natgillin/translations-raw huggingface dataset:
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.
In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Riarify significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Riarify and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06).
Poleg tega je tako v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola kot tiotropija zdravilo Riarify značilno podaljšalo čas do prvega poslabšanja (razmerje tveganja 0,80 oz. 0,84; p = 0,020 oz. 0,015), brez razlik med zdravilom Riarify in trojno kombinacijo, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus tiotropija (razmerje tveganja 1,06).
Riarify is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left.
Zdravilo Riarify je opremljeno s števcem odmerkov ali kazalnikom odmerkom, ki je na zadnji strani inhalatorja in kaže, koliko sprožitev je še ostalo.
Riarify is for inhalation use.
Zdravilo Riarify se uporablja za inhaliranje.
A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (focal score greater than or equal to 1) after 26 weeks with Riarify than with a fixed combination of beclometasone dipropionate and formoterol (57.4% versus 51.8%; p = 0.027).
Analiza odzivnih bolnikov je pokazala, da je imel značilno večji odstotek bolnikov klinično pomembno izboljšanje (fokalni seštevek 1 ali več) po 26 tednih zdravljenja z zdravilom Riarify v primerjavi s fiksno kombinacijo beklometazondipropionata in formoterola (57,4 % v primerjavi z 51,8 %; p = 0,027).
• burning sensation of the lips
• skeleč občutek na ustnicah;
• other medicines used to treat COPD (theophylline, aminophylline or corticosteroids) and diuretics may also cause a fall in your potassium level.
• drugimi zdravili za zdravljenje KOPB (teofilin, aminofilin ali kortikosteroidi) in diuretiki lahko prav tako povzroči zmanjšanje koncentracije kalija;
This endpoint was only measured in study TRINITY.
Ta opazovani dogodek so merili le v študiji TRINITY.
After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see sections 4.2 and 4.4).
Po inhaliranju naj si bolnik izpere usta ali grgra vodo, a naj je ne pogoltne, ali pa si umije zobe (glejte poglavji 4.2 in 4.4).
Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.
Glikopironij deluje tako, da zavira bronhokonstriktorno delovanje acetilholina na gladke mišične celice v dihalnih poteh, s čimer omogoči dilatacijo dihalnih poti.
Therefore, as a precautionary measure, it is preferable to avoid the use of Riarify during pregnancy and during labour.
Iz previdnostnih razlogov se je med nosečnostjo in med porodom uporabi zdravila Riarify bolje izogibati.
Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms (see section 5.2).
Farmakokinetično medsebojno delovanje Ker se glikopironij izloča v glavnem skozi ledvice, se lahko pojavijo interakcije z zdravili, ki vplivajo na mehanizem ledvičnega izločanja (glejte poglavje 5.2).
They should not remove the pressurised container from the actuator and should not use water or other liquids to clean the mouthpiece.
Tlačnega vsebnika naj ne ločuje od sprožilca in naj za čiščenje ustnika ne uporablja vode ali drugih tekočin.
• palpitations (feeling of abnormal beating of the heart)
• palpitacije (občutek nenormalnega bitja srca); • zardevanje obraza;
A total of 3,346 patients were treated with beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium 87 micrograms/5 micrograms/9 micrograms at the target dose regimen (two inhalations twice daily) in multiple dose studies.
Skupaj 3.346 bolnikov so zdravili z beklometazondipropionatom/formoterolijevim fumaratom dihidratom/glikopironijem 87 mikrogramov/5 mikrogramov/9 mikrogramov z režimom ciljnega odmerka (dve inhalaciji dvakrat na dan) v študijah z več odmerki.
Faecal excretion is the major route of beclometasone dipropionate elimination mainly as polar metabolites.
Izločanje v blatu je glavna pot izločanja beklometazondipropionata, pretežno kot polarnih presnovkov.
There was no clear evidence of pharmacokinetic interaction, however the extemporary combination showed formoterol and glycopyrronium levels transiently slightly higher immediately after dosing compared with the single components.
Jasnih dokazov o farmakokinetičnih interakcijah ni bilo, vendar je trojna kombinacija, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus glikopironija pokazala, da so ravni formoterola in glikopironija v primerjavi s posamičnimi sestavinami začasno nekoliko večje takoj po odmerjanju.
Anticholinergic agents like glycopyrronium could suppress lactation.
Antiholinergična zdravila kot glikopironij lahko zavrejo laktacijo.
Reproductive and development toxicity
Vpliv na sposobnost razmnoževanja in razvoja
This study also investigated the potential pharmacokinetic interaction between the active components of Riarify by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium.
