FrancophonIA/ELRC3.0 huggingface dataset:
English: Folic acid or folinic acid supplementation may be considered in accordance with current therapeutic guidelines.
Croatian: Može se razmotriti primjena dodataka folatne ili folinatne kiseline u skladu s važećim terapijskim smjernicama.
English: Symptoms indicating potentially severe lung injury (interstitial pneumonitis) are: dry, not productive cough, shortness of breath and fever.
Croatian: Simptomi koji ukazuju na moguće teško oštećenje pluća (intersticijski pneumonitis) su: suhi, neproduktivni kašalj, nedostatak zraka i vrućica.
English: Insufficient data is available for methotrexate exposure during pregnancy higher than 30 mg/week, but higher rates of spontaneous abortions and congenital malformations are expected.
Croatian: Dostupni podaci o izloženosti metatreksatu tijekom trudnoće u dozi višoj od 30 mg tjedno su nedostatni, ali očekuju se više stope spontanih pobačaja i kongenitalnih malformacija.
English: Handling and disposal must be consistent with that of other cytotoxic preparations in accordance with local requirements.
Croatian: Rukovanje i zbrinjavanje moraju biti sukladni onima za druge citotoksične pripravke u skladu s nacionalnim zahtjevima.
English: In patients with pathological accumulation of liquid in body cavities (“third space”), such as ascites or pleural effusions, the plasma elimination half-life of methotrexate is prolonged.
Croatian: U bolesnika s patološkim nakupljanjem tekućne u tjelesnim šupljinama („trećem prostoru“), kao što su ascites ili plućni izljevi, poluvijek eliminacije metotreksata iz plazme je produljen.
English: Generally, improvement of symptoms can be expected after 4-8 weeks of treatment.
Croatian: Obično se poboljšanje simptoma može očekivati nakon 4-8 tjedana liječenja.
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 opreza, spolno aktivnim bolesnicima ili njihovim partnericama preporučuje se uporaba pouzdane kontracepcije tijekom liječenja bolesnika i najmanje 6 mjeseci nakon prestanka primjene metotreksata.
English: The other ingredients are sodium chloride, sodium hydroxide and water for injections.
Croatian: Drugi sastojci su natrijev klorid, natrijev hidroksid i voda za injekcije.
English: Though the combination of methotrexate and sulfasalazine may enhance methotrexate efficacy by sulfasalazine related inhibition of folic acid synthesis, and thus may lead to an increased risk of adverse reactions, these were only observed in single patients within several trials.
Croatian: Iako kombinacija metotreksata i sulfasalazina može povećati djelotvornost metotreksata zbog inhibicije sinteze folatne kiseline povezane sa sulfasalazinom i tako dovesti do povećanog rizika od nuspojava, one su bile opažene samo u pojedinih bolesnika u nekoliko kliničkih ispitivanja.
English: Depending on the effects of treatment and results of blood and urine tests, the therapy is then continued or stopped.
Croatian: Ovisno o učincima liječenja i rezultatima pretraga krvi i mokraće, terapija se potom nastavlja ili prekida.
English: In the event of a massive overdose, hydration and urinary alkalisation may be required to prevent precipitation of methotrexate and/or its metabolites within the renal tubules.
Croatian: U slučaju opsežnog predoziranja može biti potrebna hidracija i alkalizacija mokraće kako bi se spriječila precipitacija metotreksata i/ili njegovih metabolita u bubrežnim tubulima.
English: On account of its possible effect on the immune system, methotrexate can falsify vaccinal and test results (immunological procedures to record the immune reaction).
Croatian: Zbog svog mogućeg utjecaja na imunološki sustav, metotreksat može dovesti do lažnih rezultata cijepljenja i pretraga (imunoloških postupaka za procjenu imunološke reakcije).
English: An overdose of methotrexate can lead to severe toxic reactions.
Croatian: Predoziranje metotreksatom može dovesti do teških toksičnih reakcija.
