FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the magnitude of effect of these covariates on trastuzumab exposure suggests that these covariates are unlikely to have a clinically meaningful effect on trastuzumab concentrations.
Croatian: Međutim, veličina učinka tih kovarijanti na izloženost trastuzumabu upućuje na to da nije vjerojatno da bi te kovarijante klinički značajno utjecale na koncentracije trastuzumaba.
English: • abnormally low oxygen levels in the blood
Croatian: • abnormalno niske razine kisika u krvi
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Croatian: Međutim, trastuzumab može povećati ukupnu izloženost jednome od metabolita doksorubicina (7-deoksi-13-dihidro-doksorubicinon, D7D).
English: Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms.
Croatian: Liječnik će Vam tijekom i nakon liječenja redovito kontrolirati srce, ali ako primijetite neki od gore navedenih simptoma o tome odmah obavijestite svog liječnika.
English: Therefore, these patients should not be treated with KANJINTI (see section 4.3).
Croatian: Te se bolesnike zato ne smije liječiti lijekom KANJINTI (vidjeti dio 4.3).
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with KANJINTI.
Croatian: Ti lijekovi (ili neki drugi antraciklini) mogu oštetiti srčani mišić i povećati rizik od srčanih problema pri primjeni lijeka KANJINTI.
English: For storage conditions of the reconstituted medicinal product, see section 6.3 and 6.6.
Croatian: Uvjete čuvanja rekonstituiranoga lijeka, vidjeti u dijelu 6.3 i 6.6.
English: Talk to your doctor, pharmacist or nurse before you are given KANJINTI if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite KANJINTI:
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Croatian: Ozbiljne reakcije uspješno su liječene potpornom terapijom, primjerice kisikom, beta-agonistima i kortikosteroidima.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop KANJINTI treatment.
Croatian: Ako se pojave znakovi zatajenja srca (srce nedostatno pumpa krv), možda ćete srčanu funkciju kontrolirati češće (svakih šest do osam tjedana), a možda ćete primati terapiju za zatajenje srca ili ćete morati prekinuti liječenje lijekom KANJINTI.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are < 1 µg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Croatian: Rezultati tih simulacija ukazuju da će najmanje 95% bolesnika postići koncentracije < 1 µg/ml (približno 3% vrijednosti Cmin,ss predviđene za populaciju ili ispiranje od približno 97%) do 7. mjeseca.
English: Caution should be exercised for pneumonitis, especially in patients being treated concomitantly with taxanes.
Croatian: Potreban je oprez u slučaju pneumonitisa, posebno u bolesnika koji istodobno primaju taksane.
English: KANJINTI is a biosimilar medicinal product.
Croatian: KANJINTI je biosličan lijek.
English: Greater than 70% of patients enrolled exhibited 3+ overexpression.
Croatian: Više od 70% uključenih bolesnica imalo je povećanu ekspresiju razine 3+.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2018
Croatian: Datum prvog odobrenja: 16. svibnja 2018
English: In this section, the following categories of frequency have been used: 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
Croatian: U ovom dijelu, za prikaz nuspojava prema učestalosti korišteni su sljedeći kriteriji: 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: If anthracyclines are used, the patient's cardiac function should be monitored carefully.
Croatian: Ako se antraciklini ipak primijene, potrebno je pažljivo pratiti srčanu funkciju bolesnika.
English: If you receive KANJINTI in combination with chemotherapy, some of them may also be due to the chemotherapy.
Croatian: Ako primate KANJINTI u kombinaciji s kemoterapijom, neke od njih mogu biti i posljedica primljene kemoterapije.
English: • abnormal heart rhythm
Croatian: • abnormalan ritam srca
English: DO NOT SHAKE.
Croatian: Ne tresti.
English: In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Croatian: Osim toga, napravljena je usporedba dvogodišnjeg liječenja trastuzumabom naspram jednogodišnjeg liječenja trastuzumabom.
English: 30-60 minutes repeated every 3 weeks for a total of six cycles
Croatian: 30-60 minuta, svaka 3 tjedna, ukupno 6 ciklusa.
