinforce the procedure.
Revisionen af gebyrforordningen er en god mulighed for at behandle dette spørgsmål.
The review of the Fee Regulation is a good opportunity to address the issue.
Det Europæiske Lægemiddelagenturs kommentarer var medtaget i dokumentet.
The European Medicines Agency's comments had been included in the document.
Agenturet offentliggør endvidere kommentarer modtaget under høringsfasen.
The Agency will also publish comments received during the consultation phase.
• Fremskridt i proceduren for udvælgelse af den administrerende direktør.
• Progress in the selection procedure for the Executive Director.
Medlemmerne blev opfordret til at komme med kommentarer og alternative forslag til mødet den 16. marts.
Members were invited to provide their comments and alternative proposals for the 16 March meeting.
Dette er et overordnet dokument, der vil blive suppleret med specifikke bilag vedrørende de operationelle områder i fremtiden.
This is an overarching document that will be supplemented by specific annexes related to the operational areas in the future.
Andre prioriterede områder svarer til de tidligere års.
Other priority areas remain similar to the previous years'.
• Bæredygtig og ansvarlig konkurrenceevne: Processen vedrørende socialt ansvar på lægemiddelområdet.
• Sustainable and responsible competitiveness: the Process on Corporate Responsibility in the field of Pharmaceuticals.
Bestyrelsen noterede sig, at det positive resultat fra 2009 var medtaget i budgettet.
The Board noted that the positive outturn from 2009 was included in the budget.
Bestyrelsen anerkendte de betydelige resultater, der er opnået i løbet af hans mandatperiode, og takkede ham for at have ledet agenturet med succes i de seneste ti år.
The Board recognised the significant achievements made during his term of office and thanked him for leading the Agency successfully over the last ten years.
• Revision af gennemsigtighedsdirektivet.
• Review of the Transparency Directive.
Forbeholdet drejer sig om indkøbssager.
The opinion relates to procurement cases.
Dette blev gjort muligt ved at reducere de planlagte udgifter til hardware og software gennem overførelse af bestemte indkøb.
This was made possible by reducing the planned expenditure for hardware and software by bringing certain procurements forward.
Der vil blive givet yderligere oplysninger på næste møde, hvor bestyrelsen vil blive bedt om at træffe en afgørelse.
Further information will be provided for the next meeting, when the Management Board will be asked to take a decision.
Forholdet til Det Europæiske Center for Forebyggelse af og Kontrol med Sygdomme (ECDC)
Relationship with the European Centre for Disease Prevention and Control (ECDC)
Prioriteterne for 2011 er i overensstemmelse med "Køreplan frem til 2015" og sikrer kontinuitet fra tidligere år.
The priorities for 2011 are in line with the 'Road map to 2015' and ensure continuity from the previous years.
Agenturet vil blive inviteret til Rådet og Europa-Parlamentets Budgetkontroludvalg med henblik på at besvare spørgsmål fra medlemmerne som del af dechargeproceduren.
The Agency will be invited to the Council and the Committee on Budgetary Control of the European Parliament to answer questions from the members as part of the discharge process.
Referatet offentliggøres på agenturets websted.
The minutes will be published on the Agency's website.
Thomas Lönngrens tiårige mandat udløber den 31. december 2010.
Thomas Lönngren ends his 10-year mandate on 31 December 2010.
Dette var det sidste bestyrelsesmøde med Thomas Lönngren som agenturets administrerende direktør.
This was the last Management Board meeting for Thomas Lönngren as the Executive Director of the Agency.
Det ekstraordinære møde, hvor der vil blive afholdt samtaler og foretaget en udnævnelse af den administrerende direktør, er planlagt til den 5. maj 2011.
The extraordinary meeting for interviewing and nominating the Executive Director is scheduled for 5 May 2011.
Forberedelse af en skriftlig procedure om ikkeautomatisk overførsel af bevillinger fra 2010 til 2011 for projekt 2014
Preparation for written procedure on non-automatic carryover of appropriations from 2010 to 2011 for Project 2014
Økonomisk kompensation for medlemsstaternes deltagelse i den sproglige kontrol - faste timepriser for 2011
Financial compensation for Member States' participation in linguistic checking - fixed flat hourly cost for 2011
Der er planer om initiativer på dette område, samtidig med at det sikres, at cost-benefit-analysen forbliver adskilt fra licensgivningsprocessen.
