FrancophonIA/ELRC3.0 huggingface dataset:
English: Jylamvo is a medicine that: - suppresses the growth of certain cells in the body that multiply rapidly (an anticancer medicine) - reduces unwanted reactions by the body's own defense mechanisms (an immunosuppressive agent) - has an anti-inflammatory effect
Slovenian: − zavira rast določenih celic v telesu, ki se hitro množijo (je zdravilo proti raku); − zmanjšuje število neželenih reakcij, ki jih povzročijo lastni obrambni mehanizmi telesa (je imunosupresiv);
English: Tell your doctor immediately if you suddenly get wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
Slovenian: Nemudoma obvestite zdravnika, če se pojavi nenadno sopenje, težave z dihanjem, zatekanje očesnih vek, obraza ali ustnic, izpuščaj ali srbenje (zlasti, če prizadene celo telo).
English: Dysarthria, Unusual cranial sensations, Tinnitus
Slovenian: neobičajni občutki v lobanji, tinitus
English: Keep to this dose exactly.
Slovenian: Natančno upoštevajte odmerek.
English: Neither haemodialysis nor peritoneal dialysis has been shown to improve the elimination of methotrexate.
Slovenian: Ugotovljeno je, da niti hemodializa niti peritonealna dializa ne pospešita izločanja metotreksata.
English: Jylamvo is for oral use and provided ready for use.
Slovenian: Zdravilo Jylamvo je namenjeno peroralni uporabi in je pripravljeno za uporabo.
English: The plunger should be pushed back gently to the seated position until it clicks into place.
Slovenian: Bat morate nežno potisniti nazaj v njegovo sedišče, dokler se ne zaskoči.
English: This evaluation should differentiate between patients with no risk factors and patients with risk factors, such as excessive prior alcohol consumption, persistent elevation of liver enzymes, history of liver disease, family history of a hereditary liver disease, diabetes mellitus, obesity and history of significant exposure to hepatotoxic medicinal product or chemicals, as well as prolonged methotrexate treatment or a cumulative total dose 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 in 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: Never take a double dose to make up for a forgotten dose but continue with the prescribed dose.
Slovenian: Če ste pozabili vzeti zdravilo Jylamvo Nikoli ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, ampak nadaljujte jemanje predpisanega odmerka.
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).
Slovenian: Eno pakiranje vsebuje eno stekleničko, nastavek za stekleničko iz LDPE in brizgo za odmerjanje iz belega polipropilena velikosti 10 ml (z večjimi razdelki skale na vsak ml in z manjšimi na vsakih 0,25 ml).
English: Always use the syringe provided to take your medicine.
Slovenian: Za jemanje zdravila vedno uporabljajte priloženo brizgo.
English: Higher dosages should be given parenterally.
Slovenian: Višje odmerke je treba dajati parenteralno.
English: Your doctor will tell you what dose you should take for your condition and when you should take the dose.
Slovenian: Zdravnik vam bo glede na vaše stanje povedal, kakšen odmerek morate vzeti in kdaj.
English: Do not miss your blood test appointments.
Slovenian: Ne izpuščajte dogovorjenih obiskov pri zdravniku za opravljanje krvnih preiskav.
English: In particular, elderly patients should be monitored at short intervals for early signs of toxicity (see section 4.2).
Slovenian: Zlasti pri starejših bolnikih je treba v kratkih časovnih presledkih preverjati zgodnje znake toksičnosti (glejte poglavje 4.2).
English: Calcium folinate is the specific antidote for neutralising the adverse toxic effects of methotrexate.
Slovenian: Kalcijev folinat je posebna oblika antidota, ki nevtralizira neželene toksične učinke metotreksata.
English: Contact with the skin or mucous membrane must be avoided.
Slovenian: Preprečevati je treba stik s kožo ali sluznico.
English: Important warning about the dosage of Jylamvo (methotrexate)
Slovenian: Pomembno opozorilo glede odmerjanja zdravila Jylamvo (metotreksat)
English: Lymphoma1
Slovenian: limfom1
English: − depression
Slovenian: − depresija,
English: Highly proliferating tissue such as malignant cells, bone marrow, foetal cells, skin epithelium and mucosa is generally more sensitive to this effect of methotrexate.
