FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: Istodobno liječenje derivatima metilksantina, steroidima ili diureticima koji ne štede kalij može uzrokovati mogući hipokalijemijski učinak β2-adrenergičkih agonista, stoga se preporučuje oprez kod njihove istodobne uporabe (vidjeti dio 4.4).
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.
Croatian: Brimica Genuair sadrži dva bronhodilatatora: aklidinij je dugodjelujući muskarinski antagonist (također poznat kao antikolinergik), a formoterol je dugodjelujući β2-adrenergički agonist.
English: A ‘click' will let you know that you are inhaling correctly.
Croatian: Zvuk „klik” će Vam dati do znanja da pravilno inhalirate lijek.
English: Formoterol is a potent selective β2-adrenoceptor agonist.
Croatian: Formoterol je jaki selektivni β2-adrenergički agonist.
English: 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 (<1/10,000) and not known (cannot be estimated from available data).
Croatian: Učestalost nuspojava definirana je prema kategorijama učestalosti: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1 000 i <1/100), rijetko (≥1/10 000 i <1/1 000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
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.
Croatian: To mogu biti znakovi stanja koje se naziva „paradoksalni bronhospazam“, koji je pretjerana i produžena kontrakcija mišića dišnih puteva koja se javlja neposredno nakon primjene bronhodilatatora.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for aclidinium bromide / formoterol fumarate dihydrate, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za aklidinijev bromid/formoterolfumarat dihidrat, znanstveni zaključci CHMP-a su sljedeći:
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je Vaš liječnik rekao da ne podnosite neke šećere, prije uzimanja ovog lijeka obratite se svom liječniku.
English: The Genuair inhaler is a multicomponent device made of plastic (polycarbonate, acrylonitrilebutadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene) and stainless steel.
Croatian: Genuair inhalator je naprava koja se sastoji od više dijelova, izrađena od plastike (polikarbonata, akrilonitril-butadien-stirena, polioksimetilena, poliester-butilen-tereftalata, polipropilena, polistirena) i nehrđajućeg čelika.
English: • Medicines called beta blockers that may be used to treat high blood pressure or other heart problems (such as atenolol or propranolol) or to treat glaucoma (such as timolol).
Croatian: • lijekove koji se nazivaju beta blokatorima koji se mogu koristiti za liječenje visokog krvnog tlaka ili drugih tegoba sa srcem (kao što su atenolol ili propranolol) ili za liječenje glaukoma (kao što je timolol).
English: As Brimica Genuair contains aclidinium and formoterol, the type and severity of adverse reactions associated with each of the components may be expected with Brimica Genuair.
Croatian: Budući da Brimica Genuair sadrži aklidinij i formoterol, vrsta i težina nuspojava povezanih sa svakom od tih sastavnica može se očekivati i uz Brimica Genuair.
English: Stop taking Brimica Genuair and seek medical help immediately if you experience any of the following:
Croatian: Prekinite s primjenom Brimica Genuaira i odmah zatražite liječničku pomoć ako primijetite bilo što od sljedećeg:
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.
Croatian: Formoterol je pokazao smanjenje plodnosti (implantacijski gubici) u štakora, kao i smanjeno rano postnatalno preživljavanje i smanjenje porođajne težine pri visokoj sistemskoj izloženosti formoterolu.
English: This medicine is for long-term use.
Croatian: Ovaj lijek namijenjen je za dugotrajnu primjenu.
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.
Croatian: Ako primijenite više Brimica Genuaira nego što ste trebali Ako mislite da ste možda primijenili više lijeka Brimica Genuair nego što ste trebali, veća je vjerojatnost da ćete iskusiti neke od nuspojava, kao što su zamagljeni vid, suha usta, mučnina, drhtanje, glavobolja, osjećaj lupanja srca ili povišeni krvni tlak, stoga morate odmah kontaktirati svog liječnika ili otići u najbližu jedinicu hitnog prijema.
English: Nonclinical data reveal no special hazard for humans with aclidinium and formoterol based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude s aklidinijem i formoterolom, na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of aclidinium.
