natgillin/translations-raw huggingface dataset:
Early breast cancer in the HERA trial was limited to operable, primary, invasive adenocarcinoma of the breast, with axillary nodes positive or axillary nodes negative if tumours at least 1 cm in diameter.
V kliničnem preskušanju BO16348 je bil zgodnji rak dojk omejen na operabilni, primarni, invazivni adenokarcinom dojk, s pozitivnimi aksilarnimi bezgavkami ali negativnimi aksilarnimi bezgavkami, če so tumorji v premeru znašali vsaj 1 cm.
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:
V študiji MO16432 so trastuzumab (uvajalni odmerek 8 mg/kg, sledil je vzdrževalni odmerek 6 mg/kg vsake 3 tedne) dajali sočasno z 10 cikli neoadjuvantne kemoterapije, in sicer:
Herzuma should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Zdravilo Herzuma se uporablja le za bolnike z metastatskim ali zgodnjim rakom dojk, katerih tumorji imajo ali čezmerno izražen HER2 ali amplifikacijo gena HER2, določeno s točno in validirano metodo (glejte poglavji 4.4 in 5.1).
Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up hazard ratios (95% CI)
Post-hoc eksplorativna analiza s preživetjem brez bolezni in simptomatskimi srčnimi dogodki Razmerje ogroženosti** dolgoročnega spremljanja (95-% IZ)
In the BCIRG 006 study, trastuzumab was administered either in combination with docetaxel, following AC chemotherapy (AC→DH) or in combination with docetaxel and carboplatin (DCarbH).
V študiji BCIRG 006 so trastuzumab dajali v kombinaciji z docetakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (AC → DH) ali v kombinaciji z docetakselom in karboplatinom (DCarbH).
Herzuma is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):
Zdravilo Herzuma je indicirano za zdravljenje odraslih bolnikov z zgodnjo obliko HER2-pozitivnega raka dojk:
Talk to your doctor, pharmacist or nurse before using Herzuma if:
Pred začetkom uporabe zdravila Herzuma se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Drugi z infuzijo povezani simptomi so lahko še občutek slabosti (navzea), bruhanje, bolečina, povečana napetost mišic in tresenje, glavobol, omotica, težave z dihanjem, piskanje pri dihanju, visok ali nizek krvni tlak, motnje srčnega ritma (hitro ali močno utripanje srca, trepetanje srca ali nereden srčni utrip), otekanje obraza in ustnic, izpuščaj in občutek utrujenosti.
Median survival (months) (95% CI)
Mediana preživetja (meseci) (95-% IZ)
One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Ena viala vsebuje 420 mg trastuzumaba, humaniziranega monoklonskega protitelesa IgG1, pridobljenega iz suspenzijske celične kulture sesalcev (ovarijske celice kitajskega hrčka) in očiščenega z afinitetno ter ionsko izmenjevalno kromatografijo, ki vključuje specifično virusno inaktivacijo ter postopke odstranjevanja.
Only an accurate and validated assay should be used to detect HER2 over expression or HER2 gene amplification.
Za ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 se lahko uporablja le natančna in validirana metoda.
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 intravenous loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w intravenous, respectively).
Farmakokinetični podatki iz študij BO15935 in M77004 pri bolnicah s HER2-pozitivnim metastatskim rakom dojk so nakazali, da izpostavljenost paklitakselu in doksorubicinu (in njunima glavnima metabolitoma 6-α hidroksilpaklitakselu, POH, in doksorubicinolu, DOL) ni bila spremenjena v prisotnosti trastuzumaba (uvajalni odmerek 8 mg/kg, ki mu je sledil odmerek 6 mg/kg intravensko vsake tri tedne ali uvajalni odmerek 4 mg/kg intravensko, ki mu je sledil odmerek 2 mg/kg intravensko enkrat na teden).
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.
