FrancophonIA/ELRC3.0 huggingface dataset:
English: The fourth week is transdermal patch-free starting on Day 22.
Croatian: U četvrtom tjednu, koji počinje 22. danom, transdermalni flaster se ne primjenjuje.
English: especially on one side of the body;
Croatian: Vašeg tijela);
English: Middle layer polyisobutylene/polybutene adhesive crospovidone non-woven polyester fabric lauryl lactate.
Croatian: Srednji sloj adheziv od poliizobutilena/polibutena krospovidon netkana poliesterska vlakna laurillaktat.
English: Backing layer low-density pigmented polyethylene outer layer polyester inner layer.
Croatian: Potporni sloj vanjski sloj od pigmentiranog polietilena niske gustoće, unutarnji poliesterski sloj.
English: There is now a new transdermal patch “Change Day” and a new “Day 1”.
Croatian: To će biti novi „dan izmjene“ transdermalnog flastera, a ujedno i novi „1. dan“.
English: A non-hormonal contraceptive must then be used concurrently for 7 days.
Croatian: U tom slučaju dodatnu, nehormonsku kontracepciju mora se istovremeno primjenjivati sljedećih 7 dana.
English: It may be that women taking the combined hormonal contraceptive are examined more often.
Croatian: Postoji mogućnost da se rak dojke otkrije češće u žena koje uzimaju kombinirane hormonske kontraceptive zato što imaju češće preglede.
English: Hepatic neoplasm*† Breast cancer*† Cervix carcinoma*† Hepatic adenoma*† Uterine leiomyoma Fibroadenoma of breast
Croatian: Krvožilni poremećaji manje čest hipertenzija rijetko hipertenzivna kriza* arterijska tromboza**† venska tromboza**† tromboza*† venska tromboembolija
English: Method
Croatian: OBLIK
English: • Never go without wearing a patch for more than 7 days in a row.
Croatian: • Razdoblje neprimjenjivanja flastera nikad ne smije biti dulje od 7 uzastopnih dana.
English: To discard the used patch, you should:
Croatian: Zbrinjavanje iskorištenog flastera:
English: Immune system disorders uncommon
Croatian: Poremećaji imunološkog sustava manje često preosjetljivost
English: In no case should there be more than 7 consecutive transdermal patch-free days.
Croatian: Razdoblje neprimjenjivanja flastera nikad ne smije biti dulje od 7 uzastopnih dana.
English: Antithrombotic treatment should be considered if EVRA has not been discontinued in advance.
Croatian: Ako primjena EVRE nije bila prethodno prekinuta, potrebno je razmotriti antitrombotsko liječenje.
English: No additional contraceptive use is required.
Croatian: Nije potrebno koristiti dodatnu kontracepciju.
English: nevirapine, efavirenz)
Croatian: primidon, okskarbazepin i felbamat)
English: • Swelling
Croatian: • omaglica
English: • Back-up contraception is not needed.
Croatian: • Dodatna kontracepcija nije potrebna.
English: Transdermal patch.
Croatian: Transdermalni flaster.
English: Hypersensitivity
Croatian: Hipertenzija
English: • Gallstones or blockage of the bile duct
Croatian: • žučni kamenci ili začepljenje žučovoda
English: • Eczema, redness of the skin
Croatian: • ekcem, crvenilo kože
English: • Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]);
Croatian: • Venska tromboembolija - prisutna VTE (na antikoagulansima) ili VTE u povijesti bolesti
English: - Chloasma may occasionally occur with the use of hormonal contraception, especially in users with a history of chloasma gravidarum.
Croatian: - Katkad se uz primjenu hormonske kontracepcije može javiti kloazma, posebice u žena u kojih se javljala i u trudnoći.
English: When there has been no hormonal contraceptive use in the preceding cycle Contraception with EVRA begins on the first day of menses.
Croatian: Kontracepcija EVROM započinje prvog dana menstruacije.
