FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2 - Primary Efficacy Endpoint - Glabellar Line Scale Score of 0 (none) or 1 (mild) at Day 30 by Investigator Assessment at Maximum Contraction, PP Population
Croatian: Tablica 2. - Primarna mjera ishoda djelotvornosti - Ljestvica ishoda u pogledu glabelarnih bora od 0 (ne postoje) do 1 (blago) na 30. dan, utvrđeno ispitivačevom ocjenom pri najjačoj kontrakciji, populacija bolesnika liječenih po protokolu
English: Tell your doctor if you have recently been injected with a medicine containing botulinum toxin (the active substance of NUCEIVA), as this may increase the effect of NUCEIVA excessively.
Croatian: Obavijestite svojeg liječnika ako ste nedavno dobili injekciju s lijekom koji sadrži botulinski toksin
English: The use of botulinum toxin is not recommended in association with aminoglycoside antibiotics, spectinomycin or other medicines that interfere with nerve impulses to the muscle.
Croatian: Ne preporučuje se uporaba botulinskog toksina zajedno s aminoglikozidnim antibioticima,
English: NUCEIVA Vs.
Croatian: NUCEIVA.
English: • Re-evaluation of the appropriateness of treatment with botulinum toxin type A. The efficacy and safety of repeat injections beyond 12 months has not been evaluated.
Croatian: Djelotvornost i sigurnost ponovljenih injekcija nakon 12 mjeseci nisu procjenjivane.
English: Rarely occurring injection site events that have been reported include erythema, paraesthesia, pruritis, pain and tenderness.
Croatian: Prijavljene nuspojave na mjestu primjene injekcije koje rijetko nastaju obuhvaćaju eritem, paresteziju,
English: Some of the antibodies formed are neutralising which may lead to treatment failure of botulinum toxin type A. It is mandatory that NUCEIVA is used for one single patient treatment only during a single session.
Croatian: Neka od stvorenih protutijela imaju neutralizirajući učinak, što može dovesti do neuspješnog liječenja botulinskim toksinom tipa A.
English: Antibodies to botulinum toxin type A may develop during treatment with botulinum toxin.
Croatian: Stvaranje protutijela može dovesti do neuspjeha liječenja botulinskim toksinom tipa
English: Each vial contains 100 Units botulinum toxin type A produced by Clostridium botulinum.
Croatian: A proizvedenog u stanicama bakterije Clostridium botulinum.
English: Antibody formation
Croatian: Stvaranje protutijela
English: How to store NUCEIVA
Croatian: Kako čuvati lijek NUCEIVA
English: Caution should also be exercised when botulinum toxin type A is used for treatment of patients with amyotrophic lateral sclerosis or with peripheral neuromuscular disorders.
Croatian: A u bolesnika s amiotrofičnom lateralnom sklerozom ili s perifernim neuromuskularnim poremećajima.
English: Amount of diluent added to 100 Unit vial (sodium chloride 9 mg/ml (0.9%) solution for injection) 2.5 mL
Croatian: (otopina natrijeva klorida za injekciju od 9 mg/ml [0,9 %]) 2,5 ml
English: Each vial contains 100 Units botulinum toxin type A After reconstitution each 0.1 mL of the solution contains 4 Units
Croatian: A Nakon rekonstitucije svakih 0,1 ml otopine sadrži 4 jedinice
English: Powder for solution for injection 1 vial
Croatian: Prašak za otopinu za injekciju
English: EXP Read the leaflet for the shelf life of the reconstituted medicine
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Undesirable effects of the substance class botulinum toxin type A
Croatian: Nuspojave tvari skupine botulinski toksin tipa
English: There are no adequate data from the use of botulinum toxin type A in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni botulinskog toksina tipa
English: • Two injections should be administered in each corrugator muscle (inferior medial and superior medial aspect) and 1 injection in the procerus muscle for a total dose of 20 Units.
Croatian: Kako bi se ublažile komplikacije ptoze (spuštanja) vjeđe, potrebno je poduzeti sljedeće korake: • Potrebno je ubrizgati dvije injekcije u svaki mišić corrugator (mišić nabirač) (donji dio medijalno i gornji dio medijalno) te jednu injekciju u tanki mišić (procerus), što čini ukupnu dozu od 20 jedinica.
