FrancophonIA/ELRC3.0 huggingface dataset:
English: If methotrexate-induced lung disease is suspected, treatment with corticosteroids should be initiated and treatment with methotrexate should not be restarted.
Croatian: U slučaju sumnje na bolest pluća izazvanu metotreksatom, potrebno je započeti liječenje kortikosteroidima, a liječenje metotreksatom ne smije se više započinjati.
English: Encephalopathy/leukoencephalopathy
Croatian: Encefalopatija/leukoencefalopatija
English: Patients with JIA should always be referred to a rheumatology unit specialising in the treatment of children/adolescents.
Croatian: Bolesnike s juvenilnim idiopatskim artritisom treba uvijek uputiti na reumatološki odjel specijaliziran za liječenje djece/adolescenata.
English: As precautionary measures, sexually active male patients or their female partners are recommended to use reliable contraception during treatment of the male patient and for at least 6 months after cessation of methotrexate.
Croatian: Kao mjera predostrožnosti, spolno aktivnim muškim bolesnicima ili njihovim partnericama savjetuje se primjenjivati pouzdanu metodu kontracepcije tijekom liječenja muškarca i još najmanje 6 mjeseci nakon prestanka primjene metotreksata.
English: If risk factors such as renal function disorders, including mild renal impairment, are present, combined administration with NSAIDs is not recommended.
Croatian: Ako su prisutni čimbenici rizika kao što su poremećaji bubrega, uključujući blago oštećenje bubrega, primjena u kombinaciji s NSAIL-ovima ne preporučuje se.
English: 75 ml amber type III glass bottle with tamper evident child-resistant closure (polypropylene with expanded polyethylene liner) containing 60 ml of oral solution.
Croatian: Boca od smeđeg stakla tipa III od 75 ml sa zatvaračem sigurnim za djecu s evidencijom otvaranja (polipropilenski zatvarač sa zaštitnim pokrovom od ekspandiranog polietilena) koja sadrži 60 ml oralne otopine.
English: Other medicines and Jylamvo
Croatian: Drugi lijekovi i Jylamvo
English: During concomitant therapy with methotrexate, therefore, serum theophylline levels should be monitored.
Croatian: Stoga tijekom istodobne terapije s metotreksatom treba pratiti razine teofilina u serumu.
English: Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction and amenorrhoea in humans during and for a short period after the discontinuation of treatment, affecting spermatogenesis and oogenesis during the period of its administration - effects that appear to be reversible on discontinuing therapy.
Croatian: Zabilježeno je da metotreksat u ljudi uzrokuje poremećaj plodnosti, oligospermiju, poremećaj menstruacije i amenoreju, tijekom liječenja i u kratkom razdoblju nakon prestanka liječenja, utječući na spermatogenezu i oogenezu tijekom razdoblja primjene - učinci koji su, čini se, reverzibilni nakon prestanka primjene.
English: Children, adolescents and the elderly treated with methotrexate should have particularly careful medical monitoring in order to detect important side effects quickly.
Croatian: Medicinsko praćenje mora biti posebice pažljivo u djece, adolescenata i starijih osoba liječenih metotreksatom kako bi se važne nuspojave brzo otkrile.
English: Jylamvo should be prescribed only by doctors who are familiar with the properties of the medicine and how it works.
Croatian: Jylamvo smiju propisati samo liječnici koji su upoznati sa svojstvima lijeka te kako on djeluje.
English: Oncology
Croatian: Onkologija
English: It is presented in a brown glass bottle containing 60 ml of solution and capped with a child-resistant closure.
Croatian: Isporučuje se u bočici od smeđeg stakla koja sadrži 60 ml otopine te je zatvorena zatvaračem sigurnim za djecu.
English: − vomiting blood, severe complications in the digestive tract
Croatian: − povraćanje krvi, teške komplikacije u probavnom sustavu
English: Because of the delayed excretion of methotrexate in patients with impaired kidney function, they should be treated with particular caution and only with low doses of methotrexate (see section 4.2).
Croatian: Zbog odgođenog izlučivanja metotreksata u bolesnika s oštećenom funkcijom bubrega, takve bolesnike treba liječiti s posebnim oprezom i to samo niskim dozama metotreksata (vidjeti dio 4.2).
