FrancophonIA/ELRC3.0 huggingface dataset:
English: Salmeterol produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting beta-2-agonists.
Slovenian: Salmeterol povzroči dolgotrajnejšo (vsaj 12-urno) bronhodilatacijo kot priporočeni odmerki konvencionalnih kratkodelujočih agonistov beta-2.
English: There are no data available for use of Seretide in children aged under 4 years.
Slovenian: Podatkov o uporabi zdravila Seretide pri otrocih, mlajših od 4 let, ni.
English: For pharmacokinetic purposes therefore each component can be considered separately.
Slovenian: S stališča farmakokinetike je torej mogoče farmakokinetiko vsakega od njiju obravnavati posebej.
English: A discussion on the appropriateness of initial maintenance therapy with the fixed dose combination took place in CHMP based on the Rapporteur's and Co-Rapporteur's Assessment Reports and the data presented by the Marketing Authorisation Holders (MAHs).
Slovenian: V CHMP so razpravljali o ustreznosti začetnega vzdrževalnega zdravljenja s kombinacijo fiksnih odmerkov na podlagi ocenjevalnih poročil poročevalca in soporočevalca ter podatkov, predloženih s strani imetnikov dovoljenja za promet z zdravilom.
English: The doctor will prescribe the lowest strength of Seretide Diskus that will best control your symptoms.
Slovenian: Zdravnik vam bo predpisal tisto najmanjšo jakost zdravila Seretide Diskus, ki bo najbolje obvladala simptome.
English: Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000mcg.
Slovenian: Zelo redki primeri zavrtega delovanja nadledvičnih žlez in akutne adrenalne krize so opisani tudi z odmerki flutikazonijevega propionata med 500 in 1000 mikrogramov.
English: Therefore the CHMP considered it acceptable to give guidance to physicians as to the most appropriate dose strategy for initiating maintenance therapy with the fixed dose combination.
Slovenian: Zato je CHMP menil, da je sprejemljivo, da zdravniki prejmejo navodila za najprimernejšo strategijo odmerjanja za začetno vzdrževalno zdravljenje s kombinacijo fiksnih odmerkov.
English: The main part of the dose is excreted in faeces as metabolites and unchanged drug.
Slovenian: Glavni del odmerka se izloči v blatu v obliki presnovkov in kot nespremenjeno zdravilo.
English: Like all medicines, Seretide can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Seretide neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: 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).
Slovenian: Tveganje za sistemske neželene učinke je večje tudi med kombinacijo flutikazonijevega propionata in drugih močnih zaviralcev CYP3A (glejte 4.5, Medsebojno delovanje z drugimi zdravili in druge oblike interakcij).
English: micrograms fluticasone propionate.
Slovenian: mikrogramov flutikazonijevega propionata.
English: The plastic devices are available in cardboard containers, which hold
Slovenian: Plastične naprave so na voljo v kartonskih vsebnikih, ki vsebujejo
English: 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.
Slovenian: 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).
English: This combination of salmeterol and fluticasone propionate when used regularly prevents asthma attacks occurring.
Slovenian: Če to kombinacijo salmeterola in flutikazonijevega propionata uporabljate redno, prepreči pojavljanje astmatičnih napadov.
English: Be careful not to confuse your Seretide inhaler with your ‘rescue' inhaler.
Slovenian: Pazite, da ne boste inhalatorja Seretide zamenjali z inhalatorjem "olajševalnega" zdravila.
English: Seretide should not be taken with medicines called β-blockers (such as atenolol, propranolol, sotalol), unless your doctor tells you to do so.
Slovenian: Zdravila Seretide ne smete jemati z zdravili, ki jih imenujemo zaviralci β (takšni so npr. atenolol, propranolol, sotalol), razen če tako naroči zdravnik.
English: For detailed instructions for use see the Patient Information Leaflet.
Slovenian: Za podrobna navodila o uporabi glejte Navodilo za uporabo.
English: 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.
Slovenian: 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.
English: Seretide Diskus should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Slovenian: Uporabo Seretide Diskusa je treba takoj prekiniti, bolnika pregledati in uvesti drugo zdravljenje, če je potrebno.
English: As with other inhalation therapy, paradoxical bronchospasm may occur (see 4.4 Special Warnings and Precautions for Use).
