natgillin/translations-raw huggingface dataset:
Hver depottablet indeholder 12 mg paliperidon. 
Each prolonged-release tablet contains 12 mg of paliperidone.
- Beholdere: Tabletterne udleveres i en plastbeholder med børnesikret låg. 
- Bottles: The tablets are supplied in a plastic bottle with a child-resistant plastic cap. Each bottle contains either 30 tablets or 350 tablets.
Hver INVEGA 3 mg depottablet indeholder 3 mg paliperidon. 
Each INVEGA 3 mg prolonged-release tablet contains 3 mg of paliperidone.
Pulmonal kongestion 
• lung congestion
Abstinenssyndrom c, induration 
ischaemia, flushing
Natriumindhold 
Printing ink
Hver depottablet indeholder 3 mg paliperidon. 
Each prolonged-release tablet contains 3 mg of paliperidone.
Sådan skal du tage INVEGA 
How to take INVEGA
30 depottabletter - EU/1/07/395/057 350 depottabletter - EU/1/07/395/058 
30 prolonged-release tablets - EU/1/07/395/057 350 prolonged-release tablets - EU/1/07/395/058
Hver depottablet indeholder 6 mg paliperidon. 
Each prolonged-release tablet contains 6 mg of paliperidone.
30 depottabletter - EU/1/07/395/063 350 depottabletter - EU/1/07/395/064 
30 prolonged-release tablets - EU/1/07/395/063 350 prolonged-release tablets - EU/1/07/395/064
bevidsthedstab, nedsat bevidsthedsniveau c, diabetisk koma c, balanceforstyrrelse, unormal koordination, rytmisk rokkebevægelse af hovedet 
diabetic coma balance disorder, coordination abnormal, head titubation
30 depottabletter - EU/1/07/395/061 350 depottabletter - EU/1/07/395/062 
30 prolonged-release tablets - EU/1/07/395/061 350 prolonged-release tablets - EU/1/07/395/062
Forhøjet kreatinkinase i blodet, muskelspasmer, stivhed i leddene, hævede led, muskelsvaghed, nakkesmerter 
Musculoskelet al and connective tissue disorders musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, muscle spasms, joint stiffness, joint swelling, muscular weakness, neck pain rhabdomyolysis c, posture abnormal
Blodpropper kan løsrives og føres med blodet til lungerne, hvor de kan forårsage brystsmerter og åndedrætsbesvær. 
• blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
30 depottabletter - EU/1/07/395/059 350 depottabletter - EU/1/07/395/060 
30 prolonged-release tablets - EU/1/07/395/059 350 prolonged-release tablets - EU/1/07/395/060
P-værdi (vs. aripiprazol) 
EXP MM/YYYY
Blæk: 
Printing ink:
14 depottabletter - EU/1/07/395/074 - KLARE 28 depottabletter - EU/1/07/395/016 - KLARE 30 depottabletter - EU/1/07/395/017 - KLARE 49 depottabletter - EU/1/07/395/018 - KLARE 56 depottabletter - EU/1/07/395/019- KLARE 98 depottabletter - EU/1/07/395/020- KLARE 
14 prolonged-release tablets - EU/1/07/395/074 - CLEAR 28 prolonged-release tablets - EU/1/07/395/016 - CLEAR 30 prolonged-release tablets - EU/1/07/395/017 - CLEAR 49 prolonged-release tablets - EU/1/07/395/018 - CLEAR 56 prolonged-release tablets - EU/1/07/395/019 - CLEAR 98 prolonged-release tablets - EU/1/07/395/020 - CLEAR
Tabletkerne: 
Bottles:
14 depottabletter - EU/1/07/395/070 28 depottabletter - EU/1/07/395/045 49 depottabletter - EU/1/07/395/046 56 depottabletter - EU/1/07/395/047 98 depottabletter - EU/1/07/395/048 
14 prolonged-release tablets - EU/1/07/395/070 28 prolonged-release tablets - EU/1/07/395/045 49 prolonged-release tablets - EU/1/07/395/046 56 prolonged-release tablets - EU/1/07/395/047 98 prolonged-release tablets - EU/1/07/395/048
• betændelse i bugspytkirtlen 
• inflammation of the pancreas
Bronkitis, infektioner i øvre luftveje, sinusitis, urinvejsinfektion, influenza 
Infections and infestations bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, influenza pneumonia, respiratory tract infection, cystitis, ear infection, tonsillitis eye infection, onychomycosis, cellulitis, acarodermatitis
14 depottabletter - EU/1/07/395/071 - KLARE 28 depottabletter - EU/1/07/395/011 - KLARE 30 depottabletter - EU/1/07/395/012 - KLARE 49 depottabletter - EU/1/07/395/013 - KLARE 56 depottabletter - EU/1/07/395/014- KLARE 98 depottabletter - EU/1/07/395/015- KLARE 
14 prolonged-release tablets - EU/1/07/395/071 - CLEAR 28 prolonged-release tablets - EU/1/07/395/011 - CLEAR 30 prolonged-release tablets - EU/1/07/395/012 - CLEAR 49 prolonged-release tablets - EU/1/07/395/013 - CLEAR 56 prolonged-release tablets - EU/1/07/395/014 - CLEAR 98 prolonged-release tablets - EU/1/07/395/015 - CLEAR
14 depottabletter - EU/1/07/395/075 - HVIDE 28 depottabletter - EU/1/07/395/036- HVIDE 30 depottabletter - EU/1/07/395/037 - HVIDE 49 depottabletter - EU/1/07/395/038- HVIDE 56 depottabletter - EU/1/07/395/039 - HVIDE 98 depottabletter - EU/1/07/395/040 - HVIDE 
14 prolonged-release tablets - EU/1/07/395/075 - WHITE 28 prolonged-release tablets - EU/1/07/395/036 - WHITE 30 prolonged-release tablets - EU/1/07/395/037 - WHITE 49 prolonged-release tablets - EU/1/07/395/038 - WHITE 56 prolonged-release tablets - EU/1/07/395/039 - WHITE 98 prolonged-release tablets - EU/1/07/395/040 - WHITE
14 depottabletter - EU/1/07/395/066 - HVIDE 28 depottabletter - EU/1/07/395/021- HVIDE 30 depottabletter - EU/1/07/395/022 - HVIDE 49 depottabletter - EU/1/07/395/023- HVIDE 56 depottabletter - EU/1/07/395/024 - HVIDE 98 depottabletter - EU/1/07/395/025 - HVIDE 
14 prolonged-release tablets - EU/1/07/395/066 - WHITE 28 prolonged-release tablets - EU/1/07/395/021 - WHITE 30 prolonged-release tablets - EU/1/07/395/022 - WHITE 49 prolonged-release tablets - EU/1/07/395/023 - WHITE 56 prolonged-release tablets - EU/1/07/395/024 - WHITE 98 prolonged-release tablets - EU/1/07/395/025 - WHITE
14 depottabletter - EU/1/07/395/076 28 depottabletter - EU/1/07/395/053 49 depottabletter - EU/1/07/395/054 56 depottabletter - EU/1/07/395/055 98 depottabletter - EU/1/07/395/056 
14 prolonged-release tablets - EU/1/07/395/076 28 prolonged-release tablets - EU/1/07/395/053 49 prolonged-release tablets - EU/1/07/395/054 56 prolonged-release tablets - EU/1/07/395/055 98 prolonged-release tablets - EU/1/07/395/056
synkope, psykomotorisk hyperaktivitet, postural svimmelhed, opmærksomhedforstyrrelse, dysartri, dysgeusi, hypæstesi, paræstesi 
Respiratory, thoracic and mediastinal disorders pharyngolarynge al pain, cough, nasal congestion dyspnoea, wheezing, epistaxis sleep apnoea syndrome, hyperventilation, pneumonia aspiration, respiratory tract congestion, dysphonia pulmonary congestion
14 depottabletter - EU/1/07/395/067 28 depottabletter - EU/1/07/395/041 49 depottabletter - EU/1/07/395/042 56 depottabletter - EU/1/07/395/043 98 depottabletter - EU/1/07/395/044 
14 prolonged-release tablets - EU/1/07/395/067 28 prolonged-release tablets - EU/1/07/395/041 49 prolonged-release tablets - EU/1/07/395/042 56 prolonged-release tablets - EU/1/07/395/043 98 prolonged-release tablets - EU/1/07/395/044
14 depottabletter - EU/1/07/395/073 28 depottabletter - EU/1/07/395/049 49 depottabletter - EU/1/07/395/050 56 depottabletter - EU/1/07/395/051 98 depottabletter - EU/1/07/395/052 
14 prolonged-release tablets - EU/1/07/395/073 28 prolonged-release tablets - EU/1/07/395/049 49 prolonged-release tablets - EU/1/07/395/050 56 prolonged-release tablets - EU/1/07/395/051 98 prolonged-release tablets - EU/1/07/395/052
14 depottabletter - EU/1/07/395/065 - KLARE 28 depottabletter - EU/1/07/395/001 - KLARE 30 depottabletter - EU/1/07/395/002- KLARE 49 depottabletter - EU/1/07/395/003- KLARE 56 depottabletter - EU/1/07/395/004- KLARE 98 depottabletter - EU/1/07/395/005- KLARE 
14 prolonged-release tablets - EU/1/07/395/065 - CLEAR 28 prolonged-release tablets - EU/1/07/395/001 - CLEAR 30 prolonged-release tablets - EU/1/07/395/002 - CLEAR 49 prolonged-release tablets - EU/1/07/395/003 - CLEAR 56 prolonged-release tablets - EU/1/07/395/004 - CLEAR 98 prolonged-release tablets - EU/1/07/395/005 - CLEAR
• hvis du har sukkersyge (diabetes) eller har øget risiko for at få sukkersyge. 
