natgillin/translations-raw huggingface dataset:
Blood sugar levels too low Increased blood sugar levels Incorrect control of plasma sugar
Prenizke ravni sladkorja v krvi Povišane ravni sladkorja v krvi Nepravilen nadzor sladkorja v plazmi
Package leaflet: Information for the user AMGLIDIA 0.6 mg/mL oral suspension
Navodilo za uporabo: informacije za uporabnika AMGLIDIA 0,6 mg/ml peroralna suspenzija glibenklamid
Dose adjustment is required in patients with mild to moderate renal impairment.
Pri bolnikih z blago do zmerno okvaro ledvic je treba odmerek prilagoditi.
AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension
AMGLIDIA 0,6 mg/ml peroralna suspenzija AMGLIDIA 6 mg/ml peroralna suspenzija
Retighten the screw cap to push the adaptor well into the bottle.
Pokrovček z navojem ponovno privijte, da nastavek dobro potisnete v steklenico.
Weakening of the blood-glucoselowering effect
Slabitev učinka zniževanja ravni glukoze v krvi
AMGLIDIA 6 mg/mL oral suspension Each mL contains 6 mg glibenclamide.
AMGLIDIA 6 mg/ml peroralna suspenzija 1 ml vsebuje 6 mg glibenklamida.
Blood sugar levels too low Incorrect control of plasma sugar
Prenizke ravni sladkorja v krvi Nepravilen nadzor sladkorja v plazmi
AMGLIDIA 0.6 mg/mL oral suspension Each mL contains 0.6 mg glibenclamide.
AMGLIDIA 0,6 mg/ml peroralna suspenzija 1 ml vsebuje 0,6 mg glibenklamida.
Transfer to sulfonylureas occurred in childhood with a median [IQR] at transfer of 4.8 years [1.7 - 11.4 years].
starosti 4,8 leta (1,7-11,4 leta).
Disopyramide used to treat an irregularity in the heartbeat
Dizopiramid, ki se uporablja za zdravljenje neenakomernega srčnega utripa
Colesevelam
Holesevelam
Patients should be closely monitored by their treating physician during the titration phase.
V fazi titracije mora lečeči zdravnik skrbno spremljati bolnike.
Please read the posology and method of administration in the SmPC attached to this prescriber's guide.
Preberite informacije o odmerjanju in načinu uporabe v povzetku glavnih značilnosti zdravila,
The signs of too low blood sugar may include: - shaking, sweating, feeling very anxious or confused, fast heart beat
- tresenje, potenje, močan občutek strahu ali zmedenost, hiter srčni utrip
Blood sugar levels too low
Prenizke ravni sladkorja v krvi
AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension glibenclamide
AMGLIDIA 0,6 mg/ml peroralna suspenzija AMGLIDIA 6 mg/ml peroralna suspenzija glibenklamid peroralna uporaba
- Transient visual disturbances.
- Navodilo shranite.
The medicine is administered as a ready-for-use oral suspension to be given using a specific marked syringe.
pripravljena za uporabo, ki se daje z uporabo posebne označene brizge.
Potentiation of the blood-glucose lowering
Potenciranje zniževanja ravni glukoze v krvi
Depending on the volume calculated per administration: If the volume per administration is 1mL or below, the 1mL syringe should be prescribed; If the volume per administration is more than 1mL, the 5mL syringe should be prescribed.
če je volumen zdravila za dajanje manjši kot 1 ml, je treba predpisati 1 ml brizgo;
• The Amglidia 0.6 mg/mL strength should not be used for posology higher than 0.6 mg/kg/day to limit the exposure to the sodium benzoate excipient.
0,6 mg/kg/dan, da se omeji izpostavljenost natrijevemu benzoatu kot pomožni snovi.
Biguanides
Dizopiramid
- Increase in sensitivity of the skin to sunlight - Transient visual disturbances.
- večja občutljivost kože na svetlobo; - začasne motnje vida; - druge spremembe, ki jih pokažejo laboratorijski krvni testi: povišane ravni belih krvničk,
MAO inhibitors
Zaviralci MAO
Glibenclamide has been shown to be effective in patients with mutations in the genes coding for the βcell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
Glibenklamid se je izkazal za učinkovitega pri bolnikih z mutacijami genov, ki kodirajo od ATP
CONDITIONS DE PRESCRIPTION ET DE DÉLIVRANCE
OZNAČEVANJE IN NAVODILO ZA UPORABO
INDICATIONS D'UTILISATION
B. NAVODILO ZA UPORABO
If the blood-glucose level exceeds
Če je raven glukoze v kapilarni krvi
Dose omission
SPROŠČANJE SERIJ
Maximum recommended posology (expressed as mg/kg/day) where the AMGLIDIA 0.6 mg/mL strength can be used
Največji priporočeni odmerek (izražen v mg/kg/dan),
If you give more AMGLIDIA to your child than you should
če opazite, da je vaš otrok bolj bled kot ponavadi.