Slovenian: Tako kot pri drugi inhalacijski terapiji se lahko pojavi paradoksen bronhospazem (glejte 4.4, Posebna opozorila in previdnostni ukrepi).
English: Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects.
Slovenian: Zato se je sočasni uporabi treba izogibati, razen če možne koristi za bolnika odtehtajo tveganje sistemskih neželenih učinkov kortikosteroidov.
English: There is a linear increase in systemic exposure with increasing inhaled dose.
Slovenian: Sistemska izpostavljenost se linearno povečuje z naraščanjem vdihanega odmerka.
English: Do not use Seretide to treat a sudden attack of breathlessness or wheezing as it will not help you immediately.
Slovenian: Seretide ne uporabljajte pri napadu težkega ali piskajočega dihanja, ker ne bo pomagal takoj.
English: The wording also indicates the importance for stepping down to inhaled corticosteroids alone once asthma control is attained.
Slovenian: Besedilo tudi nakazuje pomen postopnega prehoda na zgolj inhalacijske kortikosteroide, ko dosežemo nadzor astme.
English: Glaxo SmithKline Pharma GmbH, Albert-Schweitzer-Gasse 6 A-1140 Wien
Slovenian: Glaxo SmithKline Pharma GmbH, Albert-Schweitzer-Gasse 6, A-1140 Wien, Avstrija
English: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Slovenian: Pri vseh inhalacijskih kortikosteroidih se lahko pojavijo sistemski učinki, zlasti ob visokih odmerkih, uporabljanih dolgo časa.
English: Patients with mild persistent asthma are not considered to be candidates for a combination therapy as IMT and patients with a more severe disease would deserve more intensive therapeutic approaches.
Slovenian: Bolniki z blago perzistentno astmo ne veljajo za kandidate za kombinirano zdravljenje kot začetno vzdrževalno zdravljenje, bolniki z resnejšo boleznijo pa zaslužijo intenzivnejše terapevtske pristope.
English: Seretide Diskus should not be used to treat acute asthma symptoms for which a fast and short acting bronchodilator is required.
Slovenian: Seretide Diskusa bolnik ne sme uporabljati za zdravljenje akutnih simptomov astme: zanje je treba uporabiti hitro- in kratkodelujoč bronhodilatator.
English: The renal clearance of fluticasone propionate is negligible.
Slovenian: Ledvični očistek flutikazonijevega propionata je zanemarljiv.
English: - Breathing difficulties or wheezing (bronchospasm) worsens immediately after taking Seretide.
Slovenian: - Poslabšanje težkega dihanja in piskanja (bronhospazma) takoj po uporabi zdravila Seretide.
English: The pharmacological side effects of beta-2-agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Slovenian: Opisani so farmakološki neželeni učinki terapije z agonisti beta-2, npr. tremor, palpitacije in glavobol, ki pa so ponavadi prehodni in se med rednim zdravljenjem zmanjšajo.
English: In line with above arguments, the CHMP was not in agreement with a general recommendation for IMT of the fixed dose combination in section 4.1. but considered it acceptable to include guidance for a short term trial of initial maintenance therapy with Seretide in section 4.2.
Slovenian: Skladno z zgornjimi argumenti se CHMP ni strinjal s splošnim priporočilom za začetno vzdrževalno zdravljenje s kombinacijo fiksnih odmerkov v poglavju 4.1, meni pa, da je sprejemljivo vključiti smernice za kratkotrajno preskušanje začetnega vzdrževalnega zdravljenja z zdravilom Seretide v poglavju 4.2.
English: It counts down to 0 and numbers 5 to 0 will appear in red to warn you when there are only a few doses left.
Slovenian: Številke od 5 do 0 so rdeče barve za opozorilo, da je ostalo le še nekajodmerkov.
English: The CHMP had a concern that a general recommendation i.e. the therapeutic indication in the Summary of Product Characteristics (SPC), will result in over treatment particularly in patients who would have responded to inhaled corticosteroids alone.
Slovenian: Odbor CHMP je izrazil zaskrbljenost, da bo splošno priporočilo, tj. terapevtska indikacija v Povzetku glavnih značilnosti zdravila, povzročilo čezmerno zdravljenje, zlasti pri bolnikih, ki bi se odzvali na inhalacijske kortikosteroide same.