English: • Stomach ache or bloating
Croatian: • bol u trbuhu ili nadutost
English: An additional method of contraception is not needed if EVRA is started immediately.
Croatian: Ako je primjena EVRE odmah počela, dodatne mjere kontracepcije nisu potrebne.
English: • Change EVRA on the same day of each week.
Croatian: • Promijenite EVRA flaster na isti dan svakog tjedna, s obzirom na to da je flaster napravljen tako da djeluje tijekom 7 dana.
English: Uncommon side effects (may affect up to 1 in 100 women):
Croatian: Česte nuspojave (mogu se javiti u 1 do 10 na 100 žena):
English: Blood pressure increased Lipid disorders**
Croatian: Pretrage često porast tjelesne težine manje često povišen krvni tlak poremećaji lipida**
English: These are yellowish-brown patches or spots,
Croatian: To su žućkasto-smeđe mrlje ili pjege, osobito na licu (takozvana
English: Rare side effects (may affect up to 1 in 1,000 women):
Croatian: Manje česte nuspojave (mogu se javiti u 1 do 10 na 1000 žena):
English: If you need to place the patch on a new area on your body on a day other than your “Patch Change Day”
Croatian: Ako trebate staviti flaster na novi dio tijela na dan koji Vam inače nije “dan izmjene flastera” Ako flaster prouzroči nadraženost ili Vam izaziva nelagodu kod nošenja:
English: Erythema rare
Croatian: Opće napomene
English: • The first day after stopping the progestogen-only pill, removing the implant or when your next injection would be due, put on a patch.
Croatian: • Flaster stavite prvi dan nakon prestanka uzimanja tablete koja sadrži samo progesteron,
English: • Apply your first patch during the first 24 hours of your period
Croatian: • Primijenite prvi flaster untar 24 sata od početka menstruacije.
English: Following abortion or miscarriage
Croatian: Nakon induciranog ili spontanog pobačaja
English: Talk to your doctor or pharmacist about using another method of birth control if you use EVRA and any of the above medicines concomitantly.
Croatian: Ako istovremeno primjenjujete EVRU i bilo koji od gore navedenih lijekova, razgovarajte sa svojim liječnikom ili ljekarnikom o korištenju druge metode kontrole začeća.
English: PATCH DISPOSAL LABEL
Croatian: NALJEPNICA ZA ODLAGANJE FLASTERA
English: • Abnormal cells in your cervix
Croatian: • abnormalne stanice grlića maternice
English: • You now have a new Day 1 and a new “Patch Change Day”.
Croatian: • Taj dan je novi 1. dan a ujedno i novi “dan izmjene flastera”.
English: Pulmonary (artery) thrombosis*† Pulmonary embolism†
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja rijetko plućna (arterijska) tromboza*† plućna embolija†
English: • Vaginal dryness
Croatian: • suhoća rodnice
English: Each transdermal patch releases an average of 203 micrograms of NGMN and 33.9 micrograms of EE per 24 hours.
Croatian: Jedan transdermalni flaster tijekom 24 sata prosječno oslobodi 203 mikrograma norelgestromina i 33,9 mikrograma etinilestradiola.
English: The increased risk gradually goes down after stopping the combined hormonal contraceptive.
Croatian: Nakon prestanka primjene kombiniranih hormonskih kontraceptiva, povećani rizik postupno se smanjuje.
English: Diarrhoea
Croatian: Tumori
English: After miscarriage or abortion after 20 weeks of pregnancy • Talk to your doctor.
Croatian: Nakon spontanog ili induciranog pobačaja nakon 20. tjedna trudnoće
English: Application site reactions (erythema, irritation, pruritus, rash)
Croatian: Opći poremećaji i reakcije na mjestu primjene često opća slabost umor reakcije na mjestu primjene (eritem, nadraženost, pruritus, osip)
English: Under no circumstances should there be more than a 7-day transdermal patch-free interval between dosing cycles.