Active substance
SEZNAM POMOŽNIH SNOVI
ONCE DAILY
ENKRAT NA DAN
Children and adolescents Don't give this medicine to children or adolescents below the age of 18 years.
Otroci in mladostniki Tega zdravila ne smete dajati otrokom ali mladostnikom, mlajšim od 18 let.
contact your doctor as soon as possible.
se čim prej posvetujte z zdravnikom.
Not for acute use
Ni za akutno uporabo
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2017
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15. november 2017
The pre-specified non-inferiority margin was 50 mL.
Vnaprej določena meja neinferiornosti je bila 50 mL.
Further management should be clinically indicated or as recommended by the national poisons centre, where available.
Nadaljnje ukrepanje mora potekati, kot je klinično indicirano ali kot priporoča nacionalni Center za zastrupitve, kjer je ta na voljo.
• weakening of the bones, leading to fractures.
• oslabitev kosti, ki povzroča zlome.
Where adverse reaction frequencies differed between studies, the higher frequency is reported below.
Kjer so se pogostnosti neželenih učinkov med študijami razlikovale, je spodaj navedena večja pogostnost.
For further instructions for use and handling, see section 4.2.
Za dodatna navodila za uporabo in ravnanje glejte poglavje 4.2.
Hold this breath in for as long as possible (at least 3-4 seconds).
Dih zadržite, kolikor je mogoče dolgo (vsaj 3 do 4
Don't stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse.
Ne nehajte ga uporabljati, če vam tega ne svetuje zdravnik, tudi če se počutite bolje, ker se vam simptomi lahko poslabšajo.
Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, France
Glaxo Wellcome Production Zone Industrielle No. 2, 23. rue Lavoisier, 27000 Evreux, Francija
• painful and frequent urination (may be signs of a urinary tract infection)
• boleče in pogosto uriniranje (lahko je znak okužbe sečil),
When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life.
Če ga uporabljate redno, vam lahko pomaga obvladati težko dihanje in zmanjšati vpliv KOPB na vaše vsakdanje življenje.
The decrease in serum potassium is usually transient, not requiring supplementation.
Znižanje kalija v serumu je po navadi prehodno in ne zahteva dodajanja.
It is very important that you use Trelegy Ellipta every day, as instructed by your doctor.
Zelo pomembno je, da zdravilo Trelegy Ellipta uporabljate vsak dan, kot vam je naročil zdravnik.
At this dose, no effects on systemic exposure were observed.
Ob tem odmerku niso opazili učinkov na sistemsko izpostavljenost.
Contents of the pack and other information Step-by-step instructions
Vsebina pakiranja in dodatne informacije Navodila po korakih
Use of Rescue Medication
Uporaba rešilnega zdravila
Other side effects have occurred but their exact frequency is not known (frequency cannot be estimated from the available data):
Drugi neželeni učinki so se pojavili, a njihova natančna pogostnost ni znana (pogostnoti ni mogoče oceniti na podlagi podatkov, ki so na voljo): • zamegljen vid.
Increasing use of short-acting bronchodilators to relieve symptoms may indicate deterioration of disease control.
Naraščanje uporabe kratkodelujočih bronhodilatatorjev za olajšanje simptomov je lahko znak, da se urejenost bolezni slabša.
The first time you use Trelegy Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Ko prvič uporabite zdravilo Trelegy Ellipta, vam ni treba preverjati, ali inhalator deluje pravilno; inhalator vsebuje predhodno odmerjene odmerke in je pripravljen za takojšnjo uporabo.
If possible, show them the inhaler, the package or this leaflet.
Če je mogoče, mu pokažite inhalator, pakiranje zdravila ali to navodilo za uporabo.
If a dose is missed the next dose should be taken at the usual time the next day.
Če bolnik pozabi uporabiti odmerek, mora naslednji odmerek uporabiti naslednji dan ob običajnem času.
See section 4 ‘Possible side effects' for information on symptoms to look out for while you are using this medicine.
