FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions The table presented below is according to the MedDRA system organ classification (SOC and
Slovenian: Spodnja tabela je v skladu s klasifikacijo organskih sistemov po MedDRA (po organskih sistemih in ravni prednostnih izrazov).
English: Uncommon: Dystonia Uncommon: Tremor Not known: Dysarthria Not known: Muscle rigidity Not known: Neurological deterioration
Slovenian: Neznana pogostnost: disartrija Neznana pogostnost: togost mišic
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Slovenian: Kako jemati zdravilo Cufence Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
English: Patients primarily presenting neurological symptoms Dose recommendations are the same as for adults.
Slovenian: Bolniki, ki kažejo predvsem nevrološke simptome
English: Therefore, the recommended dose in patients with renal impairment is the same as for adults.
Slovenian: Priporočeni odmerki so enaki kot pri odraslih.
English: - The active substance is trientine.
Slovenian: Kaj vsebuje zdravilo Cufence - Učinkovina je trientin.
English: Aesica Pharmaceuticals GmbH Alfred-Nobel Strasse 10 40789 Monheim Germany
Slovenian: 40789 Monheim Nemčija
English: Lupus-like reactions (symptoms may include persistent rash, fever, joint pain, and tiredness) have been reported in some patients switched to trientine medicine after penicillamine medicine.
Slovenian: Pri nekaterih bolnikih, ki so po zdravljenju s penicilaminom prešli na zdravljenje s trientinom, so poročali reakcijah, podobnih lupusu (med simptomi so lahko trdovraten izpuščaj, vročina, bolečine v sklepih in utrujenost).
English: Package leaflet: Information for the patient Cufence 200 mg hard capsules trientine
Slovenian: Navodilo za uporabo Cufence 200 mg trde kapsule trientin
English: Patients primarily presenting hepatic symptoms The recommended dose in patients primarily presenting hepatic symptoms is the same as the recommended adult dose.
Slovenian: Bolniki, ki kažejo predvsem simptome okvare jeter
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: Univar Solutions BV
English: Not known: Lupus nephritis
Slovenian: Šelak Propilenglikol
English: Uncommon: Rash
Slovenian: Pogosti: slabost
English: Date of first authorisation: 29 March 2017
Slovenian: Datum prve odobritve: 29. marec 2017
English: *Referral EMEA/H/A-31/1463
Slovenian: * Napotitev EMEA/H/A-31/1463
English: Unopened bottle 15 months.
Slovenian: Neodprta steklenica 15 mesecev
English: Contains E214 and E219.
Slovenian: Vsebuje E214 in E219.
English: Never change the dose on your own.
Slovenian: Odmerka nikoli ne spreminjajte sami.
English: From the date of notification of the Commission Decision*
Slovenian: Od dneva obvestila o sklepu Komisije*
English: − weakness in movements, also only limited to the left or right side of the body
Slovenian: − šibkost pri premikanju, omejena tudi samo na levo ali desno stran telesa,
English: The doctor will decide whether any treatment is needed.
Slovenian: Zdravnik bo presodil, ali je potrebno kakršno koli zdravljenje.
English: It is important to tell your doctor about all the medicines you take.
Slovenian: Pomembno je, da zdravniku poveste za vsa zdravila, ki jih jemljete.
English: Medical staff and patients must be clearly instructed.
Slovenian: Zdravstveno osebje in bolniki morajo biti o tem jasno poučeni.
English: Keep the bottle tightly closed (see section 6.6).
Slovenian: Stekleničko shranjujte tesno zaprto (glejte poglavje 6.6).
English: If, one week later, appropriate laboratory tests are normal, treatment may be initiated.
Slovenian: Če so teden kasneje izvidi ustreznih laboratorijskih testov normalni, se lahko prične zdravljenje.
English: For the oncology indication recommendations in published protocols should also apply.
Slovenian: Za onkološko indikacijo je treba upoštevati tudi priporočila v objavljenih protokolih.
