FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Etopophos?
Croatian: Što je Etopophos?
English: The company that markets these medicines is Bristol-Myers Squibb.
Croatian: Te lijekove stavlja u promet tvrtka Bristol-Myers Squibb.
English: Etopophos is marketed in the following EU member States: France, Germany, Sweden and the United Kingdom.
Croatian: Etopophos je stavljen u promet u sljedećim državama članicama EU-a: Francuskoj, Njemačkoj, Švedskoj i Ujedinjenoj Kraljevini.
English: • testicular cancer, including cancer that is resistant to treatment or has come back;
Croatian: • raka testisa, uključujući rak na koji liječenje ne djeluje ili koji se vratio;
English: It is also available in the EU under the trade name Etopofos.
Croatian: U EU-u je također dostupan pod trgovačkim nazivom Etopofos.
English: Why was Etopophos reviewed?
Croatian: Zašto je Etopophos ocjenjivan?
English: Etopophos is authorised in the EU via national procedures.
Croatian: Lijek Etopophos odobren je u EU-u u okviru nacionalnih postupaka.
English: • Hodgkin's and non-Hodgkin's lymphoma;
Croatian: • Hodgkinov i ne-Hodgkinov limfom;
English: • acute myeloid leukaemia;
Croatian: • akutna mijeloidna leukemija;
English: Other sections of the SmPC harmonised include section 4.4 (special warnings and precautions), section 4.6 (fertility, pregnancy and lactation) and section 4.8 (undesirable effects).
Croatian: Drugi dijelovi usklađenog sažetka opisa svojstava lijeka uključuju dio 4.4. (posebna upozorenja i mjere opreza pri uporabi), dio 4.6. (plodnost, trudnoća i dojenje) i dio 4.8. (nuspojave).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Etopophos and associated names in the European Union (EU).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija za propisivanje lijeka Etopophos i povezanih naziva u Europskoj uniji (EU).
English: For blood cancers (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia), Etopophos is recommended for both adults and children, while its other uses are for adults only.
Croatian: U pogledu raka krvi (Hodgkinova i ne-Hodgkinova limfoma i akutne mijeloidne leukemije), lijek Etopophos preporučuje se i za odrasle i za djecu, dok su njegove druge primjene samo za odrasle.
English: • high-risk gestational trophoblastic neoplasia as first- and second-line treatments;
Croatian: • visokorizična gestacijska trofoblastična neoplazija (kao prva i druga linija liječenja);
English: Etopophos is given as a slow intravenous infusion.
Croatian: Lijek Etopophos daje se u obliku spore intravenske infuzije.
English: The CHMP recommended that Etopophos should be used in combination with other cancer treatments to treat the following cancers:
Croatian: CHMP je preporučio da se lijek Etopophos primjenjuje u kombinaciji s drugim terapijama za rak u liječenju sljedećih vrsta raka:
English: Etopophos is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer, gestational trophoblastic neoplasia (a rare tumour of the womb that occurs during pregnancy) and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Croatian: Etopophos je lijek za rak koji se primjenjuje za liječenje raka testisa, raka pluća, raka jajnika, gestacijske trofoblastične neoplazije (rijetki tumor maternice koji se javlja tijekom trudnoće) i raka krvi (Hodgkinova i ne-Hodgkinova limfoma i akutne mijeloidne leukemije).
English: EMA/251789/2017 Rev. 1 EMEA/H/A-30/1417
Croatian: 1 EMEA/H/A-30/1417
English: • small-cell lung cancer;
Croatian: • rak pluća malih stanica;
English: On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Etopophos in the EU.
Croatian: Europska je komisija 14. listopada 2015. uputila predmet CHMP-u radi usklađivanja odobrenja za stavljanje u promet lijeka Etopophos u EU-u.
English: • non-epithelial ovarian cancer.
Croatian: • neepitelijalni rak jajnika.
English: In addition, the CHMP recommended Etopophos for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.
Croatian: Osim toga, CHMP je preporučio da se lijek Etopophos primjenjuje za liječenje epitelijalnog raka jajnika koji je otporan na liječenje lijekovima koji sadržavaju platinu, bez navoda o tome da bi se trebao primjenjivati u kombinaciji s drugim lijekovima.
