FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Zato bo zdravnik opravil preiskave, s katerimi bo preveril krvne nepravilnosti (npr. nizko število belih krvnih celic, nizko število krvnih ploščic, prisotnost limfoma) ter spremembe v delovanju ledvic in jeter.
English: This activates the pen and the solution will inject automatically into the skin.
Slovenian: S tem se peresnik aktivira in raztopina samodejno injicira pod kožo.
English: Vascular disorders Rare: Hypotension, thromboembolic events
Slovenian: Žilne bolezni Redki: hipotenzija, trombembolični dogodki
English: Only mild local skin reactions were observed with Nordimet and these decreased during therapy.
Slovenian: Med zdravljenjem z zdravilom Nordimet so se na koži pojavile samo blage lokalne reakcije, ki pa so bile s trajanjem zdravljenja vse redkejše.
English: The recommended initial dose is 7.5 mg methotrexate once weekly.
Slovenian: Priporočeni začetni odmerek je 7,5 mg metotreksata enkrat tedensko.
English: - Serious, acute or chronic infections such as tuberculosis and HIV.
Slovenian: imate hudo ali obstoječo okužbo, npr. tuberkulozo ali okužbo z virusom HIV.
English: The medicinal product is for single use only.
Slovenian: Zdravilo je samo za enkratno uporabo.
English: Important warning about the dosage of Nordimet
Slovenian: Pomembno opozorilo glede odmerjanja zdravila Nordimet
English: Co-administration of proton-pump inhibitors such as omeprazole or pantoprazole can lead to interactions: concomitant administration of methotrexate and omeprazole has led to a delay in the renal elimination of methotrexate.
Slovenian: Sočasna uporaba zaviralcev protonske črpalke, kot sta omeprazol ali pantoprazol, lahko vodi do medsebojnih delovanj: sočasno jemanje metotreksata in omeprazola je povzročilo zakasnjeno ledvično izločanje metotreksata.
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.
Slovenian: Ker se metotreksat izloča predvsem skozi ledvice, lahko v primeru okvarjenega delovanja ledvic pričakujemo povišane serumske koncentracije metotreksata, kar lahko povzroči hude neželene učinke.
English: Methotrexate is a folic acid antagonist which belongs to the class of cytotoxic agents known as antimetabolites.
Slovenian: Metotreksat je antagonist folne kisline, ki spada v razred citotoksičnih zdravil, imenovanih antimetaboliti.
English: In patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis or psoriasis vulgaris, administration of folic or folinic acid may reduce methotrexate toxicity (gastrointestinal symptoms, inflammation of oral mucosa, hair loss and increase of liver enzymes) (see section 4.5).
Slovenian: Pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatičnim artritisom, psoriatičnim artritisom ali psoriazo vulgaris lahko uporaba folne ali folinske kisline zmanjša toksičnost metotreksata (gastrointestinalne simptome, vnetje ustne sluznice, izpadanje las in zvišane vrednosti jetrnih encimov) (glejte poglavje 4.5).
English: You must avoid becoming pregnant whilst taking methotrexate and for at least 6 months after treatment is stopped by using reliable contraception throughout this time (see also section “Warnings and precautions”).
Slovenian: V času zdravljenja z metotreksatom in še vsaj šest mesecev po njem ne smete zanositi, zato je treba v tem času zagotoviti zanesljivo kontracepcijo (glejte tudi poglavje »Opozorila in previdnostni ukrepi«).
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.
Slovenian: Peroralni antibiotiki, kot so tetraciklini, kloramfenikol in širokospektralni antibiotiki, ki se ne absorbirajo, lahko zmanjšajo črevesno absorpcijo metotreksata ali pa z zaviranjem črevesne flore oziroma bakterijske presnove motijo enterohepatični obtok.
English: Insert the full length of the needle into the skin fold.
Slovenian: V kožno gubo vstavite celotno iglo.
English: Methotrexate can cause birth defects, harm unborn babies or cause miscarriages.
Slovenian: Metotreksat lahko povzroči prirojene okvare, škoduje nerojenim otrokom ali povzroči splav.
English: If you do become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible.
Slovenian: Če med zdravljenjem zanosite ali sumite, da ste noseči, se takoj posvetujete z zdravnikom.
English: Methotrexate is contraindicated during pregnancy in non-oncological indications (see section 4.3).
Slovenian: Med nosečnostjo je metotreksat kontraindiciran pri neonkoloških indikacijah (glejte poglavje 4.3).
English: If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/sore pharynx/sore mouth or urinary problems you should see your doctor immediately.
