FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Danish: Hos patienter med Alzheimers demens eller demens som følge af Parkinsons sygdom dør visse nerveceller i hjernen, hvilket resulterer i lave niveauer af neurotransmitteren acetylcholin (et stof, som bruges af nervecellerne til at kommunikere med hinanden).
English: • if you suffer from trembling.
Danish: • hvis du ryster meget.
English: Patients with mild dementia dementia (MMSE 10-17)
Danish: Patienter med moderat demens (MMSE 10-17)
English: According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Danish: I overensstemmelse med dets metabolisme forekommer metaboliske interaktioner med andre lægemidler sandsynligvis ikke, selvom rivastigmin kan hæmme den butylkolinesterase-medierede metabolisme i andre stoffer.
English: 1.5 mg twice a day.
Danish: 1,5 mg to gange daglig.
English: Patients without visual hallucinations hallucinations
Danish: Patienter uden visuelle hallucinationer
English: - Capsule containers (HDPE) with LDPE caps: 250 hard capsules.
Danish: - Kapsel beholdere (HDPE) med LDPE hætter: 250 kapsler.
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Danish: Kliniske studier af demens associeret med Parkinsons sygdom Effekten af rivastigmin ved demens associeret med Parkinsons sygdom, er demonstreret i et 24ugers multicenter, dobbelt-blindt, placebo-kontrolleret hovedstudie og dets 24-ugers open-label forlængelsesfase.
English: • The highest dose that should be taken is 6 mg twice a day.
Danish: • Den højeste dosis, som bør tages, er 6 mg to gange daglig.
English: Do not use this medicine after the expiry date which is stated on the carton, blister or capsule container after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter udløbsdato (EXP).
English: In patients with Alzheimer's disease, inhibition of AChE in CSF by rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested.
Danish: Hos patienter med Alzheimers sygdom var rivastigmins hæmning af AChE i CSF dosisafhængigt op til 6 mg, der blev indgivet to gange daglig, som var den højeste dosis, som blev testet.
English: Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 10
Danish: Rivastigmin var ikke mutagen i et standardbatteri af in vitro- og in vivo-test, på nær i en kromosonal Abberation Test i humane perifere lymfocytter ved en dosis på 10
English: In healthy young men, an oral 3 mg dose decreases acetylcholinesterase (AChE) activity in CSF by approximately 40 % within the first 1.5 hours after administration.
Danish: Hos raske, unge mænd sænker en peroral dosis på 3 mg aktiviteten af acetylkolinesterase (AChE) i CSF med ca. 40% inden for den første 1,5 time efter indgift.
English: Talk to your doctor before taking Rivastigmine Actavis:
Danish: Kontakt lægen, før du bruger Rivastigmine Actavis:
English: Effects of rivastigmine on human fertility are not known.
Danish: Rivastigmins virkning på human fertilitet er ukendt
English: 56 hard capsules
Danish: 56 hårde kapsler
English: The use of rivastigmine in patients with severe dementia of Alzheimer's disease or associated with Parkinson's disease, other types of dementia or other types of memory impairment (e.g. age-related cognitive decline) has not been investigated and therefore use in these patient populations is not recommended.
Danish: Brugen af rivastigmin til patienter med svær demens af Alzheimers sygdom eller associeret med Parkinsons sygdom, andre typer demens eller andre typer hukommelsessvækkelse (f.eks. aldersrelateret kognitiv tilbagegang) er ikke undersøgt, og anvendelse hos disse patientpopulationer kan derfor ikke anbefales.
English: If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
Danish: Hvis en eller flere af disse symptomer gælder for dig, kan det være nødvendigt, at din læge følger dig tæt, mens du tager denne medicin.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [Actavis logo]
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Actavis logo]
English: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38 %) and vomiting (23 %), especially during titration.
Danish: De mest almindeligt rapporterede bivirkninger er gastrointestinale, inklusive kvalme (38 %) og opkastning (23 %), særligt under dosistitrering.
English: Cholinesterase inhibitors, including rivastigmine, have been associated with weight loss in these patients.
Danish: Kolinesterasehæmmere, inklusiv rivastigmin, har været sat i forbindelse med vægttab hos disse patienter.
English: Pharmacotherapeutic group: psychoanaleptics, anticholinesterases, ATC code: N06DA03
Danish: Farmakoterapeutisk klassifikation: psykoanaleptika, kolinesterasehæmmer, ATC-kode: N06DA03
English: The active substance of Rivastigmine Actavis is rivastigmine.
Danish: Det aktive stof i Rivastigmine Actavis er rivastigmin.
English: Hypersensitivity to the active substance, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, eller andre carbamatderivater eller over for et eller flere af hjælpestofferne anført i pkt 6.1.
