FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.
Danish: Hvis du har taget en overdosis af Entacapone Teva, skal du straks henvende dig til din læge, på apoteket eller nærmeste hospital.
English: Uncommon (may affect up to 1 in 100 people): - Heart attack.
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 personer)
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Contents of the pack and other information What Entacapone Teva contains
Danish: Pakningsstørrelser og yderligere oplysninger Entacapone Teva indeholder:
English: Patients being treated with entacapone in association with levodopa and presenting with somnolence and/or sudden sleep onset episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes have resolved (see also section 4.4).
Danish: Patienter, der er i behandling med entacapon i forbindelse med levodopa, og hvor unaturlig døsighed (somnolens) og/eller perioder med pludselige søvnanfald optræder, skal oplyses om, at de skal undlade at føre motorkøretøj og undgå at deltage i aktiviteter (f.eks. betjening af maskiner), hvor nedsat opmærksomhed kan bringe deres eget eller andres liv og helbred i fare.
English: Entacapone Teva has no effect on relieving the symptoms of Parkinson´s disease unless taken with levodopa.
Danish: Entacapone Teva har kun lindrende virkning på symptomerne fra Parkinsons sygdom, hvis det tages sammen med levodopa.
English: Entacapone should only be used in combination with levodopa/benserazide or levodopa/carbidopa.
Danish: Entacapon bør kun ordineres sammen med levodopa/benserazid eller levodopa/carbidopa.
English: The major part (95%) of the product excreted in urine is conjugated with glucuronic acid.
Danish: Den primære del af entacapon, der udskilles i urinen, konjugeres med glucuronsyre.
English: Renal insufficiency does not affect the pharmacokinetics of entacapone and there is no need for dose adjustment.
Danish: Patienter med nedsat nyrefunktion: Nyreinsufficiens påvirker ikke entacapons farmakokinetik, og det er ikke nødvendigt at justere doseringen ved nyreinsufficiens.
English: The other major class of adverse reactions are gastrointestinal symptoms, including nausea, vomiting, abdominal pain, constipation and diarrhoea.
Danish: Den anden hyppige gruppe af bivirkninger er relateret til mave-tarmkanalen og inkluderer kvalme, opkastning, abdominale smerter, forstoppelse og diarré.
English: Hepatic function tests abnormal
Danish: Unormale leverfunktionstests
English: However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine, maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Danish: Der er stadig begrænset erfaring med samtidig administration af entacapon og en række lægemidler som MAO-A-inhibitorer, tricykliske antidepressiva, noradrenalin re-uptake-hæmmere (desipramin, maprotilin og venlafaxin) samt lægemidler, som metaboliseres af COMT (f.eks. katechol-strukturforbindelser: rimiterol, isoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-methyldopa, apomorphin og paroxetin).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (30, 60, 100 or 175 film-coated tablets)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (30, 60, 100 eller 175 filmovertrukne tabletter)
English: Therefore, the use of Entacapone Teva in children cannot be recommended.
Danish: Brug af Entacapone Teva frarådes derfor til børn.
English: Isolated cases of NMS have been reported following abrupt reduction or discontinuation of entacapone and other dopaminergic treatments.
Danish: Enkeltstående tilfælde af MNS er indrapporteret efter pludselig nedsættelse eller afbrydelse af entacapon og anden tilsvarende dopaminerg behandling.
English: Entacapone Teva is available in HDPE tablet containers with polypropylene screw caps with desiccant insert containing 30, 60, 100 or 175 film-coated tablets.
Danish: Entacapone Teva fås i HPDE-tabletbeholdere med skruelåg i polypropylen med isat tørremiddel med 30, 60, 100 eller 175 filmovertrukne tabletter.
English: HDPE tablet containers with polypropylene screw caps with desiccant insert containing 30, 60, 100 or 175 film-coated tablets.
Danish: HDPE-tabletbeholder med skruelåg i polypropylen med indsat tørremiddel indeholdende 30, 60, 100 eller 175 filmovertrukne tabletter.
