natgillin/translations-raw huggingface dataset:
Detection of HER2 overexpression or HER2 gene amplification in breast cancer Trastuzumab 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 Trastuzumab se uporablja le pri bolnikih, pri katerih tumorji čezmerno izražajo HER2 ali imajo amplifikacijo gena HER2, določeno s točnim in validiranim preskusom.
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 glejte navodila za uporabo, ki so priložena metodam za določanje HER2.
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 tej podskupini niso opazili koristi v preživetju brez ponovitve bolezni (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).
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 povezani tudi s smrtnim izidom.
AUC0-21days (µg.day/mL)
AUC 0 - 21. dan (µg.dan/ml)
• Doxorubicin 60 mg/m 2 and paclitaxel 150 mg/m 2, administered 3-weekly for 3 cycles,
- doksorubicin 60 mg/m 2 in paklitaksel 150 mg/m 2, enkrat na 3 tedne, 3 cikle;
The reconstituted Trazimera results in a colourless to pale brownishyellow transparent solution and should be essentially free of visible particulates.
Raztopljeno zdravilo Trazimera je brezbarvna do rahlo rjavorumena prozorna tekočina, ki mora biti brez vidnih delcev.
• sleepiness (somnolence)
• bolečina v vratu bolezenska zaspanost (somnolenca)
Trastuzumab may persist in the circulation for up to 7 months after stopping treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov je lahko trastuzumab prisoten v krvnem obtoku do 7 mesecev po prenehanju zdravljenja (glejte poglavje 5.2).
Each 150 mg vial of Trazimera is reconstituted with 7.2 mL of sterile water for injections (not supplied).
Vsebino 150 mg viale zdravila Trazimera rekonstituiramo v 7,2 ml sterilne vode za injekcije (ni priložena).
- 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 so zasnovali za proučevanje kombinacije zdravljenja s trastuzumabom in docetakselom, bodisi po kemoterapiji AC bodisi v kombinaciji z docetakselom in karboplatinom pri bolnikih z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji.
Each 420 mg vial of Trazimera is reconstituted with 20 mL of sterile water for injections (not supplied).
Vsebino 420 mg viale zdravila Trazimera rekonstituiramo v 20 ml sterilne vode za injekcije (ni priložena).
However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Trastuzumab je bil skupaj z docetakselom učinkovit, ne glede na to, ali so bolniki predhodno prejeli adjuvantno zdravljenje z antraciklini ali ne.
- 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;
• pain in the arms and/or legs
• motnje delovanja pljuč bolečine v rokah in/ali nogah
Solutions of Trazimera for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene, polypropylene or ethylene vinyl acetate bags, or glass intravenous bottles, containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C.
Raztopine zdravila Trazimera za infundiranje so v polivinilkloridnih, polietilenskih, polipropilenskih ali etilenvinilacetatnih vrečkah ali v stekleničkah za intravensko uporabo, ki vsebujejo 0,9-odstotno (9 mg/ml) raztopino natrijevega klorida za injiciranje, fizikalno in kemično stabilne 24 ur pri temperaturah do 30 °C.
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
The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2% versus 75.4%) in favour of the AC→PH (trastuzumab) arm.
Razmerje ogroženosti se izraža kot absolutna korist v smislu 3-letnega preživetja brez ponovitve bolezni za 11,8 odstotne točke v prid skupini, ki je prejemala AC → PH (trastuzumab) (87,2 % v primerjavi s 75,4 %).
In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low dose anthracycline regimen is limited (see section 4.4).
Pri neoadjuvantnem zdravljenju so izkušnje z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, omejene (glejte poglavje 4.4).
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.
Primerjava simuliranih serumskih koncentracij trastuzumaba po monoterapiji s trastuzumabom (polnilni 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) ne dokazuje farmakokinetičnega vpliva sočasne uporabe docetaksela na farmakokinetiko trastuzumaba.
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 so korist ugotovili pri bolnikih, ki so imeli najvišjo stopnjo čezmernega izražanja beljakovine HER2, kar pomeni rezultat po metodi IHC 3+ ali 2+ ter istočasno pozitiven rezultat po metodi FISH.
