FrancophonIA/ELRC3.0 huggingface dataset:
English: PACKAGE LEAFLET: Credelio 12 mg chewable tablets for cats (0.5-2.0 kg) Credelio 48 mg chewable tablets for cats (>2.0-8.0 kg)
Danish: INDLÆGSSEDDEL: Credelio 12 mg, tyggetabletter, til katte (0,5-2,0 kg) Credelio 48 mg, tyggetabletter, til katte (> 2,0-8,0 kg)
English: For fleas, the onset of efficacy is within 12 hours of attachment for one month after product administration.
Danish: For lopper indtræder virkningen inden for 12 timer, efter loppen har bidt sig fast, inden for en måned efter administration af produktet.
English: For fleas, the onset of efficacy is within 4 hours of attachment for one month after product administration.
Danish: For lopper indtræder virkningen inden for 4 timer, efter loppen har bidt sig fast, inden for en måned efter administration af produktet.
English: The safety of the veterinary medicinal product in breeding queens has not been established.
Danish: Veterinærlægemidlets sikkerhed er ikke blevet fastlagt hos avlskatte.
English: PACKAGE LEAFLET: Credelio 56 mg chewable tablets for dogs (1.3-2.5 kg) Credelio 112 mg chewable tablets for dogs (>2.5-5.5 kg) Credelio 225 mg chewable tablets for dogs (>5.5-11 kg) Credelio 450 mg chewable tablets for dogs (>11-22 kg) Credelio 900 mg chewable tablets for dogs (>22-45 kg)
Danish: INDLÆGSSEDDEL: Credelio 56 mg, tyggetabletter, til hunde (1,3-2,5 kg) Credelio 112 mg, tyggetabletter, til hunde (>2,5-5,5 kg) Credelio 225 mg, tyggetabletter, til hunde (>5,5-11 kg) Credelio 450 mg, tyggetabletter, til hunde (>11-22 kg) Credelio 900 mg, tyggetabletter, til hunde (>22-45 kg)
English: Therefore, use of this veterinary medicinal product in kittens younger than 8 weeks of age or less than 0.5 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
Danish: Brugen af dette veterinærlægemiddel til behandling af killinger, der er under 8 uger gamle eller har en kropsvægt på mindre end 0,5 kg, bør derfor baseres på en benefit-risk-vurdering foretaget af den ansvarlige dyrlæge.
English: Use of this veterinary medicinal product in kittens younger than 8 weeks of age or less than 0.5 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
Danish: Brug af dette veterinærlægemiddel til behandling af killinger, der er under 8 uger gamle eller har en kropsvægt på mindre end 0,5 kg, bør baseres på en benefit-riskvurdering foretaget af den ansvarlige dyrlæge.
English: Sodium laurilsulfate Vanillin (flavour)
Danish: Crospovidon Natriumlaurilsulfat Vanillin (smagsstof) Silica, kolloid vandfri Magnesiumstearat
English: For ticks, the onset of efficacy is within 48 hours of attachment for one month after product administration.
Danish: For flåter indtræder virkningen inden for 48 timer, efter flåten har bidt sig fast, inden for en måned efter administration af produktet.
English: Credelio 56 mg chewable tablets for dogs (1.3-2.5 kg) Credelio 112 mg chewable tablets for dogs (>2.5-5.5 kg) Credelio 225 mg chewable tablets for dogs (>5.5-11 kg) Credelio 450 mg chewable tablets for dogs (>11-22 kg) Credelio 900 mg chewable tablets for dogs (>22-45 kg)
Danish: Credelio 56 mg, tyggetabletter, til hunde (1,3-2,5 kg) Credelio 112 mg, tyggetabletter, til hunde (>2,5-5,5 kg) Credelio 225 mg, tyggetabletter, til hunde (>5,5-11 kg) Credelio 450 mg, tyggetabletter, til hunde (>11-22 kg) Credelio 900 mg, tyggetabletter, til hunde (>22-45 kg)
English: The safety of the veterinary medicinal product in pregnant and lactating dogs has not been established.
