FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used if the patient is breastfeeding or is receiving live vaccines.
Croatian: Ne smije se koristiti u bolesnica koje doje niti bolesnika koji primaju živa cjepiva.
English: The company that markets Jylamvo will supply a guide for healthcare professionals and a patient alert card, on how to use the medicine correctly and how to avoid medication errors.
Croatian: Tvrtka koja stavlja lijek Jylamvo u promet osigurat će priručnik za zdravstvene radnike i karticu s upozorenjima za bolesnike o ispravnom korištenju lijeka kako bi se izbjegle medikacijske pogreške.
English: The Agency therefore decided that Jylamvo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Jylamvo nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The company also carried out studies that showed that it is bioequivalent to other methotrexate medicines used to treat inflammatory conditions and ALL (Methotrexat Lederle and Ebetrexat tablets).
Croatian: Provela je i ispitivanja koja su pokazala da je lijek bioekvivalentan ostalim lijekovima koji sadrže metotreksat i koji se koriste za liječenje upalnih stanja i ALL-a (Methotrexat Lederle i tablete Ebetrexat).
English: The most common side effects with Jylamvo (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver.
Croatian: Najčešće nuspojave lijeka Jylamvo (koje se mogu javiti u više od 1 na 10 osoba) jesu one koje zahvaćaju probavni sustav (kao što su upala sluznice usta, probavne smetnje, bol u trbuhu, mučnina i gubitak apetita) te krvni nalazi koji upućuju na promjene u jetri.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jylamvo have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Jylamvo nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The reference medicine for Jylamvo is Methotrexat Lederle injection.
Croatian: Referentni lijek za Jylamvo je Methotrexat Lederle za injekciju.
English: For more information about using Jylamvo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Jylamvo pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Jylamo must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system.
Croatian: Jylamvo se ne smije davati bolesnicima koji prekomjerno piju alkohol, kao ni onima koji imaju probleme s jetrom ili ozbiljne probleme s bubrezima, krvne poremećaje, oslabljeni imunosni sustav (sustav obrane tijela), teške ili dugotrajne infekcije kao što su tuberkuloza ili infekcija HIV-om, čireve u ustima, upalu u usnoj šupljini ili čireve u probavnom sustavu.
English: The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions.
Croatian: Najozbiljnije nuspojave obuhvaćaju smanjenu proizvodnju krvnih stanica, oštećenja pluća, jetre, bubrega i živaca, tromboemboliju (poteškoće uzrokovane ugrušcima u krvnim žilama) te ozbiljne alergijske i kožne reakcije.
English: The active substance in Jylamvo, methotrexate, stops cells from growing by interfering with the production of DNA.
Croatian: Aktivna tvar u lijeku Jylamvo, metotreksat, zaustavlja rast stanica ometajući proizvodnju DNK-a.
English: • severe disabling psoriasis (an inflammatory disease causing red, scaly patches on the skin) in adults when other treatments have not worked well enough;
Croatian: • teške onesposobljavajuće psorijaze (upalne bolesti koja uzrokuje crvene, ljuskave lezije na koži) u odraslih kada druge vrste liječenja nisu bile dovoljno učinkovite
English: • severe juvenile idiopathic arthritis (inflammation of joints in children) in patients from 3 years of age when NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;
Croatian: • teškog juvenilnog idiopatskog artritisa (upale zglobova u djece) u bolesnika u dobi od 3 godine i više kada nesteroidni protuupalni lijekovi (NSAIL) nisu bili dovoljno učinkoviti
English: As for every medicine, the company provided studies on the quality of Jylamvo.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kakvoći lijeka Jylamvo.
English: Jylamvo is available as a liquid to be taken by mouth and it can only be obtained with a prescription.
Croatian: Lijek Jylamvo dostupan je kao tekućina koja se uzima kroz usta i izdaje se samo na recept.
English: • active rheumatoid arthritis (a disease causing inflammation in joints) in adults;
Croatian: • aktivnog reumatoidnog artritisa (bolesti koja uzrokuje upalu zglobova) u odraslih
English: As for all medicines, data on the use of Jylamvo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Jylamvo kontinuirano se prate.
English: Other information about Jylamvo
Croatian: Ostale informacije o lijeku Jylamvo
English: What benefits of Jylamvo have been shown in studies?
Croatian: Koje su koristi od lijeka Jylamvo utvrđene u ispitivanjima?
English: Jylamvo contains the active substance methotrexate.
