FrancophonIA/ELRC3.0 huggingface dataset:
English: After the desired treatment outcome is achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose.
Croatian: Kada se postigne željeni ishod liječenja, dozu treba postupno smanjiti na najnižu moguću učinkovitu dozu održavanja.
English: What Jylamvo is and what it is used for
Croatian: Što je Jylamvo i za što se koristi
English: There is a suspected mutagenic effect in humans.
Croatian: Postoji sumnja na mutageni učinak u ljudi.
English: Keep the bottle tightly closed (see section 6.6).
Croatian: Bocu čuvati čvrsto zatvorenu (vidjeti dio 6.6).
English: Other tests may possibly be performed before and after treatment.
Croatian: Mogu biti napravljene i druge pretrage prije i poslije liječenja.
English: Keep to this dose exactly.
Croatian: Držite se točno te doze.
English: The mean terminal half-life is 6-7 hours and demonstrates considerable variations (3-17 hours).
Croatian: Srednja vrijednost terminalnog poluvijeka iznosi 6-7 sati i pokazuje znatne varijacije (3-17 sati).
English: − blurred or restricted vision
Croatian: − zamagljen ili ograničen vid
English: Vitamin products
Croatian: Vitaminski proizvodi
English: The amount of dose reduction should be decided on a case by case basis.
Croatian: O količini smanjenja doze treba odlučivati za svaki slučaj pojedinačno.
English: Children, adolescents and elderly
Croatian: Djeca, adolescenti i starije osobe
English: Jylamvo with food, drink and alcohol
Croatian: Jylamvo s hranom, pićem i alkoholom
English: It is important to tell your doctor about all the medicines you take.
Croatian: Važno je da liječniku kažete koje sve lijekove uzimate.
English: Caution: This medicine can affect your capacity to react and your ability to drive.
Croatian: Oprez: Ovaj lijek može utjecati na Vašu mogućnost reagiranja i sposobnost upravljanja vozilima.
English: Never take a double dose to make up for a forgotten dose but continue with the prescribed dose.
Croatian: Nikada nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu, nego nastavite s propisanom dozom.
English: − severe allergic reactions
Croatian: − teške alergijske reakcije
English: Response to treatment can be expected after approximately 4-8 weeks.
Croatian: Odgovor na liječenje može se očekivati nakon približno 4-8 tjedana.
English: Approximately 5-20% of methotrexate and 1-5% of 7-hydroxymethotrexate is eliminated in the bile.
Croatian: Približno 5-20 % metotreksata i 1-5 % 7-hidroksimetotreksata eliminira se u žuči.
English: Methotrexate is approximately 50% bound to serum proteins.
Croatian: Metotreksat je otprilike 50 % vezan na serumske proteine.
English: Mutagenic and carcinogenic potential
Croatian: Mutageni i kancerogeni potencijal
English: Peak serum concentrations are attained within 1-2 hours.
Croatian: Vršne koncentracije u serumu postižu se unutar 1-2 sata.
English: The doctor may increase the dose if the used dose is not effective but tolerated well.
Croatian: Liječnik može povećati dozu ako korištena doza nije djelotvorna, ali se dobro podnosi.
English: 1 can be reversible - see 4.4
Croatian: 1može biti reverzibilan - vidjeti dio 4.4
English: This can result in an increased risk of adverse reactions, although in several studies this was only observed in individual patients.
Croatian: To može rezultirati povećani rizikom od nuspojava, iako je u nekoliko ispitivanje to opaženo samo u pojedinih bolesnika.
English: Teratogenic effects have been observed in four species (rats, mice, rabbits, cats).
Croatian: Teratogeni učinci opaženi su u četiri životinjske vrste (štakori, miševi, kunići, mačke).
English: After first opening 3 months.
Croatian: Nakon prvog otvaranja 3 mjeseca
English: If you want to become pregnant, you should speak with your doctor, who may refer you for specialist advice before the planned start of treatment.
Croatian: Ako želite zatrudnjeti, morate razgovarati s liječnikom koji Vas može uputiti na specijalističko savjetovanje prije planiranog početka liječenje
English: Decide with your doctor the most suitable day of the week to take the medicine.
Croatian: Zajedno s liječnikom odlučite koji dan u tjednu je najprikladniji za uzimanje lijeka.