Primerjava farmakokinetičnih rezultatov iz dveh študij faze II (BO15935 in M77004) in ene študije faze III (HO648g), v kateri so bolnike sočasno zdravili s trastuzumabom in paklitakselom, ter dveh študij faze II, v katerih so trastuzumab v monoterapiji (WO16229 in MO16982) bolnicam s HER2pozitivnim metastatskim rakom dojk, nakazuje, da so se posamezne in povprečne najnižje serumske koncentracije trastuzumaba razlikovale znotraj študij in med njimi, jasnega vpliva sočasne aplikacije paklitaksela na farmakokinetiko trastuzumaba pa ni bilo.
Parenteral solutions should be inspected visually for particulates and discoloration prior to administration.
Parenteralne raztopine je potrebno pred dajanjem vizualno pregledati na prisotnost delcev in obarvanost.
In this final analysis, extending trastuzumab treatment for a duration of two years did not show additional benefit over treatment for 1 year [DFS HR in the intent to treat (ITT) population of 2 years versus 1 year=0.99 (95% CI: 0.87, 1.13), p-value=0.90 and OS HR=0.98 (0.83, 1.15); p-value=0.78].
Omenjena končna analiza ni pokazala dodatne koristi podaljšanja zdravljenja s trastuzumabom na dve leti v primerjavi z enoletnim zdravljenjem [razmerje ogroženosti za preživetje brez napredovanja bolezni v populaciji, ki so jo nameravali zdraviti pri dvoletnem zdravljenju v primerjavi z enoletnim zdravljenjem = 0,99 (95-% IZ: 0,87; 1,13), p-vrednost = 0,90 in razmerje ogroženosti za celokupno preživetje = 0,98 (0,83; 1,15), p-vrednost = 0,78].
It should not be administered as an intravenous push or bolus.
Zdravila se ne sme dajati kot hitro intravensko infuzijo ali bolus.
The recommended weekly maintenance dose of Herzuma is 2 mg/kg body weight, beginning one week after the loading dose.
Priporočen tedenski vzdrževalni odmerek zdravila Herzuma je 2 mg/kg telesne mase, z začetkom en teden po uvajalnem odmerku.
- intravenous paclitaxel - 80 mg/m as a continuous intravenous infusion, given every week for 12 weeks.
- paklitaksel intravensko - 80 mg/m v obliki kontinuirane intravenske infuzije, vsak teden,
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.
Izsledki študije, opravljene pri doječih opicah Cynomolgus z odmerki, 25-krat večjimi od tedenskega vzdrževalnega odmerka intravenske oblike trastuzumaba pri ljudeh (2 mg/kg), so pokazali, da se trastuzumab izloča v mleko.
As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide.
Pri tedenskem režimu (uvajalni odmerek 4 mg/kg telesne mase, nato 2 mg/kg telesne mase vsak teden) se zdravilo Herzuma daje sočasno s paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom.
1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injection in the vial containing the lyophilised Herzuma, directing the stream into the lyophilised cake.
1) Uporabite sterilno injekcijsko brizgo, počasi injicirajte ustrezno količino (kot je navedeno zgoraj) sterilne vode za injekcije v vialo, ki vsebuje liofilizirano zdravilo Herzuma, usmerite curek na liofiliziran prašek.
- in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
- v kombinaciji z adjuvantno kemoterapijo z docetakselom in karboplatinom,
Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with Herzuma treatment, although the risk is lower than with concurrent use of Herzuma and anthracyclines.
Pri bolnikih z metastatskim rakom dojk, ki so se predhodno zdravili z antraciklini, pri zdravljenju z zdravilom Herzuma tveganje za motnje v delovanju srca še vedno obstaja, le da je manjše kot pri sočasni uporabi zdravila Herzuma in antraciklinov.
Biopsy specimen - staining pattern
Vzorci biopsije - videz preparata po barvanju
Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Zdravilo Herzuma je indicirano za zdravljenje odraslih bolnikov s HER2-pozitivno metastatsko obliko raka dojk:
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution.
Ustrezno količino raztopine je treba odvzeti iz viale in dodati infuzijski vreči, ki vsebuje 250 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida.
Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH
Preglednica 9: Pregled analiz učinkovitosti za preskušanje BCIRG 006; AC → D v primerjavi z AC → DH
Herzuma 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.