Danish: Veterinærlægemidlets sikkerhed er ikke blevet fastlagt hos drægtige eller diegivende hunde.
English: Elanco
Danish: EXP
English: Parasites need to start feeding on the host to become exposed to lotilaner; therefore, the risk of the transmission of parasite borne diseases cannot be completely excluded.
Danish: Derfor kan risikoen for overførsel af parasitbårne sygdomme ikke fuldstændig udelukkes.
English: The safety of the veterinary medicinal product in breeding dogs has not been established.
Danish: Veterinærlægemidlets sikkerhed er ikke blevet fastlagt hos avlshunde.
English: For ticks, the onset of efficacy is within 24 hours of attachment for one month after product administration.
Danish: For flåter indtræder virkningen inden for 24 timer, efter flåten har bidt sig fast, inden for en måned efter administration af produktet.
English: Crospovidone Povidone K30 Sodium laurilsulfate
Danish: Povidon K30
English: In 24.3% of cases, the indication was unknown.
Danish: I 24,3 % af tilfældene var indikationen ukendt.
English: • The Committee considered the referral under Article 31 of Directive 2001/83/EC;
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 31 i Rådets direktiv 2001/83/EF.
English: These pathologies lead ultimately to blindness.
Danish: Disse patologier førte i sidste ende til blindhed.
English: These results were pooled without confirming the beneficial effect .
Danish: Disse resultater blev samlet uden, at den gavnlige virkning blev bekræftet.
English: Overall summary of the scientific evaluation of trimetazidine containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder trimetazidin (Se Bilag I)
English: None of these three studies was predefined as non-inferiority study.
Danish: Ingen af disse tre undersøgelser var prædefinerede som non-inferioritetsundersøgelser.
English: Ophthalmology
Danish: Oftalmologi
English: These cases have a low prevalence and are usually reversible after treatment discontinuation.
Danish: Disse tilfælde har en lav prævalens og er sædvanligvis reversible efter ophørt behandling.
English: The clinical experience with trimetazidine dates back to the early 70s.
Danish: Kliniske erfaringer med trimetazidin dateres tilbage til starten af 1970'erne.
English: Each study generally included multiple objectives (pharmacodynamic or clinical evaluations).
Danish: Hver undersøgelse omfattede generelt adskillige formål (farmakodynamiske eller kliniske evalueringer).
English: In doubtful cases, patients should be referred to a neurologist for appropriate investigations.
Danish: I tvivlsomme tilfælde bør patienter henvises til en neurolog for at blive undersøgt korrekt.
English: Trimetazidine medicinal products have been authorised in 21 European Member states.
Danish: Lægemidler, der indeholder trimetazidin, er godkendt i 21 EU-medlemsstater.
English: The CHMP considered all the studies submitted for this indication.
Danish: CHMP medtog alle studier, der blev indsendt til denne indikation.
English: Otology - Ear, Nose and Throat (ENT)
Danish: Otologi - øre, næse og hals
English: Annex II Scientific conclusions and grounds for variation to the terms of the Marketing Authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelsen
English: It should be noted that the study was conducted using the Bruce protocol that it is known to underestimate the treatment effect of drugs compared to the modified Bruce protocol.
Danish: Det bør bemærkes, at undersøgelsen blev udført ved hjælp af Bruce-protokollen, som er kendt for at undervurdere behandlingseffekten af lægemidler sammenlignet med den ændrede Bruce-protokol.
English: Among these studies, five studies were conducted against placebo including the additional study published in 1990 by Coyas.
Danish: Blandt disse undersøgelser blev der udført fem i forhold til placebo, herunder den ekstra undersøgelse, der blev offentliggjort i 1990 af Coyas.
English: Therefore, the results which were presented as supporting a similar efficacy than trimetazidine are not reliable.
Danish: Derfor er resultaterne, der blev fremlagt som understøttende for en lignende virkning som trimetazidin, ikke pålidelige.
