natgillin/translations-raw huggingface dataset:
Distant recurrence No. patients with event p = 0.0008 
Pojav oddaljenih metastaz: število bolnikov z dogodkom p = 0,0008
Patients are eligible for KANJINTI 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 KANJINTI so primerni bolniki, katerih rezultat čezmernega izražanja HER2 po metodi IHC znaša 3+ ali bolniki, katerih rezultat metod FISH ali CISH je pozitiven.
Tumour cell cluster with a faint/barely perceptible membranous reactivity irrespective of percentage of tumour cells stained 
Klaster tumorskih celic ima bledo, komaj zaznavno obarvanje membrane, neglede na odstotek obarvanih tumorskih celic.
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 je izkušenj z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, malo (glejte poglavje 4.4).
- intravenous cyclophosphamide, at 600 mg/m2 over 30 minutes, given every 3 weeks for 
- ciklofosfamid intravensko - 600 mg/m2 v 30 minutah, vsake 3 tedne, 4 cikle.
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 neoadjuvantno-adjuvantnega zdravljenja, zasnovano za proučevanje klinične učinkovitosti sočasnega dajanja trastuzumaba, in neoadjuvantne kemoterapije, ki je vsebovala antraciklin in taksan.
Dry eye 
• solzne oči
Death (OS event) No. patients with event p = 0.0024 
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,0024
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 pojavijo motnje v delovanju srca.
KANJINTI 420 mg powder for concentrate for solution for infusion 50 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 420 mg of trastuzumab. 
KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje 50 ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo in snemno zaporko za prah iz aluminija, ki vsebuje 420 mg trastuzumaba.
Very common side effects (may affect more than 1 in 10 people): 
Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov):
If you get any side effects, talk to your doctor, pharmacist or nurse. 
Če se pri vas pojavi kateri koli neželen učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
+Cardiac failure (congestive) 
+(kongestivno) srčno popuščanje pogosto
However, the majority of infusion-related reactions are mild to moderate in intensity (NCI-CTC grading system) and tend to occur earlier in treatment, i.e. during infusions one, two and three and lessen in frequency in subsequent infusions. 
Ponavadi se pojavijo v zgodnejših fazah zdravljenja, torej med prvo, drugo in tretjo infuzijo, ter so manj pogoste pri naslednjih infuzijah.
Hormone-receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. 
Bolniki s hormonsko odvisnimi tumorji, pri katerih je bolezen napredovala po predhodnem hormonskem zdravljenju, razen če za takšno zdravljenje niso bili primerni;
Median duration of response (months) (95%CI) 
Mediana časa odgovora (meseci) (95-% IZ)
Primary tumour type 
Vrsta primarnega tumorja n
Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained 
Klaster tumorskih celic ima močno obarvane celotne, bazolateralne ali lateralne membrane, neglede na odstotek obarvanih tumorskih celic.
STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 150 mg trastuzumab. 
NAVEDBA ENE ALI VEČ UČINKOVIN Viala vsebuje 150 mg trastuzumaba.
Cardiac dysfunction 
Motnje v delovanju srca
1+ 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.
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.1. 
Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH približno 6,1.
Table 16 Population predicted PK parameter values at steady-state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients 
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.1. 
Rekonstitucija da 21 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH približno 6,1.
Glomerulonephritis membranous Not known Glomerulonephropathy 
Bolezni sečil motnje delovanja ledvic pogosto membranski glomerulonefritis neznano glomerulonefropatija neznano ledvična odpoved neznano
The infusion may be resumed when symptoms abate. 
Ko simptomi izginejo, lahko z infuzijo nadaljujemo.
There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies. 
V študijah teratogenosti, ženske plodnosti ali pozne gestacijske toksičnosti/placentnega prehoda, ki so trajale do šest mesecev, niso ugotovili akutne ali z večkratnim odmerjanjem povezane toksičnosti.
This can lead to symptoms such as breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart fluttering or irregular heart beat) (see 2. 
To lahko privede do simptomov, kot so težave z dihanjem (vključno s težavami z dihanjem ponoči), kašelj, zadrževanje tekočine
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells 
Šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
• difficulty in breathing when lying flat 
• oteženo dihanje v ležečem položaju
1Palpitation 
1palpitacije zelo pogosto
Disease-free survival No. patients with event p = 0.0003 
Preživetje brez bolezni: število bolnikov z dogodkom p = 0,0003
which was followed by - CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by - additional cycles of adjuvant trastuzumab (to complete 1 year of treatment) 
po operaciji so sledili: - dodatni cikli trastuzumaba, danega adjuvantno (do zaključitve prvega leta zdravljenja).
