natgillin/translations-raw huggingface dataset:
Article 35 of Directive 2001/82/EC Revised reflection paper on use of 3rd and 4th generation cephalosporins in food producing animals in the EU: development of resistance and impact on human and animal health (EMEA/CVMP/SAGAM/81730/2006-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf
th generation cephalosporins in food producing animals in the EU: development of resistance and impact on human and animal health [Revidiran dokument o stališču v zvezi z uporabo cefalosporinov 3. in 4. generacije pri živalskih vrstah za proizvodnjo živil v EU: razvoj odpornosti in vpliv na zdravje ljudi in živali] (EMEA/CVMP/SAGAM/81730/2006-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004307.pdf
Opinion following an Article 35 referral for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing species
za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo cefalosporine 3. in 4. generacije za sistemsko (parenteralno in peroralno) uporabo, ki so namenjeni uporabi pri živalskih vrstah za proizvodnjo živil
generation cephalosporins in food producing animals in the European Union: development of resistance and impact on human and animal health (EMEA/CVMP/SAGAM/81730/2006-Rev.1)
CVMP je zaprosil za mnenje v zvezi z vključitvijo nasveta o preudarni rabi teh zdravil proti mikrobom v skladu z revidiranim dokumentom o stališču v zvezi z uporabo 3. in 4. generacije cefalosporinov pri živalskih vrstah za proizvodnjo živil v Evropski uniji: razvoj odpornosti in vpliv na zdravje ljudi in živali (EMEA/CVMP/SAGAM/81730/2006-Rev.1)
The CVMP was requested to give its opinion regarding the inclusion of prudent use advice for these antimicrobials in line with the revised reflection paper on the use of 3
Revised reflection paper on use of 3
oral) 3
rd and 4
200 tablets
200 tablet
Film-coated tablet Oral use bottle (HDPE)
peroralna uporaba plastenka (HDPE)
Date of first authorisation: 28 August 2000 Date of latest renewal: 28 August 2010
Datum prve odobritve: 28. avgust 2000 Datum zadnjega podaljšanja: 28. avgust 2010
Other side effects were similar.
Drugi neželeni učinki so bili podobni.
1000 New Horizons Way Vacaville, CA 95688 USA
1000 New Horizons Way Vacaville, CA 95688 ZDA
For the comparative safety profile see section 4.8.
Za primerjalni varnostni profil glejte poglavje 4.8.
Allow the vial to stand undisturbed for approximately 5 minutes.
Pustite stati vialo pri miru približno pet minut.
If not used immediately, preparation should take place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, mora priprava potekati v kontroliranih in validiranih aseptičnih pogojih.
(evening of day 1 to morning of day 15 of each cycle)
(zvečer prvega dne do jutra dneva 15 vsakega cikla)
Hyaluronidase is found in most tissues of the human body.
Hialuronidaza je prisotna v večini tkiv v telesu.
Primary efficacy analysis
Primarna analiza učinkovitosti
Some of the severe events occurred on the day of the injection.
Nekateri od hudih dogodkov so se pojavili na dan injiciranja.
There were also more local reactions at the site of injection and more increases in blood pressure.
Več je bilo tudi lokalnih reakcij na mestu injiciranja in več zvišanj krvnega tlaka.
The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Biološka aktivnost D7D in klinični vpliv zaradi dviga ravni tega metabolita nista bila jasna.
The rabbit study was performed to specifically examine local tolerance aspects.
Namen študije pri zajcih je bil specifično proučiti aspekte lokalnega prenašanja.
The primary endpoint was overall survival which was defined as the time from the date of randomization to the date of death from any cause.
Primarni končni cilj preskušanja je bilo celokupno preživetje, ki so ga definirali kot čas od dneva randomizacije do dneva smrti iz katerega koli vzroka.
Not known
Ni znano,
21 months.
21 mesecev
Herceptin is not genotoxic.
Zdravilo Herceptin ni genotoksično.
Herceptin can cause breathing difficulties, especially when it is first given.
Zdravilo Herceptin lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
Periodic Safety Update Reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
Zahteve glede predložitve rednega posodobljega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
It has been associated with a fatal outcome.
Povezan je bil s smrtnim izidom.
• sweating
· znojenje
Children and adolescents Herceptin is not recommended for anyone under the age of 18 years.
Uporaba pri otrocih in mladostnikih Zdravilo Herceptin ni priporočljivo za mlajše od 18 let.
Non-clinical data for recombinant human hyaluronidase reveal no special hazard for humans based on conventional studies of repeated dose toxicity including safety pharmacology endpoints.
