FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from this study could not be used as a basis for extrapolating the withdrawal period for the only product containing the excipient polyethylene glycol 400 (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), as differences between the absorption of residues from the injection site for these two products (i.e., given the differences on viscosities from products with different excipients) cannot be excluded, as mentioned in the section above.
Danish: Dataene fra dette studie kunne ikke anvendes som grundlag for ekstrapolering af tilbageholdelsestiden for det eneste produkt, der indeholder hjælpestoffet polyethylenglycol 400 (Tilocen, indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A), da det ikke kan udelukkes, at
English: For these 49 products, excipients listed are benzyl alcohol and propylene glycol, as well as small concentrations of different pH adjustors.
Danish: • De fremlagte data viser, at formuleringen af 49 af de omhandlede produkter er meget ens. For disse 49 produkter er de anførte hjælpestoffer benzylalkohol og propylenglycol samt små koncentrationer af forskellige pH-regulatorer.
English: 1 CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1)https://www.ema.europa.eu/documents/scientific-guideline/guideline-safety-residue-data-requirements-pharmaceuticalveterinary-medicinal-products-intended/limited-market_en.pdf the CVMP in the interests of protecting consumer safety in the Union, and requested the Committee to review all available residue depletion data and recommend withdrawal periods for sheep (meat and offal, and milk).
Danish: 1 CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1)https://www.ema.europa.eu/documents/scientific-guideline/guideline-safety-residue-data-requirements-pharmaceuticalveterinary-medicinal-products-intended/limited-market_en.pdf fåremælk fra 4 dage til 7 dage.
English: Milk from sheep is considered a minor food commodity, and in line with the CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1) extrapolation can be done from cow's milk to sheep milk.
Danish: Mælk fra får anses for at være en mindre benyttet fødevare, og tilbageholdelsestiden for fåremælk kan ekstrapoleres fra komælk, jf. CVMP's retningslinje om sikkerhed og krav til restkoncentrationsdata for veterinærlægemidler til mindre udbredt anvendelse eller til mindre benyttede dyrearter (MUMS)/begrænset marked (EMA/CVMP/SWP/66781/2005-Rev.1).
English: 10 Avenue De La Ballastiere 33500 Libourne France solution for injection for cattle, pigs, sheep and goat base injection goats, pigs, sheep
Danish: 39 Petar Rakov Str. 4550 Peshtera Bulgaria mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére mg/ml opløsning geder, svin, får
English: The European Commission issued a decision on 6 October 2009.
Danish: Europa-Kommissionen traf en afgørelse den 6. oktober 2009.
English: The review was carried out under an ‘Article 29' referral 1 .
Danish: Undersøgelsen blev gennemført i henhold til en ‘artikel 29'-indbringelse 1 .
English: Dr. Karl Broich (Germany)
Danish: Dr. Karl Broich (Tyskland)
English: London, 6 October 2009 Doc.
Danish: London, den 6. oktober 2009 Dok.
English: Dr. Concha Prieto Yerro (Spain)
Danish: Dr. Concha Prieto Yerro (Spanien)
English: The grounds for the referral were that:
Danish: Begrundelserne for indbringelsen var:
English: It is used to treat severe long-term (chronic) pain which can only be adequately treated with opioid painkillers (medicines that are related to morphine).
Danish: Det anvendes til behandling af svære langvarige (kroniske) smerter, som kun kan behandles hensigtsmæssigt med opioide smertestillende midler (lægemidler, der er beslægtet med morfin).
English: However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 4 May 2009.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og den spanske lægemiddelkontrolmyndighed henviste sagen til CHMP til voldgift den 4. maj 2009.
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Italy, the Netherlands, Portugal, Slovenia and Spain).
Danish: Det er en procedure, hvor en medlemsstat (‘referencemedlemsstaten', i dette tilfælde Tyskland) vurderer et lægemiddel med henblik på at udstede en markedsføringstilladelse, som får gyldighed i dette land, men også i andre medlemsstater (de ‘berørte medlemsstater', i dette tilfælde Østrig, Belgien, Italien, Nederlandene, Portugal, Slovenien og Spanien).
English: Why was Fentrix reviewed?
Danish: Hvorfor blev Fentrix undersøgt?
English: What is Fentrix?
Danish: Hvad er Fentrix?
English: Questions and answers on the referral for Fentrix and associated names 25, 50, 70 and 100 microgram/hour fentanyl transdermal patch
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Fentrix og tilknyttede navne fentanyl 25, 50, 70 og 100 mikrogram/time depotplaster
English: Fentrix is a ‘generic medicine'.
Danish: Fentrix er et ‘generisk lægemiddel'.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Fentrix outweigh its risks, and therefore the marketing authorisation for Fentrix should be granted in all concerned Member States.