Slovenian: Hitro proliferajoča tkiva, kot so maligne celice, kostni mozeg, zarodne celice, kožni epitelij in sluznica, so po navadi bolj občutljiva na ta učinek metotreksata.
English: • Active rheumatoid arthritis in adult patients.
Slovenian: • aktivnega revmatoidnega artritisa pri odraslih bolnikih,
English: Methotrexate can cause birth defects, harm the unborn child or cause miscarriage.
Slovenian: Metotreksat lahko povzroči prirojene okvare, škoduje nerojenim otrokom ali povzroči splav.
English: Dose reduction should be considered in elderly patients (65 years and over) due to reduced liver and kidney function as well as low folic acid reserves which occur with increased age.
Slovenian: Pri starejših ljudeh (starejših od 65 let) je treba razmisliti o zmanjšanju odmerka zaradi zmanjšanega delovanja jeter in ledvic ter manjših rezerv folne kisline, ki so posledica starosti.
English: Increased caution is required in patients with insulin-dependent diabetes mellitus as hepatic cirrhosis has developed in individual cases without any elevation of transaminases during methotrexate treatment.
Slovenian: - Večja previdnost je potrebna pri bolnikih z od insulina odvisno sladkorno boleznijo, saj se je med zdravljenjem z metotreksatom v posameznih primerih pojavila jetrna ciroza brez kakršnega koli zvišanja vrednosti transaminaz.
English: Before beginning treatment or resuming treatment after a recovery period Complete blood count with differential blood count and platelets, liver enzymes, bilirubin, serum albumin, chest X-ray and renal function tests.
Slovenian: Pred začetkom zdravljenja ali ob ponovnem pričetku zdravljenja po obdobju okrevanja Treba je opraviti celotno krvno sliko z diferencialno krvno sliko in krvnimi ploščicami, teste jetrnih encimov, bilirubina, serumskega albumina, rentgensko slikanje prsnega koša in teste delovanja ledvic.
English: In chronic toxicity studies in mice, rats and dogs, toxic effects were seen 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: If you stop taking Jylamvo
Slovenian: Če ste prenehali jemati zdravilo Jylamvo
English: Impaired elimination in patients with hepatic impairment is not known at present.
Slovenian: Motnje izločanja pri bolnikih z okvaro jeter niso znane.
English: Particular caution is required in patients with impaired pulmonary function.
Slovenian: - Posebna previdnost je potrebna pri bolnikih z okvarjenim delovanjem pljuč.
English: Dehydration may also intensify the toxicity of methotrexate.
Slovenian: Tudi dehidracija lahko poveča toksične učinke metotreksata.
English: It has not yet been possible to date to clarify whether the efficacy of methotrexate in the management of psoriasis, psoriatic arthritis and chronic polyarthritis is due either to an anti-inflammatory or immunosuppressive effect, or to what extent a methotrexate-induced increase in extracellular adenosine concentration at inflamed sites contributes to this effect.
Slovenian: Še vedno ni pojasnjeno, ali je učinkovitost metotreksata pri obvladovanju psoriaze, psoriatičnega artritisa in kroničnega poliartritisa posledica protivnetnega ali imunosupresivnega učinka in koliko k tem učinkom prispeva povečanje zunajcelične koncentracije adenozina na mestih vnetja zaradi metotreksata.
English: It is not known if methotrexate is present in semen.
Slovenian: Ni znano, ali se metotreksat izloča v semensko tekočino.
English: It is important to determine any increase in active substance levels within 48 hours of therapy, otherwise irreversible methotrexate toxicity may occur.
Slovenian: Pomembno je, da se morebitno zvišanje koncentracij zdravilne učinkovine odkrije v 48 urah zdravljenja, sicer se lahko pojavijo nereverzibilni toksični učinki metotreksata.
English: - Renal function should be monitored by renal function tests and urinalyses.
Slovenian: - Delovanje ledvic je treba spremljati s preiskavami ledvic in analizami urina.
English: Mucositis generally appears about 3 to 7 days after methotrexate application, leucopenia and thrombocytopenia follow a few days later.
Slovenian: Mukozitis se običajno pojavi od 3 do 7 dni po uporabi metotreksata, nekaj dni pozneje pa sledita še levkopenija in trombocitopenija.
