natgillin/translations-raw huggingface dataset:
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 hydroxylpaclitaxel, 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 presnovkoma 6-α hidroksil-paklitakselu, POH, in doksorubicinolu, DOL) ni bila spremenjena v prisotnosti trastuzumaba (polnitveni odmerek 8 mg/kg intravensko, ki mu je sledil odmerek 6 mg/kg intravensko vsake tri tedne ali polnitveni odmerek 4 mg/kg intravensko, ki mu je sledil odmerek 2 mg/kg intravensko enkrat na teden).
In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported.
Poleg tega so poročali tudi o primerih intersticijske bolezni pljuč, vključno s pljučnimi infiltrati, akutnem respiratornem distresnem sindromu (ARDS), pljučnici, pnevmonitisu, plevralnem izlivu, dihalni stiski, akutnem pljučnem edemu in respiratorni insuficienci.
Disease-free survival No. patients with event (%)
Preživetje brez bolezni: število bolnikov z dogodkom (%)
• abnormally low levels of fluid around baby in womb
• nenormalno malo tekočine, ki obkroža plod v maternici
Table 12 Efficacy results from MO16432
Rezultati učinkovitosti preskušanja MO16432
If LVEF has not improved, or has declined further, or symptomatic congestive heart failure (CHF) has developed, discontinuation of KANJINTI 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 KANJINTI, razen če je korist za posameznega bolnika večja od tveganja.
If LVEF has not improved, or declined further, or symptomatic CHF has developed, discontinuation of KANJINTI 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 KANJINTI, razen če je korist za posameznega bolnika večja od tveganja.
Trastuzumab1 N = 105
Kombinirano zdravljenje trastuzumab1 n = 105
Trastuzumab plus paclitaxel3 N = 32
trastuzumab in paklitaksel3 n = 32
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 siljenje na bruhanje (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.
+Lung infiltration
+pljučni infiltrati neznano
Full instructions on assay performance and results interpretation should be taken from the product information leaflet provided with the HER2 testing assays used.
Za popolna navodila o učinkovitosti metod in interpretaciji rezultatov prosimo glejte navodila za uporabo, ki so priložena testnim metodam za določanje HER2.
Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH Parameter
Pregled analiz učinkovitosti za preskušanje BCIRG 006; AC → D v primerjavi z AC → DH
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).
V preživetju brez bolezni v tej podskupini ni bilo opaziti koristi (razmerje ogroženosti = 1,16; 95-% IZ [0,73; 1,83] za DCarbH (TCH) v primerjavi z AC → D (AC → T); razmerje ogroženosti 0,97; 95-% IZ [0,60; 1,55] za AC → DH (AC → TH) v primerjavi z AC → D).
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.
p-value versus AC→P
p-vrednost v primerjavi z
AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval
AC → D = doksorubicin in ciklofosfamid, ki jima sledi docetaksel; DCarbH = docetaksel, karboplatin in trastuzumab; IZ = interval zaupanja
Baseline levels of the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed.
Izhodiščne vrednosti odcepljene HER2-ECD, ki so jih opazili pri bolnikih z metastatskim rakom želodca, so bile primerljive s tistimi pri bolnikih z metastatskim rakom dojk in zgodnjim rakom dojk; očitnega vpliva na očistek trastuzumaba niso opazili.
HER2 gene amplification should be detected using fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) of fixed tumour blocks.
Amplifikacijo gena HER2 določamo z metodo fluorescenčne hibridizacije in situ (FISH) ali metodo kromogene hibridizacije in situ (CISH) fiksiranih tumorskih blokov.
Trastuzumab plus docetaxel3 N = 92
trastuzumab in docetaksel3 n = 92
Effect of trastuzumab on the pharmacokinetics of other antineoplastic agents
Učinek trastuzumaba na farmakokinetiko drugih zdravil z delovanjem na novotvorbe
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].
The updated DFS analysis results (stratified HR = 0.61; 95% CI [0.54, 0.69]) showed a similar DFS benefit compared to the definitive primary DFS analysis, despite 24.8% patients in the AC→P arm who crossed over to receive trastuzumab.
