FrancophonIA/ELRC3.0 huggingface dataset:
English: Radiotherapy during use of methotrexate can increase the risk of soft tissue or bone necrosis.
Slovenian: Radioterapija med uporabo metotreksata lahko poveča tveganje za nekrozo mehkih tkiv ali kosti.
English: It is associated with malformations of the skull, face, heart and blood vessels, brain and limbs.
Slovenian: Povezan je z okvarami lobanje, obraza, srca in krvnih žil, možganov in okončin.
English: The duration of treatment is determined by the treating physician.
Slovenian: Trajanje zdravljenja določi lečeči zdravnik.
English: If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
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.
Slovenian: • O spontanih splavih so poročali pri 42,5 % nosečnicah, ki so bile izpostavljene nizkim odmerkom metotreksata med zdravljenjem (manj kot 30 mg na teden), v primerjavi s poročano stopnjo 22,5 % pri nosečnicah z istimi boleznimi in zdravljene z drugimi zdravili.
English: The other ingredients are sodium chloride, sodium hydroxide and water for injections.
Slovenian: Druge sestavine zdravila so natrijev klorid, natrijev hidroksid in voda za injekcije.
English: - Concurrent vaccination with live vaccines.
Slovenian: sočasno prejmete cepljenje z živimi cepivi.
English: 10) Press down on the plunger with your finger until the syringe is empty.
Slovenian: 10) S prstom pritiskajte na bat dokler se brizga ne izprazni.
English: 3) The pen is pre-filled and ready to use.
Slovenian: 3) Peresnik je napolnjen in pripravljen za uporabo.
English: Use in adults with severe forms of psoriasis vulgaris or psoriatic arthritis Your doctor will give you a single test dose of 5-10 mg, in order to assess possible side effects.
Slovenian: Uporaba pri odraslih bolnikih s hudimi oblikami luskavice ali psoriatičnim artritisom Zdravnik vam bo dal enkraten poskusni odmerek v višini 5-10 mg, da bo lahko ocenil morebitne neželene učinke.
English: Once you have taken the cap off, keep the syringe in your hand.
Slovenian: Ko ste pokrovček sneli, držite brizgo v roki.
English: What Nordimet is and what it is used for What you need to know before you use Nordimet How to use Nordimet
Slovenian: Kaj je zdravilo Nordimet in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Nordimet Kako uporabljati zdravilo Nordimet Možni neželeni učinki
English: It must be explicitly pointed out to the patient that Nordimet is applied only once a week.
Slovenian: Bolniku je treba posebno poudariti, da se zdravilo Nordimet uporablja samo enkrat tedensko.
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).
Slovenian: Uporaba pri bolnikih s tretjim prostorom porazdelitve (plevralni izliv, ascites) Ker je lahko razpolovna doba metotreksata pri bolnikih s tretjim prostorom porazdelitve štirikrat daljša od normalne, bo pri teh bolnikih morda potrebno zmanjšati odmerek, v nekaterih primerih pa uporabo metotreksata opustiti (glejte poglavji 5.2 in 4.4).
English: Therefore, it is very important that methotrexate is not given to pregnant patients or patients planning to become pregnant.
Slovenian: Zelo je pomembno, da ga nosečnice ali bolnice, ki načrtujejo nosečnost, ne jemljejo.
English: Treatment of rheumatoid arthritis with such drugs can be continued during low-dose methotrexate therapy but only under close medical supervision.
Slovenian: Zdravljenje revmatoidnega artritisa s temi zdravili lahko med terapijo z majhnimi odmerki metotreksata nadaljujemo, vendar je potreben skrben zdravniški nadzor.
English: It is especially important to tell your doctor if you are taking: - other treatments for rheumatoid arthritis or psoriasis such as leflunomide, sulphasalazine
Slovenian: Zlasti je pomembno, da zdravnika obvestite, če jemljete/prejemate: - druga zdravila za zdravljenje revmatoidnega artritisa ali luskavice, kot so leflunomid,
English: Nordimet is a medicine used to treat a range of inflammatory diseases: - active rheumatoid arthritis in adults.
Slovenian: Zdravilo Nordimet se uporablja za zdravljenje naslednjih vnetnih bolezni: - aktivnega revmatoidnega artritisa pri odraslih bolnikih.
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.
