FrancophonIA/ELRC3.0 huggingface dataset:
English: Ogivri 150 mg contains 115.2 mg sorbitol in each vial.
Croatian: Ogivri 150 mg sadrži 115,2 mg sorbitola u jednoj bočici.
English: Three -weekly dosing in metastatic breast cancer The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Croatian: Trotjedni ciklusi u liječenju metastatskog raka dojke Rezultati djelotvornosti iz ispitivanja monoterapije i kombinirane terapije trastuzumabom bez kontrolnih skupina prikazani su u Tablici 5.:
English: For patients with EBC, cardiac assessments, as performed at baseline, should be repeated every 3 months during treatment and every 6 months following discontinuation of treatment until 24 months from the last administration of trastuzumab.
Croatian: U bolesnika s ranim rakom dojke kardiološki pregled, istovjetan onom obavljenom u sklopu početne procjene, potrebno je ponavljati svaka 3 mjeseca tijekom liječenja te svakih 6 mjeseci nakon završetka liječenja do 24 mjeseca od posljednje primjene trastuzumaba.
English: For the primary endpoint, DFS, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52 % decrease in the risk of disease recurrence.
Croatian: Za primarnu mjeru ishoda, preživljenje bez bolesti, dodavanje trastuzumaba kemoterapiji paklitakselom rezultiralo je smanjenjem rizika od ponovne pojave bolesti za 52%.
English: Patients are eligible for Ogivri treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Croatian: Liječenje lijekom Ogivri preporučuje se onim bolesnicima koji imaju izrazitu ekspresiju HER2 opisanu stupnjem 3+ na temelju IHC ili pak pozitivan FISH ili CISH rezultat.
English: A study conducted in lactating Cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation demonstrated that trastuzumab is secreted in the milk.
Croatian: Ispitivanja provedena na makaki majmunima u razdoblju laktacije, kojima su davane doze dozama intravenske formulacije trastuzumaba 25 puta veće od tjednih doza održavanja u ljudi od 2 mg/kg, pokazala su da se trastuzumab izlučuje u mlijeko.
English: N Cmin,ss* (mcg/mL)
Croatian: N Cmin, ss* (µg/ml) Cmax, ss** (µg/ml)
English: Serious IRRs to trastuzumab infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Croatian: Zabilježene su ozbiljne reakcije povezane s infuzijom trastuzumaba, uključujući dispneju, hipotenziju, piskanje, hipertenziju, bronhospazam, supraventrikularnu tahiaritmiju, smanjenu zasićenost kisikom, anafilaksiju, respiratorni distres, urtikariju i angioedem (vidjeti dio 4.8).
English: • abnormal kidney development in the womb
Croatian: • abnormalni razvoj bubrega djeteta u maternici
English: Trastuzumab has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Croatian: U randomiziranom, otvorenom ispitivanju faze III ToGA (BO18255), liječenje trastuzumabom u kombinaciji s kemoterapijom uspoređivano je s liječenjem samo kemoterapijom.
English: • skin rashes
Croatian: • grčevi u nogama
English: Table 4 Efficacy results from the monotherapy and combination therapy studies Parameter
Croatian: Tablica 4. Rezultati djelotvornosti iz ispitivanja monoterapije i kombinirane terapije
English: • failure of lungs to develop in the womb
Croatian: • neuspjeli razvoj pluća djeteta u maternici
English: Ogivri 420 mg contains 322.6 mg sorbitol in each vial.
Croatian: Ogivri 420 mg sadrži 322,6 mg sorbitola u jednoj bočici.
English: Table 11 Post-Hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831 and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events
Croatian: Tablica 11. Rezultati post-hoc eksplorativne analize podataka dobivenih iz skupne analize kliničkih ispitivanja NSABP B-31/NCCTG N9831* i BCIRG006, koja uključuje događaje preživljenja bez simptoma bolesti i simptomatske srčane događaje
English: The reconstituted Ogivri solution contains 21 mg/mL of trastuzumab.
Croatian: Rekonstituirana otopina lijeka Ogivri sadrži 21 mg/ml trastuzumaba.
