natgillin/translations-raw huggingface dataset:
This includes medicines similar to Trydonis used for your lung disease.
To vključuje zdravila, podobna zdravilu Trydonis, ki se uporabljajo za zdravljenje pljučnih bolezni.
Tell your doctor if you have used more Trydonis than you should and if you experience any of these symptoms.
Zdravniku povejte, če ste uporabili več zdravila Trydonis, kot bi smeli, in imate katerega od teh simptomov.
What Trydonis is and what it is used for What you need to know before you use Trydonis How to use Trydonis
Kaj je zdravilo Trydonis in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Trydonis Kako uporabljati zdravilo Trydonis
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).
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).
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.
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.
Trydonis is available in three container sizes:
Zdravilo Trydonis je na voljo v treh velikostih vsebnika:
What Trydonis is and what it is used for
Kaj je zdravilo Trydonis in za kaj ga uporabljamo
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.
Zdravilo Trydonis ne vsebuje velikih odmerkov inhalacijskih kortikosteroidov, vendar bo morda zdravnik želel občasno izmeriti raven kortizola v krvi.
Trydonis contains a small amount of ethanol.
Pomožne snovi Zdravilo Trydonis vsebuje majhno količino etanola.
If you use more Trydonis than you should, side effects, as described in section 4, may occur.
Če ste uporabili več zdravila Trydonis, kot bi smeli, se lahko pojavijo neželeni učinki, opisani v poglavju 4.
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).
Zdravilo Trydonis ni indicirano za zdravljenje akutnih epizod bronhospazmov ali za zdravljenje akutnega poslabšanja KOPB (tj. kot rešilno zdravljenje) ni.
Remove the protective cap from the mouthpiece by pulling it away from your inhaler.
Odstranite zaščitni pokrovček z ustnika tako, da jo snamete z inhalatorja
Depending on the type of anaesthetic, it may be necessary to stop using Trydonis at least 12 hours before the anaesthesia.
Odvisno od vrste anestetika boste morda morali uporabo zdravila Trydonis prekiniti vsaj 12 ur pred anestezijo;
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.
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.
Content of the pack and other information What Trydonis contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Trydonis
Genotoxicity of Trydonis has not been evaluated, however, the single active components were devoid of genotoxic activity in the conventional test systems.
Genotoksičnosti zdravila Trydonis niso ocenili, vendar pa posamične učinkovine v običajnih testnih sistemih niso kazale genotoksične dejavnosti.
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.
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.
There are no relevant clinical data on the use of Trydonis during breast-feeding in humans.
Ni relevantnih kliničnih podatkov o uporabi zdravila Trydonis med dojenjem pri ljudeh.
Carcinogenicity studies have not been performed with Trydonis.
Študij kancerogenosti za zdravilo Trydonis niso izvedli.
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).
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).
If any of the above applies to you, tell your doctor before you use Trydonis.
Če karkoli od navedenega velja za vas, obvestite zdravnika, preden začnete uporabljati zdravilo
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):
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):
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.
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.
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.
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
Other medicines and Trydonis
Druga zdravila in zdravilo Trydonis
Trydonis has no or negligible influence on the ability to drive and use machines.
Zdravilo Trydonis nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
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.
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.
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).
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).
The maximum dose is two inhalations of Trydonis twice daily.
Največji odmerek sta dve inhalaciji zdravila Trydonis dvakrat na dan.
• decrease in bone mineral density (thinning of the bones)
• zmanjšanje mineralne gostote kosti (redčenje kosti);
Trydonis can reduce exacerbations (flare-ups) of COPD symptoms.
Zdravilo Trydonis lahko zmanjša poslabšanja (izbruhe) simptomov KOPB.
Trydonis is unlikely to affect your ability to drive and use machines.
Ni verjetno, da bi zdravilo Trydonis vplivalo na sposobnost vožnje in upravljanja strojev.
The recommended dose is two inhalations of Trydonis twice daily.
Priporočeni odmerek sta dve inhalaciji zdravila Trydonis dvakrat na dan.
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).
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 %).
Trydonis should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus.
Zdravilo Trydonis se lahko med nosečnostjo uporablja le, če so pričakovane koristi za mater večje od možnega tveganja za zarodek.
Do not stop using Trydonis or lower the dose, even if you are feeling better or you have no symptoms.
Pomembno je, da zdravilo Trydonis uporabljate vsak dan. Ne prenehajte uporabljati zdravila Trydonis in ne zmanjšujte odmerka, četudi se počutite bolje ali nimate simptomov.
