FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with rheumatological or dermatological diseases must be informed unequivocally that treatment is to be taken just once a week and not daily.
Croatian: Bolesnike s reumatološkim ili dermatološkim bolestima mora se nedvosmisleno uputiti da se lijek uzima samo jednom tjedno, a ne jednom dnevno.
English: Pleural effusions or ascites
Croatian: Pleuralne efuzije ili ascites
English: Particular caution is also required in the presence of inactive chronic infections (e.g. herpes zoster, tuberculosis, hepatitis B or C) as it is possible that activation of these infections may occur.
Croatian: Poseban oprez potreban je također u prisutnosti neaktivnih kroničnih infekcija (npr. herpes zoster, tuberkuloza, hepatitis B ili C) jer može doći do aktivacije tih infekcija.
English: In psoriasis, cell proliferation of the epithelium is markedly increased compared with normal skin.
Croatian: U psorijazi, proliferacija stanica epitela značajno je veća u usporedbi s normalnom kožom.
English: Such abnormalities should return to normal within two weeks, after which, treatment may be resumed at the discretion of the doctor.
Croatian: Takve poremećene vrijednosti trebaju se vratiti na normalne vrijednosti unutar dva tjedna, a nakon toga liječenje se može nastaviti prema odluci liječnika.
English: Treatment of rheumatoid arthritis with such medicinal products can be continued during therapy with low-dose methotrexate, but only under close medical supervision.
Croatian: Liječenje reumatoidnog artritisa takvim lijekovima može se nastaviti tijekom terapije niskom dozom metotreksata, ali samo pod pažljivim medicinskim nadzorom.
English: Alkalinisation of the urine must be tested by repeated pH monitoring (value greater than or equal to 6.8) for at least the first 24 hours after the administration of methotrexate is started.
Croatian: Alkalizacija mokraće mora se testirati ponavljanim praćenjem pH vrijednosti (vrijednost veća ili jednaka 6,8) tijekom najmanje prvih 24 sata nakon početka primjene metotreksata.
English: • Management of overdose (including the use of calcium folinate and dose interruption).
Croatian: • Zbrinjavanje predoziranja (uključujući uporabu kalcijeva folinata i prekid doze).
English: Patients should be informed of the risks of pneumonia and advised to contact their doctor immediately if they develop a persistent cough or persistent dyspnoea.
Croatian: Bolesnike treba upozoriti na rizike od pneumonije i savjetovati da se odmah obrate liječniku ako razviju uporni kašalj ili upornu dispneju.
English: Doses are usually based on the patient's BSA and maintenance treatment represents a long-term treatment.
Croatian: Doze se obično temelje na tjelesnoj površini bolesnika, a terapija održavanja predstavlja dugoročno liječenje.
English: Treatment should follow currently published therapy protocols for children (see section 4.4).
Croatian: Liječenje treba pratiti trenutno objavljene protokole terapije za djecu (vidjeti dio 4.4).
English: Treatment should follow current therapy protocols.
Croatian: Liječenje bi trebalo pratiti važeće protokole terapije.
English: These effects appear to be reversible after discontinuation of therapy in most cases.
Croatian: Čini se da su ovi učinci u većini slučajeva reverzibilni nakon prekida terapije.
English: Use in children under 3 years of age is not recommended as insufficient data on efficacy and safety are available for this patient group
Croatian: Ne preporučuje se primjena u djece mlađe od 3 godine jer su za ovu skupinu bolesnika dostupni nedostatni podaci o djelotvornosti i sigurnosti.
English: In rhesus monkeys, no malformations comparable to those seen in humans occurred.
Croatian: U rezus majmuna nisu se javile malformacije usporedive s onima opaženima u ljudi.
English: Mucositis generally appears about 3 to 7 days after methotrexate application, leucopenia and thrombocytopenia follow a few days later.
