FrancophonIA/ELRC3.0 huggingface dataset:
English: 2) Sit or lie in a relaxed, comfortable position.
Slovenian: 2) Udobno sedite ali lezite.
English: This means that the medicine may cause genetic mutation.
Slovenian: To pomeni, da lahko povzroči genske mutacije.
English: If you feel tired or dizzy, you should not drive or use machines.
Slovenian: Če čutite utrujenost ali omotico, ne upravljajte vozil in/ali strojev.
English: Parenteral administration is limited to subcutaneous injection.
Slovenian: Parenteralna uporaba je omejena na subkutano injiciranje.
English: Due to the risk of severe or even fatal toxic reactions, patients should be thoroughly informed by the doctor about the risks (including early signs and symptoms of toxicity) and recommended safety measures.
Slovenian: Zaradi možnosti pojava hudih ali celo smrtno nevarnih toksičnih reakcij mora biti bolnik v celoti seznanjen z možnimi tveganji zdravljenja (vključno z zgodnjimi znaki in simptomi toksičnosti) ter s priporočenimi varnostnimi ukrepi.
English: A blood test will be taken to check for possible reduction of white blood cells (agranulocytosis).
Slovenian: Opravil bo krvne preiskave, da bi preveril morebitno znižanje števila belih krvnih celic (agranulocitoza).
English: Note: the safety system allowing release of the safety shield, can only be activated when the syringe has been emptied by pressing the plunger all the way down.
Slovenian: Opomba: varnostni sistem, ki dopušča odstranitev varnostnega ščitnika, se lahko aktivira samo ko je brizga izpraznjena, tako da bat potisnete do konca navzdol.
English: Increased monitoring frequency should also be considered when increasing the dose.
Slovenian: O večji pogostnosti spremljanja je treba razmisliti tudi ob povečanju odmerka.
English: If serum creatinine is increased, the dose should be reduced.
Slovenian: Če je serumski kreatinin povišan, je treba odmerek zdravila zmanjšati.
English: An overactive immune system has been linked to inflammatory diseases.
Slovenian: Čezmerno aktiven imunski sistem povezujemo z vnetnimi boleznimi.
English: The solution is to be visually inspected prior to use.
Slovenian: Raztopino je treba pred uporabo vizualno preveriti.
English: Approx. 5-20% of methotrexate and 1-5% of 7hydroxymethotrexate are eliminated via the bile.
Slovenian: Približno 5-20 % metotreksata in 1-5 % 7-hidroksimetotreksata se izloči z žolčem.
English: Pulmonary diseases induced by methotrexate were not always completely reversible.
Slovenian: Z metotreksatom povzročene pljučne bolezni niso bile vedno povsem reverzibilne.
English: If the results of any of these tests are abnormal, treatment will only be resumed when all readings are back to normal.
Slovenian: Če so rezultati katere koli od teh preiskav neobičajni, bo zdravljenje prekinjeno, dokler ne bodo vrednosti zopet normalne.
English: Nordimet contains the active substance methotrexate which works by: - reducing inflammation or swelling, and - reducing the activity of the immune system (the body's own defense mechanism).
Slovenian: Zdravilo Nordimet vsebuje učinkovino metotreksat, ki deluje tako, da: - zmanjšuje vnetje ali otekanje in - zmanjšuje aktivnost imunskega sistema (lastni obrambni mehanizem telesa).
English: Do not use this medicine if you notice that the solution is not clear and contains particles.
Slovenian: Ne uporabljajte zdravila Nordimet, če opazite, da raztopina ni bistra in vsebuje delce.
English: Methotrexate may be genotoxic.
Slovenian: Metotreksat je lahko genotoksičen.
English: Also, make sure you drink plenty of liquids during treatment with Nordimet because dehydration (reduction in body water) can increase the toxicity of Nordimet.
