FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daliresp are provided with an updated Educational pack.
Croatian: Nositelj odobrenja će osigurati da svi zdravstveni djelatnici za koje se očekuje da će propisivati Daliresp dobiju obnovljeni edukacijski paket.
English: Daliresp should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Croatian: Daliresp ne treba uvoditi ili terapiju treba prekinuti kod bolesnika s karcinomima (osim bazocelularnog karcinoma).
English: The need to inform patients about the risks of Daliresp and the precautions for safe use including:
Croatian: Potrebu da se bolesnike upozori na rizike Dalirespa i mjere opreza za sigurnu primjenu uključujući:
English: Daliresp is to be used in addition to bronchodilators.
Croatian: Daliresp treba koristiti kao dodatak bronhodilatatorima..
English: Daliresp may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators.
Croatian: Daliresp 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 Dalirespom primijetite nenamjerni gubitak težine (koji nije povezan s prehranom ili tjelesnom aktivnošću).
English: If on one day you have forgotten to take a tablet of Daliresp, 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: • Copies of the patient card to be given to patients or caregivers before they receive Daliresp
Croatian: • Kopije kartice za bolesnike za uručiti bolesnicima prije nego dobiju Daliresp
English: Daliresp has been studied in clinical trials for up to one year.
Croatian: U kliničkim ispitivanjima ispitana je primjena Dalirespa u trajanju do godine dana.
English: The fact that Daliresp 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 Daliresp nije indiciran za liječenje bolesnika s KOPB-om koji ne odgovaraju odobrenoj indikaciji, niti za bolesnike s astmom ili deficijencijom alfa-1 antitripsina.
English: Thus Daliresp eases breathing problems.
Croatian: Daliresp stoga ublažava teškoće s disanjem.
English: The potential risk of infections: Dalirespshould not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Croatian: Potencijalni rizik infekcija: Dalirespne treba uvoditi ili liječenje treba prekinuti kod bolesnika s teškim akutnim infektivnim bolestima.
English: Hypromellose Macrogol 4000 Titanium dioxide (E171) Iron oxide yellow (E172)
Croatian: Ovojnica hipromeloza makrogol 4000 titanijev dioksid (E171) željezov oksid, žuti (E172)
English: Daliresp is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Croatian: Daliresp nije namijenjen liječenju iznenadnih napada nedostatka zraka (akutni bronhospazam).
English: The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide.
Croatian: Rizik psihijatrijskih poremećaja poput nesanice, tjeskobe, depresije kod bolesnika koji uzimaju Daliresp te potencijalni rizik suicida.
English: If you stop taking Daliresp
Croatian: Ako prestanete uzimati Daliresp
English: Daliresp 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: Daliresp 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: 2 What you need to know before you take Daliresp
Croatian: Što morate znati prije nego počnete uzimati Daliresp
English: What Daliresp contains - The active substance is roflumilast.
Croatian: Što Daliresp sadrži - Djelatna tvar je roflumilast.
English: Daliresp has no influence on the ability to drive and use machines.
Croatian: Daliresp ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The effect of Daliresp 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 Dalirespa može se smanjiti ako se uzima zajedno s rifampicinom (antibiotski lijek) ili fenobarbitalom, karbamazepinom ili fenitoinom (lijekovi koji se propisuju za liječenje epilepsije).
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 randomizirano 4768 bolesnika, od kojih je 2374 liječeno roflumilastom.
English: That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Croatian: Da Daliresp može izazvati gubitak težine i bolesnici se trebaju redovito vagati i bilježiti težinu na karticu za bolesnike.
English: If you forget to take Daliresp
Croatian: Ako ste zaboravili uzeti Daliresp
English: The potential cardiac risk: Daliresphas 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: Daliresp nije ispitan kod bolesnika s kongestivnim zatajenjem srca (NYHA stupanj 3 i 4) stoga se ne preporučuje kod takvih bolesnika.
English: You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Daliresp.
Croatian: Proljev, mučninu, bolove u trbuhu ili glavobolju možete osjetiti tijekom prvih tjedana liječenja Dalirespom.
English: Driving and using machines Daliresp has no influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Daliresp ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: •Obligation to conduct post-authorisation measures
Croatian: • Obveza provođenja mjera nakon davanja odobrenja
English: Do not take Daliresp - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Daliresp - ako ste alergični na roflumilast ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate umjerene ili teške tegobe s jetrom.
English: Daliresp contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor.
Croatian: Daliresp sadrži djelatnu tvar roflumilast, a to je protuupalni lijek koji zovemo inhibitorom fosfodiesteraze-4.
English: Daliresp tablets contain lactose.
Croatian: Daliresp tablete sadrže laktozu.
English: Daliresp 500 micrograms
Croatian: Daliresp 500 mikrograma
English: Daliresp is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C).