Glejte poglavje 4, "Možni neželeni učinki", za informacije o simptomih, na katere morate biti pozorni med uporabo tega zdravila.
COPD is a longterm condition characterised by breathing difficulties that slowly get worse.
KOPB je dolgotrajna bolezen, za katero so značilne težave z dihanjem, ki se polagoma slabšajo.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se z njim posvetujte, preden uporabite to zdravilo.
Health-Related Quality of Life
Zdravstvena kakovost življenja
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Pogostnost neželenih učinkov je opredeljena upoštevaje naslednji dogovor: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ter ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Don't use Trelegy Ellipta if you already use these medicines.
Ne uporabljajte zdravila Trelegy Ellipta, če že uporabljate ta zdravila.
The patient should be assessed and alternative therapy instituted if necessary.
Bolnika je treba oceniti in uvesti drugo zdravljenje, če je potrebno.
If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately.
Če se vam dihanje ali piskanje takoj po uporabi tega zdravila poslabša, zdravilo nehajte uporabljati in takoj poiščite zdravniško pomoč.
See ‘Step-by-step instructions' in this leaflet for full information.
Za celotne informacije glejte "Navodila po korakih" v tem navodilu.
Administration of Trelegy Ellipta to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus.
Uporaba zdravila Trelegy Ellipta pri nosečnicah pride v poštev le, če pričakovana korist za mater upravičuje morebitno tveganje za plod.
What is the inhaler?
Kaj je inhalator?
• pain in the back of the mouth and throat
• bolečine v zadnjem delu ust in v grlu,
If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:
Če se vam simptomi KOPB (težko dihanje, piskajoče dihanje, kašelj) ne izboljšajo ali se poslabšajo, ali če pogosteje uporabljate vaš hitrodelujoč inhalator,
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Preobčutljivost za zdravilne učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
Trelegy Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD.
Zdravilo Trelegy Ellipta morate uporabljati vsak dan in ne samo, kadar imate težave z dihanjem ali druge simptome KOPB.
Vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic indicating that vilanterol (as trifenatate) does not represent a genotoxic hazard to humans.
Vilanterol (kot alfa-fenilcinamat) in trifenilocetna kislina nista bila genotoksična; to kaže, da vilanterol (kot trifenatat) ne pomeni genotoksične nevarnosti za človeka.
Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Nemudoma nehajte uporabljati to zdravilo in nemudoma poiščite zdravniško pomoč, ker gre lahko za resno stanje, imenovano paradoksni bronhospazem.
How to use the inhaler
Kako uporabiti inhalator
Tell your doctor or pharmacist if you are taking any of these.
Zdravniku ali farmacevtu morate povedati, če jemljete katero od teh zdravil.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu .
If you use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
Če ste uporabili preveč tega zdravila, se takoj posvetujte z zdravnikom ali farmacevtom, ker boste morda potrebovali zdravniško pomoč.
Covariate analysis showed higher FF apparent clearance (42%) when comparing FF/VI to FF/UMEC/VI; however, this is not considered clinically relevant.
Kovariatna analiza je pokazala višji navidezni očistek FF (42 %) v primerjavi FF/VI s FF/UMEC/VI, vendar se ti podatki ne smatrajo za klinično relevantne.
Don't use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, embalaži in inhalatorju poleg oznake "EXP".
Some medicines may affect how this medicine works, or make it more likely that you'll have side effects.
Nekatera zdravila lahko vplivajo na delovanje tega zdravila ali povečajo verjetnost za pojav neželenih učinkov.
Because you are using this medicine for COPD, you may be at an increased risk of developing an infection of the lungs known as pneumonia.
Ker uporabljate to zdravilo za KOPB, imate morda večje tveganje za okužbo pljuč, imenovano pljučnica.
A decision must be made whether to discontinue breast-feeding or to discontinue Trelegy Ellipta therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Trelegy Ellipta, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
Umeclidinium and vilanterol belong to a group of medicines called bronchodilators.
Umeklidinij in vilanterol spadata v skupino zdravil, imenovanih bronhodilatatorji.
You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache.
Opazite lahko hitrejše bitje srca kot po navadi, občutek drhtenja, motnje vida, suha usta ali glavobol.
These patients may have also been taking other COPD medications (e.g. mucolytics or leukotriene receptor antagonists).
Ti bolniki so lahko uporabljali tudi druga zdravila za KOPB (npr. mukolitike ali antagoniste levkotrienskih receptorjev).
Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Zvišanje ravni cikličnega AMP povzroča sprostitev bronhialnih gladkih mišic in zavre sproščanje mediatorjev takojšnje preobčutljivosti iz celic, predvsem iz mastocitov.
The precise mechanism through which fluticasone furoate affects COPD symptoms is not known.
Natančen mehanizem, po katerem flutikazonfuroat vpliva na simptome KOPB, ni znan.
In vitro protein binding studies between subjects with severe renal impairment and healthy volunteers were conducted, and no clinically significant evidence of altered protein binding was seen.
In vitro so izvedli študije vezave na beljakovine pri bolnikih s hudo okvaro ledvic in zdravih prostovoljcih; te študije niso pokazale klinično pomembnih znakov spremenjene vezave na beljakovine.
Trelegy Ellipta should not be used in patients with asthma since it has not been studied in this patient population.
Zdravila Trelegy Ellipta se ne sme uporabljati pri bolnikih z astmo, ker v tej populaciji bolnikov ni raziskano.
• infection of the nose, sinuses or throat
• okužba nosu, obnosnih votlin (sinusov) ali grla,
For the 14-dose inhaler, the dose counter will also show half red when there are fewer than 10 doses left, and then will show half red with the number 0 after the last dose is used.
Na inhalatorju s 14 odmerki bo pol števca odmerkov rdečega, ko bo preostalo manj kot 10 odmerkov, po uporabi zadnjega odmerka pa bo postal popolnoma rdeč in pokazal bo številko 0.
Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse reactions, in which case patients should be monitored for systemic corticosteroid adverse reactions.
Sočasni uporabi se je treba izogniti, razen če korist odtehta povečano tveganje za pojav sistemskih neželenih učinkov kortikosteroidov; v tem primeru je treba bolnike nadzorovati glede sistemskih neželenih učinkov kortikosteroidov.
However, these higher systemic exposures remain below the threshold for FF-induced reduction of serum and urine cortisol and are not considered clinically relevant.
Vendar so bile te visoke sistemske izpostavljenosti pod pragom, nad katerim FF zniža raven kortizola v serumu in urinu in se ne smatrajo za klinično pomembne.
Patients should not stop therapy with Trelegy Ellipta without physician supervision since symptoms may recur after discontinuation.
Bolniki ne smejo končati zdravljenja z zdravilom Trelegy Ellipta brez zdravniškega nadzora, ker se lahko simptomi po prenehanju zdravljenja ponovijo.
NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Trading Services Limited GSK Logo
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GlaxoSmithKline Trading Services Limited GSK logo
In terms of other patient characteristics, a study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium.
Kar zadeva druge značilnosti bolnikov, študija slabih metabolizatorjev s CYP2D6 ni pokazala klinično pomembnega vpliva genetskega polimorfizma CYP2D6 na sistemsko izpostavljenost umeklidiniju.
• sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis).
• boleče, dvignjene lehe v ustih ali žrelu, ki jih povzroča glivična okužba (kandidoza).
There are no clinical data to support the use of Trelegy Ellipta for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Ni kliničnih podatkov, ki bi potrjevali uporabo zdravila Trelegy Ellipta za zdravljenje akutnega bronhospazma ali akutnega poslabšanja KOPB (tj. za rešilno zdravljenje).
The most frequently reported adverse reactions with Trelegy Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Najpogosteje zabeleženi neželeni učinki med uporabo zdravila Trelegy Ellipta so bili nazofaringitis (7 %), glavobol (5 %) in okužba zgornjih dihal (2 %).
The other ingredients are lactose monohydrate (see section 2 under ‘Trelegy Ellipta contains lactose') and magnesium stearate.
Pomožni snovi sta laktoza monohidrat (glejte poglavje 2 pod naslovom "Zdravilo Trelegy Ellipta vsebuje laktozo") in magnezijev stearat.
Population PK analyses for FF/UMEC/VI were conducted using a combined PK dataset from three phase III studies in 821 COPD subjects.
Populacijske farmakokinetične analize FF/UMEC/VI so izvedli s kombiniranim naborom farmakokinetičnih podatkov iz treh študij III. faze na 821 preiskovancih s KOPB.
Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g. eosinophils, macrophages, lymphocytes) and mediators (e.g. cytokines and chemokines) involved in inflammation.
Dokazano je, da imajo kortikosteroidi širok spekter vplivov na več vrst celic (npr. na eozinofilce, makrofage, limfocite) in mediatorjev (npr. na citokine in kemokine), ki sodelujejo pri vnetju.