Croatian: Mukozitis se najčešće javlja oko 3 do 7 dana nakon primjene metotreksata, leukopenija i trombocitopenija slijede nekoliko dana poslije.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Croatian: • preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: What Jylamvo looks like and contents of the pack
Croatian: Kako Jylamvo izgleda i sadržaj pakiranja
English: Anyone handling methotrexate should wash their hands before and after administering a dose.
Croatian: Svaka osoba koja rukuje metotreksatom treba oprati ruke prije i poslije primjene doze.
English: If there is the possibility of renal impairment (e.g. in elderly subjects), monitoring should take place at shorter intervals.
Croatian: Ako postoji mogućnost oštećenja bubrega (npr. u starijih osoba), praćenje treba provoditi u kraćim vremenskim razmacima.
English: In these cases, symptoms that have been commonly reported are hematological and gastrointestinal reactions.
Croatian: U tim slučajevima, najčešće zabilježeni simptomi bile su hematološke i gastrointestinalne reakcije
English: Opportunistic infections (sometimes fatal)
Croatian: Infekcije i infestacije infekcije oportunističke infekcije (katkad smrtonosne)
English: Calcium folinate is the specific antidote for neutralising the adverse toxic effects of methotrexate.
Croatian: Kalcijev folinat specifičan je antidot za neutralizaciju štetnih toksičnih učinaka metotreksata.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove (http://www.ema.europa.eu)
English: Take as prescribed by your doctor using the dosing syringe provided.
Croatian: Uzimajte kako je propisao liječnik koristeći priloženu štrcaljku za doziranje.
English: Frequency, type and severity of adverse reactions in children and adolescents are expected to be the same as in adults.
Croatian: Očekuje se da su učestalost, vrsta i težina nuspojava u djece i adolescenata jednake onima u odraslih osoba.
English: Contents of the pack and other information What Jylamvo contains
Croatian: Sadržaj pakiranja i druge informacije Što Jylamvo sadrži
English: When you have taken your dose, drink some water and swallow it to ensure you have taken your full dose and there is no methotrexate left in your mouth.
Croatian: Kada uzmete dozu, popijte malo vode i progutajte je kako biste bili sigurni da ste uzeli cijelu dozu i da Vam u ustima nema zaostalog metotreksata.
English: A blood test will be done to check for reduction in the white blood cells (agranulocytosis).
Croatian: Pretragu krvi treba provesti kako bi se provjerilo ima li smanjenja broja bijelih krvnih stanica (agranulocitoza).
English: Methotrexate can reduce the number of white blood cells and therefore weaken your immune defences.
Croatian: Metotreksat može smanjiti broj bijelih krvnih stanica i tako oslabiti obrambeni sustav Vašeg tijela.
English: Always show this card to health care professionals not familiar with your methotrexate treatment to alert them about your once weekly use (e.g. on hospital admission, change of care).
Croatian: Ovu karticu uvijek pokažite zdravstvenim radnicima koji nisu upoznati s Vašim liječenjem metotreksatom, kako biste ih upozorili na primjenu jednom tjedno (npr. prilikom prijema u bolnicu, promjene u zdravstvenoj skrbi).
English: If you think you have taken more than the prescribed dose, consult a physician immediately.
Croatian: Ako mislite da ste uzeli više od propisane doze, odmah se obratite liječniku.
English: • Active rheumatoid arthritis in adult patients.
Croatian: • Aktivni reumatoidni artritis u odraslih bolesnika.
English: It is important to determine any increase in active substance levels within 48 hours of therapy, otherwise irreversible methotrexate toxicity may occur.
Croatian: Važno je odrediti svako povećanje razina djelatne tvari u okviru 48 sati od primjene terapije; inače može doći do ireverzibilne toksičnosti uzrokovane metotreksatom.
English: The plunger and barrel should be stored in a clean dry container with the medicine and reassembled before next use.
Croatian: Klip i tijelo treba spremiti u čisti suhi spremnik s lijekom i ponovno sastaviti prije sljedeće uporabe.
