natgillin/translations-raw huggingface dataset:
5 Hvis der er tegn og symptomer på generel overstimulering af centralnervesystemet (CNS), skal det overvejes at give omhyggelig symptomatisk, klinisk behandling.
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
I en pivotal monoterapiundersøgelse med en patientpopulation, der led af moderat til svær Alzheimers sygdom (med i alt 3– 14 point i MMSE- test (Mini mental state examination) ved baseline), indgik i alt 252 ambulante patienter.
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer’ s disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Undersøgelsen viste gavnlig effekt af memantinbehandlingen sammenlignet med placebo over en behandlingsperiode på 6 måneder (vurderet ud fra analyse af observerede patienter til CIBIC- plus (Clinician´s interview based impression of change): p=0, 025, samt ADCS - ADLsev (Alzheimer´s disease cooperative study’ s activities of daily living): p=0, 003 og SIB (Severe impairment battery): p=0, 002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
I en pivotal monoterapiundersøgelse med memantin til behandling af mild til moderat Alzheimers sygdom (med i alt 10- 20 point i MMSE- test ved baseline) indgik 403 patienter.
A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer’ s disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Hos de patienter, der var blevet behandlet med memantin, sås statistisk signifikant bedre effekt end hos de patienter, der var blevet behandlet med placebo, på de primære effektmål:
Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints:
ADAS- cog (Alzheimer´s disease assessment scale) (p=0, 003) og CIBIC- plus (p=0, 004) i uge 24 (LOCF (last observation carried forward)).
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
I en anden monoterapiundersøgelse af mild til moderat Alzheimers sygdom blev i alt 470 patienter randomiseret (11- 23 point i alt ved MMSE- test ved baseline).
In another monotherapy study in mild to moderate Alzheimer’ s disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
En metaanalyse af patienter med moderat til svær Alzheimers sygdom (med mindre end 20 point ved en MMSE- test) fra de seks fase III, placebokontrollerede undersøgelser af 6 måneders varighed (inkl. monoterapiundersøgelser og undersøgelser med patienter behandlet med fastdosis acetylkolinesterasehæmmere) viste, at memantin havde statistisk signifikant effekt på de kognitive, globale og funktionelle domæner.
A meta-analysis of patients with moderate to severe Alzheimer’ s disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Når patienterne havde fået konstateret en samtidig forværring inden for alle tre domæner, viste resultaterne en statistisk signifikant effekt af memantin hvad angår forebyggelse af forværring, eftersom dobbelt så mange placebobehandlede patienter som memantinbehandlede patienter udviste forværring inden for alle tre domæner (21% vs.
When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs.
6 Biotransformation:
Biotransformation:
Elimination:
6 Elimination:
I kortidsstudier af rotter har memantin ligesom andre NMDA- antagonister kun induceret neuronal vakuolisering og nekrose (Olney- læsioner) efter doser, der medfører meget høje maksimale serumkoncentrationer.
In short term studies in rats memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations.
Da virkningerne hverken er observeret i langtidsstutudier med gnavere eller med ikke- gnavere, er den kliniske relevans af disse observationer ukendt.
As the effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical relevance of these findings is unknown.
7 Mikrokrystallinsk cellulose Kolloid vandfri silica Talkum Magnesiumstearat
Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talc Magnesium stearate
Tabletovertræk:
7 Tablet coat:
Blisterpakninger med enten 7, 10, 14 eller 20 tabletter pr. blisterstrip.
Blister packs containing either 7, 10, 14 or 20 tablets per blister strip.
Fås i pakningsstørrelser på 14, 28, 30, 42, 49 x 1, 50, 56, 56 x 1, 70, 84, 98, 98 x 1, 100, 100 x 1, 112, 980 (10 x 98) eller 1000 (20 x 50) tabletter.
Pack sizes of 14, 28, 30, 42, 49 x 1, 50, 56, 56 x 1, 70, 84, 98, 98 x 1, 100, 100 x 1, 112, 980 (10 x 98) or 1000 (20 x 50) tablets are presented.
