FrancophonIA/ELRC3.0 huggingface dataset:
English: GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701 produkt.info@gsk.com
Croatian: Tel: + 49 (0)89 360448701 produkt.info@gsk.com
English: Gastrointestinal
Croatian: Prijavljivanje nuspojava
English: Gastrointestinal Headache
Croatian: Probavne nuspojave Glavobolja
English: Seronegative subjects prior to vaccination N=15 [95% CI]
Croatian: Ispitanici koji su prije cijepljenja bili seronegativni N=15 [95% CI]
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon miješanja lijeka vidjeti u dijelu 6.3. 6.5 Vrsta i sadržaj spremnika Jedno pakiranje sadrži:
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
Croatian: • ako ste prije imali iznenadnu životno ugrožavajuću alergijsku reakciju na bilo koji sastojak ovog cjepiva (navedeno u dijelu 6) ili na bilo koju tvar koja može biti prisutna u tragovima, poput:
English: Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk
Croatian: Daljnje promjene u informacijama o lijekovima doprinose boljem informiranju zdravstvenih djelatnika i žena o riziku od tromboembolije.
English: Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should
Croatian: Uzimajući u obzir da se faktori rizika od VTE-a mijenjaju tijekom vremena, PRAC je napomenuo da se individualni rizik mora periodički ponovno ocjenjivati.
English: The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk
Croatian: PRAC je potvrdio poznati rizik od tromboembolije lijekova koji sadrže kombinirane hormonalne kontraceptive i preporučio je jasno označavanje simptoma kombiniranih tromboembolijskih događaja kao i faktora rizika od tromboembolije.
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from
Croatian: Dodatak IV Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet i detaljno pojašnjenje razlika u odnosu na preporuku PRAC-a
English: It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between
Croatian: Poznato je da je rizik od arterijske tromboembolije (ATE-a) (infarkta miokarda, moždanog udara) također povišen s primjenom KHK-a, no nema dokaza u razlikama između KHK-ova u njihovom relativnom riziku od ATE-a.
English: These are combined with varying doses of ethinylestradiol
Croatian: Ovi se lijekovi kombiniraju s varirajućim dozama etinilestradiola (EE) ili s estradiolom (E2).
English: In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrel
Croatian: Nadalje, PRAC je nametnuo provođenje ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet kako bi se bolje okarakterizirao rizik od tromboembolijskih događaja zbog klormadinona u usporedbi s lijekovima koji sadrže levonorgestrel.
English: • The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the
Croatian: • je PRAC zaključio da su daljnji podaci potrebni za kombinirane hormonalne kontraceptive koji sadrže klormadinon i nametnuo je provođenje ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet (PASS) kako bi se ocijenio relativan rizik od tromboembolijskih događaja zato što su ovi lijekovi uspoređeni s onima koji sadrže levonorgestrel.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation
Croatian: Slijedom navedenog PRAC je zaključio da omjer koristi i rizika za lijekove Evra, Ioa i Zoely u indikaciji kontracepcije ostaje povoljan, što je predmetom usuglašenih uvjeta, ograničenja, upozorenja, drugih izmjena u informacijama o lijeku i dodatnih mjera minimiziranja rizika.
English: - If you have epilepsy.
Croatian: - ako imate epilepsiju.
English: This reaction may rarely occur (may affect up to 1 in 1,000 people).
Croatian: Ta reakcija može se pojaviti rijetko (može se javiti u do 1 na 1000 osoba).
English: - If you have heart problems.
Croatian: - ako imate tegobe sa srcem.
English: Frequency of this reactin cannot be estimated from the available data.
Croatian: Učestalost ovih reakcija ne može se procijeniti iz dostupnih podataka.
English: - You can use Brimica Genuair anytime before or after food or drink.
Croatian: - Lijek Brimica Genuair možete uzeti bilo kada prije ili nakon jela ili pića.
English: To be used within 60 days of opening the bag.
Croatian: Upotrijebiti u roku od 60 dana nakon otvaranja vrećice.
English: Hypokalaemia is usually transient, not requiring supplementation.
Croatian: Hipokalijemija je uglavnom prolazna i ne zahtijeva nadomjestak.
English: Both belong to a group of medicines called bronchodilators.
