natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
or - intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days,
ili - intravenski 5-fluorouracil - 800 mg/m²/dnevno u kontinuiranoj intravenskoj infuziji tijekom
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 %).
Za skupinu koja je primala trastuzumab procijenjena je apsolutna korist od 13 postotnih bodova za stopu trogodišnjeg preživljenja bez štetnih događaja (65% naspram 52%).
Cardiac failure (congestive)
+zatajenje srca (kongestivno)
• palpitations (heart fluttering or irregular heart beat).
• osjećaj lupanja srca (lepršanje srca ili nepravilni otkucaji srca).
For intravenous use only after reconstitution and dilution
Samo za intravensku primjenu nakon rekonstitucije i razrjeđivanja.
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.
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.
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).
Ogivri može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
6.6 Special precautions for disposal and other handling Ogivri should be carefully handled during reconstitution.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Tijekom rekonstitucije, lijekom Ogivri treba rukovati oprezno.
t1/2 range from Cmax,ss to Cmin,ss (day)
Raspon t1/2 od Cmax, ss do Cmin, ss (dani)
Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5 % of patients.
Reverzibilnost blage simptomatske i asimptomatske disfunkcije lijeve klijetke dokazana je u 79,5% bolesnika liječenih trastuzumabom.
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.
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.
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).
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).
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.
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.
Sorbitol content
Sadržaj sorbitola
Patients were either naïve to trastuzumab intravenous treatment (20.3 %) or pre-exposed to trastuzumab intravenous (79.7 %).
Bolesnici ili prethodno nisu bili liječeni intravenskom formulacijom trastuzumaba (20,3%) ili su već bili izloženi intravenskoj formulaciji trastuzumaba (79,7%).
Trastuzumab intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available.
Intravensku infuziju trastuzumaba treba dati stručni zdravstveni radnik obučen za liječenje anafilaksije, a na raspolaganju treba biti oprema za hitne slučajeve.
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.
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.
Total CL range from Cmax,ss to Cmin,ss (L/day)
N Raspon ukupnog klirensa od Cmax, ss do Cmin, ss (l/dan)
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.
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.
*Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
* Cmin, ss - Cmin u stanju dinamičke ravnoteže * Cmax, ss - Cmax u stanju dinamičke ravnoteže *** vrijeme do postizanja 90% stanja dinamičke ravnoteže
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.
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.
Patients with history of myocardial infarction (MI), angina pectoris requiring medical treatment, history of or existing CHF (NYHA Class II -IV), LVEF of < 55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension (hypertension controlled by standard medical treatment eligible), and hemodynamic effective pericardial effusion were excluded from adjuvant and neoadjuvant EBC pivotal trials with trastuzumab and therefore treatment cannot be recommended in such patients.
Bolesnici koji su imali infarkt miokarda (IM) u anamnezi, anginu pektoris koju treba liječiti, ranije ili postojeće kongestivno zatajenje srca (NYHA klase II-IV), LVEF < 55%, neku drugu kardiomiopatiju, srčanu aritmiju koju treba liječiti, klinički značajnu bolest srčanih zalistaka, loše kontroliranu hipertenziju (hipertenzija kontrolirana standardnim liječenjem nije predstavljala prepreku) i hemodinamički učinkovit perikardijalni izljev bili su isključeni iz pivotalnih ispitivanja adjuvantnog i neoadjuvantnog liječenja ranog raka dojke trastuzumabom, pa se liječenje za te bolesnike ne može preporučiti.
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 trastuzumab.
U rijetkim je slučajevima u trudnica koje primaju Ogivri primijećeno smanjenje količine (amnijske) tekućine koja okružuje bebu u razvoju unutar maternice.
A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Suvišak volumena od 4% jamči da se naznačena doza od 150 mg može izvući iz svake bočice.
Post-hoc exploratory analysis with DFS and symptomatic cardiac events
Post-hoc eksplorativna analiza s preživljenjem bez bolesti i simptomatskim srčanim događajima
In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 1 year treatment arm was 0.8 %, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6 %.
U ispitivanju BO16348, nakon medijana praćenja od 8 godina, incidencija teškog kongestivnog zatajenja srca (NYHA klase III i IV) u skupini liječenoj 1 godinu trastuzumabom iznosila je 0,8%, dok je stopa blage simptomatske i asimptomatske disfunkcije lijeve klijetke iznosila
If you receive Ogivri with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Ako primate Ogivri u kombinaciji s nekim drugim lijekom za liječenje raka, poput paklitaksela, docetaksela, inhibitora aromataze, kapecitabina, 5-fluorouracila ili cisplatina, pročitajte uputu o lijeku i za te lijekove.
