natgillin/translations-raw huggingface dataset:
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
V preživetju brez bolezni v tej podskupini ni bilo opaziti koristi (razmerje ogroženosti = 1,16; 95-% IZ [0,73; 1,83] za DCarbH (TCH) v primerjavi z AC ® D (AC ® T); razmerje ogroženosti 0,97; 95-% IZ [0,60; 1,55] za AC ® DH (AC ® TH) v primerjavi z AC ® D).
6.4 Special precautions for storage Store in a refrigerator (2°C - 8°C).
6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 °C-8 °C).
Response rate (95 %CI)
Delež odgovora (95-% IZ)
Herceptin 150 mg powder for concentrate for solution for infusion Trastuzumab
Herceptin 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
You will be observed by a healthcare professional during the administration and for six hours after the start of the first administration and for two hours after the start of other administrations.
Med prvim dajanjem zdravila in šest ur po njem boste pod strokovnim nadzorom zdravstvenega osebja, pri nadaljnjih aplikacijah pa vas bodo opazovali dve uri po začetku dajanja zdravila.
NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
B-31/NCCTG N9831 in BCIRG006, ki vključujejo dogodke preživetja brez bolezni in simptomatske srčne dogodke.
Very common side effects of Herceptin: may affect more than 1 in 10 people
Zelo pogosti neželeni učinki zdravila Herceptin, ki se lahko pojavijo pri več kot 1 od 10 bolnikov,
The reconstituted Herceptin solution contains 21 mg/mL of trastuzumab.
Pripravljena raztopina zdravila Herceptin vsebuje 21 mg/ml trastuzumaba.
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 Herceptin-treated patients.
Pri 71,4 % bolnikov, zdravljenih z zdravilom Herceptin, je bilo hudo kongestivno srčno popuščanje reverzibilno (opredeljeno kot zaporedje najmanj dveh zaporednih vrednosti LVEF ≥ 50 % po dogodku).
For instructions on reconstitution of Herceptin intravenous formulation before administration, see section 6.6.
Za navodila glede rekonstitucije zdravila Herceptin v intravenski obliki pred dajanjem glejte poglavje
During the adjuvant phase of treatment, at the pre-dose Cycle 13 time point, the mean Ctrough values were 90.4 µg/mL and 62.1 µg/mL, respectively.
Med adjuvantno fazo zdravljenja pred 13. ciklom je bila v skupini s subkutano obliko zdravila Herceptin povprečna najnižja koncentracija 90,4 µg/ml, v skupini z intravensko obliko zdravila Herceptin pa 62,1 µg/ml.
The mean Ctrough during the neoadjuvant treatment phase, at the pre dose Cycle 8 time point, was higher in the Herceptin subcutaneous arm (78.7 µg/mL) than the Herceptin intravenous arm
Povprečna najnižja koncentracija pri neoadjuvantnem zdravljenju pred 8. ciklom je bila višja v skupini s subkutano obliko zdravila Herceptin (78,7 µg/ml) kot v skupini z intravensko obliko zdravila Herceptin (57,8 µg/ml).
• jaundice
· srbenje
- Study BCIRG 006 study was designed to investigate combining Herceptin treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery.
- Preskušanje BCIRG 006 je bilo zasnovano za proučevanje kombinacije zdravljenja z zdravilom Herceptin in docetakselom, bodisi po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC) bodisi v kombinaciji z docetakselom in karboplatinom pri bolnikih z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji.
Hyperhydrosis
Hipertenzija
• swelling of the lining of the heart
· šok · otekanje mrene, ki obdaja srce
A faint/barely perceptible membrane staining is detected in > 10 % of the tumour cells.
Bledo, komaj zaznavno obarvanje membrane je prisotno pri > 10 % tumorskih celic.
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9 % sodium chloride solution.
Primerno količino raztopine je treba odvzeti iz viale in dodati infuzijski vrečki, ki vsebuje 250 ml
• difficulty in breathing when lying flat
· oteženo dihanje v ležečem položaju
Median duration of follow up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm
Mediana spremljanja je bila 1,8 leta za bolnike v skupini AC → P in 2,0 leta za bolnike v skupini AC → PH.
LIST OF EXCIPIENTS L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20, α,α-trehalose dihydrate.
