FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro, trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Slovenian: V študijah in vitro je do ADCC, posredovane s trastuzumabom, preferenčno prihajalo na rakastih celicah, ki so čezmerno izražale HER2, v primerjavi z rakastimi celicami, ki HER2 niso izražale čezmerno.
English: Herpes zoster
Slovenian: • pasovec (herpes zoster),
English: 4mg/kg + 2mg/kg qw
Slovenian: 4 mg/kg + 2 mg/kg enkrat na teden
English: Such methods must clearly be precise and accurate enough to demonstrate overexpression of HER2 and must be able to distinguish between moderate (congruent with 2+) and strong (congruent with 3+) overexpression of HER2.
Slovenian: in razlikujejo med srednjim (skladno z 2+) in močnim (skladno s 3+) čezmernim izražanjem HER2.
English: • abnormally low levels of fluid around baby in womb
Slovenian: • nenormalno malo tekočine okrog ploda v maternici,
English: Based on the clinical trial results, the beneficial effects were limited to patients with the highest level of HER2 protein overexpression, defined by a 3+ score by IHC, or a 2+ score by IHC and a positive FISH result.
Slovenian: Na podlagi rezultatov kliničnega preskušanja so bili koristni učinki omejeni na bolnike z najvišjo ravnijo čezmernega izražanja proteina HER2, ki je bila opredeljena z rezultatom IHC3+ ali z rezultatom IHC2+ in pozitivnim rezultatom FISH.
English: If left ventricular ejection fraction (LVEF) percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately
Slovenian: Če odstotek iztisnega deleža levega prekata (LVEF) pade za ≥ 10 točk od začetne vrednosti IN pod 50 %, zdravljenje prekinemo in ponovno opravimo meritev LVEF v približno treh tednih.
English: 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.
Slovenian: Vsaj šest ur po začetku prve infuzije, med infuzijo in dve uri po začetku nadaljnjih infuzij boste pod nadzorom zdravstvenega osebja.
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval
Slovenian: AC→D = doksorubicin in ciklofosfamid, ki jima je sledil docetaksel; DcarbH = docetaksel, karboplatin in trastuzumab; IZ = interval zaupanja.
English: No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio=1.16, 95% CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio 0.97, 95% CI [0.60, 1.55] for AC→DH (AC→TH) versus AC→D).
Slovenian: V tej podskupini bolnikov niso opazili nikakršne koristi za preživetje brez bolezni (DFS) (razmerje tveganja = 1,16, 95 % IZ [0,73, 1,83] za DCarbH (TCH) proti AC→D (AC→T); razmerje tveganja 0,97, 95 % IZ [0,60, 1,55] za AC→DH (AC→TH) proti AC→D).
English: Time to disease progression, median months
Slovenian: Preživetje brez napredovanja bolezni, mediano število mesecev
English: Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Slovenian: Zdravilo Ontruzant je indicirano za zdravljenje odraslih bolnikov s HER2-pozitivno metastatsko obliko raka dojk:
English: • bladder and skin infections
Slovenian: • okužbe mehurja in kože,
English: In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
Slovenian: Poleg tega so opravili post-hoc eksplorativno analizo skupin podatkov iz združene analize (JA) kliničnih študij NSABP B-31/NCCTG N9831* in BCIRG006, v kateri so združili dogodke DFS in simptomatske srčne dogodke, rezultati so povzeti v preglednici 11:
English: Ontruzant should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC3+ result.
Slovenian: Zdravilo Ontruzant se uporablja le za bolnike z metastatskim rakom želodca, katerih tumorji imajo čezmerno izražen HER2, definiran kot rezultat IHC2+ s potrditvenim rezultatom SISH ali FISH, ali kot rezultat IHC3+.
English: L-histidine hydrochloride monohydrate L-histidine α,α-trehalose dihydrate polysorbate 20
Slovenian: L-histidinijev klorid monohidrat L-histidin α,α-trehaloza dihidrat polisorbat 20
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95% CI 0.51-1.79)], non-measurable [HR 1.78 (95% CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95% CI 0.29-4.97)].
