FrancophonIA/ELRC3.0 huggingface dataset:
English: Paronychia Upper respiratory tract infection
Slovak: Infekcia horných dýchacích ciest
English: n (%) [95% CI]
Slovak: N0) n (%)
English: 3.3% (13/389 patients) of Perjeta-treated patients and 6.7% (25/372 patients) of placebo-treated patients tested positive for ADA.
Slovak: % (13/389 pacientov) pacientov liečených Perjetou a u 6,7
English: Secondary efficacy endpoints were clinical response rate, breast conserving surgery rate (T2-3 tumours only), disease-free survival (DFS), and PFS. Additional exploratory pCR rates included nodal status (ypT0/isN0 and ypT0N0).
Slovak: Sekundárne ciele účinnosti boli výskyt klinickej odpovede, podiel operácií zachovávajúcich prsník (len T2-3 nádory), prežívanie bez prejavov ochorenia (disease-free survival - DFS) a PFS.
English: (71.2%) compared to the placebo arm (45.2%).
Slovak: %) v porovnaní so skupinou s placebom (11,3
English: Perjeta and trastuzumab may be resumed if the LVEF has recovered to > 45%, or to 40-45% associated with a difference of < 10% points below pre-treatment values.
Slovak: 45 % alebo na 40 - 45 % v spojení, s rozdielom o <
English: One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml.
Slovak: Jedna 14 ml injekčná liekovka koncentrátu obsahuje 420 mg pertuzumabu v koncentrácii 30 mg/ml.
English: Those studies included the pivotal trials CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225), and APHINITY (n=4804) [pooled in Table 2].
Slovak: Tieto štúdie zahŕňali pivotné skúšania CLEOPATRA (n=808),
English: * Primary progression-free survival analysis, cutoff date 13
Slovak: * Primárna analýza prežívania bez progresie ku dňu 13. máj 2011.
English: Left ventricular dys function **
Slovak: Dysfunkcia ľavej komory**
English: Among Asian patients, the incidence of febrile neutropenia was higher in the Perjeta-treated group (25.8%) compared with the placebo-treated group (11.3%).
Slovak: U ázijských pacientov bola incidencia febrilnej neutropénie vyššia v skupine liečenej Perjetou (25,8
English: In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events (see section 4.4).
Slovak: V pivotnom klinickom skúšaní CLEOPATRA sa u väčšiny pacientov v oboch liečebných skupinách vyskytla minimálne jedna leukopenická udalosť (63,0
English: Glacial acetic acid L-Histidine Sucrose
Slovak: Zoznam pomocných látok ľadová kyselina octová
English: HER2 overexpression was determined at a central laboratory and defined as a score of 3+ by IHC or an ISH amplification ratio ≥2.0 in the trials outlined below.
Slovak: Nadmerná expresia HER2 bola stanovená v centrálnom laboratóriu a bola definovaná ako skóre 3+
English: Mus culoskeletal and connective tissue disorders
Slovak: Poruchy kostrovej a svalovej sústavy a spojivového tkaniva
English: Clear to slightly opalescent, colourless to pale yellow, liquid.
Slovak: Číra až jemne opalizujúca, bezfarebná až svetložltá tekutina.
English: Most of these patients had received prior anthracycline therapy and 11% of all patients had received prior trastuzumab.
Slovak: % všetkých pacientov dostávalo predchádzajúcu liečbu trastuzumabom.
English: The vial must not be shaken.
Slovak: Injekčná liekovka sa nesmie pretrepávať.
English: No patients in the group treated with Perjeta plus trastuzumab and FEC followed by Perjeta plus trastuzumab and docetaxel experienced symptomatic LVD.
Slovak: Perjetou plus trastuzumabom a FEC, po ktorých nasledovalo podávanie Perjety plus trastuzumabu a docetaxelu, sa nevyskytla symptomatická LVD.
English: Being given this medicine
Slovak: Ako sa Perjeta podáva Podávanie tohto lieku
English: The primary endpoint of cardiac safety, i.e. the incidence of NYHA Class III/IV LVD and LVEF declines, was consistent with previous data in the neoadjuvant setting (see section 4.4. and 4.8).