English: On 21 April 2017, the European Medicines Agency completed a review of Etopophos.
Croatian: Europska agencija za lijekove dovršila je ocjenjivanje lijeka Etopophos 21. travnja 2017.
English: Etopophos contains the active substance etoposide (as etoposide phosphate) and is available as a powder to be made into a solution for infusion into a vein.
Croatian: Etopophos sadržava djelatnu tvar etopozid (kao etopozid fosfat) i dostupan je kao prašak od kojeg se priprema otopina za infuziju u venu.
English: Etopophos should not be administered during vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be given to breast-feeding women.
Croatian: Lijek Etopophos ne smije se primjenjivati tijekom cijepljenja protiv žute groznice ili drugim živim cjepivima u bolesnika s oslabljenim imunosnim sustavom te u dojilja.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs and package leaflets should be harmonised across the EU.
Croatian: U svjetlu dostavljenih podataka i znanstvene rasprave unutar Odbora, CHMP smatra da se sažetci opisa svojstava lijeka i upute za lijekove moraju uskladiti na razini EU-a.
English: Etopophos was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) utvrdila je da je u pogledu lijeka Etopophos potrebno provesti usklađivanje.
English: 150 mg Powder for concentrate for solution for infusion
Croatian: EU/1/00/145/001 Herceptin 150 mg Prašak za koncentrat za otopinu za infuziju
English: Intravenous use Vial (glass)
Croatian: Primjena u venu bočica (staklo)
English: Subcutaneous use Vial (glass)
Croatian: Potkožna primjena Bočica (staklo)
English: 600 mg Solution for injection
Croatian: EU/1/00/145/002 Herceptin 600 mg Otopina za injekciju
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Croatian: Broj (EU) odobrenja
English: Risk Management Plan (RMP)
Croatian: Plan upravljanja rizicima (RMP)
English: If this happens to you, do not drive or machines.
Croatian: Ako se to dogodi, nemojte voziti ili upravljati strojevima.
English: • At the request of the European Medicines Agency
Croatian: • Na traženje Europske agencije za lijekove
English: This leaflet was last revised in {MM/YYYY}.
Croatian: Ova uputa je zadnji put revidirana u {MM/GGGG}.
English: It may also cause some serious allergic reactions, or increase the chance of a severe infection.
Croatian: Također, može uzrokovati neke ozbiljne alergijske reakcije ili povećati mogućnost teške infekcije.
English: • every 8 weeks thereafter (see section 4.4).
Croatian: • nakon toga svakih 8 tjedana (vidjeti dio 4.4.).
English: The elimination half-life in patients is approximately 2 weeks.
Croatian: Poluvijek eliminacije u bolesnika iznosi oko 2 tjedna.
English: Do not take a double dose to make
Croatian: Nemojte uzeti dvostruku dozu kako biste
English: Leflunomide Teva with food, drink and alcohol
Croatian: Leflunomid Teva s hranom, pićem i alkoholom
English: Drugsales Ltd.
Croatian: Malta Drugsales Ltd.
English: OPA/Alu/PVC - Aluminium blisters.
Croatian: OPA/Alu/PVC - Aluminijski blisteri.
English: Infections may be more severe in nature and may, therefore, require early and vigorous treatment.
Croatian: Infekcije mogu biti teže prirode i, stoga, može biti potrebno rano i intenzivno liječenje.
English: 4.5 Interaction with other medicinal products and other forms of interaction Interactions studies have only been performed in adults.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Ispitivanja interakcija provedena su samo u odraslih.
English: For more information on these, please read section 4 (Possible Side Effects).
Croatian: Za daljnje informacije pročitajte dio 4 (Moguće nuspojave).
English: Leflunomide Teva is not recommended for use in children and adolescents below 18 years of age.
Croatian: Leflunomid Teva ne preporučuje se za primjenu u djece i adolescenata mlađih od 18 godina.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje
English: • The risk of infections, including opportunistic infections, and the contraindication for use in
Croatian: • Rizik od infekcija, uključujući i oportunističke infekcije, i kontraindikacija za primjenu u
English: Excretion data from the 14C study indicated that at least about 82 to 95 % of the dose is absorbed.
Croatian: Prema podacima iz istraživanja s 14C, najmanje 82% do 95% doze se apsorbira.
