natgillin/translations-raw huggingface dataset:
For non-inferiority of the PK co-primary endpoint, steady-state trastuzumab Ctrough value at the end of treatment Cycle 7, refer to section 5.2. 
Za neinferiornost farmakokinetičnega končnega cilja, Ctrough trastuzumaba v stanju dinamičnega ravnovesja ob koncu 7. cikla, glejte poglavje 5.2 Farmakokinetične lastnosti.
In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the Herceptin 1 year treatment arm was 0.8 %, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6 %. 
Po mediani časa spremljanja 8 let v študiji BO16348 je bila incidenca hudega kongestivnega srčnega popuščanja (NYHA razred III in IV) v skupini, ki se je eno leto zdravila z zdravilom Herceptin, 0,8 %, delež blage simptomatske in asimptomatske disfunkcije levega prekata pa
In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Herceptin (trastuzumab) and not trastuzumab emtansine. 
Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo Herceptin (trastuzumab) in ne trastuzumab emtanzin.
More patients treated with Herceptin and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6 % versus 6.5 %; p=0.377). 
zdravljenih z zdravilom Herceptin in paklitakselom, pogostejša kot pri tistih, ki so prejemali le paklitaksel (12,6 % v primerjavi s 6,5 %; p = 0,377).
They resolved within a mean of 13 days in the Herceptin intravenous treatment arm and a mean of 17 days in the Herceptin subcutaneous treatment arm. 
Dogodki so izzveneli povprečno v 13 dneh v skupini, ki se je zdravila z intravensko obliko zdravila Herceptin, in 17 dneh v skupini, ki se je zdravila s subkutano obliko istega zdravila.
Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) and the DCarbH arm (range: 0.0 to 13.1), and was 10.4 years (range: 0.0 to 12.7) in the AC→DH arm 
** Mediana dolgoročnega spremljanja v skupni analizi kliničnih študij je bila 8,3 leta (razpon: 0,1-12,1) za bolnike v skupini AC → PH in 7,9 let (razpon: 0,0-12,2) za bolnike v skupini AC → P. Mediana dolgoročnega spremljanja v študiji BCIRG 006 je bila 10,3 leta za bolnike v skupinah AC → D (razpon: 0,0-12,6) in DCarbH (razpon: 0,0-13,1) ter 10,4 leta za bolnike v skupini AC → DH (razpon: 0,0-12,7).
• Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP. 
· Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Subsequent Herceptin maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively. 
Nadaljnje vzdrževalne odmerke zdravila Herceptin (tedenski režim: 2 mg/kg; 3tedenski režim: 6 mg/kg) dajemo od 7 ali 21 dni zatem, odvisno od režima odmerjanja (tedenskega ali 3-tedenskega).
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 Herceptin. 
V redkih primerih so pri nosečnicah, ki so prejemale zdravilo Herceptin, opazili zmanjšanje količine (amnijske) tekočine, ki obdaja razvijajočega se otroka v maternici.
Post-hoc subgroup analyses indicate that positive treatment effects are limited to targeting tumours with higher levels of HER2 protein (IHC 2+/FISH+ or IHC 3+). 
Rezultati post hoc analiz podskupin kažejo, da zdravljenje tumorjev z višjimi koncentracijami HER2 proteina (IHC 2+/FISH+ ali IHC 3+) daje boljše rezultate.
Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value < 0.0001). 
Zdravljenje z AC → PH je statistično značilno izboljšalo celokupno preživetje v primerjavi z AC → P (stratificirano razmerje ogroženosti 0,64; 95-% IZ [0,55; 0,74] p vrednost log rang < 0,0001).
If symptomatic cardiac failure develops during Herceptin therapy, it should be treated with standard medicinal products for CHF. 
Če se med zdravljenjem z zdravilom Herceptin razvije simptomatsko srčno popuščanje, ga zdravimo s standardnimi zdravili za kongestivno srčno popuščanje.
If patients have been treated concurrently with a full course of low-dose anthracyclines and Herceptin in the neoadjuvant setting, no additional cytotoxic chemotherapy should be given after surgery. 
Če so se bolniki v neoadjuvantnem zdravljenju sočasno zdravili z majhnimi odmerki antraciklinov v celoti in zdravilom Herceptin, potem jim po operaciji ne smemo dati dodatne citotoksične kemoterapije.
How Herceptin is given 
Kako se zdravilo Herceptin daje
The presence of anti-trastuzumab antibodies had no impact on pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of Herceptin intravenous. 