English: IM
Croatian: ILI
English: - If you have any side effects, talk to your doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Application related adverse reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: - The active substance is: 100 Units botulinum toxin type A. - The other ingredients are human albumin and sodium chloride.
Croatian: Sadržaj pakiranja i druge informacije Što NUCEIVA sadrži - Djelatna tvar je: 100 jedinica botulinskog toksina tipa A.
English: How NUCEIVA is injected
Croatian: Kako se lijek NUCEIVA injicira
English: How to use NUCEIVA 4.
Croatian: Moguće nuspojave 5. Kako čuvati lijek NUCEIVA
English: Libertek will not help you in this situation.
Croatian: Libertek Vam u takvim situacijama neće pomoći.
English: Children and adolescents Libertek should not be used by children and adolescents under 18 years of age.
Croatian: Djeca i adolescenti Libertek nije namijenjen djeci i adolescentima mlađim od 18 godina.
English: Other medicines and Libertek
Croatian: Drugi lijekovi i Libertek
English: Interim Study Reports - with each PSUR
Croatian: Privremena izvješća ispitivanja - sa svakim PSUR-om
English: 1 What Libertek is and what it is used for
Croatian: Što je Libertek i za što se koristi
English: An updated RMP should be submitted
Croatian: Nadalje, nadopunjeni RMP treba dostaviti
English: If you take more Libertek than you should
Croatian: Ako uzmete više Liberteka nego što ste trebali
English: Thus Libertek eases breathing problems.
Croatian: Libertek stoga ublažava teškoće s disanjem.
English: Date of first authorisation: 28 February 2011 Date of latest renewal: 24 April 2015
Croatian: Datum posljednje obnove: 24. travnja 2015.
English: Libertek may need to be taken for several weeks to achieve its effect (see section 5.1).
Croatian: Libertek je ponekad potrebno uzimati više tjedana da bi se postigao učinak (vidjeti dio 5.1).
English: • Educational material for the physician.
Croatian: • Edukacijski materijal za liječnike
English: In case of an allergic reaction, stop taking Libertek and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital.
Croatian: U slučaju alergijske reakcije, prestanite uzimati Libertek i odmah se obratite svom liječniku ili se odmah javite na hitni prijem najbliže bolnice.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, ovaj lijek može izazvati nuspojave, iako se one neće javiti kod svakoga.
English: Do not take Libertek if you are or plan to become pregnant, think you may be pregnant, or are breast-feeding.
Croatian: Ne uzimajte Libertek ako planirate trudnoću, mislite da ste trudni ili ako dojite.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Libertek
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Libertek.
English: What Libertek is and what it is used for What you need to know before you take Libertek How to take Libertek
Croatian: Što je Libertek i za što se koristi Što morate znati prije nego počnete uzimati Libertek Kako uzimati Libertek
English: You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Libertek may be harmful for the unborn baby.
Croatian: Tijekom liječenja ovim lijekom ne smijete zatrudnjeti, te morate koristiti učinkovitu metodu kontracepcije za vrijeme liječenja, jer Libertek može naškoditi nerođenom djetetu.
English: There is no relevant use of Libertek in the paediatric population (under 18 years) in the indication COPD.
Croatian: Nema relevantne primjene Liberteka u pedijatrijskoj populaciji (do 18 godina) u indikaciji KOPB-a.
English: Before starting treatment with Libertek, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects.
Croatian: Prije početka primjene Liberteka obavijestite liječnika ako patite od takvih simptoma, kao i o svim dodatnim lijekovima koje uzimate, jer neki mogu povećati vjerojatnost pojave takvih nuspojava.
English: You may need to take Libertek for several weeks to achieve its beneficial effect.
Croatian: Ponekad je Libertek potrebno uzimati nekoliko tjedana da biste osjetili povoljan učinak.
English: Libertek is to be used in addition to bronchodilators.
Croatian: Libertek treba koristiti kao dodatak bronhodilatatorima.