English: Read all of this leaflet carefully before you start taking this medicine because it contains
Croatian: Pažljivo pročitajte cijelu uputu prije nego što počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: • Patients with serious infections (see section 4.4).
Croatian: • Bolesnici s ozbiljnim infekcijama (vidjeti dio 4.4.).
English: • When new information is received that may impact on the current Safety Specification,
Croatian: • Kada su primljene nove informacije koje mogu utjecati na važeći Sigurnosni profil lijeka,
English: - problems in the nerves of the arms or legs (peripheral neuropathy).
Croatian: - problemi sa živcima u rukama ili nogama (periferna neuropatija).
English: No dosage adjustment is required in patients above 65 years of age.
Croatian: Nije potrebno prilagođavati dozu u bolesnika starijih od 65 godina.
English: In addition, an updated RMP should be submitted
Croatian: Nadalje, nadopunjen RMP trebao bi biti dostavljen:
English: Pliva Ljubljana d.o.o.
Croatian: Pliva Hrvatska d.o.o.
English: Do not take Leflunomide Teva if you are pregnant, or think you may be pregnant.
Croatian: Nemojte uzimati Leflunomid Teva ako ste trudni ili mislite da biste mogli biti trudni.
English: Contents of the pack and other information
Croatian: Sadržaj pakovanja i dodatne informacije
English: In such cases patients should refrain from driving cars and using machines.
Croatian: U tim slučajevima bolesnici trebaju izbjegavati upravljanje vozilima i
English: It will take 4 to 6 weeks before you feel an improvement in your condition.
Croatian: Može biti potrebno oko 4 do 6 tjedana da se počnete osjećati bolje.
English: Computerweg 10
Croatian: Swensweg 5
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 March 2011
Croatian: Datum prvog odobrenja: 10. ožujka 2011.
English: The Physician Leaflet should contain the following key messages:
Croatian: Uputa za liječnika treba sadržavati sljedeće ključne poruke:
English: In study MN302 leflunomide was significantly less effective than methotrexate.
Croatian: U studiji MN302 leflunomid je bio značajno manje učinkovit od metotreksata.
English: Therefore, it is not recommended to drink alcohol during treatment.
Croatian: Stoga se za vrijeme liječenja ne preporučuje konzumacija alkohola.
English: No difference was observed between leflunomide and sulphasalazine (study MN301).
Croatian: Nije bilo značajnih razlika između leflunomida i sulfasalazina (studija MN301).
English: - If you have very low levels of protein in your blood (hypoproteinaemia).
Croatian: - Ako imate izrazito niske vrijednosti proteina u krvi (hipoproteinemija).
English: Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anemia (lack of red blood cells).
Croatian: Ostali simptomi koji utječu na cijeli organizam su gubitak apetita, vrućica, gubitak energije i anemija (nedostatak crvenih krvnih stanica).
English: A tuberculin reaction test should be considered for those patients with other tuberculosis risk factors.
Croatian: Treba razmotriti rizik od tuberkuloze te provođenje tuberkulinskog testa u onih bolesnika koji imaju druge rizične faktore za razvoj tuberkuloze.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove
English: The efficacy of leflunomide in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Croatian: Djelotvornost leflunomida u liječenju reumatoidnog artritisa pokazala se u 4 kontrolirana ispitivanja (1 u fazi II i 3 u fazi III).
English: The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
Croatian: Terapijski učinak obično počinje nakon 4 do 6 tjedana, a stanje se može poboljšavati sljedećih 4 do 6
English: In a carcinogenicity study in rats, leflunomide did not show carcinogenic potential.
Croatian: U ispitivanjima kancerogenosti u štakora, leflunomid nije pokazivao karcinogeni potencijal.
English: There have been reports of chronic overdose in patients taking leflunomide at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Croatian: Postoje izvješća o kroničnom predoziranju bolesnika koji su uzimali leflunomid u dozama do pet puta većima od preporučene dnevne doze, kao i izvješća o akutnom predoziranju u odraslih i djece.
English: Leflunomide Teva tablets can be taken with or without food.
Croatian: Leflunomid Teva tablete mogu se uzimati s hranom ili bez nje.
