natgillin/translations-raw huggingface dataset:
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 na prisotnost ženskih spolnih hormonov);
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.
If you experience any of the above symptoms when your treatment with KANJINTI has finished, you should see your doctor and tell them that you have previously been treated with KANJINTI.
Če se kateri koli izmed zgornjih simptomov pojavi po končanem zdravljenju z zdravilom KANJINTI, obiščite zdravnika in ga obvestite o tem, da ste se zdravili z zdravilom KANJINTI.
Some of the side effects you experience may be due to your underlying cancer.
Vzrok nekaterim neželenim učinkom, ki jih opazite, je lahko vaša bolezen - rak.
• you have ever had any other treatment for cancer.
• ste se že zdravili zaradi raka.
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), predvidene za populacijo.
Pharmacokinetic data from Study H4613g/GO01305 suggested that carboplatin had no impact on the PK of trastuzumab.
Farmakokinetični podatki iz študije H4613g/GO01305 so nakazali, da karboplatin ni imel vpliva na farmakokinetiko trastuzumaba.
As animal reproduction studies are not always predictive of human response, KANJINTI should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Izsledki študij o vplivu na sposobnost za razmnoževanje pri živalih ne veljajo vedno tudi za ljudi, zato se moramo uporabi zdravila KANJINTI med nosečnostjo izogibati, razen v primerih, ko pričakovana korist za mater upravičuje tveganje za plod.
Trastuzumab was administered weekly with chemotherapy and 3-weekly thereafter for a total of 52 weeks.
Trastuzumab so dajali tedensko s kemoterapijo, nato pa vsake 3 tedne, skupaj 52 tednov.
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 to 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 %).
Use of other reconstitution solvents should be avoided.
Uporaba drugih topil za rekonstitucijo ni dovoljena.
From a microbiological point of view, the reconstituted solution and KANJINTI infusion solution should be used immediately.
Z mikrobiološkega stališča je rekonstituirano raztopino in zdravilo KANJINTI raztopino za infundiranje treba uporabiti takoj.
Heart checks
Pregledi srca
If you have metastatic gastric cancer
Če imate metastatski rak želodca
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 (either 80 or 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).
Do not freeze the reconstituted solution.
Rekonstituirane raztopine ne zamrzujte.
Aseptic handling must be ensured when preparing the infusion.
Pri pripravi infuzije je treba zagotoviti aseptično ravnanje:
The administration of concomitant anastrozole did not appear to influence the pharmacokinetics of trastuzumab.
Sočasno dajanje anastrazola ni imelo vpliva na farmakokinetiko trastuzumaba.
• abnormal development of the kidneys of the baby in the womb
• nenormalen razvoj ledvic otroka v maternici
KANJINTI 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 KANJINTI 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.
As a result, trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2.
Posledično je trastuzumab tako v in vitro študijah kot tudi pri živalih zaviral delitev človeških tumorskih celic, ki čezmerno izražajo HER2.
Patients who receive anthracyclines after stopping KANJINTI may possibly be at increased risk of cardiac dysfunction.
Pri bolnikih, ki prejemajo antracikline po prenehanju zdravljenja z zdravilom KANJINTI, lahko obstaja večje tveganje za motnje v delovanju srca.
In general, FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2, or if there are more than 4 copies of the HER2 gene per tumour cell if no chromosome 17 control is used.
V splošnem velja, da je rezultat metode FISH pozitiven, če je razmerje med številom kopij gena HER2 na tumorsko celico in številom kopij kromosoma 17 večje ali enako 2, ali če je število kopij gena HER2 na tumorsko celico večje od 4, če ne uporabimo preverjanja s kromosomom 17.
This investigative clinical trial assay performed in a central laboratory utilised a 0 to 3+ scale.
Preiskovalno metodo so zaradi kliničnega preskušanja izvajali v centralnem laboratoriju in za vrednotenje rezultatov uporabili lestvico od 0 do 3+.