Slovak: Primárny cieľ kardiálnej bezpečnosti, t.j. incidencia poklesu LVD a LVEF triedy III/IV
English: Inflammation of your digestive tract (e.g. sore mouth) Decrease in the number of red blood cells - shown in a blood test Joint or muscle pain, muscle weakness
Slovak: • zníženie počtu červených krviniek - zistené v krvnom teste
English: th
Slovak: SA
English: Alopecia Rash
Slovak: • strata vlasov
English: Fever associated with dangerously low levels of a type of white blood cell (neutrophils) Pain in the body, arms, legs, and belly
Slovak: • horúčka súvisiaca s nebezpečne nízkou hladinou typu bielych krviniek (neutrofilov)
English: In the TRYPHAENA trial, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was 85.3% in patients treated with neoadjuvant Perjeta + TCH and 77.0% in patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC, including 66.7% and 59.5% Grade 4 neutropenia,
Slovak: % u pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou + TCH, a 77,0 % u pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou, trastuzumabom a docetaxelom po FEC, vrátane 66,7 % a 59,5 % s neutropéniou
English: Left ventricular dysfunction
Slovak: Dysfunkcia ľavej komory
English: no. of patients with an event Median months Overall Survival - secondary endpoint**
Slovak: Celkové prežívanie sekundárny koncový ukazovateľ** počet pacientov s udalosťou* Medián mesiacov Miera objektívnej odpovede
English: In BERENICE, 4.1% (16/392) of the patients treated with Perjeta tested positive for ADA.
Slovak: V klinickom skúšaní BERENICE sa pozitivita ADA zistila u 4,1
English: The breast cancer has been identified to be of the “HER2-positive” form - your doctor will test you for this.
Slovak: Čo je Perjeta a na čo sa používa Perjeta obsahuje liečivo pertuzumab a používa sa na liečenie dospelých pacientov so špecifickým typom rakoviny prsníka: keď rakovina prsníka bola označená ako „HER2-pozitívny“ typ - váš lekár vám kvôli tomu urobí testy.
English: trastuzumab and docetaxel-treated group (7.5%) compared to the trastuzumab and docetaxel-treated group (1.9%).
Slovak: %) v porovnaní so skupinou liečenou trastuzumabom a docetaxelom (1,9
English: On the first day when only Perjeta was administered, the overall frequency of infusion reactions was 9.8% in the placebo-treated group and 13.2% in the Perjeta-treated group, with the majority of infusion reactions being mild or moderate.
Slovak: V prvý deň, kedy bola podávaná len Perjeta, bola celková frekvencia reakcií na infúziu 9,8
English: Febrile neutropenia occurred in 13.7% of Perjeta-treated patients and 7.6% of placebo-treated patients.
Slovak: % pacientov liečených Perjetou a 7,6 % pacientov v skupine s placebom.
English: Perjeta must be permanently discontinued in case of NCI-CTCAE Grade 4 hypersensitivity reactions (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.2).
Slovak: 4. stupňa (anafylaxia), bronchospazmu alebo syndrómu akútnej respiračnej tiesne (pozri časť 4.2).
English: In NEOSPHERE, 8.3% of Asian patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 4.0% of Asian patients treated with neoadjuvant trastuzumab and docetaxel.
Slovak: % ázijských pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou, trastuzumabom a docetaxelom, v porovnaní so 4,0 % ázijských pacientov, ktorí dostávali neoadjuvantnú liečbu trastuzumabom a docetaxelom.
English: HR= hazard ratio; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab (Herceptin); D= docetaxel.
Slovak: ; Pla = placebo ; Ptz = pertuzumab (Perjeta)
English: Perjeta should be administered in combination with trastuzumab and docetaxel .
Slovak: Metastatický karcinóm prsníka Perjeta v kombinácii s trastuzumabom a docetaxelom
English: No definitive conclusion on adverse effects can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Slovak: Z opakovaných dávok v štúdiách zameraných na toxicitu u opíc rodu cynomolgus nemôžu byť vyvodené definitívne závery o vedľajších účinkoch na samčie reprodukčné orgány.
