FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Brimica Genuair in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Brimica Genuair za vse podskupine pediatrične populacije s KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The presentation of the safety profile is based on the experience with Brimica Genuair and the individual components.
Slovenian: Prikaz varnostnega profila temelji na izkušnjah z zdravilom Brimica Genuair in njegovima posameznima učinkovinama.
English: *Half-life consistent with product accumulation based on a known dose regimen.
Slovenian: *Razpolovni čas, ki se ujema s kopičenjem zdravila na podlagi znane odmerne sheme.
English: Preferred term
Slovenian: Izbrani izraz
English: You should not use Brimica Genuair if you are pregnant or are breast-feeding unless your doctor tells you to do so.
Slovenian: Zdravila Brimica Genuair ne smete uporabljati, če ste noseči ali dojite, razen če vam tako ne naroči zdravnik.
English: In some patients, this medicine may cause blurred vision or dizziness.
Slovenian: To zdravilo lahko pri nekaterih bolnikih povzroči zamegljen vid ali omotico.
English: Other side effects which may occur while using Brimica Genuair:
Slovenian: Drugi neželeni učinki, ki se lahko pojavijo med uporabo zdravila Brimica Genuair:
English: Do not use Brimica Genuair if you notice that the pack is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte zdravila Brimica Genuair, če opazite, da je ovojnina poškodovana ali kaže znake poseganja vanjo.
English: Stop using the medicine and contact your doctor immediately if you:
Slovenian: Prenehajte uporabljati zdravilo in se nemudoma posvetujte z zdravnikom:
English: Do not use this medicine after the expiry date which is stated on the inhaler label, carton and inhaler bag after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki inhalatorja, škatli in vrečki inhalatorja poleg oznake »EXP«.
English: Submission of the results of the agreed post-authorisation safety study (PASS) for aclidinium bromide to evaluate the overall mortality and the proposed cardiovascular safety endpoints (with an additional endpoint of cardiac arrhythmia) among patients with COPD using aclidinium/formoterol, according to a protocol agreed by the PRAC.
Slovenian: Predložitev rezultatov dogovorjene študije varnosti po izdaji dovoljenja za promet z zdravilom (post-authorisation safety study, PASS) za aklidinijev bromid za ocenjevanje skupne umrljivosti in predlaganih kardiovaskularnih varnostnih končnih točk (z dodatno končno točko srčne aritmije) pri bolnikih s KOPB, ki uporabljajo aklidinij/formoterol, skladno s protokolom, o katerem se je dogovoril odbor PRAC.
English: - Instructions for use: Refer to the Instructions for Use at the end of this leaflet for instructions on how to use the Genuair inhaler.
Slovenian: - Navodila za uporabo: Za navodila o uporabi inhalatorja Genuair glejte navodila za uporabo zdravila na koncu teh Navodil za uporabo.
English: COPD is a long-term disease; therefore, Brimica Genuair is for long-term use.
Slovenian: KOPB je dolgotrajna bolezen, zato je tudi zdravilo Brimica Genuair namenjeno za dolgotrajno uporabo.
English: If your usual COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse while you are using Brimica Genuair you should continue to use it, but go to see your doctor as soon as possible because you may need another medicine.
Slovenian: Če se vaši simptomi KOPB (zadihanost, piskajoče dihanje ali kašelj) med uporabo zdravila Brimica Genuair ne izboljšajo ali če se poslabšajo, nadaljujte z uporabo zdravila, vendar čim prej obiščite zdravnika, saj boste morda potrebovali drugo zdravilo.
English: Children and adolescents Brimica Genuair is not for use in children or adolescents below 18 years of age.
Slovenian: Otroci in mladostniki Zdravilo Brimica Genuair ni namenjeno za otroke ali mladostnike do 18. leta starosti.
English: Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Slovenian: Zdravila, ki dokazano podaljšujejo interval QTc, so povezana s povečanim tveganjem za prekatne aritmije.
English: ALUMINIUM BAG
Slovenian: ALUMINIJASTA VREČKA
English: However, paradoxical bronchospasm has been observed with other inhalation therapies.
Slovenian: Paradoksni bronhospazem pa so opazili pri drugih vrstah inhalacijskih terapij.
English: Taking Brimica Genuair regularly will reduce the effects of COPD on your everyday life.
Slovenian: Redna uporaba zdravila Brimica Genuair zmanjša učinke bolezni KOPB na vaše vsakdanje življenje.
English: Go back to ‘STEP 1 Prepare your dose' and repeat steps 1.1 to 1.6.
