natgillin/translations-raw huggingface dataset:
The pharmacokinetics of roflumilast 250 micrograms once-daily was tested in 16 patients with mild to moderate hepatic impairment classified as Child-Pugh A and B. In these patients, the total PDE4 inhibitory activity was increased by about 20% in patients with Child-Pugh A and about 90% in patients with Child-Pugh B. Simulations suggest dose proportionality between roflumilast 250 and 500 micrograms in patients with mild and moderate hepatic impairment.
Farmakokinetiko roflumilasta v odmerku 250 mikrogramov enkrat na dan so preizkusili pri 16 bolnikih z blago do zmerno jetrno okvaro stopnje Child-Pugh A in B. V tej skupini bolnikov je bilo skupno inhibitorno delovanje na PDE4 povečano za približno 20 % pri bolnikih s stopnjo Child-Pugh A in za približno 90 % pri bolnikih s stopnjo Child-Pugh B. Za bolnike z blago in zmerno jetrno okvaro simulacije kažejo sorazmernost z velikostjo odmerkov roflumilasta 250 in 500 mikrogramov.
Warnings and precautions Talk to your doctor or pharmacist before taking Daxas.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Daxas se posvetujte z zdravnikom ali farmacevtom.
Administration of the cytochrome P450 enzyme inducer rifampicin resulted in a reduction in total PDE4 inhibitory activity by about 60%.
Sočasna uporaba induktorja encima citokroma P450, rifampicina, je povzročila zmanjšanje skupnega inhibitornega delovanja na PDE4 za približno 60 %.
Roflumilast should not be used during breast-feeding.
Roflumilasta se med dojenjem ne sme uporabljati.
Roflumilast is extensively metabolised in humans, with the formation of a major pharmacodynamically active metabolite, roflumilast N-oxide.
Roflumilast se pri človeku obsežno presnavlja, pri čemer nastaja glavni farmakodinamično aktivni presnovek, roflumilast N-oksid.
Plasma protein binding of roflumilast and its N-oxide metabolite is approximately 99% and 97%, respectively.
Delež vezave roflumilasta in njegovega presnovka N-oksida na plazemske proteine znaša približno 99 % oz. 97 %.
That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females; o Patients concomitantly treated with CYP1A2/2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or CYP1A2/3A4 inhibitors (such as enoxacin).
Pri določenih populacijah lahko pride do povečane izpostavljenosti in povečanega tveganja za trajno intoleranco: o Posebne populacije s povečano inhibicijo PDE4, npr. temnopolte ženske nekadilke; o Bolniki, sočasno zdravljeni z zaviralci CYP1A2/2C19/3A4 (kot sta fluvoksamin in cimetidin) ali zaviralci CYP1A2/3A4 (kot je enoksacin).
Other side effects include the following:
Drugi možni neželeni učinki so:
Following an oral dose, the median plasma effective half-life of roflumilast and its N-oxide metabolite are approximately 17 and 30 hours, respectively.
Po peroralnem odmerku znaša mediana plazemskega efektivnega razpolovnega časa za roflumilast in njegov presnovek N-oksid približno 17 oz. 30 ur.
Elderly No dose adjustment is necessary.
Starejši Prilagajanje odmerka ni potrebno.
Roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 51 ml (pre-bronchodilator FEV1, p<0.0001), and by 53 ml (post-bronchodilator FEV1, p<0.0001).
Roflumilast 500 mikrogramov enkrat na dan je statistično pomembno izboljšal pljučno funkcijo v primerjavi s placebom, v povprečju za 51 ml (FEV1 pred bronhodilatatorjem, p < 0,0001) in za 53 ml (FEV1 po bronhodilatatorju, p < 0,0001).
In the subgroup of patients with history of frequent exacerbations (at least 2 exacerbations during the last year), the rate of exacerbations was 1.526 with roflumilast and 1.941 with placebo corresponding to a relative risk reduction of 21.3% (95% CI: 7.5% to 33.1%).