Danish: På grundlag af vurderingen af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved Fentrix opvejer risiciene, og at der derfor skal udstedes markedsføringstilladelse for Fentrix i alle de berørte medlemsstater.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Fentrix transdermal patch and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har afsluttet en voldgiftsprocedure som følge af uenighed blandt Den Europæiske Unions (EU) medlemsstater om godkendelsen af Fentrix depotplaster og tilknyttede navne.
English: This means that Fentrix is similar to a ‘reference medicine' already authorised in the European Union (EU) called Durogesic.
Danish: Det betyder, at Fentrix er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Durogesic.
English: The active substance in Fentrix, fentanyl, is an opioid that acts on receptors in the brain and spinal cord to prevent pain.
Danish: Det aktive stof i Fentrix, fentanyl, er et opioid, som virker på receptorer i hjernen og rygmarven, hvorved det forebygger smerter.
English: Helm Pharmaceuticals GmbH submitted Fentrix transdermal patch to Germany for a decentralised procedure.
Danish: Helm Pharmaceuticals GmbH forelagde ansøgning om Fentrix depotplaster for Tyskland med henblik på en decentral procedure.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Fentrix outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU, Austria, Belgium, Italy, the Netherlands, Portugal, Slovenia and Spain.
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Fentrix opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Tyskland og i følgende EU-medlemsstater: Østrig, Belgien, Italien, Nederlandene, Portugal, Slovenien og Spanien.
English: • the non-clinical local irritation and how sensitive the skin was to Fentrix were not investigated in accordance with current CHMP guidelines.
Danish: • at den ikke-kliniske lokalirritation og graden af hudens følsomhed over for Fentrix ikke var blevet undersøgt i overensstemmelse med de gældende CHMP-retningslinjer.
English: Fentrix is a transdermal patch (device that delivers the drug across the skin) that contains the active substance fentanyl.
Danish: Fentrix er et depotplaster (plaster, der afgiver lægemidlet gennem huden), som indeholder det aktive stof fentanyl.
English: • that Fentrix did not show a comparable local skin tolerability to the reference medicine, Durogesic;
Danish: • at Fentrix ikke udviste en lokal hudtolerabilitet, som var sammenlignelig med referencelægemidlet Durogesic's tolerabilitet,
English: This medicine is the same as CoAprovel, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med CoAprovel, som allerede er godkendt i Den Europæiske Union (EU).
English: Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel.
Danish: Irbesartan alene har været godkendt i EU under navnene Karvea og Aprovel siden 1997.
English: The full list of these medicines is given in the package leaflet.
Danish: Den fuldstændige liste over disse lægemidler fremgår af indlægssedlen.
English: The full EPAR for Irbesartan Hydrochlorothiazide Zentiva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Irbesartan Hydrochlorothiazid Zentiva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Hydrochlorothiazide Winthrop on 19 January 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Irbesartan Hydrochlorothiazid Winthrop den 19. januar 2007.
English: 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 Irbesartan Hydrochlorothiazide Zentiva.
Danish: 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 anvendelsesbetingelserne for Irbesartan Hydrochlorothiazid Zentiva.
English: For more information about treatment with Irbesartan Hydrochlorothiazide Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Irbesartan Hydrochlorothiazid Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The name of the medicine was changed to Irbesartan Hydrochlorothiazide Zentiva on 6 February 2012.
Danish: Lægemidlets navn blev ændret til Irbesartan Hydrochlorothiazid Zentiva den 6. februar 2012.
English: The CHMP decided that Irbesartan Hydrochlorothiazide Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Irbesartan Hydrochlorothiazid Zentiva opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan Hydrochlorothiazide Zentiva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Irbesartan Hydrochlorothiazide Zentiva.
English: The company that makes CoAprovel has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide Zentiva.
Danish: Virksomheden, som fremstiller CoAprovel, har givet tilladelse til, at dets videnskabelige oplysninger må anvendes for Irbesartan Hydrochlorothiazid Zentiva.
English: The most common side effects with Irbesartan Hydrochlorothiazide Zentiva (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 muscles).
Danish: De mest almindelige bivirkninger ved Irbesartan Hydrochlorothiazid Zentiva (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).
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Zentiva.
Danish: De undersøgelser, der blev foretaget med Karvea/Aprovel i kombination med hydrochlorothiazid som enkelttabletter, blev brugt til at understøtte brugen af Irbesartan Hydrochlorothiazid Zentiva.
English: Irbesartan Hydrochlorothiazide Zentiva was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Danish: Irbesartan Hydrochlorothiazid Zentiva var mere effektivt end placebo (en virkningsløs behandling) og hydrochlorothiazid alene til at reducere det diastoliske blodtryk.
