natgillin/translations-raw huggingface dataset:
The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10.
Rezultati učinkovitosti iz študije BCIRG 006 so povzeti v preglednicah 9 in 10.
To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures.
Za zagotovitev točnih in ponovljivih rezultatov mora biti testiranje opravljeno v specializiranem laboratoriju, ki lahko zagotavlja validacijo postopkov testiranja.
What you need to know before you are given Ontruzant Do not use Ontruzant if:
Kaj morate vedeti, preden boste dobili zdravilo Ontruzant Ne uporabljajte zdravila Ontruzant, če:
If you receive Ontruzant in combination with chemotherapy, some of them may also be due to the chemotherapy.
Če prejemate zdravilo Ontruzant skupaj s kemoterapijo, lahko nekateri od njih nastanejo tudi zaradi kemoterapije.
In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials.
Pri adjuvantnem zdravljenju so trastuzumab proučevali v 4 velikih multicentričnih randomiziranih preskušanjih.
(week)
(tedni)
If a pregnant woman is treated with trastuzumab, or if a patient becomes pregnant while receiving trastuzumab or within 7 months following the last dose of trastuzumab, close monitoring by a multidisciplinary team is desirable.
Če se nosečnica zdravi s trastuzumabom ali če bolnica zanosi med zdravljenjem s trastuzumabom ali v obdobju 7 mesecev po prejemu zadnjega odmerka trastuzumaba, je zaželeno, da jo skrbno spremlja multidisciplinarna ekipa.
Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed.
Klinično pomembnega medsebojnega delovanja med trastuzumabom in sočasno uporabljenimi zdravili v kliničnih preskušanjih, niso opazili.
From a microbiological point of view, the reconstituted solution and Ontruzant infusion solution should be used immediately.
Z mikrobiološkega stališča je treba rekonstituirano raztopino in raztopino zdravila Ontruzant za infundiranje uporabiti takoj.
• You have early breast cancer, with high levels of a protein called HER2.
• imate zgodnjega raka dojk z visoko ravnijo beljakovine, ki se imenuje HER2;
12.2 (6.2-ne)
12,2 (6,2-no)
• dry mouth and skin
• suha usta in koža,
Fatalities have occurred within hours and up to one week following infusion.
Smrt je nastopila v nekaj urah do en teden po infuziji.
In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Poleg tega so opravili primerjavo dveletnega zdravljenja s trastuzumabom z enoletnim zdravljenjem s trastuzumabom.
The dose of Ontruzant depends on your body weight.
Odmerek zdravila Ontruzant je odvisen od vaše telesne mase.
• low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever
• zmanjšano število rdečih in belih krvničk (ki pomagajo pri borbi proti okužbi), včasih z zvišano telesno temperaturo,
The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s trastuzumabom za vse podskupine pediatrične populacije za raka dojk in želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
No long-term animal studies have been performed to establish the carcinogenic potential of trastuzumab, or to determine its effects on fertility in males.
Dolgoročnih študij na živalih za ugotavljanje kancerogenega potenciala trastuzumaba ali za ugotavljanje njegovih učinkov na plodnost moških niso opravili.
Slight foaming of the product upon reconstitution is not unusual.
Lahno penjenje zdravila ob rekonstituciji ni nenavadno.
FP + H: fluoropyrimidine/cisplatin + trastuzumab FP: fluoropyrimidine/cisplatin a Odds ratio
FP + H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin a kvocient verjetnosti
However, the magnitude of effect of these covariates on trastuzumab exposure suggests that these covariates are unlikely to have a clinically meaningful effect on trastuzumab concentrations.
Vendar velikost učinka teh sospremenljivk na izpostavljenost trastuzumabu kaže, da je malo verjetno, da bi te sospremenljivke klinično pomembno vplivale na koncentracije trastuzumaba.
Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) fetal development period was observed.
Opazili so prehod trastuzumaba skozi posteljico v zgodnjem obdobju (20.-50. dan gestacije) in v poznem obdobju (120.-150. dan gestacije) razvoja ploda.