Croatian: Jylamvo sadrži djelatnu tvar metotreksat.
English: For the full list of side effects and restrictions of Jylamvo, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Jylamvo potražite u uputi o lijeku.
English: How does Jylamvo work?
Croatian: Kako djeluje Jylamvo?
English: • severe psoriatic arthritis (inflammation of joints that occurs in patients with psoriasis) in adults;
Croatian: • teškog psorijatičnog artritisa (upale zglobova koja se pojavljuje u bolesnika s psorijazom) u odraslih
English: The European Medicines Agency decided that Jylamvo was of comparable quality and was bioequivalent to the methotrexate-containing medicines Methotrexat Lederle and Ebetrexat.
Croatian: Europska agencija za lijekove zaključila je da je kakvoća lijeka Jylamvo usporediva s drugim lijekovima koji sadrže metotreksat, tj.
English: How is Jylamvo used?
Croatian: Kako se Jylamvo primjenjuje?
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: National Competent Authorities (NCAs) of Member State(s) or Reference Member State(s) (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nadležna državna tijela države(a) članice(a) ili referentne(ih) države(a) članice(a), gdje je to primjenjivo, osigurati će ispunjavanje sljedećih uvjeta od strane nositelja odobrenja:
English: Condition to the marketing authorisations
Croatian: Uvjeti odobrenja za stavljanje lijeka u promet
English: Annex IV Condition to the marketing authorisations
Croatian: Dodatak IV Uvjeti odobrenja za stavljanje lijeka u promet
English: Elderly patients (over 65 years)
Croatian: Stariji bolesnici (preko 65 godina)
English: Someone who has had a fit may be confused afterwards and may not remember what has happened.
Croatian: Netko tko je imao napadaj može biti zbunjen nakon toga i možda se neće sjećati što se dogodilo.
English: You should talk to your doctor, especially if:
Croatian: Morate razgovarati sa svojim liječnikom naročito ako:
English: The dose will be gradually adapted as follows:
Croatian: Doza će se postepeno prilagođavati kako slijedi:
English: There were no cases of seizures in the placebo group.
Croatian: Nije bilo slučajeva napadaja u placebo skupini.
English: Suicide and suicidal behaviour
Croatian: Samoubojstvo i suicidalno ponašanje
English: If you do drink a lot now, do not just stop suddenly, because that may put you at risk of having a fit.
Croatian: Ako sada pijete puno, nemojte naglo prestati, jer to može dovesti do rizika od napadaja.
English: General supportive and symptomatic measures are also recommended.
Croatian: Također su preporučene opće potporne i simptomatske mjere.
English: EEG monitoring is also recommended for the first 48 hours post-ingestion.
Croatian: Preporučuje se također nadziranje EKG prvih 48 sati poslije ingestije.
English: Results are based on last-observation-carriedforward (LOCF).
Croatian: Rezultati se temelje na zadnjem zapažanju prenesenom dalje (LOCF).
English: Biotransformation and elimination:
Croatian: Biotransformacija i eliminacija:
English: • if you have had a serious head injury or head trauma;
Croatian: • ako ste imali ozbiljnu ozljedu glave ili traumu glave;
English: Seizure was reported in approximately one third of these overdose cases.
Croatian: Napadaji su prijavljeni u oko jedne trećine ovih prijavljenih slučajeva predoziranja.
English: These symptoms may resemble serum sickness.
Croatian: Ovi simptomi mogu sličiti serumskoj bolesti.
English: You should inform your doctor before taking this medicine:
Croatian: Trebate obavijestiti svog liječnika prije uzimanja ovog lijeka:
English: Food effect:
Croatian: Učinak hrane:
English: The need for continued treatment should be evaluated after 16 weeks (see section 4.1) and reevaluated annually.
Croatian: Potreba za nastavkom liječenja će biti procijenjena nakon 16 tjedana (vidjeti dio 4.1) a zatim ponovno procjenjivana godišnje.
English: ** The incidence of seizures is approximately 0.1% (1/1,000).
Croatian: ** Incidencija napadaja je otprilike 0,1 % (1/1000).
English: • you already have or have had a condition affecting the circulation of blood in the brain (cerebrovascular disease).
Croatian: • već imate ili ste imali stanje koje utječe na cirkulaciju krvi u mozgu (cerebrovaskularne bolesti).
English: HbA1c, % Not applicable
Croatian: HbA1c, % Nije primjenjivo
English: No dosage adjustment is necessary based on gender or race.