The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
V študijo so vključili bolnike z novo diagnosticiranim lokalno napredovalim rakom dojk (stadij III) ali z zgodnjo obliko vnetnega raka dojk.
Binding of trastuzumab to HER2 inhibits ligand-independent HER2 signalling and prevents the proteolytic cleavage of its extracellular domain, an activation mechanism of HER2.
Vezava trastuzumaba na HER2 zavira od liganda neodvisno signalno pot HER2 in preprečuje proteolitično cepitev zunajcelične domene, ki predstavlja aktivacijski mehanizem HER2.
Risk factors associated with interstitial lung disease include prior or concomitant therapy with other antineoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy.
Med dejavnike tveganja, povezane z intersticijsko boleznijo pljuč, spada predhodno ali sočasno zdravljenje z drugimi zdravili z delovanjem na novotvorbe, za katere je znana povezava s to boleznijo, kot so taksani, gemcitabin, vinorelbin in zdravljenje z obsevanjem.
Weekly schedule
Tedenski režim
All candidates for treatment with KANJINTI, 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 z zdravilom KANJINTI, 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.
Early breast cancer
Zgodnji rak dojk
- 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.
- v kombinaciji s paklitakselom za zdravljenje tistih bolnikov, ki še niso prejemali kemoterapije za metastatsko bolezen in za katere antraciklini niso primerni;
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.
If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects.
Če se bo pri vas pojavila reakcija, bodo infuzijo upočasnili ali prekinili in vas po potrebi zdravili zaradi neželenih učinkov.
Patients were recruited to the trial who were previously untreated for HER2-positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction not amenable to curative therapy.
V preskušanje so vključili bolnike, ki predhodno za HER2-pozitivni neoperabilni lokalno napredovali ali ponavljajoči se in/ali metastatski adenokarcinom želodca ali gastroezofagealnega prehoda niso bili zdravljeni ali primerni za zdravljenje.
Trastuzumab plus docetaxel4 N = 110
trastuzumab in docetaksel4 n = 110
If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping KANJINTI.
Če je mogoče, se po prekinitvi zdravljenja z zdravilom KANJINTI do 7 mesecev izogibamo zdravljenju z antraciklini.
No reductions in the dose of trastuzumab were made during clinical trials.
Med kliničnimi preskušanji niso zmanjševali odmerka trastuzumaba.
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 %.
34.5% 47.3% 1.70a (1.22, 2.38)
Celokupni odgovor na zdravljenje, % 34,5 % 47,3 % 1,70a(1,22; 2,38) Trajanje odgovora, mediana (meseci)
Neutralising anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the trastuzumab intravenous arm.
Nevtralizirajoča protitelesa proti trastuzumabu so odkrili v 2 od 30 vzorcev, odvzetih po začetku zdravljenja pri bolnikih iz skupine, ki je prejemala trastuzumab v intravenski obliki.
• 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 pripravobioloških zdravil; upoštevati je treba standardne previdnostne ukrepe za varno ravnanje z intravenskimi zdravili.
If you receive KANJINTI in combination with chemotherapy, some of them may also be due to the chemotherapy.
Če prejemate skupaj z zdravilom KANJINTI tudi kemoterapijo, so lahko nekateri neželeni učinki nastali tudi zaradi kemoterapije.
Subsequent maintenance doses should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
Nadaljnje vzdrževalne odmerke dajemo 7 ali 21 dni zatem, odvisno od režima odmerjanja (tedenskega ali 3-tedenskega).
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.
Aseptic reconstitution and dilution:
Aseptična rekonstitucija in redčenje:
- following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
- po adjuvantni kemoterapiji z doksorubicinom in ciklofosfamidom, v kombinaciji s paklitakselom ali docetakselom;
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.
Observation N = 1,693
Parameter opazovanje n = 1.693
For full instructions on assay performance and interpretation please refer to the package inserts of validated FISH and CISH assays.
Za popolna navodila o učinkovitosti metod in interpretaciji rezultatov, prosimo, glejte navodila za uporabo validiranih metod FISH in CISH.
