FrancophonIA/ELRC3.0 huggingface dataset:
English: If other levodopa products are used concomitantly with a Corbilta tablet, the maximum dose recommendations should be followed.
Danish: Hvis der samtidig med Corbilta tages andre produkter indeholdende levodopa, skal anbefalingen om maksimal daglig dosis følges.
English: Because the effects of Corbilta tablets are equivalent with entacapone 200 mg tablet administered concomitantly with the commercially available standard release carbidopa/levodopa preparations in corresponding doses these results are applicable to describe the effects of Corbilta as well.
Danish: Virkningen af Corbilta-tabletter svarer til entacapon 200 mg tabletter administreret samtidig med markedsførte præparater af standardformuleringer med carbidopa/levodopa i tilsvarende doser, og disse resultater kan derfor også anvendes til at beskrive virkningen af Corbilta.
English: If you forget to take Corbilta
Danish: Hvis du har glemt at tage Corbilta
English: Hepatic impairment: It is advised that Corbilta should be administered cautiously to patients with mild to moderate hepatic impairment.
Danish: Nedsat leverfunktion: Det anbefales at Corbilta administreres med forsigtighed til patienter med mild til moderat leversvigt.
English: Women should not breast-feed during treatment with Corbilta.
Danish: Kvinder bør ikke amme, når de er i behandling med Corbilta.
English: Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see also section 4.4).
Danish: Berørte patienter udviser et kompulsivt mønster af dopaminergt lægemiddelmisbrug med anvendelse af højere doser end hensigtsmæssigt til kontrol af de motoriske symptomer, som i nogle tilfælde kan medføre svær dyskinesi (se også pkt.
English: The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Corbilta or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the postmarketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
Danish: De bivirkninger, der er opført i tabel 1, er samlet både fra poolede data fra elleve dobbeltblinde kliniske studier omfattende 3.230 patienter (1.810 behandlet med Corbilta eller entacapon i kombination med levodopa/DDC-hæmmer og 1.420 patienter behandlet med placebo i kombination med levodopa/DDC-hæmmer eller cabergolin i kombination med levodopa/DDC-hæmmer) og fra post-marketing data efter introduktion af entacapon på markedet til anvendelse i kombination med levodopa/DDC-hæmmer.
English: Discontinuation of Corbilta therapy: If Corbilta treatment (levodopa/carbidopa/entacapone) is discontinued and the patient is transferred to levodopa/DDC inhibitor therapy without entacapone, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Danish: Seponering af Corbiltabehandling: Hvis behandling med Corbilta (levodopa/carbidopa/entacapon) afbrydes, og patienten overføres til behandling med levodopa/DDC-hæmmer uden entacapon, er det nødvendigt at justere doseringen af anden antiparkinson-behandling, specielt levodopa, for at opnå tilstrækkelig kontrol over parkinsonsymptomerne.
English: If you stop taking Corbilta
Danish: Hvis du holder op med at tage Corbilta
English: However, caution should be exercised when these medicinal products are used concomitantly with Corbilta (see sections 4.3 and 4.4).
Danish: Der skal imidlertid udvises forsigtighed, når disse lægemidler anvendes samtidigt med Corbilta (se pkt.
English: Serious events of gastrointestinal haemorrhage (uncommon) and angioedema (rare) have been identified from the clinical trials with Corbilta or entacapone combined with levodopa/DDC inhibitor.
Danish: Alvorlige tilfælde af gastrointestinal blødning (ikke almindelig) og angioødem (sjælden) er påvist i kliniske studier med Corbilta eller entacapon kombineret med levodopa/DDC-hæmmer.
English: When less levodopa is required, the total daily dose of Corbilta should be reduced either by decreasing the frequency of administration by extending the time between doses, or by decreasing the strength of Corbilta at an administration.
Danish: Hvis der er behov for mindre levodopa, skal den totale daglige dosis af Corbilta reduceres enten ved at reducere doseringshyppigheden ved at øge tiden mellem doserne, eller ved at vælge en lavere styrke af Corbilta ved hver dosering.