English: Remove the syringe from the patient's mouth.
Slovenian: Odstranite brizgo iz bolnikovih ust.
English: By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: S tem ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: See also section 4 “Possible side effects”.
Slovenian: Glejte tudi poglavje 4, „Možni neželeni učinki“.
English: Decide with your doctor the most suitable day of the week to take the medicine.
Slovenian: Skupaj z zdravnikom določite najprimernejši dan v tednu za jemanje zdravila.
English: After the desired treatment outcome is achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose.
Slovenian: Ko je želeni rezultat zdravljenja dosežen, je treba odmerek postopoma zmanjševati do najmanjšega možnega učinkovitega vzdrževalnega odmerka.
English: Caution: This medicine can affect your capacity to react and your ability to drive.
Slovenian: Opozorilo: to zdravilo lahko vpliva na vašo reakcijsko sposobnost in sposobnost vožnje.
English: Therefore you must ensure that you are taking effective contraception for the whole of this period (see also section "Warnings and precautions").
Slovenian: Zato morate v tem celotnem obdobju poskrbeti za zanesljivo kontracepcijo (glejte tudi poglavje „Opozorila in previdnostni ukrepi“).
English: After first opening, throw away any unused medicine after 3 months.
Slovenian: Po prvem odprtju zavrzite vsa neuporabljena zdravila po 3 mesecih.
English: Recommended examinations and safety measures
Slovenian: Priporočeni pregledi in varnostni ukrepi
English: Treatment should follow current therapy protocols.
Slovenian: Zdravljenje mora biti v skladu z veljavnimi terapevtskimi protokoli.
English: Response to treatment can be expected after approximately 4-8 weeks.
Slovenian: Odziv na zdravljenje lahko pričakujemo po približno 4-8 tednih.
English: After first opening 3 months.
Slovenian: Po prvem odprtju 3 mesece
English: Approximately 5-20% of methotrexate and 1-5% of 7-hydroxymethotrexate is eliminated in the bile.
Slovenian: Približno 5-20 % metotreksata in 1-5 % 7-hidroksimetotreksata se izloči z žolčem.
English: In this case, treatment with methotrexate must be discontinued until the symptoms have disappeared.
Slovenian: V tem primeru je treba zdravljenje z metotreksatom prekiniti, dokler simptomi ne izginejo.
English: The tests below must be conducted weekly in the first two weeks, then every two weeks for a month; thereafter, depending on the leucocyte count and the stability of the patient, at least once a month during the next six months and then at least every three months.
Slovenian: Spodaj navedene teste je treba opraviti vsak teden v prvih dveh tednih, nato v naslednjem mesecu vsaka dva tedna; nato glede na število belih krvničk in stabilnost bolnika v naslednjih šestih mesecih vsaj enkrat mesečno in nato vsaj enkrat na tri mesece.
English: The mean terminal half-life is 6-7 hours and demonstrates considerable variations (3-17 hours).
Slovenian: Povprečni končni razpolovni čas je 6-7 ur, vendar s precejšnjimi odstopanji (3-17 ur).
English: The amount of dose reduction should be decided on a case by case basis.
Slovenian: Stopnjo znižanja odmerka je treba določiti za vsak primer posebej.
English: Children, adolescents and elderly
Slovenian: Otroci, mladostniki in starejši ljudje
English: Confirm that the dose in the syringe is correct.
Slovenian: Prepričajte se, da je odmerek v brizgi pravilen.
English: − protein in the urine
Slovenian: − beljakovine v urinu,
English: Whilst this effect can be reduced by administering calcium folinate, the concomitant use should be avoided.
Slovenian: Čeprav je ta učinek mogoče zmanjšati z dajanjem kalcijevega folinata, se je sočasni uporabi treba izogibati.
English: Most adverse reactions are reversible if they are detected early.
Slovenian: Neželeni učinki so večinoma reverzibilni, če so odkriti dovolj zgodaj.