Slovenian: Bodite tudi pozorni, da med zdravljenjem z zdravilom Nordimet zaužijete dovolj tekočine, saj lahko dehidracija (zmanjšanje deleža vode v telesu) poveča toksičnost zdravila Nordimet.
English: B-1420 Braine-l'Alleud Belgium
Slovenian: B-1420 Braine-L'Alleud Belgija
English: The appearance and degree of severity of undesirable effects depends on the dosage level and the frequency of administration.
Slovenian: Pojavnost in stopnja resnosti neželenih učinkov sta odvisni od velikosti odmerka in pogostnosti uporabe zdravila.
English: What you need to know before you use Nordimet
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Nordimet
English: 8) Apply downward pressure on the pen on to your skin until you hear and feel a “click”.
Slovenian: 8) Pritiskajte peresnik na kožo, dokler ne zaslišite in začutite »klik«.
English: In case of contamination, the affected parts are to be rinsed immediately with plenty of water (see section 6.6).
Slovenian: V primeru kontaminacije je treba prizadeto območje takoj sprati z obilo vode (glejte poglavje 6.6).
English: The safety and efficacy of Nordimet in children < 3 years of age have not been established (see section 4.4).
Slovenian: Varnost in učinkovitost zdravila Nordimet pri otrocih, mlajših od 3 let, nista bili dokazani (glejte poglavje 4.4).
English: 4) Precaution: DO NOT lift the product by the plunger or needle cover.
Slovenian: 4) Opozorilo: NE dvignite zdravila s pokrovom bata ali igle.
English: Further research is needed to establish whether serial liver chemistry tests or propeptide of type III collagen can detect hepatotoxicity sufficiently.
Slovenian: Potrebne so nadaljnje raziskave, da bi ugotovili, ali lahko z rednimi serijskimi kemijskimi jetrnimi testi ali z določanjem propeptida kolagena tipa III v zadostni meri odkrijemo hepatotoksičnost.
English: The dose for elderly patients should be lowered due to age-related reduced liver and kidney function.
Slovenian: Odmerek pri starejših ljudeh mora biti manjši zaradi zmanjšane ledvične in jetrne funkcije, povezane s starostjo.
English: Such abnormalities should return to normal within two weeks; after which, treatment may be resumed at the discretion of the doctor.
Slovenian: Take bolezenske spremembe naj bi se normalizirale v dveh tednih, potem pa se lahko zdravnik po lastni presoji odloči za ponovno uvedbo zdravljenja.
English: Patients must be instructed to report all signs and symptoms suggestive of infection.
Slovenian: Bolnikom je treba svetovati, naj poročajo o vseh znakih in simptomih, ki bi lahko kazali na okužbo.
English: A mutagenic effect is suspected in humans.
Slovenian: Pri ljudeh obstaja sum na mutageni učinek.
English: This is to make sure that the needle stays clean.
Slovenian: Tako bo igla ostala čista.
English: Clear, yellow solution with a pH of 8.0-9.0 and an osmolality of approximately 300 mOsm/kg.
Slovenian: Bistra, rumena raztopina z vrednostjo pH 8,0-9,0 in osmolalnostjo približno 300 mOsm/kg.
English: Do not press on the plunger before injecting yourself to get rid of air bubbles.
Slovenian: Ne pritiskajte na bat pred injiciranjem, da bi se znebili zračnih mehurčkov.
English: What Nordimet is and what it is used for
Slovenian: Kaj je zdravilo Nordimet in za kaj ga uporabljamo
English: Children, adolescents and the elderly being treated with Nordimet should be kept under close medical surveillance to identify possible side effects as early as possible.
Slovenian: Otroci, mladostniki in starejši ljudje, zdravljeni z zdravilom Nordimet, morajo biti pod temeljitim zdravstvenim nadzorom, da se morebitni neželeni učinki prepoznajo čim bolj zgodaj.
English: Use only once a week on …………………………………………………………….. (include weekday of use in full)
Slovenian: Uporabite samo enkrat na teden v …………………………………………………………….. (napišite dan v tednu s celo besedo)
English: These effects appear to be reversible after discontinuation of therapy in most cases.
