FrancophonIA/ELRC3.0 huggingface dataset:
English: Exercise capacity after single and twice-daily doses of nicorandil in chronic stable angina pectoris.
Danish: Meany TB, Richardson P, Camm AJ, et al. Exercise capacity after single and twice-daily doses of nicorandil in chronic stable angina pectoris.
English: 5 ESC guidelines on the management of stable coronary artery disease European Heart Journal (2013) 34,
Danish: 5 ESC guidelines on the management of stable coronary artery disease European Heart Journal (2013) 34, 29496 The IONA Study group: Effect of nicorandil on coronary events in patients with stable angina: the Impact Of
English: In conclusion, based on the assessment of the MAHs' proposals and responses and following the discussions of the Committee, the CHMP adopted harmonised sets of product information documents of Ikorel and associate names and Dancor and associated names.
Danish: Som konklusion vedtog CHMP et harmoniseret sæt produktinformationsdokumenter for Ikorel og relaterede navne samt Dancor og relaterede navne på grundlag af markedsføringstilladelsesindehaverens forslag og besvarelser samt udvalgets drøftelser.
English: failed to show any objective improvement in exercise performance as compared to placebo.
Danish: Fem (5) mg nicorandil to gange dagligt medførte ingen objektiv bedring i fysiske præstationer i forhold til placebo.
English: Most studies were performed using 10 mg b.i.d.
Danish: De fleste undersøgelser var udført med en dosering på 10 mg to gange dagligt efterfulgt af 20 mg to gange dagligt.
English: Nicorandil provides a dual mode of action leading to relaxation of vascular smooth muscle.
Danish: Nicorandil bevirker afslappelse af glatmuskulaturen i karrene ved en dobbelt virkningsmekanisme.
English: • If CCB monotherapy or combination therapy (CCB with beta-blocker) is unsuccessful, substitute the CCB with a long-acting nitrate or nicorandil.
Danish: (calciumkanalblokker med betablokker) erstattes calciumkanalblokkeren med et langtidsvirkende nitrat eller nicorandil.
English: There is a lack of clinical data concerning the safety of the use of nicorandil in cardiac failure NYHA III-IV.
Danish: Der foreligger ingen kliniske data om sikkerheden af anvendelse af nicorandil ved hjerteinsufficiens af NYHA klasse III-IV. CHMP anmodede derfor indehaverne af markedsføringstilladelse om at indsætte en erklæring om, at nicorandil bør anvendes med forsigtighed hos denne patientgruppe.
English: 6 The IONA Study group: Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in angina (IONA) randomized trial.
Danish: Nicorandil in angina (IONA) randomized trial.
English: Prevention of cardiovascular events in patients with stable coronary heart disease (CHD)
Danish: vurderbare patienter med svær hjerteinsufficiens (N.Y.H.A.
English: Comparison of nicorandil and atenolol in stable angina pectoris.
Danish: <særnavn> er indiceret hos voksne til symptomatisk behandling af stabil angina pectoris,
English: Neulasta received a marketing authorisation valid throughout the EU on 22 August 2002.
Danish: Neulasta fik en markedsføringstilladelse med gyldighed i hele EU den 22. august 2002.
English: Further information on Neulasta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Neulasta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Neulasta
Danish: Andre oplysninger om Neulasta
English: An overview of Neulasta and why it is authorised in the EU
Danish: En oversigt over Neulasta, og hvorfor det er godkendt i EU
English: As for all medicines, data on the use of Neulasta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Neulasta løbende overvåget.
English: Patients can inject themselves if they have been trained appropriately.
Danish: Patienterne kan give sig selv indsprøjtningerne, hvis de er behørigt instrueret heri.
English: What measures are being taken to ensure the safe and effective use of Neulasta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Neulasta?
English: The European Medicines Agency decided that Neulasta's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Neulasta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What is Neulasta and what is it used for?
Danish: Hvad er Neulasta, og hvad anvendes det til?
English: The most common side effect with Neulasta (which may affect more than 1 in 10 people) is pain in the bones.
Danish: Den hyppigste bivirkning ved Neulasta (som optræder hos mere end 1 ud af 10 patienter) er knoglesmerter.
English: What are the risks associated with Neulasta?
Danish: Hvilke risici er der forbundet med Neulasta?
English: For more information about using Neulasta, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Neulasta, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Why has Neulasta been approved?
Danish: Hvorfor blev Neulasta godkendt?
English: Neulasta can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Danish: Neulasta udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft eller blodforstyrrelser.