English: The analysis performed by the MAH has been repeated independently by the Italian Institutes of Health (ISS).
Danish: Den analyse, som indehaveren af markedsføringstilladelsen udførte, er uafhængigt blevet gentaget af det italienske sundhedsinstitut (»Istituto Superiore di Sanità« - ISS).
English: A significant difference was also evidenced for the time to onset of angina pectoris (p=0.049).
Danish: Der sås også en signifikant forskel i tiden til fremkomst af angina pectoris (p=0,049).
English: Its mechanism of action results partly of its effect on cellular metabolism.
Danish: Dets virkningsmekanisme skyldes delvist dets virkning på cellemetabolisme.
English: In addition, Vitte study (2002) had the same methodological weaknesses as the Wayoff and Morgon studies.
Danish: Derudover havde Vitte-undersøgelsen (2002) samme metodologiske svaghed som Wayoff- og Morgon-undersøgelserne.
English: The efficacy of trimetazidine was also summarised in a recent network meta-analysis including 358 clinical trials and 27058 patients.
Danish: Virkningen af trimetazidin blev også opsummeret i en nylig netværksmetaanalyse, der omfattede 358 kliniske undersøgelser og 27 058 patienter.
English: Finally, the most recent study using an appropriate methodology was submitted only for safety purpose as the efficacy objective was not reached (France ARMD 2, 2008).
Danish: Endelig blev den seneste undersøgelse, hvori den korrekte metodologi blev anvendt, kun indsendt af sikkerhedsformål, idet effektmålet ikke blev nået (Frankrig, ARMD 2
English: The Sellier study was an exercise study not primarily designed to assess clinical parameters.
Danish: Sellier-undersøgelsen var et studie af arbejdsbelastning, der ikke primært var designet til at vurdere kliniske parametre.
English: France on 22 April 2011 requested the CHMP to give its opinion under Article 31 of Directive 2001/83/EC on whether the marketing authorisation for trimetazidine-containing medicinal products should be maintained, varied, suspended or withdrawn on the basis of the increased Parkinson's reports.
Danish: Frankrig anmodede den 22. april 2011 Udvalget for Lægemidler til Mennesker (CHMP) om at afgive en udtalelse i henhold til artikel 31 i Rådets direktiv 2001/83/EF om, hvorvidt markedsføringstilladelsen til lægemidler, der indeholder trimetazidin, bør opretholdes, ændres, suspenderes eller trækkes tilbage på grundlag af det stigende antal rapporter om Parkinsons sygdom.
English: The most exposed population based on sales data, is patients aged more than 75 years old, and they received the treatment for very long periods mainly in cardiology indications.
Danish: Den mest eksponerede population, baseret på salgstal, er patienter over 75 år, og de fik behandlingen i meget lange perioder, hovedsageligt for kardiologiske indikationer.
English: If parkinsonian symptoms persist more than four months after drug discontinuation, a neurologist opinion should be sought.
Danish: Hvis parkinsonsymptomer vedvarer efter mere end fire måneder efter seponering af lægemidlet, bør en neurolog konsulteres.
English: Dose titration in elderly patients should be exercised with caution.
Danish: Dosistitrering hos ældre patienter bør foretages med forsigtighed.
English: The new proposed wording in the angina pectoris indication is in accordance with the available efficacy and safety data assessed.
Danish: Den nye, foreslåede formulering af indikationen for angina pectoris er i overensstemmelse med de tilgængelige, vurderede data for virkning og sikkerhed.
English: The study results may thus be considered conservative in terms of magnitude of the effect of trimetazidine.
Danish: Undersøgelsens resultater kan dermed betragtes som konservative for så hvad angår omfanget af trimetazidins virkning.
English: They were first authorised in France in 1978 and are available in three different pharmaceutical forms in the EU: 20 mg tablet, 20 mg/ml oral solution and 35 mg modified release (MR) tablet.