Slovenian: Zdi se, da so ti učinki v večini primerov po prekinitvi zdravljenja reverzibilni.
English: If not, use another pen.
Slovenian: V nasprotnem primeru uporabite drug peresnik.
English: Special precautionary measures for treatment with Nordimet Methotrexate temporarily affects sperm and egg production, which is reversible in most cases.
Slovenian: Posebni previdnostni ukrepi med zdravljenjem z zdravilom Nordimet Metotreksat začasno prizadene tvorbo semenske tekočine in jajčec, kar je v večini primerov reverzibilno.
English: An overdose of methotrexate can lead to severe toxic reactions.
Slovenian: Prevelik odmerek metotreksata lahko povzroči hude toksične reakcije.
English: Before the start of treatment and recommended follow-up examinations and precautions Before treatment is started your doctor may carry out blood tests, and also check how well your kidneys and liver are working.
Slovenian: Pred začetkom zdravljenja in priporočeni kontrolni pregledi ter previdnostni ukrepi Pred začetkom zdravljenja bo vaš zdravnik morda opravil krvne preiskave ter preveril delovanje vaših ledvic in jeter.
English: Pulmonary diseases induced by methotrexate, like pneumonitis, can occur acutely at any time of therapy, they were not always completely reversible and have been reported already at all doses (inclusive low doses of 7.5 mg/week).
Slovenian: Z metotreksatom povzročene pljučne bolezni, kot je pljučnica, se lahko pojavijo nenadoma kadar koli med zdravljenjem, niso vedno povsem reverzibilne in so o njih že poročali pri skoraj vseh odmerkih (vključno z majhnimi odmerki 7,5 mg na teden).
English: If the test dose is well tolerated, treatment will be continued after a week with a dose of approximately 7.5 mg.
Slovenian: Če boste poskusni odmerek dobro prenašali, boste po enem tednu nadaljevali zdravljenje z odmerkom približno 7,5 mg.
English: If not, use another syringe.
Slovenian: V nasprotnem primeru uporabite drugo brizgo.
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.
Slovenian: Na voljo so nezadostni podatki za izpostavljenost metotreksatu med nosečnostjo pri odmerkih nad 30 mg na teden, vendar so pričakovane višje stopnje spontanih splavov in prirojenih malformacij.
English: Nordimet may cause serious (sometimes life-threatening) side effects.
Slovenian: Zdravilo Nordimet lahko povzroči resne (včasih tudi življenjsko ogrožajoče) neželene učinke.
English: Female patients of reproductive potential must be counselled regarding pregnancy prevention and planning.
Slovenian: Bolnicam v rodnem obdobju je potrebno svetovati glede preprečevanja in načrtovanja nosečnosti.
English: Methotrexate affects spermatogenesis and oogenesis and may decrease fertility.
Slovenian: Metotreksat vpliva na spermatogenezo in oogenezo in lahko zmanjša plodnost.
English: If you suspect that you have used too much Nordimet, tell your doctor or contact the nearest hospital immediately.
Slovenian: Če sumite, da ste uporabili prevelik odmerek zdravila Nordimet, takoj obvestite zdravnika oziroma najbližjo bolnišnico.
English: Dehydration may also potentiate the toxicity of methotrexate.
Slovenian: Tudi dehidracija lahko poveča toksičnost metotreksata.
English: You may also have a chest X-ray.
Slovenian: Morda boste opravili tudi rentgensko slikanje prsnega koša.
English: Nordimet has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Nordimet ima blag vpliv na sposobnost vožnje in upravljanja strojev.
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.
Slovenian: Študije na živalih so pokazale, da je metotreksat genotoksičen, zato se tveganja za genotoksične učinke na semenčice ne more popolnoma izključiti.
English: Patients with JIA should always be referred to a rheumatology unit specializing in the treatment of children/adolescents.