English: Of the patients who experienced symptomatic heart failure, 46.7%
Slovak: Zo skupiny pacientov, u ktorých došlo k symptomatickému srdcovému zlyhávaniu sa k dátumu zberu údajov (data cut off) stav upravil u 46,7% pacientov liečených Perjetou a u 57,1
English: In the NEOSPHERE trial, diarrhoea occurred in 45.8% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel compared with 33.6% of patients treated with trastuzumab and docetaxel.
Slovak: % pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou, trastuzumabom a docetaxelom, v porovnaní s 33,6 % pacientov liečených trastuzumabom a docetaxelom.
English: Perjeta 420 mg concentrate for solution for infusion pertuzumab
Slovak: Perjeta 420 mg infúzny koncentrát pertuzumab i.v.
English: p-value
Slovak: %, p-hodnota =
English: Cardiac risk should be carefully considered and balanced against the medical need of the individual patient before use of Perjeta with an anthracycline.
Slovak: Pred každým podaním Perjety s antracyklínmi je potrebné starostlivo zvážiť kardiologické riziko a tiež prínos, individuálne u každého pacienta.
English: The incidence of symptomatic LVD was also lower in the Perjeta-treated group (1.8% in the placebo-treated group vs. 1.5% in the Perjeta-treated group) (see section 4.4).
Slovak: V skupine liečenej Perjetou bola tiež nižšia incidencia symptomatickej LVD (1,8
English: Neoadjuvant Treatment
Slovak: Neoadjuvantná liečba
English: (95% CI -11.1,-9.2) in the placebo arm. Change in diarrhoea symptoms increased to +22.3 (95% CI
Slovak: Zmena v príznakoch hnačky sa zvýšila na +22,3 (95%
English: 95% CI for ORR
Slovak: Respondéri*** 95 % IS pre ORR Úplná odpoveď (CR)
English: In the TRYPHAENA trial, rash occurred in 36.8% of patients treated with neoadjuvant Perjeta + TCH and 20.0% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Slovak: % pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou + TCH, a u 20,0 % pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou, trastuzumabom a docetaxelom po FEC.
English: In both the TRYPHAENA and APHINITY trials, the overall frequency of hypersensitivity/anaphylaxis was highest in the Perjeta and TCH treated group (13.2% and 7.6%, respectively), of which 2.6% and 1.3% of events, respectively, were NCI-CTCAE Grade 3-4.
Slovak: V obidvoch skúšaniach TRYPHAENA aj APHINITY bola celková frekvencia hypersenzitívnych/anafylaktických udalostí najvyššia v skupine liečenej Perjetou (13,2
English: Perjeta is administered intravenously by infusion.
Slovak: Perjeta sa podáva intravenózne infúziou.
English: neutropenia, and vomiting.
Slovak: boli neutropenia a febrilná neutropénia.
English: Anaemia
Slovak: Asténia
English: Tumour lysis syndrome†
Slovak: Syndróm nádorového rozpadu†
English: In the TRYPHAENA trial, diarrhoea occurred in 72.3% of patients treated with neoadjuvant Perjeta+TCH and 61.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Slovak: V klinickom skúšaní TRYPHAENA sa hnačka vyskytla u 72,3 % pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou + TCH, a u 61,4
English: During the second cycle when all medicinal products were administered on the same day, the most common infusion reactions in the Perjeta-treated group (≥ 1.0%) were fatigue, dysgeusia, drug hypersensitivity, myalgia and vomiting (see section 4.4).
Slovak: V priebehu druhého cyklu, kedy sa podávali všetky lieky v ten istý deň, boli najčastejšie reakcie na infúziu v skupine liečenej Perjetou (≥
English: Dyspepsia
Slovak: Dyspnoe
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, diarrhoea occurred in 68.4% of Perjetatreated patients and 48.7% of placebo-treated patients (see section 4.4).
Slovak: % pacientov liečených Perjetou a u 48,7 % pacientov v skupine s placebom (pozri časť 4.4).
