natgillin/translations-raw huggingface dataset:
EMEA/ CHMP/ 116517/ 2006/ DA Hvis du tager mere Seretide end du bør
EMEA/ CHMP/ 116517/ 2006/ EN Cleaning your inhaler
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Det er vigtigt kun at tage Seretide efter lægens anvisning.
If you take more Seretide than you should It is important to take Seretide as your doctor recommended.
Hvis du glemmer at tage Seretide Hvis du glemmer at tage din medicin, skal du først tage næste dosis, når det er tid igen.
If you forget to take Seretide If you forget to take your medicine, take your next dose when it is due.
Hvis du holder op med at tage Seretide Det er meget vigtigt, at du tager Seretide hver dag som ordineret, og at du ikke ophører med det uden at have aftalt det med din læge.
If you stop taking Seretide It is very important that you take your Seretide every day as directed, until you are advised to stop by your doctor.
Du må ikke stoppe behandlingen med Seretide pludseligt, da dette kan forværre dine symptomer og give problemer med kroppens hormoner.
Do not stop taking Seretide suddenly as this could make your symptoms worse and could cause problems with the body’ s hormones.
Kontakt din læge eller apotek, hvis du har yderligere spørgsmål.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Meget almindelig bivirkning (det sker hos flere end 1 ud af 10 patienter):
Very Common effects: this means that more than 1 in 10 people taking the medicine are affected.
- Hovedpine, aftager som regel ved fortsat behandling.
- Headache, although this side effect usually lessens as treatment continues.
Almindelig bivirkning (det sker hos mellem 1 og 10 ud af 100 patienter):
Common effects: means that between 1 in 10 and 1 in 100 people taking the medicine are affected.
- Svamp (ømme, hvid- gullige, hævede pletter) i mund og svælg.
- Thrush (sore, creamy-yellow, raised patches) in the mouth and throat.
Ømhed i tunge og svælg samt
Soreness of the tongue,
hæshed.
throat and hoarseness of the voice.
Tal med din læge om dette.
Your doctor may prescribe additional anti fungal medication to treat the thrush.
Disse bivirkninger er oftest
These side effects are usually
uskadelige og aftager ved fortsat behandling.
harmless and lessen as treatment continues.
Ikke almindelig bivirkning (det sker hos mellem 1 og 10 ud af 1. 000 patienter):
EMEA/ CHMP/ 116517/ 2006/ EN Uncommon effects: means that between 1 in 100 and 1 affected. - Rash
- Hududslæt.
© EMEA 2007
Meget sjælden bivirkning (det sker hos mindre end 1 ud af 10. 000 patienter):
Very rare: means that fewer than 1 in 10,000 people taking the medicine are affected.
- Overfølsomhedsreaktioner, fx kløe, hævelse (som regel i ansigtet, på læber, tunge eller i
- Signs of allergy, such as itching, swelling (usually of the face, lips, tongue or throat), difficulty
svælget), åndenød, hvæsen eller hoste (bronkospasme).
in breathing, wheezing or coughing (bronchospasm).
- Seretide kan påvirke den naturlige produktion af binyrebarkhormoner i kroppen, især efter
- Seretide may affect the normal production of steroid hormones in the body, particularly if you
indtagelse af høje doser over lang tid.
have taken high doses for long periods of time.
Virkningerne hos børn og unge er nedsat vækst, fald i knogletæthed, sløret syn, øget tryk i øjet, vægtforøgelse, højt blodtryk, rundt ansigt (” måneansigt ”) (Cushing’ s Syndrom).
The effects are slowing of growth in children and adolescents, thinning of the bones, cataract, glaucoma, weight gain, high blood pressure and rounded (moon shaped) face (Cushing’ s Syndrome).
Tal med lægen om det,
Tell your doctor, but do not stop
men hold ikke op med at tage Seretide uden samråd med lægen.
taking Seretide unless they tell you to do so.
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- Increases in the amount of sugar (glucose) in your blood (hyperglycaemia).
© EMEA 2007
If you have
Hvis du har diabetes, kan det være
diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
nødvendigt med hyppigere måling af dit blodsukker og eventuelt justering af din sædvanlige diabetesbehandling.