SEZNAM POMOŽNIH SNOVI L-histidinijev klorid monohidrat, L-histidin, polisorbat 20, α,α-trehaloza dihidrat.
Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Kapecitabin ali 5-fluorouracil so dajali skupaj s: cisplatinom - 80 mg/m2 vsake 3 tedne 6 ciklov, 1. dan vsakega cikla.
Herceptin plus paclitaxel3
zdravilo Herceptin in paklitaksel3
Table 8: Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH Parameter
Preglednica 8: Pregled analiz učinkovitosti za preskušanje BCIRG 006; AC → D v primerjavi z AC →
Disease-free survival No. patients with event p=0.0003
Preživetje brez bolezni: število bolnikov z dogodkom p = 0,0003
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
IgG1, pridobljenega iz suspenzijske celične kulture sesalcev (ovarijske celice kitajskega hrčka) in očiščenega z afinitetno ter ionsko izmenjevalno kromatografijo, ki vključuje specifično virusno inaktivacijo ter postopke odstranjevanja.
Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Zdravilo Herceptin se uporablja le za bolnike z metastatskim ali zgodnjim rakom dojk, katerih tumorji imajo ali čezmerno izražen HER2 ali amplifikacijo gena HER2, določeno s točno in validirano metodo
The European Medicines Agency has waived the obligation to submit the results of studies with Herceptin in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Herceptin za vse skupine pediatrične populacije pri raku dojk in raku želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3: Table 3 Recommended Scoring System to Evaluate the IHC Staining Patterns in Gastric Cancer Score Surgical specimen - staining pattern
Priporočeno točkovanje za vrednotenje obarvanja preparatov po metodi IHC pri raku želodca Rezultat Kirurški vzorci - videz preparata po barvanju
NSABP B-31 and NCCTG N9831.
NCCTG N9831 Parameter
Herceptin plus paclitaxel2
zdravilo Herceptin in paklitaksel2
Serious IRRs to Herceptin 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).
Poročali so o resnih reakcijah, povezanih z infuzijo zdravila Herceptin, vključno z dispnejo, hipotenzijo, piskanjem, hipertenzijo, bronhospazmom, supraventrikularno tahiaritmijo, zmanjšano saturacijo arterijske krvi s kisikom, anafilaksijo, dihalno stisko, urtikarijo in angioedemom (glejte poglavje 4.8).
For the sequence IV→SC (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described preswitching (Cycles 1-4) and post-switching (Cycles 5-8) as 53.8% vs. 56.4%, respectively; for the sequence SC→IV (SC vial and SC formulation in administration system cohorts combined), adverse event rates (all grades) were described pre- and post-switching as 65.4% vs. 48.7%, respectively.
Za prehod iv. → s.c. (skupaj za obe s.c. obliki: v viali in aplikacijskem sistemu) je bila pogostnost neželenih učinkov (vseh stopenj) pred prehodom (1. do 4. cikel) 53,8 % in po prehodu (5. do 8. cikel) 56,4 %.
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→P H group).
NCCTG N9831 je bila opravljena, ko je nastopilo 707 smrti (mediana spremljanja 8,3 leta v skupini
Chemo only (n=116)
(n = 116)
Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxyl paclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or
Učinek trastuzumaba na farmakokinetiko drugih zdravil z delovanjem na novotvorbe Farmakokinetični podatki iz študij BO15935 in M77004 pri bolnicah s HER2-pozitivnim metastatskim rakom dojk so nakazali, da izpostavljenost paklitakselu in doksorubicinu (in njunima glavnima metabolitoma 6-α hidroksil-paklitakselu, POH, in doksorubicinolu, DOL) ni bila spremenjena v prisotnosti trastuzumaba (uvajalni odmerek 8 mg/kg, ki mu je sledil odmerek 6 mg/kg iv. vsake tri tedne ali uvajalni odmerek 4 mg/kg iv., ki mu je sledil odmerek 2 mg/kg iv. enkrat na teden).
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.
Drugi z infuzijo povezani simptomi so lahko še občutek slabosti (navzea), bruhanje, bolečina, povečana napetost mišic in tresenje, glavobol, omotica, težave z dihanjem, piskanje pri dihanju, visok ali nizek krvni tlak, motnje srčnega ritma (hitro ali močno utripanje srca, trepetanje srca ali nereden srčni utrip),
• The unopened vial should be stored in a refrigerator (2°C - 8°C).
