natgillin/translations-raw huggingface dataset:
Frankrig - Activelle 0, 5 mg/ 0, 1 mg comprimé pelliculé Tyskland - Noviana Ungarn - Noviana filmtabletta Island - Activelle® low 0. 5 mg/ 0. 1 mg tablets ” filmuhúðaðar töflur Irland - Activelle low 0. 5 mg/ 0. 1 mg film- coated tablets Italien - Activelle® 0, 5 mg/ 0, 1 mg compresse film- rivestite Letland - Noviana 0, 5 mg/ 0, 1 mg apvalkotās tabletes Litauen - Activelle 0, 5 mg / 0, 1 mg plėvele dengtos tabletės Luxemborg - Activelle minor comprimés pelliculés Holland - Activelle filmomhulde tabletten Norge - Noviana 0, 5 mg/ 0, 1 mg tablett filmdrasjert Portugal - 0, 5mg Estradiol + 0. 1 mg Acetato de Noretisterona Comprimidos revestidos por película "Rumænien - Noviana comprimate filmate Slovenien - Noviana™ filmsko obložene tablete Slovakiet - Noviana filmom obalené tablety Spanien - Activelle 0, 5 mg / 0, 1 mg comprimidos recubiertos de película Sverige - Activelle 0, 5 mg/ 0, 1 mg filmdragerade tabletter Storbritannien - Noviana film- coated tablets
France - Activelle 0,5 mg/0,1 mg comprimé pelliculé Germany - Noviana Hungary - Noviana filmtabletta Iceland - Activelle® low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Ireland - Activelle low 0.5mg/0.1mg film-coated tablets Italy - Activelle® 0,5 mg/0,1 mg compresse film-rivestite Latvia - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Lithuania - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Luxembourg - Activelle minor comprimés pelliculés The Netherlands - Activelle filmomhulde tabletten Norway - Noviana 0,5 mg/0,1 mg tablett filmdrasjert Portugal - 0,5mg Estradiol + 0.1 mg Acetato de Noretisterona Comprimidos revestidos por película Romania – Noviana comprimate filmate Slovenia - Noviana™ filmsko obložene tablete Slovakia - Noviana filmom obalené tablety Spain - Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película Sweden - Activelle 0,5 mg/0,1 mg filmdragerade tabletter United Kingdom - Noviana film-coated tablets
37 BRUGERVEJLEDNING
37 This leaflet was last approved in
Instruktion i brugen af kalenderpakken
How to use the calendar pack
Sådan sætter De ugedagsskiven Drej midterskiven, således at ugedagen står ud for den lille plastikspids.
Set the day reminder Turn the inner disc to set the day of the week opposite the little plastic tab.
Drej ugedagsskiven hver dag Drej den gennemsigtige skive med uret i pilens retning frem til næste ugedag.
Move the dial every day On the next day simply move the transparent dial clockwise one space as indicated by the arrow.
London, den 12. september 2008 EMEA/ CHMP/ 496105/ 2008
London, 12 September 2008 EMEA/ CHMP/ 496102/ 2008
41, OM Activelle og tilknyttede navne
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Activelle and associated names
Internationalt fællesnavn (INN): estradiol og norethisteronacetat
Estradiol and norethisterone acetate
Activelle og tilknyttede navne, estradiol 0, 5 mg og norethisteronacetat 0, 1 mg filmovertrukne tabletter, er en kontinuerlig, kombineret hormonsubstitutionsbehandling (HRT) mod symptomer på østrogenmangel hos postmenopausale kvinder mere end 1 år efter menopausen.
Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets is a continuous combined hormone replacement therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause.
Novo Nordisk A/ S indgav ansøgninger om gensidig anerkendelse af Activelle og tilknyttede navne, estradiol 0, 5 mg og norethisteronacetat 0, 1 mg filmovertrukne tabletter, på grundlag af den markedsføringstilladelse, som Sverige havde udstedt den 3. august 2007.
Novo Nordisk A/ S submitted applications for mutual recognition of Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets on the basis of the marketing authorisation granted by Sweden on 3 August 2007.