Croatian: Razdoblje bez primjene transdermalnog flastera, ne smije biti duže od 7 dana.
English: • Inflammation of the gall bladder or colon
Croatian: • upala žučnog mjehura ili debelog crijeva
English: Malaise
Croatian: Nuspojava
English: Cholecystitis
Croatian: Dojenje
English: ALT elevations
Croatian: Porast ALT-a
English: Pruritus generalised
Croatian: Prijavljivanje nuspojava
English: SACHET LABEL
Croatian: NALJEPNICA VREĆICE
English: A non-hormonal contraceptive must be used concurrently for the first 7 consecutive days of the new cycle.
Croatian: Prvih 7 uzastopnih dana novog ciklusa mora se istovremeno koristiti i nehormonska kontracepcija.
English: A non-hormonal contraceptive must be used concurrently for the first 7 days of the new cycle.
Croatian: Prvih 7 dana novog ciklusa mora se istovremeno koristiti i nehormonska kontracepcija.
English: Cerebrovascular accident**† Cerebral haemorrhage*† Abnormal taste*
Croatian: Poremećaji živčanog sustava vrlo često glavobolja često migrena omaglica rijetko cerebrovaskularni incident**† cerebralno krvarenje*† abnormalni okus*
English: Rash pustular* Application site pustules Neoplasms benign, malignant and unspecified (incl cysts and polyps) rare
Croatian: (vulvo)vaginalne gljivične infekcije vaginalna kandidijaza rijetko pustularni osip* pustule na mjestu primjene Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) rijetko neoplazma jetre* karcinom dojke* kacinom grlića maternice* adenom jetre* leiomiom maternice, fibroadenom dojke
English: EXPIRY DATE
Croatian: 1.dan kalendar
English: Concentration Package size
Croatian: Koncentracija Veličina pakovanja
English: Blister (Aclar/polyethylene/PVC)
Croatian: Blister (Aclar/polietilena/ PVC)
English: Bottle (HDPE)
Croatian: Bočica (HDPE)
English: Bottle (polyethylene terephthalate)
Croatian: Bočica (polietilen tereftalata)
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Croatian: Put primjene Unutarnje pakovanje
English: It may harm them,
Croatian: Za što se Xospata koristi
English: Some possible side effects may be serious:
Croatian: Neke moguće nuspojave mogu biti ozbiljne:
English: A possible clinical relevance of these findings is unknown.
Croatian: Mogući klinički značaj tih nalaza nije poznat.
English: Planned HSCT
Croatian: Planirani HSCT
English: Reversibility of most of the changes was indicated by the end of the 4-week recovery period.
Croatian: Reverzibilnost većine tih promjena primijećena je do kraja 4-tjednog razdoblja oporavka.
English: • Confirm with ECG on day 9.
Croatian: • Potvrditi EKG-om 9. dana
English: The safety and efficacy of Xospata in children aged below 18 years has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Xospata u djece mlađe od 18 godina nisu još ustanovljene.
English: b. The 95% CI rate was calculated using the exact method based on binomial distribution.
Croatian: b. Stopa 95%-tnog CI izračunavala se egzaktnom metodom utemeljenom na binomnoj distribuciji.
English: None of these three metabolites exceeded 10% of overall parent exposure.
Croatian: Nijedan od ta tri metabolita nije premašio 10% ukupne izloženosti ishodišnom spoju.
English: Fifty-four percent of the patients were female.
Croatian: Pedeset i četiri posto (54%) bolesnika bile su žene.
English: In the study 42% of patients were 65 years or older and 12% were 75 years or older.
Croatian: U ispitivanju je 42% bolesnika imalo 65 ili više godina, a njih 12% bilo je u dobi od 75 ili više godina.
English: - Take Xospata once a day at the same time each day.
Croatian: - Uzmite lijek Xospata jedanput na dan, svaki dan u isto vrijeme.
English: MEC and FLAG-Ida were given for up to two cycles depending on response to first cycle.