English: − liver diseases, reduced content of blood proteins
Croatian: − bolest jetre, smanjena količina proteina u krvi
English: It is associated with malformations of the skull, face, heart and blood vessels, brain, and limbs.
Croatian: Njegova primjena je povezana s malformacijama (poremećaj oblika) lubanje, lica, srca i krvnih žila, mozga i udova.
English: Turn the bottle back the right way up and carefully remove the syringe from the adaptor, holding the syringe by the barrel rather than the plunger.
Croatian: Okrenite bočicu u pravilan uspravni položaj i pažljivo izvucite štrcaljku iz nastavka, držeći štrcaljku za tijelo a ne za klip.
English: - cancer treatments ( such as doxorubicin and procarbazine during high-dose methotrexate therapy)
Croatian: − lijekove protiv raka (kao što su doksorubicin i prokarbazin tijekom terapije visokom dozom metotreksata).
English: The combination of methotrexate and sulfasalazine can enhance the effect of methotrexate, as sulfasalazine causes inhibition of folic acid synthesis.
Croatian: Kombinacija metotreksata i sulfasalazina može povećati učinak metotreksata, jer sulfasalazin uzrokuje inhibiciju sinteze folatne kiseline.
English: - Complete blood count with differential blood count and platelets.
Croatian: - Kompletna krvna slika s diferencijalnom krvnom slikom i trombocitima.
English: Psoriasis skin changes can become worse during treatment with methotrexate if you are under UV light.
Croatian: Psorijatične promjene na koži mogu se pogoršati tijekom liječenja metotreksatom ako ste izloženi ultraljubičastom svjetlu.
English: Conditions that cause dehydration such as vomiting, diarrhoea or stomatitis Conditions that cause dehydration such as vomiting, diarrhoea or stomatitis can increase toxicity as a result of raised active substance levels.
Croatian: Stanja koja uzrokuju dehidraciju, kao što su povraćanje, proljev ili stomatitis Stanja koja uzrokuju dehidraciju, kao što su povraćanje, proljev ili stomatitis, mogu povećati toksičnost koja je posljedica povišenih razina djelatne tvari.
English: Write here in full the day of the week for intake: ______________ Do not take more than the prescribed dose.
Croatian: Ovdje upišite puni naziv dana u tjednu kada uzimate lijek: ______________
English: If creatinine clearance is less than 30 ml/min, treatment with methotrexate should not be given (see sections 4.2 and 4.3).
Croatian: Ako je klirens kreatinina niži od 30 ml/min, liječenje metotreksatom ne smije se provoditi (vidjeti dijelove 4.2 i 4.3).
English: For arthritis and psoriasis take only once a week.
Croatian: Za liječenje artritisa i psorijaze uzimati samo jednom tjedno.
English: • Hepatic impairment (bilirubin levels are >5 mg/dl [85.5 µmol/l], see section 4.2)
Croatian: • oštećenje jetre (razine bilirubina su >5 mg/dl [85,5 µmol/l], vidjeti dio 4.2).
English: If you notice any symptoms of an infection such as fever or a marked worsening in your general state of health or fever with local signs of an infection such as sore throat/inflammation of the throat or mouth or problems passing water, see your doctor immediately.
Croatian: Opazite li bilo kakve simptome infekcije kao što je vrućica ili izrazito pogoršanje svog općeg zdravstvenog stanja ili vrućicu s lokalnim znakovima infekcije kao što je grlobolja/upala grla ili usta ili otežano mokrenje,
English: Overdose could lead to serious adverse effects and may be fatal.
Croatian: Predoziranje može dovesti do ozbiljnih nuspojava i može biti smrtonosno.
English: • Major birth defects occurred in 6.6% of live births in women exposed to low-dose methotrexate treatment (less than 30 mg [15 ml]/week) during pregnancy, compared to approximately 4% of live births in disease-matched patients treated with drugs other than methotrexate.
Croatian: • Velike urođene mane javile su se u 6,6 % živorođene djece u žena izloženih terapiji niskom dozom metotreksata (manje od 30 mg [15 ml]/tjedan) tijekom trudnoće, u usporedbi s oko 4 % živorođene djece u bolesnica sa istom bolešću liječenih drugim lijekovima umjesto metotreksata.
