FrancophonIA/ELRC3.0 huggingface dataset:
English: The solution is provided ready for use, and it must be swallowed with some water to remove any methotrexate residue from the oral cavity.
Slovenian: Raztopina je pripravljena za uporabo in jo je treba zaužiti z nekaj vode, da se iz ustne votline odstranijo morebitni ostanki metotreksata.
English: They should then be rinsed thoroughly under COLD water and excess water shaken off before wiping dry with a clean paper towel.
Slovenian: Nato ju morate temeljito splakniti s HLADNO vodo, odvečno vodo pa otresti, preden ju do suhega obrišete s čisto papirnato brisačo.
English: To decrease the risk of exposure, parents and care givers should wear disposable gloves when handling methotrexate.
Slovenian: Za zmanjšanje tveganja izpostavljenosti morajo starši in skrbniki pri rokovanju z metotreksatom nositi rokavice za enkratno uporabo.
English: Pull the syringe plunger back SLOWLY so that the medicine is drawn from the bottle into the syringe until the WIDEST part of the white syringe plunger is lined up to the black syringe marking of the dose required.
Slovenian: Bat brizge za odmerjanje POČASI povlecite nazaj, tako da se zdravilo črpa iz stekleničke v brizgo, dokler NAJŠIRŠI del belega bata brizge ni poravnan s črno oznako na brizgi, ki označuje potrebni odmerek.
English: In each individual case the benefit of treatment must be weighed up against the possible risk to the foetus.
Slovenian: V vsakem posameznem primeru je treba koristi zdravljenja pretehtati glede na možno tveganje za plod.
English: Anyone handling methotrexate should wash their hands before and after administering a dose.
Slovenian: Vsakdo, ki rokuje z metotreksatom, si mora pred dajanjem odmerka in po njem umiti roke.
English: If methotrexate comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Slovenian: Če metotreksat pride v stik s kožo ali sluznico, jo takoj in temeljito umijte z milom in vodo.
English: • Reminder that patients who use methotrexate for an indication requiring a weekly dosing schedule to take the product only once weekly and to write the day of the week for intake on the card
Slovenian: • opomnik, da morajo bolniki, ki uporabljajo metotreksat za indikacijo, pri kateri se zahteva režim odmerjanja enkrat na teden, vzeti zdravilo le enkrat na teden in da je treba na opozorilno kartico zapisati dan v tednu, ko je treba vzeti zdravilo;
English: Your doctor will decide what dose of Jylamvo you should take according to the condition you are being treated for, how severe it is and your general health.
Slovenian: Priporočeni odmerek Vaš zdravnik se bo odločil, kakšen odmerek zdravila Jylamvo morate prejemati glede na stanje, zaradi katerega se zdravite, stopnjo njegove resnosti in vašega splošnega zdravstvenega stanja.
English: This difference in cell proliferation rate is the starting point for the use of methotrexate in particularly severe, generalised, treatment-resistant psoriasis and psoriatic arthritis.
Slovenian: Ta razlika v hitrosti proliferacije celic je izhodišče za uporabo metotreksata pri posebno hudih, generaliziranih in na zdravljenje neodzivnih psoriazah in psoriatičnem artritisu.
English: − low blood pressure, blood clots
Slovenian: − nizek krvni tlak, krvni strdki,
English: In children with JIA, the dose normalized area under the plasma concentration versus time-curve (AUC) of methotrexate increased with the age of the children and was lower than that found in adults.
Slovenian: Pri teh otrocih je na odmerek preračunana površina pod krivuljo časovne porazdelitve koncentracij metotreksata v plazmi (AUC) naraščala s starostjo otrok in je bila nižja od takšne površine pri odraslih.
English: It is therefore very important that methotrexate is not given to pregnant women or to women who are planning to become pregnant unless used for oncology treatment.
Slovenian: Zato je zelo pomembno, da ga nosečnice ali ženske, ki načrtujejo nosečnost, ne jemljejo, razen če se uporablja kot onkološko zdravljenje.