Response rate (95% CI)
Delež odgovora (95 % IZ)
• dry eyes
• solzenje oči
Table 4 Efficacy Results from the Monotherapy and Combination Therapy Studies Parameter Monotherapy
Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja Parameter
Disease-free survival No. patients with event (%)
Preživetje brez ponovitve bolezni: število bolnikov z dogodkom (%)
• Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
• Pri bolnikih, ki imajo hudo dispnejo v mirovanju zaradi zapletov napredovale maligne bolezni, ali pri tistih, ki potrebujejo zdravljenje s kisikom.
In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when trastuzumab was administered after anthracycline-containing chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when trastuzumab was administered concurrently with taxanes than when administered sequentially to taxanes.
Pri bolnikih z zgodnjim rakom dojk so opazili povišanje incidence simptomatskih in asimptomatskih neželenih učinkov, povezanih s srcem, ko so trastuzumab dajali po kemoterapiji, ki je vsebovala antraciklin, v primerjavi s sočasnim dajanjem z neantraciklinskim režimom, ki je vseboval docetaksel in karboplatin.
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, pri katerih so tumorji čezmerno izražali HER2 in pri katerih je prišlo do napredovanja bolezni po 1 ali več zdravljenjih njihove metastatske bolezni s kemoterapijo (le trastuzumab).
Overall Survival, Median months Progression-Free Survival, Median months
Preživetje brez napredovanja bolezni, mediana (meseci)
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 opazovani dogodek, preživetje brez ponovitve bolezni, je dodatek trastuzumaba kemoterapiji s paklitakselom zmanjšal tveganje za ponovitev bolezni za 52 %.
HER2 overexpression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks (see section 4.4).
ugotavljamo z imunohistokemijsko (IHC) metodo na fiksiranih blokih tumorskega tkiva (glejte poglavje 4.4).
Three -weekly dosing in metastatic breast cancer The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Odmerjanje enkrat na 3 tedne pri metastatskem raku dojk Preglednica 5 navaja rezultate učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine.
• bladder and skin infections
• znojenje okužbe mehurja in kože
Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous dose weekly) and docetaxel (60 mg/m2 intravenous dose) 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 (intravenski polnilni odmerek 4 mg/kg in 2 mg/kg enkrat na teden) in docetaksel (intravenski odmerek 60 mg/m2) so pokazali, da sočasna uporaba trastuzumaba ni imela vpliva na farmakokinetiko enkratnega odmerka docetaksela.
Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Pri bolnikih, ki imajo dispnejo v mirovanju zaradi zapletov napredovale maligne bolezni in sočasnih obolenj, obstaja večje tveganje pljučnih zapletov.
The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death.
Hkrati je zmanjšal tudi tveganje za smrt za 37 %.
The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of trastuzumab versus observation.
Pri primerjavi 1-letnega zdravljenja s trastuzumabom z opazovanjem so rezultati učinkovitosti iz vmesne analize učinkovitosti presegli statistično mejo, ki so jo določili vnaprej s protokolom.
Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50% after the event) was evident for 71.4% of trastuzumab-treated patients.
Pri 71,4 % bolnikov, zdravljenih s trastuzumabom, je bilo hudo kongestivno srčno popuščanje reverzibilno (opredeljeno kot zaporedje najmanj 2 zaporednih vrednosti LVEF ≥ 50 % po dogodku).
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Šibko do zmerno obarvanje celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
How to store Trazimera
Kako uporabljati zdravilo Trazimera
Detection of HER2 over expression or HER2 gene amplification in gastric cancer Only an accurate and validated assay should be used to detect HER2 over expression or HER2 gene amplification.
Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 pri raku želodca Za ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 lahko uporabljamo le natančno in validirano metodo.
*Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52% of patients from the observation arm to trastuzumab) ***There is a discrepancy in the overall sample size due to a small number of patients who were randomized after the cut-off date for the 12-month median follow-up analysis
***V celokupni velikosti vzorca je neskladje zaradi majhnega števila bolnikov, ki so jih randomizirali po preteku datuma, do katerega so upoštevali podatke za analizo po medianem 12-mesečnem spremljanju.