English: Myalgia Arthralgia Pain in extremity
Slovak: Myalgia Artralgia
English: Perjeta +TCH N=77
Slovak: Perjeta +TCH
English: Hot flushes
Slovak: Návaly horúčavy
English: The incidence of symptomatic LVD (congestive heart failure) was 1.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC (this excludes a patient who experienced symptomatic LVD
Slovak: % v skupine liečenej Perjetou plus trastuzumabom a docetaxelom po FEC (s vylúčením pacienta, u ktorého sa vyskytla symptomatická
English: In the NEOSPHERE trial, 8.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 7.5% of patients treated with trastuzumab and docetaxel.
Slovak: % pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou, trastuzumabom a docetaxelom, v porovnaní so 7,5 % pacientov liečených trastuzumabom a docetaxelom.
English: (ejection fraction decrease according to NCI-CTCAE v.4) was 7% in the group treated with dose dense AC followed by Perjeta plus trastuzumab and paclitaxel and 3.5% in the group treated with FEC
Slovak: Incidencia asymptomatickej LVD (pokles ejekčnej frakcie podľa NCI-CTCAE v. 4) bola 7 % v skupine liečenej dávkovo denzným režimom AC, po ktorom nasledovalo podávanie Perjety plus trastuzumabu a paklitaxelu, a 3,5 % v skupine liečenej FEC, po ktorých nasledovalo podávanie Perjety plus trastuzumabu a docetaxelu.
English: As well as Perjeta you will also receive trastuzumab and medicines called chemotherapy Information about these medicines is described in separate package leaflets.
Slovak: Spolu s Perjetou budete dostávať aj trastuzumab a lieky nazývané chemoterapia.
English: Five studies evaluated the effects of pertuzumab on the PK of co-administered cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin and erlotinib.
Slovak: Päť štúdí hodnotilo účinky pertuzumabu na FK súbežne podávaných cytotoxických látok, docetaxelu,
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 14 ml vial contains 420 mg of pertuzumab at a concentration of 30 mg/ml.
Slovak: Jedna 14 ml injekčná liekovka obsahuje 420 mg pertuzumabu v koncentrácii 30 mg/ml.
English: AUTHORISATION
Slovak: Perjeta
English: Hair loss
Slovak: Bolesť hlavy
English: • 3 cycles of FEC alone followed by 3 cycles of docetaxel, with trastuzumab and Perjeta given concurrently
Slovak: • 3 cykly samotnej liečby FEC, po ktorej nasledovali 3 cykly docetaxelu, so súbežne podávaným trastuzumabom a Perjetou, • 6 cyklov TCH v kombinácii s Perjetou.
English: during FEC treatment prior to receiving Perjeta plus trastuzumab and docetaxel) and also 1.3% in the group treated with Perjeta in combination with TCH.
Slovak: LVD v priebehu liečby FEC predtým, ako začal dostávať Perjetu plus trastuzumab a docetaxel) a tiež 1,3
English: Duration of Response †^ n=
Slovak: Reakcia na infúziu °°, *
English: (vs Perjeta+ Trastuzumab+ Docetaxel)
Slovak: (vs Perjeta+
English: NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion pertuzumab
Slovak: Písomná informácia pre používateľa Perjeta 420 mg infúzny koncentrát pertuzumab
English: The mean decrease from baseline at that time for physical function was -10.7 (95% CI-11.4, -10.0) in the Perjeta arm and -10.6 (95% CI -11.4, -9.9) in the placebo arm; global health status was -11.2 (95% CI -12.2, -10.2) in the Perjeta arm and -10.2
Slovak: IS -11,4; -9,9) v skupine s placebom; pre celkový zdravotý stav -11,2 (95%
English: Fever
Slovak: • horúčka
English: Roche (Magyarország) Kft. Tel: +36 - 23 446 800
Slovak: Tel: +36 - 23 446 800
English: Perjeta+ trastuzumab + docetaxel n=402
Slovak: + docetaxel n = 402
English: pCR rate in the breast and lymph node (ypT0/is N0)
Slovak: Dodatočná exploračná analýza výskytu pCR zahŕňala stav uzlín (ypT0/isN0 a ypT0N0).