Prisotnost protiteles proti trastuzumabu ni vplivala na farmakokinetiko, učinkovitost (določeno s patološkim popolnim odgovorom [pCR] in preživetjem brez dogodka (Event Free Survival [EFS])) in varnost, določeno s pojavom reakcij, povezanih z aplikacijo zdravila Herceptin v intravenski obliki.
The analysis of the efficacy co-primary endpoint, pCR, defined as absence of invasive neoplastic cells in the breast, resulted in rates of 40.7 % (95 % CI: 34.7, 46.9) in the Herceptin intravenous arm and 45.4 % (95 % CI: 39.2 %, 51.7 %) in the Herceptin subcutaneous arm, a difference of 4.7 percentage points in favour of the Herceptin subcutaneous arm. 
Analiza enega od primarnih končnih ciljev, pCR, definiranega kot odsotnost invazivnih neoplastičnih celic v dojkah, je pokazala 40,7-% delež (95-% interval zaupanja: 34,7; 46,9) v skupini z intravensko obliko zdravila Herceptin in 45,4-% (95-% interval zaupanja: 39,2; 51,7) v skupini, ki je prejemala subkutano obliko zdravila Herceptin; razlika 4,7 odstotne točke je bila v prid skupini s subkutano obliko zdravila Herceptin.
It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones). 
Uporablja se tudi v kombinaciji z zdravili, imenovanimi zaviralci aromataze, za zdravljenje bolnikov z metastatsko obliko raka dojk z velikimi količinami HER2 in pozitivnimi hormonskimi receptorji (to pomeni, da je tumor občutljiv za prisotnost ženskih spolnih hormonov).
The mean Cmax was expectedly lower in the Herceptin subcutaneous formulation (149 μg/mL) than in the intravenous arm (end of infusion value: 221 μg/mL). 
Herceptin (149 µg/ml) kot pri intravenski obliki (vrednost ob koncu infundiranja 221 µg/ml).
Currently no data from clinical trials are available on re-treatment of patients with previous exposure to Herceptin in the adjuvant setting. 
Trenutno ni na voljo podatkov iz kliničnih preskušanj, kjer bi bili bolniki po adjuvantnem zdravljenju z zdravilom Herceptin z njim ponovno zdravljeni.
After reconstitution 1 ml concentrate contains 21 mg of trastuzumab 
Po rekonstituciji 1 ml koncentrata vsebuje 21 mg trastuzumaba.
The final analysis at a median follow-up exceeding 70 months showed similar EFS and OS between patients who received Herceptin IV and those who received Herceptin SC. 
Končna analiza podatkov, pridobljenih v spremljanju z mediano več kot 70 mesecev, je pokazala podobno preživetje brez dogodka in celokupno preživetje pri bolnikih, ki so prejemali intravensko obliko zdravila Herceptin, in tistimi, ki so prejemali subkutano obliko zdravila Herceptin.
The reconstituted Herceptin results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates. 
Raztopljeno zdravilo Herceptin je brezbarvna do rahlo rumena prozorna tekočina, ki mora biti brez vidnih delcev.
Congestive heart failure (NYHA Class II-IV) is a common adverse reaction to Herceptin. 
Kongestivno srčno popuščanje (NYHA razred II-IV) je pogost neželeni učinek zdravila Herceptin.
Each vial of Herceptin is reconstituted with 7.2 mL of sterile water for injection (not supplied). 
Vsebino viale zdravila Herceptin rekonstituiramo v 7,2 ml sterilne vode za injekcije (ni dodana).
• bladder and skin infections 
· okužbe mehurja in kože
1) Using a sterile syringe, slowly inject 7.2 mL of water for injections in the vial containing the lyophilised Herceptin, directing the stream into the lyophilised cake. 
1) Uporabite sterilno injekcijsko brizgo, počasi injicirajte 7,2 ml vode za injekcije v vialo, ki vsebuje liofilizirano zdravilo Herceptin, usmerite curek na liofiliziran prašek.
In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 
V študiji BCIRG 006 je 213/1075 bolnikov v skupini DCarbH (TCH), 221/1074 bolnikov v skupini AC ® DH (AC ® TH) in 217/1073 bolnikov v skupini AC → D (AC ® T) imelo stanje zmogljivosti po Karnofskem ≤ 90 (ali 80 ali 90).
The preoperative chemotherapy regimen consisted of docetaxel (75 mg/m²) followed by FEC (5FU, epirubicin and cyclophosphamide) at a standard dose. 
