natgillin/translations-raw huggingface dataset:
Regular treatment with these three active substances helps to relieve and prevent symptoms such as shortness of breath, wheezing and cough in adult patients with chronic obstructive pulmonary disease (COPD). 
Redno zdravljenje s temi tremi učinkovinami pomaga pri lajšanju in preprečevanju simptomov, kot so kratka sapa, piskajoče dihanje in kašelj pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo
Content of the pack and other information What Riarify contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Riarify
• if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes. 
• če opazite bolečino ali težave z očesom, začasno zamegljen vid, očesne kolobarje ali barvne slike, povezane s pordelim očesom.
Before using the inhaler for the first time, the patient should release one actuation into the air in order to ensure that the inhaler is working properly (priming). 
Pred prvo uporabo inhalatorja naj bolnik sproži en odmerek v zrak, da preveri, ali inhalator deluje pravilno (priprava).
Liver appears to be the primary site of metabolism. 
Kaže, da so jetra primarno mesto presnove.
If you have or have had any medical problems or any allergies or if you are not sure if you can use Riarify, talk to your doctor or pharmacist before using the inhaler. 
Če imate ali ste imeli zdravstvene težave ali alergije oz. če niste prepričani, ali lahko uporabljate zdravilo Riarify, se pred začetkom uporabe inhalatorja posvetujte z zdravnikom ali farmacevtom.
It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you carefully follow the instructions on how to use the AeroChamber Plus spacer device and how to clean it. 
Pomembno je, da preberete navodilo, priloženo nastavku za inhaliranje AeroChamber Plus, in da natančno upoštevate navodila za uporabo in čiščenje nastavka za inhaliranje AeroChamber Plus.
Formoterol does not inhibit CYP450 enzymes at therapeutically relevant concentrations. 
Formoterol v terapevtsko pomembnih koncentracijah ne zavira encimov CYP450.
The pharmacokinetics of formoterol has not been studied in patients with hepatic impairment; however, as formoterol is primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe hepatic impairment. 
Farmakokinetike formoterola niso preučili pri bolnikih z jetrno okvaro; ker pa se formoterol pretežno izloča z jetrno presnovo, se lahko pri bolnikih s hudo jetrno okvaro pričakuje povečanje izpostavljenosti.
Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD. 
Med dejavniki tveganja za pljučnico pri bolnikih s KOPB so trenutno kajenje, višja starost, nizek indeks telesne mase (ITM) in huda oblika KOPB.
On the other hand, using other beta2-agonist medicines (which work in the same way as formoterol) may increase the effects of formoterol. 
Po drugi strani lahko uporaba drugih agonistov adrenergičnih receptorjev beta2 (zdravil, ki delujejo na enak način kot formoterol) poveča učinke formoterola.
Rinsing your mouth or gargling with water and brushing your teeth immediately after inhalation may help to prevent these side effects 
Z izpiranjem ust ali grgranjem vode in umivanjem zob takoj po inhalaciji lahko pomagate preprečiti te neželene učinke;
There are no relevant clinical data on the use of Riarify during breast-feeding in humans. 
Ni relevantnih kliničnih podatkov o uporabi zdravila Riarify med dojenjem pri ljudeh.
Riarify contains a small amount of ethanol. 
Pomožne snovi Zdravilo Riarify vsebuje majhno količino etanola.
This includes medicines similar to Riarify used for your lung disease. 
To vključuje zdravila, podobna zdravilu Riarify, ki se uporabljajo za zdravljenje pljučnih bolezni.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu, and on the website of {name of MS Agency (link)}. 
{DD. mesec LLLL} Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, in na spletni strani {ime agencije v državi članici (povezava)}.
If you use more Riarify than you should, side effects, as described in section 4, may occur. 
Če ste uporabili več zdravila Riarify, kot bi smeli, se lahko pojavijo neželeni učinki, opisani v poglavju 4.
The pressurised container is inserted in a plastic inhaler. 
Tlačni vsebnik je vložen v plastični inhalator.
This has the potential to produce adverse cardiovascular effects. 
To lahko povzroči neželene kardiovaskularne učinke.
There was no saturation of binding in the concentration range attained with therapeutic doses. 
Do nasičenja pri vezavi v razponu koncentracije, dobljene s terapevtskimi odmerki, ni prišlo.
Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however, the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such medicinal products. 