- if you are diabetic or prone to diabetes.
Nedsat leukocyttal, trombocytopeni, anæmi, nedsat hæmatokrit 
Blood and lymphatic system disorders white blood cell count decreased, thrombocytopenia, anaemia, haematocrit decreased agranulocytosis c,
Søvnløshed e Mani, agitation, depression, angst 
Psychiatric disorders insomnia mania, agitation,
Ansigtsødem, ødem e, kulderystelser, forhøjet kropstemperatur, unormal gang, tørst, brystsmerter, ubehag i brystet, utilpashed 
General disorders pyrexia, asthenia, fatigue face oedema, oedema e, chills, body temperature increased, gait abnormal, thirst, chest pain, chest discomfort, malaise hypothermia c, body temperature decreased c, drug withdrawal syndrome induration
14 depottabletter - EU/1/07/395/072 - HVIDE 28 depottabletter - EU/1/07/395/031- HVIDE 30 depottabletter - EU/1/07/395/032 - HVIDE 49 depottabletter - EU/1/07/395/033- HVIDE 56 depottabletter - EU/1/07/395/034 - HVIDE 98 depottabletter - EU/1/07/395/035 - HVIDE 
14 prolonged-release tablets - EU/1/07/395/072 - WHITE 28 prolonged-release tablets - EU/1/07/395/031 - WHITE 30 prolonged-release tablets - EU/1/07/395/032 - WHITE 49 prolonged-release tablets - EU/1/07/395/033 - WHITE 56 prolonged-release tablets - EU/1/07/395/034 - WHITE 98 prolonged-release tablets - EU/1/07/395/035 - WHITE
14 depottabletter - EU/1/07/395/068 - KLARE 28 depottabletter - EU/1/07/395/006 - KLARE 30 depottabletter - EU/1/07/395/007- KLARE 49 depottabletter - EU/1/07/395/008- KLARE 56 depottabletter - EU/1/07/395/009- KLARE 98 depottabletter - EU/1/07/395/010- KLARE 
14 prolonged-release tablets - EU/1/07/395/068 - CLEAR 28 prolonged-release tablets - EU/1/07/395/006 - CLEAR 30 prolonged-release tablets - EU/1/07/395/007 - CLEAR 49 prolonged-release tablets - EU/1/07/395/008 - CLEAR 56 prolonged-release tablets - EU/1/07/395/009 - CLEAR 98 prolonged-release tablets - EU/1/07/395/010 - CLEAR
Butylhydroxytoluen (E321) Polyethylenoxid 7000K Jernoxid (rød) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat 
Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
unormal kropsholdning 
Hepatic impairment
Diabetes mellitus d, hyperglykæmi, øget livvidde, anoreksi, forhøjede triglycerider i blodet 
Hepatobiliary disorders transaminases increased gamma-glutamyltran sferase increased, hepatic enzyme increased jaundice
Butylhydroxytoluen (E321) Jernoxid (gul) (E172) Polyethylenoxid 7000K Jernoxid (rød) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat 
Butyl hydroxytoluene (E321) Ferric oxide (yellow) (E172) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Hydroxyethylcellulose 
hyperglycaemia,
Butylhydroxytoluen (E321) Polyethylenoxid 7000K Jernoxid (rød) (E172) Jernoxid (gul) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat 
Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Ferric oxide (yellow) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Vægtøgning, øget appetit, vægttab, nedsat appetit 
Metabolism and nutrition disorders weight increased, increased appetite, weight decreased, decreased appetite diabetes mellitus d,
INVEGA indeholder: 
What is in this leaflet:
Butylhydroxytoluen (E321) Polyethylenoxid 7000K Jernoxid (rød) (E172) Jernoxid (sort) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat 
Butyl hydroxytoluene (E321) Polyethylene oxide 7000K Ferric oxide (red) (E172) Iron oxide (black) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Anafylaktisk reaktion, overfølsomhed 
hypersensitivity
Gennemsnitlig ændring (SD) P-værdi (vs. placebo) Forskel i gennemsnitlig LS (= least squares) (SE) 
Change in PANSS Score Mean baseline (SD) Mean change (SD) P-value (vs Placebo) Diff. of LS Means (SE) Responder Analysis Responder, n (%) Non-responder, n (%) P value (vs Placebo)
De foreliggende data er beskrevet i pkt. 
