natgillin/translations-raw huggingface dataset:
Adverse drug reactions reported in 12-week Restless Legs Syndrome clinical trials (ropinirole n=309, placebo n=307) 
Tabela 11 Neželene reakcije, o katerih so poročali pri bolnikih s sindromom nemirnih nog med 12tedenskimi kliničnimi raziskavami (ropinirol n = 309, placebo n = 307)
See leaflet for further information 
Za dodatne informacije glejte navodilo za uporabo.
In the four 12-week efficacy studies, patients with Restless Legs Syndrome were randomised to ropinirole or placebo, and the effects on the IRLS scale scores at week 12 were compared to baseline. 
V štirih 12-tedenski študijah učinkovitosti so bili bolniki s sindromom nemirnih nog randomizirani tako, da so prejemali bodisi ropinirol bodisi placebo.
None of the many metabolites formed are involved in the resulting activity of the product and the main metabolite is 100 times less potent than ropinirole in animal models examining dopaminergic function. 
Pri raziskovanju dopaminergičnega delovanja na živalskih modelih so bili glavni presnovki 100-krat manj učinkoviti od ropinirola.
Vomiting, abdominal pain, heartburn General disorders and administration site conditions Common 
Navzea pogosti bruhanje, abdominalna bolečina, zgaga Splošne težave in spremembe na mestu aplikacije pogosti edem okončin
Do not store above 25 °C. 
Shranjujte pri temperature do 25 °C.
Titanium dioxide (E171) Polysorbate 80 (E433). 
hipromeloza makrogol 400 titanov dioksid (E171) polisorbat 80 (E433)
Film-coated tablet. 
Filmska obloga tablete:
The side effects are generally mild and may become less after you have taken the medicine for a short time. 
Neželeni učinki so običajno blagi oziroma se lahko kmalu po pričetku jemanja ublažijo.
White oval-shaped, marked "GS" on one side and "MLE" on the other. 
Bele, ovalne tablete, označene z "GS" na eni in "MLE" na drugi strani.
ADARTREL is used to treat the symptoms of moderate to severe idiopathic Restless Legs Syndrome. 
Zdravilo ADARTREL uporabljamo za zdravljenje bolezenskih znakov zmernega do hudega idiopatičnega sindroma nemirnih nog.
Then your doctor may increase your dose by 0.5mg per week over three weeks to a dose of 2mg per day. 
V naslednjih treh tednih lahko zdravnik odmerek povečuje po 0,5 mg na teden, do doseženega odmerka 2 mg enkrat na dan.
Pharmaceutical form Route of administra tion 
Farmacevtska oblika Način uporabe zdravila
How to store ADARTREL Further information 
5 Shranjevanje zdravila ADARTREL Dodatne informacije
The pharmacokinetics of ropinirole are linear overall (Cmax and AUC) in the therapeutic range between 0.25 mg and 4 mg, after a single dose and after repeated dosing. 
Tako po enkratnem odmerku kot večkratnih odmerkih v terapevtskem območju med 0,25 mg in 4 mg so farmakokinetične lastnosti ropinirola linearne v celoti (Cmax in AUC).
Restless Legs Syndrome is a condition characterised by an irresistible urge to move the legs and occasionally the arms, usually accompanied by uncomfortable sensations such as tingling, burning or prickling. 
Sindrom nemirnih nog je bolezensko stanje, za katerega je značilna nevzdržna potreba po premikanju nog in občasno tudi rok.
Marketing authorisation Holder 
IMETNIK DOVOLJENJA ZA PROMET
BATCH NUMBER {To be completed nationally} 14. 
ŠTEVILKA SERIJE {Izpolni država članica}
CONDITIONS OF THE MARKETING AUTHORISATION 
DODATEK IV POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
ADARTREL should only be used during pregnancy after your doctor has considered the benefit to you and the potential risk of harm to your unborn child. Tell your doctor immediately if you are pregnant, you think you might be or are planning to become pregnant. 
