FrancophonIA/ELRC3.0 huggingface dataset:
English: What Herceptin is and what it is used for What you need to know before you are given Herceptin How Herceptin is given
Croatian: Što je Herceptin i za što se koristi Što morate znati prije nego počnete primati Herceptin
English: Herceptin subcutaneous formulation was locally and systemically well tolerated.
Croatian: Herceptin u supkutanoj formulaciji pokazao je dobru lokalnu i sistemsku podnošljivost.
English: No long-term animal studies have been performed to establish the carcinogenic potential of Herceptin, or to determine its effects on fertility in males.
Croatian: Nisu provedena dugoročna ispitivanja na životinjama s ciljem utvrđivanja kancerogenog potencijala lijeka Herceptin ili njegovih učinaka na plodnost muškaraca.
English: The hypodermic injection needle must be attached to the syringe immediately prior to administration followed by volume adjustment to 5 mL.
Croatian: Hipodermalna igla za injekciju mora se pričvrstiti na štrcaljku neposredno prije primjene, nakon čega volumen treba prilagoditi na 5 ml.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Croatian: Uvijek čuvajte ovaj lijek u zatvorenom originalnom pakiranju u hladnjaku na temperaturi od 2°C8°C.
English: The median duration of follow-up in the Herceptin arm was 3.8 years.
Croatian: Medijan trajanja praćenja u skupini koja je primala Herceptin iznosio je 3,8 godina.
English: Clinically significant interactions between Herceptin and the concomitant medicinal products used in clinical trials have not been observed.
Croatian: Nisu primijećene klinički značajne interakcije između lijeka Herceptin i istodobno primijenjenih lijekova koji su se koristili u kliničkim ispitivanjima.
English: P-value versus Observation
Croatian: P-vrijednost naspram opservacije
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 to 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 od 2°C do 8°C, osim ako su rekonstitucija i razrjeđivanje provedeni u kontroliranim i validiranim aseptičkim uvjetima.
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 Herceptin 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 Herceptin.
English: • the other is given as an injection under the skin (subcutaneous injection).
Croatian: • drugi koji se daje putem injekcije pod kožu (supkutanom injekcijom).
English: SISH technology is however, recommended to allow for the parallel evaluation of tumor histology and morphology.
Croatian: SISH metoda se međutim preporučuje u svrhu istodobne procjene histologije i morfologije tumora.
English: Pharma Biotech Penzberg Nonnenwald 2
Croatian: Roche Diagnostics GmbH, Pharma Biotech Penzberg Nonnenwald 2
English: New injections should be given at least 2.5 cm from the old site and never into areas where the skin is red, bruised,
Croatian: Nove injekcije treba primijeniti najmanje 2,5 cm od mjesta prethodne injekcije, ali nikada na ona područja gdje je koža crvena, s modricama, bolna na dodir ili tvrda.
English: There are no immunogenicity data available for Herceptin in gastric cancer.
Croatian: Nema dostupnih podataka o imunogenosti lijeka Herceptin kod raka želuca.
English: Aseptic preparation, handling and storage: Aseptic handling must be ensured when preparing the infusion.
Croatian: Aseptička priprema, rukovanje i čuvanje: Kod pripreme infuzije moraju se osigurati aseptički uvjeti rukovanja.
English: For storage conditions of the opened medicinal product, see section 6.3 and 6.6.
Croatian: Uvjete čuvanja otvorenoga lijeka vidjeti u dijelu 6.3 i 6.6.
English: Treatment with Herceptin 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 Herceptin 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: When Herceptin binds to HER2 it stops the growth of such cells and causes them to die.
Croatian: Kada se Herceptin veže na HER2, zaustavlja rast tih stanica i uzrokuje njihovo odumiranje.
English: Total pathological complete response* (95 % CI)
Croatian: Ukupan potpuni patološki odgovor* (95% CI)
English: Intravenous formulation
Croatian: Intravenska formulacija
English: All but one patient who reported severe hypertension had a history of hypertension before they entered the study.