English: The need to inform patients about the risks of Libertek and the precautions for safe use including:
Croatian: Potrebu da se bolesnike upozori na rizike Liberteka i mjere opreza za sigurnu primjenu uključujući:
English: Libertek has been studied in clinical trials for up to one year.
Croatian: U kliničkim ispitivanjima ispitana je primjena Liberteka u trajanju do godine dana.
English: If you stop taking Libertek
Croatian: Ako prestanete uzimati Libertek
English: Linearity/Non-linearity
Croatian: Linearnost/Nelinearnost
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EUDR popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: What Libertek contains - The active substance is roflumilast.
Croatian: Što Libertek sadrži - Djelatna tvar je roflumilast.
English: It is important to continue taking Libertek for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.
Croatian: Važno je da Libertek uzimate onoliko dugo koliko je preporučio liječnik, čak i kad nemate simptome, jer se samo tako može održati kontrola plućne funkcije.
English: The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Libertek are provided with an updated Educational pack.
Croatian: Nositelj odobrenja će osigurati da svi zdravstveni djelatnici za koje se očekuje da će propisivati Libertek dobiju obnovljeni edukacijski paket.
English: PVC/PVDC aluminum blisters in packs of 10, 30, or 90 film-coated tablets.
Croatian: PVC/PVDC aluminijski blisteri u pakiranjima s 10, 30 ili 90 filmom obloženih tableta.
English: Libertek should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Croatian: Libertek ne treba uvoditi ili terapiju treba prekinuti kod bolesnika s karcinomima (osim bazocelularnog karcinoma).
English: Moderate or severe Moderate
Croatian: Umjerena ili teška
English: 2 What you need to know before you take Libertek
Croatian: Što morate znati prije nego počnete uzimati Libertek
English: If you forget to take Libertek
Croatian: Ako ste zaboravili uzeti Libertek
English: If on one day you have forgotten to take a tablet of Libertek, just carry on the next day with the next tablet as usual.
Croatian: Ako jedan dan zaboravite uzeti tabletu, sljedeći dan samo nastavite terapiju sa sljedećom tabletom u uobičajeno vrijeme.
English: Libertek tablets contain lactose.
Croatian: Libertek tablete sadrže laktozu.
English: Libertek contains lactose
Croatian: Libertek sadrži laktozu
English: • Copies of the patient card to be given to patients or caregivers before they receive Libertek
Croatian: • Kopije kartice za bolesnike za uručiti bolesnicima prije nego dobiju Libertek
English: Libertek may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Croatian: Libertek se može uzimati s drugim lijekovima koji se koriste za liječenje KOPB-a, poput inhalacijskih ili oralnih kortikosteroida ili bronhodilatatora.
English: Talk to your doctor if, while taking this medicine, you observe an unintentional loss of body weight (not related to a diet or exercise programme).
Croatian: Obratite se liječniku ako za vrijeme terapije Libertekom primijetite nenamjerni gubitak težine (koji nije povezan s prehranom ili tjelesnom aktivnošću).
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX07
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih puteva, ostali sustavni lijekovi za opstruktivne bolesti dišnih puteva, ATK oznaka: R03DX07
English: The European Medicines Agency has waived the obligation to submit the results of studies with roflumilast in all subsets of the paediatric population in chronic obstructive pulmonary disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja roflumilasta u svim podskupinama pedijatrijske populacije u indikaciji kronične opstruktivne bolesti pluća (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The fact that Libertek is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.
Croatian: Činjenicu da Libertek nije indiciran za liječenje bolesnika s KOPB-om koji ne odgovaraju odobrenoj indikaciji, niti za bolesnike s astmom ili deficijencijom alfa-1 antitripsina.
English: The educational pack should contain the following:
Croatian: Edukacijski paket treba sadržavati sljedeće:
English: The potential risk of infections: Libertekshould not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Croatian: Potencijalni rizik infekcija: Libertekne treba uvoditi ili liječenje treba prekinuti kod bolesnika s teškim akutnim infektivnim bolestima.
English: The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Libertek and the potential risk of suicide.
