natgillin/translations-raw huggingface dataset:
Pressurised inhalation suspension
Inhalacijska suspenzija pod tlakom.
Germany Schwarz Pharma Deutschland GmbH Alfred-Nobel-Str.
Nemčija Schwarz Pharma Deutschland GmbH
EMEA/ CHMP/ 123439/ 2006/ EN
10 D- 40789 Monheim, Nemčija
10 D-40789 Monheim Germany
10 D- 40789 Monheim, Nemčija
GlaxoSmithKline (Ireland) Limited Stonemasons Way Rathfarnham, Dublin 16 Ireland
Allen & Hanbury) Stonemasons Way Rathfarnham Dublin 16 Irska
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Irska
Ireland GlaxoSmithKline (Ireland) Limited Stonemasons Way Rathfarnham, Dublin 16 Ireland
Allen & Hanbury) Stonemasons Way Rathfarnham Dublin 16 Irska
Italy GlaxoSmithKline S. p. A.
Italija GlaxoSmithKline S. p. A.
Rue du Tilleul 13 B-1332 Genval Belgium
Luksemburg GlaxoSmithKline s. a. / n. v., Rue du Tilleul 13, B- 1332 Genval, Belgija
EMEA 2007
Portugalska
Spain GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760, Tres Cantos, Madrid Spain
GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760, Tres Cantos, Madrid, Španija
Spain GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760 Tres Cantos, Madrid Spain
GlaxoSmithKline SA Parque Tecnologico de Madrid, Calle Severo Ochoa 2, 28760, Tres Cantos, Madrid, Španija
Sweden GlaxoSmithKline AB Box 516, SE-169 29 Solna Sweden
GlaxoSmithKline AB Box 516, SE- 169 29 Solna Švedska
© EMEA 2007
Nizozemska
Huis ter Heideweg 62 3705 LZ Zeist The Netherlands
Huis ter Heideweg 62, 3705 LZ Zeist, Nizozemska
United Kingdom Glaxo Wellcome UK Limited, Stockley Park West, Uxbridge Middlesex UB11 1BT United Kingdom
Velika Britanija Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West, Uxbridge, Middlesex UB11 1BT, Velika Britanija
GROUNDS FOR AMENDMENT OF THE SUMMARY
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
EMEA/ CHMP/ 123439/ 2006/ EN SCIENTIFIC CONCLUSIONS
EMEA/ CHMP/ 123439/ 2006/ SL ZNANSTVENI ZAKLJUČKI
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.
Zdravilo Seretide Evohaler in z njim povezana imena (glejte Dodatek I Mnenja) vsebujejo salmeterol in flutikazon propionat, kombinacijo fiksnih odmerkov dolgo delujočega β- agonista (LABA) salmeterola in inhalacijskega kortikosteroida (ICS) flutikazon propionata (FP), indicirano za običajno zdravljenje astme, kjer je uporaba kombiniranega izdelka (dolgo delujočega β- agonista in inhalacijskega kortikosteroida) ustrezna: - pri bolnikih, pri katerih z inhalacijskimi kortikosteroidi in » po potrebi « z inhalacijskim kratko delujočim beta- 2- agonistom ni mogoče doseči zadostnega nadzora bolezni, ali – pri bolnikih, pri katerih je bilo mogoče že z inhalacijskimi kortikosteroidi in dolgo delujočim beta- 2- agonistom vzpostaviti zadosten nadzor bolezni.
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.
Priporočilo v poglavju 4. 2 dovoljuje kratkotrajno preskušanje zdravila Seretide Evohaler pri odraslih in mladostnikih z zmerno perzistentno astmo, pri katerih je hiter nadzor astme nujen.
• 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)
1084/ 2003 za zdravilo Seretide Evohaler in z njim povezana imena (glejte Dodatek I).
