natgillin/translations-raw huggingface dataset:
SÅDAN OPBEVARER DE PROCORALAN
HOW TO STORE PROCORALAN
Brug ikke Procoralan efter den udløbsdato, som er angivet på karton og blister.
Do not use Procoralan after the expiry date which is stated on the carton and blister.
Procoralan indeholder
What Procoralan contains:
En filmovertrukket tablet indeholder 5 mg ivabradin (hvilket svarer til 5, 390 mg ivabradinhydrochlorid).
Procoralan 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine hydrochloride).
En filmovertrukket tablet indeholder 7, 5 mg ivabradin (hvilket svarer til 8, 085 mg ivabradinhydrochlorid).
Procoralan 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine hydrochloride).
Procoralans udseende og pakningsstørrelse Procoralan 5 mg tabletter er laksefarvede, aflange filmovertrukne tabletter med delekærv på begge sider, mærket med ” 5 ” på den ene side og
Procoralan 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “ 5” on one face and
Procoralan 7, 5 mg tabletter er laksefarvede, trekantede filmovertrukne tabletter, mærket med ” 7. 5 ” på den ene side og
Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “ 7.5” on one face and
Servier (Ireland) Industries Ltd Gorey Road Arklow – Co.
and Servier (Ireland) Industries Ltd Gorey Road Arklow - Co.
Wicklow Irland
Wicklow – Ireland
Industrijska cesta 1J 1290 Grosuplje – Slovenien
Industrijska cesta 1J 1290 Grosuplje – Slovenia
Hvis De vil have yderligere oplysninger om Procoralan, skal De henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Tél: +33 (0) 1 55 72 60 00
France Les Laboratoires Servier Tél: +33 (0)1 55 72 60 00
Tel: +40 21 402 09 11
România Servier Pharma SRL Tel: +40 21 402 09 11
De kan finde yderligere information om Procoralan på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside: http: // www. emea. europa. eu.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Det leveres som kapsler, 1, 5 mg (gule), 3 mg (orange), 4, 5 mg (røde), 6 mg (røde og orange), som oral opløsning, 2 mg/ ml, og som depotplastre, der afgiver enten 4, 6 eller 9, 5 mg rivastigmin gennem huden i løbet af 24 timer.
6 mg), as an oral solution (2 mg/ ml), and as transdermal patches, which release either 4.6 mg or 9.5 mg rivastigmine across the skin over 24 hours.
Prometax kapsler, oral opløsning og depotplastre anvendes ved let til middelsvær Alzheimers sygdom, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
Prometax capsules, oral solution and transdermal patches are used for the treatment of patients with mild to moderately severe Alzheimer’ s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Behandling med Prometax bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom og demens hos patienter med Parkinsons sygdom.
Treatment with Prometax should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’ s disease or dementia in patients with Parkinson’ s disease.
Behandlingen bør kun iværksættes, hvis en omsorgsgivende person regelmæssigt overvåger patientens indtagelse af Prometax.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Prometax by the patient.
Prometax kapsler eller oral opløsning gives to gange dagligt sammen med morgen - og aftensmaden.
Prometax capsules or oral solution should be given twice a day, with morning and evening meals.
De nærmere oplysninger fremgår af produktresuméet, der også er en del af EPAR.
See the Summary of Product Characteristics (also part of the EPAR) for detailed information.
Derved mindskes symptomerne på Alzheimers sygdom og på demens ved Parkinsons sygdom.
By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’ s dementia and dementia due to Parkinson’ s disease.
Prometax blev undersøgt ved let til middelsvær Alzheimers sygdom.
Prometax has been studied in mild to moderately severe Alzheimer’ s disease.
Prometax kapsler blev desuden undersøgt hos 541 patienter med demens som følge af Parkinsons sygdom.
Prometax capsules have also been studied in 541 patients with dementia due to Parkinson’ s disease.