English: An increased monitoring frequency should be considered when the dose is increased.
Slovenian: O večji pogostnosti spremljanja je treba razmisliti ob povečanju odmerka.
English: Keep to the dose exactly and follow your doctor's instructions exactly on when to take the medicine.
Slovenian: Natančno upoštevajte odmerek in zdravnikova navodila o tem, kdaj zdravilo jemati.
English: • Management of overdose (including the use of calcium folinate and dose interruption).
Slovenian: • ravnanje v primeru prevelikega odmerjanja (vključno z uporabo kalcijevega folinata in začasno prekinitvijo odmerjanja).
English: THIS PATIENT CARD IS ONLY INTENDED FOR PATIENTS WHO USE A METHOTREXATE-CONTAINING MEDICINE FOR ARTHRITIS AND PSORIASIS.
Slovenian: TA OPOZORILNA KARTICA ZA BOLNIKA JE NAMENJENA SAMO BOLNIKOM, KI UPORABLJAJO ZDRAVILO, KI VSEBUJE METOTREKSAT, ZA ZDRAVLJENJE ARTRITISA IN PSORIAZE.
English: Discard 3 months after first opening.
Slovenian: Zavrzite 3 mesece po prvem odprtju.
English: Please read this section of the summary of product characteristics very carefully.
Slovenian: Zelo pozorno preberite to poglavje v povzetku glavnih značilnosti zdravila.
English: Please read section 3 of this leaflet very carefully.
Slovenian: Prosimo, da skrbno preberete poglavje 3 tega navodila za uporabo.
English: If you are a parent or caregiver giving the medicine, wash your hands before and after giving a dose.
Slovenian: Če ste starš ali skrbnik, ki daje zdravilo, si pred dajanjem odmerka in po njem umijte roke.
English: • Inform on serious adverse effects that may be fatal and on the symptoms of overdose and steps to be taken should symptoms arise to enable the patient to seek medical help in time
Slovenian: • informacije o resnih neželenih učinkih, pri katerih je možen smrtni izid, simptomih prevelikega odmerjanja in postopanju v primeru pojava teh simptomov, da bo lahko bolnik pravočasno poiskal zdravniško pomoč;
English: If serum creatinine levels are increased, the dose should be reduced.
Slovenian: Če je serumski kreatinin povišan, je treba odmerek zdravila zmanjšati.
English: Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy.
Slovenian: Metotreksat smejo predpisovati samo zdravniki s strokovnim znanjem glede uporabe metotreksata in s popolnim razumevanj tveganj zdravljenja z metotreksatom.
English: Repeat the above instructions for each dose, as instructed by your doctor or pharmacist.
Slovenian: Za vsak odmerek preberite zgornja navodila, kot vam je naročil zdravnik ali farmacevt.
English: Do not breast-feed during treatment as methotrexate passes into the breast milk.
Slovenian: Med zdravljenjem ne dojite, ker metotreksat prehaja v materino mleko.
English: The dose normalized AUC of the metabolite 7-hydroxymethotrexate was not dependent on age.
Slovenian: Na odmerek preračunana AUC presnovka 7-hidroksimetotreksata ni bila odvisna od starosti.
English: What Jylamvo is and what it is used for What you need to know before you take Jylamvo How to take Jylamvo
Slovenian: Kaj je zdravilo Jylamvo in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Jylamvo Kako jemati zdravilo Jylamvo
English: • Information on the importance to fill in prescriptions with clear instructions about once weekly dosing, defined day of intake, and to not use abbreviations; in addition the dose should always be prescribed in mg with ml equivalence based on the correct age of the patient;
Slovenian: • informacije glede pomembnosti tega, da se na recepte napišejo jasna navodila o odmerjanju enkrat na teden in načrtovani dan jemanja zdravila ter da se pri tem ne uporabljajo okrajšave; poleg tega je treba odmerek vedno predpisati v miligramih z enakovredno navedbo v mililitrih na podlagi bolnikove starosti;
English: The plunger and barrel should be stored in a clean dry container with the medicine and reassembled before next use.