This leaflet was last revised in
• knogle- eller muskelsmerter, rygsmerter, ledsmerter 
• bone or muscle ache, back pain, joint pain
Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, indgivelsesvej, indehavere af markedsføringstilladelser i medlemsstaterne 
Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti 
Bucureşti-Ploieşti Nr. 1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti Romania
Quinta da Fonte, 19 Edifício Vasco da Gama 2770-192 Paço de Arcos Portugal 
Edifício Vasco da Gama 2770-192 Paço de Arcos Portugal
174 56 Alimos 
174 56 Alimos Greece
0,05% w/w mometason-furoat (monohydrat) beregnet som vandfrit stof 
0.05% w/w Mometasone furoate (monohydrate) calculated on the anhydrous basis
Grækenland Merck Sharp & Dohme S.A. Ag. Dimitriou 63 
Merck Sharp & Dohme S.A. Ag. Dimitriou 63
Rumænien MERCK SHARP & DOHME ROMANIA S.R.L. 
MERCK SHARP & DOHME ROMANIA S.R.L.
Storbritannien Merck Sharp & Dohme Ltd Hertford Road 
Merck Sharp & Dohme Ltd Hertford Road Hoddesdon
I proceduren for gensidig anerkendelse er Det Forenede Kongerige referencemedlemsstaten, og Østrig, Belgien, Danmark, Finland, Frankrig, Grækenland, Tyskland, Italien, Irland, Island, Luxembourg, Nederlandene, Portugal, Spanien og Sverige er de berørte medlemsstater. 
In the MRP the United Kingdom is the Reference Member State and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Iceland, Luxembourg, The Netherlands, Portugal, Spain and Sweden are Concerned Member States.
15232 Halandri, Athens, Grækenland 
15232 Halandri, Athens Greece
Anvend ikke Seretide efter den udløbsdato, som er angivet på pakningen. 
Do not use Seretide after the expiry date which is stated on the label and carton.
To pust to gange daglig 
Two puffs twice a day
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF SERETIDE EVOHALER OG TILKNYTTEDE NAVNE (SE BILAG I) 
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SERETIDE EVOHALER AND ASSOCIATED NAMES (SEE ANNEX I)
• CPMP behandlede den indbringelse, der havde fundet sted i henhold til artikel 6, stk. 13, i Kommissionens forordning (EF) nr. 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)
Behandling med Seretide bør ikke seponeres pludseligt. 
Treatment with Seretide should not be stopped abruptly.
Bemærk: 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. 
Note: 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.
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).
Hvis dine symptomer er velkontrollerede på Seretide Evohaler to gange daglig, kan din læge forsøge at nedsætte dosis til en gang daglig. 
If your symptoms are well controlled using Seretide Evohaler twice daily, your doctor may decide to reduce your dose to once daily.
Zone Industrielle No 2, 23 rue Lavoisier, La Madeleine 27000 Evreux, Frankrig 
Zone Industrielle No.2, 23 Rue Lavoisier, la madeleine, 27000 Evreux, France.
Voksne og unge fra 12 år 
Adults and adolescents 12 years and older:
Hvis din astma forværres eller er ikke er velkontrolleret (hvis din vejrtrækning er hvæsende, og du har brug for mere anfaldsmedicin), skal du ikke øge antallet af inhalationer af Seretide. 
If your asthma gets worse or is not well controlled (you will feel wheezy and need more of your fast acting ‘rescue' medicine), do not increase the number of puffs of Seretide you take.
Seretide Evohaler må kun anvendes til inhalation. 
Seretide Evohaler is for inhalation use only.
BATCHNUMMER Batch no 
BATCH NUMBER
Børn fra 4 til 12 år Seretide 25/50 Evohaler 
Children 4 to 12 years of age Seretide 25/50 Evohaler
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 asthma worse and could cause problems with the body's hormones.
Der er ikke lavet undersøgelser med Seretide inhalationsspray til børn under 4 år. 
There are no data available for use of Seretide inhaler in children aged under 4 years.
Glaxo Wellcome UK Limited, 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
Velkontrolleret astma blev opnået hurtigere med Seretide end med inhalationssteroid alene. 
Well-Controlled asthma was achieved more rapidly with Seretide than with ICS alone.
