FrancophonIA/ELRC3.0 huggingface dataset:
English: However, as severe adverse reactions may occur even at low doses, it is essential for the treating physician to monitor patients closely (see section 4.4).
Croatian: Međutim, kako se teške nuspojave mogu pojaviti čak i kod niskih doza neophodno je da nadležni liječnik pažljivo prati bolesnike (vidjeti dio 4.4).
English: In particular, elderly patients should be monitored at short intervals for early signs of toxicity (see section 4.2).
Croatian: Posebice, starije bolesnike treba pratiti u kratkim vremenskim razmacima zbog ranih znakova toksičnosti (vidjeti dio 4.2).
English: Tell your doctor immediately if you suddenly get wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
Croatian: Odmah obavijestite liječnika ako iznenada osjetite piskanje pri disanju, otežano disanje, oticanje očnih kapaka, lica ili usana, osip ili svrbež (posebice ono koje zahvaća cijelo tijelo).
English: They should then be rinsed thoroughly under COLD water and excess water shaken off before wiping dry with a clean paper towel.
Croatian: Nakon toga oba dijela treba temeljito isprati HLADNOM vodom, a suvišnu vodu otresti prije brisanja čistim papirnatim ručnikom.
English: − black or tarry stools
Croatian: − crna ili katranasta stolica
English: Your doctor should perform blood tests before the beginning of treatment to check how well your kidneys and liver are working.
Croatian: Prije početka liječenja Liječnik mora provesti pretrage krvi prije početka liječenja kako bi se provjerio rad Vaših bubrega i jetre.
English: Please read section 3 of this leaflet very carefully.
Croatian: Vrlo pažljivo pročitajte dio 3. u ovoj uputi o lijeku.
English: Methotrexate induces gene and chromosomal mutations in vitro and in vivo.
Croatian: Metotreksat izaziva genske i kromosomske mutacije in vitro i in vivo.
English: An overdose of methotrexate can cause serious reactions.
Croatian: Predoziranje metotreksatom može prouzročiti ozbiljne reakcije.
English: When you use the medicine follow the instructions below:
Croatian: Kada primjenjujete ovaj lijek, pridržavajte se uputa u nastavku:
English: For more information, please read the patient leaflet inserted in the package.
Croatian: Za više informacija pročitajte uputu o lijeku priloženu u pakiranju.
English: Due to its potentially toxic effects on the liver, additional hepatotoxic medicinal products should not be taken during treatment with methotrexate unless urgently necessary and the consumption of alcohol should be avoided or reduced (see section 4.5).
Croatian: Zbog svog potencijalno toksičnog učinka na jetru, tijekom liječenja metotreksatom ne smiju se uzimati dodatni hepatotoksični lijekovi, osim ako je to neodgodivo potrebno, a konzumaciju alkohola treba izbjegavati ili smanjiti (vidjeti dio 4.5).
English: • Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcers
Croatian: • stomatitis, ulkusi u usnoj šupljini i poznati aktivni gastrointestinalni ulkusi
English: Increased caution is required in patients with insulin-dependent diabetes mellitus as hepatic cirrhosis has developed in individual cases without any elevation of transaminases during methotrexate treatment.
Croatian: Povećan oprez potreban je u bolesnika sa šećernom bolešću ovisnom o inzulinu, jer se u pojedinačnim slučajevima ciroza jetre razvila bez ikakvih povećanja transaminaza tijekom liječenja metotreksatom.
English: Methotrexate temporarily affects sperm and egg production.
Croatian: Metotreksat privremeno utječe na proizvodnju sperme i jajnih stanica.
English: In the event of accidental overdose, a dose of calcium folinate equal to or higher than the offending dose of methotrexate should be administered intravenously or intramuscularly within 1 hour, and dosing continued until serum level of methotrexate are below 10-7 mol/L.
Croatian: U slučaju nehotičnog predoziranja, potrebno je u roku od 1 sata intravenski ili intramuskularno primijeniti dozu kalcijeva folinata, jednaku ili višu od prekomjerne doze metotreksata, a doziranje nastaviti sve dok serumska razina metotreksata ne bude ispod 10-7 mol/l.
