natgillin/translations-raw huggingface dataset:
An overdose of Riarify 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 Riarify 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).
After oral administration (40 to 80 micrograms), 6% to 10% of the dose was recovered in urine as unchanged active substance in healthy subjects; up to 8% of the dose was recovered as the glucuronide. 
Po peroralnem dajanju (40 do 80 mikrogramov) so pri zdravih prostovoljcih 6 % do 10 % odmerka potrdili v urinu v obliki nespremenjene učinkovine; do 8 % odmerka so potrdili v obliki glukuronida.
They should be advised by their doctor or pharmacist about the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled active substance to the lungs. 
Zdravnik ali farmacevt mora bolnikom svetovati o pravilni uporabi in negi inhalatorja in nastavka ter o tehniki preverjanja zagotovitve optimalne dostavitve inhalirane učinkovine v pljuča.
However, an increase in total systemic exposure of up to 2.5-fold was observed in subjects with severe renal impairment (glomerular filtration rate below 30 mL/min/1.73 m2), as a consequence of a significant reduction of the amount excreted in urine (approximately 90% reduction of glycopyrronium renal clearance). 
Vendar pa so opazili povečanje skupne sistemske izpostavljenosti za do 2,5-krat pri osebah s hudo okvaro ledvic (stopnja glomerularne filtracije pod 30 ml/min/1,73 m2) kot posledica močnega zmanjšanja količine, izločene v urin (približno 90-odstotno zmanjšanje ledvičnega očistka glikopironija).
Riarify can be used at the recommended dose in patients with mild to moderate renal impairment. 
Zdravilo Riarify se lahko uporablja v priporočenem odmerku pri bolnikih z blago do zmerno okvaro ledvic.
This should be treated immediately with a fast-acting inhaled bronchodilator (reliever). 
To je treba takoj zdraviti s hitrodelujočim inhalacijskim bronhodilatatorjem
The bioavailability of swallowed beclometasone dipropionate is negligible; however, pre-systemic conversion to beclometasone 17-monopropionate results in 41% of the dose being absorbed as the active metabolite. 
Biološka uporabnost zaužitega beklometazondipropionata je zanemarljiva; vendar predsistemska pretvorba v beklometazon 17-monopropionat povzroči, da se 41 % odmerka absorbira kot aktivni presnovek.
Do not stop using Riarify or lower the dose, even if you are feeling better or you have no symptoms. 
Pomembno je, da zdravilo Riarify uporabljate vsak dan. Ne prenehajte uporabljati zdravila Riarify in ne zmanjšujte odmerka, četudi se počutite bolje ali nimate simptomov.
Animal studies have shown impairment of fertility (see section 5.3). 
Študije na živalih so pokazale vpliv na plodnost (glejte poglavje 5.3).
Dispensing date dd/mm/yyyy 
dd/mm/llll
If mist appears after the inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2. 
Če se po inhalaciji pojavi meglica iz inhalatorja ali ustnih kotov, mora bolnik postopek ponoviti od 2.
Chemical and physical in-use stability has been demonstrated for 2 months at 25°C. 
Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 2 meseca pri temperaturi 25 °C.
A comparison across studies showed that the pharmacokinetics of beclometasone 17-monopropionate, formoterol and glycopyrronium is similar in COPD patients and in healthy subjects. 
Primerjava med študijami je pokazala, da je farmakokinetika beklometazon 17-monopropionata, formoterola in glikopironija pri bolnikih s KOPB podobna kot pri zdravih prostovoljcih.
• fall in the level of some constituents of your blood: of certain white blood cells called granulocytes, of potassium or of cortisol 
• upad ravni nekaterih sestavin krvi: nekaterih belih krvnih celic, imenovanih granulociti, kalija ali kortizola;
Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. 
Zadržite dih, kolikor dolgo ga lahko, nato pa vzemite inhalator iz ust in počasi izdihnite.
Glycopyrronium bromide is a high affinity muscarinic receptor antagonist with a greater than 4-fold selectivity for the human M3 receptors over the human M2 receptor as it has been demonstrated. 
Glikopironijev bromid je antagonist muskarinskih receptorjev z visoko afiniteto in dokazali so, da je za humane receptorje M3 več kot 4-krat bolj selektiven kot za humane receptorje M2.
Cytochrome P450 isoenzymes CYP2D6, CYP2C19 and CYP2C9 are involved in the O-demethylation of formoterol. 
V O-demetilacijo formoterola so vključeni izoencimi CYP2D6, CYP2C19 in CYP2C9 citokroma P450.
You and your doctor must make a decision whether to discontinue breast-feeding or to discontinue/abstain from Riarify 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 Riarify, pri čemer morate pretehtati prednosti dojenja za otroka in prednosti zdravljenja za vas.
• if you have an overactive thyroid gland. 
