natgillin/translations-raw huggingface dataset:
Opbevares i den originale pakning Medicinen må ikke tilføres spildevand eller husholdningsaffald.
Medicines should not be disposed of via wastewater or household waste.
Hvad Adartrel indeholder
What ADARTREL contains
- Det aktive stof er ropinirol (som hydrchlorid)
- The active substance is ropinirole (as hydrochloride)
- De øvrige indholdsstoffer er
- The other ingredients are
Lactose monohydrat, mikrokrystallinsk cellulose, natrium croscarmellose, magnesiumstearat Filmovertræk:
lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Hypromellose, macrogol 400, titandioxid (E171), polysorbat 80 (E433)
hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433).
Produktets udseende og pakningstørrelse Hvid oval tablet mærket ” GS ” på den ene side og ” MLE ” på den anden.
What ADARTREL looks like and contents of the pack This medicine is provided as oval, white, film-coated tablets marked "GS" on one side and "MLE" on the other.
Det er ikke alle pakningsstørrelser, som er markedsført.
Not all packs may be available.
Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelse:
Marketing Authorisation Holder:
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly- le Roi Cedex France Tel +33 1 39 178000 < [Se bilag I – Udfyldes nationalt] > Fremstiller:
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France tel +33 1 39 178000
SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ, United Kingdom
SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ, United Kingdom
Denne indlægsseddel blev senest godkendt den {MM/ ÅÅÅÅ}
This leaflet was last approved in
64 INDLÆGSSEDDEL
77/ 94 PACKAGE LEAFLET:
Adartrel 0, 5 mg filmovertrukne tabletter Ropinirol (som hydrochlorid)
ADARTREL 0.5 mg film-coated tablets Ropinirole (as hydrochloride)
Inden du begynder at tage medicinen, så fortæl lægen lægen, hvis du:
78/ 94 Tell your doctor before you start to take this medicine if you:
66 Bilkørsel og betjening af maskiner Adartrel kan hos enkelte give bivirkninger, som kan påvirke arbejdssikkerheden og evnen til at færdes sikkert i trafikken.
Driving and using machines This medicine does not usually affect people's normal activities.
Kontakt lægen.
Important information about some of the ingredients of ADARTREL
Vigtige oplysninger om visse af indholdsstofferne i Adartrel Patienter der er intolerante over for laktose, skal lægge mærke til, at hver Adartrel tablet indeholder en lille mængde lactose.
79/ 94 Patients who are intolerant to lactose should note that each ADARTREL tablet contains a small amount of lactose.
Børn Brug af Adartrel til børn med Restless Legs Syndrome er ikke undersøgt og derfor ordineres Adartrel normalt ikke til børn under 18 år.
Children The use of ADARTREL in children with Restless Legs Syndrome has not been studied and therefore ADARTREL is not usually prescribed in patients under 18 years of age.
67 Hvis du holder op med at tage Adartrel Hvis symptomerne bliver værre efter at du er stoppet med at tage Adartrel, så kontakt lægen.
If your symptoms worsen after you stop treatment with ADARTREL, you should contact your doctor.
Spørg din læge eller apotek, hvis du har yderligere spørgsmål.
80/ 94 If you have any further questions on the use of this product, ask your doctor or pharmacist.
Som alle andre lægemidler kan Adartrel have bivirkninger, selvom ikke alle får bivirkninger.
Like all medicines, ADARTREL can cause side effects, although not everybody gets them.
Tabletkerne:
81/ 94 Tablet core:
Hypromellose, macrogol 400, titandioxid (E171), jernoxid gul (E172), jernoxid rød (E172), indigocarmin (E132) Produktets udseende og pakningstørrelse Gul oval tablet mærket ” GS ” på den ene side og ” TES ” på den anden.
hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), indigo carmine aluminium lake (E132).
69 INDLÆGSSEDDEL
82/ 94 PACKAGE LEAFLET:
- er gravid eller tror du er gravid
83/ 94
70
- are pregnant or think you are pregnant
71 Bilkørsel og betjening af maskiner Adartrel kan hos enkelte give bivirkninger, som kan påvirke arbejdssikkerheden og evnen til at færdes sikkert i trafikken.