English: HER2 testing must be performed in a specialised laboratory which can ensure adequate validation of the testing procedures (see section 5.1).
Croatian: Testiranje ekspresije HER2 mora se provesti u specijaliziranom laboratoriju koji može osigurati odgovarajuću provjeru valjanosti postupaka testiranja (vidjeti dio 5.1).
English: The loading dose should be administered as a 90-minute intravenous infusion.
Croatian: Udarnu dozu lijeka KANJINTI potrebno je primijeniti u 90-minutnoj intravenskoj infuziji.
English: • The active substance is trastuzumab.
Croatian: • Djelatna tvar je trastuzumab.
English: Tell a doctor or nurse straight away, if you notice any of the following side effects:
Croatian: Odmah se obratite liječniku ili medicinskoj sestri ako primijetite bilo koju od sljedećih nuspojava:
English: All the terms included are based on the highest percentage seen in pivotal clinical trials.
Croatian: Sve uključene nuspojave temelje se na najvišim zabilježenim postotcima iz pivotalnih kliničkih ispitivanja.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Croatian: Farmakoterapijska skupina: antineoplastici, monoklonska protutijela, ATK oznaka: L01XC03
English: In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50% of tumour cells.
Croatian: Općenito, CISH se smatra pozitivnim ako postoji više od pet kopija HER2 gena po jezgri u više od 50% tumorskih stanica.
English: These effects mainly occur with the first intravenous infusion (“drip” into your vein) and during the first few hours after the start of the infusion.
Croatian: Ove nuspojave pojavljuju se uglavnom pri prvoj intravenskoj infuziji (drip u venu) i tijekom prvih nekoliko sati nakon početka infuzije.
English: If during treatment you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear.
Croatian: Ukoliko tijekom liječenja primijetite simptome poput zimice ili vrućice, ne smijete upravljati vozilima niti rukovati strojevima sve dok se ti simptomi ne povuku.
English: The cells are only stained in part of their membrane.
Croatian: Obojeni su samo dijelovi stanične membrane.
English: When trastuzumab binds to HER2 it stops the growth of such cells and causes them to die.
Croatian: Kada se trastuzumab veže na HER2, zaustavlja rast tih stanica i uzrokuje njihovo odumiranje.
English: (L/day)
Croatian: (l/dan)
English: For instructions on reconstitution of KANJINTI intravenous formulation before administration, see section 6.6.
Croatian: Za upute o rekonstituciji lijeka KANJINTI u intravenskoj formulaciji prije primjene vidjeti dio 6.6.
English: Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6 - 8 weeks).
Croatian: Bolesnicima koji razviju asimptomatsku disfunkciju srca mogli bi koristiti češći pregledi (primjerice, svakih 6-8 tjedana).
English: Duration of response, median months
Croatian: Trajanje odgovora, medijan u mjesecima
English: Do not use with glucose-containing solutions (see section 6.2).
Croatian: Ne smiju se koristiti otopine koje sadrže glukozu (vidjeti dio 6.2).
English: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a Odds ratio
Croatian: FP + H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin a omjer šansi
English: • blood infection
Croatian: • infekcija krvi
English: This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in foetal death.
Croatian: Ovo stanje može naškoditi Vašoj bebi u maternici i povezuje se sa smrću ploda uslijed nepotpunog razvoja pluća.
English: Other side effects can occur at any time during treatment with trastuzumab, not just related to an infusion.
Croatian: Ostale nuspojave mogu se pojaviti bilo kada tijekom liječenja trastuzumabom, a ne samo u svezi s infuzijom.
English: If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”).
Croatian: U slučaju dobrog podnošenja prve doze, sljedeće se doze mogu primijeniti u infuziji trajanja 30 minuta (pogledajte dio 2 pod "Upozorenja i mjere opreza").
English: Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms (see sections 4.4 and 4.8).