Slovenian: Bolnike z JIA je treba vselej napotiti na oddelek za revmatologijo, ki se ukvarja z zdravljenjem otrok/mladostnikov.
English: Pulmonary symptoms require a quick diagnosis and discontinuation of methotrexate therapy.
Slovenian: Pljučni simptomi zahtevajo hitro diagnosticiranje in prekinitev uporabe metotreksata.
English: Nordimet may cause a reduction in the number of white blood cells and your resistance to infection may be decreased.
Slovenian: Zdravilo Nordimet lahko povzroči zmanjšanje števila belih krvnih celic in posledično manjšo odpornost na okužbe.
English: Nordimet is for subcutaneous use (see section 6.6.
Slovenian: Zdravilo Nordimet je namenjeno subkutani uporabi (glejte poglavje 6.6).
English: You and your doctor can decide on a suitable day each week to receive your injection.
Slovenian: Skupaj z zdravnikom določite en dan v tednu, na katerega boste prejemali injekcijo.
English: Do not try to inject yourself if you have not been trained on how to do so.
Slovenian: Zdravila si ne poskušajte injicirati sami, če za to niste bili usposobljeni.
English: In the event of contamination, the affected area must be rinsed immediately with ample amount of water.
Slovenian: V primeru kontaminacije je treba prizadeto območje takoj sprati z obilno količino vode.
English: Other medicines and Nordimet
Slovenian: Druga zdravila in zdravilo Nordimet
English: Prior to using folic acid products, monitoring of vitamin B12 levels is recommended, since folic acid may mask an existing vitamin B12 deficiency, particularly in adults over 50 years of age.
Slovenian: Pred uporabo pripravkov s folno kislino je priporočljivo spremljanje vrednosti vitamina B12, saj lahko folna kislina prikrije njegovo pomanjkanje, predvsem pri bolnikih, starejših od 50 let.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: In rhesus monkeys, no malformations comparable to humans occurred.
Slovenian: Pri opicah rhesus se ni pojavila nobena malformacija, ki bi jo lahko primerjali z ljudmi.
English: Upon being distributed into body tissues, high concentrations particularly in liver, kidneys and spleen in form of polyglutamates can be found, which can be retained for weeks or months.
Slovenian: Po porazdelitvi v telesna tkiva najdemo zlasti v jetrih, ledvicah in vranici visoke koncentracije metotreksata v obliki poliglutamatov, ki se lahko zadržijo tam več tednov ali mesecev.
English: Special caution is required in patients with impaired pulmonary function.
Slovenian: Posebna previdnost je potrebna pri bolnikih z okvarjenim delovanjem pljuč.
English: Particular attention should be paid to the onset of liver toxicity.
Slovenian: Pojavu jetrne toksičnosti je treba nameniti posebno pozornost.
English: After oral application, methotrexate is absorbed from the gastrointestinal tract.
Slovenian: Po peroralni uporabi se metotreksat absorbira iz gastrointestinalnega trakta.
English: The absence of pregnancy must be confirmed before Nordimet is used.
Slovenian: Pred uporabo zdravila Nordimet je potrebno potrditi odsotnost nosečnosti.
English: In case of renal insufficiency, elimination is delayed significantly.
Slovenian: V primeru okvare ledvic se izločanje znatno podaljša.
English: Methotrexate induces gene and chromosome mutations both in vitro and in vivo.
Slovenian: Metotreksat povzroča genske in kromosomske mutacije tako in vitro kot in vivo.
English: Excretion takes place, mainly in unchanged form, primarily renal via glomerular filtration and active secretion in the proximal tubulus.
Slovenian: Metotreksat se izloča v večinoma nespremenjeni obliki predvsem skozi ledvice z glomerulno filtracijo in aktivno sekrecijo v proksimalnih tubulih.
English: Nordimet must not be used
Slovenian: Zdravila Nordimet se ne sme uporabiti.