Ta študija je preučila tudi morebitne farmakokinetične interakcije med učinkovinami v zdravilu Riarify na tak način, da je primerjala farmakokinetične podatke, pridobljene po enkratneme odmerku trojne kombinacije, ki je bila sestavljena iz fiksne kombinacije beklometazondipropionata in formoterola plus glikopironija ali po enem odmerku posamičnih sestavin beklometazondipropionata /formoterola ali glikopironija.
For glycopyrronium, there was no impact in subjects with mild and moderate renal impairment.
Pri glikopironiju ni bilo vpliva pri osebah z blago in zmerno okvaro ledvic.
Immediately after starting to breathe in, patients should firmly press down on the top of the pressurised container to release one puff.
Takoj potem ko začne vdihavati, naj bolnik čvrsto pritisne na zgornji del tlačnega vsebnika, da sprosti en vdih.
Based on plasma concentrations measured following inhalation of a single 120 micrograms dose by 12 healthy subjects, the mean terminal elimination half-life was determined to be 10 hours.
ko je 12 zdravih prostovoljcev inhaliralo en 120-mikrogramski odmerek, je bilo ugotovljeno, da je povprečna končna razpolovna doba izločanja 10 ur.
If you find it difficult to use the inhaler while starting to breathe in, you may use the AeroChamber Plus spacer device.
Če med začetkom vdihovanja težko uporabljate inhalator, lahko uporabite nastavek za inhaliranje
The second major pathway involves O-demethylation followed by conjugation at the phenolic 2'-hydroxyl group.
O-demetilacijo, ki ji sledi konjugacija pri fenolni 2'-hidroksilni skupni.
• low level in the number of certain blood cells called platelets
• nizka raven nekaterih krvnih celic, imenovanih trombociti;
After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see section 4.4 and 6.6).
Po inhaliranju naj si bolnik izpere usta ali grgra vodo, a naj je ne pogoltne, ali pa si umije zobe (glejte poglavji 4.2 in 6.6).
Patients should be advised not to drop the inhaler as this may cause the counter to count down.
Bolnikom je treba naročiti, naj pazijo, da jim inhalator ne pade iz rok, ker to lahko povzroči odštevanje števca.
The European Medicines Agency has waived the obligation to submit the results of studies with Riarify in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Riarify za vse podskupine pediatrične populacije s KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• if you have any disease of your liver or kidneys.
• če imate katero od bolezni jeter ali ledvic;
• if you have disorders of your heart rhythm such as irregular heart rate, a fast pulse rate or palpitations or if you have been told that your heart trace (ECG) is abnormal.
• če imate motnje srčnega ritma, npr. nereden srčni utrip, hitro bitje srca, razbijanje srca ali palpitacije oz. so vam povedali, da imate nenormalen posnetek delovanja srca (EKG);
• leakage of blood from a vessel into the tissues surrounding it
• iztekanje krvi iz žile v okoliško tkivo;
• if you have a tumour of the adrenal gland (known as a phaeochromocytoma).
• če imate tumor nadledvične žleze (imenovan tudi feokromocitom);
If you have been prescribed a container providing 180 puffs There is an indicator on the back of the inhaler, which tells you how many doses are left.
Če vam je zdravnik predpisal vsebnik, ki zagotavlja 180 vdihov Na zadnji strani inhalatorja je kazalnik, ki kaže, koliko odmerkov je še ostalo.
• if you experience any allergic reactions like skin allergies, hives, skin itching, skin rash (may affect up to 1 in 100 people), reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat (may affect up to 1 in 1,000 people).
• če opazite kakršne koli alergijske reakcije, kot so kožne alergije, izpuščaj, srbenje kože, osip na koži, (pojavijo se lahko pri največ 1 od 100 bolnikov), rdečina kože, oteklost kože ali sluznic,
How to use your inhaler
Kako uporabljati inhalator
Formoterol and glycopyrronium are medicines called long-acting bronchodilators.
Formoterol in glikopironij sta zdravili, imenovana dolgodelujoča bronhodilatatorja.
If you are already using Riarify
Če že uporabljate zdravilo Riarify
180 actuations
180 sprožitev
The renal clearance of formoterol is 150 mL/min.
150 ml/min.
• feeling breathless or short of breath
• občutek zasoplosti ali kratke sape;
For the 180 actuation pressurised container, each time the patient presses the pressurised container a puff of the solution is released and the counter rotates by a small amount; the number of puffs remaining is displayed in intervals of 20.
Pri tlačnem vsebniku s 180 sprožitvami se z vsakim bolnikovim pritiskom na vsebnik števec malo zasuče, število preostalih vdihov pa je prikazano v intervalih po 20.
Stop using the inhaler when the counter or indicator shows 0, as any medicine left in the inhaler may not be enough to give you a full puff.
Ko števec ali kazalnik odmerkov pokaže 0, inhalator nehajte uporabljati, saj morebitni preostali vdihi v njem morda ne bodo zadoščali za poln odmerek.