English: • Guide for healthcare professionals
Croatian: • vodič za zdravstvene radnike
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.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući one koji se dobivaju bez recepta te biljne ili prirodne pripravke.
English: This means that the medicine can cause genetic mutations.
Croatian: To znači da ovaj lijek može prouzročiti genetske mutacije.
English: If, one week later, appropriate laboratory tests are normal, treatment may be initiated.
Croatian: Ako su tjedan kasnije rezultati odgovarajućih laboratorijskih testova uredni, može se započeti s liječenje.
English: • Alcohol abuse
Croatian: • zlouporaba alkohola.
English: Do not interrupt or stop the treatment with Jylamvo without first discussing this with your doctor.
Croatian: Nemojte prekinuti ili prestati liječenje lijekom Jylamvo, a da prvo o tome ne porazgovarate s liječnikom.
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.
Croatian: Testovi navedeni u nastavku moraju se provoditi svaki tjedan prva dva tjedna, zatim svaka dva tjedna u mjesecu koji slijedi, a nakon toga ovisno o broju leukocita i stabilnosti bolesnika, najmanje jednom mjesečno tijekom sljedećih šest mjeseci te potom barem svaka tri mjeseca.
English: In each individual case the benefit of treatment must be weighed up against the possible risk to the foetus.
Croatian: U svakom pojedinačnom slučaju korist liječenja mora se odvagnuti u odnosu na mogući rizik za fetus.
English: For the oncology indication recommendations in published protocols should also apply.
Croatian: Za onkološku indikaciju potrebno je uzeti u obzir i preporuke iz objavljenih protokola.
English: • Severe, acute or chronic infections such as tuberculosis and HIV
Croatian: • teške, akutne ili kronične infekcije kao što su tuberkuloza i HIV
English: In this case, treatment with methotrexate must be discontinued until the symptoms have disappeared.
Croatian: U tom se slučaju liječenje metotreksatom mora prekinuti dok simptomi ne nestanu.
English: Response to treatment can generally be expected after approximately 4-8 weeks.
Croatian: Odgovor na liječenje može se obično očekivati nakon približno 4-8 tjedana.
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:
Croatian: Nositelj odobrenja treba osigurati da u svakoj državi članici u kojoj se Jylamvo stavlja u promet, svi zdravstveni radnici od kojih se očekuje da propisuju ili izdaju Jylamvo imaju pristup sljedećem edukacijskom paketu:
English: If clinically indicated, tuberculosis and hepatitis B and C should be excluded.
Croatian: Ako je klinički indicirano, potrebno je isključiti tuberkulozu i hepatitis B i C.
English: Whilst this effect can be reduced by administering calcium folinate, the concomitant use should be avoided.
Croatian: Iako se ovaj učinak može umanjiti primjenom kalcijeva folinata, istodobna primjena se mora izbjegavati.
English: If Jylamvo comes into contact with skin, eyes or nose, you should wash the affected area with water and soap.
Croatian: Ako Jylamvo dođe u doticaj s kožom, očima ili nosom, zahvaćena područja morate oprati vodom i sapunom.
English: If the oral route is ineffective, a change to a parenteral dosage form is indicated.
Croatian: Ako primjena peroralnim putem nije uspješna, indicirana je promjena na parenteralni oblik doziranja.
English: The doctor will calculate the dose required from the child's body surface area (m2), and the dose is expressed as mg/m2.
Croatian: Liječnik će odrediti potrebnu dozu prema tjelesnoj površini djeteta (m2), a doza je izražena u mg/m2.
English: Your doctor must carry out investigations and laboratory tests in order to detect these effects as early as possible.
Croatian: Liječnik mora provesti preglede i laboratorijske pretrage kako bi se te nuspojave otkrile što je prije moguće.
English: If the results of any test are abnormal, the treatment will not be restarted until all the values have returned to normal.
Croatian: Ako rezultati bilo koje pretrage nisu u okviru normalnih vrijednosti, liječenje neće biti nastavljeno sve dok se sve vrijednosti ne vrate na normalne vrijednosti.
English: - Liver function tests - particular attention should be given to the appearance of liver toxicity.
Croatian: - Testovi funkcije jetre - posebnu pozornost treba posvetiti pojavi toksičnosti jetre.
English: If you are a parent or caregiver giving the medicine, wash your hands before and after giving a dose.
Croatian: Ako ste roditelj ili njegovatelj koji daje lijek, operite ruke prije i poslije primjene doze.
English: % of dose to be administered
Croatian: % doze koju treba primijeniti
English: The dose should be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate.
Croatian: Dozu treba povećati postupno, ali uglavnom ne bi smjela premašiti tjednu dozu od 25 mg metotreksata.
English: If there are air bubbles in the syringe, repeat until bubbles are eliminated.
Croatian: Ako u štrcaljki ima mjehurića zraka, ponavljajte sve dok se mjehurići ne uklone.
English: IF YOU USE METHOTREXATE FOR ONE OF THE ABOVE MENTIONED INDICATIONS, YOU SHOULD ONLY TAKE METHOTREXATE ONCE A WEEK
Croatian: AKO METOTREKSAT PRIMJENJUJETE ZA NEKU OD PRETHODNO NAVEDENIH INDIKACIJA, SMIJETE GA UZIMATI SAMO JEDNOM TJEDNO
English: • Remarks on the importance of reporting ADRs
Croatian: • Napomene o važnosti prijavljivanja nuspojava
English: Jylamvo must not be administered.
Croatian: Jylamvo se ne smije primijeniti.
English: Teratogenicity - Reproductive risk
Croatian: Teratogenost - reproduktivni rizici
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.
Croatian: Nakon distribucije, pretežno se skuplja u jetri, bubrezima i slezeni u obliku poliglutamata, koji se mogu zadržati tjednima ili mjesecima.
English: The patient card shall contain the following key elements:
Croatian: Kartica za bolesnika mora sadržavati sljedeće ključne elemente:
English: This medicine is not recommended in children under 3 years of age as there is insufficient experience in this age group
Croatian: Ovaj se lijek ne preporučuje u djece mlađe od 3 godine jer nema dovoljno iskustva s tom dobnom skupinom.
English: The Guide for healthcare professionals shall contain the following key elements:
Croatian: Vodič za zdravstvene radnike sadržava sljedeće ključne elemente:
English: The dose and duration of treatment are determined individually on the basis of the patient's clinical picture and the tolerability of methotrexate.
Croatian: Doza i trajanje liječenja određuju se pojedinačno, na temelju bolesnikove kliničke slike i podnošljivosti metotreksata.
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.
Croatian: Ako sumnjate da ste Vi (ili netko drugi) uzeli previše lijeka Jylamvo, odmah se obratite liječniku ili najbližem bolničkom odjelu za hitne slučajeve.
English: To decrease the risk of exposure, parents and care givers should wear disposable gloves when handling methotrexate.
Croatian: Kako bi se smanjio rizik od izloženosti, roditelji i njegovatelji trebaju nositi jednokratne rukavice kada rukuju metotreksatom.
English: If serum creatinine levels are increased, the dose should be reduced.
Croatian: Ako su razine serumskog kreatinina povišene, dozu je potrebno smanjiti.
English: If you take more Jylamvo than you should
Croatian: Ako uzmete više lijeka Jylamvo nego što ste trebali
English: Repeat the above instructions for each dose, as instructed by your doctor or pharmacist.
Croatian: Prethodno navedene upute ponovite za svaku dozu, prema uputama liječnika ili ljekarnika.
English: Not known (frequency cannot be estimated from the available data)
Croatian: nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
English: Keep to the dose exactly and follow your doctor's instructions exactly on when to take the medicine.
Croatian: Točno se pridržavajte doze i točno slijedite upute koje Vam je dao liječnik o tome kada uzimati lijek.
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.
Croatian: Stoga je vrlo važno da se metotreksat ne daje trudnicama ili ženama koje planiraju zatrudnjeti osim ako se koristi za onkološko liječenje.
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.
Croatian: Liječnik će odlučiti koju dozu lijeka Jylamvo trebate uzimati ovisno o stanju koje liječite, koliko je ono teško te kakvo je Vaše opće zdravlje.
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.
Croatian: Preporučuje se provjeriti razine vitamina B12 prije početka primjene dodataka folatne kiseline, osobito u odraslih starijih od 50 godina, jer unos folatne kiseline može maskirati nedostatak vitamina B12.
English: If you feel tired or dizzy, you should not drive a vehicle or use machines.
Croatian: Ako osjećate umor ili omaglicu, ne smijete upravljati vozilima ili raditi sa strojevima.
English: In oncology
Croatian: U onkologiji
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).
Croatian: Osim toga, preporučuje se pažljivo praćenje bolesnika zbog mogućih ranih znakova toksičnosti (vidjeti dijelove 4.4, 4.5, 4.8 i 5.2).
English: This should also be considered during simultaneous administration of haematotoxic medicinal products.
Croatian: To treba uzeti u obzir i tijekom istodobne primjene hematotoksičnih lijekova.
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.
Croatian: NEMOJTE klip potiskivati prejako ili uštrcnuti lijek u stražnji dio usne šupljine ili u grlo jer to može izazvati gušenje.
English: It may cause allergic reactions (possibly delayed).
Croatian: Može prouzročiti alergijske reakcije (moguće i odgođene reakcije preosjetljivosti).
English: All parts of the syringe should be completely dry before using it for the next dose.
Croatian: Svi dijelovi štrcaljke trebaju biti potpuno suhi prije nego što se štrcaljka upotrijebi za sljedeću dozu.
English: − blood test showing raised liver enzymes.
Croatian: − pretrage krvi pokazuju povišene jetrene enzime.
English: Approximately 10% of the administered methotrexate dose is metabolised in the liver.
Croatian: Približno 10 % primijenjene doze metotreksata metabolizira se u jetri.
English: Testing of serum liver enzymes Transient increases in transaminases to twice or three times normal occur in 13-20% of patients.
Croatian: Testovi jetrenih enzima u serumu Prolazna povišenja transaminaza na vrijednosti dvostruko ili trostruko veće od normalnih, javljaju se u 13-20 % bolesnika.
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
Croatian: • Informacije o ozbiljnim nuspojavama koje mogu biti smrtonosne te o simptomima predoziranja i postupcima koje je potrebno poduzeti ako se ti simptomi pojave, kako bi se osiguralo da bolesnik na vrijeme potraži medicinsku pomoć.
English: Tabulated list of adverse reactions Frequencies in the table are defined according to the MedDRA convention:
Croatian: Tablični popis nuspojava Učestalosti navedene u tablici definirane su na temelju MeDRA-ine konvencije:
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.
Croatian: Ovisno o aktivnosti bolesti i podnošljivosti terapije u pojedinog bolesnika, doza se može postupno povećavati za 2,5 mg (1,25 ml) tjedno.
English: Symptoms may return after treatment discontinuation.
Croatian: Simptomi se mogu vratiti nakon prekida liječenja.
English: When administered in low doses (7.5 mg/m2 to 80 mg/m2 body surface area), the mean bioavailability of methotrexate is approximately 70%, but considerable inter- and intra-individual variations are possible (25-100%).
Croatian: Kada se primijeni u niskim dozama (od 7,5 mg/m2 do 80 mg/m2 tjelesne površine), srednja vrijednost bioraspoloživosti metotreksata iznosi približno 70 %, ali moguće su znatne inter- i intra-individualne varijacije (25-100 %).
English: If you become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible.
Croatian: Ako zatrudnite tijekom liječenja, ili sumnjate da biste mogli biti trudni, obratite se liječniku čim je prije moguće.
English: You should not drink alcohol during treatment with Jylamvo and should avoid drinking excessive amounts of coffee, caffeinated drinks and black leaf tea.
Croatian: Tijekom liječenja lijekom Jylamvo ne smijete piti alkohol i trebate izbjegavati konzumaciju prekomjerne količine kave, pića s kofeinom i crnog čaja.
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.
Croatian: Prije puštanja lijeka Jylamvo u promet u svakoj državi članici, nositelj odobrenja mora dogovoriti s nadležnim nacionalnim tijelom sadržaj i format edukacijskih materijala, uključujući medije komunikacije, načine distribucije i druge aspekte programa.
English: Such side effects cannot be excluded when methotrexate is used to treat other diseases.
Croatian: Takve nuspojave ne mogu se isključiti kada se metotreksat koristi za liječenje drugih bolesti.
English: The half-life may be prolonged up to four-fold in patients with a third distribution compartment (pleural effusion, ascites).
Croatian: Poluvijek se može četverostruko produljiti u bolesnika s trećim odjeljkom distribucije (pleuralna efuzija, ascites).
English: How to take the medicine
Croatian: Kako primjenjivati lijek
English: For contraception advice for men see section 4.6.
Croatian: Za savjet o kontracepciji za muškarce vidjeti dio 4.6.
