FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names remains positive, subject to amendments in the product information.
Danish: På grundlag af de foreliggende data fandt CVMP, at benefit/risk-forholdet for Baytril 2.5% injectable, Baytril 5% injectable og Baytril 10% injectable og relaterede navne fortsat er positivt, forudsat at der foretages ændringer i produktinformationen.
English: Opinion following an Article 340F referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names EMA/538940/2014
Danish: Udtalelse efter en artikel 34-indbringelse0F for Baytril 2.5% injectable, Baytril 5% injectable og Baytril 10% injectable og relaterede navne EMA/538940/2014
English: Opinion following an Article 341 referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names
Danish: Udtalelse efter en artikel 34-indbringelse1 for Baytril 2.5% injectable, Baytril 5% injectable og Baytril 10% injectable og relaterede navne
English: 28 months.
Danish: 28 måneder.
English: There were corresponding decreases in OFF time.
Danish: Der var et tilsvarende fald i OFF tid.
English: In individual cases, only some of these symptoms and/or findings may be evident.
Danish: I enkelte tilfælde er kun nogle af disse symptomer og/eller fund tilstede.
English: Poly(vinyl alcohol) Talc
Danish: Poly(vinylalkohol) Talcum
English: After taking one of them, wait at least 2 to 3 hours before taking the other.
Danish: Vent mindst 2 til 3 timer efter at du har taget det ene af dem, til du tager det andet.
English: Follow the instructions that your doctor has given you.
Danish: Følg den vejledning lægen har givet dig.
English: Titanium dioxide (E171) Macrogol
Danish: Titandioxid (E171) Macrogol
English: Approximately 10-20% is excreted in urine.
Danish: Omkring 10-20% udskilles i urinen.
English: The results are given in Table 2.
Danish: Resultaterne fremgår af Tabel 2.
English: Review of treatment is recommended if such symptoms develop.
Danish: Det anbefales at genoverveje behandlingen, hvis disse symptomer opstår.
English: Management of acute overdose is symptomatic.
Danish: Behandling af en akut overdosis er symptomatisk.
English: See Section 2 Warnings and precautions.
Danish: Se punkt 2 Advarsler og forsigtighedsregler.
English: The amount of levodopa available to the brain is increased.
Danish: Mængden af tilgængelig levodopa til hjernen øges.
English: It is estimated that 80-90% of the dose is excreted in faeces, although this has not been confirmed in man.
Danish: Det skønnes, at 80-90% af en dosering udskilles i fæces, selvom dette ikke er verificeret i mennesket.
English: Other important side effects which may occur:
Danish: Følgende vigtige bivirkninger kan også forekomme:
English: Of the metabolites found in urine only about 1% have been formed through oxidation.
Danish: Af de metabolitter, der findes i urinen, er kun ca. 1% omdannet via oxidation.
English: Therefore, do not take Entacapone Teva and iron supplements at the same time.
Danish: Du må derfor ikke tage Entacapone Teva og jerntilskud på samme tid.
English: Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Danish: Fortæl din læge, hvis du oplever nogen af disse symptomer; Lægen vil diskutere måder at reducere og kontrollere disse symptomer.
English: In study I, daily ON time (hours) was measured from home diaries and in study II, the proportion of daily ON time.
Danish: I studie I blev daglig ON tid (timer) målt ud fra hjemmedagbøger og i studie II andelen af daglig ON tid.
English: A small amount of entacapone, the (E)-isomer, is converted to its (Z)-isomer.
Danish: En lille mængde entacapon, (E)-isomeren, omdannes til (Z)-isomeren.
English: Ísland ratiopharm Oy Finnland
Danish: Ratiopharm Oy Finnland
English: 4.5% (0 h 35 min) CI95% 0.93%, 7.97%
Danish: 4,5% (0 t 35 min) CI95%, 0,93%, 7,97%
English: General characteristics of the active substance
Danish: Generelle karakteristika af det aktive indholdsstof
English: Absorption There are large intra- and interindividual variations in the absorption of entacapone.
