natgillin/translations-raw huggingface dataset:
Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Volumen (ml) = tjelesna težina (kg) x doza (4 mg/kg za udarnu dozu ili 2 mg/kg za održavanje) 21 (mg/ml, koncentracija rekonstituirane otopine)
Hazard ratio versus
Omjer hazarda naspram
Patients treated with trastuzumab are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
(klase II-IV prema udruženju New York Heart Association [NYHA]) ili asimptomatske disfunkcije srca.
Subsequent Ontruzant maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Sljedeću dozu održavanja lijeka Ontruzant (tjedni ciklusi: 2 mg/kg; trotjedni ciklusi: 6 mg/kg) treba primijeniti 7 dana nakon toga u tjednom rasporedu doziranja, odnosno 21 dan nakon toga u trotjednom rasporedu doziranja.
Causing excessive foaming during reconstitution or shaking the reconstituted Ontruzant may result in problems with the amount of Ontruzant that can be withdrawn from the vial.
Stvaranje prevelike pjene tijekom rekonstitucije ili protresanje rekonstituirane otopine može uzrokovati poteškoće s izvlačenjem odgovarajuće količine lijeka Ontruzant iz bočice.
The test method for HER2 overexpression used to determine eligibility of patients in the pivotal trastuzumab monotherapy and trastuzumab plus paclitaxel clinical trials employed immunohistochemical staining for HER2 of fixed material from breast tumours using the murine monoclonal antibodies CB11 and 4D5.
Metoda testiranja povećane ekspresije HER2, primijenjena u ključnim kliničkim ispitivanjima u svrhu odabira bolesnika pogodnih za monoterapiju trastuzumabom ili liječenje kombinacijom trastuzumaba i paklitaksela, bila je imunohistokemijska metoda određivanja HER2 u fiksiranom materijalu uzetom iz tumora dojke pomoću CB11 i 4D5 mišjih monoklonskih protutijela.
Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Jaka potpuna, bazolateralna ili lateralna membranska reaktivnost u ≥10% tumorskih stanica
Determine the volume of the solution required:
Potrebni volumen otopine odredite na sljedeći način:
If the patient has missed a dose of Ontruzant by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible.
Ako je bolesnik propustio primiti dozu lijeka Ontruzant za tjedan dana ili manje, nužno je što prije primijeniti uobičajenu dozu održavanja (tjedni ciklusi: 2 mg/kg; trotjedni ciklusi: 6 mg/kg).
Ontruzant vial
Ontruzant bočica
What Ontruzant is and what it is used for
Pogledajte dio 4. Što se nalazi u ovoj uputi: Što je Ontruzant i za što se koristi
Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Ontruzant je indiciran u liječenju odraslih bolesnika s HER2-pozitivnim metastatskim rakom dojke:
Median duration of follow-up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm ** Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) arm and the DCarbH arm (range: 0.0 to 13.1), and was 10.4 years (range: 0.0 to 12.7) in the AC→DH arm
** Medijan trajanja dugoročnog praćenja za klinička ispitivanja obuhvaćena zajedničkom analizom iznosio je 8,3 godine (raspon:od 0,1 do 12,1) u skupini koja je primala AC→PH kemoterapiju te 7,9 godina (raspon: od 0,0 do 12,2) u skupini koja je primala AC→P kemoterapiju; medijan trajanja dugoročnog praćenja za ispitivanje BCIRG 006 iznosio je 10,3 godine i u skupini koja je primala AC→D (raspon: od 0,0 do 12,6) i u onoj koja je primala DCarbH kemoterapiju (raspon: od 0,0 do 13,1), dok je u skupini koja je primala AC→DH kemoterapiju iznosio 10,4 godine (raspon: od 0,0 do 12,7).
Once the infusion is prepared it should be administered immediately.
Pripremljenu otopinu za infuziju potrebno je primijeniti odmah.
Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Volumen (ml) = tjelesna težina (kg) x doza (8 mg/kg za udarnu dozu ili 6 mg/kg za održavanje) 21 (mg/ml, koncentracija rekonstituirane otopine)
The reconstituted Ontruzant results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Rekonstituirani Ontruzant bezbojna je do blijedožuta prozirna otopina i ne smije sadržavati vidljive čestice.
If anthracyclines are used, the patient's cardiac function should be monitored carefully.
potrebno je pažljivo pratiti srčanu funkciju bolesnika.
In a subsequent trial with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2% in patients receiving trastuzumab and docetaxel, compared with 0% in patients receiving docetaxel alone.
U kasnijem ispitivanju u kojem se prospektivno pratila srčana funkcija, incidencija simptomatskog kongestivnog zatajenja srca bila je 2,2% u bolesnika koji su primali trastuzumab i docetaksel, u usporedbi s 0% u bolesnika koji su primali samo docetaksel.
