FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, blurred vision or other problems with seeing.
Slovenian: Pomembno je, da imate to opozorilno kartico pri sebi in jo pokažete zdravstvenemu delavcu, ki vas obravnava; - če dobite epileptični napad ali simptome, ki se hitro poslabšujejo, kot so glavobol, zmanjšana pozornost, zmedenost, zamegljen vid ali druge težave z vidom.
English: Deaths, n (%)
Slovenian: (95 % IZ b)
English: You may feel dizzy after taking Xospata.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Po jemanju zdravila Xospata se boste morda počutili omotično.
English: PC SN NN
Slovenian: Vistor hf
English: Cough
Slovenian: SN
English: 12.5 1.3 Very common
Slovenian: 1,3 zelo pogosti mialgija
English: How to store Xospata
Slovenian: Shranjevanje zdravila Xospata
English: • Symptoms include fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Slovenian: pljučni edem, hipotenzijo, hitro pridobivanje telesne mase, periferni edem, izpuščaje in disfunkcijo ledvic.
English: 80 mg or 120 mgb.
Slovenian: • Če je potrjeno, razmislite o zmanjšanju odmerka na 80 mg ali 120 mg b.
English: Acute kidney injury
Slovenian: Bolezni sečil akutna okvara ledvic pogosti
English: Xospata dosing
Slovenian: Odmerjanje zdravila Xospata
English: Musculoskeletal pain
Slovenian: 0,3 zelo pogosti mišično-skeletne bolečine pogosti
English: Astellas Pharma d.o.o Tel: +386 14011400
Slovenian: Tel: +386 14011400
English: Cardiac failure
Slovenian: Žilne bolezni hipotenzija
English: Date of first authorisation: 26 April 2018
Slovenian: Datum prve odobritve: 26. april 2018
English: In addition, two Phase IIIb studies were conducted to support the clinical efficacy and safety of Trydonis.
Slovenian: Izvedli so tudi dve študiji faze IIIb v podporo klinični učinkovitosti in varnosti zdravila Trydonis.
English: However, available safety data from longterm clinical studies have not raised any significant safety concerns (see section 5.1).
Slovenian: Vendar pa razpoložljivi podatki o varnosti iz dolgoročnih kliničnih študij niso dali povoda za znatne pomisleke glede varnosti (glejte poglavje 5.1).
English: Using Trydonis together with:
Slovenian: Uporaba zdravila Trydonis skupaj z:
English: Some medicines may increase the effects of Trydonis and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Slovenian: Nekatera zdravila lahko povečajo učinke zdravila Trydonis in zdravnik vas bo morda želel skrbno spremljati, če jemljete ta zdravila (vključno z nekaterimi zdravili za zdravljenje okužbe z virusom HIV: ritonavirjem, kobicistatom).
English: It is recommended that treatment with Trydonis should not be stopped abruptly.
Slovenian: Priporoča se, da se zdravljenja z zdravilom Trydonis ne prekine nenadoma.
English: Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females), either congenital or induced by medicinal products as these patients were excluded from clinical trials with Trydonis.
Slovenian: Previdnost je potrebna tudi pri zdravljenju bolnikov z znanim podaljšanjem intervala QTc ali sumom nanj (QTc > 450 milisekund za moške ali > 470 milisekund za ženske), bodisi prirojenim ali povzročenim z zdravili, saj so bili ti bolniki izključeni iz kliničnih preskušanj z zdravilom Trydonis.
English: If you are using Trydonis or high doses of other inhaled corticosteroids over long periods and you come into a situation of stress (e.g. being taken to hospital after an accident, having a serious injury or before an operation) you may need more of this medicine.
Slovenian: Če uporabljate zdravilo Trydonis ali velike odmerke inhaliranih kortikosteroidov in ste v stresni okoliščini (npr. če vas po nesreči odpeljejo v bolnišnico, če imate resno poškodbo ali pred operacijo) boste morda potrebovali več tega zdravila.
English: The clinical development programme of Trydonis was conducted in patients with moderate, severe or very severe COPD.
Slovenian: Klinični razvojni program zdravila Trydonis so izvedli pri bolnikih z zmerno, hudo ali zelo hudo KOPB.
English: The aerosol particles of Trydonis are on average much smaller than the particles delivered in non-extrafine formulations.
Slovenian: Aerosolni delci zdravila Trydonis so povprečno veliko manjši kot delci v formulacijah, ki niso v obliki izredno majhnih delcev.