English: If you forget to take Rivastigmine Actavis
Danish: Hvis du har glemt at tage Rivastigmine Actavis
English: Although a treatment effect was demonstrated in the overall study population, the data suggested that a larger treatment effect relative to placebo was seen in the subgroup of patients with moderate dementia associated with Parkinson's disease.
Danish: Selvom behandlingseffekten blev demonstreret i den samlede studiepopulation, indikerede data, at en større behandlingseffekt i forhold til placebo blev set i subgruppen af patienter med moderat demens associeret med Parkinsons sygdom.
English: ADAS-Cog: improvement of at least 4 points CIBIC-Plus: improvement PDS: improvement of at least 10%
Danish: ADAS-Cog: mindst 4pointsforbedring CIBIC-Plus: forbedring PDS: mindst 10% forbedring
English: Rivastigmine Actavis should not be given at the same time as other medicines with similar effects to Rivastigmine Actavis.
Danish: Du må ikke tage Rivastigmine Actavis samtidig med andre lægemidler, der har en virkning, der virker på samme måde som Rivastigmine Actavis.
English: Therefore, women on rivastigmine should not breast-feed.
Danish: Kvinder i behandling med rivastigminbør derfor ikke amme.
English: If you take more Rivastigmine Actavis than you should If you accidentally take more Rivastigmine Actavis than you should, inform your doctor.
Danish: Hvis du har taget for meget Rivastigmine Actavis Hvis du ved en fejltagelse er kommet til at tage mere Rivastigmine Actavis, end du har fået besked på, skal du sige det til din læge.
English: Less than 1 % of the administered dose is excreted in the faeces.
Danish: Under 1% af den indgivne dosis udskilles med fæces.
English: Allergic dermatitis (disseminated)
Danish: Kløe allergisk dermatitis (dissemineret)
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with predefined adverse events that may reflect worsening of parkinsonian symptoms.
Danish: Tabel 3 angiver antallet og procentdelen af patienter fra det specifikke kliniske 24-ugers studie, der blev udført med rivastigmin hos patienter med demens, der er associeret med Parkinsons sygdom med præ-definerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
English: • Tell your caregiver that you are taking Rivastigmine Actavis.
Danish: • Fortæl dine nærmeste, at du er i behandling med Rivastigmine Actavis.
English: • if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.
Danish: • hvis du får en hudreaktion, som spreder sig uden for selve plasteret, hvis der er en kraftigere lokal reaktion (som fx blærer, tiltagende hudirritation, hævelse), og hvis det ikke bliver bedre inden for 48 timer efter, at plasteret er fjernet.
English: n (%)
Danish: Rivastigmin n (%)
English: Rivastigmine Actavis should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Danish: Rivastigmine Actavis bør ikke gives sammen med metoclopramid (et lægemiddel som bruges til at lindre eller forebygge kvalme og opkastning).
English: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10 % improvement on the PDS.
Danish: Klinisk relevant forbedring var i disse studier på forhånd defineret som en mindst 4-pointsforbedring af ADAS-Cog, forbedring af CIBIC-Plus eller en forbedring på mindst 10% af PDS.
English: Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms.
Danish: Som andre kolinomimetika kan rivastigmine forværre eller fremkalde ekstrapyramidale symptomer.
English: Based on evidence from animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Danish: Resultater fra dyrestudier viser, at CYP-isoenzymer kun i ringe grad er involveret i rivastigmins metabolisering.
English: If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily to reduce the possibility of adverse reactions (e.g. vomiting).
Danish: Hvis behandlingen afbrydes i mere end tre dage, skal behandlingen genoptages med 1,5 mg 2 gange daglig for at mindske risikoen for bivirkninger (f.eks. opkastninger).
English: • if you have, or have ever had, irregular or slow heartbeat.
Danish: • hvis du har eller nogensinde har haft uregelmæssig eller langsom hjerterytme.
English: The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with rivastigmine transdermal patches: agitation (common).
Danish: Yderligere er følgende bivirkning blevet observeret i et studie med patienter med demens associeret med Parkinsons sygdom, som har fået behandling med rivastigmin depotplaster: agitation (almindelig).
English: The Cmax of rivastigmine was approximately 60 % higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Danish: Cmax for rivastigmin var cirka 60% højere, og AUC for rivastigmin var mere end dobbelt så høj hos personer med let til moderat nedsat leverfunktion end hos raske personer.
