natgillin/translations-raw huggingface dataset:
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 
brez IKS (samo KDAB) nizkoodmerni IKS ( ≤ 500 mikrogramov BDP ali ekvivalentno/dan srednjeodmerni IKS (> 500 do 1000 mikrogramov BDP ali ekvivalentno/dan) kumulativni rezultati vseh 3 ravni terapije *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
Seretide contains lactose up to 12.5 milligram /dose. 
Seretide vsebuje do 12,5 mg laktoze na odmerek.
- The other ingredient is lactose monohydrate (which contains milk proteins). 
- Pomožna snov je laktoza monohidrat (ki vsebuje mlečne beljakovine).
The recommendation included in section 4.2 allows a short term trial of Seretide Diskus 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 Diskus pri odraslih in mladostnikih z zmerno perzistentno astmo, pri katerih je hiter nadzor astme nujen.
However, the amount of lactose in this medicine does not normally cause problems in lactose intolerant people. 
Količina laktoze v tem zdravilu praviloma ne povzroča težav osebam, ki laktoze ne prenesejo.
Use of the inhaler 
Uporaba inhalatorja
Wipe the mouthpiece of the Diskus with a dry tissue to clean it. 
Ustnik Diskusa očistite tako, da ga obrišete s suho krpico.
If you find it difficult to breathe or your wheezing gets worse after taking Seretide, stop using it immediately and tell your doctor straightaway so they can assess your treatment. 
Če po uporabi zdravila Seretide težko dihate ali se piskanje poslabša, zdravilo nemudoma nehajte uporabljati in takoj povejte zdravniku, da bo ponovno pretehtal vaše zdravljenje.
The main pathway is metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4. 
Glavna pot je presnova v neaktiven presnovek karboksilne kisline z encimom CYP3A4 citokroma P450.
Seretide Asthma clinical trials 
Klinična preskušanja zdravila Seretide pri astmi
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. 
Tako kot pri drugi inhalacijski terapiji se lahko pojavi paradoksen bronhospazem s takojšnjim poslabšanjem piskajočega dihanja po uporabi zdravila.
- Headache, although this side effect usually lessens as treatment continues. 
- Glavobol (ta neželeni učinek se med nadaljevanjem zdravljenja ponavadi zmanjša).
Patients should be given the strength of Seretide containing the appropriate fluticasone propionate dosage for the severity of their disease. 
Bolniki morajo dobiti jakost zdravila Seretide, v kateri je odmerek flutikazonijevega propionata, ustrezen izrazitosti njihove bolezni.
It is also highlighted that Seretide is not appropriate as IMT in patients with mild and severe asthma and that in general inhaled corticosteroids remain the first line treatment for most patients. 
Poudarjeno je tudi, da zdravilo Seretide kot začetno vzdrževalno zdravljenje ni primerno za bolnike z blago in hudo astmo in da v splošnem inhalacijski kortikosteroidi ostajajo zdravilo prvega izbora pri večini bolnikov.
Treatment with Seretide should not be stopped abruptly in patients with asthma due to risk of exacerbation. 
Zdravljenja z zdravilom Seretide pri bolnikih z astmo ne smete prekiniti nenadoma, ker obstaja nevarnost za poslabšanje.
The inhalation powder is contained in blisters held on a formed PVC coated base, with a peelable foil laminate lid. 
Prašek za inhaliranje je v pretisnih omotih na formirani, s PVC prekriti podlagi z odlepno prekrivno folijo iz laminata.
Consideration should be given to increasing corticosteroid therapy. 
V poštev pride povečanje terapije s kortikosteroidom.
The MAHs applied for a type II variation subject to MRP to extend the current approved indications to include initial maintenance therapy (IMT) with the fixed dose combination in patients with chronic persistent asthma. 