English: Blood pressure decreased
Croatian: 1sniženi krvni tlak
English: Median duration of response (months) (95 %CI)
Croatian: Medijan trajanja odgovora (mjeseci) (95% CI)
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below:
Croatian: Konačni rezultati ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831 sažeto su prikazani u Tablici 8. u nastavku:
English: • haemorrhoids (swelling of blood vessels around the back passage)
Croatian: • hemoroidi (oticanje krvnih žila oko anusa)
English: • conjunctivitis (discharge with itching of the eyes and crusty eyelids)
Croatian: • konjunktivitis (iscjedak uz svrbež očiju i praćen sasušenim sekretom na kapcima)
English: For IV use only
Croatian: Samo za intravensku primjenu
English: Ogivri should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
Croatian: Ogivri treba davati samo onim bolesnicima s metastatskim rakom želuca čije tumorske stanice pokazuju povećanu ekspresiju HER2 određenu imunohistokemijski kao 2+ i potvrđenu SISH-om ili FISH-om, ili određenu imunohistokemijski kao 3+.
English: Cmin (mcg/mL)
Croatian: N Cmin (µg/ml)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1341/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1341/002
English: cycles
Croatian: Trotjedni ciklusi
English: Ogivri 150 mg powder for concentrate for solution for infusion 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.
Croatian: Ogivri 150 mg prašak za koncentrat za otopinu za infuziju Staklena bočica od 15 ml (bezbojno staklo tipa I) s butilnim gumenim čepom obloženim slojem fluorosmole sadrži 150 mg trastuzumaba.
English: - The resulting solution contains approximately 21 mg/mL trastuzumab.
Croatian: Tako pripremljena otopina sadrži otprilike 21 mg/ml trastuzumaba.
English: • based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of
Croatian: • za udarnu dozu trastuzumaba od 4 mg/kg tjelesne težine ili za daljnje tjedne doze održavanja od
English: Table 12 Efficacy results from MO16432 Parameter
Croatian: Rezultati djelotvornosti iz ispitivanja MO16432
English: - in combination with neoadjuvant chemotherapy followed by adjuvant Ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and
Croatian: Ogivri za lokalno uznapredovalu (uključujući upalnu) bolest ili tumore promjera > 2 cm (vidjeti dijelove 4.4 i 5.1).
English: Median Survival (months) (95 %CI)
Croatian: Medijan preživljenja (mjeseci) (95% CI)
English: As a three-weekly regimen the recommended initial loading dose of trastuzumab is 8 mg/kg body weight.
Croatian: U trotjednim ciklusima preporučena početna udarna doza trastuzumaba iznosi 8 mg/kg tjelesne težine.
English: Strong complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Croatian: 3+ Jaka, potpuna, bazolateralna ili lateralna membranska reaktivnost u ≥ 10% tumorskih stanica
English: Primary efficacy analysis DFS Hazard ratios (95 % CI) p-value p < 0.0001
Croatian: Primarna analiza djelotvornosti Omjeri hazarda za preživljenje bez bolesti (95% CI) p-vrijednost p < 0,0001
English: Ogivri 420 mg powder for concentrate for solution for infusion 50 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab.
Croatian: Ogivri 420 mg prašak za koncentrat za otopinu za infuziju Staklena bočica od 50 ml (bezbojno staklo tipa I) s butilnim gumenim čepom obloženim slojem fluorosmole sadrži 420 mg trastuzumaba.
English: In addition, a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
Croatian: Dodatno je provedena post-hoc eksplorativna analiza podataka dobivenih iz skupne analize kliničkih ispitivanja NSABP B-31/NCCTG N9831* i BCIRG006, koja uključuje preživljenje bez bolesti i simptomatske srčane događaje.
English: • based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:
Croatian: • za udarnu dozu trastuzumaba od 8 mg/kg tjelesne težine ili za daljnje trotjedne doze održavanja od 6 mg/kg tjelesne težine na sljedeći način:
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy; additionally, the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Croatian: - Ispitivanja NSABP B-31 i NCCTG N9831 koja su obuhvaćena zajedničkom analizom s ciljem istraživanja kliničke koristi kombiniranog liječenja trastuzumabom i paklitakselom nakon kemoterapije doksorubicinom i ciklofosfamidom (AC protokol), a u ispitivanju NCCTG N9831
English: Ejection fraction decreased*
Croatian: 1undulacija srca smanjena ejekcijska frakcija*
English: Distant Recurrence No. patients with event
Croatian: Broj bolesnica s događajem
English: The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Croatian: Preporučena doza održavanja koja se primjenjuje u trotjednim intervalima iznosi 6 mg/kg tjelesne težine, a počinje se primjenjivati 3 tjedna nakon udarne doze.