English: (See renal function monitoring)
Slovenian: (Glejte poglavje o spremljanju delovanja ledvic.)
English: Spillages must be wiped immediately.
Slovenian: Razlitje je treba takoj pobrisati.
English: Response to treatment can generally be expected after approximately 4-8 weeks.
Slovenian: Odziv na zdravljenje lahko običajno pričakujemo po približno 4-8 tednih.
English: How to take the medicine
Slovenian: Kako jemati zdravilo
English: If you feel tired or dizzy, you should not drive a vehicle or use machines.
Slovenian: Če čutite utrujenost ali omotico, ne upravljajte vozil in/ali strojev.
English: Write here in full the day of the week for intake: ______________ Do not take more than the prescribed dose.
Slovenian: Tukaj v celoti zapišite dan v tednu, ko je treba vzeti zdravilo: ______________ Ne vzemite večjega odmerka od predpisanega.
English: Use in children and adolescents
Slovenian: Uporaba pri otrocih, mladostnikih
English: The patient card shall contain the following key elements:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednje ključne elemente:
English: If the results of any test are abnormal, the treatment will not be restarted until all the values have returned to normal.
Slovenian: Če bodo rezultati katere koli od teh preiskav neobičajni, bo zdravljenje prekinjeno, dokler ne bodo vrednosti spet normalne.
English: After distribution, it collects predominantly in the liver, kidneys and spleen in the form of polyglutamates, which can be retained for weeks or months.
Slovenian: Po porazdelitvi se zbira pretežno v jetrih, ledvicah in vranici v obliki poliglutamatov, ki se lahko zadržijo tam več tednov ali mesecev.
English: You will possibly also have an X-ray of your chest.
Slovenian: Morda boste opravili tudi rentgensko slikanje prsnega koša.
English: 1 can be reversible - see 4.4
Slovenian: 1 Je lahko reverzibilen - glejte poglavje 4.4.
English: Because of the possibility of severe or even fatal toxic reactions, patients should be extensively informed by the treating doctor of the risks involved (including early signs and symptoms of toxicity) and the recommended safety measures.
Slovenian: Zaradi možnosti pojava hudih ali celo smrtno nevarnih toksičnih reakcij morajo biti bolniki podrobno seznanjeni z možnimi tveganji zdravljenja (vključno z zgodnjimi znaki in simptomi toksičnosti) ter s priporočenimi varnostnimi ukrepi.
English: In addition, close monitoring of patients for possible early signs of toxicity is recommended (see sections 4.4, 4.5, 4.8 and 5.2).
Slovenian: Poleg tega je zaradi morebitnih zgodnjih znakov toksičnosti priporočljivo natančno spremljanje bolnikov (glejte poglavja 4.4, 4.5, 4.8 in 5.2).
English: Jylamvo with food, drink and alcohol
Slovenian: Zdravilo Jylamvo skupaj s hrano, pijačo in alkoholom
English: Turn the bottle upside down.
Slovenian: Stekleničko obrnite navzdol.
English: Symptoms may return after treatment discontinuation.
Slovenian: Simptomi se lahko po prekinitvi zdravljenja znova pojavijo.
English: This means that the medicine can cause genetic mutations.
Slovenian: To pomeni, da lahko povzroči genske mutacije.
English: Peak serum concentrations are attained within 1-2 hours.
Slovenian: Najvišje plazemske koncentracije so dosežene po 1-2 urah.
English: In some cases the ability to drive or use machines may be affected.
Slovenian: V nekaterih primerih je lahko sposobnost upravljanja vozil ali strojev zmanjšana.
English: • Severe, acute or chronic infections such as tuberculosis and HIV
Slovenian: • resne, akutne ali kronične okužbe, kot sta tuberkuloza in okužba z virusom HIV;
English: The dose and duration of treatment are determined individually on the basis of the patient's clinical picture and the tolerability of methotrexate.