Danish: Absorption Der er store intra- og internindividuelle variationer i absorptionen af entacapon.
English: Reduction of levodopa dosage decreases the severity and frequency of these reactions.
Danish: Reduktion af levodopadosis nedsætter sværhedsgraden og hyppigheden af disse bivirkninger.
English: This leads to a higher levodopa AUC.
Danish: Dette medfører højere levodopa AUC.
English: Your doctor may need to review your treatments.
Danish: Der kan være behov for, at din læge ændrer din behandling.
English: • if you have liver disease;
Danish: • hvis du har en leversygdom;
English: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen Hungary
Danish: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen Ungarn
English: The total clearance of entacapone is about 800 ml/min.
Danish: Den totale clearance af entacapon er ca. 800 ml/min.
English: Approximately 92% of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
Danish: Cirka 92% af en dosis elimineres under betaeliminationsfasen med en eliminationshalveringstid på 30 minutter.
English: Pharmacokinetic interaction with benserazide has not been studied.
Danish: Farmakokinetiske interaktioner med benserazid er ikke undersøgt.
English: The % change from baseline in OFF time was -24% in the entacapone group and 0% in the placebo group in study I. The corresponding figures in study II were -18% and -5%.
Danish: Den %-vise ændring fra baseline i OFF tid var -24% i entacapongruppen og 0% i placebogruppen i undersøgelse I. De tilsvarende resultater er -18% og -5% for undersøgelse II.
English: The post-marketing data include isolated cases of overdose in which the reported highest daily dose of entacapone has been 16,000 mg.
Danish: Data efter markedsføring inkluderer enkeltstående tilfælde af overdosering, hvor den højest rapporterede daglige dosis af entacapon var 16.000 mg.
English: Prolonged or persistent diarrhoea appearing during use of entacapone may be a sign of colitis.
Danish: Længerevarende eller vedvarende diarré, der optræder ved anvendelse af entacapon, kan være tegn på colitis.
English: In human plasma the unbound fraction is about 2.0% in the therapeutic concentration range.
Danish: I humant plasma er den ikke bundne fraktion ca. 2,0% i det terapeutiske koncentrationsområde.
English: The bioavailability of entacapone is about 35% after an oral dose.
Danish: Biotilgængeligheden er ca. 35% efter en oral dosering.
English: Clinical interaction studies with diazepam and non-steroidal antiinflammatory medicinal products have not been carried out.
Danish: Kliniske interaktionsforsøg med diazepam og non steroide antiinflammatoriske lægemidler er ikke udført.
English: It is a reversible, specific, and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa preparations.
Danish: Det er en reversibel, specifik og primært perifert virkende COMT-hæmmer udviklet til samtidig administration med levodopapræparater.
English: Only traces of entacapone are found unchanged in urine.
Danish: Kun spormængder af entacapon udskilles uændret i urinen.
English: Very common: Dyskinesia Common:
Danish: Meget almindelig: Dyskinesi Almindelig:
English: Entacapone may be used with selegiline (a selective MAO-B inhibitor), but the daily dose of selegiline should not exceed 10 mg.
Danish: Entacapon kan anvendes med selegilin (en selektiv MAO-B-hæmmer), men den daglige dosis af selegilin bør ikke overstige 10 mg.
English: • if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure);
Danish: • hvis du har en svulst på binyren (kaldet fæokromocytoma; det kan øge risikoen for svært forhøjet blodtryk);
English: Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: Fortæl din læge, hvis du eller din familie/behandler bemærker, at du udvikler stærk trang eller adfærd, som er usædvanlig for dig, eller hvis du ikke kan modstå lysten eller fristelsen for at udføre bestemte aktiviteter, som kan skade dig selv eller andre.
English: In the event of prolonged or persistent diarrhoea, the medicinal product should be discontinued and appropriate medical therapy and investigations considered.
Danish: I tilfælde af længerevarende eller vedvarende diarré bør lægemidlet seponeres og passende behandling og undersøgelser overvejes.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: The (Z)-isomer and traces of other metabolites account for the remaining 5%.
Danish: (Z)-isomeren og andre metabolitter udgør de resterende 5%.