English: 2 Lymphoma/Lymphoproliferative disorders: there have been reports of individual cases of lymphoma and other lymphoproliferative disorders which subsided in a number of cases once treatment with methotrexate had been discontinued.
Croatian: 2limfom / limfoproliferativni poremećaji: prijavljeni su pojedinačni slučajevi limfoma i drugih limfoproliferativnih poremećaja koji su se povukli u određenom broju slučajeva nakon što je prekinuta primjena metotreksata
English: If you have any questions, please talk to your doctor or pharmacist before you take this medicine.
Croatian: Ako imate pitanja, obratite se liječniku ili ljekarniku prije nego što uzmete ovaj lijek.
English: If such adverse reactions occur, the dose should either be reduced or treatment discontinued and appropriate countermeasures taken (see section 4.9).
Croatian: Ako se takve nuspojave pojave, dozu treba smanjiti ili prekinuti liječenje te poduzeti odgovarajuće protumjere (vidjeti dio 4.9).
English: Therapeutic management of overdose
Croatian: Terapijsko zbrinjavanje predoziranja
English: In children with JIA, the dose normalized area under the plasma concentration versus time-curve (AUC) of methotrexate increased with the age of the children and was lower than that found in adults.
Croatian: površina ispod krivulje koncentracije metotreksata u plazmi naspram vremena (AUC), normalizirana za dozu, povećala se s dobi djece, a bila je niža nego ona nađena u odraslih.
English: The antidote in the event of an overdose is calcium folinate.
Croatian: Protulijek (antidot) u slučaju predoziranja je kalcijev folinat.
English: It acts by competitive inhibition of the enzyme dihydrofolate reductase and thus inhibits DNA synthesis.
Croatian: Djeluje kompetitivnom inhibicijom enzima dihidrofolat reduktaza i tako inhibira sintezu DNK-a.
English: - Examination of the mouth and throat for mucosal changes.
Croatian: - Pregled usne šupljine i grla zbog mogućih promjena na sluznici.
English: As treatment with methotrexate at higher doses commonly used in cancer treatment can cause infertility and genetic mutations, it may be advisable for male patients treated with methotrexate doses higher than 30 mg (15 ml)/week to consider sperm preservation before the beginning of treatment (see also section "Warnings and precautions").
Croatian: Kako liječenje većim dozama metotreksata, uobičajeno korištenima za liječenje raka, može uzrokovati neplodnost i genetske mutacije, muškim se bolesnicima liječenima metotreksatom u dozama većim od 30 mg (15 ml)/tjedan savjetuje da razmotre mogućnost pohrane sperme prije nego što započnu liječenje (pogledajte i dio "Upozorenja i mjere opreza").
English: If pregnancy occurs during treatment with methotrexate and up to six months thereafter, medical advice should be given regarding the risk of harmful effects on the child associated with treatment and ultrasonography examinations should be performed to confirm normal foetal development.
Croatian: Ako se tijekom liječenja i još do 6 mjeseci nakon prestanka liječenja metotreksatom dogodi trudnoća, potrebno je pružiti liječnički savjet o rizicima štetnog učinka na dijete povezanog s terapijom i potrebno je provoditi ultrazvučne preglede radi potvrde normalnog razvoja fetusa.
English: Ensure that you drink a lot of fluids during treatment with Jylamvo because dehydration (the reduction of body water) can increase the side effects of methotrexate.
Croatian: Pobrinite se da tijekom liječenja lijekom Jylamvo pijete dovoljno tekućine jer dehidracija (smanjena količina vode u tijelu) može povećati nuspojave metotreksata.
English: If your doctor considers that continuing treatment with methotrexate is essential, you must stop breast-feeding.
Croatian: Ako liječnik smatra da je važno nastaviti liječenje metotreksatom, morate prestati dojiti.
English: Recommended follow-up examinations and precautions
Croatian: Preporučeni kontrolni pregledi i mjere opreza
English: However, in clinical trials in which NSAIDs and salicylic acid were administered adjuvantly to patients with rheumatoid arthritis, no increase in adverse reactions was observed.