English: − a blood disorder characterised by the appearance of very large red blood cells (megaloblastic anaemia)
Croatian: − poremećaj krvi s pojavom vrlo velikih crvenih krvnih stanica (megaloblastična anemija)
English: If liver enzymes are constantly increased, a dose reduction or treatment discontinuation should be considered.
Croatian: Ako su jetreni enzimi neprekidno povišeni, potrebno je razmotriti smanjenje doze ili prekid liječenja.
English: Cell proliferation is usually greater in malignant tumours than in normal tissue and methotrexate can therefore exert a sustained effect on malignant growth without causing irreversible damage to normal tissue.
Croatian: Proliferacija stanica obično je veća u zloćudnim tumorima nego u normalnom tkivu, pa metotreksat stoga može izvršiti produljeni učinak na rast zloćudnih stanica bez da ireverzibilno ošteti normalno tkivo.
English: Vitamin preparations or other products containing folic acid, folinic acid or their derivatives may decrease the effectiveness of methotrexate (see sections 4.2 and 4.5).
Croatian: Vitaminski pripravci ili drugi proizvodi koji sadrže folatnu kiselinu, folinatnu kiselinu ili njihove derivate mogu smanjiti učinkovitost metotreksata (vidjeti dijelove 4.2 i 4.5).
English: Excretion occurs predominantly in the unchanged form by glomerular filtration and active secretion in the proximal tubule via the kidneys.
Croatian: Izlučivanje se pretežno događa u nepromijenjenom obliku glomerularnom filtracijom i aktivnom sekrecijom u proksimalnim tubulima putem bubrega.
English: Female patients of reproductive potential must be counselled regarding pregnancy prevention and planning.
Croatian: Bolesnice reproduktivne dobi mora se savjetovati o sprječavanju i planiranju trudnoće.
English: The duration of the treatment is determined by the treating physician.
Croatian: O trajanju liječenja odlučuje nadležni liječnik.
English: Treatment should not be initiated or should be discontinued if there are any abnormalities in liver function tests or liver biopsies, or if these develop during therapy.
Croatian: Liječenje se ne smije započeti ili ga treba prekinuti ako testovi funkcije jetre ili biopsije jetre pokažu bilo kakve poremećaje ili ako se oni razviju tijekom terapije.
English: The severity of these reactions depends on the dose, mode and duration of application of methotrexate.
Croatian: Težina tih reakcija ovisi o dozi, načinu i trajanju primjene metotreksata.
English: Pharmacokinetic interactions between methotrexate, anticonvulsants (reduced serum methotrexate levels) and 5-fluoruracil (increased half-life of 5-fluoruracil) must be borne in mind.
Croatian: U obzir se moraju uzeti farmakokinetičke interakcije metotreksata, antikonvulziva (smanjene razine metotreksata u serumu) i 5-fluorouracila (produljen poluvijek 5-fluorouracila).
English: In rheumatological indications, there is no evidence to support use of liver biopsies in monitoring hepatotoxicity.
Croatian: reumatološkim indikacijama nema dokaza koji bi poduprli provođenje biopsije jetre u svrhu praćenja hepatotoksičnosti.
English: The MAH should implement the agreed targeted follow-up questionnaires for all medication errors resulting in overdose.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet treba provesti dogovorene ciljane upitnike za praćenje svih medikacijskih pogrešaka koje su rezultirale predoziranjem.
English: Neither haemodialysis nor peritoneal dialysis has been shown to improve the elimination of methotrexate.
Croatian: Pokazalo se da ni hemodijaliza ni peritonejska dijaliza ne poboljšavaju eliminaciju metotreksata.
English: In patients with unimpaired elimination mechanisms, myelosuppression and mucositis are generally reversible within 14 to 28 days.
Croatian: U bolesnika u kojih mehanizmi eliminacije nisu oštećeni, mijelosupresija i mukozitis uglavnom su reverzibilni unutar 14 do 28 dana.
English: Shake the bottle.
Croatian: Protresite bočicu.
