natgillin/translations-raw huggingface dataset:
Treatment was stepped up every 12 weeks until **Total control was achieved or the highest dose of study drug was reached.
Zdravljenje so vsakih 12 tednov stopnjevali navzgor, dokler **ni bilo doseženo popolno obvladanje ali pa najvišji odmerek proučevanega zdravila.
Therefore, Annex III may not necessarily represent the current text.
Zaradi tega je možno, da ta zapis ne predstavlja trenutno veljavnega besedila.
The incidence in placebo was not taken into account.
Incidenca pri placebu ni upoštevana.
Once the counter shows 0, your inhaler is empty.
Ko števec pokaže 0, je inhalator prazen.
The respective mechanisms of action of both drugs are discussed below:
Mehanizma delovanja obeh zdravil sta obravnavana spodaj:
Adults and adolescents 12 years and older:
Odrasli in mladostniki, stari 12 let in več:
<Detailed information on this medicine is available on the web site of {MA/Agency}>
Podrobne informacije o zdravilu so objavljene na spletni strani {MA/agencija}
A recommendation in section 4.2 “Posology and method of administration” was considered acceptable.
Priporočilo v poglavju 4.2 “Odmerjanje in način uporabe”, je bilo opredeljeno kot sprejemljivo.
Germany atmadisc Diskus
Nemčija atmadisc Diskus
When you first take Seretide Diskus out of the box, it will be in the closed position.
Ko Seretide Diskus prvič vzamete iz škatle, je v zaprtem položaju.
If you forget to take your medicine, take your next dose when it is due.
Če ste pozabili vzeti zdravilo, vzemite naslednji odmerek, ko je čas zanj.
Please tell your doctor if you are taking or have recently taken any other medicines, including those for asthma or any medicines obtained without a prescription.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi za astmo, ali katerokoli zdravilo, ki ste ga dobili brez recepta.
Your Diskus is now ready for you to use.
Diskus je zdaj pripravljen za uporabo.
Recommended Doses:
Priporočeni odmerki:
The lever will return to its original position and is reset.
Vzvod se vrne v izhodiščni položaj in je tako znova nastavljen.
- When you close the Diskus, it clicks shut.
Ko se Diskus zapre, klikne.
Each single dose of Seretide provides:
En posamični odmerek zdravila Seretide vsebuje:
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.
Opredelitev pogostnosti je: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 in < 1/10), občasni (≥ 1/1000 in < 1/100) in zelo redki (< 1/10.000) vključno s posameznimi primeri.
R03AK06
Oznaka ATC: R03AK06
*Reported commonly in placebo
*Pogosto opisani pri placebu
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SERETIDE DISKUS AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SERETIDE DISKUS IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
On 12 August 2005, the MAHs presented to the EMEA a referral under Article 6(13) of Commission Regulation (EC) No 1084/2003.
Imetniki dovoljenja za promet z zdravilom so 12. avgusta 2005 Evropski agenciji za zdravila predložili napotitev v skladu s členom 6(13) Uredbe Komisije (ES) št. 1084/2003.
See your doctor immediately so they can review your condition and assess the medication you need to take.
Takoj obiščite zdravnika, da bo presodil vaše stanje in ocenil, katera zdravila morate jemati.
WHAT SERETIDE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO SERETIDE IN ZA KAJ GA UPORABLJAMO
Caution is recommended and long-term treatment with such drugs should if possible be avoided.
Potrebna je previdnost; če je mogoče, se je dolgotrajnemu zdravljenju s takšnimi zdravili treba izogniti.
A dose indicator on the Diskus indicates the number of doses left.
Kazalnik odmerkov na Diskusu kaže število preostalih odmerkov.
Less than 5% of the dose is excreted in urine, mainly as metabolites.
Manj kot 5 % odmerka se izloči v urinu, v glavnem v obliki presnovkov.
When you close the Diskus, the lever automatically moves back to the original position, with the outer casing protecting the Diskus when not in use.
Ko Diskus zaprete, se vzvod samodejno vrne v začetni položaj, ohišje pa varuje Diskus, kadar ta ni v uporabi.
Do not breathe into your Diskus inhaler.
Ne dihajte v inhalator Diskus.
In several EU Member States Seretide Diskus and associated names (see Annex I) are approved through the Mutual Recognition Procedure (MRP).
V številnih državah članicah EU so zdravilo Seretide Diskus in z njim povezana imena (glejte Dodatek I) odobrena s postopkom medsebojnega priznavanja (MRP).