Croatian: Rizik psihijatrijskih poremećaja poput nesanice, tjeskobe, depresije kod bolesnika koji uzimaju Libertek te potencijalni rizik suicida.
English: These studies in rats with radiolabeled roflumilast also indicate low penetration across the blood-brain barrier.
Croatian: Ispitivanja na štakorima s radiooznačenim roflumilastom pokazuju slabi prolaz kroz krvno-moždanu barijeru.
English: Libertek is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Croatian: Libertek nije namijenjen liječenju iznenadnih napada nedostatka zraka (akutni bronhospazam).
English: The rate of exacerbations (as defined in the protocols) were not significantly reduced by roflumilast in the individual studies (relative risk reduction: 13.5% in study M2-111 and 6.6% in study M2-112; p= not significant).
Croatian: Stopa egzacerbacija (definiranih po protokolu) nije se u pojedinačnim ispitivanjima na roflumilastu značajno smanjila (relativno smanjenje rizika 13,5%- u ispitivanju M2-111 i 6,6% u ispitivanju M2-112; p=nije značajno).
English: Lactose monohydrate Maize starch Povidone (K90) Magnesium stearate
Croatian: Jezgra laktoza hidrat kukuruzni škrob povidon (K90) magnezijev stearat
English: Driving and using machines Libertek has no influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Libertek ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Libertek is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Croatian: Libertek se koristi za terapiju održavanja teškog KOPB-a kod odraslih koji su u prošlosti imali često pogoršanje simptoma KOPB-a (takozvane egzacerbacije) i koji imaju kronični bronhitis.
English: Libertek has no influence on the ability to drive and use machines.
Croatian: Libertek ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The effect of Libertek may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy).
Croatian: Djelovanje Liberteka može se smanjiti ako se uzima zajedno s rifampicinom (antibiotski lijek) ili fenobarbitalom, karbamazepinom ili fenitoinom (lijekovi koji se propisuju za liječenje epilepsije).
English: Libertek 500 micrograms
Croatian: Libertek 500 mikrograma
English: Each pack contains 10, 30, or 90 film-coated tablets.
Croatian: Jedno pakiranje sadrži 10, 30 ili 90 filmom obloženih tableta.
English: This study should be appropriate to compare the incidences of all-cause mortality, major cardiovascular events, new diagnosis of cancer, all-cause hospitalisation, hospitalisation related to respiratory disease, suicide or hospitalisation for suicide attempt, and new diagnosis of depression, tuberculosis or viral hepatitis B or C in roflumilast treated COPD patients compared with COPD patients not treated with roflumilast.
Croatian: Ovo ispitivanje mora omogućiti usporedbu incidencije smrtnosti od svih uzroka, značajnih kardiovaskularnih događaja, novodijagnosticiranih karcinoma, hospitalizacija od svih uzroka, hospitalizacija povezanih s respiratornim bolestima, suicida ili hospitalizacija zbog pokušaja suicida, novodijagnosticirane depresije, tuberkuloze ili virusnog hepatitisa B ili C kod bolesnika s KOPB-om liječenih roflumilastom u usporedbi s bolesnicima s KOPB-om koji nisu liječeni roflumilastom.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjenje u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim dopunama Plana.
English: 10 film-coated tablets 30 film-coated tablets 90 film-coated tablets
Croatian: 10 filmom obloženih tableta 30 filmom obloženih tableta 90 filmom obloženih tableta
English: That Libertek may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Croatian: Da Libertek može izazvati gubitak težine i bolesnici se trebaju redovito vagati i bilježiti težinu na karticu za bolesnike.
English: All patients should be informed about the risks of Libertek and the precautions for safe use and should be given a patient card before starting Libertek.
Croatian: Bolesnike treba obavijestiti o rizicima Liberteka i mjerama predostrožnosti za sigurnu primjenu, te im prije početka terapije uručiti karticu za bolesnike.
English: Do not take Libertek - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Libertek - ako ste alergični na roflumilast ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate umjerene ili teške tegobe s jetrom.
English: Following intravenous or oral administration of radiolabeled roflumilast, about 20% of the radioactivity was recovered in the faeces and 70% in urine as inactive metabolites.
