FrancophonIA/ELRC3.0 huggingface dataset:
English: However, animal studies to evaluate this specific risk have not been conducted.
Croatian: Nisu, međutim, provedena ispitivanja na životinjama kojima bi se procijenio taj rizik.
English: There is no indication that these effects are of clinical relevance.
Croatian: Nema indicija da su ti učinci klinički značajni.
English: A more than 3-fold increase was seen in another 5 patients.
Croatian: Više nego trostruko povećanje vrijednosti zabilježeno je u drugih 5 bolesnika.
English: • every 8 weeks thereafter (see section 4.4).
Croatian: • nakon toga svakih 8 tjedana (vidjeti dio 4.4).
English: It is considered essential that monitoring recommendations are strictly adhered to.
Croatian: Najvažnije je strogo se pridržavati preporučenih kontrola.
English: It may take about 4 weeks or longer until you start to feel an improvement in your condition.
Croatian: Može biti potrebno približno 4 tjedana ili više da se počnete osjećati bolje.
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: mild increase in blood pressure
Croatian: blagi porast krvnog tlaka
English: No special requirements for disposal.
Croatian: Nema posebnih zahtjeva za zbrinjavanje.
English: Zentiva Italia S.r.l.
Croatian: Italia Zentiva Italia S.r.l.
English: Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.
Croatian: Bolesnike je potrebno pomno pratiti zbog znakova i simptoma pretjerane izloženosti lijekovima i potrebno je razmotriti smanjenje doze tih lijekova.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Pharmacokinetic data in elderly (>65 years) are limited but consistent with pharmacokinetics in younger adults.
Croatian: Podaci o farmakokinetici u starijih bolesnika (> 65 godina) ograničeni su, ali odgovaraju farmakokinetici u mlađih odraslih osoba.
English: Patients with a history of tuberculosis should be carefully monitored because of the possibility of reactivation of the infection.
Croatian: Bolesnici s tuberkulozom u anamnezi moraju biti pozorno praćeni zbog mogućnosti reaktivacije infekcije.
English: The tablets are packed in blisters or bottles.
Croatian: Tablete su pakirane u blistere ili bočice.
English: For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
Croatian: Za dodatne informacije o ispitivanju uzorka obratite se nositelju odobrenja za stavljanje lijeka u promet ili njegovom lokalnom predstavniku (vidjeti dio 7.).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility
Croatian: granično (reverzibilno) smanjenje koncentracije spermija, ukupnog broja spermija i brze progresivne pokretljivosti
English: This includes any possible side effects not listed in this leaflet.
Croatian: Ovo uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
English: OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel)
Croatian: Učinak na oralne kontraceptive (0,03 mg etinilestradiol i 0,15 mg levonorgestrel)
English: • The risk of infections, including opportunistic infections, and the contraindication for use in immuno-compromised patients.
Croatian: • Rizik od infekcija, uključujući i oportunističke infekcije, i kontraindikacija za primjenu u imunokompromitiranih bolesnika.
English: • Patients with serious infections (see section 4.4).
Croatian: • Bolesnici s ozbiljnim infekcijama (vidjeti dio 4.4).
English: No dose adjustment is required in patients above 65 years of age.
Croatian: Nije potrebno prilagođavati dozu u bolesnika starijih od 65 godina.
English: Infections and infestations Rare:
Croatian: Infekcije i infestacije Rijetko:
English: Falsely low levels of calcium can be detected.
Croatian: Mogu se utvrditi lažno niske razine kalcija.
English: Waiting period
Croatian: Razdoblje čekanja
English: Tell your doctor if you have unexplained chronic diarrhoea.
Croatian: Obratite se svom liječniku ako imate neobjašnjivi kronični proljev.
English: NSAIDS/Corticosteroids
Croatian: NSAIL/Kortikosteroidi
English: However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity.
Croatian: Međutim, nije zabilježen očiti utjecaj ovog povećanja izloženosti rosuvastatinu u plazmi na aktivnost HMG-CoA reduktaze.
English: If used together, the dose of rosuvastatin should not exceed 10 mg once daily.
Croatian: Ako se koriste zajedno, doza rosuvastatina ne smije prijeći 10 mg jedanput dnevno.
English: In study MN302 leflunomide was significantly less effective than methotrexate.
Croatian: U ispitivanju MN302 leflunomid je bio značajno manje učinkovit od metotreksata.
English: What Leflunomide Zentiva is and what it is used for
Croatian: Što je Leflunomide Zentiva i za što se koristi
English: For further information on the laboratory testing please contact your doctor.
Croatian: Za dodatne informacije o laboratorijskim pretragama obratite se svome liječniku.
