natgillin/translations-raw huggingface dataset:
If you receive KANJINTI 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.
Če prejemate zdravilo KANJINTI z drugimi zdravili za zdravljenje raka, kot so paklitaksel, docetaksel, zaviralec aromataze, kapecitabin, 5-fluorouracil ali cisplatin, preberite tudi navodila za uporabo teh zdravil.
The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects.
Prvi odmerek vašega zdravljenja se daje v 90 minutah; med dajanjem boste zaradi možnosti pojava neželenih učinkov pod nadzorom zdravstvenega osebja.
• followed by adequate storage of the prepared solution for intravenous infusion to ensure maintenance of the aseptic conditions.
• Po pripravi je treba pripravljeno raztopino za intravensko infundiranje ustrezno shraniti, da je zagotovljeno vzdrževanje aseptičnih pogojev.
• infections
• okužbe
The safety of continuation or resumption of trastuzumab in patients who experience cardiac dysfunction has not been prospectively studied.
Varnosti nadaljevanja ali ponovnega dajanja trastuzumaba pri bolnikih, pri katerih se je pojavila motnja v delovanju srca, niso proučevali prospektivno.
• Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium).
• Sindrom razpada tumorja (skupina presnovnih zapletov, ki se pojavijo po zdravljenju raka, za katero so značilne visoke vrednosti kalija in fosfata ter nizke vrednosti kalcija v krvi).
The main test method used to determine HER2 positivity in the pivotal trial of docetaxel, with or without trastuzumab, was immunohistochemistry.
Glavna testna metoda, ki so jo uporabili za določitev pozitivnosti HER2 v ključnem preskušanju docetaksela skupaj s trastuzumabom ali brez njega, je bila imunohistokemija.
In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
V študiji neoadjuvantnega-adjuvantnega zgodnjega raka dojk (BO22227) z mediano spremljanja, ki je presegla 70 mesecev, so se pri 10,1 % bolnikov (30/296), zdravljenih z intravensko obliko trastuzumaba, razvila protitelesa proti trastuzumabu.
The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster non-linear clearance (lower Km) (p < 0.001).
Eksplorativne analize sospremenljivk, opravljene samo s podatki za podskupino bolnikov, kažejo, da so imeli bolniki z višjimi vrednostmi odcepljenega HER2-ECD antigena hitrejši nelinearni očistek (nižjo Km) (p < 0,001).
Other medicines and KANJINTI
Druga zdravila in zdravilo KANJINTI
1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
1 Označuje neželene učinke, o katerih so večinoma poročali v zvezi z infuzijskimi reakcijami.
The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+).
Podatki kažejo, da so bili koristni učinki pri bolnikih z višjo stopnjo čezmernega izražanja HER2 (3+) večji.
Amongst the most serious and/or common adverse reactions reported in trastuzumab usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Med najbolj resnimi in/ali pogostimi neželenimi učinki, o katerih so do zdaj poročali pri uporabi trastuzumaba, so motnje v delovanju srca, infuzijske reakcije, hematotoksičnost (še posebno nevtropenija), okužbe in pljučni neželeni učinki.
HER2 testing is mandatory prior to initiation of therapy (see sections 4.4 and 5.1).
Pred začetkom zdravljenja je potrebno testiranje na HER2 (glejte poglavji 4.4 in 5.1).
Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with KANJINTI.
Zato bo zdravnik preveril delovanje vašega srca pred zdravljenjem, med njim (vsake tri mesece) in po zdravljenju z zdravilom KANJINTI (od dve do pet let).
Studies indicate that breast cancer patients whose tumours overexpress HER2 have a shortened disease-free survival compared to patients whose tumours do not overexpress HER2.
Študije kažejo, da imajo bolniki z rakom dojk, katerih tumorji čezmerno izražajo HER2, krajše preživetje brez bolezni v primerjavi z bolniki, katerih tumorji ne izražajo HER2.
• You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2.