Croatian: Daliresp je kontraindiciran kod bolesnika s umjerenim ili teškim zatajenjem jetre (Child Pugh B ili C).
English: Daliresp 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: Daliresp 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: All patients should be informed about the risks of Daliresp and the precautions for safe use and should be given a patient card before starting Daliresp.
Croatian: Bolesnike treba obavijestiti o rizicima Dalirespa i mjerama predostrožnosti za sigurnu primjenu, te im prije početka terapije uručiti karticu za bolesnike.
English: The clinical data with Daliresp in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daliresp should be used with caution in these patients.
Croatian: Klinički podaci o primjeni Dalirespa kod bolesnika s blagim oštećenjem jetre klasificiranim kao Child-Pugh A nisu dovoljni da bi se preporučilo smanjenje doze (vidjeti dio 5.2), stoga Daliresp kod tih bolesnika treba koristiti uz oprez.
English: Daliresp contains Lactose
Croatian: Daliresp sadrži laktozu
English: Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.
Croatian: Primjena Dalirespa kod bolesnika s kongestivnim zatajenjem srca (NYHA stupnjevi 3 i 4) nije ispitana te se liječenje takvih bolesnika ne preporučuje.
English: In clinical COPD studies, approximately 16% of patients experienced adverse reactions with roflumilast (compared to 5% in placebo).
Croatian: U kliničkim ispitivanjima kod bolesnika s KOPB-om, približno 16% bolesnika liječenih Dalirespom imalo je nuspojave (u usporedbi s 5% na placebu).
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g.multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Dalirespshould not be initiated or should be stopped in these patients.
Croatian: Nedostatak iskustva kod bolesnika s HIV-infekcijom ili aktivnim hepatitisom, s teškim imunološkim bolestima (npr. multipla skleroza, eritemski lupus, multifokalna leukoencefalopatija) ili koji se liječe imunosupresivnom terapijom (osim kratkotrajne terapije sistemskim kortikosteroidima).Kod takvih bolesnika Dalirespne treba uvoditi ili terapiju treba prekinuti.
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daliresp (see section 4.3).
Croatian: Bolesnici s umjerenim i teškim oštećenjem jetre klasificiranim kao Child-Pugh B ili C ne smiju uzimati Daliresp (vidjeti dio 4.3).
English: Rescue medicinal products Daliresp is not indicated as rescue medicinal product for the relief of acute bronchospasms.
Croatian: Lijekovi za hitno ublažavanje simptoma Daliresp nije indiciran kao lijek za hitno ublažavanje akutnog bronhospazma.
English: How to store Daliresp
Croatian: Kako čuvati Daliresp
English: Both roflumilast and roflumilast N-oxide have intrinsic phosphodiesterase 4 (PDE4) inhibitory activity.
Croatian: I roflumilast i roflumilast N-oksid snažno inhibiraju fosfodiesterazu 4 (PDE4).
English: If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended todiscontinue treatment with Daliresp.
Croatian: Ako dođe do pojave novih ili pogoršanja postojećih psihijatrijskih simptoma ili ako se prepoznaju suicidalne misli ili ponašanje, preporučuje se prekinuti liječenje Dalirespom.
English: Analysis
Croatian: Model analize
English: 3 How to take Daliresp
Croatian: Kako uzimati Daliresp
English: Daliresp is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.
Croatian: Daliresp se ne preporučuje bolesnicima koji u povijesti bolesti imaju depresiju povezanu sa suicidalnim mislima ili ponašanjem.
English: Women of childbearing age should be advised to use an effective method of contraception during treatment.
Croatian: Ženama u reproduktivnoj dobi treba savjetovati da tijekom liječenja koriste učinkovitu metodu kontracepcije. roflumilast se ne preporučuje ženama u reproduktivnoj dobi koje ne koriste kontracepciju.
English: What Daliresp looks like and contents of the pack Daliresp 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Croatian: Daliresp 500 mikrograma filmom obložene tablete su žute filmom obložene tablete u obliku slova D, s utisnutim “D” s jedne strane.
English: Daliresp 500 micrograms tablets roflumilast
Croatian: Daliresp 500 mikrograma tablete roflumilast
English: The educational pack should contain the following: • Summary of Product Characteristics and Patient Information Leaflet for Daliresp
Croatian: • Sažetak opisa svojstava lijeka i uputu o lijeku za Daliresp
English: Daliresp 500 micrograms film-coated tablets roflumilast
Croatian: Daliresp 500 mikrograma filmom obložene tablete roflumilast
English: Laboratorio Tau, S.A. Tel: +34 91 301 91 00
Croatian: Tel: +34 91 301 91 00
English: (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Croatian: Daliresp se ne preporučuje ako imate jednu ili više sljedećih bolesti: - tešku imunološku bolest poput HIV-infekcije, multiple skleroze (MS), eritemskog lupusa (LE) ili progresivne multifokalne leukoencefalopatije (PML) - tešku akutnu infektivnu bolest poput tuberkuloze ili akutnog hepatitisa, - karcinom (osim bazocelularnog karcinoma, vrste sporo napredujućeg karcinoma kože) - ili teško oštećenje funkcije srca Ne postoje primjereni podaci o primjeni Dalirespa u takvim okolnostima.