English: These include the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale, a performance based measure of cognition), the CIBIC-Plus (Clinician's Interview Based Impression of Change-Plus, a comprehensive global assessment of the patient by the physician incorporating caregiver input), and the PDS (Progressive Deterioration Scale, a caregiver-rated assessment of the activities of daily living including personal hygiene, feeding, dressing, household chores such as shopping, retention of ability to orient oneself to surroundings as well as involvement in activities relating to finances, etc.).
Danish: Disse omfatter ADAS-Cog (Alzheimer´s Disease Assessment ScaleCognitive subscale,en præstationsbaseret måling af kognition), CIBIC-Plus (Clinician´s Interview Based Impression of Change-Plus,en omfattende global vurdering af patienten, der dannes af den behandlende læge med input fra den omsorgsgivende person) og PDS (Progressive Deterioration Scale,den omsorgsgivende persons vurdering af dagligdagsaktiviteter, som indbefatter personlig hygiejne, fødeindtagelse, påklædning, husføring som indkøb, opretholdelse af evner så som at orientere sig i forhold til omgivelserne og involvere sig i økonomiske anliggender,etc.
English: If you have to undergo surgery whilst taking Rivastigmine Actavis, tell your doctor before you are given any anaesthetics, because Rivastigmine Actavis may exaggerate the effects of some muscle relaxants during anaesthesia.
Danish: Hvis du skal gennemgå en operation, mens du er i behandling med Rivastigmine Actavis, skal du fortælle det til din læge, inden du modtager nogen form for bedøvelse, da Rivastigmine Actavis kan forstærke virkningen af muskelafslappende midler under bedøvelse.
English: Manufacturer Specifar S.A 1, 28 Octovriou str. 123 51 Ag. Varvara Athens
Danish: Fremstiller Specifar S.A 1, 28 Octovriou str. 123 51 Ag. Varvara Athen Grækenland
English: Metabolism and nutrition disorders Very common
Danish: Metabolisme og ernæring Meget almindelig Almindelig
English: Some people who have accidentally taken too much Rivastigmine Actavis have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations.
Danish: Nogle personer, som er kommet til at tage for meget Rivastigmine Actavis, har oplevet kvalme, opkastning, diarré, forhøjet blodtryk og hallucinationer.
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
Danish: Nogle tilfælde af alvorlig opkastning blev associeret med oesophagusruptur (se pkt 4.4).
English: By blocking these enzymes, Rivastigmine Actavis allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's disease and dementia associated with Parkinson's disease.
Danish: Ved at blokere disse enzymer kan Rivastigmine Actavis medvirke til, at acetylcholin-indholdet øges i hjernen, hvilket hjælper med at reducere symptomerne på Alzheimers sygdom eller demens som følge af Parkinsons sygdom.
English: As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during anaesthesia.
Danish: Som kolinesterasehæmmer kan rivastigmin muligvis forstærke virkningerne af muskelrelaksantia af succinylkolintypen under anæstesi.
English: Shellac, propylene glycol, red iron oxide (E172).
Danish: Shellak, Propylenglycol, Rød jernoxid (E172).
English: • if you have, or have ever had, asthma or severe respiratory disease.
Danish: • hvis du har eller har haft astma eller en svær luftvejssygdom.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlige for batchfrigivelse
English: Nervous system disorders Very common
Danish: Nervesystemet Meget almindelig Almindelig
English: Rivastigmine Actavis might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
Danish: Rivastigmine Actavis kan påvirke antikolinerg medicin (medicin, der bruges mod mavekramper og Parkinsons sygdom eller til at forebygge transportsyge).
English: Rivastigmine Actavis may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Danish: Rivastigmine Actavis kan give svimmelhed og døsighed, specielt i starten af behandlingen, eller når dosis øges.
English: Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be observed with caution and clinical monitoring (ECG) may also be required.
Danish: Da bradykardi udgør en risikofaktor i forbindelse med torsades de pointes skal samtidig behandling med rivastigmin og torsades de pointes-inducerende lægemidler såsom antipsykotika fx vissephenothiaziner (chlorpromazin, levomepromazin) samt benzamider (sulpirid, sultoprid, amisulprid, tiaprid, veraliprid), pimozid, haloperidol, droperidol, cisaprid, citalopram, diphemanil, erythromycin intravenøst, halofantrin, mizolastin, methadon, pentamidin ogmoxifloxacin gives med forsigtighed og klinisk monitorering (EKG) kan også være påkrævet.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer's dementia and in the treatment of dementia in patients with idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med rivastigmin hos alle undergrupper af den pædiatriske population ved behandling af Alzheimers demens og demens hos patienter med idiopatisk Parkinsons sygdom (se pkt.
English: Caution when Rivastigmine Actavis is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions).