The infusion may be resumed when symptoms abate.
Ko simptomi izginejo, se lahko z infuzijo nadaljuje.
Death (OS event): No. patients with event (%)
Št. bolnikov z dogodkom (%)
Death (OS event) No. patients with event p=0.0182
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0182
Patients are eligible for Trazimera treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Za zdravljenje z zdravilom Trazimera so primerni bolniki, pri katerih rezultat čezmernega izražanja HER2 po metodi IHC znaša 3+, ali pri katerih je rezultat metod FISH ali CISH pozitiven.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Zdravila za parenteralno dajanje je treba pred uporabo vizualno pregledati, saj ne smejo vsebovati delcev ali biti obarvana.
• based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:
• za polnilni odmerek 8 mg trastuzumaba/kg telesne mase ali za nadaljnje 3-tedenske odmerke 6 mg trastuzumaba/kg telesne mase s pomočjo formule:
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2:
Priporočeni način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici 2.
Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Močno obarvanje celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20, sucrose.
L-histidinijev klorid monohidrat, L-histidin, polisorbat 20, saharoza.
15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.
15 ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 150 mg trastuzumaba.
In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of trastuzumab with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant trastuzumab, up to a total treatment duration of 1 year.
Študija MO16432 je bila multicentrično randomizirano preskušanje na področju neoadjuvantnoadjuvantnega zdravljenja, zasnovanega za proučevanje klinične učinkovitosti sočasnega dajanja trastuzumaba in neoadjuvantne kemoterapije, ki je vsebovala antraciklin in taksan.
White lyophilised powder or cake.
bel liofiliziran prašek ali pogača
or - intravenous paclitaxel - 175 mg/m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
- paklitaksel intravensko - 175 mg/m 2 v obliki kontinuirane intravenske infuzije, vsake 3 tedne, skupaj 4 cikle (na 1. dan vsakega cikla).
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3:
Priporočeni način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici 3.
Tumour cell cluster with a faint ⁄ barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Skupek tumorskih celic ima bledo, komaj zaznavno obarvane membrane, ne glede na odstotek obarvanih tumorskih celic.
Patients with HER2+ tumours were randomised to receive either neoadjuvant chemotherapy concurrently with neoadjuvant-adjuvant trastuzumab, or neoadjuvant chemotherapy alone.
Bolnike s HER2-pozitivnimi tumorji so randomizirali v skupino, ki je prejemala neoadjuvantno kemoterapijo sočasno z neoadjuvantnim-adjuvantnim trastuzumabom, ali v skupino, ki je prejemala le neoadjuvantno kemoterapijo.
Trazimera 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 Trazimera mora uvesti zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4.4).
SISH technology is however, recommended to allow for the parallel evaluation of tumour histology and morphology.
Za vzporedno oceno histologije in morfologije tumorja je priporočljiva tehnika SISH.
• based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
• za polnilni odmerek 4 mg trastuzumaba/kg telesne mase ali za nadaljnje tedenske odmerke 2 mg trastuzumaba/kg telesne mase s pomočjo formule:
Trazimera vial
Izpiranje trastuzumaba
and 7.1% to 42.6% for FISH.
79,5 % bolnikov.
A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Manjši del bolnikov so testirali z metodo FISH.
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 trastuzumab dajali sočasno z neoadjuvantno kemoterapijo, ki je vključevala štiri cikle epirubicina (kumulativni odmerek 300 mg/m2), mediana spremljanja je presegla
Serious IRRs to trastuzumab infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Poročali so o resnih reakcijah, povezanih z infuzijo trastuzumaba, vključno z dispnejo, hipotenzijo, piskajočim dihanjem, hipertenzijo, bronhospazmom, supraventrikularno tahiaritmijo, zmanjšano nasičenostjo arterijske krvi s kisikom, anafilaksijo, dihalno stisko, urtikarijo in angioedemom (glejte poglavje 4.8).