Croatian: Bolesnike je potrebno promatrati najmanje 6 sati nakon početka prve infuzije te 2 sata nakon početka svake sljedeće infuzije kako bi se uočili simptomi poput vrućice i zimice ili drugi simptomi koji su vezani uz primjenu infuzije (vidjeti dio 4.4 i 4.8).
English: There is no experience with overdose in human clinical trials.
Croatian: Nema iskustva s predoziranjem u kliničkim ispitivanjima na ljudima.
English: Infusion reactions, allergic-like reactions and hypersensitivity
Croatian: Infuzijske reakcije, reakcije slične alergijama i preosjetljivost
English: No long-term animal studies have been performed to establish the carcinogenic potential of trastuzumab, or to determine its effects on fertility in males.
Croatian: Nisu provedena dugoročna ispitivanja na životinjama s ciljem utvrđivanja kancerogenog potencijala trastuzumaba ili njegovih učinaka na plodnost muškaraca.
English: There are no immunogenicity data available for trastuzumab in gastric cancer.
Croatian: Nema dostupnih podataka o imunogenosti trastuzumaba kod raka želuca.
English: Use of other reconstitution solvents should be avoided.
Croatian: Uporabu drugih otapala za rekonstituciju potrebno je izbjegavati.
English: • you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer).
Croatian: • Ako ste ikada primali ili trenutno primate lijek koji se zove doksorubicin ili epirubicin (lijekovi za liječenje raka).
English: It may take up to 7 months for KANJINTI to be removed from your body.
Croatian: Može biti potrebno i do 7 mjeseci da se KANJINTI ukloni iz Vašeg tijela.
English: Due to non-linear elimination, total clearance increased with decreasing concentration.
Croatian: Zbog nelinearne eliminacije, ukupan se klirens povećavao sa smanjenjem koncentracije.
English: A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile.
Croatian: Model s dva odjeljka te paralelnom linearnom i nelinearnom eliminacijom iz središnjeg odjeljka opisivao je profil koncentracije trastuzumaba kroz vrijeme.
English: HER2 testing is mandatory prior to initiation of therapy (see sections 4.4 and 5.1).
Croatian: Testiranje ekspresije HER2 je obvezatno prije početka liječenja (vidjeti dijelove 4.4 i 5.1).
English: Your doctor may prescribe KANJINTI for the treatment of breast and gastric cancer when:
Croatian: Vaš liječnik Vam može propisati KANJINTI za liječenje raka dojke i želuca ako:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C - 8°C.
Croatian: Ako se lijek ne primijeni odmah, vrijeme i uvjeti čuvanja prije uporabe postaju odgovornost korisnika i obično ne bi trebali biti dulji od 24 sata na temperaturi 2°C - 8°C.
English: See section 5.1 for chemotherapy combination dosing.
Croatian: Vidjeti dio 5.1 za doziranje u kombinaciji s kemoterapijom.
English: The efficacy results from study BO18225 are summarised in table 13: Table 13 Efficacy results from BO18225
Croatian: Rezultati djelotvornosti dobiveni ispitivanjem BO18225 sažeti su u Tablici 13: Tablica 13. Rezultati djelotvornosti iz ispitivanja BO18225
English: • performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
Croatian: • Pripremu mora provesti kvalificirano osoblje pod aseptičkim uvjetima i u skladu s pravilima dobre prakse, osobito onima koja se odnose na aseptičku pripremu lijekova za parenteralnu primjenu.
English: In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials.
Croatian: U adjuvantnom je liječenju trastuzumab ispitivan u 4 velika multicentrična, randomizirana ispitivanja.
English: For monotherapy, the rate was 6% - 9%.
Croatian: Kod primjene u monoterapiji, stopa je iznosila 6% do 9%.
English: Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed.
Croatian: Nisu primijećene klinički značajne interakcije između trastuzumaba i istodobno primijenjenih lijekova koji su se koristili u kliničkim ispitivanjima.
English: No incompatibilities between KANJINTI and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Croatian: Nisu primijećene inkompatibilnosti između lijeka KANJINTI i polivinilkloridnih, polietilenskih ili polipropilenskih vrećica.