English: If anaesthesia with halogenated anaesthetics is planned, it should be ensured that Trydonis is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias.
Slovenian: Če je načrtovana anestezija s halogeniranimi anestetiki, je treba zagotoviti, da se zdravilo Trydonis ne uporabi vsaj 12 ur pred začetkom anestezije, saj obstaja tveganje srčnih aritmij.
English: You should only use Trydonis during pregnancy if you are advised to do so by your doctor.
Slovenian: Zdravilo Trydonis uporabljajte med nosečnostjo le, če vam tako svetuje zdravnik.
English: What you need to know before you use Trydonis Do not use Trydonis:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Trydonis Ne uporabljajte zdravila Trydonis:
English: This includes medicines similar to Trydonis used for your lung disease.
Slovenian: To vključuje zdravila, podobna zdravilu Trydonis, ki se uporabljajo za zdravljenje pljučnih bolezni.
English: Tell your doctor if you have used more Trydonis than you should and if you experience any of these symptoms.
Slovenian: Zdravniku povejte, če ste uporabili več zdravila Trydonis, kot bi smeli, in imate katerega od teh simptomov.
English: What Trydonis is and what it is used for What you need to know before you use Trydonis How to use Trydonis
Slovenian: Kaj je zdravilo Trydonis in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Trydonis Kako uporabljati zdravilo Trydonis
English: There are no relevant data on the use of Trydonis in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see section 4.4 and section 5.2).
Slovenian: Relevantnih podatkov o uporabi zdravila Trydonis pri bolnikih s hudo okvaro jeter ni, zato je treba zdravilo pri teh bolnikih uporabljati previdno (glejte poglavje 4.4 in poglavje 5.2).
English: If you see 'mist' coming from the top of the inhaler or the sides of your mouth, this means that Trydonis will not be getting into your lungs as it should.
Slovenian: Če opazite, da z vrha inhalatorja ali ob robu ust uhaja »meglica«, to pomeni, da zdravilo Trydonis ne bo prišlo v vaša pljuča tako, kot bi moralo.
English: Trydonis is available in three container sizes:
Slovenian: Zdravilo Trydonis je na voljo v treh velikostih vsebnika:
English: What Trydonis is and what it is used for
Slovenian: Kaj je zdravilo Trydonis in za kaj ga uporabljamo
English: Trydonis 87/5/9 mcg
Slovenian: Trydonis 87/5/9 µg
English: Trydonis does not contain a high-dose inhaled corticosteroid, but your doctor may wish to measure the cortisol levels in your blood from time to time.
Slovenian: Zdravilo Trydonis ne vsebuje velikih odmerkov inhalacijskih kortikosteroidov, vendar bo morda zdravnik želel občasno izmeriti raven kortizola v krvi.
English: Trydonis contains a small amount of ethanol.
Slovenian: Pomožne snovi Zdravilo Trydonis vsebuje majhno količino etanola.
English: If you use more Trydonis than you should, side effects, as described in section 4, may occur.
Slovenian: Če ste uporabili več zdravila Trydonis, kot bi smeli, se lahko pojavijo neželeni učinki, opisani v poglavju 4.
English: Trydonis is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Slovenian: Zdravilo Trydonis ni indicirano za zdravljenje akutnih epizod bronhospazmov ali za zdravljenje akutnega poslabšanja KOPB (tj. kot rešilno zdravljenje) ni.
English: Remove the protective cap from the mouthpiece by pulling it away from your inhaler.
Slovenian: Odstranite zaščitni pokrovček z ustnika tako, da jo snamete z inhalatorja
English: Depending on the type of anaesthetic, it may be necessary to stop using Trydonis at least 12 hours before the anaesthesia.
Slovenian: Odvisno od vrste anestetika boste morda morali uporabo zdravila Trydonis prekiniti vsaj 12 ur pred anestezijo;
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Trydonis and to contact their doctor immediately should any of these signs or symptoms develop.
Slovenian: Bolnike je treba obvestiti o znakih in simptomih akutnega glavkoma z zaprtim zakotjem in jim naročiti, naj prenehajo uporabljati zdravilo Trydonis in se takoj posvetujejo z zdravnikom, če se pojavijo ti znaki ali simptomi.
English: Content of the pack and other information What Trydonis contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Trydonis
English: Genotoxicity of Trydonis has not been evaluated, however, the single active components were devoid of genotoxic activity in the conventional test systems.