English: Mogilska 80, 31-546, Krakow, Poland
Danish: 31-546, Krakow, Polen
English: Adverse drug reactions* Psychiatric disorders
Danish: Tabel 1 * Bivirkninger Psykiske forstyrrelser
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL (60, 100 or 175 film-coated tablets)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET (60, 100 eller 175 filmovertrukne tabletter)
English: Entacapone thus prolongs the clinical response to levodopa.
Danish: Dermed forlænger entacapon den kliniske effekt af levodopa.
English: Entacapone Teva aids levodopa in relieving the symptoms of Parkinson's disease.
Danish: Entacapone Teva understøtter levodopa og lindrer derved symptomerne på Parkinsons sygdom.
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Entacapone Teva in association with levodopa (see section 4.4).
Danish: Patologisk spillelyst, forøget libido, hyperseksualitet, kompulsiv brug af penge og indkøb, spiseorgie og tvangsspisning kan opstå hos patienter, som bliver behandlede med dopaminagonister og/eller andre dopaminerge behandlinger, såsom Comtess i kombination med levodopa (se pkt.
English: If you forget to take Entacapone Teva
Danish: Hvis du har glemt at tage Entacapone Teva
English: If you stop taking Entacapone Teva
Danish: Hvis du holder op med at tage Entacapone Teva
English: Entacapone may form chelates with iron in the gastrointestinal tract.
Danish: Entacapon kan i mave-tarmkanalen danne chelater med jern.
English: - Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and entacapone (see section 4.5).
Danish: - Samtidig brug af en selektiv MAO-A-hæmmer plus en selektiv MAO-B-hæmmer og entacapon
English: Daily ON time (Mean ±SD) Study I: Daily On time (h)
Danish: Daglig ON tid (middelværdi ±SD) Undersøgelse I: Daglig ON tid (timer) Entacapon (n=85)
English: • if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Entacapone Teva);
Danish: Kontakt din læge eller apoteket, som kan undersøge, om din medicin kan tages sammen med Entacapone Teva;
English: In doses of 1,400 to 2,000 mg per day, the following side effects are more common: - Uncontrollable movements; - nausea; - abdominal pain.
Danish: Ved doser på 1.400 til 2.000 mg pr. dag er følgende bivirkninger mere almindelige:
English: Entacapone is administered orally and simultaneously with each levodopa/carbidopa or levodopa/benserazide dose.
Danish: Entacapon administreres peroralt samtidig med hver dosering af levodopa/benserazid eller levodopa/carbidopa.
English: Due to its affinity to cytochrome P450 2C9 in vitro (see section 5.2), entacapone may potentially interfere with medicinal products with metabolism dependent on this isoenzyme, such as S-warfarin.
Danish: 5.2), kan entacapon potentielt interferere med lægemidler med metabolisme, der er afhængig af dette isoenzym, såsom S-warfarin.
English: See section 4 Possible side effects for the characteristics of NMS;
Danish: Se symptomer på NMS i punkt 4 Bivirkninger
English: Other medicines and Entacapone Teva
Danish: Brug af anden medicin sammen med Entacapone Teva:
English: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem, The Netherlands
Danish: Swensweg 5, 2031 GA Haarlem, Nederlandene
English: - Entacapone Teva taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
Danish: • Entacapone Teva taget sammen med levodopa kan i sjældne tilfælde få dig til at føle dig meget døsig om dagen og medføre, at du pludseligt falder i søvn.
English: methyl transferase (COMT), e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine,dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
Danish: • rimiterol, isoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-methyldopa, apomorfin
English: Cardiac disorders**
Danish: Hjerte **
English: No interaction of entacapone with carbidopa has been observed with the recommended treatment schedule.
Danish: Der er ikke med den rekommanderede administration og dosering observeret nogen interaktion med carbidopa.