English: Due to its effect on the immune system, methotrexate may impair the response to vaccinations and affect the results of immunological tests.
Slovenian: Imunski sistem Metotreksat lahko zaradi svojega učinka na imunski sistem spremeni odziv na cepljenje in vpliva na rezultate imunoloških preiskav.
English: In one case in which methotrexate was combined with pantoprazole, renal elimination of the metabolite 7-hydroxymethotrexate was inhibited and myalgia and shivering occurred.
Slovenian: V enem primeru, pri katerem so metotreksat kombinirali s pantoprazolom, so poročali o zaviranju ledvičnega izločanja presnovka 7-hidroksimetotreksata ter pojavu mialgije in drhtenja.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznam EURD), opredeljenem v členu 107c(7)
English: In psoriasis, cell proliferation of the epithelium is markedly increased compared with normal skin.
Slovenian: Proliferacija celic epitelija pri psoriazi je v primerjavi s proliferacijo celic epitelija pri normalni koži izrazito hitrejša.
English: - Liver function tests - particular attention should be given to the appearance of liver toxicity.
Slovenian: - Preiskave delovanja jeter - pojavu jetrne toksičnosti je treba nameniti posebno pozornost.
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 v rodni dobi/kontracepcija pri ženskah 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: Acute liver degeneration, Liver failure, Reactivation of chronic hepatitis,
Slovenian: akutna degeneracija jeter, jetrna odpoved, reaktivacija kroničnega hepatitisa,
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic products.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi za citotoksična zdravila.
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: After oral administration, methotrexate is absorbed from the gastrointestinal tract.
Slovenian: Absorpcija Po peroralni uporabi se metotreksat absorbira iz gastrointestinalnega trakta.
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, je treba uvesti zdravljenje s kortikosteroidi, zdravljenja z metotreksatom pa ne smemo znova začeti.
English: Jylamvo should be prescribed only by doctors who are familiar with the properties of the medicine and how it works.
Slovenian: Zdravilo Jylamvo lahko predpišejo le zdravniki, ki poznajo njegove lastnosti in delovanje.
English: If you notice any symptoms of an infection such as fever or a marked worsening in your general state of health or fever with local signs of an infection such as sore throat/inflammation of the throat or mouth or problems passing water, see your doctor immediately.
Slovenian: Če opazite kakršne koli simptome okužbe, kot je zvišana telesna temperatura ali izrazito poslabšanje splošnega zdravstvenega stanja ali zvišana telesna temperatura s simptomi lokalne okužbe, npr. boleče grlo/vneto žrelo ali vneta usta ali težave z uriniranjem, nemudoma obiščite zdravnika.
English: This can be done with methotrexate as an intramuscular or subcutaneous administration and is recommended for patients who exhibit inadequate absorption of the oral form of methotrexate or who do not tolerate oral administration well.
Slovenian: To je mogoče z dajanjem metotreksata intramuskularno ali subkutano in je priporočljivo za bolnike, pri katerih absorpcija peroralne oblike metotreksata ni zadostna, ali bolnike, ki peroralnega dajanja ne prenašajo dobro.
English: Radiotherapy during the use of methotrexate can increase the risk for soft tissue or bone necrosis.
Slovenian: Radioterapija med uporabo metotreksata lahko poveča tveganje za nekrozo mehkih tkiv ali kosti.
English: Common accepted single doses lie in the range of 20-40 mg (10-20 ml)/m² body surface area.
Slovenian: Splošno sprejeti posamezni odmerki znašajo 20-40 mg (10-20 ml)/m² telesne površine.
English: • The potential for fatal overdose due to medication errors (ME), including daily instead of once weekly use;
Slovenian: • informacije o možnosti prevelikega odmerjanja s smrtnim izidom zaradi napak pri uporabi zdravila, vključno z odmerjanjem vsak dan namesto enkrat na teden;
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.
Slovenian: Simptomi, povezani s pljuči (še posebno suh, neproduktiven kašelj), ali nespecifični pnevmonitis, ki se pojavi med zdravljenjem z metotreksatom, so lahko znak, da je prišlo do morebitne nevarne okvare; zdravljenje je v takem primeru treba prekiniti in uvesti natančno spremljanje.
English: For more information, please read the patient leaflet inserted in the package.