Forskellen vedrører den endometrielle sikkerhed af Activelle 0, 5 mg/ 0, 1 mg, som er blevet utilstrækkeligt påvist i henhold til CHMP' s retningslinjer for HRT- produkter (EMEA/ CHMP/ 021/ 97 rev 1), og dette gav anledning til alvorlig bekymring for folkesundheden.
This refers to endometrial safety of Activelle 0.5 mg/ 0.1 mg, which had been insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/ CHMP/ 021/ 97 rev 1) and this was considered to be of serious public health concern.
Ingemar Persson (S).
The Rapporteur was Dr Pierre Demolis (FR) as Rapporteur and Co-Rapporteur(s) was Dr Ingemar Persson (SE).
Efter gennemgang af alle fremlagte oplysninger og den faglige drøftelse i Udvalget vurderede CHMP på sit møde i juni 2008, at benefit/ risk- forholdet for Activelle og tilknyttede navne er positivt, at Frankrigs og Tysklands indvendinger ikke skulle stå i vejen for udstedelse af en markedsføringstilladelse, og at produktresuméet, etiketteringen og indlægssedlen i referencemedlemsstaten skulle ændres.
During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Activelle and associated names, that the objections raised by France and Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Udvalget vedtog en positiv udtalelse efter en flertalsafstemning den 26. juni 2008.
A positive opinion was adopted by majority on 26 June 2008.
Listen med berørte produktnavne fremgår af bilag I.
The list of the product names concerned is given in Annex I.
De faglige konklusioner fremgår af bilag II, og produktresuméet findes i bilag III.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa- Kommissionen den 11. september 2008.
The final opinion was converted into a Decision by the European Commission on 11 September 2008.
4, i direktiv 2001/ 83/ EF, som ændret.
1 Article 29(4) of Directive 2001/ 83/ EC, as amended.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
1 Indehaver af Medlemsstat
1/ 94 Marketing Member state
markedsføringstill delse
authorisation Holder
Indgivelses vej
Route of administra tion
Route de Versailles, 78163 Marly- le- Roi Cedex, France Østrig
Route de Versailles, 78163 Marly-le-Roi Cedex, France Austria
1, 0 mg
1.0 mg
Route de Versailles, 78163 Marly- le- Roi Cedex, France Cypern
Route de Versailles, 78163 Marly-le-Roi Cedex, France Cyprus
ADARTREL
Marketing
2, 0 mg
3/ 94
Oral anvendelse
Member state
3 Indehaver af Medlemsstat
authorisation Holder
Route de Versailles, 78163 Marly- le- Roi Cedex, France Danmark
Denmark
4 Indehaver af Medlemsstat
Member state
Route de Versailles, 78163 Marly- le- Roi Cedex, France Finland
Route de Versailles, 78163 Marly-le-Roi Cedex, France Estonia
5 Indehaver af Medlemsstat
Member state
GlaxoSmithKline α. ε. β. ε, Κηφισίας 266, 152 32 Χαλάνδρι, Αθήνα, Ελλάδα
KG, Theresienhöhe 11, 80339 München, Germany
1, 0 mg
6/ 94
6 Indehaver af Medlemsstat
authorisation Holder
7 Indehaver af Medlemsstat
Marketing
markedsføringstill delse
7/ 94
Ansøger
Member state
Særnavn
authorisation Holder
Styrker
Applicant Invented name
Lægemiddelform
Strengths
Indgivelses vej
Pharmaceutical form
Marly- le- Roi Cedex, France
Route of administra tion
8 Indehaver af Medlemsstat
8/ 94 Marketing Member state
Route de Versailles, 78163 Marly- le- Roi Cedex, France Italien
Route de Versailles, 78163 Marly-le-Roi Cedex, France Italy
Route de Versailles, 78163 Marly- le- Roi Cedex, France Litauen
Route de Versailles, 78163 Marly-le-Roi Cedex, France Lithuania
10 Indehaver af Medlemsstat
10/ 94 Marketing Member state
0, 5 mg
1.0 mg
Route de Versailles, 78163 Marly- le- Roi Cedex, France Malta
Route de Versailles, 78163 Marly-le-Roi Cedex, France Luxembourg
2, 0 mg
0.25 mg
0, 25 mg
0.5 mg
Norge
Strengths
11 Indehaver af Medlemsstat
Route de Versailles, 78163 Marly-le-Roi Cedex, France Netherlands
markedsføringstill delse
Laboratoire GlaxoSmithKline, 100 Route de Versailles, 78163 Marly-le-Roi Cedex, France
Ansøger
ADARTREL
Særnavn
1.0 mg
Styrker
Film-coated tablet
Lægemiddelform
Oral use
Indgivelses vej
Netherlands
Route de Versailles, 78163 Marly- le- Roi Cedex, France Norge
Laboratoire GlaxoSmithKline, 100 Route de Versailles, 78163 Marly-le-Roi Cedex, France
Polen
Norway
Polen
Route de Versailles, 78163 Marly-le-Roi Cedex, France Poland
12 Indehaver af Medlemsstat
Poland
Særnavn
ADARTREL
Styrker
2.0 mg
Lægemiddelform
Film-coated tablet
Indgivelses vej
Oral use
Beecham Portuguesa, Produtos Farmacêuticos
Beecham Portuguesa, Produtos Farmacêuticos e Químicos, Lda., Rua Dr.
