natgillin/translations-raw huggingface dataset:
16 Metabolisme - og ernæringsforstyrrelser
Metabolism and nutritional disorders
Sygdomme i hud og subkutane væv
16 Skin and subcutaneous tissue disorders General
17 Almene symptomer og reaktioner på administrationsstedet
site conditions
Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24- ugers studie, der blev udført med Exelon hos patienter med demens, der er associeret med Parkinsons sygdom med præ- definerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted 17 with Exelon in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
19 Tabel 4
Table 4
Kliniske undersøgelser af demens, der er associeret med Parkinsons sygdom Effekten af rivastigmin ved demens, der er associeret med Parkinsons sygdom, er demonstreret i et 24 - ugers multicenter, dobbelt- blindt, placebo- kontrolleret hovedstudie og dets 24- ugers open- label forlængelsesfase.
19 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.
20 hos patienter med visuelle hallucinationer (se tabel 6).
Similarly a larger treatment effect was observed in those patients with visual hallucinations (see Table 6).
22 6. 3 Opbevaringstid
6.3 Shelf life
- HDPE flaske med plastik lukke med indre tætningsanordning.
- HDPE bottles with plastic closure with induction innerseal.
6. 6 Regler for destruktion
22 6.6 Special precautions for disposal
Exelon 4, 5 mg hårde kapsler
Exelon 4.5 mg hard capsules
Hver kapsel indeholder rivastigminhydrogentartrat svarende til 4, 5 mg rivastigmin.
Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 4.5 mg.
Råhvidt til svagt gulligt pulver i en kapsel med rød hætte og rød skal, med ” EXELON 4, 5 mg ” præget med hvidt på kapselskallen.
Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ EXELON 4,5 mg ” on body.
24 Der kan foregå vedligeholdelsesbehandling så længe, der er terapeutisk effekt for patienten.
24 Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
25 overledningsdefekter (sino- atrialt blok, atrio- ventrikulært blok) (jævnfør afsnit 4. 8).
25 Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
26 4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Derfor bør rivastigmin- behandlede demenspatienters evne til fortsat at køre bil eller betjene indviklede maskiner løbende vurderes af den behandlende læge.
26 continue driving or operating complex machines should be routinely evaluated by the treating physician.
27 Gastrointestinale sygdomme
Gastrointestinal disorders
Sygdomme i hud og subkutane væv
27 Skin and subcutaneous tissue disorders General
Meget almindelig Almindelig Almindelig Almindelig Almindelig Almindelig Almindelig Ikke almindelig
Common Common Common system disorders Very common Common Common Common Common Common Common Uncommon disorders Common Uncommon Uncommon
Tremor Svimmelhed Somnolens Hovedpine Forværring af Parkinsons sygdom Bradykinesi Dyskinesi Dystoni
Insomnia Anxiety Restlessness Tremor Dizziness Somnolence Headache Worsening of Parkinson’ s disease Bradykinesia Dyskinesia Dystonia Bradycardia Atrial Fibrillation Atrioventricular block
Almindelig Almindelig Ikke almindelig
Gastrointestinal disorders
Meget almindelig Meget almindelig Almindelig Almindelig
Very common Very common Common Common Common
Kvalme Opkastning Diarré Abdominale smerter og dyspepsi
Nausea Vomiting Diarrhoea Abdominal pain and dyspepsia Salivary hypersecretion
Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24- ugers studie, der blev udført med Exelon hos patienter med demens, der er associeret med Parkinsons sygdom med præ- definerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted 28 with Exelon in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
9 timer, anbefales det i tilfælde af asymptomatisk overdosering ikke at indgive yderligere
Treatment As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours.
30 Tabel 4
Table 4
Kliniske undersøgelser af demens, der er associeret med Parkinsons sygdom Effekten af rivastigmin ved demens, der er associeret med Parkinsons sygdom, er demonstreret i et 24 - ugers multicenter, dobbelt- blindt, placebo- kontrolleret hovedstudie og dets 24- ugers open- label forlængelsesfase.