English: Entacapone Teva 200 mg film-coated tablets entacapone
Danish: Entacapone Teva 200 mg filmovertrukne tabletter entacapon
English: Nausea
Danish: • kvalme
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG ANTAL(PAKNINGSSTØRRELSE)
English: Entacapone Teva 200 mg film-coated tablets entacapone oral use
Danish: Entacapone Teva 200 mg filmovertrukne tabletter entacapon oral brug
English: In addition, Entacapone Teva taken with levodopa may make you feel very drowsy, or cause you to sometimes find yourself suddenly fall asleep.
Danish: Entacapone Teva taget sammen med levodopa kan endvidere gøre dig meget søvnig eller af og til få dig til pludseligt at falde i søvn.
English: Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Danish: Entacapon i forbindelse med levodopa er i isolerede tilfælde blevet sat i forbindelse med udtalt træthed (somnolens) i dagtimerne og episoder, hvor patienten pludselig falder i søvn.
English: Each tablet contains 200 mg of entacapone
Danish: Hver tablet indeholder 200 mg entacapon
English: - Hepatic impairment.
Danish: • hjerteanfald.
English: Entacapone Teva taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Danish: Samtidig brug af Entacapone Teva og levodopa kan gøre dig mere sløv, og nogen gange kan du pludseligt falde i søvn.
English: Not known (frequency cannot be estimated from the available data): - Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes; - discolouration of skin, hair, beard and nails.
Danish: • tyktarmsbetændelse (colitis), leverbetændelse (hepatitis) med gulfarvning af huden og det hvide i øjnene
English: How to take Entacapone Teva
Danish: Sådan skal du tage Entacapone Teva
English: It is characterised by stiffness, muscle twitching, shaking, agitation and confusion, coma, high body temperature, increased heart rate and unstable blood pressure; - a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems.
Danish: Det er karakteriseret ved stivhed, muskeltrækninger, rysten, uro og forvirring, bevidstløshed, høj feber, hurtig hjerterytme og ustabilt blodtryk.
English: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 731 402 02
Danish: Ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +32 3 820 73 73
English: Each film-coated tablet contains 200 mg entacapone.
Danish: Hver filmovertrukket tablet indeholder 200 mg entacapon.
English: Week 8-24 10.7±2.2
Danish: Baseline Uge 8-24
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid Entacapone Teva nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: What Entacapone Teva is and what it is used for What you need to know before you take Entacapone Teva How to take Entacapone Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Entacapone Teva Sådan skal du tage Entacapone Teva Bivirkninger
English: Entacapone Teva 200 mg film-coated tablets
Danish: Entacapone Teva 200 mg filmovertrukne tabletter.
English: vivid dreams, and confusion; - heart or artery disease events (e.g. chest pain).
Danish: • hallucinationer (se/høre/føle/lugte noget, som i virkeligheden ikke er der), søvnløshed, livlige drømme, forvirring • symptomer på hjerte- eller karsygdom (f.eks. brystsmerter).
English: - Keep this leaflet.
Danish: (se pkt.
English: if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time, a general medical evaluation including liver function should be considered.
Danish: • hvis du inden for relativt kort tid får tiltagende appetitløshed, føler dig svækket, udmattet og taber i vægt.
English: Entacapone in association with levodopa has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson's disease and caution should therefore be exercised when driving or operating machines (see also section 4.7).
Danish: Entacapon i forbindelse med levodopa er sat i forbindelse med unaturlig døsighed (somnolens) samt episoder med pludselig søvn-anfald hos patienter med Parkinsons sygdom.
English: Rare (may affect up to 1 in 1,000 people): - Rashes; - abnormal results in liver function test.
Danish: Sjælden (kan påvirke op til 1 ud af 1.000 personer)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (30 film-coated tablets)
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Patients with hepatic impairment See section 4.3.
Danish: Patienter med nedsat leverfunktion: Se pkt.
English: Tabulated list of adverse reactions
Danish: Bivirkninger listet i tabelform
English: Hepatobiliary disorders
Danish: • mavesmerter
English: Urine discoloration
Danish: • hududslæt
English: Do not drive or operate machinery if you experience these side effects.