4mg/kg + 2mg/kg qw
4mg/kg + 2mg/kg jedanput na tjedan
- The BCIRG 006 study was designed to investigate combining trastuzumab treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery.
- Ispitivanje BCIRG 006 s ciljem istraživanja kombiniranog liječenja trastuzumabom i docetakselom nakon AC kemoterapije ili u kombinaciji s docetakselom i karboplatinom u bolesnica s HER2-pozitivnim ranim rakom dojke nakon kirurškog zahvata.
In general, SISH or FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2.
Općenito se SISH ili FISH smatra pozitivnim ako je omjer broja genskih kopija HER2 po tumorskoj stanici i broja kopija kromosoma 17 veći ili jednak 2. Klinička djelotvornost i sigurnost
- 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.
- 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 dodatno je istraživana sekvencijska terapija trastuzumabom nakon AC→P kemoterapije, u bolesnica s HER2-pozitivnim ranim rakom dojke nakon kirurškog zahvata.
Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Procjenjuje se da će otprilike 40% bolesnika u tijeku liječenja trastuzumabom razviti neki oblik reakcije povezane s infuzijom.
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 je davan (udarna doza od 8 mg/kg, zatim doza održavanja od 6 mg/kg svaka 3 tjedna) istodobno s 10 ciklusa neoadjuvantne kemoterapije kako slijedi:
Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N=8386) and in post-marketing
Tablica 1: Nuspojave prijavljene kod primjene intravenskog trastuzumaba u monoterapiji ili u kombinaciji s kemoterapijom u ključnim kliničkim ispitivanjima (N=8386) i nakon stavljanja lijeka u promet Klasifikacija organskih sustava
Administration in combination with paclitaxel or docetaxel In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
U ključnim kliničkim ispitivanjima (H0648g, M77001) paklitaksel ili docetaksel primjenjivan je dan nakon prve doze trastuzumaba (za dozu vidjeti Sažetak opisa svojstava lijeka za paklitaksel ili docetaksel) i neposredno nakon sljedećih doza trastuzumaba ako je bolesnik prethodnu dozu trastuzumaba dobro podnio.
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.
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)).
In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7% versus 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9% ) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
Za primarnu mjeru ishoda ispitivanja BCIRG 006, preživljenje bez bolesti, omjer hazarda apsolutno je povoljan u smislu trogodišnjeg preživljenja bez bolesti s razlikom od 5,8 postotnih bodova (86,7% naspram 80,9%) u korist AC→DH skupine (trastuzumab) i 4,6 postotnih bodova (85,5% naspram 80,9%) u korist DCarbH skupine (trastuzumab) u usporedbi s AC→D skupinom.
*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
Ontruzant intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Ontruzant u intravenskoj formulaciji nije namijenjen za potkožnu primjenu i smije se primijeniti isključivo intravenskom infuzijom.
Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction.
Bolesnici s dispnejom u mirovanju zbog komplikacija uznapredovale zloćudne bolesti i popratnih komorbiditeta, mogu imati povećan rizik od infuzijskih reakcija sa smrtnim ishodom.
It is not known whether trastuzumab is secreted in human milk.
Nije poznato izlučuje li se trastuzumab u majčino mlijeko.
Administration as an intravenous push or bolus is prohibited.
Ne primjenjujte je kao intravensku injekciju ili bolus.
Comparison of trastuzumab PK data from Study M77004 in which women with HER2-positive MBC were treated concomitantly with trastuzumab, paclitaxel and doxorubicin to trastuzumab PK data in studies where trastuzumab was administered as monotherapy (H0649g) or in combination with anthracycline plus cyclophosphamide or paclitaxel (H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.
Usporedba podataka o farmakokinetici trastuzumaba iz ispitivanja M77004, u kojem su žene s HER2-pozitivnim metastatskim rakom dojke bile istodobno liječene trastuzumabom, paklitakselom i doksorubicinom, s podacima o farmakokinetici trastuzumaba iz ispitivanja u kojima se trastuzumab primjenjivao u monoterapiji (H0649g) ili u kombinaciji s antraciklinom plus ciklofosfamid ili paklitaksel (ispitivanje H0648g), ukazala je na to da doksorubicin i paklitaksel nemaju utjecaja na farmakokinetiku trastuzumaba.
Table 12 Efficacy results from MO16432
Tablica 12: Rezultati djelotvornosti iz ispitivanja MO16432 Parametar
HER2 overexpression assessment
Procjena povećane ekspresije HER2
Reactions include chills, fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4).
Te reakcije uključuju zimicu, vrućicu, dispneju, hipotenziju, piskanje pri disanju, bronhospazam, tahikardiju, smanjenu zasićenost kisikom, respiratorni distres, osip, mučninu, povraćanje i glavobolju (vidjeti dio 4.4).
