FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja referentnog lijeka koji sadrži trastuzumab u svim podskupinama pedijatrijske populacije za rak dojke i želuca (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Treatment with Ogivri 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 Ogivri 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: • 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: Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Croatian: Ponekad se za vrijeme liječenja i katkad nakon prestanka liječenja mogu pojaviti srčani problemi koji mogu biti ozbiljni.
English: After reconstitution with sterile water for injections, the reconstituted solution is physically and chemically stable for 48 hours at 2°C-8°C.
Croatian: Nakon rekonstitucije sterilnom vodom za injekcije rekonstituirana otopina fizički je i kemijski stabilna tijekom 48 sati na temperaturi od 2 °C do 8 °C.
English: The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarized in Table 6:
Croatian: Rezultati djelotvornosti dobiveni ispitivanjem BO16348 nakon medijana praćenja od 12 mjeseci* i 8 godina** sažeti su u Tablici 6.:
English: No incompatibilities between Ogivri and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Croatian: Nisu primijećene inkompatibilnosti između lijeka Ogivri i polivinilkloridnih, polietilenskih ili polipropilenskih vrećica.
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 trastuzumab-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 trastuzumabom.
English: Do not breast-feed your baby during Ogivri therapy and for 7 months after the last dose of Ogivri as this medicine may pass to your baby through your breast milk.
Croatian: Nemojte dojiti dijete za vrijeme terapije lijekom Ogivri ni 7 mjeseci nakon posljednje doze lijeka jer se Ogivri preko Vašeg mlijeka može prenijeti na Vaše dijete.
English: • anaphylactic reactions (serious sudden allergic reaction with symptoms such as rash, itchy skin,
Croatian: • anafilaktičke reakcije (ozbiljne iznenadne alergijske reakcije sa simptomima kao što su osip,
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite were unclear.
Croatian: D7D niti klinički značaj povećanih koncentracija toga metabolita.
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 trastuzumab, 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 trastuzumaba ili dulje ako je uočeno daljnje smanjenje LVEF-a.
English: • Hypersensitivity to the active substance, murine proteins, or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar, mišje proteine ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Other side effects can occur at any time during treatment with Ogivri, not just related to an infusion.
Croatian: Ostale nuspojave mogu se pojaviti bilo kada tijekom liječenja lijekom Ogivri, a ne samo u vezi s infuzijom.
English: If you experience any of the above symptoms when your treatment with Ogivri has finished, you should see your doctor and tell them that you have previously been treated with Ogivri.
Croatian: Ako se neki od gore navedenih simptoma jave nakon prestanka liječenja lijekom Ogivri, javite se svojem liječniku i recite mu da ste prethodno bili liječeni lijekom Ogivri.
English: L-histidine hydrochloride
Croatian: L-histidinklorid
English: During an Ogivri infusion, chills, fever and other flu like symptoms may occur.
Croatian: Za vrijeme infuzije lijeka Ogivri mogu se pojaviti zimica, vrućica i drugi simptomi nalik gripi.
English: If an alternate route of administration is required, other trastuzumab products offering such an option should be used
Croatian: Ako je potreban alternativni put primjene, treba koristiti druge lijekove koji sadrže trastuzumab i omogućuju takvu primjenu.
English: If you stop using Ogivri
Croatian: Ako prestanete primati Ogivri
English: The presence of anti-trastuzumab antibodies had no impact on pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Croatian: Prisutnost protutijela na trastuzumab nije utjecala na farmakokinetiku, djelotvornost (određenu potpunim patološkim odgovorom [engl. pathological complete response, pCR] i preživljenjem bez događaja [engl. event-free survival, EFS]) niti sigurnost određenu na temelju nastupa reakcija povezanih s primjenom trastuzumaba za intravensku primjenu.
English: Patients treated with trastuzumab are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Croatian: U bolesnika liječenih trastuzumabom postoji povećan rizik od razvoja kongestivnog zatajenja srca (CHF) (klase II - IV prema New York Heart Association [NYHA]) ili asimptomatske disfunkcije srca.
English: At the time of the analysis a total of 349 randomised 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: The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0 %).
Croatian: Učestalost je bila najviša u bolesnika koji su trastuzumab primali istodobno s taksanima (2,0%).
English: Your doctor may prescribe Ogivri for the treatment of breast and gastric cancer when:
Croatian: Vaš liječnik Vam može propisati Ogivri za liječenje raka dojke i želuca ako:
English: Trastuzumab 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 trastuzumabom smije započeti samo liječnik s iskustvom u primjeni citotoksične kemoterapije (vidjeti dio 4.4), a lijek smije primijeniti samo zdravstveni radnik.