Driving and using machines This medicine does not usually affect people's normal activities.
Børn Brug af Adartrel til børn med Restless Legs Syndrome er ikke undersøgt og derfor ordineres Adartrel normalt ikke til børn under 18 år.
84/ 94 Children The use of ADARTREL in children with Restless Legs Syndrome has not been studied and therefore ADARTREL is not usually prescribed in patients under 18 years of age.
72 Hvis du holder op med at tage Adartrel Hvis symptomerne bliver værre efter at du er stoppet med at tage Adartrel, så kontakt lægen.
If your symptoms worsen after you stop treatment with ADARTREL, you should contact your doctor.
4 HVILKE MULIGE BIVIRKNINGER ADARTREL HAR
85/ 94 4 POSSIBLE SIDE EFFECTS
Hypromellose, macrogol 400, titandioxid (E171), jernoxid gul (E172), indigocarmin (E132) Produktets udseende og pakningstørrelse Grøn oval tablet mærket ” GS ” på den ene side og ” SJG ” på den anden.
hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
74 INDLÆGSSEDDEL
87/ 94 PACKAGE LEAFLET:
Inden du begynder at tage medicinen, så fortæl lægen lægen, hvis du:
88/ 94 Tell your doctor before you start to take this medicine if you:
76 Bilkørsel og betjening af maskiner Adartrel kan hos enkelte give bivirkninger, som kan påvirke arbejdssikkerheden og evnen til at færdes sikkert i trafikken.
Driving and using machines This medicine does not usually affect people's normal activities.
Vigtige oplysninger om visse af indholdsstofferne i Adartrel Patienter der er intolerante over for laktose, skal lægge mærke til, at hver Adartrel tablet indeholder en lille mængde lactose.
89/ 94 Patients who are intolerant to lactose should note that each ADARTREL tablet contains a small amount of lactose.
77 Hvis du holder op med at tage Adartrel Hvis symptomerne bliver værre efter at du er stoppet med at tage Adartrel, så kontakt lægen.
If your symptoms worsen after you stop treatment with ADARTREL, you should contact your doctor.
Spørg din læge eller apotek, hvis du har yderligere spørgsmål.
90/ 94 If you have any further questions on the use of this product, ask your doctor or pharmacist.
78
91/ 94
Hypromellose, macrogol 400, titandioxid (E171), jernoxid gul (E172), jernoxid rød (E172).
hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172),
Produktets udseende og pakningstørrelse Lyserød oval tablet mærket ” GS ” på den ene side og ” GYG ” på den anden.
What ADARTREL looks like and contents of the pack This medicine is provided as oval, pink, film-coated tablets marked "GS" on one side and "GYG" on the other.
79 BILAG IV
92/ 94 ANNEX IV
80 BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
93/ 94 CONDITIONS OF THE MARKETING AUTHORISATION
Det nævnte post- marketing commitment er krævet af CHMP og skal inden for den givne tidsfrist indsendes til referencemedlemsstaten:
The conditions considered essential for the safe and effective use of the Ropirinole are the following Post-Authorisation Commitment requested by the CHMP and to be submitted to the Reference Member State in the timeline are detailed below:
Modul 5 – Clinical
Module 5 – Clinical
Clinical
Clinical
At indsende den endelige study report fra den kliniske undersøgelse (ROR104836), “ A randomised, double- blind, placebo- controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome. ” Undersøgelsen forventes at starte i februar 2006.
To submit the final study report from the clinical study (ROR104836), “ A randomised, double-blind, placebo- controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome .” The study is expected to commence in Feb 06.
Den endelige study report
The final study report will be
vil være tilgængelig 6 måneder efter sidste patientbesøg i undersøgelsen.
available 6 months after the last patient visit in the study.
