FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder considers it inconceivable that the risks posed to the environment associated with the use of Ecomectin 18.7 mg/g Oral Paste for Horses in particular are any greater than those posed by other ivermectin-based products, particularly as the concentration of the active ingredient and the proposed usage regime is identical to that of the reference and other similar products.
Danish: Indehaveren af markedsføringstilladelsen finder det utænkeligt, at de miljørisici, der specielt er forbundet med anvendelsen af Ecomectin 18,7 mg/g, oral pasta til heste, skulle være større end dem, der er forbundet med andre ivermectin-baserede produkter, navnlig da koncentrationen af det aktive indholdsstof og den påtænkte anvendelse er identisk med, hvad der gælder for referencelægemidlet og andre tilsvarende lægemidler.
English: The paste is given by oral route.
Danish: Pastaen gives oralt.
English: Based on this, the applicant argued that the horse should be classed as “minor use/minor species” and that no Phase II risk assessment is required.
Danish: Ansøgeren hævdede, at heste derfor bør betragtes som en "mindre udbredt art", og at en fase II-risikovurdering er unødvendig.
English: PECSOIL- Pasture animals = 0.48 µg.kg-1
Danish: PECJORD for græsædende dyr = 0,48 µg.kg-1
English: The Marketing Authorisation Holder should provide an updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II;
Danish: Indehaveren af markedsføringstilladelsen skal forelægge en ajourført miljørisikovurdering i overensstemmelse med CVMP's retningslinjer herfor, herunder en eventuel begrundelse for undtagelse fra fase II;
English: The Marketing Authorisation Holder should provide complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment;
Danish: Indehaveren af markedsføringstilladelsen skal forelægge samtlige oplysninger, der er forelagt referencemedlemsstaten og CMD(v) vedrørende miljørisikovurderingen.
English: Ireland notified the EMEA on 4 July 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding Ecomectin 18.7 mg/g Oral Paste for Horses.
Danish: Irland meddelte den 4. juli 2007 til EMEA, at der ikke var opnået enighed om Ecomectin 18,7 mg/g, oral pasta til heste, i koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - veterinær (CMD(v)).
English: The Marketing Authorisation Holder considers that the guidelines were written primarily for new molecules where the risk to the environment has not been characterized and that it is not the case for ivermectin-containing veterinary medicinal products that have been in extensive worldwide use for nearly 25 years and that real risk or detrimental environmental effect attributable to ivermectin-based veterinary medicinal products would have been observed.
Danish: Indehaveren af markedsføringstilladelsen finder, at retningslinjerne primært tager sigte på nye molekyler, der endnu ikke er blevet karakteriseret med hensyn til miljørisiko, hvilket ikke gælder veterinærmedicinske produkter indeholdende ivermectin.
English: Member State Marketing Authorisation
Danish: Produktets handelsbetegnelse
English: The use of Ecomectin 18.7 Oral Paste for Horses does not result in an increase of the exposure to the environment compared to products for major species and therefore the conclusions of their environmental impact assessment is applicable for this product for horses.
Danish: Anvendelsen af Ecomectin 18,7 mg/g, oral pasta til heste, medfører ikke en større indvirkning på miljøet end den, der forårsages af produkter til vigtige arter.
English: Belgium As above
Danish: Grækenland Som ovenstående
English: Pharmaceutical Strength Animal species Frequency and route Recommended dose
Danish: Doseringshyppighed og indgivelsesvej
English: Ivermax 18.7 mg/g Oral Paste for Horses
Danish: Ivermax 18,7 mg/g, oral pasta til heste
English: Ecomectin 18.7 mg/g Oral Paste for Horses
Danish: Ecomectin 18,7 mg/g, oral pasta til heste
English: Animec 18.7 mg/g Oral Paste for Horses
Danish: Animec 18,7 mg/g, oral pasta til heste
English: Tizoval 18.7 mg/g Oral Paste for Horses
Danish: Tizoval 18,7 mg/g, oral pasta til heste
English: Divamectin 18.7 mg/g Oral Paste for Horses
Danish: Divamectin 18,7 mg/g, oral pasta til heste
English: Vetimec 18.7 mg/g Oral Paste for Horses
Danish: Vetimec 18,7 mg/g, oral pasta til heste
English: Consequently, the PRAC has agreed the following:
Danish: PRAC har derfor vedtaget følgende:
English: Adopted at the 7-10 April 2015 PRAC
Danish: Vedtaget den 7.-10. april 2015, PRAC
English: Use only if no other alternative if available.