English: Calcium folinate is the specific antidote for neutralising the adverse toxic effects of methotrexate.
Slovenian: Kalcijev folinat je specifičen antidot, ki nevtralizira neželene toksične učinke metotreksata.
English: Some patients showed no signs of overdose.
Slovenian: Pri nekaterih bolnikih se pri prevelikem odmerjanju simptomi niso pojavili.
English: If pregnancy occurs during treatment with methotrexate and up to six months thereafter, medical advice should be given regarding the risk of harmful effects on the child associated with treatment and ultrasonography examinations should be performed to confirm normal foetal development.
Slovenian: Če pride do nosečnosti med zdravljenjem z metotreksatom in do šest mesecev po njem, se mora bolnica posvetovati z zdravnikom o tveganju za škodljive učinke na otroka, povezanega z zdravljenjem, in opraviti ultrazvočne preiskave za potrditev normalnega razvoja plodu.
English: It acts by the competitive inhibition of the enzyme dihydrofolate reductase and thus inhibits DNA synthesis.
Slovenian: Deluje s kompetitivnim zaviranjem encima dihidrofolat-reduktaze in tako zavira sintezo DNK.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Very rare: lymphoma (see “description” below)
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Zelo redki: limfom (glejte »opis« spodaj)
English: See also section “Pregnancy, breast-feeding and fertility”.
Slovenian: Glejte tudi poglavje »Nosečnost, dojenje in plodnost«.
English: - Examination of the oral cavity and throat for mucosal changes.
Slovenian: - Pregled ustne votline in žrela glede sprememb na sluznici.
English: Chronic toxicity studies in mice, rats and dogs showed toxic effects in the form of gastrointestinal lesions, myelosuppression and hepatotoxicity.
Slovenian: Študije kronične toksičnosti na miših, podganah in psih so pokazale toksične učinke v obliki gastrointestinalnih lezij, mielosupresije in hepatotoksičnosti.
English: Once Nordimet starts working, the doctor may reduce the dose gradually to the lowest possible effective maintenance dose.
Slovenian: Ko začne zdravilo Nordimet delovati, lahko zdravnik postopoma zmanjšuje odmerek do najmanjšega možnega učinkovitega vzdrževalnega odmerka.
English: Depending on the effects of treatment and results of blood and urine tests, the therapy is then continued or stopped.
Slovenian: Glede na učinek zdravljenja ter rezultate krvnih in urinskih preiskav z zdravljenjem nadaljujemo ali ga prekinemo.
English: Patients receiving therapy should be appropriately monitored, so that signs of possible toxic effects or adverse reactions can be recognised and assessed without delay.
Slovenian: Bolniki, ki se zdravijo, morajo biti pod ustreznim nadzorom, tako da se lahko čim prej odkrije in oceni znake morebitnih toksičnih ali neželenih učinkov.
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.
Slovenian: Pri bolnikih s patološkim kopičenjem tekočin v telesnih votlinah (»tretji prostor«), kot sta ascites ali plevralni izliv, je razpolovni čas izločanja metotreksata iz plazme podaljšan.
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)
Slovenian: Pri starejših ljudeh je treba razmisliti o zmanjšanju odmerka zaradi zmanjšanega delovanja jeter in ledvic ter manjših rezerv folata, ki so posledica starosti (glejte poglavja 4.4, 4.5, 4.8 ali 5.2).
English: Long-term studies in rats, mice and hamsters did not show any evidence of a tumorigenic potential of methotrexate.
Slovenian: Dolgotrajne študije na podganah, miših in hrčkih niso pokazale tumorogenega potenciala metotreksata.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http//www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: The average weekly dose is 15-20 mg. Generally, a weekly dose of 25 mg should not be exceeded.
Slovenian: Povprečni tedenski odmerek znaša 15−20 mg. Na splošno se ne sme preseči tedenskega odmerka 25 mg.
English: Do not use if the date has passed.
