FrancophonIA/ELRC3.0 huggingface dataset:
English: Herceptin 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: Herceptin 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: In patients with EBC eligible for neoadjuvant-adjuvant treatment, Herceptin should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens, i.e., with maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin 360 mg/m2.
Croatian: U bolesnika s ranim rakom dojke koji zadovoljavaju uvjete za neoadjuvantno-adjuvantno liječenje Herceptin se smije davati istodobno s antraciklinima isključivo u bolesnika koji prije nisu primali kemoterapiju i samo uz protokole s niskim dozama antraciklina, tj. onih s najvećom kumulativnom dozom doksorubicina od 180 mg/m2 ili epirubicina od 360 mg/m2.
English: In the BCIRG 006 study HER2 positive, EBC was defined as either lymph node positive or high risk node negative patients with no (pN0) lymph node involvement, and at least 1 of the following factors: tumour size greater than 2 cm, estrogen receptor and progesterone receptor negative, histological and/or nuclear grade 2-3, or age < 35 years).
Croatian: U ispitivanju BCIRG 006 HER2 pozitivni rani rak dojke bio je definiran bilo kao tumor s pozitivnim limfnim čvorovima ili visokorizični tumor s negativnim limfnim čvorovima te barem jednim od sljedećih čimbenika: tumor veći od 2 cm, negativni estrogenski i progesteronski receptori, histološki i/ili nuklearni gradus 2 do 3 ili dob < 35 godina).
English: - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
Croatian: - u kombinaciji s docetakselom u liječenju bolesnika koji nisu prethodno primali kemoterapiju za metastatsku bolest.
English: No. patients with event (%) A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab
Croatian: Smrt (događaj ukupnog preživljenja): broj bolesnica s događajem (%) A: doksorubicin; C: ciklofosfamid; P: paklitaksel; H: trastuzumab
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval
Croatian: AC→D = doksorubicin i ciklofosfamid nakon kojih slijedi docetaksel; AC→DH = doksorubicin i ciklofosfamid nakon kojih slijede docetaksel i trastuzumab; CI = interval pouzdanosti
English: The reconstituted Herceptin results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Croatian: Rekonstituirani Herceptin je bezbojna do blijedožuta prozirna otopina bez vidljivih čestica.
English: No. patients with event p=0.0024
Croatian: broj bolesnica s događajem p=0,0024
English: Dry eye
Croatian: • suhe oči
English: 1 Blood pressure decreased
Croatian: 1 snižen krvni tlak
English: - Studies NSABP B-31 and NCCTG N9831 that comprise the joint analysis were designed to investigate the clinical utility of combining Herceptin treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding Herceptin 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 lijekom Herceptin i paklitakselom nakon kemoterapije doksorubicinom i ciklofosfamidom (AC protokol), a u ispitivanju NCCTG N9831 dodatno je istraživana sekvencijska terapija lijekom Herceptin nakon AC→P kemoterapije u bolesnica s HER2 pozitivnim ranim rakom dojke nakon kirurškog zahvata.
English: Median duration of follow up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm
Croatian: Medijan trajanja praćenja iznosio je 1,8 godina za bolesnice u skupini koja je primila AC→P kemoterapiju i 2,0 godine za bolesnice u skupini koja je primala AC→PH kemoterapiju.
English: - capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles
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: 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 Score Staining pattern
Croatian: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi nalazi se u Tablici 2: Tablica 2: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi Rezultat Karakteristika obojenja
English: Table 8: Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH Parameter
Croatian: Tablica 8: Pregled analize djelotvornosti u ispitivanju BCIRG 006; AC→D naspram AC→DH
English: The pivotal trial BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus treatment with Herceptin intravenous formulation based on coprimary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively) (See Section 5.1. of Herceptin subcutaneous formulation SmPC).