Danish: Anvendes kun, hvis der ikke er andre behandlingsmuligheder.
English: Only Summary of Products Characteristics for Daklinza
Danish: Kun produktresumé for Daklinza
English: Considering the seriousness of the condition, the PRAC concluded that an update of the product information is warranted.
Danish: I betragtning af sygdommens alvorlighed konkluderede PRAC, at produktinformationen bør ajourføres.
English: Interferon alfa-2a; interferon alfa-2b; interferon beta-1a; interferon beta-1b; peginterferon alfa-2a; peginterferon alfa2b; peginterferon beta-1a - Pulmonary arterial hypertension (EPITT no 18059)
Danish: Interferon alfa-2a, interferon alfa-2b, interferon beta-1a, interferon beta-1b, peginterferon alfa-2a, peginterferon alfa2b, peginterferon beta-1a - pulmonal arteriel hypertension (EPITT nr. 18059)
English: “*Class label for interferon products, see below Pulmonary arterial hypertension.” Section 4.8c
Danish: »*Vedrørende klassebetegnelse for interferonlægemidler: se pulmonal arteriel hypertension nedenfor.« Punkt 4.8c
English: • The MAHs should distribute a direct healthcare professional communication (DHPC) according to the text and communication plan agreed with the PRAC and CHMP
Danish: • Indehaverne af markedsføringstilladelse udsender en direkte henvendelse til sundhedspersoner (DHPC) i henhold til den tekst og kommunikationsplan, der er aftalt mellem PRAC og CHMP
English: Daclatasvir; sofosbuvir; sofosbuvir, ledipasvirArrhythmia (EPITT no 18177)
Danish: Daclatasvir; sofosbuvir; sofosbuvir, ledipasvir - Arytmi (EPITT nr. 18177)
English: The PRAC has noted that amiodarone was involved in cases with the most suggestive causal relationship.
Danish: PRAC har bemærket, at amiodaron var involveret i de tilfælde, hvor der var stærkest formodning om årsagssammenhæng.
English: • Taking into account that the mechanism for the drug-drug interaction with amiodarone remains unclear, the MAHs should ensure that planned non-clinical studies investigate both the potential pharmacodynamic and pharmacokinetic effects.
Danish: • På baggrund af den fortsat uafklarede mekanisme ved lægemiddelinteraktion med amiodaron sørger indehaverne af markedsføringstilladelse for, at planlagte ikke-kliniske undersøgelser omfatter både potentielle farmakodynamiske og farmakokinetiske virkninger.
English: Based on published clinical and non-clinical data and on spontaneous reports, the PRAC considers that a causal relationship between the use of interferons alfa and beta and the development of pulmonary arterial hypertension, a rare but severe event, cannot be excluded.
Danish: På grundlag af offentliggjorde kliniske og ikke-kliniske data og spontane indberetninger finder PRAC, at det ikke kan udelukkes, at der er årsagssammenhæng mellem anvendelse af interferon alfa og beta og pulmonal arteriel hypertension, en sjælden, men alvorlig hændelse.
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on <adapt according to the product>.
Danish: På grund af amiodarons lange halveringstid skal der desuden foretages passende overvågning af patienter, som inden for de seneste måneder har fået seponeret amiodaron og skal sættes i behandling med <tilpasses efter produktet>.
English: In the light of available evidence from case reports in EudraVigilance and from data submitted by the MAH, the PRAC has agreed that there is a reasonable possibility of a causal relationship between capillary leak syndrome and the use of trabectedin.
Danish: På baggrund af foreliggende evidens fra case-rapporter i EudraVigilance og data indsendt af indehaveren af markedsføringstilladelse har PRAC fastslået, at der er rimelig sandsynlighed for en årsagssammenhæng mellem kapillærlækage-syndrom og anvendelse af trabectedin.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction Amiodarone
Danish: Punkt 4.5 - Interaktion med andre lægemidler og andre former for interaktion Amiodaron
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on <brand name> when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Danish: Da disse tilfælde er potentielt livstruende, bør amiodaron kun anvendes hos patienter i behandling med <særnavn>, når andre antiarytmika ikke tolereres eller er kontraindiceret.
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating <brand name>.
Danish: Hvis samtidig brug af amiodaron findes nødvendig, anbefales tæt overvågning af patienterne ved initiering af behandlingen med <særnavn>.