English: Methotrexate induces gene and chromosome mutations both in vitro and in vivo.
Croatian: Metotreksat izaziva genske i kromosomske mutacije kako in vitro, tako i in vivo.
English: A droplet may appear at the tip of the needle.
Croatian: Na vrhu igle može se pojaviti kapljica.
English: Particular caution should therefore also be exercised in the presence of existing folic acid deficiency.
Croatian: Stoga je također potreban poseban oprez kad je prisutan nedostatak folatne kiseline.
English: However, in clinical studies, where NSAIDs and salicylic acid were given as concomitant medicinal products to patients with rheumatoid arthritis, no increase of adverse reactions was observed.
Croatian: Međutim, u kliničkim ispitivanjima u kojima su se NSAIL-ovi i salicilatna kiselina istovremeno davali kao lijekovi bolesnicima s reumatoidnim artritisom nije bilo opaženo povećanje nuspojava.
English: Closer monitoring of liver enzymes should be undertaken in patients concomitantly taking other hepatotoxic medicinal products (e.g. leflunomide).
Croatian: Pažljivije praćenje jetrenih enzima potrebno je provoditi u bolesnika koji istovremeno uzimaju druge hepatotoksične lijekove (e.g. leflunomid).
English: • Major birth defects occurred in 6.6% of live births in women exposed to low-dose methotrexate treatment (less than 30 mg/week) during pregnancy, compared to approximately 4% of live births in in disease-matched patients treated with drugs other than methotrexate.
Croatian: • Veliki urođeni defekti nastali u 6,6% živorođene djece žena izloženih liječenju niskom dozom metotreksata (nižom od 30 mg tjedno) tijekom trudnoće, u usporedbi s približno 4% živorođene djece u bolesnica s istom bolešću liječenih drugim lijekovima umjesto metotreksata.
English: Insert the full length of the needle into the skin fold.
Croatian: Umetnite iglu u punoj duljini u kožu.
English: Radiotherapy during use of methotrexate can increase the risk of soft tissue or bone necrosis.
Croatian: Radioterapija tijekom primjene metotreksata može povećati rizik od nekroze mekih tkiva ili kosti.
English: - Check the syringe is not damaged and the medicine in it is a clear, yellow solution.
Croatian: - Provjerite da štrcaljka nije oštećena i da je lijek u njoj bistra, žuta otopina.
English: Approximately 10% of the administered methotrexate is metabolised intrahepatically.
Croatian: Približno 10% primijenjenog metotreksata metabolizira se u jetri.
English: Use in patient with a third distribution space (pleural effusions, ascitis) As the half-life of methotrexate can be prolonged to 4 times the normal length in patients who possess a third distribution space, dose reduction or, in some cases, discontinuation of methotrexate administration may be required (see sections 5.2 and 4.4).
Croatian: Primjena u bolesnika s distribucijom u treći prostor (pleuralni izljev, ascites) Budući da u bolesnika u kojih postoji distribucija u treći prostor poluvijek metotreksata može biti produljen 4 puta u odnosu na normalni poluvijek, može biti potrebno sniziti dozu ili, u nekim slučajevima, prekinuti primjenu metotreksata (vidjeti dijelove 5.2 i 4.4).
English: Methotrexate leads to increased plasma levels of mercaptopurines.
Croatian: Metotreksat uzrokuje povišene razine merkaptopurina u plazmi.
English: Regular alcohol consumption and administration of additional hepatotoxic medicinal products increase the probability of hepatotoxic effects of methotrexate.
Croatian: Redovito konzumiranje alkohola i primjena dodatnih hepatotoksičnih lijekova povećavaju vjerojatnost hepatotoksičnih učinaka metotreksata.
English: Patients with JIA should always be referred to a rheumatology unit specializing in the treatment of children/adolescents.
Croatian: Bolesnike s juvenilnim idiopatskim artritisom uvijek treba uputiti na reumatološku jedinicu specijaliziranu za liječenje djece/adolescenata.