(75 mg/m2), ki so mu sledili FEC (5-FU, epirubicin in ciklofosfamid) v običajnem odmerku.
Patients experiencing administration-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate. 
Bolnikom, pri katerih se pojavijo simptomi, povezani z dajanjem zdravila (glejte poglavje 4.4), je treba svetovati, naj ne vozijo avtomobilov ali upravljajo strojev, dokler ti ne izzvenijo.
PHARMACEUTICAL FORM Solution for injection 
FARMACEVTSKA OBLIKA raztopina za injiciranje
Herceptin is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing 150 mg of trastuzumab. 
Zdravilo Herceptin je prašek za koncentrat za raztopino za intravensko infundiranje, ki je na voljo v stekleni viali z gumijastim zamaškom, ki vsebuje 150 mg trastuzumaba.
+Cardiac failure (congestive) 
+(kongestivno) srčno popuščanje
Single doses of Herceptin alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with metastatic gastric cancer patients. 
Enkratnih odmerkov zdravila Herceptin samega, večjih od 10 mg/kg, v kliničnih preskušanjih niso dajali; v kliničnem preskušanju pri bolnikih z metastatskim rakom želodca so proučevali vzdrževalni odmerek 10 mg/kg vsake tri tedne, ki je sledil uvajalnemu odmerku 8 mg/kg.
1) Using a sterile syringe, slowly inject 7.2 mL of sterile water for injection in the vial containing the lyophilised Herceptin, directing the stream into the lyophilised cake. 
1) Uporabite sterilno injekcijsko brizgo, počasi injicirajte 7,2 ml sterilne vode za injekcije v vialo, ki vsebuje liofilizirano zdravilo Herceptin, usmerite curek na liofiliziran prašek.
weekly) and docetaxel (60 mg/m2 IV) in Japanese women with HER2- positive MBC, suggested that concomitant administration of Herceptin had no effect on the single dose pharmacokinetics of docetaxel. 
enkrat na teden) in docetaksel (60 mg/m2 iv.) so nakazali, da sočasna aplikacija zdravila Herceptin ni imela vpliva na farmakokinetiko enkratnega odmerka docetaksela.
The 600 mg dose should be administered as a subcutaneous injection only over 2-5 minutes every three weeks. 
Način uporabe Odmerek 600 mg moramo dati izključno s subkutano injekcijo v 2 do 5 minutah vsake tri tedne.
Clear to opalescent solution, colourless to yellowish. 
Bistra do opalescenčna raztopina, brezbarvna do rumenkasta.
All candidates for treatment with Herceptin, but especially those with prior anthracycline and cyclophosphamide exposure, should undergo baseline cardiac assessment including history and physical examination and electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging. 
Vsi kandidati za zdravljenje z zdravilom Herceptin, posebno tisti, ki so se predhodno zdravili z antraciklini in ciklofosfamidom, morajo opraviti osnovni pregled srca, vključno z anamnezo in fizičnim pregledom, elektrokardiogramom (EKG), ehokardiogramom in/ali radioizotopsko ventrikulografijo ali magnetnoresonančnim slikanjem.
MARKETING AUTHORISATION NUMBER(S) EU/1//00/145/001 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/00/145/001
• If you have any further questions, ask your doctor or pharmacist. 
· Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
• the other is given as an injection under the skin (subcutaneous injection). 
· ena se daje kot infuzija v veno (intravenska infuzija), · druga se daje kot injekcija pod kožo (subkutana ali podkožna injekcija).
Women of childbearing potential / Contraception Women of childbearing potential should be advised to use effective contraception during treatment with Herceptin and for 7 months after treatment has concluded (see section 5.2). 
Ženske v rodnem obdobju/Kontracepcija Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom Herceptin ter še 7 mesecev po zaključku zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
In study MO16432, Herceptin (8 mg/kg loading dose, followed by 6 mg/kg maintenance every 3 weeks) was administered concurrently with 10 cycles of neoadjuvant chemotherapy as follows: 
V preskušanju MO16432 so zdravilo Herceptin (uvajalni odmerek 8 mg/kg, sledil je vzdrževalni odmerek 6 mg/kg vsake 3 tedne) dajali sočasno z 10 cikli neoadjuvantne kemoterapije, in sicer:
Do not use with glucose-containing solutions 
Ne uporabljajte raztopin, ki vsebujejo glukozo (glejte poglavje
• abnormal development of the kidneys of the baby in the womb 
· nenormalen razvoj ledvic otroka v maternici
• conjunctivitis 
· konjunktivitis
Some of the side effects you experience may be due to your underlying breast cancer. 