V podskupini bolnikov z anamnezo pogostih poslabšanj (vsaj 2 poslabšanji v preteklem letu) je pogostnost poslabšanj znašala 1,526 ob roflumilastu in 1,941 ob placebu, kar pomeni zmanjšanje relativnega tveganja za 21,3 % (95 % interval zaupanja: 7,5 % do 33,1 %).
Daxas may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Zdravilo Daxas lahko jemljete skupaj z drugimi zdravili za zdravljenje KOPB, kot so inhalacijski ali peroralni bronhodilatatorji.
A total of 1935 patients were randomised to doubleblind medication and approximately 70% were also using a long-acting muscarinic antagonist (LAMA) through the course of the trial.
Na dvojno slepo zdravljenje je bilo vsega skupaj randomiziranih 1.935 bolnikov, približno 70 % bolnikov pa je med preskušanjem uporabljalo tudi dolgodelujoče antagoniste muskarinskih receptorjev (LAMA).
No epididymal toxicity or changes in semen parameters were present in any other rodent or non-rodent species including monkeys in spite of higher exposures.
Kljub visokim stopnjam izpostavljenosti niso opazili toksičnosti za epididimis ali sprememb v parametrih sperme pri nobeni drugi vrsti glodavcev ali ne-glodavcev, vključno z opicami.
Therefore, the concomitant treatment with theophylline is not recommended.
Iz tega razloga sočasno zdravljenje s teofilinom ni priporočljivo.
In one of two rat embryofetal development studies, a higher incidence of incomplete skull bone ossification was seen at a dose producing maternal toxicity.
V eni od dveh študij o embriofetalnem razvoju na podganah so pri odmerku, ki je bil za mater toksičen, zabeležili večjo pojavnost nepopolnega zakostenevanja lobanjskih kosti.
Weight decreased Decreased appetite
Presnovne in prehranske motnje zmanjšanje telesne mase zmanjšan apetit
The educational material for the prescriber should include information on the following key elements:
Izobraževalno gradivo za zdravnika mora vsebovati naslednje ključne informacije:
Patients and caregivers should be requested to report any changes in the patient`s behaviour or mood or suicidal ideation.
Bolnikom in skrbnikom je treba naročiti, da poročajo o kakršnih koli spremembah v bolnikovem vedenju ali razpoloženju ali o pojavu samomorilnih misli.
Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes viral infection or herpes zoster.
Izkušnje so omejene tudi pri bolnikih s predhodno diagnozo tuberkuloze, virusnega hepatitisa, okužbe s herpes virusom ali herpes zostrom.
The incidence observed was also higher in patients less than 75 years old, treated with roflumilast when compared to those treated with placebo (3.1% vs 2.0%).
Večjo pojavnost so opazili tudi pri bolnikih, mlajših od 75 let, ki so se zdravili z roflumilastom, v primerjavi z bolniki, ki so prejemali placebo (3,1 % v primerjavi z
The tolerability of roflumilast was evaluated in a 12-week randomised, double-blind, parallel group trial (RO-2455-302-RD) in patients with severe COPD associated with chronic bronchitis.
V 12-tedenski randomizirani, dvojno slepi študiji z vzporednimi skupinami so ovrednotili prenašanje roflumilasta (v študiji RO-2455-302-RD) pri bolnikih, ki so imeli hudo KOPB, povezano s kroničnim bronhitisom.
The N-oxide metabolite is the major metabolite observed in the plasma of humans.
Presnovek N-oksid je glavni presnovek v človeški plazmi.
In an interaction study with an oral contraceptive containing gestodene and ethinyl oestradiol, the total PDE4 inhibitory activity was increased by 17%.
V študiji o medsebojnem delovanju s peroralnim kontraceptivom, ki vsebuje gestoden in etinilestradiol, se je skupno inhibitorno delovanje na PDE4 povečalo za 17 %.
Daxas contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Zdravilo Daxas vsebuje učinkovino roflumilast, ki je protivnetno zdravilo, imenovano zaviralec fosfodiesteraze 4.
Patients should be advised to weigh themselves at regular intervals and record the weight in the patient card.
Bolnikom je treba svetovati, da se sami redno tehtajo in zabeležijo telesno maso na kartico za bolnike.