The median duration of follow-up was 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm.
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.
Table 4 Efficacy results from the monotherapy and combination therapy studies Parameter
Tablica 4: Rezultati djelotvornosti iz ispitivanja monoterapije i kombinirane terapije Parametar
Trastuzumab 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 (trastuzumab alone).
Trastuzumab je u kliničkim ispitivanjima primjenjivan kao monoterapija u liječenju bolesnika s metastatskim rakom dojke koji pokazuje povećanu ekspresiju HER2 i u kojih jedan ili više kemoterapijskih protokola liječenja metastatske bolesti nije polučio uspjeh (samo trastuzumab).
Death (OS event): No. patients with event p=0.014**
Smrt (događaj ukupnog preživljenja): broj bolesnica s događajem p=0,014**
Comparison of PK results from two Phase II studies (BO15935 and M77004) and one Phase III study (H0648g) in which patients were treated concomitantly with trastuzumab and paclitaxel and two Phase II studies in which trastuzumab was administered as monotherapy (W016229 and MO16982), in women with HER2-positive MBC indicates that individual and mean trastuzumab trough serum concentrations varied within and across studies but there was no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of trastuzumab.
Usporedbom farmakokinetičkih rezultata iz dvaju ispitivanja faze II (BO15935 i M77004) i jednoga ispitivanja faze III (H0648g) u kojemu su bolesnice istodobno liječene trastuzumabom i paklitakselom te dvaju ispitivanja faze II u kojima je trastuzumab primjenjivan u monoterapiji (W016229 i MO16982) u žena s HER2-pozitivnim metastatskim rakom dojke, utvrđeno je da pojedinačne i srednje vrijednosti najnižih koncentracija trastuzumaba u serumu variraju unutar svakoga ispitivanja i između svih ispitivanja, ali nije utvrđen jasan učinak istodobne primjene paklitaksela na farmakokinetiku trastuzumaba.
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)
Docetaksel je primjenjivan na sljedeći način: - intravenski docetaksel - 100 mg/m2 u intravenskoj infuziji tijekom 1 sata, svaka 3 tjedna u 4 ciklusa (2. dan 1. ciklusa docetaksela, a potom 1. dan svakog sljedećeg ciklusa)
One 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab
Jedna bočica od 15 ml (bezbojno staklo tipa I) s butilnim gumenim čepom presvučenim fluoro-rezinskim filmom sadrži 150 mg trastuzumaba.
Pregnancy 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 trastuzumab intravenous formulation and have revealed no evidence of impaired fertility or harm to the fetus.
Ispitivanjima utjecaja na reprodukciju provedenim na makaki majmunima s dozama intravenske formulacije trastuzumaba do 25 puta većim od tjedne doze održavanja u ljudi od 2 mg/kg nije dokazano smanjenje plodnosti niti opasnost za fetus.
Response rate (95%CI)
Stopa odgovora (95%CI)
One 40 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab
Jedna bočica od 40 ml (bezbojno staklo tipa I) s butilnim gumenim čepom presvučenim fluoro-rezinskim filmom sadrži 420 mg trastuzumaba.
2) Swirl the vial gently to aid reconstitution.
2) Bočicu lagano vrtite kružnim pokretima kako bi se pospješila rekonstitucija.
Overall response rate,%
Višak volumena od 4%
Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous trastuzumab alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting.
U tablici 1 prikazane su nuspojave povezane s primjenom intravenskog trastuzumaba u monoterapiji ili u kombinaciji s kemoterapijom u ključnim kliničkim ispitivanjima i nakon stavljanja lijeka u promet.
Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg loading dose as an intravenous infusion and 2 mg/kg infusion weekly) and docetaxel (60 mg/m2 intravenous infusion) in Japanese women with HER2-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel.
Podaci iz ispitivanja JP16003, ispitivanja trastuzumaba (udarna doza od 4 mg/kg u obliku intravenske infuzije, nakon koje slijedi doza od 2 mg/kg u infuziji jedanput tjedno) i docetaksela (60 mg/m2 u intravenskoj infuziji) s jednom skupinom žena japanskog podrijetla s HER2-pozitivnim metastatskim rakom dojke, ukazali su na to da istodobna primjena trastuzumaba ne utječe na farmakokinetiku jednokratne doze docetaksela.
L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
L-histidinklorid hidrat, L-histidin, α,α-trehaloza dihidrat, polisorbat 20.
Cysts and polyps)
(uključujući ciste i polipe)
L-histidine hydrochloride monohydrate L-histidine α,α-trehalose dihydrate polysorbate 20
L-histidinklorid hidrat L-histidin α,α-trehaloza dihidrat polisorbat 20
The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8% versus 45.7%;
Učestalost pojave metastaza u jetri bila je znatno smanjena u bolesnica liječenih kombinacijom trastuzumaba i paklitaksela u usporedbi sa samim paklitakselom (21,8% naspram 45,7%; p=0,004).