Slovenian: Vrnite se na ‘KORAK 1 Priprava odmerka' in ponovite korake 1.1 do
English: 1.5 Release the orange button (Figure F).
Slovenian: 1.5 Sprostite oranžni gumb (Slika F).
English: Brimica Genuair should be discontinued in case of overdose.
Slovenian: Zdravljenje z zdravilom Brimica Genuair je treba v primeru prevelikega odmerjanja prekiniti.
English: These may be signs of a condition called “paradoxical bronchospasm”, which is an excessive and prolonged contraction of the airway muscles immediately following treatment with a bronchodilator.
Slovenian: To so lahko znaki stanja, imenovanega »paradoksni bronhospazem«: prekomernega in dolgotrajnega skrčenja mišic v dihalnih poteh takoj po uporabi bronhodilatatorja.
English: - The other ingredient is lactose monohydrate (see end of section 2 under ‘Brimica Genuair contains lactose' for more information).
Slovenian: - Druga sestavina zdravila je laktoza monohidrat (za več informacij glejte konec poglavja 2 pod naslovom »Zdravilo Brimica Genuair vsebuje laktozo«).
English: c. Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).
Slovenian: c) Odstranite pokrovček, tako da rahlo stisnete puščici, označeni na vsaki strani (Slika B).
English: The safety experience with Brimica Genuair comprised exposure in clinical trials at the recommended therapeutic dose for up to 12 months, and in post-marketing experience.
Slovenian: Izkušnje o varnosti z zdravilom Brimica Genuair vključujejo izpostavljenost v kliničnih preskušanjih do 12 mesecev pri priporočenem terapevtskem odmerku in izkušnje iz obdobja trženja zdravila.
English: b. Do not press the orange button until you are ready to take a dose.
Slovenian: b) Ne pritisnite oranžnega gumba, dokler niste pripravljeni, da vzamete odmerek.
English: The main plasma protein that binds aclidinium is albumin.
Slovenian: Glavni plazemski protein, ki veže aklidinijev bromid, je albumin.
English: Mean effective half-lives* observed for both aclidinium and formoterol (based on the accumulation ratio) are approximately 10 hours.
Slovenian: Povprečni efektivni razpolovni čas* tako aklidinija kot formoterola (na podlagi razmerja kopičenja) je bil približno 10 ur.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco na galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze, ne smejo jemati tega zdravila.
English: After inhalation, 6% to 9% of the delivered dose of formoterol is excreted in the urine unchanged or as direct conjugates of formoterol.
Slovenian: Po inhalaciji se od 6 % do 9 % dostavljenega odmerka formoterola izloči v urinu v nespremenjeni obliki ali v obliki njegovega konjugata.
English: [arrow] Tear here
Slovenian: [puščica] Odprite tukaj.
English: No clinically significant effects of Brimica Genuair on cardiac rhythm were observed on 24-hour Holter monitoring in a subset of 551 patients, of whom 114 received Brimica Genuair twice daily.
Slovenian: Poleg tega niso opazili nobenih klinično pomembnih učinkov zdravila Brimica Genuair na srčni ritem v 24-urnem spremljanju z napravo Holter v podskupini 551 bolnikov, od katerih jih je 114 prejemalo zdravilo Brimica Genuair dvakrat na dan.
English: • When a red band appears in the dose indicator, this means you are nearing your last dose(Figure
Slovenian: • Ko se na indikatorju odmerka pojavi rdeča oznaka, to pomeni, da se približujete zadnjemu odmerku (Slika N), ali
English: 1.3 Hold the inhaler horizontally with the mouthpiece facing you and the orange button on top (Figure D).
Slovenian: 1.3 Držite inhalator vodoravno, z ustnikom obrnjenim proti vam in z oranžnim gumbom na vrhu (Slika D).
English: The plasma protein binding of aclidinium determined in vitro most likely corresponded to the protein binding of the metabolites due to the rapid hydrolysis of aclidinium in plasma; plasma protein binding was 87% for the carboxylic acid metabolite and 15% for the alcohol metabolite.
Slovenian: Vezava aklidinija na plazemske proteine, ki je bila ugotovljena in vitro, je najverjetneje ustrezala vezavi presnovkov na proteine zaradi hitre hidrolize aklidinija v plazmi; vezanje na plazemske proteine je znašalo 87 % za karboksikislinski presnovek in 15 % za alkoholni presnovek.
English: Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.
