FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee considered that carisoprodol is indicated primarily for acute low back pain, however, because of the nature of low back pain this has resulted in a tendency for more chronic use of the drug, increasing the risk of dependence.
Danish: De nedre rygsmerters karakter har dog medført en tendens til en mere kronisk brug af lægemidlet, hvilket øger risikoen for afhængighed.
English: The Committee concluded that there is increasing evidence for carisoprodol-associated risk of abuse, psychomotor impairment and intoxications.
Danish: Udvalget konkluderede, at der er stadig større dokumentation for, at carisoprodol giver risiko for misbrug, psykomotorisk svækkelse og forgiftning.
English: Carisoprodol is associated with a risk of abuse, psychomotor impairment and intoxication.
Danish: Carisoprodol giver risiko for misbrug, psykomotorisk svækkelse og forgiftning.
English: There is available evidence that carisoprodol is associated with a risk of abuse, psychomotor impairment and intoxication.
Danish: Der er dokumentation for, at carisoprodol giver risiko for misbrug, psykomotorisk svækkelse og forgiftning.
English: The Committee considered that the efficacy of carisoprodol containing products is poorly documented; only three relatively old studies are available to demonstrate efficacy in acute low back pain.
Danish: Kun tre relativt gamle undersøgelser viser effektiviteten ved nedre rygsmerter.
English: Tritazide has been authorised in the EU since 1993, first in Germany and then in the following countries: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Danish: Tritazide har været godkendt i EU siden 1993, først i Tyskland dernæst i følgende lande: Østrig, Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Luxembourg, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, og Sverige.
English: London, 18 March 2009 Doc.
Danish: London, den 18. marts 2009 Doc.
English: Ref. EMEA/CHMP/204584/2009
Danish: Ref. EMEA/202985/2009
English: • Treatment of hypertension
Danish: • Behandling af hypertension
English: Tritazide and associated names should be started at the lowest available dosage.
Danish: Tritazide og tilknyttede navne bør påbegyndes ved den lavest mulige dosis.
English: What is Tritazide?
Danish: Hvad er Tritazide?
English: Tritazide is authorised in the European Union (EU) via national procedures.
Danish: Tritazide er godkendt i EU efter nationale procedurer.
English: Tritazide can also be available in the EU and the EEA under other trade names: Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, and Triatec Comp Mite,Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur, Idroquark..
Danish: Tritazide findes muligvis også i EU og EØS under følgende andre handelsbetegnelser: Tritace Plus, Triatec Plus, Triatec Comp, Tritace Comp, Tritace Comb, Triatec Composto, Triatec Composto Forte, Cardace Comp, Cardace Plus, Cotriatec, Delix Plus, Ramilich Comp, Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor D, and Triatec Comp Mite,Hypren Plus, Hypren Plus Forte, Vesdil Plus, Ramipril HCT Zentiva, Unipril Diur og Idroquark.
English: Why was Tritazide reviewed?
Danish: Hvorfor blev Tritazide vurderet igen?
English: In most cases the initial recommended dose was the same, but there were differences with respect to subsequent titration (both in terms of frequency of increase and maximum daily dose).
Danish: I de fleste tilfælde var den anbefalede startdosis den samme, men der var forskelle i forbindelse med den efterfølgende titrering (både i forhold til hyppighed af øgning og maksimal daglig dosis).
English: 4.5 Interactions
Danish: 4.5 Interaktion
English: The CHMP adopted the following harmonised wording:
Danish: CHMP vedtog følgende harmoniserede formulering:
English: The CHMP endorsed the current list of products which interact or may interact with Tritazide, including additional text reinforcing lithium toxicity.
Danish: CHMP godkendte den aktuelle liste over produkter, som interagerer eller kan interagere med Tritazide, herunder yderligere tekst, som underbygger lithiumtoksicitet.
English: The European Medicines Agency (EMEA) has completed a review of Tritazide.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har foretaget en vurdering af Tritazide.
English: On 18 January 2008, the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Tritazide in the EU and the EEA.
Danish: Den 18. januar 2008 henviste Europa-Kommissionen sagen til Udvalget for Humanmedicinske Lægemidler med henblik på harmonisering af markedsføringstilladelserne for Tritazide i EU og EØS.
English: It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
Danish: Det virker ved at øge urinproduktionen, reducere mængden af væske i blodet og sænke blodtrykket.
English: • Clinically relevant electrolyte disturbances which may worsen following treatment with
Danish: • Klinisk relevante elektrolytforstyrrelser, som kan forværre den efterfølgende behandling med
English: This is in line with the recommendation of the CHMP's Pharmacovigilance Working Party on use of ACE inhibitors in pregnancy.