English: As there is no experience in pregnant women, entacapone should not be used during pregnancy.
Danish: Da der ikke er erfaring med administration af entacapon til gravide kvinder, bør entacapon ikke anvendes under graviditet.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V*.
English: Entacapone and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Danish: Entacapon og jernpræparater bør tages med mindst 2-3 timers mellemrum (se pkt.
English: When Entacapone Teva is given at higher doses:
Danish: Hvis Entacapone Teva gives i større doser:
English: You may also use other medicines to treat Parkinson's disease at the same time.
Danish: Du kan også tage anden medicin til behandling af Parkinsons sygdom samtidigt.
English: The pharmacokinetic properties of entacapone are similar in both young and elderly adults.
Danish: De farmakokinetiske egenskaber for entacapon er de samme både i unge og ældre patienter.
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18 % [CI90 11-26%].
Danish: I et interaktionsstudie med raske forsøgspersoner sås ingen ændringer af S-warfarin på plasmaniveau, mens AUC for R-warfarin i gennemsnit øgedes med 18 % [CI90 11-26%].
English: Date of first authorisation: 18/02/2011 Date of latest renewal: 19/11/2015
Danish: Dato for fornyelse: 19/11/2015
English: ** The incidence rates of myocardial infarction and other ischemic heart disease events (0.43% and 1.54%, respectively) are derived from an analysis of 13 double-blind studies involving 2082 patients with end-of-dose motor fluctuations receiving entacapone.
Danish: ** Incidensraterne af myokardieinfarkt og andre tilfælde af iskæmisk hjertesygdom (henholdsvis 0,43% og 1,54%) stammer fra en analyse af 13 dobbeltblinde undersøgelser med 2.082 patienter med motoriske end-of-dose fluktuationer, der fik entacapon.
English: After absorption from the gastrointestinal tract, entacapone is rapidly distributed to the peripheral tissues with a distribution volume of 20 litres at steady state (Vdss).
Danish: Efter absorption fra mave-tarmkanalen fordeles entacapon hurtigt til de perifere væv med et fordelingsvolumen på 20 liter ved steady state (Vdss).
English: Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Danish: Entacapon bindes til humant albumin - bindingssted II, hvilket også kan binde adskillige andre lægemidler inklusive diazepam og ibuprofen.
English: The daily dose of levodopa should be reduced by about 10-30% by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Danish: Den daglige dosis af levodopa bør eventuelt reduceres med 10-30% ved at forlænge doseringsintervallet og/eller ved at reducere mængden af levodopa pr. dosis, afhængig af patientens kliniske tilstand.
English: Entacapone is extensively bound to plasma proteins, mainly to albumin.
Danish: Entacapon bindes betydeligt til plasmaproteiner, primært til albumin.
English: Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
Danish: Dyskinesier (27%), kvalme (11%), diarré (8%), abdominal smerte (7%) og mundtørhed (4,2%) blev rapporteret signifikant hyppigere med entacapon end placebo i samlede (poolede) data fra kliniske studier, hvor 406 patienter har fået den aktive medicin, og 296 patienter har fået placebo.
English: Because of its mechanism of action, entacapone may interfere with the metabolism of medicinal products containing a catechol group and potentiate their action.
Danish: På grund af sin virkningsmekanisme kan entacapon indvirke på metabolismen af stoffer, der indeholder en catechol-gruppe og potensere deres effekt.
English: The (E)-isomer accounts for 95% of the AUC of entacapone.
Danish: (E)-isomeren udgør ca. 95% af AUC for entacapon.
English: Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19) (see section
Danish: Entacapon udviser lav eller ingen hæmning af andre typer af P450 isoenzymer (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A og CYP2C19) (se pkt.
English: 1 h 20 min CI95% 45 min, 1 h 56 min
Danish: CI95%, 45 min, 1 t 56 min
English: • if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury.
Danish: • hvis du tidligere har haft en sjælden muskelsygdom, der kaldes rhabdomyolyse, som ikke var udløst af en skade.