Zdravilo ADARTREL se sme med nosečnostjo uporabljati le po skrbni presoji zdravnika o možnih koristih za mater in možnih tveganjih, ki jih zdravljenje predstavlja za nerojenega otroka.
Each film-coated tablet contains 1 mg of ropinirole (as hydrochloride). 
Vsaka filmsko obložena tableta vsebuje 1 mg ropinirola (v obliki klorida).
2 BEFORE YOU TAKE ADARTREL 
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ADARTREL
Adverse drug reactions reported in Parkinson's disease clinical trials at doses up to 24 mg/day 
Tabela 12 Neželene reakcije, o katerih so poročali pri bolnikih s Parkinsonovo boleznijo, ki so se v kliničnih raziskavah zdravili z odmerki do 24 mg/dan
Taking ADARTREL with food and drink Taking ADARTREL with food may reduce the likelihood of you feeling or being sick. 
Jemanje zdravila ADARTREL skupaj s hrano in pijačo Jemanje zdravila ADARTREL skupaj s hrano lahko zmanjša pojavnost ali občutek slabosti.
NAME OF THE MEDICINAL PRODUCT ADARTREL 1 mg film-coated tablets Ropinirole NAME OF THE MARKETING AUTHORISATION HOLDER Laboratoire GlaxoSmithKline {See Annex I- to be completed nationally} EXPIRY DATE exp {MM YYYY} BATCH NUMBER lot {XYYYY} OTHER 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Laboratoire GlaxoSmithKline {Glejte Dodatek I - Izpolni država članica}
Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with ropinirole, dose adjustment maybe required. 
Če bolniki med zdravljenjem z ropinirolom kajenje opustijo ali z njim pričnejo, bo torej morda potrebno odmerek ropinirola prilagoditi.
4 POSSIBLE SIDE EFFECTS 
MOŽNI NEŽELENI UČINKI
- The active substance is ropinirole (as hydrochloride) - The other ingredients are 
- Zdravilna učinkovina je ropinirol (v obliki klorida).
Unchanged ropinirole and the metabolites are mainly excreted through the kidneys. 
Ropinirol se v glavnem izloča preko ledvic v nespremenjeni obliki in v obliki presnovkov.
ADARTREL 1 mg film-coated tablets 
ADARTREL 1 mg filmsko obložene tablete
Each film-coated tablet contains 2 mg of ropinirole (as hydrochloride). 
Vsaka filmsko obložena tableta vsebuje 2 mg ropinirola (v obliki klorida).
Each film-coated tablet contains 0.5 mg of ropinirole (as hydrochloride). 
Vsaka filmsko obložena tableta vsebuje 0,5 mg ropinirola (v obliki klorida).
ADARTREL 2 mg film-coated tablets 
ADARTREL 2 mg filmsko obložene tablete
Ropinirole should be administered with caution to patients with moderate hepatic impairment. 
Pri bolnikih z zmerno okvaro jeter je potrebna previdnost pri uporabi ropinirola.
Post marketing reports 
Poročila po pridobitvi dovoljenja za promet
Syncope, dyskinesia, somnolence 
Bolezni živčevja zelo pogosti sinkopa, diskinezija, somnolenca
ADARTREL 1 mg film-coated tablets Ropinirole (as hydrochloride) 
ADARTREL 1 mg filmsko obložene tablete Ropinirol (v obliki klorida)
ADARTREL 0.25 mg film-coated tablets 
ADARTREL 0,25 mg filmsko obložene tablete
ADARTREL 0.5 mg film-coated tablets 
ADARTREL 0,5 mg filmsko obložene tablete
ADARTREL 2 mg film-coated tablets Ropinirole (as hydrochloride) 
ADARTREL 2 mg filmsko obložene tablete Ropinirol (v obliki klorida)
hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172). 
Hipromeloza, makrogol 400, titanov dioksid (E171), rumeni železov oksid (E172) in rdeči železov oksid (E172).
Pink oval-shaped, marked "GS" on one side and "GYG" on the other. 