Croatian: Pivotalno ispitivanje BO22227 bilo je dizajnirano tako da dokaže neinferiornost liječenja supkutanom formulacijom lijeka Herceptin u odnosu na intravensku formulaciju lijeka Herceptin na temelju dviju primarnih mjera ishoda - za farmakokinetiku i djelotvornost (Ctrough trastuzumaba prije primjene doze u 8. ciklusu odnosno stopa potpunog patološkog odgovora [engl. pathological complete response, pCR] pri definitivnom kirurškom zahvatu) (vidjeti dio 5.1 Sažetka opisa svojstava lijeka za supkutanu formulaciju lijeka Herceptin).
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 Surgical specimen - staining pattern
Croatian: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi nalazi se u Tablici 3: Tablica 3 Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi u raku želuca Rezultat Kirurški uzorak karakteristika obojenja
English: In the pivotal trial BO22227, Herceptin was administered concurrently with neoadjuvant chemotherapy that contained four cycles of epirubicin (cumulative dose 300 mg/m2); at a median follow-up exceeding 70 months, the incidence of cardiac failure/congestive cardiac failure was 0.3% in the Herceptin intravenous arm and 0.7% in the Herceptin subcutaneous arm.
Croatian: U pivotalnom ispitivanju BO22227, Herceptin se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od četiri ciklusa epirubicina (kumulativna doza: 300 mg/m2); nakon medijana praćenja od više od 70 mjeseci, incidencija zatajenja srca/kongestivnog zatajenja srca iznosila je 0,3% u skupini koja je primala lijek Herceptin za intravensku primjenu te 0,7% u skupini koja je primala lijek Herceptin za supkutanu primjenu.
English: The test method for HER2 overexpression used to determine eligibility of patients in the pivotal Herceptin monotherapy and Herceptin plus paclitaxel clinical trials employed immunohistochemical staining for HER2 of fixed material from breast tumours using the murine monoclonal antibodies
Croatian: Metoda testiranja povećane ekspresije HER2, primijenjena u pivotalnim kliničkim ispitivanjima u svrhu odabira bolesnica pogodnih za monoterapiju lijekom Herceptin ili liječenje kombinacijom lijeka Herceptin i paklitaksela, uključivalo je imunohistokemijske metode određivanja HER2 u materijalu uzetom iz tumora dojke pomoću CB11 i 4D5 mišjih monoklonskih protutijela.
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40 % of patients who are treated with Herceptin will experience some form of infusion-related reaction.
Croatian: Procjenjuje se da će otprilike 40 % bolesnika u tijeku liječenja lijekom Herceptin razviti neki oblik infuzijske reakcije.
English: Herceptin has been used in clinical trials as monotherapy for patients with MBC who have tumours that overexpress HER2 and who have failed one or more chemotherapy regimens for their metastatic disease (Herceptin alone).
Croatian: Herceptin je u kliničkim ispitivanjima primjenjivan kao monoterapija u liječenju bolesnica s metastatskim rakom dojke koji pokazuje povećanu ekspresiju HER2 i progresiju bolesti nakon jedne ili više kemoterapijskih linija liječenja metastatske bolesti (samo Herceptin).
English: Roche (Hellas) A.E. Τηλ: +30 210 61 66 100
Croatian: Τηλ: +30 210 61 66 100
English: The population predicted PK exposure parameter values (median with 5th - 95th Percentiles) for Herceptin SC dosing regimens in EBC patients are shown in Table 13 below.
Croatian: Vrijednosti parametara farmakokinetičke izloženosti predviđene za populaciju (medijan i 5. do 95. percentil) uz režime doziranja supkutane formulacije lijeka Herceptin u bolesnika s ranim rakom dojke prikazane su u nastavku, u Tablici 13.
English: Serious IRRs to Herceptin 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 lijeka Herceptin uključujući dispneju, hipotenziju, piskanje, hipertenziju, bronhospazam, supraventrikularnu tahiaritmiju, smanjenu zasićenost kisikom, anafilaksiju, respiratorni distres, urtikariju i angioedem (vidjeti dio 4.8).
English: Linear clearance was 0.111 L/day and the central compartment volume (Vc) was 2.91 L. The Michaelis-Menten parameter values were 11.9 mg/day and 33.9 µg/mL for Vmax and Km, respectively.
