natgillin/translations-raw huggingface dataset:
En undergruppe fra GOAL- undersøgelsen (Gaining Optimal Asthma Control study), dvs. stratum 1, addendum, fase 1 (patienter, der ikke fik inhaleret corticosteroid ved indledningen af undersøgelsen, og som opfyldte kriterierne for moderat persisterende astma og er blevet randomiseret til Seretide 50/ 100 eller fluticasonpropionat 100 mcg), kan anses som en passende målgruppe til vurderingen af hensigtsmæssigheden af Seretide som initial vedligeholdelsesbehandling.
A subpopulation from the GOAL study (Gaining Optimal Asthma ControL study) i. e. stratum 1, addendum, step 1 (patients without ICS at entry who fulfilled the criteria for moderate persistent asthma and who are randomised to Seretide 50/ 100 or FP 100 mcg), can be considered as an adequate target population to assess the adequacy of Seretide as IMT.
EMEA/ CHMP/ 116517/ 2006/ DA Det primære endepunkt i GOAL- undersøgelsen var den
EMEA/ CHMP/ 116517/ 2006/ EN
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CHMP var betænkelig over, at en generel anbefaling, dvs. den terapeutiske indikation i produktresuméet, kan frygtes at føre til overbehandling af især patienter, som ville have responderet på inhalerede corticosteroider alene.
The CHMP had a concern that a general recommendation i. e. the therapeutic indication in the Summary of Product Characteristics (SPC), will result in over treatment particularly in patients who would have responded to inhaled corticosteroids alone.
Forslaget fra indehaverne af markedsføringstilladelserne om at lade den terapeutiske indikation omfatte “ patienter med persisterende astma, som ikke kan kontrolleres tilstrækkeligt alene med de efter behov inhalerede korttidsvirkende beta- 2- agonister og som frembyder mindst to af følgende kliniske tegn på astma: begrænset luftflow, daglig brug af livsvigtig medicin, daglige symptomer (om dagen og/ eller om natten) "blev ikke fundet acceptabelt, da det ikke effektivt identificerer en patientgruppe med behov for kombinationsbehandling.
The MAH’ s proposed therapeutic indication to include “ patients with persistent asthma not adequately controlled on "as needed" inhaled short- acting beta-2-agonists alone who exhibit a combination of at least two of the following clinical features of asthma: airflow limitation, daily use of rescue medication, daily symptoms (day-time and/ or night-time )” was not considered acceptable as it does not effectively identify a population in need of combination therapy.
Global Initiative for Asthma (GINA)) beskriver omstændigheder, der kan føre til, at vedligeholdelsesbehandling indledes med kombinationen.
Nevertheless the CHMP acknowledged that current clinical guidelines (e. g. the Global Initiative for Asthma (GINA) guidelines) describe circumstances which could lead to the initiation of maintenance therapy with the combination.
Det blev fundet acceptabelt at give en sådan anbefaling i afsnit 4. 2 "Dosering og indgivelsesmåde".
A recommendation in section 4.2 “ Posology and method of administration” was considered acceptable.
Den i afsnit 4. 2 indføjede anbefaling giver mulighed for kortvarig forsøgsvis brug af Seretide Diskus hos voksne patienter med moderat persisterende astma og tvingende behov for hurtig astmakontrol.
The recommendation included in section 4.2 allows a short term trial of Seretide Diskus in adults and adolescents with moderate persistent asthma for whom rapid control of asthma is essential.
Startdosis er 1 inhalation af 50 mcg salmeterol/ 100 mcg fluticasonpropionat to gange dagligt.
The initial starting dose is 1 inhalation of 50 mcg salmeterol/ 100 mcg FP twice daily.
Foruden ajourføringen af produktresuméets afsnit 4. 2 er der i afsnit 5. 1 "Farmakodynamiske egenskaber" indsat visse faktuelle oplysninger fra GOAL- undersøgelsen, navnlig vedrørende det tidsmæssige aspekt ved opnåelse af hurtigere kontrol med Seretide end med inhalerede corticosteroider alene.
