natgillin/translations-raw huggingface dataset:
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
KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer Astma Til behandling af astma, hvor behandling med et kombinationsprodukt (langtidsvirkende ß2-agonist og inhalationssteroid) er hensigtsmæssig: - hos patienter, der ikke er velkontrollerede på inhalationssteroid og korttidsvirkende ß2-agonist ved behov,
CLINICAL PARTICULARS 4.1 Therapeutic indications Seretide is indicated in the regular treatment of asthma where use of a combination product (longacting 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.
Hver dosis Seretide indeholder:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each single actuation of Seretide provides:
Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelse <[Se bilag I - Udfyldes nationalt]>
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: [See Annex I - To be completed nationally]
Nederlandene GlaxoSmithKline B.V.
Belgium GlaxoSmithKline s.a./n.v.
GlaxoSmithKline Oy, Piispansilta 9A, P.O. Box 24, FIN-02231 Espoo, Finland
Box 24 FIN-02231, Espoo Finland
Beholderen skal trykkes ned i starten af en indånding gennem munden, og dosis inhaleres roligt og dybt.
Just after starting to breathe in through their mouth, patients should press down on the top of the inhaler to release Seretide, while still breathing in steadily and deeply.
**) Total kontrol blev defineret som: ingen symptomer, ingen brug af korttidsvirkende ß2-agonister (behovsmedicin), ≥ 80 % af forventet lungefunktion, ingen natlig opvågnen, ingen eksacerbationer og ingen bivirkninger, der førte til ændring i behandlingen.
No ICS (SABA alone) Low dose ICS ( ≤500mcg BDP or equivalent/day) Medium dose ICS (>500-1000mcg BDP or equivalent/day) Pooled results across the 3 treatment levels *Well controlled asthma; occasional symptoms or SABA use or less than 80% predicted lung function plus no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy **Total control of asthma; no symptoms, no SABA use, greater than or equal to 80% predicted lung function, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy.
Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc forte DosierAerosol FCKW-frei 25 µg/250 µg
D-40789 Monheim Germany atmadisc forte DosierAerosol FCKW-frei 25 µg/250 µg Druckgasinhalation, Suspension
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.
For at få kontrol over din astma skal du tage Seretide hver dag som anvist af din læge.
Therefore, it must be taken every day as directed by your doctor.
Seretide Evohaler og andre navne (se bilag I) 25/125 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
Seretide Evohaler and associated names (see Annex I) 25/125 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Seretide Evohaler og andre navne (se bilag I) 25/50 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
Seretide Evohaler and associated names (see Annex I) 25/50 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) Seretide Evohaler og andre navne (se bilag I) 25/125 mikrogram/dosis inhalationsspray {(sær)navn og tilhørende navne (Se bilag I) styrke lægemiddelform} [Se bilag I - Udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Seretide Evohaler and associated names (see Annex I) 25/125 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
Seretide Evohaler og andre navne (se bilag I) 25/250 mikrogram/dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
Seretide Evohaler and associated names (see Annex I) 25/250 microgram/dose pressurised inhalation, suspension [See Annex I - To be completed nationally]
For at opnå fuld effekt skal Seretide tages hver dag - også i perioder uden symptomer.
Patients should be made aware that Seretide Evohaler must be used daily for optimum benefit, even when asymptomatic.
ANVENDELSESMÅDE Omrystes.
INSTRUCTIONS ON USE
Seretide inhalationsspray er en suspension, som skal omrystes før brug.
Seretide is supplied to you in a metered dose inhaler which delivers your medicine in a pressurised suspension for you to inhale.
Patienten skal instrueres godt i, hvordan sprayen skal bruges, som beskrevet i indlægssedlen i pakningen.
Patients should be instructed in the proper use of their inhaler (see patient information leaflet) During inhalation, the patient should preferably sit or stand.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xiapex den 28. februar 2011.
The European Commission granted a marketing authorisation valid throughout the European Union for Xiapex on 28 February 2011.
Dette svækker og nedbryder strengen eller plakken.
This weakens and disrupts the cord or plaque.