Trydonis is a medicine to help breathing that contains the three active substances:
Zdravilo Trydonis pomaga pri dihanju in vsebuje tri učinkovine:
Infants and neonates born to mothers receiving substantial doses of Trydonis should be observed for adrenal suppression.
Pri dojenčkih in novorojenčkih, rojenim materam, ki so prejele večje odmerke zdravila Trydonis, je treba zato spremljati pojav zaviranja nadledvičnih žlez.
If this occurs you should stop using Trydonis and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing.
Če se to zgodi, prenehajte uporabljati zdravilo Trydonis in nemudoma uporabite hitrodelujoči "inhalator z olajševalcem", da boste obvladali kratko sapo in piskajoče dihanje.
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.
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.
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
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
Trydonis can be used at the recommended dose in patients with mild to moderate renal impairment.
Zdravilo Trydonis se lahko uporablja v priporočenem odmerku pri bolnikih z blago do zmerno okvaro ledvic.
Caution is also required when Trydonis is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia.
Previdnost je potrebna tudi pri uporabi zdravila Trydonis pri bolnikih s tirotoksikozo, sladkorno boleznijo, feokromocitomom in nezdravljeno hipokaliemijo.
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).
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).
Trydonis should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Uporabo zdravila Trydonis je treba takoj prekiniti, bolnika pregledati in uvesti drugo zdravljenje, če je to potrebno.
No specific studies have been performed with Trydonis with regard to the safety in human fertility.
Specifičnih študij varnosti zdravila Trydonis glede plodnosti pri ljudeh niso izvedli.
You should not use Trydonis during breast-feeding.
Zdravila Trydonis ne uporabljajte med dojenjem.
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).
Ker se glikopironij izloča v glavnem skozi ledvice, se lahko pojavijo interakcije z zdravili, ki vplivajo na mehanizem ledvičnega izločanja (glejte poglavje 5.2).
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.
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.
Therefore, as a precautionary measure, it is preferable to avoid the use of Trydonis during pregnancy and during labour.
Iz previdnostnih razlogov se je med nosečnostjo in med porodom uporabi zdravila Trydonis bolje izogibati.
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.
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.
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.
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.
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).
Prav tako se zaradi antiholinergičnega učinka glikopironija dolgotrajnega sočasnega dajanja zdravila Trydonis z drugimi zdravili, ki vsebujejo antiholinergike, ne priporoča (glejte poglavje 4.5).
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.
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".
Wipe inside and outside of the mouthpiece and the inhaler with a clean, dry cloth or tissue.
Zunanjost in notranjost ustnika ter inhalator obrišite s čisto suho krpo ali papirnatim robčkom
There are no or limited amount of data from the use of Trydonis in pregnant women.
Podatkov o uporabi zdravila Trydonis pri nosečnicah ni oziroma so omejeni.
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.
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.
In repeat dose inhalation studies with Trydonis in rats and dogs of up to 13 weeks duration, the main observed alterations were related to effects on the immune system (probably due to systemic corticosteroid effects of beclometasone dipropionate and its active metabolite beclometasone17-monopropionate) and on the cardiovascular system (probably related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium).
V inhalacijskih študijah toksičnosti pri ponavljajočih odmerkih z zdravilom Trydonis pri podganah in psih, ki so trajale do 13 tednov, so bile glavne opažene spremembe povezane z učinki na imunski sistem (verjetno zaradi sistemskih učinkov kortikosteroidov beklometazondipropionata in njegovega aktivnega presnosvka beklometazon 17-monopropionata) in na kardiovaskularni sistem (verjetno povezano z beta2 adrenergičnim delovanjem formoterola formoterola in antimuskarinskim delovanjem glikopironija).
Cleaning of the Trydonis inhaler
Čiščenje inhalatorja z zdravilom Trydonis
Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Trydonis with the AeroChamber Plus spacer device increased the total systemic exposure (AUC0-t) to glycopyrronium.
Farmakokinetični podatki po enkratnem odmerku (glejte poglavje 5.2) so pokazali, da je v primerjavi z redno uporabo brez nastavka uporaba zdravila Trydonis z nastavkom AeroChamber Plus povečala skupno sistemsko izpostavljenost (AUC0-t) glikopironiju.
In patients with severe hepatic impairment, Trydonis should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Pri bolnikih s hudo okvaro jeter se lahko zdravilo Trydonis uporablja le, če so pričakovane koristi večje od možnih tveganj (glejte poglavje 5.2).