ADARTREL e
ADARTREL
Químicos, Lda., Rua Dr.
Portugal
Beecham Portuguesa, Produtos Farmacêuticos e Químicos, Lda., Rua Dr.
Beecham Portuguesa, Produtos Farmacêuticos
ADARTREL
ADARTREL e
Portugal
Químicos, Lda., Rua Dr.
13 Indehaver af Medlemsstat
Slovakia
Indgivelses vej
Slovakia
Slovakiet
Strengths
Slovenien
Knezov stradon 90, 1000 Ljubljana, Slovenia Slovenia
Slovenien
ADARTREL
14 Indehaver af Medlemsstat
15/ 94 Marketing Member state
Route de Versailles, 78163 Marly- le- Roi Cedex, France Spanien
Route de Versailles, 78163 Marly-le-Roi Cedex, France Sweden
Sverige
UK
Det Forenede Kongerige
16/ 94 Marketing Member state
Filmovertrukket tablet
Invented name
Oral anvendelse
Strengths
15 Indehaver af Medlemsstat
Pharmaceutical form
markedsføringstill delse
Route of administra tion
Styrker
UK
16 BILAG II
17/ 94 ANNEX II
9 FAGLIGE KONKLUSIONER
18/ 94 SCIENTIFIC CONCLUSIONS
Inden afslutningen af den gensidige anerkendelses- procedure indbragte Spanien og Nederlandene en sag for EMEA ud fra den betragtning, at dette lægemiddel muligvis udgør en risiko for folkesundheden, eftersom sikkerhed og virkning for ropinirol til langtidsbehandling af Restless Legs Syndrome (RLS) efter deres opfattelse ikke er påvist.
Before the end of a mutual recognition procedure, Spain and the Netherlands, presented to the EMEA a referral considering that this medicinal product might present a risk to public health since they were of the opinion that safety and efficacy in long-term treatment of ropinirole in restless legs syndrome had not been demonstrated.
De spørgsmål, der blev drøftet, vedrørte oplysninger om virkning i de kliniske undersøgelser, navnlig hos andelen af patienter med en funktionel påvirkning samt langtidsvirkningen, sikkerheden og benefit/ risk- forholdet.
The issues discussed included the efficacy data provided in the clinical trials, particularly in the subset of patients having a functional impact and the long-term efficacy and safety as well as the benefit-risk ratio.
Markedsføringsindehaveren har defineret svær idiopatisk RSL som en tilstand hos patienter, der har opnået et scoringsresultat ved baseline på 24 point eller mere på den internationale RLS - graderingsskala (IRLS).
The MAH has defined severe idiopathic RLS as those patients who have an International Restless Legs Syndrome Rating Scale (IRLS) baseline score of 24 points or more.
Tolerabilitetsprofilen for ropinirol skal i denne patientpopulation ifølge dokumentationen analyseres på baggrund af den fysiske tilstand, som i væsentlig grad påvirker patienternes livskvalitet, hvilket navnlig skyldes, at RLS- patienter lider af kronisk søvnløshed.