30 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.
31 hos patienter med visuelle hallucinationer (se tabel 6).
Similarly a larger treatment effect was observed in those patients with visual hallucinations (see Table 6).
33 6. 3 Opbevaringstid
6.3 Shelf life
6. 6 Regler for destruktion
33 6.6 Special precautions for disposal
Exelon 6, 0 mg hårde kapsler
Exelon 6.0 mg hard capsules
Hver kapsel indeholder rivastigminhydrogentartrat svarende til 6, 0 mg rivastigmin.
Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 6.0 mg.
Råhvidt til svagt gulligt pulver i en kapsel med rød hætte og orange skal, med ” EXELON 6 mg ” præget med rødt på kapselskallen.
Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “ EXELON 6 mg ” on body.
35 Der kan foregå vedligeholdelsesbehandling så længe, der er terapeutisk effekt for patienten.
35 Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
36 overledningsdefekter (sino- atrialt blok, atrio- ventrikulært blok) (jævnfør afsnit 4. 8).
36 Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
37 4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Derfor bør rivastigmin- behandlede demenspatienters evne til fortsat at køre bil eller betjene indviklede maskiner løbende vurderes af den behandlende læge.
37 continue driving or operating complex machines should be routinely evaluated by the treating physician.
Sygdomme i hud og subkutane væv
38 Skin and subcutaneous tissue disorders General
39 Metabolisme - og ernæringsforstyrrelser
Metabolism and nutritional disorders General
Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24- ugers studie, der blev udført med Exelon hos patienter med demens, der er associeret med Parkinsons sygdom med præ- definerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted 39 with Exelon in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
En initial dosis på 0, 03 mg/ kg intravenøs atropinsulfat
An initial dose of 0.03 mg/ kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
40% inden for den første 1, 5 time efter indgift.
40 functionally intact cholinergic neurones.
Enzymets aktivitet er tilbage på baseline- niveau ca.
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.
41 Tabel 4
Table 4
Kliniske undersøgelser af demens, der er associeret med Parkinsons sygdom Effekten af rivastigmin ved demens, der er associeret med Parkinsons sygdom, er demonstreret i et 24 - ugers multicenter, dobbelt- blindt, placebo- kontrolleret hovedstudie og dets 24- ugers open- label forlængelsesfase.
41 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.
42 hos patienter med visuelle hallucinationer (se tabel 6).
Similarly a larger treatment effect was observed in those patients with visual hallucinations (see Table 6).
44 6. 3 Opbevaringstid
6.3 Shelf life
6. 6 Regler for destruktion
44 6.6 Special precautions for disposal
Exelon 2 mg/ ml oral opløsning
Exelon 2 mg/ ml oral solution
Hver ml indeholder rivastigmin- hydrogentartrat svarende til 2, 0 mg rivastigmin- base.
Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg.
Rivastigmin oral opløsning skal indtages to gange daglig sammen med henholdsvis morgen - og aftensmåltid.
Rivastigmine oral solution should be administered twice a day, with morning and evening meals.
Rivastigmin oral opløsning og rivastigmin- kapsler kan substitueres ved ens dosis.
Rivastigmine oral solution and rivastigmine capsules may be interchanged at equal doses.
46 Vedligeholdelsesdosis Den effektive dosis er 3 til 6 mg to gange daglig; for at opnå maksimal terapeutisk fordel skal patienterne holdes på den højeste dosis, som de tåler godt.
46 day.
47 passende dosisjustering som anbefalet i afsnit 4. 2.
In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
Der skal udvises forsigtighed ved brug af rivastigmin til patienter med sygt sinussyndrom eller overledningsdefekter (sino- atrialt blok, atrio- ventrikulært blok) (jævnfør afsnit 4. 8).
47 Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
Rivastigmin bør ikke anvendes under graviditet, medmindre det er klart
Rivastigmine should not be used during pregnancy unless clearly necessary.
48 nødvendigt.