Croatian: Protokoli MEC i FLAG-Ida davali su se tijekom najviše dva ciklusa, ovisno o odgovoru na prvi ciklus.
English: - Xospata can be taken with or without food.
Croatian: - Xospata se može uzimati s hranom ili bez nje.
English: There is no known specific antidote for Xospata.
Croatian: Nema poznatog specifičnog protulijeka za lijek Xospata.
English: EU/1/19/1399/001 84 film coated tablets
Croatian: EU/1/19/1399/001 84 filmom obložene tablete
English: If this happens, do not drive or use machines.
Croatian: U tom slučaju nemojte upravljati vozilima niti raditi sa strojevima.
English: Your doctor will tell you what dose of Xospata to take.
Croatian: Liječnik će Vam reći koliku dozu lijeka Xospata trebate uzeti.
English: • Carry this card with you at all times, especially when you travel or when you see another doctor.
Croatian: • Uvijek nosite ovu karticu sa sobom, osobito kad putujete ili posjećujete nekog drugog liječnika.
English: Do not give Xospata to children and adolescents under 18 years because it is not known whether it is safe and effective in this age group.
Croatian: Xospata se ne smije davati djeci i adolescentima mlađima od 18 godina jer nije poznato je li sigurna i učinkovita u toj dobnoj skupini.
English: However, the predicted increase on gilteritinib exposure was less than 2-fold.
Croatian: Međutim, predviđeno povećanje izloženosti gilteritinibu bilo je manje nego dvostruko.
English: Figure 1: Kaplan-Meier plot of overall survival in ADMIRAL study
Croatian: Slika 1: Kaplan-Meierova krivulja ukupnog preživljenja u ispitivanju ADMIRAL
English: - if you are allergic to gilteritinib or any of the other ingredients of this medicine (listed in section
Croatian: - ako ste alergični na gilteritinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Efficacy and safety was evaluated in the active-controlled, phase 3 study (2215-CL-0301) .
Croatian: Djelotvornost i sigurnost ocjenjivale su se u aktivnim lijekom kontroliranom ispitivanju faze 3 (2215-CL-0301).
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego uzmete ovaj lijek.
English: Getting medical treatment early may stop the problem from becoming more serious.
Croatian: Ranim se liječenjem može spriječiti da to stanje postane ozbiljnije.
English: The decision to re-introduce gilteritinib treatment after an event of QT prolongation should be based on a careful consideration of benefits and risks.
Croatian: Odluku o ponovnom uvođenju liječenja gilteritinibom nakon događaja produljenja QT intervala treba temeljiti na pažljivom razmatranju koristi i rizika.
English: What Xospata looks like and contents of the pack
Croatian: Kako Xospata izgleda i sadržaj pakiranja
English: Your doctor may decide to increase or lower your dose or temporarily interrupt treatment.
Croatian: Vaš će liječnik možda odlučiti povećati ili smanjiti dozu ili privremeno prekinuti liječenje.
English: QTc interval >500 msec
Croatian: QTc interval > 500 ms
English: The demographic and baseline characteristics were well-balanced between the two treatment arms.
Croatian: Demografske i početne značajke bile su dobro ujednačene u obje liječene skupine.
English: The population estimate of central and peripheral volume of distribution were 1092 L and 1100 L, respectively.
Croatian: Procijenjeni centralni i periferni volumen distribucije u populaciji iznosio je 1092 l odnosno 1100 l.
English: The majority of patients (83.8%) had an ECOG performance status score of 0 or 1.
Croatian: Većina bolesnika (83,8%) imala je funkcionalni ECOG status 0 ili 1.
English: Embryofoetal toxicity and contraception
Croatian: Embriofetalna toksičnost i kontracepcija
English: Contents of the pack and other information What Xospata contains
Croatian: Sadržaj pakiranja i druge informacije Što Xospata sadrži
English: It is important that you keep this Alert Card with you and show it to any healthcare professional you see.
