natgillin/translations-raw huggingface dataset:
Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).
Ontruzant je indiciran u liječenju odraslih bolesnika s HER2-pozitivnim ranim rakom dojke:
The results of this substudy suggested that the exposure to the bioactive metabolites (e.g. 5-FU) of capecitabine was not affected by concurrent use of cisplatin or by concurrent use of cisplatin plus trastuzumab.
Rezultati ovog podispitivanja ukazali su na to da istodobna primjena cisplatina ili istodobna primjena cisplatina i trastuzumaba nije utjecala na izloženost bioaktivnim metabolitima (npr. 5-FU)
HER2 over expression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks; HER2 gene amplification should be detected using in situ hybridisation using either SISH or FISH on fixed tumour blocks.
Povećana ekspresija HER2 utvrđuje se imunohistokemijskom (IHC) metodom procjene fiksiranih blokova tumorskog tkiva; HER2 genska amplifikacija utvrđuje se hibridizacijom in situ, npr. SISH ili
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.
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
Primary efficacy analysis DFS hazard ratios (95% CI) p-value p<0.0001
Primarna analiza djelotvornosti Omjeri hazarda za preživljenje bez bolesti (95% CI) p-vrijednost p<0,0001
Very common side effects of Ontruzant (may affect more than 1 in 10 people):
Vrlo česte nuspojave lijeka Ontruzant (mogu se javiti u više od 1 na 10 osoba):
Table 8 Final overall survival analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Tablica 8: Konačna analiza ukupnog preživljenja iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831
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.
U vrijeme analize umrlo je 349 od ukupnog broja randomiziranih bolesnika: 182 bolesnika
which was followed by • CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by • additional cycles of adjuvant trastuzumab (to complete 1 year of treatment)
nakon čega su poslije kirurškog zahvata slijedili • dodatni ciklusi adjuvantnog trastuzumaba (do dovršetka 1 godine liječenja).
Ontruzant 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 IHC3+ result.
Ontruzant se smije davati samo onim bolesnicima s metastatskim rakom želuca čije tumorske stanice pokazuju povećanu ekspresiju HER2 određenu imunohistokemijski kao 2+ i potvrđenu srebrom povećanom in situ hibridizacijom (SISH) ili fluorescentnom in situ hibridizacijom (FISH), ili određenu imunohistokemijski kao 3+.
Each 150 mg vial of Ontruzant is reconstituted with 7.2 mL of sterile water for injection (not supplied).
150 mg rekonstituira se sa 7,2 ml sterilne vode za injekcije (nije priložena u pakiranju).
The recommended initial loading dose of Ontruzant is 4 mg/kg body weight.
Preporučena početna udarna doza lijeka Ontruzant iznosi 4 mg/kg tjelesne težine.
Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with trastuzumab treatment, although the risk is lower than with concurrent use of trastuzumab and anthracyclines.
Pri liječenju trastuzumabom rizik od disfunkcije srca povećan je i u bolesnika s metastatskim rakom dojke koji su prije primali antracikline, premda je on manji od rizika koji postoji kod istodobne primjene trastuzumaba i antraciklina.
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1Heart beat irregular
1nepravilni otkucaji srca
Median duration of response (months) (95%CI)
Medijan trajanja odgovora (mjeseci) (95%CI)
Musculoskeletal and connective tissue disorders
Poremećaji mišićno koštanog sustava i vezivnog tkiva artralgija
• Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles, which was followed by Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
• doksorubicin 60 mg/m2 plus paklitaksel 150 mg/m2, svaka 3 tjedna u 3 ciklusa, nakon čega je slijedio
Each 420 mg vial of Ontruzant is reconstituted with 20 mL of sterile water for injection (not supplied).
420 mg rekonstituira se s 20 ml sterilne vode za injekcije (nije priložena u pakiranju).
Ontruzant contains the active substance trastuzumab, which is a monoclonal antibody.
Što je Ontruzant i za što se koristi Ontruzant sadrži djelatnu tvar trastuzumab koji je monoklonsko protutijelo.
No. patients with event p=0.0275
Broj bolesnika s događajem p=0,0275
• swelling of the face, lips and throat
• oticanje lica, usana i grla • zatajenje bubrega
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:
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.
• based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
• za udarnu dozu trastuzumaba od 4 mg/kg tjelesne težine ili tjedne doze održavanja od 2 mg/kg tjelesne težine:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 150 mg powder for concentrate trastuzumab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ontruzant 150 mg prašak za koncentrat trastuzumab
Hazard ratio vs AC→D (95% CI)
Omjer hazarda naspram AC→D (95% CI)
The pre-planned final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831 was performed when 707 deaths had occurred (median follow-up 8.3 years in the AC→PH group).
NCCTG N9831 provedena je nakon 707 smrtnih slučajeva (medijan praćenja od 8,3 godine u skupini koja je primala AC→PH kemoterapiju).