English: Close the container lid tightly and place the container out of reach of children.
Croatian: Zatvaračem čvrsto zatvorite spremnik i spremite ga izvan dohvata djece.
English: In the event of any significant drop in leukocytes or platelets, treatment must be discontinued immediately and appropriate supportive therapy instituted.
Croatian: U slučaju svakog značajnijeg sniženja broja leukocita ili trombocita, liječenje se odmah mora prekinuti i uvesti odgovarajuća potporna terapija.
English: Very rare: Agranulocytosis, severe courses of bone marrow depression, lymphoproliferative disorders (see “description below”).
Croatian: Vrlo rijetko: agranulocitoza, težak tijek depresije koštane srži, limfoproliferativni poremećaji (vidjeti „opis niže“)
English: It must be injected once weekly and it is recommended to always inject Nordimet on the same day of the week.
Croatian: Mora se ubrizgati jednom tjedno i preporučuje se uvijek ubrizgati
English: Before initiating therapy or upon resuming therapy after a rest period Complete blood count with differential blood count and platelets, liver enzymes, bilirubin, serum albumin, chest X-ray and renal function tests must be conducted.
Croatian: Prije početka terapije ili po nastavku terapije nakon razdoblja odmora Mora se napraviti kompletna krvna slika s diferencijalnom krvnom slikom i trombocitima, jetrenim enzimima, bilirubinom, serumskim albuminom, rendgenska snimka prsnog koša te testovi funkcije bubrega.
English: As methotrexate is predominantly excreted via the renal route, increased concentrations can be expected in cases of renal impairment, which may result in severe adverse reactions.
Croatian: Budući da se metotreksat prvenstveno izlučuje putem bubrega, povišene koncentracije mogu se očekivati u slučajevima oštećenja funkcije bubrega, što može rezultirati teškim nuspojavama.
English: Dose reduction should be considered in elderly patients due to reduced liver and kidney function as well as lower folate reserves which occur with increased age (see sections 4.4, 4.5, 4.8 or 5.2)
Croatian: U starijih bolesnika potrebno je razmotriti sniženje doze zbog smanjene funkcije jetre i bubrega, kao i manjih rezervi folata, koji nastaju s uznapredovalnom dobi (vidjeti dijelove 4.4, 4.5, 4.8 ili
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/week).
Croatian: Ograničeni klinički dokazi ne ukazuju na povećan rizik od malformacija ili pobačaja nakon izloženosti oca niskoj dozi metotreksata (nižoj od 30 mg tjedno).
English: During methotrexate therapy, opportunistic infection can occur including pneumocystis jiroveci pneumonia, which may take a lethal course.
Croatian: Tijekom terapije metotreksatom mogu nastati oportunističke infekcije, uključujući pneumoniju uzrokovanu s Pneumocystis jiroveci, čiji tijek može biti smrtonosan.
English: Tell your doctor straight away if you get any sudden 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 razvijete piskanje pri disanju, otežano disanje, oticanje vjeđa, lica ili usana, osip ili svrbež (osobito ako zahvaća cijelo tijelo).
English: The most relevant adverse reaction is suppression of the haematopoietic system and gastrointestinal disorders.
Croatian: Najznačajnija nuspojava je supresija hematopoetskog sustava i gastrointestinalni poremećaji.
English: In women of child-bearing age any possibility of pregnancy must be excluded with appropriate measures, e.g. a pregnancy test before starting treatment.
Croatian: U žena reproduktivne dobi mora se isključiti svaka mogućnost trudnoće pomoću odgovarajućih mjera, npr. testom na trudnoću prije početka liječenja.
English: In patients with impaired renal function, concomitant administration of NSAIDs is not recommended.
Croatian: U bolesnika s oštećenjem funkcije bubrega ne preporučuje se istovremena primjena NSAIL-ova.
English: Methotrexate is contraindicated if bilirubin values are > 5 mg/dl (85.5 µmol/L) (see section 4.3).