English: Irbesartan Hydrochlorothiazide Zentiva 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.
Danish: Irbesartan Zentiva 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.
English: The dose of Irbesartan Hydrochlorothiazide Zentiva to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Danish: Dosen af Irbesartan Hydrochlorothiazid Zentiva afhænger af den dosis af irbesartan eller hydrochlorothiazid, som patienten tog tidligere.
English: Previously known as Irbesartan Hydrochlorothiazide Winthrop.
Danish: Tidligere kendt som Irbesartan Hydrochlorothiazid Winthrop.
English: Irbesartan Hydrochlorothiazide Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Danish: Irbesartan Hydrochlorothiazid Zentiva må ikke anvendes til personer, som er overfølsomme (allergiske) over for irbesartan, hydrochlorothiazid, sulfonamider eller andre af indholdsstofferne.
English: Care must be taken when using Irbesartan Hydrochlorothiazide Zentiva with other medicines that have an effect on blood potassium levels.
Danish: Der skal udvises forsigtighed, når Irbesartan Hydrochlorothiazid Zentiva anvendes sammen med andre lægemidler, som kan påvirke indholdet af kalium i blodet.
English: Irbesartan Hydrochlorothiazide Zentiva 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.
Danish: Irbesartan Hydrochlorothiazid Zentiva 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.
English: For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Zentiva, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Irbesartan Hydrochlorothiazid Zentiva fremgår af indlægssedlen.
English: Irbesartan Hydrochlorothiazide Zentiva contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Irbesartan Hydrochlorothiazid Zentiva indeholder to aktive stoffer, irbesartan og hydrochlorothiazid.
English: Irbesartan Hydrochlorothiazide Zentiva may be added to some other treatments for hypertension.
Danish: Irbesartan Hydrochlorothiazid Zentiva kan bruges som tillægsbehandling til visse andre behandlinger mod hypertension.
English: Irbesartan Hydrochlorothiazide Zentiva is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Danish: Irbesartan Hydrochlorothiazid Zentiva anvendes til voksne med essentiel hypertension (forhøjet blodtryk), hvis blodtryk ikke kan reguleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
English: Irbesartan Hydrochlorothiazide Zentiva is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Irbesartan Hydrochlorothiazide Zentiva er et lægemiddel, der indeholder de to aktive stoffer irbesartan og hydrochlorothiazid.
English: 25 mg hydrochlorothiazide once a day are not recommended.
Danish: Doser på mere end 300 mg irbesartan og 25 mg hydrochlorothiazid en gang dagligt anbefales ikke.
English: Other information about Irbesartan Hydrochlorothiazide Zentiva
Danish: Andre oplysninger om Irbesartan Hydrochlorothiazid Zentiva:
English: What is the risk associated with Irbesartan Hydrochlorothiazide Zentiva?
Danish: Hvilken risiko er der forbundet med Irbesartan Hydrochlorothiazid Zentiva?
English: EPAR summary for the public irbesartan / hydrochlorothiazide
Danish: Irbesartan/hydrochlorothiazid
English: Why has Irbesartan Hydrochlorothiazide Zentiva been approved?
Danish: Hvorfor blev Irbesartan Hydrochlorothiazid Zentiva godkendt?
English: What is Irbesartan Hydrochlorothiazide Zentiva?
Danish: Hvad er Irbesartan Hydrochlorothiazid Zentiva?
English: How has Irbesartan Hydrochlorothiazide Zentiva been studied?
Danish: Hvordan blev Irbesartan Hydrochlorothiazid Zentiva undersøgt?
English: How is Irbesartan Hydrochlorothiazide Zentiva used?
Danish: Hvordan anvendes Irbesartan Hydrochlorothiazid Zentiva?
English: What is Irbesartan Hydrochlorothiazide Zentiva used for?
Danish: Hvad anvendes Irbesartan Hydrochlorothiazide Zentiva til?
English: What benefit has Irbesartan Hydrochlorothiazide Zentiva shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Irbesartan Hydrochlorothiazid Zentiva?
English: - If you have a weak heart (heart failure).
Danish: hvis De har et svagt hjerte (hjertesvigt).
English: The following wording was adopted:
Danish: Følgende ordlyd blev vedtaget:
English: Member State EU/EEA
Danish: Medlemsland/EU /EEA
English: It is important that you complete the course of treatment, even if you begin to feel better after a few days.
Danish: Det er vigtigt, at De gennemfører hele behandlingsforløbet, selv om De begynder at føle Dem bedre efter et par dage.
English: The text proposed for 4.4 was shortened in order to make it clearer.
Danish: Den foreslåede tekst i punkt 4.4 blev forkortet for at gøre den klarere.