English: If combined treatment is required, the blood count and renal function should be monitored.
Croatian: Ako se mora primjenjivati kombinirana terapija, potrebno je pratiti krvnu sliku i funkciju bubrega.
English: • Spontaneous abortions have been reported in 42.5% of pregnant women exposed to low-dose methotrexate treatment (less than 30 mg [15 ml]/week), compared to a reported rate of 22.5% in disease-matched patients treated with drugs other than methotrexate.
Croatian: • Spontani pobačaji prijavljeni su u 42,5 % trudnica izloženih terapiji niskom dozom metotreksata (manje od 30 mg [15 ml]/tjedan), u usporedbi sa stopom od 22,5 % u bolesnica sa istom bolešću liječenih drugim lijekovima umjesto metotreksata.
English: The possibility of delayed methotrexate clearance should be considered in combination with other cytostatic medicinal products.
Croatian: Mogućnost odgođenog klirensa metotreksata treba uzeti u obzir u kombinaciji s drugim citostaticima.
English: Diarrhoea and ulcerative stomatitis may be signs of toxic effects and require the discontinuation of treatment, otherwise haemorrhagic enteritis and death from intestinal perforation may occur.
Croatian: Proljev i ulcerativni stomatitis mogu biti znakovi toksičnih učinaka i zahtijevaju prekid liječenja; inače može doći do perforacije crijeva i posljedičnog hemoragijskog enteritisa te smrtnog ishoda.
English: Methotrexate is contraindicated during pregnancy in non-oncological indications (see section 4.3).
Croatian: Metotreksat je kontraindiciran tijekom trudnoće u neonkološkim indikacijama (vidjeti dio 4.3).
English: The prescriber should specify the day of intake on the prescription.
Croatian: Liječnik koji propisuje lijek mora na receptu naznačiti dan uzimanja lijeka.
English: • Breast-feeding (see section 4.6)
Croatian: • Trudnoća (vidjeti dio 4.6)
English: Take Jylamvo only once a week.
Croatian: smije uzeti samo jedanput tjedno.
English: Although the clinical presentation is variable, patients with methotrexate-induced lung diseases typically suffer from fever, cough, dyspnoea or hypoxaemia.
Croatian: Iako su kliničke slike različite, za bolesnike s plućnim bolestima izazvanim metotreksatom tipično je da imaju vrućicu, kašalj, dispneju ili hipoksemiju.
English: (See renal function monitoring)
Croatian: (Vidjeti praćenje funkcije bubrega.)
English: This medicine can be taken with or without food.
Croatian: Ovaj se lijek može uzimati uz jelo ili natašte.
English: One ml of solution contains 2 mg methotrexate.
Croatian: Jedan ml otopine sadrži 2 mg metotreksata.
English: Methotrexate can affect the production of sperm, which is associated with the possibility of birth defects.
Croatian: Metotreksat može utjecati na stvaranje sperme, što je povezano s mogućim urođenim manama.
English: Therefore, methotrexate should only be administered by, or under the supervision of, doctors whose knowledge and experience includes treatment with antimetabolites.
Croatian: Stoga metotreksat smiju primjenjivati ili njegovu primjenu nadzirati samo liječnici sa znanjem i iskustvom u primjeni terapije antimetabolitima.
English: − infections
Croatian: − infekcije
English: Pull the syringe plunger back SLOWLY so that the medicine is drawn from the bottle into the syringe until the WIDEST part of the white syringe plunger is lined up to the black syringe marking of the dose required.
Croatian: Klip štrcaljke POLAKO povlačite prema natrag, tako da lijek iz boce ulazi u štrcaljku sve dok se NAJŠIRI dio bijelog klipa štrcaljke ne poravna s crnom oznakom na štrcaljki koja pokazuje potrebnu dozu.
English: PATIENT CARD TEXT
Croatian: TEKST KARTICE ZA BOLESNIKA
English: Radiotherapy during the use of methotrexate can increase the risk for soft tissue or bone necrosis.