- Feeling anxious, disturbed sleep and behavioural changes, such as being unusually active and
- Uro, søvnforstyrrelse og ændret adfærd, herunder hyperaktivitet og irritabilitet (især hos børn).
irritable (mainly in children).
- Åndenød eller hvæsende vejrtrækning (bronkospasme) kan forværres umiddelbart efter du har
- Breathing difficulties or wheezing (bronchospasm) worsens immediately after taking Seretide.
- Led - og muskelsmerter.
- Aching, swollen joints and muscle pain.
Seretide indeholder
What Seretide contains
- De aktive stoffer er 50 mikrogram salmeterol som salmeterolxinafoat og 100, 250 eller 500
- The active substance(s) are 50 micrograms salmeterol (as xinafoate) and 100, 250 or 500
Fremstiller Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), EMEA/ CHMP/ 116517/ 2006/ DA
EMEA/ CHMP/ 116517/ 2006/ EN What Seretide looks like and contents of the pack
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Telefon +44 1920 463993 Fax +44 1920 864000
Tel: +44 (0)1920 463993 Fax: +44 (0)1920 864000
Østrig Belgien Danmark Finland Frankrig Tyskland Grækenland Irland Italien Luxembourg Nederlandene Portugal Spanien Sverige
Austria Belgium Denmark Finland France Germany Greece Ireland Italy Luxembourg The Netherlands Portugal Spain Sweden United Kingdom
Seretide Diskus Seretide Diskus Seretide Seretide Diskus Seretide Diskus Atmadisc Diskus Seretide Diskus Seretide Diskus Seretide Diskus Seretide Diskus Seretide Diskus Seretaide Diskus Seretide Accuhaler Seretide Diskus
Seretide Diskus Seretide Diskus Seretide Seretide Diskus Seretide Diskus atmadisc Diskus Seretide Diskus Seretide Diskus Seretide Diskus Seretide Diskus Seretide Diskus Seretaide Diskus Seretide Accuhaler Seretide Diskus Seretide Accuhaler
{MM/ ÅÅÅÅ}
[To be completed nationally]
Yderligere information om dette lægemiddel er tilgængelig på Lægemiddelstyrelsens hjemmeside: www. laegemiddelstyrelsen. dk ---------------------------------------------------------------------------------------------------------
< Detailed information on this medicine is available on the web site of {MA/Agency} >
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4. juli 2006 EMEA/ 306065/ 2006
4 July 2006 EMEA/ 306065/ 2006
1084/ 2003 FOR
SUMMARY INFORMATION ON REFERRAL OPINION PERSUANT TO ARTICLE 6(13) OF COMMISSSION REGULATION (EC) No 1084/ 2003 FOR
BAGGRUND Seretide Diskus og tilknyttede navne (se bilag I) indeholder salmeterol og fluticasonpropionat, som er en fastdosiskombination af den langtidsvirkende beta- agonist salmeterol og det inhalerede corticosteroid fluticasonpropionat, og er indiceret til standardbehandling af astma, når det er hensigtsmæssigt at anvende et kombinationsprodukt (langtidsvirkende beta- 2- agonist og inhaleret corticosteroid): - hos patienter, som ikke kan kontrolleres tilstrækkeligt med inhalerede corticosteroider og inhaleret korttidsvirkende beta- 2- agonist givet efter behov, eller - hos patienter, der allerede kontrolleres tilstrækkeligt med både inhaleret corticosteroid og langtidsvirkende beta- 2- agonist.
BACKGROUND INFORMATION Seretide Diskus and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β -agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘ as needed’ inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Seretide Diskus og tilknyttede navne er godkendt i en række EU- medlemsstater gennem proceduren for gensidig anerkendelse.
In several EU Member States Seretide Diskus and associated names are approved through the Mutual Recognition Procedure (MRP).
Indehaverne af markedsføringstilladelserne havde i juli 2004 indgivet ansøgning om en type II - ændring i henhold til proceduren for gensidig anerkendelse med henblik på at udvide indikationen til at omfatte initial vedligeholdelsesbehandling med fastdosiskombinationen for patienter med kronisk persisterende astma.
The Marketing Authorisation Holders submitted a type II variation subject to the MRP in July 2004 to extend the indication to include initial maintenance therapy with the fixed dose combination in patients with chronic persistent asthma.