However, these animal experimental results do not seem to be relevant for man given recommended doses.
A kot kaže, ti eksperimentalni izsledki pri živalih niso pomembni za človeka pri uporabi priporočenih humanih odmerkov.
There are no data available for human breast milk.
Podatkov o materinem mleku pri človeku ni.
Your Diskus is now ready for you to use again.
Diskus je spet pripravljen za uporabo.
Very rare events were derived from postmarketing spontaneous data.
Podatki o zelo redkih učinkih izvirajo iz pomarketinških spontanih prijav.
Push your thumb away from you as far as it will go and you hear a click.
S palcem potisnite proč od sebe, kolikor daleč gre; slišali boste klik.
The CHMP performed a re-evaluation of the type II variation application data.
CHMP je ponovno ovrednotil podatke v vlogi za spremembo tipa II.
Do not use Seretide after the expiry date which is stated on the label and carton.
Zdravila Seretide ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
Do not stop taking Seretide suddenly as this could make your symptoms worse and could cause problems with the body's hormones.
Zdravila Seretide ne nehajte jemati nenadoma, ker to lahko poslabša simptome in povzroči težave s hormoni v telesu.
The dose can then be inhaled and the device closed.
Potem je mogoče odmerek vdihniti in napravo zapreti.
Both non-selective and selective beta-blockers should be avoided unless there are compelling reasons for their use.
Izogniti se je treba neselektivnim in selektivnim zaviralcem beta, razen če je njihova uporaba nujna.
15232 Halandri, Athens, Greece
15232 Halandri, Athens, Grčija
Over a 12 month period the risk of COPD exacerbations was reduced from 1.42 per year to 0.99 per year compared with placebo and the risk of exacerbations requiring oral corticosteroids was significantly reduced from 0.81 to 0.47 per year compared with placebo.
Tveganje za poslabšanja KOPB se je med 12-mesečnim obdobjem v primerjavi s placebom zmanjšalo od 1,42 na leto na 0,99 na leto, tveganje za poslabšanja, ki so zahtevala peroralne kortikosteroide, pa se je v primerjavi s placebom značilno zmanjšalo z 0,81 na 0,47 na leto.
Side effects may also occur if you get an infection or at times of extreme stress (such as after a serious accident or if you have surgery).
Ti se lahko pojavijo tudi, če zbolite za okužbo, in v primerih izrednega stresa (npr. po resni poškodbi ali po operaciji).
Very Rare
zelo redko
In some cases, Seretide may not be suitable to be taken with other medicines.
Včasih zdravila Seretide ni primerno jemati z drugimi zdravili.
If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
Če imate diabetes, bodo morda potrebne pogostejše kontrole krvnega sladkorja; prav tako boste morda morali prilagoditi svojo običajno terapijo za diabetes.
Using the Diskus:
Uporaba Diskusa:
• the CHMP considered the referral made under Article 6(13) of Commission Regulation (EC) N 1084/2003 for Seretide Diskus and associated names (see Annex I)
• CHMP je upošteval napotitev v skladu s členom 6(13) Uredbe Komisije (ES) št. 1084/2003 za zdravilo Seretide Diskus in z njim povezana imena (glejte Dodatek I).
The main objection relating to the identification of the patient population especially those patients who would respond to inhaled corticosteroids alone had not been adequately identified.
Glavni ugovor, ki se nanaša na identifikacijo populacije bolnikov, zlasti tistih, ki bi se odzvali samo na inhalacijske kortikosteroide, ni bil zadostno opredeljen.
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.
Ti učinki med nadaljevanjem zdravljenja ponavadi izzvenijo, a če ste večje odmerke uporabljali dolgo časa, se morate posvetovati z zdravnikom ali farmacevtom.
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.
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.
Nevertheless the CHMP acknowledged that current clinical guidelines (e.g. the Global Initiative for Asthma (GINA) guidelines) describe circumstances which could lead to the initiation of maintenance therapy with the combination.
Vseeno pa je CHMP priznal, da trenutne klinične smernice (denimo smernice Globalne iniciative za astmo (GINA)) opisujejo okoliščine, ki bi lahko privedle do uvedbe vzdrževalnega zdravljenja s kombinacijo.
To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids during this time.
Za preprečitev simptomov vam bo zdravnik med takšnimi obdobji morda predpisal dodatne kortikosteroide.
The mouthpiece is then placed in the mouth and the lips closed round it.
Nato je treba ustnik dati v usta in ustnice stisniti okrog njega.
