natgillin/translations-raw huggingface dataset:
Hvis binyrebarkfunktionen er nedsat på grund af tidligere brug af systemiske steroider bør der især udvises forsigtighed ved igangsættelse af behandling med Viani.
The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time.
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.
Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk.
Det er derfor vigtigt, at patienten undersøges jævnligt, og at der reduceres til den laveste dosis inhalationssteroid, der giver astmakontrol.
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.
Det anbefales, at højden måles jævnligt på børn i langtidsbehandling med inhalerede kortikosteroider.
The extent of the adrenal impairment may require specialist advice before elective procedures.
Langtidsbehandling med høje doser inhaleret kortikosteroid kan resultere i nedsat binyrebarkfunktion og akut binyrebarkinsufficiens.
Ritonavir can greatly increase the concentration of fluticasone propionate in plasma.
Børn og unge under 16 år, der får høje doser fluticasonpropionat (typisk > 1000 mikg/ dag), er specielt i risikogruppen.
Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects.
I meget sjældne tilfælde er disse tilstande set ved doser på 500- 1000 mikg.
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 bør overvejes at lægge systemiske kortikosteroider oven i behandlingen i stressperioder eller i forbindelse med operation.
4.5 Interaction with other medicinal products and other forms of interaction
Da brugen af spacer sammen med inhalationssprayen kan øge mængden af det aktive stof i lungerne, kan det eventuelt føre til øget risiko for systemiske bivirkninger, idet den systemiske absorption hovedsageligt sker gennem lungerne.
Both non-selective and selective beta-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use.
Inhalationsbehandlingen med fluticasonpropionat bør minimere behovet for perorale steroider.
Concomitant use of other beta-adrenergic containing drugs can have a potentially additive effect.
Patienter, der har været i behandling med høje doser steroider, er i risiko for nedsat binyrebarkfunktion i længere tid.
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.
Denne risiko bør altid tages i betragtning i stresssituationer, herunder kirurgiske indgreb, og relevant steroiddosis vurderes, eventuelt med bistand fra specialist.
Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.
Ritonavir kan i høj grad øge plasmakoncentrationen af fluticasonpropionat.
In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg b. i. d. increased the fluticasone propionate plasma concentrations several hundred fold, resulting in markedly reduced serum cortisol concentrations.
Derfor skal samtidig brug undgås, med mindre fordelen for patienten opvejer risikoen for systemiske bivirkninger forårsaget af glukokortikoider.
Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected.
Der er også øget risiko for systemiske bivirkninger ved samtidig brug af fluticasonpropionat og andre potente CYP3A- hæmmere (se pkt.
Cases of Cushing’ s syndrome and adrenal suppression have been reported.
4. 5 ” Interaktion med andre lægemidler og andre former for interaktion ”).
The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
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%.
Både selektive og ikke- selektive ß- blokkere skal så vidt muligt undgås.
This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone.
15/ 41
18/ 44
Der er rapporter om tilfælde af Cushings syndrom og binyrebarksuppression.
propionate exposure and the risk of systemic side-effects.
Hyppigheden defineres således:
Adverse events which have been associated with salmeterol/ fluticasone propionate are given below, listed by system organ class and frequency.
Meget almindelig (> 1/ 10), almindelig (> 1/ 100 og < 1/ 10), ikke almindelig (> 1/ 1000 og < 1/ 100) og meget sjælden (< 1/ 10. 000, inklusive enkeltstående rapporter).
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 and < 1/ 10), uncommon (≥ 1/ 1000 and < 1/ 100), and very rare (< 1/ 10,000) including isolated reports.
Meget sjældne bivirkninger er generelt fundet fra indberetninger efter markedsføring.
Very rare events were derived from post- marketing spontaneous data.
EMEA/ CHMP/ 123448/ 2006/ DA
EMEA/ CHMP/ 123448/ 2006/ EN System Organ Class Adverse Event
16/ 41
19/ 44
Organklasse Infektioner og infestationer
Infections & Infestations
Bivirkning Candidiasis i mund og svælg
Candidiasis of the mouth and throat
Symptomatisk candidiasis kan behandles med topikale midler mod svamp samtidig med anvendelse af Viani.
Symptomatic candidiasis can be treated with topical anti- fungal therapy whilst still continuing with the Viani Evohaler.