GlaxoSmithKline forventer at fremsende den endelige study report
GlaxoSmithKline expect to submit the final study report by
juli 2009
July 09
81
94/ 94
London, 3. april 2006 EMEA/ CHMP/ 416317/ 2005
London, 3 April 2006 EMEA/ CHMP/ 416317/ 2005
UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
2 Adartrel Internationalt fællesnavn (INN):
OPINION FOLLOWING AN ARTICLE 29(2) REFERRAL Adartrel International Non-Proprietary Name (INN):
Adartrel er en selektiv dopaminagonist, som virker på undertyper af D2 - og D3 – dopaminreceptorer, både centralt og perifert.
Adartrel is a selective dopamine agonist at the D2- and D3-dopamine receptor subtypes and is active both centrally and peripherally.
På sit møde den 12. - 15. juni 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at der skulle udstedes en markedsføringstilladelse, forudsat at en række vigtige betingelser til sikring af en sikker og effektiv anvendelse af lægemidlet var opfyldt.
During its 12-15 September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee was of the opinion that a marketing authorisation should be granted subject to certain conditions considered essential for the safe and effective use of the medicinal product.
Listen over de pågældende lægemiddelnavne fremgår af bilag I.
The list of product names concerned is given in the Annex I.
De faglige konklusioner findes i bilag II og produktresuméet i bilag III.
The scientific conclusions are provided in the Annex II, together with the Summary of Product Characteristics in the Annex III.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa- Kommissionen den 3. april 2006.
The final opinion was converted into a Decision by the European Commission on 3 April 2006.
LISTE MED NAVNE, LÆGEMIDDELFORMER, LÆGEMIDDELSTYRKER, INDGIVELSESMÅDE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
1 Medlemsstat Østrig
1 Member State Austria
Indehaver af markedsføringstilladelsen Takeda Pharma Ges. m. b. H.
Marketing Authorisation Holder Takeda Pharma Ges. m. b. H.
Lægemidlets navn AGOPTON
Product name AGOPTON
Styrke 15 mg
Strength 15 mg
Lægemiddelform Kapsel
Pharmaceutical form Capsule
Indgivelsesmåde Oral anvendelse
Route of administration Oral use
AGOPTON AGOPTON Rapid AGOPTON Rapid
AGOPTON AGOPTON Rapid AGOPTON Rapid
Kapsel Smeltetabletter Smeltetabletter
Capsule Oro-dispersible tablet Oro-dispersible tablet
1130 Brussels, Belgien
1130 Brussels, Belgium
Kapsel Kapsel
Capsule Capsule
Smeltetabletter Smeltetabletter
Oro-dispersible tablet Oro-dispersible tablet
92816 Puteaux cedex, Frankrig
92816 Puteaux cedex, France
75601 Paris Cedex 12, Frankrig
75601 Paris Cedex 12, France
AGOPTON LANZOR LANZOR
AGOPTON LANZOR LANZOR
Kapsel Kapsel Kapsel
Capsule Capsule Capsule
2 Grækenland
2 Greece
Kapsel Kapsel Smeltetabletter Smeltetabletter
Capsule Capsule Oro-dispersible tablet Oro-dispersible tablet
Gedeon Richter H- 1103 Budapest, Gyomroi ut 19- 21 Ungarn
Gedeon Richter H-1103 Budapest, Gyomroi ut 19-21 Hungary
Berkshire SL6 0PH Storbritannien
Berkshire SL6 0PH UK
Smeltetabletter Smeltetabletter
Oro-dispersible tablet
Cyanamid of Great Briain Ltd.
Cyanamid of Great Briain Ltd.
Fareham Road, GOSPORT Hampshire PO13 0AS, Storbritannien
Fareham Road, GOSPORT Hampshire PO13 0AS, UK
30mg
30mg
oral Oral anvendelse
Gastro-resistant granules Oral use for oral suspension
LANSOX
LANSOX
Oral anvendelse
Capsule Oral use
LANSOX LANGAST LANGAST LANSOX LANSOX
LANSOX LANGAST LANGAST LANSOX LANSOX LANGAST LANGAST
30 mg 15 mg 30 mg 15 mg 30 mg
30 mg 15 mg 30 mg 15 mg 30 mg 15 mg 30 mg
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Capsule Oral use Capsule Oral use Capsule Oral use Oro-dispersible tablet Oral use Oro-dispersible tablet Oral use Oro-dispersible tablet Oral use Oro-dispersible tablet Oral use
Sigma- Tau S. p. A.