English: While this interaction is not expected to adversely impact the efficacy of oral contraceptives, consideration should be given to the type of oral contraceptive treatment.
Croatian: Iako se ne očekuje negativan utjecaj ove interakcije na djelotvornost oralnih kontraceptiva, potrebno je razmotriti vrstu terapije oralnim kontraceptivima.
English: leucopenia (leucocytes >2 G/L)
Croatian: leukopenija (leukociti > 2 g/l).
English: No difference was observed between leflunomide and sulphasalazine (study MN301).
Croatian: Nije bilo značajnih razlika između leflunomida i sulfasalazina (ispitivanje MN301).
English: These data do not allow an effective and safe dose recommendation.
Croatian: Iz tih podataka nije moguće preporučiti učinkovitu i sigurnu dozu.
English: Store in the original package.
Croatian: Čuvati u originalnom pakiranju.
English: The effect of leflunomide on improvement of function and on reduction of skin lesions was modest.
Croatian: Učinak leflunomida na poboljšanje funkcionalne sposobnosti i smanjenje kožnih lezija bio je skroman.
English: These washout procedures may be repeated if clinically necessary.
Croatian: Navedeni postupci ispiranja mogu se ponoviti ako je klinički potrebno.
English: Date of latest renewal: 08 January 2015
Croatian: Datum posljednje obnove: 08. siječnja 2015.
English: The leflunomide treatment effect was evident by 1 month, stabilised by 3 to 6 months and continued throughout the course of treatment.
Croatian: Terapijski učinak leflunomida bio je očigledan nakon mjesec dana, a stabiliziran nakon 3 do 6 mjeseci, što se nastavilo u daljnjem tijeku liječenja.
English: As similar drug-drug interactions cannot be excluded for leflunomide at recommended doses, the following study results and recommendations should be considered in patients treated with leflunomide:
Croatian: Budući da se slične interakcije među lijekovima ne mogu isključiti za leflunomid u preporučenim dozama, sljedeći rezultati ispitivanja i preporuke moraju se razmotriti u bolesnika liječenih leflunomidom:
English: anorexia, weight loss (usually insignificant), asthenia
Croatian: anoreksija, gubitak težine (obično beznačajan), astenija
English: There have been reports of chronic overdose in patients taking Leflunomide Zentiva 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 lijek Leflunomide Zentiva u dozama do pet puta većima od preporučene dnevne doze, kao i izvješća o akutnom predoziranju u odraslih i djece.
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 mjeseci.
English: Pharmacotherapeutic group: selective immunosuppressants, ATC code: L04AA13.
Croatian: Farmakoterapijska skupina: selektivni imunosupresivi, ATK oznaka: L04AA13.
English: In a carcinogenicity study in rats, leflunomide did not show carcinogenic potential.
Croatian: U ispitivanjima kancerogenosti u štakora leflunomid nije pokazivao kancerogeni potencijal.
English: Women of childbearing potential have to use effective contraception during and up to 2 years after treatment (see “waiting period” below) or up to 11 days after treatment (see abbreviated “washout period” below).
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja i do 2 godine nakon liječenja (vidjeti „razdoblje čekanja“ u nastavku teksta) ili do 11 dana nakon liječenja (vidjeti skraćeno pod "period ispiranja" u nastavku teksta).
English: The efficacy of Leflunomide Zentiva in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Croatian: Djelotvornost lijeka Leflunomide Zentiva u liječenju reumatoidnog artritisa pokazala se u 4 kontrolirana ispitivanja (1 u fazi II i 3 u fazi III).
English: • active psoriatic arthritis.
Croatian: • aktivnim psorijatičnim artritisom.
English: Do not use this medicine after the expiry date which is stated on the packaging.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
English: Some patients may even still feel further improvements after 4 to 6 months of therapy.
Croatian: Neki bolesnici čak mogu osjetiti daljnje poboljšanje nakon 4 do 6 mjeseci liječenja.
English: mild allergic reactions
Croatian: blage alergijske reakcije
English: Tablet core:
Croatian: Jezgra tablete:
English: Classification of expected frequencies:
Croatian: Klasifikacija očekivane učestalosti:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: Toxicity in animals was found at doses equivalent to human therapeutic doses.
Croatian: Toksičnost u životinja zabilježena je pri primjeni doza koje odgovaraju terapijskim dozama u ljudi.
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: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Croatian: Liječnici koji propisuju lijek moraju biti upozoreni na rizik od lažno negativnog rezultata tuberkulinskog kožnog testa, osobito u teško bolesnih i imunokompromitiranih bolesnika.
