natgillin/translations-raw huggingface dataset:
Patients should be advised to get a new inhaler when the dose counter or indicator shows the number 20.
Bolniku je treba svetovati, da si priskrbi nov inhalator, ko števec ali kazalnik odmerkov kaže številko 20.
There are no relevant data on the use of Riarify in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see section 4.4 and section 5.2).
Relevantnih podatkov o uporabi zdravila Riarify pri bolnikih s hudo okvaro jeter ni, zato je treba zdravilo pri teh bolnikih uporabljati previdno (glejte poglavje 4.4 in poglavje 5.2).
• if you have low blood levels of potassium (hypokalaemia).
• če imate nizko raven kalija v krvi (hipokaliemijo).
For instructions for use, see section 6.6.
Za navodila o uporabi glejte poglavje 6.6.
There is an approximately linear increase in systemic exposure with increasing inhaled dose.
Povečanje sistemske izpostavljenosti je približno linearno z večanjem inhaliranega odmerka.
• if you have narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you have an aneurysm (abnormal bulging of the blood vessel wall).
• če imate zožitev arterij (imenovana tudi kot arterioskleroza), če imate visok krvni tlak ali če imate anevrizmo (nenormalno razširjen del krvne žile);
Concomitant use of other beta-adrenergic medicinal products can have potentially additive effects; therefore, caution is required when other beta-adrenergic medicinal products are prescribed concomitantly with formoterol.
Sočasna uporaba drugih beta-adrenergičnih zdravil ima lahko aditivni učinek, zato je pri predpisovanju drugih beta-adrenergičnih zdravil sočasno s formoterolom potrebna previdnost.
Therefore, blood glucose should be monitored during treatment following established guidelines in patients with diabetes.
Zato je treba med zdravljenjem spremljati ravni glukoze v krvi po uveljavljenih smernicah za bolnike s sladkorno boleznijo.
Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Tega zdravila ne uporabljajte za zdravljenje nenadnih napadov kratke sape ali piskajočega dihanja.
Riarify does not contain a high-dose inhaled corticosteroid, but your doctor may wish to measure the cortisol levels in your blood from time to time.
Zdravilo Riarify ne vsebuje velikih odmerkov inhalacijskih kortikosteroidov, vendar bo morda zdravnik želel občasno izmeriti raven kortizola v krvi.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Riarify and to contact their doctor immediately should any of these signs or symptoms develop.
Bolnike je treba obvestiti o znakih in simptomih akutnega glavkoma z zaprtim zakotjem in jim naročiti, naj prenehajo uporabljati zdravilo Riarify in se takoj posvetujejo z zdravnikom, če se pojavijo ti znaki ali simptomi.
Your COPD may be getting worse and your doctor may need to prescribe different treatment.
Morda se vam KOPB slabša in vam bo moral zdravnik predpisati kakšna druga zdravila.
This may be obtained by the patients using the AeroChamber Plus by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation.
Bolnik lahko to doseže z nastavkom AeroChamber Plus v enem stalnem počasnem in globokem vdihu skozi nastavek in brez prekinitev med sprožitvijo in inhalacijo.
Do not pierce the pressurised container.
Vsebnika pod tlakom ne smete prebosti.
The inhalation of formoterol may cause a rise in blood glucose levels.
Inhaliranje formoterola lahko povzroči povišanje ravni glukoze v krvi.
At the same time, patients should breathe in slowly and deeply through the mouth until the lungs are full of air (this should take approximately 4 - 5 seconds).
Istočasno naj bolnik počasi in globoko vdihne skozi usta, da se pljuča napolnijo z zrakom (to naj traja približno 4-5 sekund).
• if you have an infection of the mouth or throat.
• če imate okužbo ust ali žrela.
• unusually fast heart beat and disorders of the heart rhythm
• neobičajno hiter srčni utrip in motnje srčnega ritma;
• if you are due to have an anaesthetic.
• če boste morali dobiti katerega od anestetikov.
Glycopyrronium has a quaternary ammonium structure which limits its passage across biological membranes and produces slow, variable and incomplete gastrointestinal absorption.
Glikopironij ima strukturo kvarternega amonija, kar omejuje njegovo prehajanje skozi biološke membrane in povzroči počasno, spremenljivo in nepopolno absorpcijo v prebavilih.