Croatian: Radioterapija tijekom primjene metotreksata može povećati rizik od nekroze mekih tkiva ili kostiju.
English: In the antineoplastic treatment, myelosuppression and mucositis are the predominant dose-limiting toxic effects of methotrexate.
Croatian: U antineoplastičnom liječenju, mijelosupresija i mukozitis prevladavajući su toksični učinci metotreksata koji ograničavaju dozu.
English: After oral administration, methotrexate is absorbed from the gastrointestinal tract.
Croatian: Nakon peroralne primjene metotreksat se apsorbira iz gastrointestinalnog sustava.
English: Put the cap back on the bottle with the adaptor left in place.
Croatian: Vratite zatvarač na bočicu s tim da nastavak i dalje ostane svom mjestu.
English: The active substance is methotrexate.
Croatian: Djelatna tvar je metotreksat.
English: In animal studies, methotrexate has shown reproductive toxicity, especially during the first trimester (see section 5.3).
Croatian: U ispitivanjima na životinjama metotreksat je pokazao reproduktivnu toksičnost, osobito tijekom prvog tromjesečja
English: If the lymphomas fail to regress spontaneously, cytotoxic treatment must be initiated.
Croatian: Ako se limfom ne povuče spontano, potrebno je započeti s citotoksičnom terapijom.
English: Oral antibiotics such as tetracyclines, chloramphenicol and non-absorbable broad-spectrum antibiotics may reduce intestinal absorption of methotrexate or interfere with the enterohepatic circulation by inhibiting intestinal flora or suppressing bacterial metabolism.
Croatian: Oralni antibiotici kao što su tetraciklini, kloramfenikol i antibiotici širokog spektra koji se ne apsorbiraju, mogu smanjiti apsorpciju metotreksata u crijevima ili ometati njegovu enterohepatičku cirkulaciju inhibicijom crijevne flore ili supresijom metabolizma bakterija.
English: Severe side effects can occur even when methotrexate is used at low doses.
Croatian: Teške nuspojave mogu se pojaviti čak i kad se uzimaju male doze metotreksata.
English: Diarrhoea can be a possible side effect of Jylamvo and requires an interruption of therapy.
Croatian: Proljev može biti moguća nuspojava lijeka Jylamvo i zahtijeva privremeni prekid terapije.
English: Keep the bottle tightly closed to protect the integrity of the product and minimise the risk of accidental spillage.
Croatian: Bocu čuvajte čvrsto zatvorenu kako biste zaštitili integritet lijeka i umanjili rizik od nehotičnog prolijevanja.
English: How to take Jylamvo
Croatian: Kako uzimati Jylamvo
English: Radiation-induced dermatitis and sunburn can reappear during methotrexate therapy (recall reactions).
Croatian: Dermatitis izazvan zračenjem i opekline od sunca mogu se ponovno pojaviti tijekom terapije metotreksatom (odzivne reakcije).
English: Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Croatian: Kako čuvati Jylamvo Lijek čuvajte izvan pogleda i dohvata djece, po mogućnosti u zaključanom ormariću.
English: Jylamvo is for oral use and provided ready for use.
Croatian: Jylamvo se primjenjuje kroz usta i dobije se spreman za uporabu.
English: Any serious decrease in leucocyte or platelet counts indicates the immediate discontinuation of treatment and appropriate supportive therapy.
Croatian: slučaju svakog ozbiljnog smanjenja broja leukocita ili trombocita, liječenje se mora odmah prekinuti i započeti odgovarajuću potpornu terapiju.
English: − pain, muscle weakness, changes in the sense of taste (metallic taste), inflammation of the membrane lining the brain resulting in paralysis or vomiting, pins and needles in arm and legs
Croatian: − bol, mišićna slabost, promjene osjeta okusa (metalni okus), upala moždanih ovojnica koja uzrokuje paralizu ili povraćanje, trnci i bockanje u rukama i nogama
English: Symptoms of overdose The symptoms following oral overdose predominantly affect the haematopoietic and gastrointestinal systems.
Croatian: Simptomi nakon oralnog predoziranja pretežno zahvaćaju hematopoetski i gastrointestinalni sustav.
English: Please read this section of the summary of product characteristics very carefully.