Study MO22982 investigated switching between the trastuzumab intravenous and trastuzumab subcutaneous formulation with a primary objective to evaluate patient preference for either intravenous or the subcutaneous route of trastuzumab administration.
U ispitivanju MO22982 istraživao se prelazak s intravenske formulacije trastuzumaba na supkutanu formulaciju trastuzumaba i obrnuto, a primarni je cilj bio ocijeniti daju li bolesnici prednost intravenskom ili supkutanom putu primjene trastuzumaba.
Ogivri may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful.
Ogivri se može propisati u kombinaciji s kemoterapijskim lijekovima paklitakselom ili docetakselom u prvoj liniji liječenja metastatskog raka dojke ili može biti propisan sam ako su se drugi oblici liječenja pokazali neuspješnima.
If the patient has missed a dose of trastuzumab by more than one week, a re-loading dose of trastuzumab should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; threeweekly regimen: 8 mg/kg) as soon as possible.
Ako je bolesnik propustio primiti dozu trastuzumaba za više od tjedan dana, potrebno je što prije ponoviti udarnu dozu trastuzumaba u infuziji trajanja približno 90 minuta (tjedni ciklusi: 4 mg/kg; trotjedni ciklusi: 8 mg/kg).
Primary tumor type
Vrsta primarnog tumora
Paclitaxel2 N = 77
Paklitaksel2 N=77
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.
5 dana, svaka 3 tjedna u 6 ciklusa (od 1. do 5. dana svakog ciklusa) Bilo koja od navedenih terapija primjenjivana je uz: - cisplatin - 80 mg/m² svaka 3 tjedna u 6 ciklusa, 1. dan svakog ciklusa.
In patients receiving trastuzumab after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) > 25 kg/m2.
U bolesnika koji su trastuzumab primali nakon završetka adjuvantne kemoterapije, rizik od disfunkcije srca povezivao se s većom kumulativnom dozom antraciklina primijenjenoga prije početka liječenja trastuzumabom te indeksom tjelesne mase (BMI) većim od 25 kg/m².
Ogivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Ogivri je u kombinaciji s kapecitabinom ili 5-fluorouracilom i cisplatinom indiciran u liječenju odraslih bolesnika s HER2 pozitivnim metastatskim adenokarcinomom želuca ili gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered trastuzumab concurrently with a taxane following anthracycline therapy up to 2.37 % compared to approximately 1 % in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and trastuzumab).
U jednom od 3 provedena pivotalna ispitivanja s medijanom vremena praćenja od 5,5 godina (BCIRG006), u bolesnica koje su nakon anatraciklinske terapije trastuzumab primale istodobno s taksanima, zabilježen je kontinuirani porast kumulativne stope simptomatskih srčanih događaja ili događaja povezanih s LVEF-om; do 2,37% u odnosu na oko 1% u dvije usporedne skupine (antraciklin plus ciklofosfamid uz nastavak liječenja taksanima te kombinacija taksana, karboplatina i trastuzumaba).
Trastuzumab plus docetaxel4 N = 110
Trastuzumab s docetakselom4 N=110
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule Study BO15935
1 Ispitivanje WO16229: udarna doza 8 mg/kg, zatim 6 mg/kg u trotjednim ciklusima 2 Ispitivanje MO16982: udarna doza 6 mg/kg tjedno kroz 3 tjedna, zatim 6 mg/kg u trotjednim ciklusima 3 Ispitivanje BO15935
The incidence of symptomatic cardiac dysfunction was 1.7 % in the trastuzumab arm.
Incidencija simptomatske disfunkcije srca u skupini koja je primala trastuzumab iznosila je 1,7%.
In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low dose anthracycline regimen is limited (see section 4.4).
U neoadjuvantnom liječenju iskustvo s istodobnom primjenom trastuzumaba i niske doze antraciklina je ograničeno (vidjeti dio 4.4).
After reconstitution, 1 mL concentrate contains 21 mg of trastuzumab.
Nakon rekonstitucije 1 ml koncentrata sadrži 21 mg trastuzumaba.