Croatian: Sve osim jedne bolesnice koje su prijavile tešku hipertenziju imale su hipertenziju u anamnezi i prije uključivanja u ispitivanje.
English: The interval between consecutive Herceptin subcutaneous formulation administrations should not be less than three weeks.
Croatian: Razmak između dvije uzastopne primjene lijeka Herceptin u supkutanoj formulaciji ne smije biti manji od tri tjedna.
English: Herceptin should only be given by a doctor or nurse.
Croatian: Herceptin smiju primijeniti samo liječnik ili medicinska sestra.
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Herceptin, or longer if a continuous decrease of LVEF is observed.
Croatian: U bolesnika koji primaju kemoterapiju koja sadrži antracikline, preporučuje se daljnje praćenje jednom godišnje do 5 godina od posljednje primjene lijeka Herceptin ili dulje ako je uočeno daljnje smanjenje LVEF-a.
English: +Cardiac failure (congestive)
Croatian: + zatajenje srca (kongestivno)
English: What you need to know before you are given Herceptin
Croatian: Što morate znati prije nego počnete primati Herceptin
English: In the adjuvant treatment setting, Herceptin was investigated in 4 large multicentre, randomised, trials.
Croatian: U adjuvantnom je liječenju Herceptin ispitivan u 4 velika multicentrična, randomizirana ispitivanja:
English: At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8 %) in the control arm and 167 patients (56.8 %) in the treatment arm.
Croatian: U vrijeme analize umrlo je 349 od ukupnog broja randomiziranih bolesnika: 182 bolesnika (62,8%) u kontrolnoj skupini i 167 bolesnika (56,8%) u ispitivanoj skupini.
English: Paediatric population There is no relevant use of Herceptin in the paediatric population.
Croatian: Pedijatrijska populacija Nije opravdana primjena lijeka Herceptin u pedijatrijskoj populaciji.
English: Herceptin contains the active substance trastuzumab, which is a monoclonal antibody.
Croatian: Herceptin sadrži djelatnu tvar trastuzumab, koji je monoklonsko protutijelo.
English: Based on the observed data in study BO22227, steady state with the intravenous formulation was reached at cycle 8.
Croatian: Na temelju podataka opaženih u ispitivanju BO22227, kod primjene intravenske formulacije, stanje dinamičke ravnoteže postignuto je u 8. ciklusu.
English: Herceptin intravenous formulation is given as an intravenous infusion (“drip”) directly into your veins.
Croatian: Herceptin u intravenskoj formulaciji se primjenjuje intravenskom infuzijom („drip“) direktno u venu.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13
Croatian: Međutim, trastuzumab može povećati ukupnu izloženost jednome od metabolita doksorubicina (7-deoksi-13-dihidro-doksorubicinon, D7D).
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Herceptin therapy and for 7 months after the last dose.
Croatian: Budući da se humani IgG1 izlučuje u majčino mlijeko u ljudi, a nema spoznaja o mogućem štetnom učinku na novorođenče, žene ne bi smjele dojiti tijekom liječenja lijekom Herceptin ni 7 mjeseci nakon posljednje doze lijeka.
English: The majority of patients with cardiac symptoms and evidence of a clinical benefit of Herceptin treatment continued on therapy without additional clinical cardiac events.
Croatian: Većina bolesnika sa simptomima srčane bolesti i dokazanom kliničkom koristi liječenja lijekom Herceptin nastavila je liječenje bez dodatnih klinički manifestnih srčanih događaja.
English: Median months Overall Response Rate, % 34.5 % 47.3 % 1.70a (1.22, 2.38) 0.0017
Croatian: 34,5% 47,3% 1,70a (1,22; 2,38)
English: Greater than 70 % of patients enrolled exhibited 3+ overexpression.
Croatian: Više od 70 % uključenih bolesnica imalo je povećanu ekspresiju razine 3+.
English: After a median follow-up of
Croatian: Medijan praćenja
English: *Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
Croatian: *Cmin,ss - Cmin u stanju dinamičke ravnoteže **Cmax,ss = Cmax u stanju dinamičke ravnoteže *** vrijeme do postizanja 90% stanja dinamičke ravnoteže
English: Do not stop using this medicine without talking to your doctor first.