Slovenian: V eksplorativni analizi podskupin, ki so jo opravili v preskušanju ToGA (BO18255), ni bilo opazne koristi za celotno preživetje, če so dodali trastuzumab pri bolnikih z oceno splošnega stanja zmogljivosti po ECOG PS (Eastern Cooperative Oncology Group Performance Status) 2 pred začetkom zdravljenja [HR 0,96 (95 % IZ 0,51-1,79)], bolnikih z nemerljivo boleznijo [HR 1,78 (95 % IZ 0,87-3,66)] in lokalno napredovalo boleznijo [HR 1,20 (95 % IZ 0,29-4,97)].
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Parenteralna zdravila je treba pred dajanjem vizualno pregledati glede delcev in obarvanja.
English: - intravenous paclitaxel - 175 mg/m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
Slovenian: - paklitaksel intravensko - 175 mg/m2 v obliki kontinuirane intravenske infuzije, vsake 3 tedne, skupaj 4 cikle (na 1. dan vsakega cikla).
English: Total CL range from Cmax,ss to Cmin,ss
Slovenian: od Cmax,ss do Cmin,ss
English: IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridization (SISH) or a FISH technique must be applied.
Slovenian: Kot prvi način testiranja priporočajo IHC, kadar je treba ugotoviti tudi stanje genske amplifikacije HER2, pa je treba uporabiti bodisi s srebrom ojačeno hibridizacijo in situ
English: Administration as an intravenous push or bolus is prohibited.
Slovenian: Dajanje zdravila v obliki hitre intravenske injekcije ali bolusa je prepovedano.
English: Trastuzumab plus paclitaxel2 N=68
Slovenian: Trastuzumab in paklitaksel2 N = 68
English: +Lung infiltration
Slovenian: +pljučni infiltrati neznana
English: Comparison of trastuzumab PK data from Study M77004 in which women with HER2-positive MBC were treated concomitantly with trastuzumab, paclitaxel and doxorubicin to trastuzumab PK data in studies where trastuzumab was administered as monotherapy (H0649g) or in combination with anthracycline plus cyclophosphamide or paclitaxel (H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.
Slovenian: Primerjava farmakokinetičnih podatkov trastuzumaba iz študije M77004, v kateri so bolnike s HER2-pozitivnim metastatskim rakom dojk sočasno zdravili s trastuzumabom, paklitakselom in doksorubicinom, in študij, v katerih so dajali trastuzumab v monoterapiji (H0649g) ali v kombinaciji z antraciklinom in ciklofosfamidom ali paklitakselom (H0648g), so nakazali, da učinka doksorubicina in paklitaksela na farmakokinetiko trastuzumaba ni.
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Slovenian: Pri bolnikih, ki imajo dispnejo v mirovanju zaradi zapletov napredovale maligne bolezni in soobolenj, je lahko tveganje pljučnih dogodkov zvečano.
English: Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
Slovenian: Pri bolnikih, pozitivnih na hormonske receptorje, je moralo biti neuspešno tudi hormonsko zdravljenje,
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2:
Slovenian: Priporočeni način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici 2:
English: • anaphylactic reactions (serious allergic reaction)
Slovenian: • anafilaktične reakcije (resna alergijska reakcija), • zvišana raven kalija,
English: Biopsy specimen - staining pattern
Slovenian: Bioptični vzorec - videz preparata po obarvanju
English: Primary efficacy analysis DFS hazard ratios (95% CI) p-value p<0.0001
Slovenian: Primarna analiza učinkovitosti Razmerja tveganja DFS (95 % IZ) Vrednost p p < 0,0001
English: • pain in the arms and/or legs
Slovenian: • bolečina v zgornjih in/ali spodnjih udih,
English: Median Survival (months) (95%CI)
Slovenian: Mediano preživetje (meseci) (95 % IZ)
English: The reconstituted solution should not be frozen.
Slovenian: Rekonstituirane raztopine ne zamrzujte.
English: • weight loss
Slovenian: • izguba teka,
English: L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Slovenian: L-histidinijev klorid monohidrat, L-histidin, α,α-trehaloza dihidrat, polisorbat 20.