EMEA/ CHMP/ 123448/ 2006/ DA 4. 9 Overdosering
EMEA/ CHMP/ 123448/ 2006/ EN
17/ 41
20/ 44
Der er ingen oplysninger om overdosering i de kliniske afprøvninger, men med de to stoffer givet hver for sig er der set følgende:
There have been very rare reports of hyperglycaemia (see 4.4 Special Warnings and Precautions for Use).
Tremor, hovedpine og takykardi.
As with other inhalation therapy, paradoxical bronchospasm may occur (see 4.4 Special Warnings and Precautions for Use).
Antidot:
4.9 Overdose
En kardioselektiv ß- blokker, som skal gives med forsigtighed til patienter med tidligere bronkospasme.
There are no data available from clinical trials on overdose with Viani, however data on overdose with both drugs are given below:
Hvis Viani skal seponeres på grund af overdosering af ß- agonist- delen, skal der tages højde for fortsat steroidbehandling.
The signs and symptoms of salmeterol overdose are tremor, headache and tachycardia.
Ligeledes kan der opstå hypokaliæmi, og kaliumtilskud skal overvejes.
The preferred antidotes are cardioselective beta-blocking agents, which should be used with caution in patients with a history of bronchospasm.
GOAL viste, at der var flere patienter i behandling med Viani, der opnåede astmakontrol, end i gruppen, der kun fik inhalationssteroid og med en mindre dosis inhalationssteroid..
GOAL showed more patients treated with Viani achieved asthma control than patients treated with ICS alone and this control was attained at a lower corticosteroid dose.
EMEA/ CHMP/ 123448/ 2006/ DA Afprøvningsresultater:
EMEA/ CHMP/ 123448/ 2006/ EN
18/ 41
21/ 44
71%
71% 41%
**) 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.
*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.
4. 2).
The results of this study suggest that Viani 50/ 100mcg bd may be considered as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is deemed essential (see section 4.2).
Derfor kan hvert stof betragtes for sig rent farmakokinetisk.
Salmeterol acts locally in the lung therefore plasma levels are not an indication of therapeutic effects.
EMEA/ CHMP/ 123448/ 2006/ DA Salmeterol:
EMEA/ CHMP/ 123448/ 2006/ EN Fluticasone propionate:
19/ 41
22/ 44
EMEA/ CHMP/ 123448/ 2006/ DA 6. 3 Opbevaringstid
EMEA/ CHMP/ 123448/ 2006/ EN 6.3 Shelf life
20/ 41
23/ 44
6. 4 Særlige opbevaringsforhold Må ikke opbevares over 25°C.
Do not store above 25°C.
1 x 120 doser 3 x 120 doser 10 x 120 doser (kun til hospitals - og apoteksbrug)
or 10 x 120 actuations Inhaler - hospital/ pharmacy use only (for dispensing purposes)
21/ 41
24/ 44
22/ 41
25/ 44
23/ 41
26/ 44
Viani Evohaler og andre navne (se bilag I) 25/ 50 mikrogram/ dosis inhalationsspray
Viani Evohaler and associated names (see Annex I) 25/ 50 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
ANVENDELSESMÅDE OG INDGIVELSESVEJ( E)
1 X 120 puffs
Omrystes.
3 X 120 puffs
ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
10 X 120 puffs (hospital or pharmacy use only)
Opbevares utilgængeligt for børn.
METHOD AND ROUTE(S) OF ADMINISTRATION
EVENTUELLE ANDRE SÆRLIGE ADVARSLER
Shake well before use
UDLØBSDATO
Read the package leaflet before use
Anvendes senest
Inhalation use
SÆRLIGE OPBEVARINGSBETINGELSER
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
[Udfyldes nationalt]
Keep out of the reach and sight of children
Må ikke opbevares over 25ºC EMEA/ CHMP/ 123448/ 2006/ DA
OTHER SPECIAL WARNING(S), IF NECESSARY
24/ 41
27/ 44
25/ 41
28/ 44
EMEA/ CHMP/ 123448/ 2006/ DA
EMEA/ CHMP/ 123448/ 2006/ EN PARTICULARS TO APPEAR ON THE OUTER PACKAGING
26/ 41
29/ 44
Viani Evohaler og andre navne (se bilag I) 25/ 125 mikrogram/ dosis inhalationsspray [Se bilag I - Udfyldes nationalt]
Viani Evohaler and associated names (see Annex I) 25/ 125 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
Må ikke opbevares over 25ºC
OTHER SPECIAL WARNING(S), IF NECESSARY
EMEA/ CHMP/ 123448/ 2006/ DA
EMEA/ CHMP/ 123448/ 2006/ EN 8.
