natgillin/translations-raw huggingface dataset:
These events have been observed in patients receiving Herceptin therapy alone or in combination with paclitaxel or docetaxel, particularly following anthracycline (doxorubicin or epirubicin) containing chemotherapy. 
Ti su događaji primijećeni u bolesnika koji su primali monoterapiju lijekom Herceptin ili Herceptin u kombinaciji s paklitakselom ili docetakselom, osobito nakon kemoterapije koja je sadržavala antracikline (doksorubicin ili epirubicin).
Each vial of Herceptin is reconstituted with 7.2 mL of water for injections (not supplied). 
Sadržaj jedne bočice lijeka Herceptin rekonstituira se u 7,2 ml vode za injekcije (nije priložena u pakiranju).
Herceptin plus paclitaxel3 
Herceptin plus paklitaksel3
You will be observed by a health care professional during the infusion and for at least six hours after the start of the first infusion and for two hours after the start of other infusions. 
Zdravstveni radnik promatrat će Vas tijekom primjene lijeka i najmanje šest sati nakon početka prve primjene te dva sata nakon početka svake sljedeće primjene.
Total CL range from Cmax,ss to 
Raspon ukupnog klirensa od Cmax,ss do Cmin,ss
Herceptin 1 Year N = 1702*** 
N = 1702***
• Administration-related reactions: 37.2 % versus 47.8 % for the intravenous formulation versus subcutaneous formulation, respectively during the treatment phase; 
• reakcije povezane s primjenom lijeka tijekom razdoblja liječenja: 37,2% uz intravensku naspram 47,8% uz supkutanu formulaciju
Some of the side effects you experience may be due to your underlying breast cancer. 
Neke nuspojave koje primijetite mogu biti posljedica samog raka dojke.
In the pivotal trial (BO22227) Herceptin subcutaneous formulation was administered in the neoadjuvant/adjuvant setting in patients with early breast cancer. 
U pivotalnom ispitivanju (BO22227) Herceptin u supkutanoj formulaciji davao se u sklopu neoadjuvantnog/adjuvantnog liječenja bolesnica s ranim rakom dojke.
• You should use effective contraception during treatment with Herceptin and for at least 7 months after treatment has ended. 
• Tijekom liječenja lijekom Herceptin i najmanje 7 mjeseci nakon završetka liječenja potrebno je koristiti učinkovitu kontracepciju.
In the pivotal trial MO16432, Herceptin was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2) . 
U pivotalnom ispitivanju MO16432, Herceptin se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od tri ciklusa doksorubicina (kumulativna doza 180 mg/m2).
In the NSABP B-31 and NCCTG N9831 studies Herceptin was administered in combination with paclitaxel, following AC chemotherapy. 
U sklopu ispitivanja NSABP B-31 i NCCTG N9831 Herceptin je primjenjivan u kombinaciji s paklitakselom nakon AC kemoterapije.
- 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) 
- intravenski 5-fluorouracil - 800 mg/m²/dnevno u kontinuiranoj intravenskoj infuziji tijekom 5 dana, svaka 3 tjedna u 6 ciklusa (od 1. do 5. dana svakog ciklusa)
8mg/kg + 6mg/kg q3w 
8 mg/kg + 6 mg/kg jedanput svaka 3
Early breast cancer in the BO16348 Study was limited to operable, primary, invasive adenocarcinoma of the breast, with axillary nodes positive or axillary nodes negative if tumors at least 1 cm in diameter. 
Rani rak dojke u ispitivanju BO16348 bio je ograničen isključivo na operabilni, primarni, invazivni adenokarcinom dojke, s pozitivnim ili negativnim aksilarnim čvorovima, ako je promjer tumora iznosio najmanje 1 cm.
However, Herceptin plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines. 
Kombinacija lijeka Herceptin i docetaksela bila je, međutim, učinkovita bez obzira na to jesu li bolesnice prethodno primale adjuvantnu antraciklinsku terapiju.
So far, no results are available which compare the efficacy of Herceptin administered with chemotherapy in the adjuvant setting with that obtained in the neo-adjuvant/adjuvant setting. 
Za sada nema rezultata usporedbe djelotvornosti lijeka Herceptin davanog s kemoterapijom kao adjuvantno liječenje i kao neoadjuvantno/adjuvantno liječenje.