Behandlingens virkning blev hovedsagelig bedømt ved ændringen i symptomer på to hovedområder: dels kognitive funktioner (evnen til at tænke, lære og huske), dels overordnede funktioner (en kombination af flere områder bestående af generel funktionsevne, kognitive symptomer, adfærd og evne til at udføre daglige aktiviteter).
The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
I endnu en undersøgelse hos 27 patienter blev det vist, at Prometax kapsler og oral opløsning giver samme indhold af aktivt stof i blodet.
An additional study in 27 patients was used to show that Prometax capsules and oral solution produced similar levels of the active substance in the blood.
Hvilken fordel viser undersøgelserne, der er ved Prometax?
What benefit has Prometax shown during the studies?
AZILECT var mere effektivt end placebo til at begrænse symptomerne.
Prometax was more effective than placebo at controlling symptoms.
Hos de patienter, der fik Prometax, 6 til 9 mg dagligt, øgedes de kognitive symptomer med 0, 2 points fra et udgangspunkt på 22, 9 points ved undersøgelsens start (lavere score = bedre præstationer).
In the three studies of Prometax capsules in patients with Alzheimer’ s dementia, patients taking doses of Prometax between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Hos patienterne på placebo var stigningen 4, 4 points.
For the global score, patients taking Prometax capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Også som depotplaster var Prometax mere effektivt end placebo til at forhindre forværring af demens.
The Prometax transdermal patches were also more effective than placebo in preventing dementia from getting worse.
Udgangspunktet var omkring 24 points.
The patients with dementia due to Parkinson’ s disease taking Prometax capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Også i score vedrørende overordnede funktioner var der større bedring hos de patienter, der fik Prometax.
The global symptom score also improved more in the patients taking Prometax.
Bivirkningerne af Prometax afhænger af den form for demens, patienten har, og om patienten får kapsler, oral opløsning eller depotplastre.
The types of side effects seen with Prometax depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used.
Som helhed er de almindeligste bivirkninger (ses hos flere end 1 patient ud af 10) kvalme og opkastning, især i den fase, hvor dosis af Prometax øges.
Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick) and vomiting, particularly during the phase when the dose of Prometax is being increased.
Den fuldstændige liste over de indberettede bivirkninger for Prometax fremgår af indlægssedlen.
For the full list of all side effects reported with Prometax, see the Package Leaflet.
Prometax bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for rivastigmin, andre stoffer afledt af carbamat eller andre af indholdsstofferne.
Prometax should not be used in people who may be hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at virkningen af Prometax på symptomerne på Alzheimers sygdom er beskeden, men at den hos nogle patienter er vigtig.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Prometax has a modest effectiveness in treating the symptoms of Alzheimer’ s dementia, although this does reflect an important benefit in some patients.
Udvalget konkluderede først, at fordelene ved Prometax ikke opvejer risiciene til behandling af demens ved Parkinsons sygdom.
The Committee initially concluded that for the treatment of dementia due to Parkinson’ s disease, Prometax’ s benefits did not outweigh its risks.
Udvalget afgjorde derfor, at fordelene ved Prometax opvejer risiciene til behandling af let til middelsvær Alzheimers sygdom og let til middelsvær demens ved idiopatisk Parkinsons sygdom.
Therefore, the Committee decided that Prometax’ s benefits are greater than its risks for the treatment of mild to moderately severe Alzheimer’ s dementia and mild to moderately severe dementia in patients with idiopathic Parkinson ’ s disease.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Prometax.
The Committee recommended that Prometax be given marketing authorisation.
2/ 3 Andre oplysninger om Prometax:
2/ 3 Other information about Prometax:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Prometax til Novartis Europharm Limited den 4. december 1998.
The European Commission granted a marketing authorisation valid throughout the European Union to Novartis Europharm Limited for Prometax on 4 December 1998.
Denne tilladelse blev fornyet den 4. december 2003 og den 4. december 2008.
The marketing authorisation was renewed on 4 December 2003 and on 4 December 2008.
Den fuldstændige EPAR for Prometax findes her.