English: Side effects reported with Neulasta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Neulasta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Neulasta has been studied in two main studies involving 467 patients with breast cancer who were being treated with chemotherapy.
Danish: Neulasta er undersøgt i to hovedstudier med 467 patienter med brystkræft, som var i behandling med kemoterapi.
English: Neulasta was as effective as filgrastim in reducing the duration of severe neutropenia.
Danish: Neulasta var lige så effektivt som filgrastim til at afkorte varigheden af svær neutropeni.
English: Neulasta is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Danish: Neulasta gives som en enkeltdosis på 6 mg, der injiceres under huden mindst 24 timer efter afslutningen af hver behandlingsserie med kemoterapi (behandling med kræftlægemidler).
English: The active substance in Neulasta, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Danish: Det aktive stof i Neulasta, pegfilgrastim, består af filgrastim, der minder meget om det menneskelige protein granulocyt-kolonistimulerende faktor (G-CSF).
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (neutropenia accompanied by fever).
Danish: Neulasta gives specifikt for at reducere varigheden af neutropeni og forebygge såkaldt febril neutropeni (neutropeni ledsaget af feber).
English: In both studies, the effectiveness of a single injection of Neulasta was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles.
Danish: I begge studier blev virkningen af en enkelt injektion af Neulasta sammenlignet med flere daglige injektioner af filgrastim i hver af fire behandlingsserier med kemoterapi.
English: For the full list of side effects and restrictions with Neulasta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Neulasta fremgår af indlægssedlen.
English: Neulasta is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Danish: Neulasta er ikke beregnet til brug hos patienter med blodkræfttypen kronisk myeloid leukæmi eller myelodysplastisk syndrom (tilstand, hvor der produceres et stort antal blodlegemer, som kan udvikle sig til leukæmi).
English: In Neulasta, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I Neulasta er filgrastim blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol).
English: How is Neulasta used?
Danish: Hvordan anvendes Neulasta?
English: Neulasta is effective at reducing the duration of severe neutropenia during chemotherapy and its side effects were considered manageable.
Danish: Neulasta er effektivt til at reducere varigheden af svær neutropeni under behandling med kemoterapi, og bivirkningerne vurderes at være håndterbare.
English: What benefits of Neulasta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Neulasta?
English: The company that markets Neulasta will ensure that patients or carers using the medicine are provided with an alert card explaining how to use the injection device that delivers the medicine.
Danish: Virksomheden, der markedsfører Neulasta, skal udarbejde et patientkort, der forklarer, hvordan patienterne eller deres omsorgspersoner skal anvende den fyldte pen ved indgivelse af lægemidlet.
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Danish: Neulasta fås som en fyldt pen med injektionsvæske til indsprøjtning under huden.
English: How does Neulasta work?
Danish: Hvordan virker Neulasta?
English: In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle.
Danish: I begge studier havde patienterne svær neutropeni i ca. 1,7 dage i deres første behandlingsserie med kemoterapi sammenholdt med ca. 5-7 dage, hvis der ikke blev anvendt nogen stimulerende faktor.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Neulasta have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Neulasta.
English: Neulasta is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Danish: Neulasta er et lægemiddel, der anvendes hos kræftpatienter til behandling af neutropeni (lavt antal neutrofiler, en type hvide blodlegemer).
English: Use of scopolamine as an antidote is not recommended.
Danish: Anvendelse af scopolamin som antidot anbefales ikke .
English: Individual response to rivastigmine cannot be predicted.
Danish: Individuel respons på rivastigmin kan ikke forudsiges.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage medicinen, da den indeholder vigtige oplysninger.
English: Protein binding of rivastigmine is approximately 40 %.
Danish: Proteinbindning af rivastigmin er ca. 40%.
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppighed er angivet efter følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Your doctor will tell you what dose of Rivastigmine Actavis to take.
Danish: Din læge vil fortælle dig, hvilken dosis Rivastigmine Actavis du skal tage.
English: • if you have a low body weight.
Danish: • hvis din kropsvægt er lav.
English: Absolute bioavailability after a 3 mg dose is about 36 %±13 %.
Danish: Absolut biotilgængelighed efter en 3 mg dosis er ca. 36% ±13%.
English: If this applies to you, tell your doctor and do not take Rivastigmine Actavis.
Danish: Hvis dette gælder for dig, skal du fortælle det til din læge og ikke tage Rivastigmine Actavis.
English: Dose titration should then be carried out as described above.
Danish: Dosistitrering skal udføres som tidligere beskrevet.