English: What you need to know before you take Corbilta
Danish: Det skal du vide, før du begynder at tage Corbilta
English: When decarboxylation of levodopa is reduced with the co-administration of a DDC inhibitor, a lower dose of levodopa can be used and the incidence of adverse reactionssuch as nausea is reduced.
Danish: Når decarboxyleringen af levodopa reduceres ved samtidig administration af en DDC-hæmmer, kan en lavere dosis af levodopa benyttes, og forekomsten af bivirkninger såsom kvalme reduceres.
English: The evidence of the therapeutic effects of Corbilta is based on two phase III double-blind studies, in which 376 Parkinson's disease patients with end-of-dose motor fluctuations received either entacapone or placebo with each levodopa/DDC inhibitor dose.
Danish: De terapeutiske virkninger af Corbilta er vist i to fase III dobbeltblinde studier, hvor 376 patienter med Parkinsons sygdom med motoriske end-of-dose-fluktuationer blev behandlet med enten entacapon eller placebo ved hver levodopa/DDC-hæmmer dosis.
English: How to transfer patients not currently treated with entacapone to Corbilta
Danish: Sådan overføres patienter, der ikke er i behandling med entacapon til Corbilta
English: Corbilta is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.
Danish: Corbilta er ikke egnet til behandling af symptomer i nervebanerne (f.eks. ufrivillige bevægelser, rysten, muskelstivhed og muskeltrækninger), der er forårsaget af andre typer medicin.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid,skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Thus, a control of INR is recommended when Corbilta is initiated for patients receiving warfarin.
Danish: Det anbefales derfor at kontrollere INR ved behandlingsstart med Corbilta hos patienter, der allerede er i behandling med warfarin.
English: - If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
English: Usually Corbilta is to be used in patients who are currently treated with corresponding doses of standard release levodopa/DDC inhibitor and entacapone.
Danish: Sædvanligvis bør Corbilta anvendes til patienter, der allerede er i behandling med tilsvarende doser af standardformuleringer med levodopa/DDC-hæmmer og entacapon.
English: However, a longer dosing interval of Corbilta may be considered for patients who are receiving dialysis therapy (see section 4.2).
Danish: Imidlertid bør et længere doseringsinterval med Corbilta overvejes for patienter i dialysebehandling (se pkt.
English: - If you are taking Corbilta 200 mg/50 mg/200 mg, do not take more than 7 tablets of this strength per day.
Danish: - Hvis du tager Corbilta 200 mg/50 mg/200 mg, må du ikke tage mere end 7 tabletter af denne styrke pr. dag.
English: How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide) preparations and entacapone tablets to Corbilta a. Patients who are currently treated with entacapone and with standard release levodopa/carbidopa in doses equal to Corbilta tablet strengths can be directly transferred to corresponding Corbilta tablets.
Danish: Skift af patienter i behandling med levodopa/DDC-hæmmer (carbidopa eller benserazid)-præparater og entacapon-tabletter til Corbilta a. Patienter, der allerede er i behandling med entacapon og standardformuleringer med levodopa/carbidopa i styrker tilsvarende Corbilta, kan overføres direkte til den tilsvarende Corbiltatablet.
English: Corbilta is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Danish: Corbilta er indiceret til behandling af voksne patienter med Parkinsons sygdom og motoriske end-ofdose fluktuationer, som ikke kan stabiliseres på behandling med levodopa/dopa-decarboxylase (DDC) hæmmere.
English: Initiation of Corbilta may be considered at corresponding doses to current treatment in some patients with Parkinson's disease and end-of-dose motor fluctuations, who are not stabilised on their current standard release levodopa/DDC inhibitor treatment.
Danish: Initiering af behandling med Corbilta kan påtænkes i tilsvarende doser som nuværende behandling hos nogle patienter med Parkinsons sygdom og motoriske end-of-dose fluktuationer, som ikke er stabiliseret på den eksisterende behandling med standardformulering af levodopa/DDC-hæmmer.