Pakningsstørrelserne 49 x 1, 56 x 1, 98 x 1 og 100 x 1 filmovertrukne tabletter findes i unitdose blisterpakninger.
The pack sizes 49 x 1, 56 x1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blister.
Lundbeck A/ S Ottiliavej 9, DK- 2500 Valby Danmark
Lundbeck A/ S Ottiliavej 9, DK-2500 Valby Denmark
MARKEDSFØRINGSTILLADELSESNUMRE EU/ 1/ 02/ 219/ 001- 3 EU/ 1/ 02/ 219/ 007- 012 EU/ 1/ 02/ 219/ 014- 021
EU/ 1/ 02/ 219/ 001-3 EU/ 1/ 02/ 219/ 007-012 EU/ 1/ 02/ 219/ 014-021
Detaljerede oplysninger om dette produkt findes på websitet for European Medicines Agency (EMEA) http: // www. emea. europa. eu.
8 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Ebixa 10 mg/ g orale dråber, opløsning.
Ebixa 10 mg/ g oral drops, solution.
1 g opløsning indeholder 10 mg memantinhydrochlorid (svarende til 8, 31 mg memantin).
1 g of solution contains 10 mg of memantine hydrochloride (equivalent to 8.31 mg memantine).
En dråbe opløsning svarer til 0, 5 mg memantinhydrochlorid.
One drop of solution is equivalent to 0,5 mg memantine hydrochloride.
4. 4.
1 g of solution contains 100 mg of sorbitol E420 and 0.5 mg potassium, see section 4.4.
Ebixa skal gives én gang om dagen og bør indtages på samme tidspunkt hver dag.
Ebixa should be administered once a day and should be taken at the same time every day.
Patienten bør tage 10 dråber (5 mg) dagligt i 7 dage.
The patient should take 10 drops (5 mg) per day for 7 days.
Patienten bør tage 20 dråber (10 mg) dagligt i 7 dage.
The patient should take 20 drops (10 mg) per day for 7 days.
Patienten bør tage 30 dråber (15 mg) dagligt i 7 dage.
The patient should take 30 drops (15 mg) per day for 7 days.
Patienten bør tage 40 dråber (20 mg) én gang dagligt.
The patient should take 40 drops (20 mg) once a day.
10 Den anbefalede vedligeholdelsesdosis er 20 mg dagligt.
10 Maintenance dose
På baggrund af de kliniske studier er den anbefalede dosis til patienter over 65 år 20 mg pr. dag (40 dråber en gang dagligt), som beskrevet ovenfor.
On the basis of the clinical studies the recommended dose for patients over the age of 65 years is 20 mg per day (40 drops once a day) as described above.
Samtidig brug af andre N- metyl- D- aspartat( NMDA) - antagonister såsom amantadin, ketamin eller dextromethorfan bør undgås.
Concomitant use of other N-methyl-D-aspartate(NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Effekten af barbiturater og neuroleptika kan blive reduceret.
Concomitant
Der findes en publiceret kasuistik, der også viser en mulig risiko ved kombination af memantin og fenytoin. • Andre aktive stoffer såsom cimetidin, ranitidin, procainamid, quinidin, quinin og nikotin, der bruger samme renale kationiske transportsystem som amantadin, kan muligvis også have interaktion med memantin, hvilket kan medføre en risiko for forhøjede plasmaniveauer. • Der er mulighed for en reduktion i serumkoncentrationen af hydrochlorothiazid (HCT), når memantin administreres sammen med HCT eller sammen med kombinationspræparater med HCT. • Efter markedsføringen er der rapporteret enkeltstående tilfælde af INR (International normalized ratio) stigninger hos patienter i samtidig behandling med warfarin.
There is one published case report on a possible risk also for the combination of memantine and phenytoin. • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels. • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. • In post marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
12 Hjertelidelser Nervesystemet
12 Cardiac disorders Nervous system disorders
I tilfælde af overdosering med doser under 140 mg eller ukendt dosis har patienterne haft symptomer, der stammede fra centralnervesystemet (forvirring, døsighed, sløvhed (søvntrang), svimmelhed, agitation, aggression, hallucinationer og gangforstyrrelser) og/ eller fra mave- tarmkanalen (opkastning og diarré).