Danish: De blev først godkendt i Frankrig i 1978 og fås i tre forskellige lægemiddelformer i EU: 20 mg tablet, 20 mg/ml oral opløsning og 35 mg depottablet.
English: Of note, all the data submitted and assessed for this referral are newly available data since the first authorisation of trimetazidine.
Danish: Det bør bemærkes, at alle indsendte og vurderede data for denne indbringelse er nyligt tilgængelige data efter den første godkendelse af trimetazidin.
English: The majority of the patients who recovered, had their symptoms disappeared within four months after trimetazidine withdrawal.
Danish: Hos størstedelen af de patienter, der blev raske, forsvandt symptomerne inden for fire måneder efter seponering af trimetazidin.
English: The presence of stable angina pectoris is a pivotal inclusion criterion as it identifies the target population for the use of anti-anginal drugs.
Danish: Tilstedeværelsen af stabil angina pectoris er et betydningsfuldt inklusionskriterium, da det fastsætter målgruppen for brug af antianginøse lægemidler.
English: The CHMP endorsed a communication, Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review.
Danish: CHMP godkendte en DHPC-meddelelse (»Dear Healthcare Professional Communication«) for at videregive resultatet af den nuværende udredning.
English: These changes are considered adequate to manage the risk of pakinsonian symptoms and tremors.
Danish: Disse ændringer anses som værende tilstrækkelige til at håndtere risikoen for parkinsonsymptomer og tremor.
English: Of the ten studies submitted, nine do not apply the relevant methodological principles currently required to demonstrate efficacy.
Danish: Ud af de ti indsendte undersøgelser er de ni ikke tilpasset de relevante principper for den metodologi, der aktuelt kræves til påvisning af en virkning.
English: The most recent study conducted with trimetazidine 35 mg from 1999 (France, ARMD 2) related to a higher number of patients monitored for 3 to 5 years.
Danish: Den seneste undersøgelse med trimetazidin 35 mg fra 1999 (Frankrig, ARMD 2) vedrørte et større antal patienter, der blev overvåget i 3 til 5 år.
English: The reporting rate of Parkinson's syndrome plausibly related to trimetazidine is stable over time since the last 8 years, despite the increase, since 2007, in the number of spontaneous reports of Parkinson's syndrome and related symptoms.
Danish: Rapporteringsfrekvensen for Parkinsons syndrom med mulig relation til trimetazidin har været stabil over tid de seneste 8 år på trods af en stigning siden 2007 i antallet af spontane rapporteringer af Parkinsons syndrom og beslægtede symptomer.
English: A prescription study in France showed that trimetazidine was prescribed in patients in cardiovascular indications in 45.3% of cases, in ENT indications in 30% of cases and in ophthalmological indications in 0.4% of cases.
Danish: En receptundersøgelse i Frankrig viste, at trimetazidin blev ordineret til patienter for kardiovaskulære indikationer i 45,3 % af tilfældene, for øre-næse-hals-indikationer i 30 % af tilfældene og for oftalmologiske indikationer i 0,4 % af tilfældene.
English: In response to the CHMP's request regarding the re-evaluation of the risk/benefit ratio of trimetazidine (all forms and dosages) in its ophthalmologic indications, the clinical package submitted comprises of nine studies.
Danish: Som svar på CHMP's anmodning om reevaluering af risk/benefit-forholdet for trimetazidin (alle former og doseringer) til oftalmologiske indikationer omfatter den indsendte, kliniske pakke ni undersøgelser.
English: Less than 50% of patients included in the VASCO study had chronic stable angina despite probable coronary artery disease.
Danish: Under 50 % af de indskrevne patienter i VASCO-undersøgelsen havde kronisk, stabil angina på trods af mulig koronararteriesygdom.
English: Two additional and more recent studies were focused on dizziness but the exploratory nature of the Sterkers study (2001) and the extremely small populations included (28 patients) do not make it possible to give any demonstrative weight to the results reported.