Slovenian: Suha usta, učinek, ki ga opažajo pri zdravljenju z antiholinergiki, so lahko dolgoročno povezana z zobno gnilobo.
English: There are no data available on the use of Brimica Genuair in pregnant women.
Slovenian: Podatkov o uporabi zdravila Brimica Genuair pri nosečnicah ni.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom, preden uporabite to zdravilo.
English: Brimica Genuair should not be used in asthma; clinical studies of Brimica Genuair in asthma have not been conducted.
Slovenian: Zdravilo Brimica Genuair ni namenjeno uporabi pri astmi; klinične študije z zdravilom Brimica Genuair pri astmi niso bile izvedene.
English: The mouthpiece is covered with a removable orange protective cap.
Slovenian: Ustnik je prekrit z odstranljivim oranžnim zaščitnim pokrovčkom.
English: Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of β2-adrenergic agonists, therefore caution is advised in their concomitant use (see section 4.4).
Slovenian: Sočasno hipokaliemično zdravljenje z metilksantinskimi derivati, steroidi ali diuretiki, ki ne varčujejo s kalijem, lahko stopnjuje možni hipokaliemični učinek agonistov β2-adrenergičnih receptorjev, zato je pri sočasni uporabi potrebna previdnost (glejte poglavje 4.4).
English: In the long-term, dry mouth can be associated with tooth decay, so it is important to pay attention to oral hygiene.
Slovenian: Suha usta so lahko na dolgi rok povezana z zobno gnilobo, zaradi česar morate biti pozorni na ustno higieno.
English: • On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size.
Slovenian: • Ob prvi uporabi, vsak inhalator vsebuje najmanj 60 odmerkov ali najmanj 30 odmerkov,
English: Formoterol is a potent selective β2-adrenoceptor agonist.
Slovenian: Formoterol je močan selektivni agonist β2-adrenergičnih receptorjev.
English: During these studies, patients were permitted to continue their stable treatment with inhaled corticosteroids, low doses of oral corticosteroids, oxygen therapy (if less than 15h/day) or methylxanthines and to use salbutamol as rescue medication.
Slovenian: Med trajanjem teh študij so lahko bolniki nadaljevali stalno zdravljenje s kortikosteroidi za vdihavanje, nizkimi odmerki peroralnih kortikosteroidov, zdravljenjem s kisikom (če je krajše od 15 ur/dan) ali metilksantini in uporabo salbutamola kot reševalnega zdravila.
English: Efficacy was assessed by measures of lung function, symptomatic outcomes, disease-specific health status, rescue medication use, and exacerbations.
Slovenian: Učinkovitost so ocenjevali z merjenjem pljučne funkcije, simptomatskimi izidi, od bolezni odvisnim zdravstvenim stanjem, uporabo reševalnega zdravila in pojavom poslabšanj.
English: In addition to improving pulmonary function, formoterol has been shown to improve symptoms and quality of life in patients with COPD.
Slovenian: Formoterol poleg izboljšanja pljučne funkcije dokazano izboljšuje simptome in kakovost življenja bolnikov s KOPB.
English: COPD exacerbation reductions
Slovenian: Zmanjšanje poslabšanja KOPB
English: The Genuair inhaler is a multicomponent device made of plastic (polycarbonate, acrylonitrilebutadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene) and stainless steel.
Slovenian: Inhalator Genuair sestavlja več kosov, izdelanih iz plastike (polikarbonata, akrilonitril-butadien-stirena, polioksimetilena, poliester-butilen-tereftalata, polipropilena, polistirena) in nerjavnega jekla.
English: Lung volumes, exercise endurance and physical activity The effect of Brimica Genuair on lung volumes, exercise endurance and physical activity was investigated in an 8-week parallel, randomised, placebo-controlled clinical study in COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Slovenian: Pljučni volumni, obremenitvena vzdržljivost in telesna dejavnost Vpliv zdravila Brimica Genuair na pljučne volumne, obremenitveno vzdržljivost in telesno dejavnost so raziskali v 8-tedenski vzporedni, randomizirani, s placebom kontrolirani klinični študiji bolnikov s KOPB, ki so imeli hiperinflacijo (funkcionalna rezidualna kapaciteta [FRC] > 120 %).
English: In Phase III clinical studies, the frequency of notable increases in blood glucose with Brimica Genuair was low (0.1%) and similar to placebo.
Slovenian: V kliničnih študijah 3. faze zdravila Brimica Genuair je bila pogostnost pomembnega povečanja glukoze v krvi nizka (0,1 %) in podobna ravni s placebom.