Slovenian: Genotoksičnosti zdravila Trydonis niso ocenili, vendar pa posamične učinkovine v običajnih testnih sistemih niso kazale genotoksične dejavnosti.
English: However, in a 104-week rat inhalation carcinogenicity study and an oral 26-week carcinogenicity study in transgenic Tg.rasH2 mice, glycopyrronium bromide showed no carcinogenic potential and published data concerning longterm studies conducted with beclometasone dipropionate and formoterol fumarate in rats do not indicate a clinically relevant carcinogenic potential.
Slovenian: Vendar pa v 104-tedenski študiji kancerogenosti pri podganah z inhaliranjem in peroralni 26-tedenski študiji kancerogenosti pri transgeni miši Tg.rasH2 glikopironijev bromid ni pokazal kancerogenega potenciala, objavljeni podatki v zvezi z dolgoročnimi študijami, izvedenimi z beklometazondipropionatom in formoterolijevim fumaratom pri podganah pa ne kažejo klinično pomembnega kancerogenega potenciala.
English: There are no relevant clinical data on the use of Trydonis during breast-feeding in humans.
Slovenian: Ni relevantnih kliničnih podatkov o uporabi zdravila Trydonis med dojenjem pri ljudeh.
English: Carcinogenicity studies have not been performed with Trydonis.
Slovenian: Študij kancerogenosti za zdravilo Trydonis niso izvedli.
English: There is a risk of worsening shortness of breath and wheezing immediately after using Trydonis and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people).
Slovenian: Takoj po uporabi zdravila Trydonis obstaja tveganje za poslabšanje kratke sape in piskajočega dihanja, kar se imenuje paradoksni bronhospazem (pojavi se lahko pri največ 1 od 1.000 bolnikov).
English: If any of the above applies to you, tell your doctor before you use Trydonis.
Slovenian: Če karkoli od navedenega velja za vas, obvestite zdravnika, preden začnete uporabljati zdravilo
English: Tell your doctor if you have any of the following while using Trydonis as they could be symptoms of a lung infection (may affect up to 1 in 10 people):
Slovenian: Zdravniku morate povedati, če imate med jemanjem zdravila Trydonis kar koli od naštetega, ker so to lahko simptomi okužbe pljuč (pojavi se lahko pri največ 1 od 10 bolnikov):
English: If you have or have had any medical problems or any allergies or if you are not sure if you can use Trydonis, talk to your doctor or pharmacist before using the inhaler.
Slovenian: Če imate ali ste imeli zdravstvene težave ali alergije oz. če niste prepričani, ali lahko uporabljate zdravilo Trydonis, se pred začetkom uporabe inhalatorja posvetujte z zdravnikom ali farmacevtom.
English: Both studies were conducted in patients with a clinical diagnosis of COPD with severe to very severe airflow limitation (FEV1 less than 50% predicted), with symptoms assessed as a COPD Assessment Test (CAT) score of 10 or above, and with at least one COPD exacerbation in the previous year.
Slovenian: obe navedeni študiji so bili vključeni bolniki s klinično diagnozo KOPB s hudo do zelo hudo omejitvijo pretoka zraka (FEV1 manj kot 50 % predvidenega) s simptomi, ocenjenimi z oceno 10 ali več po testu za oceno KOPB (CAT, COPD Assessment Test) in z najmanj enim poslabšanjem KOPB
English: Other medicines and Trydonis
Slovenian: Druga zdravila in zdravilo Trydonis
English: Trydonis has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Trydonis nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, Trydonis should be discontinued immediately and alternative therapy instituted.
Slovenian: Če se pojavijo znaki, ki kažejo na alergijsko reakcijo, zlasti angioedem (vključno s težavami pri dihanju ali požiranju, oteklostjo jezika, ustnic in obraza), urtikarijo ali kožni izpuščaj, je treba uporabo zdravila Trydonis takoj prekiniti in uvesti drugo zdravljenje.
English: Trydonis was also statistically significantly superior to a fixed combination of beclometasone dipropionate and formoterol, to tiotropium and to a fixed combination of indacaterol and glycopyrronium in terms of improvement in quality of life (measured by the Saint George Respiratory Questionnaire - SGRQ - total score).
Slovenian: Zdravilo Trydonis je bilo tudi statistično značilno boljše od fiksne kombinacije beklometazondipropionata in formoterola, od tiotropija in fiksne kombinacije indakaterola in glikopironija v smislu izboljšanja kakovosti življenja (izmerjeno kot skupni seštevek po vprašalniku SGRQ - Saint George Respiratory Questionnaire).