English: Detection of HER2 overexpression or HER2 gene amplification in gastric cancer Only an accurate and validated assay should be used to detect HER2 overexpression or HER2 gene amplification.
Slovenian: Odkrivanje čezmernega izražanja HER2 ali genske amplifikacije HER2 pri raku želodca Za odkrivanje čezmernega izražanja HER2 ali genske amplifikacije HER2 se sme uporabljati le natančna in validirana metoda.
English: Early breast cancer (neoadjuvant-adjuvant setting)
Slovenian: Zgodnji rak dojke (neoadjuvantno-adjuvantno zdravljenje)
English: Serious IRRs to trastuzumab infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Slovenian: Poročali so o resnih reakcijah na infuzijo trastuzumaba, vključno z dispnejo, hipotenzijo, sopenjem, hipertenzijo, bronhospazmom, supraventrikularno tahiaritmijo, zmanjšano saturacijo arterijske krvi s kisikom, anafilaksijo, dihalno stisko, urtikarijo in angioedemom (glejte poglavje 4.8).
English: Combination treatment with trastuzumab and anastrozole Trastuzumab has been studied in combination with anastrozole for first-line treatment of MBC in HER2 overexpressing, hormone-receptor (i.e. estrogen-receptor (ER) and/or progesterone-receptor (PR)) positive postmenopausal patients.
Slovenian: Kombinirano zdravljenje s trastuzumabom in anastrozolom Trastuzumab so proučevali v kombinaciji z anastrozolom za zdravljenje prve izbire metastatskega raka dojk pri bolnicah po menopavzi s čezmerno izraženim HER2 in pozitivnimi hormonskimi receptorji (t.j.
English: Trastuzumab has been used in clinical trials as monotherapy for patients with MBC who have tumours that overexpress HER2 and who have failed one or more chemotherapy regimens for their metastatic disease (trastuzumab alone).
Slovenian: Metastatski rak dojk Trastuzumab so uporabljali v kliničnih preskušanjih kot monoterapijo pri bolnikih z metastatsko obliko raka dojk, katerih tumorji so čezmerno izražali HER2 in pri katerih je bilo zdravljenje neuspešno po eni ali več kemoterapevtskih zdravljenjih njihove metastatske bolezni (samo trastuzumab).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ontruzant 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by several chromatography steps including specific viral inactivation and removal procedures.
Slovenian: Ontruzant 150 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 150 mg trastuzumaba, humaniziranega monoklonskega protitelesa IgG1, ki je pridobljeno iz suspenzije kulture celic sesalcev (ovarijske celice kitajskega hrčka) in očiščeno z več kromatografskimi stopnjami, vključno s specifičnimi postopki inaktivacije ter odstranjevanja virusov.
English: In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7% versus 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9% ) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
Slovenian: V študiji BCIRG 006 se razmerje tveganja za glavni cilj, DFS, izraža kot absolutna korist skupine AC→DH (trastuzumab) v smislu 3 letnega preživetja brez bolezni za 5,8 odstotne točke (86,7 % v primerjavi z 80,9 %), korist skupine DCarbH (trastuzumab) pa za 4,6 odstotne točke v primerjavi s skupino AC→D (85,5 % v primerjavi z 80,9 %).
English: Trastuzumab may persist in the circulation for up to 7 months after stopping trastuzumab treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Slovenian: 7 mesecev glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov (glejte poglavje 5.2).
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous infusion) 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.
Slovenian: S primerjavo simuliranih serumskih koncentracij trastuzumaba po monoterapiji s trastuzumabom (polnilni odmerek 4 mg/kg, 2 mg/kg enkrat na teden v obliki intravenske infuzije) in ugotovljenih serumskih koncentracij pri japonskih bolnikih s HER2-pozitivnim metastatskim rakom dojk (študija JP16003) niso ugotovili nikakršnih dokazov o farmakokinetičnem vplivu sočasnega dajanja docetaksela na farmakokinetiko trastuzumaba.