Seretide 50/100 mikrogram er uegnet til voksne og børn med alvorlig astma. 
Note: Seretide 25/50 microgram strength is not appropriate in adults and children with severe asthma.
Til små børn kan Seretide inhalationsspray bruges i en såkaldt spacer, det kan især være gavnligt, hvis du eller dit barn har svært ved at koordinere inhalationen med samtidig at skulle afgive et pust fra sprayen. 
A spacer device may be used to improve treatment with Seretide particularly with young children, if you or your child has difficultly co-ordinating breathing in through your mouth and pressing the can to release a puff at the same time.
Symptomatisk candidiasis kan behandles med topikale midler mod svamp samtidig med anvendelse af Seretide. 
Symptomatic candidiasis can be treated with topical antifungal therapy whilst still continuing with the Seretide Evohaler.
Den maksimale godkendte dosis fluticasonpropionat i Seretide spray til børn er 100 mikrogram to gange dagligt. 
The maximum licensed dose of fluticasone propionate delivered by Seretide inhaler in children is 100mcg twice daily.
Trykbeholder. 
Pressurised container.
• 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.
Det er meget vigtigt, at du bruger Seretide hver dag som anvist, indtil din læge fortæller dig andet. 
It is very important that you take your Seretide every day as directed, until you are advised to stop by your doctor.
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-2agonist. 
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 longacting beta-2-agonist.
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.
I så fald skal Seretide straks seponeres, patienten undersøges, og om nødvendigt gives anden behandling. 
Seretide Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
CHMP fandt det ikke berettiget at eksponere hele den tilsigtede målgruppe for betaagonistrelaterede bivirkninger, 
CHMP considered it not acceptable to expose the whole target population to beta-agonists related adverse events.
Glaxo SmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Østrig 
Glaxo SmithKline Pharma GmbH Albert Schweitzer Gasse 6 1140 Wien
Din læge vil bestræbe sig på at ordinere den laveste dosis Seretide Evohaler, som kan holde dine symptomer under kontrol. 
The doctor will prescribe the lowest strength of Seretide Evohaler that will best control your symptoms.
Du bør ikke anvende Seretide - hvis du lider af hjertesygdomme, herunder uregelmæssig eller hurtig hjertebanken, eller forøget hormonproduktion fra skjoldbruskkirtlen, forhøjet blodtryk, sukkersyge (Seretide kan forhøje dit blodsukker), lavt indhold af kalium i blodet, eller hvis du er eller har været i behandling for tuberkulose (tb). 
Your doctor will supervise your treatment more closely if you have medical conditions such as heart disease including an irregular or fast heart beat, overactive thyroid gland, high blood pressure, diabetes mellitus (Seretide may increase your blood sugar), low potassium in your blood or if you are being, or have been treated for have tuberculosis (TB).
Seretide indeholder - De aktive stoffer er 25 mikrogram salmeterol som salmeterolxinafoat og 50, 125 eller 250 
What Seretide contains - The active substance(s) are 25 micrograms salmeterol (as xinafoate) and 50, 125 or 250
Seretide må ikke opbevares koldt, da det kan forringe virkningen af medicinen. 
Do not store Seretide Evohaler in a cold place, as your medicine may not work as well.
Der gik 16 dage med behandling med Seretide, før 50% af patienterne opnåede velkontrolleret astma i sammenligning med 37 dage for den gruppe, der fik inhalationssteroid alene. 
The time on treatment for 50% of subjects to achieve a first individual Well-Controlled week was 16 days for Seretide compared to 37 days for the ICS group.
Huis ter Heideweg 62, 3705 LZ Zeist, Nederlandene 
3705 LZ Zeist
Luxembourg GlaxoSmithKline s.a./n.v., Rue du Tilleul 13, B-1332 Genval, Belgien 
Belgium GlaxoSmithKline s.a./n.v., Rue du Tilleul 13
Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc mite DosierAerosol FCKW-frei 25 µg/50 µg Druckgasinhalation, Suspension 
D-40789 Monheim Germany atmadisc mite DosierAerosol FCKW-frei 25 µg/50 µg Druckgasinhalation, Suspension
- Det øvrige indholdsstof er norfluran. 
- The other ingredient is Norflurane (HFA 134a).
Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc Dosier-Aerosol FCKW-frei 25 µg/125 µg Druckgasinhalation, Suspension 
D-40789 Monheim Germany atmadisc Dosier-Aerosol FCKW-frei 25 µg/125 µg Druckgasinhalation, Suspension
ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Læs indlægssedlen inden brug. 
METHOD AND ROUTE(S) OF ADMINISTRATION Shake well before use