FrancophonIA/ELRC3.0 huggingface dataset:
English: The review of valproate was conducted by the EMA's Pharmacovigilance and Risks Assessment Committee (PRAC), following which the CMDh endorsed the PRAC's recommendations.
Croatian: Pregled lijeka valproat proveo je Odbor za ocjenu rizika na području farmakovigilancije (PRAC) pri EMA-i, nakon kojeg je CMDh potvrdio preporuke PRAC-a.
English: The CMDh,* a regulatory body representing EU Member States, has agreed to strengthen warnings on the use of valproate medicines in women and girls due to the risk of malformations and developmental problems in babies who are exposed to valproate in the womb.
Croatian: CMDh*, regulatorno tijelo koje predstavlja države članice EU-a, suglasno je da treba pojačati upozorenja o primjeni lijekova koji sadrže valproat u žena i djevojaka uslijed rizika od malformacija i problema u razvoju novorođenčadi koja je izložena valproatu u maternici.
English: − Do not prescribe valproate for female patients who can have children if they are not using effective methods of contraception or if they are already pregnant - such use is now contraindicated.
Croatian: Ne propisujte valproat bolesnicama reproduktivne dobi ako ne koriste djelotvorne metode kontracepcije ili ako su već trudne - ta uporaba je sada kontraindicirana.
English: The warnings aim to ensure that patients are aware of the risks and that they take valproate only when clearly necessary.
Croatian: Cilj je upozorenja osigurati da kod bolesnica postoji svjesnost o rizicima te da uzimaju valproat samo u slučaju kada je očito neophodan.
English: Women to be better informed of risks of valproate use in pregnancy and need for contraception
Croatian: Žene treba bolje informirati o rizicima primjene valproata tijekom trudnoće i potrebi za kontracepcijom
English: Doctors in the EU are now advised not to prescribe valproate for epilepsy or bipolar disorder in pregnant women, in women who can become pregnant or in girls unless other treatments are ineffective or not tolerated.
Croatian: Liječnicima u EU-u sada se savjetuje da ne propisuju valproat za liječenje epilepsije ili bipolarnog poremećaja u trudnica, u žena reproduktivne dobi ili u djevojaka osim ako druge terapije nisu učinkovite ili se ne podnose dobro.
English: • Do not stop taking your valproate medicine without consulting your doctor as doing so could cause harm to you or an unborn child.
Croatian: • Ne prekidajte terapiju lijekom valproat bez prethodnog savjetovanja s liječnikom budući da time možete nanijeti štetu sebi ili nerođenom djetetu.
English: − Ensure that the treatment of epilepsy or bipolar disorder is supervised by a doctor experienced in treating these conditions.
Croatian: Provjerite da li liječenje epilepsije ili bipolarnog poremećaja nadzire liječnik iskusan u liječenju tih stanja.
English: Meador K, Reynolds MW, Crean S, et al. Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts.
Croatian: Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts.
English: − Consider alternative treatments if a female patient becomes or plans to become pregnant during valproate treatment.
Croatian: Razmotrite alternativne terapije ako bolesnica zatrudni ili planira zatrudnjeti tijekom terapije valproatom.
English: The active ingredients are listed on the packages as valproic acid, sodium valproate, valproate semisodium or valpromide.
Croatian: Djelatne tvari navedene su na ambalaži: valproična kiselina, natrijev valproat, seminatrijev valproat ili valpromid.
English: − Inform patients of the risks of taking valproate during pregnancy.
Croatian: Obavijestite bolesnice o rizicima uzimanja valproata tijekom trudnoće.
English: Regularly review the need for treatment and re-assess the balance of the benefits and risks for female patients taking valproate and for girls reaching puberty.
Croatian: Redovito preispitujte potrebu terapije i ponovno ocjenjujte omjer koristi i rizika za bolesnice koje uzimaju valproat te za djevojčice u pubertetu.
English: Information to healthcare professionals Following an evaluation of the data on the risks of valproate use during pregnancy, the recommendations for the use of valproate in women and girls have been updated:
Croatian: Nakon evaluacije podataka o rizicima primjene valproata tijekom trudnoće, preporuke za primjenu valproata u žena i djevojaka su ažurirane:
English: − Advise patients taking valproate medicines about effective contraception during their treatment.
Croatian: Savjetujte bolesnice koje uzimaju lijekove koji sadrže valproat o učinkovitoj kontracepciji tijekom terapije.
English: Doctors should ensure that their patients are adequately informed of the risks of taking valproate during pregnancy, and should regularly review the need for treatment in female patients who can have children.