• imate metastatskega raka dojk (raka dojk, ki se je razširil še na druga mesta zunaj prvotnega tumorja), pri katerem so izražene velike količine HER2.
For the other parameters the improvements seen for the combination were for overall response (16.5% versus 6.7%); clinical benefit rate (42.7% versus 27.9%); time to progression (4.8 months versus 2.4 months).
Pri drugih parametrih so bila izboljšanja pri kombinaciji vidna pri celokupnem odgovoru (16,5 % v primerjavi s 6,7 %), deležu klinične koristi (42,7 % v primerjavi s 27,9 %) in času do napredovanja bolezni (4,8 meseca v primerjavi z 2,4 meseca).
Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6 - 8 weeks).
Za bolnike z asimptomatičnimi motnjami v delovanju srca je koristen pogostejši nadzor (npr. vsakih 6 do 8 tednov).
They include weakening of the heart muscle possibly leading to heart failure, inflammation of the lining around the heart and heart rhythm disturbances.
Vključujejo slabenje srčne mišice z možnim prehodom v srčno popuščanje, vnetje osrčnika in motnje srčnega ritma.
The majority of patients with cardiac symptoms and evidence of a clinical benefit of trastuzumab treatment continued on therapy without additional clinical cardiac events.
Pri večini bolnikov s srčnimi simptomi in znaki klinične koristi zdravljenja s trastuzumabom je nadaljevanje zdravljenja z njim potekalo brez dodatnih kliničnih zapletov v delovanju srca.
Administration in combination with an aromatase inhibitor In the pivotal trial (BO16216) trastuzumab and anastrozole were administered from day 1.
Odmerjanje v kombinaciji z zaviralcem aromataze V ključni študiji (BO16216) so trastuzumab in anastrozol dajali od 1. dne dalje.
The median duration of follow-up was 2.9 years in the AC→D arm and 3.0 years in each of the AC→DH and DCarbH arms.
Mediana spremljanja je bila 2,9 let v skupini AC → D in 3,0 let v skupinah AC → DH in DCarbH.
The efficacy of trastuzumab in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied.
Učinkovitost trastuzumaba v kombinaciji s paklitakselom pri bolnikih, ki niso prejeli predhodne kemoterapije z antraciklinom, ni bila proučevana.
The median overall survival was extended by 4.6 months for patients in the combination arm.
Mediana celokupnega preživetja je bila v skupini, ki je jemala kombinacijo zdravil, daljša za 4,6 meseca.
• You should use effective contraception during treatment with KANJINTI and for at least 7 months after KANJINTI treatment has ended.
• Med zdravljenjem z zdravilom KANJINTI in vsaj še 7 mesecev po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo.
Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Zdravilo shranjujte v dobro zaprti originalni ovojnini pri temperaturi 2 °C - 8 °C, v hladilniku.
In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of KANJINTI, or longer if a continuous decrease of LVEF is observed.
Pri bolnikih, ki prejemajo kemoterapijo z antraciklini, je priporočljivo nadaljnje spremljanje, ki ga je treba izvajati letno do 5 let po zadnjem dajanju zdravila KANJINTI ali dlje, če iztisni delež levega prekata (LVEF) stalno pada.
KANJINTI is for intravenous use only.
Zdravilo KANJINTI je samo za intravensko uporabo.
• You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-fluorouracil and cisplatin.
• imate metastatskega raka želodca, pri katerem so izražene velike količine HER2, v kombinaciji z drugimi zdravili za zdravljenje raka, kapecitabinom ali 5-fluorouracilom in cisplatinom.
Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for
Linearni očistek je bil 0,136 l/dan za bolnike z MBC, 0,112 l/dan za bolnike z EBC in 0,176 l/dan za bolnike z AGC.
Trastuzumab may have a minor influence on the ability to drive or use machines (see section 4.8).
Trastuzumab ima lahko blag vpliv na sposobnost vožnje in upravljanje strojev (glejte poglavje 4.8).