English: Package Leaflet for Sovaldi, Harvoni, Daklinza Section 2 - What you need to know before you take <brand name> Warnings and precautions Talk to your doctor or pharmacist before taking <brand name> you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if have taken this medicine) Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
Danish: Indlægsseddel for Sovaldi, Harvoni og Daklinza Afsnit 2 - Det skal du vide, før du begynder at tage <særnavn> Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager <særnavn> hvis du får eller inden for de seneste måneder har fået lægemidlet amiodaron mod uregelmæssig hjerterytme (lægen kan overveje andre behandlinger, hvis du har taget dette lægemiddel) Sig det straks til lægen, hvis du tager et lægemiddel mod hjerteproblemer, og du under behandlingen oplever:
English: All patients receiving <brand name> in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Danish: Alle patienter, som får <særnavn> i kombination med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler, skal ligeledes advares om symptomerne på bradykardi og hjerteblok og tilrådes at søge øjeblikkelig lægehjælp, hvis de kommer ud for dem.
English: The PRAC has assessed cases of severe arrhythmia associated with the use of sofosbuvir (including in combination with ledipasvir) and/or daclatasvir, in particular in patients with established cardiac disorders and treated with bradycardic medications.
Danish: PRAC har vurderet tilfælde af svær arytmi ved brug af sofosbuvir (herunder i kombination med ledipasvir) og/eller daclatasvir, navnlig hos patienter med manifest hjertesygdom i behandling med bradykardifremkaldende lægemidler.
English: • The MAHs should closely monitor all cardiac events with and without the concomitant use of amiodarone, beta-blocking agents and other antiarrhythmic agents and present updates of the cumulative safety reviews in the next PSURs.
Danish: • Indehaverne af markedsføringstilladelse overvåger nøje alle kardiale hændelser med og uden samtidig anvendelse amiodaron, betablokkere og andre antiarytmika og fremlægger ajourføringer af den kumulative sikkerhedsoversigt i de kommende PSUR.
English: Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with {X}.
Danish: Pulmonal arteriel hypertension er iagttaget på forskellige tidspunkter under behandlingen, også flere år efter påbegyndelse af behandlingen med {X}.
English: • The MAHs of Sovaldi, Harvoni and Daklinza should submit a variation within 1 month, to amend the product information as described below (<new text underlined / text to be removed with strikethrough>)
Danish: • Indehaverne af markedsføringstilladelse for Sovaldi, Harvoni og Daklinza indsender inden for en måned en ansøgning om ændring af produktinformationen som beskrevet nedenfor (<ny tekst er understreget/tekst som skal slettes er gennemstreget>).
English: • Fainting Other medicines and <brand name> Tell your doctor if you take any of the following medicines: amiodarone, used to treat irregular heart beats
Danish: • besvimelsesanfald Brug af anden medicin sammen med <særnavn> Fortæl det til lægen, hvis du tager nogen af følgende lægemidler: amiodaron mod uregelmæssig hjerterytme
English: Therefore the PRAC has agreed that the marketing authorisation holders (MAHs) of interferon alfa and beta containing products should submit a variation within 2 months to amend the product information as described below (new text underlined):
Danish: PRAC har derfor vedtaget, at indehaverne af markedsføringstilladelse for lægemidler indeholdende interferon alfa og beta inden for to måneder indsender en ansøgning om ændring af produktinformationen som beskrevet nedenfor (ny tekst er understreget):
English: Section 4 - Possible side effects
Danish: Punkt 4.8 - Bivirkninger
English: Therefore, the MAH for trabectedin should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Danish: Indehaveren af markedsføringstilladelsen for trabectedin skal derfor inden for to måneder indsende en ansøgning om ændring af produktinformationen som beskrevet nedenfor (ny tekst er understreget).
English: Close monitoring is recommended if this medicinal product is administered with <brand name> (see sections 4.4 and 4.8).
Danish: Tæt overvågning anbefales, hvis dette lægemiddel administreres med <særnavn> (se pkt.
English: The long half-life of amiodarone should be considered when deciding on cases for reviews
Danish: Ved afgørelser om de gennemgåede tilfælde bør amiodarons lange halveringstid tages i betragtning
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with {X}.
Danish: Bivirkningerne kan indtræde på forskellige tidspunkter under behandlingen, typisk flere måneder efter påbegyndelse af behandlingen med {X}.