English: Breast-feeding
Slovak: Nazofaryngitída
English: HR (95% CI)
Slovak: HR (pomer rizika) (95%
English: Placebo + trastuzumab + Chemotherapy N=2404
Slovak: chemoterapia N=2404
English: In the TRYPHAENA trial, febrile neutropenia occurred in 17.1% of patients treated with neoadjuvant Perjeta + TCH, and 9.3% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Slovak: % pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou + TCH, a u 9,3 % pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou, trastuzumabom a docetaxelom po FEC.
English: België/Belgique/Belgien N.V. Roche S.A.
Slovak: Nederland Roche Nederland B.V.
English: General disorders and adminis tration s ite conditions
Slovak: Celkové poruchy a reakcie v mieste podania
English: Interstitial lung disease Pleural effusion
Slovak: Neutropénia Leukopénia Anémia
English: The infusion should be discontinued immediately and permanently if the patient experiences a NCICTCAE Grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.4).
Slovak: 4. stupňa (anafylaxia), bronchospazmus alebo syndróm akútnej respiračnej tiesne (pozri časť 4.4).
English: Other special populations
Slovak: Osobitné skupiny pacientov
English: was 8.3% in the group treated with Perjeta plus trastuzumab and FEC (5-fluorouracil, epirubicin, cyclophosphamide) followed by Perjeta plus trastuzumab and docetaxel; 9.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC; and 6.6% in the group treated with
Slovak: epirubicín, cyklosfamid, po ktorých nasledovalo podávanie Perjety plus trastuzumabu a docetaxelu); 9,3
English: A. LABELLING
Slovak: • zápcha
English: consecutive LVEF measurements above 50%) at the data cutoff.
Slovak: % pacientov užívajúcich placebo (za upravený stav sa považovali 2 po sebe nasledujúce merania s LVEF nad 50%).
English: The incidence of asymptomatic LVD
Slovak: Incidencia hnačky NCI-CTCAE
English: NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion
Slovak: Perjeta 420 mg infúzny koncentrát
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, the overall frequency of investigator reported hypersensitivity/anaphylaxis events during the entire treatment period was 9.3% in the placebo-treated group and 11.3% in the Perjeta-treated group, of which 2.5% and 2.0% were NCI-CTCAE Grade 3-4, respectively.
Slovak: V pivotnom klinickom skúšaní CLEOPATRA s metastatickým karcinómom prsníka bola celková frekvencia hypersenzitívnych/anafylaktických udalostí zaznamenaných skúšajúcimi v priebehu celého obdobia liečby 9,3
English: Heartburn
Slovak: Docetaxel)
English: trastuzumab and docetaxel compared with 29.0% of patients treated with trastuzumab and docetaxel.
Slovak: % pacientov, ktorí dostávali neoadjuvantnú liečbu Perjetou, trastuzumabom a docetaxelom, v porovnaní s 29,0 % pacientov liečených trastuzumabom a docetaxelom.
English: Shortness of breath
Slovak: Dyspepsia Bolesť brucha
English: followed by Perjeta plus trastuzumab and docetaxel.
Slovak: Perjeta plus trastuzumab a docetaxel, • Perjeta plus trastuzumab,
English: Leucopenia
Slovak: Trastuzumab
English: Placebo+ trastuzumab + docetaxel n=406
Slovak: + docetaxel n = 406
English: Anaphylactic reaction°,
Slovak: Anafylaktická reakcia°, *
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1
Slovak: Roche Pharma AG Tel:
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was balanced in the two treatment groups (86.3% of Perjeta-treated patients and 86.6% of placebo-treated patients, including 60.7% and 64.8% Grade 4 neutropenia, respectively).
Slovak: % pacientov liečených Perjetou a 86,6 % pacientov v skupine s placebom, vrátane 60,7 % a 64,8
English: What Perjeta looks like and contents of the pack Perjeta is a concentrate for solution for infusion.
Slovak: Ako vyzerá Perjeta a obsah balenia
English: No differences in pertuzumab PK were observed in patients with early breast cancer compared to patients with metastatic breast cancer.
Slovak: Medzi pacientmi so včasným karcinómom prsníka a mestastatickým karcinómom prsníka neboli pozorované rozdiely vo FK
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution Do not shake
Slovak: Na intravenózne použitie po riedení Nepretrepávajte
English: Nausea
Slovak: Pruritus
English: Hrvatska
Slovak: Paronychia
English: Ísland
Slovak: Deutschland
English: respectively.