Slovenian: Še vedno ni pojasnjeno, ali je učinkovitost metotreksata pri obvladovanju psoriaze, psoriatičnega artritisa in kroničnega poliartritisa posledica protivnetnega ali imunosupresivnega učinka in v kakšni meri k tem učinkom prispeva povečanje zunajcelične koncentracije adenozina na mestih vnetja zaradi metotreksata.
English: Temporary increases in transaminases to two or three times the upper limit of normal have been reported in patients at a frequency of 13-20 %.
Slovenian: Pri 13-20 % bolnikov so poročali o prehodnem dvigu vrednosti transaminaz za dva- do trikrat nad zgornjo mejo normalne vrednosti.
English: B-1420 Braine-L'Alleud
Slovenian: B-1420 Braine-l'Alleud Belgija
English: If you forget to use Nordimet
Slovenian: Če ste pozabili vzeti zdravilo Nordimet
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.
Slovenian: Če s peroralne uporabe preidete na subkutano, bo morda treba zmanjšati odmerek zaradi spremenljive biološke uporabnosti metotreksata po peroralni uporabi.
English: A droplet may appear at the tip of the needle.
Slovenian: Na konici igle se lahko pojavi kapljica.
English: If you have experienced problems with your skin after radiation therapy (radiation induced dermatitis) or sun-burn, these conditions can reappear when taking Nordimet.
Slovenian: Če ste imeli po obsevalni terapiji težave s kožo (dermatitis, povzročen z obsevanjem) ali sončne opekline, se lahko te med zdravljenjem z zdravilom Nordimet znova pojavijo.
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.
Slovenian: • Večje prirojene okvare so se pojavile pri 6,6% živorojenih otrok žensk, izpostavljenih zdravljenju z metotreksatom z majhnim odmerkom (manj kot 30 mg na teden) med nosečnostjo, v primerjavi s približno 4 % živorojenih otrok bolnic, z istimi boleznimi, zdravljenih z drugimi zdravili.
English: When administered in small doses, methotrexate passes into the body fluids in minimal amounts; under high doses (300 mg/kg body weight), concentrations between 4 and 7 µg/ml have been measured in the body fluids.
Slovenian: Pri uporabi majhnih odmerkov v telesne tekočine prehajajo minimalne količine metotreksata; v primeru velikih odmerkov (300 mg/kg telesne mase) pa so izmerjene koncentracije v telesnih tekočinah znašale med 4 in 7 µg/ml.
English: In animal experiments non-steroidal anti-inflammatory drugs (NSAIDs) including salicylic acid caused reduction of tubular methotrexate secretion and consequently increased its toxic effects.
Slovenian: Pri poskusih na živalih so nesteroidna protivnetna zdravila (NSAR), vključno s salicilno kislino, povzročila zmanjšano tubularno izločanje metotreksata in posledično povečala njegove toksične učinke.
English: Enzyme diagnostics does not allow any reliable prediction of the development of a morphologically detectable hepatotoxicity, i.e. even in case of normal transaminases, hepatic fibrosis only histologically identifiable or, more rarely, also hepatocirrhosis may be present.
Slovenian: Zgolj na podlagi encimske diagnostike ni mogoče zanesljivo napovedati razvoja morfološko zaznavne hepatotoksičnosti, kar pomeni, da je celo v primeru normalnih vrednosti jetrnih transaminaz mogoče prepoznati jetrno fibrozo samo histološko ali pa je lahko, sicer redkeje, prisotna tudi jetrna ciroza.
English: Dose in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic arthritis
Slovenian: Odmerjanje pri otrocih in mladostnikih, mlajših od 16 let, s poliartikularnimi oblikami juvenilnega idiopatičnega artritisa
English: Particular caution should therefore also be exercised in the presence of existing folic acid deficiency.
Slovenian: Zato je potrebna posebna previdnost tudi pri bolnikih z obstoječim pomanjkanjem folne kisline.
English: If you wish to become pregnant you should consult your doctor, who may refer you for specialist advice before the planned start of treatment.
Slovenian: Če želite zanositi, se posvetujte s svojim zdravnikom, ki vas bo morda pred uvedbo zdravljenja napotil k specialistu.
English: Vitamin preparations or other products containing folic acid, folinic acid or their derivatives may decrease the effectiveness of methotrexate.
Slovenian: Vitaminski pripravki ali drugi izdelki, ki vsebujejo folno kislino, folinsko kislino ali njune derivate, lahko zmanjšajo učinkovitost metotreksata.
