natgillin/translations-raw huggingface dataset:
In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95 % CI 0.51-1.79)], non-measurable [HR 1.78 (95 % CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95 % CI 0.29-4.97)]. 
V eksplorativni analizi podskupin, ki so jo opravili v preskušanju TOGA (BO18255), ni bilo opazne koristi v celokupnem preživetju z dodatkom trastuzumaba pri bolnikih z oceno splošnega stanja zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 2 pred začetkom zdravljenja [razmerje ogroženosti 0,96 (95-% interval zaupanja 0,51-1,79)], bolnikih z nemerljivo boleznijo [razmerje ogroženosti 1,78 (95-% interval zaupanja 0,87--3,66)] in bolnikih z lokalno napredovalo boleznijo [razmerje ogroženosti 1,20 (95-% interval zaupanja 0,29-4,97)].
- The resulting solution contains approximately 21 mg/mL trastuzumab. 
- Pripravljena raztopina vsebuje približno 21 mg/ml trastuzumaba.
- 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). 
- Študija BO16348 je bila zasnovana za primerjavo enoletnega in dvoletnega zdravljenja s trastuzumabom (odmerjanjem na 3 tedne) z opazovanjem bolnikov z zgodnjo obliko HER2
• failure of lungs to develop in the womb 
• okvara pri razvoju pljuč v maternici
Table 4 Efficacy results from the monotherapy and combination therapy studies Parameter 
Preglednica 4 Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja
Trastuzumab 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 s trastuzumabom mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje 4.4).
A vial of Ogivri reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC-8ºC after reconstitution and must not be frozen. 
Po rekonstituciji vsebine viale zdravila Ogivri s sterilno vodo za injekcije (ni dodana) je pripravljena raztopina stabilna 48 ur pri temperaturi 2 °C - 8 °C.
Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients 
Preglednica 16 Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC Režim
Death (OS event) No. patients with event p = 0.0182 
Smrt (dogodek celokupnega preživetja) št. bolnikov z dogodkom p < 0,0182
In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed. 
Temu je sledilo adjuvantno dajanje trastuzumaba do skupno enega leta zdravljenja.
However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines. 
Trastuzumab pa je bil skupaj z docetakselom učinkovit ne glede na to, ali so bolniki prej prejeli adjuvantno terapijo z antraciklini ali ne.
Ogivri 150 mg powder for concentrate for solution for infusion This medicine contains 115.2 mg sorbitol in each vial. 
Zdravilo Ogivri vsebuje sorbitol Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje 115,2 mg sorbitola v eni viali.
• 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 uvajalni odmerek 4 mg trastuzumaba/kg telesne mase ali za nadaljnje tedenske odmerke 2 mg trastuzumaba/kg telesne mase s pomočjo formule:
Hazard Ratio (95 % CI) p = 0.0555 
Razmerje ogroženosti (95-% IZ) p < 0,0555
Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter 
Preglednica 5 Rezultati učinkovitosti monoterapije in kombiniranega zdravljenja iz študij brez primerjalne skupine
which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles, 
čemur je sledilo: - paklitaksel 175 mg/m², dan enkrat na tri tedne, 4 cikle,
Primary efficacy analysis DFS Hazard ratios (95 % CI) p-value p < 0.0001 
Primarna analiza učinkovitosti Razmerje ogroženosti za preživetje brez bolezni (95-% IZ) p-vrednost p < 0,0001
- in combination with neoadjuvant chemotherapy followed by adjuvant Ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 
Ogivri, za lokalno napredovalo (tudi vnetno) bolezen ali tumorje > 2 cm v premeru (glejte poglavji 4.4 in 5.1).
Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 
telesna masa (kg) × odmerek (8 mg/kg za uvajanje ali 6 mg/kg za vzdrževanje)
Median follow-up 12 months* 
12 mesecev*
Table 14 Population predicted cycle 1 PK exposure values (median with 5th - 95th percentiles) fortrastuzumab intravenous dosing regimens in MBC, EBC and AGC patients 
Preglednica 14 Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, za cikel 1 (mediana s 5.-95. percentilom) za režima odmerjanja trastuzumaba v intravenski obliki pri bolnikih z MBC, EBC in AGC
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.