· Neodprto vialo shranjujte v hladilniku (2 °C do 8 °C).
8mg/kg + 6mg/kg q3w
8 mg/kg + 6mg/kg na tri tedne
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
V študiji BCIRG 006 se razmerje ogroženosti za primarni cilj, preživetje brez bolezni, izraža kot absolutna korist skupine AC → DH (zdravilo Herceptin) v smislu 3-letnega preživetja brez bolezni za
NAME OF THE MEDICINAL PRODUCT Herceptin 600 mg solution for injection in vial
IME ZDRAVILA Herceptin 600 mg raztopina za injiciranje v viali
In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when Herceptin was administered after anthracycline-containing chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when Herceptin was administered concurrently with taxanes than when administered sequentially to taxanes.
Pri bolnikih z zgodnjim rakom dojk so opazili povišanje incidence simptomatskih in asimptomatskih neželenih učinkov, povezanih s srcem, ko so zdravilo Herceptin dajali po kemoterapiji, ki je vsebovala antraciklin v primerjavi s sočasnim dajanjem z neantraciklinskim režimom, ki je vseboval docetaksel in karboplatin.
In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when Herceptin (intravenous formulation) was administered after anthracyclinecontaining chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when Herceptin (intravenous formulation) was administered concurrently with taxanes than when administered sequentially to taxanes.
Pri bolnikih z zgodnjim rakom dojk so opazili povišanje incidence simptomatskih in asimptomatskih neželenih učinkov, povezanih s srcem, ko so zdravilo Herceptin (v intravenski obliki) dajali po kemoterapiji, ki je vsebovala antraciklin v primerjavi s sočasnim dajanjem z neantraciklinskim režimom, ki je vseboval docetaksel in karboplatin.
When Herceptin was administered after completion of adjuvant chemotherapy NYHA Class III-IV heart failure was observed in 0.6 % of patients in the one-year arm after a median follow-up of 12 months.
Srčno popuščanje razreda III−IV po NYHA se je po mediani časa spremljanja 12 mesecev pojavilo pri 0,6 % bolnikov v skupini, ki se je z zdravilom Herceptin po zaključku adjuvantne kemoterapije zdravila eno leto.
The European Medicines Agency has waived the obligation to submit the results of studies with Herceptin in all subsets of the paediatric population for breast cancer (see section 4.2 for information on paediatric use).
Herceptin za vse skupine pediatrične populacije pri raku dojk (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
No. patients with event p=0.014**
Smrt (dogodek celokupnega preživetja): število bolnikov z dogodkom p = 0,014**
The median duration of follow up was 1.8
Mediani čas spremljanja 8 let
Talk to your doctor, pharmacist or nurse before you are given Herceptin if:
Preden boste prejeli zdravilo Herceptin zdravniku, farmacevtu ali medicinski sestri povejte, če:
In the neoadjuvant setting, the experience of concurrent administration of Herceptin and low dose anthracycline regimen is limited (see section 4.4).
Herceptin sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, malo (glejte poglavje 4.4).
• Do not use Herceptin if you notice any particulate matter or discoloration prior to administration.
· Če pred dajanjem opazite kakršne koli delce ali obarvanje, ne uporabljajte zdravila Herceptin.
for Herceptin IV Dosing Regimens in MBC, EBC and AGC Patients
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo, v stanju dinamičnega ravnovesja za režima odmerjanja zdravila Herceptin v iv. obliki pri bolnikih z MBC, EBC in AGC
pCR (absence ofinvasive neoplastic cells in breast Non-responders Exact 95% CI for pCR Rate*
pCR (odsotnost invazivnih neoplastičnih celic v dojkah)
AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel,
AC → D = doksorubicin in ciklofosfamid, ki jima sledi docetaksel; AC → DH = doksorubicin in ciklofosfamid,
Pulmonary hypoplasia
Pljučni zapleti
Strong complete membrane staining is detected in > 10 % of the tumour cells.
Močno obarvane celotne membrane pri > 10 % tumorskih celic.