English: • Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Croatian: • Ponekad se tijekom liječenja, a katkad i nakon prestanka liječenja mogu javiti srčane tegobe, koje mogu biti ozbiljne.
English: Paediatric population There is no relevant use of trastuzumab in the paediatric population.
Croatian: Pedijatrijska populacija Nije opravdana primjena trastuzumaba u pedijatrijskoj populaciji.
English: Treatment with KANJINTI alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Croatian: Liječenje lijekom KANJINTI samim ili u kombinaciji s taksanom može utjecati na srce, osobito ako ste nekada već uzimali antracikline (taksani i antraciklini su dvije vrste lijekova koji se koriste za liječenje raka).
English: Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with KANJINTI.
Croatian: Stoga će se srčana funkcija kontrolirati prije, tijekom (svaka tri mjeseca) i nakon (najviše dvije do pet godina) liječenja lijekom KANJINTI.
English: Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2).
Croatian: U slučaju pojave infuzijske reakcije, infuziju je potrebno prekinuti ili usporiti, a bolesnika promatrati do povlačenja svih opaženih simptoma (vidjeti dio 4.2).
English: KANJINTI contains the active substance trastuzumab, which is a monoclonal antibody.
Croatian: KANJINTI sadrži djelatnu tvar trastuzumab, koji je monoklonsko protutijelo.
English: In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file.
Croatian: Kako bi se poboljšala sljedivost ovog lijeka, vaš liječnik ili ljekarnik trebaju zabilježiti naziv i broj serije lijeka koji ste dobili, u vaš zdravstveni karton.
English: 1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
Croatian: 1 Označava nuspojave koje su uglavnom prijavljivane u vezi s reakcijama izazvanima infuzijom.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not shake.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported.
Croatian: Zabilježeni su i slučajevi početnog poboljšanja praćenog kliničkim pogoršanjem i odgođenim reakcijama s brzim kliničkim pogoršanjem nakon početnog poboljšanja.
English: The median duration of follow-up in the trastuzumab arm was 3.8 years.
Croatian: Medijan trajanja praćenja u skupini koja je primala trastuzumab iznosio je 3,8 godina.
English: Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
Croatian: Bolesnicima u kojih su se razvili simptomi izazvani infuzijskom reakcijom (vidjeti dio 4.4) treba savjetovati da ne upravljaju vozilima niti rukuju strojevima dok se simptomi ne povuku.
English: • you have had heart failure, coronary artery disease, heart valve disease (heart murmurs), high blood pressure, taken any high blood pressure medicine or are currently taking any high blood pressure medicine.
Croatian: • Ako ste imali zatajenje srca, bolest srčanih arterija, bolest srčanih zalistaka (šum na srcu), visok krvni tlak, ako ste uzimali lijekove za liječenje visokog krvnog tlaka ili trenutno uzimate lijekove za liječenje visokog krvnog tlaka.
English: The majority of patients with cardiac symptoms and evidence of a clinical benefit of trastuzumab treatment continued on therapy without additional clinical cardiac events.
Croatian: Većina bolesnika sa simptomima srčane bolesti i dokazanom kliničkom koristi liječenja trastuzumabom nastavila je liječenje bez dodatnih klinički manifestnih srčanih događaja.
English: • you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na trastuzumab, mišje proteine ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Experience of concurrent administration of trastuzumab with low-dose anthracycline regimens is currently limited to two trials (MO16432 and BO22227).
Croatian: Iskustvo s istodobnom primjenom trastuzumaba i protokola s niskim dozama antraciklina zasada je ograničeno na dva ispitivanja (MO16432 i BO22227).
English: • You have early breast cancer, with high levels of a protein called HER2.
Croatian: • bolujete od ranog raka dojke s visokom razinom proteina koji se zove HER2.
English: The majority of these events occur during or within 2.5 hours of the start of the first infusion.
Croatian: Većina tih nuspojava javlja se unutar 2,5 sata od početka prve infuzije.