Croatian: Vrijednost Michaelis-Mentenova parametra iznosila je 11,9 mg/dan za Vmax te 33,9 µg/ml za Km.
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 Herceptin.
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 lijeka Herceptin.
English: Herceptin 150 mg powder for concentrate for solution for infusion Trastuzumab
Croatian: Herceptin 150 mg prašak za koncentrat za otopinu za infuziju trastuzumab
English: • abnormal thinking
Croatian: • poremećeno razmišljanje
English: Median Survival (months) (95 %CI)
Croatian: Medijan preživljenja (mjeseci) (95 %CI)
English: Metastatic breast cancer
Croatian: Metastatski rak želuca
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab at median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P
Croatian: A: doksorubicin, C: ciklofosfamid, P: paklitaksel, H: trastuzumab * Uz medijan trajanja praćenja od 1,8 godina za bolesnice u skupini koja je primala AC→P kemoterapiju i
English: Patients are eligible for Herceptin 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 Herceptin preporučuje se onim bolesnicima koji imaju izrazitu ekspresiju HER2 opisanu stupnjem 3+ na temelju IHC ili pak pozitivan FISH ili CISH rezultat.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC).
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (2ºC - 8 ºC).
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: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi nalazi se u Tablici 2: Tablica 2: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi kod raka dojke
English: • abnormally low levels of fluid around baby in womb
Croatian: • abnormalno niska razina tekućine koja okružuje plod u maternici • neuspjeli djetetov razvoj pluća u maternici
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: 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: Table 1: Undesirable effects reported with intravenous Herceptin monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8386) and in post-marketing
Croatian: Tablica 1: Nuspojave prijavljene kod primjene intravenske formulacije lijeka Herceptin u monoterapiji ili u kombinaciji s kemoterapijom u pivotalnim kliničkim ispitivanjima (N = 8386) i nakon stavljanja lijeka u promet
English: Acne
Croatian: • akne
English: LIST OF EXCIPIENTS L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20, α,α-trehalose dihydrate.
Croatian: POPIS POMOĆNIH TVARI L-histidinklorid hidrat, L-histidin, polisorbat 20, α,α-trehaloza dihidrat.
English: The main test method used to determine HER2 positivity in the pivotal trial of docetaxel, with or without Herceptin, was immunohistochemistry.
Croatian: Glavna metoda određivanja povećane ekspresije HER2 primijenjena u pivotalnom kliničkom ispitivanju docetaksela u monoterapiji ili kombinaciji s lijekom Herceptin bila je imunohistokemija.
English: A final analysis was performed after a median follow-up of 8 years, which showed that 1 year Herceptin treatment is associated with a 24 % risk reduction compared to observation only (HR=0.76,
Croatian: Završna analiza provedena nakon medijana praćenja od 8 godina ukazala je na smanjenje rizika od 24% u skupini liječenoj lijekom Herceptin tijekom 1 godine u usporedbi usporedbi sa samo opservacijom (HR=0,76, 95% CI 0,67; 0,86).
English: (n=1074)
Croatian: AC→DH (n=1074)
English: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92
Croatian: Vrijednosti parametara nelinearne eliminacije bile su 8,81 mg/dan za maksimalnu brzinu eliminacije (Vmax) i 8,92 µg/ml za Michaelis-Mentenovu konstantu (Km) u bolesnika s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca.
English: Herceptin Intravenous
Croatian: Herceptin za intravensku primjenu
English: The pharmacokinetics of trastuzumab at a dose of 600 mg administered three-weekly by the subcutaneous route was compared to the intravenous route (8 mg/kg loading dose, 6 mg/kg maintenance every three weeks) in the phase III study BO22227.
Croatian: U ispitivanju faze III BO22227, farmakokinetika trastuzumaba u dozi od 600 mg primijenjene supkutano svaka tri tjedna uspoređena je s intravenskim putem primjene (udarna doza od 8 mg/kg, doza održavanja od 6 mg/kg svaka tri tjedna).