No staining is observed or membrane staining is observed in < 10% of the tumour cells. 
Obarvanje ni prisotno ali pa so obarvane membrane pri < 10 % vseh tumorskih celic v preparatu.
LIST OF EXCIPIENTS Excipients: histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20. 
SEZNAM POMOŽNIH SNOVI Pomožne snovi: histidin, histidinijev klorid monohidrat, trehaloza dihidrat, polisorbat 20.
- The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery. 
- Preskušanji NSABP B-31 in NCCTG N9831, ki imata skupno analizo, sta bili zasnovani za proučevanje klinične koristi kombinacije zdravljenja s trastuzumabom in paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC).
LIST OF EXCIPIENTS Histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20. 
SEZNAM POMOŽNIH SNOVI Histidin, histidinijev klorid monohidrat, trehaloza dihidrat, polisorbat 20.
KANJINTI 420 mg powder for concentrate for solution for infusion 
KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje
Patients with HER2+ tumours were randomised to receive either neoadjuvant chemotherapy concurrently with neoadjuvant-adjuvant trastuzumab, or neoadjuvant chemotherapy alone. 
Bolniki s HER2-pozitivnimi tumorji so bili randomizirani v skupino, ki je prejemala neoadjuvantno kemoterapijo sočasno z neoadjuvantnim trastuzumabom najprej, nato pa še adjuvantno, ali v skupino, ki je prejemala le neoadjuvantno kemoterapijo.
• tremor 
• tresenje (tremor)
Tumour cell cluster with a weak to moderate complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained 
Klaster tumorskih celic ima šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane, neglede na odstotek obarvanih tumorskih celic.
KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for concentrate for solution for infusion 
KANJINTI 150 mg prašek za koncentrat za raztopino za infundiranje KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje
4 adverse reaction in the 2-year treatment arm (20.4%) compared with the 1-year treatment arm 
Več bolnikov je doživelo najmanj en neželeni učinek stopnje 3 ali 4 v skupini z dvoletnim zdravljenjem (20,4 %) v primerjavi s skupino z enoletnim zdravljenjem (16,3 %).
Patients with EBC should be treated with KANJINTI for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1). 
Podaljšanje zdravljenja zgodnjega raka dojk na več kot eno leto ni priporočljivo (glejte poglavje 5.1).
The reconstituted KANJINTI solution contains 21 mg/mL of trastuzumab. 
Pripravljena raztopina zdravila KANJINTI vsebuje 21 mg/ml trastuzumaba.
In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or 
V skupni analizi preskušanj NSABP B-31 in NCCTG N9831 je bil zgodnji rak dojk omejen na ženske z operabilnim rakom dojk z visokim tveganjem, opredeljenim kot pozitivna oblika HER2 s pozitivnimi aksilarnimi bezgavkami ali pozitivna oblika HER2 z negativnimi bezgavkami z dejavniki visokega tveganja (velikost tumorja > 1 cm in negativni estrogenski receptorji ali velikost tumorja > 2 cm neodvisno od hormonskega statusa).
Pulmonary hypoplasia 
• mišična šibkost
KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for concentrate for solution for infusion trastuzumab 
KANJINTI 150 mg prašek za koncentrat za raztopino za infundiranje KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
• capecitabine - 1,000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle) 
Kemoterapijo so dajali, kot je navedeno spodaj: - kapecitabin - 1.000 mg/m2 peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
Metastatic gastric cancer 
Metastatski rak dojk
MBC EBC Table 15 Population predicted steady-state PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients 
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja (mediana s 5.-95. percentilom) za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
- Study BO16348 was designed to compare one and two years of three-weekly trastuzumab treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable). 
Pri adjuvantnem zdravljenju so trastuzumab proučevali v 4 obsežnih, multicentričnih, randomiziranih preskušanjih: - Študija BO16348 je bila zasnovana za primerjavo enoletnega in dvoletnega zdravljenja s trastuzumabom (odmerjanjem na 3 tedne) z opazovanjem bolnikov z zgodnjo obliko HER2pozitivnega raka dojk po operaciji, standardni kemoterapiji in radioterapiji (kar so uporabili).
KANJINTI 150 mg powder for concentrate for solution for infusion 
KANJINTI 150 mg prašek za koncentrat za raztopino za infundiranje
+Pleural effusion 
+dihalna stiska neznano
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab. 
Rekonstitucija da 7,4 ml raztopine za enkratno uporabo in vsebuje približno 21 mg/ml trastuzumaba.
Do not use KANJINTI if you notice any particulate matter or discolouration prior to administration. 
Če pred dajanjem opazite kakršne koli delce ali obarvanje, ne uporabljajte zdravila KANJINTI.