Slovenian: Bat in telo shranjujte v čistem, suhem vsebniku skupaj z zdravilom in ju pred naslednjo uporabo ponovno sestavite.
English: Methotrexate induces gene and chromosomal mutations in vitro and in vivo.
Slovenian: Metotreksat povzroča genske in kromosomske mutacije in vitro in in vivo.
English: Testing of serum liver enzymes Transient increases in transaminases to twice or three times normal occur in 13-20% of patients.
Slovenian: - Preiskave jetrnih encimov v serumu - pri 13-20 % bolnikov se prehodno povišajo vrednosti transaminaz na dva- do trikratno normalno vrednost.
English: Always show this card to health care professionals not familiar with your methotrexate treatment to alert them about your once weekly use (e.g. on hospital admission, change of care).
Slovenian: To kartico vedno pokažite zdravstvenim delavcem, ki niso seznanjeni z vašim zdravljenjem z metotreksatom, da jih opozorite na uporabo zdravila enkrat na teden (npr. ob sprejemu v bolnišnico ali zamenjavi skrbnika).
English: Dose in acute lymphoblastic leukaemia (ALL)
Slovenian: Odmerek pri akutni limfoblastni levkemiji (ALL)
English: If bilirubin levels are >5 mg/dl (85.5 µmol/l), methotrexate is contraindicated (see sections 4.3 and 4.4).
Slovenian: Če je vrednost bilirubina > 5 mg/dl (85,5 µmol/l), je uporaba metotreksata kontraindicirana (glejte poglavji 4.3 in 4.4).
English: If your doctor considers that continuing treatment with methotrexate is essential, you must stop breast-feeding.
Slovenian: Če zdravnik meni, da je nadaljevanje zdravljenja z metotreksatom nujno potrebno, morate dojenje prekiniti.
English: Patients should be encouraged to report all signs and symptoms suggestive of infection to their doctor.
Slovenian: Bolnike je treba spodbujati, da svojemu zdravniku poročajo o vseh znakih in simptomih, ki bi lahko kazali na okužbo.
English: Contents of the pack and other information What Jylamvo contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Jylamvo
English: With every prescription, healthcare professionals should advise the patient and/or caregiver on how to measure the prescribed dose.
Slovenian: Vsakič, ko se zdravilo predpiše, mora zdravstveni delavec bolnika in/ali skrbnika poučiti, kako odmeriti predpisani odmerek;
English: Any unused medicine or waste material should be disposed of in accordance with local requirements for cytotoxic products - check with your pharmacist.
Slovenian: Neuporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi za citotoksična zdravila - preverite pri farmacevtu.
English: When you have taken your dose, drink some water and swallow it to ensure you have taken your full dose and there is no methotrexate left in your mouth.
Slovenian: Ko vzamete odmerek, popijte nekaj vode in jo pogoltnite, da boste zagotovo vzeli ves odmerek in da v vaših ustih ne bo ostankov metotreksata.
English: For psoriasis patients the need of a liver biopsy prior to and during therapy is controversial.
Slovenian: Za bolnike s psoriazo je potreba po opravljanju biopsije jeter pred uvedbo zdravljenja in med njim sporna.
English: For contraception advice for men see section 4.6.
Slovenian: Za nasvete glede kontracepcije pri moških glejte poglavje 4.6.
English: Further research is needed to establish whether serial liver function tests or determinations of propeptide of type III collagen are appropriate for detecting hepatotoxicity.
Slovenian: - Potrebne so nadaljnje raziskave, da bi ugotovili, ali lahko z rednimi preiskavami delovanja jeter ali določanjem propeptida kolagena tipa III zadostno odkrijemo hepatotoksičnost.