The AUC0-21 days following Cycle 12 dose was approximately 20 % higher with the Herceptin subcutaneous formulation than the Herceptin intravenous dose, with mean AUC values of 2610 µg/mL•day and 2179 µg/mL•day, respectively. 
Nakon primjene doze u 12. ciklusu AUC0-21 dan bio je približno 20% veći kod primjene lijeka Herceptin u supkutanoj formulaciji nego kod primjene intravenske formulacije lijeka Herceptin, pri čemu su srednje vrijednosti AUC-a iznosile 2610 µg/ml•dan, odnosno 2179 µg/ml•dan.
Table 5: Efficacy results from study BO16348 
Tablica 5: Rezultati djelotvornosti iz ispitivanja BO16348
For instructions on reconstitution of Herceptin intravenous formulation before administration, see section 6.6. 
Za upute o rekonstituciji lijeka Herceptin u intravenskoj formulaciji prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany 
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Njemačka
In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is Herceptin (trastuzumab) and not Kadcyla (trastuzumab emtansine). 
U svrhu sprečavanja medikacijskih pogrešaka, važno je provjeriti naljepnice na bočicama kako biste bili sigurni da je lijek koji se priprema i primjenjuje Herceptin (trastuzumab), a ne Kadcyla (trastuzumab emtanzin).
In a subsequent trial with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2 % in patients receiving Herceptin and docetaxel, compared with 0 % in patients receiving docetaxel alone. 
U kasnijem ispitivanju u kojem se prospektivno pratila srčana funkcija, incidencija simptomatskog kongestivnog zatajenja srca bila je 2,2% u bolesnica koje su primale Herceptin i docetaksel, u usporedbi s 0% u bolesnika koje su primale samo docetaksel.
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: 
U ispitivanju MO16432, Herceptin (udarna doza od 8 mg/kg, zatim doza održavanja od 6 mg/kg svaka 3 tjedna) je davan istodobno s 10 ciklusa neoadjuvantne kemoterapije,
Causing excessive foaming during reconstitution or shaking the reconstituted Herceptin may result in problems with the amount of Herceptin that can be withdrawn from the vial. 
Stvaranje prevelike pjene tijekom rekonstitucije ili protresanje rekonstituiranog lijeka Herceptin može uzrokovati poteškoće s izvlačenjem odgovarajuće količine lijeka Herceptin iz bočice.
Severe pulmonary events have been reported with the use of Herceptin in the post-marketing setting (see section 4.8). 
Teške plućne reakcije pri primjeni lijeka Herceptin zabilježene su u razdoblju nakon stavljanja lijeka u promet (vidjeti dio 4.8).
- Study BO16348 was designed to compare one and two years of three-weekly Herceptin treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable). 
- Ispitivanje BO16348 s ciljem usporedbe liječenja lijekom Herceptin u trotjednim ciklusima tijekom jedne i dvije godine i opservacije u bolesnica s HER2 pozitivnim tumorom dojke u ranom stadiju nakon kirurškog zahvata, završene kemoterapije i radioterapije (ako su provedeni).
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. 
Ako je bolesnik propustio primiti dozu lijeka Herceptin za tjedan dana ili manje, nužno je što prije primijeniti uobičajenu dozu održavanja (tjedni ciklusi: 2 mg/kg; trotjedni ciklusi: 6 mg/kg).
Cardiac assessments, as performed at baseline, should be repeated every 3 months during treatment and every 6 months following discontinuation of treatment until 24 months from the last administration of Herceptin. 
Kardiološke preglede, istovjetne onom obavljenom u sklopu početne procjene, potrebno je ponavljati svaka 3 mjeseca tijekom liječenja te svakih 6 mjeseci nakon završetka liječenja do 24 mjeseca od posljednje primjene lijeka Herceptin.
Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”). 
a neke su bolesnice preminule (pogledajte dio 2 pod "Upozorenja i mjere opreza").
If you receive Herceptin with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products. 
Ako primate Herceptin u kombinaciji s nekim drugim lijekom za liječenje raka, poput paklitaksela, docetaksela, inhibitora aromataze, kapecitabina, 5-fluorouracila ili cisplatina, pročitajte uputu o lijeku i za te lijekove.