Croatian: Međutim, u kliničkim ispitivanjima u kojima su NSAIL-ovi i salicilatna kiselina primjenjivani kao adjuvantni lijekovi u bolesnika s reumatoidnim artritisom, nije bilo opaženo povećanje nuspojava.
English: Important warning about the dosage of Jylamvo (methotrexate)
Croatian: Važno upozorenje o doziranju lijeka Jylamvo (metotreksata)
English: A weekly dose of 25 mg (12.5 ml) should not be exceeded.
Croatian: Ne smije se prekoračiti tjedna doza od 25 mg (12,5 ml).
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, antimetabolites, folic acid analogues, ATC code: L01BA01
Croatian: Farmakoterapijska skupina: antineoplastici i imunomodulatori, antimetaboliti, analozi folatne kiseline, ATK oznaka: L01BA01
English: Methotrexate should be discontinued in patients with pulmonary symptoms and an immediate examination (including chest X-ray) should be performed to exclude infection and tumours.
Croatian: U bolesnika s plućnim simptomima primjenu metotreksata treba prekinuti i odmah obaviti pregled (uključujući rendgensko snimanje prsnog koša) kako bi se isključilo infekciju i tumore.
English: Lymphoma1
Croatian: limfom1
English: Patients with pathological fluid accumulations (pleural effusion, ascites) As the half-life of methotrexate can be prolonged four-fold in patients with pathological fluid accumulations, it may be necessary to reduce the dose and in some cases even to discontinue methotrexate (see sections 4.4 and 5.2).
Croatian: Bolesnici s patološkim nakupljanjem tekućine (pleuralna efuzija, ascites) S obzirom da se poluvijek metotreksata može četverostruko produljiti u bolesnika s patološkim nakupljanjem tekućine, može biti potrebno smanjiti dozu, a u nekim slučajevima čak i prekinuti primjenu metotreksata (vidjeti dijelove 4.4 i 5.2).
English: This can be done with methotrexate as an intramuscular or subcutaneous administration and is recommended for patients who exhibit inadequate absorption of the oral form of methotrexate or who do not tolerate oral administration well.
Croatian: To se može provoditi primjenom metotreksata intramuskularno ili supkutano, a preporučuje se za bolesnike koji pokazuju neodgovarajuću apsorpciju oralnog oblika metotreksata ili koji peroralnu primjenu ne podnose dobro.
English: The usual caution should be exercised in handling cytostatics.
Croatian: Potreban je oprez uobičajen za rukovanje citostaticima.
English: • The need to inform patients and relatives/carers about the once weekly dosing;
Croatian: • Potrebu da se bolesnika i njegove rođake/njegovatelje mora informirati o režimu doziranja jednom tjedno.
English: Each pack contains one bottle, a bottle adaptor and a white dosing syringe.
Croatian: Svako pakiranje sadrži jednu bočicu, nastavak za bočicu i bijelu štrcaljku za doziranje.
English: Turn the bottle upside down.
Croatian: Okrenite bočicu naopako.
English: − blood in the urine or stool
Croatian: − krv u mokraći ili stolici
English: Pulmonary symptoms require a rapid diagnosis and discontinuation of methotrexate therapy.
Croatian: Plućni simptomi zahtijevaju brzo postavljanje dijagnoze i prekid terapije metotreksatom.
English: In addition, pulmonary alveolar haemorrhage has been reported with methotrexate used in rheumatologic and related indications.
Croatian: Pored toga, zabiljeeni su slučajevi plućne alveolarne hemoragije pri primjeni metotreksata u reumatološkim i njima povezanim indikacijama.
English: The plunger should be pushed back gently to the seated position until it clicks into place.
Croatian: Klip treba polako potiskivati dok ne „klikne” na svoje mjesto.
English: The plunger and barrel should then be separated and both washed thoroughly in the warm soapy water.
Croatian: Zatim se klip i tijelo trebaju razdvojiti te i jedno i drugo temeljito oprati sapunom u toploj vodi.