Croatian: Ovaj dio sažetka opisa svojstava lijeka pročitajte vrlo pažljivo.
English: • Recommendation to always show the card to and alert new HCPs about the once weekly dosing of the patient's methotrexate (e.g. on hospital admission, change of carer, etc.)
Croatian: • Preporuku da se kartica uvijek pokaže novom zdravstvenom radniku, kako bi ga se upozorilo na režim doziranja metotreksata jednom tjedno (npr. prilikom prijema u bolnicu, promjene u zdravstvenoj skrbi itd.)
English: - If you have any further questions, ask your doctor or pharmacist.
Croatian: − Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Methotrexate can be taken with or without food.
Croatian: Metotreksat se može uzimati uz jelo ili natašte.
English: Methotrexate can reduce the clearance of theophylline.
Croatian: Metotreksat može smanjiti klirens teofilina.
English: One ml of solution contains 2 mg methyl hydroxybenzoate (as the sodium salt), and 0.2 mg ethyl hydroxybenzoate.
Croatian: Jedan ml otopine sadrži 2 mg metilhidroksibenzoata (u obliku natrijeve soli) i 0,2 mg etilhidroksibenzoata.
English: Accordingly, particular caution should be exercised in patients with pre-existing folic acid deficiency.
Croatian: Stoga je potreban poseban oprez u bolesnika s postojećim nedostatkom folatne kiseline.
English: Combination therapy with methotrexate and leflunomide may increase the risk for pancytopenia.
Croatian: Kombinirana terapija metotreksata i leflunomida može povećati rizik od pancitopenije.
English: Ensure that the patient is sitting up or standing before giving the medicine.
Croatian: Pazite da prije davanja lijeka bolesnik bude u sjedećem ili stojećem položaju.
English: If women of a sexually mature age are treated, effective contraception must be used during treatment and for at least six months after.
Croatian: Ako se lijek primjenjuje u spolno zrelih bolesnica, mora se primjenjivati učinkovita kontracepcija tijekom liječenja i još najmanje šest mjeseci nakon toga.
English: The solution is provided ready for use, and it must be swallowed with some water to remove any methotrexate residue from the oral cavity.
Croatian: Otopina se dobije spremna za primjenu, a mora se progutati s malo vode kako bi se iz usne šupljine uklonili ostaci metotreksata.
English: Limited clinical evidence does not indicate an increased risk of malformations or miscarriage following paternal exposure to low-dose methotrexate (less than 30 mg [15 ml]/week).
Croatian: Ograničeni klinički dokazi ne ukazuju na povećani rizik od malformacija ili pobačaja nakon paternalnog izlaganja niskim dozama metotreksata (manje od 30 mg
English: If you suspect you have a severe side effect, talk to your doctor immediately.
Croatian: Ako sumnjate da imate teške nuspojave, odmah se obratite liječniku.
English: Renal impairment and patients at risk of renal impairment As methotrexate is eliminated mainly via the kidneys, increased concentrations are to be expected in the presence of renal impairment, which may result in severe adverse reactions.
Croatian: Oštećenje bubrega i bolesnici pod rizikom od oštećenja bubrega Budući da se metotreksat izlučuje uglavnom putem bubrega, ako postoji oštećenje bubrega očekuju se njegove povišene koncentracije, što može rezultirati teškim nuspojavama.
English: For psoriasis patients the need of a liver biopsy prior to and during therapy is controversial.
Croatian: Mišljenja o potrebi provođenja biopsije jetre prije i tijekom terapije u bolesnika s psorijazom proturječna su.
English: Most frequently (very common) observed adverse reactions of methotrexate include gastrointestinal disorders (e.g. stomatitis, dyspepsia, abdominal pain, nausea, loss of appetite) and abnormal liver function tests (e.g. increased alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase).
Croatian: Najčešće primijećene (vrlo česte) nuspojave metotreksata uključuju gastrointestinalne poremećaje (npr. stomatitis, dispepsija, bol u abdomenu, mučnina, gubitak apetita) i poremećeni testovi funkcije jetre (npr. povišene vrijednosti alanin aminotransferaza (ALAT), aspartat aminotransferaza (ASAT),
English: In therapy-refractory cases the weekly dosage may be increased to 20 mg (10 ml)/m² BSA/week.