Comparison of trastuzumab PK data from Study M77004 in which women with HER2-positive MBC were treated concomitantly with Herceptin, paclitaxel and doxorubicin to trastuzumab PK data in studies where Herceptin was administered as monotherapy (H0649g) or in combination with anthracycline plus cyclophosphamide or paclitaxel (Study H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab. 
Usporedba podataka o farmakokinetici trastuzumaba iz ispitivanja M77004, u kojem su žene s HER2 pozitivnim metastatskim rakom dojke bile istodobno liječene lijekom Herceptin, paklitakselom i doksorubicinom, s podacima o farmakokinetici trastuzumaba iz ispitivanja u kojima se Herceptin primjenjivao u monoterapiji (H0649g) ili u kombinaciji s antraciklinom plus ciklofosfamidom ili paklitakselom (ispitivanje H0648g), ukazala je na to da doksorubicin i paklitaksel nemaju utjecaja na farmakokinetiku trastuzumaba.
Amongst the most serious and/or common adverse reactions reported in Herceptin usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions. 
Među najozbiljnije i/ili najčešće nuspojave dosad prijavljene pri primjeni lijeka Herceptin (u intravenskoj i supkutanoj formulaciji) ubrajaju se disfunkcija srca, reakcije povezane s infuzijom, hematotoksičnost (osobito neutropenija) infekcije i plućne nuspojave.
Herceptin should be inspected visually to ensure there is no particulate matter or discolouration prior to administration. 
Herceptin prije primjene treba pregledati da se uvjerite da ne sadrži čestice i da nije došlo do promjene boje.
The mean AUC0-21 days following the Cycle 7 dose was approximately 10 % higher with the Herceptin subcutaneous formulation as compared to the Herceptin intravenous formulation, with mean AUC values of 2268 µg/mL•day and 2056 µg/mL•day, respectively. 
Nakon primjene doze u 7. ciklusu, srednja vrijednost AUC0-21 dan bila je približno 10% veća kod primjene lijeka Herceptin u supkutanoj formulaciji nego kod primjene intravenske formulacije lijeka Herceptin, pri čemu su srednje vrijednosti AUC-a bile 2268 µg/ml•dan, odnosno 2056 µg/ml•dan.
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 
U ispitivanju BCIRG 006 je 213/1075 bolesnica u skupini DCarbH (TCH), 221/1074 bolesnica u skupini AC→DH (AC→TH) i 217/1073 bolesnica u skupini AC→D (AC→T) imalo Karnofsky status ≤90 (bilo 80 ili 90).
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. 
U svrhu sprečavanja medikacijskih pogrešaka, važno je provjeriti naljepnice na bočicama kako biste bili sigurni da je lijek koji se priprema i primjenjuje Herceptin (trastuzumab), a ne trastuzumab emtanzin.
The updated DFS analysis results (stratified HR = 0.61; 95% CI [0.54, 0.69]) showed a similar DFS benefit compared to the definitive primary DFS analysis, despite 24.8% patients in the AC→P arm who crossed over to receive Herceptin. 
Nadopunjeni rezultati analize preživljenja bez bolesti (stratificirani omjer hazarda = 0,61; 95% CI [0,54; 0,69]) pokazuju sličnu korist za preživljenje bez bolesti kao i konačna primarna analiza preživljenja bez bolesti, unatoč prijelazu 24,8% bolesnika iz skupine liječene AC→P kemoterapijom u skupinu koja je primala Herceptin.
1 Heart beat irregular 
1 nepravilni otkucaji srca
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Overall survival (death) - No. patients with event - No. patients without event 
Ukupno preživljenje (smrt) - broj bolesnica s događajem 40 (2,4 %) - broj bolesnica bez događaja
Analyses with longer term follow-up of a median duration exceeding 40 months supported the noninferior efficacy of Herceptin subcutaneous compared to Herceptin intravenous with comparable results of both EFS and OS (3-year EFS rates of 73% in the Herceptin intravenous arm and 76% in the Herceptin subcutaneous arm, and 3-year OS rates of 90% in the Herceptin intravenous arm and 92% in the Herceptin subcutaneous arm). 