Referencemedlemsstaten og de berørte medlemsstater afviste type II- ændringen med den begrundelse, at det samlede benefit/ risk- forhold var negativt for indikationen initial vedligeholdelsesbehandling.
The RMS and CMSs rejected the type II variation based on the grounds that the overall risk/ benefit was unfavourable for the initial maintenance therapy indication.
13, i Kommissionens forordning (EF) nr.
On 12 August 2005 the Marketing Authorisation Holders presented to the EMEA a referral under article 6(13) of Commission Regulation (EC) No 1084/ 2003.
Calvo Rojas.
The Rapporteur and Co-Rapporteur appointed were Dr D Lyons and Dr G Calvo Rojas, respectively.
På grundlag af vurderingen af de foreliggende oplysninger og vurderingsrapporterne fra rapportøren vedtog CHMP den 27. april 2006 en udtalelse, hvori det anbefalede godkendelse af ændringen af markedsføringstilladelserne med ændringer i produktresumé, etikettering og indlægsseddel.
Based on evaluation of the available data and the Rapporteur’ s assessment reports, the CHMP adopted an opinion on 27 April 2006 recommending the variation to the terms of the Marketing Authorisations with amendments to the Summary of Product Characteristics, Labelling and Package leaflet.
De faglige konklusioner findes i bilag II, og det ændrede produktresumé og den ændrede etikettering og indlægsseddel findes i bilag III.
The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics, Labelling and Package Leaflet in the Annex III.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa- Kommissionen den 4. juli 2006.
The final opinion was converted into a Decision by the European Commission on 4 July 2006.
Oplysningerne i dette dokument og bilagene afspejler udelukkende CHMP’ s udtalelse af 27. april 2006.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged *Note: the information given in this document and Annexes reflect only the CHMP Opinion dated 27 April 2006.
EMEA/ CHMP/ 123439/ 2006/ DA
EMEA/ CHMP/ 123439/ 2006/ EN
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Seretide forte Dosieraerosol
Seretide forte Dosieraerosol
Inhalationsspray, suspension.
Pressurised inhalation, suspension
Glaxo SmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Østrig
Glaxo SmithKline Pharma GmbH Albert Schweitzer Gasse 6 1140 Wien Austria
GlaxoSmithKline s. a. / n. v., Rue du Tilleul 13, B- 1332 Genval, Belgien
Rue du Tilleul 13 B-1332 Genval Belgium
GlaxoSmithKline Pharma A/ S, Nykær 68, DK- 2605 Brøndby, Danmark
GlaxoSmithKline Pharma A/ S Nykær 68 DK-2605 Brøndby Denmark
Finland
© EMEA 2007
Box 24, FIN- 02231 Espoo, Finland
Box 24 FIN-02231, Espoo Finland
Inhalationsspray, suspension.
Pressurised inhalation suspension
Tyskland Schwarz Pharma Deutschland
Germany Schwarz Pharma Deutschland GmbH Alfred-Nobel-Str.
atmadisc mite Dosier -
atmadisc mite Dosier- Aerosol FCKW-frei 25 µg/ 50 µg Druckgasinhalation, Suspension
Inhalationsspray,
Pressurised inhalation suspension
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Greece
Island GlaxoSmithKline ehf Thverholt 14, 105 Reykjavik, Island
GlaxoSmithKline ehf Thverholt 14, 105 Reykjavik Iceland
Allen & Hanbury) Stonemasons Way Rathfarnham Dublin 16 Island
GlaxoSmithKline (Ireland) Limited Stonemasons Way Rathfarnham, Dublin 16 Ireland
Allen & Hanbury) Stonemasons Way Rathfarnham Dublin 16 Irland
GlaxoSmithKline (Ireland) Limited Stonemasons Way Rathfarnham, Dublin 16 Ireland
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Allen & Hanbury) Stonemasons Way Rathfarnham Dublin 16 Irland
Ireland GlaxoSmithKline (Ireland) Limited Stonemasons Way Rathfarnham, Dublin 16 Ireland
250 Evohaler
250 Evohaler
Italien GlaxoSmithKline S. p. A.
Italy GlaxoSmithKline S. p. A.