27/ 41
30/ 44
28/ 41
31/ 44
Viani Evohaler og andre navne (se bilag I) 25/ 125 mikrogram/ dosis inhalationsspray
Viani Evohaler and associated names (see Annex I) 25/ 125 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
29/ 41
32/ 44
Viani Evohaler og andre navne (se bilag I) 25/ 250 mikrogram/ dosis inhalationsspray
Viani Evohaler and associated names (see Annex I) 25/ 250 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
< [Udfyldes nationalt] >
Norflurane (HFA 134a)
[Udfyldes nationalt]
OTHER SPECIAL WARNING(S), IF NECESSARY
Må ikke opbevares over 25ºC EMEA/ CHMP/ 123448/ 2006/ DA
EXPIRY DATE
30/ 41
33/ 44
31/ 41
34/ 44
32/ 41
35/ 44
33/ 41
36/ 44
Viani Evohaler og andre navne (se bilag I) 25/ 50 mikrogram/ dosis inhalationsspray Viani Evohaler og andre navne (se bilag I) 25/ 125 mikrogram/ dosis inhalationsspray Viani Evohaler og andre navne (se bilag I) 25/ 250 mikrogram/ dosis inhalationsspray
Viani Evohaler and associated names (see Annex I) 25/ 50 microgram/ dose pressurised inhalation, suspension Viani Evohaler and associated names (see Annex I) 25/ 125 microgram/ dose pressurised inhalation, suspension Viani Evohaler and associated names (see Annex I) 25/ 250 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
Inhalationssprayen forstøver væsken til meget små inhalérbare dråber.
Viani is supplied to you in a metered dose inhaler which delivers your medicine in a pressurised suspension for you to inhale.
Viani virker ikke på pludselige anfald af åndenød og hvæsende vejrtrækning, hvor du skal bruge den hurtigvirkende anfaldsmedicin, som du altid bør have på dig.
Therefore, it must be taken every day as directed by your doctor.
For at få kontrol over din astma skal du tage Viani hver dag som anvist af din læge.
Viani does not work in controlling sudden attacks of breathlessness and wheezing where you would need to use your fast acting ‘ rescue’ medication.
- hvis du lider af hjertesygdomme, herunder uregelmæssig eller hurtig hjertebanken, eller forøget
Do not take Viani If you are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate or to the other ingredient Norflurane (HFA 134a).
Så bør din læge overvåge din behandling tættere.
Take special care with Viani 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 (Viani may increase your blood sugar), low potassium in your blood or if you are being, or have been treated for have tuberculosis (TB).
34/ 41
37/ 44
Dosering Det er meget vigtigt, at du bruger Viani hver dag som anvist, indtil din læge fortæller dig andet.
Dosage It is very important that you take your Viani every day as directed, until you are advised to stop by your doctor.
Viani Evohaler må kun anvendes til inhalation.
Viani Evohaler is for inhalation by mouth only.
Viani 25/ 50 Evohaler To pust to gange daglig Viani 25/ 125 Evohaler To pust to gange daglig Viani 25/ 250 Evohaler To pust to gange daglig
Viani 25/ 50 Evohaler Viani 25/ 125 Evohaler Viani 25/ 250 Evohaler
Viani 25/ 50 Evohaler
Viani 25/ 50 Evohaler
Dette lægemiddel anbefales
This medicine if not recommended
ikke til børn under 4 år.
for use in children below 4 years of age.
EMEA/ CHMP/ 123448/ 2006/ DA Hvis du får åndenød, eller din hvæsende vejrtrækning
EMEA/ CHMP/ 123448/ 2006/ EN
35/ 41 bliver værre, efter brug af Viani, skal
38/ 44
© EMEA 2007 du straks
© EMEA 2007
holde op med at tage Viani og kontakte din læge, så din behandling kan blive taget op til revision.