NAME OF THE MEDICINAL PRODUCT Herceptin 150 mg powder for concentrate for solution for infusion
IME ZDRAVILA Herceptin 150 mg prašek za koncentrat za raztopino za infundiranje
cycles.
Cikel n
(95 % CI) p-value p<0.0001
Razmerje ogroženosti za preživetje brez bolezni (95-% IZ) p-vrednost p < 0,0001
N
O
• swelling of the face, lips and throat
· poškodba/odpoved jeter · otekanje obraza, ustnic in grla · odpoved ledvic
Patients with MBC should be treated with Herceptin until progression of disease.
Bolnike z metastatskim rakom dojk je treba z zdravilom Herceptin zdraviti do napredovanja bolezni.
Patients were either naïve to Herceptin IV treatment (20.3%) or preexposed to Herceptin IV (79.7%).
Bolniki še niso prejemali zdravila Herceptin v intravenski obliki (20,3 %) ali pa so bili predhodno izpostavljeni zdravilu
The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below:
Končni rezultati za celokupno preživetje iz skupne analize študij NSABP B-31 in NCCTG N9831 so povzeti v spodnji preglednici 8.
Ejection fraction decreased*
1trepetanje srca zmanjšanje iztisnega deleža*
Table 3: Efficacy results from the monotherapy and combination therapy studies Parameter
Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja Parameter
In the clinical study comparing these two formulations, infections and cardiac events leading to hospitalisation were more frequent with the subcutaneous formulation.
Ko so obliki primerjali v klinični študiji, so ugotovili, da so se pri podkožni obliki večkrat pojavile okužbe in neželeni učinki, povezani s srcem, ki so zahtevali bolnišnično zdravljenje.
• you have had heart failure, coronary artery disease, heart valve disease (heart murmurs), high blood pressure, taken any high blood pressure medicine or are currently taking any high blood pressure medicine.
visok krvni tlak, če jemljete ali ste jemali zdravila proti visokemu krvnemu tlaku;
Baseline levels of the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed.
Izhodiščne vrednosti odcepljene HER2-ECD, ki so jih opazili pri bolnikih z metastatskim rakom želodca, so bile primerljive s tistimi pri bolnikih z metastatskim rakom dojk in zgodnjim rakom dojk;
Women of childbearing potential
Uporaba pri otrocih in mladostnikih
• haemorrhoids
· hemeroidi
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja eritem izpuščaj
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule Study BO15935
Študija MO16982: uvajalni odmerek 6 mg/kg na teden 3 tedne; sledil je odmerek 6 mg/kg po 3tedenskem režimu.
+Acute pulmonary oedema
+dispneja kašelj epistaksa rinoreja
• If you get any side effects, talk to your doctor, pharmacist or nurse.
· Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Patients with EBC should be treated with Herceptin for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Podaljšanje zdravljenja zgodnjega raka dojk na več kot eno leto ni priporočljivo (glejte poglavje 5.1).
Gastrointestinal disorders Diarrhoea
Bolezni prebavil diareja bruhanje navzea
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 6.
Rezultati učinkovitosti iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 v času končne analize preživetja brez bolezni* so povzeti v preglednici 6.
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Šibko do srednje močno obarvane celotne, bazolateralne ali lateralne membrane pri > 10 % tumorskih celic.
years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm.
2,0 leta za bolnike v skupini AC → PH.
In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is Herceptin (trastuzumab) and not Kadcyla (trastuzumab emtansine).
da je pripravljeno in uporabljeno zdravilo Herceptin (trastuzumab) in ne zdravilo Kadcyla (trastuzumab emtanzin).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Herceptin 600 mg solution for injection
IME ZDRAVILA IN POT(I) UPORABE Herceptin 600 mg raztopina za injiciranje trastuzumab le za subkutano uporabo
AC→P (n=1679)
(n = 1679)
Patients with HER2+ tumours were randomised to receive either neoadjuvant chemotherapy concurrently with neoadjuvant-adjuvant Herceptin, or neoadjuvant chemotherapy alone.
Bolniki s HER2-pozitivnimi tumorji so bili randomizirani v skupino, ki je prejemala neoadjuvantno kemoterapijo sočasno z neoadjuvantnim zdravilom Herceptin najprej, nato pa še adjuvantno, ali v skupino, ki je prejemala le neoadjuvantno kemoterapijo.
The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 7:
Končni rezultati za celokupno preživetje iz skupne analize študij NSABP B-31 in NCCTG N9831 so povzeti v spodnji preglednici 7.
How to store Herceptin
Shranjevanje zdravila Herceptin
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.
Rezultati učinkovitosti iz skupne analize preskušanj NSABP B-31 in NCCTG N9831 v času končne analize preživetja brez bolezni* so povzeti v preglednici 7.
- Studies NSABP B-31 and NCCTG N9831 that comprise the joint analysis were designed to investigate the clinical utility of combining Herceptin treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding Herceptin sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
- Preskušanji NSABP B-31 in NCCTG N9831, ki imata skupno analizo, sta bili zasnovani za proučevanje klinične koristi kombinacije zdravljenja z zdravilom Herceptin in paklitakselom po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC).
Reproduction studies have been conducted in Cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg Herceptin intravenous formulation and have revealed no evidence of impaired fertility or harm to the fetus.
Študije o vplivu na sposobnost za razmnoževanje so opravili pri opicah Cynomolgus z odmerki, ki so bili do 25-krat večji od tedenskega vzdrževalnega odmerka intravenske oblike zdravila Herceptin pri ljudeh (2 mg/kg).
• Keep this medicine out of the sight and reach of children.
· Zdravilo shranjujte nedosegljivo otrokom!
Paclitaxel, in combination with Herceptin, was administered as follows: - intravenous paclitaxel - 80 mg/m2 as a continuous intravenous infusion, given every week for 12 weeks.
Odmerjanje paklitaksela v kombinaciji z zdravilom Herceptin je bilo naslednje: paklitaksel intravensko - 80 mg/m2 v obliki kontinuirane intravenske infuzije, vsak teden, skupaj 12 tednov ali paklitaksel intravensko - 175 mg/m2 v obliki kontinuirane intravenske infuzije, vsake 3
which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
· paklitaksel 175 mg/m2, dan enkrat na tri tedne, 4 cikle; sledili so
No. patients with event p=0.0008
Pojav oddaljenih metastaz: število bolnikov z dogodkom p = 0,0008
• failure of the lungs of the baby to develop in the womb
· okvara pri razvoju pljuč otroka v maternici · nenormalen razvoj ledvic otroka v maternici
The recommended maintenance dose of Herceptin at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Priporočen vzdrževalni odmerek zdravila Herceptin je 6 mg/kg telesne mase po 3 tednih od prejema uvajalnega odmerka, in nato v tritedenskih razmakih.
Herceptin treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only.
Zdravljenje z zdravilom Herceptin mora vpeljati zdravnik z izkušnjami s citotoksično kemoterapijo (glejte poglavje
• The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
· Pomožne snovi so L-histidinijev klorid monohidrat, L-histidin, α,α-trehaloza dihidrat in polisorbat 20.
• itchiness
· tesnoba
Patients with MBC or MGC should be treated with Herceptin until progression of disease.
Bolnike z metastatskim rakom dojk ali metastatskim rakom želodca je treba z zdravilom Herceptin zdraviti do napredovanja bolezni.
Table 4 Efficacy Results from the Monotherapy and Combination Therapy Studies
Rezultati učinkovitosti iz študij monoterapije in kombiniranega zdravljenja
Study MO22982 investigated switching between the Herceptin intravenous and Herceptin subcutaneous formulation with a primary objective to evaluate patient preference for either the intravenous or the subcutaneous route of trastuzumab administration.
V študiji MO22982 so proučevali prehajanje med zdravljenjem z zdravilom Herceptin v intravenski in subkutani obliki.
• pain, swelling, redness or tingling of hands and/or feet
· rdečina, oteklina ali ranice v ustih in/ali žrelu · bolečina, oteklina, rdečina ali zbadanje v rokah in/ali nogah
+Acute respiratory distress syndrome
+pljučnica astma motnje delovanja pljuč
Table 15 Population Predicted Steady State PK Exposure Values (median with 5th - 95th Percentiles)
Farmakokinetične vrednosti izpostavljenosti, predvidene za populacijo (mediana s 5.-95.