English: No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio = 1.16, 95 % CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio
Croatian: Nije primijećena prednost u pogledu preživljenja bez bolesti u toj podskupini bolesnica (omjer hazarda = 1,16; 95% CI [0,73; 1,83] za skupinu DCarbH (TCH), naspram AC→D (AC→T); omjer hazarda od 0,97; 95% CI [0,60; 1,55] za AC→DH (AC→TH) naspram AC→D.
English: What Herceptin looks like and contents of the pack Herceptin is a solution for injection that is supplied in a glass vial with a butyl rubber stopper containing 5 mL (600 mg) of trastuzumab.
Croatian: Herceptin je otopina za injekciju koja dolazi u staklenoj bočici s butilnim gumenim čepom, a sadrži 5 ml (600 mg) trastuzumaba.
English: Pre-medication may be used to reduce risk of occurrence of ARRs.
Croatian: Rizik od pojave reakcija na primjenu lijeka može se smanjiti premedikacijom.
English: • Doxorubicin 60mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles,
Croatian: kako slijedi: • doksorubicin 60 mg/m2 plus paklitaksel 150 mg/m2, svaka 3 tjedna u 3 ciklusa,
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 7:
Croatian: Konačni rezultati ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831 sažeto su prikazani u Tablici 7 u nastavku:
English: • Do not freeze the reconstituted solution.
Croatian: • Rekonstituirana otopina ne smije se zamrzavati.
English: Table 1 Undesirable Effects Reported with Intravenous Herceptin Monotherapy or in Combination with Chemotherapy in Pivotal Clinical Trials (N = 8386) and in Post-Marketing
Croatian: Tablica 1 Nuspojave prijavljene kod primjene intravenske formulacije lijeka Herceptin u monoterapiji ili u kombinaciji s kemoterapijom u pivotalnim kliničkim ispitivanjima (N=8386) i nakon stavljanja lijeka u promet
English: Table 5 Efficacy Results from the Non-Comparative Monotherapy and Combination Therapy Studies Parameter
Croatian: Tablica 5 Rezultati djelotvornosti iz nekomparativnih ispitivanja monoterapije i kombinirane terapije Parametar
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: confidence interval for the difference in pCR rates was -4.0, establishing the non-inferiority of Herceptin subcutaneous for the co-primary endpoint
Croatian: Donja granica jednostranog intervala pouzdanosti od 97,5% za razliku u stopama pCR-a iznosila je -4,0, što je potvrdilo neinferiornost lijeka Herceptin za supkutanu primjenu s obzirom na te primarne mjere ishoda.
English: Event-free survival
Croatian: Preživljenje bez događaja
English: MARKETING AUTHORISATION NUMBER(S) EU/1//00/145/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/145/001
English: The recommended weekly maintenance dose of Herceptin is 2 mg/kg body weight, beginning one week after the loading dose.
Croatian: Preporučena doza održavanja lijeka Herceptin koja se primjenjuje u tjednim intervalima iznosi 2 mg/kg tjelesne težine, a počinje se primjenjivati tjedan dana nakon udarne doze.
English: Early breast cancer - (neoadjuvant-adjuvant setting)
Croatian: Rani rak dojke - (neoadjuvantno-adjuvantno liječenje)
English: The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2 % versus 75.4 %)
Croatian: Omjer hazarda apsolutno je povoljan u smislu trogodišnjeg preživljenja bez bolesti s razlikom od 11,8 postotnih bodova (87,2 % naspram 75,4 %) u korist skupine liječene AC→PH kemoterapijom (lijekom
English: MBC 805 0.213 - 0.259 EBC 390 0.184 - 0.221
Croatian: rani rak dojke 390 0,184 - 0,221
English: Primary tumor type N
Croatian: Vrsta primarnog tumora
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: Table 9 Overview of Efficacy Analyses BCIRG 006 AC→D versus AC→DH Parameter
Croatian: Tablica 9 Pregled analize djelotvornosti u ispitivanju BCIRG 006; AC→D naspram AC→DH
English: Herceptin 600 mg solution for injection in vial Trastuzumab
Croatian: Herceptin 600 mg otopina za injekciju u bočici trastuzumab
English: The data also suggested that the pharmacokinetics of cisplatin were not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus Herceptin.