English: The occurrence of blurred vision or dizziness may influence the ability to drive or to use machines.
Slovenian: Pojav zamegljenega vida ali omotice lahko vpliva na sposobnost vožnje ali upravljanja s stroji.
English: Hypersensitivity to the active substances or to the excipient listed in section 6.1.
Slovenian: Preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: There are no data regarding the specific use of aclidinium/formoterol in patients with renal or hepatic impairment.
Slovenian: Na voljo ni nobenih podatkov o specifični uporabi aklidinija/formoterola pri bolnikih z ledvično ali jetrno okvaro.
English: Other medicines and Brimica Genuair
Slovenian: Druga zdravila in zdravilo Brimica Genuair
English: The onset of action of Brimica Genuair was comparable to the effect of the fast-acting β2-agonist formoterol 12 micrograms.
Slovenian: Začetek delovanja zdravila Brimica Genuair je primerljiv z učinkom hitro delujočega agonista β2 formoterola 12 mikrogramov.
English: Bronchodilators relax the muscles in your airways, which allows the airways to open more widely and helps you to breathe more easily.
Slovenian: Bronhodilatatorji sproščajo mišice v dihalnih poteh, kar omogoča širše odprtje dihalnih poti in s tem pripomorejo k lažjemu dihanju.
English: Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of aclidinium.
Slovenian: Biološka transformacija prek encimov CYP450 igra manjšo vlogo pri skupnem presnovnem očistku aklidinija.
English: Based on the above mentioned data, the PRAC considered that ‘peripheral oedema' should be removed from the list of adverse drug reactions in section 4.8 of the SmPC and ‘Swelling of hands, ankles or feet' should be deleted in section 4 of the Package Leaflet.
Slovenian: Na podlagi zgoraj omenjenih podatkov odbor PRAC meni, da je treba "periferne edeme" odstraniti s seznama neželenih učinkov zdravila v poglavju 4.8 Povzetka glavnih značilnosti zdravila in "Otekanje dlani, gležnjev ali stopal" izbrisati iz poglavja 4 Navodila za uporabo.
English: In case such effects occur, treatment may need to be discontinued.
Slovenian: Če se pojavijo ti učinki, je treba razmisliti o prekinitvi zdravljenja.
English: The Brimica Genuair clinical development programme was conducted in patients with moderate or severe COPD.
Slovenian: Klinični razvojni program zdravila Brimica Genuair je bil izveden pri bolnikih z zmerno ali hudo KOPB.
English: If you use more Brimica Genuair than you should If you think you may have used more Brimica Genuair than you should, you are more likely to experience some of its side effects, such as blurred vision, dry mouth, feeling sick, shaking/tremor, headache, palpitations or an increase in blood pressure, therefore you must immediately contact your doctor or go to the nearest emergency unit.
Slovenian: Če ste uporabili večji odmerek zdravila Brimica Genuair, kot bi smeli Če mislite, da ste uporabili več zdravila Brimica Genuair, kot bi smeli, obstaja verjetnost, da se bodo pri vas pojavili kateri od njegovih neželenih učinkov, kot so zamegljen vid, suha usta, občutek slabosti, tresenje/tresavica, glavobol, palpitacije ali povečan krvni tlak, zato se takoj posvetujte z zdravnikom ali obiščite najbližjo ambulanto za nujno pomoč.
English: Longacting β2-adrenergic agonists should be used with caution in patients with history of or known prolongation of the QTc-interval or treated with medicinal products affecting the QTc interval (see section 4.5).
Slovenian: Agoniste β2-adrenergičnih receptorjev z dolgotrajnim delovanjem je treba uporabljati previdno pri bolnikih z anamnezo podaljšanja intervala QTc ali znanim podaljšanjem tega intervala in pri bolnikih, ki se zdravijo z zdravili, ki vplivajo na interval QTc (glejte poglavje 4.5).
English: These include medicines for the treatment of: o depression (such as monoamine oxidase inhibitors or tricyclic antidepressants), o bacterial infections (such as erythromycin, clarithromycin, telithromycin), o allergic reactions (anti-histamines).
Slovenian: Med njimi so zdravila za zdravljenje: o depresije (kot so zaviralci monoaminooksidaze ali triciklični antidepresivi), o bakterijskih okužb (kot so eritromicin, klaritromicin, telitromicin), o alergijske reakcije (antihistaminiki).
English: Also contains: Lactose See leaflet for further information
Slovenian: Vsebuje tudi: laktozo Za dodatne informacije glejte navodilo za uporabo.