Croatian: Metotreksat je kontraindiciran ako su vrijednosti bilirubina > 5 mg/dl (85,5 µmol/l) (vidjeti dio 4.3).
English: Methotrexate is a powerful human teratogen, with an increased risk of spontaneous abortions, intrauterine growth restriction and congenital malformations in case of exposure during pregnancy.
Croatian: Metotreksat u ljudi ima jako teratogeno djelovanje, uz povećan rizik od spontanih pobačaja, zastoja u intrauterinom rastu i kongenitalnih malformacija u slučaju izloženosti tijekom trudnoće.
English: If you stop taking Nordimet
Croatian: Ako prestanete primjenjivati Nordimet
English: Subcutaneous, intravenous and intramuscular administration demonstrated similar bioavailability.
Croatian: Supkutana, intravenska i intramuskularna primjena pokazale su sličnu bioraspoloživost.
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg/week.
Croatian: Dostupni dokazi ne pokazuju da postoji povećan rizik od malformacija ili pobačaja ako otac uzima metotreksat u dozi nižoj od 30 mg tjedno.
English: Once you have taken the cap off, keep the syringe in your hand.
Croatian: Nakon što ste uklonili zatvarač, držite brizgalicu u ruci.
English: Place the yellow needle shield against the area of injection so that the entire rim of the needle shield is touching the skin.
Croatian: Prislonite žuti štitnik za iglu na mjesto injekcije tako da štitnik za iglu cijelim rubom dodiruje kožu.
English: Nordimet contains sodium
Croatian: Nordimet sadrži natrij
English: The safety shield on the syringe will automatically cover the needle to prevent any needlestick injuries.
Croatian: Sigurnosni štit na štrcaljki će automatski pokriti iglu, kako bi se spriječile ozljede uslijed uboda iglom.
English: Nordimet is also available in multipacks containing 12 prefilled pens in 3 cartons (4 pens and alcohol swabs per carton).
Croatian: Nordimet je također dostupan u višestrukim pakiranjima koja sadrže 12 napunjenih brizgalica u 3 kutije (4 brizgalice i alkoholna tupfera po kutiji).
English: 5) Visually inspect the syringe.
Croatian: 5) Vizualno pregledajte štrcaljku.
English: In therapy-refractory cases the weekly dose may be increased up to 20 mg/m² BSA per week.
Croatian: U terapijski refraktornim slučajevima, tjedna se doza može povisiti čak i na 20 mg/m² površine tijela.
English: 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: Limfom/limfoproliferativni poremećaji: zabilježeni su pojedinačni slučajevi limfoma i drugih limfoproliferativnih poremećaja koji se u određenom broju slučajeva povukao nakon prestanka liječenja metotreksatom.
English: Dosage in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic arthritis
Croatian: Doza u djece i adolescenata mlađih od 16 godina s poliartritičnim oblicima juvenilnog idiopatskog artritisa
English: Methotrexate should be discontinued in patients with pulmonary symptoms and a thorough investigation (including chest x-ray) should be made to exclude infection and tumours.
Croatian: U bolesnika s plućnim simptomima treba prekinuti primjenu metotreksata te provesti temeljite pretrage (uključujući rendgensko snimanje prsnog koša) kako bi se isključili infekcija i tumori.
English: Increased monitoring frequency should also be considered when increasing the dose.
Croatian: Učestalije praćenje također treba razmotriti kad se povisuje doza.
English: In the event of contamination, the affected area must be rinsed immediately with ample amount of water.
Croatian: U slučaju kontaminacije, zahvaćeno područje mora se odmah isprati obilnom količinom vode.
English: This assessment should differentiate between patients without any risk factors and patients with risk factors, e.g. excessive prior alcohol consumption, persistent elevation of liver enzymes, history of liver disease, family history of hereditary liver disorders, diabetes mellitus, obesity and previous contact with hepatotoxic medicinal products or chemicals and prolonged methotrexate treatment or cumulative doses of 1.5 g or more.