When trastuzumab was administered after completion of adjuvant chemotherapy NYHA class III-IV heart failure was observed in 0.6% of patients in the one-year arm after a median follow-up of 12 months. 
Srčno popuščanje razreda III−IV po NYHA se je po mediani časa spremljanja 12 mesecev pojavilo pri 0,6 % bolnikov v skupini, ki se je s trastuzumabom po zaključku adjuvantne kemoterapije zdravila eno leto.
This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab. 
Rekonstitucija da 21 ml raztopine za enkratno uporabo in vsebuje približno 21 mg/ml trastuzumaba.
Distant recurrence No. patients with event p < 0.0001 
Pojav oddaljenih metastaz: število bolnikov z dogodkom p < 0,0001
How to store KANJINTI 
Kako uporabljati zdravilo KANJINTI
Biopsy specimen - staining pattern HER2 overexpression assessment 
Vzorci biopsije - videz preparata po barvanju
Hazard Ratio (95% CI) 
Razmerje ogroženosti (95-% IZ)
• The other ingredient(s) are histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20. 
• Pomožne snovi so histidin, histidinijev klorid monohidrat, trehaloza dihidrat in polisorbat 20.
Febrile neutropenia 
• vročinski oblivi
+Acute pulmonary oedema 
+akutni pljučni edem neznano
Disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Distant disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Overall survival (death) - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation 
Preživetje brez pojava oddaljenih metastaz - št. bolnikov z dogodkom - št. bolnikov brez dogodka P-vrednost v primerjavi z opazovanjem
Overall survival No. patients with event 
Celokupno preživetje Število bolnikov z dogodkom 22
Hazard Ratio vs AC→P (95% CI) p-value 
Razmerje ogroženosti v primerjavi z AC → P (95-% IZ) p-vrednost
Reproduction studies have been conducted in cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation and have revealed no evidence of impaired fertility or harm to the foetus. 
Študije o vplivu na sposobnost za razmnoževanje so opravili pri opicah Cynomolgus z odmerki, ki so bili do 25-krat večji od tedenskega vzdrževalnega odmerka intravenske oblike trastuzumaba pri ljudeh (2 mg/kg).
• deafness 
• omotica
KANJINTI vial 
Viala zdravila KANJINTI
3+ Strong complete membrane staining is detected in > 10% of the tumour cells. 
Močno obarvane celotne membrane pri > 10 % tumorskih celic.
Immune thrombocytopenia 
• vnetje dojk tesnoba
No reactivity or membranous reactivity in any tumour cell 
Obarvanje ni prisotno pri nobeni tumorski celici.
The recommended maintenance dose of KANJINTI at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose. 
Priporočen vzdrževalni odmerek zdravila KANJINTI je 6 mg/kg telesne mase po 3 tednih od prejema polnitvenega odmerka, in nato v tritedenskih razmakih.
t1/2 range from 
Obseg t1/2 od Cmax, ss do
The incidence of symptomatic cardiac dysfunction was 1.7% in the trastuzumab arm. 
Pogostnost simptomatske motnje v delovanju srca je bila v skupini, ki je prejemala trastuzumab,
or - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 
- paklitaksel intravensko - 80 mg/m2 v obliki kontinuirane intravenske infuzije, vsak teden, skupaj 12 tednov ali - paklitaksel intravensko - 175 mg/m2 v obliki kontinuirane intravenske infuzije, vsake 3 tedne,
Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies 
Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine
Disease-free survival No. patients with event p < 0.0001 
Preživetje brez bolezni: število bolnikov z dogodkom p < 0,0001
Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model. 
Obdobje izpiranja trastuzumaba je bilo ocenjeno po intravenski aplikaciji zdravila enkrat na teden ali enkrat na tri tedne s pomočjo populacijskega farmakokinetičnega modela.
Papilloedema 
trastuzumab
Hazard Ratio versus AC→P (95% CI) 
Razmerje ogroženosti v primerjavi z AC → P (95-% IZ)
KANJINTI and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting. 
Pri zdravljenju metastatskega raka dojk kombinacije zdravila KANJINTI in antraciklinov ne smemo dajati sočasno.
It is important for you to keep all your appointments to receive KANJINTI. 
Če je bil odmerek zdravila KANJINTI izpuščen Pomembno je, da pridete na vse dogovorjene termine za prejem zdravila KANJINTI.
Paclitaxel, in combination with trastuzumab, was administered as follows: - intravenous paclitaxel - 80 mg/m2 as a continuous intravenous infusion, given every week for 
Odmerjanje docetaksela je bilo naslednje: - docetaksel intravensko - 100 mg/m2 v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj
2+ A weak to moderate complete membrane staining is detected in > 10% of the tumour cells. 