Sigma-Tau S. p. A.
Via Pontina km.
Via Pontina km.
30, 400 00040 Pomezia, Roma,
30,400 00040 Pomezia, Roma,
LIMPIDEX LIMPIDEX LIMPIDEX ZOTON
LIMPIDEX LIMPIDEX
30 mg 15 mg 30 mg 15 mg
30 mg 15 mg
Kapsel Smeltetabletter Smeltetabletter Kapsel
Capsule Oro-dispersible tablet
ZOTON ZOTON
ZOTON ZOTON ZOTON
Smeltetabletter Smeltetabletter
Capsule Oro-dispersible tablet Oro-dispersible tablet
2803 PE GOUDA, Holland
2803 PE GOUDA, The Netherlands
de Santo Adriao, Portugal
de Santo Adriao, Portugal
Kapsel Smeltetabletter
Capsule
Smeltetabletter
Oro-dispersible tablet Oro-dispersible tablet
General Mitre, 151 08022 - Barcelona, Spanien
General Mitre, 151 08022 -Barcelona, Spain
BAMALITE BAMALITE OPIREN Flas OPIREN Flas BAMALITE Flas BAMALITE Flas
BAMALITE BAMALITE OPIREN Frash OPIREN Frash BAMALITE Frash BAMALITE Frash
15 mg 30 mg 15 mg 30 mg 15 mg 30 mg
15 mg 30 mg 15 mg 30 mg 15 mg 30 mg
Kapsel Kapsel Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter
Capsule Capsule Oro-dispersible tablet Oro-dispersible tablet Oro-dispersible tablet Oro-dispersible tablet
Kapsel Smeltetabletter Smeltetabletter
Capsule Oro-dispersible tablet
John Wyeth & Brother Limited
John Wyeth & Brother Limited Trading as Wyeth Pharmaceuticals
4 Trading as Wyeth Pharmaceuticals Huntercombe Lane South
Huntercombe Lane South Taplow, Maidenhead
Taplow, Maidenhead Berkshire SL6 0PH
Berkshire SL6 0PH
Enterogranulat opløsning
Gastro-resistant granules Oral use
til
UK
oral Oral anvendelse
for oral suspension
Oral anvendelse Oral anvendelse
Oro-dispersible Tablet Oral use Oro-dispersible Tablet Oral use
Capsule
Capsule
Capsule Capsule Capsule Smeltetabletter Smeltetabletter
Capsule Capsule Capsule Oro-dispersible tablet Oro-dispersible tablet
Capsule Smeltetabletter Smeltetabletter
Capsule Oro-dispersible tablet Oro-dispersible tablet
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
7 FAGLIGE KONKLUSIONER
7 SCIENTIFIC CONCLUSIONS
Da produktresuméet for Agopton og tilknyttede navne (lansoprazol) ikke er enslydende i de forskellige EU- medlemsstater på grund af divergerende nationale beslutninger, er det nødvendigt at harmonisere produktresuméet for Agopton og tilknyttede navne i Europa.
Due to the fact that Agopton and associated names (lansoprazole) does not have the same Summary of Product Characteristics (SPC) in the various Member States in the European Union as a result of divergent national decisions, a harmonisation of the SPC for Agopton and associated names, throughout Europe has become necessary.
Terapeutiske indikationer • Behandling af NSAID- relaterede godartede gastriske og duodenale ulcera hos patienter, der kræver fortsat NSAID- behandling • Profylakse af NSAID- relaterede gastriske ulcera, duodenale ulcera og lindring af symptomer hos patienter, der kræver fortsat behandling • Symptomatisk gastroøsofageal reflukssygdom.
Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment
Dosering og indgivelsesmåde • Forskelle i dosisanbefalingen til eradikation af H. pylori: indføjelse af specifikke anbefalinger til, hvilke antibiotika der skal benyttes • Dosis og doseringsplan i forbindelse med symptomatisk gastroøsofageal reflukssygdom.
Dosage recommendation for the eradication of H. pylori differences: inclusion of specific recommendations on the antibiotics to be used
Der blev anmodet om udarbejdelse af et harmoniseret produktresumé i forbindelse med alle andre relevante afsnit.
Further issues: it was requested to present a harmonised SPC for all other relevant sections Quality aspects do not form part of the current arbitration procedure.
Behandling af NSAID- relaterede gastriske ulcera, duodenale ulcera og gastroduodenale erosioner samt lindring af de tilknyttede symptomer hos patienter, der kræver fortsat NSAID- behandling
Treatment of NSAID-associated gastric ulcers, duodenal ulcers and gastroduodenal erosions, and relief of the associated symptoms, in patients requiring continued NSAID treatment
Mavesyre spiller en central rolle i patogenesen af gastroduodenale ulcera, og syrehæmning har vist sig effektivt til at hele NSAID- relaterede ulcera.
Gastric acid is central in the pathogenesis of gastroduodenal ulcers and acid inhibition has been shown to effectively heal NSAID-associated ulcers.
Helingen forsinkes hos patienter, der fortsat tager NSAID' er.
In patients who continue to take NSAID medication healing is delayed.
Der er fremlagt to hovedundersøgelser til understøttelse af den foreslåede indikation i forbindelse med heling af ulcera.
Two pivotal studies for the support of the proposed indication in ulcer healing have been presented:
Begge undersøgelser var dobbeltblinde, randomiserede multicenterundersøgelser med parallelgrupper og positiv kontrol designet til at vurdere sikkerheden og virkningen af lansoprazol 15 mg og 30 mg od sammenlignet med ranitidin 150 mg bid.
Both of them were double-blind, positive-controlled, randomised, parallel group, multi-centre studies designed to evaluate the safety and efficacy of lansoprazole 15 mg and 30 mg o.d. in comparison to ranitidine 150 mg b.d.
Derfor kan dosen på 15 mg ikke anbefales til heling af NSAID- relaterede gastriske ulcera.
Therefore the 15 mg dose cannot be recommended for healing of NSAID-associated gastric ulcers.
8 hvordan ulcerationen helede, og resultaterne er inkonsistente på tværs af de forskellige symptomer/ parametre og metoder, der er benyttet til vurdering af symptomerne.
The evaluation of the symptoms yielded less clear results than for the healing of the ulceration, and the results are inconsistent across the different symptoms/parameters and methods used to assess the symptoms.
Dataene fra de to hovedundersøgelser samt understøttende data fra den åbne, udvidede undersøgelse og den komparative undersøgelse med omeprazol og misoprostol understøtter indikationen "behandling af NSAID- relaterede godartede gastriske og duodenale ulcera hos patienter, der kræver fortsat NSAID- behandling".
The data from the 2 pivotal studies as well as supportive data from the open-label extension study and the comparative study with omeprazole and misoprostol, support the indication: “Treatment of NSAID associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment”.
Undersøgelserne understøtter brugen af lansoprazol 30 mg od i 4- 8 uger i forbindelse med denne indikation.
The studies support the use of lansoprazole 30 mg o.d for 4-8 weeks for this indication.
Der findes meget få data vedrørende indikationerne "lindring af symptomer" og "heling af gastroduodenale erosioner", og de er ikke tilstrækkelige til godkendelse af disse indikationer.
Data concerning
• Profylakse af NSAID- relaterede gastriske ulcera, duodenale ulcera og gastroduodenale erosioner samt forebyggelse af de tilknyttede symptomer hos patienter, der kræver fortsat NSAID- behandling
8 the indications “relief of symptoms” and “healing of gastroduodenal erosions” are scarce and are not sufficient for approval of these indications. • Prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers, gastroduodenal erosions, and prevention of the associated symptoms, in patients who require continued NSAID treatment For the prevention of NSAID associated ulceration, one pivotal study was presented.