Croatian: Ta bi procjena trebala razlikovati bolesnike bez ikakvih čimbenika rizika od onih s čimbenicima rizika, npr. prethodnim prekomjernim konzumiranjem alkohola, trajno povišenim jetrenim enzimima, bolešću jetre u anamnezi, obiteljskom anamnezom nasljednih jetrenih poremećaja, šećernom bolešću, pretilošću i prethodnim kontaktom s hepatotoksičnim lijekovima ili kemikalijama te produljenim liječenjem metotreksatom ili kumulativnim dozama od 1,5 g ili više.
English: It has not yet been clarified, as to whether the efficacy of methotrexate, in the management of psoriasis, psoriatic arthritis and chronic polyarthritis, is due to an anti-inflammatory or immunosuppressive effect and to which extent a methotrexate-induced increase in extracellular adenosine concentration at inflamed sites contributes to these effects.
Croatian: Još nije razjašnjeno je li djelotvornost metotreksata u liječenju psorijaze, psorijatičnog artritisa i kroničnog poliartritisa posljedica protuupalnog ili imunosupresivnog učinka i u kojoj mjeri metotreksatom izazvano povišenje izvanstanične koncentracije adenozina na mjestima upale pridonosi tim učincima.
English: Once Nordimet starts working, the doctor may reduce the dose gradually to the lowest possible effective maintenance dose.
Croatian: Kad Nordimet jednom počne djelovati, liječnik može postupno sniziti dozu na najnižu moguću djelotvornu dozu održavanja.
English: Dose in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic arthritis
Croatian: Doziranje u djece i adolescenata mlađih od 16 godina s poliartritičnim oblicima juvenilnog idiopatskog artritisa
English: Methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea in humans, during and for a short period after cessation of therapy, and to cause impaired fertility, 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 oligospermiju, poremećaj menstruacije i amenoreju za vrijeme i tijekom kratkog razdoblja nakon prestanka terapije, te da narušava plodnost, utječući na spermatogenezu i oogenezu u razdoblju primjene - učinci za koje se čini da su reverzibilni nakon prestanka terapije.
English: Special precautionary measures for treatment with Nordimet Methotrexate temporarily affects sperm and egg production, which is reversible in most cases.
Croatian: Metotreksat privremeno utječe na stvaranje sperme i jajnih stanica, što se u većini slučajeva oporavi.
English: Vascular disorders Rare: Hypotension, thromboembolic events
Croatian: Krvožilni poremećji Rijetko: hipotenzija, tromboembolijski događaji
English: If lymphomas should fail to regress spontaneously, initiation of cytotoxic therapy is required.
Croatian: Ako se limfom ne povuče spontano, potrebno je započeti s citotoksičnom terapijom.
English: You should see a yellow fluid through the viewing window.
Croatian: Kroz prozorčić biste trebali vidjeti žutu tekućinu.
English: If you forget to use Nordimet
Croatian: Ako ste zaboravili primijeniti Nordimet
English: Any used syringe should be discarded.
Croatian: Sve uporabljene brizgalice moraju se baciti.
English: Delayed methotrexate clearance should be considered in combination with other cytostatic medicinal products.
Croatian: Potrebno je uzeti u obzir odgođeni klirens metotreksata u kombinaciji s drugim citostatičkim lijekovima.
English: The following syringes are available:
Croatian: Dostupne su sljedeće brizgalice:
English: • Spontaneous abortions have been reported in 42.5% of pregnant women exposed to lowdose methotrexate treatment (less than 30 mg/week), compared to a reported rate of 22.5% in disease-matched patients treated with drugs other than methotrexate.
Croatian: • Spontani pobačaji zabilježeni su u 42,5% trudnica izloženih liječenju niskom dozom metotreksata (nižoj od 30 mg tjedno), u usporedbi sa zabilježenom stopom od 22,5% u bolesnica s istom bolesti ali liječenih drugim lijekovima umjesto metotreksata.