Slovenian: Za več informacij preberite navodilo za uporabo, ki je priloženo pakiranju zdravila.
English: Probenecid and weak organic acids can also reduce the tubular secretion of methotrexate and thus likewise cause an indirect increase in dose.
Slovenian: Probenecid in šibke organske kisline lahko zmanjšajo tubularno izločanje metotreksata ter s tem prav tako posredno povečajo njegov odmerek.
English: Each pack contains one bottle, a bottle adaptor and a white dosing syringe.
Slovenian: Eno pakiranje vsebuje eno stekleničko, nastavek za stekleničko in belo brizgo za odmerjanje.
English: Ensure that you drink a lot of fluids during treatment with Jylamvo because dehydration (the reduction of body water) can increase the side effects of methotrexate.
Slovenian: Med zdravljenjem z zdravilom Jylamvo poskrbite, da boste zaužili dovolj tekočine, saj lahko dehidracija (zmanjšanje deleža vode v telesu) poveča toksičnost metotreksata.
English: Take Jylamvo only once a week.
Slovenian: Zdravilo Jylamvo jemljite samo enkrat tedensko.
English: It is recommended to check levels of vitamin B12 prior to initiating folic acid supplementation, particularly in adults aged over 50 years, as folic acid intake may mask a vitamin B12 deficiency.
Slovenian: Pred dodajanjem folne kisline je predvsem pri bolnikih, starejših od 50 let, priporočljivo spremljanje vrednosti vitamina B12, saj lahko folna kislina prikrije njegovo pomanjkanje.
English: In the event of a massive overdose, hydration and alkalinisation of the urine may be required to prevent precipitation of methotrexate and/or its metabolites in the renal tubules.
Slovenian: Pri izrazito prevelikem odmerjanju bosta za preprečitev precipitacije metotreksata in/ali njegovih presnovkov v ledvičnih tubulih morda potrebni hidratacija in alkalizacija urina.
English: Patients with pathological fluid accumulations (pleural effusion, ascites) As the half-life of methotrexate can be prolonged four-fold in patients with pathological fluid accumulations, it may be necessary to reduce the dose and in some cases even to discontinue methotrexate (see sections 4.4 and 5.2).
Slovenian: Bolniki s patološkim kopičenjem tekočin (plevralnim izlivom, ascitesom) Ker je lahko razpolovni čas metotreksata pri bolnikih s patološkim kopičenjem tekočin štirikrat daljši od normalnega, bo pri teh bolnikih morda treba zmanjšati odmerek, v nekaterih primerih pa uporabo metotreksata opustiti (glejte poglavji 4.4 in 5.2).
English: Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction and amenorrhoea in humans during and for a short period after the discontinuation of treatment, 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 zmanjšani plodnosti, oligospermiji, menstrualnih motnjah in amenoreji med zdravljenjem in kratek čas po prekinitvi zdravljenja, kar vpliva na spermatogenezo in oogenezo med časom jemanja - za te učinke se zdi, da so po prekinitvi zdravljenja reverzibilni.
English: - cancer treatments ( such as doxorubicin and procarbazine during high-dose methotrexate therapy)
Slovenian: − zdravila proti raku (kot sta doksorubicin in prokarbazin v času zdravljenja z visokim odmerkom metotreksata)
English: − black or tarry stools
Slovenian: − črno ali katranasto blato,
English: Put the cap back on the bottle with the adaptor left in place.
Slovenian: Pokrovček namestite nazaj na stekleničko, pri čemer nastavek pustite nameščen.
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 teratogeno delovanje pri ljudeh in je povezan s povečanim tveganjem za spontane splave, intrauterini zaostanek v rasti ter kongenitalne malformacije v primeru izpostavljenosti med nosečnostjo.
English: Methotrexate can reduce the number of white blood cells and therefore weaken your immune defences.
Slovenian: Metotreksat lahko povzroči zmanjšanje števila belih krvnih celic in posledično slabši imunski odziv.
English: Especially strict monitoring of the patient is indicated following prior radiotherapy (especially of the pelvis), functional impairment of the haematopoietic system (e.g., following prior radio- or chemotherapy), impaired general condition as well as advanced age and in very young children.