English: There are reports of death due to sepsis, septic shock, renal failure and aplastic anaemia.
Slovenian: Poročali so o smrtnih primerih zaradi sepse, septičnega šoka, ledvične odpovedi in aplastične anemije.
English: Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose.
Slovenian: Ko je želeni rezultat zdravljenja dosežen, je treba odmerek postopoma zmanjševati do najmanjšega možnega učinkovitega vzdrževalnega odmerka.
English: Pregnant health care personnel should not handle and/or administer methotrexate.
Slovenian: Noseče zdravstvene delavke ne smejo ravnati z metotreksatom in/ali ga dajati bolnikom.
English: Make sure you hold the skin fold throughout the injection.
Slovenian: Kožno gubo držite stisnjeno ves čas injiciranja.
English: One should be aware of pharmacokinetic interactions between methotrexate, anticonvulsant medicinal products (reduced methotrexate blood levels), and 5-fluorouracil (increased t½ of 5--fluorouracil).
Slovenian: Treba se je zavedati farmakokinetičnega medsebojnega delovanja metotreksata z antikonvulzivi (znižujejo plazemske koncentracije metotreksata) in s 5-fluorouracilom (podaljša se t1/2 5-fluorouracila).
English: Dosage in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic arthritis
Slovenian: Odmerek pri otrocih in mladostnikih, mlajših od 16 let, s poliartikularnimi oblikami juvenilnega idiopatičnega artritisa
English: Approximately 10% of the administered methotrexate is metabolised intrahepatically.
Slovenian: Približno 10 % uporabljenega odmerka metotreksata se presnovi v jetrih.
English: Particular caution should be exercised in the presence of inactive, chronic infections (e.g. herpes zoster, tuberculosis, hepatitis B or C) due to possible activation.
Slovenian: Previdnost je še zlasti potrebna v primeru neaktivnih kroničnih okužb (npr. herpes zoster, tuberkuloza, hepatitis B ali C), saj lahko pride do njihove ponovne aktivacije.
English: Persistent anomalies of liver-related enzymes and/or decrease in serum albumin may be indicative for severe hepatotoxicity.
Slovenian: Stalno odstopanje vrednosti jetrnih encimov in/ali znižanje serumskega albumina lahko nakazujejo hudo obliko hepatotoksičnosti.
English: If methotrexate induced lung disease is suspected, treatment with corticosteroids should be initiated and treatment with methotrexate should not be restarted.
Slovenian: V primeru suma na pljučno bolezen, povzročeno z metotreksatom, uvedemo zdravljenje s kortikosteroidi, zdravljenja z metotreksatom pa ne smemo znova začeti.
English: - Liver function tests.
Slovenian: - Testi delovanja jeter.
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).
Slovenian: Omejeni klinični dokazi ne kažejo na povečano tveganje za nastanek malformacij ali splavov, ki so posledica izpostavljenosti očetu majhnim odmerkom metotreksata (manj kot 30 mg na teden).
English: During methotrexate therapy, opportunistic infection can occur including pneumocystis jiroveci pneumonia, which may take a lethal course.
Slovenian: Med zdravljenjem z metotreksatom se lahko pojavijo oportunistične okužbe, vključno s Pneumocystis jiroveci povzročeno pljučnico, ki je lahko smrtna.
English: 10) Wait another 2-3 seconds before removing the pen from your skin.
Slovenian: 10) Pred umikom peresnika počakajte še 2-3 sekunde.
English: If a patient presents with pulmonary symptoms, the possibility of pneumocystis jiroveci pneumonia should be taken into account.
Slovenian: Če se pojavijo pljučni simptomi, je treba upoštevati možnost, da gre za pljučnico, ki jo povzroča Pneumocystis jiroveci.
English: Methotrexate is injected once weekly.
Slovenian: Metotreksat se injicira enkrat tedensko.
English: - Renal function should be monitored via renal function tests and urinanalysis (see sections 4.2 and 4.3).
Slovenian: - Ledvično funkcijo je treba spremljati s testi delovanja ledvic in analizami urina (glejte poglavji 4.2 in 4.3).
English: Neither haemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination.
Slovenian: Ugotovljeno je, da niti hemodializa niti peritonealna dializa ne pospešita izločanja metotreksata.
English: Any used syringe should be discarded.
Slovenian: Vse uporabljene brizge je treba zavreči.