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3:
Slovenian: Priporočeni način vrednotenja rezultatov obarvanja preparatov po metodi IHC je naveden v preglednici 3:
English: Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Slovenian: Drugi simptomi, povezani z infuzijo, so: slabost (navzea), bruhanje, bolečina, zvečana napetost mišic in tresenje, glavobol, omotica, oteženo dihanje, sopenje, zvišan ali znižan krvni tlak, motnje srčnega ritma
English: At 8 years, the disease-free survival rate was estimated to be 77.2% (95% CI: 75.4, 79.1) in the AC→PH arm, an absolute benefit of 11.8% compared with the AC→P arm.
Slovenian: Po 8 letih so ocenili, da je bila v skupini AC→PH pogostnost preživetja brez bolezni 77,2 % (95 % IZ: 75,4, 79,1), kar je absolutna korist 11,8 % v primerjavi s skupino AC→P.
English: • abnormal heart rhythm
Slovenian: • upočasnjen srčni utrip, • nenormalen srčni ritem,
English: • numbness or tingling of the fingers and toes
Slovenian: • odrevenelost ali mravljinčenje v prstih rok in nog,
English: No. patients with event p=0.0275
Slovenian: število bolnikov z dogodkom p = 0,0275
English: Ontruzant is given every 3 weeks for early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Slovenian: Pri zgodnji obliki raka dojk, metastatskem raku dojk in metastatskem raku želodca se zdravilo Ontruzant daje vsake 3 tedne.
English: Trastuzumab has also been used in combination with paclitaxel or docetaxel for the treatment of patients who have not received chemotherapy for their metastatic disease.
Slovenian: Trastuzumab so uporabljali tudi v kombinaciji s paklitakselom ali docetakselom za zdravljenje bolnikov, ki predhodno niso prejeli kemoterapije za svojo metastatsko bolezen.
English: Death (OS event) No. patients with event p=0.0182
Slovenian: Smrt (dogodek OS) število bolnikov z dogodkom p = 0,0182
English: Ontruzant 150 mg powder for concentrate for solution for infusion Appropriate aseptic technique should be used.
Slovenian: Ontruzant 150 mg prašek za koncentrat za raztopino za infundiranje Uporabljati morate ustrezno aseptično tehniko.
English: There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies.
Slovenian: V študijah teratogenosti, ženske plodnosti ali toksičnosti v pozni nosečnosti/prenosa skozi placento ni bilo znakov akutne ali z več odmerki povezane toksičnosti ali toksičnosti za razmnoževanje v študijah, ki so trajale do 6 mesecev.
English: Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).
Slovenian: Zdravilo Ontruzant je indicirano za zdravljenje odraslih bolnikov z zgodnjo obliko HER2-pozitivnega raka dojk:
English: • failure of the lungs of the baby to develop in the womb
Slovenian: • okvara pri razvoju pljuč otroka v maternici,
English: The population predicted PK exposure values (median with 5th-95th Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (Cycle 1), Table 15 (steady-state), and Table 16 (PK parameters).
Slovenian: 95. percentilom), in vrednosti farmakokinetičnih parametrov pri klinično pomembnih koncentracijah (Cmax in Cmin) pri bolnikih z MBC, EBC in AGC, zdravljenih z odobrenima shemama odmerjanja enkrat na teden in enkrat na tri tedne, kažejo preglednica 14 (1. cikel), preglednica 15 (stanje mirovanja) in preglednica 16 (farmakokinetični parametri).
English: Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Slovenian: Močna popolna bazolateralna ali lateralna membranska reaktivnost v ≥ 10 % tumorskih celic.
English: - The BCIRG 006 study was designed to investigate combining trastuzumab treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery.
Slovenian: - Študija BCIRG 006 je bila zasnovana za proučevanje kombiniranja zdravljenja s trastuzumabom in docetakselom bodisi po kemoterapiji z antraciklinom in ciklofosfamidom (kemoterapiji AC), bodisi v kombinaciji z docetakselom in karboplatinom pri bolnikih z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji.
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 7.
Slovenian: Rezultati učinkovitosti iz združene analize preskušanj NSABP B-31 in NCCTG 9831 v času končne analize DFS* so povzeti v preglednici 7.