Rescue medicinal products Daxas is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Zdravila za prvo pomoč Zdravilo Daxas ni indicirano kot zdravilo za prvo pomoč pri zdravljenju akutnih bronhospazmov.
The proportion of patients who experienced at least 1 adverse event during the double-blind treatment period were 648 (66.9%) patients and 572 (59.2%) patients in the roflumilast and placebo groups, respectively.
Med dvojno slepim zdravljenjem se je vsaj 1 neželeni učinek pojavil pri 648 bolnikih (66,9 %) v skupini z roflumilastom in 572 bolnikih (59,2 %) v skupini s placebom.
• multiple sclerosis or SLE
• multipla skleroza ali sistemski eritematozni lupus
Lactose monohydrate Maize starch Povidone
Jedro laktoza monohidrat koruzni škrob povidon magnezijev stearat
Seventeen (1.8%) patients in the roflumilast group and 18 (1.9%) patients in the placebo group died during the double-blind treatment period due to any reason and 7 (0.7%) patients in each group due to a COPD exacerbation.
Med dvojno slepim zdravljenjem je 17 bolnikov (1,8 %) v skupini z roflumilastom in 18 bolnikov (1,9 %) v skupini s placebom umrlo zaradi katerega koli razloga, 7 bolnikov (0,7 %) v vsaki skupini pa zaradi poslabšanja KOPB.
Daxas is not recommended if you have one or more of the following diseases: - severe immunological diseases such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Zdravljenje z zdravilom Daxas ni priporočljivo, če imate eno ali več naslednjih bolezni: - resne bolezni imunskega sistema, kot so okužba s HIV, multipla skleroza (MS), eritematozni lupus (EL) ali progresivna multifokalna levkoencefalopatija (PML), - resne akutne infekcijske bolezni, kot sta tuberkuloza ali akutni hepatitis, - raka (razen bazalnoceličnega karcinoma - počasi napredujoča oblika kožnega raka), - resno okvaro srčne funkcije.
Starting dose titration trial
Študija titracije začetnega odmerka
The limited experience in patients with latent infections such as tuberculosis, viral hepatitis or herpes infections.
Omejene izkušnje pri bolnikih z latentnimi okužbami, npr. tuberkulozo, virusnim hepatitisom ali herpetičnimi okužbami.
Clinical data are considered insufficient to recommend dose adjustment and caution should be observed in patients with mild liver impairment (Child-Pugh A).
Klinični podatki so nezadostni, da bi priporočali prilagajanje odmerkov, zato je pri bolnikih z blago okvaro jeter (Child-Pugh A) potrebna previdnost.
Therefore, following administration of roflumilast, the total PDE4 inhibition is considered to be the combined effect of both roflumilast and roflumilast N-oxide.
Po vnosu roflumilasta naj bi bila torej skupna inhibicija PDE4 posledica kombiniranega učinkovanja roflumilasta in roflumilast N-oksida.
Daxas is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Zdravilo Daxas je kontraindiciranopri bolnikih z zmerno ali hudo okvaro jeter (Child-PughB ali C).
Steady state plasma concentrations of roflumilast and its N-oxide metabolite are reached after approximately 4 days for roflumilast and 6 days for roflumilast N-oxide following once-daily dosing.
Plazemske koncentracije roflumilasta in njegovega presnovka N-oksida ob odmerjanju enkrat na dan dosežejo stanje dinamičnega ravnovesja po približno 4 dneh za roflumilast in 6 dneh za roflumilast N-oksid.
The other ingredients are lactose monohydrate (see section 2 under “Daxas contains lactose”), maize starch, povidone, magnesium stearate.
Pomožne snovi so laktoza monohidrat (glejte poglavje 2 pod naslovom "Zdravilo Daxas vsebuje laktozo"), koruzni škrob, povidon in magnezijev stearat.
A slight reduction in male fertility was seen in conjunction with epididymal toxicity in rats.
Pri podganah so zabeležili blago zmanjšanje plodnosti samcev v povezavi s toksičnim delovanjem na epididimis.
Post-bronchodilator FEV1 increased for the roflumilast group by 52 mL (95% CI: 40, 65 mL) and decreased for the placebo group by 4 mL (95% CI: -16, 9 mL).