Croatian: Obje pripadaju skupini lijekova pod nazivom bronhodilatatori.
English: • Medicines that lower the amount of potassium in your blood.
Croatian: • lijekove koji snižavaju količinu kalija u Vašoj krvi.
English: Blood pressure increased
Croatian: Povišen krvni tlak
English: Some patients may not hear the ‘click'.
Croatian: Neki bolesnici možda neće čuti „klik“.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako su Vam rekli Vaš liječnik ili ljekarnik.
English: - The recommended dose is one inhalation in the morning and one inhalation in the evening.
Croatian: - Preporučena doza je jedna inhalacija ujutro i jedna inhalacija navečer.
English: Dose indicator moves slowly from 60 to 0: 60, 50, 40, 30, 20, 10, 0.
Croatian: Pokazivač doze polako se pomiče od 60 prema 0: 60, 50, 40, 30, 20, 10, 0.
English: The recommended dose is one inhalation twice daily.
Croatian: Preporučena doza je jedna inhalacija dvaput dnevno.
English: Formoterol is eliminated primarily by metabolism.
Croatian: Formoterol se eliminira primarno putem metabolizma.
English: Brimica Genuair should only be used during pregnancy if the expected benefits outweigh the potential risks.
Croatian: Brimica Genuair se tijekom trudnoće smije koristiti samo ako je očekivana korist veća od potencijalnih rizika.
English: The medicine must be used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Croatian: Ovaj lijek mora se koristiti svakodnevno, dvaput na dan, a ne samo kad imate probleme s disanjem ili druge simptome KOPB-a.
English: Bronchospasm, including paradoxical
Croatian: Bronhospazam, uključujući paradoksalni
English: If the control window still does not change to red, you may have forgotten to release the orange button before inhaling, or you may not have inhaled strongly enough.
Croatian: Ako kontrolni prozorčić ni tada ne postane crven, možda ste zaboravili otpustiti narančasti gumb prije inhalacije ili možda niste dovoljno snažno udahnuli.
English: Some side effects may be serious: if you get any of these side effects, tell your doctor immediately.
Croatian: Neke nuspojave mogu biti ozbiljne: ako dobijete bilo koju od ovih nuspojava, odmah obavijestite liječnika.
English: A behavioural intervention program was added to both treatment groups for an additional 4 weeks.
Croatian: Bihevioralni intervencijski program dodan je u obje liječene skupine u trajanju od dodatnih 4 tjedna.
English: The plasma protein binding of formoterol is 61% to 64% (34% primarily to albumin).
Croatian: Vezanje formoterola na proteine plazme iznosi od 61% do 64% (34% uglavnom na albumin).
English: Children and adolescents Brimica Genuair is not for use in children or adolescents below 18 years of age.
Croatian: Djeca i adolescenti Brimica Genuair nije namijenjen djeci i adolescentima mlađim od 18 godina.
English: Talk to your doctor, pharmacist or nurse before using Brimica Genuair, if you have any of the following conditions/symptoms: - If you have asthma.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Brimica Genuair ako imate neko od sljedećih stanja/simptoma: - ako imate astmu.
English: If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time.
Croatian: Ako se propusti jedna doza, potrebno ju je uzeti što je prije moguće i potom sljedeću dozu treba uzeti u uobičajeno vrijeme.
English: Supportive and symptomatic treatment is indicated.
Croatian: Potrebno je uvesti suportivno i simptomatsko liječenje.
English: *As the primary endpoint did not achieve statistical significance, all p-values for secondary endpoints are tested at a nominal significance level of 0.05, and no formal statistical inference can be drawn.
Croatian: *Budući da nije postignuta statistička značajnost primarne mjere ishoda, sve p-vrijednosti sekundarnih mjera ishoda ispitivane su pri nominalnoj razini značajnosti od 0,05 i nikakav formalni statistički zaključak nije moguć.
English: Infectious and infestations
Croatian: Infekcije i infestacije
English: • Each time you load a dose by pressing the orange button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
Croatian: • Svaki put kad pripremite dozu pritiskom na narančasti gumb, pokazivač doze malo se pomakne prema sljedećem broju (50, 40, 30, 20, 10 ili 0).
English: If you are affected by either of these side effects, do not drive or use machines until the dizziness has cleared or your vision has returned to normal.