English: +1Wheezing
Slovenian: +1sopenje
English: • pain, swelling, redness or tingling of hands and/or feet
Slovenian: • bolečina, otekanje, rdečina ali mravljinčenje dlani in/ali stopal,
English: What Ontruzant is and what it is used for What you need to know before you are given Ontruzant How Ontruzant is given
Slovenian: Kaj je zdravilo Ontruzant in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Ontruzant Kako boste dobili zdravilo Ontruzant
English: • redness, swelling or sores in your mouth and/or throat
Slovenian: • rdečina, otekanje ali razjede v ustih in/ali žrelu,
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients
Slovenian: Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja za shemi odmerjanja trastuzumaba v intravenski infuziji pri bolnikih z MBC, EBC in AGC
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below:
Slovenian: Končni rezultati OS iz združene analize študij NSABP B-31 in NCCTG N9831 so povzeti v preglednici 8 v nadaljevanju:
English: in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
Slovenian: v kombinaciji z docetakselom za zdravljenje tistih bolnikov, ki še niso prejemali kemoterapije za svojo metastatsko bolezen;
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50% after the event) was evident for 71.4% of trastuzumab-treated patients.
Slovenian: Pri 71,4 % bolnikov, zdravljenih s trastuzumabom, je bilo hudo kongestivno srčno popuščanje reverzibilno (opredeljeno kot zaporedje najmanj dveh zaporednih vrednosti LVEF ≥ 50 % po dogodku).
English: +Bronchospasm
Slovenian: +bronhospazem neznana
English: +Anaphylactic reaction
Slovenian: +anafilaktična reakcija neznana
English: Infusion related reaction
Slovenian: povezane z infuzijo.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use only after reconstitution and dilution.
Slovenian: Samo za intravensko uporabo po rekonstituciji in razredčenju.
English: • Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
Slovenian: • Bolniki, ki imajo hudo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni, ali tisti, ki potrebujejo zdravljenje s kisikom.
English: - capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
Slovenian: - kapecitabin - 1000 mg/m2 peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
English: The median duration of follow-up was 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm.
Slovenian: Mediano trajanje spremljanja je bilo 1,8 leta v skupini AC→P in 2,0 leti v skupini AC→PH.
English: Each 420 mg vial of Ontruzant is reconstituted with 20 mL of sterile water for injection (not supplied).
Slovenian: Eno 420 mg vialo zdravila Ontruzant rekonstituirajte s 20 ml sterilne vode za injekcije (ni priložena).
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction.
Slovenian: Pri bolnikih, ki imajo dispnejo v mirovanju zaradi zapletov napredovale maligne bolezni in soobolenja, obstaja večje tveganje za reakcije, povezane z aplikacijo, s smrtnim izidom.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions.
Slovenian: Podrobnosti ukrepov za zmanjševanje tveganj, ki so skladni z načrtom za obvladovanje tveganj
English: The recommended weekly maintenance dose of Ontruzant is 2 mg/kg body weight, beginning one week after the loading dose.
Slovenian: Priporočen tedenski vzdrževalni odmerek zdravila Ontruzant je 2 mg/kg telesne mase, s katerim začnemo en teden po polnilnem odmerku.
English: Hazard ratio versus
Slovenian: Razmerje tveganja proti
English: • jaundice (yellowish discoloration of the skin or eyes)
Slovenian: • zlatenica (rumenkasto obarvanje kože ali oči), • vnetje ali brazgotinjenje pljuč.
English: STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab.
Slovenian: Viala vsebuje 420 mg trastuzumaba.
English: However, trastuzumab plus docetaxel was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Slovenian: Je pa bil trastuzumab skupaj z docetakselom učinkovit ne glede na to, ali so bolniki prej prejeli adjuvantno terapijo z antraciklini ali ne.
English: 8mg/kg + 6mg/kg q3w
Slovenian: 8 mg/kg + 6 mg/kg enkrat na 3 tedne
English: Ontruzant should be carefully handled during reconstitution.
Slovenian: Navodila za rekonstitucijo: Z zdravilom Ontruzant je treba med rekonstitucijo previdno ravnati.