In addition to the update in section 4.2 of the SPC, some factual data from the GOAL study in particular the timing of reaching more rapidly control with Seretide than with ICS alone have been included in section 5.1 “ Pharmacodynamic properties” of the SPC.
De oplysninger, der aktuelt gives i produktresuméets afsnit 5. 1, er ligeledes bragt i overensstemmelse med anbefalingen i afsnit 4. 2.
The information currently in section 5.1 of the SPC have also been amended in line with the recommendation in section 4.2.
Der er forelagt oplysninger fra seks hovedundersøgelser og to støttende undersøgelser til at underbygge sikkerheden af salmeterol/ fluticasonpropionat anvendt som indledende vedligeholdelsesbehandling.
Data from six pivotal studies and two supporting studies have been presented to confirm the safety profile of salmeterol/ FP when initiated as maintenance treatment.
Selv om at sikkerhedsprofilen for salmeterol/ fluticasonpropionat er veldokumenteret, fandt CHMP det ikke berettiget at eksponere hele den tilsigtede målgruppe for øget forekomst af beta- agonistrelaterede bivirkninger.
Although the safety profile of salmeterol/ fluticasone propionate is well known, the CHMP considered it not justified to expose the whole intended target population to an increased incidence of beta-agonists related adverse events.
Som konsekvens heraf var CHMP ikke enig i, at afsnit 4. 1 skulle indeholde en generel anbefaling om initial vedligeholdelsesbehandling med fastdosiskombinationen, men fandt det acceptabelt, der at der i afsnit 4. 2 indsættes en vejledning i forsøgsvis initial kortvarig vedligeholdelsesbehandling med Seretide.
In line with above arguments, the CHMP was not in agreement with a general recommendation for IMT of the fixed dose combination in section 4.1. but considered it acceptable to include guidance for a short term trial of initial maintenance therapy with Seretide in section 4.2.
1084/ 2003, for Seretide Diskus og tilknyttede navne (jf. bilag I),
• the CHMP considered the referral made under Article 6(13) of Commission Regulation (EC) N 1084/ 2003 for Seretide Diskus and associated names (see Annex I)
• CHMP fandt det ikke acceptabelt, at produktresuméets afsnit 4. 1 skal indeholde en generel anbefaling af initial vedligeholdelsesbehandling med fastdosiskombinationen af salmeterol og fluticasonpropionat hos patienter med moderat persisterende astma, da dette kan tænkes at føre til overbehandling af især patienter, som ville have responderet på inhalerede EMEA/ CHMP/ 116517/ 2006/ DA
CHMP considered it not acceptable to expose the whole target population to beta-agonists related adverse events.
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• CHMP fandt det dog acceptabelt, at produktresuméets afsnit 4. 2 indeholder en anbefaling om kortvarig forsøgsvis brug af fastdosiskombinationen af salmeterol og fluticason som initial vedligeholdelsesbehandling af voksne og unge patienter med moderat persisterende astma og tvingende behov for hurtig astmakontrol,
and adolescents with moderate persistent asthma for whom rapid control of asthma is essential, in section 4.2 of the SPC is acceptable.
• CHMP fandt, er der i produktresuméets afsnit 5. 1 bør indsættes visse faktuelle oplysninger fra GOAL- undersøgelsen, navnlig vedrørende det tidsmæssige aspekt ved opnåelse af hurtigere kontrol ved hjælp af Seretide end med inhalerede corticosteroider alene, og at det er nødvendigt med visse ændringer i dette afsnit i henhold til den vedtagne anbefaling i afsnit 4. 2,
• the CHMP agreed that factual data from the GOAL study in particular the timing of reaching more rapidly control with Seretide than with ICS alone should be included in section 5.1 of the SPC and that some amendments in this section were necessary in line with the agreed recommendation in section 4.2.
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Dette bilag III (Produktresumé, Etikettering og Indlægsseddel) var bilag til Europa- Kommissionens beslutning angående denne artikel 6( 13) arbitreringssag vedrørende Seretide Diskus og tilknyttede navne.
This Annex III (Summary of Product Characteristics, Labelling and Package Leaflet) is the one that was Annexed to the Commission Decision on this Article 6(13) referral for Seretide Diskus and associated names.