6.6 Special precautions for disposal and other handling Appropriate aseptic technique should be used for reconstitution and dilution procedures.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Za postopek rekonstitucije in redčenja je treba uporabiti ustrezno aseptično tehniko.
This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in foetal death.
Tako stanje lahko škodi otroku v maternici in je povezano z nedozorelostjo pljuč ter lahko privede do plodove smrti.
Trastuzumab has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Trastuzumab so proučevali v randomiziranem, odprtem preskušanju faze III ToGA (BO18255) v kombinaciji s kemoterapijo v primerjavi s samo kemoterapijo.
Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab.
Študija JP19959 je bila podštudija BO18255 (ToGA) pri japonskih bolnikih in bolnicah z napredovalim rakom želodca, v kateri so proučevali farmakokinetiko kapecitabina in cisplatina s trastuzumabom ali brez njega.
Trastuzumab may persist in the circulation for up to 7 months after stopping KANJINTI treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Trastuzumab je lahko po prenehanju zdravljenja z zdravilom KANJINTI v krvnem obtoku prisoten do 7 mesecev glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov (glejte poglavje 5.2).
+ Denotes adverse reactions that have been reported in association with a fatal outcome.
+ Označuje neželene učinke, o katerih so poročali v povezavi s smrtnim izidom.
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.
V redkih primerih so pri nosečnicah, ki so prejemale trastuzumab, opazili zmanjšanje količine (amnijske) tekočine, ki obdaja razvijajočega se otroka v maternici.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo.
For early breast cancer, metastatic breast cancer and metastatic gastric cancer, KANJINTI is given every 3 weeks.
Pri zgodnji obliki raka dojk, metastatskem raku dojk in metastatskem raku želodca se zdravilo KANJINTI daje vsake 3 tedne.
After aseptic dilution in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9%) solution for injection, chemical and physical stability of KANJINTI has been demonstrated for up to 30 days at 2°C - 8°C, and subsequently for 24 hours at temperatures not exceeding 30°C.
Po aseptičnem redčenju v polivinilkloridnih, polietilenskih ali polipropilenskih vrečkah, ki vsebujejo raztopino 9 mg/ml (0,9 %) natrijevega klorida za injiciranje, je kemijska in fizikalna stabilnost zdravila KANJINTI dokazana do 30 dni pri temperaturi 2 °C-8 °C in kasneje 24 ur pri temperaturah, ki ne presežejo 30 °C.
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%; p = 0.004).
Pogostnost napredovanja v jetrih je bila signifikantno zmanjšana pri bolnikih, zdravljenih s kombinacijo trastuzumaba in paklitaksela, v primerjavi s samim paklitakselom (21,8 % v primerjavi s 45,7 %; p = 0,004).
Most of the patients (79%) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF.
Pri večini bolnikov (79 %), pri katerih so se pojavile motnje v delovanju srca v teh preskušanjih, je prišlo do izboljšanja po standardnem zdravljenju za kongestivno srčno popuščanje.
The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1% versus 4.6% in the 1-year treatment arm).
Delež asimptomatskih motenj v delovanju srca je bil večji v skupini z dvoletnim zdravljenjem (8,1 % v primerjavi s 4,6 % v skupini z enoletnim zdravljenjem).
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.
Pri bolnikih, ki so prejemali trastuzumab po zaključku adjuvantne kemoterapije, je bilo tveganje za pojav motnje v delovanju srca povezano z višjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo trastuzumaba in visokim indeksom telesne mase (body mass index - BMI) > 25 kg/m2.
In the ToGA (BO18255) trial, patients whose tumours were either IHC3+ or FISH positive were defined as HER2 positive and thus included in the trial.
V preskušanju ToGA (BO18255) so bolnike, katerih tumorji so bili IHC3+ ali FISH pozitivni, definirali kot HER2 pozitivne in jih vključili v preskušanje.
The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7%-10%).
Najvišji delež motenj v delovanju srca je bil pri bolnikih, ki so trastuzumab prejemali sočasno z antraciklinom/ciklofosfamidom (27 %), bil je signifikantno višji kot pri jemanju samega antraciklina/ciklofosfamida (7 do 10 %).