V skupini, ki je prejemala roflumilast, se je vrednost FEV1 po bronhodilatatorju povečala za 52 ml (95 % interval zaupanja: 40, 65 ml), v skupini, ki je prejemala placebo, pa zmanjšala za 4 ml (95 % interval zaupanja: -16, 9 ml).
Roflumilast is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Roflumilast ni priporočljiv za bolnike z anamnezo depresije, ki je bila povezana s samomorilnimi mislimi ali vedenjem.
Experience in patients with latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster is limited.
Izkušnje pri bolnikih z latentnimi okužbami, npr. tuberkulozo, virusnim hepatitisom, okužbo s herpes virusom in herpes zostrom, so omejene.
Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daxas (see section 4.3).
Bolniki z zmerno ali hudo okvaro jeter stopnje Child-Pugh B ali C zdravila Daxas ne smejo jemati (glejte poglavje 4.3).
Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C should not take roflumilast (see section 4.3).
Bolniki z zmerno ali hudo jetrno okvaro stopnje Child-Pugh B ali C roflumilasta ne smejo jemati (glejte poglavje 4.3).
There was a trend towards a reduction in moderate or severe exacerbations in subjects treated with roflumilast compared with placebo over 52 weeks, which did not achieve statistical significance (Table 2).
Pri bolnikih, ki so se zdravili z roflumilastom, so v primerjavi z bolniki, ki so prejemali placebo, opazili tendenco k zmanjšanju zmernih ali hudih poslabšanj v 52-tedenskem obdobju, ki pa ni dosegla statistične značilnosti (preglednica 2).
Daxas is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.
Zdravilo Daxas ni priporočljivo za bolnike z anamnezo depresije, ki je bila povezana s samomorilnimi mislimi ali vedenjem.
The rate of severe COPD exacerbations and changes in FEV1 were evaluated as key secondary endpoints.
Kot ključna sekundarna opazovana dogodka so vrednotili delež hudih poslabšanj KOPB in spremembe vrednosti FEV1.
Moderate or severe hepatic impairment (Child-Pugh B or C).
Zmerna ali huda okvara jeter (Child-Pugh B ali C).
Rare side effects (may affect up to 1 in 1,000 people) - male breast enlargement - decreased sense of taste - respiratory tract infections (excluding pneumonia) - bloody stools, constipation - elevation of liver or muscle enzymes (seen in blood tests) - wheals (urticaria).
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - povečanje dojk pri moških - zmanjšan občutek okušanja - okužbe dihalnih poti (razen pljučnice) - krvavo blato, zaprtost - zvišana vrednost jetrnih ali mišičnih encimov (opaženo pri krvnih preiskavah) - izpuščaj (koprivnica).
How to take Daxas
Kako jemati zdravilo Daxas
Uncommon side effects (may affect up to 1 in 100 people) - trembling, sensation of spinning head (vertigo), dizziness - sensation of rapid or irregular heartbeat (palpitations) - gastritis, vomiting - reflux of stomach acid to the gullet (acid regurgitations), indigestion - rash - muscle pain, muscle weakness or cramps - back pain - feeling of weakness or tiredness, feeling unwell.
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - tresenje, občutek vrtenja v glavi (vrtoglavica), omotica - občutek hitrega in nepravilnega bitja srca (palpitacije) - vnetje želodčne sluznice, bruhanje - vračanje želodčne kisline v požiralnik (regurgitacija kisline), slaba prebava - izpuščaj - bolečine v mišicah, oslabelost mišic ali mišični krči - bolečina v hrbtu - občutek šibkosti ali utrujenosti, splošno slabo počutje.
A total of 1323 patients were randomised to receive roflumilast 500 micrograms once a day for 12 weeks (n=443), roflumilast 500 micrograms every other day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (n=439), or roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (n=441).
Skupno so 1.323 bolnikov randomizirali na bodisi prejemanje roflumilasta v odmerku 500 mikrogramov enkrat na dan 12 tednov (n = 443), na prejemanje roflumilasta v odmerku 500 mikrogramov vsak drugi dan 4 tedne in nato roflumilasta v odmerku 500 mikrogramov enkrat na dan 8 tednov (n = 439) ali na prejemanje roflumilasta v odmerku 250 mikrogramov enkrat na dan 4 tedne in nato roflumilasta v odmerku 500 mikrogramov enkrat na dan 8 tednov (n = 441).