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination and gait disturbance) and/ or of gastrointestinal origin (vomiting and diarrhoea).
I en central monoterapiundersøgelse med en patientpopulation, der led af moderat til svær Alzheimers sygdom (med en samlet Mini mental state examination (MMSE) score ved baseline på 3 – 14), indgik i alt 252 ambulante patienter.
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer’ s disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Undersøgelsen viste gavnlig effekt af memantinbehandlingen sammenlignet med placebo over en behandlingsperiode på 6 måneder (” observed cases analysis ” for the Clinician´s interview based impression of change (CIBIC- plus): p=0, 025; Alzheimer´s disease cooperative study – activities of daily living (ADCS- ADLsev): p=0, 003; Severe impairment battery (SIB): p=0, 002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinican´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of the daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
I en central monoterapiundersøgelse med memantin til behandling af mild til moderat Alzheimers sygdom (med en samlet MMSE score ved baseline på 10 – 22) indgik 403 patienter.
A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer’ s disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Hos patienter behandlet med memantin sås statistisk signifikant bedre effekt end hos patienter behandlet med placebo på de primære effektmål:
Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints:
Alzheimer´s disease assessment scale (ADAS- cog) (p=0, 003) og CIBIC- plus (p=0, 004) i uge 24 (Last observation carried forward (LOCF)).
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
I en anden monoterapiundersøgelse med mild til moderat Alzheimers sygdom blev i alt 470 patienter randomiseret (samlet MMSE score ved baseline 11 – 23).
In another monotherapy study in mild to moderate Alzheimer’ s disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
En metaanalyse af patienter med moderat til svær Alzheimers sygdom (med en samlet MMSE score < 20) fra de seks fase III, placebokontrollerede undersøgelser af 6 måneders varighed (inkl. monoterapiundersøgelser og undersøgelser med patienter behandlet med fastdosis acetylkolinesterasehæmmere) viste, at memantin havde statistisk signifikant effekt på de kognitive, globale og funktionelle domæner.
A meta-analysis of patients with moderate to severe Alzheimer’ s disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
14 Elimination:
14 Elimination:
Da virkningerne hverken er observeret i langtidsstudier med gnavere eller med ikke- gnavere, er den kliniske relevans af disse observationer ukendt.
As the effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical relevance of these findings is unknown.
15 4 år.
4 years.
15/ 05/ 2002 Dato for seneste genregistrering:
15/ 05/ 2002 Date of latest renewal:
Detaljerede oplysninger om dette produkt fås på websitet for European Medicines Agency (EMEA) http: // www. emea. europa. eu.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Ebixa 20 mg filmovertrukne tabletter..
Ebixa 10 mg film-coated tablets.
Hver filmovertrukket tablet indeholder 15 mg memantinhydrochlorid svarende til 12. 46 mg memantin.
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
1. uge (dag 1- 7):
17 Week 1 (day 1-7):
17 Patienten bør tage én 5 mg filmovertrukket tablet pr. dag (hvid til grålighvid, oval- aflang) i 7 dage.
The patient should take one 5 mg film-coated tablet per day (white to off-white, oval-oblong) for 7 days.
Patienten bør tage én 10 mg filmovertrukket tablet pr. dag (hvid til grålighvid, aflang og indsnævrende mod midten, bikonveks med delekærv på begge sider) i 7 dage.
The patient should take one 10 mg film-coated tablet per day (white to off-white, centrally tapered oblong, biconvex, with a single breakline on both sides) for 7 days.
Patienten bør tage én 15 mg filmovertrukket tablet pr. dag (gråligorange, oval- aflang) i 7 dage.
The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong film) for 7 days.
Patienten bør tage én 20 mg filmovertrukket tablet pr. dag (gråligrød, oval- aflang) i 7 dage. '
The patient should take one 20 mg film-coated tablet per day (grey-red, oval-oblong film) for 7 days.