Each 420 mg vial of Ogivri is reconstituted with 20 mL of sterile water for injections (not supplied). 
Vsebino 420-mg viale zdravila Ogivri rekonstituiramo v 20 ml sterilne vode za injekcije (ni dodana).
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: 
Dodatno so izvedli post-hoc eksplorativno analizo podatkov iz skupne analize kliničnih študij NSABP B-31/NCCTG N9831* in BCIRG006, ki vključujejo dogodke preživetja brez bolezni in simptomatske srčne dogodke.
In the 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, zasnovano za proučevanje klinične učinkovitosti sočasnega dajanja trastuzumaba in neoadjuvantne kemoterapije, ki je vsebovala antraciklin in taksan.
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 skupine, ki je prejemala AC → PH (trastuzumab), v smislu 3-letnega preživetja brez bolezni za 11,8 odstotne točke (87,2 % v primerjavi s 75,4 %).
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 %.
Anaphylactic reaction 
+anafilaktična reakcija neznano
Talk to your doctor, pharmacist or nurse before you are given Ogivri if: 
Preden boste prejeli zdravilo Ogivri, zdravniku, farmacevtu ali medicinski sestri povejte, če:
Table 7 Summary of efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis* 
Preglednica 7 Povzetek rezultatov učinkovitosti iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 v času končne analize preživetja brez bolezni*:
Rare side effects: may affect up to 1 in 1000 people 
Redki neželeni učinki, ki se lahko pojavijo pri največ 1 od 1.000 bolnikov:
What Ogivri contains 
Kaj vsebuje zdravilo Ogivri
Surgical specimen - staining pattern 
Rezultat Kirurški vzorci - videz preparata po barvanju
Patients are eligible for Ogivri 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 Ogivri so primerni bolniki, katerih rezultat čezmernega izražanja HER2 po metodi IHC znaša 3+ ali bolniki, katerih rezultat metod FISH ali CISH je pozitiven.
Event-free survival No. patients with event 
Preživetje brez bolezni št. bolnikov z dogodkom
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.
Cardiac failure (congestive) 
+(kongestivno) srčno popuščanje
Ogivri 150 mg powder for concentrate for solution for infusion 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab. 
Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Ena 15-ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 150 mg trastuzumaba.
Death (OS event) No. patients with event p = 0.0024 
Smrt (dogodek celokupnega preživetja) št. bolnikov z dogodkom p < 0,0024
STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 420 mg trastuzumaba.
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 
Preglednica 15 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
N Cmin,ss* (mcg/mL) 
Režim Vrsta primarnega tumorja n Cmin, ss* (μg/ml) Cmax, ss** (μg/ml)
Strong complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells 
3+ Močno obarvane celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
The reconstituted Ogivri solution contains 21 mg/mL of trastuzumab. 
Pripravljena raztopina zdravila Ogivri vsebuje 21 mg/ml trastuzumaba.
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). 
ali - docetaksel intravensko - 75 mg/m² v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 6 ciklov (na 2. dan prvega cikla z docetakselom, nato na 1. dan vsakega nadaljnjega cikla), čemur je sledilo: - karboplatin (pri tarčni AUC 6 mg/ml/min) v obliki intravenske infuzije v 30 do 60 minutah, vsake 3 tedne, skupaj 6 ciklov.
Hazard Ratio versus AC→P (95 % CI) 
Razmerje ogroženosti v primerjavi z AC→P (95% IZ)
Anaphylactic shock 
+anafilaktični šok neznano
Distant recurrence No. patients with event p = 0.0008 
Pojav oddaljenih metastaz št. bolnikov z dogodkom p < 0,0008
Patients with EBC should be treated with trastuzumab 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).
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval * At the time of the definitive analysis of DFS. 
A: doksorubicin; C: ciklofosfamid; P: paklitaksel; D: docetaksel; Carb: karboplatin; H: trastuzumab IZ = interval zaupanja * V času končne analize preživetja brez bolezni.
Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion 
Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule Study BO15935 
2 Študija MO16982: uvajalni odmerek 6 mg/kg na teden 3 tedne; sledil je odmerek 6 mg/kg po 3-tedenskem režimu
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega febrilna nevtropenija
Uncommon side effects: may affect up to 1 in 100 people 
Občasni neželeni učinki, ki se lahko pojavijo pri največ 1 od 100 bolnikov:
21 (mg/mL, concentration of reconstituted solution) The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection. 