Danish: Vær forsigtig, hvis du tager Rivastigmine Actavis sammen med betablokkere (lægemidler som atenolol, som bruges til behandling af hypertension, hjertekrampe (angina pectoris) og andre hjertesygdomme).
English: PHARMACEUTICAL FORM AND CONTENTS 28 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 28 hårde kapsler
English: Uncommon (may affect up to 1 in 100 people) • Uneven heartbeat and poor control of movements
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter) • Uregelmæssig hjerterytme (puls), dårlig kontrol over bevægelser
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort
English: Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block, atrial fibrillation and tachycardia)
Danish: Kardielle arytmier (f.eks. bradykardi, atrioventrikulært blok, atrieflimren og takykardi)
English: PHARMACEUTICAL FORM AND CONTENTS 250 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 250 hårde kapsler
English: Adjusted treatment difference p-value versus placebo
Danish: Justeret behandlingsforskel p-værdi versus placebo ikke relevant
English: Some cases of severe vomiting were associated with oesophageal rupture (see section 4.8).
Danish: Nogle tilfælde af alvorlig opkastning blev associeret med oesophagusruptur (jævnfør afsnit 4.8).
English: Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
Danish: Studier med drægtige rotter og kaniner med peroral indgift af rivastigmin gav ingen indikation for et teratogent potentiale.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Actavis Group PTC ehf
English: Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules Red iron oxide (E172)
Danish: Rivastigmine Actavis 3 mg, 4,5 mg og 6 mg hårde kapsler Rød jernoxid (E172)
English: Capsule content: Magnesium stearate, colloidal anhydrous silica, hypromellose and microcrystalline cellulose.
Danish: Indhold i kapsel:Magnesiumstearat, Silica, kolloid vandfri, Hypromellose, Mikrokrystallinsk cellulose
English: Restlessness Hallucination, visual Depression
Danish: Visuelle hallucinationer Depression
English: The following additional adverse reactions have been observed with rivastigmine transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Danish: Følgende bivirkninger er blevet observeret med rivastigmin depotplastre: Delirium, feber, nedsat appetit, inkontinens (almindelig), psykomotorisk hyperaktivitet (ualmindelig), solbrændthed, nældefeber, blærer, allergisk dermatitis (ikke kendt).
English: What you need to know before you take Rivastigmine Actavis
Danish: Det skal du vide, før du begynder at bruge Rivastigmine Actavis
English: If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with Parkinson's disease are observed during treatment, these may respond to omitting one or more doses.
Danish: Hvis der observeres bivirkninger i løbet af behandlingen f.eks. kvalme, opkastning, mavesmerter eller appetitløshed, vægttab eller forværring af ekstrapyramidale symptomer (f.eks. tremor) hos patienter med demens, associeret med Parkinsons sygdom, vil disse muligvis kunne undgås ved udeladelse af en eller flere doser.
English: You should not breast-feed during treatment with Rivastigmine Actavis.
Danish: Du må ikke amme, mens du er i behandling med Rivastigmine Actavis depotplastre.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR CAPSULE CONTAINER
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL KAPSELBEHOLDER
English: • if you have, or have ever had, an active stomach ulcer.
Danish: • hvis du har eller nogensinde har haft aktivt mavesår.
English: Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with rivastigmine capsules.
Danish: Tabel 2 viser bivirkninger, der er rapporteret fra kliniske studier med rivastigmin kapsler, hos patienter med demens associeret med Parkinsons sygdom.
English: Magnesium stearate Silica colloidal, anhydrous Hypromellose Microcrystalline cellulose
Danish: Indhold i kapsel Magnesiumstearat Silica, kolloid vandfri Hypromellose Mikrokrystallinsk cellulose
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristic, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Furthermore, rivastigmine can induce dizziness and somnolence, mainly when initiating treatment or increasing the dose.
Danish: Ydermere kan rivastigmin medføre svimmelhed og døsighed, specielt ved behandlingsstart eller dosisøgning.
English: Therefore, caution should be exercised when rivastigmine is combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, calcium channel antagonists, digitalis glycoside, pilocarpin).
Danish: Der skal derfor udvises forsigtighed, når rivastigmin kombineres med betablokkere og andre stoffer, som kan føre til bradykardi (f.eks. klasse III-antiarytmika, calciumantagonister, digitalisglykosider, pilocarpin).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske til blister
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Rivastigmine Actavis Fortæl det altid til lægen eller på apotekspersonalet, hvis du bruger anden medicin, har brugt det for nylig eller muligvis vil komme til det.
English: ITT + RDO population (n=87)
Danish: ITT + RDO population
English: There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer's disease.
Danish: Der er ikke relevante at anvende rigvastigmin hos den pædiatriske population til indikationen Alzheimers sygdom.