48 4.7 Effects on ability to drive and use machines
Derfor bør rivastigmin- behandlede demenspatienters evne til fortsat at køre bil eller betjene indviklede maskiner løbende vurderes af den behandlende læge.
Therefore, the ability of patients with dementia on rivastigmine to continue driving or operating complex machines should be routinely evaluated by the treating physician.
49 Gastrointestinale sygdomme
49
Kvalme Opkastning Diarré Abdominale smerter og dyspepsi Mavesår og sår på tolvfingertarmen Gastrointestinal blødning Pankreatitis Nogle tilfælde af alvorlig opkastning blev associeret med esophagusruptur (se pkt 4. 4).
oesophageal rupture (see section 4.4).
Sygdomme i hud og subkutane væv
Skin and subcutaneous tissue disorders General
Meget almindelig Meget almindelig Almindelig Almindelig Almindelig
Very common Very common Common Common Common
Kvalme Opkastning Diarré Abdominale smerter og dyspepsi Hypersekretion af spyt
Nausea Vomiting Diarrhoea Abdominal pain and dyspepsia Salivary hypersecretion
Almene symptomer og reaktioner på administrationsstedet
50 General disorders and administration site conditions
Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24- ugers studie, der blev udført med Exelon hos patienter med demens, der er associeret med Parkinsons sygdom med præ- definerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
with Exelon in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
I tilfælde af overdosering, som efterfølges af svær
Treatment As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose of rivastigmine should be administered for the next 24 hours.
51 kvalme og opkastning, bør anvendelse af antiemetika overvejes.
In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered.
Rivastigmin er en acetyl - og butyrylkolinesterasehæmmer af carbamattypen, som menes at lette kolinerg neurotransmission ved at nedsætte nedbrydningen af acetylkolin, som er frigjort af funktionelt intakte kolinerge neuroner.
Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
52 Tabel 4
Table 4
CIBIC- Plus: forbedring PDS: mindst 10% forbedring Mindst 4- pointsforbedring af ADAS- Cog med ingen forværring af CIBIC- Plus og PDS
CIBIC-Plus: improvement PDS: improvement of at
Kliniske undersøgelser af demens, der er associeret med Parkinsons sygdom Effekten af rivastigmin ved demens, der er associeret med Parkinsons sygdom, er demonstreret i et 24 - ugers multicenter, dobbelt- blindt, placebo- kontrolleret hovedstudie og dets 24- ugers open- label forlængelsesfase.
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.
53 hos patienter med visuelle hallucinationer (se tabel 6).
Similarly a larger treatment effect was observed in those patients with visual hallucinations (see Table 6).
Tabel 6
53 Table 6
36% ±13%.
Absolute bioavailability after a 3 mg dose is about 36% ± 13%.
9%.
Administration of rivastigmine oral solution with food delays absorption (tmax) by 74 min and lowers Cmax by 43% and increases AUC by approximately 9%.
54 udskillelsesvej.
54 Excretion Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Personer med nedsat nyrefunktion Cmax og AUC for rivastigmin var mere end dobbelt så høj hos personer med moderat nedsat nyrefunktion sammenlignet med raske personer; der var dog ingen ændringer af Cmax og AUC for rivastigmin hos personer med svært nedsat nyrefunktion.
Subjects with renal impairment Cmax and AUC of rivastigmine were more than twice as high in subjects with moderate renal impairment compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in subjects with severe renal impairment.
Natriumbenzoat Citronsyre Natriumcitrat Vandopløselig quinolingult farve (E 104) Renset vand
Sodium benzoate Citric acid Sodium citrate Quinoline yellow WS dye (E104) Purified water
55 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 3 Opbevaringstid
55 6.3 Shelf life
Exelon 4, 6 mg/ 24 timer depotplaster
Exelon 4.6 mg/ 24 h transdermal patch
24 timer.
Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Ydersiden af det bagerste lag er beige og mærket ” Exelon ”, ” 4. 6 mg/ 24 h ” og ” AMCX ”.
The outside of the backing layer is beige and labelled with “ Exelon”, “ 4.6 mg/ 24 h” and “ AMCX”.
Behandlingen bør indledes og overvåges af en læge, der har erfaring med diagnosticering og behandling af Alzheimers demens.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’ s dementia.
Rivastigmindosis
Transdermal patches
24 timer in vivo
Rivastigmine dose load
Exelon 4, 6 mg/ 24 timer
Rivastigmine in vivo release rates per 24 h
Exelon 9, 5 mg/ 24 timer
Exelon 4.6 mg/ 24 h Exelon 9.5 mg/ 24 h
Behandlingen indledes med 4, 6 mg/ 24 timer.
Treatment is started with 4.6 mg/ 24 h.
Efter mindst fire ugers behandling, og hvis denne dosis ifølge den behandlende læge tåles godt, bør dosis øges til 9, 5 mg/ 24 timer, som er den anbefalede virksomme dosis.
After a minimum of four weeks of treatment and if well tolerated according to the treating physician, this dose should be increased to 9.5 mg/ 24 h, which is the recommended effective dose.
Vedligeholdelsesdosis 9, 5 mg/ 24 timer er den anbefalede daglige vedligeholdelsesdosis, som kan anvendes, så længe der er terapeutisk effekt for patienten.
Maintenance dose 9.5 mg/ 24 h is the recommended daily maintenance dose which can be continued for as long as the patient is deriving therapeutic benefit.
Behandlingen med depotplaster kan genoptages ved samme dosis, hvis behandlingen kun er afbrudt i nogle dage.
Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than several days.
Er afbrydelsen af længere varighed, genoptages behandlingen med 4, 6 mg/ 24 timer.
Otherwise treatment should be re-initiated with 4.6 mg/ 24 h.
5. 2), kan patienter, som behandles med Exelon kapsler eller oral opløsning, skiftes til Exelon depotplastre, som følger: • En patient, som får en dosis på 3 mg/ dag oral rivastigmin, kan skiftes til 4, 6 mg/ 24 timer depotplastre. • En patient, som får en dosis på 6 mg/ dag oral rivastigmin, kan skiftes til 4, 6 mg/ 24 timer depotplastre. • En patient, som får en stabil og veltolereret dosis på 9 mg/ dag oral rivastigmin, kan skiftes til 9, 5 mg/ 24 timer depotplastre.
Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients 57 treated with Exelon capsules or oral solution can be switched to Exelon transdermal patches as follows: • A patient on a dose of 3 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a dose of 6 mg/ day oral rivastigmine can be switched to 4.6 mg/ 24 h transdermal patches. • A patient on a stable and well tolerated dose of 9 mg/ day oral rivastigmine can be switched to 9.5 mg/ 24 h transdermal patches.
Hvis den orale dosis på 9 mg/ dag ikke er stabil og veltolereret, anbefales et skift til 4, 6 mg/ 24 timer depotplastre. • En patient, som får en dosis på 12 mg/ dag oral rivastigmin, kan skiftes til 9, 5 mg/ 24 timer depotplastre.
If the oral dose of 9 mg/ day has not been stable and well tolerated, a switch to 4.6 mg/ 24 h transdermal patches is recommended. • A patient on a dose of 12 mg/ day oral rivastigmine can be switched to 9.5 mg/ 24 h transdermal patches.
Efter at have skiftet til 4, 6 mg/ 24 timer depotplastre, bør dosis på 4, 6 mg/ 24 timer, forudsat at denne er veltolereret efter minimum 4 ugers behandling, øges til 9, 5 mg/ 24 timer, som er den anbefalede effektive dosis.
After switching to 4.6 mg/ 24 h transdermal patches, provided these are well tolerated after a minimum of four weeks of treatment, the dose of 4.6 mg/ 24 h should be increased to 9.5 mg/ 24 h, which is the recommended effective dose.