English: cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting)
Croatian: hladna, vlažna koža, ubrzan, oslabljen puls, omaglica, slabost i nesvjestica)
English: • if you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
Croatian: • ako zbog raka imate ozbiljnih poteškoća s disanjem u mirovanju ili Vam je potrebno liječenje kisikom.
English: At the time of a safety update after a median of 3.5-3.8 years follow up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Croatian: U vrijeme kontrole sigurnosti primjene nakon medijana praćenja od 3,5 do 3,8 godina, analiza preživljenja bez bolesti ponovno je potvrdila značajnu korist prikazanu u konačnoj analizi preživljenja bez bolesti.
English: Glucose solutions must not be used for dilution since these cause aggregation of the protein.
Croatian: Za razrjeđivanje se ne smiju koristiti otopine glukoze jer izazivaju taloženje proteina.
English: Study H0649g: IHC3+ patient subset
Croatian: 1 Ispitivanje H0649g: IHC3+ podskupina bolesnica
English: Observation N = 1693
Croatian: Opservacija N=1693
English: *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52 % of patients from the observation arm to trastuzumab) *** There is a discrepancy in the overall sample size due to a small number of patients who were randomised after the cut-off date for the 12-month median follow-up analysis
Croatian: **Završna analiza (uključujući prijelaz 52% bolesnika iz opservacijske skupine na trastuzumab) *** Postoji nesrazmjer u ukupnoj veličini uzorka zbog malog broja bolesnika koji su randomizirani nakon završnog datuma za analizu medijana praćenja od 12 mjeseci
English: Do not use Ogivri if you notice any particulate matter or discoloration prior to administration.
Croatian: Ogivri se ne smije upotrijebiti ako primijetite bilo kakve čestice ili promjenu boje prije primjene.
English: (12.3-ne)
Croatian: (12,3-np)
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Ogivri može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: For overall survival, the HR was 0.75 (95 % CI 0.51-1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95 % CI 0.41-0.81) in the IHC 3+/FISH+ group.
Croatian: HR za ukupno preživljenje je bio 0,75 (95% CI 0,51 - 1,11) u skupini IHC 2+/FISH+ i 0,58 (95% CI 0,41 - 0,81) u skupini IHC 3+/FISH+.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions.
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“ (dio 4.4).
English: Docetaxel3 N = 94
Croatian: Docetaksel3 N=94
English: In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3-0.4 %).
Croatian: U 3 pivotalna klinička ispitivanja adjuvantne primjene trastuzumaba u kombinaciji s kemoterapijom, incidencija disfunkcije srca stupnja 3/4 (osobito simptomatsko kongestivno zatajenje srca) je bila slična u bolesnika koji su primili samo kemoterapiju (dakle, nisu primili trastuzumab) i u bolesnika koji su primili trastuzumab nakon taksana (0,3 - 0,4%).
English: • jaundice (yellowing of the skin and the whites of the eyes)
Croatian: • žutica (žutilo kože i bjeloočnica)
English: - capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
Croatian: - kapecitabin - 1000 mg/m² peroralno, dvaput dnevno, tijekom 14 dana svaka 3 tjedna u 6 ciklusa (od večeri 1. dana do jutra 15. dana svakog ciklusa)
English: In this trial, 87 % of patients entered had disease that was IHC3+, and 95 % of patients entered had disease that was IHC3+ and/or FISH-positive.
Croatian: U tom je ispitivanju 87% bolesnica bilo IHC3+, a 95% njih je bilo IHC3+ i/ili FISH pozitivno.
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given Ogivri.
Croatian: Vrlo rijetko su bolesnici koji su i prije liječenja imali znatne poteškoće s disanjem preminuli nakon primjene lijeka Ogivri.
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1 % (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
Croatian: U sklopu ispitivanja neoadjuvantnog-adjuvantnog liječenja ranog raka dojke (BO22227), nakon medijana praćenja od više od 70 mjeseci, u 10,1% (30/296) bolesnika liječenih trastuzumabom za intravensku primjenu razvila su se protutijela na trastuzumab.
English: Experience of concurrent administration of trastuzumab with low dose anthracycline regimens is currently limited to the trial MO16432.
Croatian: Iskustvo s istodobnom primjenom trastuzumaba i protokola s niskim dozama antraciklina zasada je ograničeno na ispitivanje MO16432.