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EMEA/ CHMP/ 116517/ 2006/ DA 1.
EMEA/ CHMP/ 116517/ 2006/ EN
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Seretide Diskus og andre navne (se bilag I) 50/ 100 mikrogram/ dosis inhalationspulver, afdelt Seretide Diskus og andre navne (se bilag I) 50/ 250 mikrogram/ dosis inhalationspulver, afdelt Seretide Diskus og andre navne (se bilag I) 50/ 500 mikrogram/ dosis inhalationspulver, afdelt
Seretide Diskus and associated names (see Annex I) 50/ 500 microgram/ dose inhalation powder, pre- dispensed.
En liste over alle hjælpestoffer er anført under. pkt 6. 1
For a full list of excipients, see section 6.1.
Inhalationspulver, afdelt i Diskus.
Inhalation powder, pre-dispensed.
Astma Til behandling af astma, hvor behandling med en kombinationsprodukt (langtidsvirkende ß2- agonist og inhalationssteroid) er hensigtsmæssig:
Seretide is indicated in the regular treatment of asthma where use of a combination product (long- acting beta-2-agonist and inhaled corticosteroid) is appropriate:
- hos patienter, der ikke er velkontrollerede på inhalationssteroid og korttidsvirkende ß2- agonist
- patients not adequately controlled with inhaled corticosteroids and ‘ as needed’ inhaled short
ved behov, eller
acting beta-2-agonist or
- hos patienter, der allerede er velkontrollerede på både inhalationssteroid og langtidsvirkende ß2 -
- patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-
agonist. OBS:
agonist.
OBS:
Note:
Seretide 50/ 100 mikrogram er uegnet til både børn og voksne med alvorlig astma.
Seretide 50/ 100 microgram strength is not appropriate in adults and children with severe asthma.
Kronisk Obstruktiv Lungesygdom (KOL) Til symptomatisk behandling af svær KOL (FEV1 < 50% af forventet) og tilbagevendende forværringer, hvor fast behandling med bronkodilatator ikke er tilstrækkelig.
Seretide is indicated for the symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Dosis skal titreres til laveste effektive dosis.
Seretide Diskus is for inhalation use only.
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Patienterne skal have Seretide i den styrke fluticasonpropionat, der passer til sværhedsgraden af deres astma.
Patients should be made aware that Seretide Diskus must be used daily for optimum benefit, even when asymptomatic.
Lægen skal være opmærksom på, at hos astmapatienter er fluticasonpropionat dobbelt så effektiv som andre steroider til inhalation.
As an alternative, patients requiring a long acting beta-2-agonist could be titrated to Seretide given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control.
Fx svarer 100 mikg fluticasonpropionat til ca.
Patients should be given the strength of Seretide containing the appropriate fluticasone propionate dosage for the severity of their disease.
200 mikg beclometasondipropionat eller budesonid.
Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as other inhaled steroids at approximately half the microgram daily dose.
Hvis en patient har brug for doser, der ligger uden for de anbefalede, bør der ordineres ß- agonister og/ eller kortikosteroider.
If an individual patient should require dosages outside the recommended regimen, appropriate doses of beta-agonist and/ or corticosteroid should be prescribed.
Eller 1 inhalation af 50 mikg salmeterol og 500 mikg fluticasonpropionat 2 gange daglig.
One inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. or One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily. or One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Det anbefales at finde den mest hensigtsmæssige dosis inhalationssteroid, før der anvendes en fast kombination hos patienter med svær astma.
Seretide 50/ 100 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma.
50 mikg salmeterol og 100 mikg fluticasonpropionat 2 gange daglig.
One inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily.
Den maksimale godkendte dosis af fluticasonpropionat i Seretide i Diskus til børn er 100 mikg 2 gange dagligt.
EMEA/ CHMP/ 116517/ 2006/ EN
Den maksimale godkendte dosis fluticasonpropionat i Seretide inhalationspulver i Diskus er 100 mikrogram to gange daglig.
The maximum licensed dose of fluticasone propionate delivered by Seretide Diskus in children is 100mcg twice daily.