• če imate čezmerno aktivno žlezo ščitnico.
Check that the dose counter (60/120 puffs) has moved down by one or that the dose indicator (180 puffs) has rotated by a small amount. 
Preverite, ali se je številka na števcu odmerkov (60/120 vdihov) zmanjšala za eno ali pa se je kazalnik odmerkov (180 vdihov) nekoliko obrnil.
Caution is also required when Riarify is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia. 
Previdnost je potrebna tudi pri uporabi zdravila Riarify pri bolnikih s tirotoksikozo, sladkorno boleznijo, feokromocitomom in nezdravljeno hipokaliemijo.
Glucocorticoids are excreted in human milk. 
Glukokortikoidi se izločajo v materino mleko.
The cumulative urinary excretion of formoterol after single inhalation from a dry powder inhaler increased linearly in the 12-96 micrograms dose range. 
Izločanje Kumulativno izločanje formoterola v urinu po enkratni inhalaciji iz inhalatorja s suhim praškom se je povečevalo linearno v razponu odmerka 12-96 mikrogramov.
In patients with severe hepatic impairment, Riarify 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 Riarify uporablja le, če so pričakovane koristi večje od možnih tveganj (glejte poglavje 5.2).
In COPD patients receiving repeated twice daily administration of inhaled glycopyrronium, the fraction of the dose excreted in urine ranged from 13.0% to 14.5% at steady state. 
Pri bolnikih s KOPB, ki so prejeli ponavljajoče odmerke inhaliranega glikopironija dvakrat na dan, je bila frakcija odmerka, izločenega v urinu, v razponu od 13,0 % do 14,5 % v stanju dinamičnega ravnovesja.
• muscle cramps and pain in muscles 
• mišični krči in bolečine v mišicah;
Take another puff, following the instructions starting again from step 2. 
Naredite dodaten vdih: znova začnite pri 2. koraku in upoštevajte navodila.
Hypersensitivity reactions, including erythema, lips, face, eye and pharyngeal oedema 
občasni preobčutljivostne reakcije, vključno z eritemom, ustnicami, obrazom, očmi in faringealnim edemom redki
Dermatitis allergic1 
Bolezni imunskega sistema alergijski dermatitis1
Concomitant treatment with monoamine oxidase inhibitors, including medicinal products with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions. 
Sočasno zdravljenje z zaviralci monoaminooksidaze, vključno z zdravili, ki imajo podobne lastnosti kot furazolidon in prokarbazina, lahko pri bolnikih sproži hipertenzivno reakcijo.
Riarify 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 Riarify 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.
Their lips should then be placed around the mouthpiece, with the tongue flat under it. 
Potem z ustnicami objemite ustnik, jezik naj bo plosko pod njim.
If any of the above applies to you, tell your doctor before you use Riarify. 
Če karkoli od navedenega velja za vas, obvestite zdravnika, preden začnete uporabljati zdravilo
The fraction of an inhaled dose that is swallowed after administration with a metered dose inhaler may range between 60% and 90%. 
Delež inhaliranega odmerka, ki ga bolnik pogoltne po uporabi zdravila z inhalatorjem z določenim odmerkom, je v razponu od 60 % do 90 %.
Not known (frequency cannot be estimated from the available data): • blurred vision. 
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines can prolong the QT interval and increase the risk of ventricular arrhythmias. 
Sočasno zdravljenje s kinidinom, dizopiramidom, prokainamidom, antihistaminiki, zaviralci monoaminooksidaze, tricikličnimi antidepresivi in fenotiazini lahko podaljša interval QT in poveča tveganje ventrikularnih aritmij.
Lower respiratory tract infection (fungal) 
občasni okužbe spodnjih dihal (glivične)
Inhaled beclometasone dipropionate is rapidly absorbed through the lungs; prior to absorption there is extensive conversion to beclometasone 17-monopropionate via esterase enzymes that are found in most tissues. 
Inhalirani beklometazondipropionat se hitro absorbira skozi pljuča; pred absorpcijo pride do ekstenzivne pretvorbe v beklometazon 17-monopropionat z encimi esteraze, ki so prisotni v večini tkiv.
• flu 
• gripa;
Cleaning of the Riarify inhaler 
Čiščenje inhalatorja z zdravilom Riarify
Do not remove the pressurised container from the inhaler and do not use water or other liquids to clean your inhaler. 
Ne odstranite vsebnika pod tlakom iz inhalatorja, za čiščenje inhalatorja pa ne uporabljajte vode ali kakšne druge tekočine.
• upset stomach 
• razdažen želodec;
The effect of organic cation transport inhibition (using cimetidine as a probe inhibitor of OCT2 and MATE1 transporters) in the kidneys on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 16% and a slight decrease in renal clearance by 20% due to co administration of cimetidine. 