English: It is recommended to specify a certain day of the week as “day for injection”.
Slovenian: Priporočljivo je določiti en stalni dan v tednu za injiciranje.
English: In humans, methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea.
Slovenian: Pri ljudeh so za metotreksat poročali, da povzroča oligospermijo, menstrualno disfunkcijo in amenorejo.
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.
Slovenian: V primeru izrazito prevelikega odmerjanja bosta za preprečitev precipitacije metotreksata in/ali njegovih presnovkov v ledvičnih tubulih morda potrebni hidracija in alkalizacija urina.
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.
Slovenian: Metotreksat ima močno teratogena delovanje pri ljudeh, in je povezan s povečanim tveganjem za spontane splave, intrauterino zaostanek v rasti in kongenitalne malformacije v času izpostavljenosti med nosečnostjo.
English: Administration of additional haematotoxic medicinal products (e.g. metamizole) increases the probability of severe haematoxic effects of methotrexate.
Slovenian: Uporaba dodatnih hematotoksičnih zdravil (npr. metamizola) poveča verjetnost hudih hematotoksičnih učinkov metotreksata.
English: Sodium chloride Sodium hydroxide Water for injections
Slovenian: natrijev klorid natrijev hidroksid voda za injekcije
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.
Slovenian: Vsak primer je treba oceniti posebej ter razlikovati med bolniki brez dejavnikov tveganja in bolniki z dejavniki tveganja, kot so čezmerno uživanje alkohola v preteklosti, stalno povišane vrednosti jetrnih encimov, predhodne bolezni jeter, družinska anamneza dednih jetrnih bolezni, sladkorna bolezen, debelost, znatnejša izpostavljenost hepatotoksičnim zdravilom ali kemikalijam v preteklosti ter dolgotrajno zdravljenje z metotreksatom ali njegovim kumulativnim odmerkom v višini 1,5 g ali več.
English: Increased caution should generally be exercised in patients with insulin-dependent diabetes mellitus, as during methotrexate therapy hepatocirrhosis developed in isolated cases without intermittent increase in transaminases.
Slovenian: Večja previdnost je na splošno potrebna pri bolnikih z od insulina odvisno sladkorno boleznijo, saj se je med zdravljenjem z metotreksatom v posameznih primerih pojavila jetrna ciroza brez intermitentnega zvišanja vrednosti transaminaz.
English: If you accidently get methotrexate on the surface of the skin or soft tissues you must rinse with plenty of water.
Slovenian: Če pride metotreksat pomotoma v stik s kožo ali mehkimi tkivi, sperite prizadeto mesto z obilo vode.
English: Remove the syringe from the box by the body as shown in the picture below.
Slovenian: Brizgo vzemite iz ovojnine, tako da primete telo brizge, kot je prikazano na spodnji sliki.
English: Conditions leading to dehydration such as emesis, diarrhoea or stomatitis, can increase the toxicity of methotrexate due to elevated levels of the active substance.
Slovenian: Stanja, ki povzročajo dehidracijo, kot so bruhanje, diareja ali stomatitis, lahko povečajo toksičnost metotreksata zaradi zvišanih koncentracij učinkovine.
English: You should see a yellow fluid through the viewing window.
Slovenian: Skozi kontrolno okence morate videti rumeno tekočino.
English: Particularly in the case of orthopaedic surgery where susceptibility to infection is high, a combination of methotrexate with immune-modulating medicinal products must be used with caution.
Slovenian: Zlasti pri ortopedskih kirurških posegih, kjer je dovzetnost za okužbe visoka, je ob sočasni uporabi metotreksata in imunomodulirajočih učinkovin potrebna posebna pozornost.
English: 5) Visually inspect the syringe.
Slovenian: 5) Vizualno preglejte brizgo.
English: The recommended dose is 10-15 mg/m² body surface area (BSA) per week.
Slovenian: Priporočeni odmerek je 10-15 mg/m² telesne površine tedensko.
English: Symptoms indicating potentially severe lung injury (interstitial pneumonitis) are: dry, not productive cough, shortness of breath and fever.
Slovenian: Simptomi, ki kažejo na morebitno hudo poškodbo pljuč (intersticijska pljučnica) so: suh, neproduktiven kašelj, zadihanost in zvišana telesna temperatura.
English: Methotrexate treatment of rheumatoid arthritis represents long-term treatment.