English: Dosage in children and adolescents with polyarthritic forms of juvenile idiopathic arthritis
Croatian: Doziranje u djece i adolescenata s poliartritičnim oblicima juvenilnog idiopatskog artritisa
English: When used in oncological indications, methotrexate should not be administered during pregnancy in particular during the first trimester of pregnancy.
Croatian: Kada se primjenjuje u onkološkim indikacijama, metotreksat se ne smije uzimati u trudnoći, osobito u prvom tromjesečju.
English: If the drug is used during pregnancy or if the patient becomes pregnant while taking methotrexate the patient should be informed of the potential risk to the foetus.
Croatian: Ako se lijek koristi tijekom trudnoće ili ako bolesnica zatrudni dok uzima metotreksat, bolesnicu treba obavijestiti o mogućem riziku za fetus.
English: Methotrexate can cause birth defects, harm the unborn child or cause miscarriage.
Croatian: Metotreksat može uzrokovati urođene mane, naškoditi nerođenom djetetu ili prouzročiti pobačaj.
English: Caution should be exercised if NSAIDs and methotrexate are administered within 24 hours, since in this case methotrexate plasma levels can rise and toxicity be increased as a result.
Croatian: Potreban je oprez ako se NSAIL-ovi i metotreksat primijene unutar 24 sata, jer se u tom slučaja razine metotreksata u plazmi mogu povećati te posljedično povećava toksičnost.
English: Contact your doctor immediately if you develop any of the side effects listed below:
Croatian: Odmah se obratite liječniku ako razvijete bilo koju nuspojavu navedenu u nastavku:
English: The syringe should be held under water and the plunger drawn in and out several times until all traces of medicine are removed from inside the syringe including the tip.
Croatian: Štrcaljku treba držati pod vodom i klip uvlačiti i izvlačiti nekoliko puta sve dok svi tragovi lijeka ne budu uklonjeni iz unutrašnjosti štrcaljke uključujući vrh.
English: Methotrexate has been shown to be genotoxic in animal studies, such that the risk of genotoxic effects on sperm cells cannot completely be excluded.
Croatian: Utvrđeno je da je metotreksat genotoksičan u ispitivanjima na životinjama, tako da se genotoksični učinak na spermatozoide ne može u potpunosti isključiti.
English: Long-term studies in rats, mice and hamsters revealed no evidence of a tumorigenic potential of methotrexate.
Croatian: Dugoročna ispitivanja u štakora, miševa i hrčaka nisu otkrila dokaze za tumorogeni potencijal metotreksata.
English: • Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.
Croatian: • Poliartritični oblici aktivnog, teškog juvenilnog idiopatskog artritisa (JIA) u adolescenata i djece u dobi od 3 i više godina, kada odgovor na nesteroidne protuupalne lijekove (NSAIL) nije odgovarajući.
English: • Reminder that patients who use methotrexate for an indication requiring a weekly dosing schedule to take the product only once weekly and to write the day of the week for intake on the card
Croatian: • Podsjetnik da bolesnici koji metotreksat primjenjuju u indikaciji koja zahtijeva tjedni režim doziranja lijek primjenjuju samo jednom tjedno te da u karticu upišu dan u tjednu kada uzimaju lijek.
English: Because of the reduced liver and kidney function and the lower folate reserves in elderly patients, a relatively low dosage should be chosen for them.
Croatian: Zbog smanjene funkcije jetre i bubrega te nižih rezervi folata u starijih bolesnika, za njih treba odabrati relativno niske doze.
English: − thirst and/or frequent urination
Croatian: − žeđ i/ili često mokrenje
English: Parents, care givers and patients should be advised to keep methotrexate out of the reach of children, preferably in a locked cupboard.
Croatian: Roditeljima, njegovateljima i bolesnicima treba savjetovati da metotreksat čuvaju izvan dohvata djece, poželjno u zaključanom ormariću.
English: Persistent abnormalities of liver enzymes and/or a decrease in serum albumin can indicate severe hepatotoxicity.