Slovenian: Odmerek in trajanje zdravljenja sta določena individualno, na podlagi bolnikove klinične slike in njegove sposobnosti prenašanja metotreksata.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal or natural medicinal products.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili brez recepta in zdravili rastlinskega izvora.
English: It may cause allergic reactions (possibly delayed).
Slovenian: Ti pomožni snovi lahko povzročita alergijske reakcije (ki so lahko zapoznele).
English: Very common (≥1/10) Common (≥ 1/100 to <1/10) Uncommon (≥1/1,000 to < 1/100) Rare (≥1/10,000 to <1/1,000)
Slovenian: občasni (≥ 1/1 000 do < 1/100) redki (≥ 1/10 000 do <1/1 000) zelo redki (< 1/10 000)
English: In these cases, symptoms that have been commonly reported are hematological and gastrointestinal reactions.
Slovenian: V teh primerih so bili simptomi, o katerih so običajno poročali, hematološke in gastrointestinalne reakcije.
English: This can result in an increased risk of adverse reactions, although in several studies this was only observed in individual patients.
Slovenian: S tem se poveča tudi tveganje za nastop neželenih učinkov, vendar so v več študijah poročali le o posameznih takšnih primerih.
English: • The need to inform patients and relatives/carers about the once weekly dosing;
Slovenian: • potrebo po seznanitvi bolnikov in njihovih sorodnikov/skrbnikov z odmerjanjem enkrat na teden;
English: These effects appear to be reversible after discontinuation of therapy in most cases.
Slovenian: Za te učinke se zdi, da so po prekinitvi zdravljenja v večini primerov reverzibilni.
English: The doctor will calculate the dose required from the child's body surface area (m2), and the dose is expressed as mg/m2.
Slovenian: Zdravnik bo izračunal ustrezen odmerek na podlagi otrokove telesne površine (m2), odmerek pa bo izražen v mg/m2.
English: Depending on the individual activity of the disease and tolerability by the patient, the dose may be increased gradually by 2.5 mg (1.25 ml) per week.
Slovenian: Glede na napredovanje bolezni pri posamezniku in toleranco bolnika se lahko odmerek postopoma povečuje za 2,5 mg (1,25 ml) na teden.
English: The duration of the treatment is determined by the treating physician.
Slovenian: Trajanje zdravljenja določi lečeči zdravnik.
English: Approximately 10% of the administered methotrexate dose is metabolised in the liver.
Slovenian: Približno 10 % uporabljenega odmerka metotreksata se presnovi v jetrih.
English: Methotrexate therapy should only be resumed with particular caution, after careful consideration of the need for treatment and with increased vigilance for the possible recurrence of toxicity.
Slovenian: Zdravljenje z metotreksatom se lahko ponovno uvede le zelo previdno, po skrbnem premisleku o potrebi po zdravljenju in s povečano pazljivostjo glede možne ponovitve toksičnosti.
English: Do not use Jylamvo if you are trying to become pregnant.
Slovenian: Zdravila Jylamvo ne uporabljajte, če načrtujete nosečnost.
English: Female patients of reproductive potential must be counselled regarding pregnancy prevention and planning.
Slovenian: Bolnicam v rodni dobi je treba svetovati glede preprečevanja in načrtovanja nosečnosti.
English: Pleural effusions or ascites
Slovenian: Plevralni izlivi ali ascites
English: Methotrexate is approximately 50% bound to serum proteins.
Slovenian: Metotreksat se veže na serumske beljakovine v približno 50 %.
English: • Alcohol abuse
Slovenian: • čezmerno uživanje alkohola;
English: A blood test will be done to check for reduction in the white blood cells (agranulocytosis).
Slovenian: Opravil bo krvne preiskave, da bi preveril morebitno znižanje števila belih krvnih celic (agranulocitozo).
English: − thirst and/or frequent urination
Slovenian: − žeja in/ali pogosto uriniranje,
English: If clinically indicated, tuberculosis and hepatitis B and C should be excluded.