Učinek zaviranja organskega kationskega prenašalca (z uporabo cimetidina kot primarnega zaviralca prenašalcev OCT2 in MATE1) v ledvicah na dispozicijo inhaliranega glikopironija je pokazal omejeno povečanje skupne sistemske izpostavljenosti (AUC0-t) za 16 % in majhno zmanjšanje ledvičnega izločanja za 20 % zaradi sočasnega dajanja cimetidina.
After priming, the counter/indicator should read 60, 120 or 180. 
Po pripravi mora števec/kazalnik odmerkov kazati 60, 120 ali 180.
Following intravenous dosing, the disposition of beclometasone dipropionate and its active metabolite is characterised by high plasma clearance (150 and 120 L/h respectively), with a small volume of distribution at steady state for beclometasone dipropionate (20 L) and larger tissue distribution for its active metabolite (424 L). 
Po intravenskem odmerjanju je za dispozicijo beklometazondipropionata in njegovega aktivnega presnovka značilen velik očistek v plazmi (150 oz. 120 l/h), z majhno količino porazdelitve v stanju dinamičnega ravnovesja za beklometazondipropionat (20 l) in večjo porazdelitvijo njegovega aktivnega presnovka v tkivu (424 l).
Pack sizes of 1 container of 60, 120 or 180 actuations and multipacks of 2 or 3 containers of 120 actuations each. 
Velikosti pakiranja so po 1 vsebnik s 60, 120 ali 180 sprožitev in skupna pakiranja z 2 ali 3 vsebniki s 120 sprožitev.
Psychomotor hyperactivity1, sleep disorders1, anxiety, depression1, aggression1, behavioural changes (predominantly in children) 1 
občasni psihomotorična hiperaktivnost1, motnje spanja1, anksioznost, depresija1, agresija1, spremenjeno vedenje (predvsem pri otrocih)1
Additional instructions for specific groups of patients For patients with weak hands it may be easier to hold the inhaler with both hands. 
Bolniki s šibkimi rokami bodo inhalator morda lažje držali z obema rokama.
Reduction of COPD exacerbations 
Zmanjšanje poslabšanj KOPB
Following glycopyrronium inhalation, the lung bioavailability was 10.5% (with activated charcoal ingestion) while the absolute bioavailability was 12.8% (without activated charcoal ingestion) confirming the limited gastrointestinal absorption and indicating that more than 80% of glycopyrronium systemic exposure was from lung absorption. 
Po inhalaciji glikopironija je bila biološka uporabnost v pljučih 10,5 % (z zaužitjem aktivnega oglja), medtem ko je bila absolutna biološka uporabnost 12,8 % (brez zaužitja aktivnega oglja), kar potrjuje omejeno absorpcijo v prebavilih in kaže, da je več kot 80 % sistemske izpostavljenosti glikopironiju posledica absorpcije v pljučih.
Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Riarify 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 Riarify z nastavkom AeroChamber Plus povečala skupno sistemsko izpostavljenost (AUC0-t) glikopironiju.
Additional there are multipacks containing either 2 or 3 pressurised containers with 120 puffs, each. 
Dodatno so na voljo skupna pakiranja, ki vsebujejo dva ali tri tlačne vsebnike, od katerih vsak omogoča 120 vdihov.
The elimination half-life determined after oral administration is 2-3 hours. 
Razpolovni čas izločanja, ugotovljen po peroralnem dajanju, je 2 do 3 ure.
You should not use Riarify during breast-feeding. 
Zdravila Riarify ne uporabljajte med dojenjem.
Glucocorticoids are widely used for the suppression of inflammation in chronic inflammatory diseases of the airways such as COPD. 
Glukokortikoidi se obsežno uporabljajo za zaviranje vnetij pri kroničnih vnetnih boleznih dihalnih poti, kot je KOPB.
• medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level. 
• zdravili za zdravljenje srčnih bolezni (digoksin) lahko povzroči zmanjšanje koncentracije kalija v krvi.
Effect of renal impairment 
Učinek okvare ledvic
Therefore, the index fingers should be placed on the top of the pressurised container and both thumbs on the base of the inhaler. 
V ta namen je treba kazalca položiti na vrh, palca pa na spodnji del tlačnega vsebnika.
There are no or limited amount of data from the use of Riarify in pregnant women. 
Podatkov o uporabi zdravila Riarify pri nosečnicah ni oziroma so omejeni.
120 and 180 actuation pressurised container: 22 months. 
Tlačni vsebnik s 120 in 180 sprožitvami: 22 mesecev.
Effects on lung function 
Vpliv na pljučno funkcijo
injection, 40% of the dose was excreted in the urine within 24 hours. 
injekciji glikopironija se je 40 % odmerka izločilo v urinu v
To inhale the second puff, patients should keep the inhaler in a vertical position for approximately 30 seconds and repeat steps 2 to 6. 