Currently no data from clinical trials are available on re-treatment of patients with previous exposure to trastuzumab in the adjuvant setting.
Trenutno ni na voljo podatkov iz kliničnih preskušanj, kjer bi bili bolniki po adjuvantnem zdravljenju s trastuzumabom z njim ponovno zdravljeni.
Paclitaxel2 N = 77
paklitaksel2 n = 77
Effect of antineoplastic agents on trastuzumab pharmacokinetics
Učinek zdravil z delovanjem na novotvorbe na farmakokinetiko trastuzumaba
• anaphylactic reactions
• anafilaktične reakcije
• 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection, or
150 mg trastuzumaba, ki ga je treba raztopiti v 7,2 ml vode za injekcije, ali
DCarbH (vs. AC→D) (BCIRG 006)
DCarbH (v primerjavi z AC → D) (BCIRG 006)
The bag should be gently inverted to mix the solution in order to avoid foaming.
Vrečko je treba nežno obračati in zmešati raztopino tako, da se izognemo penjenju.
In general, SISH or FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2.
V splošnem velja, da je rezultat metode SISH ali FISH pozitiven, če je razmerje med številom kopij gena HER2 na tumorsko celico in številom kopij kromosoma 17 večje ali enako 2.
Pharmacokinetic data from Study H4613g/GO01305 in patients with metastatic or locally advanced inoperable HER2-positive cancer suggested that trastuzumab had no impact on the PK of carboplatin.
Farmakokinetični podatki iz študije H4613/GO01305 pri bolnikih z metastatskim ali lokalno napredovalim neoperabilnim HER2-pozitivnim rakom so nakazali, da trastuzumab ni imel vpliva na farmakokinetiko karboplatina.
After reconstitution 1 mL concentrate contains 21 mg of trastuzumab.
Po rekonstituciji 1 ml koncentrata vsebuje 21 mg trastuzumaba.
Patients with history of myocardial infarction (MI), angina pectoris requiring medical treatment, history of or existing CHF (NYHA class II - IV), LVEF of < 55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension (hypertension controlled by standard medical treatment eligible), and haemodynamic effective pericardial effusion were excluded from adjuvant and neoadjuvant EBC pivotal trials with trastuzumab and therefore treatment cannot be recommended in such patients.
Bolniki z anamnezo miokardnega infarkta, angino pektoris, ki jo je treba zdraviti, anamnezo kongestivnega srčnega popuščanja ali prisotnim kongestivnim srčnim popuščanjem (NYHA razred II-IV), LVEF < 55 %, drugimi kardiomiopatijami, srčno aritmijo, ki jo je treba zdraviti, klinično pomembno boleznijo srčnih zaklopk, slabo uravnano hipertenzijo (hipertenzijo, ki bi bila primerno nadzorovana s standardnim zdravljenjem) in hemodinamsko efektivno perikardialno efuzijo niso bili vključeni v adjuvantna in neoadjuvantna ključna preskušanja zgodnjega raka dojk s trastuzumabom.
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 tumour types, and healthy volunteers, in 18 Phase I, II and III trials receiving trastuzumab intravenously.
Farmakokinetika trastuzumaba je bila ocenjena z analizo populacijskega farmakokinetičnega modela z uporabo združenih podatkov 1.582 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 trastuzumab v intravenski obliki.
If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of KANJINTI therapy has been seen.
Pri bolnikih s kontinuiranim upadanjem funkcije levega prekata, ki ostajajo asimptomatični, naj zdravnik razmisli o ukinitvi zdravljenja z zdravilom KANJINTI, če klinična korist ni bila opazna.
KANJINTI may affect your ability to drive a car or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo KANJINTI lahko vpliva na vašo sposobnost za vožnjo ali upravljanje strojev.
The pre-planned final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831 was performed when 707 deaths had occurred (median follow-up 8.3 years in the AC→PH group).