The rate (per patient per year) of moderate exacerbations (requiring intervention with systemic glucocorticosteroids) or severe exacerbations (resulting in hospitalisation and/or leading to death) after 1 year was 1.142 with roflumilast and 1.374 with placebo corresponding to a relative risk reduction of 16.9% (95% CI: 8.2% to 24.8%) (primary endpoint, p=0.0003).
Pogostnost (na bolnika na leto) zmernih poslabšanj (ki so zahtevala uporabo sistemskih glukokortikoidov) ali resnih poslabšanj (ki so imela za posledico sprejem v bolnišnico in/ali so povzročila smrt) po 1 letu je znašala 1,142 za roflumilast in 1,374 za placebo, kar pomeni zmanjšanje relativnega tveganja za 16,9 % (95 % interval zaupanja: 8,2 % do 24,8 % (primarni klinični izid, p = 0,0003).
In vitro studies and clinical interaction studies suggest that the metabolism of roflumilast to its N-oxide metabolite is mediated by CYP1A2 and 3A4.
Študije in vitro in klinične študije medsebojnega delovanja kažejo, da presnova roflumilasta v njegov presnovek N-oksid poteka preko CYP1A2 in 3A4.
In Study RO-2455-404-RD when compared with the overall population, the total PDE4 inhibitory activity determined from ex vivo unbound fractions was found to be 15% higher in patients ≥75 years of age, and 11% higher in patients with baseline body weight <60 kg (refer to section 4.4).
V študiji RO-2455-404-RD je bilo na osnovi ex vivo nevezanih frakcij ugotovljeno, da je skupno inhibitorno delovanje na PDE4 v primerjavi s splošno populacijo pri bolnikih, starih ≥ 75 let, večje za 15 % in pri bolnikih z izhodiščno telesno maso, manjšo od 60 kg, večje za 11 % (glejte poglavje 4.4).
The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g.multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daxas should not be initiated or should be stopped in these patients.
Pomanjkanje izkušenj pri bolnikih z okužbo HIV ali aktivnim hepatitisom, z resnimi imunološkimi boleznimi (npr. multiplosklerozo, eritematoznimlupusom, multifokalno leukoencefalopatijo) ali na zdravljenju z imunosupresivnimi zdravili (razen kratkotrajnega zdravljenja s sistemskimikortikosteroidi) in zdravila Daxas se pri teh bolnikih ne sme uvajati oz. ga je treba ukiniti.
Prolongation of gestation was seen in mice.
Pri miših so opazili podaljšanje brejosti.
Daxas 250 micrograms tablets are white to off-white, embossed with ‘D' on one side and ‘250' on the other side.
Daxas 250 mikrogramov tablete so bele do sivo-bele barve in imajo na eni strani izbočeno črko “D”, na drugi strani pa oznako “250”.
Caution is necessary in Child-Pugh A patients (see section 4.2).
Pri bolnikih s stopnjo Child-Pugh A je potrebna previdnost (glejte poglavje 4.2).
More patients in the roflumilast group (27.6%) than placebo (19.8%) withdrew study medication due to any reason (risk ratio: 1.40; 95% CI: 1.19 to 1.65).
V študiji je bilo zdravljenje zaradi katerega koli razloga prekinjeno pri več bolnikov v skupini z roflumilastom (27,6 %) kot v skupini s placebom (19,8 %) (razmerje tveganja: 1,40; 95 % interval zaupanja: 1,19 do 1,65).
The plasma AUC of the N-oxide metabolite on average is about 10-fold greater than the plasma AUC of roflumilast.
Plazemska površina pod krivuljo za presnovek N-oksid je v povprečju 10-krat večja od plazemske površine pod krivuljo za roflumilast.
Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase-4 (PDE4) inhibitory activity.
Za obe spojini, roflumilast in roflumilast N-oksid, je značilno intrinzično inhibitorno delovanje na fosfodiesterazo 4 (PDE4).