Croatian: Nemojte prestati primati Herceptin ako o tome prethodno niste razgovarali sa svojim liječnikom.
English: Approximately 17 % of cardiac dysfunction related events occurred after completion of Herceptin.
Croatian: Približno 17% događaja povezanih s disfunkcijom srca nastupilo je nakon završetka liječenja lijekom Herceptin.
English: In addition, comparison of two years of Herceptin treatment versus one year of Herceptin treatment was performed.
Croatian: Osim toga, napravljena je usporedba dvogodišnjeg liječenja lijekom Herceptin naspram jednogodišnjeg liječenja lijekom Herceptin.
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Herceptin is given every 3 weeks.
Croatian: Za rani rak dojke, metastatski rak dojke i metastatski rak želuca, Herceptin se primjenjuje svaka 3 tjedna.
English: Do not dilute with glucose solutions since these cause aggregation of the protein.
Croatian: Za razrjeđivanje ne koristite otopine glukoze jer izazivaju taloženje proteina.
English: The safety of continuation or resumption of Herceptin in patients who experience cardiac dysfunction has not been prospectively studied.
Croatian: Sigurnost kontinuirane ili ponovne primjene lijeka Herceptin u bolesnika u kojih se razvila disfunkcija srca nije prospektivno ispitana.
English: The difference in serious adverse event rates between formulations was mainly due to infections with or without neutropenia (4.4 % versus 8.1 %) and cardiac disorders (0.7 % versus 1.7 %);
Croatian: Razlika u stopama ozbiljnih štetnih događaja između tih dviju formulacija uglavnom je bila posljedica infekcija, praćenih neutropenijom ili bez nje (4,4% naspram 8,1%) i srčane poremećaje (0,7% naspram 1,7%)
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: Like all medicines, Herceptin can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Herceptin može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: If the patient misses a dose of Herceptin subcutaneous formulation, it is recommended to administer the next 600 mg dose (i.e. the missed dose) as soon as possible.
Croatian: Ako bolesnik propusti primiti dozu supkutane formulacije lijeka Herceptin, preporučuje se što prije dati sljedeću dozu od 600 mg (tj. propuštenu dozu).
English: After transfer of the solution to the syringe, it is recommended to replace the transfer needle by a syringe closing cap to avoid drying of the solution in the needle and not compromise the quality of the medicinal product.
Croatian: Nakon prebacivanja otopine u štrcaljku, preporučuje se zamijeniti iglu korištenu za prijenos zaštitnim zatvaračem za štrcaljku kako bi se izbjeglo sušenje otopine u igli i narušavanje kvalitete lijeka.
English: These events have occasionally been fatal and may occur as part of an infusion-related reaction or with delayed onset.
Croatian: Ti su slučajevi ponekad imali smrtni ishod, a mogu se pojaviti u sklopu infuzijskih reakcija ili s odgođenim nastupom.
English: The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of Herceptin versus observation.
Croatian: Rezultati djelotvornosti iz privremene analize djelotvornosti nadmašili su prethodno definiranu statističku graničnu vrijednost za usporedbu skupine liječene lijekom Herceptin tijekom 1 godine naspram opservacija.
English: The recommended dose for Herceptin subcutaneous formulation is 600 mg irrespective of the patient's body weight.
Croatian: Preporučena doza formulacije lijeka Herceptin za supkutanu primjenu iznosi 600 mg, neovisno o tjelesnoj težini bolesnika.
English: On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the Herceptin infusion.
Croatian: U vrlo rijetkim slučajevima infuzijski i plućni simptomi pojavili su se nakon više od 6 sati od početka infuzije lijeka Herceptin.
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: Death (OS event)
Croatian: Smrt (događaj ukupnog preživljenja)
English: The preoperative chemotherapy regimen consisted of docetaxel (75 mg/m²) followed by FEC (5FU, epirubicin and cyclophosphamide) at a standard dose.