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 7.
Croatian: Rezultati djelotvornosti iz skupne analize ispitivanja NSABP B-31 i NCCTG 9831 u trenutku konačne analize preživljenja bez bolesti* prikazani su sažeto u Tablici 7.
English: + 20 mL
Croatian: bočica od 420 mg + 20 mL
English: Gallop rhythm present
Croatian: Učestalost galopni ritam nepoznato
English: 1 hour) with or without trastuzumab, 60 % of the patients had received prior anthracycline-based adjuvant chemotherapy.
Croatian: U pivotalnom ispitivanju docetaksela (100 mg/m² u jednosatnoj infuziji) u kombinaciji s trastuzumabom ili bez njega, 60% bolesnica prethodno je liječeno antraciklinskom adjuvantnom kemoterapijom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ogivri 150 mg powder for concentrate trastuzumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ogivri 150 mg prašak za koncentrat trastuzumab
English: Strong complete membrane staining is detected in > 10 % of the tumour cells.
Croatian: Jaka obojenost cijele membrane otkrivena u > 10% tumorskih stanica.
English: Reactions include chills, fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4).
Croatian: dispneju, hipotenziju, piskanje pri disanju, bronhospazam, tahikardiju, smanjenu zasićenost kisikom, respiratorni distres, osip, mučninu i povraćanje i glavobolju (vidjeti dio 4.4).
English: The recommended weekly maintenance dose of trastuzumab is 2 mg/kg body weight, beginning one week after the loading dose.
Croatian: Preporučena doza održavanja trastuzumaba koja se primjenjuje u tjednim intervalima iznosi 2 mg/kg tjelesne težine, a počinje se primjenjivati tjedan dana nakon udarne doze.
English: Trastuzumab may persist in the circulation for up to 7 months after stopping Ogivri treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Croatian: Na temelju populacijske farmakokinetičke analize svih dostupnih podataka (vidjeti dio 5.2), trastuzumab može biti prisutan u cirkulaciji do 7 mjeseci nakon prestanka liječenja lijekom Ogivri.
English: • based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
Croatian: • za udarnu dozu trastuzumaba od 4 mg/kg tjelesne težine ili za daljnje tjedne doze održavanja od 2 mg/kg tjelesne težine na sljedeći način:
English: Anaphylactic reaction
Croatian: +anafilaktička reakcija nepoznato
English: Distant recurrence No. patients with event p = 0.0008
Croatian: Pojava udaljenih metastaza Broj bolesnica s događajem p = 0,0008
English: A faint/barely perceptible membrane staining is detected in > 10 % of the tumour cells.
Croatian: Blijeda, jedva uočljiva obojenost membrane u > 10% tumorskih stanica.
English: Hazard Ratio versus AC→P (95 % CI)
Croatian: Omjer hazarda naspram AC→P (95% CI)
English: Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab
Croatian: Ogivri 150 mg prašak za koncentrat za otopinu za infuziju Ogivri 420 mg prašak za koncentrat za otopinu za infuziju trastuzumab
English: which was followed by
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: Hydrochloric acid (for pH adjustment)
Croatian: L-histidin sorbitol makrogol 3350 kloridna kiselina (za prilagodbu pH) natrijev hidroksid (za prilagodbu pH)
English: Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion
Croatian: Ogivri 150 mg prašak za koncentrat za otopinu za infuziju Ogivri 420 mg prašak za koncentrat za otopinu za infuziju
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Croatian: 2+ Slaba do umjereno potpuna, bazolateralna ili lateralna membranska reaktivnost u ≥ 10% tumorskih stanica
English: Pulmonary fibrosis
Croatian: +plućna fibroza nepoznato
English: • infection of lungs
Croatian: • plućna infekcija
English: Disease-free survival No. patients with event p = 0.0003
Croatian: Preživljenje bez bolesti Broj bolesnica s događajem p = 0,0003
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ogivri 420 mg powder for concentrate trastuzumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ogivri 420 mg prašak za koncentrat trastuzumab
English: N = 172
Croatian: Trastuzumab1 N=172
English: A weak to moderate complete membrane staining is detected in > 10 % of the tumour cells.