Croatian: Biotransformacija putem enzima CYP450 ima manju ulogu u ukupnom metaboličkom klirensu aklidinija.
English: Brimica Genuair demonstrated a rapid onset of action within 5 minutes of the first inhalation relative to placebo (p<0.0001).
Croatian: Brimica Genuair pokazao je brzi nastup djelovanja unutar 5 minuta od prve inhalacije u odnosu na placebo (p < 0,0001).
English: Also contains: Lactose See leaflet for further information
Croatian: Također sadrži: laktozu Za dodatne informacije pogledati uputu o lijeku.
English: In long-term safety studies, Brimica Genuair was associated with sustained efficacy when administered over a one-year treatment period with no evidence of tachyphylaxis.
Croatian: U dugoročnim ispitivanjima sigurnosti primjene, Brimica Genuair je bio povezan s održanom djelotvornošću kod primjene u razdoblju duljem od 1 godine bez dokaza o tahifilaksiji.
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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja s Brimica Genuairom u svim podskupinama pedijatrijske populacije u KOPB-u (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you are not sure of how to use Brimica Genuair, contact your doctor or pharmacist.
Croatian: Ako niste sigurni kako koristiti Brimica Genuair, obratite se svom liječniku ili ljekarniku.
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.
Croatian: Tijekom ovih ispitivanja, bolesnicima je bilo dopušteno nastaviti njihovu stabilnu terapiju inhalacijskim kortikosteroidima, niskim dozama oralnih kortikosteroida, terapiju kisikom (ako je manja od 15 sati dnevno) ili metilksantinima te koristiti salbutamol kao lijek za hitno ublažavanje simptoma.
English: When aclidinium and formoterol were administered in combination by the inhaled route, the pharmacokinetics of each component showed no relevant differences from those observed when the medicinal products were administered separately.
Croatian: Kada su se aklidinij i formoterol primjenjivali zajedno putem inhalacije, farmakokinetika svake sastavnice nije pokazala bitne razlike od one primijećene kad su lijekovi primijenjeni odvojeno.
English: What Brimica Genuair is and what it is used for
Croatian: Što je Brimica Genuair i za što se koristi
English: The most frequently reported adverse reactions with Brimica Genuair were nasopharyngitis (7.9%) and headache (6.8%).
Croatian: Najčešće prijavljene nuspojave lijeka Brimica Genuair bile su nazofaringitis (7,9%) i glavobolja
English: It is unknown whether aclidinium (and/or its metabolites) or formoterol are excreted in human milk.
Croatian: Nije poznato izlučuju li se aklidinij (i/ili njegovi metaboliti) ili formoterol u majčino mlijeko u ljudi.
English: As studies in rats have shown excretion of small amounts of aclidinium (and/or its metabolites) and formoterol into milk, the use of Brimica Genuair by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
Croatian: Kako su ispitivanja na štakorima pokazala izlučivanje manjih količina aklidinija (i/ili njegovih metabolita) i formoterola u mlijeko, uporaba Brimica Genuaira kod dojilja smije se razmotriti samo ako je korist za ženu veća od bilo kojeg mogućeg rizika za dojenče.
English: • Any medicines that may be similar to Brimica Genuair to treat breathing difficulties.
Croatian: • bilo koje lijekove koji su slični Brimica Genuairu za liječenje poteškoća s disanjem.
English: Do not use Brimica Genuair if you notice that the pack is damaged or shows signs of tampering.
Croatian: Brimica Genuair se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili su vidljivi znakovi neovlaštenog otvaranja.
English: [arrow] Tear here
Croatian: [strelica] Ovdje otvorite
English: In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see section 4.5).
Croatian: U bolesnika s teškim KOPB-om, hipokalijemija može biti potencirana hipoksijom i istodobnim liječenjem (vidjeti dio 4.5).
English: Aclidinium is rapidly and extensively hydrolysed to its pharmacologically inactive alcohol- and carboxylic acid-derivatives.