English: In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations).
Slovenian: Študije vpliva na sposobnost razmnoževanja na živalih so pokazale, da glukokortikosteroidi izzovejo malformacije (palatoshizo, malformacije okostja).
English: Acute: Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function.
Slovenian: Akutno: Akutno vdihavanje flutikazonijevega propionata v odmerkih, ki presegajo priporočene, lahko povzroči prehodno zavrtje delovanja nadledvičnih žlez.
English: Adverse events which have been associated with salmeterol fluticasone propionate are given below, listed by system organ class and frequency.
Slovenian: Neželeni učinki, povezani s salmeterolom/flutikazonijevim propionatom, so navedeni spodaj po organskem sistemu in pogostnosti.
English: As with all inhaled medication containing corticosteroids, Seretide should be administered with caution in patients with pulmonary tuberculosis.
Slovenian: Kot vsa inhalacijska zdravila s kortikosteroidi je treba tudi Seretide uporabljati previdno pri bolnikih s pljučno tuberkulozo.
English: The CHMP has recommended the granting of the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III.
Slovenian: CHMP je priporočil odobritev spremembe dovoljenj za promet z zdravilom, katerega Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so navedeni v Dodatku III.
English: Fluticasone propionate:
Slovenian: Flutikazonijev propionat:
English: Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection or any rapid reduction in dosage.
Slovenian: Med okoliščinami, ki lahko sprožijo akutno adrenalno krizo, so poškodbe, operacije, okužbe in vsako hitro znižanje odmerka.
English: The information currently in section 5.1 of the SPC have also been amended in line with the recommendation in section 4.2.
Slovenian: Dopolnili so tudi podatke, trenutno navedene v poglavju 5.1 Povzetka glavnih značilnosti zdravila, skladno s priporočilom v poglavju 4.2.
English: - Feeling anxious, disturbed sleep and behavioural changes, such as being unusually active and irritable (mainly in children).
Slovenian: - Občutek tesnobe, motnje spanja in vedenjske spremembe, npr. nenavadna dejavnost in razdražljivost (predvsem pri otrocih).
English: Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk.
Slovenian: Ogroženi so lahko tudi bolniki, ki so v preteklosti potrebovali visoke odmerke nujne terapije s kortikosteroidi.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: What Seretide is and what it is used for Before you take Seretide How to take Seretide Possible side effects How to store Seretide Further information
Slovenian: Kaj je zdravilo Seretide in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Seretide Kako jemati zdravilo Seretide Možni neželeni učinki
English: In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly day-time symptoms the dose should be given in the morning.
Slovenian: V primeru uporabe enkrat na dan morajo bolniki z anamnezo nočnih simptomov odmerek uporabiti zvečer, bolniki z anamnezo simptomov pretežno v dnevnem času pa zjutraj.
English: Pre-Study Treatment
Slovenian: terapija pred študijo
English: Psychiatric Disorders Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children)
Slovenian: Psihiatrične motnje anksioznost, motnje spanja in vedenjske spremembe, vključno s hiperaktivnostjo in razdražljivostjo (predvsem pri otrocih)
English: GlaxoSmithKline (Ireland) Limited (trading as: Allen & Hanbury) Stonemasons Way, Rathfarnham, Dublin 16
Slovenian: GlaxoSmithKline (Ireland) Limited (trading as: Allen & Hanbury) Stonemasons Way, Rathfarnham, Dublin 16, Irska
English: It helps the airways in the lung to stay open making it easier for air to get in and out.
Slovenian: Pomaga, da ostanejo dihalne poti v pljučih odprte in tako olajšuje dotok in iztok zraka.
English: The MAHs were of the opinion that the issues identified during the MRP were issues of clinical management and as such cannot be addressed by conducting further clinical trials.
Slovenian: Imetniki dovoljenja za promet z zdravilom so menili, da težave, ugotovljene tekom postopka za medsebojno priznavanje, zadevajo klinično upravljanje in jih kot takih torej ni moč reševati z izvajanjem nadaljnjih kliničnih preskušanj.
English: The Diskus device holds blisters containing Seretide in powder form.