Vzrok nekaterim neželenim učinkom, ki jih opazite, je lahko vaša bolezen - rak dojk.
• anaphylactic reactions 
· anafilaktične reakcije
The recommended weekly maintenance dose of Herceptin is 2 mg/kg body weight, beginning one week after the loading dose. 
Priporočen tedenski vzdrževalni odmerek zdravila Herceptin je 2 mg/kg telesne mase, z začetkom en teden po uvajalnem odmerku.
For overall survival, the HR was 0.75 (95 % CI 0.51-1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95 % CI 0.41-0.81) in the IHC 3+/FISH+ group. 
Razmerje ogroženosti za celokupno preživetje je bilo 0,75 (95-% interval zaupanja 0,51 do 1,11) v IHC 2+/FISH+ skupini, v IHC 3+/FISH+ skupini pa je razmerje ogroženosti bilo 0,58 (95-% interval zaupanja 0,41 do 0,81).
After a median follow-up of 
Mediani čas spremljanja
Asthma 
· astma
Do not breast-feed your baby during Herceptin therapy and for 7 months after the last dose of Herceptin as Herceptin may pass to your baby through your breast milk. 
Med zdravljenjem z zdravilom Herceptin in 7 mesecev po zadnjem odmerku zdravila ne smete dojiti, ker lahko to zdravilo prehaja v materino mleko in s tem do vašega otroka.
Herceptin should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. 
Zdravilo Herceptin se uporablja le za bolnike z metastatskim rakom želodca, katerih tumorji imajo čezmerno izražen HER2, definiran kot IHC2+ z nadaljnjim potrditvenim SISH ali FISH rezultatom ali kot IHC3+.
This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. 
Rekonstitucija da 7,4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ml trastuzumaba, s pH približno 6,0.
Herceptin plus docetaxel4 
zdravilo Herceptin in docetaksel4
Patients were treated with Herceptin until progression of disease. 
Bolniki so prejemali zdravilo Herceptin do napredovanja bolezni.
Ask your doctor, pharmacist or nurse for advice before taking any medicine. 
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden boste vzeli katero koli zdravilo.
If the patient has missed a dose of Herceptin by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible. 
Izpuščeni odmerki Če je bolnik izpustil odmerek zdravila Herceptin za en teden ali manj, mu je treba običajni vzdrževalni odmerek (tedenski režim: 2 mg/kg; 3-tedenski režim: 6 mg/kg) dati čim prej.
By comparison of simulated serum trastuzumab concentrations after Herceptin monotherapy (4 mg/kg loading/2 mg/kg q1w IV) and observed serum concentrations in Japanese women with HER2- positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found. 
S primerjavo simuliranih serumskih koncentracij trastuzumaba po monoterapiji z zdravilom Herceptin (uvajalni odmerek 4 mg/kg, 2 mg/kg enkrat na teden, iv.) in opaženih serumskih koncentracijah pri japonskih bolnicah s HER2-pozitivnim metastatskim rakom dojk (študija JP16003) ni dokazov o farmakokinetičnem vplivu sočasne aplikacije docetaksela na farmakokinetiko trastuzumaba.
The highest rate of cardiac dysfunction was seen in patients receiving Herceptin concurrently with anthracycline/cyclophosphamide (27 %), and was significantly higher than for anthracycline/cyclophosphamide alone (7 % - 10 %). 
Herceptin prejemali sočasno z antraciklinom/ciklofosfamidom (27 %), bil je signifikantno višji kot pri jemanju samega antraciklina/ciklofosfamida (7 do 10 %).
During a Herceptin infusion, chills, fever and other flu like symptoms may occur. 
Med infuzijo zdravila Herceptin se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi simptomi, podobni gripi.
Administration-related reactions/hypersensitivity 
Reakcije, povezane z aplikacijo/preobčutljivostjo
Neutralizing anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the Herceptin intravenous arm. 
Nevtralizirajoča protitelesa proti trastuzumabu so odkrili v 2 od 30 vzorcev, odvzetih po začetku zdravljenja pri bolnikih iz skupine, ki je prejemala zdravilo Herceptin v intravenski obliki.
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,
Herceptin may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful. 
Zdravilo Herceptin se lahko predpiše v kombinaciji s citostatikoma paklitakselom ali docetakselom kot prvo zdravljenje metastatskega raka dojk ali pa se uporablja samostojno, če so bile ostale oblike zdravljenja neuspešne.
The recommended initial loading dose is 8 mg/kg body weight. 
Priporočen uvajalni odmerek je 8 mg/kg telesne mase.
Intravenous formulation 
Intravenska oblika
In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of Herceptin (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of Herceptin if the preceding dose of Herceptin was well tolerated. 
Odmerjanje v kombinaciji s paklitakselom ali docetakselom V ključnih študijah (H0648g, M77001) so paklitaksel ali docetaksel dali en dan po uvajalnem odmerku zdravila Herceptin (za odmerek glejte Povzetek glavnih značilnosti zdravila za paklitaksel ali docetaksel) in takoj po nadaljnjih odmerkih zdravila Herceptin, če je bolnik predhoden odmerek zdravila Herceptin dobro prenašal.
Observation N=1693 
Parameter opazovanje n = 1693
- intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) 
5-fluorouracil intravensko - 800 mg/m2/dan v obliki kontinuirane intravenske infuzije 5 dni, dano vsake 3 tedne, skupaj 6 ciklov (dnevi 1 do 5 vsakega cikla).
Women of childbearing potential should be advised to use effective contraception during treatment with Herceptin and for 7 months after treatment has concluded (see section 5.2). 
Ženske v rodnem obdobju Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom Herceptin ter še 7 mesecev po zaključku zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
No incompatibilities between Herceptin subcutaneous formulation and polypropylene or polycarbonate syringe material or stainless steel transfer and injection needles and polyethylene Luer cone stoppers have been observed. 
Med podkožno obliko zdravila Herceptin in polipropilenskim ali polikarbonatnim materialom brizg niso ugotovili inkompatibilnosti; prav tako jih niso ugotovili z iglami iz nerjavečega jekla za prenos in injiciranje ali polietilenskimi koničnimi zamaški luer.
All of the severe ARRs with the Herceptin subcutaneous formulation occurred during concurrent administration with chemotherapy. 
Vse resne reakcije, povezane z aplikacijo, ki so nastopile pri subkutani obliki zdravila Herceptin, so se pojavile pri sočasni aplikaciji s kemoterapijo.
The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumor types, and healthy volunteers, in 18 Phase I, II and III trials receiving Herceptin IV. A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile. 
5.2 Farmakokinetične lastnosti Farmakokinetika trastuzumaba je bila ocenjena z analizo populacijskega farmakokinetičnega modela z uporabo združenih podatkov 1582 preizkušancev, vključno z bolniki s HER2-pozitivnim metastatskim rakom dojk (metastatic breast cancer - MBC), zgodnjim rakom dojk (early breast cancer - EBC), napredovalim rakom želodca (advanced gastric cancer - AGC) ali drugimi vrstami tumorjev in zdravimi prostovoljci, ki so v 18 kliničnih preskušanjih faze I, II in III prejemali zdravilo Herceptin v iv. obliki.
However, Herceptin plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines. 
Zdravilo Herceptin pa je bilo skupaj z docetakselom učinkovito ne glede na to, ali so bolniki prej prejeli adjuvantno terapijo z antraciklini ali ne.
In this final analysis, extending Herceptin treatment for a duration of two years did not show additional benefit over treatment for 1 year [DFS HR in the intent to treat (ITT) population of 2 years versus 1 year=0.99 (95 % CI: 0.87, 1.13), p-value=0.90 and OS HR=0.98 (0.83, 1.15); p-value= 0.78]. 
Omenjena končna analiza ni pokazala dodatne koristi podaljšanja zdravljenja z zdravilom Herceptin na dve leti v primerjavi z enoletnim zdravljenjem [razmerje ogroženosti za preživetje brez napredovanja bolezni v populaciji, ki so jo nameravali zdraviti pri dvoletnem zdravljenju v primerjavi z enoletnim zdravljenjem = 0,99 (95-% IZ: 0,87; 1,13), p-vrednost = 0,90 in razmerje ogroženosti za celokupno preživetje = 0,98 (0,83; 1,15), p-vrednost = 0,78].
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. 
Parenteralne raztopine je potrebno vizualno pregledati na prisotnost delcev in obarvanost pred dajanjem zdravila.
Herceptin may also be given once a week for metastatic breast cancer. 
Pri metastatskem raku dojk lahko zdravilo Herceptin dajemo tudi enkrat na teden.