Posodobljeni rezultati analize preživetja brez bolezni (stratificirano razmerje ogroženosti 0,61; 95-% IZ [0,54; 0,69] so pokazali podobno korist v preživetju brez bolezni v primerjavi s končno primarno analizo preživetja brez bolezni, ne glede na to, da je 24,8 % bolnikov v skupini AC → P prešlo na zdravljenje s trastuzumabom.
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3-weekly schedule 2.
Študija WO16229: polnitveni odmerek 8 mg/kg, sledil je odmerek 6 mg/kg po 3-tedenskem režimu.
This will then be reduced to a maintenance dose of 6 mg/kg body weight every three weeks, beginning three weeks after your first dose.
To se nato zmanjša na vzdrževalni odmerek 6 mg/kg telesne mase na vsake tri tedne, ki se začne uporabljati tri tedne po prvem odmerku.
If left ventricular ejection fraction (LVEF) percentage drops ≥ 10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately
Če odstotek iztisnega deleža levega prekata (LVEF) pade za ≥ 10 točk od začetne vrednosti IN pod 50 %, zdravljenje prekinemo in ponovno opravimo meritev LVEF v približno treh tednih.
KANJINTI should be carefully handled during reconstitution.
Med rekonstitucijo moramo z zdravilom KANJINTI pazljivo ravnati.
For time to response and duration of response no difference could be recorded between the arms.
Med skupinama ni bilo razlik v času do odgovora na zdravljenje in trajanju odgovora.
There was a correlation between shed antigen and SGOT/AST levels; part of the impact of shed antigen on clearance may have been explained by SGOT/AST levels.
Del vpliva odcepljenega antigena na očistek bi bilo mogoče pojasniti z vrednostmi SGOT/AST.
• heartburn (dyspepsia)
• zgaga (dispepsija)
- Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles,
- doksorubicin 60 mg/m2 in paklitaksel 150 mg/m2, dana enkrat na tri tedne, 3 cikle;
N Cmin,ss*
Cmin, ss
which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
temu je sledil - paklitaksel 175 mg/m2, dan enkrat na tri tedne, 4 cikle;
KANJINTI should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
Zdravilo KANJINTI 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+.
+Pulmonary fibrosis
+pljučna fibroza neznano
• numbness or tingling of the fingers and toes
• otrplost ali zbadanje v prstih rok in nog
given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with:
dano vsake 3 tedne, skupaj 6 ciklov (dnevi 1 do 5 vsakega cikla).
Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction.
Pri bolnikih, ki imajo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni in soobolenja, obstaja večje tveganje infuzijske reakcije s smrtnim izidom.
Progression free survival was doubled in the trastuzumab plus anastrozole arm compared to anastrozole (4.8 months versus 2.4 months).
Preživetje brez napredovanja bolezni je bilo v skupini, ki je prejemala trastuzumab in anastrozol, dvakrat daljše (4,8 meseca) kot v skupini, ki je jemala le anastrozol (2,4 meseca).
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab
A: doksorubicin; C: ciklofosfamid; P: paklitaksel; H: trastuzumab; IZ: interval zaupanja
• liver damage/failure
• poškodba/odpoved jeter
For the primary endpoint, DFS, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52% decrease in the risk of disease recurrence.
Kar zadeva primarni cilj, preživetje brez bolezni, je dodatek trastuzumaba kemoterapiji s paklitakselom zmanjšal tveganje za ponovitev bolezni za 52 %.
• redness, swelling or sores in your mouth and/or throat
• rdečina, oteklina ali ranice v ustih in/ali žrelu
Trastuzumab plus paclitaxel2 N = 68
trastuzumab in paklitaksel2 n = 68
Severe pulmonary adverse reactions occur in association with the use of trastuzumab and have been associated with a fatal outcome.
V povezavi z uporabo trastuzumaba se pojavljajo hudi pljučni neželeni učinki, ki so bili povezani tudi s smrtnim izidom.