If you have metastatic or early breast cancer You will be given KANJINTI on either a three-weekly or once weekly cycle.
Če imate metastatsko ali zgodnjo obliko raka dojk Zdravilo KANJINTI boste prejeli vsake tri tedne ali enkrat na teden.
If anthracyclines are used, the patient's cardiac function should be monitored carefully.
Če bolnika zdravimo z antraciklini, je treba skrbno spremljati delovanje njegovega srca.
Observation N = 1697***
opazovanje n = 1.697***
Trastuzumab 1 Year N = 1,702***
1 leto n = 1.702***
Long term follow-up efficacy analysis**
Dolgoročno spremljanje**
The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death.
Dodatek trastuzumaba kemoterapiji s paklitakselom je hkrati zmanjšal tudi tveganje za smrt za 37 %.
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * At median duration of follow-up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs AC→P
A: doksorubicin; C: ciklofosfamid; P: paklitaksel; H: trastuzumab; IZ: interval zaupanja * Po mediani spremljanja 1,8 leta za bolnike v skupini AC → P in 2,0 leta za bolnike v skupini AC → PH. ** Vrednost p za celokupno preživetje ni presegla vnaprej določene statistične meje za primerjavo AC → PH z AC → P.
For any other method that may be used for the assessment of HER2 protein or gene expression, the analyses should only be performed by laboratories that provide adequate state-of-the-art performance of validated methods.
Analize za katero koli drugo metodo, ki se lahko uporablja za oceno ekspresije beljakovine ali gena HER2, lahko izvajajo le laboratoriji, ki uporabljajo ustrezne sodobne validirane metode.
After aseptic reconstitution with sterile water for injections, chemical and physical stability of the reconstituted solution has been demonstrated for 48 hours at 2°C - 8°C.
Po aseptični rekonstituciji s sterilno vodo za injekcije je kemijska in fizikalna stabilnost rekonstituirane raztopine dokazana za 48 ur pri temperaturi od 2 °C - 8 °C.
There is no fertility data available.
Podatkov o vplivu na plodnost ni.
Total CL range from Cmax,ss to Cmin,ss
Obseg celokupnega očistka od Cmax, ss do Cmin, ss
- in combination with neoadjuvant chemotherapy followed by adjuvant KANJINTI therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
- v kombinaciji z neoadjuvantno kemoterapijo, čemur sledi adjuvantno zdravljenje z zdravilom KANJINTI, za lokalno napredovalo (tudi vnetno) bolezen ali tumorje > 2 cm v premeru (glejte poglavji 4.4 in 5.1).
Like all medicines, KANJINTI can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo KANJINTI neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Bolnike, ki so predhodno prejemali adjuvantno kemoterapijo na osnovi antraciklinov, so zdravili s paklitakselom (175 mg/m2, infundirano v 3 urah) samim ali skupaj s trastuzumabom.
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 srčno popuščanje, NYHA razred II-IV, je pogost neželeni učinek, povezan z uporabo trastuzumaba; povezan je bil tudi s smrtnim izidom (glejte poglavje 4.4).
No incompatibilities between KANJINTI and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Med zdravilom KANJINTI in polivinilkloridnimi, polietilenskimi ali polipropilenskimi vrečkami inkompatibilnosti niso opazili.
Detection of HER2 overexpression or HER2 gene amplification
Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2
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.
V študiji za primerjavo metod (študija D008548) so med tehnikama SISH in FISH za ugotavljanje amplifikacije gena HER2 pri bolnikih z rakom želodca ugotovili visoko stopnjo ujemanja (> 95 %).
There is no experience with overdose in human clinical trials.
Izkušenj s prevelikim odmerjanjem v kliničnih preskušanjih pri ljudeh nimamo.
• you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients of this medicine (listed in section 6).