English: - Corbilta contains sucrose, and therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: - Corbilta indeholder saccharose, og bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/galactosemalabsorption og sucrase-isomaltasemangel.
English: - Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/levodopa.
Danish: - Dopaminergt dysreguleringssyndrom (DDS) er en addiktiv forstyrrelse, der medfører overdreven brug af lægemidlet, som er set hos visse patienter, der er blevet behandlet med carbidopa/levodopa.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including 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 containing levodopa including Corbilta.
Danish: Patienter og omsorgspersoner skal informeres om, at der kan forekomme adfærdssymptomer på impulskontrolforstyrrelser, herunder patologisk spilletrang, øget libido, hyperseksualitet, tvangsforbrug eller sygelig købelyst, udtalt overspisning og spiseforstyrrelser hos patienter, der behandles med dopaminagonister og/eller andre dopaminerge lægemidler, der indeholder levodopa, herunder Corbilta.
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 containing levodopa including Corbilta (see section
Danish: Impulskontrolforstyrrelser: patologisk spilletrang, øget libido, hyperseksualitet, tvangsforbrug eller sygelig købelyst, udtalt overspisning og spiseforstyrrelser kan optræde hos patienter, der behandles med dopaminagonister og/eller andre dopaminerge lægemidler, der indeholder levodopa, herunder Corbilta (se pkt.
English: You should not breast-feed during treatment with Corbilta.
Danish: Du må ikke amme, når du er i behandling med Corbilta.
English: If you during the treatment with Corbilta experience the following symptoms, contact your doctor immediately: - Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure.
Danish: Hvis du under behandling med Corbilta bemærker følgende symptomer, skal du kontakte din læge øjeblikkeligt: - Dine muskler bliver meget stive eller rykker kraftigt, du begynder at ryste, bliver ophidset, forvirret, får feber, høj puls eller store udsving i dit blodtryk.
English: No particular studies on the pharmacokinetics of carbidopa and levodopa in patients with hepatic impairment are reported, however, it is advised that Corbilta should be administered cautiously to patients with mild or moderate hepatic impairment.
Danish: Der er ikke rapporteret om specifikke farmakokinetiske studier med carbidopa og levodopa hos patienter med nedsat leverfunktion, men det anbefales imidlertid, at Corbilta gives med forsigtighed til patienter med mild til moderat nedsat leverfunktion.
English: - If you are taking Corbilta 175 mg/43.75 mg/200 mg tablets, do not take more than 8 tablets of this strength per day.
Danish: - Hvis du tager Corbilta 175 mg/43,75 mg/200 mg, må du ikke tage mere end 8 tabletter af denne styrke pr. dag.
English: If you suddenly stop taking of Corbilta and other antiparkinsonian medicines it may result in unwanted side effects.
Danish: Hvis du pludselig stopper med at tage Corbilta og anden medicin mod Parkinsons sygdom, kan der opstå bivirkninger.
English: Corbilta contains sucrose
Danish: Corbilta indeholder saccharose
English: Consult your doctor if during the treatment with Corbilta you: - notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure.
Danish: Tal med din læge, hvis du under behandling med Corbilta: - bemærker at dine muskler bliver meget stive eller rykker kraftigt, eller hvis du begynder at ryste, bliver ophidset, forvirret, får feber, høj puls eller store forandringer i blodtrykket.
English: Corbilta contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet.
Danish: Corbilta indeholder tre virksomme stoffer (levodopa, carbidopa og entacapon) i én filmovertrukket tablet.
English: What Corbilta contains
Danish: Corbilta indeholder:
English: Always leave at least an hour between Corbilta tablets, to avoid possible side effects.
Danish: For at undgå eventuelle bivirkninger skal der altid være mindst én time mellem Corbilta-tabletterne.
English: - The active substances of Corbilta are levodopa, carbidopa and entacapone.
Danish: - Aktive stoffer: levodopa, carbidopa og entacapon.