Slovenian: Če se pojavi vnetje s simptomi, kot so zvišana telesna temperatura in hudo poslabšanje splošnega zdravstvenega stanja ali zvišana telesna temperatura s simptomi lokalne okužbe, npr. boleče grlo/boleče žrelo/boleča usta, ali težave z uriniranjem, nemudoma obiščite zdravnika.
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.
Slovenian: Pri uporabi metotreksata so poročali o oligospermiji, menstrualnih motnjah in amenoreji med zdravljenjem in kratek čas po prekinitvi zdravljenja ter o zmanjšani plodnosti, ki vpliva na spermatogenezo in oogenezo v obdobju dajanja zdravila - videti je, da so ti učinki ob prekinitvi zdravljenja reverzibilni.
English: In cases of possible renal impairment (e.g. in elderly patients), closer monitoring is required.
Slovenian: Pri bolnikih, ki bi lahko imeli okvarjeno delovanje ledvic (npr. pri starejših ljudeh), je potrebno pogostejše spremljanje.
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.
Slovenian: Če se pojavijo pljučni simptomi, zdravljenje z metotreksatom prekinemo in opravimo temeljito preiskavo (vključno z rentgenskim slikanjem prsnega koša), da izključimo možnost okužbe in prisotnost tumorjev.
English: Nordimet is also available in multipacks containing 12 prefilled pens in 3 cartons (4 pens and alcohol swabs per carton).
Slovenian: Zdravilo Nordimet je na voljo tudi v skupnem pakiranju, ki vsebuje 12 napolnjenih injekcijskih peresnikov v 3 škatlah (4 peresniki in alkoholna blazinica na škatlo).
English: If you are not sure what to do, talk to your doctor or nurse immediately.
Slovenian: Če ste negotovi, se nemudoma posvetujte z zdravnikom ali medicinsko sestro.
English: Method and duration of administration
Slovenian: Postopek in trajanje zdravljenja
English: Concomitant administration of folate antagonists such as trimethoprim /sulphamethoxazole has been reported to cause an acute megaloblastic pancytopenia in rare instances.
Slovenian: Med sočasno uporabo antagonistov folatov, kot sta trimetoprim/sulfametoksazol, so v redkih primerih poročali o pojavu akutne megaloblastne pancitopenije.
English: Nordimet must only be used once a week.
Slovenian: Zdravilo Nordimet se sme uporabljati samo enkrat tedensko.
English: However, an increased monitoring frequency is indicated if the dose is increased.
Slovenian: V primeru povečanja odmerka je indicirano pogostejše spremljanje.
English: In the case of contamination, the parts concerned should be rinsed with plenty of water.
Slovenian: V primeru kontaminacije je treba območje sprati z obilo vode.
English: It must be injected once weekly and it is recommended to always inject Nordimet on the same day of the week.
Slovenian: Priporočljivo je, da zdravilo Nordimet vedno injiciramo na isti dan v tednu.
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.
Slovenian: Vendar v kliničnih študijah, kjer so bolniki z revmatoidnim artritisom sočasno prejemali NSAR in salicilno kislino, niso opazili povečanega tveganja za neželene učinke.
English: How to use Nordimet
Slovenian: Kako uporabljati zdravilo Nordimet
English: 12) Discard the used syringe into the sharps bin provided.
Slovenian: 12) Uporabljeno brizgo zavrzite v zabojnik za ostre odpadke.
English: Common: Headache, tiredness, drowsiness.
Slovenian: Pogosti: glavobol, utrujenost, zaspanost
English: As methotrexate is transferred into human milk and may cause toxicity in breast-feeding children, treatment is contraindicated during breast-feeding (see section 4.3).
Slovenian: Metotreksat prehaja v materino mleko in lahko povzroči toksične učinke pri dojenih otrocih, zato je njegova uporaba v času dojenja kontraindicirana (glejte poglavje 4.3).
English: - Alcohol abuse.
Slovenian: uživate večje količine alkohola.
English: Open the blister pack by peeling back the top layer all the way off the blister pack as shown.
Slovenian: Odprite pretisni omot, tako da odlepite zgornji sloj, kot je nakazano na sliki.
English: 11) Visually inspect the pen through the viewing window.
Slovenian: 11) Vizualno preglejte peresnik skozi kontrolno okence.
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.
Slovenian: Pri ženskah v rodni dobi je treba izključiti nosečnost z ustreznimi metodami, kot je test nosečnosti, preden začnemo z zdravljenjem.