The efficacy results from study BO18225 are summarised in table 13: Table 13 Efficacy results from BO18225
Rezultati učinkovitosti za preskušanje BO18225 so povzeti v preglednici 13.
- in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
- v kombinaciji z docetakselom za zdravljenje tistih bolnikov, ki še niso prejemali kemoterapije za metastatsko bolezen;
It may take up to 7 months for KANJINTI to be removed from your body.
Izločanje zdravila KANJINTI iz vašega telesa lahko traja do 7 mesecev.
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.
V naslednjem preskušanju, v katerem so prospektivno spremljali srčno delovanje, je bila incidenca simptomatičnega kongestivnega srčnega popuščanja pri bolnikih, ki so prejemali trastuzumab in docetaksel, 2,2-% v primerjavi z 0-% pri bolnikih, zdravljenih samo z docetakselom.
+Bronchospasm
+bronhospazem neznano
Each 150 mg vial of KANJINTI is reconstituted with 7.2 mL of sterile water for injections (not supplied).
Eno 150 mg vialo zdravila KANJINTI rekonstituirajte s 7,2 ml sterilne vode za injekcije (ni dodana).
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 (Study H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.
Primerjava med farmakokinetičnimi podatki trastuzumaba iz študije M77004, v kateri so bolnice s HER2-pozitivnim metastatskim rakom dojk sočasno zdravili s trastuzumabom, paklitakselom in doksorubicinom in študij, v katerih so trastuzumab dajali v monoterapiji (H0649g) ali v kombinaciji z antraciklinom in ciklofosfamidom ali paklitakselom (študija H0648g), so nakazali, da učinka doksorubicina in paklitaksela na farmakokinetiko trastuzumaba ni.
The infusion may be continued after the symptoms improve.
Po izboljšanju simptomov boste lahko z infuzijo nadaljevali.
• The recommended starting dose for the three-weekly cycle is 8 mg/kg body weight.
• Priporočeni začetni odmerek za tri-tedensko shemo odmerjanja je 8 mg/kg telesne mase.
- 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.
- Preskušanje BCIRG 006 je bilo zasnovano za proučevanje kombinacije zdravljenja s trastuzumabom in docetakselom, bodisi po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC) bodisi v kombinaciji z docetakselom in karboplatinom pri bolnikih z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji.
Early breast cancer (neoadjuvant-adjuvant setting)
Zgodnji rak dojk (neoadjuvantno-adjuvantno zdravljenje)
Based on the clinical trial results, the beneficial effects were limited to patients with the highest level of HER2 protein overexpression, defined by a 3+ score by IHC, or a 2+ score by IHC and a positive FISH result.
Na osnovi rezultatov kliničnega preskušanja je bila korist ugotovljena pri bolnikih, ki so imeli najvišjo stopnjo čezmernega izražanja proteina HER2, kar pomeni rezultat po IHC metodi 3+, ali pa 2+ ter istočasno pozitiven rezultat po metodi FISH.
PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
FARMACEVTSKA OBLIKA Prašek za koncentrat za raztopino za infundiranje.
KANJINTI intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Intravenska oblika zdravila KANJINTI ni namenjena subkutani aplikaciji in se lahko daje le z intravensko infuzijo.
Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting (see section 4.8).
V obdobju po prihodu zdravila na trg so pri uporabi trastuzumaba poročali o hudih pljučnih zapletih (glejte poglavje 4.8).
The recommended weekly maintenance dose of KANJINTI is 2 mg/kg body weight, beginning one week after the loading dose.
Priporočen tedenski vzdrževalni odmerek zdravila KANJINTI je 2 mg/kg telesne mase, z začetkom en teden po polnitvenem odmerku.
• The recommended starting dose for the once weekly cycle is 4 mg/kg body weight.
• Priporočeni začetni odmerek za shemo odmerjanja enkrat na teden je 4 mg/kg telesne mase.