English: The usual dose for adults is one bottle bag once daily.
Danish: Den normale dosis for voksne er én flaske pose dagligt.
English: frequency cannot be estimated from the available data
Danish: hyppigheden kan ikke vurderes ud fra de tilgængelige oplysninger
English: A precautionary measure would be to more frequently monitor the INR.
Danish: En foranstaltning ville være at monitorere INR hyppigere.
English: Studies in rats (p.o. and i.v.)
Danish: Studier udført på rotter (p.o. og i.v.)
English: The major concern was the need for further qualification of the conditions of use.
Danish: Den største betænkelighed vedrørte behovet for en yderligere begrænsning af anvendelsesbetingelserne.
English: M1 and M2 are the only metabolites relevant in humans, both are microbiologically inactive.
Danish: M1 og M2 er de eneste relevante metabolitter hos mennesker, og begge er mikrobiologiske inaktive.
English: which was associated with severe maternal toxicity.
Danish: ), der var associeret med svær maternal toksicitet.
English: If you are female or elderly, you may be more sensitive to ECG changes.
Danish: Hvis De er kvinde eller en ældre person, kan De være mere følsom over for EKG-ændringer.
English: Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission.
Danish: Endvidere skal der iværksættes passende infektionskontrol for at nedsætte risikoen for transmission.
English: The CHMP maintained its previous position.
Danish: CHMP fastholdt sin tidligere holdning.
English: The recommended dose and duration of treatment should not be exceeded (see section 2.
Danish: De anbefalede doser og behandlingsvarigheden bør ikke overskrides (se afsnittet 2.
English: No specific countermeasures after accidental overdose are recommended.
Danish: Der anbefales ingen specifikke forholdsregler efter accidentel overdosering.
English: The infectious and inflammatory conditions, age and general status of the patient appear to be risk factors.
Danish: Infektions- og inflammationsforholdene, alder og patientens almene tilstand synes at være risikofaktorer.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF OCTEGRA AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF OCTEGRA OG TILHØRENDE NAVNE (SE BILAG I)
English: The CHMP considered that the literature reviews were neither valid nor helpful.
Danish: CHMP var af den opfattelse, at litteraturgennemgangen hverken var gyldig eller nyttig.
English: 95, Marathonos Avenue 190-09 Pikermi Greece
Danish: 95, Marathonos Avenue 190-09 Pikermi
English: If necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Danish: Om nødvendigt bør dosis af det orale antikoagulantia justeres passende.
English: The CHMP maintained its previous position, as no new data was provided.
Danish: CHMP fastholdt sit tidligere synspunkt, eftersom der ikke blev fremlagt nogen nye data.
English: H. influenzae and M. catarrhalis
Danish: H. influenzae og M. catarrhalis
English: After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Danish: Efter kommissionsbeslutningen vil medlemsstaternes lægemiddelmyndigheder i samarbejde med referencelandets lægemiddelmyndighed opdatere produktinformationen efter behov.
English: The Applicant attended an oral explanation at the May 2009 CHMP, during which the Applicant argumentation and data previously submitted in the context of the written responses was re-iterated.
Danish: Ansøgeren afgav mundtlig redegørelse på CHMP's møde i maj 2009, hvor ansøgerens argumentation og de tidligere fremsendte data i forbindelse med de skriftlige svar blev gentaget.
English: If any such data was necessary, the Applicant should work with already established projects, adequately designed to collect reliable data prospectively.
Danish: Hvis sådanne data var nødvendige, skulle ansøgeren arbejde med allerede eksisterende projekter, som er tilrettelagt således, at der prospektivt kan indsamles pålidelige data.
English: Any prospective surveillance study would need to be very carefully designed such that data collected from year to year could be compared with some degree of confidence and the Applicant proposal would not fulfil this requirement.
Danish: Det er nødvendigt, at enhver prospektiv overvågningsundersøgelse tilrettelægges meget nøje på en sådan måde, at de indsamlede data fra år til år kan sammenlignes med en vis grad af sikkerhed, og ansøgerens forslag opfylder ikke dette krav.
English: - If you have a very slow heart rate (bradycardia).
Danish: hvis De har et meget langsomt puls (bradykardi).
English: Pseudomonas aeruginosa *Activity has been satisfactorily demonstrated in clinical studies.
Danish: Pseudomonas aeruginosa *Aktivitet er tilfredsstillende dokumenteret i kliniske studier.
English: Outcomes by pathogen did not reveal any potentially alarming differences between treatments.
Danish: Patogenresultaterne viste ikke nogen potentielt alarmerende forskel på behandlingerne.
English: If you are affected in this way do not drive or operate machinery.
Danish: Hvis De påvirkes på denne måde, må De ikke køre bil eller betjene maskiner.