Analize podataka prikupljenih tijekom dugotrajnijeg praćenja, čiji je medijan bio dulji od 40 mjeseci, podupirale su neinferiornu djelotvornost lijeka Herceptin za supkutanu primjenu u odnosu na lijek Herceptin za intravensku primjenu, uz usporedive rezultate i za preživljenje bez događaja (engl. event-free survival, EFS) i za OS (3-godišnja stopa EFS-a iznosila je 73% u skupini liječenoj lijekom Herceptin za intravensku primjenu te 76% u skupini liječenoj lijekom Herceptin za supkutanu primjenu, dok je 3-godišnja stopa OS-a iznosila 90% odnosno 92%).
• you are allergic to trastuzumab (the active substance of Herceptin), murine (mouse) proteins, or any of the other ingredients of this medicine (listed in section 6). 
• ako ste alergični na trastuzumab (djelatnu tvar lijeka Herceptin), mišje proteine ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
• Hypersensitivity to trastuzumab, murine proteins, hyaluronidase or to any of the other excipients listed in section 6.1. 
• Preosjetljivost na trastuzumab, mišje proteine, hijaluronidazu ili neku od pomoćnih tvari navedenih u dijelu 6.1.
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. 
Sljedeću dozu održavanja lijeka Herceptin (tjedni ciklusi: 2 mg/kg; trotjedni ciklusi: 6 mg/kg) treba primijeniti 7 dana nakon toga ako bolesnik prima tjedni raspored doziranja, odnosno 21 dan nakon toga ako prima trotjedni raspored doziranja.
Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1). 
Herceptin treba davati samo onim bolesnicima s metastatskim ili ranim rakom dojke čije tumorske stanice pokazuju povećanu ekspresiju HER2 ili HER2 gensku amplifikaciju što je potvrđeno preciznom i validiranom metodom (vidjeti dijelove 4.4 i 5.1).
L-histidine hydrochloride monohydrate α,α-trehalose dihydrate 
L-histidinklorid hidrat α,α-trehaloza dihidrat
One 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab. 
Jedna staklena bočica od 15 ml (bezbojno staklo tipa I) s butilnim gumenim čepom presvučenim fluoro-rezinskim filmom sadrži 150 mg trastuzumaba.
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva eritem osip
- in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. 
- u kombinaciji s paklitakselom u liječenju bolesnika koji prethodno nisu primali kemoterapiju za metastatsku bolest i onih koji nisu pogodni za liječenje antraciklinom.
Switching treatment between Herceptin intravenous and Herceptin subcutaneous formulation and vice versa 
Prelazak s liječenja intravenskom formulacijom lijeka Herceptin na supkutanu formulaciju lijeka
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. 
Ako su bolesnici u sklopu neoadjuvantnog liječenja istodobno primali antracikline u niskim dozama i Herceptin, nakon operacije ne smiju primati nikakvu drugu citotoksičnu kemoterapiju.
- in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. 
- u kombinaciji s inhibitorom aromataze u liječenju postmenopauzalnih bolesnica s metastatskim rakom dojke pozitivnim na hormonske receptore, koje nisu prethodno liječene trastuzumabom.
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. 
Usporedbom simuliranih koncentracija trastuzumaba u serumu nakon monoterapije lijekom Herceptin (udarna doza od 4 mg/kg intravenski / 2 mg/kg intravenski jedanput tjedno) i opaženih koncentracija u serumu žena japanskog podrijetla s HER2-pozitivnim metastatskim rakom dojke (ispitivanje JP16003) nisu pronađeni dokazi farmakokinetičkog učinka istodobne primjene docetaksela na farmakokinetiku trastuzumaba.
In the post-marketing setting, cases of foetal renal growth and/or function impairment in association with oligohydramnios, some associated with fatal pulmonary hypoplasia of the foetus, have been reported in pregnant women receiving Herceptin. 
U razdoblju nakon stavljanja lijeka u promet, u trudnica koje su primale Herceptin prijavljeni su slučajevi narušenog rasta i/ili funkcije bubrega kod fetusa povezani s oligohidramnionom, od kojih su neki bili povezani s fatalnom pulmonalnom hipoplazijom fetusa.
12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95 % CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8 % versus 78.2 %) in favour of the Herceptin arm. 
Nakon medijana praćenja od 12 mjeseci, omjer hazarda (engl. hazard ratio, HR) za preživljenje bez simptoma bolesti (engl. disease-free survival, DFS) iznosio je 0,54 (95% CI 0,44; 0,67), što znači da je apsolutno povoljan u smislu dvogodišnjeg preživljenja bez simptoma bolesti s razlikom od 7,6 postotnih bodova (85,8 % naspram 78,2 %) u korist skupine liječene lijekom Herceptin.