- Very fast heart rate (tachycardia).
- Zelo hitro bitje srca (tahikardija)
Seretide Diskus is also used for the regular treatment of the symptoms of severe Chronic Obstructive Pulmonary Disease (COPD).
Seretide Diskus uporabljamo tudi za redno zdravljenje simptomov hude kronične pljučne obstruktivne bolezni (KOPB).
Additionally, hypokalaemia can occur and potassium replacement should be considered.
Poleg tega se lahko pojavi hipokaliemija in priporočljivo utegne biti nadomeščanje kalija.
The primary endpoint in the GOAL study was the proportion of patients reaching asthma control (well-control of asthma).
Primarna končna točka v študiji GOAL je bil delež bolnikov, pri katerih je bil doežen nadzor astme (dober nadzor astme).
CHMP considered it not acceptable to expose the whole target population to beta-agonists related adverse events.
CHMP meni, da ni sprejemljivo, da bi celotno ciljno populacijo izpostavili neželenim učinkom, povezanim z beta-agonisti.
Percentage of Patients Attaining *Well Controlled (WC) and **Totally Controlled (TC) Asthma over 12 months Salmeterol/FP
Odstotek bolnikov, ki so dosegli *dobro urejenost (DU) in **popolno urejenost (PU) astme v 12 mesecih salmeterol/FP
You must use your fast acting ‘rescue' medicine (such as salbutamol) for this purpose which you should carry with you at all times.
V takšnem primeru morate uporabiti hitrodelujoče "olajševalno" zdravilo (npr. salbutamol), ki ga morate imeti vedno pri sebi.
No studies of the effect on the ability to drive and use machines have been performed.
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
Systemic absorption occurs mainly through the lungs and is initially rapid then prolonged.
Do sistemske absorpcije pride predvsem skozi pljuča in je uvodoma hitra in potem podaljšana.
B-1332 Genval
B-1332 Genval, Belgija
- Put the mouthpiece to your lips; breathe in steadily and deeply through the Diskus, not through your nose.
- Položite ustnik na ustnice; počasi in enakomerno vdihnite skozi Diskus (ne skozi nos).
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 Diskus and associated names.
Opomba: Ta Dodatek III (Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo) je bil priložen k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu s členom 6(13) za zdravilo Seretide Diskus in z njim povezana imena.
If your symptoms are well controlled using Seretide Diskus twice daily, your doctor may decide to reduce your dose to once daily.
Če so simptomi dobro obvladani z uporabo Seretide Diskusa dvakrat na dan, se bo zdravnik morda odločil za zmanjšanje odmerka na enkrat na dan.
If you stop taking Seretide
Če nehate jemati Seretide
Ritonavir can greatly increase the concentration of fluticasone propionate in plasma.
Ritonavir lahko močno zviša koncentracijo flutikazonijevega propionata v plazmi.
To work properly in controlling asthma and treating COPD symptoms, Seretide must be taken every day as directed by your doctor.
Za ustrezno obvladanje astme in zdravljenje simptomov KOPB morate Seretide jemati vsak dan, kot vam je predpisal zdravnik.
This amount does not normally cause problems in lactose intolerant people.
Ta količina ponavadi ne povzroča težav osebam z intoleranco za laktozo.
Some types of antiviral and antifungal medication (such as ritonavir, ketoconazole and itraconazole) may increase the amount of fluticasone propionate in your body and therefore increase your risk of having side effects.
Nekatera protivirusna in protiglivična zdravila (npr. ritonavir, ketakonazol in itrakonazol) lahko povečajo količino flutikazonijevega propionata v telesu in s tem tveganje za neželene učinke.
Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as other inhaled steroids at approximately half the microgram daily dose.
Zdravniki se morajo zavedati, da je pri bolnikih z astmo flutikazonijev propionat enako učinkovit kot drugi inhalirani steroidi v dnevnem odmerku približno pol mikrograma.
Chronic Obstructive Pulmonary Disease (COPD)
Kronična obstruktivna pljučna bolezen (KOPB)
Fluticasone propionate is cleared very rapidly from the systemic circulation.
Flutikazonijev propionat se zelo hitro očisti iz sistemskega obtoka.
- Seretide may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time.
- Seretide lahko neugodno vpliva na normalno nastajanje steroidnih hormonov v telesu, zlasti če dolgo časa uporabljate velike odmerke.
PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed 1 x 28 inhalations
FARMACEVTSKA OBLIKA IN VSEBINA Prašek za inhaliranje, odmerjen 1 x 28 inhalacij
Although the safety profile of salmeterol/fluticasone propionate is well known, the CHMP considered it not justified to expose the whole intended target population to an increased incidence of beta-agonists related adverse events.
Čeprav je profil varnosti salmeterola/flutikazon propionata dobro poznan, je CHMP mnenja, da ni upravičeno izpostavljati celotne načrtovane ciljne populacije povečani incidenci neželenih učinkov, povezanih z beta-agonisti.
- Increases in the amount of sugar (glucose) in your blood (hyperglycaemia).
- Zvišanje sladkorja (glukoze) v krvi (hiperglikemija).
The CHMP considered the use of “Control of Asthma” as the primary efficacy variable a reliable parameter of the patient clinical status and, as such, clinically meaningful.
CHMP je ocenil „nadzor astme“ kot primarno spremenljivko učinkovitosti za zanesljivo mero bolnikovega kliničnega stanja in kot takega za klinično smiselnega.
EFFICACY
UČINKOVITOST
Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone.
Če se simptomi obvladujejo z najmanjšo jakostjo kombinacije, uporabljene dvakrat na dan, lahko naslednji korak vključuje preizkus inhalacijskega kortikosteroida samega.
Very common, common and uncommon events were derived from clinical trial data.
Podatki o zelo pogostih, pogostih in občasnih učinkih izvirajo iz kliničnih preskušanj.
This medicinal product is authorised in the Member States of the EEA under the following names:
To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni: [Izpolni država članica].
The foil protects the powder for inhalation from the effects of the atmosphere.
Pretisni omoti ščitijo prašek za vdihavanje pred atmosferskimi učinki.
If you notice these symptoms or they appear suddenly after taking Seretide, tell your doctor immediately as you could be allergic to Seretide.
Če opazite te simptome ali če se pojavijo nenadoma po uporabi zdravila Seretide, morate to takoj povedati zdravniku, kajti morda ste alergični na Seretide.
The signs and symptoms of salmeterol overdose are tremor, headache and tachycardia.
Znaki in simptomi prevelikega odmerjanja salmeterola so tremor, glavobol in tahikardija.
Note: Seretide 50/100 microgram strength is not appropriate in adults and children with severe asthma.
Opomba: Seretide v jakosti 50/100 mikrogramov ni primeren za odrasle in otroke s hudo astmo.
The devices are packed in cartons which hold:
Naprave so pakirane v škatlah, ki vsebujejo:
This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.
To ne zahteva nujnega ukrepanja, ker se delovanje nadledvičnih žlez v nekaj dneh popravi, kar je potrjeno z meritvami kortizola v plazmi.
Patients should be regularly reassessed by a doctor, so that the strength of Seretide they are receiving remains optimal and is only changed on medical advice.
Bolnike mora zdravnik redno kontrolirati, da ostane uporabljana jakost zdravila Seretide optimalna in se spremeni le na zdravniški nasvet.
Tell your doctor, but do not stop taking Seretide unless they tell you to do so.
Povedati morate zdravniku, vendar ne nehajte uporabljati zdravila Seretide, dokler vam ne naroči tako.
Seretide is indicated for the symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Seretide je indiciran za simptomatsko zdravljenje bolnikov s hudo KOPB (FEV1 < 50 % predvidenega normalnega) in anamnezo ponavljajočih se poslabšanj, ki imajo izrazite simptome kljub redni bronhodilatacijski terapiji.
The extent of the adrenal impairment may require specialist advice before elective procedures.
Zaradi izrazitosti adrenalne prizadetosti utegne biti pred elektivnimi postopki potreben posvet s specialistom.
Animal studies with salmeterol xinafoate have shown embryofoetal toxicity only at high exposure levels.
Študije salmeterolijevega ksinafoata na živalih so pokazale embriofetalne toksične učinke le pri visoki izpostavljenosti.
- Rinse your mouth with water and spit it out as this may help prevent the occurrence of thrush and hoarseness.
- Izperite usta z vodo in vodo izpljunite: to pomaga preprečiti pojav gobic in hripavosti.
Children 4 years and older:
Otroci od 4. leta dalje:
Slide the lever away from you as far as it will go until it clicks.
Potisnite vzvod od sebe, kolikor daleč gre, dokler ne klikne.
If an individual patient should require dosages outside the recommended regimen, appropriate doses of beta-agonist and/or corticosteroid should be prescribed.