The full EPAR for Prometax can be found here.
Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsel, hårde Kapsel, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu)
blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu)
2 mg/ ml 4, 6 mg/ 2 4 timer
2 mg/ ml 4.6 mg/ 24 h
Oral opløsning Depotplaster
Oral solution Transdermal patch
Oral anvendelse Transdermal anvendelse
Oral use Transdermal use
flaske (brunt glas) brev (papir/ polyester/ alu/ pol yacrylonitril)
bottle (amber glass) sachet (paper/ polyester/ alu/ poly acrylonitrile)
1 flaske 7 breve
1 bottle 7 sachets
4, 6 mg/ 2 4 timer
4.6 mg/ 24 h
brev (papir/ polyester/ alu/ pol yacrylonitril)
sachet (paper/ polyester/ alu/ poly acrylonitrile)
9, 5 mg/ 2 4 timer
9.5 mg/ 24 h
Prometax 1, 5 mg hårde kapsler
Prometax 1.5 mg hard capsules
Råhvidt til svagt gulligt pulver i en kapsel med gul hætte og gul skal, der er præget “ ENA 713 1, 5 mg ” med rødt på kapselskallen.
Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ ENA 713 1,5 mg” on body.
4. 8).
In other cases, Prometax has been discontinued (see section 4.8).
Bivirkningerne i tabel 1 er blevet akkumuleret hos patienter med Alzheimers demens, som har modtaget behandlng med Prometax.
The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer’ s dementia treated with Prometax.
Følgende bivirkninger er blevet observeret med Prometax depotplaster: angst, delirium, feber (almindelig).
The following additional adverse reactions have been observed with Prometax transdermal patches: anxiety, delirium, pyrexia (common).
Tabel 2 viser de bivirkninger, der er rapporteret hos patienter, som modtog behandling med Prometax, og som havde med demens, der var associeret med Parkinsons sygdom.
Table 2 shows the adverse reactions reported in patients with dementia associated with Parkinson’ s disease treated with Prometax.
Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24- ugers studie, der blev udført med Prometax 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 6 with Prometax in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
ADAS- Cog, en måling af kognition og den globale måling ADCS- CGIC (Alheimer’ s Disease Cooperative Study- Clinician’ s Global Impression of Change).
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 Study- Clinician’ s Global Impression of Change).
9 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, der var associeret med Parkinsons sygdom.
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.
ADAS- C og Prometax
ADAS-Cog Prometax
ADAS- C og ADAS- C og Placebo Prometax
ADAS-Cog ADAS-Cog Placebo Prometax
Rivastigmins
In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (< 10%).
10 totale plasmaclearance var ca.
Based on evidence from in vitro and animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Udskillelse Der findes ikke uændret rivastigmin i urinen; renal udskillelse af metabolitterne er den væsentligste udskillelsesvej.
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.
10 compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in subjects with severe renal impairment.
11 6. 2 Uforligeligheder
6.2 Incompatibilities
04. 12. 1998 Dato for seneste fornyelse:
Date of first authorisation:04.12.1998 Date of latest renewal:
Prometax 3, 0 mg hårde kapsler
Prometax 3.0 mg hard capsules
Råhvidt til svagt gulligt pulver i en kapsel med orange hætte og orange skal, der er præget “ ENA 713 3 mg ” med rødt på kapselskallen.
Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “ ENA 713 3 mg” on body.
Tabel 3 angiver antallet og procentdelen af patienterne fra det specifikke 24- ugers studie, der blev udført med Prometax 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 Prometax in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
20 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, der var associeret med Parkinsons sygdom.
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.
21 totale plasmaclearance var ca.
Based on evidence from in vitro and animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
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.
21 compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in subjects with severe renal impairment.