Croatian: Liječnici trebaju osigurati da su njihove pacijentice primjereno informirane o rizicima uzimanja valproata tijekom trudnoće, te trebaju redovito preispitivati potrebu za liječenjem u pacijentica reproduktivne dobi.
English: The CMDh position was agreed by consensus, and the recommendations on the use of valproate in women and girls will be implemented by EU Member States according to an agreed timetable.
Croatian: Mišljenje CMDh-a doneseno je konsenzusom, a preporuke o primjeni valproata u žena i djevojaka primijenit će se prema usuglašenom rasporedu.
English: − Only prescribe valproate medicines for epilepsy and bipolar disorder if other treatments are ineffective or not tolerated.
Croatian: Propisujte lijekove koji sadrže valproat u slučaju epilepsije i bipolarnog poremećaja samo ako su druge terapije neučinkovite ili se ne podnose.
English: Women and girls who have been prescribed valproate should not stop taking their medicines without consulting their doctor as doing so could result in harm to themselves or to an unborn child.
Croatian: Žene i djevojke kojima je propisan valproat ne smiju prekinuti terapiju lijekom bez prethodnog savjetovanja s liječnikom budući da na ovaj način mogu naštetiti sebi ili nerođenom djetetu.
English: − Exclude pregnancy before starting a female patient on valproate treatment for migraine.
Croatian: Isključite trudnoću bolesnice prije početka terapije valproatom za potrebe liječenja migrene.
English: Doctors should also re-assess the balance of the benefits and risks of valproate medicines for any female patient who becomes or plans to become pregnant and for girls reaching puberty.
Croatian: Liječnici također trebaju redovito ocjenjivati koristi i rizike lijekova koji sadrže valproat u slučaju pacijentica koje zatrudne ili planiraju trudnoću kao i u djevojčica u pubertetu.
English: • For treatment of epilepsy and bipolar disorder in female patients who can have children
Croatian: • Za liječenje epilepsije i bipolarnog poremećaja u bolesnica reproduktivne dobi
English: Meador KJ, Baker GA, Browning N, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study.
Croatian: Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study.
English: The recommendations on the use of valproate in women and girls will be implemented by EU Member States according to an agreed timetable.
Croatian: Države članice EU-a primijenit će preporuke o primjeni valproata u žena i djevojaka prema usuglašenom rasporedu.
English: − Ensure that female patients who can become pregnant are aware that they must keep to their contraception throughout treatment.
Croatian: Provjerite jesu li bolesnice reproduktivne dobi upoznate da trebaju primjenjivati kontracepciju tijekom cijelog razdoblja terapije.
English: Cohen MJ, Meador KJ, Browning N, et al. Fetal antiepileptic drug exposure: motor, adaptive, and emotional/behavioral functioning at age 3 years.
Croatian: Fetal antiepileptic drug exposure: motor, adaptive, and emotional/behavioral functioning at age 3 years.
English: Meador KJ, Penovich P, Baker GA, et al. Antiepileptic drug use in women of childbearing age.
Croatian: Meador KJ, Penovich P, Baker GA, et al.
English: Christensen J, Grønborg TK, Sørensen MJ, et al. Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.
Croatian: Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.
English: Bromley RL, Mawer G, Clayton-Smith J, et al. Autism spectrum disorders following in utero exposure to antiepileptic drugs.
Croatian: Bromley RL, Mawer G, Clayton-Smith J, et al.
English: Cohen MJ, Meador KJ, Browning N, et al. Fetal antiepileptic drug exposure: Adaptive and emotional/behavioral functioning at age 6years.
Croatian: Fetal antiepileptic drug exposure: Adaptive and emotional/behavioral functioning at age 6years.
English: Cummings C, Stewart M, Stevenson M, et al. Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine.
Croatian: Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine.
English: Thomas SV, Ajaykumar B, Sindhu K, et al. Motor and mental development of infants exposed to antiepileptic drugs in utero.
Croatian: 5. Thomas SV, Ajaykumar B, Sindhu K, et al.
English: Allergic reactions may rarely occur (may affect up to 1 in 1,000 people).
Croatian: Alergijske reakcije mogu se javiti rijetko (mogu se javiti u do 1 na 1000 osoba).
English: You can use Eklira Genuair any time before or after food or drink.
Croatian: Lijek Eklira Genuair možete koristiti u bilo koje vrijeme prije ili nakon hrane ili pića.
English: If you forget a dose of Eklira Genuair, inhale the dose as soon as you remember.