Šibko do srednje močno obarvane celotne membrane pri > 10 % tumorskih celic.
Median TTP (months) (95%CI) Median Survival (months) (95%CI) 
Mediana TTP (meseci) (95-% IZ)
Retinal haemorrhage 
Izpiranje trastuzumaba
• cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle. 
Kapecitabin ali 5-fluorouracil so dajali skupaj s: - cisplatinom - 80 mg/m2 vsake 3 tedne 6 ciklov, 1. dan vsakega cikla.
In addition, terms reported in the post marketing setting are included in Table 1. 
Dodatno so v preglednici 1 vključeni neželeni učinki, o katerih so poročali v obdobju po prihodu zdravila na trg.
infection of lungs pain in the arms and/or legs lung disorders itchy rash back pain sleepiness (somnolence) 
• bolečina v rokah in/ali nogah okužba pljuč
+Respiratory distress 
Pljučni zapleti
The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.51-0.79) for FP versus FP + H, respectively. 
Mediana celokupnega preživetja v skupini, ki je imela visoko izražen HER2, je bila 11,8 meseca za skupino, ki ni prejemala trastuzumaba, v primerjavi s 16 meseci za skupino, ki je prejemala tudi trastuzumab - razmerje ogroženosti 0,65 (95-% interval zaupanja; 0,51-0,83).
- intravenous docetaxel - 100 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle) 
6 ciklov (na 2. dan prvega cikla z docetakselom, nato na 1. dan vsakega nadaljnjega cikla).
AC→DH (n = 1074) Hazard Ratio vs AC→D (95% CI) p-value 
Razmerje ogroženosti v primerjavi z AC → D (95-% IZ) p-vrednost
+1Wheezing 
+1piskanje zelo pogosto
or - intravenous paclitaxel - 175 mg/m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle). 
ali - docetaksel intravensko - 75 mg/m2 v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj
The recommended scoring system to evaluate the IHC staining patterns is as stated in table 2: 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 dojk
HER2 over expression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks; HER2 gene amplification should be detected using in situ hybridisation using either SISH or FISH on fixed tumour blocks. 
Amplifikacijo gena HER2 se določa z metodo hibridizacije in situ, torej s SISH ali FISH fiksiranih tumorskih blokov.
• dizziness 
• gluhost
• respiratory distress 
• bolečina v trebuhu
Pneumonitis 
Bolezni živčevja
Hazard Ratio vs AC→D (95% CI) 
Razmerje ogroženosti v primerjavi z AC → D (95-% IZ)
NAME OF THE MEDICINAL PRODUCT KANJINTI 420 mg powder for concentrate for solution for infusion trastuzumab 
KANJINTI 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Liver tenderness 
• vnetje jeter depresija
• chest pain 
• dihalna stiska
The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose. 
Priporočen vzdrževalni odmerek je 6 mg/kg telesne mase po 3 tednih od prejema polnitvenega odmerka, in nato v tritedenskih razmakih.
The recommended scoring system to evaluate the IHC staining patterns is as stated in table 3: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer Score Surgical specimen - staining pattern 
Priporočen način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici
Thinking abnormal 
• bolezni ledvic nenormalno razmišljanje
Dry skin 
• kožni izpuščaj
6.1 List of excipients 
4.1 Terapevtske indikacije
• fatigue 
• driska
The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy. 
Če trastuzumab dajemo z docetakselom po antraciklinski terapiji, je lahko tveganje za nevtropenijo rahlo povečano.
DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831. 
Ob končni analizi celokupnega preživetja iz skupne analize študij NSABP B-31 in NCCTG N9831 so opravili tudi analizo preživetja brez bolezni.
Immune system disorders 
Bolezni imunskega sistema preobčutljivost pogosto
Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays. 
Za zmanjšanje odmerka ali odlog dajanja paklitaksela, docetaksela ali zaviralca aromataze glejte njihove Povzetke glavnih značilnosti zdravila.
Docetaxel was administered as follows: 
Odmerjanje doksorubicina in ciklofosfamida, ki so ju dajali sočasno, je bilo naslednje:
Cmax 
MBC
Ear and labyrinth disorders 
Ušesne bolezni, vključno z motnjami labirinta gluhost občasno
NAME OF THE MEDICINAL PRODUCT KANJINTI 150 mg powder for concentrate for solution for infusion trastuzumab 
KANJINTI 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker. 
To vključuje zaviralec angiotenzinske konvertaze ali zaviralec angiotenzinskih receptorjev in antagonist receptorjev beta.