Primerno količino raztopine je treba odvzeti iz viale in dodati infuzijski vrečki, ki vsebuje 250 ml raztopine natrijevega klorida (0,9 %) za injiciranje.
Study MO22982 investigated switching between the trastuzumab intravenous and trastuzumab subcutaneous formulation with a primary objective to evaluate patient preference for either intravenous or the subcutaneous route of trastuzumab administration. 
V študiji MO22982 so proučevali prehajanje med zdravljenjem s trastuzumabom v intravenski in subkutani obliki.
Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab 
Ogivri 150 mg prašek za koncentrat za raztopino za infundiranje Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Ogivri is given as an infusion into a vein (intravenous infusion, drip), this intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only. 
Intravenska oblika zdravila Ogivri ni namenjena subkutanemu (podkožnemu) dajanju in se lahko daje le z intravensko infuzijo.
STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 150 mg trastuzumab. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 150 mg trastuzumaba.
Very common side effects: may affect more than 1 in 10 people 
Zelo pogosti neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov • okužbe
Ogivri 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 containing 420 mg of trastuzumab. 
Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje Ena 50-ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 420 mg trastuzumaba.
N = 172 
Trastuzumab1 n = 172
Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8386) and in post-marketing System organ class 
Preglednica 1 Neželeni učinki, o katerih so poročali pri intravenski obliki trastuzumaba v monoterapiji ali v kombinaciji s kemoterapijo v ključnih kliničnih preskušanjih
Distant recurrence No. patients with event p < 0.0001 
Pojav oddaljenih metastaz št. bolnikov z dogodkom p < 0,0001
Biopsy specimenstaining pattern 
Vzorci biopsije - videz preparata po barvanju
Hydrochloric acid (for pH adjustment) 
L-histidin sorbitol makrogol 3350 klorovodikova kislina (za prilagoditev pH) natrijev hidroksid (za prilagoditev pH)
360 mg/m2. 
8 mg/kg).
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 
Preglednica 3 Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku želodca
Each vial contains either; o 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injections, or o 420 mg trastuzumab that has to be dissolved in 20 mL of water for injections. 
• 150 mg trastuzumaba, ki ga je treba raztopiti v 7,2 ml vode za injekcije, ali
Volume (mL) = Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance) 
volumen (ml) = telesna masa (kg) × odmerek (4 mg/kg za uvajanje ali 2 mg/kg za vzdrževanje) 21 (mg/ml, koncentracija pripravljene raztopine)
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 
Podatki iz študije JP16003 z eno skupino, v kateri so japonske bolnice s HER2-pozitivnim metastatskim rakom dojk prejemale trastuzumab (uvajalni 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.
- in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease 
- kot monoterapija za zdravljenje tistih bolnikov, ki so za svojo metastatsko bolezen predhodno že prejemali najmanj dve liniji kemoterapije.
- 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).
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 
Preglednica 2 Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku dojk
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.
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 je prejemala FP, v primerjavi s 16 meseci za skupino, ki je prejemala FP + H - razmerje ogroženosti 0,65 (95-% interval zaupanja; 0,51-0,83).
given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with: - 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.
For the sequence intravenous → subcutaneous (subcutaneous vial and subcutaneous formulation in administration system cohorts combined), adverse event rates (all grades) were described preswitching (Cycles 1-4) and post-switching (Cycles 5-8) as 53.8 % vs. 56.4 %, respectively; for the sequence subcutaneous → intravenous (subcutaneous vial and subcutaneous formulation in administration system cohorts combined), adverse event rates (all grades) were described pre- and post-switching as 65.4 % vs. 48.7 %, respectively. 
Za prehod intravensko → subkutano (skupaj za obe subkutani obliki: v viali in aplikacijskem sistemu) je bila pogostnost neželenih učinkov (vseh stopenj) pred prehodom (1. do 4. cikel) 53,8 % in po prehodu (5. do 8. cikel) 56,4 %.