English: The maximum dose is two inhalations of Trydonis twice daily.
Slovenian: Največji odmerek sta dve inhalaciji zdravila Trydonis dvakrat na dan.
English: • decrease in bone mineral density (thinning of the bones)
Slovenian: • zmanjšanje mineralne gostote kosti (redčenje kosti);
English: Trydonis can reduce exacerbations (flare-ups) of COPD symptoms.
Slovenian: Zdravilo Trydonis lahko zmanjša poslabšanja (izbruhe) simptomov KOPB.
English: Trydonis is unlikely to affect your ability to drive and use machines.
Slovenian: Ni verjetno, da bi zdravilo Trydonis vplivalo na sposobnost vožnje in upravljanja strojev.
English: The recommended dose is two inhalations of Trydonis twice daily.
Slovenian: Priporočeni odmerek sta dve inhalaciji zdravila Trydonis dvakrat na dan.
English: The use of Trydonis with the AeroChamber Plus spacer in COPD patients increased the lung delivery of beclometasone 17-monopropionate, formoterol and glycopyrronium (maximum plasma concentration increased by 15%, 58% and 60% respectively).
Slovenian: Učinek nastavka Uporaba zdravila Trydonis z nastavkom AeroChamber Plus pri bolnikih s KOPB je povečala v pljučih doseženo količino beklometazon 17-monopropionata, formoterola in glikopironija (največja koncentracija v plazmi se je povečala za 15 %, 58 % oz. 60 %).
English: Trydonis should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus.
Slovenian: Zdravilo Trydonis se lahko med nosečnostjo uporablja le, če so pričakovane koristi za mater večje od možnega tveganja za zarodek.
English: Do not stop using Trydonis or lower the dose, even if you are feeling better or you have no symptoms.
Slovenian: Pomembno je, da zdravilo Trydonis uporabljate vsak dan. Ne prenehajte uporabljati zdravila Trydonis in ne zmanjšujte odmerka, četudi se počutite bolje ali nimate simptomov.
English: Trydonis is a medicine to help breathing that contains the three active substances:
Slovenian: Zdravilo Trydonis pomaga pri dihanju in vsebuje tri učinkovine:
English: Infants and neonates born to mothers receiving substantial doses of Trydonis should be observed for adrenal suppression.
Slovenian: Pri dojenčkih in novorojenčkih, rojenim materam, ki so prejele večje odmerke zdravila Trydonis, je treba zato spremljati pojav zaviranja nadledvičnih žlez.
English: If this occurs you should stop using Trydonis and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing.
Slovenian: Če se to zgodi, prenehajte uporabljati zdravilo Trydonis in nemudoma uporabite hitrodelujoči "inhalator z olajševalcem", da boste obvladali kratko sapo in piskajoče dihanje.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trydonis therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mothers.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Trydonis, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: 1 Adverse reactions reported in the SmPC of at least one of the individual components, but not observed as adverse reactions in the clinical development of Trydonis
Slovenian: 1 Neželeni učinki, poročani v povzetku glavnih značilnosti zdravila za vsaj eno od posamičnih sestavin, ki pa jih niso opazili med neželenimi učinki v kliničnem razvoju zdravila Trydonis
English: Trydonis can be used at the recommended dose in patients with mild to moderate renal impairment.
Slovenian: Zdravilo Trydonis se lahko uporablja v priporočenem odmerku pri bolnikih z blago do zmerno okvaro ledvic.
English: Caution is also required when Trydonis is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia.
Slovenian: Previdnost je potrebna tudi pri uporabi zdravila Trydonis pri bolnikih s tirotoksikozo, sladkorno boleznijo, feokromocitomom in nezdravljeno hipokaliemijo.
English: An overdose of Trydonis may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists or anticholinergics and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Slovenian: Preveliko odmerjanje zdravila Trydonis lahko povzroči znake in simptome zaradi delovanja posamičnih sestavin, vključno s tistimi, ki se pojavijo pri prevelikem odmerjanju drugih agonistov adrenergičnih receptorjev beta2 ali antiholinergikov in so skladni z znanimi učinki razreda inhalacijskih kortikosteroidov (glejte poglavje 4.4).