Vnaprej načrtovana končna analiza celokupnega preživetja iz skupne analize študij NSABP B-31 in NCCTG N9831 je bila opravljena, ko je nastopilo 707 smrti (mediana spremljanja 8,3 leta v skupini AC → PH).
If the patient has missed a dose of KANJINTI 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 zdravila KANJINTI 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.
Volume (mL) = Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
volumen (ml) = telesna masa (kg) x odmerek (4 mg/kg za uvajanje ali 2 mg/kg za vzdrževanje) 21 (mg/ml, koncentracija pripravljene raztopine)
Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
volumen (ml) = telesna masa (kg) x odmerek (8 mg/kg za uvajanje ali 6 mg/kg za vzdrževanje) 21 (mg/ml, koncentracija pripravljene raztopine)
Patients assigned to receive trastuzumab were given an initial loading dose of 8 mg/kg, followed by 6 mg/kg every three weeks for either one or two years.
Bolniki, ki so bili določeni za prejemanje trastuzumaba, so prejeli začetni polnitveni odmerek 8 mg/kg telesne mase, nato pa so prejemali eno ali dve leti 6 mg/kg telesne mase vsake tri tedne.
EBC in the HERA trial was limited to operable, primary, invasive adenocarcinoma of the breast, with axillary nodes positive or axillary nodes negative if tumours at least 1 cm in diameter.
V kliničnem preskušanju HERA je bil zgodnji rak dojk omejen na operabilni, primarni, invazivni adenokarcinom dojk, s pozitivnimi aksilarnimi bezgavkami ali negativnimi aksilarnimi bezgavkami, če so tumorji v premeru znašali vsaj 1 cm.
Regimen Primary tumour type N
Režim Vrsta primarnega tumorja n
1Blood pressure increased
1zvišanje krvnega tlaka zelo pogosto
If symptomatic cardiac failure develops during KANJINTI therapy, it should be treated with standard medicinal products for CHF.
Če se med zdravljenjem z zdravilom KANJINTI razvije simptomatsko srčno popuščanje, ga zdravimo s standardnimi zdravili za kongestivno srčno popuščanje.
Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8,386) and in post-marketing
Neželeni učinki, o katerih so poročali pri intravenski obliki trastuzumaba v monoterapiji ali v kombinaciji s kemoterapijo v ključnih kliničnih preskušanjih (n = 8.386) in v obdobju po prihodu zdravila na trg
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).
The reconstituted KANJINTI results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Raztopljeno zdravilo KANJINTI je brezbarvna do rahlo rumena prozorna tekočina, ki mora biti brez vidnih delcev.
2) Swirl the vial gently to aid reconstitution.
2) Vialo rahlo vrtite do raztopitve.
KANJINTI 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 KANJINTI 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.
Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart of a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet.
Simptomi lahko vključujejo težave z ledvicami (oslabelost, kratko sapo, utrujenost in zmedenost), težave s srcem (trepetanje srca ali hitrejše ali počasnejše bitje srca), krče, bruhanje ali drisko in mravljinčenje v ustih, dlaneh ali stopalih.
SISH technology is however, recommended to allow for the parallel evaluation of tumour histology and morphology.
Vendar pa je za paralelno oceno histologije in morfologije tumorja priporočljiva tehnika SISH.
Sites of progression
Mesta napredovanja bolezni
So far, no results are available which compare the efficacy of trastuzumab administered with chemotherapy in the adjuvant setting with that obtained in the neo-adjuvant/adjuvant setting.
Trenutno še ni na voljo rezultatov, ki bi primerjali učinkovitost trastuzumaba, danega skupaj s kemoterapijo pri adjuvantnem zdravljenju, z učinkovitostjo pri neoadjuvantnem/adjuvantnem zdravljenju.
KANJINTI intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available.
Intravensko infuzijo zdravila KANJINTI mora dajati zdravstveno osebje, usposobljeno za ukrepanje ob anafilaksiji; na voljo mora biti oprema za urgentno ukrepanje.
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 %.