50 mikg salmeterol og 500 mikg fluticasonpropionat 2 gange daglig.
One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Der er ingen oplysninger om brug af Seretide hos patienter med nedsat leverfunktion.
The mouthpiece is then placed in the mouth and the lips closed round it.
Brug af Diskus Diskus åbnes ved hjælp af fingergrebet.
Seretide is contraindicated in patients with hypersensitivity (allergy) to any of the active substances or to the excipient (see 6.1 List of Excipients).
For klargøring trykkes dosisknappen ned.
4.4 Special warnings and precautions for use
Derefter sættes mundstykket mellem tænderne, og læberne lukkes tæt om det.
Patients should be advised to have their medicinal product to be used for relief in an acute asthma attack available at all times.
Dosis kan nu inhaleres.
Consideration should be given to increasing corticosteroid therapy.
Diskus lukkes efter brug.
For patients with asthma or COPD, consideration should be given to additional corticosteroid therapies.
EMEA/ CHMP/ 116517/ 2006/ DA 4. 3 Kontraindikationer
EMEA/ CHMP/ 116517/ 2006/ EN
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Overfølsomhed over for indholdsstofferne (se pkt.
There have been very rare reports of increases in blood glucose levels (see 4.8 Undesirable Effects) and this should be considered when prescribing to patients with a history of diabetes mellitus.
6. 1 ” Hjælpestoffer ”).
Potentially serious hypokalaemia may result from systemic beta-2-agonist therapy but following inhalation at therapeutic doses plasma levels of salmeterol are very low.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing.
Behandling af astma bør følge et trinvist skema og patienterne bør kontrolleres både klinisk og med lungefunktionsundersøgelse med henblik på dosistitrering.
Seretide Diskus should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Seretide er ikke til akut brug.
Seretide contains lactose up to 12.5 milligram / dose.
Her skal anvendes en korttidsvirkende bronkodilatator med hurtigt indsættende virkning, som patienten altid bør have på sig.
This amount does not normally cause problems in lactose intolerant people.
Øget brug af korttidsvirkende bronkodilatatorer betyder forværring, og patientens tilstand bør revurderes af en læge.
Care should be taken when transferring patients to Seretide therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy.
Pludselig og tiltagende forværring af astmasymptomer er potentielt livstruende og patienten skal snarest tilses af en læge.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Sådanne symptomer bør føre til overvejelse om højere steroiddosis.
These effects are much less likely to occur than with oral corticosteroids.
Hvis den valgte dosis Seretide ikke giver tilstrækkelig effekt, bør patienten også undersøges af lægen for eventuelt behov for øget steroiddosis.
Possible systemic effects include Cushing’ s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Seponering hos patienter med KOL kan føre til symptomer og bør kun ske i samråd med lægen.
It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
Der bør udvises forsigtighed ved lungetuberkulose, som ved al anden inhalationsbehandling med kortikosteroider.
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.
Seretide bør gives med forsigtighed ved alvorlige hjerte- kar- sygdomme, inkl. hjertearytmi, diabetes mellitus, ubehandlet hypokaliæmi og tyreotoksikose.
Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis.
I meget sjældne tilfælde har der været set forhøjet blodsukkerniveau (se pkt.
Children and adolescents < 16years taking high doses of fluticasone propionate (typically ≥ 1000mcg/ day) may be at particular risk.
4. 8 ” Bivirkninger ”), som skal tages med i overvejelserne, når medicinen udskrives til diabetes- patienter.
Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000mcg.
Systemisk behandling med ß2- agonister kan resultere i potentielt alvorlig hypokaliæmi, men efter inhalation i terapeutiske doser er der meget lave plasmakoncentrationer af salmeterol.
Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection or any rapid reduction in dosage.
Som ved anden inhalationsbehandling kan paradoks bronkospasme forekomme med akut øget hvæsen efter indtagelse af dosis.
Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures.
I så fald skal Seretide straks seponeres, patienten undersøges, og om nødvendigt gives anden behandling.
Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Seretide indeholder op til 12, 5 mg laktose pr. dosis.
Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk.
Denne mængde giver normalt ikke problemer hos laktose- intolerante patienter.