English: According to this daily carbidopa dose, the maximum recommended daily dose of Corbilta175 mg/43.75 mg/200 mg is 8 tablets per day and Corbilta 200 mg/50 mg/200 mg dose is 7 tablets per day.
Danish: I henhold til denne daglige carbidopa dosis, er den anbefalede daglige maksimale dosis for styrken 175 mg/43,75 mg/200 mg 8 tabletter pr.dag og for 200 mg/50 mg/200 mg 7 tabletter pr. dag.
English: Corbilta comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Danish: Corbilta findes i seks forskellige pakningsstørrelser (10, 30, 100, 130, 175 eller 250 tabletter).
English: - stomach ulcers or convulsions - if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon - any form of severe mental disorder like psychosis - chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
Danish: - nyre- eller hormonrelaterede sygdomme - mavesår eller mavekramper - hvis du får længerevarende diarré Kontakt lægen, da det kan være tegn på betændelse i tyktarmen - en alvorlig mental lidelse, som f.eks. en psykose - kronisk åbenvinklet grøn stær, da det i givet fald kan være nødvendigt at justere dosis og at kontrollere trykket i dine øjne.
English: For example, a patient taking one tablet of 50 mg/12.5 mg of levodopa/carbidopa with one tablet of entacapone 200 mg four times daily can take one 50 mg/12.5 mg/200 mg Corbilta tablet four times daily in place of their usual levodopa/carbidopa and entacapone doses.
Danish: F.eks. kan en patient, der tager en tablet på 50 mg/12,5 mg levodopa/carbidopa samtidig med en tablet entacapon på 200 mg 4 gange dagligt, i stedet tage en 50 mg/12,5 mg/200 mg Corbilta-tablet 4 gange dagligt.
English: Talk to your doctor or pharmacist before taking Corbilta if you have or have ever had: - a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood vessels - asthma or any other disease of the lungs - a liver problem, because your dose may need to be adjusted - kidney or hormone-related diseases
Danish: Kontakt lægen eller apotekspersonalet, før du tager Corbilta, hvis du har eller tidligere har haft: - et hjerteinfarkt eller anden sygdom i hjertet, herunder forstyrrelser i hjerterytmen, eller i blodårerne - asthma eller anden lungesygdom - problemer med leveren, da det i givet fald kan være nødvendigt at justere dosis
English: b. When initiating Corbilta therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Corbilta tablets (50 mg/12.5 mg/200 mg or 75 mg/18.75 mg/200 mg or 100 mg/25 mg/200 mg or 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg or 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg), Corbilta dosing should be carefully titrated for optimal clinical response.
Danish: b. Ved initiering af Corbiltabehandling hos patienter, der allerede er i behandling med entacapon og levodopa/carbidopa i doser, der ikke findes i styrker tilsvarende Corbilta tabletter (50 mg/12,5 mg/200 mg eller 75 mg/18,75 mg/200 mg eller 100 mg/25 mg/200 mg eller 125 mg/31,25 mg/200 mg eller 150 mg/37,5 mg/200 mg eller 175 mg/43,75 mg/200 mg eller 200 mg/50 mg/200 mg), bør doseringen af Corbilta omhyggeligt titreres til et optimalt klinisk respons.
English: How to take Corbilta
Danish: Sådan skal du tage Corbilta
English: Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Corbilta may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin.
Danish: 5.2) kan Corbilta potentielt interferere med aktive substanser, hvis metabolisering er afhængig af dette isoenzym, som f.eks. Swarfarin.
English: - If you are taking Corbilta 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
Danish: - Hvis du tager Corbilta 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg,
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: Det kan omfatte: - voldsom trang til at spille umådeholdent på trods af alvorlige personlige eller familiære konsekvenser - forandret eller øget seksuel lyst og adfærd, der giver betydelig bekymring for dig eller andre, for eksempel en øget sextrang - ukontrolleret og udtalt købelyst eller pengeforbrug - udtalt overspisning (at spise store mængder af mad i løbet af kort tid) eller tvangsspisning (at spise mere mad end normalt og mere end nødvendigt for at stille sulten).