Croatian: Trajno poremećene vrijednosti jetrenih enzima i/ili sniženje serumskog albumina mogu ukazivati na tešku hepatotoksičnost.
English: For higher doses, there is insufficient data to estimate the risks of malformations or miscarriage following paternal exposure.
Croatian: Za više doze nema dovoljno podataka za procjenu rizika od malformacija ili pobačaja nakon paternalnog izlaganja metotreksatu.
English: In oncologic indications, women who are planning to become pregnant are advised to consult a genetic counselling centre, if possible, prior to therapy and men should seek advice about the possibility of sperm preservation before starting therapy as methotrexate can be genotoxic at higher doses (see section 4.4).
Croatian: U onkološkim indikacijama ženama koje planiraju zatrudnjeti savjetuje se da se prije terapije obrate centru za genetičko savjetovanje ako je moguće, a muškarci bi trebali potražiti savjet o mogućnosti pohrane sperme prije nego što započnu s terapijom, budući da metotreksat može biti genotoksičan pri višim dozama (vidjeti dio 4.4).
English: The main metabolite is 7-hydroxymethotrexate.
Croatian: Glavni je metabolit 7-hidroksimetotreksat.
English: Pleural effusions and ascites should be drained prior to initiation of methotrexate treatment (see section 4.2).
Croatian: Pleuralne efuzije i ascites treba drenirati prije započinjanja liječenja metotreksatom (vidjeti dio 4.2).
English: • Detailed description regarding strength of the solution and the dose volumes to help clarify the appropriate dose of the oral solution.
Croatian: • Detaljni opis koji se odnosi na jačinu otopine i volumene doze kako bi se pomoglo u utvrđivanju odgovarajuće doze oralne otopine.
English: Methotrexate affects spermatogenesis and oogenesis and may decrease fertility.
Croatian: Metotreksat utiče na spermatogenezu i oogenezu i može smanjiti plodnost.
English: Further research is needed to establish whether serial liver function tests or determinations of propeptide of type III collagen are appropriate for detecting hepatotoxicity.
Croatian: Potrebna su dodatna istraživanja kako bi se ustanovilo jesu li serijski testovi funkcije jetre ili određivanja propeptida kolagena tipa III odgovarajući načini otkrivanja hepatotoksičnosti.
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg (15 ml)/week.
Croatian: Dostupni dokazi ne ukazuju na povećani rizik od malformacija ili pobačaja ako otac uzima metotreksat u dozi manjoj od 30 mg (15 ml)/tjedan.
English: You will possibly also have an X-ray of your chest.
Croatian: Možda će provesti i rendgensko snimanje prsnog koša.
English: Your doctor will therefore do tests to check for any changes in your blood (such as a low white blood cell count, a low blood platelet count, lymphomas), kidneys or liver.
Croatian: Stoga će liječnik provesti pretrage zbog mogućih promjena u Vašoj krvi (kao što je niski broj bijelih krvnih stanica, niski broj krvnih pločica, limfomi), bubrezima ili jetri.
English: The risk of an interaction between NSAIDs and methotrexate should be considered in patients with a low methotrexate dose, particularly in the case of impaired kidney function.
Croatian: Rizik od interakcije NSAIL-ova i metotreksata treba razmotriti u bolesnika s niskom dozom metotreksata, osobito u slučaju oštećene funkcije bubrega.
English: There is a pronounced enterohepatic circulation.
Croatian: Postoji izražena enterohepatička cirkulacija.
English: Dysarthria, Unusual cranial sensations, Tinnitus
Croatian: neuobičajene kranijalne senzacije, tinitus
English: − yellow colouring of the skin (jaundice) or dark urine
Croatian: − žuta boja kože (žutica) ili tamna mokraća
English: Lung-related symptoms (particularly a dry, non-productive cough) or non-specific pneumonitis that occurs during treatment with methotrexate can be a sign of potentially dangerous damage and require the discontinuation of treatment and careful monitoring.