English: A chest X-ray must be taken in order to be able to exclude an infection.
Croatian: Mora se napraviti rendgen prsnog koša kako bi se mogla isključiti infekcija.
English: When methotrexate was discontinued prior to conception, normal pregnancies have been reported.
Croatian: Kada je primjena metotreksata bila prekinuta prije začeća, zabilježene su normalne trudnoće.
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.
Croatian: Bolesnike se mora pratiti tijekom liječenja na odgovarajući način kako bi se znakove mogućih toksičnih učinaka ili nuspojava otkrilo i procijenilo s minimalnom odgodom.
English: Remember to inform your doctor about the treatment with Jylamvo if you are prescribed another medicine during treatment.
Croatian: Ne zaboravite obavijestiti liječnika o terapiji lijekom Jylamvo ako Vam je tijekom liječenja propisan još neki lijek.
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.
Croatian: Preporučuje se primjena probne doze od 2,5-5 mg (1,25-2,5 ml) tjedan dana prije započinjanja terapije kako bi se otkrile nuspojave koje se javljaju rano.
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)
Croatian: vrlo često (≥1/10) često (≥ 1/100 i <1/10) manje često (≥1/1000 i < 1/100)
English: Taking too much of Jylamvo (methotrexate) may be fatal.
Croatian: Uzimanje previše lijeka Jylamvo (metotreksata) može biti smrtonosno.
English: Your doctor may adjust the dose to suit you according to your response to treatment and side effects.
Croatian: Vaš liječnik može prilagoditi dozu kako bi Vam odgovarala sukladno Vašem odgovoru na liječenje i nuspojavama.
English: • Immunodeficiency
Croatian: • imunodeficijencija
English: Methotrexate can have a genotoxic effect.
Croatian: Metotreksat može imati genotoksičan učinak.
English: Do not use the medicine after the expiry date which is stated on the carton and label after ‘Exp'.
Croatian: Lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake „EXP”.
English: With every prescription, healthcare professionals should advise the patient and/or caregiver on how to measure the prescribed dose.
Croatian: Prilikom izdavanja svakog recepta zdravstveni radnici trebaju bolesnika i/ili njegovatelja savjetovati o načinu mjerenja propisane doze.
English: In some cases the ability to drive or use machines may be affected.
Croatian: U nekim slučajevima sposobnost upravljanja vozilima ili rada sa strojevima može biti narušena.
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.
Croatian: Zbog mogućnosti pojave teških ili čak smrtonosnih toksičnih reakcija, nadležni liječnik mora bolesnike opširno upoznati s uključenim rizicima (uključujući rane znakove i simptome toksičnosti) i preporučenim mjerama sigurnosti.
English: It is not known if methotrexate is present in semen.
Croatian: Nije poznato je li metotreksat prisutan u sjemenu muškarca.
English: There is a risk of excessive immunosuppression with risk of lymphoproliferation when the combination is used.
Croatian: Postoji rizik od prekomjerne imunosupresije uz rizik od limfoproliferacije kada se primjenjuje ta kombinacija.
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.
Croatian: Terapija metotreksatom smije se nastaviti samo uz poseban oprez, nakon pažljivog razmatranja potrebe za liječenjem te uz povećanu pozornost zbog mogućeg povratka toksičnosti.
English: 3 has been reported for methotrexate used in rheumatologic and related indications 4 see remarks on liver biopsy in section 4.4
Croatian: 3zabilježena pri primjeni metotreksata u reumatološkim i njima povezanim indikacijama 4vidjeti napomene o biopsiji jetre u dijelu 4.4
English: Do not use Jylamvo during pregnancy except if your doctor has prescribed it for oncology treatment.
Croatian: Ne primjenjujte Jylamvo u trudnoći osim ako Vam ga liječnik ne propiše u sklopu onkološkog liječenja.
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).
Croatian: Plućne bolesti izazvane metotreksatom, kao što je pneumonitis, mogu se pojaviti akutno i u bilo kojem trenutku tijekom liječenja, nisu uvijek potpuno reverzibilne i dosad su primijećene pri svim dozama (uključujući niske doze od 7,5 mg (3,75 ml tjedno).
English: See also section “Pregnancy, breast-feeding and fertility”.
Croatian: Pogledajte također dio “Trudnoća, dojenje i plodnost”.