English: If this happens, you should not drive or use any tools or machines (see Driving and using machines).
Danish: Hvis dette sker, må du ikke køre bil eller betjene maskiner (se Trafik- og arbejdssikkerhed).
English: Some of the adverse reactions, such as dyskinesia, nausea, and abdominal pain, may be more common with the higher doses (1,400 to 2,000 mg per day) than with the lower doses of entacapone.
Danish: Visse af disse bivirkninger, som dyskinesier, kvalme og abdominale smerter, kan være hyppigere ved højere doser (1.400-2.000 mg per dag) end ved lavere doser af entacapon.
English: Mogilska 80, 31-546, Krakow Poland
Danish: Mogilska 80, 31-546, Krakow Polen
English: If you experience such effects at the start of treatment with Entacapone Teva you should contact your doctor who may decide to adjust your dosage of levodopa.
Danish: Hvis du oplever sådanne bivirkninger i begyndelsen af behandlingen med Entacapone Teva, skal du kontakte din læge, som kan vælge at justere din levodopadosis.
English: Entacapone can be taken with or without food (see section 5.2).
Danish: Entacapon kan indtages sammen med eller uden fødeindtagelse (se pkt.
English: According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
Danish: Ifølge in vitro forsøg er signifikantforskydning ikke forekommet ved terapeutiske koncentrationer af lægemidlet.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: COMT inhibition in red blood cells closely follows the plasma concentrations of entacapone, thus clearly indicating the reversible nature of COMT inhibition.
Danish: COMT-inhiberingen i de røde blodlegemer følger tæt plasmakoncentrationen, hvilket indikerer den reversible natur af COMThæmningen.
English: • if you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6);
Danish: • hvis du er (allergisk over for entacapon eller et af de øvrige indholdsstoffer i Entacapone Teva (angivet i punkt 6);
English: The safety of entacapone in infants is unknown.
Danish: Sikkerheden ved administration af entacapon til børn er ukendt.
English: Do not use this medicine after the expiry date which is stated on the carton and tablet container label after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og på etiketten på tabletbeholderen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: 305, 74770 Opava-Komarov Czech Republic
Danish: 305, 74770 Opava-Komarov Tjekkiet
English: EU/1/10/665/001 - 30 tablets EU/1/10/665/002 - 60 tablets EU/1/10/665/003 - 100 tablets EU/1/10/665/004 - 175 tablets
Danish: EU/1/10/665/001 - 30 tabletter EU/1/10/665/002 - 60 tabletter EU/1/10/665/003 - 100 tabletter EU/1/10/665/004 - 175 tabletter
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Entacapone Teva and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Danish: Malignt neuroleptika syndrom (NMS) er en alvorlig, men sjælden reaktion på visse lægemidler, som især kan forekomme, hvis behandling med Entacapone Teva og andre lægemidler til behandling af Parkinsons sygdom pludseligt stoppes, eller hvis dosis pludseligt nedsættes.
English: • if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS).
Danish: • hvis du tidligere har haft en sjælden reaktion på antipsykotisk medicin kaldet malignt neuroleptikasyndrom (NMS).
English: Patients should be regularly monitored for the development of impulse control disorders.
Danish: Patienter skal monitoreres regelmæssigt for udvikling af patologiske vane- og impulshandlinger.
English: EU/1/10/665/002 - 60 tablets EU/1/10/665/003 - 100 tablets EU/1/10/665/004 - 175 tablets
Danish: EU/1/10/665/002 - 60 tabletter EU/1/10/665/003 - 100 tabletter EU/1/10/665/004 - 175 tabletter
English: Starch, pregelatinised Magnesium stearate
Danish: Stivelse, prægelatiniseret Magnesiumstearat
English: 305, 74770 Opava-Komarov, Czech Republic
Danish: 305, 74770 Opava-Komarov, Den Tjekkiske Republik
English: Entacapone (n=85) Placebo (n=86)
Danish: Placebo (n=86)
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 ~4 μM).
Danish: Data fra in vitro forsøg, hvor der er anvendt humant levermikrosomalt materiale, indikerer at entacapon hæmmer cytokrom P450 2C9 (IC50 ~4 µM).
