natgillin/translations-raw huggingface dataset:
opkastninga, diarréa, mavesmerter (inkl. forstoppelsea, smerter i dyspepsia, mellemgulvet), mundtørheda ubehag i maven
dyspepsia, dry a mouth
Hud og subkutane væv
35 Skin and subcutaneous tissue disorders
udslæt (inkl. generaliseret allergisk udslæt, pruritus, makulært udslæt, kontaktdermatitis, exanthem) (se pkt. hudirritation 4. 4), erythema, pruritus, 34
rash (incl. rash, allergic; macular, exanthema)(see section 4.4), a erythema; pruritus, a hyperhydrosis,
Systemorganklasse i
generalized pruritus, dermatitis contact, skin irritation
Meget
Musculoskeletal and connective tissue disorder
Almindelig
joint swelling
Usædvanlig
Reproductive system and breast disorder
Sjælden
erectile dysfunction
henhold til MedDRA
General disorders
almindelig > 1/ 10
application site b
> 1/ 100, ≤1/ 10
oedema peripheral,
> 1/ 1. 000, ≤1/ 100
gait disturbance,
≤1/ 1. 000
and administration site conditions
hyperhidrosisa Knogler, led, muskler og bindevæv
reactions (including a erythema, a
Det reproduktive system og mammae
asthenic b conditions (incl. a fatigue, asthenia,
erektil dysfunktion
feeling abnormal, a weight increased,
Almene symptomer og reaktioner på administrationsstede t
pruritus, irritationa, a
4. 4)
malaise), weight
perifere ødemera, asteniske tilstandeb (inkl. trætheda, svaghed, utilpashed), vægttab
burning, a dermatitis, inflammation, papulae, vesicle, blister, pain, hypersensitivity) (see section 4.4)
gangforstyrrelsea, ildebefindende, vægtøgninga
decreased
Traumer, forgiftninger og behandlingskomplik ationer a
Injury, poisoning and procedural complications a
Disse bivirkninger er i samlede placebokontrollerede forsøg rapporteret mindst 1% hyppigere end hos de patienter, som fik placebo b Overordnet begreb
These adverse drug reactions have been reported in the pooled placebo-controlled trials 1% more frequent than in the placebo-treated patients b High Level Term
Farmakoterapeutisk klassifikation:
36 Pharmacotherapeutic group:
35 Rotigotin er en non- ergolin D3/ D2/ D1- dopaminagonist til behandling af Parkinsons syge.
Rotigotine is a non-ergolinic D3/ D2/ D1 dopamine agonist for the treatment of Parkinson’ s disease.
Kliniske forsøg Neupros effekt ved behandlingen af tegn og symptomer ved idiopatisk Parkinsons sygdom er vurderet i et multinationalt lægemiddeludviklingsprogram bestående af fire pivotale, parallelle, randomiserede, dobbeltblinde, placebokontrollerede forsøg.
The effectiveness of Neupro in the treatment of the signs and symptoms of idiopathic Parkinson's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies.
Der blev foretaget to yderligere forsøg med patienter, som samtidig blev behandlet med L- dopa.
Two additional trials were conducted in patients who were receiving concomitant levodopa therapy.
Ved slutningen af vedligeholdelsesbehandlingen sås en forbedring på mindst 30% hos 57% og 55% af forsøgspersonerne, som fik henholdsvis rotigotin 8 mg/ 24 t og 12 mg/ 24 t og hos 34% af forsøgspersonerne, som fik placebo.
At the end of the maintenance treatment an improvement of at least 30% was seen in 57% and 55% of the subjects receiving rotigotine 8 mg/ 24 h and 12 mg/ 24 h, respectively and in
Med rotigotin var
37 34% of the subjects receiving placebo (Differences 22% and 21%, respectively CI95% 10%; 35% and 8%; 33%, respectively, p < 0.001 for both rotigotine groups).
36 middelreduktionen i “ off ” - tid henholdsvis 2, 7 og 2, 1 timer, mens der i den placebobehandlede arm sås en reduktion på 0, 9 timer.
With rotigotine, the mean reductions in “ off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm a reduction of 0.9 hours was observed.