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.
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.
Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC.
Linearni klirens iznosio je 0,136 l na dan za metastatski rak dojke, 0,112 l na dan za rani rak dojke i 0,176 l na dan za uznapredovali rak želuca.
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.
rizik od disfunkcije srca povezivao se s većom kumulativnom dozom antraciklina primijenjenoga prije početka liječenja trastuzumabom te indeksom tjelesne mase (ITM) većim od >25 kg/m2.
Disease-free survival No. patients with event (%)
broj bolesnica s događajem (%)
Hazard ratio (95% CI)
Omjeri hazarda (95% CI)
You will be observed by a health care professional during the infusion and for at least six hours after the start of the first infusion and for two hours after the start of other infusions.
Za vrijeme infuzije i najmanje šest sati nakon početka prve infuzije te dva sata nakon početka sljedećih infuzija bit ćete pod nadzorom zdravstvenog radnika.
• dry mouth and skin
• suhoća usta i kože • suhe oči
Neutralizing anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the trastuzumab intravenous arm.
Neutralizirajuća protutijela na trastuzumab pronađena su u uzorcima prikupljenima nakon početka ispitivanja u 2 od 30
• somnolence (sleepiness)
• izrazita pospanost (pospanost)
Patients are eligible for trastuzumab treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Za liječenje trastuzumabom pogodni su oni bolesnici koji imaju izrazitu ekspresiju HER2 opisanu stupnjem 3+ na temelju IHC-a ili pak pozitivan FISH ili CISH rezultat.
1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injection in the vial containing the lyophilised Ontruzant, directing the stream into the lyophilised cake.
Upute za rekonstituciju 1) Sterilnom štrcaljkom polagano ubrizgajte odgovarajući volumen (kao što je gore navedeno) sterilne vode za injekcije u bočicu koja sadrži liofilizirani Ontruzant, usmjeravajući mlaz u liofilizirani kolačić.
The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
U ispitivanje su uključeni bolesnici s novodijagnosticiranim, lokalno uznapredovalim rakom dojke (stadija III) ili upalnim ranim rakom dojke.
Median TTP (months) (95%CI)
Medijan TTP (mjeseci) (95%CI)
At 8 years, the survival rate was estimated to be 86.9% in the AC→PH arm and 79.4% in the AC→P arm, an absolute benefit of 7.4% (95% CI 4.9%, 10.0%).
79,4% u skupini koja je primala AC→P kemoterapiju, što ukazuje na apsolutnu korist od 7,4% (95% CI 4,9%; 10,0%).
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 ključna ispitivanja s medijanom vremena praćenja od 5,5 godina (BCIRG006), u bolesnika koji su nakon anatraciklinske terapije primali trastuzumab istodobno s taksanom, zabilježen je kontinuirani porast kumulativne stope simptomatskih srčanih događaja ili događaja povezanih s LVEF-om i do
Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting (see section 4.8).
U razdoblju nakon stavljanja lijeka u promet, pri primjeni trastuzumaba zabilježeni su teški plućni događaji (vidjeti dio 4.8).
No. patients with event p=0.0555
Broj bolesnika s događajem p=0,0555
Death (OS event) No. patients with event p=0.0182
Smrt (događaj ukupnog preživljenja): broj bolesnika s događajem p=0,0182
These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Ti se simptomi mogu liječiti analgeticima/antipireticima, poput meperidina ili paracetamola, ili antihistaminicima, poput difenhidramina.U većine bolesnika dolazi do povlačenja simptoma, nakon čega se nastavlja s daljnjim infuzijama trastuzumaba.
Median TTP (months) (95%CI) Median survival (months) (95%CI)
Medijan TTP (mjeseci) (95%CI) Medijan preživljenja (mjeseci) (95%CI)
Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxyl-paclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg loading dose as an intravenous infusion followed by 6 mg/kg q3w or 2 mg/kg q1w infusion, respectively).
Učinak trastuzumaba na farmakokinetiku drugih antineoplastika Farmakokinetički podaci iz ispitivanja BO15935 i M77004 u žena s HER2-pozitivnim metastatskim rakom dojke ukazali su na to da prisutnost trastuzumaba (udarna doza od 8 mg/kg odnosno 4 mg/kg u obliku intravenske infuzije, nakon koje slijedi doza od 6 mg/kg u infuziji svaka 3 tjedna odnosno od 2 mg/kg jedanput tjedno) nije promijenila izloženost paklitakselu i doksorubicinu (i njihovim glavnim metabolitima 6-α hidroksil-paklitakselu, POH, i doksorubicinolu, DOL).