English: Salicylates, phenylbutazone, phenytoin, barbiturates, tranquillisers, oral contraceptives, tetracyclines, amidopyrine derivatives, sulfonamides and p-aminobenzoic acid displace methotrexate from serum albumin binding and thus increase bioavailability (indirect dose increase).
Slovenian: Salicilati, fenilbutazon, fenitoin, barbiturati, pomirjevala, peroralni kontraceptivi, tetraciklini, aminopirinski derivati, sulfonamidi in p-aminobenzojska kislina izpodrivajo metotreksat s serumskega albumina ter s tem povečajo njegovo biološko uporabnost (posredno zvečanje odmerka).
English: Rare: Pulmonary fibrosis, Pneumocystis jiroveci pneumonia, shortness of breath and bronchial asthma, pleural effusion.
Slovenian: Redki: pljučna fibroza, s Pneumocystis jiroveci povzročena pljučnica, zadihanost in bronhialna astma, plevralni izliv
English: Excessive consumption of beverages containing caffeine or theophylline (coffee, soft drinks containing caffeine, black tea) should be avoided during methotrexate therapy since the efficacy of methotrexate may be reduced due to possible interaction between methotrexate and methylxanthines at adenosine receptors.
Slovenian: Med zdravljenjem z metotreksatom se je treba izogibati prekomernemu uživanju pijač, ki vsebujejo kofein ali teofilin (kava, brezalkoholne pijače s kofeinom, črni čaj), saj se lahko zaradi možnega medsebojnega delovanja metotreksata in metilksantinov na adenozinskih receptorjih zmanjša učinkovitost metotreksata.
English: Probenecid and mild organic acids may also reduce tubular methotrexate secretion, and thus cause indirect dose elevations, too.
Slovenian: Probenecid in šibke organske kisline lahko zmanjšajo tubularno izločanje metotreksata ter prav tako posredno povečajo njegov odmerek.
English: Methotrexate is known to cause bone disorders such as joint and muscle pain and osteoporosis.
Slovenian: Znano je, da metotreksat povzroča bolezni kosti, kot sta bolečina v sklepih in mišicah ter osteoporoza.
English: You should not interrupt or discontinue Nordimet treatment before discussing with your doctor.
Slovenian: Če ste prenehali uporabljati zdravilo Nordimet Zdravljenja z zdravilom Nordimet ne smete prekiniti brez predhodnega posveta z zdravnikom.
English: Dosage errors in the use of Nordimet can result in serious adverse reactions, including death.
Slovenian: Napake pri odmerjanju zdravila Nordimet lahko povzročijo resne neželene učinke, vključno s smrtjo.
English: Regular alcohol consumption and administration of additional hepatotoxic medicinal products increase the probability of hepatotoxic effects of methotrexate.
Slovenian: Redno uživanje alkohola in sočasna uporaba drugih hepatotoksičnih zdravil povečata tveganje za hepatotoksične učinke metotreksata.
English: Common: Leukopenia, anaemia, thrombopenia.
Slovenian: Pogosti: levkopenija, anemija, trombocitopenija
English: During therapy
Slovenian: Med zdravljenjem
English: Very rare: Agranulocytosis, severe courses of bone marrow depression, lymphoproliferative disorders (see “description below”).
Slovenian: Zelo redki: agranulocitoza, hujši poteki zaviranja delovanja kostnega mozga, limfoproliferativne bolezni (glejte opis spodaj)
English: Encephalopathy / Leukoencephalopathy have been reported in oncologic patients receiving methotrexate therapy and cannot be excluded for methotrexate therapy in non-oncologic indications.
Slovenian: Pri onkoloških bolnikih, ki so se zdravili z metotreksatom, so poročali o encefalopatiji/levkoencefalopatiji, ki ju pri zdravljenju neonkoloških indikacij z metotreksatom ne moremo izključiti.
English: Methotrexate has been shown to have a teratogenic effect in humans; it has been reported to cause foetal death and/or congenital abnormalities (e.g. craniofacial, cardiovascular, central nervous system and extremity-related).
Slovenian: Ugotovljeno je teratogeno delovanje metotreksata pri ljudeh: poročali so o smrti ploda in/ali prirojenih nepravilnostih (npr. obrazno-lobanjskega dela, srčno-žilnega sistema, centralno-živčnega sistema in okončin).
English: Not known: Osteonecrosis of jaw (secondary to lymphoproliferative disorders)
Slovenian: Neznana pogostnost: osteonekroza čeljusti (sekundarno zaradi limfoproliferativnih bolezni)
English: If use of methotrexate during the breast-feeding period should become necessary, breast-feeding is to be stopped prior to treatment.