English: Blood pressure increased
Croatian: 1povišeni krvni tlak
English: If symptomatic cardiac failure develops during trastuzumab therapy, it should be treated with standard medicinal products for CHF.
Croatian: Ako se tijekom liječenja trastuzumabom razvije simptomatsko zatajenje srca, potrebno je primijeniti standardne lijekove koji se propisuju za CHF.
English: A vial of Ogivri reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC-8ºC after reconstitution and must not be frozen.
Croatian: Sadržaj bočice lijeka Ogivri rekonstituiran sa vodom za injekcije (nije priložena u pakiranju) stabilan je 48 sati na temperaturi od 2 °C do 8 °C nakon rekonstitucije i ne smije se zamrzavati.
English: The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27 %), and was significantly higher than for anthracycline/cyclophosphamide alone (7 % - 10 %).
Croatian: Najviša stopa srčane disfunkcije zabilježena je u bolesnica koje su primale trastuzumab istodobno s antraciklinom/ciklofosfamidom (27%), što je bilo značajno više nego kod primjene samo antraciklina/ciklofosfamida (7% - 10%).
English: Any remaining reconstituted solution should be discarded.
Croatian: Preostalu rekonstituiranu otopinu potrebno je baciti.
English: Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (> 50 years), low LVEF (< 55 %) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Croatian: Faktori rizika za srčani događaj utvrđeni u četiri velika ispitivanja adjuvantnog liječenja uključivali su stariju dob (> 50 godina), nizak LVEF (< 55%) na početku liječenja, prije ili nakon početka liječenja paklitakselom, pad LVEF-a za 10 - 15 bodova te prethodnu ili istodobnu primjenu antihipertenziva.
English: Study H0648g: IHC3+ patient subset
Croatian: 2 Ispitivanje H0648g: IHC3+ podskupina bolesnica
English: Once the infusion is prepared it should be administered immediately.
Croatian: Pripremljenu infuziju potrebno je odmah primijeniti.
English: When trastuzumab was administered after completion of adjuvant chemotherapy NYHA Class III - IV heart failure was observed in 0.6 % of patients in the one-year arm after a median follow-up of 12 months.
Croatian: Kada se trastuzumab primjenjivao nakon završetka adjuvantne kemoterapije, zatajenje srca NYHA klase III-IV primijećeno je u 0,6% bolesnika iz skupine liječene godinu dana nakon medijana od 12 mjeseci praćenja.
English: Patients with EBC should be treated with trastuzumab for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Croatian: U bolesnika s ranim rakom dojke liječenje trastuzumabom traje godinu dana ili do povrata bolesti, što god nastupi ranije; ne preporučuje se produljiti liječenje ranog raka dojke dulje od jedne godine (vidjeti dio 5.1).
English: Amongst the most serious and/or common adverse reactions reported in trastuzumab usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Croatian: Među najozbiljnije i/ili najčešće nuspojave dosad prijavljene pri primjeni trastuzumaba (u intravenskoj i supkutanoj formulaciji) ubrajaju se disfunkcija srca, reakcije povezane s infuzijom, hematotoksičnost (osobito neutropenija) infekcije i plućne nuspojave.
English: In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9 % and 12 % when it was combined with paclitaxel compared with 1 % - 4 % for paclitaxel alone.
Croatian: U pivotalnim ispitivanjima intravenske formulacije trastuzumaba u metastatskoj bolesti, incidencija srčane disfunkcije kretala se između 9% i 12% kod primjene u kombinaciji s paklitakselom, u usporedbi s 1% - 4% kod primjene samo paklitaksela.
English: or - intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days,
Croatian: ili - intravenski 5-fluorouracil - 800 mg/m²/dnevno u kontinuiranoj intravenskoj infuziji tijekom
English: An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65 % versus 52 %).
Croatian: Za skupinu koja je primala trastuzumab procijenjena je apsolutna korist od 13 postotnih bodova za stopu trogodišnjeg preživljenja bez štetnih događaja (65% naspram 52%).
English: Cardiac failure (congestive)
Croatian: +zatajenje srca (kongestivno)
English: • palpitations (heart fluttering or irregular heart beat).
Croatian: • osjećaj lupanja srca (lepršanje srca ili nepravilni otkucaji srca).
English: For intravenous use only after reconstitution and dilution
Croatian: Samo za intravensku primjenu nakon rekonstitucije i razrjeđivanja.