English: Daliresp 500 micrograms film-coated tablets
Croatian: Daliresp 500 mikrograma filmom obložene tablete
English: It can request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Croatian: Može zatražiti ponovno ispitivanje mišljenja u roku od 15 dana nakon primitka obavijesti o ovome negativnom mišljenju.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 November 2015 EMA/765377/2015 EMEA/H/C/003858
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20. studenoga 2015. EMA/861010/2015 EMEA/H/C/003858
English: This means that it was intended to be similar to a biological medicine (the ‘reference medicine') already authorised in the European Union (EU).
Croatian: To znači da je bilo planirano da bude sličan biološkom lijeku („referentnom lijeku”) koji je već odobren u Europskoj uniji (EU).
English: It was to be available as a solution for injection.
Croatian: Trebao je biti dostupan kao otopina za injekciju.
English: Two additional studies in patients with type 1 and type 2 diabetes compared the safety and effectiveness of Solumarv and Humulin S.
Croatian: U dvama dodatnim ispitivanjima u bolesnika koji boluju od dijabetesa tipa 1 i 2 uspoređena je sigurnost i učinkovitost lijekova Solumarv i Humulin S.
English: What is Solumarv?
Croatian: Što je Solumarv?
English: Diabetes is a condition in which the body does not produce enough insulin to control the level of blood sugar or in which the body is unable to use insulin effectively.
Croatian: Dijabetes je bolest pri kojoj tijelo ne proizvodi dovoljno inzulina kako bi se kontrolirala razina šećera u krvi ili kada tijelo ne može učinkovito koristiti inzulin.
English: The CHMP's main concern was that the company did not define the manufacturing process for Solumarv in sufficient detail.
Croatian: Glavna zabrinutost CHMP-a bila je da tvrtka nije dovoljno detaljno definirala postupak proizvodnje Solumarva.
English: Solumarv was developed as a biosimilar medicine.
Croatian: Solumarv je razvijen kao biosličan lijek.
English: The reference medicine for Solumarv in this application was Humulin S.
Croatian: U ovome zahtjevu referentni lijek za Solumarv bio je Humulin S.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes affected by the Committee's opinion.
Croatian: Tvrtka je obavijestila CHMP da ne postoje klinička ispitivanja ili programi milosrdnog davanja na koje utječe mišljenje CHMP-a.
English: The company presented results of studies in healthy people designed to show that Solumarv is similar to its reference medicine Humulin S in terms of biological activity and how the body handles the medicine.
Croatian: Tvrtka je predstavila rezultate ispitivanja u zdravih ljudi koja su provedena kako bi se dokazalo da je Solumarv sličan svojem referentnom lijeku Humulinu S u smislu biološkog djelovanja i načina na koji tijelo podnosi lijek.
English: Refusal of the marketing authorisation for Solumarv (insulin human) EMA/765377/2015
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Solumarv (ljudski inzulin) EMA/861010/2015
English: Solumarv was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels.
Croatian: Solumarv se trebao koristiti za liječenje bolesnika s dijabetesom kojima je potreban inzulin kako bi regulirali razine šećera u krvi.
English: As such, it was not possible to show that Solumarv used in clinical studies was representative of batches intended for the market and that its quality was comparable to Humulin S's.
Croatian: Nije se moglo dokazati da je Solumarv koji je korišten u kliničkim ispitivanjima bio reprezentativan za serije planirane za stavljanje na tržište te da je njegova kvaliteta bila usporediva s kvalitetom lijeka Humulin S.
English: On 19 November 2015, the Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorisation for the medicinal product Solumarv, intended for the treatment of diabetes.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) preporučio je odbijanje izdavanja odobrenja za stavljanje u promet lijeka Solumarv, namijenjen za liječenje dijabetesa.
English: Refusal of the marketing authorisation for Solumarv (insulin human)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Solumarv (ljudski inzulin)
English: What was Solumarv expected to be used for?
Croatian: Za što se Solumarv trebao koristiti?
English: The CHMP concluded that Solumarv could not be approved as a biosimilar of Humulin S and recommended that it be refused marketing authorisation.
Croatian: CHMP je zaključio da se lijek Solumarv nije mogao odobriti kao biosličan lijek lijeku Humulin S te je preporučio odbijanje odobrenja za stavljanje lijeka na tržište.