Initiatives are planned in this field, while ensuring that cost/benefit assessment remains separate from the licensing process.
Maarit Kokki fra ECDC (punkt 17)
Maarit Kokki of ECDC (point 17)
Medlemmerne blev bedt om at afgive erklæring om specifikke interesser, der kunne betragtes som skadelige for deres uafhængighed med hensyn til dagsordenspunkterne.
Members were asked to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
En af de vigtigste prioriteter for agenturet er gennemførelsen af den nye lovgivning om lægemiddelovervågning, herunder etableringen af det syvende videnskabelige udvalg.
One of the key priorities for the Agency is the implementation of the new pharmacovigilance legislation, including the establishment of the seventh scientific committee.
Der blev ikke afgivet erklæringer om interessekonflikt.
No conflict of interests was declared.
Agenturet forventer at kunne offentliggøre rapporten i begyndelsen af 2011.
The Agency expects to publish the report at the beginning of 2011.
Der kan navnlig opstå problemer, hvis producenten har en monopollignende stilling på markedet.
Problems may occur particularly where the manufacturer has a quasi-monopoly on the market.
Arbejdsprogram 2011
Work programme 2011
Politikkerne vedrørende aktindsigt gennemføres gradvist under hensyn til ikt-værktøjers tilgængelighed.
The access policies will be implemented gradually, taking into account the availability of ICT tools.
Bestyrelsen noterede sig endvidere, at agenturet vil foretage en forhåndsbetaling af 2010's lønjustering til alle berettigede ansatte inden udgangen af december.
The Board also noted that the Agency will make an advance payment of the 2010 salary adjustment to all eligible staff by the end of December.
Dette vil blive diskuteret på mødet for cheferne for de nationale lægemiddelstyrelser og derefter med interessenterne.
This will be discussed at the Heads of Medicines Agencies meeting and then with stakeholders.
Agenturet forbereder en gennemførelsesplan for køreplanen, der har titlen "Fra vision til virkelighed".
The Agency is preparing the road map implementation plan, entitled 'From vision to reality'.
Bestyrelsen mener dog, at det er vigtigt at forstå opgavernes faktiske omfang i forhold til, hvad der kræves af lovgivningen, inden der træffes en beslutning om, på hvilken måde de to agenturer skal deltage, og hvordan ledelsen skal foregå.
However, the Board considers it to be important to understand the actual scope of tasks required by the legislation before a decision is taken about how the two agencies will be involved and leadership decided.
Bestyrelsen var enstemmig i sin udtalelse om, at procedurerne ikke bør indstilles i alle tilfælde, hvor der modtages observationer fra medlemmer.
The Board was unanimous in its opinion that the procedures should not be suspended in all cases where observations from members are received.
Overførsel af bevillinger i 2010-budgettet i overensstemmelse med finansforordningens artikel 23, stk. 2
Transfers of appropriations in the 2010 budget in accordance with Article 23(2) of the Financial Regulation
(Der er blevet iværksat en konsekvensanalyse, der inden marts 2011 skal følges af en offentlig høring, inden fremlæggelsen af en endelig rapport senest i juni 2011.)
(An impact assessment has been launched, to be followed by a public consultation by March 2011, before issuing a final report by June 2011.)
I betragtning af de nye opgavers kompleksitet og tidsplanerne for gennemførelsen har agenturet udarbejdet en prioriteret gennemførelsesplan i samarbejde med Europa-Kommissionen.
Given the complexity of the new tasks and the timelines for implementation, the Agency has prepared a prioritised implementation plan, in collaboration with the European Commission.
Bestyrelsen noterede sig, at agenturet oplever en stigning i antallet og kompleksiteten af anmodninger om aktindsigt, hvilket sætter de begrænsede ressourcer under pres.
The Board noted that the Agency is experiencing an increase in the number and complexity of requests for access to documents, which puts pressure on limited resources.
Budgettet dækker ikke i tilstrækkeligt omfang omkostningerne til de ikt-projekter, der er nødvendige for at gennemføre lovgivningen om lægemiddelovervågning.
The budget does not cover adequately the costs of ICT projects needed for the implementation of the pharmacovigilance legislation.
Bestyrelsen var bekymret for, at Europa-Kommissionen ikke vil stille ressourcer til rådighed til de nye opgaver.
The Board was concerned that resources for the new tasks will not be made available by the European Commission.