This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered.
Hvis binyrebarkfunktionen er nedsat på grund af tidligere brug af systemiske steroider bør der især udvises forsigtighed ved igangsættelse af behandling med Seretide.
Ritonavir can greatly increase the concentration of fluticasone propionate in plasma.
Systemisk påvirkning kan opstå efter inhalation af steroider, især ved høje doser givet i længere perioder, men det er langt mindre sandsynligt end ved peroral steroidbehandling.
Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects.
Eventuel systemisk påvirkning kan omfatte Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, fald i knogletæthed, katarakt og glaukom.
There is also an increased risk of systemic side effects when combining fluticasone propionate with other potent CYP3A inhibitors (see 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction).
Det er derfor vigtigt, at patienten undersøges jævnligt, og at der reduceres til den laveste dosis inhalationssteroid, der giver astmakontrol.
4.5 Interaction with other medicinal products and other forms of interaction
Det anbefales, at højden måles jævnligt på børn i langtidsbehandling med inhalerede kortikosteroider.
Both non-selective and selective beta-blockers should be avoided unless there are compelling reasons for their use.
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Børn og unge under 16 år, der får høje doser fluticasonpropionat (typisk > 1000 mikg/ dag), er specielt i risikogruppen.
Concomitant use of other beta-adrenergic containing drugs can have a potentially additive effect.
Akut binyrebarkinsufficiens kan opstå på grund af traume, operation, infektion eller for hurtig nedsættelse af dosis og kan føre til spisevægring, mavesmerter, vægttab, træthed, hovedpine, kvalme, opkastning, hypotension, opmærksomhedstab, hypoglykæmi og kramper.
Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver.
Det bør overvejes at lægge systemiske kortikosteroider oven i behandlingen i stressperioder eller i forbindelse med operation.
Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.
Inhalationsbehandlingen med fluticasonpropionat bør minimere behovet for perorale steroider.
Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected.
Patienter, der har været i behandling med høje doser steroider, er i risiko for nedsat binyrebarkfunktion i længere tid.
Cases of Cushing’ s syndrome and adrenal suppression have been reported.
Denne risiko bør altid tages i betragtning i stresssituationer, herunder kirurgiske indgreb, og relevant steroiddosis vurderes, eventuelt med bistand fra specialist.
The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.
Ritonavir kan i høj grad øge plasmakoncentrationen af fluticasonpropionat.
In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%.
Derfor skal samtidig brug undgås, med mindre fordelen for patienten opvejer risikoen for systemiske bivirkninger forårsaget af glukokortikoider.
This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone.
Der er også øget risiko for systemiske bivirkninger ved samtidig brug af fluticasonpropionat og andre potente CYP3A- hæmmere (se pkt.
Co-treatment with other potent CYP3A inhibitors, such as itraconazole, is also expected to increase the systemic fluticasone propionate exposure and the risk of systemic side-effects.
4. 5 ” Interaktion med andre lægemidler og andre former for interaktion ”).
Caution is recommended and long-term treatment with such drugs should if possible be avoided.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.6 Pregnancy and lactation
Både selektive og ikke- selektive ß- blokkere skal så vidt muligt undgås.
There are insufficient data on the use of salmeterol and fluticasone propionate during pregnancy and lactation in man to assess the possible harmful effects.
Samtidig brug af andre ß- adrenerge stoffer kan have en potentiel additiv effekt.
Administration of Seretide to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Således er klinisk signifikante interaktioner forårsaget af fluticasonpropionat ikke sandsynlige.
The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.
Der findes ikke data om denne interaktion ved inhaleret fluticasonpropionat, men en udpræget højere plasmakoncentration af fluticasonpropionat er forventelig.
There are no data available for human breast milk.
Der er rapporter om tilfælde af Cushings syndrom og binyrebarksuppression.
Both salmeterol and fluticasone propionate are excreted into breast milk in rats.
Derfor bør kombinationen af de to stoffer undgås, med mindre fordelen for patienten opvejer den øgede risiko for systemiske bivirkninger forårsaget af glukokortikoider.
Administration of Seretide to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.