English: Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in
Croatian: Podaci o farmakokinetici u starijih bolesnika (>65 godina) ograničeni su, ali odgovaraju
English: Some people will notice further improvement after 4 to 6 months of treatment.
Croatian: Neki bolesnici čak mogu osjećati daljnje poboljšanje i nakon 4 do 6 mjeseci liječenja.
English: Leflunomide Teva is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Croatian: Leflunomid Teva ne preporučuje se bolesnicima mlađima od 18 godina jer djelotvornost i sigurnost kod juvenilnog reumatoidnog artritisa (JRA) nisu ustanovljene (vidjeti dijelove 5.1. i 5.2.).
English: - If you are pregnant, think you may be pregnant, or are breast-feeding.
Croatian: - Ako ste trudni, mislite da biste mogli biti trudni ili dojite.
English: Folate supplementation was optional and only used in 10 % of patients.
Croatian: Folati su nadoknađivani prema potrebi i uzimalo ih je samo 10% bolesnika.
English: For further information on the laboratory testing please contact your doctor.
Croatian: Za dodatne informacije o laboratorijskim pretragama obratite se svom liječniku.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Croatian: POSEBNO UPOZORENJE DA LIJEK TREBA ČUVATI IZVAN POGLEDA
English: You will normally take Leflunomide Teva over long periods of time.
Croatian: Leflunomid Teva ćete uobičajeno uzimati tijekom duljeg vremenskog razdoblja.
English: - If you suffer from a severe condition that affects your immune system e.g. AIDS.
Croatian: Ako bolujete od bolesti koja utječe na Vaš imunološki sustav (npr. AIDS).
English: The usual starting dose is 100 mg once a day for 3 days.
Croatian: Uobičajena početna doza je 100 mg jedanput na dan tijekom prva 3 dana.
English: - If you have ever had tuberculosis or interstitial lung disease (lung disease).
Croatian: - Ako ste ikad imali tuberkulozu ili intersticijsku plućnu bolest (bolest pluća).
English: The pattern of adverse events of leflunomide and methotrexate seems to be similar, but the dose used in lighter subjects resulted in a relatively low exposure (see section 5.2).
Croatian: Čini se da je obrazac pojavljivanja nuspojava leflunomida i metotreksata sličan, ali doza korištena kod lakših ispitanika dovela je do relativno slabe izloženosti (vidjeti dio 5.2.).
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures.
Croatian: Informacije navedene u Uputi za liječnika trebaju uključivati informacije o smanjenju doze, prekidu terapije i postupcima eliminacije lijeka.
English: In vitro studies indicate that A771726 inhibits cytochrome P4502C9 (CYP2C9) activity.
Croatian: In vitro ispitivanja pokazuju da A771726 inhibira aktivnost citokroma P4502C9 (CYP2C9).
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje
English: This should be confirmed by a blood test.
Croatian: To se treba potvrditi laboratorijskim pretragama.
English: If you take more Leflunomide Teva than you should If you or someone else swallows a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
Croatian: Ako uzmete više Leflunomida Teva nego što ste trebali Ako Vi ili netko drugi uzme više tableta odjednom, odnosno ako mislite da je dijete progutalo neku od tableta, odmah se javite u najbližu hitnu službu ili svom liječniku.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: • UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
English: Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
Croatian: Sa sobom uzmite ovu uputu, sve preostale tablete i bočicu kako bi Vaš liječnik ili liječnici u hitnoj službi znali koje ste tablete popili.
English: Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency:
Croatian: Alanin aminotransferazu (ALT) ili serumsku glutamopiruvat transferazu (SGPT) i kompletnu krvnu sliku, uključujući diferencijalnu bijelu krvnu sliku i broj trombocita, mora se provjeravati istodobno i u
English: Leflunomide Teva can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Croatian: Leflunomid Teva može povremeno uzrokovati probleme s krvi, jetrom, plućima ili živcima u rukama ili nogama.
English: This metabolite is responsible for essentially all the in vivo activity of leflunomide.
Croatian: Taj je metabolit odgovoran za gotovo svu in vivo aktivnost leflunomida.
English: If you are still able to have a child, you must not take Leflunomide Teva without using reliable contraception for at least 2 years after treatment.