English: There is no relevant use of Brimica Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Slovenian: Zdravilo Brimica Genuair ni primerno za uporabo pri otrocih in mladostnikih (do 18. leta starosti) za indikacijo KOPB.
English: Maximal bronchodilator effects (peak FEV1) relative to baseline were evident from day one (304 ml) and were maintained over the 6-month treatment period (326 ml).
Slovenian: Največji učinki bronhodilatacije (največja vrednost FEV1) glede na izhodiščno vrednost so bili očitni od prvega dne (304 ml) in so ostali prisotni celotno 6-mesečno obdobje zdravljenja (326 ml).
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Slovenian: Odbor CHMP zato priporoča spremembo pogojev dovoljenj za promet z zdravilom.
English: Formoterol showed reduced fertility (implantation losses) in rats, as well as decreased early postnatal survival and birth weight with high systemic exposure to formoterol.
Slovenian: Pri formoterolu so opazili zmanjšano plodnost (implantacijske izgube) pri podganah ter zmanjšanje zgodnjega postnatalnega preživetja in mase ob rojstvu z visoko sistemsko izpostavljenostjo formoterolu.
English: What you need to know before you use Brimica Genuair
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Brimica Genuair
English: On the basis of the scientific conclusions for aclidinium bromide / formoterol fumarate dihydrate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aclidinium bromide / formoterol fumarate dihydrate is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za aklidinijev bromid/formoterolijev fumarat dihidrat odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo aklidinijev bromid/formoterolijev fumarat dihidrat nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: When the orange button will not return to its full upper position and is locked in a middle position, you have reached the last dose (Figure O).
Slovenian: Ko je za inhalacijo pripravljen zadnji odmerek, se oranžni gumb ne vrne v popolnoma zgornji položaj, temveč ostane zaklenjen v srednjem položaju (Slika O).
English: Brimica Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo Brimica Genuair je indicirano za vzdrževalno bronhodilatacijsko zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
English: In Phase III studies, clinically meaningful bronchodilator effects were seen within 5 minutes of the first dose and were maintained over the dosing interval.
Slovenian: V študijah 3. faze so klinično pomemben bronhodilatoren učinek opažali v prvih petih minutah po prvem odmerku, pri čemer se je učinek ohranil v celotnem intervalu po prvem odmerku.
English: Formoterol does not inhibit CYP450 enzymes at therapeutically relevant concentrations.
Slovenian: Formoterol ne zavira encimov CYP450 pri terapevtsko pomembnih koncentracijah.
English: - Getting started - Step 1: Prepare your dose - Step 2: Inhale your medicine - Additional information
Slovenian: Navodila za uporabo so razdeljena v poglavja: - Začetek - Korak 1: Priprava odmerka - Korak 2: Inhaliranje zdravila - Dodatne informacije
English: After you have taken the last dose, the inhaler has to be disposed of.
Slovenian: Ko uporabite zadnji odmerek, je treba inhalator zavreči.
English: Brimica Genuair contains two bronchodilators: aclidinium is a long-acting muscarinic antagonist (also known as an anticholinergic) and formoterol is a long-acting β2-adrenergic agonist.
Slovenian: Zdravilo Brimica Genuair vsebuje dva bronhodilatatorja: aklidinij, dolgo delujoči muskarinski antagonist (poznan tudi pod imenom antiholinergik), in formoterol, dolgo delujoči agonist β2-adrenergičnih receptorjev.
English: Similarly, in pooled clinical studies with Duaklir Genuair/Brimica Genuair and its mono-component, ‘peripheral oedema' was numerically less common on the active treatment than on placebo.
Slovenian: Podobno so bili v združenih kliničnih študijah zdravil Duaklir Genuair/Brimica Genuair in njunih posameznih učinkovin "periferni edemi" številčno manj pogosti z aktivnim zdravljenjem kot s placebom.
English: 1.6 Make sure the control window is now green (Figure G).
Slovenian: 1.6 Prepričajte se, da je kontrolno okence sedaj obarvano zeleno (Slika G).
English: - develop swelling of the face, throat, lips or tongue (with or without difficulty breathing or swallowing), severe itchy bumps on the skin (hives) as these may be symptoms of an allergic reaction.
Slovenian: - če se vam pojavijo oteklost obraza, žrela, ustnic ali jezika (s težavami z dihanjem ali brez takšnih težav) ali močno srbeče bulice na koži (koprivnica): to so lahko simptomi alergijske reakcije.