Croatian: Ako zaboravite dozu Eklira Genuair, inhalirajte dozu čim se sjetite.
English: Children and adolescents Eklira Genuair is not for use in children or adolescents below 18 years of age.
Croatian: Djeca i adolescenti Eklira Genuair nije namijenjen djeci i adolescentima mlađim od 18 godina.
English: It is important to instruct the patients to carefully read the Instructions for Use in the Package Leaflet, which is packed together with each inhaler.
Croatian: Važno je bolesnicima napomenuti da pažljivo pročitaju upute za uporabu navedene u uputi o lijeku, koja se nalazi u pakiranju svakog inhalatora.
English: What Eklira Genuair looks like and contents of the pack Eklira Genuair is a white or almost white powder.
Croatian: Kako Eklira Genuair izgleda i sadržaj pakiranja Eklira Genuair je bijel ili gotovo bijeli prašak.
English: The effects of Eklira Genuair last for 12 hours; therefore, you should try to use your Eklira Genuair inhaler at the same time every morning and evening.
Croatian: Učinci Eklira Genuair traju 12 sati; stoga nastojte koristiti Eklira Genuair uvijek u isto vrijeme ujutro odnosno navečer.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eklira Genuair therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti/suzdržati se od liječenja lijekom Eklira Genuair uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: COPD is a long-term disease; therefore, it is recommended that Eklira Genuair is used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Croatian: KOPB je dugotrajna bolest; stoga se preporučuje koristiti lijek Eklira Genuair svakodnevno, dvaput na dan, a ne samo kada se pojave problemi s disanjem ili drugi simptomi KOPB-a.
English: - 4.6 units a Minimum clinically important difference (MCID) of at least 1 unit change in TDI.
Croatian: - 4,6 jedinica a Minimalna klinički značajna razlika (MCID, eng. minimum clinically important difference) promjena od najmanje 1 jedinice u TDI.
English: Do not use Eklira Genuair - if you are allergic to aclidinium bromide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Eklira Genuair - ako ste alergični na aklidinijev bromid ili na neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: If you use more Eklira Genuair than you should If you think you may have used more Eklira Genuair than you should, contact your doctor or pharmacist.
Croatian: Ako primijenite više lijeka Eklira Genuair nego što ste trebali Ako mislite da ste možda primijenili više lijeka Eklira Genuair nego što ste trebali, obratite se svom liječniku ili ljekarniku.
English: You should not use Eklira Genuair if you are pregnant or are breast-feeding unless your doctor tells you so.
Croatian: Ne smijete uzimati Eklira Genuair ako ste trudni ili dojite, osim ako to ne odredi Vaš liječnik.
English: b MCID of at least - 4 units change in SGRQ.
Croatian: b MCID promjena od najmanje - 4 jedinice u SGRQ. c
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: The use of Eklira Genuair with these medicines is not recommended.
Croatian: Ne preporučuje se uzimanje Eklira Genuair uz ove lijekove.
English: Eklira Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into your lungs.
Croatian: Eklira Genuair je inhalator suhog praška koji koristi Vaše disanje za dostavu lijeka izravno u Vaša pluća.
English: This leaflet was last revised in <{month YYYY}>.
Croatian: Ova je uputa zadnji puta revidirana u {mjesec GGGG}.
English: Administration of Eklira Genuair may cause paradoxical bronchospasm.
Croatian: Primjena lijeka Eklira Genuair može uzrokovati paradoksalni bronhospazam.
English: If this occurs, treatment with Eklira Genuair should be stopped and other treatments considered.
Croatian: Ako dođe do toga, liječenje lijekom Eklira Genuair treba prekinuti i razmotriti uzimanje drugih lijekova.
English: There is no relevant use of Eklira Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Croatian: Nema relevantne primjene lijeka Eklira Genuair u djece i adolescenata (mlađih od 18 godina) u indikaciji KOPB-a.
English: Other medicines and Eklira Genuair
Croatian: Drugi lijekovi i Eklira Genuair
English: What Eklira Genuair is and what it is used for What you need to know before you use Eklira Genuair How to use Eklira Genuair
Croatian: Što je Eklira Genuair i za što se koristi Što morate znati prije nego počnete primjenjivati Eklira Genuair Kako primjenjivati Eklira Genuair Moguće nuspojave
English: c Odds ratio, increase in the likelihood of achieving the MCID compared to placebo.
Croatian: Omjer izgleda, povećanje vjerojatnosti postizanja MCID u usporedbi s placebom.