Za vdihavanje drugega vdiha naj bolnik približno 30 sekund drži inhalator navpično in ponovi korake od 2 do 6.
In patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, especially if associated with a significant body weight reduction, Riarify 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 Riarify uporablja le, če so pričakovane koristi večje od možnih tveganj (glejte poglavje 5.2).
These may be signs of an acute attack of narrow-angle glaucoma (may affect up to 1 in 10,000 people). 
To so lahko znaki akutnega napada glavkoma z zaprtim zakotjem (pojavi se lahko pri največ 1 od 10.000 bolnikov).
Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1). 
Vzdrževalno zdravljenje pri odraslih bolnikih z zmerno do hudo obliko kronične obstruktivne pljučne bolezni (KOPB), ki ni ustrezno zdravljena s kombinacijo inhalacijskega kortikosteroida in dolgodelujočega agonista adrenergičnih receptorjev beta2 ali s kombinacijo dolgodelujočega agonista adrenergičnih receptorjev beta2 in dolgodelujočega antagonista muskarinskih receptorjev (za učinke na obvladovanje simptomov in preprečevanje poslabšanja glejte poglavje 5.1).
• if you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary heart disease), disease of your heart valves or any other abnormalities of your heart or if you have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal). 
• če imate kakršne koli težave s srcem, kot je angina pektoris (srčna bolečina, bolečina v prsnem košu), ste imeli pred kratkim srčni infarkt (miokardni infarkt), imate srčno popuščanje, zožitev arterij okoli srca (koronarno bolezen srca), bolezen srčnih zaklopk ali katero koli drugo nepravilnost srca ali če imate stanje, imenovano hipertrofična obstruktivna kardiomiopatija
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists (see section 4.4). 
Sočasno zdravljenje z derivati ksantina, steroidi ali diuretiki lahko še okrepi morebitno hipokaliemično delovanje agonistov adrenergičnih receptorjev beta2 (glejte poglavje 4.4).
Multipack outer carton Also enter the date of dispensing on each individual pack. 
Datum izdaje zapišite tudi na vsako posamično pakiranje.
The systemic exposure to beclometasone dipropionate, formoterol and glycopyrronium has been investigated in a pharmacokinetic study conducted in healthy subjects. 
Sistemsko izpostavljenost beklometazondipropionatu, formoterolu in glikopironiju so preučili v farmakokinetični študiji, ki so jo opravili pri zdravih prostovoljcih.
Formoterol is a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction. 
Formoterol je selektivni agonist adrenergičnih receptorjev beta2, ki pri bolnikih z reverzibilno obstrukcijo dihal povzroči sprostitev gladkih mišic v bronhijih.
Formoterol is widely metabolised and the prominent pathway involves direct conjugation at the phenolic hydroxyl group. 
Formoterol se obsežno presnovi, pomembne poti zajemajo neposredno konjugacijo pri fenolni hidroksilni skupini.
Angioedema1 
občasni angioedem1
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 Riarify 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 Riarify v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola in s tiotropijem.
Additionally, due to the anticholinergic effect of glycopyrronium, the long-term co-administration of Riarify with other anticholinergic-containing medicinal products is not recommended (see section 4.5). 
Prav tako se zaradi antiholinergičnega učinka glikopironija dolgotrajnega sočasnega dajanja zdravila Riarify z drugimi zdravili, ki vsebujejo antiholinergike, ne priporoča (glejte poglavje 4.5).
This endpoint was only measured in study TRILOGY. 
Ta opazovani dogodek so merili le v študiji TRILOGY.
In repeat dose inhalation studies with Riarify 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 Riarify 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).
It is noted that single component glycopyrronium, formulated as pressurised metered dose inhaler, which was used in the PK studies, is not available on the market. 
Opomba: glikopironija kot posamične učinkovine v formulaciji inhalatorja pod tlakom z odmerjenim odmerkom, ki je bil uporabljen v farmakokinetičnih študijah, ni na voljo na trgu.
If you develop worsening shortness of breath or wheezing (breathing with a whistling sound), straight after inhaling your medicine, stop using Riarify 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 Riarify in nemudoma uporabite hitrodelujoči
If you have any further questions on the use of this medicine, ask your doctor or pharmacist 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
Before priming the 60, 120 or 180 actuation pressurised containers, the counter/indicator should read 61, 121 or 180, respectively. 
Pred pripravo tlačnega vsebnika s 60, 120 ali 180 sprožitvami mora števec/kazalnik odmerkov kazati 61, 121 oz. 180.
In an inhalation study in telemetered dogs, the cardiovascular system was a major target system for acute effects of Riarify (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 Riarify (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.
No specific studies have been performed with Riarify with regard to the safety in human fertility. 
Specifičnih študij varnosti zdravila Riarify glede plodnosti pri ljudeh niso izvedli.