Beklometazon je manj odvisen od presnove s pomočjo encimov CYP3A kot nekateri drugi kortikosteroidi in na splošno medsebojno delovanje ni verjetno, vendar ni mogoče izključiti možnosti sistemskih učinkov pri sočasni uporabi močnih zaviralcev CYP3A (npr. ritonavirja, kobicistata), zato se pri uporabi tovrstnih zdravil priporočata previdnost in ustrezno spremljanje.
Mean renal clearance was similar across the range of doses tested and after single and repeated inhalation (range 281-396 mL/min). 
Povprečni ledvični očistek je bil podoben za vse testirane razpone odmerkov tako po enkratni in ponavljajoči inhalaciji (razpon 281-396 ml/min).
Plasma protein binding of formoterol is 61-64% with 34% bound to albumin. 
61 % do 64 %, pri čemer se 34 % veže na albumine.
• increase of blood pressure 
• povišanje krvnega tlaka;
If you have been using a different inhaler containing beclometasone dipropionate previously, ask your doctor for advice, as the effective dose of beclometasone dipropionate in Riarify for the treatment of COPD may be lower than that of some other inhalers. 
Če ste že uporabljali kateri drugi inhalator z beklometazondipropionatom, se posvetujte z zdravnikom, saj je učinkoviti odmerek beklometazondipropionata v zdravilu Riarify za zdravljenje KOPB morda manjši kot v nekaterih drugih inhalatorjih.
The following side effects can also occur with high-dose inhaled corticosteroids used over a long time, but the frequency is not known (frequency cannot be estimated from the available data) at present: 
Pri dolgotrajni uporabi visokoodmernih inhaliranih kortikosteroidov se prav tako lahko pojavijo naslednji neželeni učinki, vendar trenutno pogostnost ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): • depresija;
Tell your doctor if you have any of the following while using Riarify as they could be symptoms of a lung infection (may affect up to 1 in 10 people): 
Zdravniku morate povedati, če imate med jemanjem zdravila Riarify kar koli od naštetega, ker so to lahko simptomi okužbe pljuč (pojavi se lahko pri največ 1 od 10 bolnikov):
There is a risk of worsening shortness of breath and wheezing immediately after using Riarify and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people). 
Takoj po uporabi zdravila Riarify obstaja tveganje za poslabšanje kratke sape in piskajočega dihanja, kar se imenuje paradoksni bronhospazem (pojavi se lahko pri največ 1 od 1.000 bolnikov).
There was no evidence for overadditive effects of the triple combination when compared with the single components. 
Dokazov čezmerno aditivnih učinkov trojne kombinacije v primerjavi s posamičnimi učinkovinami ni bilo.
COPD is a serious longterm disease in which the airways become blocked and air sacs inside the lungs become damaged, leading to difficulty breathing. 
KOPB je resna, dolgotrajna bolezen, pri kateri postanejo dihalne poti blokirane, zračni mešički v pljučih, pa se poškodujejo, kar povzroči težave z dihanjem.
For the second puff, keep the inhaler in the upright position for about half a minute, then repeat steps 2 to 5. 
Za drugi vdih držite inhalator ravno približno pol minute, nato ponovite korake od 2 do 5.
The systemic availability of the active metabolite arises from lung (36%) and from gastrointestinal absorption of the swallowed dose. 
Sistemska razpoložljivost aktivnega presnovka izhaja iz pljuč (36 %) in absorpcije zaužitega odmerka v prebavilih.
Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy. 
Povečana uporaba olajševalnih bronhodilatatorjev kaže na slabšanje osnovne bolezni, zato je treba zdravljenje ponovno oceniti.
• decrease of blood pressure 
• znižanje krvnega tlaka;
The total systemic exposure (as measured by AUC0-t) was slightly reduced for beclometasone 17-monopropionate (by 37%) and formoterol (by 24%), while it was increased for glycopyrronium (by 45%). 
Skupna sistemska izpostavljenost (izmerjena z AUC0-t) je bila nekoliko zmanjšana za beklometazon 17-monopropionat (za 37 %) in formoterol (za 24 %), medtem ko se je za glikopironij povečala (za 45 %).
The terminal elimination half-lives are 0.5 hours and 2.7 hours for beclometasone dipropionate and beclometasone 17-monopropionate respectively. 
Končna razpolovna doba izločanja je 0,5 ure za beklometazondipropionat in 2,7 ure za beklometazon 17-monopropionat.
For in-use storage conditions, see section 6.3. 
Za pogoje shranjevanja med uporabo glejte poglavje 6.3.
Alternatively, patients may simply breathe in and out (through the mouth) after the actuation, as instructed in the spacer leaflet, to obtain the active substance. 