English: Eklira Genuair also improved daily symptoms of COPD (dyspnoea, cough and sputum production) and night-time and early morning symptoms.
Croatian: Eklira Genuair također je poboljšao dnevne simptome KOPB-a (dispneja, kašalj i stvaranje sputuma) noćne i ranojutarnje simptome.
English: Eklira Genuair should be used with caution in patients who had a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the “New York Heart Association”.
Croatian: Eklira Genuair treba koristiti oprezno kod bolesnika koji su imali infarkt miokarda u prethodnih 6 mjeseci, nestabilnom anginom, novo dijagnosticiranom aritmijom u prethodna 3 mjeseca, ili hospitalizacijom u prethodnih 12 mjeseci zbog zatajenja srca klase III i IV, prema „New York Heart Association“ (NYHA) klasifikaciji.
English: What Eklira Genuair is and what it is used for
Croatian: Što je Eklira Genuair i za što se koristi
English: The European Medicines Agency has waived the obligation to submit the results of studies with Eklira 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 Eklira Genuairom u svim podskupinama pedijatrijske populacije za KOPB (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The most frequently reported adverse reactions with Eklira Genuair were headache (6.6%) and nasopharyngitis (5.5%).
Croatian: Sažetak sigurnosnog profila Najčešće prijavljene nuspojave lijeka Eklira Genuair bile su glavobolja (6,6%) i nazofaringitis (5,5%).
English: Eklira Genuair contains lactose
Croatian: Eklira Genuair sadrži laktozu
English: The following side effects may occur whilst using Eklira Genuair: Common: may affect up to 1 in 10 people - Headache - Inflammation of the sinuses (sinusitis) - Common cold (nasopharyngitis) - Cough - Diarrhoea - Nausea
Croatian: Tijekom uporabe Eklira Genuair mogu se pojaviti sljedeće nuspojave: Česte: mogu se javiti u do 1 na 10 osoba - Glavobolja - Upala sinusa (sinusitis) - Obična prehlada (nazofaringitis) - Kašalj - Proljev - Mučnina
English: What you need to know before you use Eklira Genuair
Croatian: Što morate znati prije nego počnete primjenjivati Eklira Genuair
English: Stop taking Eklira Genuair and seek medical help immediately: - if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Croatian: Prekinite s uzimanjem Eklira Genuair i odmah zatražite liječničku pomoć: - ako osjetite pritisak u prsima, kašalj, piskanje ili nedostatak zraka neposredno nakon uzimanja lijeka.
English: Animal studies have shown excretion of small amounts of aclidinium bromide/metabolites into milk.
Croatian: Ispitivanja na životinjama pokazala su izlučivanje manjih količina aklidinijeva bromida/metabolita u mlijeko.
English: If you are not sure of how to use Eklira Genuair, contact your doctor or pharmacist.
Croatian: Ako niste sigurni kako koristiti lijek Eklira Genuair, obratite se svom liječniku ili ljekarniku.
English: The active ingredient of Eklira Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators.
Croatian: Djelatna tvar lijeka Eklira Genuair je aklidinijev bromid koji spada u skupinu lijekova pod nazivom bronhodilatatori.
English: Eklira Genuair may have minor influence on the ability to drive and use machines.
Croatian: Eklira Genuair malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Eklira Genuair is indicated for maintenance treatment and should not be used to treat a sudden attack of breathlessness or wheezing.
Croatian: Eklira Genuair se koristi u terapiji održavanja i ne smije se koristiti za liječenje iznenadnog napadaja nedostatka zraka ili piskanja.
English: Similar observations were made with Eklira Genuair in the 3 month study.
Croatian: Slična opažanja zabilježena su s lijekom Eklira Genuair u 3-mjesečnom ispitivanju.
English: Clinical efficacy studies showed that Eklira Genuair provided clinically meaningful improvements in lung function (as measured by the forced expiratory volume in 1 second [FEV1]) over 12 hours following morning and evening administration, which were evident within 30 minutes of the first dose (increases from baseline of 124-133 mL).
Croatian: U klinička ispitivanjima djelotvornosti Eklira Genuair pokazao je klinički značajna poboljšanja plućne funkcije (mjereno forsiranim izdisajnim volumenom u prvoj sekundi [FEV1]) tijekom 12 sati nakon jutarnje i večernje primjene, koja su bila vidljiva u roku od 30 minuta nakon prve doze (povećanje od početne vrijednosti za 124-133 mL).