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje
Trastuzumab has also been used in combination with paclitaxel or docetaxel for the treatment of patients who have not received chemotherapy for their metastatic disease.
Trastuzumab so uporabljali tudi v kombinaciji s paklitakselom ali docetakselom za zdravljenje bolnikov, ki predhodno niso prejeli kemoterapije za metastatsko bolezen.
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).
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 %), korist skupine DCarbH (trastuzumab) pa za 4,6 odstotne točke v primerjavi s skupino AC → D (85,5 % v primerjavi z 80,9 %).
• failure of the lungs of the baby to develop in the womb
• okvara pri razvoju pljuč otroka v maternici
In vitro, trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
V in vitro študijah je do s trastuzumabom posredovane ADCC preferenčno prihajalo na rakastih celicah, ki so čezmerno izražale HER2, v primerjavi s celicami, pri katerih se HER2 ni čezmerno izražal.
Three-weekly schedule
3-tedenski režim
KANJINTI 420 mg powder for concentrate for solution for infusion 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.
KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje 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.
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 so v kliničnih preskušanjih uporabljali kot monoterapijo pri bolnikih z metastatsko obliko raka dojk, katerih tumorji so čezmerno izražali HER2 in pri katerih je prišlo do napredovanja bolezni po eni ali več kemoterapevtskih zdravljenjih njihove metastatske bolezni (le trastuzumab).
Detection of HER2 overexpression or HER2 gene amplification in breast cancer KANJINTI should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 pri raku dojk Zdravilo KANJINTI se uporablja le pri bolnikih, katerih tumorji čezmerno izražajo HER2 ali imajo amplifikacijo gena HER2, določeno s točno in validirano metodo.
Median duration of response (months) (range) Median TTP (months) (95%CI)
Mediana časa odgovora (meseci) (razpon) Mediana TTP (meseci) (95-% IZ)
A careful risk-benefit assessment should be made before deciding to treat with KANJINTI.
Pred odločitvijo za zdravljenje z zdravilom KANJINTI je treba skrbno pretehtati razmerje med koristjo in tveganjem.
Table 8 Final overall survival analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Končna analiza celokupnega preživetja iz skupne analize preskušanj NSABP B-31 in NCCTG N9831
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 (polnitveni 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: polnitveni odmerek 6 mg/kg na teden 3 tedne; sledil je odmerek 6 mg/kg po 3-tedenskem režimu.
Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in table 4.
Tedensko odmerjanje pri metastatskem raku dojk Preglednica 4 navaja rezultate učinkovitosti iz študij monoterapije in kombiniranega zdravljenja.
Rare side effects (may affect up to 1 in 1,000 people):
Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov):
Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous weekly) and docetaxel (60 mg/m2 intravenous) in Japanese women with HER2-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel.
Podatki iz študije JP16003 z eno skupino, v kateri so japonske bolnice s HER2-pozitivnim metastatskim rakom dojk prejemale trastuzumab (polnitveni odmerek 4 mg/kg intravensko in 2 mg/kg intravensko enkrat na teden) in docetaksel (60 mg/m2 intravensko) so nakazali, da sočasna aplikacija trastuzumaba ni imela vpliva na farmakokinetiko enkratnega odmerka docetaksela.
Metastatic breast cancer
Metastatski rak želodca
KANJINTI 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 KANJINTI mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4.4).
The recommended initial loading dose of KANJINTI is 4 mg/kg body weight.
Priporočen polnitveni odmerek zdravila KANJINTI je 4 mg/kg telesne mase.
Febrile neutropenia, leukopenia, anaemia, thrombocytopenia and neutropenia occurred very commonly.
Febrilna nevtropenija in levkopenija sta se pojavljali zelo pogosto.
However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Trastuzumab pa je bilo skupaj z docetakselom učinkovit ne glede na to, ali so bolniki prej prejeli adjuvantno terapijo z antraciklini ali ne.
• Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
• Pri bolnikih, ki imajo hudo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni, ali pri tistih, ki potrebujejo zdravljenje s kisikom.