• swelling or bleeding at the back of the eyes
• otekanje ali krvavitev v očesnem ozadju,
Chemotherapy was administered as follows:
Kemoterapijo so dajali takole:
If the first dose is well tolerated the next doses may be given over 30 minutes.
Če boste dobro prenesli prvi odmerek, vam bodo naslednje odmerke dajali po 30 minut.
The presence of anti-trastuzumab antibodies had no impact on pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Prisotnost protiteles proti trastuzumabu ni vplivala na farmakokinetiko, učinkovitost (določeno s patološkim popolnim odgovorom [pCR] in preživetjem brez dogodka (Event Free Survival [EFS]) in varnost, določeno s pojavom reakcij, povezanih z aplikacijo intravenskega trastuzumaba.
The loading dose should be administered as a 90-minute intravenous infusion.
Polnilni odmerek zdravila Ontruzant se daje kot 90-minutna intravenska infuzija.
These events may occur as part of an infusion-related reaction or with a delayed onset.
Ti dogodki se lahko pojavijo kot del reakcije na infuzijo ali pa nastopijo pozneje.
Therefore, these patients should not be treated with trastuzumab (see section 4.3).
Zato teh bolnikov ne smemo zdraviti s trastuzumabom (glejte poglavje 4.3).
Total pathological complete response* (95% CI)
Popoln patološki celoten odziv* (95 % IZ)
Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of trastuzumab (see section 4.4) and have been associated with a fatal outcome.
Hude anafilaktične reakcije, pri katerih je potrebno takojšnje dodatno posredovanje, se lahko navadno pojavijo bodisi med prvo bodisi med drugo infuzijo trastuzumaba (glejte poglavje 4.4) in so bile povezane s smrtnim izidom.
In this trial, 87% of patients entered had disease that was IHC3+, and 95% of patients entered had disease that was IHC3+ and/or FISH-positive.
V tem preskušanju je imelo 87 % vključenih bolnikov bolezen, ki je bila IHC3+, 95 % vključenih bolnikov pa je imelo bolezen, ki je bila IHC3+ in/ali FISH-pozitivna.
Other medicines and Ontruzant
Druga zdravila in zdravilo Ontruzant
Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2).
Če se pojavi reakcija na infuzijo, je treba infundiranje trastuzumaba prekiniti ali upočasniti hitrost infundiranja, bolnika pa je treba spremljati, dokler vsi opaženi simptomi ne izzvenijo (glejte poglavje 4.2).
Patients were treated with trastuzumab until progression of disease.
Bolnike so zdravili s trastuzumabom do napredovanja bolezni.
Your doctor may prescribe Ontruzant for the treatment of breast and gastric cancer when:
Zdravnik vam lahko predpiše zdravilo Ontruzant za zdravljenje raka dojk in raka želodca, kadar:
The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a trastuzumab containing regimen after progression of disease.
Razlika ni bila statistično značilna, vendar pa je več kot polovica bolnic iz skupine, ki je jemala le anastrozol po napredovanju bolezni, prešla na shemo, ki je vsebovala trastuzumab.
For instructions on reconstitution of Ontruzant intravenous formulation before administration, see section 6.6.
Za navodila glede rekonstitucije zdravila Ontruzant v intravenski obliki pred dajanjem glejte poglavje 6.6.
Very rarely, patients with severe breathing difficulties before treatment have died when they were given Ontruzant.
Zelo redko je pri bolnikih, ki so imeli pred zdravljenjem hude težave z dihanjem, prišlo do smrtnih primerov ob prejemu zdravila Ontruzant;
This investigative clinical trial assay performed in a central laboratory utilised a 0 to 3+ scale.
Pri tej raziskovalni metodi v kliničnem preskušanju, ki so jo opravljali v centralnem laboratoriju, so uporabljali lestvico od 0 do 3+.
Occasionally, symptoms start later than six hours after the infusion begins.
Včasih se simptomi pojavijo več kot šest ur po začetku infuzije.
Once the infusion is prepared it should be administered immediately.