Slovenian: Zdravljenje revmatoidnega artritisa z metotreksatom pomeni dolgoročno zdravljenje.
English: Alcohol consumption must be avoided during treatment with methotrexate.
Slovenian: Med zdravljenjem z metotreksatom se je treba izogibati uživanju alkohola.
English: The dose should be adjusted as follows:
Slovenian: Odmerek je treba prilagoditi kot sledi spodaj:
English: They are to be informed about the necessity to immediately consult the physician if symptoms of intoxication occur, as well as about the subsequent necessary monitoring of symptoms of intoxication (including regular laboratory tests).
Slovenian: Prav tako jih je potrebno obvestiti o nadaljnjem spremljanju simptomov toksičnih učinkov (vključno z rednimi laboratorijskimi preiskavami).
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.
Slovenian: Pred začetkom zdravljenja ali pred ponovno uvedbo zdravljenja po prekinitvi Treba je opraviti celotno krvno sliko z diferencialno krvno sliko in krvnimi ploščicami, teste jetrnih encimov, bilirubina, serumskiega albumina, rentgensko slikanje prsnega koša in teste delovanja ledvic.
English: The use of nitrous oxide potentiates the effect of methotrexate on folate metabolism, yielding increased toxicity such as severe unpredictable myelosuppression and stomatitis.
Slovenian: Uporaba dušikovega oksida okrepi učinek metotreksata na biotransformacijo folne kisline, zaradi česar se pojavi večja toksičnost, ki se odraža kot huda, nepredvidljiva mielosupresija in stomatitis.
English: Antibiotics, like penicillin, glycopeptides, sulfonamides, ciprofloxacin and cefalotin can, in individual cases, reduce the renal clearance of methotrexate, so that increased serum concentrations of methotrexate with simultaneous haematological and gastro-intestinal toxicity may occur.
Slovenian: Antibiotiki, kot so penicilini, glikopeptidi, sulfonamidi, ciprofloksacin in cefalotin, lahko v posameznih primerih zmanjšajo ledvični očistek metotreksata, kar lahko vodi do povečanih serumskih koncentracij metotreksata ter sočasne hematološke in gastrointestinalne toksičnosti.
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
Slovenian: V primeru nenamernega prevelikega odmerjanja mora bolnik v času ene ure od prejema prevelikega odmerka metotreksata prejeti intravenski ali intramuskularni odmerek kalcijevega folinata, ki je enak ali večji od neustreznega odmerka metotreksata, odmerjanje pa ponavljati, dokler se serumska koncentracija metotreksata ne zniža pod 10
English: How to give yourself an injection of Nordimet
Slovenian: Kako si sami injicirate zdravilo Nordimet
English: The combined use of methotrexate and leflunomide may increase the risk for pancytopenia.
Slovenian: Sočasna uporaba metotreksata in leflunomida lahko poveča tveganje za pojav pancitopenije.
English: This particularly applies to the co-administration of medicinal products which affect methotrexate excretion, cause kidney damage (e.g. NSAIDs) or can potentially lead to haematopoietic disorders.
Slovenian: To se nanaša zlasti na primere sočasne uporabe zdravil, ki vplivajo na izločanje metotreksata, povzročajo okvare ledvic (npr. NSAR) ali pa lahko vodijo do morebitnih motenj pri tvorbi krvi.
English: This is to make sure that the pen is not accidentally activated and that the needle stays clean.
Slovenian: Tako peresnika ne boste pomotoma aktivirali in igla bo ostala čista.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially “sodium-free“.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
English: Dosage in patients with psoriasis vulgaris and psoriatic arthritis It is recommended that a test dose of 5-10 mg be administered subcutaneously one week prior to initiation of therapy, in order to detect idiosyncratic adverse effects.
Slovenian: Odmerjanje pri bolnikih s psoriazo vulgaris in psoriatičnim artritisom Priporočljiva je subkutana uporaba testnega odmerka v višini 5-10 mg en teden pred začetkom zdravljenja, da se ugotovijo morebitni idiosinkratični neželeni učinki.
English: If lymphomas should fail to regress spontaneously, initiation of cytotoxic therapy is required.
Slovenian: Če limfom ne kaže znakov spontane regresije, je treba uvesti citotoksično zdravljenje.
English: You will feel and hear a second “click” once the injection is completed.
Slovenian: Po končanem injiciranju boste znova zaslišali in začutili »klik«.