I pramipexol- gruppen fik patienterne 0, 375 mg den første uge, 0, 75 mg i den anden uge og blev yderligere titreret med ugentlige trin på 0, 75 mg til deres optimale dosis op til et maksimum på 4, 5 mg/ dag.
In the pramipexole group, patients received 0,375 mg in the first week, 0.75 mg in the second week and were titrated further in weekly increments of 0.75 mg to their optimal dose up to a maximum of 4.5 mg/ day.
Patienter i begge behandlingsgrupper fik vedligeholdelsesdosis i 4 måneder.
Patients in each treatment group were maintained for 4 months.
Særlige patientgrupper Da behandling med Neupro indledes med en lav dosis og gradvis titreres i overensstemmelse med klinisk tolerabilitet for at opnå optimal behandlingseffekt, er det ikke nødvendigt at foretage dosisjustering baseret på køn, vægt eller alder.
Special patient groups
37 Hos patienter med moderat nedsat leverfunktion eller let til svært nedsat nyrefunktion sås ingen relevante stigninger i rotigotins plasmaniveauer.
In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant increases of rotigotine plasma levels were observed.
I kroniske - og langtids- toksicitetsforsøg blev hovedeffekten forbundet med dopaminagonist- relateret farmakodynamisk effekt og den deraf følgende reducerede prolaktinsekretion.
In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.
38 Ikke relevant.
Not applicable.
39 1.
40 1.
Neupro 6 mg/ 24 timer depotplaster
Neupro 6 mg/ 24 h transdermal patch
Hvert plaster afgiver 6 mg rotigotin per 24 timer.
Each patch releases 6 mg of rotigotine per 24 hours.
Hvert plaster på 30 cm2 indeholder 13, 5 mg rotigotin.
Each patch of 30 cm2 contains 13.5 mg of rotigotine.
Den ydre side af bagsidelaget er beige og påtrykt Neupro 6 mg/ 24 timer.
The outside of the backing layer is tan-coloured and imprinted with Neupro 6 mg/ 24 h.
4 mg/ 24 t eller 6 mg/ 24 t kan være effektive doser hos nogle patienter.
4 mg/ 24 h or 6 mg/ be effective doses in some patients.
40 Behandlingsseponering Behandlingen med Neupro bør seponeres gradvist.
41 Treatment discontinuation Neupro should be discontinued gradually.
Patologisk spil, øget libido og hyperseksualitet er blevet rapporteret hos patienter, der behandles med dopaminagonister, herunder rotigotin.
42 Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotigotine.
På grund af mulig additiv effekt bør der udvises forsigtighed, når patienter tager beroligende lægemidler eller andre CNS– depressiva (centralnervesystem) (f. eks. benzodiazepiner, antipsykotika, antidepressiva) eller indtager alkohol i kombination med rotigotin.
Because of possible additive effects, caution should be advised when patients are taking sedating medicinal products or other CNS (central nervous system) depressants (e. g. benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with rotigotine.
42 Samtidig administration af L- dopa og karbidopa med rotigotin havde ingen effekt på rotigotins farmakokinetik, og rotigotin havde ingen indflydelse på L- dopa og karbidopas farmakokinetik.
Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.
Samtidig administration af omeprazol (CYP2C19- hæmmer) i doser på 40 mg/ dag, havde ingen effekt på rotigotins farmakokinetik eller metabolisme hos raske frivillige.
43 Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/ day, had no effect on the pharmacokinetics and metabolism of rotigotine in healthy volunteers.
Baseret på analysen af de samlede placebo- kontrollerede kliniske forsøg, som i alt omfatter 1083 Neupro - og 508 placebo- behandlede patienter, rapporterede 73, 0% af patienterne på Neupro og 56, 3% af patienterne på placebo mindst en bivirkning.
Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,083 Neupro- and 508 placebo-treated patients, 73.0% of the patients on Neupro and 56.3% of patients on placebo reported at least one adverse reaction.