Slovak: pertuzumabu.
English: Cough
Slovak: FEC
English: 6.1 List of excipients
Slovak: 6.2 Inkompatibility Roztok glukózy (5
English: Neutropenia
Slovak: Dojčenie
English: 96.2% versus 96.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Slovak: v skupine s placebom a 89,9% v skupine pacientov liečených Perjetou voči 86,7% v skupine s placebom pri 4 rokoch.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Slovak: Miera odpovede pri liečbe kombináciou
English: Nodal status Positive
Slovak: Stav uzlín
English: In APHINITY, the incidence of symptomatic heart failure (NYHA class III or IV) with a LVEF
Slovak: V klinickom skúšaní NEOSPHERE bola incidencia neutropénie 3. - 4. stupňa podľa NCI-CTCAE
English: Perjeta + trastuzumab + chemotherapy
Slovak: Perjetou+trastuzumabom+docetaxelom.
English: Other medicines and Perjeta Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Slovak: Ak teraz užívate, alebo ste v poslednom čase užívali, či práve budete užívať ďalšie lieky, povedzte to svojmu lekárovi alebo zdravotnej sestre.
English: Paraesthesia
Slovak: Závrat Parestézia
English: Number (%) of patients with event HR [95% CI]
Slovak: (%) pacientov s udalosťou
English: In the APHINITY trial, a higher incidence of diarrhoea was reported in the Perjeta-treated arm
Slovak: V klinickom skúšaní TRYPHAENA bola incidencia febrilnej neutropénie vyššia u pacientov,
English: Response5 79 (79.8%) 89 (88.1%) 69 (67.6%) 65 (71.4%) FEC: 5-fluorouracil, epirubicin, cyclophosphamide; TCH: docetaxel, carboplatin and trastuzumab, CMH:
Slovak: FEC: 5-fluóruracil, epirubicín, cyklofosfamid; TCH: docetaxel, karboplatina a trastuzumab, CMH: Cochranov-Mantelov-Haenszelov
English: No dedicated renal impairment trial for Perjeta has been conducted.
Slovak: Neuskutočnilo sa žiadne klinické skúšanie s Perjetou zamerané na poruchu funkcie obličiek.
English: decline of at least 10% points from baseline and to <50% was <1% (0.6% of Perjeta-treated patients vs 0.3% of placebo-treated patients).
Slovak: V štúdii APHINITY bola incidencia symptomatického srdcového zlyhávania (triedy III alebo IV podľa NYHA) s poklesom LVEF o minimálne 10% až <50% bodov oproti východiskovým hodnotám nižšia ako 1% (0,6
English: 80.6% of placebo-treated patients had recovered at the data cutoff.
Slovak: u pacientov liečených Perjetou voči 88,7% u pacientov v skupine s placebom.
English: The application was withdrawn at ‘day 120'.
Slovak: Žiadosť bola stiahnutá na 120. deň.
English: This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Slovak: Znamená to, že výbor CHMP vyhodnotil pôvodnú dokumentáciu predloženú spoločnosťou a pripravil zoznam otázok.
English: It was to be used on its own or with other anticancer medicines.
Slovak: Liek sa mal používať samostatne alebo v kombinácii s inými protirakovinovými liekmi.
English: The company provided data on docetaxel from the published literature.
Slovak: Spoločnosť predložila údaje o docetaxele z publikovanej literatúry.
English: This means that Docetaxel Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere.
Slovak: To znamená, že liek Docetaxel Mylan mal byť podobný referenčnému lieku, ktorý je už v Európskej únii povolený pod názvom Taxotere.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Slovak: Docetaxel tiež pôsobí na nerakovinové bunky, napríklad krvinky, čo môže zapríčiniť vedľajšie účinky.
English: Other substances are added to docetaxel to help it form small spherical structures called ‘micelles' that are suitable for injection.
Slovak: K docetaxelu sa pridávajú ďalšie látky, ktoré mu napomáhajú vytvárať malé guľovité štruktúry nazývané micely, ktorú sú vhodné na injekčnú aplikáciu.