English: If you take more Leflunomide Zentiva than you should
Croatian: Ako uzmete više lijeka Leflunomide Zentiva nego što ste trebali
English: • The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Croatian: • Potreba za savjetovanjem bolesnika o važnim rizicima povezanima s terapijom leflunomidom i odgovarajućim mjerama opreza za vrijeme uzimanja ovoga lijeka.
English: paraesthesia, headache, dizziness, peripheral neuropathy Cardiac disorders
Croatian: parestezije, glavobolja, omaglica, periferna neuropatija Srčani poremećaji
English: Zentiva Pharma UK Limited Tel: +44 (0) 845 372 7101
Croatian: United Kingdom Zentiva Pharma UK Limited Tel: +44 (0) 845 372 7101
English: Your doctor will also check your blood pressure regularly as Leflunomide Zentiva can cause an increase in blood pressure.
Croatian: Liječnik će Vam također redovito kontrolirati krvni tlak jer Leflunomide Zentiva može uzrokovati njegovo povišenje.
English: Leflunomide Zentiva is not recommended for use in children and adolescents below 18 years of age.
Croatian: Djeca i adolescenti Leflunomide Zentiva se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
English: CPK increased
Croatian: povećanje CPK
English: The tablets should be swallowed whole with sufficient amounts of liquid.
Croatian: Tablete se moraju progutati cijele s dovoljnom količinom tekućine.
English: Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Croatian: Breast Cancer Resistance Protein) i/ili supstrate organskog anionskog transportnog polipeptida B1 i B3 (OATP1B1/B3)
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Leflunomide Zentiva from your body.
Croatian: To se razdoblje može smanjiti na nekoliko tjedana ako uzimate neke lijekove koji ubrzavaju uklanjanje lijeka Leflunomide Zentiva iz tijela.
English: Leflunomide is indicated for the treatment of adult patients with:
Croatian: Leflunomid je indiciran u liječenju odraslih bolesnika s:
English: Combinations with other treatments
Croatian: Kombinacija s ostalim načinima liječenja
English: LDH increased
Croatian: povećanje LDH
English: In the event of an overdose or toxicity, colestyramine or charcoal is recommended to accelerate elimination.
Croatian: U slučaju predoziranja ili toksičnosti preporučuje se kolestiramin ili aktivni ugljen kako bi se ubrzala eliminacija.
English: This medicinal product contains lactose (see leaflet for further information).
Croatian: Ovaj lijek sadrži laktozu (vidjeti uputu o lijeku za dodatne informacije).
English: Uncommon: hypokalaemia, hyperlipidemia, hypophosphataemia Rare:
Croatian: Manje često: hipokalijemija, hiperlipidemija, hipofosfatemija Rijetko:
English: The unbound fraction of A771726 is about 0.62%.
Croatian: Nevezana frakcija A771726 iznosi oko 0,62%.
English: Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anaemia (lack of red blood cells).
Croatian: Ostali simptomi koji utječu na cijeli organizam su gubitak teka, vrućica, gubitak energije i anemija (nedostatak crvenih krvnih stanica).
English: Treatment withdrawal may be considered taking into account patient's disease and past history.
Croatian: Može se razmotriti prestanak liječenja, uzimajući u obzir sadašnje stanje bolesti, kao i prošlost bolesti.
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing.
Croatian: Liječnici i bolesnici trebaju biti upoznati s postojanjem ad hoc savjetodavne službe za pružanje informacije o laboratorijskim pretragama koncentracije leflunomida u plazmi.
English: Co-treatment with other hepatotoxic medicinal products was frequently present.
Croatian: Često su istodobno primjenjivani drugi hepatotoksični lijekovi.
English: You will then need a blood test to make sure that Leflunomide Zentiva has been sufficiently removed from your body, and you should then wait for at least another 3 months before attempting to father a child. - if you are due to have a specific blood test (calcium level).
Croatian: Trebat ćete napraviti krvne pretrage kako biste bili sigurni da je Leflunomide Zentiva u dovoljnoj mjeri uklonjen iz tijela i nakon toga pričekati još najmanje 3 mjeseca prije pokušaja ostvarivanja očinstva. - ako morate napraviti određenu krvnu pretragu (utvrđivanje razina kalcija).
English: • Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.
Croatian: • Bolesnici s umjerenom do teškom bubrežnom insuficijencijom zbog nedostatnih kliničkih iskustava za tu skupinu bolesnika.
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: However there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
Croatian: Međutim, zabilježene su velike razlike u krajnjem ishodu, odnosno u nekih se bolesnika neuropatija povukla dok su drugi imali trajne simptome.
English: Thus, the overall incidence of infections can increase (in particular of rhinitis, bronchitis and pneumonia).
Croatian: Stoga i ukupna incidencija infekcija također može porasti (osobito rinitisa, bronhitisa i pneumonije).