Vedligeholdelsesdosis Den anbefalede vedligeholdelsesdosis er 20 mg pr. dag.
The recommended maintenance dose is 20 mg per day.
18 I de fleste kliniske forsøg blev patienter med nyligt myokardieinfarkt, ubehandlet hjerteinsufficiens (NYHA klasse III- IV) eller ukontrolleret hypertension ekskluderet.
18 In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
10 mg tabletterne indeholder lactosemonohydrat.
The 10 mg film-coated tablets contain lactose monohydrate.
19 Moderat til svær Alzheimers sygdom nedsætter normalt evnen til at føre et motorkøretøj eller betjene maskiner.
19 4.8 Undesirable effects
I kliniske forsøg med 1. 784 patienter i behandling med Ebixa for mild til svær demens og med 1. 595 patienter i placebobehandling adskilte den generelle incidensrate for bivirkninger reaktioner med Ebixa sig ikke fra placebobehandlingen, og de uønskede hændelser var som regel milde til moderate.
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse events were usually mild to moderate in severity.
I tilfælde af overdosering med doser under 140 mg eller ukendt dosis har patienterne haft symptomer, der stammede fra centralnervesystemet (forvirring, døsighed, sløvhed (søvntrang), svimmelhed, agitation, aggression, hallucinationer og gangforstyrrelser) og/ eller fra mave- tarmkanalen (opkastning og diarré).
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/ or of gastrointestinal origin (vomiting and diarrhoea).
20 I det alvorligste tilfælde af overdosering overlevede patienten en peroral indtagelse af i alt 2. 000 mg memantin med virkninger på centralnervesystemet (koma i 10 dage, og senere hen diplopi og agitation).
In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
I et andet tilfælde med stor overdosis overlevede patienten også og kom sig.
20 In another case of a large overdose, the patient also survived and recovered.
ADAS- cog (Alzheimer´s disease assessment scale) (p=0, 003) og CIBIC- plus (p=0, 004) i uge 24 (LOCF (last observation carried forward)).
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
I en anden monoterapiundersøgelse af mild til moderat Alzheimers sygdom blev i alt 470 patienter randomiseret (11- 23 point i alt i MMSE- test ved baseline).
In another monotherapy study in mild to moderate Alzheimer’ s disease a total of 470 patients (MMSE total scores at baseline of 11-23) were randomised.
Når patienterne havde fået konstateret en samtidig forværring inden for alle tre domæner, viste resultaterne en statistisk signifikant effekt af memantin hvad angår forebyggelse af forværring, eftersom dobbelt så mange placebobehandlede patienter som
When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs.
Absorption:
21 Absorption:
22 Der er ikke observeret nogen genotoksicitet efter afprøvning af memantin ved standardundersøgelser.
No genotoxicity has been observed following testing of memantine in standard assays.
Lactosemonohydrat Mikrokrystallinsk cellulose Kolloid vandfri silica Talkum Magnesiumstearat
Lactose monohydrate Microcrystalline cellulose Colloidal anhydrous silica Talc Magnesium stearate
23 Hver pakke indeholder 28 filmovertrukne tabletter i 4 PVDC/ PE/ PVC/ Al- blisterstrips eller PP/ Al - blisterstrips med 7 filmovertrukne tabletter på 5 mg, 7 filmovertrukne tabletter på 10 mg, 7 filmovertrukne tabletter på 15 mg og 7 filmovertrukne tabletter på 20 mg
Each pack contains 28 film-coated tablets in 4 PVDC/ PE/ PVC/ Al-blister or PP/ Al-blisters with 7 film- coated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film- coated tablets of 20 mg.
Filmovertrukket tablet.
Film-coated tablets.
Svagt røde til gråligrøde filmovertrukne tabletter på 20 mg, ovale- aflange tabletter præget med ” 20 ” på den ene side og ” MEM ” på den anden side.
Pale red to grey-red, oval-oblong film-coated tablets with imprint “ 20 ” on one side and imprint “ MEM” on the other side.
De filmovertrukne tabletter kan indtages uafhængigt af måltider.
The film- coated tablets can be taken with or without food.
For at reducere risikoen for bivirkninger opnås vedligeholdelsesdosen ved en gradvis dosisøgning på 5 mg om ugen i de første 3 uger som følger.
In order to reduce the risk of undesirable effects the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows.
Patienten bør tage en filmovertrukket 5 mg- tablet dagligt i 7 dage.
The patient should take one 5 mg film-coated tablet per day for 7 days.
Patienten bør tage en filmovertrukket 10 mg- tablet dagligt i 7 dage.
The patient should take one 10 mg film-coated tablet per day for 7 days.
Patienten bør tage en filmovertrukket 15 mg- tablet dagligt i 7 dage.
The patient should take one 15 mg film-coated tablet per day for 7 days.
Patienten bør tage en filmovertrukket 20 mg- tablet dagligt.
The patient should take one 20 mg film-coated tablet per day.
Vedligeholdelsesdosis:
25 Maintenance dose
25 Den anbefalede vedligeholdelsesdosis er 20 mg dagligt.
The recommended maintenance dose is 20 mg per day.
26 sig gældende for ketamin og dextromethorfan (se også under punkt 4. 4).
The 26 same may be true for ketamine and dextromethorphan (see also section 4.4).
27 Hjertelidelser Nervesystemet
27 Cardiac disorders Nervous system disorders
28 Farmakoterapeutisk klassifikation:
PHARMACOLOGICAL PROPERTIES
Ved indgivelse af daglige doser på 5 til 30 mg udregnedes en gennemsnitlig cerebrospinalvæske (CSV) / serumværdi på 0, 52.
When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/ serum ratio of 0.52 was calculated.
29 Elimination:
29 Elimination:
Hypromellose Macrogol 400 Titandioxid (E 171)
Hypromellose Macrogol 400 Titanium dioxide (E 171) Iron oxide yellow and red (E 172)
30 Gul og rød jernoxid (E 172)
30 6.2 Incompatibilities
PVDC/ PE/ PVC/ Alu- blisterstrip eller PP/ Al- blisterstrip.
Blister packs containing 14 film-coated tablets per PVDC/ PE/ PVC/ Al-blister or PP/ Al-blister strip.
Der findes pakkestørrelser på 14, 28, 42, 49 x 1, 56, 56 x 1, 70, 84, 98, 98 x 1, 100 x 1, 112 eller 840 (20 x 42) filmovertrukne tabletter.
Pack sizes of 14, 28, 42, 49 x 1, 56, 56 x 1, 70, 84, 98, 98 x 1, 100 x 1, 112 or 840 (20 x 42) film- coated tablets are presented.
Pakkestørrelserne på 49 x 1, 56 x1, 98 x 1 og 100 x 1 filmovertrukne tabletter fås i unitdosis blister.
The pack sizes 49 x 1, 56 x1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blister.
31 BILAG II
31 ANNEX II
FREMSTILLER ANSVARLIG( E) FOR BATCHFRIGIVELSE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURNG AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Lundbeck A/ S Ottiliavej 9 DK- 2500 Valby DANMARK
Lundbeck A/ S Ottiliavej 9 DK-2500 Valby DENMARK
Bivirkningsovervågningssystem
Pharmacovigilance system
Før lægemidlet markedsføres, og så længe det markedsførte lægemiddel anvendes, skal indehaveren af markedsføringstilladelsen sikre, at der er et bivirkningsovervågningssystem på plads, og at det fungerer, som beskrevet i version 4. 0 (12. november 2007), modul 1. 8. 1. af markedsføringstilladelsen.
The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 (12 November 2007) presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Indehaveren af markedsføringstilladelsen forpligter sig til at udføre undersøgelser og yderligere bivirkningsovervågningsaktiviteter som beskrevet i Bivirkningsovervågningsplanen som aftalt i version 4 (8. februar 2008) af Risk Management Plan (RMP) beskrevet i modul 1. 8. 2. af markedsføringstilladelsen og alle eventuelle opdateringer af RMP, som aftalt af CHMP.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 (8 February 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.