Croatian: Ako imate bilo koju od ovih nuspojava, nemojte voziti niti upravljati strojevima dok omaglica ne prestane, a Vaš vid se vrati u normalu.
English: Further information regarding these two substances is provided below.
Croatian: Dodatne informacije o ove dvije tvari navedene su u nastavku.
English: Breathlessness and other symptomatic outcomes:
Croatian: Nedostatak zraka i drugi simptomatski ishodi:
English: This medicine should not be used for the treatment of asthma.
Croatian: Ovaj se lijek ne smije koristiti za liječenje astme.
English: In some patients, this medicine may cause blurred vision or dizziness.
Croatian: U nekih bolesnika, ovaj lijek može uzrokovati zamagljen vid ili omaglicu.
English: Other side effects which may occur while using Brimica Genuair:
Croatian: Ostale nuspojave koje se mogu pojaviti dok koristite Brimica Genuair:
English: In case such effects occur, treatment may need to be discontinued.
Croatian: Ako dođe do takvih učinaka, možda će trebati prekinuti terapiju.
English: Other medicines and Brimica Genuair
Croatian: Drugi lijekovi i Brimica Genuair
English: The combination of these substances with different mechanisms of action results in additive efficacy compared to that achieved with either component alone.
Croatian: Kombinacija tih tvari s različitim mehanizmima djelovanja rezultira aditivnom djelotvornosti u usporedbi s onom koja se postiže svakom sastavnicom zasebno.
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.
Croatian: Ako Vam se uobičajeni simptomi KOPB-a (nedostatak zraka, piskanje, kašalj) ne poboljšaju ili se pogoršaju dok koristite Brimica Genuair, nastavite ga koristiti, ali posjetite svog liječnika što je prije moguće, jer ćete možda trebati još jedan lijek.
English: This section contains information on how to use your Genuair inhaler.
Croatian: Ovaj dio sadrži informacije o načinu uporabe Genuair inhalatora.
English: If you use Brimica Genuair with some other medicines, the effect of Brimica Genuair or the other medicines may be altered.
Croatian: Ako uzimate Brimica Genuair s drugim lijekovima, učinci Brimica Genuaira ili drugih lijekova mogu se promijeniti.
English: If this occurs, medicinal product should be stopped and other treatment will be considered.
Croatian: Ako dođe do toga, liječenje treba prekinuti i razmotriti uzimanje drugih lijekova.
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).
Croatian: Kada se narančasti gumb ne želi u potpunosti vratiti u početni položaj, već se zaključa u srednjem položaju, došli ste do zadnje doze (Slika O).
English: A video demonstration on how to use the Genuair inhaler is also available on www.genuair.com and through the code below.
Croatian: Video demonstracija o načinu uporabe Genuair inhalatora dostupna je na www.genuair.com i putem donjeg QR kôda.
English: It is important to instruct the patients to read the Instructions for Use in the Package Leaflet.
Croatian: Važno je bolesnicima napomenuti da pažljivo pročitaju upute za uporabu navedene u uputi o lijeku.
English: Tell your doctor or pharmacist if you are taking:
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate:
English: *Half-life consistent with product accumulation based on a known dose regimen.
Croatian: *Poluvrijeme u skladu s akumulacijom lijeka na temelju poznatog režima doziranja.
English: Dry mouth, which has been observed with anticholinergic treatment, may in the long term be associated with dental caries.
Croatian: Suha usta, koja su zabilježena uz liječenje antikolinergicima, dugoročno mogu biti povezana sa zubnim karijesom.
English: • If your inhaler appears to be damaged or if you lose the cap, or
Croatian: • ako inhalator koji imate izgleda oštećeno ili ako izgubite kapicu inhalatora
English: Aclidinium is a competitive, selective muscarinic receptor antagonist, with a longer residence time at the M3 receptors than the M2 receptors.
Croatian: Aklidinij je kompetitivni, selektivni antagonist muskarinskih receptora, s duljim vremenom vezanja na M3 nego na M2 receptorima.
English: However, paradoxical bronchospasm has been observed with other inhalation therapies.
Croatian: Međutim, paradoksalni bronhospazam je primijećen u drugim inhalacijskim terapijama.
English: The main plasma protein that binds aclidinium is albumin.