Ko je infuzija pripravljena, jo uporabite takoj.
Experience of concurrent administration of trastuzumab with low-dose anthracycline regimens is currently limited to the trial MO16432.
Izkušnje z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, so trenutno omejene na preskušanje MO16432.
Trastuzumab 1 Year N=1702***
Trastuzumab 1 leto N = 1702***
The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
Volumen centralnega prostora je bil 2,62 l pri bolnikih z MBC in EBC in 3,63 l pri bolnikih z AGC.
In a method comparison study (study D008548) a high degree of concordance (>95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
V študiji primerjave metod (študija D008548) so ugotovili visoko stopnjo skladnosti (> 95 %) za tehniki SISH in FISH za odkrivanje genske amplifikacije HER2 pri bolnikih z rakom želodca.
Women of childbearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has concluded (see section 5.2).
Ženske v rodni dobi Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem s trastuzumabom in še 7 mesecev po koncu zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
• hypertonia
• hipertonija
It may take up to 7 months for Ontruzant to be removed from the body.
Lahko traja do 7 mesecev, da se zdravilo Ontruzant odstrani iz telesa.
Observation N=1697***
Opazovanje N = 1697***
After reconstitution with sterile water for injection the reconstituted solution is physically and chemically stable for 48 hours at 2°C-8°C.
Po rekonstituciji s sterilno vodo za injekcije je rekonstituirana raztopina fizikalno in kemijsko stabilna 48 ur pri 2 °C-8 °C.
Treatment with Ontruzant (alone or with a taxane) may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Samostojno zdravljenje z zdravilom Ontruzant ali v kombinaciji s taksanom lahko vpliva na srce, posebno še, če ste se kdaj zdravili z antraciklinom (taksani in antraciklini sta dve drugi vrsti zdravil, ki se uporabljata za zdravljenje raka).
In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with intravenous trastuzumab developed antibodies against trastuzumab.
V študiji neoadjuvantnega-adjuvantnega zgodnjega raka dojk (BO22227) z mediano spremljanja, ki je presegla 70 mesecev, so se pri 10,1 % bolnikov (30/296), zdravljenih z intravensko trastuzumabom, razvila protitelesa proti trastuzumabu.
The rate of infusion-related reactions of all grades varied between studies depending on the indication, the data collection methodology, and whether trastuzumab was given concurrently with chemotherapy or as monotherapy.
Pogostnost reakcij, povezanih z infuzijo, vseh stopenj je bila različna po študijah glede na indikacijo, metodologijo zbiranja podatkov in glede na to, ali so dajali trastuzumab sočasno s kemoterapijo ali v monoterapiji.
A vial of Ontruzant reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen.
Viala zdravila Ontruzant, rekonstituirana z vodo za injekcije (ni priložena), je stabilna 48 ur pri 2 ºC8 ºC po rekonstituciji in je ne smete zamrzniti.
On the basis of the scientific conclusions for trastuzumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing trastuzumab is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za trastuzumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo trastuzumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Ontruzant is given as an infusion into a vein (intravenous infusion, “drip”).
Zdravilo Ontruzant se daje kot infuzija v veno (intravenska infuzija, kapalna infuzija).
All the terms included are based on the highest percentage seen in pivotal clinical trials.
Pri vseh navedenih neželenih učinkih je upoštevan najvišji odstotek, ugotovljen v ključnih kliničnih preskušanjih.
1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
1 Označuje neželene učinke, o katerih so večinoma poročali v povezavi z reakcijami, povezanimi z infuzijo.
The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects (see section 2 under “Warnings and precautions”).
Prvi odmerek zdravila boste prejemali 90 minut, med prejemanjem pa vas bo zaradi možnosti pojava neželenih učinkov, opazoval zdravstveni delavec (glejte poglavje 2 pod “Opozorila in previdnostni ukrepi”).
• You should use effective contraception during treatment with Ontruzant and for at least 7 months after treatment has ended.