English: Opportunistic infections (sometimes fatal)
Slovenian: Infekcijske in parazitske bolezni okužbe oportunistične okužbe (včasih smrtne)
English: Persistent abnormalities of liver enzymes and/or a decrease in serum albumin can indicate severe hepatotoxicity.
Slovenian: Stalno odstopanje vrednosti jetrnih encimov in/ali znižanje serumskega albumina lahko nakazujeta hudo obliko hepatotoksičnosti.
English: The MAH shall ensure that, in each Member State where Jylamvo is marketed, all healthcare professionals who are expected to prescribe or dispense Jylamvo have access to the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da v vsaki državi članici, v kateri se zdravilo Jylamvo trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo zdravilo Jylamvo predpisovali ali izdajali, prejmejo paket izobraževalnega gradiva, ki vsebuje naslednje:
English: The prescriber should specify the day of intake on the prescription.
Slovenian: Zdravnik, ki predpisuje zdravilo, mora določiti dan jemanja na receptu.
English: • Severe renal impairment (creatinine clearance less than 30 ml/min, see section 4.2)
Slovenian: • huda okvara ledvic (kreatininski očistek manjši od 30 ml/min, glejte poglavje 4.2);
English: *has been reported for methotrexate used in patients with underlying rheumatologic disease.
Slovenian: *o tem so poročali pri uporabi metotreksata pri bolnikih z osnovno revmatološko boleznijo.
English: Patients must be appropriately monitored during treatment so that signs of possible toxic effects or adverse reactions can be detected and evaluated with minimal delay.
Slovenian: Bolniki morajo biti med zdravljenjem pod ustreznim nadzorom, tako da se lahko čim prej odkrijejo in ocenijo znaki morebitnih toksičnih ali neželenih učinkov.
English: The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.
Slovenian: Zdravnik, ki predpisuje zdravilo, mora zagotoviti, da se bodo bolniki ali njihovi skrbniki zmožni držati režima odmerjanja enkrat na teden.
English: Dosage in children and adolescents with polyarthritic forms of juvenile idiopathic arthritis
Slovenian: Odmerjanje pri otrocih in mladostnikih s poliartikularnimi oblikami juvenilnega idiopatičnega artritisa
English: • Guide for healthcare professionals
Slovenian: • vodnik za zdravstvene delavce,
English: Wipe up spillages immediately.
Slovenian: Razlitje takoj pobrišite.
English: − viral, fungal or bacterial systemic infections,
Slovenian: − sistemske virusne, glivične ali bakterijske okužbe,
English: The MAH should implement the agreed targeted follow-up questionnaires for all medication errors resulting in overdose.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora uvesti dogovorjene vprašalnike za spremljanje vseh napak pri uporabi zdravila, ki privedejo do prevelikega odmerjanja.
English: Ask the patient to swallow the medicine and then to drink some water, making sure no medicine is left in the mouth.
Slovenian: Prosite bolnika, da pogoltne zdravilo in nato spije nekaj vode, da v ustih ne bo ostankov zdravila.
English: Methotrexate can reduce the clearance of theophylline.
Slovenian: Metotreksat lahko zmanjša očistek teofilina.
English: If such adverse reactions occur, the dose should either be reduced or treatment discontinued and appropriate countermeasures taken (see section 4.9).
Slovenian: Če se takšni neželeni učinki pojavijo, je treba zmanjšati odmerek ali prekiniti zdravljenje in uvesti ustrezne ukrepe (glejte poglavje 4.9).
English: Jylamvo must not be administered.
Slovenian: Zdravilo Jylamvo se ne sme uporabiti.
English: Methotrexate can cause serious (sometimes life-threatening) side effects.
Slovenian: Metotreksat lahko povzroči hude (včasih tudi življenjsko ogrožajoče) neželene učinke.
English: When used in oncological indications, methotrexate should not be administered during pregnancy in particular during the first trimester of pregnancy.