Croatian: Slaba do umjerena obojenost cijele membrane u > 10% tumorskih stanica.
English: The recommended maintenance dose of trastuzumab at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Croatian: Preporučena doza održavanja trastuzumaba koja se primjenjuje u trotjednim intervalima iznosi 6 mg/kg tjelesne težine, a počinje se primjenjivati 3 tjedna nakon udarne doze.
English: Anaphylactic shock
Croatian: +anafilaktički šok nepoznato
English: 21 (mg/mL, concentration of reconstituted solution) The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Croatian: Odgovarajuću količinu otopine potrebno je izvući iz bočice i dodati u infuzijsku vrećicu koja sadrži 250 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju.
English: HR (95 % CI) p-value
Croatian: HR (95% CI)
English: Death (OS event) No. patients with event p = 0.0182
Croatian: Broj bolesnica s događajem p = 0,0182
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2: Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer Score Staining pattern
Croatian: Tablica 2. Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi kod raka dojke
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer Score
Croatian: Tablica 3. Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi kod raka želuca
English: Volume (mL) = Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance)
Croatian: tjelesna težina (kg) × doza (4 mg/kg za udarnu dozu ili 2 mg/kg za dozu održavanja) 21 (mg/ml, koncentracija rekonstituirane otopine)
English: Distant recurrence No. patients with event p < 0.0001
Croatian: Pojava udaljenih metastaza Broj bolesnica s događajem p < 0,0001
English: Common side effects: may affect up to 1 in 10 people
Croatian: Česte nuspojave: mogu se javiti u do 1 na 10 osoba
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog eritem
English: Lung infiltration
Croatian: +plućni infiltrat nepoznato
English: This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Croatian: Time se dobiva 21 ml otopine za jednokratnu primjenu, koja sadrži približno 21 mg/ml trastuzumaba, s pH vrijednošću od približno 6,0.
English: 8 mg/kg + 6 mg/kg q3w
Croatian: 8 mg/kg + 6 mg/kg jedanput svaka 3 tjedna metastatski rak dojke 805 28,7
English: Table 14 Population predicted cycle 1 PK exposure values (median with 5th - 95th percentiles) fortrastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Croatian: Vrijednosti farmakokinetičke izloženosti predviđene za populaciju u 1. ciklusu (medijan i 5. do 95. percentil) uz režime doziranja intravenske formulacije trastuzumaba u bolesnika s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca
English: Palpitation
Croatian: 1palpitacije
English: Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous weekly) and docetaxel (60 mg/m2 intravenous) in Japanese women with HER2
Croatian: Podaci iz ispitivanja JP16003, ispitivanja trastuzumaba (intravenska udarna doza od 4 mg/kg, nakon koje slijedi intravenska doza od 2 mg/kg jedanput tjedno) i docetaksela (60 mg/m² intravenski) s jednom skupinom žena japanskog podrijetla s HER2-pozitivnim metastatskim rakom dojke, ukazali su da istodobna primjena trastuzumaba ne utječe na farmakokinetiku jednokratne doze docetaksela.
English: The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95 % CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95 % CI 0.51-0.79) for FP versus FP + H, respectively.
Croatian: Medijan ukupnog preživljenja u skupini s visokom ekspresijom HER2 koja nije primala trastuzumab iznosio je 11,8 mjeseci u usporedbi sa 16 mjeseci u skupini koja je primala trastuzumab, omjer hazarda (HR) 0,65 (95% CI 0,51 - 0,83).
English: The updated DFS analysis results (stratified HR = 0.61; 95% CI [0.54, 0.69]) showed a similar DFS benefit compared to the definitive primary DFS analysis, despite 24.8 % patients in the AC→P arm who crossed over to receive trastuzumab.