According to the literature, the tolerability profile of ropinirole in this population of patients must be analysed in the context of a physical condition that significantly affects the quality of life of patients mainly due to the fact that RLS patients suffer with chronic insomnia.
På denne baggrund viser de kliniske undersøgelsesdata om sikkerhed, at ropinirol har en acceptabel tolerabilitet og sikkerhedsprofil hos RSL- patienter over det relevante dosisområde 0, 25 - 4mg/ dag.
In this context the clinical trial safety data demonstrate that ropinirole has an acceptable tolerability and safety profile in RLS patients over the dose range 0.25 - 4mg/ day.
Der er blevet fremlagt en indgående vurdering af de mest almindelige bivirkninger i målgruppen (scoringsresultat ved baseline på 24- 40 point).
A detailed assessment of the most common adverse events in the target population (IRLS baseline score 24-40 points) has been provided.
De bivirkninger, der er specifikke for RLS- patienter, såsom augmentation og reboundeffekter, er blevet drøftet.
The adverse events that are specific to RLS patients, such as augmentation and rebound effects have been discussed.
Der blev ingen klinisk signifikant effekt observeret på QT- intervallet.
No clinically significant effect on the QT interval was observed.
Det er imidlertid meget vigtigt, at hovedparten af tilfældene af augmentation i forbindelse med ropinirol var af begrænset klinisk betydning, eftersom patienterne generelt fortsatte med ropinirol- behandling uden seponering, og i hovedparten af tilfældene øgede forskerne ikke doseringen af ropinirol som følge af augmentationen.
More importantly the majority of the ropinirole episodes of augmentation had limited clinical significance as generally patients continued on ropinirole treatment without discontinuation and, in the majority of the events the investigators did not increase the dose of ropinirole as a result of the augmentation.
Et rebound- fænomen efter ropinirolbehandlingens ophør (rebound ved slutningen af behandlingen) kan ikke udelukkes.
A rebound phenomenon following discontinuation of ropinirole treatment (end of treatment rebound) cannot be excluded.
I kliniske undersøgelser var det samlede gennemsnitlige scoringsresultat på den internationale RLS- graderingskala 7- 10 dage efter behandlingsophør højere hos patienter behandlet med ropinirol end hos patienter behandlet med placebo.
In clinical trials, although the average IRLS total scores 7-10 days after withdrawal of therapy were higher in ropinirole-treated patients than in placebo-treated patients, the severity of symptoms following withdrawal of therapy generally did not exceed the baseline assessment in ropinirole-treated patients.
Sværhedsgraden af symptomer efter ophør af behandling lå generelt ikke over baseline- vurderingen hos patienter behandlet med ropinirol.
The MAH agreed to revise the SPC, sections 4.2 and 5.1, to specify that ropinirole is indicated in moderate to severe idiopathic restless legs syndrome.
Markedsføringsindehaveren indvilligede i at ændre afsnit 5. 1 med henblik på at præcisere, at patienter behandlet med ropinirol havde et højere scoringsresultat på den internationale RLS- graderingsskala end patienter behandlet med placebo ved den opfølgende vurdering.
The MAH agreed to revise also section 5.1, to specify that ropinirole treated patients had higher IRLS scores at follow up assessment compared to placebo treated patients.
10 I den moderate til svære RLS- population ses fordelene ved behandling med ropinirol i alle resultater - målt på en ensartet måde.
In the moderate to severe RLS population the benefit of treating with ropinirole is seen in all outcomes measured in a consistent way.
Selvom sikkerhedsprofilen er forbundet med ubehagelige bivirkninger såsom kvalme og opkastning, forekommer disse hovedsageligt tidligt i behandlingen og anses for at være håndterbare.
The safety profile although pledged by uncomfortable adverse events like nausea and vomiting is mostly a problem in the early phase of the treatment and is considered
Benefit/ risk- forholdet for den moderate til svære RLS, som defineret i produktresuméet, anses for at være gunstigt.
The benefit-risk assessment is considered favourable for the moderate to severe RLS as defined in the SPC.