• Med zdravljenjem z zdravilom Ontruzant in še vsaj 7 mesecev po končanju zdravljenja morate uporabljati učinkovito kontracepcijo.
The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+).
Podatki kažejo, da je bilo več koristnih učinkov pri bolnikih z višjo stopnjo čezmernega izražanja HER2 (3+).
Early breast cancer is defined as non-metastatic primary invasive carcinoma of the breast.
Zgodnji rak dojk je definiran kot primarni invazivni karcinom dojk brez metastaz.
Contents of the pack and other information What Ontruzant contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ontruzant
On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the trastuzumab infusion.
V zelo redkih primerih so se pri bolnikih pojavili simptomi reakcije na infuzijo in simptomi, povezani s pljuči, več kot šest ur po začetku infuzije trastuzumaba.
Trastuzumab 1 Year N=1693
Trastuzumab 1 leto N = 1693
In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy.
V ključnem preskušanju docetaksela (100 mg/m2, infundiranih v času 1 ure) s trastuzumabom ali brez njega je 60 % bolnikov predhodno prejelo adjuvantno kemoterapijo na podlagi antraciklinov.
+Cardiac failure (congestive)
+popuščanje srca (kongestivno)
Monitoring may help to identify patients who develop cardiac dysfunction.
Spremljanje lahko olajša prepoznati bolnike, pri katerih se pojavijo motnje v delovanju srca.
Ontruzant is for single-use only, as the product contains no preservatives.
Zdravilo Ontruzant je samo za enkratno uporabo, ker ne vsebuje konservansov.
Some of these side effects may be serious and may lead to hospitalisation.
Nekateri od teh neželenih učinkov so lahko resni in bo morda potrebno zdravljenje v bolnišnici.
Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Trastuzumab je tudi močan mediator od protiteles odvisne celične citotoksičnosti (antibody-dependent cell-mediated cytotoxicityADCC).
The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarized in Table 6:
Rezultati učinkovitosti iz preskušanja BO16348 po medianem času spremljanja 12 mesecev* in 8 let** so povzeti v preglednici 6:
• You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2.
• imate metastatskega raka dojk (raka dojk, ki se je razširil še na druga mesta zunaj prvotnega tumorja) z visoko ravnijo HER2.
following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
po operaciji, kemoterapiji (neoadjuvantni ali adjuvantni) in radioterapiji (če je primerno) (glejte poglavje 5.1);
For any other method that may be used for the assessment of HER2 protein or gene expression, the analyses should only be performed by laboratories that provide adequate state-of-the-art performance of validated methods.
Glede vseh drugih metod, ki bi se uporabljale za določanje beljakovine ali izražanja gena HER2, smejo analize opravljati le laboratoriji, ki uporabljajo ustrezne sodobne validirane metode.
Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out.
Podrobnejših farmakokinetičnih študij pri starejših in tistih z ledvično ali jetrno okvaro niso opravili.
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 ravni HER2-ECD v krvi, ki so jih ugotovili pri bolnikih z MGC, so bile primerljive s tistimi pri bolnikih z MBC in EBC, očitnega vpliva na očistek trastuzumaba niso ugotovili.
At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Do časa analize je umrlo skupaj 349 randomiziranih bolnikov: 182 bolnikov (62,8 %) v kontrolni skupini in 167 bolnikov
The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0%).
Pogostnost je bila največja pri bolnikih, ki so prejeli trastuzumab sočasno s taksanom (2,0 %).
A volume overage of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Volumski presežek 4 % zagotavlja, da lahko iz vsake viale odvzamete označeni odmerek 150 mg.
The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death.
Dodatek trastuzumaba kemoterapiji s paklitakselom je povzročil tudi 37-odstotno zmanjšanje tveganja smrti.
This intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Ta intravenska oblika zdravila ni namenjena za subkutano uporabo in se sme dajati samo kot intravenska infuzija.
The majority of patients experienced resolution of symptoms and subsequently received further infusions of trastuzumab.
Pri večini bolnikov so simptomi izzveneli in so bolniki nato prejeli nadaljnje infuzije trastuzumaba.