Croatian: Predoperacijski kemoterapijski protokol obuhvaćao je docetaksel (75 mg/m2), a nakon njega FEC (5FU, epirubicin i ciklofosfamid) u standardnoj dozi.
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Herceptin.
Croatian: Ako je moguće, uputno je izbjegavati primjenu antraciklinske terapije do 7 mjeseci nakon prestanka primjene lijeka Herceptin.
English: • prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Croatian: • Priprema se mora provesti u komori s laminarnim protokom ili mikrobiološkom zaštitnom kabinetu uz standardne mjere opreza za sigurno rukovanje lijekovima za intravensku primjenu.
English: The 13week study was performed to confirm that the change in route of administration and the use of the novel excipient recombinant human hyaluronidase (rHuPH20) did not have an effect on the Herceptin safety characteristics.
Croatian: Trinaestotjedno istraživanje provedeno je kako bi se potvrdilo da promjena puta primjene te primjena nove pomoćne tvari, rekombinantne humane hijaluronidaze (rHuPH20) ne utječu na sigurnosne značajke lijeka Herceptin.
English: How to store Herceptin Herceptin will be stored by the health professionals at the hospital or clinic.
Croatian: Herceptin će čuvati zdravstveni radnici u bolnici ili klinici.
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: * Observed with combination therapy following anthracyclines and combined with taxanes
Croatian: * Opaženo u kombinacijskoj terapiji nakon antraciklina i u kombinaciji s taksanima.
English: Herceptin should not be mixed or diluted with other products.
Croatian: Herceptin se ne smije miješati niti razrjeđivati s drugim lijekovima.
English: The difference between formulations was mainly observed during the adjuvant treatment phase (monotherapy) and was mainly due to postoperative wound infections, but also to various other infections such as respiratory tract infections, acute pyelonephritis and sepsis.
Croatian: Razlika između formulacija uglavnom je primijećena tijekom faze adjuvantnoga liječenja (monoterapija), a prvenstveno je bila posljedica poslijeoperacijskih infekcija rane, ali i raznih drugih infekcija, poput infekcija dišnog sustava, akutnog pijelonefritisa i sepse.
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1 % versus 4.6 % in the 1-year treatment arm).
Croatian: Stopa asimptomatske disfunkcije srca bila je povećana u skupini liječenoj tijekom 2 godine (8,1% naspram 4,6% u skupini liječenoj tijekom 1 godine).
English: Most of the patients (79 %) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF.
Croatian: U većine bolesnica (79%) u kojih se u tim ispitivanjima razvila srčana disfunkcija došlo je do poboljšanja nakon što su primile standardnu terapiju za kongestivno zatajenje srca.
English: Median follow-up 8 years**
Croatian: 8 godina**
English: If you experience any of the above symptoms when your treatment with Herceptin has finished, you should see your doctor and tell them that you have previously been treated with Herceptin.
Croatian: Ako se neki od gore navedenih simptoma jave nakon prestanka liječenja lijekom Herceptin, javite se svojem liječniku i recite mu da ste prethodno bili liječeni lijekom Herceptin.
English: • Post-operative wound infections (severe and/or serious): 1.7 % versus 3.0 % for the intravenous formulation versus subcutaneous formulation, respectively;
Croatian: • poslijeoperacijske infekcije rane (teške i/ili ozbiljne): 1,7% za intravensku formulaciju naspram 3,0% za supkutanu formulaciju)
English: Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of Herceptin (see section 4.4) and have been associated with a fatal outcome.
Croatian: Teške anafilaktičke reakcije koje zahtijevaju dodatnu hitnu intervenciju obično se javljaju tijekom 1. ili 2. infuzije lijeka Herceptin (vidjeti dio 4.4) i mogu završiti smrtnim ishodom.
English: Results were consistent with the known safety profile for Herceptin intravenous and Herceptin subcutaneous formulations.
Croatian: Rezultati su bili u skladu s poznatim sigurnosnim profilom formulacija lijeka Herceptin za intravensku i supkutanu primjenu.
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: • Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterized by high blood levels of potassium and phosphate, and low blood levels of calcium).