English: Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Danish: Under hyppighed kendes ikke (kan ikke vurderes ud fra de foreliggende oplysninger) tilføjes: Pulmonal arteriel hypertension - en sygdom, der medfører svær forsnævring af blodkarrene i lungerne med deraf følgende højt blodtryk i de blodkar, der fører blodet fra hjertet til lungerne.
English: • Palpitations
Danish: • svimmelhed
English: Cases of severe bradycardia and heart block have been observed when <brand name> is used in combination with <adapt according to the product> and concomitant amiodarone with or without other drugs that lower heart rate.
Danish: Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af <særnavn> i kombination med <tilpasses efter produktet> samtidig med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler.
English: [Interferon alfa-containing products]
Danish: [Lægemidler indeholdende interferon alfa]
English: Frequency ‘uncommon': Cases of suspected capillary leak syndrome have been reported with trabectedin.
Danish: Punkt 4.8 - Bivirkninger »Ikke almindelig«: Der er indberettet tilfælde af formodet kapillærlækage-syndrom med trabectedin.
English: Section 4.8 - Undesirable effects [Interferon alfa and beta containing products] “Pulmonary arterial hypertension*” should be added under the System Organ Class (SOC) “Respiratory, thoracic and mediastinal disorders” with the frequency “not known”.
Danish: Under systemorganklassen »luftveje, thorax og mediastinum« tilføjes »pulmonal arteriel hypertension*« med hyppighed »ikke kendt«.
English: Cases of severe bradycardia and heart block have been observed when <brand name> is used in combination with <adapt according to the product> and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Danish: Der er iagttaget svær bradykardi og hjerteblok ved anvendelse af <særnavn> i kombination med <tilpasses efter produktet> samtidig med amiodaron og/eller andre hjertefrekvenssænkende lægemidler (se pkt.
English: No clinically relevant effects on the pharmacokinetics of either medicinal product are expected when daclatasvir is coadministered with any of the following: PDE-5 inhibitors, medicinal products in the ACE inhibitor class (e.g. enalapril), medicinal products in the angiotensin II receptor antagonist class (e.g. losartan, irbesartan, olmesartan, candesartan, valsartan), amiodarone, disopyramide, propafenone, flecainide, mexilitine, quinidine or antacids.
Danish: irbesartan, olmesartan, candesartan, valsartan), amiodaron, disopyramid, propafenon, flecainid, mexilitin, kinidin eller antacida.
English: Pulmonary arterial hypertension [Interferon alfa-containing products]
Danish: Pulmonal arteriel hypertension
English: Summary of Product Characteristics for Sovaldi, Harvoni, Daklinza
Danish: Produktresumé for Sovaldi, Harvoni og Daklinza Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Svær bradykardi og hjerteblok
English: Statistical superiority was also analysed.
Danish: Statistisk superioritet blev også analyseret.
English: The overall occurence was low.
Danish: Den samlede forekomst var lav.
English: • Make sure to use the latest version
Danish: • Sørg for det er den nyeste version
English: Patients were followed-up for 2 years.
Danish: Patienterne blev fulgt i 2 år.
English: Data from non-interventional studies
Danish: Data fra non-interventionsstudier
English: Dear Patient,
Danish: Kære patient,
English: In addition, in a non-interventional study [Graham DJ et al., Circulation.
Danish: Ydermere, i et non-interventionsstudie [Graham DJ et al., Circulation.
English: Pradaxa is used in adults to:
Danish: Pradaxa anvendes til voksne for at:
English: 28-35 days
Danish: 28-35 dage
English: Cmax and AUC were dose proportional.
Danish: Cmax og AUC var dosisproportionale.
English: 2-3 days before (> 48 hours)
Danish: 2-3 dage før (> 48 timer)
English: % refers to yearly event rate
Danish: % refererer til den årlige event rate
English: Specific treatment options are available.
Danish: Specifikke behandlingsmuligheder er tilgængelige.
English: The increase was statistically significant in this study (p=0.022).
Danish: Stigningen var statistisk signifikant i sidstnævnte studie (p=0,022).
English: The half-life was independent of dose.
Danish: Halveringstiden var uafhængig af dosis.
English: - if you need to have an operation:
Danish: - hvis du har behov for en operation:
English: No human data available.
Danish: Der er ingen tilgængelige data for mennesker.
English: Similar values for CrCL were found in RE-COVER II.
Danish: Tilsvarende værdier for CrCL sås i RE-COVER II.
English: Your doctor may decide to keep you under closer observation or change your medicine.
Danish: Din læge kan i så fald beslutte at holde dig under nøje observation eller ændre din medicin.