Slovenian: Pri onkoloških indikacijah se metotreksat ne sme dajati med nosečnostjo, še posebno v prvem trimesečju nosečnosti.
English: It acts by 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: Cases of overdose have been reported, sometimes fatal, due to erroneous daily intake instead of weekly intake of oral methotrexate.
Slovenian: Poročali so o nekaterih, tudi smrtnih primerih prevelikega odmerjanja zaradi napačnega vnosa peroralnega metotreksata dnevno namesto tedensko.
English: The plunger and barrel should then be separated and both washed thoroughly in the warm soapy water.
Slovenian: Bat in telo morate nato ločiti in oba temeljito sprati v topli milnici.
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 genotoksični učinek metotreksata, zato tveganja za genotoksične učinke na semenčice ne moremo povsem izključiti.
English: The antidote in the event of an overdose is calcium folinate.
Slovenian: Antidot pri prekomernem odmerjanju je kalcijev folinat.
English: Long-term studies in rats, mice and hamsters revealed no evidence of a tumorigenic potential of methotrexate.
Slovenian: Dolgotrajne študije na podganah, miših in hrčkih niso pokazale tumorogenega potenciala metotreksata.
English: Parents, care givers and patients should be advised to keep methotrexate out of the reach of children, preferably in a locked cupboard.
Slovenian: Staršem, skrbnikom in bolnikom je treba naročiti, naj metotreksat hranijo nedosegljivo otrokom, po možnosti v zaklenjeni omarici.
English: - Complete blood count with differential blood count and platelets.
Slovenian: - Celotna krvna slika z diferencialno krvno sliko in krvnimi ploščicami.
English: If the oral route is ineffective, a change to a parenteral dosage form is indicated.
Slovenian: Če peroralna pot ni učinkovita, je indicirana zamenjava farmacevtske oblike v parenteralno.
English: If liver enzymes are constantly increased, a dose reduction or treatment discontinuation should be considered.
Slovenian: - Če so vrednosti jetrnih encimov stalno povišane, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
English: Methotrexate affects spermatogenesis and oogenesis and may decrease fertility.
Slovenian: Plodnost Metotreksat vpliva na spermatogenezo in oogenezo ter lahko zmanjša plodnost.
English: Tabulated list of adverse reactions Frequencies in the table are defined according to the MedDRA convention:
Slovenian: Preglednica z neželenimi učinki Neželeni učinki v spodnji preglednici so razvrščeni po pogostnosti v skladu z dogovorom MedDRA:
English: Other medicines and Jylamvo
Slovenian: Druga zdravila in zdravilo Jylamvo
English: Following the occurrence of haematemesis, black-coloured stools or blood in the stools, treatment must be discontinued.
Slovenian: Če se pojavi hematemeza, črno obarvano blato ali kri v blatu, je treba zdravljenje prekiniti.
English: • Causes of ME, severity and outcomes.
Slovenian: • vzroke napak pri uporabi zdravila, resnost in izide;
English: Remove the bottle cap and push the adaptor firmly into the top of the bottle.
Slovenian: Odstranite pokrovček stekleničke in nastavek močno potisnite na vrh stekleničke.
English: However, a risk cannot be completely excluded and there is no information regarding higher methotrexate doses.
Slovenian: Vendar pa tveganja ni mogoče povsem izključiti in podatkov v zvezi z višjimi odmerki ni. Metotreksat je lahko genotoksičen.
English: Use in children under 3 years of age is not recommended as insufficient data on efficacy and safety are available for this patient group
Slovenian: Uporaba zdravila pri otrocih, mlajših od treh let, zaradi nezadostnih podatkov o varnosti in učinkovitosti v tej starostni skupini ni priporočljiva.
English: Taking too much of Jylamvo (methotrexate) may be fatal.
Slovenian: Če vzamete preveč zdravila Jylamvo (metotreksat), je lahko to smrtno nevarno.