Zdravilo Herzuma se uporablja le za bolnike z metastatskim rakom želodca, katerih tumorji imajo čezmerno izražen HER2, definiran kot IHC2+ z nadaljnjim potrditvenim SISH ali FISH rezultatom ali kot IHC3+.
The recommended initial loading dose of Herzuma is 4 mg/kg body weight.
Priporočen uvajalni odmerek zdravila Herzuma je 4 mg/kg telesne mase.
Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH
Preglednica 10: Pregled analiz učinkovitosti za preskušanje BCIRG 006; AC → D v primerjavi DCarbH
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule 2.
Študija WO16229: uvajalni odmerek 8 mg/kg, sledil je odmerek 6 mg/kg po 3-tedenskem režimu.
If LVEF has not improved, or declined further, or symptomatic CHF has developed, discontinuation of Herzuma should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Če se LVEF ne izboljša ali pride do nadaljnjega zmanjšanja ali se razvije simptomatsko srčno popuščanje, je potreben resen razmislek o prekinitvi zdravljenja z zdravilom Herzuma, razen če je korist za posameznega bolnika večja od tveganja.
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) 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
Po mediani spremljanja 1,8 leta za bolnike v skupini AC → P in 2,0 leta za bolnike v skupini AC → PH. ** Mediana dolgoročnega spremljanja za skupno analizo kliničnih študij je bila 8,3 leta (razpon: 0,1 do 12,1) za skupino AC → PH in 7,9 let (razpon: 0,0 do 12,2) za skupino AC → P; mediana dolgoročnega spremljanja za študijo BCIRG 006 je bila 10,3 leta pri obeh skupinah AC → D (razpon: 0,0 do 12,6) in skupino DCarbH (razpon: 0,0 do 13,1), in je bila 10,4 leta (razpon: 0,0 do 12,7) v skupini AC → DH
Herzuma should be carefully handled during reconstitution.
Med rekonstitucijo moramo z zdravilom Herzuma pazljivo ravnati.
In patients with EBC eligible for neoadjuvant-adjuvant treatment, Herzuma should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m or epirubicin
Pri bolnikih z zgodnjim rakom dojk, ki so primerni za neoadjuvantno-adjuvantno zdravljenje, se zdravilo Herzuma uporablja sočasno z antraciklini le pri bolnikih, ki še niso bili zdravljeni s kemoterapijo, in to samo pri shemah z majhnimi odmerki antraciklinov (največji kumulativni odmerek doksorubicina 180 mg/m ali epirubicina 360 mg/m
s r.o Tel: + 420 227 129 111
Tel: + 420 227 129 111
A careful risk-benefit assessment should be made before deciding to treat with Herzuma.
Pred odločitvijo za zdravljenje z zdravilom Herzuma je treba skrbno pretehtati razmerje med koristjo in tveganjem.
If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Herzuma should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Če se LVEF ne izboljša ali pride do nadaljnjega zmanjšanja ali se razvije simptomatsko kongestivno srčno popuščanje, je potreben resen razmislek o prekinitvi zdravljenja z zdravilom Herzuma, razen če je korist za posameznega bolnika večja od tveganja.
Median follow-up 8 years**
Mediani čas spremljanja 8 let
It may take up to 7 months for Herzuma to be removed from your body.
Izločanje zdravila Herzuma iz vašega telesa lahko traja do 7 mesecev.
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.
V študiji BCIRG 006 se razmerje ogroženosti za primarni cilj, preživetje brez bolezni, izraža kot absolutna korist skupine AC → DH (trastuzumab) v smislu 3-letnega preživetja brez bolezni za 5,8 odstotne točke (86,7 % v primerjavi z 80,9 %), v korist skupine DCarbH (trastuzumab) pa za 4,6 odstotne točke v primerjavi s skupino AC → D (85,5 % v primerjavi z 80,9 %).