Safety pharmacology
Farmakologija varnosti
Do not use this medicine with a beta-blocker medicine (used for treating certain heart problems such as angina or for reducing blood pressure) unless your doctor has chosen a beta-blocker that does not affect your breathing.
Tega zdravila ne uporabljajte z antagonisti adrenergičnih receptorjev beta (uporabljajo se za zdravljenje nekaterih težav s srcem, kot je angina pektoris, ali za zmanjševanje krvnega tlaka), razen če je zdravnik izbral antagonista adrenergičnih receptorjev beta, ki ne vpliva na vaše dihanje.
It is recommended that serum potassium levels are monitored in such situations.
V takih situacijah se priporoča nadziranje serumske koncentracije kalija.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Pri vseh inhalacijskih kortikosteroidih se lahko pojavijo sistemski učinki, zlasti ob visokih odmerkih, ki se jih jemlje dolgo časa.
The patient should be advised to read the Package Leaflet carefully and follow the instructions for use as given in the leaflet.
Bolniku je treba svetovati, da natančno prebere Navodilo za uporabo in sledi napotkom v navodilu.
Riarify is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Zdravilo Riarify ni indicirano za zdravljenje akutnih epizod bronhospazmov ali za zdravljenje akutnega poslabšanja KOPB (tj. kot rešilno zdravljenje) ni.
Riarify is available in three container sizes:
Zdravilo Riarify je na voljo v treh velikostih vsebnika:
Particular caution is advised in severe COPD as this effect may be potentiated by hypoxia.
Posebna pozornost se svetuje pri hudi obliki KOPB, ker lahko hipoksija stopnjuje ta učinek.
Genotoxicity of Riarify has not been evaluated, however, the single active components were devoid of genotoxic activity in the conventional test systems.
Genotoksičnosti zdravila Riarify niso ocenili, vendar pa posamične učinkovine v običajnih testnih sistemih niso kazale genotoksične dejavnosti.
Depending on the type of anaesthetic, it may be necessary to stop using Riarify at least 12 hours before the anaesthesia.
Odvisno od vrste anestetika boste morda morali uporabo zdravila Riarify prekiniti vsaj 12 ur pred anestezijo;
Non-cardioselective beta-blockers (including eye drops) should be avoided in patients taking inhaled formoterol.
Nekardioselektivnim zaviralcem beta adrenergičnih receptorjev (vključno s kapljicami za oko) se je treba pri bolnikih, ki uporabljajo inhalacijski formoterol, izogniti.
Paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.
Paradoksni bronhospazem se lahko pojavi s takojšnjim poslabšanjem piskajočega dihanja in kratke sape po odmerjanju.
Both studies were conducted in patients with a clinical diagnosis of COPD with severe to very severe airflow limitation (FEV1 less than 50% predicted), with symptoms assessed as a COPD Assessment Test (CAT) score of 10 or above, and with at least one COPD exacerbation in the previous year.
obe navedeni študiji so bili vključeni bolniki s klinično diagnozo KOPB s hudo do zelo hudo omejitvijo pretoka zraka (FEV1 manj kot 50 % predvidenega) s simptomi, ocenjenimi z oceno 10 ali več po testu za oceno KOPB (CAT, COPD Assessment Test) in z najmanj enim poslabšanjem KOPB v preteklem letu.
However, in a 104-week rat inhalation carcinogenicity study and an oral 26-week carcinogenicity study in transgenic Tg.rasH2 mice, glycopyrronium bromide showed no carcinogenic potential and published data concerning long-term studies conducted with beclometasone dipropionate and formoterol fumarate in rats do not indicate a clinically relevant carcinogenic potential.
Vendar pa v 104-tedenski študiji kancerogenosti pri podganah z inhaliranjem in peroralni 26-tedenski študiji kancerogenosti pri transgeni miši Tg.rasH2 glikopironijev bromid ni pokazal kancerogenega potenciala, objavljeni podatki v zvezi z dolgoročnimi študijami, izvedenimi z beklometazondipropionatom in formoterolijevim fumaratom pri podganah pa ne kažejo klinično pomembnega kancerogenega potenciala.
Tell your doctor if you have used more Riarify than you should and if you experience any of these symptoms.
Zdravniku povejte, če ste uporabili več zdravila Riarify, kot bi smeli, in imate katerega od teh simptomov.
TDI was only measured in study TRILOGY.
TDI so merili le v študiji TRILOGY.
After dispensing:
Po izdaji:
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.