The doctor will prescribe the lowest strength of Viani Evohaler that will best control your symptoms.
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 Viani.
If your symptoms are well controlled using Viani Evohaler twice daily, your doctor may decide to reduce your dose to once daily.
Kontakt din læge øjeblikkelig, så du bliver undersøgt og lægen kan finde ud af, hvilken medicin, du skal have.
This may be either once at night if you have night-time symptoms or once in the morning if you have daytime symptoms.
Vær opmærksom på ikke at forveksle Viani med din anfaldsmedicin.
A spacer device may be used to improve treatment with Viani 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.
Brugsanvisning Få lægen, sygeplejersken eller apoteket til at vise dig, hvordan du skal bruge din spray.
If you find it difficult to breathe or your wheezing gets worse after taking Viani, stop using it immediately and tell your doctor straightaway so they can assess your treatment.
Medicinen er i en trykbeholder i plastichylster med mundstykke.
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 Viani you take.
Beholderen er forsynet med en dosistæller, som viser, hvor mange doser, der er tilbage.
See your doctor immediately so they can review your condition and assess the medication you need to take.
Antal doser ses i et vindue i plastichylstret (dosistæller).
Do not use Viani to treat a sudden attack of breathlessness or wheezing as it will not help you immediately.
Klargøring Ryst sprayen, før du bruger den første gang.
You must use your fast acting ‘ rescue’ medicine (such as salbutamol) for this purpose which you should carry with you at all times.
Tag beskyttelseshætten af ved at klemme let om siderne
Be careful not to confuse your Viani inhaler with your ‘ rescue’ inhaler.
med tommel - og pegefinger og træk den af.
Instructions for proper use Your doctor, nurse or pharmacist should instruct you in the proper use of your inhaler.
Tryk nogle pust ud i luften, indtil dosistælleren står på 120, for at sikre, at den virker ordentligt.
The medicine is contained in a pressurised can in a plastic casing with a mouthpiece.
Dosistælleren tæller ned, hver gang du trykker et pust ud i luften.
The can has a counter attached to show you how many puffs of medicine are left.
Pas på ikke at tabe sprayen, det kan få dosistælleren til at tælle ned.
The number will show through a window at the back of the plastic casing.
Hvis sprayen ikke har været brugt i en uge eller mere, skal den gøres klar igen.
Testing the inhaler
Fjern beskyttelseshætten, ryst sprayen og tryk 2 pust ud i luften.
If using your inhaler for the first time, remove the mouthpiece cover by holding the sides of the inhaler with your thumb and forefinger.
Sådan bruger du din spray
Gently squeeze the sides of the cover and pull apart.
Det er vigtigt at begynde med så rolig en indånding som muligt før du tager din medicin.
Each time the can is pressed, a puff of medicine is released and the counter will count down by one.
36/ 41
39/ 44
Sæt mundstykket mellem tænderne og lad læberne slutte tæt omkring det uden at bide i det.
Do not
6.
bite it.
37/ 41
40/ 44
Hold vejret i 5- 10 sekunder og fjern sprayen fra munden.
Just after starting to breathe in through your mouth, press down on the top of the can to release a puff while still breathing in steadily and deeply.
Skyl munden med vand og spyt ud - eller børst tænder - for at modvirke svamp og hæshed.
Continue holding your breath for a few seconds, or as long as is comfortable.
Gentag punkt 3- 8, hvis lægen har ordineret 2 pust.
Rinse your mouth with water and spit it out as this may help prevent the occurrence of thrush and hoarseness.
Ryst sprayen før hvert pust og vent ½ minut mellem hvert pust.
If your doctor has told you to take two puffs, wait about half a minute before you take another puff by repeating steps 3 to 8.
Når dosistælleren viser 20, bør du købe en ny spray.
You should get a replacement when the counter shows the number 020.
Når dosistælleren står på 0, er den tom.
Stop using the inhaler when the counter reads 000.
Rengøring af sprayen Sørg for rengøring af din spray mindst 1 gang om ugen for at undgå tilstopning.
To clean your inhaler:
- Fjern aldrig metalbeholderen fra plastichylstret.
- Do not remove the metal can from the plastic casing during cleaning or at any other time.
- Sæt beskyttelseshætten på igen.
- Replace the mouthpiece cover.