- formålet med indbringelsen af sagen var at påvise sikkerhed og virkning ved
- the scope of the referral was that the safety and efficacy in long-term treatment of ropinirole in
langtidsbehandling af Restless Legs Syndrome med ropinirol,
restless legs syndrome should be demonstrated,
- på grundlag af den forelagte dokumentation og den faglige drøftelse i udvalget
- based on the documentation submitted and the scientific discussion within the Committee, the
ændres det af ansøgeren foreslåede produktresumé som angivet i bilag III.
Summary of Products Characteristic proposed by the applicant has been amended as set out in Annexe III.
11 BILAG III
20/ 94 ANNEX III
PRODUKTRESUME, MÆRKNING PÅ EMBALLAGE OG INDLÆGSSEDDEL
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
12 A.
21/ 94 A.
13 1 LÆGEMIDLETS NAVN
22/ 94 1 NAME OF THE MEDICINAL PRODUCT
Adartrel 0, 25 mg filmovertrukne tabletter
ADARTREL 0.25 mg film-coated tablets.
Hver filmovertrukket tablet indeholder 0, 25 mg af ropinirol (som hydrochlorid).
Each film-coated tablet contains 0.25 mg of ropinirole (as hydrochloride).
6. 1.
Lactose For a full list of excipients, see section 6.1.
3 LÆGEMIDDELFORM
3 PHARMACEUTICAL FORM Film-coated tablet.
Hvid oval tablet mærket ” GS ” på den ene side og ” MLE ” på den anden.
White oval-shaped, marked "GS" on one side and "MLE" on the other.
4. 1 Terapeutiske indikationer Adartrel er indiceret til symptomatisk behandling af moderat til svær idiopatisk Restless Legs Syndrome (RLS) (se afsnit 5. 1).
ADARTREL is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1).
Voksne Individuel dosistitrering anbefales i henhold til effekt og tolerans.
Individual dose titration against efficacy and tolerability is recommended.
Behandlingsinitiering (uge 1) Den anbefalede initiale dosis er 0, 25 mg en gang dagligt i 2 dage (administreret som nævnt ovenfor).
Treatment initiation (week 1)
Behandlingsregime (uge 2 og fremefter) Efter behandlingsinitiering øges daglig dosis indtil optimal terapeutisk respons opnås.
If this dose is well tolerated the dose should be increased to 0.5 mg once daily for the remainder of week 1.
Middeldosis i kliniske forsøg var 2 mg en gang daglig for patienter med moderat til svær Restless Legs Syndrome.
Therapeutic regimen (week 2 onwards)
Til nogle patienter kan dosis øges gradvist op til maksimalt 4 mg en gang daglig for at opnå optimal forbedring.
Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved.
Doser over 4 mg en gang daglig er ikke undersøgt i Restless Legs Syndrome patienter.
The average dose in clinical trials, in patients with moderate to severe Restless Legs Syndrome, was 2 mg once a day.
Tabel 1:
The dose may be increased to 1 mg once a day at week 2.
Dosistitrering
In clinical trials the dose was increased by 0.5 mg each week to 3 mg once a day and then by 1 mg up to the maximum recommended dose of 4 mg once a day as shown in table 1.
4.
Doses above 4 mg once daily have not been investigated in Restless Legs Syndrome patients.
2. 1. 1 Uge 2
23/ 94 Table 1
4. 2. 1. 1 Uge 2 3 4
Dose titration
5 *
Week
6 *
2
7 *
3
2.
7*
1. 2 Dosis( mg) en 1 gang daglig
1
1, 5 2
2
* For at opnå optimal bedring i nogle patienter
* To achieve optimal improvement in some patients.
14 Patientens respons på ropinirol bør evalueres efter 3 måneders behandling (se afsnit 5. 1).
The patient’ s response to ropinirole should be evaluated after 3 months treatment (see section 5.1).
Hvis behandlingen afbrydes i mere end et par dage bør re- initiering ske med dosistitrering som beskrevet ovenfor.
If treatment is interrupted for more than a few days it should be re-initiated by dose titration carried out as above.
Børn og unge Adartrel er ikke anbefalet til brug hos børn under 18 år p. g. a. mangel på data vedrørende sikkerhed og effekt.