Danish: To yderligere og senere undersøgelser fokuserede på svimmelhed, men Sterkers-undersøgelsens (2001) eksplorative art og de ekstremt små inkluderede populationer (28 patienter) gør det ikke muligt at anvende de rapporterede resultater med overbevisende vægt.
English: Of importance the efficacy was confirmed in patients at maximal dose of metoprolol as well as in patients with recurrent angina.
Danish: Af betydning kan nævnes, at virkningen blev bekræftet hos patienter ved en maksimal dosis metoprolol samt hos patienter med recidiverende angina.
English: The VASCO study was conducted in symptomatic and asymptomatic patients with chronic ischemic heart disease.
Danish: VASCO-undersøgelsen blev udført med symptomatiske og asymptomatiske patienter med kronisk, iskæmisk hjertesygdom.
English: Trimetazidine has no hemodynamic effect on blood pressure or heart rate.
Danish: Trimetazidin har ingen hæmodynamisk virkning på blodtryk eller hjertefrekvens.
English: However, some patients had symptoms only partially reversible after TMZ withdrawal, and the connection to TMZ in some cases of non-reversible symptoms cannot be ruled out.
Danish: Visse patienter havde imidlertid symptomer, der kun delvist var reversible efter seponering af trimetazidin, og forbindelsen til trimetazidin kan i visse tilfælde af ikke-reversible symptomer ikke udelukkes.
English: • The Committee reviewed all available submitted data from clinical studies, published literature and post-marketing experience on the safety of trimetazidine containing medicinal products, in particular with regards to the Parkinson syndrome and related events.
Danish: • Udvalget gennemgik alle tilgængelige, indsendte data fra kliniske undersøgelser, offentliggjort litteratur og erfaringer efter markedsføring om sikkerheden af lægemidler, der indeholder trimetazidin, især med hensyn til Parkinsons syndrom og beslægtede hændelser.
English: The studies suggested limited methodology in the ENT field and do not confirm the current methodology of investigation by applying the basic statistical principles of clinical trials methodology.
Danish: Undersøgelserne tydede på en begrænset metodologi inden for ørenæse-hals-området og bekræfter ikke den aktuelle undersøgelsesmetodologi, som anvender de grundlæggende, statistiske principper for metodologi i kliniske undersøgelser.
English: Patients with a cardiovascular profile were significantly older (mean age: 74.8 years) than those with an ophthalmological and ENT profile (70.3 years and 63.5 years, respectively).
Danish: Patienter med en kardiovaskulær profil var signifikant ældre (gennemsnitsalder på 74,8 år) end patienter med en oftalmologisk profil eller en øre-næse-halsprofil (hhv. 70,3 år og 63,5 år).
English: In addition the two studies by Manchanda (1997 and 2003) and four other minor studies are considered supportive of the efficacy of trimetazidine in add-on to calcium channel blockers (CCBs).
Danish: Derudover anses de to undersøgelser af Manchanda (1997 og 2003) og fire andre mindre undersøgelser som understøttende for virkningen af trimetazidin som supplement til calciumkanalblokkere (CCB'er).
English: By decreasing fatty acid oxidation at the level of 3-ketoacyl coenzyme A thiolase, it favours glucose oxidation, which improves the use of the cells' energy reserves in the event of ischaemia.
Danish: Ved at nedsætte fedtsyreoxidationen på niveau med 3ketoacylcoenzym A-thiolase fremmer det glucoseoxidationen, hvilket forbedrer brugen af cellernes energireserver i tilfælde af iskæmi.
English: The VASCO study showed a significant difference in the effect on ergometric parameters between trimetazidine at the highest dosage (140 mg) and placebo in the group of symptomatic patients.
Danish: VASCO-undersøgelsen viste en signifikant forskel i virkningen på ergometriske parametre mellem trimetazidin ved den højeste dosering (140 mg) og placebo i gruppen af symptomatiske patienter.
English: The TRIMPOL-II showed that trimetazidine significantly improves exercise capacity and exerciseinduced myocardial ischemia when added to metoprolol.