Danish: Hvis du får disse bivirkninger, må du ikke køre bil motorcykel eller arbejde med værktøj eller maskiner.
English: Very rare (may affect up to 1 in 10,000 people): - Agitation; - decreased appetite, weight loss; - hives.
Danish: Meget sjælden (kan påvirke op til 1 ud af 10.000 personer)
English: Erythematous or maculopapular rash
Danish: Erytematøst og makulopapuløst udslæt
English: You may experience the following side effects: - Inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious personal or family consequences; - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive; - uncontrollable excessive shopping or spending; - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
Danish: • Spiseorgie (spiser store mængder mad på meget kort tid) eller tvangsspisning (spiser mere mad end normalt eller mere end der skal til for at gøre dig mæt).
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret iseptember 2015.
English: Very common (may affect more than 1 in 10 people): - Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias); - feeling sick (nausea); - harmless reddish-brown discoloration of urine.
Danish: • ukontrollerbare bevægelser med besvær med at udføre ønskede bevægelser (dyskinesier)
English: Similarly, no interactions between entacapone and selegiline were observed in repeated-dose studies in parkinsonian patients.
Danish: I kliniske forsøg med længere behandlingstid hos Parkinsonpatienter fandtes ikke interaktion med selegilin.
English: blister (PVC/alu) 3 x 28 tablets (24 active + 4 placebo)
Danish: 3 x 28 tabletter (24 aktive + 4 placebo)
English: Pharmaceutical Form Route of Administration
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage
English: o The need for monitoring and when to withhold treatment.
Danish: o Behovet for at monitorere behandlingen, og hvornår behandling skal tilbageholdes.
English: Prior to launch of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder.
Danish: Før lancering af lægemidlet i medlemsstaten, skal den nationale kompetente myndighed aftale indholdet af og formatet for undervisningsmaterialet med indehaveren af markedsføringstilladelsen.
English: The educational material for Healthcare Professionals should be a leaflet that includes information on the following key elements:
Danish: Undervisningsmaterialet til sundhedspersonale skal være en brochure, som indeholder oplysninger om følgende nøgleelementer:
English: o The need to check that the patient knows how to correctly use the bronchodilator.
Danish: o Behovet for at kontrollere, at patienten ved, hvordan denne anvender bronkodilatoren korrekt.
English: o The need to review the patient after approximately six weeks to assess for signs and symptoms of bronchospasm.
Danish: o Behovet for at evaluere patienten efter ca. 6 uger for at vurdere, om der er tegn og symptomer på bronkospasme.
English: The Marketing Authorisation Holder (MAH) should ensure that at launch all Healthcare Professionals who are expected to use and/or prescribe Bronchitol are provided with an educational pack.
Danish: Indehaveren af markedsføringstilladelsen skal sikre sig, at alt sundhedspersonale, som forventes at anvende og/eller ordinere Bronchitol, ved lanceringen bliver forsynet med en undervisningspakke.
English: o How to interpret the results of the Bronchitol initiation dose assessment as Pass, Fail or Incomplete.
Danish: o Hvordan resultaterne af vurderingen af den initiale Bronchitol-dosis skal fortolkes som Bestået, Dumpet eller Ufuldstændig.
English: The risk of haemoptysis during treatment o That Bronchitol has not been studied in patients with a history of significant haemoptysis (>60 ml) in the previous three months.
Danish: Risikoen for hæmoptyse under behandling o At Bronchitol ikke er undersøgt hos patienter med signifikante episoder af hæmoptyse (>60 ml) i de foregående tre måneder.
English: o How to perform the Bronchitol initiation dose assessment safely and how long to monitor the patient for.
Danish: o Hvordan vurderingen af den initiale Bronchitol-dosis udføres på en sikker måde, og hvor længe patienten skal monitoreres.