Ogivri 150 mg contains 115.2 mg sorbitol in each vial. 
Ena 150 mg viala zdravila Ogivri vsebuje 115,2 mg sorbitola.
Lung infiltration 
+pljučni infiltrati neznano
Hepatocellular injury 
Bolezni jeter, žolčnika in žolčevodov hepatocelularna poškodba hepatitis
Ogivri 420 mg contains 322.6 mg sorbitol in each vial. 
Ena 420 mg viala zdravila Ogivri vsebuje 322,6 mg sorbitola.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ogivri 150 mg powder for concentrate trastuzumab 
IME ZDRAVILA IN POT(I) UPORABE Ogivri 150 mg prašek za koncentrat trastuzumab le za intravensko uporabo
• deafness 
• driska
Primary tumor type N 
Režim Vrsta primarnega tumorja n Cmin (μg/ml)
Docetaxel was administered as follows: - 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). 
Odmerjanje docetaksela je bilo naslednje: - docetaksel intravensko - 100 mg/m² v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 4
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,
Hazard Ratio vs AC→D (95 % CI) p-value 
Razmerje ogroženosti v primerjavi z AC→D (95-% IZ) p-vrednost
or - intravenous paclitaxel - 175 mg/ m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle). 
ali - paklitaksel intravensko - 175 mg/m² v obliki kontinuirane intravenske infuzije, vsake 3 tedne,
Pulmonary fibrosis 
+pljučna fibroza neznano
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ogivri 420 mg powder for concentrate trastuzumab 
IME ZDRAVILA IN POT(I) UPORABE Ogivri 420 mg prašek za koncentrat trastuzumab le za intravensko uporabo
Disease-free survival No. patients with event p = 0.0003 
Preživetje brez bolezni št. bolnikov z dogodkom p < 0,0003
Upper respiratory tract infection 
+pljučnica astma motnje delovanja pljuč
The recommended maintenance dose of trastuzumab at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose. 
Priporočen vzdrževalni odmerek trastuzumaba je 6 mg/kg telesne mase po 3 tednih od prejema uvajalnega odmerka, in nato v tritedenskih razmakih.
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells 
2+ Šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane pri ≥ 10 % tumorskih celic.
Hazard Ratio vs AC→P (95% CI) p-value 
Razmerje ogroženosti v primerjavi z AC→P (95-% IZ) p-vrednost
Trastuzumab and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting. 
Pri adjuvantnem zdravljenju raka dojk trastuzumaba in antraciklinov ne smemo dajati sočasno.
Disease-free survival No. patients with event p < 0.0001 
Preživetje brez bolezni št. bolnikov z dogodkom p < 0,0001
Neutropenia 
pvrednost
Combination Therapy 
Kombinirano zdravljenje
EBC 
MBC EBC
How to store Ogivri 
Shranjevanje zdravila Ogivri
Ogivri vial 
• vnetje dojk
- capecitabine - 1000 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 - 1000 mg/m² peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
Do not use Ogivri if you notice any particulate matter or discoloration prior to administration. 
Če pred dajanjem opazite kakršne koli delce ali obarvanje, ne uporabljajte zdravila Ogivri.
NAME OF THE MEDICINAL PRODUCT Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab 
Ogivri 420 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
Cmin (mcg/mL) 
dan (μg.dan/ml)
BGP Products Switzerland GmbH Eesti filiaal 
BGP Products Ges.m.b.H.
Paclitaxel, in combination with trastuzumab, was administered as follows: - intravenous paclitaxel - 80 mg/ m2 as a continuous intravenous infusion, given every week for 
- paklitaksel intravensko - 80 mg/m² v obliki kontinuirane intravenske infuzije, vsak teden, skupaj 12 tednov;
- intravenous cyclophosphamide, at 600 mg/ m2 over 30 minutes, given every 3 weeks for 4 
- doksorubicin v obliki intravenskega bolusa - 60 mg/m², vsake 3 tedne, 4 cikle; - ciklofosfamid intravensko - 600 mg/m² v 30 minutah, vsake 3 tedne, 4 cikle.
Death (OS event): No. patients with event p < 0.0001 
Smrt (dogodek celokupnega preživetja): št. bolnikov z dogodkom p = 0,014**