Croatian: Ako ste još uvijek u reproduktivnoj dobi, ne smijete uzimati Leflunomid Teva ako ne upotrebljavate učinkovitu kontracepciju još najmanje 2 godine nakon završetka terapije.
English: If Leflunomide Teva has been sufficiently removed from your body, you should wait at least another 6 weeks before you become pregnant.
Croatian: Ako je Leflunomid Teva u dovoljnoj mjeri uklonjen iz Vašeg organizma, trebate pričekati još barem 6 tjedana prije nego što
English: Therefore, closer monitoring of liver enzymes and haematological parameters is recommended in the initial phase after switching.
Croatian: Stoga se preporučuje pažljivija kontrola jetrenih enzima i hematoloških parametara u početnoj fazi nakon
English: If you forget to take Leflunomide Teva In case you forget to take a dose, take it as soon as you remember.
Croatian: Ako ste zaboravili uzeti Leflunomid Teva Ako ste zaboravili uzeti dozu lijeka, uzmite je čim se sjetite.
English: However, in study US301 no significant differences were observed between leflunomide and methotrexate in the primary efficacy parameters.
Croatian: Međutim, u studiji US301 nisu zabilježene statistički značajne razlike između leflunomida i metotreksata u vrijednostima primarne djelotvornosti.
English: These washout procedures may be repeated if clinically necessary.
Croatian: Ispiranje ("washout" postupak) može se ponoviti ako je klinički potrebno.
English: How to take Leflunomide Teva
Croatian: Kako čuvati Leflunomid Teva
English: You will then need a blood test to make sure that Leflunomide Teva has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child.
Croatian: Trebat ćete napraviti krvne pretrage kako biste bili sigurni da je Leflunomid Teva u dovoljnoj mjeri uklonjen iz tijela i nakon toga pričekati najmanje sljedeća tri mjeseca prije pokušaja ostvarivanja očinstva.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
Croatian: Ako Vam je liječnik rekao da imate bolest nepodnošenja nekih šećera, posavjetujte se sa svojim liječnikom prije nego što počnete uzimati ovaj lijek.
English: It has immunomodulating/immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties.
Croatian: Ima imunomodulirajuća/imunosupresivna svojstva, djeluje antiproliferativno i ima protuupalna svojstva.
English: Study MN303 was an optional 6-month blinded continuation of MN301 without the placebo arm, resulting in a 12-month comparison of leflunomide and sulphasalazine.
Croatian: Studija MN303 bila je neobavezni slijepi šestomjesečni nastavak studije MN301 bez placeba, što je rezultiralo 12-mjesečnom usporedbom leflunomida i sulfasalazina.
English: Not known side effects (frequency cannot be estimated from the available data):
Croatian: Nepoznate nuspojave (učestalost se ne može procijeniti na osnovi raspoloživih podataka):
English: The unbound fraction of A771726 is about 0.62 %.
Croatian: A771726 iznosi oko 0,62%.
English: This 2 years may be reduced to a few weeks if you take a treatment, recommended by your doctor, which speeds up removal of Leflunomide Teva
Croatian: To se razdoblje od 2 godine može smanjiti na nekoliko tjedana ako po preporuci liječnika uzimate i terapiju koja ubrzava uklanjanje Leflunomida Teva iz tijela.
English: Women of childbearing potential should be told that a waiting period of 2 years after treatment discontinuation is required before they may become pregnant.
Croatian: Ženama reproduktivne dobi treba reći da moraju proći dvije godine od prekida liječenja do moguće trudnoće.
English: The symptoms include inflammation of joints, swelling, difficulty moving and pain.
Croatian: Njegovi simptomi uključuju upalu i oticanje zglobova, otežano kretanje i bolove.
English: - Any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening.
Croatian: - Bilo kojeg simptoma infekcije kao što su vrućica, grlobolja ili kašalj jer ovaj lijek može povećati rizik od teških infekcija koje mogu biti opasne po život.
English: Leflunomide is effective in animal models of arthritis and of other autoimmune diseases and transplantation, mainly if administered during the sensitisation phase.
Croatian: Leflunomid je učinkovit na životinjskim modelima artritisa i ostalih autoimunih bolesti te transplantacije uglavnom ako se primjenjuje u fazi senzibilizacije.
English: Respiratory reactions
Croatian: Jetrene reakcije