Croatian: Nadopunjeni rezultati analize preživljenja bez bolesti (stratificirani omjer hazarda = 0,61; 95% CI [0,54; 0,69]) pokazuju sličnu korist za preživljenje bez bolesti kao i konačna primarna analiza preživljenja bez bolesti, unatoč prijelazu 24,8% bolesnika iz skupine liječene AC→P kemoterapijom u skupinu koja je primala trastuzumab Nakon 8 godina procijenjena stopa preživljenja bez bolesti iznosila je 77,2% (95% CI: 75,4; 79,1) u skupini liječenoj AC→PH kemoterapijom, što ukazuje na apsolutnu korist od 11,8% u usporedbi s liječenjem AC→P kemoterapijom.
English: Docetaxel was administered as follows: - intravenous docetaxel - 100 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle).
Croatian: Docetaksel je primjenjivan na sljedeći način: - intravenski docetaksel - 100 mg/m² u intravenskoj infuziji tijekom 1 sata, svaka 3 tjedna u 4
English: Hazard Ratio vs AC→D (95 % CI) p-value
Croatian: Omjer hazarda naspram AC→D (95% CI) p-vrijednost
English: Table 15 Population predicted steady state PK exposure values (median with 5th - 95th percentiles)for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Croatian: Vrijednosti farmakokinetičke izloženosti u stanju dinamičke ravnoteže predviđene za populaciju (medijan i 5. do 95. percentil) uz režime doziranja intravenske formulacije trastuzumaba u bolesnika s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca
English: White blood cell count decreased/leukopenia
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija anemija neutropenija smanjeni broj bijelih krvnih stanica/leukopenija
English: Disease-free survival No. patients with event p < 0.0001
Croatian: Preživljenje bez bolesti Broj bolesnica s događajem p < 0,0001
English: • nausea (feeling sick)
Croatian: • pospanost (izrazita pospanost)
English: Table 7 Summary of efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis*
Croatian: Sažetak rezultata djelotvornosti iz skupne analize ispitivanja NSABP B-31 i NCCTG 9831 u trenutku konačne analize preživljenja bez bolesti*:
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Prije primjene, parenteralne lijekove treba pregledati kako bi se isključila prisutnost čestica ili promjena boje.
English: Trastuzumab and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Croatian: Kod adjuvantnog liječenja ne smiju se istodobno davati trastuzumab i antraciklini.
English: Patients with MBC or MGC should be treated with trastuzumab until progression of disease.
Croatian: U bolesnika s metastatskim rakom dojke ili metastatskim rakom želuca liječenje trastuzumabom traje do progresije bolesti.
English: They include weakening of the heart muscle possibly leading to heart failure, inflammation (swollen, red, hot, and in pain) of the lining around the heart and heart rhythm disturbances.
Croatian: Oni uključuju slabljenje srčanog mišića, što može uzrokovati zatajenje srca, upalu (oteknuće, crvenilo, toplinu i bol) srčane ovojnice i poremećaje srčanog ritma.
English: Surgical specimen - staining pattern
Croatian: Rezultat Kirurški uzorakkarakteristika obojenja
English: Death (OS event) No. patients with event p = 0.0024
Croatian: Broj bolesnica s događajem p = 0,0024
English: Gastrointestinal disorders Diarrhoea
Croatian: +pneumonija astma plućni poremećaji
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: How Ogivri is given
Croatian: Kako ćete primati Ogivri
English: Pleural effusion
Croatian: • osip koji svrbi
English: The median overall survival was extended by 4.6 months for patients in the combination arm.
Croatian: 4,6 mjeseci u skupini koja je primala kombiniranu terapiju.
English: - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease
Croatian: - kao monoterapija u liječenju bolesnika koji su prošli najmanje dvije linije kemoterapije za metastatsku bolest.
English: If left ventricular ejection fraction (LVEF) percentage drops ≥ 10 points from baseline AND to below 50 %, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Croatian: Ako postotak LVEF-a padne za ≥ 10 bodova ispod početne vrijednosti
English: You can help by reporting any side effects you may get.
Croatian: Prijavljivanjem svih sumnji na nuspojavu i Vi možete pomoći.
English: Heart beat irregular
Croatian: 1nepravilni otkucaji srca
English: Mylan Healthcare B.V. Tel: +31 (0)20 426 3300
Croatian: Tel: +31 (0)20 426 3300