Croatian: Važno je da uvijek nosite tu Karticu s upozorenjima sa sobom i da je pokažete svim zdravstvenim radnicima koje posjetite.
English: If you take more Xospata than you should
Croatian: Ako uzmete više lijeka Xospata nego što ste trebali
English: These may be signs of an inflammation of the pancreas (pancreatitis).
Croatian: To mogu biti znakovi upale gušterače (pankreatitisa).
English: A risk to the breast-fed children cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: Xospata is taken by mouth as tablets.
Croatian: Xospata se uzima kroz usta u obliku tableta.
English: The patient alert card will be integrated in the packaging and the content will be agreed as part of the labelling (Annex III).
Croatian: Kartica s upozorenjima za bolesnika bit će dio pakiranja, a njezin će se sadržaj dogovoriti u sklopu označivanja (Prilog III.).
English: IMPORTANT INFORMATION FOR HEALTHCARE PROVIDERS
Croatian: VAŽNE INFORMACIJE ZA ZDRAVSTVENE RADNIKE
English: 5HT2B receptor or sigma nonspecific receptor
Croatian: Receptor 5HT2B ili nespecifičan sigma receptor
English: Chemotherapy (N=124)
Croatian: Kemoterapija (N=124)
English: My name: ________________________________________________________________________ My contact number: ____________________________________________________________ Emergency contact: ________________________________________________________________ Emergency contact number: ________________________________________________________ Name of Haematologist/Oncologist/Oncology Nurse: _____________________________________ Contact number: _______________________________________________________________ After-hours contact number: _____________________________________________________ Name of my Hospital: ______________________________________________________________ My Hospital contact number: ____________________________________________________
Croatian: Moje ime: _________________________________________________________________________ Moj broj telefona: __________________________________________________________________
English: Frequency categories are defined as follows: 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); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Do not stop taking this medicine unless your doctor tells you to.
Croatian: Nemojte prestati uzimati ovaj lijek ako Vam to ne kaže Vaš liječnik.
English: • Please ensure you show this card to any doctor, pharmacist or nurse for any medical treatment or at any visits to the hospital or clinic.
Croatian: • Obavezno pokažite ovu karticu svakom liječniku, ljekarniku ili medicinskoj sestri kad primate bilo kakvo liječenje i pri svakom posjetu bolnici ili klinici.
English: ADMIRAL study (2215-CL-0301)
Croatian: Ispitivanje ADMIRAL (2215-CL-0301)
English: - if you have a history of low levels of the salts potassium or magnesium in your blood, as this may increase the risk of an abnormal heart rhythm.
Croatian: - ako u povijesti bolesti imate niske razine kalijevih ili magnezijevih soli u krvi, jer to može povećati rizik od poremećaja srčanog ritma
English: • Please contact your doctor immediately, if you develop any side effects, in particular those listed on this card.
Croatian: • Odmah se obratite svom liječniku ako primijetite bilo kakve nuspojave, osobito one navedene u ovoj kartici.
English: Some cases had concomitant acute febrile neutrophilic dermatosis.
Croatian: U nekim se slučajevima istodobno javila i akutna febrilna neutrofilna dermatoza.
English: You will also find this information in the Patient Alert Card that is included in the packaging.
Croatian: Ove ćete informacije pronaći i u Kartici s upozorenjima za bolesnika, koja se nalazi u pakiranju lijeka.
English: * Frequency is based on central laboratory values.
Croatian: *Učestalost se temelji na vrijednostima utvrđenima u središnjem laboratoriju.
English: You may feel dizzy after taking Xospata.
Croatian: Možda ćete osjećati omaglicu nakon što uzmete lijek Xospata.
English: Approximately 16.4% of the total dose was excreted in urine as unchanged drug and metabolites.
Croatian: Približno 16,4% ukupne doze izlučilo se kroz mokraću u obliku neizmijenjenog lijeka i metabolita.
English: Xospata may affect the way these medicines work, or these medicines may affect how Xospata works.