Croatian: Nakon intravenske ili peroralne primjene radiooznačenog roflumilasta oko 20% radioaktivnosti izlučeno je fecesom i 70% u mokraći u obliku neaktivnih metabolita.
English: In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomized and treated of whom 2,374 were treated with roflumilast.
Croatian: U dva jednaka potvrdna jednogodišnja ispitivanja (M2-124 i M2-125) i dva dodatna šestomjesečna ispitivanja (M2-127 i M2-128) ukupno je i randomizirano 4768 bolesnika, od kojih je 2374 liječeno roflumilastom.
English: Libertek contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Croatian: Libertek sadrži djelatnu tvar roflumilast, a to je protuupalni lijek koji zovemo inhibitorom fosfodiesteraze-4.
English: The potential cardiac risk: Libertek has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Croatian: Potencijalni kardiološki rizik: Libertek nije ispitan kod bolesnika s kongestivnim zatajenjem srca (NYHA stupanj 3 i 4) stoga se ne preporučuje kod takvih bolesnika.
English: A total of 1935 patients were randomised to double-blind medication and approximately 70% were also using a long-acting muscarinic antagonist (LAMA) through the course of the trial.
Croatian: Dvostruko-slijepo je randomizirano ukupno 1935 bolesnika, a za trajanja ispitivanja je približno 70% također primjenjivalo dugodjelujuće muskarinske antagoniste (LAMA).
English: The recommended dose is one 500 micrograms tablet once daily.
Croatian: Preporučena doza je jedna tableta od 500 mikrograma jedanput na dan.
English: Post-bronchodilator FEV1 showed a clinically significant improvement in favour of Roflumilast by 56 mL over placebo (95% CI: 38, 73 mL).
Croatian: Postbronhodilatacijski FEV1 pokazao je klinički značajno poboljšanje u korist roflumilasta za 56 ml u odnosu na placebo (95% CI: 38,73 ml).
English: The clinical data with Libertek in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Libertek should be used with caution in these patients.
Croatian: Klinički podaci o primjeni Liberteka kod bolesnika s blagim oštećenjem jetre klasificiranim kao Child-Pugh A nisu dovoljni da bi se preporučilo smanjenje doze (vidjeti dio 5.2), stoga Libertek kod tih bolesnika treba koristiti uz oprez.
English: In this case, roflumilast treatment should be reassessed (see section 4.4).
Croatian: U tom slučaju treba ocijeniti opravdanost terapije (vidjeti dio 4.4).
English: You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Libertek.
Croatian: Proljev, mučninu, bolove u trbuhu ili glavobolju možete osjetiti tijekom prvih tjedana liječenja Libertekom.
English: Upon in vitro stimulation of human neutrophils, monocytes, macrophages or lymphocytes, roflumilast and roflumilast N-oxide suppress the release of inflammatory mediators e.g. leukotriene B4, reactive oxygen species, tumor necrosis factor α, interferon γ and granzyme B.
Croatian: Nakon in vitro stimulacije ljudskih neutrofila, monocita, makrofaga ili limfocita, roflumilast i roflumilast N-oksid zaustavljaju oslobađanje upalnih posrednika poput leukotriena B4, reaktivnih oblika kisika, faktora nekroze tumora α, interferona γ i granzima B.
English: This will allow quick identification of new safety information.
Croatian: Ovaj je lijek pod dodatnim praćenjem.Time se omogućuje brzo otkrivanje novih sigurnosnih informacija.
English: 2-Sided p-value
Croatian: Dvostrana p vrijednost
English: Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Croatian: Libertek je indiciran za terapiju održavanja teške kronične opstruktivne plućne bolesti (KOPB) (postbronhodilatacijski FEV1 manji od 50% predviđenog) povezane s kroničnim bronhitisom kod odraslih bolesnika s učestalim egzacerbacijama u anamnezi, kao dodatak liječenju bronhodilatatorima.
English: Libertek is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Croatian: Libertek je kontraindiciran kod bolesnika s umjerenim ili teškim zatajenjem jetre (Child Pugh B ili C).