Slovenian: Zdravila ne uporabite, če je rok uporabnosti že potekel.
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.
Slovenian: Limfom/limfoproliferativne bolezni: poročali so o posameznih primerih pojava limfoma in drugih limfoproliferativnih bolezni, ki pa je v številnih primerih po prekinitvi zdravljenja z metotreksatom izzvenel.
English: In the event of a constant increase in liver-related enzymes, consideration should be given to reducing the dose or discontinuing therapy.
Slovenian: V primeru stalnega povišanja vrednosti jetrnih encimov je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
English: 3) The syringe is pre-filled and ready to use.
Slovenian: 3) Brizga je napolnjena in pripravljena za uporabo.
English: Generally, improvement of symptoms can be expected after 4-8 weeks of treatment.
Slovenian: Izboljšanje simptomov lahko na splošno pričakujemo po 4-8 tednih zdravljenja.
English: 8) Hold the syringe in the hand you write with (like a pencil) and with your other hand, make a fold in the skin by gently pinching the skin of the injection place with your forefinger and thumb.
Slovenian: 8) Držite brizgo v roki s katero pišete (kot svinčnik), s palcem in kazalcem druge roke pa nežno stisnite kožo na mestu injiciranja, tako da ustvarite kožno gubo.
English: The following syringes are available:
Slovenian: Na voljo so naslednje brizge:
English: Do not miss appointments for blood tests.
Slovenian: Ne izpuščajte dogovorjenih obiskov pri zdravniku za opravljanje krvnih preiskav.
English: Subcutaneous, intravenous and intramuscular administration demonstrated similar bioavailability.
Slovenian: Subkutana, intravenska in intramuskularna uporaba izkazujejo podobno biološko uporabnost.
English: Methotrexate may reduce theophylline clearance.
Slovenian: Metotreksat lahko zmanjša očistek teofilina.
English: The major metabolite is 7-hydroxymethotrexate.
Slovenian: Glavni presnovek je 7-hidroksimetotreksat.
English: The adverse toxic effects of methotrexate mainly affect the haematopoietic and gastrointestinal system.
Slovenian: Neželeni toksični učinki metotreksata prizadenejo predvsem hematopoetski in gastrointestinalni sistem.
English: For higher doses, there is insufficient data to estimate the risks of malformations or miscarriage following paternal exposure.
Slovenian: Za večje odmerke ni dovolj podatkov za oceno tveganja malformacij ali splavov po izpostavljenosti pri očetu.
English: - Methotrexate may, due to its effect on the immune system, impair the response to vaccinations and interfere with the result of immunological tests.
Slovenian: - Metotreksat lahko zaradi svojega učinka na imunski sistem spremeni odziv na cepljenje in vpliva na rezultate imunoloških preiskav.
English: Depending on the clinical picture and the changes of laboratory parameters, the therapy is then continued or discontinued.
Slovenian: Glede na klinično sliko in spremembe laboratorijskih parametrov z zdravljenjem bodisi nadaljujemo bodisi ga prekinemo.
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).
Slovenian: Nemudoma obvestite svojega zdravnika, če se pojavi nenadno sopenje, težave z dihanjem, zatekanje očesnih vek, obraza ali ustnic, izpuščaj ali srbenje (zlasti, če prizadene celo telo).
English: Use in children under 3 years of age is not recommended due to insufficient experience of using this medicine in this age group.
Slovenian: Uporaba zdravila pri otrocih, mlajših od 3 let, ni priporočljiva zaradi nezadostnih podatkov o varnosti in učinkovitosti v tej starostni skupini.
English: Rare: Stress fracture.
Slovenian: Redki: stresni zlom
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.
Slovenian: Kot previdnostni ukrepi se spolno aktivnim bolnikom ali njihovim partnericam priporoča uporaba učinkovite kontracepcije med zdravljenjem bolnika in vsaj 6 mesecev po prenehanju uporabe metotreksata.