English: Higher dosages should be given parenterally.
Croatian: Više doze potrebno je davati parenteralno.
English: In view of its possible effects on the immune system, methotrexate can falsify vaccinal and test results (immunological procedures to assess the immune reaction).
Croatian: S obzirom na njegove moguće učinke na imunološki sustav, metotreksat može dovesti do lažnih rezultata cijepljenja i pretraga (imunoloških postupaka za procjenu imunološke rekacije).
English: Contact with the skin or mucous membrane must be avoided.
Croatian: Mora se izbjeći dodir s kožom ili sluznicom.
English: − skin lesions resembling sunburn or dermatitis after radiotherapy
Croatian: − oštećenje kože koje nalikuje opeklinama od sunca ili dermatitis nakon terapije zračenjem
English: Methotrexate has been shown to be teratogenic to humans; it has been reported to cause foetal death, miscarriages and/or congenital abnormalities (e.g. craniofacial, cardiovascular, central nervous system and extremity-related).
Croatian: Pokazalo se da je metotreksat teratogen u ljudi; zabilježeno je da uzrokuje fetalnu smrt, pobačaje i/ili kongenitalne abnormalnosti (npr. kraniofacijalne, kardiovaskularne, središnjeg živčanog sustava i udova).
English: Remove the syringe from the patient's mouth.
Croatian: 12. Izvadite štrcaljku iz bolesnikovih usta.
English: If a patient develops pulmonary symptoms, the possibility of Pneumocystis jiroveci pneumonia should be considered.
Croatian: Ako bolesnik razvije plućne simptome, potrebno je razmotriti mogućnost da se radi o pneumoniji izazvanoj gljivicom Pneumocystis jirovecii.
English: In rheumatological and dermatological diseases
Croatian: U reumatološkim i dermatološkim bolestima
English: It has not yet been possible to date to clarify whether the efficacy of methotrexate in the management of psoriasis, psoriatic arthritis and chronic polyarthritis is due either to an anti-inflammatory or immunosuppressive effect, or to what extent a methotrexate-induced increase in extracellular adenosine concentration at inflamed sites contributes to this effect.
Croatian: Dosad nije bilo moguće razjasniti je li djelotvornost metotreksata u liječenju psorijaze, psorijatičnog artritisa i kroničnog poliartritisa zbog protuupalnog ili imunosupresivnog učinka ili do koje mjere porast koncentracije izvanstaničnog adenozina izazvan metotreksatom na mjestima upale pridonosi tom učinku.
English: In the treatment of rheumatological or dermatological diseases, Jylamvo (methotrexate) must only be taken once a week.
Croatian: U liječenju reumatoloških ili dermatoloških bolesti Jylamvo (metotreksat) se smije primjenjivati samo jedanput tjedno.
English: As methotrexate passes into breast milk and may cause toxicity in breast-fed children, treatment is contraindicated during the lactation period (see section 4.3).
Croatian: Budući da metotreksat prelazi u majčino mlijeko i može uzrokovati toksičnost u dojenčadi, liječenje je kontraindicirano u razdoblju laktacije (vidjeti dio 4.3).
English: Any unused medicine or waste material should be disposed of in accordance with local requirements for cytotoxic products - check with your pharmacist.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima za citotoksične lijekove - provjerite s ljekarnikom.
English: In one case in which methotrexate was combined with pantoprazole, renal elimination of the metabolite 7-hydroxymethotrexate was inhibited and myalgia and shivering occurred.
Croatian: U jednom slučaju u kojem je metotreksat bio kombiniran s pantoprazolom, eliminacija metabolita 7-hidroksimetotreksata putem bubrega bila je inhibirana te su se pojavili mijalgija i drhtanje.
English: What you need to know before you take Jylamvo Do not take Jylamvo
Croatian: Što morate znati prije nego počnete uzimati Jylamvo
English: If use during the lactation period should become necessary, breast-feeding is to be stopped prior to treatment.
Croatian: Ako primjena u razdoblju dojenja postane neophodna, dojenje treba prekinuti prije liječenja.