43 Systemorganklasse i
System/ organ
Immunsystemet Metabolisme og ernæring
44 Metabolism and nutrition disorders
hørehallucinationer, tvangsforstyrrelser illusioner), forvirret (inklusive
auditory hallucination, illusion), confusion state, abnormal dreamsa, insomnia
døsigheda, svimmelheda
somnolence, dizzinessa
ortostatisk hypertensiona, hypotension (se hypotension pkt.
cough, hiccup, dyspnoea
Hud og subkutane væv
45 Skin and subcutaneous tissue disorders
udslæt (inkl. generaliseret allergisk udslæt, pruritus, makulært udslæt, kontaktdermatitis, exanthem) (se pkt. hudirritation 4. 4), erythema, pruritus, 44
rash (incl. rash, allergic; macular, exanthema)(see section 4.4), a erythema; pruritus, a hyperhydrosis,
hævede led
a
Almene symptomer og reaktioner på administrationsstede t
pruritus
4. 4)
, irritation, a
perifere ødemera, asteniske tilstandeb (inkl. trætheda, svaghed, utilpashed), vægttab
malaise), weight
gangforstyrrelsea, ildebefindende, vægtøgninga
burning, dermatitis,
Traumer, forgiftninger og behandlingskomplik ationer a
inflammation, papulae, vesicle, blister, pain, hypersensitivity) (see section 4.4) Injury, poisoning and procedural complications a
Farmakoterapeutisk klassifikation:
46 Pharmacotherapeutic group:
45 Rotigotin er en non- ergolin D3/ D2/ D1- dopaminagonist til behandling af Parkinsons syge.
Rotigotine is a non-ergolinic D3/ D2/ D1 dopamine agonist for the treatment of Parkinson’ s disease.
Med rotigotin var
47 34% of the subjects receiving placebo (Differences 22% and 21%, respectively CI95% 10%; 35% and 8%; 33%, respectively, p < 0.001 for both rotigotine groups).
46 middelreduktionen i “ off ” - tid henholdsvis 2, 7 og 2, 1 timer, mens der i den placebobehandlede arm sås en reduktion på 0, 9 timer.
With rotigotine, the mean reductions in “ off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm a reduction of 0.9 hours was observed.
47 Hos patienter med moderat nedsat leverfunktion eller let til svært nedsat nyrefunktion sås ingen relevante stigninger i rotigotins plasmaniveauer.
In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant increases of rotigotine plasma levels were observed.
6. 2 Uforligeligheder
49 6.2 Incompatibilities
48 Ikke relevant.
Not applicable.
Neupro 8 mg/ 24 timer depotplaster
Neupro 8 mg/ 24 h transdermal patch
Hvert plaster afgiver 8 mg rotigotin per 24 timer.
Each patch releases 8 mg of rotigotine per 24 hours.
Hvert plaster på 40 cm2 indeholder 18, 0 mg rotigotin.
Each patch of 40 cm2 contains 18.0 mg of rotigotine.
Den ydre side af bagsidelaget er beige og påtrykt Neupro 8 mg/ 24 timer.
The outside of the backing layer is tan-coloured and imprinted with Neupro 8 mg/ 24 h.
Dosering til patienter med Parkinsons sygdom i tidlige stadier:
Dosing in patients with early stage Parkinson’ s disease:
50 Behandlingsseponering Behandlingen med Neupro bør seponeres gradvist.
51 Treatment discontinuation Neupro should be discontinued gradually.
Patologisk spil, øget libido og hyperseksualitet er blevet rapporteret hos patienter, der behandles med dopaminagonister, herunder rotigotin.
52 Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotigotine.
Sel om disse komplikationer kan fortage sig, når behandling ophører, er det ikke altid de forsvinder fuldstændigt.
While these complications may resolve when treatment is discontinued, complete resolution does not always occur.
52 Samtidig administration af L- dopa og karbidopa med rotigotin havde ingen effekt på rotigotins farmakokinetik, og rotigotin havde ingen indflydelse på L- dopa og karbidopas farmakokinetik.
Co-administration of L-dopa and carbidopa with rotigotine had no effect on the pharmacokinetics of rotigotine, and rotigotine had no effect on the pharmacokinetics of L-dopa and carbidopa.