English: The starting time of the VKA should be adjusted based on CrCL as follows:
Danish: Starttidspunkt for VKA bør justeres baseret på CrCL:
English: The effects of Pradaxa on pregnancy and the unborn child are not known.
Danish: Virkningen af Pradaxa på graviditet og et ufødt barn kendes ikke.
English: Pradaxa is dialyzable.
Danish: Pradaxa er dialyserbart.
English: Pradaxa is not recommended in children and adolescents below 18 years old.
Danish: Pradaxa anbefales ikke til børn og unge under 18 år.
English: • SSRIs or SNRIs
Danish: • SSRI eller SNRI
English: Age (years) 65 ≤ and < 75
Danish: Alder (år) 65 ≤ og < 75
English: These affect P-gp (either as inhibitor or as inducer).
Danish: Disse påvirker P-gp (enten som inhibitor eller som induktor).
English: • Keep this card with you at all times
Danish: • Bær altid kortet på dig
English: The patient population was 64 % male, 70 % Caucasian and 16 % Asian.
Danish: I patientpopulationen var 64 % mænd, og 70 % var kaukasiske og 16 % asiatiske.
English: • Recent biopsy, major trauma
Danish: • Nylig biopsi, større traume
English: Should not be performed
Danish: Bør ikke udføres
English: • The use of coagulation tests and their interpretation
Danish: • Brug af koagulationstest og tolkning af samme
English: Benefit-risk assessment
Danish: Benefit-risk-vurdering
English: It was demonstrated in a further study that slow and delayed absorption is usually only present on the day of surgery.
Danish: Et andet studie viste, at langsom og forsinket absorption normalt kun ses på operationsdagen.
English: Estimated half-life (hours)
Danish: Estimeret halveringstid (timer)
English: Take Pradaxa exactly as prescribed.
Danish: Tag Pradaxa nøjagtigt som foreskrevet.
English: Coagulation factor concentrates (activated or non-activated) or recombinant Factor VIIa may be taken into account.
Danish: Koagulationsfaktor-koncentrater (aktiveret eller ikke-aktiveret) eller rekombinant faktor VIIa kan overvejes.
English: Pradaxa ® Information for Patients About your treatment
Danish: Pradaxa ® Information til patienter Om din behandling
English: Therapy should be continued long term.
Danish: Behandlingen skal fortsættes på lang sigt.
English: No further increase in bioavailability was observed after another 7 days.
Danish: Efter yderligere 7 dage sås ingen øget biotilgængelighed.
English: Possible side effects are listed below, grouped by how likely they are to happen.
Danish: De nedenfor anførte mulige bivirkninger er grupperet efter, hvor ofte de kan forekomme:
English: Not calculable*
Danish: Ikke mulig at beregne*
English: Blister and bottle 3 years
Danish: Blister og beholder 3 år
English: Concomitant use should be avoided.
Danish: Samtidig anvendelse bør undgås.
English: which would be 1.3-fold upper limit of normal.
Danish: hvilket er 1,3 gange den øvre normalgrænse.
English: Pradaxa is for oral use.
Danish: Pradaxa er til oral anvendelse.
English: No rebound effect was observed.
Danish: Der blev ikke observeret nogen rebound-effekt.
English: Name of the patient
Danish: Patientens navn
English: Until then, INR values should be interpreted with caution.
Danish: Indtil da bør INRværdier tolkes med forsigtighed.
English: The physician educational pack should contain:
Danish: Uddannelsesmateriale for læger skal indeholde:
English: In all patients and especially in the elderly (>75 years), as renal impairment may be frequent in this age group:
Danish: Alle patienter og især ældre (> 75 år), da nedsat nyrefunktion kan forekomme hyppigt i denne aldersgruppe:
English: Do not stop taking Pradaxa without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early.
Danish: Du må ikke holde op med at tage Pradaxa uden først at tale med lægen, da risikoen for at udvikle en blodprop kan være større, hvis du stopper for tidligt med behandlingen.
English: In some cases these bleedings may not be obvious.
Danish: Sådanne blødninger er ikke altid synlige.
English: These patients require frequent observation for neurological signs and symptoms of spinal or epidural haematoma.
Danish: Disse patienter kræver hyppig observation for neurologiske tegn og symptomer på spinalt eller epiduralt hæmatom.
English: Totals of 2,076 patients (knee) and 3,494 (hip) were treated respectively.
Danish: I alt blev 2.076 patienter (knæ) og 3.494 (hofte) behandlet.