Filmsko obložena tableta Rožnate, ovalne tablete, označene z "GS" na eni in "GYG" na drugi strani.
6.4 Special precautions for storage 
Posebni varnostni ukrepi za odstranjevanje
You should check with your doctor or pharmacist if you are not sure. 
Če ste negotovi se posvetujte z zdravnikom ali s farmacevtom.
ADARTREL 0.25 mg film-coated tablets Ropinirole (as hydrochloride) 
ADARTREL 0,25 mg filmsko obložene tablete Ropinirol (v obliki klorida)
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France 
Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex Francija
Elderly 
ADARTREL.
7 MARKETING AUTHORISATION HOLDER Laboratoire GlaxoSmithKline 100, route de Versailles 
IMETNIK DOVOLJENJA ZA PROMET Laboratoire GlaxoSmithKline
What ADARTREL looks like and contents of the pack This medicine is provided as oval, white, film-coated tablets marked "GS" on one side and "MLE" on the other. 
Izgled zdravila ADARTREL in vsebina pakiranja Zdravilo je na voljo v obliki belih, ovalnih filmsko obloženih tablet, ki so označene z "GS" na eni in "MLE" na drugi strani.
What ADARTREL looks like and contents of the pack This medicine is provided as oval, pink, film-coated tablets marked "GS" on one side and "GYG" on the other. 
Izgled zdravila ADARTREL in vsebina pakiranja Zdravilo je na voljo v obliki rožnatih, ovalnih filmsko obloženih tablet, ki so označene z "GS" na eni in "GYG" na drugi strani.
ADARTREL 0.5 mg film-coated tablets Ropinirole (as hydrochloride) 
ADARTREL 0,50 mg filmsko obložene tablete Ropinirol (v obliki klorida)
- have liver disease - have a serious heart complaint - have a serious mental health problem In these situations your doctor should carefully supervise the treatment. 
V teh primerih mora zdravnik vaše zdravljenje skrbno nadzirati.
hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433). 
Hipromeloza, makrogol 400, titanov dioksid (E171) in polisorbat
hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), indigo carmine aluminium lake (E132). 
Hipromeloza, makrogol 400, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172) in indigotin
Ropinirole 
B. OVOJNINA
What ADARTREL looks like and contents of the pack This medicine is provided as oval, green, film-coated tablets marked "GS" on one side and "SJG" on the other. 
Izgled zdravila ADARTREL in vsebina pakiranja Zdravilo je na voljo v obliki zelenih, ovalnih filmsko obloženih tablet, ki so označene z "GS" na eni in "SJG" na drugi strani.
What ADARTREL looks like and contents of the pack This medicine is provided as oval, yellow, film-coated tablets marked "GS" on one side and "TES" on the other. 
Izgled zdravila ADARTREL in vsebina pakiranja Zdravilo je na voljo v obliki rumenih, ovalnih filmsko obloženih tablet, ki so označene z "GS" na eni in "TES" na drugi strani.
hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), indigo carmine aluminium lake (E132). 
Hipromeloza, makrogol 400, titanov dioksid (E171), rumeni železov oksid (E172) in indigotin (E132).
Yellow oval-shaped, marked "GS" on one side and "TES" on the other. 
Filmsko obložena tableta Rumene, ovalne tablete, označene z "GS" na eni in "TES" na drugi strani.
Each film-coated tablet contains 0.25 mg of ropinirole (as hydrochloride). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka filmsko obložena tableta vsebuje 0,25 mg ropinirola (v obliki klorida).
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172). 
hipromeloza makrogol 400 titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
Dose reduction should be considered if patients experience significant undesirable effects. 
V primeru pojava znatnejših neželenih učinkov je potrebno razmisliti o zmanjšanju odmerka.
Green oval-shaped, marked "GS" on one side and "SJG" on the other. 
Filmsko obložena tableta Zelene, ovalne tablete, označene z "GS" na eni in "SJG" na drugi strani.