Croatian: Glavni protein plazme koji veže aklidinij je albumin.
English: Taking Brimica Genuair regularly will reduce the effects of COPD on your everyday life.
Croatian: Redovito uzimanje lijeka Brimica Genuair će smanjiti utjecaj KOPB-a na Vaš svakodnevni život.
English: By opening the airways, the medicine helps relieve symptoms such as shortness of breath.
Croatian: Otvarajući dišne putove, lijek pomaže ublažiti simptome kao što je nedostatak zraka.
English: Aclidinium/formoterol did not statistically significantly reduce the average number of night-time awakenings due to COPD compared with placebo or formoterol.
Croatian: Aklidinij/formoterol nije statistički značajno smanjio prosječni broj noćnih buđenja uzrokovanih KOPB-om u usporedbi s placebom ili formoterolom.
English: Medicinal products that are known to prolong the QTc interval are associated with an increased risk of ventricular arrhythmias.
Croatian: Lijekovi za koje se zna da produljuju QTc interval povezuju se s povišenim rizikom od ventrikularnih aritmija.
English: Nevertheless, it is considered unlikely that Brimica Genuair administered at the recommended dose will affect fertility in humans.
Croatian: Usprkos tome, smatra se malo vjerojatnim da će Brimica Genuair davan u preporučenoj dozi utjecati na plodnost u ljudi.
English: EU/1/14/963/001 1 inhaler with 60 doses EU/1/14/963/002 3 inhalers each with 60 doses EU/1/14/963/003 1 inhaler with 30 doses
Croatian: EU/1/14/963/001 1 inhalator sa 60 doza EU/1/14/963/002 3 inhalatora svaki sa 60 doza EU/1/14/963/003 1 inhalator sa 30 doza
English: If β-adrenergic blockers are required (including eye drops), cardioselective beta-adrenergic blockers are preferred, although they should also be administered with caution.
Croatian: Ako su β-adrenergički blokatori potrebni (što uključuje kapi za oči), preporučuju se kardioselektivni beta-adrenergički blokatori, iako se i oni trebaju koristiti s oprezom.
English: Mean effective half-lives* observed for both aclidinium and formoterol (based on the accumulation ratio) are approximately 10 hours.
Croatian: Srednja vrijednost efektivnih poluvremena* opaženih i za aklidinij i za formoterol (na temelju brzine akumulacije) su otprilike 10 sati.
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.
Croatian: Vezanje aklidinija za proteine plazme određeno in vitro najvjerojatnije odgovara vezanju metabolita za proteine plazme zbog brze hidrolize aklidinija u plazmi; vezanje na proteine plazme bilo je 87% za metabolit karboksilne kiseline i 15% za alkoholni metabolit.
English: • Medicines which can cause a type of change in the electrical activity of the heart known as QT interval prolongation (observed in an electrocardiogram).
Croatian: • lijekove koji mogu uzrokovati promjenu u električnoj aktivnosti srca koja se naziva produljenje QT intervala (što se opaža na elektrokardiogramu).
English: These effects are known exaggerated pharmacological responses observed with β2-agonists.
Croatian: Ovi učinci su poznati pretjerani farmakološki odgovori opaženi kod β2-agonista.
English: Since aclidinium bromide is quickly broken down in plasma, the level of systemic anticholinergic undesirable effects is low.
Croatian: Budući da se aklidinijev bromid brzo razgrađuje u plazmi, razina sistemskih antikolinergičkih nuspojava je niska.
English: Nasopharyngitis Urinary tract infection Sinusitis
Croatian: Nazofaringitis Infekcija urinarnog trakta Sinusitis
English: Name and address of the manufacturer responsible for batch release Industrias Farmacéuticas Almirall, S.A.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Industrias Farmacéuticas Almirall, S.A.
English: Hypokalaemia increases susceptibility to cardiac arrhythmias.
Croatian: Hipokalijemija povećava podložnost srčanim aritmijama.
English: Stop using the medicine and contact your doctor immediately if you:
Croatian: Prestanite uzimati lijek i odmah se obratite liječniku ako:
English: There is no relevant use of Brimica Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Croatian: Nema relevantne primjene lijeka Brimica Genuair u djece i adolescenata (mlađih od 18 godina) za indikaciju KOPB-a.