Luxembourg GlaxoSmithKline s. a. / n. v., Rue du Tilleul 13, B- 1332 Genval, Belgien
Rue du Tilleul 13 B-1332 Genval Belgium
Portugal
EMEA 2007
Portugal Glaxo Wellcome Farmacêutica, Lda.
Portugal Glaxo Wellcome Farmacêutica, Lda.
Spanien GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760, Tres Cantos, Madrid, Spanien
Spain GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760 Tres Cantos, Madrid Spain
Seretide Evohaler mite
Seretide Evohaler mite
Seretide Evohaler forte
Seretide Evohaler forte
Nederlandene GlaxoSmithKline B. V.
GlaxoSmithKline B. V.
Huis ter Heideweg 62, 3705 LZ Zeist, Nederlandene
Huis ter Heideweg 62 3705 LZ Zeist The Netherlands
Seretide 25/ 50
Seretide
Seretide 25/ 125
Seretide
© EMEA 2007
The Netherlands
Det Forenede Glaxo Wellcome UK Limited, Kongerige trading as Allen & Hanburys Stockley Park West, Uxbridge, Middlesex UB11 1BT, Det Forenede Kongerige
United Kingdom Glaxo Wellcome UK Limited, Stockley Park West, Uxbridge Middlesex UB11 1BT United Kingdom
50 Evohaler
Seretide 50 Evohaler
125 Evohaler
Seretide 125 Evohaler
250 Evohaler
Seretide 250 Evohaler
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EMEA/ CHMP/ 123439/ 2006/ DA FAGLIGE KONKLUSIONER
EMEA/ CHMP/ 123439/ 2006/ EN SCIENTIFIC CONCLUSIONS
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Seretide Evohaler og tilknyttede navne (se bilag I til udtalelsen) indeholder salmeterol og fluticasonpropionat, som er en fastdosiskombination af den langtidsvirkende beta- agonist salmeterol og det inhalerede corticosteroid fluticasonpropionat, der er indiceret til standardbehandling af astma, når det er hensigtsmæssigt at anvende et kombinationsprodukt (langtidsvirkende beta- 2- agonist og inhaleret corticosteroid): - hos patienter, som ikke kan kontrolleres tilstrækkeligt med inhalerede corticosteroider og inhaleret korttidsvirkende beta- 2- agonist givet efter behov, eller - hos patienter, der allerede kontrolleres tilstrækkeligt med både inhaleret corticosteroid og langtidsvirkende beta- 2 - agonist.
Seretide Evohaler and associated names (see Annex I of Opinion) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β -agonist (LABA) salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate (FP) indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘ as needed’ inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long- acting beta-2-agonist.
Seretide Evohaler og tilknyttede navne (se bilag I) er godkendt i en række EU- medlemsstater gennem proceduren for gensidig anerkendelse.
In several EU Member States Seretide Evohaler and associated names (see Annex I) are approved through the Mutual Recognition Procedure (MRP).
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.
Patients with mild persistent asthma are not considered to be candidates for a combination therapy as IMT and patients with a more severe disease would deserve more intensive therapeutic approaches.
Patienter med mild persisterende astma betragtes ikke som egnede kandidater til kombinationsbehandling som initial
The primary endpoint in the GOAL study was the proportion of patients reaching asthma control (well-control of asthma).
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Den i afsnit 4. 2 indføjede anbefaling giver mulighed for kortvarig forsøgsvis brug af Seretide Evohaler 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 Evohaler in adults and adolescents with moderate persistent asthma for whom rapid control of asthma is essential.
Startdosis er 2 inhalationer af 25 mcg salmeterol/ 100 mcg fluticasonpropionat to gange dagligt.
The initial starting dose is 2 inhalations of 25 mcg salmeterol and 50 mcg FP twice daily.
1084/ 2003, for Seretide Evohaler 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 Evohaler and associated names (see Annex I)
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CHMP fandt det ikke berettiget at eksponere hele den tilsigtede målgruppe for beta - agonistrelaterede bivirkninger,
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 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,
• 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 Evohaler 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 Evohaler and associated names.
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EMEA/ CHMP/ 123439/ 2006/ DA 1.
EMEA/ CHMP/ 123439/ 2006/ EN 1.