Predklinični podatki o rekombinantni humani hialuronidazi ne kažejo posebnega tveganja za ljudi na osnovi konvencionalnih študij toksičnosti ponavljajočih se odmerkov, vključno z varnostnimi farmakološkimi končnimi točkami.
Herceptin should only be given by a doctor or nurse.
Zdravilo Herceptin lahko daje le zdravnik ali medicinska sestra.
• Risk Management Plan (RMP)
ZDRAVILA · Načrt za obvladovanje tveganja (RMP)
The frequency of occurrence of hypoprothrombinemia is not known.
Pogostnost pojavljanja hipoprotrombinemije ni znana.
• swelling or bleeding at the back of the eyes
· otekanje ali krvavitev v ozadju oči
Specific percentages for these are not available.
natančnih odstotkih ni podatkov.
dihydro-doxorubicinone, D7D).
dihidro-doksorubicinonu, D7D).
Do not stop using this medicine without talking to your doctor first.
Ne prenehajte uporabljati tega zdravila brez posvetovanja z zdravnikom.
When Herceptin binds to HER2 it stops the growth of such cells and causes them to die.
Ko se zdravilo Herceptin veže na HER2, zaustavi rast teh celic in povzroči njihovo smrt.
All doses should be taken at the right time every three weeks.
Vse odmerke morate prejeti v ustreznem času vsake tri tedne.
Do not dilute with glucose solutions since these cause aggregation of the protein.
Ne redčite z raztopinami glukoze, ker le-te povzročajo agregacijo beljakovin.
• you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
· imate hude težave z dihanjem v mirovanju zaradi raka ali če potrebujete zdravljenje s kisikom.
It is not known whether Herceptin can affect reproductive capacity.
Ni znano, ali lahko zdravilo Herceptin škodljivo vpliva na sposobnost za razmnoževanje.
No. patients with event (%)
Št. bolnikov z dogodkom (%)
No grade 4 or grade 5 adverse events were reported.
O neželenih učinkih stopnje 4 ali 5 niso poročali.
• allergic reactions
· alergijske reakcije
Greater than 70 % of patients enrolled exhibited 3+ overexpression.
Več kot 70 % vključenih bolnikov je izkazovalo čezmerno izražanje stopnje 3+.
However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13
Trastuzumab pa lahko zviša celokupno izpostavljenost enemu metabolitu doksorubicina (7-deoksi-13
For monotherapy, the rate was 6 % - 9 %.
Za monoterapijo je bil odstotek 6 do 9.
The injection site should be alternated between the left and right thigh.
Mesto injiciranja je treba menjavati med levim in desnim stegnom.
• dry mouth and skin
· suha usta in koža
Death (OS event):
Smrt (dogodek celokupnega preživetja):
Therefore, these patients should not be treated with Herceptin (see section 4.3).
Zato takih bolnikov ne smemo zdraviti z zdravilom Herceptin (glejte poglavje 4.3).
If you stop using Herceptin
Če ste prenehali uporabljati zdravilo Herceptin
Long term follow-up efficacy analysis**
Analiza dolgoročnega spremljanja učinkovitosti**
Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5 % of patients.
Reverzibilnost blage simptomatske in asimptomatske disfunkcije levega prekata je bila dokazana pri 79,5 % bolnikov.
All but one patient who reported severe hypertension had a history of hypertension before they entered the study.
Vsi bolniki razen enega, pri katerem so poročali o hudi hipertenziji, so imeli hipertenzijo že pred vključitvijo v študijo.
t1/2 range from Cmax,ss to
Obseg t1/2 od Cmax, ss do
Only patients with a large amount of HER2 will be treated with Herceptin.
Le bolniki z velikim številom HER2 bodo zdravljeni z zdravilom Herceptin.
• Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
· Včasih se lahko med zdravljenjem ali občasno tudi po končanem zdravljenju pojavijo težave s srcem, ki so lahko resne.
Unopened vial 4 years
6.3 Rok uporabnosti Neodprta viala 4 leta
• depression
· depresija
Approximately 17 % of cardiac dysfunction related events occurred after completion of Herceptin.
Približno 17 % dogodkov, povezanih z motnjo delovanja srca, je nastopilo po zaključku zdravljenja z zdravilom Herceptin.
• Infusion solutions should be used immediately after dilution.
· Infuzijsko raztopino je treba uporabiti takoj po razredčitvi.
• Medicines should not be disposed of via wastewater or household waste.
· Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Docetaxel3 N=94
docetaksel3 n = 94
Observation N= 1697***
opazovanje n = 1697***
What Herceptin is and what it is used for What you need to know before you are given Herceptin How Herceptin is given
Kaj je zdravilo Herceptin in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Herceptin Kako se zdravilo Herceptin daje
TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
TTP = čas do napredovanja bolezni (time to progression); “no” - ni bilo mogoče oceniti ali pa še ni bilo doseženo; IZ = interval zaupanja
FP + H: Fluoropyrimidine/cisplatin + Herceptin FP: Fluoropyrimidine/cisplatin a Odds ratio
FP+H: fluoropirimidin/cisplatin + Herceptin FP: fluoropirimidin/cisplatin a: razmerje obetov
What Herceptin is and what it is used for
Kaj je zdravilo Herceptin in za kaj ga uporabljamo
Based on the observed data in study BO22227, steady state with the intravenous formulation was reached at cycle 8.
Glede na opažene podatke v študiji BO22227 je bilo stanje dinamičnega ravnovesja pri intravenski obliki doseženo v 8. ciklu.
Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of Herceptin (see section 4.4) and have been associated with a fatal outcome.
Hude anafilaktične reakcije, ki zahtevajo takojšnje dodatno posredovanje se lahko pojavijo, ponavadi med prvo ali drugo infuzijo zdravila Herceptin (glejte poglavje 4.4); povezane so lahko tudi s smrtnim izidom.
• pain in the arms and/or legs
· bolečina v rokah in/ali nogah
Primary tumor type and Regimen
Vrsta primarnega tumorja in režim
Bioavailability of trastuzumab given as the subcutaneous formulation was estimated to be 77.1%, and the first order absorption rate constant was estimated to be 0.4 day-1.
Biološka uporabnost trastuzumaba, danega v subkutani obliki, je bila ocenjena na 77,1 %, konstanta hitrosti absorpcije prvega reda pa na 0,4 dni-1.
Total pathological complete response* (95 % CI)
Skupni popolni patološki odgovor* (95-% IZ)
Two different types (formulations) of Herceptin exist:
Obstajata dve različni obliki zdravila Herceptin:
Overexpression of HER2 is observed in 20 %-30 % of primary breast cancers.
Čezmerno izražanje HER2 so opazili pri 20 do 30 % primarnega raka dojk.
Herceptin 1 Year N = 1702***
Herceptin 1 leto n = 1702***
Herceptin was administered weekly with chemotherapy and 3 weekly thereafter for a total of 52 weeks.
Zdravilo Herceptin so dajali tedensko s kemoterapijo, nato pa vsake 3 tedne, skupaj 52 tednov.
Chemo + Herceptin (n=115)
Kemoterapija + zdravilo Herceptin (n = 115)
Your doctor will closely supervise your therapy.
Vaš zdravnik bo vaše zdravljenje pozorno spremljal.
New injections should be given at least 2.5 cm from the old site and never into areas where the skin is red, bruised,
Nove injekcije damo najmanj 2,5 cm oddaljeno od prejšnjega mesta injiciranja in nikoli na področja, kjer je koža pordela, ima modrice, je nežna ali trda.
• sleepiness (somnolence)
· zaspanost (somnolenca)
Women who become pregnant should be advised of the possibility of harm to the fetus.
Ženske, ki zanosijo, je treba opozoriti na možnost poškodb ploda.
How to store Herceptin Herceptin will be stored by the health professionals at the hospital or clinic.
Shranjevanje zdravila Herceptin Zdravilo Herceptin shranujujejo zdravstveni delavci v bolnišnici ali na kliniki.
• you have ever had or are currently using a medicine called doxorubicin or epirubicin (medicines used to treat cancer).
· prejemate ali ste kadar koli prejeli zdravilo, ki se imenuje doksorubicin ali epirubicin (zdravili, ki se uporabljata za zdravljenje raka).
The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of Herceptin versus observation.
Rezultati učinkovitosti iz vmesne analize učinkovitosti so presegli s protokolom vnaprej določeno statistično mejo za primerjavo enoletnega zdravljenja z zdravilom Herceptin z opazovanjem.
What you need to know before you are given Herceptin Do not use Herceptin if:
Kaj morate vedeti, preden boste prejeli zdravilo Herceptin Ne uporabljajte zdravila Herceptin, če:
Herceptin subcutaneous formulation was locally and systemically well tolerated.
Subkutano obliko zdravila Herceptin so lokalno in sistemsko dobro prenašali.
Other side effects that have been reported with Herceptin use: frequency cannot be estimated from the available data
Drugi neželeni učinki, o katerih so poročali v zvezi z uporabo zdravila Herceptin in za katere pogostnosti ni mogoče oceniti iz podatkov, ki so na voljo:
Herceptin loading dose should be administered as a 90-minute intravenous infusion.
Uvajalni odmerek zdravila Herceptin se daje kot 90-minutna intravenska infuzija.
In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50 % of tumour cells.
V splošnem velja, da je rezultat metode CISH pozitiven, če obstaja več kot 5 kopij gena HER2 na jedro v več kot 50 % tumorskih celic.
Each carton contains one vial.
Vsaka škatla vsebuje eno vialo.
• abnormal thinking
· nenormalno razmišljanje
Each vial contains 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection.
Ena viala vsebuje 150 mg trastuzumaba, ki ga je treba raztopiti v 7,2 ml vode za injekcije.
The dose of Herceptin depends on your body weight.
Odmerek zdravila Herceptin je odvisen od vaše telesne mase.
• Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy.
· Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila Herceptin v času nosečnosti.
The mean Ctrough at the subcutaneous pre- dose cycle 18 was 90.7 µg/mL and is similar to that of cycle 13, suggesting no further increase after cycle 13.
Povprečna najnižja koncentracija pri subkutanem dajanju pred 18. ciklom je bila 90,7 µg/ml in je bila podobna tisti pred 13. ciklom, kar nakazuje, da po 13. ciklu ni nadaljnjega zvišanja.
• you have ever had any other treatment for cancer.
· ste se že zdravili zaradi raka.
• Do not freeze the reconstituted solution.
· Rekonstituirane raztopine ne zamrzujte.
*Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
*Cmin, ss - Cmin v stanju dinamičnega ravnovesja **Cmax, ss = Cmax v stanju dinamičnega ravnovesja *** čas do 90 % stanja dinamičnega ravnovesja
Primary tumor type N
Vrsta primarnega tumorja n
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; običajno ne presegajo 24 ur pri temperaturi od 2 °C do 8 °C, razen če sta rekonstitucija in redčenje potekala v kontroliranih in validiranih aseptičnih pogojih.
If during treatment, you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear.
Če se med zdravljenjem pojavijo simptomi, kot je mrzlica ali zvišana telesna temperatura, ne smete voziti ali upravljati strojev, dokler ti simptomi ne izginejo.
The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Rezultati teh simulacij kažejo, da bo najmanj 95 % bolnikov do 7. meseca doseglo koncentracije < 1 μg/ml (približno 3 % Cmin, ss predvidene za populacijo ali približno 97-% izpiranje).
Paediatric population There is no relevant use of Herceptin in the paediatric population.
Pediatrična populacija Uporaba zdravila Herceptin pri pediatrični populaciji ni smiselna.
The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a Herceptin containing regimen after progression of disease.
Razlika ni bila statistično značilna, vendar pa je več kot polovica bolnikov iz skupine, ki je jemala le anastrozol po napredovanju bolezni, prešla na shemo, ki je vsebovala zdravilo Herceptin.
The 13week study was performed to confirm that the change in route of administration and the use of the novel excipient recombinant human hyaluronidase (rHuPH20) did not have an effect on the Herceptin safety characteristics.
Študija, ki je trajala 13 tednov, pa je bila opravljena, da bi potrdili, da sprememba poti aplikacije in uporaba nove pomožne snovi humane hialuronidaze (rHuPH20) ni imela vpliva na varnostne lastnosti zdravila Herceptin.
For storage conditions of the opened medicinal product, see section 6.3 and 6.6.
Za pogoje shranjevanja odprtega zdravila glejte poglavji 6.3 in 6.6.
P-value versus Observation
P-vrednost v primerjavi z opazovanjem
In the adjuvant treatment setting, Herceptin was investigated in 4 large multicentre, randomised, trials.
Pri adjuvantnem zdravljenju so zdravilo Herceptin proučevali v 4 obsežnih, multicentričnih,
At the time of a safety update after a median of 3.5-3.8 years follow up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Ob pregledu varnosti po mediani spremljanja 3,5 do 3,8 leta je analiza preživetja brez bolezni ponovno potrdila velikost koristi, prikazane v končni analizi preživetja brez bolezni.
Other medicines and Herceptin
Druga zdravila in zdravilo Herceptin
Linear clearance was 0.111 L/day and the central compartment volume (Vc) was 2.91 L. The Michaelis-Menten parameter values were 11.9 mg/day and 33.9 µg/mL for Vmax and Km, respectively.
Linearni očistek je bil 0,111 l/dan, volumen centralnega prostora (Vc) pa 2,9 l. Vrednosti Michaelis-Mentenovih parametrov sta bili 11,9 mg/dan za Vmax in 33,9 µg/ml za Km.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 600 mg/5 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 600 mg/5 ml
Reproductive toxicology studies with rHuPH20 revealed embryofetal toxicity in mice at high systemic exposure, but did not show teratogenic potential.
Študije vpliva na sposobnost razmnoževanja z rHuPH20 so pokazale embriofetalno toksičnost pri miših pri visoki sistemski izpostavljenosti brez teratogenega potenciala.
1 Blood pressure increased
1zvišanje krvnega tlaka
Upon opening of the vial, the solution should be used immediately.
Ko vialo odprete, je treba raztopino uporabiti takoj.
The most frequent severe reaction was drug hypersensitivity.
Najbolj pogost resen neželeni učinek je bil preobčutljivost za zdravilo.
Herceptin intravenous formulation is given as an intravenous infusion (“drip”) directly into your veins.
Zdravilo Herceptin v intravenski obliki se daje kot intravenska infuzija (»s kapljanjem«) neposredno v vaše žile.
Herceptin may have a minor influence on the ability to drive or use machines (see section 4.8).
Zdravilo Herceptin ima lahko blag vpliv na sposobnost vožnje in upravljanje strojev (glejte poglavje 4.8).
Experience of concurrent administration of trastuzumab with low dose anthracycline regimens is currently limited to two trials (MO16432 and BO22227).
Izkušnje z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, so trenutno vezane na dve študiji (MO16432 in BO22227).
The rate was highest in patients who were administered Herceptin concurrently with a taxane (2.0 %).
Delež je bil najvišji pri bolnikih, ki so zdravilo Herceptin prejeli sočasno s taksanom (2,0 %).
Cycle 1 297 Cycle 7 (steady state)
Cikel 1 297 Cikel 7 (stanje dinamičnega ravnovesja) Izpiranje trastuzumaba
• prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
· Priprava mora potekati v komori z laminarnim pretokom zraka ali v varnostni komori za pripravo bioloških zdravil; upoštevati je treba standardne previdnostne ukrepe za varno ravnanje z intravenskimi zdravili.
Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded.
so bili vključeni, tisti z 0 ali 1+ pa izključeni.
Treatment with Herceptin alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Samostojno zdravljenje z zdravilom Herceptin ali v kombinaciji s taksanom lahko vpliva na srce, še posebno, če ste se kdaj zdravili z antraciklinom (taksani in antraciklini sta dve drugi vrsti zdravil, ki se uporabljata za zdravljenje raka).
The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster nonlinear clearance (lower Km) (P < 0.001).
Eksplorativne analize sospremenljivk, opravljene samo s podatki za podskupino bolnikov, kažejo, da so imeli bolniki z višjimi vrednostmi odcepljene HER2-ECD hitrejši nelinearni očistek (nižjo Km) (p < 0,001).
Herceptin may affect your ability to drive a car or operate machines.
Zdravilo Herceptin lahko vpliva na vašo sposobnost za vožnjo ali upravljanje strojev.
Herceptin SC (N=260)
Herceptin s.c. (n = 260)
At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8 %) in the control arm and 167 patients (56.8 %) in the treatment arm.
Do časa analize je umrlo skupaj 349 randomiziranih bolnikov: 182 bolnikov (62,8 %) v kontrolni skupini in 167 bolnikov (56,8 %) v skupini, ki je prejemala tudi zdravilo Herceptin.
Results were consistent with the known safety profile for Herceptin intravenous and Herceptin subcutaneous formulations.
Rezultati so bili skladni z znanim varnostnim profilom zdravila Herceptin v intravenski in subkutani obliki.
Herceptin has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Zdravilo Herceptin so proučevali v randomiziranem, odprtem preskušanju faze III ToGA (BO18255) v kombinaciji s kemoterapijo v primerjavi s samo kemoterapijo.
• feeling weak and unwell
· občutek šibkosti in slabo počutje
Patients treated with Herceptin are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Pri bolnikih, ki so se zdravili z zdravilom Herceptin, obstaja večje tveganje za pojav kongestivnega srčnega popuščanja (New York Heart Association - NYHA, razred II-IV) ali asimptomatične motnje v delovanju srca.