Danish: TRIMPOL-II viste, at trimetazidin signifikant forbedrer belastningskapaciteten og belastningsinduceret myokardiel iskæmi, når det tilsættes metoprolol.
English: They are studies whereby the results, often presented as statistically in favour of trimetazidine, are disputable mainly for methodological reasons.
Danish: Disse undersøgelsers resultater, som i statistikken ofte var til fordel for brug af trimetazidin, kan diskuteres, hovedsageligt af metodologiske årsager.
English: However, the TRIMPOL-II study (2001), the study by Sellier (2003) and the revised data from the VASCO study (2011) were the studies providing evidence generated in support of the add-on indication of trimetazidine in symptomatic patients with angina pectoris.
Danish: TRIMPOL-II-undersøgelsen (2001), undersøgelsen af Sellier (2003) og de reviderede data fra VASCO-undersøgelsen (2011) var imidlertid undersøgelser, der genererede evidens som støtte for den ekstra indikation for trimetazidin til symptomatiske patienter med angina pectoris.
English: The main studies conducted versus placebo were Wayoff study (tinnitus, dizziness, hearing loss) and Morgon study (tinnitus).
Danish: De vigtigste undersøgelser, der blev udført i forhold til placebo, var Wayoffundersøgelsen (tinnitus, svimmelhed, høretab) og Morgon-undersøgelsen (tinnitus).
English: The non-comparative nature of three studies conducted in patients with heterogeneous ocular disorders, did not allow concluding to the existence of a clinical benefit.
Danish: Som følge af den ikke-komparative metode i de tre undersøgelser, der blev udført med patienter med heterogene øjensygdomme, er det ikke muligt at konkludere om, hvorvidt der foreligger en klinisk fordel.
English: Some new potential, very rare and reversible adverse effects were highlighted during the referral procedure, including trombocytopenia, agranulocytosis and liver dysfunction and have been included in the risk management plan (RMP) and reflected in the relative sections of the SmPC.
Danish: Visse nye, potentielle, meget sjældne og reversible bivirkninger blev fremhævet under proceduren for indbringelse af sager, inklusive trombocytopeni, agranulocytose og nedsat leverfunktion, og er blevet inkluderet i risikostyringsplanen og nævnt i de relevante afsnit i produktresuméet.
English: They also mixed ENT pathologies and symptomatologies from different etiologies such as tinnitus, different kinds of vertigo or deafness.
Danish: De blandede også øre-næse-halspatologier og symptomatologier fra forskellige ætiologier såsom tinnitus, forskellige former for vertigo eller døvhed.
English: In order to show a benefit on daily episodes of angina it is important to adequately assess the baseline occurrence of angina and sublingual nitrate use and to calculate the sample size on the basis of the expected treatment effect.
Danish: For at vise en gavnlig virkning på daglige anginaepisoder er det vigtigt i tilstrækkelig grad at vurdere forekomsten af angina ved baseline og brugen af sublingual nitrat samt beregne prøvestørrelsen ud fra den forventede behandlingseffekt.
English: In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) the recommended dose has been added in the SmPC.
Danish: For patienter med moderat nedsat nyrefunktion (creatinin-clearance [30-60] ml/min) er den anbefalede dosis blevet tilføjet i produktresuméet.
English: Most ophthalmologic trimetazidine clinical trials have been conducted with the 20 mg strength but in some studies the daily doses used (20mg and 40 mg/day) were lower than those recommended in the current marketing authorisation (60 mg or 70 mg), which is also a limit of these studies, particularly in documenting the safety at the registered dosage.
Danish: De fleste oftalmologiske kliniske undersøgelser med trimetazidin er blevet udført med en dosering på 20 mg, men i nogle undersøgelser anvendtes daglige doseringer (20 mg og 40 mg/dag), som var lavere end dem, der anbefales i den nuværende markedsføringstilladelse (60 mg eller 70 mg), hvilket også udgør en begrænsning i forhold til disse undersøgelser, især hvad angår påvisning af sikkerheden ved den registrerede dosering.