Imetniki dovoljenja za promet z zdravilom so zaprosili za spremembo tipa II, ki je predmet postopka medsebojnega priznavanja, za razširitev trenutno odobrenih indikacij, in sicer tako, da bi vključevale začetno vzdrževalno zdravljenje (IMT) s kombinacijo fiksnih odmerkov pri bolnikih s kronično perzistentno astmo.
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).
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 %.
To help prevent side effects occurring, your doctor will make sure you are on the lowest dose of Seretide that will control your asthma. 
Za preprečitev neželenih učinkov bo zdravnik poskrbel, da boste uporabljali najmanjši odmerek zdravila Seretide, ki bo obvladal astmo.
The maximum licensed dose of fluticasone propionate delivered by Seretide Diskus in children is 100mcg twice daily. 
Največji odobreni odmerek flutikazonijevega propionata, ki ga odda Seretide Diskus, je pri otrocih 100 mikrogramov dvakrat na dan.
In animal studies foetal abnormalities occur after administration of beta-2-adrenoreceptor agonists and glucocorticosteroids (see 5.3 Preclinical Safety Data). 
V študijah na živalih se po uporabi agonistov adrenergičnih receptorjev beta 2 in glukokortikosteroidi pojavijo nenormalnosti pri plodu (glejte 5.3, Predklinični podatki o varnosti).
Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. 
Ko je astma obvladana je treba zdravljenje znova oceniti in pretehtati, ali naj bolnik preide na terapijo z inhalacijskim kortikosteroidom.
The patient should also be medically reviewed where the current dosage of Seretide has failed to give adequate control of asthma. 
Prav tako je bolnika treba pregledati, če trenutni odmerek zdravila Seretide astme ne obvlada ustrezno.
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. 
Po inhalacijski uporabi je koncentracija flutikazonijevega propionata v plazmi v normalnih okoliščinah nizka zaradi obsežne presnove prvega prehoda in velikega sistemskega očistka s citokromom P450 3A4 v črevesu in jetrih.
Administration of Seretide to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. 
Uporaba zdravila Seretide pri nosečnicah pride v poštev le, če je pričakovana korist za mater večja od vsakega možnega tveganja za plod.
• 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. 
• CHMP se strinja, da je treba dejanske podatke iz študije GOAL, še zlasti časovni načrt doseganja hitrejšega nadzora z zdravilom Seretide kot z inhalacijskimi kortikosteroidi samimi, vključiti v poglavje 5.1 Povzetka glavnih značilnosti zdravila in da so nekatera dopolnila v tem poglavju skladno z dogovorjenim priporočilom v poglavju 4.2 nujna.
For example, 100mcg of fluticasone propionate is approximately equivalent to 200mcg of beclomethasone dipropionate (CFC containing) or budesonide. 
Tako npr. 100 mikrogramov flutikazonijevega propionata ustreza približno 200 mikrogramom beklometazonijevega dipropionata (ki vsebuje klorfluoroogljikovodike) ali budezonida.
The MAHs have demonstrated in a series of substantial and well conducted clinical studies that in patients with moderate chronic persistent asthma poorly controlled on a short acting β-agonist alone the introduction of combination therapy with salmeterol and fluticasone is more effective in improving disease control than the introduction of salmeterol or fluticasone alone. 
Imetniki dovoljenja za promet z zdravilom so z zaporedjem dobro podprtih in vodenih kliničnih študij pokazali, da je pri bolnikih z zmerno kronično perzistentno astmo, ki so slabo nadzorovani le z uporabo kratko delujočega β-agonista, uvedba kombiniranega zdravljenja s salmeterolom in flutikazonom učinkovitejša pri izboljšanju nadzora nad boleznijo kot pa zdravljenje samo s salmeterolom ali samo flutikazonom.
The management of asthma should normally follow a stepwise programme and patient response should be monitored clinically and by lung function tests. 
Obvladovanje astme mora praviloma potekati stopenjsko; bolnikov odziv morate kontrolirati klinično in s preiskavami delovanja pljuč.
- Aching, swollen joints and muscle pain. 
- Boleči, otekli sklepi in bolečine v mišicah.
Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, without the adverse effects observed when corticosteroids are administered systemically. 
V priporočenih odmerkih inhalirani flutikazonijev propionat ima v pljučih glukokortikoidno protivnetno delovanje; s tem zmanjša simptome in poslabšanja astme brez neželenih učinkov, opaznih med sistemsko uporabo kortikosteroidov.
United Kingdom Glaxo Wellcome UK Limited, Stockley Park West, Uxbridge, Middlesex UB11 1BT 
Velika Britanija Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West, Uxbridge, Middlesex UB11 1BT, Velika Britanija
Your doctor will need to know if you have recently been treated with corticosteroids (orally or by injection). 
Zdravniku morate povedati, če ste pred kratkim dobivali kakšne kortikosteroide (bodisi da ste jih uživali, bodisi da ste jih dobivali v injekcijah).
Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician. 
Če bolnikova uporaba kratkodelujočih bronhodilatatorjev za olajšanje narašča, to kaže na slabšanje urejenosti bolezni in bolnikovo stanje morate znova oceniti.
Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected. 
Za inhalirani flutikazonijev propionat informacij o tej interakciji ni, a pričakovati je mogoče izrazito povečanje koncentracije flutikazonijevega propionata v plazmi.
In cases of fluticasone propionate overdose Seretide therapy may still be continued at a suitable dosage for symptom control. 
V primeru prevelikega odmerjanja flutikazonijevega propionata je mogoče terapijo z zdravilom Seretide kljub temu nadaljevati v ustreznem odmerku za obvladanje simptomov.
Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-roi Cedex, France 
Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-roi Cedex, Francija
After the Commission Decision, the Member State competent authorities will update Annex III as required. 
Pristojne oblasti držav članic bodo informacije o zdravilu posodobile v skladu z zahtevami, ko bo podana odločba Komisije.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
There are no data available for use of Seretide in patients with hepatic impairment. 
Podatkov o uporabi zdravila Seretide pri bolnikih z okvaro jeter ni.
For patients with asthma or COPD, consideration should be given to additional corticosteroid therapies. 
Pri bolnikih z astmo ali KOPB pride v poštev dodatna terapija s kortikosteroidi.
Children 4 to 12 years of age Seretide 50/100 Diskus 
Otroci v starosti od 4 do 12 let Seretide 50/100 Diskus en vdih dvakrat na dan
When salmeterol and fluticasone propionate were administered in combination by the inhaled route, the pharmacokinetics of each component were similar to those observed when the drugs were administered separately. 
Če sta salmeterol in flutikazonijev propionat uporabljena skupaj v inhalaciji, je farmakokinetika vsakega od njiju podobna, kot če sta uporabljeni posamezno.
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles). 
Srčne bolezni palpitacije tahikardija motnje srčnega ritma (vključno z atrijsko fibrilacijo, supraventrikularno tahikardijo in ekstrasistolami)
• the CHMP considered that an initial maintenance therapy indication with the fixed dose combination of salmeterol and fluticasone propionate in patients with moderate persistent asthma in section 4.1 of the SPC is not acceptable as it could result in overtreatment particularly in patients who would have responded to inhaled corticosteroids alone. 
• 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 same.
Do not play with the lever as this opens the blisters and wastes medicine. 
Ne igrajte se z vzvodom, ker to odpira pretisne omote in zdravilo gre v nič.
- Feeling shaky and fast or irregular heartbeat (palpitations). 
- Občutek drhtenja in hiter ali nereden srčni utrip (palpitacije).
The results of this study suggest that Seretide 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). 
Izsledki te študije kažejo, da se lahko Seretide 50/100 mikrogramov dvakrat na dan uporablja kot uvodno vzdrževalno zdravljenje za bolnike z zmerno, persistentno astmo, pri katerih je hitro obvladanje astme ključno (glejte poglavje 4.2).