English: This difference in cell proliferation rate is the starting point for the use of methotrexate in particularly severe, generalised, treatment-resistant psoriasis and psoriatic arthritis.
Croatian: Ta razlika u brzini proliferacije stanica početna je točka za primjenu metotreksata u posebno teškoj, generaliziranoj psorijazi i psorijatičnom artritisu otpornima na liječenje.
English: Since cases of encephalopathy/leukoencephalopathy have occurred in cancer patients treated with methotrexate, this cannot be ruled out either for patients with non-cancer indications.
Croatian: Budući da je u bolesnika s rakom liječenih metotreksatom bilo slučajeva encefalopatije/leukoencefalopatije, to se ne može isključiti ni u bolesnike s drugim indikacijama.
English: Discard 3 months after first opening.
Croatian: Bacite 3 mjeseca nakon prvog otvaranja.
English: − spitting or coughing blood*
Croatian: − pljuvanje ili iskašljavanje krvi*
English: − pain or difficulties in passing urine
Croatian: − bol ili teškoće pri mokrenju
English: • Severe renal impairment (creatinine clearance less than 30 ml/min, see section 4.2)
Croatian: • teško oštećenje bubrega (klirens kreatinina manji od 30 ml/min, vidjeti dio 4.2).
English: Methotrexate-induced haematopoietic suppression may occur abruptly and with apparently safe dosages.
Croatian: Hematopoetska supresija izazvana metotreksatom može nastupiti naglo i pri naizgled sigurnim dozama.
English: Women who are pregnant, planning to be or breast-feeding should not handle methotrexate.
Croatian: Trudnice, žene koje planiraju zatrudnjeti ili dojilje ne smiju rukovati metotreksatom.
English: The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.
Croatian: Liječnik koji propisuje lijek mora biti siguran da se bolesnici ili njihovi njegovatelji mogu pridržavati režima primjene jednom tjedno.
English: Opportunistic infections can occur during treatment with methotrexate, including Pneumocystis jiroveci pneumonia, which can also have a fatal outcome.
Croatian: Tijekom liječenja metotreksatom mogu se pojaviti oportunističke infekcije, uključujući pneumoniju izazvanu gljivicom Pneumocystis jirovecii koja može imati i smrtni ishod.
English: Common accepted single doses lie in the range of 20-40 mg (10-20 ml)/m² body surface area.
Croatian: Opće prihvaćene pojedinačne doze kreću se u rasponu od 20-40 mg (10-20 ml)/m² tjelesne površine.
English: Wash the syringe immediately after use with fresh warm, soapy water and rinse well.
Croatian: Nakon upotrebe štrcaljku odmah operite svježom toplom vodom i sapunom i dobro je isperite.
English: Particular caution is required in patients with impaired pulmonary function.
Croatian: Poseban oprez potreban je u bolesnika s oštećenom plućnom funkcijom.
English: Methotrexate can cause serious (sometimes life-threatening) side effects.
Croatian: Metotreksat može prouzročiti ozbiljne (katkad po život opasne) nuspojave.
English: - Respiratory tract examination - patients must be monitored for symptoms of a lung function disorder and lung function tests performed if necessary.
Croatian: - Pregled dišnog sustava - bolesnike se mora pratiti zbog simptoma poremećaja plućne funkcije te provoditi testove funkcije pluća ako je potrebno.
English: Patients should be encouraged to report all signs and symptoms suggestive of infection to their doctor.
Croatian: Bolesnike treba poticati da liječnika obavijeste o svim znakovima i simptomima koji mogu upućivati na infekciju.
English: In the event of a massive overdose, hydration and alkalinisation of the urine may be required to prevent precipitation of methotrexate and/or its metabolites in the renal tubules.
Croatian: U slučaju jakog predoziranja, hidracija i alkalinizacija mokraće mogu biti potrebne kako bi se spriječilo taloženje metotreksata i/ili njegovih metabolita u tubulima bubrega.
English: Methotrexate is a folic acid antagonist that, as an antimetabolite, belongs to the class of cytotoxic active substances.