Croatian: Nije potrebna prilagodba doze na temelju spola ili rase.
English: A decrease in the pregnancy rate of mated female rats also occurred.
Croatian: Smanjenje stope trudnoće parenih ženki štakora se također dogodilo.
English: Events were generally self-limited; the majority of events resolved within 4 weeks and almost all resolved by Week 24.
Croatian: Događaji su uglavnom bili samoograničavajući; većina događaja se riješila u roku od 4 tjedna i gotovo svi su bili riješeni do 24. tjedna.
English: However, only Caucasian and Black subjects were investigated to a significant extent.
Croatian: Međutim, samo su bijeli i crni ispitanici ispitani u značajnoj mjeri.
English: Do not delay, contact your doctor or your nearest hospital emergency department immediately.
Croatian: Nemojte odgađati, odmah se javite liječniku ili u najbliži odjel hitne pomoći u bolnici.
English: The tablets should be swallowed whole with some water.
Croatian: Tablete treba progutati cijele s malo vode.
English: Cardiac rhythm and vital signs should be monitored.
Croatian: Treba nadzirati srčani ritam i vitalne znakove.
English: • if you regularly use medicines to help you to sleep (sedatives);
Croatian: • ako redovito koristite lijekove koji Vam pomažu spavati (sedative);
English: Activated charcoal should be administered.
Croatian: Treba se primijeniti aktivni ugljen.
English: 56-Week Data
Croatian: Podaci 56. tjedana
English: Changes in mean blood pressure are described in Section 4.4.
Croatian: Promjene u srednjoj vrijednosti krvnog tlaka su opisane u dijelu 4.4.
English: • you have a history of mania (feeling elated or over-excited, which causes unusual behaviour).
Croatian: • imate povijest manije (osjećaj euforije ili pretjerane uzbuđenosti što uzrokuje neuobičajeno ponašanje).
English: Fasting insulin, % change
Croatian: Inzulin natašte, % promjene
English: In case of doubt, check with your doctor, who might consider to interrupt the treatment depending on your situation.
Croatian: U slučaju sumnje, provjerite sa svojim liječnikom koji može razmotriti prekid liječenja, ovisno o
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2015
Croatian: Datum prvog odobrenja: 26. ožujka 2015.
English: Upon initiating treatment, the dose should be escalated over a 4-week period as follows:
Croatian: Nakon započinjanja liječenja, dozu treba povisivati tijekom razdoblja od 4 tjedna kako slijedi:
English: Effect on weight loss and weight maintenance
Croatian: Učinak na gubitak težine i održavanje težine
English: After 16 weeks and each year after your treatment initiation, your doctor will evaluate whether you should continue to take Mysimba.
Croatian: Nakon 16 tjedana i svake godine nakon početka Vašeg liječenja, Vaš liječnik će procijeniti da li trebate nastaviti uzimati lijek Mysimba.
English: 6.5 Nature and contents of container PVC/PCTFE/PVC/Aluminium blisters.
Croatian: 6.5 Vrsta i sadržaj spremnika PVC/PCTFE/PVC/aluminij blisteri.
English: • ≥ 30 kg/m2 (obese), or
Croatian: • ≥ 30 kg/m2 (pretili), ili
English: Tell your doctor straight away, if you notice any of the following serious side effects: - Suicidal thoughts and feeling depressed
Croatian: Odmah se obratite svojem liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava: - Suicidalne misli i osjećaj depresije
English: The enzyme responsible for the main elimination pathway is not known.
Croatian: Enzim koji je odgovoran za glavni put eliminacije nije poznat.
English: Your doctor may carry out a blood test to ensure that your body has cleared these medicines before starting your treatment.
Croatian: Vaš liječnik može obaviti krvne testove kako bi osigurao da se Vaše tijelo očistilo od tih lijekova prije nego počnete liječenje.
English: Your doctor may suggest you do not drink alcohol while you are taking Mysimba, or try to drink as little as possible.
Croatian: Vaš liječnik može predložiti da ne pijete alkohol dok uzimate lijek Mysimba, ili da pokušate piti što je manje moguće.
English: 95% confidence intervals calculated as LS Mean ± 1.96 × Standard Error.
Croatian: 95% intervali pouzdanosti izračunati kao srednja vrijednost LS ±1,96 x standardna greška.
English: There was no effect on male fertility at this dose level.
Croatian: Nije bilo učinka na mušku plodnost kod te razine doza.
English: Treatment was initiated with a dose escalation period.