Croatian: Aklidinij se brzo i opsežno hidrolizira na svoje farmakološki neaktivne metabolite, derivate alkohola i karboksilne kiseline.
English: What you need to know before you use Brimica Genuair
Croatian: Što morate znati prije nego počnete primjenjivati Brimica Genuair
English: The bag and the desiccant should be thrown away.
Croatian: Vrećicu i sredstvo za sušenje treba baciti.
English: Do not use this medicine after the expiry date which is stated on the inhaler label, carton and inhaler bag after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici inhalatora, kutiji i vrećici inhalatora iza oznake „EXP“.
English: As a consequence of the differential density of muscarinic receptors and β2-adrenoceptors in the central and peripheral airways of the lung, muscarinic antagonists should be more effective in relaxing central airways and β2-adrenergic agonists should be more effective in relaxing peripheral airways; relaxation of both central and peripheral airways with combination treatment may contribute to its beneficial effects on lung function.
Croatian: Kao posljedica različitih gustoća muskarinskih receptora i β2-adrenoceptora u centralnim i perifernim dišnim putovima pluća, muskarinski antagonisti bi trebali biti učinkovitiji u opuštanju centralnih dišnih putova, a β2-adrenergički agonisti bi trebali biti učinkovitiji u opuštanju perifernih dišnih putova; opuštanje i centralnih i perifernih dišnih putova kombiniranim liječenjem može doprinijeti pozitivnom učinku na funkciju pluća.
English: Insomnia Anxiety
Croatian: Nesanica Anksioznost
English: Preferred term
Croatian: Preporučeni izraz
English: Bronchodilation is induced by causing direct relaxation of airway smooth muscle as a consequence of the increase in cyclic AMP through activation of adenylate cyclase.
Croatian: Bronhodilataciju uzrokuje izravno opuštanje glatkih mišića dišnih putova što je posljedica povećanja cikličkog AMP-a kroz aktivaciju adenilat ciklaze.
English: No pharmacokinetics studies have been performed with aclidinium/formoterol in elderly subjects.
Croatian: Nisu provedena farmakokinetička ispitivanja s aklidinijem/formoterolom u starijih ispitanika.
English: ALUMINIUM BAG
Croatian: ALUMINIJSKA VREĆICA
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.
Croatian: Na temelju gore spomenutih podataka, PRAC smatra da je „periferni edem“ potrebno izbrisati iz popisa nuspojava u dijelu 4.8 Sažetka opisa svojstava lijeka i „Oticanje ruku, gležnjeva i stopala“ iz djela 4. upute o lijeku.
English: Moreover, post-marketing reports of ‘peripheral oedema' did not show positive re-challenge.
Croatian: Nadalje, izvještaji o „perifernom edemu“ nakon stavljanja lijeka u promet nisu pokazali ponovno pojavljivanje nuspojave nakon ponovnog uvođenja terapije (re-challenge).
English: Orange button
Croatian: Narančasti gumb
English: - Brimica Genuair is for inhalation use.
Croatian: - Brimica Genuair namijenjen je za primjenu inhalacijom.
English: Hypersensitivity to the active substances or to the excipient listed in section 6.1.
Croatian: Preosjetljivost na djelatne tvari ili na pomoćnu tvar navedenu u dijelu 6.1.
English: If you see halos around lights or coloured images, have eye pain or discomfort or suffer temporary blurring of vision, go to see your doctor for advice as soon as possible.
Croatian: Ako vidite krugove (halo) oko svjetla ili obojene slike, osjećate bol u očima ili neugodu ili Vam se privremeno zamagli vid, odmah se savjetujte s liječnikom.
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.
Croatian: U kliničkim ispitivanjima faze III, učestalost značajnog povećanja glukoze u krvi s Brimica Genuairom bila je niska (0,1%) i slična placebu.
English: In clinical studies, paradoxical bronchospasm was not observed with Brimica Genuair at its recommended dose.
Croatian: U kliničkim ispitivanjima nije primijećen paradoksalni bronhospazam s Brimica Genuairom u preporučenoj dozi.