There is no relevant use of Riarify in the paediatric population (under 18 years of age) for the indication of COPD.
Zdravilo Riarify ni namenjeno za uporabo pri pediatrični populaciji (pri otrocih, starih do 18 let) za indikacijo kronične obstruktivne pljučne bolezni (KOPB).
• medicines for treating - abnormal heart rhythms (quinidine, disopyramide, procainamide), - allergic reactions (antihistamines), - symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines can cause some changes in the electrocardiogram (ECG, heart trace).
• zdravili za zdravljenje - nenormalnega srčnega ritma (kinidin, dizopiramid, prokainamid), - alergijskih reakcij (antihistaminiki), - simptomov depresije ali duševnih bolezni, kot so zaviralci monoaminooksidaze (na primer fenelzin in izokarboksazid), triciklični antidepresivi (na primer amitriptilin in imipramin),
Beta-blockers (including beta-blocker eye-drops) may reduce the effects of formoterol or make it not work at all.
Antagonisti adrenergičnih receptorjev beta (to velja tudi za kapljice za oko z antagonisti adrenergičnih receptorjev beta) lahko zmanjšajo učinek formoterola ali pa formoterol morda sploh ne bo deloval.
Riarify should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Zdravilo Riarify je treba pri bolnikih z aktivno ali mirujočo pljučno tuberkulozo ter glivično in virusno okužbo dihal uporabljati previdno.
For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Riarify are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation).
Beklometazondipropionat v obliki izredno majhnih delcev ima veliko močnejši učinek kot formulacije, kjer porazdelitev ni v obliki izredno majhnih delcev (100 mikrogramov beklometazondipropionata v obliki izredno majhnih delcev v zdravilu Riarify ustreza 250 mikrogramom beklometazondipropionata v formulacijah, ki niso v obliki izredno majhnih delcev).
Each pack contains one pressurised container either providing 60 puffs, 120 puffs or 180 puffs.
Eno pakiranje vsebuje en tlačni vsebnik, ki omogoča 60 vdihov, 120 vdihov ali 180 vdihov.
Patients should hold the inhaler vertically with its body upwards and place the mouthpiece between their teeth without biting.
Bolnik naj drži inhalator navpično, tako da je njegovo telo obrnjeno navzgor, in vstavi ustnik med zobe, vendar ga ne sme ugrizniti.
If you forget to use Riarify
Če ste pozabili uporabiti zdravilo Riarify
For the 60 and 120 actuation pressurised containers each time the patient presses the container a puff of the solution is released and the counter counts down by one.
Pri tlačnem vsebniku s 60 in 120 sprožitvami vsak bolnikov pritisk na vsebnik sprosti vdih raztopine, števec pa se pomakne za eno navzdol.
This incorporates a mouthpiece provided with a plastic protective cap, and either a dose counter (containers with 60 and 120 puffs) or a dose indicator (containers with 180 puffs).
Sestavljata ga ustnik s plastičnim zaščitnim pokrovčkom in bodisi števec odmerkov (vsebniki s 60 in 120 vdihi) ali kazalnikom odmerkov (vsebniki s 180 vdihi).
• inflammation of the mucous membrane of the mouth with or without ulcers
• vnetje ustne sluznice z razjedami ali brez;
The pressurised container is inserted in a polypropylene inhaler which incorporates a mouthpiece and a dose counter (60 actuations or 120 actuations per pressurised container) or dose indicator (180 actuations per pressurised container) and is provided with a polypropylene mouthpiece cap.
Tlačni vsebnik je vstavljen v polipropilenski inhalator, ki ga sestavljata ustnik in števec odmerkov (60 sprožitev ali 120 sprožitev na tlačni vsebnik) ali kazalnik odmerka (180 sprožitev na tlačni vsebnik) in je na voljo s polipropilenskim pokrovčkom ustnika.
The pharmacokinetics of beclometasone dipropionate in patients with hepatic impairment has not been studied, however, as beclometasone dipropionate undergoes a very rapid metabolism via esterase enzymes present in intestinal fluid, serum, lungs and liver to form the more polar products beclometasone 21-monopropionate, beclometasone 17-monopropionate and beclometasone, hepatic impairment is not expected to modify the pharmacokinetics and safety profile of beclometasone dipropionate.
Farmakokinetike beklometazondipropionata pri bolnikih z jetrno okvaro niso preučili, vendar pa se ne pričakuje, da bi jetrna okvara spremenila farmakokinetiko in profil varnosti beklometazondipropionata, saj se beklometazondipropionat zelo hitro presnovi z encimi esteraze, ki so prisotni v črevesnem soku, serumu, pljučih in jetrih, in tvori bolj polarne produkte, beklometazon 21monopropionat, beklometazon 17-monopropionat in beklometazon.