English: o The need of pre-medication by a bronchodilator 5-15 minutes before the Bronchitol initiation dose assessment and before each therapeutic administration of Bronchitol.
Danish: o Behovet for præmedicinering med en bronkodilator 5-15 minutter før vurderingen af den initiale Bronchitol-dosis og før terapeutisk administration af Bronchitol.
English: o The risk of bronchospasm during long term treatment even if the Bronchitol initiation dose assessment was initially passed and the need to reiterate it in case of doubt.
Danish: o Risikoen for bronkospasme under langvarig behandling, også selv om vurderingen af den initiale Bronchitol-dosis var bestået, og behovet for at gentage den i tvivlstilfælde.
English: o That therapeutic doses of Bronchitol should only be prescribed if the patient has passed the initiation dose assessment.
Danish: o At terapeutiske doser af Bronchitol kun må ordineres, hvis patienten har bestået vurderingen af initialdosen.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL PÅLÆGGES AF MEDLEMSSTATERNE
English: The risk of bronchospasm during treatment o The need to perform the Bronchitol initiation dose assessment to identify patients who have bronchial hyperresponsiveness in response to inhaled mannitol by measuring the degree of bronchoconstriction that occurs following sequential administrations of mannitol.
Danish: Risikoen for bronkospasme under behandling o Behovet for at udføre vurdering af initialdosen af Bronchitol for at identificere patienter, som har bronkial hyperreaktivitet over for inhaleret mannitol, ved at måle graden af bronkokonstriktion, som forekommer efter sekventiel administration af mannitol.
English: The potential risk of cough related sequelae during treatment o The need to train the patient to minimise cough during administration in using the correct inhalation technique.
Danish: Den potentielle risiko for hosterelaterede følger under behandling o Behovet for at undervise patienten i at minimere hoste under administration ved at benytte korrekt inhalationsteknik.
English: Summary of Product Characteristics and Patient Information Leaflet Educational material for Healthcare Professionals
Danish: Undervisningspakken skal indeholde følgende: Produktresumé og indlægsseddel Undervisningsmateriale til sundhedspersonale.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BILAG 127A BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL PÅLÆGGES AF MEDLEMSSTATERNE
English: Commission decision date: 22/03/2017.
Danish: Dato for Kommissionens beslutning: 22/03/2017.
English: The prescribing information for these medicines will be updated in line with the above recommendations.
Danish: Ordineringsoplysningerne for disse lægemidler vil blive opdateret i overensstemmelse med ovenstående anbefalinger.
English: They have been authorised for up to 20 years as Valette and other trade names via national procedures in the following EU Member States: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Danish: De har været godkendt i op til 20 år under handelsnavnet Valette og andre handelsnavne via nationale procedurer i følgende EU-medlemsstater: Østrig, Belgien, Bulgarien, Tjekkiet, Estland, Tyskland, Ungarn, Letland, Litauen, Luxembourg, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Spanien.
English: • The currently available safety data do not raise any new safety concerns.
Danish: • De aktuelt tilgængelige sikkerhedsdata giver ikke anledning til nye sikkerhedsmæssige betænkeligheder.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Danish: Gennemgangen blev foretaget af Udvalget for Humanmedicinske Lægemidler (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets udtalelse.
English: Dienogest and ethinylestradiol are two types of hormones, a progestogen and an oestrogen.
Danish: Dienogest og ethinyløstradiol er to typer hormoner, et progestogen og et østrogen.
English: Regarding the risk of side effects, the CHMP considered that the available data do not raise any new safety concern.
Danish: Hvad angår risikoen for bivirkninger, vurderer CHMP, at de tilgængelige data ikke giver anledning til nye sikkerhedsmæssige betænkeligheder.
English: This alters the production of oils in the skin and also suppresses ovulation.
Danish: Dermed ændres hudens olieproduktion, ligesom ægløsningen undertrykkes.
English: They work by blocking the effects of a class of hormones called androgens.
Danish: De virker ved at blokere virkningen af androgene hormoner.