Not all pack sizes may be available in your country.
V vaši državi na trgu morda ni vseh navedenih pakiranj.
other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g.
druga dolgodelujoča zdravila, podobna temu zdravilu, ki se uporabljajo za zdravljenje težav z dihanjem, npr. tiotropij, indakaterol.
Tabulated summary of adverse reactions The safety profile of Trelegy Ellipta is based on three phase III clinical studies.
Povzetek neželenih učinkov v preglednici Ugotovljene varnostne značilnosti zdravila Trelegy Ellipta temeljijo na treh kliničnih študijah III. faze.
The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium and vilanterol was assessed in healthy volunteers.
Vpliv zmernega zaviralca P-gp verapamila (v odmerku 240 mg enkrat na dan) na farmakokinetiko umeklidinija in vilanterola v stanju dinamičnega ravnovesja so ocenili pri zdravih prostovoljcih.
Significant reductions were observed over all other timepoints for UMEC/VI (p<0.001) and for the all but two of the of timepoints for FF/VI (p≤0.021).
Značilno zmanjšanje je bilo opaženo na vseh drugih časovnih točkah za UMEC/VI (p < 0,001) in na vseh časovnih točk razen dveh za FF/VI (p ≤ 0,021).
Interaction with CYP3A4 inhibitor
Medsebojno delovanje z zaviralci CYP3A4
It is not possible to accidentally take extra medicine or a double dose in one inhalation.
Pri eni inhalaciji ni mogoče pomotoma uporabiti dodatne količine zdravila ali dvojnega odmerka.
When you take the inhaler out of the sealed tray, it will be in the ‘closed' position.
Ko vzamete inhalator iz embalaže, bo v položaju "zaprto".
No clinically relevant effects requiring dose adjustment were observed.
Pokazala ni nobenih klinično pomembnih vplivov, ki bi zahtevali prilagoditev odmerka.
Fluticasone furoate, umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp).
Flutikazonfuroat, umeklidinij in vilanterol so substrati P-glikoproteinskega prenašalca (P-gp).
Cardioselective beta-blockade should only be considered for profound vilanterol overdose effects that are clinically concerning and unresponsive to supportive measures.
Kardioselektivna blokada beta pride v poštev le pri zelo izrazitih učinkih prevelikega odmerjanja vilanterola, ki so klinično zaskrbljujoči in se ne odzovejo na podporne ukrepe.
It should not be used to relieve a sudden attack of breathlessness or wheezing.
Ne smete ga uporabljati za olajšanje nenadnega napada težkega dihanja ali piskanja.
Fluticasone furoate is a corticosteroid with potent anti-inflammatory activity.
Flutikazonfuroat je kortikosteroid z močnim protivnetnim delovanjem.
The inhaler contains two aluminium foil laminate blister strips that deliver a total of 14 or 30 doses (14 or 30 day supply).
Inhalator vsebuje dva pretisna trakova iz laminata aluminijske folije, ki oddata skupno 14 ali 30 odmerkov (14- ali 30-dnevna zaloga).
Each inhaler contains either 14 or 30 doses (14 or 30 day supply).
Vsak inhalator vsebuje 14 ali 30 odmerkov (zaloga za 14 ali 30 dni).
An approximately 1.4-fold increase in umeclidinium AUC was observed with no effect on vilanterol AUC.
Opazili so približno 1,4-kratno povečanje AUC umeklidinija in nobenega vpliva na AUC vilanterola.
Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol, which could lead to an increased potential for adverse reactions.
Previdnost je potrebna med sočasno uporabo z močnimi zaviralci CYP3A4 (npr. ketokonazol, ritonavir, zdravila, ki vsebujejo kobicistat), ker obstaja možnost večje sistemske izpostavljenosti flutikazonfuroatu in vilanterolu, to pa lahko poveča možnost neželenih učinkov.
Once the tray is opened Trelegy Ellipta is ready to use.
Ko je embalaža odprta, je zdravilo Trelegy Ellipta pripravljeno za uporabo.
Trelegy Ellipta is for inhalation use only.
Zdravilo Trelegy Ellipta je namenjeno samo za inhalacijsko uporabo.
The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day.
Priporočeni in največji odmerek je ena inhalacija zdravila Trelegy Ellipta 92/55/22 mikrogramov enkrat na dan, vsak dan ob istem času.