Slovenian: Še posebno strog nadzor je potreben pri bolnikih, ki so predhodno prestali radioterapijo (zlasti medenice), pri bolnikih z okvarjenim delovanjem hematopoetskega sistema (npr. po predhodni radioterapiji ali kemoterapiji), pri splošno oslabelih bolnikih ter pri starostnikih in zelo majhnih otrocih.
English: Concurrent folic acid supplementation of 5 mg twice weekly (except on the day of administration) is indicated additionally.
Slovenian: Dodatno je indicirano sočasno dodajanje 5 mg folne kisline dvakrat tedensko (razen na dan jemanja odmerka).
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.
Slovenian: Pri dajanju nesteroidnih protivnetnih zdravil in metotreksata v razmaku 24 ur je potrebna previdnost, saj se v tem primeru lahko povišajo vrednosti metotreksata v plazmi, zaradi česar se poveča tudi toksičnost.
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.
Slovenian: Če se zdravilo uporablja med nosečnostjo ali če bolnica med zdravljenjem z metotreksatom zanosi, jo je treba obvestiti o možnih tveganjih za plod.
English: Turn the bottle back the right way up and carefully remove the syringe from the adaptor, holding the syringe by the barrel rather than the plunger.
Slovenian: Stekleničko obrnite nazaj s pravilno smerjo navzgor in pazljivo odstranite brizgo z nastavka, pri čemer je ne držite za bat, ampak za telo.
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.
Slovenian: Razpoložljivi dokazi ne kažejo na povečano tveganje za prirojene okvare ali splav, če oče jemlje manj kot 30 mg (15 ml) metotreksata na teden.
English: Doses are usually based on the patient's BSA and maintenance treatment represents a long-term treatment.
Slovenian: Odmerki so običajno določeni glede na bolnikovo telesno površino, vzdrževalno zdravljenje pa je dolgoročno.
English: Do not interrupt or stop the treatment with Jylamvo without first discussing this with your doctor.
Slovenian: Zdravljenja z zdravilom Jylamvo ne smete prekiniti brez predhodnega posveta z zdravnikom.
English: DO NOT push down the plunger too hard or squirt the medicine to the back of the mouth or throat as this may cause choking.
Slovenian: NE potiskajte navzdol premočno in zdravila NE brizgajte v zadnji del ust ali žrelo, saj lahko to povzroči dušenje.
English: − lymphoproliferative disorders (excessive growth of white blood cells)
Slovenian: − limfoproliferativne bolezni (prevelika rast belih krvničk),
English: • Major birth defects occurred in 6.6% of live births in women exposed to low-dose methotrexate treatment (less than 30 mg [15 ml]/week) during pregnancy, compared to approximately 4% of live births in disease-matched patients treated with drugs other than methotrexate.
Slovenian: • Hude prirojene okvare so bile prisotne pri 6,6 % živorojenih otrok žensk, ki so bile med nosečnostjo izpostavljene zdravljenju z majhnimi odmerki metotreksata (manj kot 30 mg [15 ml] na teden), v primerjavi s približno 4 % odstotki pri živorojenih otrocih bolnic z istimi boleznimi, ki so bile zdravljene z drugimi zdravili kot metotreksatom.
English: Your doctor should perform blood tests before the beginning of treatment to check how well your kidneys and liver are working.
Slovenian: Pred začetkom zdravljenja Pred začetkom zdravljenja mora zdravnik opraviti krvne preiskave, da preveri delovanje vaših ledvic in jeter.
English: Acute or chronic interstitial pneumonia, often in association with blood eosinophilia, may occur and deaths have been reported.
Slovenian: Pojavi se lahko akutna ali kronična intersticijska pljučnica, ki je pogosto povezana z eozinofilijo, poročali pa so tudi o smrtnih primerih.
English: Children, adolescents and the elderly treated with methotrexate should have particularly careful medical monitoring in order to detect important side effects quickly.
Slovenian: Otroci, mladostniki in starejši ljudje, zdravljeni z metotreksatom, morajo biti pod temeljitim zdravstvenim nadzorom, da se morebitni neželeni učinki čim hitreje prepoznajo.
English: 10 Gently place the tip of the syringe into the patient's mouth and direct it to the inside of the cheek.
Slovenian: Konico brizge nežno namestite v bolnikova usta in jo usmerite na notranjo stran lica.