• ste alergični na trastuzumab, murine (mišje) beljakovine ali katero koli sestavino tega zdravila
Malignant neoplasm progression Not known Neoplasm progression
napredovanje maligne neoplazme neznano napredovanje neoplazme neznano
Time to disease progression, Median months
Čas do napredovanja bolezni, mediana (meseci)
* Observed with combination therapy following anthracyclines and combined with taxanes.
* Opaženo pri kombinirani uporabi po antraciklinih in sočasno s taksani.
• intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days,
ali - 5-fluorouracil intravensko - 800 mg/m2/dan v obliki kontinuirane intravenske infuzije 5 dni,
If LVEF percentage drops ≥ 10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Če odstotek LVEF pade za ≥ 10 točk od začetne vrednosti IN pod 50 %, zdravljenje prekinemo in ponovno opravimo meritev LVEF v približno treh tednih.
Each carton contains 1 vial of powder.
Ena škatla vsebuje 1 vialo s praškom.
Docetaxel3 N = 94
docetaksel3 n = 94
EBC is defined as non-metastatic primary invasive carcinoma of the breast.
Zgodnji rak dojk je definiran kot nemetastatski, primarni, invazivni karcinom dojk.
Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2's extracellular domain.
Trastuzumab se z visoko afiniteto in specifičnostjo veže na poddomeno IV, jukstamembransko regijo zunajcelične domene HER2.
What KANJINTI is and what it is used for What you need to know before you are given KANJINTI How KANJINTI is given
Kaj je zdravilo KANJINTI in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo KANJINTI Kako uporabljati zdravilo KANJINTI Možni neželeni učinki
• acute accumulation of fluid in the lungs
• akutno nabiranje tekočine v pljučih
Neoadjuvant-adjuvant treatment
Neoadjuvantno-adjuvantno zdravljenje
These are very common (may affect more than 1 in 10 people).
Ti so zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov).
There are no immunogenicity data available for trastuzumab in gastric cancer.
Za uporabo trastuzumaba pri raku želodca ni na voljo podatkov o imunogenosti.
Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (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.
Študije stopnje HER2-pozitivnosti pri raku želodca s pomočjo imunohistokemije (IHC) in fluorescenčne hibridizacije in situ (FISH) ali kromogene hibridizacije in situ (CISH) so pokazale veliko variabilnost HER2-pozitivnosti - od 6,8 % do 34,0 % za metodo IHC in 7,1 % do 42,6 % za metodo FISH.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po rekonstituciji in razredčitvi.
No long-term animal studies have been performed to establish the carcinogenic potential of trastuzumab, or to determine its effects on fertility in males.
Za ugotovitev kancerogenega potenciala trastuzumaba ali učinkov na plodnost pri moških niso opravili nobenih dolgotrajnih študij na živalih.
Occasionally, symptoms start later than six hours after the infusion begins.
Občasno se lahko simptomi pojavijo po več kot šestih urah po pričetku infuzije.
IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridisation (SISH) or a FISH technique must be applied.
Kot prva metoda je priporočena imunohistokemijska metoda, v primerih, ko pa je potreben tudi status amplifikacije gena HER2, pa je treba uporabiti tehniko hibridizacije in situ s srebrom (SISH) ali FISH.
If the patient has missed a dose of KANJINTI by more than one week, a re-loading dose of KANJINTI should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
Če je bolnik izpustil odmerek zdravila KANJINTI za več kot en teden, mu je treba čim prej ponovno dati polnitveni odmerek zdravila KANJINTI v približno 90 minutah (tedenski režim: 4 mg/kg; 3-tedenski režim: 8 mg/kg).
This translates into an absolute benefit in terms of an 8 year disease-free survival rate of 6.4 percentage points in favour of 1 year trastuzumab treatment.
To se izraža kot absolutna korist enoletnega zdravljenja s trastuzumabom v smislu 8-letnega preživetja brez bolezni za 6,4 odstotne točke.
Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 (HER2).
Trastuzumab je oblikovan tako, da se selektivno veže na antigen, ki se imenuje humani receptor za epidermalni rastni dejavnik 2 (HER2).