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.
klase III-IV primijećeno je u 0,6% bolesnika iz skupine liječene godinu dana nakon medijana od 12 mjeseci praćenja.
• jaundice (yellowish discoloration of the skin or eyes)
• žutica (žućkasta promjena boje kože ili očiju) • upala ili ožiljci na plućima
Death (OS event) No. patients with event p=0.0024
Smrt (događaj ukupnog preživljenja): broj bolesnika s događajem p=0,0024
Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients
Tablica 16: Vrijednosti farmakokinetičkih parametara u stanju dinamičke ravnoteže predviđene za populaciju uz režime doziranja intravenske infuzije trastuzumaba u bolesnika s metastatskim rakom dojke (MBC), ranim rakom dojke (EBC) i uznapredovalim rakom želuca (AGC)
Chemo only (n=116)
Samo kemoterapija (n=116)
MBC 805
MBC 805 EBC
The reconstituted Ontruzant solution contains 21 mg/mL of trastuzumab.
Rekonstituirana otopina lijeka Ontruzant sadrži 21 mg/ml trastuzumaba.
Ontruzant 150 mg powder for concentrate for solution for infusion Ontruzant 420 mg powder for concentrate for solution for infusion
Ontruzant 150 mg prašak za koncentrat za otopinu za infuziju Ontruzant 420 mg prašak za koncentrat za otopinu za infuziju
8mg/kg + 6mg/kg q3w
8mg/kg + 6mg/kg jedanput svaka tri tjedna
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The main test method used to determine HER2 positivity in the pivotal trial of docetaxel, with or without trastuzumab, was immunohistochemistry.
Glavna metoda određivanja povećane ekspresije HER2 primijenjena u ključnom kliničkom ispitivanju docetaksela u monoterapiji ili kombinaciji s trastuzumabom bila je imunohistokemija.
No staining is observed or membrane staining is observed in <10% of the tumour cells
Nema vidljive obojenosti ili se obojenost membrane primjećuje u <10% tumorskih stanica
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 420 mg powder for concentrate for solution for infusion trastuzumab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ontruzant 420 mg prašak za koncentrat za otopinu za infuziju trastuzumab
Strong complete membrane staining is detected in >10% of the tumour cells.
Jaka obojenost cijele membrane otkrivena u >10% tumorskih stanica.
Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Nakupina tumorskih stanica sa slabom do umjereno potpunom, bazolateralnom ili lateralnom membranskom reaktivnošću bez obzira na postotak obojenih tumorskih stanica
The following list of side effects can occur at any time during treatment with Ontruzant, not just related to an infusion.
Nuspojave sa sljedećeg popisa mogu nastati u bilo koje vrijeme tijekom liječenja lijekom Ontruzant,
Table 14 Population predicted cycle 1 PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients
Tablica 14: Vrijednosti farmakokinetičke izloženosti predviđene za populaciju u 1. ciklusu (medijan s rasponom od 5. do 95. percentila) uz režime doziranja intravenske formulacije trastuzumaba u bolesnika s metastatskim rakom dojke (MBC), ranim rakom dojke (EBC) i uznapredovalim rakom želuca (AGC)
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 AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)*
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
Ontruzant 420 mg powder for concentrate for solution for infusion
Ontruzant 420 mg prašak za koncentrat za otopinu za infuziju
A faint/barely perceptible membrane staining is detected in >10% of the tumour cells.
Blijeda, jedva uočljiva obojenost membrane u >10% tumorskih stanica.
Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer
Tablica 3: Preporučena ljestvica vrednovanja rezultata imunohistokemijskog bojenja preparata u raku želuca
As a three-weekly regimen the recommended initial loading dose of Ontruzant is 8 mg/kg body weight.
U trotjednim ciklusima preporučena početna udarna doza lijeka Ontruzant iznosi 8 mg/kg tjelesne težine.
Median Survival (months) (95%CI)
Medijan preživljenja (mjeseci) (95%CI)
Detection of HER2 overexpression or HER2 gene amplification in gastric cancer Only an accurate and validated assay should be used to detect HER2 overexpression or HER2 gene amplification.
Za otkrivanje povećane ekspresije HER2 ili HER2 genske amplifikacije potrebno je primjenjivati samo precizne i validirane metode.
Each 150 mg vial of Ontruzant is reconstituted with 7.2 mL of water for injections (not supplied).
Sadržaj jedne bočice lijeka Ontruzant od 150 mg rekonstituira se sa 7,2 ml vode za injekcije (nije priložena u pakiranju).
DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831.
Analiza preživljenja bez bolesti također je provedena prilikom konačne analize ukupnog preživljenja iz skupne analize ispitivanja NSABP B--31 i NCCTG N9831.
Each 420 mg vial of Ontruzant is reconstituted with 20 mL of water for injections (not supplied).
Sadržaj jedne bočice lijeka Ontruzant od 420 mg rekonstituira se s 20 ml vode za injekcije (nije priložena u pakiranju).
Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value <0.0001).
(stratificirani omjer hazarda = 0,64; 95% CI [0,55; 0,74]; log-rang p-vrijednost <0,0001).
Formal cardiological assessment should be considered in patients in whom there are cardiovascular concerns following baseline screening.
U bolesnika u kojih nakon početne procjene postoji sumnja na kardiovaskularnu bolest, potrebno je razmotriti formalnu kardiološku procjenu.
Ontruzant 150 mg powder for concentrate for solution for infusion
Ontruzant 150 mg prašak za koncentrat za otopinu za infuziju
Tumour cell cluster with a faint⁄barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Nakupina tumorskih stanica s vrlo slabom/jedva primjetnom membranskom reaktivnošću bez obzira na postotak obojenih tumorskih stanica
STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab.
Bočica sadrži 420 mg trastuzumaba.
Ontruzant should be carefully handled during reconstitution.
Tijekom rekonstitucije, lijekom Ontruzant treba rukovati oprezno.
In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving Ontruzant.
U rijetkim je slučajevima u trudnica koje primaju Ontruzant primijećeno smanjenje količine
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3:
Preporučena ljestvica vrednovanja rezultata imunohistokemijskog bojenja preparata nalazi se u tablici 3:
The data also suggested that the pharmacokinetics of cisplatin were not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus trastuzumab.
Podaci su također ukazali na to da istodobna primjena kapecitabina ili istodobna primjena kapecitabina i trastuzumaba ne utječe na farmakokinetiku cisplatina.
in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
AC kemoterapije (AC→DH) ili u kombinaciji s docetakselom i karboplatinom (DCarbH).
A weak to moderate complete membrane staining is detected in >10% of the tumour cells.
Slaba do umjerena obojenost cijele membrane u >10% tumorskih stanica.
The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Preporučena doza održavanja koja se primjenjuje u trotjednim intervalima iznosi 6 mg/kg tjelesne težine, a počinje se primjenjivati tri tjedna nakon udarne doze.
- intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
- intravenski 5-fluorouracil - 800 mg/m² na dan u kontinuiranoj intravenskoj infuziji tijekom 5 dana, svaka 3 tjedna u 6 ciklusa (od 1. do 5. dana svakog ciklusa).
- Study BO16348 was designed to compare one and two years of three-weekly trastuzumab treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
U adjuvantnom je liječenju trastuzumab ispitivan u 4 velika multicentrična, randomizirana ispitivanja: - Ispitivanje BO16348 s ciljem usporedbe liječenja trastuzumabom u trotjednim ciklusima tijekom jedne i dvije godine i opservacije u bolesnika s HER2-pozitivnim tumorom dojke u ranom stadiju nakon kirurškog zahvata, završene kemoterapije i radioterapije (ako su provedeni).
• 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: Volume (mL) =
• za udarnu dozu trastuzumaba od 8 mg/kg tjelesne težine ili daljnje trotjedne doze održavanja od 6 mg/kg tjelesne težine:
AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH
AC→D = doksorubicin i ciklofosfamid nakon kojih slijedi docetaksel; AC→DH = doksorubicin i ciklofosfamid nakon kojih slijede docetaksel i trastuzumab; CI = interval pouzdanosti
Table 6 Efficacy results from Study BO16348 Median follow-up 12 months*
Tablica 6: Rezultati djelotvornosti iz ispitivanja BO16348
Uncommon side effects of Ontruzant (may affect up to 1 in 100 people):
Manje česte nuspojave lijeka Ontruzant (mogu se javiti u do 1 na 100 osoba):
However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone, D7D).
Međutim, trastuzumab može povećati ukupnu izloženost jednome od metabolita doksorubicina
Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer
Tablica 2: Preporučena ljestvica vrednovanja rezultata imunohistokemijskog bojenja preparata kod raka dojke Rezultat
Distant recurrence No. patients with event p<0.0001
broj bolesnika s događajem p<0,0001
How Ontruzant is given
Kako ćete primati Ontruzant
The recommended maintenance dose of Ontruzant at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Preporučena doza održavanja lijeka Ontruzant koja se primjenjuje u trotjednim intervalima iznosi 6 mg/kg tjelesne težine, a počinje se primjenjivati 3 tjedna nakon udarne doze.
CI)
I
Common side effects of Ontruzant (may affect up to 1 in 10 people):
Česte nuspojave lijeka Ontruzant (mogu se javiti u do 1 na 10 osoba):
Distant recurrence No. patients with event p=0.0008
broj bolesnika s događajem p=0,0008
By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous infusion) and observed serum concentrations in Japanese women with HER2-positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
Usporedbom simuliranih koncentracija trastuzumaba u serumu nakon monoterapije trastuzumabom (udarna doza od 4 mg/kg / 2 mg/kg u intravenskoj infuziji jedanput tjedno) i opaženih koncentracija u serumu žena japanskog podrijetla s HER2-pozitivnim metastatskim rakom dojke (ispitivanje
Hazard ratio versus observation *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 randomized after the cut-off date for the 12-month median follow-up analysis
***Postoji nesrazmjer u ukupnoj veličini uzorka zbog malog broja bolesnika koji su randomizirani nakon završnog datuma za analizu medijana praćenja od 12 mjeseci.
Instructions for reconstitution:
POPIS POMOĆNIH TVARI Pomoćne tvari:
MBC EBC Table 15 Population predicted steady state PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients tumour type N Cmin,ss* Regimen Primary (µg/mL)
Tablica 15: Vrijednosti farmakokinetičke izloženosti u stanju dinamičke ravnoteže predviđene za populaciju (medijan s rasponom od 5. do 95. percentila) uz režime doziranja intravenske formulacije trastuzumaba u bolesnika s metastatskim rakom dojke (MBC), ranim rakom dojke (EGC) i uznapredovalim rakom želuca (AGC)
Merck Sharp & Dohme B.V. Tel.: 0800 9999000
Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3737
+Acute pulmonary oedema
+dispneja kašalj epistaksa rinoreja
Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table 4:
Rezultati djelotvornosti iz ispitivanja monoterapije trastuzumabom ili njegove primjene u kombiniranoj terapiji prikazani su u tablici 4:
Detection of HER2 overexpression or HER2 gene amplification in breast cancer Trastuzumab should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Trastuzumab se smije primjenjivati samo u onih bolesnika s tumorima čije stanice pokazuju povećanu ekspresiju HER2 ili HER2 gensku amplifikaciju utvrđenu točnom i validiranom metodom.
Renal and urinary disorders Renal disorder
babinje i perinatalno oligohidramnion nepoznato renalna hipoplazija nepoznato
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Prije primjene, parenteralne lijekove treba vizualno pregledati da ne sadrže čestice ili da nisu promijenili boju.
Three-weekly dosing in metastatic breast cancer The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Rezultati djelotvornosti iz ispitivanja monoterapije i kombinirane terapije trastuzumabom bez kontrolnih skupina prikazani su u tablici 5:
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2:
Preporučena ljestvica vrednovanja rezultata imunohistokemijskog bojenja preparata nalazi se u tablici 2.
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Time se dobiva 7,4 ml otopine za jednokratnu primjenu koja sadrži približno 21 mg/ml trastuzumaba pH vrijednosti od približno 6,0.
This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Time se dobiva 21 ml otopine za jednokratnu primjenu koja sadrži približno 21 mg/ml trastuzumaba pH vrijednosti od približno 6,0.
After a median follow-up of 12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95% CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8% versus 78.2%) in favour of the trastuzumab arm.
(95% CI 0,44; 0,67), što znači da je apsolutno povoljan u smislu dvogodišnjeg preživljenja bez simptoma bolesti s razlikom od 7,6 postotnih bodova (85,8% naspram 78,2%) u korist skupine liječene trastuzumabom.
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 0.97, 95% CI [0.60, 1.55] for AC→DH (AC→TH) versus AC→D).
Nije primijećena prednost u pogledu preživljenja bez bolesti u toj podskupini bolesnika (omjer hazarda = 1,16; 95% CI [0,73; 1,83] za skupinu DCarbH (TCH),
Time to disease progression, median months
Preživljenje bez progresije bolesti, medijan u mjesecima Vrijeme do progresije bolesti, medijan u mjesecima Stopa ukupnog odgovora na liječenje, %
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.
Ispitivanja provedena na makaki majmunima u razdoblju laktacije, kojima su davane doze intravenske formulacije trastuzumaba 25 puta veće od tjednih doza održavanja u ljudi od 2 mg/kg,
Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model.
Ispiranje trastuzumaba Razdoblje ispiranja trastuzumaba procijenjeno je nakon intravenske primjene lijeka jedanput na tjedan ili jedanput svaka 3 tjedna uz pomoć populacijskog farmakokinetičkog modela.
• difficulty in breathing when lying flat
• otežano disanje u ležećem položaju • oštećenje/zatajenje jetre
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.
Medijan ukupnog preživljenja u skupini s visokom ekspresijom HER2 koja je primala fluoropirimidin i cisplatin iznosio je 11,8 mjeseci u usporedbi sa 16 mjeseci u skupini koja je uz fluoropirimidin i cisplatin primala i trastuzumab, omjer hazarda (HR) 0,65 (95% CI 0,51-0,83).