Druga možnost je, da bolnik po sprožitvi preprosto vdihava in izdihava (skozi usta), kot navaja navodilo za nastavek, da s tem dobi učinkovino.
The long-term co-administration of Riarify with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4). 
Dolgotrajnega sočasnega dajanja zdravila Riarify z drugimi zdravili, ki vsebujejo antiholinergike, niso preučili in se zato ne priporoča (glejte poglavje 4.4).
This medicine is contained in a pressurised container in a plastic inhaler with a mouthpiece. 
To zdravilo je na voljo v tlačnem vsebniku, ki je v plastičnem inhalatorju z ustnikom.
After use, patients should close the inhaler with the protective mouthpiece cover and check the dose counter or dose indicator. 
Po uporabi naj bolnik inhalator zapre z zaščitnim pokrovčkom ustnika in preveri števec oz. kazalnik odmerkov.
Riarify is unlikely to affect your ability to drive and use machines. 
Ni verjetno, da bi zdravilo Riarify vplivalo na sposobnost vožnje in upravljanja strojev.
If your symptoms get worse or are difficult to control (e.g. if you are using a separate “reliever” inhaler more frequently) or if your “reliever” inhaler does not improve your symptoms, see your doctor immediately. 
Če se vam simptomi poslabšajo, jih težko obvladujete (če npr. pogosteje uporabljate ločen "inhalator z olajševalcem"), ali vam vaš "inhalator z olajševalcem" ne izboljša simptomov, čim prej obiščite zdravnika.
• pain in muscles, bones or joints of the chest 
• bolečine v mišicah, kosteh ali sklepih prsnega koša;
Depending on the container size prescribed to you, check that the dose counter reads 61 or 121 and that the dose indicator reads 180 
Glede na velikost vsebnika, ki vam je bila predpisana, preverite, ali je odčitek na števcu odmerkov 61 ali 121, kazalnik odmerkov pa kaže na 180.
CYP2D6 was found to be the only enzyme responsible for glycopyrronium metabolism. 
Ugotovili so, da je CYP2D6 edini encim, odgovoren za presnovo glikopironija.
Glucocorticoid agents are known to cause effects in the early gestation phase, while beta2-sympathomimetic agents like formoterol have tocolytic effects. 
Znano je, da glukokortikoidna zdravila povzročajo učinke v zgodnji gestacijski fazi, medtem ko imajo beta2-simpatomimetična zdravila, kot je formoterol, tokolitične učinke.
This may increase the likelihood of abnormal heart rhythms. 
To lahko poveča verjetnost za nenormalen srčni ritem;
Riarify was also statistically significantly superior to a fixed combination of beclometasone dipropionate and formoterol, to tiotropium and to a fixed combination of indacaterol and glycopyrronium in terms of improvement in quality of life (measured by the Saint George Respiratory Questionnaire - SGRQ - total score). 
Zdravilo Riarify je bilo tudi statistično značilno boljše od fiksne kombinacije beklometazondipropionata in formoterola, od tiotropija in fiksne kombinacije indakaterola in glikopironija v smislu izboljšanja kakovosti življenja (izmerjeno kot skupni seštevek po vprašalniku SGRQ - Saint George Respiratory Questionnaire).
Breathe in slowly and deeply through your mouth to fill your lungs with air (this should take about 4-5 seconds). 
Počasi in globoko vdihnite skozi usta, da se pljuča napolnijo z zrakom (to naj traja približno 4
Hypokalaemia may also be potentiated by concomitant treatment with other medicinal products which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics (see section 4.5). 
Hipokaliemijo lahko okrepi tudi sočasno zdravljenje z drugimi zdravili, ki lahko inducirajo hipokaliemijo, kot so derivati ksantina, steroidi in diuretiki (glejte poglavje 4.5).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS AND MULTIPACK ONLY: contains Blue Box) 
ZUNANJA OVOJNINA (SAMO ENOJNA PAKIRANJA IN SKUPNA PAKIRANJA: vsebuje Blue Box)
After use, replace the protective cap. 
Po uporabi zaprite z zaščitnim pokrovčkom.
• pain in arms or legs 
• bolečine v rokah ali nogah;
For pharmacists: Enter the date of dispensing to the patient on the pack. 
Na pakiranje vpišite datum, ko ste zdravilo izdali bolniku.
Riarify has no or negligible influence on the ability to drive and use machines. 
Zdravilo Riarify nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Do not breathe out into the inhaler. 
Ne izdihujte v inhalator.
The recommended dose is two inhalations of Riarify twice daily. 