English: Entacapone should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Danish: Entacapon bør gives med forsigtighed til patienter, der tager andre lægemidler, som forårsager ortostatisk hypotension.
English: If you are receiving dialysis for renal insufficiency, your doctor may tell you to increase the time between doses.
Danish: Hvis du er i dialyse på grund af nedsat nyrefunktion, vil din læge måske bede dig om at øge tiden mellem doserne.
English: Therefore, caution should be exercised when driving or using machines.
Danish: Derfor bør forsigtighed udvises, når der føres bil eller betjenes maskiner.
English: Nederland
Danish: Nederlandene
English: Some of the side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment.
Danish: Nogle af bivirkningerne skyldes oftest en øget virkning af levodopabehandlingen og er mest almindelige i begyndelsen af behandlingen.
English: Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
Danish: Hverken MNS eller rhabdomyolyse er blevet rapporteret i forbindelse med entacaponbehandling i kontrollerede studier, hvor entacaponbehandling blev brat afsluttet.
English: Suddenly stopping Entacapone Teva and other medicines to treat Parkinson´s disease may result in unwanted side effects.
Danish: Pludseligt stop med brug af Entacapone Teva og anden medicin til behandling af Parkinsons sygdom kan give uønskede bivirkninger.
English: The following adverse reactions, listed below in Table 1, have been accumulated both from clinical studies with entacapone and since the introduction of entacapone into the market.
Danish: Bivirkningerne listet i nedenstående Tabel 1 er akkumuleret både fra kliniske studier med entacapon og efter markedsføring af entacapon.
English: Regarding reproduction toxicity, decreased foetal weight and a slightly delayed bone development were noticed in rabbits at systemic exposure levels in the therapeutic range.
Danish: Med hensyn til reproduktionstoksicitetsforsøg sås lavere fostervægt og let forsinket knogleudvikling hos kaniner ved systeiske eksponeringsniveauer i det terapeutiske område.
English: Iron oxide yellow (E172) Lecithin (soya) Iron oxide red (E172)
Danish: Jernoxid-gul (E172) Lecithin, soja Jernoxid-rød (E172)
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Danish: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Storbritannien
English: Your doctor may advise you to slowly discontinue the treatment with Entacapone Teva and other medicines to treat Parkinson's disease.
Danish: Din læge kan råde dig til langsomt at stoppe behandlingen med Entacapone Teva og andre lægemidler til behandling af Parkinsons sygdom.
English: The metabolism of the medicinal product is slowed in patients with mild to moderate liver insufficiency (Child-Pugh Class A and B), which leads to an increased plasma concentration of entacapone in both the absorption and elimination phases (see section 4.3).
Danish: Entacapons metabolisme er nedsat i patienter med mild til moderat leverinsufficiens (Child-Pugh klasse A og B), hvilket medfører øget plasmakoncentration af entacapon i både absorptions- og eliminationsfasen (se pkt.
English: Hence, patients who are taking standard levodopa/benserazide preparations may need a larger reduction of levodopa dose when entacapone is initiated.
Danish: Dette kan medføre, at patienter, der behandles med levodopa/benserazidstandardformuleringer, behøver en større reduktion af deres levodopadosis, når entacaponbehandlingen påbegyndes.
English: Pharmacotherapeutic group: other dopaminergic agents, ATC code: N04BX02.
Danish: Farmakoterapeutisk klassifikation: Antiparkinsonmidler, andre dopaminerge stoffer, ATC-kode kode: N04BX02.
English: Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Danish: Entacapon er indiceret som adjuvant til levodopa/benserazid eller levodopa/carbidopa hos voksne patienter med Parkinsons sygdom og end-of-dose fluktuationer, der ikke kan stabiliseres på disse kombinationer.
English: Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
Danish: Teva Pharma Belgium N.V./S.A./A.G Tel/Tél: +32 3 820 73 73
English: The elimination of entacapone occurs mainly by non-renal metabolic routes.
Danish: Entacapon elimineres primært via den non-renale rute.