The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
V študijo so vključili bolnike z na novo diagnosticiranim lokalno napredovalim (stadij III) ali vnetnim zgodnjim rakom dojk.
In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of <55%, older age.
Previdnost je potrebna tudi pri zdravljenju bolnikov z zvečanim srčnim tveganjem, npr. hipertenzijo, dokumentirano koronarno arterijsko boleznijo, kongestivnim srčnim popuščanjem, LVEF < 55 %, starejših bolnikih.
1Blood pressure increased
1zvišan krvni tlak
Ontruzant may have a minor influence on the ability to drive or use machines (see section 4.8).
Zdravilo Ontruzant ima lahko blag vpliv na sposobnost vožnje in upravljanje strojev (glejte poglavje 4.8).
These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Lahko se zdravijo z analgetikom/antipiretikom, kot je meperidin (petidin) ali paracetamol, ali antihistaminikom, kot je difenhidramin.
The efficacy of trastuzumab in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied.
Učinkovitosti trastuzumaba v kombinaciji s paklitakselom pri bolnikih, ki niso predhodno prejeli adjuvantnih antraciklinov, niso proučevali.
This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in fetal death.
To stanje lahko škoduje otroku v maternici in ga povezujejo z nedozorelostjo pljuč, kar lahko povzroči smrt ploda.
As animal reproduction studies are not always predictive of human response, trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus.
Izsledki študij o vplivu na sposobnost za razmnoževanje pri živalih ne veljajo vedno tudi za ljudi, zato se moramo uporabi trastuzumaba v nosečnosti izogibati, razen v primerih, ko pričakovana korist za mater upravičuje tveganje za plod.
Trastuzumab has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Trastuzumab so raziskovali v randomiziranem, odprtem preskušanju 3. faze ToGA (BO18255) v kombinaciji s kemoterapijo v primerjavi s samo kemoterapijo.
For the other parameters the improvements seen for the combination were for overall response (16.5% versus 6.7%); clinical benefit rate (42.7% versus 27.9%); time to progression (4.8 months versus 2.4 months).
Pri drugih parametrih so bila izboljšanja pri kombinaciji vidna pri celotnem odzivu (16,5 % proti 6,7 %); pogostnosti klinične koristi (42,7 % proti 27,9 %) in času do napredovanja bolezni (4,8 meseca proti 2,4 meseca).
A volume overage of 5% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Volumski presežek 5 % zagotavlja, da lahko iz vsake viale odvzamete označeni odmerek 420 mg.
The efficacy results from Study MO16432 are summarized in Table 12.
Rezultati učinkovitosti iz študije MO16432 so povzeti v preglednici 12.
These are very common (may affect more than 1 in 10 people).
Ti so zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov).
Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6-8 weeks).
Za bolnike z asimptomatičnimi motnjami v delovanju srca je koristen pogostejši nadzor (npr. vsakih 6 do 8 tednov).
Docetaxel3 N=94
Docetaksel3 N = 94
If you experience any of the above symptoms when your treatment with Ontruzant has finished, you should see your doctor and tell them that you have previously been treated with Ontruzant.
Če se kateri koli od zgornjih simptomov pojavi po končanem zdravljenju z zdravilom Ontruzant, obiščite zdravnika in ga obvestite o tem, da ste se zdravili z zdravilom Ontruzant.
The efficacy results from study BO18225 are summarized in Table 13:
Rezultati učinkovitosti iz študije BO18225 so povzeti v preglednici 13:
• insomnia (inability to sleep)
• nespečnost (nezmožnost spati),
To ensure validation of testing procedures and the generation of accurate and reproducible results, HER2 testing must be performed in a laboratory staffed by trained personnel.
Da bodo zagotovljeni validacija postopkov testiranja in natančni in reproducibilni rezultati testiranja, mora testiranje HER2 opravljati laboratorij, v katerem je zaposleno kvalificirano osebje.
2) Swirl the vial gently to aid reconstitution.
2) Nežno vrtite vialo, da pospešite rekonstitucijo.