A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (focal score greater than or equal to 1) after 26 weeks with Trydonis than with a fixed combination of beclometasone dipropionate and formoterol (57.4% versus 51.8%; p = 0.027).
Analiza odzivnih bolnikov je pokazala, da je imel značilno večji odstotek bolnikov klinično pomembno izboljšanje (fokalni seštevek 1 ali več) po 26 tednih zdravljenja z zdravilom Trydonis v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola (57,4 % v primerjavi z 51,8 %; p = 0,027).
A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (reduction versus baseline of greater than or equal to 4) after 26 and 52 weeks with Trydonis than with a fixed combination of beclometasone dipropionate and formoterol and with tiotropium.
Analiza odzivnih bolnikov je pokazala, da je imel značilno večji odstotek bolnikov klinično pomembno izboljšanje (zmanjšanje glede na izhodišče za 4 ali več) po 26 oz. 52 tednih zdravljenja z zdravilom Trydonis v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola in s tiotropijem.
If you forget to use Trydonis
Če ste pozabili uporabiti zdravilo Trydonis
This study also investigated the potential pharmacokinetic interaction between the active components of Trydonis by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium.
Ta študija je preučila tudi morebitne farmakokinetične interakcije med učinkovinami v zdravilu Trydonis na tak način, da je primerjala farmakokinetične podatke, pridobljene po enkratneme odmerku trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus glikopironija ali po enem odmerku posamičnih sestavin beklometazondipropionata /formoterola ali glikopironija.
It is preferable to avoid the use of Trydonis during labour due to the inhibitory effects of formoterol on uterine contractions.
Med rojevanjem se je uporabi zdravila Trydonis bolje izogniti zaradi zaviralnih učinkov formoterola na krčenje maternice.
In patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, especially if associated with a significant body weight reduction, Trydonis should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Pri bolnikih s hudo okvaro ledvic, vključno s tistimi s končno ledvično odpovedjo, ki zahteva dializno zdravljenje, zlasti če je povezana s pomembnim zmanjšanjem telesne mase, se lahko zdravilo Trydonis uporablja le, če so pričakovane koristi večje od možnih tveganj (glejte poglavje 5.2).
The European Medicines Agency has waived the obligation to submit the results of studies with Trydonis in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Trydonis za vse podskupine pediatrične populacije s KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Trydonis is for inhalation use.
Zdravilo Trydonis se uporablja za inhaliranje.
Trydonis is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left.
Zdravilo Trydonis je opremljeno s števcem odmerkov ali kazalnikom odmerkom, ki je na zadnji strani inhalatorja in kaže, koliko sprožitev je še ostalo.
Related to Trydonis
V povezavi z zdravilom Trydonis
If you stop using Trydonis
Če ste prenehali uporabljati zdravilo Trydonis
There is no relevant use of Trydonis in the paediatric population (under 18 years of age) for the indication of COPD.
Zdravilo Trydonis ni namenjeno za uporabo pri pediatrični populaciji (pri otrocih, starih do 18 let) za indikacijo kronične obstruktivne pljučne bolezni (KOPB).
If you are already using Trydonis
Če že uporabljate zdravilo Trydonis
What Trydonis looks like and contents of the pack
Izgled zdravila Trydonis in vsebina pakiranja
For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Trydonis are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation).
Beklometazondipropionat v obliki izredno majhnih delcev ima veliko močnejši učinek kot formulacije, kjer porazdelitev ni v obliki izredno majhnih delcev (100 mikrogramov beklometazondipropionata v obliki izredno majhnih delcev v zdravilu Trydonis ustreza 250 mikrogramom beklometazondipropionata v formulacijah, ki niso v obliki izredno majhnih delcev).
How to use Trydonis
Kako uporabljati zdravilo Trydonis
Trydonis should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Zdravilo Trydonis je treba pri bolnikih z aktivno ali mirujočo pljučno tuberkulozo ter glivično in virusno okužbo dihal uporabljati previdno.
Compared with tiotropium, Trydonis significantly improved IC by 39 mL (p = 0.025) and 60 mL (p = 0.001) after 26 and 52 weeks of treatment respectively.
V primerjavi s tiotropijem je zdravilo Trydonis značilno izboljšalo IC za 39 ml (p = 0,025) oz. 60 ml (p = 0,001) po 26 oz. 52 tednih zdravljenja.