Danish: Dette er i overensstemmelse med anbefalingen fra CHMP's arbejdsgruppe vedrørende lægemiddelovervågning i forbindelse med brug af ACE-hæmmere under graviditet.
English: The majority of the contraindications are related to use of ramipril as a component of Tritazide.
Danish: Størstedelen af kontraindikationerne vedrører brugen af ramipril som komponent i Tritazide.
English: The CHMP included also new warnings for: pregnancy, surgery, electrolyte disturbances, and cough.
Danish: CHMP inkluderede endvidere nye advarsler vedrørende: graviditet, kirurgisk behandling, elektrolytforstyrrelser og hoste.
English: The combination ramipril 2.5 mg/ HCTZ 12.5 mg led to greater reduction in blood pressure than the treatment with individual components and the combination of 5 mg/25 mg produced a better therapeutic effect than doubling the ramipril dose to 10 mg.
Danish: Kombinationen ramipril 2,5 mg/HCTZ 12,5 mg medførte større fald i blodtrykket end behandling med individuelle komponenter, og kombinationen af 5 mg/25 mg havde en bedre terapeutisk effekt, end når dosis af ramipril blev fordoblet til 10 mg.
English: Hydrochlorothiazide (HCTZ) is a diuretic.
Danish: Hydrochlorothiazid (HCTZ) er et diuretikum.
English: The CHMP discussed the areas where there was a divergence identified in the dose recommendations.
Danish: CHMP drøftede de områder, hvor der var afvigelser i doseringsvejledningen.
English: • History of angioedema (hereditary, idiopathic or due to previous angioedema wit ACE
Danish: • Tidligere angioødem (hereditært, idiopatisk eller som følge af tidligere angioødem med ACE
English: Considering that no major concern can be established concerning the safety, efficacy and clinical adverse event of the ramipril/HCTZ combination in non responders to HCTZ and ramipril alone, the CHMP adopted the following two harmonised wordings for indications:
Danish: I betragtning af at der ikke kan påvises nogen større problemer i forhold til sikkerhed, effekt og kliniske bivirkninger i forbindelse med kombinationen ramipril/HCTZ hos patienter, der ikke responderer på HCTZ og ramipril alene, vedtog CHMP følgende to harmoniserede formuleringer af indikationer:
English: The CHMP noted that some of the contraindications in local SPCs (such as acute hypertension or primary aldosteronism) were in fact non-indications.
Danish: CHMP bemærkede, at nogle af kontraindikationerne i lokale produktresuméer (såsom akut hypertension og primær aldosteronisme) faktisk var ikke-indikationer.
English: The CHMP included under this session the warning about primary hyperaldosteronism, therefore adopted the following harmonised wording: The combination ramipril + hydrochlorothiazide does not represent a treatment of choice for primary hyperaldosteronism.
Danish: CHMP inkluderede i denne runde advarslen om primær hyperaldosteronisme og vedtog derfor den følgende harmoniserede formulering: Kombinationen af ramipril og hydrochlorothiazid udgør ikke et behandlingstilbud mod primær hyperaldosteronisme.
English: The company that markets Tritazide is Sanofi-aventis.
Danish: Tritazide markedsføres af virksomheden Sanofi-aventis.
English: 24 January 2008
Danish: 24. januar 2008.
English: The administration of the fixed combination of ramipril and hydrochlorothiazide is usually recommended after dosage titration with one of the individual components.
Danish: Behandling med den faste kombination af ramipril og hydrochlorothiazid anbefales sædvanligvis efter dosistitrering med en af de individuelle komponenter.
English: • Severe impairment of renal function with a creatinine clearance below 30 ml/min in undialysed patients
Danish: • Svært nedsat nyrefunktion med en kreatininclearance på under 30 ml/min.
English: The CHMP also noted that there were limited trial data regarding titration steps with the combination.
Danish: CHMP bemærkede endvidere, at der kun i begrænset omfang findes forsøgsdata vedrørende titreringsprocessen for denne kombination.
English: If ramipril + hydrochlorothiazide is used in a patient with primary hyperaldosteronism, then careful monitoring of plasma potassium level is required.
Danish: Hvis ramipril og hydrochlorothiazid anvendes til en patient med primær hyperaldosteronisme, kræver det omhyggelig overvågning af kalium-plasmaniveauet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tritazide in the European Union and the European Economic Area (EEA).
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) er af den opfattelse, at der er behov for at harmonisere ordinationsoplysningerne for Tritazide i Den Europæiske Union (EU) og Det Europæiske Økonomiske Samarbejdsområde (EØS).
English: The CHMP noted inconsistencies in the wording of the indication across countries, with terms including ‘essential hypertension', ‘arterial hypertension' and ‘arterial essential hypertension' being used.
Danish: CHMP bemærkede, at der var uoverensstemmelser i indikationens ordlyd i de forskellige lande, idet der blev anvendt både "essentiel hypertension", "arteriel hypertension" og "arteriel essentiel hypertension".
English: The review was carried out under an ‘Article 30' referral1.
Danish: Vurderingen blev gennemført inden for rammerne af en indbringelsesprocedure i henhold til artikel
English: • This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Danish: • Denne fastdosiskombination er indiceret til patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af ramipril eller hydrochlorothiazid alene.
English: Tritazide contains two active substances, ramipril and hydrochlorothiazide.
Danish: Tritazide indeholder de to aktive stoffer ramipril og hydrochlorothiazid.
English: Tritazide tablets containing ramipril and hydrochlorothiazide
Danish: Tritazide-tabletter indeholdende ramipril og hydrochlorothiazid
English: Tritazide is used in the treatment of hypertension and it is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Danish: Tritazide anvendes til behandling af hypertension og er indiceret til patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende alene ved hjælp af ramipril eller hydrochlorothiazid.
English: The CHMP highlighted that fact that the indication should be hypertension, and as add-on therapy when each monotherapy has failed.
Danish: CHMP påpegede, at indikationen bør være hypertension, og som tillægsbehandling efter mislykket monoterapi.
English: inhibitors or AIIRAs(Angiotensin II Receptor Antagonists))
Danish: hæmmere eller angiotensin II-receptorantagonister (AIIRA)).
English: Ramipril is an angiotensin converting enzyme (ACE) inhibitor.
Danish: Ramipril er en ACE-hæmmer (Angiotensin Converting Enzyme).
English: Tritazide has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentraliserede procedurer (CMD(h)), at Tritazide bør harmoniseres.
English: The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Danish: Dosis skal fastlægges efter individuel vurdering af patientprofilen (se pkt.
English: TRITAZIDE (see section 4.4)
Danish: TRITAZIDE (se pkt.
English: If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily.
Danish: De maksimale tilladte doser er 10 mg ramipril og 25 mg hydrochlorothiazid dagligt.
English: • Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin
Danish: • Overfølsomhed over for det aktive stof, over for et eller flere af hjælpestofferne eller andre
English: • Lactation (see section 4.6)
Danish: • Amning (se pkt.
English: Converting Enzyme) inhibitors (see section 6.1)
Danish: ACE-hæmmere (Angiotensin Converting Enzyme) (se pkt.
English: • Severe impairment of liver function, hepatic encephalopathy
Danish: • Svært nedsat leverfunktion, leverencefalopati.
English: Applicant company name, address
Danish: Ansøger Firmanavn, adresse
English: Annex I List of medicinal products and presentations
Danish: Fortegnelse over lægemidler og lægemiddelform
English: Spain
Danish: Storbritannien
English: End of December 2018
Danish: Ultimo december 2018
English: The final study report should be submitted by:
Danish: Endelig rapport over undersøgelsen forelægges senest:
English: The protocol of this study should be submitted to the PRAC within 6 months after notification of the EC Decision.
Danish: Protokollen til denne undersøgelse forelægges PRAC senest 6 måneder efter meddelelsen om Kommissionens beslutning.
English: For chlormadinone-containing combined hormonal contraceptives The MAHs for chlormadinone containing CHCs should carry out a post-authorisation safety study to compare the risk of VTE with chlormadinone/ethinyestradiol versus levonorgestrel/ethinyestradiol.
Danish: Indehaverne af markedsføringstilladelse for kombinerede hormonale kontraceptiva indeholdende chlormadinon udfører en sikkerhedsundersøgelse efter markedsføringstilladelse til sammenligning af risikoen for venøs tromboemboli ved chlormadinon/ethinylestradiol med levonorgestrel/ethinylestradiol.
English: National Competent Authorities of Member States or Reference Member States, if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Danish: De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaterne sikrer, at indehaverne af markedsføringstilladelse opfylder følgende betingelser:
English: Memantine Mylan should be given once a day at the same time every day.
Danish: Memantine Mylan bør gives én gang dagligt på samme tidspunkt hver dag.
English: The full EPAR for Memantine Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Memantine Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In addition, overstimulation of the NMDA receptors may result in cell damage or death.
Danish: Desuden kan overstimulering af NMDAreceptorerne medføre cellebeskadigelse eller -død.
English: This is a summary of the European public assessment report (EPAR) for Memantine Mylan.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Memantine Mylan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine Mylan on 22 April 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Memantine Mylan den 22. april 2013.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Memantine Mylan should be reassessed on a regular basis.
Danish: Tolerance og dosis bør vurderes inden for 3 måneder efter behandlingens start, og herefter bør fordelene ved at fortsætte behandlingen med Memantine Mylan regelmæssigt genvurderes.
English: To prevent side effects, the dose of Memantine Mylan is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg.