Če posamezen bolnik potrebuje odmerke zunaj priporočene sheme, mu morate predpisati ustrezne odmerke agonista beta in/ali kortikosteroida.
This medicine if not recommended for use in children below 4 years of age.
Tega zdravila ni priporočljivo uporabljati pri otrocih do 4. leta starosti.
OPEN: to open your Diskus, hold the outer case in one hand and put the thumb of your other hand on the thumbgrip.
ODPIRANJE: Diskus odprite: z eno roko primite ohišje, palec druge roke pa položite na nastavek za palec.
Lactose monohydrate (which contains milk proteins).
Laktoza monohidrat (ki vsebuje mlečne beljakovine).
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%.
V majhni študiji pri zdravih prostovoljcih je nekoliko manj močni zaviralec CYP3A ketokonazol zvišal izpostavljenost flutikazonijevemu propionatu po eni sami inhalaciji za 150 %.
These side effects are usually harmless and lessen as treatment continues.
Ti neželeni učinki so ponavadi neškodljivi in se med nadaljevanjem zdravljenja zmanjšajo.
There are insufficient data on the use of salmeterol and fluticasone propionate during pregnancy and lactation in man to assess the possible harmful effects.
O uporabi salmeterola in flutikazonijevega propionata med nosečnostjo in dojenjem pri človeku ni dovolj podatkov, da bi lahko ocenili možne škodljive učinke.
Rua Dr. António Loureiro Borges, 3, Arquiparque , Miraflores 1495131 Algés
Rua Dr. António Loureiro Borges, 3, Arquiparque , Miraflores 1495131 Algés, Portugalska
Seretide contains salmeterol and fluticasone propionate which have differing modes of action.
Seretide vsebuje salmeterol in flutikazonijev propionat, ki imata različen mehanizem delovanja.
Salmeterol is one of a group of medicines called long-acting bronchodilators (effect lasting for at least 12 hours).
Salmeterol spada v skupino zdravil, ki jih imenujemo dolgodelujoči bronhodilatatorji (njihov učinek traja vsaj 12 ur).
It is very important that you take your Seretide every day as directed, until you are advised to stop by your doctor.
Zelo pomembno je, da Seretide uporabljate vsak dan in po navodilih, dokler vam zdravnik ne svetuje, da nehate.
The only safety concerns for human use derived from animal studies of salmeterol xinafoate and fluticasone propionate given separately were effects associated with exaggerated pharmacological actions.
Za človeka edino pomembne varnostne ugotovitve iz živalskih študij ločeno uporabljenih salmeterolijevega ksinafoata in flutikazonijevega propionata so učinki, povezani s čezmernim farmakološkim delovanjem.
Seretide Diskus is for inhalation use only.
Seretide Diskus je namenjen samo za inhaliranje.
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.
Koristni učinki vdihanega flutikazonijevega propionata bi morali minimizirati potrebo po peroralnih steroidih, toda bolnike, ki preidejo s peroralnih steroidov, lahko še dolgo ogroža zmanjšanje adrenalne rezerve.
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 inhalations of Seretide you take.
Če se vam astma poslabša ali ni dobro obvladana (kar pomeni, da ste pogosteje zasopli in morate pogosteje uporabljati hitrodelujoče "olajševalno" zdravilo), ne povečujte števila vdihov zdravila Seretide.
The disposition of fluticasone propionate is characterised by high plasma clearance (1150ml/min), a large volume of distribution at steady-state (approximately 300l) and a terminal half-life of approximately 8 hours.
Za odstranjevanje flutikazonijevega propionata so značilni velik očistek iz plazme (1150 ml/min), velik volumen porazdelitve v stanju dinamičnega ravnovesja (približno 300 l) in terminalni razpolovni čas približno 8 ur.
If Seretide therapy has to be withdrawn due to overdose of the beta agonist component of the drug, provision of appropriate replacement steroid therapy should be considered.
Če je treba terapijo z zdravilom Seretide ukiniti zaradi prevelikega odmerjanja agonista beta v zdravilu, morate pretehtati ustrezno nadomestno terapijo s steroidom.
The possible side effects associated with Seretide are unlikely to affect your ability to drive or use machines.
Ni verjetno, da bi možni neželeni učinki, povezani z jemanjem zdravila Seretide, neugodno vplivali na vašo sposobnost upravljanja vozil in strojev.
Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely.
Klinično pomembne interakcije zdravil zaradi flutikazonijevega propionata zato niso verjetne.
Do not take a double dose to make up for a forgotten dose.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjega.