natgillin/translations-raw huggingface dataset:
Nail disorder Pruritus Dry skin
Bolezni kože in podkožja alopecija izpuščaj bolezni nohtov pruritus suha koža
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.
V preskušanju NEOSPHERE se je pri 8,4 % bolnic, ki so prejele neoadjuvantno zdravljenje z zdravilom Perjeta, trastuzumabom in docetakselom, pojavila febrilna nevtropenija, v primerjavi s 7,5 % bolnic, ki so se zdravile s trastuzumabom in docetakselom.
Dose adjustments of pertuzumab are not needed in patients with mild or moderate renal impairment.
Pri bolnikih z blago do zmerno okvaro ledvic prilagajanje odmerka pertuzumaba ni potrebno.
No events of febrile neutropenia were reported after cessation of docetaxel.
Po prenehanju dajanja docetaksela niso poročali o primerih febrilne nevtropenije.
In the neoadjuvant setting, Perjeta should be administered for 3 to 6 cycles in combination with trastuzumab and chemotherapy, as part of a complete treatment regimen for early breast cancer (see section 5.1).
Pri neoadjuvantnem zdravljenju, ki predstavlja del celostnega zdravljenja zgodnjega raka dojk, je treba zdravilo Perjeta dajati 3 do 6 ciklov v kombinaciji s trastuzumabom in kemoterapijo (glejte poglavje
After a median follow-up of 45.4 months, the APHINITY study showed a 19% (hazard ratio [HR] =
Po spremljanju, ki je mediano trajalo 45,4 meseca, je študija APHINITY pokazala 19-odstotno zmanjšanje (razmerje ogroženosti 0,81; 95-% interval zaupanja 0,66; 1,00; p-vrednost 0,0446)
The highest incidence of diarrhoea (all Grades) was reported during the targeted therapy+taxane chemotherapy period (61.4% of patients in the Perjeta arm vs. 33.8% of patients in the placebo arm).The incidence of diarrhoea was much lower after chemotherapy cessation, affecting
O največji pojavnosti driske (vseh stopenj) so poročali med obdobjem ciljnega zdravljenja ob hkratni kemoterapiji s taksanom (61,4 % bolnikov v skupini z zdravilom Perjeta in
The infusion may be resumed when symptoms abate.
Ko simptomi izzvenijo, lahko z infundiranjem nadaljujemo.
No patients in the group treated with Perjeta plus trastuzumab and FEC followed by Perjeta plus trastuzumab and docetaxel experienced symptomatic LVD.
Pri nobeni bolnici iz skupine, zdravljene z zdravilom Perjeta, trastuzumabom in shemo FEC, ki mu je sledilo zdravljenje z zdravilom Perjeta, trastuzumabom in docetakselom, ni prišlo do pojava simptomatske LVD.
Within each frequency grouping and SOC, ADRs are presented in the order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
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.
V preskušanju NEOSPHERE se je pri 8,3 % azijskih bolnicah, ki so se neoadjuvantno zdravile z zdravilom Perjeta, trastuzumabom in docetakselom, pojavila febrilna nevtropenija, v primerjavi s 4,0 % azijskih bolnic, ki so se neoadjuvantno zdravile s trastuzumabom in docetakselom.
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).
Sekundarni končni cilji učinkovitosti so bili delež kliničnega odgovora, delež operacij z ohranitvijo dojke (le T2-3 tumorji), preživetje brez bolezni (DFS - disease-free survival) in preživetje brez napredovanja bolezni (PFS - progression-free survival).
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution Do not shake
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po razredčenju
The loading dose of 8 mg/kg of trastuzumab IV should be readministered over approximately 90 minutes, followed by a maintenance dose of 6 mg/kg IV administered every 3 weeks thereafter.
Ponovno je treba dati uvajalni odmerek trastuzumaba 8 mg/kg, apliciran intravensko v približno 90 minutah, ki mu sledi vzdrževalni odmerek 6 mg/kg,
Name and address of the manufacturer responsible for batch release Roche Pharma AG
Ime in naslov izdelovalca, odgovornega za sproščanje serij
p-value (Log-Rank test, stratified1) 3 year event-free rate3 [95% CI] Secondary Endpoints1
3-letni delež brez dogodkov3 [95-% IZ] Sekundarni opazovani dogodki1
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
V preskušanju neoadjuvantnega zdravljenja TRYPHAENA je bila incidenca LVD (tekom celotnega obdobja zdravljenja) 8,3 % v skupini, ki je po zdravljenju z zdravilom Perjeta, trastuzumabom in shemo FEC (5-fluorouracil, epirubicin, ciklofosfamid) prejela zdravilo Perjeta, trastuzumab in docetaksel; 9,3 % v skupini, ki je po zdravljenju s shemo FEC prejela zdravilo Perjeta, trastuzumab in docetaksel; in 6,6 % v skupini, zdravljeni z zdravilom Perjeta v kombinaciji s shemo TCH (docetaksel,
Being given this medicine
NAČIN IZDAJANJA ZDRAVILA
Disease Free Survival (DFS)
Napredovanje bolezni (PD)
• 3 cycles of FEC followed by 3 cycles of docetaxel, all given concurrently with Perjeta and trastuzumab
• 3 cikli sheme FEC, ki so ji sledili 3 cikli zdravljenja z docetakselom, oboje sočasno z zdravilom Perjeta in trastuzumabom,
Perjeta is given with other cancer treatments (trastuzumab andchemotherapy).
• Zdravilo Perjeta se daje skupaj s še dvema drugima zdraviloma proti raku (trastuzumabom in kemoterapijo).
Pertuzumab displayed linear pharmacokinetics within the recommended dose range.
Linearnost/nelinearnost V priporočenem območju odmerjanja je pertuzumab pokazal linearno farmakokinetiko.
Docetaxel N=73
trastuzumab docetaksel n = 73
In NEOSPHERE, two patients in the Perjeta and docetaxel-treated group experienced anaphylaxis.
V preskušanju NEOSPHERE je pri dveh bolnicah iz skupine, ki je prejemala zdravilo Perjeta in docetaksel, prišlo do pojava anafilaksije.
and all patients were female.
Vsi vključeni bolniki so bili ženskega spola, demografska struktura je bila dobro uravnotežena
Perjeta 420 mg concentrate for solution for infusion pertuzumab
Perjeta 420 mg koncentrat za raztopino za infundiranje pertuzumab
Each vial contains a total of 420 mg pertuzumab at a concentration of 30 mg/ml
Ena 14 ml viala vsebuje 420 mg pertuzumaba s koncentracijo 30 mg/ml.
Shortness of breath
• težko dihanje
• 3 cycles of FEC alone followed by 3 cycles of docetaxel, with trastuzumab and Perjeta given concurrently
• 3 cikli samostojne sheme FEC, ki so ji sledili 3 cikli zdravljenja z docetakselom, sočasno s trastuzumabom in zdravilom Perjeta,
It should not be administered as an intravenous push or bolus.
Zdravila se ne sme dajati v obliki bolusa.
Most events were Grade 1 or 2 in severity, occurred in the first two cycles, and responded to standard therapies, such as topical or oral treatment for acne.
Večina dogodkov je bila po resnosti opredeljena kot 1. ali 2. stopnje in se je pojavila v prvih dveh ciklih.
21.0, 23.6) in the Perjeta arm versus +9.2 (95% CI 8.2, 10.2) in the placebo arm.
Ocena simptomov driske se je v skupini z zdravilom Perjeta povečala na +22,3 (95-% IZ 21,0; 23,6) in v skupini s placebom na +9,2 (95-% IZ 8,2; 10,2).
Baseline albumin and lean body weight were the most significant covariates influencing CL. CL decreased in patients with higher baseline albumin concentrations and increased in patients with greater lean body weight.
Ta je bil manjši pri večji izhodiščni koncentraciji albumina in večji pusti telesni masi.
Do not freeze
Ne zamrzujte
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,
V preskušanju TRYPHAENA je bila incidenca nevtropenije stopnje 3-4 po merilih NCI-CTCAE (različica 3) 85,3 % pri bolnicah, ki so se neoadjuvantno zdravile z zdravilom Perjeta in shemo TCH, ter 77,0 % pri bolnicah, ki so se neoadjuvantno zdravile s kombinacijo zdravila Perjeta, trastuzumaba in docetaksela po shemi FEC, pri čemer se je nevtropenija stopnje 4 pojavila pri 66,7 % bolnic, ki so se neoadjuvantno zdravile z zdravilom Perjeta in shemo TCH in 59,5 % bolnic, ki so se neoadjuvantno zdravile s kombinacijo zdravila Perjeta, trastuzumaba in docetaksela po shemi FEC.
In the neoadjuvant trial TRYPHAENA, the incidence of LVD (during the overall treatment period)
V neoadjuvantnem obdobju preskušanja BERENICE je bila incidenca simptomatske LVD NYHA
In the NEOSPHERE trial, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was 74.5% in patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel compared with 84.5% in patients treated with trastuzumab and docetaxel, including 50.9% and 60.2% Grade 4 neutropenia, respectively.
V preskušanju NEOSPHERE je bila incidenca nevtropenije stopnje 3-4 po merilih NCI-CTCAE (različica 3) 74,5 % pri bolnicah, ki so se neoadjuvantno zdravile z zdravilom Perjeta, trastuzumabom in docetakselom, v primerjavi s 84,5 % pri bolnicah, ki so se zdravile s trastuzumabom in docetakselom, pri čemer se je nevtropenija stopnje 4 pojavila pri 50,9 % bolnic, ki so se neoadjuvantno zdravile z zdravilom Perjeta, trastuzumabom in docetakselom, in 60,2 % bolnic, ki so se zdravile s trastuzumabom in docetakselom.
The bag should be gently inverted to mix the solution in order to avoid foaming.
Da bi preprečili penjenje raztopine, je treba vrečko previdno obračati, da se tekočina premeša.
Perjeta+ Trastuzuma b N=107
trastuzumab docetaksel n = 107
No differences in pertuzumab PK were observed in patients with early breast cancer compared to patients with metastatic breast cancer.
Pri bolnikih z zgodnjim rakom dojk in bolnikih z metastatskim rakom dojk ni bilo razlik v farmakokinetiki pertuzumaba.
(vs. Trastuzumab +Docetaxel)
trastuzumab + docetaksel)
6.5 Nature and contents of container
FARMACEVTSKA OBLIKA IN VSEBINA
In the neoadjuvant period of the BERENICE trial, the incidence of NYHA Class III/IV symptomatic LVD (congestive heart failure according to NCI-CTCAE v.4) was 1.5% in the group treated with dose dense doxorubicin and cyclophosphamide (AC) followed by Perjeta plus trastuzumab and paclitaxel and none of the patients (0%) experienced symptomatic LVD in the group treated with FEC followed by Perjeta in combination with trastuzumab and docetaxel.
razreda III/IV (kongestivnega srčnega popuščanja po merilih NCI-CTCAE v.4) v skupini, zdravljeni s pogostimi odmerki (angl. dose dense) doksorubicina in ciklofosfamida, čemur je sledilo zdravilo Perjeta v kombinaciji s trastuzumabom in paklitakselom, 1,5 %.
In addition, ADRs reported in the post-marketing setting are included in Table 2.
V preglednici 2 so vključeni tudi neželeni učinki, o katerih so poročali v obdobju trženja zdravila.
Leucopenia
trastuzumab
You should use effective contraception during treatment with Perjeta and for 6 months after stopping treatment.
6 mesecev po koncu zdravljenja morate uporabljati učinkovito kontracepcijsko zaščito.
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).
Pojavnost simptomatskega srčnega popuščanja (razred III ali IV po NYHA) z zmanjšanjem LVEF za vsaj 10 odstotnih točk od izhodiščne vrednosti in na < 50 % je bila v študiji APHINITY < 1 % (0,6 %
pCR rate in the breast and lymph node (ypT0/is N0)
Dodatni eksplorativni deleži pCR vključujejo status bezgavk (ypT0/isN0 in ypT0N0).
See section 4 “Serious side effects” for more details about infusion reactions to look out for during the infusion and thereafter.
Za podrobnosti o infuzijskih reakcijah, na katere morate biti pozorni med infuzijo zdravila in po njej, glejte poglavje 4, “Resni neželeni učinki”.
Glacial acetic acid, L-histidine, sucrose and polysorbate 20.
koncentrirana ocetna kislina, L-histidin, saharoza, polisorbat 20, voda za injekcije
Asymptomatic or mildly symptomatic (NYHA class II)
incidenca LVD razreda III/IV po NYHA ali upad
TRYPHAENA is a multicentre, randomised phase II clinical trial conducted in 225 adult female patients with HER2-positive locally advanced, operable, or inflammatory breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy.
TRYPHAENA je multicentrično, randomizirano, klinično preskušanje faze II pri 225 odraslih bolnicah s HER2-pozitivnim lokalno napredovalim, operabilnim ali vnetnim rakom dojk (T2-4d;
(71.2%) compared to the placebo arm (45.2%).
V preskušanju APHINITY so poročali o večji pojavnosti driske v skupini z zdravilom Perjeta (71,2 %) kot v skupini s placebom (45,2 %).
When administered with Perjeta, docetaxel can be started at 75 mg/m2, and subsequently escalated to 100 mg/m2 depending on the chosen regimen and tolerability of the initial dose.
Začetni odmerek docetaksela ob zdravilu Perjeta je lahko 75 mg/m2, nato pa se ga poveča na
Fatigue
Driska
Interstitial lung disease Pleural effusion
Žilne bolezni oblivi vročine
In the pivotal trial CLEOPATRA in metastatic breast cancer, rash occurred in 51.7% of Perjeta-treated patients, compared with 38.9% of placebo-treated patients.
Izpuščaj V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk se je izpuščaj pojavil pri 51,7 %
In the hormone receptor-positive subgroup estimates of IDFS rates were 94.8% versus 94.4% at 3 years and 93.0% versus 91.6% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Po 4 letih je bil ta delež pri bolnikih v podskupini s pozitivnimi hormonskimi receptorji, ki so prejemali zdravilo Perjeta, 93,0 %, pri bolnikih, ki so prejemali placebo, pa 91,6 %.
Name and address of the manufacturer of the biological active substance(s) Genentech, Inc.
Ime in naslov izdelovalca biološke učinkovine
Ask your doctor or nurse to give you information about these other medicines.
Z zdravnikom ali medicinsko sestro se posvetujte, preden dobite zdravilo Perjeta:
FEC Perjeta+ Trastuzumab
FEC Perjeta +
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.
V obeh preskušanjih TRYPHAENA in APHINITY je bila v skupini, zdravljeni z zdravilom Perjeta in shemo TCH, skupna pogostnost preobčutljivosti/anafilaksije največja (13,2 % v preskušanju
The 840 mg loading dose of pertuzumab should be re-administered as a 60 minute infusion, followed by a maintenance dose of 420 mg IV administered every 3 weeks thereafter.
Ponovno je treba dati uvajalni 840-mg odmerek pertuzumaba v 60minutni intravenski infuziji, ki mu sledi vzdrževalni odmerek
In the lymph node- negative subgroup, estimates of IDFS rates were 97.5% versus 98.4% at 3 years and
V podskupini z negativnimi bezgavkami je bil ocenjeni delež IDFS po 3 letih pri bolnikih, ki so prejemali zdravilo Perjeta, 97,5 %, pri bolnikih, ki so prejemali placebo, pa 98,4 %.
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.
1,3 % v skupini bolnic, ki so po zdravljenju s FEC prejele zdravilo Perjeta, trastuzumab in docetaksel (izključena je bolnica, pri kateri se je simptomatska LVD pojavila med zdravljenjem s FEC pred prejemom zdravila Perjeta, trastuzumaba in docetaksela) ter tudi 1,3 % v skupini, zdravljeni z zdravilom Perjeta v kombinaciji s shemo TCH.
NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion
Perjeta 420 mg koncentrat za raztopino za infundiranje
Hair loss
Razredčena raztopina
There was no evidence of any PK interaction between pertuzumab and any of these agents.
Med pertuzumabom in navedenimi zdravili niso ugotovili nobenih farmakokinetičnih medsebojnih delovanj.
NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion pertuzumab
Navodilo za uporabo Perjeta 420 mg koncentrat za raztopino za infundiranje pertuzumab
Trastuzum ab +Docetaxel N=107
Parameter trastuzumab + docetaksel n = 107
p-value (Log-Rank test, stratified1) 3 year event-free rate2 [95% CI]
HR [95-% IZ] Vrednost p (log-rang test, stratificirani1)
18.1% of patients in the Perjeta arm vs. 9.2% of patients in the placebo arm in the post-chemotherapy targeted therapy period.
Po zaključku kemoterapije je bila pojavnost driske precej manjša; med obdobjem ciljnega zdravljenja po kemoterapiji je prizadela 18,1 % bolnikov v skupini z zdravilom Perjeta in 9,2 % bolnikov v skupini s placebom.
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.
bolnikc, ki so se neoadjuvantno zdravile z zdravilom Perjeta in shemo TCH, in pri 20,0 % bolnic, ki so se neoadjuvantno zdravile s kombinacijo zdravila Perjeta, trastuzumaba in docetaksela po shemi FEC.
Estimates of IDFS rates in the lymph node- positive subgroup were 92.0% versus 90.2% at 3 years and 89.9% vs. 86.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Ocenjeni delež IDFS je bil v podskupini s pozitivnimi bezgavkami po 3 letih pri bolnikih, ki so prejemali zdravilo Perjeta, 92,0 %, pri bolnikih, ki so prejemali placebo, pa 90,2 %.
Dose modification
• spremembe nohtov
96.2% versus 96.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Po 4 letih je bil ta delež pri bolnikih v podskupini z negativnimi bezgavkami, ki so prejemali zdravilo Perjeta, 96,2 %, pri bolnikih, ki so prejemali placebo, pa 96,7 %.
An observation period of 30 - 60 minutes is recommended after completion of each infusion.
Po koncu vsakega infundiranja je bolnike priporočljivo opazovati 30 do 60 minut.
Stomatitis
Izdelovalec
Neutropenia
• nespečnost
Diarrhoeal events responded well to proactive management with anti-diarrhoeal agents.
Driska se je umirila in bila obvladljiva po uvedbi zdravil proti driski.
(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
Incidenca asimptomatske LVD (zmanjšanja iztisnega deleža levega prekata po merilih NCI-CTCAE v.4) je bila 7 % v skupini, zdravljeni s pogostimi odmerki doksorubicina in ciklofosfamida, čemur je sledilo zdravilo Perjeta v kombinaciji s trastuzumabom in paklitakselom, in
Weak, numb, tingling or prickling sensations mainly affecting the feet and legs Nose bleeds
• šibkost, odrevenelost, mravljinčenje, zbadanje, zlasti v stopalih in nogah
Inflammation of the nail bed where the nail and skin meet Condition in which the left ventricle of the heart is functionally impaired with or without symptoms
• funkcijska okvara levega prekata srca, ki je lahko simptomatska ali prikrita (ne daje simptomov)
The infusion rate may be slowed or interrupted if the patient develops an infusion reaction (see section 4.8).
Če se razvije infuzijska reakcija, se hitrost infuzije upočasni ali infundiranje prekine (glejte poglavje
NA
ali
Five studies evaluated the effects of pertuzumab on the PK of co-administered cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin and erlotinib.
FEC: 5-fluorouracil, epirubicin, ciklofosfamid; TCH: docetaksel, karboplatin and trastuzumab, CMH: CochranMantel-Haenszel, IZ: interval zaupanja
Tell your doctor straight away, if you get pregnant during treatment with Perjeta or during the 6 months after stopping treatment.
• Če med zdravljenjem z zdravilom Perjeta ali v 6 mesecih po koncu zdravljenja zanosite, morate o tem takoj obvestiti zdravnika.
Grounds for the variation to the terms of the marketing authorisation(s)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Drug hypersensitivity°,
preobčutljivost na zdravilo°, *
• Trastuzumab plus docetaxel
tras tuzumab + docetaksel)
The primary endpoint of the study was progression-free survival (PFS) as assessed by an independent review facility (IRF) and defined as the time from the date of randomisation to the date of disease progression or death (from any cause) if the death occurred within 18 weeks of the last tumour assessment.
Opredeljen je bil kot čas od datuma randomizacije do datuma napredovanja bolezni ali do smrti (zaradi kakršnega koli vzroka),
Patients were randomised to receive one of the following neoadjuvant regimens for 4 cycles prior to surgery:
Bolnice so pred operacijo randomizirali v enega od naslednjih neoadjuvantnih shem (prejele so 4
The incidence of asymptomatic LVD
Incidenca simptomatske LVD (kongestivnega srčnega popuščanja) je bila
Key to abbreviations (Table 5): HR: Hazard Ratio; CI: Confidence Interval
3-letni delež brez dogodkov2 [95-% IZ] Legenda okrajšav (preglednica 5): HR = razmerje ogroženosti, IZ = interval zaupanja.
How you are given Perjeta
Kako boste prejeli zdravilo Perjeta Prejemanje tega zdravila
In the APHINITY trial, a higher incidence of diarrhoea was reported in the Perjeta-treated arm
Po oceni raziskovalca se je anafilaksija skupno pojavila pri 2 bolnikih v skupini, ki je prejemala placebo,
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).
LVEF, je bila skladna z že znanimi podatki pri neoadjuvantnem zdravljenju (glejte poglavji 4.4 in
Fever associated with dangerously low levels of a type of white blood cell (neutrophils) Pain in the body, arms, legs, and belly
• zvišana telesna temperatura, povezana z nevarno majhnim številom vrste belih krvih celic
Difference in ORR:
Razlika v deležu objektivnega odgovora:
How to store Perjeta
Shranjevanje zdravila Perjeta
No pharmacokinetic (PK) interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel in a sub-study of 37 patients in the randomised, pivotal trial CLEOPATRA in metastatic breast cancer.
CLEOPATRA pri metastatskem raku dojk, niso opazili medsebojnega farmakokinetičnega delovanja med pertuzumabom in trastuzumabom in tudi ne med pertuzumabom in docetakselom.
Fertility
BERENICE.
Table 1 Recommendations regarding delayed or missed doses Time between two sequential infusions
Priporočila glede zamujenih ali izpuščenih odmerkov
Decreas ed appetite
v dojki in bezgavki
Keep this medicine out of the sight and reach of children.
• Zdravilo shranjujte nedosegljivo otrokom!
• Perjeta plus docetaxel.
• zdravilo Perjeta in docetaksel.
Therefore, care must be taken to ensure the sterility of the prepared solution for infusion and should be prepared by a healthcare professional.
Zdravilo Perjeta ne vsebuje protimikrobnih konzervansov, zato ga mora pripraviti zdravstveni delavec; pri tem je treba uporabiti aseptične postopke za zagotovitev sterilnosti pripravljene raztopine.
In the neoadjuvant trial NEOSPHERE, in which patients received 4 cycles of Perjeta as neoadjuvant treatment, the incidence of LVD (during the overall treatment period) was higher in the Perjeta,
V preskušanju neoadjuvantnega zdravljenja NEOSPHERE, v katerem so bolnice za neoadjuvantno zdravljenje prejele 4 cikle zdravila Perjeta, je bila incidenca LVD (tekom celotnega obdobja zdravljenja) večja v skupini, zdravljeni z zdravilom Perjeta, trastuzumabom in docetakselom (7,5 %), v primerjavi s skupino, zdravljeno s trastuzumabom in docetakselom (1,9 %).
• the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)
• neoadjuvantno zdravljenje odraslih bolnikov s HER2-pozitivnim, lokalno napredovalim,
Overall, 2 patients in the placebo-treated group and 4 patients in the Perjeta-treated group experienced events described as anaphylaxis by the investigator (see section
in pri 4 bolnikih v skupini, ki je prejemala zdravilo Perjeta (glejte poglavje 4.4).