Slovenian: Če je klinično indicirano, je treba izključiti tuberkulozo ter hepatitis B in C. Med zdravljenjem
English: Treatment with moderately high and high doses of methotrexate should not be initiated at urinary pH values of less than 7.0.
Slovenian: - Zdravljenje z zmerno visokimi in visokimi odmerki metotreksata se ne sme uvesti, če so vrednosti pH urina manjše od 7,0.
English: In rheumatological indications, there is no evidence to support use of liver biopsies in monitoring hepatotoxicity.
Slovenian: Pri revmatoloških indikacijah ni dokazov, ki bi podprli opravljanje biopsije jeter za spremljanje hepatotoksičnosti.
English: 2 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: 2 Limfom/limfoproliferativne bolezni: obstajajo poročila o posameznih primerih limfoma in drugih limfoproliferativnih bolezni, ki so se v številnih primerih izboljšali po prekinitvi zdravljenja z metotreksatom.
English: You should not drink alcohol during treatment with Jylamvo and should avoid drinking excessive amounts of coffee, caffeinated drinks and black leaf tea.
Slovenian: Med zdravljenjem z zdravilom Jylamvo ne smete uživati alkohola in se morate izogibati prekomernemu pitju kave, pijač s kofeinom in črnega čaja.
English: If you suspect that you (or someone else) have (has) taken too much Jylamvo, tell your doctor immediately or contact the nearest hospital casualty department.
Slovenian: Če sumite, da ste vzeli (ali je vzel kdo drug) prevelik odmerek zdravila Jylamvo, o tem takoj obvestite zdravnika ali pokličite urgentni oddelek najbližje bolnišnice.
English: If there is the possibility of renal impairment (e.g. in elderly subjects), monitoring should take place at shorter intervals.
Slovenian: Če obstaja možnost okvare delovanja ledvic (npr. pri starejših ljudeh), morajo biti časovni presledki, v katerih se izvaja nadzor, krajši.
English: There is a suspected mutagenic effect in humans.
Slovenian: Pri ljudeh obstaja sum na mutageni učinek.
English: Teratogenicity - Reproductive risk
Slovenian: Teratogenost - tveganje za razmnoževanje
English: If Jylamvo comes into contact with skin, eyes or nose, you should wash the affected area with water and soap.
Slovenian: Če zdravilo Jylamvo pride v stik s kožo, očmi ali nosom, morate prizadeto območje sprati z vodo in milom.
English: In rhesus monkeys, no malformations comparable to those seen in humans occurred.
Slovenian: Pri opicah rhesus se ni pojavila nobena malformacija, ki bi jo lahko primerjali z ljudmi.
English: What Jylamvo is and what it is used for
Slovenian: Kaj je zdravilo Jylamvo in za kaj ga uporabljamo
English: % of dose to be administered
Slovenian: % odmerka, ki bo uporabljen
English: Teratogenic effects have been observed in four species (rats, mice, rabbits, cats).
Slovenian: Reproduktivna toksičnost Teratogene učinke so ugotovili pri štirih živalskih vrstah (podganah, miših, kuncih, mačkah).
English: • Concurrent vaccination with live vaccines
Slovenian: • sočasno cepljenje z živimi cepivi.
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: The severity of these reactions depends on the dose, mode and duration of application of methotrexate.
Slovenian: Stopnja resnosti teh učinkov je odvisna od odmerka, načina in trajanja uporabe metotreksata.
English: In animal studies, methotrexate has shown reproductive toxicity, especially during the first trimester (see section 5.3).
Slovenian: Študije na živalih so pokazale reproduktivno toksičnost, zlasti med prvim trimesečjem (glejte poglavje 5.3).
English: − severe allergic reactions
Slovenian: − hude alergijske reakcije,
English: Cell proliferation is usually greater in malignant tumours than in normal tissue and methotrexate can therefore exert a sustained effect on malignant growth without causing irreversible damage to normal tissue.