Samtidig administration af omeprazol (CYP2C19- hæmmer) i doser på 40 mg/ dag, havde ingen effekt på rotigotins farmakokinetik eller metabolisme hos raske frivillige.
53 Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg / day, had no effect on the pharmacokinetics and metabolism of rotigotine in healthy volunteers.
Samtidig administration af rotigotin (3 mg/ 24 t) havde ingen effekt på perorale kontraceptiva (0, 03 mg ethinyløstradiol, 0, 15 mg levonorgestrel).
Co-administration of rotigotine (3 mg/ 24 h) did not affect the pharmacodynamics and pharmacokinetics of oral contraceptives (0.03mg ethinylestradiol, 0.15mg levonorgestrel).
53 Systemorganklasse i
System/ organ
Immunsystemet Metabolisme og ernæring
54 Metabolism and nutrition disorders
hoste, hikkea, dyspnø
vomiting, a diarrhoea,
Mave- tarm- kanalen
constipationa, a
Hud og subkutane væv
55 Skin and subcutaneous tissue disorders
udslæt (inkl. generaliseret allergisk udslæt, pruritus, makulært udslæt, kontaktdermatitis, exanthem) (se pkt. hudirritation 4. 4), erythema, pruritus, 54
rash (incl. rash, allergic; macular, exanthema)(see section 4.4), a erythema; pruritus, hyperhydrosisa,
hyperhidrosisa Knogler, muskler, led og bindevæv
reactions (including a erythema, a
5. 1 Farmakodynamiske egenskaber
56 5.1 Pharmacodynamic properties
55 Rotigotin er en non- ergolin D3/ D2/ D1- dopaminagonist til behandling af Parkinsons syge.
Rotigotine is a non-ergolinic D3/ D2/ D1 dopamine agonist for the treatment of Parkinson’ s disease.
To forsøg, som undersøgte Neupros behandlingseffekt ved tegn og symptomer på idiopatisk Parkinsons sygdom blev udført med patienter, som ikke samtidig blev behandlet med en dopaminagonist, og som enten var L- dopa- naive, eller hvor den tidligere L- dopa- behandling varede ≤6 måneder.
Two trials investigating the effectiveness of Neupro in the treatment of the signs and symptoms of idiopathic Parkinson’ s disease were conducted in patients who were not receiving concomitant dopamine agonist therapy and were either L-dopa naïve or previous L-dopa treatment was ≤ 6 months.
Ved slutningen af vedligeholdelsesbehandlingen sås en forbedring på mindst 30% hos 57% og 55% af forsøgspersonerne, som fik henholdsvis rotigotin 8 mg/ 24 t og 12 mg/ 24 t og hos 34% af forsøgspersonerne, som fik placebo.
At the end of the maintenance treatment an improvement of at least 30% was seen
Med rotigotin var
57 in 57% and 55% of the subjects receiving rotigotine 8 mg/ 24 h and 12 mg/ 24 h, respectively and in 34% of the subjects receiving placebo (Differences 22% and 21%, respectively CI95% 10%; 35% and 8%; 33%, respectively, p < 0.001 for both rotigotine groups).
56 middelreduktionen i “ off ” - tid henholdsvis 2, 7 og 2, 1 timer, mens der i den placebobehandlede arm sås en reduktion på 0, 9 timer.
With rotigotine, the mean reductions in “ off” time were 2.7 and 2.1 hours, respectively whereas in the placebo-treated arm a reduction of 0.9 hours was observed.
57 Hos patienter med moderat nedsat leverfunktion eller let til svært nedsat nyrefunktion sås ingen relevante stigninger i rotigotins plasmaniveauer.
In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant increases of rotigotine plasma levels were observed.
6. 2 Uforligeligheder
59 6.2 Incompatibilities
58 Ikke relevant.
Not applicable.
EU/ 1/ 05/ 331/ 010 - 012 EU/ 1/ 05/ 331/ 032 - 037
EU/ 1/ 05/ 331/ 010 - 012 EU/ 1/ 05/ 331/ 032 - 037
59 1.
60 1.
Neupro 2 mg/ 24 timer 4 mg/ 24 timer 6 mg/ 24 timer 8 mg/ 24 timer Depotplaster
Neupro 2 mg/ 24 h 4 mg/ 24 h 6 mg/ 24 h 8 mg/ 24 h Transdermal patch
Neupro 2 mg/ 24 timer depotplaster Hvert plaster afgiver 2 mg rotigotin per 24 timer.
Neupro 2 mg/ 24 h transdermal patch Each patch releases 2 mg of rotigotine per 24 hours.
Neupro 4 mg/ 24 timer depotplaster Hvert plaster afgiver 4 mg rotigotin per 24 timer.
Neupro 4 mg/ 24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Neupro 6 mg/ 24 timer depotplaster Hvert plaster afgiver 6 mg rotigotin per 24 timer.
Neupro 6 mg/ 24 h transdermal patch Each patch releases 6 mg of rotigotine per 24 hours.
Neupro 8 mg/ 24 timer depotplaster Hvert plaster afgiver 8 mg rotigotin per 24 timer.
Neupro 8 mg/ 24 h transdermal patch Each patch releases 8 mg of rotigotine per 24 hours.
Den ydre side af bagsidelaget er beige og påtrykt Neupro 2 mg/ 24 timer, 4 mg/ 24 timer, 6 mg/ 24 timer eller 8 mg/ 24 timer.
The outside of the backing layer is tan-coloured and imprinted with Neupro 2 mg/ 24 h, 4 mg/ 24 h, 6 mg/ 24 h or 8 mg/ 24 h.
60 Dosering Dosisanbefalingerne er angivet i den nominelle dosis.
61 Dosage The dose recommendations made are in nominal dose.
Neupro- pakken til indledende behandling indeholder 4 forskellige æsker (en for hver styrke) med 7 plastre i hver til de første fire ugers behandling.
Neupro treatment initiation pack contains 4 different packages (one for each strength) with 7 patches each, for the first four weeks of therapy.
Afhængig af patientens respons er muligvis ikke alle følgende dosistrin nødvendige eller det kan efter uge 4 være nødvendigt med højere doser, som ikke er indeholdt i denne pakke.
Depending on the patient’ s response, not all of the following dose steps may be required or additional higher doses may be needed after week 4, which are not covered by this package.
På behandlingens første dag begynder patienten med Neupro 2 mg/ 24 timer.
On the first day of treatment the patient starts with Neupro 2 mg/ 24 h.
I den anden uge anvender patienten Neupro 4 mg/ 24 timer.
During the second week, the patient takes Neupro 4 mg/ 24 h.
I den tredje uge anvender han eller hun Neupro 6 mg/ 24 timer og i den fjerde uge Neupro 8 mg/ 24 timer.
During the third week, he or she takes Neupro 6 mg/ 24 h and during the fourth week Neupro 8 mg/ 24 h.
Æskerne er mærket med ” Uge 1 (2, 3 eller 4) ”.
The packages are marked with “ Week 1 (2, 3 or 4 )”.
4. 3 Kontraindikationer
62 4.3 Contraindications
61 Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance or to any of the excipients.
Patologisk spil, øget libido og hyperseksualitet er blevet rapporteret hos patienter, der behandles med dopaminagonister, herunder rotigotin.
Pathologic gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists, including rotiogotine.
Hvis depotplasteret forårsager hududslæt eller irritation, bør direkte sollys på området undgås, til huden heler.
63 If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals.
Baseret på analysen af de samlede placebo- kontrollerede kliniske forsøg, som i alt omfatter 1083 Neupro - og 508 placebo- behandlede patienter, rapporterede 73, 0% af patienterne på Neupro og 56, 3% af patienterne på placebo mindst en bivirkning.
64 Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,083 Neupro- and 508 placebo-treated patients, 73.0% of the patients on Neupro and 56.3% of patients on placebo reported at least one adverse reaction.
dyskinesia, postural svimmelhed, a
dyskinesia, dizziness postural, headachea
synkope, vasovagal krampe, synkope, dystoni, bevidstløshed
syncope, vasovagal convulsion, loss of syncope, dystonia, consciousness hypersomnia, lethargia, disturbance in attention, memory impaired, paraesthesia, dysgeusia, balance disorder, tremor
4. 4) Øre og labyrint
Eye disorders (see section 4.4)
visuel forstyrrelse, fotopsi, sløret syn svimmelhed (inkl.
visual disturbance, photopsia, blurred vision
64
65 Ear and labyrinth disorders
Systemorganklasse i henhold til MedDRA
vertigo (incl. positional)
Meget almindelig > 1/ 10
Cardiac disorders
Almindelig > 1/ 100, ≤1/ 10
atrial fibrillation, heart rate increased, palpitations a
Usædvanlig Sjælden > 1/ 1. 000, ≤1/ 100 ≤1/ 1. 000
supraventricular tachycardia
positions - svimmelhed) Hjerte
Vascular disorders
hoste, hikkea, dyspnø
nauseaa
Mave- tarm- kanalen
vomiting, a diarrhoea,
kvalmea,
abdominal pain (incl. upper
opkastninga, diarréa, forstoppelsea, dyspepsia, a
constipationa, a
65 Neupro er forbundet med døsighed inklusive udpræget døsighed om dagen og pludselige søvnepisoder.
Neupro has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
Disse er som regel reversible efter dosisreduktion eller seponering af behandlingen.
66 Patients treated with dopamine agonists including Neupro, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
Patienterne blev titreret til deres optimale dosis rotigotin med ugentlige trin på 2 mg/ 24 t
The patients were titrated to their optimal dose of rotigotine in weekly increments of 2 mg/ 24 h starting at 2 mg/ 24 h to a maximum dose of 8 mg/ 24 h over 4 weeks.
8 mg/ 24 t, hos 92% af patienterne i rotigotin- armen,.
67 At the end of the maintenance treatment in 92% of the subjects in the rotigotine arm, the optimal dose was the maximal dose allowed i. e.
67 Distribution Rotigotins in vitro- binding til plasmaproteiner er cirka 92%.
68 The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Denne mutagene effekt kan muligvis tilskrives rotigotins clastogene effekt, men denne effekt bekræftedes ikke in vivo i musemikronukleustesten eller i UDS- testen (Unscheduled DNA Synthesis) med rotter.
This mutagenic effect could be attributed to a clastogenic effect of rotigotine.
Da den mutagene effekt forløb mere eller mindre parallelt med en reduceret relativ total vækst af cellerne, kan
This effect was not confirmed in vivo in the Mouse Micronucleus Test in the rat Unscheduled DNA Synthesis (UDS) test.
68 den muligvis tilskrives stoffets cytotoksiske effekt.
Since it ran more or less parallel with a decreased relative total growth of the cells, it may be related to a cytotoxic effect of the compound.
Pakken til indledende behandling indeholder 28 depotplastre i 4 æsker med hver 7 plastre på 2 mg, 4 mg, 6 mg, og 8 mg, individuelt forseglede i breve.
The treatment initiation pack contains 28 transdermal patches in 4 cartons with 7 patches of 2 mg, 4 mg, 6 mg, and 8 mg each, individually sealed in sachets.
Shannon, Industrial Estate,
Shannon, Industrial Estate, Co. Clare, Ireland
69 Co.
70 8.
70 BILAG II
71 ANNEX II
71 A.
72 A.
Clare, Irland
Shannon Industrial Estate Shannon, Co. Clare Ireland
Pharmacovigilance system Indehaveren af markedsføringstilladelsen skal garantere, at pharmacovigilanceplanen, som det er præsenteret i version 5 (13 marts 2008) i Module 1. 8. 1. i markedsføringstilladelsen, er i orden og fungerer før og mens produktet er på markedet.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 5 (13 March 2008) presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Dette blev tiltrådt i version 6 (18 april 2008) af Risk Management Planen (RMP) præsenteret i Module 1. 8. 2 i markedsføringstilladelsen med efterfølgende opdateringer af RMP og konfirmeret af GHMP.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 6 (18 April 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.
Ifølge GHMP Guideline om Risk management systemer for humane lægemidler bør den næste opdatering af RMP indsendes på samme tid som den næste Periodiske Sikkerheds Opdatering (PSUR).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).