English: - Blisters (Al/PVC): 28, 56 and 112 hard capsules.
Danish: - Blistre (Al/PVC): 28, 56 og 112 kapsler.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25ºC
English: • if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for rivastigmin eller et af de øvrige indholdsstoffer i lægemidlet (angivet i pkt.
English: C-rivastigmine, renal elimination was rapid and essentially complete (>90 %) within 24 hours.
Danish: C-Rivastigmin var renal udskillelse hurtig og nærmest fuldstændig (>90%) inden for 24 timer.
English: The capsules are packed in blisters available in three different pack sizes (28, 56 and 112 capsules) and capsule containers of 250 capsules, but these may not all be available in your country.
Danish: Kapslerne er pakket i blisterkort, der findes i tre forskellige pakningsstørrelser (28, 56 eller 112 kapsler) og kapselbeholdere med 250 kapsler, men ikke alle er nødvendigvis tilgængelige i dit land.
English: Possible dose adjustments or temporarily stopping treatment can be considered if needed.
Danish: Mulige dosisjusteringer eller midlertidig seponering af behandlingen kan overvejes, hvis det findes nødvendigt.
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 apoteket til råds, før du bruger dette lægemiddel.
English: In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
Danish: I tilfælde af alvorlig opkastning associeret med rivastigmin-behandling, skal der foretages passende dosisjustering som anbefalet i afsnit 4.2.
English: Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
Danish: Vedligeholdelsesbehandling kan fortsætte så længe, der er terapeutisk effekt for patienten.
English: • Take Rivastigmine Actavis twice a day, in the morning and evening, with food.
Danish: • Tag Rivastigmine Actavis to gange om dagen (morgen og aften) sammen med mad.
English: If you find you have forgotten to take your dose of Rivastigmine Actavis, wait and take the next dose at the usual time.
Danish: Hvis du finder ud af, at du har glemt at tage en dosis Rivastigmine Actavis, skal du blot vente og tage næste dosis på det sædvanlige tidspunkt.
English: • Urinary incontinence (inability to retain adequate urine)
Danish: • Inkontinens (manglende evne til at kunne tilbageholde urin)
English: A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of rivastigmine by 23% in patients with Alzheimer's disease (n=75 smokers and 549 non-smokers) following rivastigmine oral capsule doses of up to 12 mg/day.
Danish: En farmakokinetisk populationsanalyse viste, at nicotin øger den orale clearence af rivastigmin med 23% hos patienter med Alzheimers sygdom (n=75 rygere og 549 ikke-rygere), der får rivastigmin kapsler i en dosis på op til 12 mg/dag.
English: Discontinuation should also be considered when evidence of a therapeutic effect is no longer present.
Danish: Behandlingsophør bør også overvejes, når der ikke længere er tegn på terapeutisk effekt.
English: Not known (frequency cannot be estimated from the available data) • Allergic reaction where the patch was used, such as blisters or skin inflammation
Danish: Ikke kendt (hyppighed kan ikke beregnes ud fra tilgængelige data) • Allergisk reaktion de steder, hvor plastret blev brugt, såsom blærer eller hudirritationer
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemideel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: At least 4 points improvement on ADASCog with no worsening on CIBIC-Plus and PDS *p<0.05, **p<0.01, ***p<0.001
Danish: Mindst 4-pointsforbedring af ADAS-Cog med ingen forværring af CIBIC-Plus og PDS *p<0,05, **p<0,01, ***p<0,001
English: Peak plasma concentrations are reached in approximately 1 hour.
Danish: Maksimale plasmakoncentrationer opnås efter ca. 1 time.
English: The efficacy of rivastigmine has been established through the use of three independent, domain specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods.
Danish: Effekten af rivastigmin er påvist ved brug af tre uafhængige og domænespecifikke vurderingsredskaber, som blev vurderet med periodiske intervaller gennem 6 måneders behandlingsperioder.
English: The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose.
Danish: Den effektive dosis er 3 til 6 mg to gange daglig; for at opnå maksimal terapeutisk udbytte skal patienterne holdes på den højeste veltolererede dosis.
English: During therapy patient's weight should be monitored.
Danish: Patientens vægt bør monitoreres gennem behandlingen.
English: Rivastigmine should be administered twice a day, with morning and evening meals.
Danish: Rivastigmin skal indtages to gange daglig sammen med morgen- og aftensmåltid.
English: If you have not taken Rivastigmine Actavis for more than three days, do not take the next dose until you have talked to your doctor.