Slovenian: Proliferacija celic je v malignih tumorjih običajno hitrejša kot v normalnem tkivu, zato metotreksat lahko trajno učinkuje na maligno rastoče tkivo, ne da bi pri tem nereverzibilno poškodoval normalno tkivo.
English: Vitamin products
Slovenian: Vitaminski pripravki
English: − severe fatigue.
Slovenian: − huda utrujenost
English: Because of the reduced liver and kidney function and the lower folate reserves in elderly patients, a relatively low dosage should be chosen for them.
Slovenian: Zaradi zmanjšanega delovanja jeter in ledvic ter manjših rezerv folata pri starejših bolnikih je zanje treba izbrati manjši odmerek.
English: Contact your doctor immediately if you develop any of the side effects listed below:
Slovenian: Takoj obvestite svojega zdravnika, če se pojavi kateri od naslednjih neželenih učinkov:
English: It is recommended that a test dose of 2.5-5 mg (1.25-2.5 ml) be administered one week prior to initiation of therapy, in order to detect early occurring adverse reactions.
Slovenian: Priporočljiva je uporaba testnega odmerka v višini 2,5-5 mg (1,25-2,5 ml) en teden pred začetkom zdravljenja, da se ugotovijo morebitni neželeni učinki.
English: Treatment should follow currently published therapy protocols for children (see section 4.4).
Slovenian: Pri zdravljenju je treba upoštevati trenutno objavljene protokole zdravljenja za otroke (glejte poglavje 4.4).
English: Since cases of encephalopathy/leukoencephalopathy have occurred in cancer patients treated with methotrexate, this cannot be ruled out either for patients with non-cancer indications.
Slovenian: Ker so se pri bolnikih z rakom, zdravljenih z metotreksatom, pojavili primeri encefalopatije/levkoencefalopatije, tega ni mogoče izključiti niti pri bolnikih brez indikacij raka.
English: Your doctor may adjust the dose to suit you according to your response to treatment and side effects.
Slovenian: Zdravnik bo odmerek prilagodil tako, da vam bo ustrezal glede na vaš odziv na zdravljenje in neželene učinke.
English: Do not use Jylamvo during pregnancy except if your doctor has prescribed it for oncology treatment.
Slovenian: Zdravila Jylamvo ne uporabljajte, če ste noseči, razen če vam ga je zdravnik predpisal kot onkološko zdravljenje.
English: Take as prescribed by your doctor using the dosing syringe provided.
Slovenian: Jemljite tako, kot vam je predpisal zdravnik, pri čemer uporabite priloženo brizgo za odmerjanje.
English: Methotrexate-induced lung diseases such as pneumonitis can occur acutely and at any time during treatment, are not always completely reversible and have already been observed at all doses (including low doses of 7.5 mg (3.75 ml)/week).
Slovenian: Z metotreksatom povzročene pljučne bolezni, kot je pljučnica, se lahko nenadoma pojavijo kadar koli med zdravljenjem in niso vedno povsem reverzibilne, o njih pa so poročali že pri skoraj vseh odmerkih (vključno z majhnimi odmerki 7,5 mg (3,75 ml) tedensko).
English: Frequency, type and severity of adverse reactions in children and adolescents are expected to be the same as in adults.
Slovenian: Pediatrična populacija Pričakovati je, da so pogostnost, vrsta in stopnja resnosti neželenih učinkov pri otrocih in mladostnikih enake kot pri odraslih.
English: An overdose of methotrexate can cause serious reactions.
Slovenian: Odmerek metotreksata lahko povzroči hude reakcije.
English: • The pharmacist should counsel the patient about the inadvertent daily instead of once-weekly dosing.
Slovenian: • farmacevt mora bolniku svetovati glede nenamernega dnevnega namesto tedenskega odmerjanja;
English: Prior to launch of Jylamvo in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila Jylamvo na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega gradiva, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
English: If there are air bubbles in the syringe, repeat until bubbles are eliminated.
Slovenian: Če so v brizgi zračni mehurčki, postopek ponavljajte, dokler mehurčkov ne bo več.