English: Each vial contains either; o 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injections, or o 420 mg trastuzumab that has to be dissolved in 20 mL of water for injections.
Croatian: Jedna bočica sadrži: o 150 mg trastuzumaba koji treba otopiti u 7,2 ml vode za injekcije ili o 420 mg trastuzumaba koji treba otopiti u 20 ml vode za injekcije.
English: 4.7 Effects on ability to drive and use machines Ogivri may have a minor influence on the ability to drive and use machines (see section 4.8).
Croatian: Ogivri može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
English: 6.6 Special precautions for disposal and other handling Ogivri should be carefully handled during reconstitution.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Tijekom rekonstitucije, lijekom Ogivri treba rukovati oprezno.
English: t1/2 range from Cmax,ss to Cmin,ss (day)
Croatian: Raspon t1/2 od Cmax, ss do Cmin, ss (dani)
English: Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5 % of patients.
Croatian: Reverzibilnost blage simptomatske i asimptomatske disfunkcije lijeve klijetke dokazana je u 79,5% bolesnika liječenih trastuzumabom.
English: In a method comparison study (study D008548) a high degree of concordance (>95 %) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Croatian: U ispitivanju uspoređivanja metoda (ispitivanje D008548) u bolesnika s rakom želuca ustanovljen je visok stupanj podudarnosti (> 95%) za SISH i FISH metode utvrđivanja genske amplifikacije HER2.
English: In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or HER2 positive and lymph node negative with high risk features (tumor size > 1 cm and ER negative or tumor size > 2 cm, regardless of hormonal status).
Croatian: U skupnoj analizi ispitivanja NSABP B-31 i NCCTG N9831 rani rak dojke je bio ograničen isključivo na žene s operabilnim rakom dojke visokog rizika, definiranim kao HER2 pozitivan s pozitivnim aksilarnim limfnim čvorovima ili HER2 pozitivan s negativnim aksilarnim limfnim čvorovima sa značajkama visokog rizika (veličina tumora > 1 cm i ER negativan ili veličina tumora > 2 cm, bez obzira na hormonski status).
English: In order to prevent medication errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is trastuzumab and not trastuzumab emtansine.
Croatian: U svrhu sprečavanja medikacijskih pogrešaka važno je provjeriti naljepnice na bočicama kako biste bili sigurni da je lijek koji se priprema i primjenjuje trastuzumab, a ne trastuzumab emtanzin.
English: Sorbitol content
Croatian: Sadržaj sorbitola
English: Patients were either naïve to trastuzumab intravenous treatment (20.3 %) or pre-exposed to trastuzumab intravenous (79.7 %).
Croatian: Bolesnici ili prethodno nisu bili liječeni intravenskom formulacijom trastuzumaba (20,3%) ili su već bili izloženi intravenskoj formulaciji trastuzumaba (79,7%).
English: Trastuzumab intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available.
Croatian: Intravensku infuziju trastuzumaba treba dati stručni zdravstveni radnik obučen za liječenje anafilaksije, a na raspolaganju treba biti oprema za hitne slučajeve.
English: In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Ogivri (trastuzumab) and not trastuzumab emtansine.
Croatian: U svrhu sprečavanja medikacijskih pogrešaka, važno je provjeriti naljepnice na bočicama kako biste bili sigurni da je lijek koji se priprema i primjenjuje Ogivri (trastuzumab), a ne trastuzumab emtanzin.
English: Total CL range from Cmax,ss to Cmin,ss (L/day)
Croatian: N Raspon ukupnog klirensa od Cmax, ss do Cmin, ss (l/dan)
English: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8 % to 34.0 % for IHC and 7.1 % to 42.6 % for FISH.
Croatian: Ispitivanja stupnja ekspresije HER2 u bolesnika s rakom želuca uporabom imunohistokemije (IHC) i fluorescentne in situ hibridizacije (FISH) ili kromogene in situ hibridizacije (CISH) pokazala su veliku varijabilnost ekspresije HER2 u rasponu od 6,8% do 34,0% kod IHC-a i od 7,1% do 42,6% kod FISH-a.
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: Study JP19959 was a sub study of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer (AGC) to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab.
Croatian: Ispitivanje JP19959 bilo je podispitivanje ispitivanja BO18255 (ToGA), provedenoga u muškaraca i žena japanskog podrijetla s uznapredovalim rakom želuca u kojemu se ispitivala farmakokinetika kapecitabina i cisplatina primijenjenih u kombinaciji s trastuzumabom ili bez njega.