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Seretide Evohaler og andre navne (se bilag I) 25/ 50 mikrogram/ dosis inhalationsspray Seretide Evohaler og andre navne (se bilag I) 25/ 125 mikrogram/ dosis inhalationsspray Seretide Evohaler og andre navne (se bilag I) 25/ 250 mikrogram/ dosis inhalationsspray
Seretide Evohaler and associated names (see Annex I) 25/ 250 microgram/ dose pressurised inhalation, suspension.
Hver dosis Seretide indeholder:
Each single actuation of Seretide provides:
44, 110 og 220 mikrogram fluticasonpropionat.
This is equivalent to 21 micrograms of salmeterol and 44, 110 or 220 micrograms of fluticasone propionate delivered from the actuator (delivered dose).
Astma Til behandling af astma, hvor behandling med et 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:
-
- or
hos patienter, der ikke er velkontrollerede på inhalationssteroid og korttidsvirkende ß2- agonist ved behov,
patients not adequately controlled with inhaled corticosteroids and ‘ as needed’ inhaled short acting beta-2-agonist
hos patienter, der allerede er velkontrollerede på både inhalationssteroid og langtidsvirkende ß2- agonist.
patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Kun til inhalation.
Seretide Evohaler is for inhalation use only.
Dosis skal titreres til laveste effektive dosis.
Patients should be regularly reassessed by a doctor, so that the strength of Seretide they are receiving remains optimal and is only changed on medical advice.
I så fald anbefales det, at patienter med natlige symptomer tager Seretide om aftenen, og patienter med symptomer om dagen tager Seretide om morgenen.
Where the control of symptoms is
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Patienterne skal have Seretide i den styrke fluticasonpropionat, der passer til sværhedsgraden af deres astma.
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.
Bemærk, at Seretide 25 mikg salmeterol og 50 mikg fluticasonpropionat er utilstrækkelig til voksne og børn med svær astma.
In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly day-time symptoms the dose should be given in the morning.
Lægen skal være opmærksom på, at hos astmapatienter er fluticasonpropionat dobbelt så effektivt som andre steroider til inhalation.
Seretide 25/ 50 microgram strength is not appropriate in adults and children with severe asthma.
Fx svarer 100 mikg fluticasonpropionat til ca.
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.
200 mikg beclometasondipropionat eller budesonid.
For example, 100mcg of fluticasone propionate is approximately equivalent to 200mcg of beclomethasone dipropionate (CFC containing) or budesonide.
- To pust (50 mikrogram salmeterol og 250 mikrogram fluticasonpropionat) to gange
Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily. or Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily. or Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
Her er den anbefalede dosis 50 mikrogram salmeterol og 100 mikrogram fluticasonpropionat 2 gange daglig.
In these cases, the recommended initial dose is two inhalations of 25 micrograms salmeterol and 50 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 25/ 50 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.
To pust (50 mikrogram salmeterol og 100 mikrogram fluticasonpropionat) to gange daglig.
Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily.
4. 4 ” Særlige advarsler og forsigtighedsregler vedrørende brugen ”).
EMEA/ CHMP/ 123439/ 2006/ EN
Specielle patientgrupper:
© EMEA 2007
Der er ingen oplysninger om brug af Seretide hos patienter med nedsat leverfunktion.
The use of a spacer device with the inhaler in order to derive greater therapeutic benefit is recommended for patients (in particular young children) who have difficulty co-ordinating inhalation with actuation (see section 4.4 Special Warnings and Precautions for use)
EMEA/ CHMP/ 123439/ 2006/ DA Brug af inhalationsspray
EMEA/ CHMP/ 123439/ 2006/ EN Special patient groups:
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Patienten skal instrueres godt i, hvordan sprayen pakningen.
There is no need to adjust the dose in elderly patients or in those with renal impairment.
skal bruges, som beskrevet i indlægssedlen
There are no data available for use of Seretide in patients with hepatic impairment.
i
Instructions for Use:
Patienten skal helst sidde eller stå op under inhalationen.
Patients should be instructed in the proper use of their inhaler (see patient information leaflet) During inhalation, the patient should preferably sit or stand.
Sprayen skal holdes lodret under inhalationen.
The inhaler has been designed for use in a vertical position.
På den måde sikres det, at den virker.
Before using for the first time patients should remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, and release puffs into the air until the counter reads 120 to make sure that it works.