English: Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Croatian: Eklira Genuair je indiciran u terapiji održavanja bronhodilatacije za ublažavanje bronhoopstruktivnih simptoma, u odraslih bolesnika s kroničnom opstruktivnom bolesti pluća (KOPB) (vidjeti dio 5.1).
English: Regular use of Eklira Genuair can help you when you have ongoing shortness of breath related to your disease to help you minimise the effects of the disease on your everyday life and reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Croatian: Redovito uzimanje lijeka Eklira Genuair može Vam pomoći kad osjećate nedostatak zraka povezan s bolešću te tako pomoći u smanjiti učinke bolesti na svakodnevni život i broj epizoda razbuktavanja bolesti (višednevnog pogoršanja simptoma KOPB-a).
English: EU/1/12/778/003 3 inhalers each containing 60 doses
Croatian: EU/1/12/778/003 3 inhalatora od kojih svaki sadrži 60 doza
English: A placebo-controlled trial in 1791 patients with moderate to very severe COPD treated with Eklira Genuair up to 36 months did not identify other adverse reactions.
Croatian: U placebom kontroliranom ispitivanju provedenom u 1791 bolesnika s umjerenim do vrlo teškim KOPB-om liječena lijekom Eklira Genuair tijekom razdoblja do 36 mjeseci nisu utvrđene nikakve druge nuspojave.
English: Eklira Genuair statistically significantly reduced lung hyperinflation at rest (functional residual capacity [FRC]=0.197 L [95% CI=0.321, 0.072; p=0.002]; residual volume [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) and also improved trough inspiratory capacity (by 0.078 L; 95% CI=0.01, 0.145; p=0.025) and reduced dyspnoea during exercise (Borg scale) (by 0.63 Borg units; 95% CI=1.11, 0.14; p=0.012).
Croatian: Eklira Genuair statistički je značajno smanjio hiperinflaciju pluća u mirovanju (funkcionalni rezidualni kapacitet [FRC]=0,197 l [95% CI=0,321, 0,072; p=0,002]; rezidualni volumen [RV]=0,238 l [95% CI=0,396, 0,079; p=0,004]) te je također poboljšao najniži inspiracijski kapacitet (za 0,078 l; 95% CI=0,01, 0,145; p=0,025) i smanjio dispneju tijekom vježbanja (Borgova ljestvica) (za 0,63 jedinica na Borgovoj ljestvici; 95% CI=1,11, 0,14; p=0,012).
English: In the 6-month study, patients receiving Eklira Genuair 322 µg twice daily experienced a clinically meaningful improvement in their lung function (as measured by FEV1).
Croatian: 6-mjesečnom ispitivanju, bolesnici koji su primali Eklira Genuair od 322 µg dvaput dnevno imali su kliničko značajno poboljšanje funkcije pluća (mjereno s FEV1).
English: The Table below shows symptom relief obtained after 6 months treatment with Eklira Genuair.
Croatian: Tablica u nastavku prikazuje ublažavanje simptoma postignuto nakon 6 mjeseci liječenja Eklira Genuairom.
English: Eklira Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious, longterm lung disease characterised by breathing difficulties.
Croatian: Eklira Genuair se koristi za pomoć pri otvaranju dišnih puteva i ublažavanje simptoma KOPB-a, ozbiljne, dugotrajne plućne bolesti koju karakterizira otežano disanje.
English: In the long-term safety studies, Eklira Genuair was associated with bronchodilatory efficacy when administered over a 1-year treatment period.
Croatian: U dugotrajnom ispitivanju sigurnosti primjene, Eklira Genuair se pokazao djelotvornim u bronhodilataciji kod primjene u razdoblju duljem od 1 godine.
English: The Eklira Genuair Phase III clinical development programme included 269 patients treated with Eklira Genuair 322 µg twice daily in one 6-month randomised, placebo-controlled study and 190 patients treated with Eklira Genuair 322 µg twice daily in one 3-month randomised, placebocontrolled study.
Croatian: Faza III kliničkog programa razvoja lijeka Eklira Genuair uključivala je 269 bolesnika liječenih Eklira Genuairom od 322 µg dvaput dnevno u jednom 6-mjesečnom randomiziranom, placebom kontroliranom ispitivanju i 190 bolesnika liječenih Eklira Genuairom od 322 µg dvaput dnevno u jednom 3-mjesečnom randomiziranom, placebom kontroliranom ispitivanju.
English: What Eklira Genuair contains - The active substance is aclidinium bromide.
Croatian: Što Eklira Genuair sadrži - Djelatna tvar je aklidinijev bromid.