Croatian: U slučajevima refrakternim na terapiju, tjedna se doza može povećati na 20 mg (10 ml)/m² tjelesne površine tjedno.
English: Severe visual disturbances
Croatian: − teški poremećaji vida
English: Ethyl parahydroxybenzoate (E214) and sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
Croatian: Etilparahidroksibenzoat (E214) i natrijev metilparahidroksibenzoat (E219) mogu uzrokovati alergijske reakcije (moguće i odgođene reakcije preosjetljivosti).
English: A 10 ml oral dosing syringe is provided for accurate measurement of the prescribed dose (see Package Leaflet).
Croatian: Za točno mjerenje propisane doze priložena je oralna štrcaljka za doziranje od 10 ml (vidjeti uputu o lijeku).
English: Antibiotics such as penicillins, glycopeptides, sulphonamides, ciprofloxacin and cefalotin can in individual cases reduce the renal clearance of methotrexate, so that increased serum methotrexate concentrations can occur, accompanied by haematological and gastrointestinal toxicity.
Croatian: Antibiotici kao što su penicilini, glikopeptidi, sulfonamidi, ciprofloksacin i cefalotin mogu u pojedinačnim slučajevima smanjiti bubrežni klirens metotreksata, tako da se mogu pojaviti povišene koncentracije metotreksata u serumu, praćene hematološkom i gastrointestinalnom toksičnošću.
English: Elimination in patients with impaired renal function is markedly delayed.
Croatian: Eliminacija u bolesnika s oštećenom funkcijom bubrega izrazito je odgođena.
English: Dosage in adults with severe forms of psoriasis and adult patients with psoriatic arthritis
Croatian: Doziranje u odraslih s teškim oblicima psorijaze i odraslih bolesnika s psorijatičnim artritisom
English: Methotrexate crosses the placental barrier in rats and monkeys.
Croatian: Metotreksat prolazi kroz posteljicu u štakora i majmuna.
English: − pathological change of the white matter of the brain (leukoencephalopathy)
Croatian: − patološka promjena bijele moždane tvari (leukoencefalopatija) − krvarenja (hemoragije)
English: In patients with rheumatoid arthritis or psoriasis, folic acid or folinic acid supplementation may reduce methotrexate toxicity, such as gastrointestinal symptoms, stomatitis, alopecia and elevated liver enzymes.
Croatian: U bolesnika s reumatoidnim artritisom ili psorijazom, dodaci folatne ili folinatne kiseline mogu smanjiti toksičnost metotreksata, kao što su gastrointestinalni simptomi, stomatitis, alopecija i povišeni jetreni enzimi.
English: Dosage in adult patients with rheumatoid arthritis
Croatian: Doziranje u odraslih bolesnika s reumatoidnim artritisom
English: The dose normalized AUC of the metabolite 7-hydroxymethotrexate was not dependent on age.
Croatian: 7-hidroksimetotreksata normaliziran za dozu nije bio ovisan o dobi.
English: Pneumocystis jiroveci pneumonia and other lung infections, Chronic obstructive pulmonary disease, Pleural effusion
Croatian: Pneumocystis jirovecii i druge infekcije pluća, kronična opstruktivna plućna bolest,
English: Excessive consumption of caffeine- or theophylline-containing beverages (coffee, caffeinated beverages, black tea) should be avoided during methotrexate therapy as the effect of methotrexate may be reduced by the possible interaction between methotrexate and methylxanthines at the adenosine receptors.
Croatian: Tijekom terapije metotreksatom treba izbjegavati prekomjernu konzumaciju pića koja sadrže kofein ili teofilin (kava, pića s dodatkom kofeina, crni čaj) jer se učinak metotreksata može smanjiti zbog moguće interakcije metotreksata i metilksantina na receptorima za adenozin.
English: − lymphoma (lump in neck, groin or armpits with associated backache, weight loss or night sweats)
Croatian: − limfom (kvržica u vratu, preponama ili pazusima s povezanim bolom u leđima, gubitkom težine ili noćnim znojenjem)