Indgivelsesmåde Depotplasteret påføres én gang dagligt på ren, tør, hårløs intakt sund hud på ryg, overarm eller bryst på et sted, hvor stramt tøj ikke kan gnide mod plasteret.
Method of administration Transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by tight clothing.
Depotplasteret trykkes godt ned, indtil kanterne sidder godt fast.
The transdermal patch should be pressed down firmly until the edges stick well.
Depotplasteret kan anvendes i hverdagssituationer, herunder badning og varmt vejr.
It can be used in everyday situations, including bathing and during hot weather.
Depotplasteret udskiftes efter 24 timer.
The transdermal patch should be replaced by a new one after 24 hours.
Der må kun påføres ét depotplaster ad gangen.
Only one transdermal patch should be worn at a time.
Patienten og den omsorgsgivende person skal instrueres i dette.
Patients and caregivers should be instructed accordingly.
5. 2).
No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Børn og unge (under 18 år):
Children and adolescents (age below 18 years):
Rivastigmin bør ikke anvendes til børn og unge.
Rivastigmine is not recommended for use in children and adolescents.
Overfølsomhed over for det aktive stof, andre carbamatderivater eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance, to other carbamate derivatives or to any of the excipients used in the formulation.
Hvis behandlingen afbrydes i mere end nogle dage, skal den genoptages med 4, 6 mg/ 24 timer.
If treatment is interrupted for more than several days, it should be re-initiated with 4.6 mg/ 24 h.
4. 8).
Gastrointestinal disorders such as nausea and vomiting are dose-related, and may occur when initiating treatment and/ or increasing the dose (see section 4.8).
Patienter med Alzheimers demens kan tabe sig, når de tager kolinesterasehæmmere, inklusive 58 rivastigmin.
Patients with Alzheimer’ s disease may lose weight whilst taking cholinesterase inhibitors, including rivastigmine.
Patientens vægt bør overvåges under behandling med Exelon depotplastre.
The patient’ s weight should be monitored during therapy with Exelon transdermal patches.
4. 8). • til patienter, som er prædisponeret for urinvejsobstruktion og krampeanfald, da kolinomimetika kan forårsage eller forværre disse sygdomme. • til patienter, som tidligere har haft astma eller kronisk obstruktiv lungesygdom.
58 Care must be taken when prescribing Exelon transdermal patches: • to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8) • to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8) • to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases. • to patients with a history of asthma or obstructive pulmonary disease.
5. 3).
Contact with the eyes should be avoided after handling Exelon transdermal patches (see section 5.3).
Specielle populationer: • Patienter med en legemsvægt på under 50 kg kan opleve flere bivirkninger og har større risiko for at måtte afbryde behandlingen på grund af bivirkninger. • Leverinsufficiens:
Special populations: • Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions. • Hepatic impairment:
5. 2).
Patients with clinically significant hepatic impairment might experience more adverse reactions (see section 5.2).
Der er ikke udført specifikke interaktionsundersøgelser med Exelon depotplastre.
No specific interaction studies have been conducted with Exelon transdermal patches.
Den warfarin- inducerede stigning i protrombin- tid påvirkes ikke af indgift af rivastigmin.
The increase in prothrombin time induced by warfarin is not affected by administration of oral rivastigmine.
Eksempler på disse lægemidler er: antacida, antiemetika, antidiabetika, centralt virkende antihypertensiva, betablokkere, calciumkanalblokkere, inotrope midler, midler mod angina pectoris, non- steroide antiinflammatoriske stoffer, østrogener, analgetika, benzodiazepiner og antihistaminer.
Concomitant administration of rivastigmine with commonly prescribed medicinal products, such as antacids, antiemetics, antidiabetics, centrally acting antihypertensives, beta blockers, calcium channel blockers, inotropic agents, antianginals, non-steroidal anti-inflammatory agents, oestrogens, analgesics, benzodiazepines and antihistamines, was not associated with an alteration in the kinetics of rivastigmine or an increased risk of clinically relevant untoward effects.