English: - The other ingredient is lactose monohydrate (see end of section 2 under ‘Brimica Genuair contains lactose' for more information).
Croatian: - Drugi sastojak je laktoza hidrat (za više informacija vidjeti dio 2. „Brimica Genuair sadrži laktozu“).
English: Show the packaging of Brimica Genuair.
Croatian: Pokažite pakiranje Brimica Genuaira.
English: Getting Started:
Croatian: Početak:
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).
Croatian: Među njima su lijekovi za liječenje: o depresije (kao što su inhibitori monoaminooksidaze ili triciklički antidepresivi), o bakterijskih infekcija (kao što su eritromicin, klaritromicin, telitromicin), o alergijskih reakcija (antihistaminici).
English: Diarrhoea Nausea Dry mouth
Croatian: Proljev Mučnina Suha usta
English: A slight increase in the incidence of uterine leiomyomas has been observed in rats and mice; an effect which is considered to be a classeffect in rodents after long-term exposure to high doses of β2-adrenoreceptor agonists.
Croatian: Maleno povišenje u incidenciji leiomioma maternice primijećeno je u štakora i miševa, učinak za koji se smatra da je učinak razreda u štakora nakon dugotrajne izloženosti visokim dozama β2-adrenergičkih agonista.
English: There are no data available on the use of Brimica Genuair in pregnant women.
Croatian: Nema podataka o primjeni Brimica Genuaira u trudnica.
English: Formoterol does not inhibit the CYP450 enzymes at therapeutically relevant concentrations (see section 5.2).
Croatian: Formoterol ne inhibira enzime CYP450 u terapijski relevantnim koncentracijama (vidjeti dio 5.2).
English: The MAH shall complete, within the stated timeframe, the below measure: Description
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere:
English: Go back to ‘STEP 1 Prepare your dose' and repeat steps 1.1 to 1.6.
Croatian: Vratite se na „1. KORAK: Pripremite dozu“ i ponovite korake od 1.1 do 1.6.
English: You should not use this medicine to treat a sudden attack of breathlessness or wheezing.
Croatian: Ne smije se koristiti za liječenje iznenadnog napadaja nedostatka zraka ili piskanja.
English: (Figure N), or
Croatian: (Slika N), ili
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).
Croatian: Maksimalni bronhodilatacijski učinak (vršna vrijednost FEV1) u odnosu na početnu vrijednost postignut je od prvog dana (304 ml) i održavan je tijekom razdoblja liječenja od 6 mjeseci (326 ml).
English: Due to its anticholinergic activity, Brimica Genuair should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).
Croatian: U skladu s njegovim antikolinergičkim djelovanjem, Brimica Genuair treba primjenjivati s oprezom kod bolesnika sa simptomatskom hiperplazijom prostate, retencijom urina ili glaukomom uskog kuta (iako je vrlo mala vjerojatnost izravnog kontakta lijeka s očima).
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).
Croatian: β2-adrenergički agonisti dugog djelovanja trebaju se oprezno koristiti kod bolesnika s anamnezom produljenja QTc intervala ili poznatim produljenjem QTc intervala ili su liječeni lijekovima koji utječu na QTc interval (vidjeti dio 4.5).
English: The prominent pathway involves direct glucuronidation, with O-demethylation followed by glucuronide conjugation being a further metabolic pathway.
Croatian: značajni put uključuje izravnu glukuronidaciju, s O-demetilacijom koju slijedi konjugacija u glukoronid koja je daljnji metabolički put.
English: High doses of Brimica Genuair may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms; the most frequent of which include blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and hypertension.
Croatian: Visoke doze Brimica Genuaira mogu dovesti do pretjeranih antikolinergičkih i/ili β2-adrenergičkih znakova i simptoma, od kojih su najčešći zamagljen vid, suha usta, mučnina, mišićni spazam, tremor, glavobolja, palpitacije i hipertenzija.
English: There are no data regarding the specific use of aclidinium/formoterol in patients with renal or hepatic impairment.