Undersøgelsen varede 12 uger.
This study was a randomized, parallel-group, active- and placebo-controlled, multi-center, multinational study to evaluate the use of lansoprazole, misoprostol and placebo in the prevention of ulcers and erosions in patients continuing to take NSAIDs.
Mens resultaterne for de to doser lansoprazol og for misoprostol lignede hinanden meget, var alle tre behandlinger markant bedre sammenlignet med placebo, og dette er bekræftet ved statistisk analyse (p < 0, 001 for hver sammenligning mellem aktiv behandling og placebo).
The study duration was 12 weeks While the results for the two doses of lansoprazole and for misoprostol are very similar, all three treatments were markedly better than placebo and this is confirmed by statistical analysis (p < 0.001 for each active vs. placebo comparison).
Lansoprazol er (ligesom misoprostol) effektivt til at reducere risikoen for gastriske og duodenale ulcera hos patienter, der kræver fortsat NSAID- behandling.
Lansoprazole (like misoprostol) is effective in reducing the risk of gastric or duodenal ulcers in patients who need to continue NSAIDs.
Undersøgelserne, der blev fremlagt af indehaveren af markedsføringstilladelsen, påviste, at lansoprazol er effektivt til behandling og forebyggelse af gastrisk ulceration, der er forbundet med indtag af NSAID' er.
Only a small minority of patients developed duodenal ulcers The studies presented by the MAH demonstrated efficacy of lansoprazole in the treatment and prevention of gastric ulceration associated with continued intake of NSAIDs.
Begrænsede data, velkendte kliniske fakta om duodenal ulceration og en klasseeffekt af PPI' er understøtter inklusionen af duodenale ulcera i indikationen.
Limited data, well known-clinical facts about duodenal ulceration and an class effect of PPIs support the inclusion of duodenal ulcers into the indication.
Profylaktisk behandling bør dog kun anbefales til højrisikopatienter – yderligere oplysninger om dette forslag findes i produktresuméet.
However, prophylactic treatment should be recommended only for patients at high risk, see SPC for detailed proposal.
Der blev fremlagt to randomiserede, dobbeltblinde hovedundersøgelser med parallelgrupper og fem understøttende undersøgelser til vurdering af effekten af lansoprazol til behandling af symptomatisk gastroøsofageal reflukssygdom.
The data do not support the indication “prevention of symptoms” nor “prophylaxis of gastroduodenal erosions”. • Symptomatic gastroesophageal reflux disease (4.1 and 4.2) Two pivotal randomised, double-blind, parallel-group trials and 5 supportive studies to evaluate the efficacy of lansoprazole for treatment of symptomatic gastroesophageal reflux disease were submitted.
Den anbefalede dosis er 15- 30 mg od med anbefalinger om yderligere undersøgelser, hvis patienten ikke responderer inden for 4 uger.
The recommended dose should be 15-30 mg o.d. with recommendations regarding further investigation, should the patient not respond within 4 weeks.
Forskellige sygdomskoncepter for "symptomatisk gastroøsofageal reflukssygdom" og andre "funktionelle sygdomme", f. eks. "dyspepsi", er ved at blive opstillet i hele Europa og giver sig udtryk i forskellig etikettering.
Different disease concepts for “symptomatic gastroesophageal reflux disease” and other “functional diseases” e.g. “dyspepsia”, are established throughout Europe and reflected in different labelling.
9 2.
2.
Eradikation af H. pylori har vist sig at være en definitiv kur mod duodenale ulcera og de fleste gastriske ulcera.
Posology and methods of administration • Eradication of Helicobacter pylori Eradication of H. pylori has been shown to be a definitive cure for duodenum ulcer and most gastric ulcers.
I Maastricht Consensus hedder det, at behandlingsregimer til eradikation af H. pylori skal være enkle, veltolererede og opnå en eradikationsrate på over 80% på basis af en behandlingsintention.
The Maastricht Consensus states that treatment regimens for eradication of H. pylori should be simple, well tolerated and achieve an eradication rate of over 80% on an intention to treat basis.