English: Hence, methotrexate should be only administered by, or under the supervision of, doctors whose knowledge and experience include the use of antimetabolite therapy.
Croatian: Stoga bi metotreksat trebali primjenjivati ili njegovu primjenu nadzirati samo liječnici sa znanjem i iskustvom u primjeni terapije antimetabolitima.
English: When switching from oral use to subcutaneous use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.
Croatian: Kad se s peroralne prelazi na supkutanu primjenu, može biti potrebno smanjenje doze zbog promjenjive bioraspoloživosti metotreksata nakon peroralne primjene.
English: The recommended initial dose is 7.5 mg methotrexate once weekly.
Croatian: Preporučena početna doza je 7,5 mg metotreksata jednom tjedno.
English: Your doctor will do tests to check for abnormalities developing in the blood (e.g. low white blood cells, low platelets, lymphoma) and changes in the kidney and the liver.
Croatian: Liječnik će provesti pretrage da provjeri nastaju li poremećaji u krvi (npr. nizak broj bijelih krvnih stanica, nizak broj krvnih pločica, limfom) i promjene u bubrezima i jetri.
English: Methotrexate may reduce theophylline clearance.
Croatian: Metotreksat može smanjiti klirens teofilina.
English: Particularly elderly patients should be examined for early signs of toxicity in short intervals.
Croatian: Osobito je potrebno u kratkim vremenskim razmacima pregledavati starije bolesnike na rane znakove toksičnosti.
English: Oral antibiotics such as tetracyclines, chloramphenicol and non-absorbable broad-spectrum antibiotics may reduce intestinal methotrexate absorption or interfere with the enterohepatic circulation, due to inhibition of the intestinal flora or suppression of bacterial metabolism.
Croatian: Oralni antibiotici poput tetraciklina, kloramfenikola i antibiotika širokog spektra koji se ne apsorbiraju mogu smanjiti apsorpciju metotreksata u crijevima ili ometati njegovu enterohepatičku cirkulaciju zbog inhibicije crijevne flore ili supresije metabolizma bakterija.
English: For psoriasis patients the need of a liver biopsy prior to and during therapy is controversial.
Croatian: Potreba za biopsijom jetre prije i tijekom terapije sporna je i u bolesnika s psorijazom.
English: Methotrexate can affect sperm production with the potential to cause birth defects.
Croatian: Metotreksat može utjecati na stvaranje sperme s mogućnošću uzrokovanja urođenih mana.
English: Sodium chloride Sodium hydroxide Water for injections
Croatian: natrijev klorid natrijev hidroksid voda za injekcije
English: Men should not donate semen during therapy or for 6 months following discontinuation of methotrexate.
Croatian: Muškarci ne smiju donirati sjeme tijekom liječenja i 6 mjeseci nakon prestanka primjene metotreksata.
English: Any contact of methotrexate with skin and mucosa is to be avoided.
Croatian: Mora se izbjegavati svaki kontakt metotreksata s kožom i sluznicama.
English: Very common (may affect more than 1 in 10 people): loss of appetite, nausea (feeling sick), vomiting, tummy pain, inflammation and ulcers in the mouth and throat, and increase in liver enzymes.
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): gubitak apetita, mučnina, povraćanje, bol u trbuhu, upala i ranice u ustima i grlu i povišeni jetreni enzimi.
English: Therefore, the possible risks of effects on reproduction, pregnancy loss and congenital malformations should be discussed with female patients of childbearing potential (see section 4.6).
Croatian: Stoga je s bolesnicama reproduktivne dobi potrebno razgovarati o mogućim rizicima učinaka na reprodukciju, gubitku trudnoće i kongenitalnim malformacijama (vidjeti dio 4.6).
English: The recommended dose is 10-15 mg/m² body surface area (BSA) per week.
Croatian: Preporučena doza je 10-15 mg/m² površine tijela tjedno.