Croatian: • Sindrom tumorske lize (skup metaboličkih komplikacija koje se javljaju nakon terapije za rak, a očituju se visokim razinama kalija i fosfata te niskim razinama kalcija u krvi).
English: Your doctor may consider switching your Herceptin intravenous treatment to Herceptin subcutaneous treatment (and vice versa) if considered appropriate for you.
Croatian: Vaš će liječnik možda razmotriti mogućnost da Vas prebaci s liječenja intravenskom formulacijom lijeka Herceptin na liječenje supkutanom formulacijom lijeka Herceptin (i obrnuto), ako bude smatrao da je to prikladno za Vas.
English: Recombinant human hyaluronidase (rHuPH20) L-histidine
Croatian: Rekombinantna humana hijaluronidaza (rHuPH20) L-histidin
English: Body weight and serum alanine aminotransferase (SGPT/ALT) showed a statistically significant influence on PK, however, simulations demonstrated that no dose adjustments are required in EBC patients.
Croatian: Tjelesna težina i razina alanin aminotransferaze u serumu (SGPT/ALT) imale su statistički značajan utjecaj na farmakokinetiku, ali simulacije su pokazale da nije potrebno prilagođavati dozu u bolesnika s ranim rakom dojke.
English: • dry mouth and skin
Croatian: • suhoća usta i kože
English: • one is given as an infusion into a vein (intravenous infusion)
Croatian: • jedan koji se daje putem infuzije u venu (intravenskom infuzijom)
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50 % after the event) was evident for 71.4 % of Herceptin-treated patients.
Croatian: Reverzibilnost teškog kongestivnog zatajenja srca (definirana kao slijed od najmanje dviju uzastopnih vrijednosti LVEF ≥ 50% nakon događaja) bila je primjetna u 71,4% bolesnika liječenih lijekom Herceptin.
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: sljedeće se doze mogu primijeniti u infuziji trajanja 30 minuta (pogledajte dio 2 pod "Upozorenja i mjere opreza").
English: Herceptin is for single-use only.
Croatian: Herceptin je namijenjen samo za jednokratnu primjenu.
English: No incompatibilities between Herceptin and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Croatian: Nisu primijećene inkompatibilnosti između lijeka Herceptin i polivinilkloridnih, polietilenskih ili polipropilenskih vrećica.
English: • Serious adverse events (most of which were identified because of in-patient hospitalisation or prolongation of existing hospitalisation): 14.1 % for the intravenous formulation versus 21.5 % for the subcutaneous formulation.
Croatian: • ozbiljni štetni događaji (većina je identificirana zahvaljujući hospitalizaciji bolesnika ili produljenju postojeće hospitalizacije): 14,1% uz intravensku naspram 21,5% uz supkutanu formulaciju.
English: Herceptin treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only.
Croatian: Liječenje lijekom Herceptin smije započeti samo liječnik s iskustvom u primjeni citotoksične kemoterapije (vidjeti dio 4.4), a lijek smije primijeniti samo zdravstveni radnik.
English: 1Palpitation
Croatian: 1palpitacije
English: Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) fetal 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: (vs. AC→D) (BCIRG 006)
Croatian: (naspram AC→D) (BCIRG 006)
English: Other side effects that have been reported with Herceptin use: frequency cannot be estimated from the available data
Croatian: Ostale nuspojave koje su prijavljene pri primjeni lijeka Herceptin: učestalost se ne može procijeniti iz dostupnih podataka
English: • Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy.
Croatian: • Liječnik će Vam objasniti rizike i koristi primjene lijeka Herceptin tijekom trudnoće.
English: Single doses of up to 960 mg of Herceptin subcutaneous formulation have been administered with no reported untoward effects.
Croatian: Primijenjene su jednokratne doze do 960 mg lijeka Herceptin u supkutanoj formulaciji, pri čemu nisu prijavljeni štetni učinci.
English: The local reactions included erythema, pruritus, oedema, rash and pain at the site of the injection.
Croatian: Lokalne reakcije uključivale su eritem, pruritus, edem, osip i bol na mjestu primjene injekcije.