Croatian: Podaci su također ukazali da istodobna primjena kapecitabina ili istodobna primjena kapecitabina i lijeka Herceptin ne utječe na farmakokinetiku cisplatina.
English: A study conducted in lactating Cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/kg Herceptin intravenous formulation demonstrated that trastuzumab is secreted in the milk.
Croatian: Ispitivanja provedena na makaki majmunima u razdoblju laktacije, kojima su davane doze intravenske formulacije lijeka Herceptin 25 puta veće od tjednih doza održavanja u ljudi od 2 mg/kg, pokazala su da se trastuzumab izlučuje u mlijeko.
English: Table 4: Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter
Croatian: Tablica 4: Rezultati djelotvornosti iz nekomparativnih ispitivanja monoterapije i kombinirane terapije Parametar
English: - intravenous push doxorubicin, at 60 mg/ m2, given every 3 weeks for 4 cycles.
Croatian: - brza intravenska injekcija doksorubicina u dozi od 60 mg/m2, svaka 3 tjedna, u 4 ciklusa.
English: 6.4 Special precautions for storage Store in a refrigerator (2°C - 8°C).
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (2°C - 8°C)
English: • The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Croatian: • Drugi sastojci su L-histidinklorid hidrat, L-histidin, α,α-trehaloza dihidrat, polisorbat 20.
English: Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous Herceptin alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting.
Croatian: Tablici 1 prikazane su nuspojave prijavljene kod primjene intravenske formulacije lijeka Herceptin u monoterapiji ili u kombinaciji s kemoterapijom u pivotalnim kliničkim ispitivanjima i nakon stavljanja lijeka u promet.
English: Table 16 Population Predicted PK Parameter Values at Steady State for Herceptin IV Dosing
Croatian: Tablica 16 Vrijednosti farmakokinetičkih parametara u stanju dinamičke ravnoteže predviđene za populaciju uz režime doziranja intravenske formulacije lijeka Herceptin u bolesnika s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca
English: Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg Herceptin intravenous formulation and have revealed no evidence of impaired fertility or harm to the fetus.
Croatian: Ispitivanjima utjecaja na reprodukciju provedenim na makaki majmunima s dozama intravenske formulacije lijeka Herceptin do 25 puta većim od tjedne doze održavanja u ljudi od 2 mg/kg, nije dokazano smanjenje plodnosti niti opasnost za fetus.
English: Strong complete membrane staining is detected in > 10 % of the tumour cells.
Croatian: Jaka obojenost cijele membrane otkrivena u > 10 % tumorskih stanica.
English: Infusion related reaction
Croatian: Reakcije povezane s primjenom lijeka
English: Disease-free survival No. patients with event (%)
Croatian: Preživljenje bez bolesti: broj bolesnica s događajem (%) 261 (15,5)
English: (n=1073)
Croatian: AC→D (n=1073)
English: Weekly dosing in metatstatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Croatian: Tjedni ciklusi u liječenju metastatskog raka dojke Rezultati djelotvornosti iz ispitivanja monoterapije lijekom Herceptin ili njegove primjene u kombiniranoj terapiji prikazani su u Tablici 3:
English: Herceptin Subcutaneous
Croatian: Herceptin za supkutanu primjenu
English: Rare side effects of Herceptin: may affect up to 1 in 1,000 people
Croatian: Rijetke nuspojave lijeka Herceptin: mogu se javiti u do 1 na 1000 osoba
English: + Denotes adverse reactions that have been reported in association with a fatal outcome.
Croatian: Označava prijavljene nuspojave povezane sa smrtnim ishodom.
English: The lower boundary of the one-sided 97.5 %
Croatian: Točan 95% CI za stopu pCR-a Razlika u pCR-u (s.c. skupina minus i.v. skupina) Donja granica jednostranog CI od 97,5% za razliku u pCR-u