22 6. 2 Uforligeligheder
6.2 Incompatibilities
04. 12. 1998 Dato for seneste fornyelse:
04.12.1998 Date of latest renewal:
Prometax 4, 5 mg hårde kapsler
Prometax 4.5 mg hard capsules
Råhvidt til svagt gulligt pulver i en kapsel med rød hætte og rød skal, der er præget “ ENA 713 4, 5 mg ” med hvidt på kapselskallen.
Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ ENA 713 4,5 mg” on body.
27 Metabolisme - og ernæringsforstyrrelser
Metabolism and nutritional disorders
28 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 Prometax 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 Prometax in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
31 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, der var associeret med Parkinsons sygdom.
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.
32 totale plasmaclearance var ca.
Based on evidence from in vitro and animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
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.
32 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.
33 6. 2 Uforligeligheder
6.2 Incompatibilities
6. 5 Emballagetype og pakningsstørrelser
33 6.5 Nature and contents of container
Prometax 6, 0 mg hårde kapsler
Prometax 6.0 mg hard capsules
Råhvidt til svagt gulligt pulver i en kapsel med rød hætte og orange skal, der er præget “ ENA 713 6 mg ” med rødt på kapselskallen.
Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “ ENA 713 6 mg” on body.
Alzheimers sygdom kan medføre gradvis forringelse af køreegenskaber eller nedsætte evnen til at
As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines.
Ydermere kan rivastigmin medføre svimmelhed og døsighed, specielt ved indledning af behandling eller øgning af dosis.
37 continue driving or operating complex machines should be routinely evaluated by the treating physician.
38 Metabolisme - og ernæringsforstyrrelser
Metabolism and nutritional disorders
39 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 Prometax hos patienter med demens, der er associeret med Parkinsons sygdom med præ- definerede bivirkninger, der muligvis kan reflektere en forværring af Parkinsons symptomer.
39 Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with Prometax in patients with dementia associated with Parkinson’ s disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
42 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, der var associeret med Parkinsons sygdom.
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.
Tabel 6
42 Table 6
43 totale plasmaclearance var ca.
Based on evidence from in vitro and animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Efter indgift af 14C- rivastigmin var renal udskillelse hurtig og nærmest fuldstændig (> 90%) inden for 24 timer.
Following administration of 14C-rivastigmine, renal elimination was rapid and essentially
Prometax 2 mg/ ml oral opløsning
Prometax 2 mg/ ml oral solution
Vedligeholdelsesdosis Den effektive dosis er 3 til 6 mg to gange daglig; for at opnå maksimal terapeutisk fordel skal
46 Maintenance dose 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.
I tilfælde af alvorlig opkastning, der er associeret med rivastigmin- behandling, skal der foretages passende dosisjustering som anbefalet i afsnit 4. 2.
47 In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
47 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).
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).
Hvorvidt rivastigmin udskilles i human mælk, vides ikke.
It is not known if rivastigmine is excreted into human
48 Kvinder i behandling med rivastigmin bør derfor ikke amme.
Therefore, women on rivastigmine should not breast-feed.
Almindelig Sjælden
Very common Very common Very common Common Rare Very rare Very rare
smerter og dyspepsi sår på tolvfingertarmen
Nausea Vomiting Diarrhoea Abdominal pain and dyspepsia Gastric and duodenal ulcers Gastrointestinal haemorrhage Pancreatitis
Meget sjælden Meget sjælden Ikke kendt
Not known
Gastrointestinal blødning Pankreatitis Nogle tilfælde af alvorlig opkastning blev associeret med esophagusruptur (se pkt 4. 4).
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
Meget almindelig Meget almindelig Almindelig Almindelig Almindelig subkutane væv Almindelig
Musculoskeletal and connective tissue disorders
Kvalme Opkastning Diarré Abdominale smerter og dyspepsi Hypersekretion af spyt Øget svedtendens
Muscle rigidity
Knogler, led, muskler og bindevæv
Metabolism and nutritional disorders
Muskelrigiditet
Anorexia Dehydration
50
50 General disorders and administration site conditions
Anoreksi Dehydrering
Fatigue and asthenia Gait abnormality