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. 
V nujnih primerih in v elektivnih okoliščinah, v katerih je verjeten stres, je vedno treba upoštevati možnost rezidualne okvare in poskrbeti za ustrezno terapijo s kortikosteroidi.
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 tuberculosis (TB). 
Bodite posebno pozorni pri uporabi zdravila Seretide Zdravnik bo vaše zdravljenje spremljal natančneje, če imate kakšno zdravstveno težavo, npr. bolezen srca (vključno z nerednim ali hitrim srčnim utripom), čezmerno dejavno ščitnico, visok krvni tlak, diabetes mellitus (Seretide lahko zviša krvni sladkor), nizek kalij v krvi ali se zdravite oz. ste se zdravili zaradi tuberkuloze.
Symptomatic candidiasis can be treated with topical antifungal therapy whilst still continuing with the Seretide Diskus. 
Simptomatsko kandidozo je mogoče zdraviti z lokalno antimikotično terapijo ob nadaljevanju uporabe Seretide Diskusa.
If you forget to take Seretide 
Če ste pozabili vzeti zdravilo Seretide
The MAH's proposed therapeutic indication to include “patients with persistent asthma not adequately controlled on "as needed" inhaled shortacting beta-2-agonists alone who exhibit a combination of at least two of the following clinical features of asthma: airflow limitation, daily use of rescue medication, daily symptoms (day-time and/or night-time)” was not considered acceptable as it does not effectively identify a population in need of combination therapy. 
Predlog imetnikov dovoljenja za promet z zdravilom, naj terapevtska indikacija vsebuje „bolnike s perzistentno astmo, ki niso zadostno nadzorovani z zgolj inhalacijskimi kratko delujočimi beta-2-agonisti, uporabljenimi „po potrebi“, in ki kažejo kombinacijo vsaj dveh od naslednjih kliničnih lastnosti astme: omejitev zračnega pretoka, dnevna uporaba rešilnih zdravil, dnevni simptomi (podnevi in/ali ponoči)“, ni sprejemljiv, saj ne opredeljuje učinkovito populacije, ki potrebuje kombinirano zdravljenje.
As Seretide contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. 
Seretide vsebuje salmeterol in flutikazonijev propionat, zato je mogoče pričakovati takšno vrsto in izrazitost neželenih reakcij, kot so povezane z vsako posamezno od teh dveh snovi.
Seretide Diskus United Kingdom Seretide Accuhaler 
Seretide Diskus Velika Britanija S eretide Accuhaler
Cases of Cushing's syndrome and adrenal suppression have been reported. 
Opisani so primeri Cushingovega sindroma in zavrtja nadledvičnih žlez.
In general inhaled corticosteroids remain the first line treatment for most patients. 
Pri večini bolnikov inhalacijski kortikosteroidi na splošno ostajajo zdravila prvega izbora.
Very rare: means that fewer than 1 in 10,000 people taking the medicine are affected. 
Zelo redki: dobi jih manj kot 1 na 10.000 oseb, ki jemljejo to zdravilo.
CLOSE: - To close the Diskus, slide the thumbgrip back towards you, as far as it will go. 
Diskus zaprite tako, da nastavek za palec potisnete nazaj proti sebi, kolikor daleč gre.
• 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 and adolescents with moderate persistent asthma for whom rapid control of asthma is essential, in section 4.2 of the SPC is acceptable. 
• CHMP pa se strinja, da je priporočilo za kratkotrajno preskušanje s kombinacijo salmeterola in flutikazon propionata v fiksnih odmerkih kot začetno vzdrževalno zdravljenje pri odraslih in mladostnikih z zmerno perzistentno astmo, pri katerih je hiter nadzor astme nujen, v poglavju 4.2 Povzetka glavnih značilnosti zdravila sprejemljivo.
Salmeterol xinafoate and fluticasone propionate 
Salmeterolijev ksinafoat in flutikazonijev propionat
If you are using high doses of Seretide for a long time, one of the active ingredients, fluticasone propionate, may stop the natural production of steroid hormones by the adrenal gland. 
Če dolgo časa uporabljate velike odmerke zdravila Seretide, lahko flutikazonijev propionat, ki je ena od obeh zdravilnih učinkovin, zavre naravno nastajanje steroidnih hormonov v nadledvičnih žlezah.
Both hoarseness and incidence of candidiasis may be relieved by gargling with water after using the product. 
Hripavost in pogostnost kandidoze je mogoče zmanjšati z grgranjem vode po uporabi zdravila.
PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. 
FARMACEVTSKA OBLIKA Prašek za inhaliranje, odmerjen.
GOAL showed more patients treated with Seretide achieved asthma control than patients treated with ICS alone and this control was attained at a lower corticosteroid dose. 
Študija GOAL je pokazala, da je obvladanje simptomov astme doseglo več bolnikov, ki so dobivali Seretide, kot bolnikov, ki so dobivali samo IKS (inhalacijski kortikosteroid) in da je bilo to obvladanje doseženo pri nižjih odmerkih kortikosteroida.
The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women. 
Pri nosečnicah je treba uporabljati najmanjši učinkoviti odmerek flutikazonijevega propionata, potreben za ustrezno obvladanje astme.
Headache Tremor 
Bolezni živčevja glavobol tremor
*Very Common Common 
*zelo pogosto pogosto
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Inhalation use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo.
Patients should be advised to have their medicinal product to be used for relief in an acute asthma attack available at all times. 
Bolnikom naročite, naj imajo vedno pri sebi zdravilo za olajšanje akutnega napada astme.
HOW TO TAKE SERETIDE 
KAKO JEMATI ZDRAVILO SERETIDE
For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician. 
Pri bolnikih s KOPB lahko prenehanje zdravljenja spremlja tudi simptomatska dekompenzacija, zato mora opustitev potekati pod zdravniškim nadzorstvom.
Cleaning your inhaler 
Čiščenje inhalatorja
What Seretide looks like and contents of the pack Inhalation powder, pre-dispensed. 
Izgled zdravila Seretide in vsebina pakiranja Prašek za inhaliranje, odmerjen.
Seretide Diskus contains up to 12.5 milligrams of lactose in each dose. 
V vsakem odmerku zdravila Seretide Diskus je do 12,5 miligramov laktoze.
There is a counter on top of the Diskus which tells you how many doses are left. 
Na vrhu Diskusa je števec, ki kaže število preostalihodmerkov.
Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. 
Zaradi flutikazonijevega propionata v zdravilu se nekaterim bolnikom pojavita hripavost in kandidoza (gobice) v ustih in žrelu.
Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. 
Dolgotrajno zdravljenje z velikimi odmerki inhalacijskih kortikosteroidov lahko klinično zavre delovanje nadledvičnih žlez in povzroči akutno adrenalno krizo.
This is to reduce the risk of affecting the function of your adrenal gland. 
To je potrebno, da bi zmanjšali tveganje za prizadetost delovanja nadledvičnih žlez.
These effects include stomach pain, tiredness, loss of appetite, sickness, diarrhoea, weight loss, headache or drowsiness, low levels of potassium in your blood, low blood pressure and seizures. 
Med takšnimi učinki so bolečine v želodcu, utrujenost, izguba apetita, slabost, driska, hujšanje, glavobol ali zaspanost, nizka koncentracija kalija v krvi, nizek krvni tlak in konvulzije (napadi krčev).
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.
Adults and adolescents 12 years and over Seretide 50/100 Diskus 
Odrasli in mladostniki, starejši od 12 let Seretide 50/100 Diskus en vdih dvakrat na dan