EMEA/ CHMP/ 123448/ 2006/ DA Hvis du tager mere Viani end du bør
EMEA/ CHMP/ 123448/ 2006/ EN
38/ 41
41/ 44
Hvis du ved en fejltagelse kommer til at tage en for stor dosis, kan du få bivirkninger som hurtigere hjertebanken end sædvanligt, rysten, hovedpine, muskeltræthed, ømme led og nedsat produktion af binyrebarkhormoner.
These effects usually wear off with continued treatment, however, if you have used larger doses for a long period of time, you should contact your doctor or pharmacist for advice.
Du må ikke stoppe behandlingen med Viani pludseligt, da dette kan forværre dine symptomer og give problemer med kroppens hormoner.
Do not stop taking Viani suddenly as this could make your asthma worse and could cause problems with the body’ s hormones.
Ikke almindelig bivirkning (det sker hos mellem 1 og 10 ud af 1. 000 patienter):
Uncommon effects: means that between 1 in 100 and 1 in 1000 people taking the medicine are affected.
- Hududslæt.
- Rash
- Meget hurtig puls (takykardi).
Very fast heart rate (tachycardia).
39/ 41
42/ 44
Hvis du har diabetes, kan det være
If you have
nødvendigt med hyppigere måling af dit blodsukker og eventuelt justering af din sædvanlige diabetesbehandling.
diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
- Uro, søvnforstyrrelse og ændret adfærd, herunder hyperaktivitet og irritabilitet (især hos børn).
- Feeling anxious, disturbed sleep and behavioural changes, such as being unusually active and
- Åndenød eller hvæsende vejrtrækning (bronkospasme) kan forværres umiddelbart efter du har
irritable (mainly in children).
taget Viani.
- Breathing difficulties or wheezing (bronchospasm) worsens immediately after taking Viani.
Metalbeholderen må ikke punkteres eller brændes, heller ikke når den er tømt.
Do not puncture, break or burn it even if you think it is empty.
- De aktive stoffer er 25 mikrogram salmeterol som salmeterolxinafoat og 50, 125 eller 250
- The active substance(s) are 25 micrograms salmeterol (as xinafoate) and 50, 125 or 250
Produktets udseende og pakningstørrelse
What Viani looks like and contents of the pack
Medicinen leveres i æsker med:
The devices are packed in cartons of 1, 3 or 10 Evohalers.
1, 3 eller 10 x Evohaler.
Not all pack sizes may be marketed.
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
[See Annex I - To be completed nationally]
EMEA/ CHMP/ 123448/ 2006/ DA
EMEA/ CHMP/ 123448/ 2006/ EN Manufacturer:
40/ 41
43/ 44
Indehaveren af markedsføringstilladelsen og fremstiller
Zone Industrielle No.2, 23 Rue Lavoisier, la madeleine, 27000 Evreux, France.
Østrig Belgien Finland Frankrig Tyskland Irland Italien Luxembourg Portugal Spanien Sverige
Austria Belgium Finland France Germany Ireland Italy Luxembourg Portugal Spain Sweden United Kingdom
Viani Dosieraerosol Viani Viani Evohaler Viani Viani Viani Evohaler Aliflus Viani Veraspir Inalador Brisair Viani Evohaler
Viani Dosieraerosol Viani Viani Evohaler Viani Viani Viani Evohaler Aliflus Viani Veraspir Inalador Brisair Viani Evohaler Viani Evohaler
41/ 41
44/ 44
4. juli 2006 EMEA/ 306455/ 2006
4 July 2006 EMEA/ 306455/ 2006
BAGGRUND Viani Evohaler 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 Viani Evohaler 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.
Viani Evohaler og tilknyttede navne er godkendt i en række EU- medlemsstater gennem proceduren for gensidig anerkendelse.
In several EU Member States Viani Evohaler and associated names are approved through the Mutual Recognition Procedure (MRP).
London, den 29. maj 2007 Ref. dok.
London, 29 May 2007 Doc. Ref.
EMEA/ CHMP/ 275055/ 2007
EMEA/ 144030/ 2007
UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 30 OM Xefo og tilknyttede navne Internationalt fællesnavn (INN): lornoxicam
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Xefo and associated names International Non-Proprietary Name (INN): lornoxicam