Priporočeni odmerek sta dve inhalaciji zdravila Riarify dvakrat na dan.
1 Adverse reactions reported in the SmPC of at least one of the individual components, but not observed as adverse reactions in the clinical development of Riarify 
1 Neželeni učinki, poročani v povzetku glavnih značilnosti zdravila za vsaj eno od posamičnih sestavin, ki pa jih niso opazili med neželenimi učinki v kliničnem razvoju zdravila Riarify
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (MULTIPACK ONLY: no Blue Box is included) 
VMESNA ZUNANJA ŠKATLA (SAMO SKUPNA PAKIRANJA: Blue Box ni vključen)
You should inhale the medicine through your mouth and this takes the medicine directly into your lungs. 
Zdravilo inhalirajte skozi usta, tako da pride direktno v pljuča.
The relative proportion of the two enantiomers remained constant over the dose range studied and there was no evidence of relative accumulation of one enantiomer over the other after repeated dosing. 
Relativni delež dveh enantiomer je ostal konstanten v preučevanem razponu odmerka; znakov relativne akumulacije ene od enantiomer na račun druge po večkratnem odmerjanju niso opazili.
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 
(≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki
Absorption of formoterol is linear following inhalation of 12 to 96 micrograms of formoterol. 
Absorpcija formoterola je linearna po inhalaciji 12 do 96 mikrogramov formoterola.
If this occurs you should stop using Riarify and use your quick-acting “reliever” inhaler straightaway to treat the shortness of breath and wheezing. 
Če se to zgodi, prenehajte uporabljati zdravilo Riarify in nemudoma uporabite hitrodelujoči "inhalator z olajševalcem", da boste obvladali kratko sapo in piskajoče dihanje.
• some anaesthetics can increase the risk of abnormal heart rhythms. 
• nekaterimi anestetiki lahko poveča tveganje za nepravilnosti srčnega ritma;
Riarify can reduce exacerbations (flare-ups) of COPD symptoms. 
Zdravilo Riarify lahko zmanjša poslabšanja (izbruhe) simptomov KOPB.
Pressurised container (coated aluminium), with a metering valve. 
Tlačni vsebnik (obložen z aluminijem) z odmernim ventilom.
When to get a new inhaler 
Kdaj morate dobiti nov inhalator
Riarify should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. 
Uporabo zdravila Riarify je treba takoj prekiniti, bolnika pregledati in uvesti drugo zdravljenje, če je to potrebno.
The maximum dose is two inhalations of Riarify twice daily. 
Največji odmerek sta dve inhalaciji zdravila Riarify dvakrat na dan.
injection while after inhalation in COPD patients it ranged from 5 to 12 hours at steady state. 
injiciranju, medtem ko je bil po inhalaciji pri bolnikih s KOPB v razponu od 5 do 12 ur v stanju dinamičnega ravnovesja.
Infants and neonates born to mothers receiving substantial doses of Riarify should be observed for adrenal suppression. 
Pri dojenčkih in novorojenčkih, rojenim materam, ki so prejele večje odmerke zdravila Riarify, je treba zato spremljati pojav zaviranja nadledvičnih žlez.
Riarify is a medicine to help breathing that contains the three active substances: 
Zdravilo Riarify pomaga pri dihanju in vsebuje tri učinkovine:
Repeat dose toxicity 
Toksičnost pri ponavljajočih odmerkih
Riarify should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus. 
Zdravilo Riarify se lahko med nosečnostjo uporablja le, če so pričakovane koristi za mater večje od možnega tveganja za zarodek.
Their action is mediated by the binding to glucocorticoid receptors in the cytoplasm resulting in the increased transcription of genes coding for antiinflammatory proteins. 
Njihovo delovanje poteka z vezavo glukokortikoidnih receptorjev v citoplazmi, kar poveča transkripcijo genov, ki kodirajo protivnetne proteine.
What Riarify is and what it is used for 
Kaj je zdravilo Riarify in za kaj ga uporabljamo
Patients should then check the dose counter or dose indicator to ensure it has moved accordingly. 
Bolnik naj nato preveri števec odmerka ali kazalnik odmerka in se prepriča, da se je števec ustrezno premaknil.
Other medicines and Riarify 
Druga zdravila in zdravilo Riarify
Chemical and physical in-use stability has been demonstrated for 4 months at 25°C. 
Kemična in fizikalna stabilnost za uporabo sta bili dokazani za 4 mesece pri temperaturi 25 °C.
Carcinogenicity studies have not been performed with Riarify. 
Študij kancerogenosti za zdravilo Riarify niso izvedli.