C. PACKAGE LEAFLET 
C. NAVODILO ZA UPORABO
Table 1 
Tabela 1 Povečevanje odmerka
BATCH NUMBER 
ŠTEVILKA SERIJE Lot {XYYYY}
- The other ingredients are Tablet core: 
- Pomožne snovi so:
During inhalation you will hear a whirring noise. 
Med vdihovanje boste slišali brneč zvok.
Check 
preverite
If you use more Xoterna Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit. 
Če ste uporabili večji odmerek zdravila Xoterna Breezhaler, kot bi smeli Če ste vdihnili preveč tega zdravila ali če kdo drug pomotoma uporabi vaše kapsule, takoj obvestite zdravnika ali pojdite do najbližjega oddelka za nujno pomoč.
The chances of the capsule breaking into small pieces will be increased if the capsule is pierced more than once. 
Možnost, da se kapsula tako zdrobi, je večja, če kapsulo nehote predrete več kot enkrat.
If this happens, carefully loosen the capsule by tapping the base of the inhaler. 
Če se to zgodi, previdno sprostite kapsulo z rahlim trkanjem od spodnji del inhalatorja.
The capsules must be administered only using the Xoterna Breezhaler inhaler (see section 6.6). 
Kapsule so namenjene samo uporabi z inhalatorjem Xoterna Breezhaler (glejte poglavje 6.6).
Do not use Xoterna Breezhaler - if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Xoterna Breezhaler - če ste alergični na indakaterol, glikopironij ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
- The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Xoterna Breezhaler contains lactose”). 
- Drugi sestavini inhalacijskega praška sta laktoza monohidrat in magnezijev stearat (glejte poglavje 2 pod “Zdravilo Xoterna Breezhaler vsebuje laktozo”).
The recommended dose is the inhalation of the content of one capsule once daily using the Xoterna Breezhaler inhaler. 
Priporočeni odmerek je inhalacija vsebine ene kapsule enkrat na dan z uporabo inhalatorja Xoterna Breezhaler.
Administration of Xoterna Breezhaler may result in paradoxical bronchospasm which can be life-threatening. 
Odmerjanje zdravila Xoterna Breezhaler lahko povzroči paradoksni bronhospazem, ki je lahko življenjsko nevaren.
The European Medicines Agency has waived the obligation to submit the results of studies with Xoterna Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Xoterna Breezhaler za vse podskupine pediatrične populacije pri kronični obstruktivni pljučni bolezni (KOPB) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
COPD is a long-term disease and you should use Xoterna Breezhaler every day and not only when you have breathing problems or other symptoms of COPD. 
- KOPB je dolgotrajna bolezen in zdravilo Xoterna Breezhaler morate uporabljati vsak dan, ne le takrat, ko težko dihate ali imate katerega od drugih simptomov KOPB.
The safety and efficacy of Xoterna Breezhaler in children have not been established. 
Varnost in učinkovitost zdravila Xoterna Breezhaler pri otrocih nista bili dokazani.
The presentation of the safety profile is based on the experience with Xoterna Breezhaler and the individual active substances. 
Predstavitev varnostnih lastnosti temelji na izkušnjah z uporabo zdravila Xoterna Breezhaler in njegovih posameznih učinkovin.
Xoterna Breezhaler is recommended to be administered at the same time of the day each day. 
Zdravilo Xoterna Breezhaler je priporočeno uporabiti vsak dan ob istem času.
Xoterna Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication. 
Zdravila Xoterna Breezhaler se ne sme uporabljati za zdravljenje astme, saj o uporabi pri tej indikaciji ni na voljo nobenih podatkov.
Xoterna Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards. 
Zdravilo Xoterna Breezhaler, ki so ga odmerjali zjutraj, je zmanjšalo dinamično hiperinflacijo pljuč in podaljšalo čas, ko so bolniki lahko izvajali vajo, in sicer od prvega odmerka dalje.
Therefore, Xoterna Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. 