Croatian: Liječenje je započeto s razdobljem eskalacije doze.
English: Similarly, efavirenz 600 mg once daily for two weeks reduced the exposure of bupropion by approximately 55% in healthy volunteers.
Croatian: Isto tako, efavirenz 600 mg jednom dnevno tijekom dva tjedna smanjio je izloženost bupropionu za oko 55 % u zdravih dobrovoljaca.
English: Patients should be advised to notify their prescribing physician if they experience these symptoms.
Croatian: Bolesnike treba savjetovati da obavijeste svoje nadležne liječnike ako dožive ove simptome.
English: • if you regularly drink alcohol (see “Mysimba with alcohol”);
Croatian: • ako redovito pijete alkohol (vidjeti „Lijek Mysimba s alkoholom”);
English: Faecal excretion is a minor elimination pathway.
Croatian: Fekalno izlučivanje je manji eliminacijski put.
English: Effect on body composition
Croatian: Učinak na sastav tijela
English: Elevation of blood pressure
Croatian: Povišenje krvnog tlaka
English: Time to resolution for vomiting was typically rapid (within one week) and almost all events resolved within 4 weeks.
Croatian: Vrijeme do rješavanja povraćanja je bilo obično brzo (unutar tjedan dana), a gotovo svi događaji su bili riješeni u roku od 4 tjedna.
English: • medicines to help you to sleep (sedatives such as diazepam).
Croatian: • lijekovi koji Vam pomažu spavati (sedativi, kao što je diazepam).
English: At recommended doses in humans, bupropion does not induce its own metabolism.
Croatian: U preporučenim dozama kod ljudi, bupropion ne inducira vlastiti metabolizam.
English: This is important because some conditions make it more likely that you could have side effects (see also section 4).
Croatian: To je važno jer neka stanja čine pojavu nuspojava vjerojatnijom (vidjeti također dio 4).
English: However, studies on abuse liability in humans and extensive clinical experience show that bupropion has low abuse potential.
Croatian: Međutim, ispitivanja o odgovornosti zlouporabe u ljudi i opsežno kliničko iskustvo pokazuju da bupropion ima niski potencijal zlouporabe.
English: Pack sizes: 28, 112 tablets.
Croatian: Veličina pakiranja: 28, 112 tableta.
English: The prescriber guide shall contain the following key elements: - a reminder of the indication and the need to discontinue treatment if there are concerns with the safety or tolerability of ongoing treatment, or if after 16 weeks patients have lost less than 5% of their initial body weight;
Croatian: Vodič za propisivanje će sadržavati sljedeće ključne elemente: - podsjetnik na indikaciju i potrebu za prekidom liječenja, ako postoji zabrinutost za sigurnost i podnošljivost liječenja koje je u tijeku, ili ako su nakon 16 tjedana bolesnici izgubili manje od 5% svoje početne tjelesne težine;
English: The study protocol, including key aspects of the DMC charter, has to be agreed before initiation of the study.
Croatian: Protokol ispitivanja, uključujući glavne aspekte ugovora Povjerenstva za nadzor podataka, moraju biti dogovoreni prije početka ispitivanja.
English: Mouse and rat studies confirm the absence of carcinogenicity in these species.
Croatian: Ispitivanja u miševa i štakora potvrđuju odsutnost kancerogenosti u ovih vrsta.
English: The tablets should preferably be taken with food.
Croatian: Tablete treba po mogućnosti uzeti sa hranom.
English: 28-Week Data
Croatian: Podaci 28. tjedana
English: Mysimba is available in packs containing 28 or 112 tablets.
Croatian: Lijek Mysimba je dostupan u pakiranju koje sadrži 28 ili 112 tableta.
English: What Mysimba is and what it is used for
Croatian: Što je Mysimba i za što se koristi
English: Your doctor will closely monitor you for side effects and/or may need to adjust the dose of the other medicines or Mysimba.
Croatian: Vaš liječnik će Vas pozorno pratiti na nuspojave i/ili možda morati prilagoditi dozu drugog lijeka ili lijeka Mysimba.
English: Do not drive, use any tools or machines, or perform dangerous activities until you know how this medicine affects you.
Croatian: Nemojte upravljati vozilima, raditi s alatima ili strojevima, ili obavljati opasne aktivnosti sve dok ne saznate kako ovaj lijek utječe na Vas.
English: This medicine works on areas on the brain involved in the control of food intake and energy expenditure.
Croatian: Ovaj lijek djeluje na područje mozga uključeno u kontrolu unosa hrane i potrošnju energije.