Slovenian: Če je uporaba metotreksata v času dojenja nujno potrebna, je treba pred začetkom zdravljenja dojenje prekiniti.
English: During treatment with Nordimet, you must not drink any alcohol and should avoid excessive consumption of coffee, soft drinks containing caffeine and black tea as this may enhance side effects or interfere with the efficacy of Nordimet.
Slovenian: Zdravilo Nordimet skupaj s hrano, pijačo in alkoholom Med zdravljenjem z zdravilom Nordimet ne smete uživati alkohola in se izogibajte prekomernemu uživanju kave, brezalkoholnih pijač s kofeinom in črnega čaja, saj lahko okrepijo neželene učinke ali zmanjšajo učinkovitost zdravila Nordimet.
English: The safety shield on the syringe will automatically cover the needle to prevent any needlestick injuries.
Slovenian: Varnostni ščitnik na brizgi po tem avtomatsko pokrije iglo in tako prepreči poškodbe zaradi vboda z iglo.
English: 4) Choose an injection site and clean it with the enclosed alcohol swab.
Slovenian: 4) Izberite mesto injiciranja in ga očistite s priloženo alkoholno blazinico.
English: Hence, methotrexate should be only administered by, or under the supervision of, doctors whose knowledge and experience include the use of antimetabolite therapy.
Slovenian: Zato sme zdravljenje z metotreksatom uvesti in nadzorovati samo zdravnik, ki je usposobljen in izkušen v uporabi antimetabolitov.
English: reactivation of inactive chronic infection), sepsis, conjunctivitis.
Slovenian: Redki: okužba (vključno s ponovno aktivacijo neaktivne kronične okužbe), sepsa, konjunktivitis
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).
Slovenian: Najpogostejši (zelo pogosti) opaženi neželeni učinki metotreksata vključujejo bolezni prebavil (npr. stomatitis, dispepsija, bolečina v trebuhu, navzea, izguba apetita) in nenormalne teste jetrne funkcije (zvišane vrednosti alanin-aminotransferaze (ALAT), aspartat-aminotransferaze (ASAT), bilirubina in alkalne fosfataze).
English: Only clear solutions practically free from particles should be used.
Slovenian: Uporabi se lahko samo bistra raztopina brez vidnih delcev.
English: The pre-filled pens are designed to prevent needlestick injury and reuse.
Slovenian: Napolnjeni injekcijski peresniki so zasnovani tako, da preprečijo poškodbe zaradi vboda z iglo in ponovno uporabo.
English: In patients with impaired renal function, concomitant administration of NSAIDs is not recommended.
Slovenian: Pri bolnikih z okvaro ledvic sočasna uporaba nesteroidnih protivnetnih zdravil (NSAR) ni priporočljiva.
English: In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate as toxicity will markedly increase.
Slovenian: V izjemnih primerih bi bil lahko klinično upravičen odmerek, večji od 25 mg, vendar zaradi izrazitega povečanja toksičnosti tedenski odmerek metotreksata ne sme preseči 30 mg.
English: During methotrexate therapy concurrent vaccination with live vaccines must not be carried out (see sections 4.3 and 4.4).
Slovenian: Cepljenja z živimi cepivi se med zdravljenjem z metotreksatom ne sme izvajati (glejte poglavji 4.3 in 4.4).
English: Women of childbearing potential / contraception in females Women must not get pregnant during methotrexate therapy, and effective contraception must be used during treatment with methotrexate and at least 6 months thereafter (see section 4.4).
Slovenian: Ženske med zdravljenjem z metotreksatom ne smejo zanositi in morajo v času zdravljenja z metotreksatom in še vsaj šest mesecev po njem uporabljati učinkovito kontracepcijo (glejte poglavje 4.4).
English: Nordimet is for single use only.
Slovenian: Zdravilo Nordimet je samo za enkratno uporabo.
English: Response to treatment can generally be expected after 2-6 weeks.
Slovenian: Odziv na zdravljenje lahko pričakujemo na splošno po 2-6 tednih.
English: The safety shield on the pen is now locked to prevent any needlestick injuries.
Slovenian: Ščitnik na peresniku je zdaj zaklenjen, kar preprečuje vsakršne poškodbe z iglo.
English: 6) Choose an injection site and clean it with the enclosed alcohol swab.
Slovenian: 6 ) Izberite mesto injiciranja in ga očistite s priloženo alkoholno blazinico.