Croatian: Xospata može utjecati na način na koji ti lijekovi djeluju, jednako kao što ti lijekovi mogu utjecati na djelovanje lijeka Xospata.
English: If you take more tablets than you should, contact your doctor.
Croatian: Ako ste uzeli više tableta nego što ste trebali, obratite se svom liječniku.
English: There have been reports of pancreatitis.
Croatian: Prijavljeni su slučajevi pankreatitisa.
English: CHRYSALIS study (2215-CL-0101)
Croatian: Ispitivanje CHRYSALIS (2215-CL-0101)
English: Adverse reactions not observed in clinical studies, but seen in animals (safety pharmacology/repeat dose toxicity) at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Croatian: Nuspojave koje nisu zabilježene u kliničkim ispitivanjima, ali su zapažene u životinja (sigurnosna farmakologija/toksičnost ponovljenih doza) pri razinama izloženosti sličnima razinama izloženosti u ljudi i s mogućom važnošću za kliničku primjenu, bile su sljedeće:
English: Xospata may harm your unborn baby and should not be used during pregnancy.
Croatian: Xospata može naškoditi nerođenu djetetu i stoga se ne smije uzimati tijekom trudnoće.
English: It is unknown whether gilteritinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception.
Croatian: Nije poznato može li gilteritinib smanjiti učinkovitost hormonskih kontraceptiva pa bi žene koje koriste hormonsku kontracepciju uz nju trebale koristiti i mehaničku metodu kontracepcije.
English: Hypokalaemia or hypomagnesaemia should therefore be corrected prior to and during Xospata treatment.
Croatian: Stoga hipokalijemiju ili hipomagnezijemiju treba korigirati prije i tijekom liječenja lijekom Xospata.
English: Xospata is used if AML is linked to an alteration of a gene called FLT3, and is given to patients whose disease has come back or has not improved after previous treatment.
Croatian: Xospata se koristi ako je AML povezan s promjenom u genu zvanom FLT3 i daje se bolesnicima kojima se bolest vratila ili se nije poboljšala nakon prethodnog liječenja.
English: Due to in vitro binding to 5HT2B (see section 4.5), there is a potential impact on cardiac development in patients less than 6 months of age.
Croatian: Zbog vezivanja za 5HT2B in vitro (vidjeti dio 4.5) lijek može utjecati na razvoj srca u bolesnika mlađih od 6 mjeseci.
English: The gastrointestinal tract was identified as one of the target organs similar as in adult rats.
Croatian: Probavni sustav utvrđen je kao jedan od ciljnih organa, slično kao i u odraslih štakora.
English: What you need to know before you take Xospata Do not take Xospata
Croatian: Što morate znati prije nego počnete uzimati lijek Xospata Nemojte uzimati lijek Xospata
English: Your doctor may do a test to check if you have developed PRES and will stop Xospata treatment if it is confirmed that you have PRES.
Croatian: Vaš će liječnik možda provesti test kako bi utvrdio je li se kod Vas razvio PRES te će prekinuti liječenje lijekom Xospata ako se potvrdi da imate PRES.
English: • This patient is being treated with Xospata (gilteritinib), which can cause differentiation syndrome.
Croatian: • Ovaj se bolesnik liječi lijekom Xospata (gilteritinib), koji može uzrokovati sindrom diferencijacije.
English: Prior to the launch of Xospata in each Member State the MAH must agree about the content and format of the physician educational material, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Xospata u promet u svakoj državi članici, nositelj odobrenja mora s nacionalnim nadležnim tijelom dogovoriti sadržaj i format edukacijskog materijala za liječnike, uključujući komunikacijska sredstva, modalitete distribucije i sve druge aspekte programa.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xospata in one or more subsets of the paediatric population in the treatment of acute myeloid leukaemia.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Xospata u jednoj ili više podskupina pedijatrijske populacije za liječenje akutne mijeloične leukemije.