Breathe out as slowly and deeply as possible, in order to empty your lungs. 
Čim počasneje in čim bolj globoko izdihnite, kolikor je le mogoče, da izpraznite pljuča.
It is reasonable to assume that beclometasone dipropionate and its metabolites are also excreted into breast-milk. 
Razumno je predvidevati, da se tudi beklometazondipropionat in njegovi presnovki izločajo v materino mleko.
Peak plasma concentrations of the unchanged active substance occur within 0.5 to 1 hours after oral administration. 
Največje koncentracije nespremenjene učinkovine v plazmi se pojavijo v 0,5 do 1 ure po peroralni uporabi.
Patients should not breathe out into the inhaler. 
Bolnik ne sme izdihniti v inhalator.
The use of Riarify with the AeroChamber Plus spacer in COPD patients increased the lung delivery of beclometasone 17-monopropionate, formoterol and glycopyrronium (maximum plasma concentration increased by 15%, 58% and 60% respectively). 
Učinek nastavka Uporaba zdravila Riarify z nastavkom AeroChamber Plus pri bolnikih s KOPB je povečala v pljučih doseženo količino beklometazon 17-monopropionata, formoterola in glikopironija (največja koncentracija v plazmi se je povečala za 15 %, 58 % oz. 60 %).
They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias). 
Poveča se lahko tudi tveganje za motnje srčnega ritma (prekatne aritmije);
Vision, blurred1 (see also section 4.4) 
Očesne bolezni zamegljen vid1 (glejte tudi poglavje 4.4)
The absolute bioavailability following inhalation is approximately 2% and 62% of the nominal dose for unchanged beclometasone dipropionate and beclometasone 17-monopropionate respectively. 
Absolutna biološka uporabnost po inhalaciji je približno 2 % nominalnega odmerka za nespremenjen beklometazondipropionat in 62 % za beklometazon 17-monopropionat.
To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient's inhalation technique. 
Za zagotovitev pravilne uporabe zdravila mora zdravnik ali drug zdravstveni delavec bolniku pokazati, kako se inhalator pravilno uporablja, nato pa redno preverjati ustreznost bolnikove tehnike inhaliranja.
For the regular cleaning of the inhaler, patients should remove weekly the cap from the mouthpiece and wipe the outside and inside of the mouthpiece with a dry cloth. 
Za redno čiščenje inhalatorja mora bolnik vsak teden sneti pokrov z ustnika in ustnik od zunaj in znotraj obrisati s suho krpo.
60 actuation pressurised container: 21 months. 
Tlačni vsebnik s 60 sprožitvami: 21 mesecev.
Stand or sit up when inhaling. 
Med vdihavanjem stojte ali sedite.
In order to reduce the risk of oropharyngeal candida infection, patients should be advised to rinse their mouth or gargle with water without swallowing it or brush their teeth after inhaling the prescribed dose. 
Z namenom zmanjšanja orofaringealnih okužb s kandido je treba bolnikom svetovati, da si usta izperejo z vodo ali jo grgrajo, a naj je ne pogoltnejo, ali da si po inhaliranju predpisanega odmerka umijejo zobe.
If you are using Riarify or high doses of other inhaled corticosteroids over long periods and you come into a situation of stress (e.g. being taken to hospital after an accident, having a serious injury or before an operation) you may need more of this medicine. 
Če uporabljate zdravilo Riarify ali velike odmerke inhaliranih kortikosteroidov in ste v stresni okoliščini (npr. če vas po nesreči odpeljejo v bolnišnico, če imate resno poškodbo ali pred operacijo)
The metabolic pattern of glycopyrronium in vitro (humans, dogs, rats, mice and rabbits liver microsomes and hepatocytes) was similar among species and the main metabolic reaction was the hydroxylation on the phenyl or ciclopentyl rings. 
Presnovni vzorec glikopironija in vitro (jetrni mikrosomi in hepatociti ljudi, psov, podgan, miši in kuncev) je bil med vrstami podoben, pri čemer je bila glavna presnovna reakcija hidroksilacija na fenilnih ali ciklopentilnih obročih.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Riarify therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mothers. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Riarify, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, Riarify should be discontinued immediately and alternative therapy instituted. 
ki kažejo na alergijsko reakcijo, zlasti angioedem (vključno s težavami pri dihanju ali požiranju, oteklostjo jezika, ustnic in obraza), urtikarijo ali kožni izpuščaj, je treba uporabo zdravila Riarify takoj prekiniti in uvesti drugo zdravljenje.