PHARMACEUTICAL FORM Solution for injection 
OBLIK Otopina za injekciju
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. 
13 dana u skupini koja je primala intravensku formulaciju lijeka Herceptin te unutar prosječno 17 dana u skupini koja je primala Herceptin u supkutanoj formulaciji.
In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of Herceptin with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant Herceptin, up to a total treatment duration of 1 year. 
U sklopu neoadjuvantnog-adjuvantnog liječenja, multicentrično, randomizirano ispitivanje MO16432 osmišljeno je da ispita kliničku djelotvornost istodobne primjene lijeka Herceptin s neoadjuvantnom kemoterapijom, koja je uključivala i antraciklin i taksan, nakon čega je slijedilo adjuvantno liječenje lijekom Herceptin do ukupno 1 godine liječenja.
A final analysis was performed after a median follow-up of 8 years, which showed that 1 year Herceptin treatment is associated with a 24 % risk reduction compared to observation only (HR=0.76, 95 % CI 0.67, 0.86). 
Završna analiza provedena nakon medijana praćenja od 8 godina ukazala je na smanjenje rizika od 24% u skupini liječenoj lijekom Herceptin tijekom 1 godine u usporedbi sa samo opservacijom (HR=0,76, 95% CI 0,67; 0,86).
The rate of severe infections (NCI CTCAE grade ≥3) was 5.0 % versus 7.1 %, in the Herceptin intravenous formulation arm and the Herceptin subcutaneous formulation arm respectively. 
Stopa teških infekcija (NCI CTCAE stupnja ≥ 3) iznosila je 5,0% u skupini koja je primala intravensku formulaciju lijeka Herceptin naspram 7,1% u skupini koja je primala Herceptin u supkutanoj formulaciji.
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. 
Farmakokinetika trastuzumaba ocjenjivala se u analizi populacijskog farmakokinetičkog modela, u kojoj su se koristili objedinjeni podaci prikupljeni u 1582 ispitanika, uključujući bolesnike s HER2 pozitivnim metastatskim rakom dojke, ranim rakom dojke, uznapredovalim rakom želuca ili drugim vrstama tumora te zdrave dobrovoljce koji su primali intravensku formulaciju lijeka Herceptin u 18 ispitivanja faze I, II i III.
No. patients with event p=0.0555 
Broj bolesnica s događajem p=0,0555
If you receive Herceptin with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, carboplatin or cisplatin you should also read the patient information leaflets for these products. 
Ako primate Herceptin u kombinaciji s nekim drugim lijekom za liječenje raka, poput paklitaksela, docetaksela, inhibitora aromataze, karboplatina ili cisplatina, pročitajte uputu o lijeku i za te lijekove.
An absolute benefit of 13 percentage points in favour of the Herceptin arm was estimated in terms of 3-year event-free survival rate (65 % versus. 
Za skupinu koja je primala Herceptin procijenjena je apsolutna korist od 13 postotnih bodova za stopu trogodišnjeg preživljenja bez događaja (65% naspram 52%).
Table 11: Efficacy results from MO16432 
Tablica 11: Rezultati djelotvornosti iz ispitivanja MO16432
The recommended initial loading dose of Herceptin is 4 mg/kg body weight. 
Preporučena početna udarna doza lijeka Herceptin iznosi 4 mg/kg tjelesne težine.
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures. 
Jedna bočica sadrži 150 mg trastuzumaba, humaniziranog IgG1 monoklonskog protutijela proizvedenog u kulturi stanica sisavaca u suspenziji (stanice jajnika kineskog hrčka) i pročišćenog afinitetnom i ionsko-izmjenjivačkom kromatografijom uključujući specifičnu inaktivaciju virusa i postupke uklanjanja.
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 može dovesti do simptoma kao što su nedostatak zraka (uključujući nedostatak zraka tijekom noći), kašalj, zadržavanje tekućine (oticanje) u nogama ili rukama te osjećaj lupanja srca (lepršanje srca ili nepravilni otkucaji srca) (pogledajte odlomak „Kontrole rada srca“ u dijelu 2).