For the sequence intravenous → subcutaneous (subcutaneous vial and subcutaneous formulation in administration system cohorts combined), adverse event rates (all grades) were described preswitching (Cycles 1-4) and post-switching (Cycles 5-8) as 53.8 % vs. 56.4 %, respectively; for the sequence subcutaneous → intravenous (subcutaneous vial and subcutaneous formulation in administration system cohorts combined), adverse event rates (all grades) were described pre- and post-switching as 65.4 % vs. 48.7 %, respectively.
Kod slijeda intravenski → supkutano (objedinjene kohorte koje su primale supkutanu formulaciju u bočici i supkutanu formulaciju u sustavu za primjenu), stopa štetnih događaja (svih stupnjeva) prije prelaska (1. - 4. ciklus) iznosila je 53,8%, a nakon prelaska (5. - 8. ciklus) 56,4%; kod slijeda supkutano → intravenski (objedinjene kohorte koje su primale supkutanu formulaciju u bočici i supkutanu. formulaciju u sustavu za primjenu), stopa štetnih događaja (svih stupnjeva) prije prelaska iznosila je 65,4%, a nakon prelaska 48,7%.
Each 150 mg vial contains 115.2 mg sorbitol (E420).
Jedna bočica od 150 mg sadrži 115,2 mg sorbitola (E420).
Ogivri is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC): - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1) - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Ogivri je indiciran u liječenju odraslih bolesnika s HER2 pozitivnim ranim rakom dojke: - nakon kirurškog zahvata, kemoterapije (neoadjuvantne ili adjuvantne) i radioterapije (ako su provedeni) (vidjeti dio 5.1) - nakon adjuvantne kemoterapije doksorubicinom i ciklofosfamidom u kombinaciji s paklitakselom ili docetakselom - u kombinaciji s adjuvantnom kemoterapijom koja uključuje docetaksel i karboplatin - u kombinaciji s neoadjuvantnom kemoterapijom nakon koje slijedi adjuvantna terapija lijekom
Pre-switching rates (Cycles 1-4) for serious adverse events, grade 3 adverse events and treatment discontinuations due to adverse events were low (< 5 %) and similar to post-switching rates (Cycles 58).
Stope ozbiljnih štetnih događaja, štetnih događaja 3. stupnja i prekida liječenja zbog štetnih događaja zabilježene prije prelaska (1. - 4. ciklus) bile su niske (< 5%) i slične onima primijećenima nakon prelaska (5. - 8. ciklus).
- The other ingredient(s) are L-histidine hydrochloride, L-histidine, Sorbitol (see section 2 “Ogivri contains sorbitol”), Macrogol 3350, Hydrochloric acid and Sodium hydroxide (for pH adjustment).
- Drugi sastojci su L-histidinklorid, L-histidin, sorbitol (vidjeti dio 2, „Ogivri sadrži sorbitol“), makrogol 3350, kloridna kiselina i natrijev hidroksid (za prilagodbu pH).
• You should use effective contraception during treatment with Ogivri and for at least 7 months after treatment has ended.
• Tijekom liječenja lijekom Ogivri i najmanje 7 mjeseci nakon završetka liječenja potrebno je koristiti učinkovitu kontracepciju.
Long term follow-up** Hazard ratios (95 % CI)
Dugoročno praćenje** Omjeri hazarda (95% CI)
A final analysis was performed after a median follow-up of 8 years, which showed that 1 year trastuzumab treatment is associated with a 24 % risk reduction compared to observation only (HR = 0.76, 95 % CI 0.67, 0.86).
Završna analiza provedena nakon medijana praćenja od 8 godina ukazala je na smanjenje rizika od 24% u skupini liječenoj trastuzumabom tijekom 1 godine u usporedbi samo s opservacijom (HR=0,76, 95% CI 0,67; 0,86).
In the pivotal trial MO16432, trastuzumab was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2).
U pivotalnom ispitivanju MO16432, trastuzumab se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od tri ciklusa doksorubicina (kumulativna doza 180 mg/m²).
Despite the cross-over to trastuzumab in the control arm, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52 % decrease in the risk of disease recurrence.
Unatoč prijelazu na liječenje trastuzumabom u kontrolnoj skupini, dodavanje trastuzumaba kemoterapiji paklitakselom rezultiralo je smanjenjem rizika od ponovne pojave bolesti za 52%.
Congestive heart failure (NYHA Class II - IV) is a common adverse reaction associated with the use of trastuzumab and has been associated with a fatal outcome (see section 4.4).
Kongestivno zatajenje srca (NYHA klase II - IV), česta je nuspojava primjene trastuzumaba, ponekad povezana i sa smrtnim ishodom (vidjeti dio 4.4).
Combination treatment with Trastuzumab and anastrozole Trastuzumab has been studied in combination with anastrozole for first line treatment of MBC in HER2 overexpressing, hormone-receptor (i.e. estrogen-receptor (ER) and/or progesterone-receptor (PR)) positive postmenopausal patients.
Kombinirano liječenje trastuzumabom i anastrozolom Trastuzumab je ispitivan u kombinaciji s anastrozolom u prvoj liniji liječenja postmenopauzalnih bolesnica s metastatskim rakom dojke pozitivnim na povećanu ekspresiju HER2 i hormonske receptore (tj. estrogenske (ER) i/ili progesteronske receptore (PR)).
The efficacy of trastuzumab in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied.
Nije ispitana djelotvornost lijeka trastuzumab u kombinaciji s paklitakselom u bolesnica koje prethodno nisu primile adjuvantnu terapiju antraciklinima.
Each 150 mg vial of Ogivri is reconstituted with 7.2 mL of sterile water for injections (not supplied).
Svakih 150 mg lijeka Ogivri rekonstituira se sa 7,2 ml sterilne vode za injekcije (nije priložena u pakiranju).
No reactivity or membranous reactivity in < 10 % of tumour cells
Nema reaktivnosti ili membranske reaktivnosti u < 10% tumorskih stanica
Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of Ogivri that can be withdrawn from the vial.
Stvaranje prevelike pjene tijekom rekonstitucije ili prejako protresanje rekonstituirane otopine može uzrokovati poteškoće s izvlačenjem odgovarajuće količine lijeka Ogivri iz bočice.
In study MO16432, trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg maintenance every 3 weeks) was administered concurrently with 10 cycles of neoadjuvant chemotherapy as follows:
U ispitivanju MO16432 trastuzumab (udarna doza od 8 mg/kg, zatim doza održavanja od 6 mg/kg svaka 3 tjedna) je davan istodobno s 10 ciklusa neoadjuvantne kemoterapije, kako slijedi:
A volume overage of 4.8 % ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Suvišak volumena od 4,8% jamči da se naznačena doza od 420 mg može izvući iz svake bočice.
Ogivri is for single-use only, as the product contains no preservatives.
Lijek Ogivri namijenjen je samo za jednokratnu primjenu jer ne sadrži konzervanse.
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.
Kardiološke preglede, istovjetne 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.
L-histidine hydrochloride, L-histidine, sorbitol, macrogol 3350, hydrochloric acid and sodium hydroxide.
POPIS POMOĆNIH TVARI L-histidinklorid, L-histidin, sorbitol, makrogol 3350, kloridna kiselina i natrijev hidroksid.
Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Bolesnice koje su prethodno primale antraciklinsku adjuvantnu kemoterapiju liječene su paklitakselom (175 mg/m² u trosatnoj infuziji) u kombinaciji s trastuzumabom ili bez njega.
Do not use with glucose-containing solutions.
Ne smije se koristiti s otopinama koje sadrže glukozu.
Ogivri intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Ogivri u intravenskoj formulaciji nije namijenjen za supkutanu primjenu i smije se primijeniti isključivo intravenskom infuzijom.
Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH Parameter
Pregled analize djelotvornosti u ispitivanju BCIRG 006; AC→D u odnosu na DcarbH Parametar
More patients treated with trastuzumab and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6 % versus 6.5 %; p = 0.377).
Pojava metastaza u središnjem živčanom sustavu bila je češća u bolesnica liječenih trastuzumabom i paklitakselom u odnosu na one liječene samo paklitakselom (12,6% naspram 6,5%; p=0,377).
If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Ako se LVEF ne poboljša ili se još više smanji, ili ako se razvije simptomatsko kongestivno zatajenje srca (engl. congestive heart failure, CHF), potrebno je ozbiljno razmotriti mogućnost prekida liječenja trastuzumabom, osim u slučaju kada koristi za pojedinog bolesnika nadmašuju rizike.
Trastuzumab plus paclitaxel2 N = 68
Trastuzumab s paklitakselom2 N=68
CLINICAL PARTICULARS 4.1 Therapeutic indications Breast cancer
4.1 Terapijske indikacije