 Doxorubicin 60mg/m and paclitaxel 150 mg/m 2, administered 3-weekly for 3 cycles,
• doksorubicin 60 mg/m in paklitaksel 150 mg/m 2, dana enkrat na tri tedne, 3 cikle;
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 so proučevali v kombinaciji z anastrozolom v prvi liniji zdravljenja metastatskega raka dojk pri bolnicah v postmenopavzi s čezmerno izraženim HER2 in pozitivnimi hormonskimi receptorji (estrogenski ali progesteronski receptorji ali oboje).
A vial of Herzuma reconstituted with water for injections (not supplied) is stable for 7 days at 2ºC - 8ºC after reconstitution and must not be frozen.
Po rekonstituciji vsebine viale zdravila Herzuma z vodo za injekcije (ni dodana) je pripravljena raztopina stabilna 7 dni pri temperaturi 2 °C-8 °C.
VIAL LABEL
NALEPKE NA VIALI
One case of tumour lysis syndrome with trastuzumab administration as monotherapy lends further support.
En primer sindroma razpada tumorja pri trastuzumabu, uporabljenem v monoterapiji, dodatno podpira to dejstvo.
Duration of response, median months
Trajanje odgovora, mediana (meseci)
Cmax,ss** (μg/mL)
Cmax, ss** (µg/ml)
Do not breast-feed your baby during Herzuma therapy and for 7 months after the last dose of Herzuma as Herzuma may pass to your baby through your breast milk.
Med zdravljenjem z zdravilom Herzuma in 7 mesecev po zadnjem odmerku zdravila ne smete dojiti, ker lahko to zdravilo prehaja v materino mleko in s tem do vašega otroka.
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.
Izsledki te podštudije so nakazali, da sočasna uporaba cisplatina ali sočasna uporaba cisplatina in trastuzumaba ni vplivala na izpostavljenost biološko aktivnim metabolitom kapecitabina (npr. 5-FU).
In an exploratory subgroup analysis performed in the TOGA (BO18255) trial, there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95% CI 0.51 - 1.79)], non-measurable [HR 1.78 (95% CI 0.87 - 3.66)] and locally advanced disease [HR 1.20 (95% CI 0.29 - 4.97)].
V eksplorativni analizi podskupin, ki so jo opravili v preskušanju ToGA (BO18255), ni bilo opazne koristi v celokupnem preživetju z dodatkom trastuzumaba pri bolnikih z oceno splošnega stanja zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 2 pred začetkom zdravljenja [razmerje ogroženosti 0,96 (95-% interval zaupanja 0,51 do 1,79)], bolnikih z nemerljivo boleznijo [razmerje ogroženosti 1,78 (95-% interval zaupanja 0,87 do 3,66)] in bolnikih z lokalno napredovalo boleznijo [razmerje ogroženosti 1,20 (95-% interval zaupanja 0,29 do 4,97)].
- intravenous 5-fluorouracil - 800 mg/m 2/day as a continuous intravenous infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle)
ali - 5-fluorouracil intravensko - 800 mg/m 2/dan v obliki kontinuirane intravenske infuzije 5 dni, dano vsake 3 tedne, skupaj 6 ciklov (dnevi 1 do 5 vsakega cikla).
Trastuzumab plus paclitaxel N=32
trastuzumab in paklitaksel n = 32
Administration in combination with paclitaxel or docetaxel
Odmerjanje v kombinaciji s paklitakselom ali docetakselom
Herzuma treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only.
Zdravljenje z zdravilom Herzuma mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4.4).
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).
Pokazala je, da je 1-letno zdravljenje s trastuzumabom povezano s 24-% zmanjšanjem tveganja v primerjavi s samo opazovanjem (razmerje ogroženosti = 0,76; 95-% IZ: 0,67; 0,86).
Herzuma should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Zdravilo Herzuma se uporablja le pri bolnikih, katerih tumorji čezmerno izražajo HER2 ali imajo amplifikacijo gena HER2, določeno s točno in validirano metodo.
Detection of HER2 overexpression or HER2 gene amplification in breast cancer
Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 pri raku želodca
A volume overage of 4% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
4-% presežek volumna omogoča, da na nalepki naveden odmerek 420 mg res odvzamemo iz viale.