Iz tega razloga se sme zdravilo Xoterna Breezhaler v nosečnosti uporabiti samo v primeru, da pričakovana korist za bolnico upravičuje potencialno tveganje za plod.
The safety experience with Xoterna Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose. 
Izkušnje glede varnosti pri uporabi zdravila Xoterna Breezhaler so pridobljene pri izpostavljenosti zdravilu v trajanju do 15 mesecev v priporočenem terapevtskem odmerku.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Xoterna Breezhaler should any of these signs or symptoms develop. 
Bolnike je treba seznaniti z znaki in simptomi akutnega glavkoma zaprtega zakotja in jim naročiti, naj v primeru pojava teh simptomov ali znakov prenehajo uporabljati zdravilo Xoterna Breezhaler.
The co-administration of Xoterna Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4). 
Sočasne uporabe zdravila Xoterna Breezhaler z drugimi zdravili, ki vsebujejo antiholinergične učinkovine, niso proučevali in zato ni priporočena (glejte poglavje 4.4).
Other most common adverse reactions related to the medicinal product (at least 3% of patients for Xoterna Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache. 
Drugi najbolj pogosti neželeni učinki, ki jih povzroča zdravilo (pri najmanj 3 % bolnikov, ki so prejemali zdravilo Xoterna Breezhaler, in z večjo pogostnostjo kot pri uporabi placeba), so bili kašelj, nazofaringitis in glavobol.
Following inhalation of Xoterna Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose. 
Ocenjujejo, da je po inhaliranju zdravila Xoterna Breezhaler absolutna biološka uporabnost indakaterola v razponu od 61 % do 85 % prejetega odmerka, za glikopironij pa znaša približno 47 % prejetega odmerka.
You should not use Xoterna Breezhaler unless your doctor tells you to do so. 
Zdravila Xoterna Breezhaler ne smete uporabljati, razen če vam tako naroči zdravnik.
• Xoterna Breezhaler capsules must always be stored in the blister card and only removed immediately before use. 
• Xoterna Breezhaler kapsule vedno shranjujte v pretisnem omotu in jih vzemite iz njega šele tik pred uporabo.
Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 
Zdravilo Xoterna Breezhaler je indicirano kot vzdrževalno bronhodilatatorno zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
There is no relevant use of Xoterna Breezhaler in the paediatric population (under 18 years) in the indication COPD. 
Zdravilo Xoterna Breezhaler ni primerno za uporabo pri pediatrični populaciji (v starosti pod 18 let) za indikacijo KOPB.
In patients with severe renal impairment or end-stage renal disease requiring dialysis, Xoterna Breezhaler should be used only if the expected benefit outweighs the potential risk. 
Pri bolnikih s hudo okvaro ledvic ali s končno ledvično odpovedjo, ki potrebujejo dializo, se sme zdravilo Xoterna Breezhaler uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje.
The Xoterna Breezhaler clinical Phase III development programme included six studies in which over 8,000 patients were enrolled: 1) a 26-week placebo- and active-controlled (indacaterol once daily, glycopyrronium once daily, open-label tiotropium once daily) study; 2) a 26-week active-controlled (fluticasone/salmeterol twice daily) study; 3) a 64-week active-controlled (glycopyrronium once daily, open-label tiotropium once daily) study; 4) a 52-week placebo-controlled study; 5) a 3-week placeboand active-controlled (tiotropium once daily) exercise tolerance study; and 6) a 52-week activecontrolled (fluticasone/salmeterol twice daily) study. 
Klinični razvojni program študij faze III zdravila Xoterna Breezhaler je vključeval šest študij, v katere je bilo vključenih več kot 8.000 bolnikov: 1) 26-tedensko s placebom in aktivno kontrolirano študijo (indakaterol enkrat na dan, glikopironij enkrat na dan in odprto zdravljenje s tiotropijem enkrat na dan), 2) 26-tedensko aktivno kontrolirano študijo (flutikazon/salmeterol dvakrat na dan), 3) 64-tedensko aktivno kontrolirano študijo (glikopironij enkrat na dan, odprto zdravljenje s tiotropijem enkrat na dan), 4) 52-tedensko s placebom kontrolirano študijo, 5) 3-tedensko s placebom in aktivno (s tiotropijem enkrat na dan) kontrolirano študijo prenašanja napora in 6) 52-tedensko aktivno kontrolirano študijo (flutikazon/salmeterol dvakrat na dan).