English: While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Corbilta strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
Danish: Da der er begrænset erfaring med brug af totale døgndoser større end 200 mg carbidopa, og den anbefalede maksimale daglige dosis af entacapon er 2000 mg, er den maksimale dosis derfor 10 tabletter pr. dag for Corbiltastyrker på 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg og 150 mg/37,5 mg/200 mg. 10 Corbilta-tabletter med styrken 150 mg/37,5 mg/200 mg svarer til 375 mg carbidopa pr. dag.
English: - if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon - any form of severe mental disorder like psychosis - chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
Danish: Kontakt lægen, da det kan være tegn på betændelse i tyktarmen - en alvorlig mental lidelse, som f.eks. en psykose - kronisk åbenvinklet grøn stær, da det i givet fald kan være nødvendigt at justere dosis og at kontrollere trykket i dine øjne.
English: corbilta 125/31.25/200 mg [carton only]
Danish: corbilta 125/31,25/200 mg [kun karton]
English: corbilta 75/18.75/200 mg [carton only]
Danish: corbilta 75/18,75/200 mg [kun karton]
English: corbilta 175/43.75/200 mg [carton only]
Danish: corbilta 175/43,75/200 mg [kun karton]
English: Do not take Corbilta if you - are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6) - have narrow-angle glaucoma (an eye disorder) - have a tumour of the adrenal gland - are taking certain medicines for treating depression (combinations of selective MAO-A and
Danish: Tag ikke Corbilta, hvis du: - er allergisk over for levodopa, carbidopa eller entacapon eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) - har snævervinklet glaukom (en øjensygdom) - har en svulst i binyrerne - tager visse lægemidler mod depression (kombinationer af selektive MAO-A og MAO-B-hæmmere eller ikke-selektive MAO-hæmmere) - tidligere har haft malignt neuroleptikasyndrom (MNS - dette er en sjælden reaktion overfor lægemidler, som bruges til behandling af alvorlige mentale lidelser) - har haft ikke-traumatisk rabdomyolyse (en sjælden muskellidelse).
English: corbilta 50/12.5/200 mg [carton only]
Danish: corbilta 50/12,5/200 mg [kun karton]
English: corbilta 150/37.5/200 mg [carton only]
Danish: corbilta 150/37,5/200 mg [kun karton]
English: Talk to your doctor or pharmacist before taking Corbilta if you have or have ever had: - a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood vessels - asthma or any other disease of the lungs - a liver problem, because your dose may need to be adjusted - kidney or hormone-related diseases - stomach ulcers or convulsions
Danish: Kontakt lægen eller apotekspersonalet, før du tager Corbilta, hvis du har eller tidligere har haft: - et hjerteinfarkt eller anden sygdom i hjertet, herunder forstyrrelser i hjerterytmen, eller i blodårerne - asthma eller anden lungesygdom
English: corbilta 100/25/200 mg [carton only]
Danish: corbilta 100/25/200 mg [kun karton]
English: Talk to your doctor or pharmacist if you think the effect of Corbilta is too strong or too weak, or if you experience possible side effects.
Danish: - Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Tell your doctor if you experience any of these behaviors; they will discuss ways of managing or reducing the symptoms.
Danish: Lægerne vil drøfte hvordan symptomerne kan kontrolleres eller nedsættes.
English: Vascular disorders: Common:
Danish: Vaskulære sygdomme Almindelig:
English: corbilta 200/50/200 mg [carton only]
Danish: corbilta 200/50/200 mg [kun karton]
English: Corbilta 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored filmcoated tablets marked with ‘LCE 150' on one side.
Danish: Corbilta 150 mg/37,5 mg /200 mg: Brun- eller grårøde, aflange, ellipse-formede filmovertrukne tabletter uden delekærv mærket ”LCE 150” på den ene side.
English: Corbilta 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Danish: Corbilta 75 mg/18,75 mg/200 mg findes i fem forskellige pakningsstørrelser (10, 30, 100, 130 eller 175 tabletter).