English: There is no saturation of binding sites in the concentration range reached with therapeutic doses.
Croatian: Nema zasićenosti na mjestima vezanja u rasponu koncentracija koji se dostiže terapijskim dozama.
English: The presentation of the safety profile is based on the experience with Brimica Genuair and the individual components.
Croatian: Prikaz sigurnosnog profila zasniva se na iskustvu s Brimica Genuairom i njegovim pojedinačnim sastavnicama.
English: Rash Pruritus
Croatian: Osip Pruritus
English: COPD is a long-term disease; therefore, Brimica Genuair is for long-term use.
Croatian: KOPB je dugotrajna bolest; stoga je Brimica Genuair namijenjen za dugotrajnu primjenu.
English: Each delivered dose contains approximately 11 mg lactose (as monohydrate).
Croatian: Jedna isporučena doza sadrži približno 11 mg laktoze (u obliku hidrata).
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEVOM
English: 1.2 Look at the control window (should be red, Figure C).
Croatian: 1.2 Pogledajte kontrolni prozorčić (mora biti crvene boje, Slika C).
English: Brimica Genuair contains lactose
Croatian: Brimica Genuair sadrži laktozu
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.
Croatian: U ispitivanjima faze III, klinički značajni bronhodilatacijski učinci vidjeli su se unutar 5 minuta nakon prve doze i bili su održani za vrijeme intervala doziranja.
English: Dry mouth has been observed with medicines like Brimica Genuair.
Croatian: Suha usta su zabilježena uz lijekove poput Brimica Genuaira.
English: No dose adjustments are necessary in these patients.
Croatian: Nije potrebno prilagođavati dozu kod ovih bolesnika.
English: 1.5 Release the orange button (Figure F).
Croatian: Otpustite narančasti gumb (Slika F).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove..
English: What Brimica Genuair looks like and contents of the pack Brimica Genuair is a white or almost white inhalation powder.
Croatian: Kako Brimica Genuair izgleda i sadržaj pakiranja Brimica Genuair je bijeli ili gotovo bijeli prašak za inhalaciju.
English: Bronchodilators relax the muscles in your airways, which allows the airways to open more widely and helps you to breathe more easily.
Croatian: Bronhodilatatori opuštaju mišiće u dišnim putovima, što omogućava da se dišni putovi više otvore i pomaže Vam da lakše dišete.
English: In addition to improving pulmonary function, formoterol has been shown to improve symptoms and quality of life in patients with COPD.
Croatian: Uz poboljšanje funkcije pluća, formoterol dokazano poboljšava simptome i kvalitetu života bolesnika s KOPB-om.
English: Plasma levels of the acid metabolite are approximately 100-fold greater than those of the alcohol metabolite and the unchanged active substance following inhalation.
Croatian: Razine kiselinskog metabolita u plazmi su oko 100 puta više od razina alkoholnog metabolita i nepromijenjene djelatne tvari nakon inhalacije.
English: Make sure you release the button so the inhaler can work correctly.
Croatian: Obavezno otpustite gumb da bi inhalator mogao pravilno raditi.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics, ATC code: R03AL05
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih putova, adrenergici u kombinaciji s antikolinergicima, ATK oznaka: R03AL05
English: After inhalation, 6% to 9% of the delivered dose of formoterol is excreted in the urine unchanged or as direct conjugates of formoterol.
Croatian: Nakon inhalacije, 6% do 9% isporučene doze formoterola izlučuje se u urinu nepromijenjeno ili kao izravni konjugat formoterola.
English: Even though the orange button is locked, your last dose may still be inhaled.
Croatian: Iako je narančasti gumb zaključan u srednjem položaju, ipak možete inhalirati zadnju dozu.
English: β-adrenergic blockers β-adrenergic blockers may weaken or antagonise the effect of β2-adrenergic agonists.
Croatian: β-adrenergički blokatori β-adrenergički blokatori mogu oslabiti ili antagonizirati učinke β2-adrenergičkih agonista.
English: Brimica Genuair should not be used in asthma; clinical studies of Brimica Genuair in asthma have not been conducted.
Croatian: Brimica Genuair se ne smije koristiti kod astme; nisu provedena klinička ispitivanja primjene Brimica Genuaira kod astme.