Danish: For at undgå bivirkninger øges dosis af Memantine Mylan gradvist i løbet af de tre første uger af behandlingen: I den første uge er dosis 5 mg, i den anden uge er den 10 mg, og i den tredje uge er den 15 mg. Fra uge fire og fremover er den anbefalede vedligeholdelsesdosis 20 mg én gang dagligt.
English: Memantine Mylan is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Danish: Memantine Mylan er et lægemiddel til behandling af patienter med moderat til svær Alzheimers sygdom, dvs. en type demens (en hjernesygdom), der gradvis påvirker hukommelse, intellektuelle evner og adfærd.
English: This means that Memantine Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Danish: Det betyder, at Memantine Mylan er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Ebixa.
English: The Committee recommended that Memantine Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Memantine Mylan godkendes til anvendelse i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Mylan has been shown to have comparable quality and to be bioequivalent to Ebixa.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Memantine Mylan er af sammenlignelig kvalitet og er bioækvivalent med Ebixa.
English: Memantine Mylan is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Danish: Memantine Mylan fås som tabletter (10 mg og 20 mg) og udleveres kun efter recept.
English: The active substance in Memantine Mylan, memantine, is an antidementia medicine.
Danish: Det aktive stof i Memantine Mylan, memantin, er et lægemiddel mod demens.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine Mylan by the patient.
Danish: Behandlingen bør kun iværksættes, hvis en omsorgsgivende person regelmæssigt overvåger patientens indtagelse af Memantine Mylan.
English: Memantine Mylan is a ‘generic medicine'.
Danish: Memantine Mylan er et "generisk lægemiddel".
English: Safety information has been included in the summary of product characteristics and the package leaflet for Memantine Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Memantine Mylan, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: What measures are being taken to ensure the safe and effective use of Memantine Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Memantine Mylan?
English: For more information about treatment with Memantine Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Memantine Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the benefits and risks of Memantine Mylan?
Danish: Hvilke fordele og risici er der forbundet med Memantine Mylan?
English: Other information about Memantine Mylan
Danish: Andre oplysninger om Memantine Mylan
English: What is Memantine Mylan and what is it used for?
Danish: Hvad er Memantine Mylan, og hvad anvendes det til?
English: Because Memantine Mylan is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa.
Danish: Da Memantine Mylan er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Ebixa.
English: It is not intended to provide practical advice on how to use Memantine Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Memantine Mylan bør anvendes.
English: Because Memantine Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Memantine Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Memantine Mylan memantine
Danish: Memantine Mylan memantin
English: For practical information about using Memantine Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Memantine Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Memantine Mylan approved?
Danish: Hvorfor er Memantine Mylan blevet godkendt?
English: How has Memantine Mylan been studied?
Danish: Hvordan er Memantine Mylan blevet undersøgt?
English: How is Memantine Mylan used?
Danish: Hvordan anvendes Memantine Mylan?
English: How does Memantine Mylan work?
Danish: Hvordan virker Memantine Mylan?
English: The remaining arms were continued in a blinded fashion.
Danish: De resterende arme fortsatte i den blindede form.
English: Trizivir can be taken with or without food.
Danish: Trizivir kan tages med eller uden mad.
English: See Section 4 for more information.
Danish: Se punkt 4 for flere oplysninger.
English: So it is very important to talk to your doctor about any changes in your health.
Danish: Derfor er det meget vigtigt, at du fortæller lægen om enhver ændring i dit helbred.
English: • if they have been taking combination therapy for a long time
Danish: • hvis du har været i kombinationsbehandling i lang tid
English: 32 weeks 26 % 144 weeks
Danish: 32 uger 144 uger
English: The effect of food on the rate and extent of absorption was also studied.
Danish: Desuden blev indvirkningen af mad på hastigheden og omfanget af absorptionen undersøgt.
English: The anaemia may necessitate transfusions.
Danish: Anæmien kan nødvendiggøre transfusioner.
English: You need to be aware of the extra risks:
Danish: Du skal derfor være opmærksom på disse ekstra risici:
English: “Pull here” (with Alert card attached)
Danish: “Træk her” (med oplysningskort vedhæftet)
English: Criteria to be used to verify the success of proposed risk minimisation activity: Implementation of the education program will be monitored by the MAH via auditing.
Danish: Kriterier, som skal benyttes til at verificere succesen af de foreslåede risikominimeringsaktiviteter: Implementering af uddannelsesprogrammet vil blive monitoreret af MAH via auditering.
English: They are listed by body system, organ class and absolute frequency.
Danish: De er listet efter organklasse og absolut frekvens.
English: ATC Code: J05AR04.
Danish: ATC-kode: J05A R04.
English: Summary of the safety profile
Danish: Opsummering af sikkerhedsprofil