English: Do not stop using this medicine without talking to your doctor first.
Croatian: Nemojte prestati primati KANJINTI ako o tome prethodno niste razgovarali sa svojim liječnikom.
English: What you need to know before you are given KANJINTI
Croatian: Što morate znati prije nego počnete primati KANJINTI
English: It is important for you to keep all your appointments to receive KANJINTI.
Croatian: Važno je da odete na sve zakazane preglede kako biste primili KANJINTI.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C - 8°C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.
Croatian: Ako se lijek ne primijeni odmah, vrijeme i uvjeti čuvanja prije uporabe postaju odgovornost korisnika i obično ne bi trebali biti dulji od 24 sata na temperaturi 2°C - 8°C, osim ako su rekonstitucija i razrjeđivanje provedeni u kontroliranim i validiranim aseptičkim uvjetima.
English: During a KANJINTI infusion, chills, fever and other flu like symptoms may occur.
Croatian: Za vrijeme infuzije lijeka KANJINTI mogu se pojaviti zimica, vrućica i drugi simptomi nalik gripi.
English: KANJINTI intravenous formulation is given as an intravenous infusion (“drip”) directly into your veins.
Croatian: KANJINTI u intravenskoj formulaciji se primjenjuje intravenskom infuzijom („drip“) direktno u venu.
English: Dose reduction
Croatian: Smanjenje doze
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarised in table 6:
Croatian: Rezultati djelotvornosti dobiveni ispitivanjem BO16348, nakon medijana praćenja od 12 mjeseci* i 8 godina**, sažeti su u Tablici 6:
English: Fatalities have occurred within hours and up to one week following infusion.
Croatian: Smrtni ishod nastupio je u vremenu od nekoliko sati do jednog tjedna nakon infuzije.
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised KANJINTI, directing the stream into the lyophilised cake.
Croatian: 1) Sterilnom štrcaljkom polagano ubrizgajte odgovarajući volumen (kao što je gore navedeno) sterilne vode za injekcije u bočicu koja sadrži liofilizirani KANJINTI, usmjeravajući mlaz u liofilizirani kolačić.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije kontuzije često
English: Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) foetal development period was observed.
Croatian: Primijećeno je da trastuzumab prolazi kroz posteljicu za vrijeme ranog (20.-50. dan gestacije) i kasnog (120.-150. dan gestacije) perioda fetalnog razvoja.
English: Effect of trastuzumab on the pharmacokinetics of other antineoplastic agents
Croatian: Učinak trastuzumaba na farmakokinetiku drugih antineoplastika
English: Do not use with glucose-containing solutions.
Croatian: Ne smijete koristiti s otopinama koje sadrže glukozu.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in “Warnings and precautions” (see section 4.4).
Croatian: Pojedinosti o mjerama za smanjenje rizika u skladu s Europskim planom upravljanja rizicima navedene su u dijelu „Posebna upozorenja i mjere opreza pri uporabi“ (vidjeti dio 4.4).
English: Table 6 Efficacy results from study BO16348
Croatian: Tablica 6. Rezultati djelotvornosti iz ispitivanja BO16348
English: There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies.
Croatian: Nije bilo dokaza akutne toksičnosti niti toksičnosti povezane s višekratnim dozama u ispitivanjima trajanja do 6 mjeseci, kao ni dokaza reprodukcijske toksičnosti u teratološkim ispitivanjima, ispitivanjima ženske plodnosti ili ispitivanjima kasne gestacijske toksičnosti/prolaza kroz placentu.
English: If a pregnant woman is treated with KANJINTI, or if a patient becomes pregnant while receiving KANJINTI or within 7 months following the last dose of KANJINTI, close monitoring by a multidisciplinary team is desirable.
Croatian: Ako se lijekom KANJINTI liječi trudnicu, ili ako bolesnica zatrudni tijekom liječenja lijekom KANJINTI ili unutar 7 mjeseci nakon posljednje doze lijeka KANJINTI, poželjno je pažljivo praćenje od strane multidisciplinarnog tima.