English: Solumarv is a medicine that contains the active substance human insulin.
Croatian: Solumarv je lijek koji sadrži djelatnu tvar ljudski inzulin.
English: How is Solumarv expected to work?
Croatian: Kako je Solumarv trebao djelovati?
English: Solumarv was intended as a replacement for the insulin made by the body.
Croatian: Solumarv je trebao biti zamjena za inzulin koji proizvodi tijelo.
English: The company that applied for authorisation is Marvel Lifesciences Ltd.
Croatian: Marvel Lifesciences Ltd. jest tvrtka koja je podnijela zahtjev za izdavanje odobrenja.
English: For inflammatory conditions it is taken once a week, on the same day each week.
Croatian: Za upalne bolesti uzima se jedanput tjedno, istog dana svakog tjedna.
English: Further information on Jylamvo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/jylamvo.
Croatian: Više informacija o lijeku Jylamvo dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/jylamvo.
English: What is Jylamvo and what is it used for?
Croatian: Što je Jylamvo i za što se koristi?
English: Jylamvo received a marketing authorisation valid throughout the EU on 29 March 2017.
Croatian: Lijek Jylamvo dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 29. ožujka 2017.
English: The doctor may check with the patient or the patient's carer that the medicine can reliably be taken once a week.
Croatian: Liječnik može provjeriti s bolesnikom ili njegovim njegovateljem može li se lijek pouzdano uzimati jedanput tjedno.
English: This especially affects fast-growing cells such as cancer cells.
Croatian: To osobito utječe na brzorastuće stanice kao što su stanice raka.
English: Jylamvo (methotrexate)
Croatian: Jylamvo (metatreksat)
English: The dose that the patient takes each week depends on which inflammatory condition it is being used for, how well the treatment is working and, in the case of children, on the child's height and weight.
Croatian: Doza koju bolesnik uzima svaki tjedan ovisi o tomu koje se upalno stanje liječi, koliko je liječenje učinkovito i, u slučaju djece, o njihovoj visini i tjelesnoj težini.
English: The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses.
Croatian: Tvrtka je dostavila podatke iz objavljene literature o koristima i rizicima metotreksata u odobrenim primjenama.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Jylamvo is given in a different way.
Croatian: To znači da je sličan „referentnom lijeku” koji sadrži istu djelatnu tvar, ali Jylamvo se primjenjuje na drugačiji način.
English: What measures are being taken to ensure the safe and effective use of Jylamvo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Jylamvo?
English: In most cases, methotrexate medicines are used for long-term treatment.
Croatian: U većini slučajeva lijekovi koji sadrže metotreksat koriste se za dugotrajna liječenja.
English: The company will also send out follow-up questionnaires for dosing errors that result in overdose.
Croatian: Tvrtka će dostaviti i kontrolne upitnike o pogreškama u doziranju koje za posljedicu imaju predoziranje.
English: Why is Jylamvo authorised in the EU?
Croatian: Zašto je lijek Jylamvo odobren u EU-u?
English: For acute lymphoblastic leukaemia, the dose of Jylamvo depends on the patient's height and weight.
Croatian: U slučaju akutne limfoblastične leukemije, doza lijeka Jylamvo ovisi o visini i tjelesnoj težini bolesnika.
English: The way methotrexate works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.
Croatian: Način na koji metotreksat djeluje u bolesnika s artritisom i psorijazom nije u cijelosti poznat, ali se smatra da koristi metotreksata proizlaze iz njegove sposobnosti ublažavanja upale i suzbijanja prekomjerno aktivnog imunosnog sustava.
English: Side effects reported with Jylamvo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Jylamvo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: • acute lymphoblastic leukaemia (ALL), a cancer of white blood cells, in adults and children over the age of 3 years.
Croatian: • akutne limfoblastične leukemije (ALL), raka bijelih krvnih stanica, u odraslih i djece starije od 3
English: What are the risks associated with Jylamvo?
Croatian: Koji su rizici povezani s lijekom Jylamvo?
English: It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Croatian: Smiju ga propisivati samo liječnici sa znanjem i iskustvom u primjeni metotreksata koji potpuno razumiju rizike povezane s liječenjem metotreksatom.
English: How often methotrexate is given depends on the other medicines it is used with.
Croatian: Učestalost primjene metotreksata ovisi o tome s kojim se drugim lijekovima koristi.
English: Jylamvo is an anti-inflammatory and cancer medicine used to treat the following conditions:
Croatian: Jylamvo je lijek protiv upala i raka koji se koristi za liječenje sljedećih stanja:
English: Jylamvo is a ‘hybrid medicine'.
Croatian: Jylamvo je „hibridni lijek”.
English: An overview of Jylamvo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Jylamvo i zašto je odobren u EU-u