English: Pulmonary symptoms require a rapid diagnosis and discontinuation of methotrexate therapy.
Slovenian: - Pljučni simptomi zahtevajo hitro diagnosticiranje in prekinitev zdravljenja z metotreksatom.
English: Other tests may possibly be performed before and after treatment.
Slovenian: Med zdravljenjem ali po njem se lahko opravljajo tudi druge preiskave.
English: − pathological change of the white matter of the brain (leukoencephalopathy)
Slovenian: − patološke spremembe bele substance možganov (levkoencefalopatija),
English: This event may also be associated with vasculitis and other comorbidities.
Slovenian: Ti primeri bi lahko bili povezani z vaskulitisom in drugimi sočasnimi boleznimi.
English: Patients should be informed of the risks of pneumonia and advised to contact their doctor immediately if they develop a persistent cough or persistent dyspnoea.
Slovenian: Bolnike je treba seznaniti s tveganjem za pljučnico in jim svetovati, da ob pojavu trdovratnega kašlja ali dispneje nemudoma obiščejo zdravnika.
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 ustalile v dveh tednih, potem pa se lahko zdravnik po lastni presoji odloči za ponovno uvedbo zdravljenja.
English: Patients should be informed that they must notify the doctor immediately if any symptoms of an overdose occur and that the symptoms of the overdose need to be monitored (including regular laboratory tests).
Slovenian: Bolnike je treba opozoriti, da naj se v primeru pojava simptomov prevelikega odmerjanja nemudoma posvetujejo z zdravnikom in da je treba simptome prevelikega odmerjanja nadzorovati (vključno z rednimi laboratorijskimi preiskavami).
English: • A statement about the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Jylamvo.
Slovenian: • izjavo o odgovornosti zdravnika, ki zdravilo predpiše, glede določanja, kateri bolniki so primerni za uporabo zdravila Jylamvo na domu ali za samostojno uporabo.
English: In rheumatological and dermatological diseases
Slovenian: Revmatološke in dermatološke bolezni
English: If you do become pregnant during treatment, you should be offered advice regarding the risk of harmful effects on the child through treatment.
Slovenian: Če med zdravljenjem zanosite, vam zdravnik mora svetovati glede tveganja za škodljive učinke na otroka zaradi zdravljenja.
English: Treatment of rheumatoid arthritis with such medicinal products can be continued during therapy with low-dose methotrexate, but only under close medical supervision.
Slovenian: Zdravljenje revmatoidnega artritisa s temi zdravili se lahko med terapijo z majhnimi odmerki metotreksata nadaljuje, vendar je potreben skrben zdravniški nadzor.
English: • Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.
Slovenian: • poliartikularnih oblik hudega aktivnega juvenilnega idiopatičnega artritisa (JIA) pri mladostnikih in otrocih, starih tri leta ali več, pri katerih je bil odziv na nesteroidna protivnetna zdravila (NSAID) nezadosten,
English: The main metabolite is 7-hydroxymethotrexate.
Slovenian: Glavni presnovek je 7-hidroksimetotreksat.
English: If you become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible.
Slovenian: Če ste med zdravljenjem zanosili ali menite, da bi lahko bili noseči, se takoj posvetujte z zdravnikom.
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 ukrep se spolno aktivnim bolnikom ali njihovim partnericam priporoča, da uporabljajo učinkovito kontracepcijo med zdravljenjem bolnika in še vsaj 6 mesecev po prenehanju zdravljenja z metotreksatom.
English: − kidney failure, reduction or lack of urine production, abnormal levels of electrolytes in blood
Slovenian: − odpoved ledvic, zmanjšana ali pomanjkljiva tvorba urina, nenormalna vrednost elektrolitov v krvi,
English: If you think you have taken more than the prescribed dose, consult a physician immediately.
Slovenian: Če mislite, da ste vzeli večji odmerek zdravila od predpisanega, se takoj posvetujte z zdravnikom.