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 štetnih događaja leflunomida i metotreksata sličan, ali doza primijenjena u lakših ispitanika dovela je do relativno slabe izloženosti (vidjeti dio 5.2).
English: This can include medical history, possible previous contact with tuberculosis, and/or appropriate screening such as lung x-ray, tuberculin test and/or interferon-gamma release assay, as applicable.
Croatian: To može uključivati povijest bolesti, mogući prethodni kontakt s tuberkulozom i/ili prikladnu metodu probira kao što je rentgensko snimanje pluća, tuberkulinski test i/ili test otpuštanja interferona gama, ovisno o primjenjivosti.
English: Leflunomide Zentiva belongs to a group of medicines called anti-rheumatic medicines.
Croatian: Leflunomide Zentiva pripada skupini lijekova koji se zovu antireumatski lijekovi.
English: The risk associated with combination therapy, in particular in long-term treatment, is unknown.
Croatian: Nije poznat rizik povezan s kombiniranom terapijom, posebice u dugotrajnoj primjeni.
English: • Patients with severe immunodeficiency states, e.g. AIDS.
Croatian: • Bolesnici s teškim stanjima imunodeficijencije, npr. AIDS.
English: However, in study US301 no significant differences were observed between leflunomide and methotrexate in the primary efficacy parameters.
Croatian: Međutim, u ispitivanju US301 nisu zabilježene statistički značajne razlike između leflunomida i metotreksata u vrijednostima primarne djelotvornosti.
English: However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.
Croatian: Međutim, sporedni metabolit TFMA (4-trifluorometilanilin) uzrokovao je klastogenost i točkaste mutacije in vitro, dok su nedostatne informacije o njegovom potencijalu izazivanja tog učinka in vivo.
English: Switching to other treatments
Croatian: Prijelaz na druge načine liječenja
English: Česká republika
Croatian: Češka Republika
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom laktaze ili malapsorpcijom glukoze-galaktoze ne bi trebali uzimati ovaj lijek.
English: The Marketing Authorisation Holder (MAH) shall ensure that any changes to the safety profile of the reference medicinal product requiring changes to the Risk Management Plan or Product Information are immediately implemented for Leflunomide Zentiva.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet dužan je osigurati da se sve promjene sigurnosnog profila referentnog lijeka koje zahtijevaju promjenu Plana upravljanja rizicima ili Informacije o proizvodu smjesta implementiraju za Leflunomide Zentiva.
English: Pustular psoriasis and worsening of psoriasis have been reported after the use of leflunomide.
Croatian: Pustularna psorijaza i pogoršanje psorijaze prijavljeni su nakon primjene leflunomida.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: The safety data obtained from both treatment groups were consistent with the known safety profile of leflunomide, however, the incidence of gastrointestinal adverse events and of elevated liver enzymes tended to be higher in the patients receiving the loading dose of 100 mg leflunomide.
Croatian: Sigurnosni podaci dobiveni za obje skupine bili su konzistentni s poznatim sigurnosnim profilom leflunomida, ali je incidencija gastrointestinalnih poremećaja i povišenih jetrenih enzima bila viša u bolesnika koji su primali udarnu dozu od 100 mg leflunomida.
English: If you take more Leflunomide Zentiva than you should, contact your doctor or get other medical advice.
Croatian: Ako uzmete više lijeka Leflunomide Zentiva nego što ste trebali, odmah se javite svom liječniku ili zatražite savjet drugog zdravstvenog djelatnika.
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: Ispitivanje MN303 bilo je neobavezan slijepi 6-mjesečni nastavak ispitivanja MN301 bez placeba, što je rezultiralo 12-mjesečnom usporedbom leflunomida i sulfasalazina.
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 promjene načina liječenja.
English: Leflunomide Zentiva can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Croatian: Leflunomide Zentiva može povremeno uzrokovati probleme s krvi, jetrom, plućima ili živcima u rukama ili nogama.
English: To minimise any possible risk, men wishing to father a child should consider discontinuing use of leflunomide and taking colestyramine 8 g 3 times daily for 11 days or 50 g of activated powdered charcoal 4 times daily for 11 days.
Croatian: Kako bi se mogući rizik sveo na najmanju moguću mjeru, muškarci koji žele biti očevi trebaju razmotriti prekid liječenja leflunomidom te uzimati kolestiramin u dozi od 8 g tri puta na dan tijekom 11 dana ili 50 g aktivnog ugljena u prahu četiri puta na dan tijekom 11 dana.
English: Leflunomide Zentiva can make you feel dizzy which may impair your ability to concentrate and react.
Croatian: Leflunomide Zentiva može izazvati omaglicu, što može smanjiti sposobnost koncentracije i reagiranja.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet: