natgillin/translations-raw huggingface dataset:
The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 mcg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients.
Vrednosti parametrov nelinearnega izločanja so bile 8,81 mg/dan za največjo hitrost izločanja (Vmax) in 8,92 µg/ml za Michaelis-Mentenovo konstanto (Km) za bolnike z MBC, EBC in AGC.
- The active substance is trastuzumab.
- Učinkovina je trastuzumab.
Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2).
Če se pojavi infuzijska reakcija, je potrebno infundiranje zdravila Ogivri prekiniti ali upočasniti njegovo hitrost in bolnika nadzorovati, dokler vsi simptomi ne izzvenijo (glejte poglavje 4.2).
Any remaining reconstituted solution should be discarded.
Ostanke rekonstituirane raztopine je treba zavreči.
For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Ogivri is given every 3 weeks.
Pri zgodnji obliki raka dojk, metastatskem raku dojk in metastatskem raku želodca se zdravilo Ogivri daje vsake 3 tedne.
L-histidine hydrochloride
L-histidinijev klorid hidrat
• fluid retention (swelling) in the legs or arms,
• zadrževanje tekočine (otekanje) v nogah ali rokah,
In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of trastuzumab, or longer if a continuous decrease of LVEF is observed.
Pri bolnikih, ki prejemajo kemoterapijo z antraciklini, je priporočljivo nadaljnje spremljanje, ki ga je treba izvajati letno do 5 let po zadnjem dajanju trastuzumaba ali dlje, če iztisni delež levega prekata (LVEF) stalno pada.
After reconstitution with sterile water for injections, the reconstituted solution is physically and chemically stable for 48 hours at 2°C-8°C.
Po rekonstituciji s sterilno vodo za injekcije je rekonstituirana raztopina fizikalno in kemijsko stabilna 48 ur pri temperaturi od 2 °C-8 °C.
Glucose solutions must not be used for dilution since these cause aggregation of the protein.
Za redčenje ne uporabljajte raztopin glukoze, ker le-te povzročajo agregacijo beljakovin.
Paediatric population There is no relevant use of trastuzumab in the paediatric population.
Pediatrična populacija Trastuzamab ni namenjen za uporabo pri pediatrični populaciji.
Other side effects can occur at any time during treatment with Ogivri, not just related to an infusion.
Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Ogivri in niso povezani le z infuzijo.
If you stop using Ogivri
Če ste prenehali uporabljati zdravilo Ogivri
6.6 Special precautions for disposal and other handling Ogivri should be carefully handled during reconstitution.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Med rekonstitucijo se mora z zdravilom Ogivri pazljivo ravnati.
If you receive Ogivri 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.
Če prejemate zdravilo Ogivri z drugimi zdravili za zdravljenje raka, kot so paklitaksel, docetaksel, zaviralec aromataze, kapecitabin, 5-fluorouracil ali cisplatin, preberite tudi navodila za uporabo teh zdravil.
Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Ogivri is a biosimilar medicinal product.
Zdravilo Ogivri je podobno biološko zdravilo.
You must tell your doctor before receiving this medicine if you have HFI or if you can no longer take sweet foods or drinks because you feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Preden prejmete to zdravilo, morate zdravnika obvestiti o svoji intoleranci za fruktozo, prav tako mu morate povedati, če ne morete več uživati sladke hrane ali sladkih napitkov, ker vam je slabo, bruhate ali se neprijetno počutite (npr. napenjanje, krči v trebuhu, driska).
Sorbitol content
Vsebnost sorbitola
420 mg vial
420-mg viala
Patients treated with trastuzumab 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 s trastuzumabom, obstaja večje tveganje za pojav kongestivnega srčnega popuščanja (New York Heart Association - NYHA, razred II−IV) ali asimptomatične motnje v delovanju srca.
Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Zdravilo shranjujte v dobro zaprti originalni ovojnini pri temperaturi 2 °C - 8 °C, v hladilniku.
Experience of concurrent administration of trastuzumab with low dose anthracycline regimens is currently limited to the trial MO16432.
Izkušnje z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, so trenutno vezane na študijo MO16432.
Time to steadystate*** (week)
Čas do stanja dinamične ga ravnovesja *** (tedni)
Study H0649g: IHC3+ patient subset
1 Študija H0649g: IHC 3+ podskupina bolnikov
For the other parameters the improvements seen for the combination were for overall response (16.5 % versus 6.7 %); clinical benefit rate (42.7 % versus 27.9 %); time to progression (4.8 months versus 2.4 months).
Pri drugih parametrih so bila izboljšanja pri kombinaciji vidna pri celokupnem odgovoru (16,5 % v primerjavi s 6,7 %), deležu klinične koristi (42,7 % v primerjavi s 27,9 %) in času do napredovanja bolezni (4,8 meseca v primerjavi z 2,4 meseca).
Study JP19959 was a sub study of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer (AGC) to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab.
Študija JP19959 je bila podštudija BO18255 (ToGA) pri japonskih bolnikih in bolnicah z napredovalim rakom želodca (AGC - advanced gastric cancer), v kateri so proučevali farmakokinetiko kapecitabina in cisplatina s trastuzumabom ali brez njega.
Ogivri is for single-use only, as the product contains no preservatives.
Zdravilo Ogivri je namenjeno samo za enkratno uporabo, saj ne vsebuje konzervansov.
The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27 %), and was significantly higher than for anthracycline/cyclophosphamide alone (7 % - 10 %).
Najvišji delež motenj v delovanju srca je bil pri bolnikih, ki so trastuzumab prejemali sočasno z antraciklinom/ciklofosfamidom (27 %), bil je signifikantno višji kot pri jemanju samega antraciklina/ciklofosfamida (7 do 10 %).
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1341/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/18/1341/001 EU/1/18/1341/002
The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8 % versus 45.7 %; p = 0.004).
Pogostnost napredovanja v jetrih je bila signifikantno zmanjšana pri bolnikih, zdravljenih s kombinacijo trastuzumaba in paklitaksela, v primerjavi s samim paklitakselom (21,8 % v primerjavi s 45,7 %; p = 0,004).
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P
A: doksorubicin; C: ciklofosfamid; P: paklitaksel; H: trastuzumab; IZ: interval zaupanja * Po mediani spremljanja 1,8 leta za bolnike v skupini AC → P in 2,0 leta za bolnike v skupini AC → PH. ** Vrednost p za celokupno preživetje ni presegla vnaprej določene statistične meje za primerjavo AC → PH
Study H0648g: IHC3+ patient subset
2 Študija H0648g: IHC 3+ podskupina bolnikov
In patients receiving trastuzumab after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) > 25 kg/m2.
Pri bolnikih, ki so prejemali trastuzumab po zaključku adjuvantne kemoterapije, je bilo tveganje za pojav motnje v delovanju srca povezano z višjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo trastuzumaba in visokim indeksom telesne mase (body mass index - BMI) > 25 kg/m².
Trastuzumab plus docetaxel4 N = 110
Trastuzumab plus docetaksel4 n = 110
At the time of the analysis a total of 349 randomised 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 Ogivri.
• if you are allergic to trastuzumab, murine (mouse) proteins, or any of the other ingredients of this medicine (listed in section 6).
• ste alergični na trastuzumab, murine (mišje) beljakovine ali katero koli sestavino tega zdravila
If you experience any of the above symptoms when your treatment with Ogivri has finished, you should see your doctor and tell them that you have previously been treated with Ogivri.
Če se kateri koli izmed zgornjih simptomov pojavi po končanem zdravljenju z zdravilom Ogivri, obiščite zdravnika in ga obvestite o tem, da ste se zdravili z zdravilom Ogivri.
MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Bolniki z MBC in EBC so imeli podobne farmakokinetične parametre (npr. očistek, volumen centralnega prostora (Vc)) in izpostavljenosti v stanju dinamičnega ravnovesja (Cmin, Cmax in AUC).
Congestive heart failure (NYHA Class II - IV) is a common adverse reaction associated with the use of trastuzumab and has been associated with a fatal outcome (see section 4.4).
Kongestivno srčno popuščanje, NYHA razred II-IV, je pogost neželeni učinek, povezan z uporabo trastuzumaba; povezan je bil tudi s smrtnim izidom (glejte poglavje 4.4).
or - intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days,
ali - 5-fluorouracil intravensko - 800 mg/m²/dan v obliki kontinuirane intravenske infuzije 5 dni,
In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3-0.4 %).
V treh ključnih kliničnih preskušanjih pri adjuvantnem zdravljenju s trastuzumabom v kombinaciji s kemoterapijo je bila incidenca motenj v delovanju srca stopnje 3/4 (še posebno simptomatskega kongestivnega srčnega popuščanja) podobna pri bolnikih, ki so prejeli le kemoterapijo (to je, da niso prejeli trastuzumaba), in pri bolnikih, ki so prejeli trastuzumab zaporedno po taksanu (0,3 do 0,4 %).
No incompatibilities between Ogivri and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Med zdravilom Ogivri in polivinilkloridnimi, polietilenskimi ali polipropilenskimi vrečkami inkompatibilnosti niso opazili.
Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Bolnike, ki so predhodno prejemali adjuvantno kemoterapijo na osnovi antraciklinov, so zdravili s paklitakselom (175 mg/m², infundirano v 3 urah) samim ali skupaj s trastuzumabom.
Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary.
Bolniki z dedno intoleranco na fruktozo tega zdravila ne smejo jemati, razen če je to nujno potrebno.
Observation N = 1693
Opazovanje n = 1693
Docetaxel3 N = 94
Docetaksel3 n = 94
*Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover of 52 % of patients from the observation arm to trastuzumab) *** There is a discrepancy in the overall sample size due to a small number of patients who were randomised after the cut-off date for the 12-month median follow-up analysis
** Končna analiza (vključno s prehodom 52 % bolnikov z opazovanja na trastuzumab) *** V celokupni velikosti vzorca je neskladje zaradi majhnega števila bolnikov, ki so jih randomizirali po preteku datuma, do katerega so upoštevali podatke za analizo po mediano 12-mesečnem spremljanju.
During an Ogivri infusion, chills, fever and other flu like symptoms may occur.
Med infuzijo zdravila Ogivri se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi simptomi, podobni gripi.
In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Ogivri (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 Ogivri (trastuzumab) in ne trastuzumab emtanzin.
Blood pressure increased
1zvišanje krvnega tlaka
In order to prevent medication errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is 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 trastuzumab in ne trastuzumab emtanzin.
Other medicines and Ogivri
Druga zdravila in zdravilo Ogivri
L-histidine hydrochloride, L-histidine, sorbitol, macrogol 3350, hydrochloric acid and sodium hydroxide.
L-histidinijev klorid hidrat, L-histidin, sorbitol, makrogol 3350, klorovodikova kislina in natrijev hidroksid.
Trastuzumab may persist in the circulation for up to 7 months after stopping Ogivri treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Trastuzumab je lahko po prenehanju zdravljenja z zdravilom Ogivri v krvnem obtoku prisoten do 7 mesecev glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov (glejte poglavje 5.2).
A detailed history with regards to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
Za vsakega bolnika je treba pred dajanjem tega zdravila priskrbeti podrobno anamnezo v zvezi s simptomi intolerance na fruktozo.
AUCss, 0-21days (mcg.day/mL)
AUCss, 0-21. dan (μg.dan/ml)
A volume overage of 4.8 % ensures that the labelled dose of 420 mg can be withdrawn from each vial.
4,8-% presežek volumna omogoča, da se na nalepki naveden odmerek 420 mg res odvzame iz viale.
If you receive Ogivri in combination with chemotherapy, some of them may also be due to the chemotherapy.
Če prejemate skupaj z zdravilom Ogivri tudi kemoterapijo, so lahko nekateri neželeni učinki nastali tudi zaradi kemoterapije.
Ogivri 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 Ogivri 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.
Do not breast-feed your baby during Ogivri therapy and for 7 months after the last dose of Ogivri as this medicine may pass to your baby through your breast milk.
Med zdravljenjem z zdravilom Ogivri in 7 mesecev po zadnjem odmerku zdravila ne smete dojiti, ker lahko to zdravilo prehaja v materino mleko in s tem do vašega otroka.
All candidates for treatment with trastuzumab, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging.
Vsi kandidati za zdravljenje s trastuzumabom, 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.
What Ogivri looks like and contents of the pack
Izgled zdravila Ogivri in vsebina pakiranja
A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.
4-% presežek volumna omogoča, da se na nalepki naveden odmerek 150 mg res odvzame iz viale.
If symptomatic cardiac failure develops during trastuzumab therapy, it should be treated with standard medicinal products for CHF.
Če se med zdravljenjem s trastuzumabom razvije simptomatsko srčno popuščanje, ga zdravimo s standardnimi zdravili za kongestivno srčno popuščanje.
From a microbiological point of view, the reconstituted solution and Ogivri infusion solution should be used immediately.
Z mikrobiološkega stališča je treba pripravljeno raztopino zdravila Ogivri za infundiranje uporabiti takoj.
If the patient has missed a dose of trastuzumab by more than one week, a re-loading dose of trastuzumab should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; threeweekly regimen: 8 mg/kg) as soon as possible.
Če je bolnik izpustil odmerek trastuzumaba za več kot en teden, mu je treba čim prej ponovno dati uvajalni odmerek trastuzumaba v približno 90 minutah (tedenski režim: 4 mg/kg; 3-tedenski režim:
If the patient has missed a dose of trastuzumab 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.
Če je bolnik izpustil odmerek trastuzumaba 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.
Each 150 mg vial contains 115.2 mg sorbitol (E420).
Ena 150 mg viala vsebuje 115,2 mg sorbitola (E420).
Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (> 50 years), low LVEF (< 55 %) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Dejavniki tveganja za pojav neželenega učinka, povezanega s srcem, ki so jih opazili v štirih velikih adjuvantnih študijah, so vključevali starost nad 50 let, majhno osnovno vrednost LVEF (< 55 %), majhno vrednost LVEF pred začetkom zdravljenja s paklitakselom ali po njem, upad LVEF za 10 do 15 točk in predhodno ali sočasno uporabo zdravil za zniževanje krvnega tlaka.
In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 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 s trastuzumabom, 0,8 %, delež blage simptomatske in asimptomatske disfunkcije levega prekata pa 4,6 %.
Death (OS event): No. patients with event (%)
Smrt (dogodek celokupnega preživetja): št. bolnikov z dogodkom (%)
In the final population PK model, in addition to primary tumour type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab.
V končnem populacijskem farmakokinetičnem modelu so bile kot statistično pomembne sospremenljivke, ki vplivajo na izpostavljenost trastuzumabu, poleg vrste primarnega tumorja opredeljene tudi telesna masa, serumska aspartat-aminotransferaza in albumin.
In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9 % and 12 % when it was combined with paclitaxel compared with 1 % - 4 % for paclitaxel alone.
V ključnih preskušanjih z intravensko danim trastuzumabom pri metastatski bolezni je bila incidenca motenj v delovanju srca pri bolnikih, ki so zdravilo prejemali sočasno s paklitakselom, v razponu od 9 do 12 % v primerjavi z 1 do 4 % pri samostojnem jemanju paklitaksela.
What Ogivri is and what it is used for What you need to know before you are given Ogivri How Ogivri is given
Kaj je zdravilo Ogivri in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Ogivri Kako se zdravilo Ogivri daje Možni neželeni učinki
Paclitaxel2 N = 77
Paklitaksel2 n = 77
The reconstituted Ogivri results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Raztopljeno zdravilo Ogivri je brezbarvna do rahlo rumena prozorna tekočina, ki mora biti brez vidnih delcev.
If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of trastuzumab therapy has been seen.
Pri bolnikih s kontinuiranim upadanjem funkcije levega prekata, ki ostajajo asimptomatični, naj zdravnik razmisli o ukinitvi zdravljenja s trastuzumabom, če klinična korist ni bila opazna.
Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of Ogivri that can be withdrawn from the vial.
Povzročitev pretiranega penjenja med rekonstitucijo ali tresenje že pripravljene raztopine lahko povzroči težave s količino zdravila Ogivri, ki se ga odvzame iz viale.
4.4 Special warnings and precautions for use Traceability
4.4 Posebna opozorila in previdnostni ukrepi
Despite the cross-over to trastuzumab in the control arm, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52 % decrease in the risk of disease recurrence.
Kljub prehodu na trastuzumab v kontrolni skupini, je dodatek trastuzumaba kemoterapiji s paklitakselom zmanjšal tveganje za ponovitev bolezni za 52 %.
Ogivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Zdravilo Ogivri je v kombinaciji s kapecitabinom ali 5-fluorouracilom in cisplatinom indicirano za zdravljenje odraslih bolnikov s HER2-pozitivnim metastatskim adenokarcinomom želodca ali gastroezofagealnega prehoda, ki še niso prejemali zdravil za zdravljenje raka za metastatsko bolezen.
Trastuzumab intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available.
Intravensko infuzijo trastuzumaba mora dajati zdravstveno osebje, usposobljeno za ukrepanje ob anafilaksiji; na voljo mora biti oprema za urgentno ukrepanje.
DCarbH (vs. AC→D) (BCIRG 006)
DCarbH (v primerjavi z AC→D) (BCIRG 006)
More patients treated with trastuzumab and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6 % versus 6.5 %; p = 0.377).
Progresija v osrednjem živčnem sistemu je bila pri bolnikih, zdravljenih s trastuzumabom in paklitakselom, pogostejša kot pri tistih, ki so prejemali le paklitaksel (12,6 % v primerjavi s 6,5 %; p = 0,377).
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 trastuzumab.
Preglede srca, enake kot je bil osnovni, je treba med zdravljenjem ponoviti vsake 3 mesece in vsakih 6 mesecev po končanem zdravljenju do 24 mesecev po prejemu zadnjega odmerka trastuzumaba.
Trastuzumab plus paclitaxel3 N = 32
Trastuzumab plus paklitaksel3 n = 32