English: Immune system disorders Rare: Allergic reactions, anaphylactic shock, hypogammaglobulinaemia.
Slovenian: Bolezni imunskega sistema Redki: alergijske reakcije, anafilaktični šok, hipogamaglobulinemija
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).
Slovenian: Metotreksat lahko zaradi svojega učinka na imunski sistem spremeni odziv na cepljenje in vpliva na rezultate testov (imunološke postopke za ugotavljanje imunskega odziva).
English: Respiratory, thoracic and mediastinal disorders Common: Pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti: pljučnica, intersticijski alveolitis/pljučnica, pogosto povezan z eozinofilijo.
English: Impaired elimination in presence of hepatic insufficiency is not known.
Slovenian: Motnje izločanja zaradi okvare jeter niso znane.
English: Please read section 3 of this leaflet very carefully.
Slovenian: Zelo pozorno preberite poglavje 3 tega navodila za uporabo.
English: Teratogenicity - Reproductive risk
Slovenian: Teratogenost-tveganje za vpliv na reprodukcijo
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.
Slovenian: Kombinacija metotreksata in sulfasalazina lahko z zaviranjem sinteze folne kisline s sulfasalazinom poveča učinkovitost metotreksata in s tem tudi tveganje za nastop neželenih učinkov, vendar je več študij poročalo le o posameznih takšnih primerih.
English: Very rare: Loss of libido, impotence, gynaecomastia, oligospermia, impaired menstruation, vaginal discharge.
Slovenian: Zelo redki: izguba libida, impotenca, ginekomastija, oligospermija, menstrualne motnje, izcedek iz nožnice
English: Musculoskeletal and connective tissue disorders Uncommon: Arthralgia, myalgia, osteoporosis.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni: artralgija, mialgija, osteoporoza
English: Co-administration of medicinal products which cause folate deficiency (e.g. sulphonamides, trimethoprim-sulphamethoxazole) can lead to increased methotrexate toxicity.
Slovenian: Sočasna uporaba zdravil, ki povzročajo pomanjkanje folatov (npr. sulfonamidi, trimetoprim/sulfametoksazol), lahko poveča toksičnost metotreksata.
English: Very rare: Impaired vision, Retinopathy.
Slovenian: Redki: motnje vida Zelo redki: poslabšan vid, retinopatija
English: In the event of any significant drop in leukocytes or platelets, treatment must be discontinued immediately and appropriate supportive therapy instituted.
Slovenian: Ob vsakem občutnejšem padcu števila belih krvničk in krvnih ploščic je treba z uporabo zdravila prekiniti takoj in uvesti ustrezno podporno zdravljenje.
English: Half-life may be prolonged to 4 times the normal length in patients with third spaces (pleural effusion, ascites).
Slovenian: Razpolovni čas je lahko pri bolnikih s tretjim prostorom porazdelitve (plevralni izliv, ascites) do štirikrat daljši od normalne vrednosti.
English: What Nordimet contains
Slovenian: Kaj vsebuje zdravilo Nordimet
English: Cytotoxic: handle with caution.
Slovenian: Citotoksično: ravnajte previdno.
English: BSA), methotrexate has a mean bioavailability of approximately 70%, although considerable inter- and intra-subject variations are possible (25-100%).
Slovenian: Pri uporabi manjših odmerkov (7,5 mg/m² do 80 mg/m² telesne površine) je povprečna biološka uporabnost približno 70 %, vendar pa so možne precejšnje inter- in intraindividualne razlike (25-100 %).
English: Effective methotrexate clearance has been reported with acute, intermittent haemodialysis using a high-flux dialyser.
Slovenian: Poročali so o učinkovitem očistku metotreksata z akutno, intermitentno visokopretočno hemodializo.
English: Central nervous system (CNS) symptoms, such as fatigue and confusion, can occur during treatment.
Slovenian: Med zdravljenjem se lahko pojavijo simptomi centralnega živčnega sistema, kot sta utrujenost in zmedenost.
English: Symptoms typically include dyspnoea, cough (especially a dry non-productive cough), thoracic pain and fever for which patients should be monitored at each follow-up visit.
Slovenian: Značilne simptome, ki vključujejo dispnejo, kašelj (zlasti suh, neproduktiven), bolečino v prsnem košu in zvišano telesno temperaturo, je treba spremljati ob vsakem nadaljnjem obisku pri zdravniku.
English: - Assessment of respiratory system.
Slovenian: - Ocena delovanja dihal.
English: Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic agents.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi za citotoksična zdravila.