Concomitant treatment with long acting muscarinic antagonists (LAMA) A higher incidence of weight decrease, decreased appetite, headache and depression was observed during Study RO-2455-404-RD in patients receiving concomitant roflumilast and long-acting muscarinic antagonists (LAMA) plus concomitant inhaled corticosteroids (ICS) and long acting B2 agonists (LABA) compared to those treated only with concomitant roflumilast, ICS and LABA.
Sočasno zdravljenje z dolgodelujočimi muskarinskimi antagonisti (LAMA) V študiji RO-2455-404-RD so pri bolnikih, ki so se sočasno zdravili z roflumilastom in dolgodelujočimi muskarinskimi antagonisti (LAMA) ter inhalacijskimi kortikosteroidi in dolgodelujočimi agonisti adrenergičnih receptorjev beta-2 (LABA), opazili večjo pojavnost zmanjšanja telesne mase, zmanjšanja apetita, glavobola in depresije v primerjavi z bolniki, ki so se sočasno zdravili le z roflumilastom, inhalacijskimi kortikosteroidi in LABA.
The rate of severe exacerbations was reduced in the overall patient group (rate ratio: 0.76; 95% CI: 0.60 to 0.95) with a rate of 0.24 per patient/year compared to a rate of 0.32 per patient/year in patients treated with placebo.
Delež hudih poslabšanj se je zmanjšal v celotni populaciji bolnikov (razmerje deležev: 0,76; 95 % interval zaupanja: 0,60 do 0,95) z deležem 0,24 na bolnikov-let v primerjavi z deležem 0,32 na bolnikov-let pri bolnikih, ki so prejemali placebo.
Roflumilast or placebo treatment was added to continuous treatment with a long-acting bronchodilator, in particular salmeterol in Study M2-127 or tiotropium in Study M2-128.
natančneje salmeterolom v študiji M2-127 ali tiotropijem v študiji M2-128.
Roflumilast is not recommended during pregnancy.
Uporaba roflumilasta med nosečnostjo ni priporočljiva.
Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation.
Bolnikom in skrbnikom je treba naročiti, da zdravnika obvestijo o kakršnih koli spremembah v vedenju ali razpoloženju in o pojavu kakršnih koli samomorilnih misli.
In a pooled analysis of the one-year studies M2-124 and M2-125, roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 48 ml (pre-bronchodilator FEV1, primary endpoint, p<0.0001), and by 55 ml (post-bronchodilator FEV1, p<0.0001).
V analizi združenih podatkov iz enoletnih študij M2-124 in M2-125 je roflumilast 500 mikrogramov enkrat na dan pomembno izboljšal pljučno funkcijo v primerjavi s placebom, v povprečju za 48 ml (FEV1 pred bronhodilatatorjem, primarni klinični izid, p < 0,0001) in za 55 ml (FEV1 po bronhodilatatorju, p < 0,0001).
There are no clinical data to support the concomitant treatment with theophylline for maintenance therapy.
Kliničnih podatkov, ki bi podpirali sočasno vzdrževalno zdravljenje s teofilinom, ni na razpolago.
Patient Card
Opozorilna kartica za bolnika
Renal impairment No dose adjustment is necessary.
Okvara ledvic Prilagajanje odmerka ni potrebno.
A total of 2,690 patients were included and randomised in two supportive 1-year studies (M2-111 and M2-112).
V dve podporni enoletni študiji (M2-111 in M2-112) je bilo vključeno in randomizirano skupno 2.690 bolnikov.
The discontinuation rate for those receiving 500 micrograms every other day for 4 weeks followed by 500 micrograms once a day for 8 weeks was not statistically significantly different to those receiving 500 micrograms once a day for 12 weeks.
Odstotek prekinitev zdravljenja med tistimi, ki so prejemali 500 mikrogramov vsak drugi dan 4 tedne in nato 500 mikrogramov enkrat na dan 8 tednov, se ni statistično značilno razlikoval od odstotka prekinitev zdravljenja pri tistih, ki so prejemali 500 mikrogramov enkrat na dan 12 tednov.