English: Swallow your tablets whole.
Croatian: Progutajte cijele tablete.
English: You must have stopped taking any opiate medicines at least 7-10 days before starting Mysimba.
Croatian: Morate prestali uzimati bilo koje opijatne lijekove najmanje 7-10 dana prije početka uzimanja lijeka Mysimba.
English: Reproduction toxicity:
Croatian: Reproduktivna toksičnost:
English: EU/1/14/988/002 28 tablets
Croatian: EU/1/14/988/002 28 tableta
English: The relevance of these observations to human fertility is not known (see section 5.3).
Croatian: Relevantnost tih opažanja za ljudsku plodnost nije poznata (vidjeti dio 5.3).
English: Talk to your doctor or pharmacist before taking Mysimba.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Mysimba.
English: * P-value <0.05 (nominal values) compared to placebo group.
Croatian: * P-vrijednost < 0,05 (nominalna vrijednost) uspoređena sa skupinom na placebu.
English: In the combined Phase 3 studies, the mean age was 46 years, 83% were female, and 77% were White, 18% were Black and 5% were other races.
Croatian: U kombiniranim ispitivanjima faze 3, prosječna dob je bila 46 godina, 83 % su bile žene, a 77 % su bili bijelci, 18 % su bili crnci i 5 % su bili drugih rasa.
English: Your doctor may test your blood before initiating treatment with Mysimba if you have high blood sugar (diabetes) or if you are older than 65, so that your doctor can decide if you should take this medicine or if you need to take a different dose.
Croatian: Vaš liječnik može testirati Vašu krv prije početka liječenja s lijekom Mysimba ako imate visoku razinu šećera u krvi (dijabetes), ili ako ste stariji od 65 godina, tako da Vaš liječnik može odlučiti trebate li uzimati ovaj lijek ili trebate li uzimati drugačiju dozu.
English: Skip the missed dose and take your next dose at the next usual time.
Croatian: Preskočite propuštenu dozu i uzmite sljedeću dozu u sljedeće uobičajeno vrijeme.
English: Your doctor may also recommend stopping treatment if there are concerns about increased blood pressure, or other concerns with the safety or tolerability of this medicine.
Croatian: Vaš liječnik može preporučiti prestanak liječenja, ako postoji zabrinutost oko povišenog krvnog tlaka, ili druge zabrinutosti oko sigurnosti i podnošljivosti ovog lijeka.
English: Data in animals suggest a potential for abuse of bupropion.
Croatian: Podaci u životinja ukazuju na potencijal zlouporabe bupropiona.
English: • Patients with a current or previous diagnosis of bulimia or anorexia nervosa
Croatian: • Bolesnici s trenutnom ili prethodnom dijagnozom bulimije ili anoreksije nervoze
English: Stevens Johnson Syndrome is a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
Croatian: Stevens-Johnsonov sindrom je rijetko stanje kože s teškim mjehurićima i krvarenjem na usnama, očima, ustima, nosu i genitalijama.
English: Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, Ireland
Croatian: Suite 2 Stafford House, Strand Road, Portmarnock, Co.
English: Fits are more likely if you take too much, if you take some other medicines or if you are at a higher than usual risk of fits (see section 2).
Croatian: Napadaji će se vjerojatnije dogoditi ako se uzme previše lijeka, ako uzimate neke druge lijekove ili imate veći rizik od uobičajenog od napadaja (vidjeti dio 2).
English: If you take too many tablets, you may be more likely to have a fit or other side effects similar to those described in section 4 below.
Croatian: Ako uzmete previše tableta, vjerojatnije je da ćete imati napadaj ili druge nuspojave slične onima koje su opisane u dijelu 4 u nastavku.
English: If a dose is missed, patients should not take an additional dose, but take the prescribed next dose at the usual time.
Croatian: Ako se propusti doza, bolesnici ne smiju uzeti dodatnu dozu, nego uzeti propisanu sljedeću dozu u uobičajeno vrijeme.
English: • excessive use of alcohol or addiction to cocaine or stimulants
Croatian: • prekomjerna uporaba alkohola ili ovisnost o kokainu ili stimulansima
English: Erythema multiforme is a severe condition of the skin that may affect the mouth and other parts of the body, with red, often itchy spots starting on the limbs.
Croatian: Multiformni eritem je teško stanje kože koje može zahvatiti usta i druge dijelove tijela, s crvenim područjima koja često svrbe i koja počinju na udovima.