Croatian: Metotreksat je antagonist folatne kiseline koji, kao antimetabolit, pripada skupini citotoksičnih djelatnih tvari.
English: Due to its effect on the immune system, methotrexate may impair the response to vaccinations and affect the results of immunological tests.
Croatian: Imunološki sustav Zbog svog učinka na imunološki sustav, metotreksat može narušiti odgovor na cjepiva i utjecati na rezultate imunoloških testova.
English: Women of childbearing potential/Contraception in females Women must not get pregnant during methotrexate therapy, and effective contraception must be used during treatment with methotrexate and at least 6 months thereafter (see section 4.4).
Croatian: Žene reproduktivne dobi/kontracepcija u žena Tijekom terapije metotreksatom žene ne smiju zatrudnjeti, i moraju primjenjivati učinkovitu kontracepciju tijekom liječenja metotreksatom i još najmanje 6 mjeseci nakon toga (vidjeti dio 4.4).
English: • The potential for fatal overdose due to medication errors (ME), including daily instead of once weekly use;
Croatian: • Postojanje mogućnosti predoziranja sa smrtnim ishodom zbog medikacijskih pogrešaka, uključujući dnevnu primjenu umjesto primjene jednom tjedno.
English: If you stop taking Jylamvo
Croatian: Ako prestanete uzimati Jylamvo
English: • Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over
Croatian: • Terapija održavanja u akutnoj limfoblastičnoj leukemiji (ALL) u odraslih, adolescenata i djece u dobi od 3 i više godina.
English: If methotrexate is administered in combination with chemotherapy regimens, the dosage should take into consideration any overlapping toxicity of the other medicinal product components.
Croatian: Ako se metotreksat primjenjuje u kombinaciji s režimima kemoterapije, prilikom određivanja doziranja treba uzeti u obzir preklapanje toksičnosti s komponentama drugog lijeka.
English: Conversely, co-administration of medicinal products containing folinic acid or vitamin preparations containing folic acid or derivatives may impair the efficacy of methotrexate.
Croatian: Suprotno tome, istodobna primjena lijekova koji sadrže folinatnu kiselinu ili vitaminskih pripravaka koji sadrže folatnu kiselinu ili derivate može narušiti djelotvornost metotreksata.
English: In chronic toxicity studies in mice, rats and dogs, toxic effects were seen in the form of gastrointestinal lesions, myelosuppression and hepatotoxicity.
Croatian: U ispitivanjima kronične toksičnosti u miševa, štakora i pasa, toksični učinci opaženi su u obliku gastrointestinalnih lezija, mijelosupresije i hepatotoksičnosti.
English: Probenecid and weak organic acids can also reduce the tubular secretion of methotrexate and thus likewise cause an indirect increase in dose.
Croatian: Probenecid i slabe organske kiseline također mogu smanjiti tubularno izlučivanje metotreksata i time neizravno prouzročiti povećanje doze.
English: Animal studies showed that the administration of NSAIDs including salicylic acid resulted in reduced tubular methotrexate secretion and accordingly potentiated its toxic effects.
Croatian: Ispitivanja na životinjama pokazala su da je primjena NSAIL-ova uključujući salicilatnu kiselinu rezultirala smanjenim tubularnim izlučivanjem metotreksata, a time i pojačanjem njegovih toksičnih učinaka.
English: Acute or chronic interstitial pneumonia, often in association with blood eosinophilia, may occur and deaths have been reported.
Croatian: Može se pojaviti akutna ili kronična intersticijska pneumonija, često povezana s eozinofilijom krvi, a zabilježeni su i smrtni slučajevi.
English: An increased monitoring frequency should be considered when the dose is increased.
Croatian: Učestalije praćenje treba uzeti u obzir kada se povećava doza.
English: If bilirubin levels are >5 mg/dl (85.5 µmol/l), methotrexate is contraindicated (see sections 4.3 and 4.4).
Croatian: Ako su razine bilirubina >5 mg/dl (85,5 µmol/l), metotreksat je kontraindiciran (vidjeti dijelove 4.3 i 4.4).