However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Trastuzumab pa je bil skupaj z docetakselom učinkovito ne glede na to, ali so bolniki prej prejeli adjuvantno terapijo z antraciklini ali ne.
1) Using a sterile syringe, slowly inject 7.2 mL of water for injections in the vial containing the lyophilised Herzuma, directing the stream into the lyophilised cake.
1) Uporabite sterilno injekcijsko brizgo, počasi injicirajte 7,2 ml vode za injekcije v vialo, ki vsebuje liofilizirano zdravilo Herzuma, usmerite curek na liofiliziran prašek.
What Herzuma contains
Kaj vsebuje zdravilo Herzuma
1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy.
V ključnem preskušanju docetaksela (100 mg/m2, infudirano v 1 uri) s trastuzumabom ali brez njega je 60 % bolnikov predhodno prejelo adjuvantno kemoterapijo na osnovi antraciklinov.
Herzuma is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing 150 mg of trastuzumab.
Zdravilo Herzuma je prašek za koncentrat za raztopino za intravensko infundiranje, ki je na voljo v stekleni viali z gumijastim zamaškom, ki vsebuje 150 mg trastuzumaba.
Three-weekly dosing in metastatic breast cancer
Odmerjanje enkrat na 3 tedne pri metastatskem raku dojk
A volume overage of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
4-% presežek volumna omogoča, da na nalepki naveden odmerek 150 mg res odvzamemo iz viale.
As a three-weekly regimen the recommended initial loading dose of Herzuma is 8 mg/kg body weight.
Pri 3-tedenskem režimu je priporočen uvajalni odmerek zdravila Herzuma 8 mg/kg telesne mase.
By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous) 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.
S primerjavo simuliranih serumskih koncentracij trastuzumaba po monoterapiji s trastuzumabom (uvajalni odmerek 4 mg/kg, 2 mg/kg enkrat na teden, intravensko) in opaženih serumskih koncentracijah pri japonskih bolnicah s HER2-pozitivnim metastatskim rakom dojk (študija JP16003) ni dokazov o farmakokinetičnem vplivu sočasne aplikacije docetaksela na farmakokinetiko trastuzumaba.
Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule 3.
Študija MO16982: uvajalni odmerek 6 mg/kg na teden 3 tedne; sledil je odmerek 6 mg/kg po 3-tedenskem režimu.
Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (Cycle 1), Table 15 (steady-state), and Table 16 (PK parameters).
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo (mediana s 5.-95. percentilom), in vrednosti farmakokinetičnih parametrov pri klinično pomembnih koncentracijah (Cmax in Cmin) za bolnike z MBC, EBC in AGC, zdravljene z odobrenim tedenskim in 3-tedenskim režimom odmerjanja, so prikazane v preglednici 14 (cikel 1), preglednici 15 (stanje dinamičnega ravnovesja) in preglednici 16 (farmakokinetični parametri).
Herzuma may also be given once a week for metastatic breast cancer.
Pri metastatskem raku dojk lahko zdravilo Herzuma dajemo tudi enkrat na teden.
Risk factors associated with interstitial lung disease include prior or concomitant therapy with other anti-neoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy.
spada predhodno ali sočasno zdravljenje z drugimi zdravili z delovanjem na novotvorbe, za katere je znana povezava s to boleznijo, kot so taksani, gemcitabin, vinorelbin in zdravljenje z obsevanjem.
Table 11 Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831 and BCIRG 006 clinical studies combining DFS events and symptomatic cardiac events
Post-hoc eksplorativna analiza podatkov iz skupne analize kliničnih študij NSABP B-31/NCCTG N9831 in BCIRG006, ki vključujejo dogodke preživetja brez bolezni in simptomatske srčne dogodke.
In the pivotal trial BO22227, trastuzumab 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 trastuzumab intravenous arm.
V ključnem preskušanju BO22227 so zdravilo trastuzumab dajali sočasno z neoadjuvantno kemoterapijo, ki je vključevala štiri cikle epirubicina (kumulativni odmerek 300 mg/m2), mediana spremljanja je presegla 70 mesecev.