Croatian: Nema podataka o specifičnoj uporabi aklidinija/formoterola u bolesnika s oštećenjem bubrega ili jetre.
English: Adverse reactions associated with Brimica Genuair were similar to those of the individual components.
Croatian: Nuspojave povezane s Brimica Genuairom bile su slične onima njegovih pojedinačnih sastavnica.
English: Brimica Genuair should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval such as monoamine oxidase inhibitors, tricyclic antidepressants, antihistamines or macrolides because the action of formoterol, a component of Brimica Genuair, on the cardiovascular system may be potentiated by these medicinal products.
Croatian: Brimica Genuair s oprezom moraju uzimati bolesnici koji se liječe lijekovima za koje se zna da produljuju QTc interval kao što su inhibitori monoaminooksidaze, triciklički antidepresivi, antihistaminici ili makrolidi zato što djelovanje formoterola, sastavnice Brimica Genuaira, na kardiovaskularni sustav može biti potencirano ovim lijekovima.
English: Rare (may affect up to 1 in 1,000 people) - Sudden difficulty in breathing or swallowing, swelling of the tongue, throat, lips or face, skin rash and/or itching - these may be signs of an allergic reaction
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba) - Iznenadne poteškoće u disanju ili gutanju, oticanje jezika, grla, usana ili lica, osip na koži i/ili svrbež - mogu biti znakovi alergijske reakcije
English: The onset of action of Brimica Genuair was comparable to the effect of the fast-acting β2-agonist formoterol 12 micrograms.
Croatian: Nastup djelovanja Brimica Genuaira bio je usporediv s učinkom brzodjelujućeg β2-agonista formoterola u dozi od 12 mikrograma.
English: Angioedema Anaphylactic reaction
Croatian: Angioedem Anafilaktička reakcija
English: Co-administration of Brimica Genuair with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products has not been studied and is not recommended.
Croatian: Istodobna primjena Brimica Genuaira s drugim lijekovima koji sadrže antikolinergike i/ili dugodjelujuće β2-adrenergičke agoniste nije ispitana i ne preporučuje se.
English: Although no formal in vivo drug interaction studies have been performed with Brimica Genuair, it has been used concomitantly with other COPD medicinal products including short-acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Croatian: Iako formalna in vivo ispitivanja interakcija lijekova s Brimica Genuairom nisu provedena, on se koristio istodobno s drugim lijekovima za KOPB uključujući kratkodjelujuće β2-adrenergičke bronhodilatatore, metilksantine te oralne i inhalacijske steroide bez kliničkih dokaza o interakciji lijekova.
English: In vitro studies have shown that aclidinium at the therapeutic dose or its metabolites do not inhibit or induce any of the cytochrome P450 (CYP450) enzymes and do not inhibit esterases (carboxylesterase, acetylcholinesterase and butyrylcholinesterase).
Croatian: In vitro ispitivanja pokazala su da aklidinij u terapijskoj dozi ili njegovi metaboliti ne inhibiraju i ne induciraju nijedan od enzima citokroma P450 (CYP450) i ne inhibiraju esteraze (karboksilesterazu, acetilkolinesterazu i butirilkolinesterazu).
English: Brimica Genuair improved daily symptoms of COPD such as ‘breathlessness', ‘chest symptoms', ‘cough and sputum' (assessed by E-RS total score) as well as overall night-time symptoms, overall early morning symptoms and symptoms limiting early morning activities compared to placebo, aclidinium and formoterol but the improvements were not always statistically significant.
Croatian: Brimica Genuair je poboljšao dnevne simptome KOPB-a kao što su „nedostatak zraka“, „simptomi u prsištu“, „kašalj i ispljuvak“ (procijenjeno prema E-RS ukupnom rezultatu), kao i ukupne noćne i ukupne ranojutarnje simptome, te simptome koji ograničavaju ranojutarnje aktivnosti u usporedbi s placebom, aklidinijem i formoterolom, no poboljšanja nisu uvijek bila statistički značajna.