English: Trydonis should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Slovenian: Uporabo zdravila Trydonis je treba takoj prekiniti, bolnika pregledati in uvesti drugo zdravljenje, če je to potrebno.
English: No specific studies have been performed with Trydonis with regard to the safety in human fertility.
Slovenian: Specifičnih študij varnosti zdravila Trydonis glede plodnosti pri ljudeh niso izvedli.
English: You should not use Trydonis during breast-feeding.
Slovenian: Zdravila Trydonis ne uporabljajte med dojenjem.
English: Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms (see section 5.2).
Slovenian: Ker se glikopironij izloča v glavnem skozi ledvice, se lahko pojavijo interakcije z zdravili, ki vplivajo na mehanizem ledvičnega izločanja (glejte poglavje 5.2).
English: You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Trydonis therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Slovenian: Vi in zdravnik se morate odločiti med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Trydonis, pri čemer morate pretehtati prednosti dojenja za otroka in prednosti zdravljenja za vas.
English: Therefore, as a precautionary measure, it is preferable to avoid the use of Trydonis during pregnancy and during labour.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo in med porodom uporabi zdravila Trydonis bolje izogibati.
English: Simulations performed with a pharmacokinetic model showed that even when covariates had extreme values (body weight less than 40 kg and concomitant glomerular filtration rate below 27 mL/min/1.73 m²), exposure to Trydonis active substances remains in approximately a 2.5-fold range compared to the exposure in a typical patient with median covariate values.
Slovenian: Simulacije, opravljene na farmakokinetičnem modelu, so pokazale, da je tudi v primeru izjemnih vrednosti sospremenljivk (telesna masa manj kot 40 kg in sočasno stopnja glomerularne filtracije pod 27 ml/min/1,73 m²) izpostavljenost učinkovinam v zdravilu Trydonis ostala v razponu približno 2,5-kratnika v primerjavi z izpostavljenostjo običajnega bolnika z mediano vrednostjo sospremenljivk.
English: Trydonis contains beclometasone dipropionate, formoterol and glycopyrronium in a solution formulation resulting in an aerosol with extrafine particles with an average mass median aerodynamic diameter (MMAD) of around 1.1 micrometres and co-deposition of the three components.
Slovenian: Zdravilo Trydonis vsebuje beklometazondipropionat, formoterol in glikopironij v obliki raztopine, iz katere nastane aerosol z izredno majhnimi delci s srednjim masnim aerodinamičnim premerom (MMAD - mass median aerodynamic diameter) približno 1,1 mikrometra in kodepozicijo treh učinkovin.
English: Additionally, due to the anticholinergic effect of glycopyrronium, the long-term co-administration of Trydonis with other anticholinergic-containing medicinal products is not recommended (see section 4.5).
Slovenian: Prav tako se zaradi antiholinergičnega učinka glikopironija dolgotrajnega sočasnega dajanja zdravila Trydonis z drugimi zdravili, ki vsebujejo antiholinergike, ne priporoča (glejte poglavje 4.5).
English: If you develop worsening shortness of breath or wheezing (breathing with a whistling sound), straight after inhaling your medicine, stop using Trydonis inhaler and use your quick-acting “reliever” inhaler straightaway.
Slovenian: Če se vam takoj po inhaliranju zdravila poslabša kratka sapa ali piskajoče dihanje (dihanje s piskajočim zvokom), nehajte uporabljati zdravilo Trydonis in nemudoma uporabite hitrodelujoči "inhalator z olajševalcem".
English: Wipe inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
Slovenian: Zunanjost in notranjost ustnika ter inhalator obrišite s čisto suho krpo ali papirnatim robčkom
English: There are no or limited amount of data from the use of Trydonis in pregnant women.
Slovenian: Podatkov o uporabi zdravila Trydonis pri nosečnicah ni oziroma so omejeni.
English: In an inhalation study in telemetered dogs, the cardiovascular system was a major target system for acute effects of Trydonis (increase in heart rate, decrease in blood pressure, ECG changes at higher doses), effects probably mainly related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium.
Slovenian: V inhalacijski študiji s telemetriranimi psi je bil kardiovaskularni sistem glavni ciljni sistem za akutne učinke zdravila Trydonis (zvišanje srčnega utripa, zmanjšanje krvnega tlaka, spremembe na EKG pri večjih odmerkih), kar so učinki, ki so najverjetneje v glavnem povezani z beta2 adrenergičnim delovanjem formoterola in antimuskarinskim delovanjem glikopironija.