Slovenian: Naprava Diskus vsebuje pretisne omote, v katerih je Seretide v obliki praška.
English: 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.
Slovenian: Pri bolnikih, ki potrebujejo dolgodelujoč agonist beta-2, je druga možnost prilagoditev zdravila Seretide na enkrat na dan, če bi to po zdravnikovem mnenju zadoščalo za ohranitev ustrezne urejenosti bolezni.
English: It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
Slovenian: Bolnike morate zato redno kontrolirati in odmerek inhaliranega kortikosteroida zmanjšati do najnižjega odmerka, s katerim je mogoče astmo učinkovito obvladovati.
English: In patients with asthma or COPD a lesser degree of systemic exposure to inhaled fluticasone propionate has been observed.
Slovenian: Pri bolnikih z astmo ali KOPB so opažali manjšo stopnjo sistemske izpostavljenosti flutikazonijevemu propionatu.
English: The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects.
Slovenian: Kombinaciji se je treba izogniti, razen če koristi odtehtajo večje tveganje za neželene učinke sistemskih glukokortikoidov.
English: - Thrush (sore, creamy-yellow, raised patches) in the mouth and throat.
Slovenian: - Gobice (občutljive, kremno rumene dvignjene lehe) v ustih in žrelu.
English: Fluticasone propionate is one of a group of medicines called corticosteroids which reduces swelling and irritation in the lungs.
Slovenian: Flutikazonijev propionat spada v skupino zdravil, ki jih imenujemo kortikosteroidi; zmanjšuje oteklino in draženje v pljučih.
English: Seretide is contraindicated in patients with hypersensitivity (allergy) to any of the active substances or to the excipient (see 6.1 List of Excipients).
Slovenian: Seretide je kontraindiciran pri bolnikih, ki so preobčutljivi za (alergični na) katerokoli zdravilno učinkovino ali pomožno snov (glejte 6.1, Seznam pomožnih snovi).
English: If you are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate or to the other ingredient lactose monohydrate.
Slovenian: Če ste alergični na (preobčutljivi za) salmeterolijev ksinafoat, flutikazonijev propionata ali monohidrat laktoze, ki je pomožna snov v zdravilu.
English: 1 x Diskus 28 inhalations or 1, 2, 3 or 10 x Diskus each containing 60 inhalations Not all pack sizes may be marketed.
Slovenian: 1, 2, 3 ali 10 Diskusov, od katerem je v vsakem 60 vdihov Na trgu ni vseh navedenih pakiranj.
English: The preferred antidotes are cardioselective beta-blocking agents, which should be used with caution in patients with a history of bronchospasm.
Slovenian: Prednostni antidoti so kardioselektivni zaviralci beta, ki pa jih je treba previdno uporabljati pri bolnikih z anamnezo bronhospazma.
English: Administration of Seretide to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Slovenian: Uporaba zdravila Seretide pride pri doječih ženskah v poštev le, če je pričakovana korist za mater večja od vsakega možnega tveganja za otroka.
English: Other unidentified metabolites are also found in the faeces.
Slovenian: V blatu se pojavijo tudi drugi, neidentificirani presnovki.
English: Care should be taken when transferring patients to Seretide therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy.
Slovenian: Pri prehodu bolnikov na zdravljenje z zdravilom Seretide je potrebna previdnost, zlasti če je mogoče domnevati, da je delovanje nadledvičnih žlez prizadeto zaradi predhodnega sistemskega zdravljenja s steroidi.
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA <[Izpolni država članica]>
English: - Signs of allergy, such as itching, swelling (usually of the face, lips, tongue or throat), difficulty in breathing, wheezing or coughing (bronchospasm).
Slovenian: - Znaki alergije, npr. srbenje, otekanje (ponavadi obraza, ustnic, jezika ali žrela), težko dihanje, piskanje ali kašelj (bronhospazem).
English: Seretide should be administered with caution in patients with severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
Slovenian: Seretide je treba previdno uporabljati pri bolnikih s hudimi srčno-žilnimi boleznimi, vključno z motnjami srčnega ritma, diabetesom mellitusom, nezdravljeno hipokaliemijo ali tirotoksikozo.