ADARTREL is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Ældre Ropinirolclearance er nedsat hos patienter over 65 år.
The clearance of ropinirole is decreased in patients over 65 years of age.
Nedsat nyrefunktion Hos patienter med mild til moderat nedsat nyrefunktion (kreatininclearance mellem 30 og 50 ml/ min) er dosisjustering ikke nødvendig.
No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/ min).
4. 3 Kontraindikationer 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.
Svær nedsat nyrefunktion (kreatininclearance < 30 ml/ min).
Severe renal impairment (creatinine clearance < 30 ml/ min)
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen Ropinirol bør ikke bruges til behandling af neuroleptisk akathisia og tasikinesia (neuroleptisk induceret ufrivillig trang til at gå), eller sekundær Restless Legs Syndrome (for eksempel forårsaget af nyresvigt, jernmangel eller graviditet).
Ropinirole should not be used to treat neuroleptic akathisia, tasikinesia (neuroleptic-induced compulsive tendency to walk), or secondary Restless Legs Syndrome (e. g. caused by renal failure, iron deficiency anaemia or pregnancy).
Ved behandling med ropinirol er observeret paradoksal forværring af Restless Legs Syndrome, hvor symptomerne begynder tidligere på dagen end forventet (augmentation) og symptomerne vender tilbage tidligt på morgenen (rebound effekt).
During treatment with ropinirole, paradoxical worsening of Restless Legs Syndrome symptoms occurring with earlier onset (augmentation), and reoccurrence of symptoms in the early morning hours (early morning rebound), may be observed.
Ved Parkinsons sygdom er ropinirol – ikke almindeligt - sat i forbindelse med somnolens og episoder, hvor patienten pludseligt falder i søvn (se sektion 4. 8), men ved Restless Legs Syndrome et dette fænomen meget sjældent.
In Parkinson’ s disease, ropinirole has been associated uncommonly with somnolence and episodes of sudden sleep onset (see section 4.8) however, in Restless Legs Syndrome, this phenomenon is very rare.
Patienter, der har oplevet somnolens og/ eller episoder, hvor de pludseligt falder i søvn, skal undlade at føre motorkøretøj eller betjene maskiner.
Patients who have experienced somnolence and/ or an episode of sudden sleep onset must refrain from driving or operating machines.
Ropinirol skal gives med forsigtighed til patienter med moderat leversvigt.
24/ 94 Ropinirole should be administered with caution to patients with moderate hepatic impairment.
Da tabletterne indeholder laktose, bør produktet ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af heriditær lactasemangel (Lapp Lactase deficiency) eller glucose / galactose malabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
4. 5 Interaktion med andre lægemidler og andre former for interaktion Ropinirol metaboliseres fortrinsvis af cytochrom P450 isoenzymet CYP1A2.
Ropinirole is principally metabolised by the cytochrome P450 isoenzyme CYP1A2.
Hos patienter, der allerede får
A pharmacokinetic study (with a ropinirole dose of 2 mg, three times a day) revealed that ciprofloxacin increased the Cmax and AUC of ropinirole by 60% and 84% respectively, with a potential risk of adverse events.
15 ropinirol, kan det derfor være nødvendigt at justere dosis af ropinirol, når lægemidler der vides at hæmme CYP1A2, f. eks. ciprofloxacin, enoxacin eller fluvoxamin introduceres eller seponeres.
Hence, in patients already receiving ropinirole, the dose of ropinirole may need to be adjusted when medicinal products known to inhibit CYP1A2, e. g. ciprofloxacin, enoxacin or fluvoxamine, are introduced or withdrawn.
En farmakokinetisk interaktionsundersøgelse mellem ropinirol (med en dosis på 2 mg 3 gange daglig) og theofyllin, som repræsentant for et CYP1A2- substrat, viste ingen ændringer i farmakokinetikken af hverken ropinirol eller theofyllin.
A pharmacokinetic interaction study between ropinirole (at a dose of 2 mg, three times a day) and theophylline, a substrate of CYP1A2, revealed no change in the pharmacokinetics of either ropinirole or theophylline.