Overall the effect on heart rate over time did not show a consistent pharmacodynamic effect of Xoterna Breezhaler. 
V celoti rezultati opazovanja delovanja na srčno frekvenco v danem času niso potrdili enotnega farmakodinamičnega učinka zdravila Xoterna Breezhaler.
Xoterna Breezhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists. 
Pri uporabi zdravila Xoterna Breezhaler je potrebna previdnost pri bolnikih s konvulzivnimi motnjami ali s hipertiroidizmom in pri bolnikih, ki so neobičajno odzivni na agoniste beta-2 adrenergičnih receptorjev.
Upon initiation of treatment with Xoterna Breezhaler plasma glucose should be monitored more closely in diabetic patients. 
Pri sladkornih bolnikih je treba po začetku zdravljenja z zdravilom Xoterna Breezhaler še bolj natančno spremljati koncentracije glukoze v plazmi.
What Xoterna Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide. 
Kaj vsebuje zdravilo Xoterna Breezhaler - Učinkovini sta indakaterol (v obliki maleata) in glikopironijev bromid.
In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Xoterna Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2). 
Pri bolnikih s hudo okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije manj kot 30 ml/min/1,73 m2), med katere sodijo tudi tisti s končno ledvično odpovedjo, ki potrebujejo dializno zdravljenje, se sme zdravilo Xoterna Breezhaler uporabljati samo v primeru, da pričakovana korist presega potencialno tveganje (glejte poglavje 5.2).
There are no data available for the use of Xoterna Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2). 
O uporabi zdravila Xoterna Breezhaler pri bolnikih s hudo okvaro jeter ni na voljo nobenih podatkov, zato je pri teh bolnikih potrebna previdnost (glejte poglavje 5.2).
Smoking status and baseline FEV1 had no apparent effect on systemic exposure to indacaterol and glycopyrronium after inhalation of Xoterna Breezhaler. 
Status kajenja in izhodiščna vrednost FEV1 nimata opaznega vpliva na sistemsko izpostavljenost indakaterolu in glikopironiju po inhlairanju zdravila Xoterna Breezhaler.
During long-term clinical studies, more patients on Xoterna Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%). 
V dolgoročnih kliničnih študijah so klinično opazne spremembe v koncentraciji glukoze v krvi pogosteje opažali pri bolnikih, ki so jemali zdravilo Xoterna Breezhaler v priporočenem odmerku, (4,9 %) v primerjavi s tistimi, ki so jemali placebo (2,7 %).
This will also help you to remember to use it. You can inhale Xoterna Breezhaler any time before or after food or drink. 
Zdravilo Xoterna Breezhaler lahko inhalirate kadarkoli, pred ali po uživanju hrane oziroma pijače.
Following inhalation of Xoterna Breezhaler, the median time to reach peak plasma concentrations of indacaterol and glycopyrronium was approximately 15 minutes and 5 minutes, respectively. 
Po inhalaciji zdravila Xoterna Breezhaler znaša mediana vrednost časa, ko indakaterol in glikopironij dosežeta najvišjo koncentracijo v plazmi, približno 15 minut oziroma 5 minut.
Xoterna Breezhaler has not been investigated in patients for whom diabetes mellitus is not well controlled, therefore caution and appropriate monitoring are advised in such patients. 
Uporabe zdravila Xoterna Breezhaler niso proučevali pri bolnikih, ki niso imeli dobro urejene sladkorne bolezni, zato sta pri uporabi zdravila pri takšnih bolnikih priporočena previdnost in ustrezno spremljanje.