For intravenous use only after reconstitution and dilution.
za intravensko uporabo, samo po rekonstituciji in redčenju Pred uporabo preberite priloženo navodilo!
• you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Trazimera, če: • ste alergični na trastuzumab, murine (mišje) beljakovine ali katerokoli sestavino tega zdravila
30 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab.
30 ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 420 mg trastuzumaba.
Table 14 Population Predicted Cycle 1 PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients Regimen
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, za 1. cikel (mediana s 5.-95. percentilom) za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile.
Časovno-koncentracijski profil trastuzumaba so opisali z dvoprostornim modelom z vzporednim linearnim in nelinearnim izločanjem iz centralnega prostora.
Breast inflammation/mastitis
Motnje reprodukcije in dojk vnetje dojk/mastitis pogosti
The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below:
Končni rezultati za celokupno preživetje iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 so povzeti v spodnji preglednici 8.
8mg/kg + 6mg/kg q3w
8 mg/kg + 6mg/kg na 3 tedne
No. patients with event
Število bolnikov z dogodkom 46
Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Tedensko odmerjanje pri metastatskem raku dojk Preglednica 4 navaja rezultate učinkovitosti iz študij monoterapije in kombiniranega zdravljenja.
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 vključujejo mrzlico, zvišano telesno temperaturo, dispnejo, hipotenzijo, piskajoče dihanje, bronhospazem, tahikardijo, zmanjšano nasičenost s kisikom, dihalno stisko, izpuščaj, navzeo, bruhanje in glavobol (glejte poglavje 4.4).
clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Bolniki z MBC in EBC so imeli podobne farmakokinetične parametre (npr. očistek, volumen centralnega prostora (Vc)) in izpostavljenosti v stanju dinamičnega ravnovesja (Cmin, Cmax in AUC), predvidene za populacijo.
In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
Post-hoc raziskovalna analiza podatkov iz skupne analize kliničnih preskušanj NSABP B- 31/NCCTG N9831* in BCIRG 006, ki vključujejo dogodke preživetja brez ponovitve bolezni in simptomatske srčne dogodke.
The data also suggested that the pharmacokinetics of cisplatin were not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus trastuzumab.
Podatki so pokazali tudi, da sočasna uporaba kapecitabina ali sočasna uporaba kapecitabina in trastuzumaba ni vplivala na farmakokinetiko cisplatina.
- The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, sucrose, polysorbate 20.
- Druge sestavine zdravila so L-histidinijev klorid monohidrat, L-histidin, saharoza in polisorbat
Distant recurrence No. patients with event p=0.0008
Pojav oddaljenih metastaz: število bolnikov z dogodkom p = 0,0008
A faint/barely perceptible membrane staining is detected in >10% of the tumour cells.
Bledo, komaj zaznavno obarvanje membrane je prisotno pri > 10 % tumorskih celic.
In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks).
Med zdravljenjem je treba nadzorovati delovanje srca pri vseh bolnikih (npr. vsakih 12 tednov), kar olajša razpoznavo bolnikov, pri katerih se pojavljajo motnje v delovanju srca.
Respiratory distress
Pljučni zapleti
Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with trastuzumab (see section 4.4).
Pri bolnikih, ki so se zdravili s trastuzumabom, so opazili znake in simptome motenj v delovanju srca, kot so dispneja, ortopneja, povečan kašelj, pljučni edem, galop S3 ali zmanjšan ventrikularni srčni iztis (glejte poglavje 4.4).
• abnormal or impaired blood clotting
• nenormalno ali slabše strjevanje krvi
Table 2 Recommended Scoring System to Evaluate the IHC Staining Patterns in Breast Cancer Score Staining pattern
Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku želodca
Trazimera intravenous formulation is not intended for subcutaneous administration and should be administered via an intravenous infusion only.
Intravenska oblika zdravila Trazimera ni namenjena subkutanemu (podkožnemu) dajanju in se ga lahko daje le z intravensko infuzijo.
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 hibridizacije in situ, torej z metodo SISH ali FISH na fiksiranih blokih tumorskega tkiva.
* are summarized in Table 7.
Analiza je povzeta v preglednici 11.