Danish: Hvis du ikke har taget Rivastigmine Actavis i mere end tre dage, må du ikke tage den næste dosis, før du har talt med din læge.
English: If adverse reactions persist, the daily dose should be temporarily reduced to the previous welltolerated dose or the treatment may be discontinued.
Danish: Hvis bivirkningerne varer ved, bør den daglige dosis midlertidigt nedsættes til den tidligere veltolererede dosis, eller behandlingen kan seponeres.
English: Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Danish: Der findes ikke uændret Rivastigmin i urinen; renal udskillelse af metabolitterne er den væsentligste udskillelsesvej.
English: These events led to the discontinuation of rivastigmine in some cases (e.g. discontinuations due to tremor 1.7 % on rivastigmine vs. 0 % on placebo).
Danish: Disse hændelser førte i nogle tilfælde til seponering af rivastigmin (f.eks. seponering grundet tremor 1,7% ved rivastigmine versus 0% ved placebo).
English: Therapy with rivastigmine should only be started if a caregiver is available who will regularly monitor intake of the medicinal product by the patient.
Danish: Rivastigmibehandling bør kun påbegyndes, hvis der er en plejegivende person, som løbende vil holde øje med indtagelsen af lægemidlet hos patienten.
English: Clinical monitoring is recommended for these adverse reactions.
Danish: Klinisk monitorering af disse bivirkninger anbefales.
English: Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day.
Danish: Derfor bør den kliniske effekt af rivastigmin revurderes løbende, specielt hos patienter, der behandles med doser der er mindre end 3 mg to gange daglig.
English: Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Danish: Bivirkninger i tabel 1og tabel 2 er opstillet i henhold til MedDRA organklasse og hyppighed.
English: Hard capsule (Capsule).
Danish: Hårde kapsler (Kapsler).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Date of latest renewal: 15 February 2016
Danish: Dato for første markedsføringstilladelse: 16. juni 2011 Dato for seneste fornyelse: 15. februar 2016
English: Patients with Alzheimer's disease may lose weight.
Danish: Patienter med Alzheimers sygdom kan opleve vægttab.
English: As a consequence of rivastigmine's interaction with its target enzyme, the increase in bioavailability is about 1.5-fold greater than that expected from the increase in dose.
Danish: Som følge af rivastigmin reaktion med sit målenzym er stigningen i biotilgængelighed ca. 1,5 gange højere end forventet fra øgningen af dosis.
English: There have been rare post-marketing reports of patients experiencing allergic dermatitis (disseminated) when administered rivastigmine irrespective of the route of administration (oral, transdermal).
Danish: Der har været sjældne post-marketing-indberetninger om patienter, der har fået allergisk dermatitis (dissemineret) i huden efter administration af rivastigmin uanset administrationsvej (oral, transdermal).
English: Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
Danish: Efterfølgende øgninger til 4,5 mg og dernæst 6 mg to gange daglig skal også være baseret på god tolerance ved den aktuelle dosis og kan overvejes efter mindst to ugers behandling på det pågældende dosisniveau.
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10 %).
Danish: Denne metabolit viser in vitro minimal hæmning af acetylkolinesterase (<10%).
English: Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer's Disease Cooperative StudyClinician's Global Impression of Change).
Danish: Effekten blevet fastslået ved hjælp af to uafhængige skalaer, som blev vurderet ved regelmæssige intervaller i løbet af en 6-måneders behandlingsperiode, som vist i tabel 5 nedenfor: ADAS-Cog, en måling af kognition og den globale måling ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change).
English: Do not take Rivastigmine Actavis
Danish: Tag ikke Rivastigmine Actavis
English: An initial dose of 0.03 mg/kg intravenous atropine sulfate is recommended, with subsequent doses based on clinical response.
Danish: En initial dosis på 0,03 mg/kg intravenøs atropinsulfat anbefales med efterfølgende doser afhængigt af klinisk respons.
English: 112 hard capsules
Danish: 112 hårde kapsler
English: Rivastigmine Actavis is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Rivastigmine Actavis anvendes til behandling af voksne patienter med mild til moderat svær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis påvirker hukommelse, åndsevner og adfærd.
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30 %.
Danish: Indgift af rivastigminsammen med føde forsinker optagelsen (tmax) med 90 min, sænker Cmax og øger AUC med ca. 30%.
English: However, rivastigmine may be used in this patient population and close monitoring is necessary.
Danish: Rivastigmin kan imidlertid anvendes hos denne patientpopulation, men det er nødvendigt at følge patienterne tæt.