Croatian: Simptomi povezani s plućima (osobito suh, neproduktivan kašalj) ili nespecifični pneumonitis koji se javlja tijekom liječenja metotreksatom, može biti znak potencijalno opasnog oštećenja i zahtijeva prekid liječenja te pažljivo praćenje.
English: • Recommendation to monitor patients for signs and symptoms of overdose (these predominantly affect the haematopoietic and gastrointestinal systems)
Croatian: • Preporuke za praćenje bolesnika zbog mogućih znakova i simptoma predoziranja (oni uglavnom zahvaćaju hematopoetski i gastrointestinalni sustav).
English: Methotrexate should be used only with great caution, if at all, in patients who have a significant liver disease, particularly if this is/was alcohol-related.
Croatian: Metotreksat se smije primjenjivati samo s velikim oprezom, ako uopće, u bolesnika sa značajnom bolešću jetre, posebice ako je/je bila povezana s alkoholom.
English: Treatment with moderately high and high doses of methotrexate should not be initiated at urinary pH values of less than 7.0.
Croatian: Liječenje umjereno visokim i visokim dozama metotreksata ne smije se započeti ako su pH vrijednosti mokraće manje od 7,0.
English: − red eyes, damage to the retina of the eye
Croatian: − crvenilo očiju, oštećenje mrežnice oka
English: Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage.
Croatian: Bocu čuvati čvrsto zatvorenu kako bi se spriječilo prolijevanje lijeka i smanjio rizik od slučajnog prolijevanja.
English: Do not breast-feed during treatment as methotrexate passes into the breast milk.
Croatian: Nemojte dojiti tijekom liječenja jer se metotreksat izlučuje u majčino mlijeko.
English: • Information on the importance to fill in prescriptions with clear instructions about once weekly dosing, defined day of intake, and to not use abbreviations; in addition the dose should always be prescribed in mg with ml equivalence based on the correct age of the patient;
Croatian: • Podatke o važnosti propisivanja lijeka uz jasno navedene upute o doziranju jednom tjedno, definiranim danom primjene lijeka i bez korištenja kratica; nadalje, podatak da doza uvijek mora biti propisana u miligramima, s ekvivalentnom vrijednošću u mililitrima, na temelju točne dobi bolesnika.
English: Ask the patient to swallow the medicine and then to drink some water, making sure no medicine is left in the mouth.
Croatian: 13. Zamolite bolesnika da proguta lijek, a zatim popije malo vode kako bi se osiguralo da nimalo lijeka nije zaostalo u ustima.
English: • The pharmacist should counsel the patient about the inadvertent daily instead of once-weekly dosing.
Croatian: • Ljekarnik mora informirati bolesnika o nehotičnom dnevnom doziranju umjesto doziranja jednom tjedno.
English: Concurrent folic acid supplementation of 5 mg twice weekly (except on the day of administration) is indicated additionally.
Croatian: Istodobno dodavanje 5 mg folatne kiseline dvaput tjedno (osim na dan primjene) dodatno je indicirano.
English: Dehydration may also intensify the toxicity of methotrexate.
Croatian: Dehidracija također može pojačati i toksičnost metotreksata.
English: Each pack contains one bottle, an LDPE bottle adaptor and a 10 ml white polypropylene dosing syringe (with major graduations at every 1 ml and minor graduations at every 0.25 ml).
Croatian: Svako pakiranje sadrži jednu bocu, LDPE nastavak za bocu i bijelu propilensku dozirnu štrcaljku od 10 ml (s većim mjernim oznaka za svaki 1 ml i manjim oznakama na svakih 0,25 ml).
English: Cases of overdose have been reported, sometimes fatal, due to erroneous daily intake instead of weekly intake of oral methotrexate.
Croatian: Prijavljeni su slučajevi predoziranja, katkad sa smrtnim ishodom, zbog pogrešne primjene oralnog metotreksata jednom dnevno umjesto jednom tjedno.