English: If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: These effects are much less likely to occur than with oral corticosteroids.
Slovenian: Pojav teh učinkov je veliko manj verjeten kot med uporabo peroralnih kortikosteroidov.
English: Only take these medicines whilst on Seretide, if told to do so by your doctor.
Slovenian: Zato takšna zdravila uporabljajte hkrati z zdravilom Seretide le, če vam tako naroči zdravnik.
English: In addition to the update in section 4.2 of the SPC, some factual data from the GOAL study in particular the timing of reaching more rapidly control with Seretide than with ICS alone have been included in section 5.1 “Pharmacodynamic properties” of the SPC.
Slovenian: Poleg posodobitve v poglavju 4.2 Povzetka glavnih značilnosti zdravila so vključili še nekatere dejanske podatke iz študije GOAL, zlasti časovni načrt doseganja hitrejšega nadzora z zdravilom Seretide kot z inhalacijskimi kortikosteroidi samimi, v poglavje 5.1 Povzetka glavnih značilnosti zdravila, „Farmakodinamične lastnosti“.
English: The issue to be considered by CHMP was whether it is appropriate to introduce initial maintenance therapy with the fixed dose combination of salmeterol and fluticasone propionate in all patients with chronic persistent asthma.
Slovenian: Problematika, ki bi jo moral obravnavati Odbor za zdravila za uporabo v humani medicini (CHMP), se je nanašala na vprašanje, ali je primerno uvesti začetno vzdrževalno zdravljenje s kombinacijo fiksnih odmerkov salmeterola in flutikazon propionata pri vseh bolnikih s kronično perzistentno astmo.
English: Seretide is not intended for the initial management of mild asthma.
Slovenian: Zdravilo Seretide ni namenjeno začetnemu zdravljenju blage astme.
English: A twelve month study (Gaining Optimal Asthma ControL, GOAL), in 3416 adult and adolescent patients with persistent asthma, compared the safety and efficacy of Seretide versus inhaled corticosteroid (Fluticasone Propionate) alone to determine whether the goals of asthma management were achievable.
Slovenian: Dvanajstmesečna študija GOAL (Gaining Optimal Asthma ControL) pri 3416 odraslih in mladostnikih s persistentno astmo je primerjala varnost in učinkovitost zdravila Seretide in samega inhalacijskega kortikosteroida (flutikazonijevega propionata) za ugotovitev dosegljivosti obvladanja astme.
English: Patients should be made aware that Seretide Diskus must be used daily for optimum benefit, even when asymptomatic.
Slovenian: Bolnikom je treba pojasniti, da morajo za najboljši učinek Seretide Diskus uporabljati vsak dan, tudi kadar nimajo simptomov.
English: Sliding the lever of the Diskus opens a small hole in the mouthpiece and opens a blister in a foil strip, ready for you to inhale the powder.
Slovenian: Ko na Diskusu potisnete vzvod, to odpre majhno odprtino v ustniku in pretisni omot v folijskem traku; naprava je tako pripravljena, da iz nje vdihnete prašek.
English: Potentially serious hypokalaemia may result from systemic beta-2-agonist therapy but following inhalation at therapeutic doses plasma levels of salmeterol are very low.
Slovenian: Posledica terapije z agonistom beta-2 je lahko potencialno resna hipokaliemija, toda po vdihavanju terapevtskih odmerkov salmeterola je njegova koncentracija v plazmi zelo nizka.
English: LIST OF EXCIPIENTS Lactose monohydrate
Slovenian: SEZNAM POMOŽNIH SNOVI laktoza monohidrat
English: Seretide does not work in controlling sudden attacks of breathlessness and wheezing where you would need to use your fast acting ‘rescue' medication.
Slovenian: Vendar pa Seretide ne more obvladati nenadnih napadov težkega in piskajočega dihanja: v takšnem primeru morate uporabiti hitrodelujoče "rešilno" zdravilo.
English: Children and adolescents <16years taking high doses of fluticasone propionate (typically ≥ 1000mcg/day) may be at particular risk.
Slovenian: Še posebej ogroženi so lahko otroci in mladostniki, mlajši od 16 let, ki uporabljajo velike odmerke flutikazonijevega propionata (tipično ≥ 1000 mikrogramov/dan).