• the CHMP agreed, however, that a recommendation for a short term trial with the fixed dose combination of salmeterol and fluticasone propionate as initial maintenance therapy in adults
• CHMP je upošteval, da indikacija začetnega vzdrževalnega zdravljenja s kombinacijo salmeterola in flutikazon propionata v fiksnih odmerkih pri bolnikih z zmerno perzistentno astmo v poglavju 4. 1 Povzetka glavnih značilnosti zdravila ni sprejemljiva, saj lahko povzroči čezmerno zdravljenje, še zlasti pri bolnikih, ki bi se odzvali na inhalacijske kortikosteroide
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EMEA/ CHMP/ 123439/ 2006/ EN 1.
EMEA/ CHMP/ 123439/ 2006/ SL 1.
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Seretide Evohaler and associated names (see Annex I) 25/ 50 microgram/ dose pressurised inhalation, suspension.
Seretide Evohaler in z njim povezana imena (glejte Dodatek I) 25/ 50 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom.
Seretide Evohaler and associated names (see Annex I) 25/ 125 microgram/ dose pressurised inhalation, suspension.
Seretide Evohaler in z njim povezana imena (glejte Dodatek I) 25/ 125 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom.
Seretide Evohaler and associated names (see Annex I) 25/ 250 microgram/ dose pressurised inhalation, suspension.
Seretide Evohaler in z njim povezana imena (glejte Dodatek I) 25/ 250 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom.
Each single actuation of Seretide provides:
Ena sprožitev Seretida zagotavlja:
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:
Seretide je indiciran za redno zdravljenje astme, kadar je primerna uporaba kombiniranega zdravila (dolgodelujočega agonista beta 2 in inhaliranega kortikosteroida):
- or
- ali
patients not adequately controlled with inhaled corticosteroids and ‘ as needed’ inhaled short acting beta-2-agonist
pri bolnikih, nezadostno urejenih z inhaliranimi kortikosteroidi in inhaliranim kratkodelujočim agonistom beta- 2, uporabljanim "po potrebi",
patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
pri bolnikih, ki so že ustrezno urejeni z inhaliranima kortikosteroidom in dolgodelujočim agonistom beta- 2.
EMEA/ CHMP/ 123439/ 2006/ EN
Če se simptomi obvladujejo z najmanjšo jakostjo kombinacije, uporabljene dvakrat na dan, lahko naslednji korak vključuje preizkus EMEA/ CHMP/ 123439/ 2006/ SL
maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone.
inhalacijskega kortikosteroida samega.
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.
Pri bolnikih, ki potrebujejo dolgodelujoč agonist beta- 2, je druga možnost prilagoditev Seretida na enkrat na dan, če bi to po zdravnikovem mnenju zadoščalo za ohranitev ustrezne urejenosti bolezni.
Seretide 25/ 50 microgram strength is not appropriate in adults and children with severe asthma.
Seretide v jakosti 25/ 50 mikrogramov ni primeren za odrasle in otroke s hudo astmo.
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.
Dve inhalaciji 25 mikrogramov salmeterola in 50 mikrogramov flutikazonijevega propionata dvakrat na dan. ali Dve inhalaciji 25 mikrogramov salmeterola in 125 mikrogramov flutikazonijevega propionata dvakrat na dan. ali Dve inhalaciji 25 mikrogramov salmeterola in 250 mikrogramov flutikazonijevega propionata dvakrat na dan.
A short term trial of Seretide may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential.
Pri bolnikih z zmerno, persistentno astmo (tj. z vsakodnevnimi simptomi, vsakodnevno uporabo olajševalnega zdravila in zmerno do hudo obstrukcijo zračnega pretoka), ki bi jim koristilo hitro obvladanje astme, je mogoče poskusiti z uvodnim 12- tedenskim vzdrževalnim zdravljenjem s Seretidom.
Seretide is not intended for the initial management of mild asthma.
Jakost zdravila Seretide, 50/ 100 mikrogramov, ni primerna za odrasle in otroke s hudo astmo.
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.
Pri bolnikih s hudo astmo je pred uvedbo katere koli fiksne kombinacije priporočljivo določiti ustrezni odmerek inhalacijskega kortikosteroida.
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)
Uporaba nastavka za inhaliranje, ki izboljšuje terapevtsko korist, je priporočljiva pri bolnikih (zlasti majhnih otrocih), ki težko uskladijo vdih in sprožitev (glejte poglavje 4. 4, Posebna opozorila in previdnostni ukrepi).
EMEA/ CHMP/ 123439/ 2006/ EN Special patient groups:
EMEA/ CHMP/ 123439/ 2006/ SL Posebne skupine bolnikov:
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Patients should be instructed in the proper use of their inhaler (see patient information leaflet) During inhalation, the patient should preferably sit or stand.
Med vdihavanjem naj bolnik po možnosti sedi ali stoji.
If the inhaler has not been used for a week or more remove the mouthpiece cover, the patients should shake the inhaler well and release two puffs into the air.
Če inhalator ni bil uporabljen teden dni ali več, mora bolnik odstraniti pokrovček ustnika, inhalator dobro pretresti in dva odmerka sprožiti v zrak.
Each time the inhaler is activated the number on the counter will count down by one.
Ob vsaki sprožitvi inhalatorja se števec pomakne za eno navzdol.
Patients should breathe out as far as is comfortable and then place the mouthpiece in your mouth between their teeth and close their lips around it, Patients should be instructed not to bite the mouth piece.
Naročite mu, naj ne grize vanj.
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.
Tik po začetku vdiha skozi usta naj pritisne na vrh pločevinke, da bo sprostil Seretide; medtem naj še naprej enakomerno in globoko vdihuje.
Patients should continue holding their breath for as long as is comfortable.
Dih naj zadržuje, kolikor dolgo lahko, ne da bi bilo neprijetno.
If patients are going to take a second puff they should keep the inhaler upright and wait about half a minute before repeating steps 2 to 6.
Če mora narediti še drugi vdih, naj inhalator drži pokonci, počaka približno pol minute in potem ponovi korake od 2 do 6.
EMEA/ CHMP/ 123439/ 2006/ EN Cleaning:
Čiščenje:
Replace the mouthpiece cover.
Znova namestite pokrovček ustnika.
DO NOT PUT THE METAL CONTAINER IN WATER
KOVINSKEGA VSEBNIKA NE POLAGAJTE V VODO.
4.3 Contraindications
© EMEA 2007
Seretide Evohaler should not be used to treat acute asthma symptoms for which a fast and short acting bronchodilator is required.
Seretide Evohalerja bolnik ne sme uporabljati za zdravljenje akutnih simptomov astme: zanje je treba uporabiti hitro - in kratkodelujoč bronhodilatator.
Seretide should be administered with caution in patients with severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
Seretide je treba previdno uporabljati pri bolnikih s hudimi srčno- žilnimi boleznimi, vključno z motnjami srčnega ritma, diabetesom mellitusom, nezdravljeno hipokaliemijo ali tirotoksikozo.
There have been very rare reports of increases in blood glucose levels (see 4.8 Undesirable Effects) and this should be considered when prescribing to patients with a history of diabetes mellitus.
Opisani so redki primeri zvišane koncentracije glukoze v krvi (glejte 4. 8, Neželeni učinki); to morate upoštevati, če zdravilo predpišete bolniku z anamnezo diabetesa mellitusa.
Potentially serious hypokalaemia may result from systemic beta-2-agonist therapy, but following inhalation at therapeutic doses plasma levels of salmeterol are very low.
Posledica terapije z agonistom beta- 2 je lahko potencialno resna hipokaliemija, toda po vdihavanju terapevtskih odmerkov salmeterola je njegova koncentracija v plazmi zelo nizka.
Possible
Otrokom, ki dolgo uporabljajo inhalirane kortikosteroide, je priporočljivo redno kontrolirati telesno višino.
EMEA/ CHMP/ 123439/ 2006/ EN
Še posebej ogroženi so lahko otroci in EMEA/ CHMP/ 123439/ 2006/ SL
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.
mladostniki, mlajši od 16 let, ki uporabljajo velike odmerke flutikazona (tipično ≥ 1000 mikrogramov/ dan).
Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis.
Zelo redki primeri zavrtega delovanja nadledvičnih žlez in akutne adrenalne krize so opisani tudi z odmerki flutikazonijevega propionata med 500 in 1000 mikrogramov.
Children and adolescents < 16years taking high doses of fluticasone (typically ≥ 1000mcg/ day) may be at particular risk.
Med okoliščinami, ki lahko sprožijo akutno adrenalno krizo, so poškodbe, operacije, okužbe in vsako hitro znižanje odmerka.
Situations, which could potentially trigger acute adrenal crisis, include trauma, surgery, infection or any rapid reduction in dosage.
Pojavni simptomi so praviloma nedoločni; med njimi so lahko anoreksija, bolečine v trebuhu, hujšanje, utrujenost, glavobol, navzeja, bruhanje, hipotenzija, motnje zavesti, hipoglikemija in konvulzije.
Concomitant use of other beta-adrenergic containing drugs can have a potentially additive effect.
Sočasna uporaba drugih zdravil, ki vsebujejo beta- adrenergike, ima lahko aditiven učinek.
The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.
Pričakovati je, da sistemsko izpostavljenost flutikazonijevemu propionatu in tveganje za sistemske neželene učinke poveča tudi sočasno zdravljenje z drugimi močnimi zaviralci CYP3A, npr. z itrakonazolom.
EMEA/ CHMP/ 123439/ 2006/ EN
V študijah na živalih se po uporabi EMEA/ CHMP/ 123439/ 2006/ SL
There are insufficient data on the use of salmeterol and fluticasone propionate during pregnancy and lactation in man to assess the possible harmful effects.
agonistov adrenergičnih receptorjev beta 2 in glukokortikosteroidi pojavijo nenormalnosti pri plodu (glejte 5. 3, Predklinični podatki o varnosti).
Adverse events which have been associated with salmeterol/ fluticasone propionate are given below, listed by system organ class and frequency.
Neželeni učinki, povezani s salmeterolom/ flutikazonijevim propionatom, so navedeni spodaj po organskem sistemu in pogostnosti.
EMEA/ CHMP/ 123439/ 2006/ EN System Organ Class Adverse Event
Organski sistem Infekcijske in parazitske bolezni
Infections & Candidiasis of the mouth Infestations
Neželeni učinek kandidoza ust in žrela
Common
Pogostnost pogosto
Cutaneous hypersensitivity reactions
kožne preobčutljivostne reakcije
Angioedema (mainly facial and oropharyngeal oedema), Respiratory symptoms (dyspnoea and/ or bronchospasm), Anaphylactic reactions
angioedem (predvsem edem obraza in orofaringealni edem), dihalni simptomi (dispneja in/ ali bronhospazem), anafilaktične reakcije
Respiratory, Thoracic & Mediastinal
EMEA/ CHMP/ 123439/ 2006/ SL Organski sistem Bolezni dihal, prsnega koša in
Throat irritation
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Common
© EMEA 2007 Pogostnost pogosto
*Reported commonly in placebo
* Pogosto opisani pri placebu
Symptomatic candidiasis can be treated with topical anti- fungal therapy whilst still continuing with the Seretide Evohaler.
Simptomatsko kandidozo je mogoče zdraviti z lokalno antimikotično terapijo ob nadaljevanju uporabe Seretide Evohalerja.
Possible systemic effects include Cushing’ s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma (see 4.4 Special Warnings and Precautions For Use).
Med možnimi sistemskimi učinki so Cushingov sindrom, Cushingoidne značilnosti, zavrtje delovanja nadledvičnih žlez, upočasnitev rasti pri otrocih in mladostnikih, zmanjšanje mineralne gostote kosti, katarakta in glavkom (glejte 4. 4, Posebna opozorila in previdnostni ukrepi).
There have been very rare reports of hyperglycaemia (see 4.4 Special Warnings and Precautions for Use).
Opisani so redki primeri hiperglikemije (glejte 4. 4, Posebna opozorila in previdnostni ukrepi).
As with other inhalation therapy, paradoxical bronchospasm may occur (see 4.4 Special Warnings and Precautions for Use).
Tako kot pri drugi inhalacijski terapiji se lahko pojavi paradoksen bronhospazem (glejte 4. 4, Posebna opozorila in previdnostni ukrepi).
Chronic overdose of inhaled fluticasone propionate:
Kronično preveliko odmerjanje flutikazonijevega propionata: glejte poglavje 4. 4:
Refer to section 4.4: risk of adrenal suppression.
Tveganje za zavrtje delovanja nadledvičnih žlez.
5.
EMEA/ CHMP/ 123439/ 2006/ SL 5.
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.
Pri 50% oseb je bil prvi posamezni teden z dobro nadzorovanostjo dosežen po 16 dneh zdravljenja z zdravilom Seretide oziroma po 37 dneh zdravljenja z inhalacijskim kortikosteroidom.
Pre-Study Treatment No ICS (SABA alone) Low dose ICS (≤ 500mcg BDP or equivalent/ day)
terapija pred študijo brez IKS (samo KDAB) nizkoodmerni IKS (≤ 500 mikrogramov BDP ali ekvivalentno/ dan
WC TC 78% 50% 75% 44%
DU PU 78% 50% 75% 44%
WC 70% 60%
DU 70% 60%
TC 40% 28%
PU 40% 28%
Medium dose ICS (> 500-1000mcg BDP 62% or equivalent/ day)
srednjeodmerni IKS (> 500 do 1000 mikrogramov BDP ali ekvivalentno/ dan)
29%
62% 29%
*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.
* Dobro urejena astma: občasni simptomi ali uporaba KDAB (kratkodelujočega agonista beta) ali manj kot 80% predvidene pljučne funkcije ter brez prebujanj ponoči, brez poslabšanj in brez neželenih učinkov, ki bi zahtevali spremembo terapije. ** Popolnoma urejena astma: brez simptomov, brez uporabe KDAB, ≥ 80% predvidene pljučne funkcije, brez prebujanj ponoči, brez poslabšanj in brez neželenih učinkov, ki bi zahtevali spremembo terapije.
Salmeterol:
EMEA/ CHMP/ 123439/ 2006/ SL Salmeterol:
Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid anti- inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, with less adverse effects than when corticosteroids are administered systemically.
V priporočenih odmerkih inhalirani flutikazonijev propionat ima v pljučih glukokortikoidno protivnetno delovanje; s tem zmanjša simptome in poslabšanja astme z manj neželenimi učinki kot med sistemsko uporabo kortikosteroidov.
In addition there are only limited data available on the pharmacokinetics of salmeterol because of the technical difficulty of assaying the drug in plasma due to the low plasma concentrations at therapeutic doses (approximately 200 picogram/ ml or less) achieved after inhaled dosing.
Podatki o farmakokinetiki salmeterola so poleg tega omejeni zaradi tehnične težavnosti določanja koncentracije v plazmi, ki je po vdihavanju terapevtskih odmerkov nizka (približno 200 pikogramov/ ml ali manj.
EMEA/ CHMP/ 123439/ 2006/ EN Fluticasone propionate:
Flutikazonijev propionat:
The absolute bioavailability of inhaled fluticasone propionate in healthy subjects varies between approximately 10-30% of the nominal dose depending on the inhalation device used.
Absolutna biološka uporabnost vdihanega flutikazonijevega propionata pri zdravih preiskovancih je med približno 10 in 30% nominalnega odmerka, odvisno od uporabljene inhalacijske naprave.
The remainder of the inhaled dose may be swallowed but contributes minimally to systemic exposure due to the low aqueous solubility and pre-systemic metabolism, resulting in oral availability of less than 1%.
Preostanek vdihanega odmerka bolnik sicer lahko pogoltne, vendar to zaradi majhne vodotopnosti in zaradi predsistemske presnove le minimalno pripomore k sistemski izpostavljenosti, tako da je peroralna uporabnost manj kot 1%.
5.3 Preclinical safety data
EMEA/ CHMP/ 123439/ 2006/ SL 5. 3 Predklinični podatki o varnosti
The non-CFC propellant, Norflurane, has been shown to have no toxic effect at very high vapour concentrations, far in excess of those likely to be experienced by patients, in a wide range of animal species exposed daily for periods of two years.
To je bilo preizkušeno pri širokem krogu živalskih vrst, izpostavljenih v dveletnem obdobju.
EMEA/ CHMP/ 123439/ 2006/ EN 6.3 Shelf life
Navedba smiselno ni potrebna.
© EMEA 2007
6. 3 Rok uporabnosti
The suspension is contained in an internally lacquered, 8ml aluminium alloy pressurised container sealed with a metering valve.
Suspenzija je v 8- ml vsebniku pod tlakom, izdelanem iz aluminijske zlitine, ki je z notranje strani lakiran in je zaprt z odmerno zaklopko.
The canister has a counter attached to it, which shows how many actuations of medicine are left.
Na pločevinki je nameščen števec, ki kaže, koliko sprožitev je še preostalo.
1 x 120 actuations Inhaler
1 inhalator s 120 sprožitvami
or 3 x 120 actuations Inhaler
ali 3 inhalatorje s 120 sprožitvami
or 10 x 120 actuations Inhaler - hospital/ pharmacy use only (for dispensing purposes)
EMEA/ CHMP/ 123439/ 2006/ SL ali 10 inhalatorjev s 120 sprožitvami – samo za
EMEA/ CHMP/ 123439/ 2006/ EN
EMEA/ CHMP/ 123439/ 2006/ SL OZNAČEVANJE IN NAVODILO
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EMEA/ CHMP/ 123439/ 2006/ EN
EMEA/ CHMP/ 123439/ 2006/ SL PODATKI NA ZUNANJI OVOJNINI
Seretide Evohaler and associated names (see Annex I) 25/ 50 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
Seretide Evohaler in povezana imena (Glejte Dodatek I) 25/ 50 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom [Glejte Dodatek I – Izpolni država članica]
25 micrograms of salmeterol (as xinafoate) and 50 micrograms of fluticasone propionate per actuation
v enem odmerku je 25 mikrogramov salmeterola (kot ksinafoat) in 50 mikrogramov flutikazonijevega propionata
Pressurised inhalation, suspension
Inhalacijska suspenzija pod tlakom
1 X 120 puffs
1 X 120 sprožitev
Shake well before use
Dobro pretresite pred uporabo.
EMEA/ CHMP/ 123439/ 2006/ EN 7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Do not store above 25°C
Shranjujte pri temperature do 25 °C.
Do not puncture, break or burn even when apparently empty
Vsebnika ne smete prebosti, poškodovati ali vreči v ogenj, četudi menite, da je vsebnik prazen.
EVOHALER LABEL
NALEPKA NA PRŠILNIKU
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBNOST PO TEŽI VOLUMNU ALI ENOTI
120 puffs
[Izpolni država članica]
EMEA/ CHMP/ 123439/ 2006/ EN PARTICULARS TO APPEAR ON THE OUTER PACKAGING
EMEA/ CHMP/ 123439/ 2006/ SL PODATKI NA ZUNANJI OVOJNINI
Seretide Evohaler and associated names (see Annex I) 25/ 125 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
Seretide Evohaler in povezana imena (Glejte Dodatek I) 25/ 125 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom [Glejte Dodatek I – Izpolni država članica]