natgillin/translations-raw huggingface dataset:
This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
To je bilo randomizirano preskušanje faze II, v katerem so primerjali učinkovitost in varnost bevacizumaba in placeba.
In one clinical trial, the incidence of hypertension of grade ≥ 3 was two fold higher in patients aged > 65 years than in the younger age group (<65 years).
V enem kliničnem preskušanju je bila incidenca hipertenzije stopnje ≥ 3 dvakrat višja pri bolnikih, starih nad 65 let, v primerjavi s skupino, ki je vključevala mlajše bolnike (< 65 let).
Dosage and frequency of administration
Odmerjanje in pogostnost dajanja
Randomised patients with stage IV disease
Randomizirane bolnice z boleznijo stadija IV
CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Podatek o rasi obstaja za 29,3 % bolnic in skoraj vse bolnice so bile belke.
Patients with central nervous system metastases, including previously treated or resected brain lesions, were excluded.
Bolniki z metastazami v osrednjem živčevju, vključno s predhodno zdravljenimi ali odstranjenimi lezijami v možganih, niso bili vključeni.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
· Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.
3 Končno celokupno analizo so opravili, ko je 46,7 % bolnic umrlo (s podatki zbranimi do 31. marca 2013).
All treatments were continued until disease progression.
Vsa zdravljenja so izvajali, dokler ni bolezen napredovala.
The majority of patients had serous adenocarcinoma histologic type (85% in CPP and CPB15, 86% in CPB15+).
Večina bolnic je imela serozni histološki tip adenokarcinoma (85 % v CPP in CPB15, 86 % v CPB15+ skupini).
The analysis of the primary endpoint showed no difference between the Avastin + Placebo arm and the Avastin + Erlotinib arm (median PFS 8.5 versus 9.9 months).
Analiza primarnega cilja raziskave ni pokazala razlik med skupino z zdravilom Avastin + placebom in skupino z zdravilom Avastin + erlotinibom (mediana preživetja brez napredovanja bolezni 8,5 v primerjavi z 9,9 meseca).
3 One-sided log-rank p-value Subject to a p-value boundary of 0.0116.
Odvisna od meje p-vrednosti, ki je 0,0116.
Please let your doctor, pharmacist or nurse know if you have previously experienced problems after injections, such as dizziness/feeling of fainting, breathlessness, swelling or skin rash.
Svojega zdravnika, farmacevta ali medicinsko sestro obvestite, če ste že imeli težave po injiciranju, kot je omotica/občutek slabotnosti, težave pri dihanju (zasoplost), otekanje ali kožni izpuščaj;
See Section 4.
Preglednica 4.
These were most commonly NCI-CTCAE v.3 Grade 1 epistaxis that lasted less than 5 minutes, resolved without medical intervention and did not require any changes in the Avastin treatment regimen.
Večinoma je šlo za epistakse stopnje 1 po lestvici NCI-CTCAE v.3, ki so trajale manj kot 5 minut, so prenehale brez zdravniške pomoči in niso zahtevale sprememb sheme zdravljenja z zdravilom Avastin.
Fistulae have also been reported in post-marketing experience.
O fistulah so poročali tudi v obdobju trženja zdravila.
Approximately 350 patients were randomised into each of the 4 trial arms in the Part II of the trial.
V vsako od štirih skupin preskušanja v delu II preskušanja je bilo randomiziranih približno 350 bolnikov.
With or without gross residual disease.
2 Z ali brez preostanka bolezni.
● This medicine may cause bleeding, especially tumour-related bleeding.
· to zdravilo lahko povzroči krvavitve, posebno krvavitve, povezane s tumorjem.
Your doctor should advise you about using contraception during treatment with Avastin and for at least 6 months after the last dose of Avastin.
Vaš zdravnik vam bo svetoval uporabo primerne kontracepcije med zdravljenjem z zdravilom Avastin in še najmanj 6 mesecev po njegovem zadnjem odmerku.
Within each frequency category, adverse reactions are presented in the order of decreasing seriousness.
V razvrstitvah pogostnosti so vsi neželeni učinki navedeni po padajoči resnosti.
● Avastin can increase the incidence of high blood pressure.
· zdravilo Avastin lahko poveča pojavnost visokega krvnega tlaka.
● It is possible that Avastin may cause bleeding in and around your brain.
· možno je, da lahko zdravilo Avastin povzroči krvavitve v možganih in okoli možganov.
Frequency Not Known
Neznana pogostnost
The pharmacokinetics of bevacizumab were evaluated in 152 children, adolescents and young adults (7 months to 21 years, 5.9 to 125 kg) across 4 clinical studies using a population pharmacokinetic model.
Farmakokinetiko bevacizumaba so ocenili pri 152 otrocih, mladostnikih in mlajših odraslih (7 mesecev do 21 let; 5,9 do 125 kg) v 4 kliničnih študijah z uporabo populacijskega farmakokinetičnega modela.
• PLD 40 mg/m2 as a 1 mg/min IV infusion on Day 1 only every 4 weeks.
· PLD 40 mg/m2 kot intravenska infuzija s hitrostjo 1 mg/min samo 1. dan vsake 4 tedne.
Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
a Termini predstavljajo skupino neželenih učinkov, ki opisujejo medicinski pojem namesto posameznega stanja ali prednostni izraz po MedDRA (Medical Dictionary for Regulatory Activites).
The dose of Avastin needed depends on your body weight and the kind of cancer to be treated.
Potrebni odmerek zdravila Avastin je odvisen od telesne mase in vrste raka, ki ga zdravimo.
Avastin should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Zdravilo Avastin dokončno opustimo, če klinično pomembne hipertenzije ni mogoče ustrezno uravnati z antihipertenzivnimi zdravili ali če se je pri bolniku pojavila hipertenzivna kriza ali hipertenzivna encefalopatija.
Therefore, the risk of CNS haemorrhage in such patients has not been prospectively evaluated in randomised clinical trials (see section 4.8).
Tveganje za krvavitev v osrednjem živčevju pri teh bolnikih zato ni bilo prospektivno ocenjeno v randomiziranih kliničnih preskušanjih (glejte poglavje 4.8).
• epidemiological studies\non-interventional or observational studies,
· v epidemioloških študijah/neinterventnih ali opazovalnih študijah ali · s presojo poročil posameznih primerov.
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete katero koli zdravilo.
Patients with untreated CNS metastases were routinely excluded from clinical trials with Avastin, based on imaging procedures or signs and symptoms.
Bolniki z nezdravljenimi zasevki v osrednjem živčevju so bili rutinsko izključeni iz kliničnih preskušanj z zdravilom Avastin, glede na postopke slikanj ali znake in simptome.
Depending on the dose prescribed for you, some or all of the contents of the Avastin vial will be diluted with sodium chloride solution before use.
Odvisno od odmerka, ki vam ga je predpisal zdravnik, je treba del ali vso vsebino viale zdravila Avastin pred uporabo razredčiti z raztopino natrijevega klorida.
In an exploratory analysis, the extent of Avastin benefit on overall survival was less pronounced in the subgroup of patients who did not have adenocarcinoma histology.
V eksplorativni analizi so ugotovili, da je bila korist zdravila Avastin glede celokupnega preživetja manj izražena v podskupini bolnikov, ki ni imela adenokarcinoma.
Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Bolezni živčevja hipertenzivna encefalopatija (zelo redko) (glejte tudi poglavje 4.4 in odstavek Hipertenzija v poglavju 4.8)
Statistical analyses were performed independently for 1) patients who received capecitabine in combination with Avastin or placebo; 2) patients who received taxane-based or anthracycline-based chemotherapy in combination with Avastin or placebo.
Statistične analize so neodvisno izvedli za 1) bolnike, ki so prejemali kapecitabin v kombinaciji z zdravilom Avastin ali placebom; 2) bolnike, ki so prejemali kemoterapijo na osnovi taksanov ali antraciklinov v kombinaciji z zdravilom Avastin ali placebom.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 °C - 8 °C).
There was no exclusion criterion for prior anti-angiogenic therapy.
Predhodna antiangiogena terapija ni bila izključitveni kriterij.
Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensin-converting enzyme inhibitors, diuretics and calcium-channel blockers.
Hipertenzija je bila v večini primerov ustrezno uravnana s peroralnimi antihipertenzivi, kot so zaviralci angiotenzinske konvertaze, diuretiki in blokatorji kalcijevih kanalčkov.
Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all Avastin treated patients.
Smrtni izidi so bili zabeleženi v približno tretjini resnih primerov perforacij prebavil; to pomeni od 0,2 do 1 % vseh bolnikov, zdravljenih z zdravilom Avastin.
60.0 years in the CP arm and 59.0 years in the CPB arm.
Mediana starost je bila 60,0 let v skupini CP in 59,0 let v skupini CPB.
The value for clearance is, on average, equal to 0.188 and 0.220 L/day for female and male patients, respectively.
Povprečna vrednost za očistek je bila pri bolnicah 0,188 l/dan, pri bolnikih pa 0,220 l/dan.
The corresponding frequencies in the control group receiving chemotherapy alone were 1.1% vs. 0.8%, respectively.
Ustrezajoče pogostnosti v kontrolni skupini, ki je prejemala samo kemoterapijo so bile 1,1 % v primerjavi z 0,8 %.
There have also been less common reactions of minor mucocutaneous haemorrhage in other locations, such as gingival bleeding or vaginal bleeding.
Manj pogosto je prihajalo tudi do manjših krvavitev iz kože in sluznic na drugih mestih, kot na primer krvavitev iz dlesni ali vaginalnih krvavitev.
Palmar-plantar erythrodysaesthesia syndrome
sindrom palmarnoplantarne eritrodisestezije
*Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
*Bevacizumab je rekombinantno humanizirano monoklonsko protitelo, pridobljeno s tehnologijo rekombinantne DNA iz celic ovarija kitajskega hrčka.
Tables 1 and 2 list adverse reactions associated with the use of Avastin in combination with different chemotherapy regimens in multiple indications.
V preglednicah 1 in 2 so našteti neželeni učinki, ki so povezani z uporabo zdravila Avastin v kombinaciji z različnimi shemami kemoterapije pri več indikacijah.
Tell your doctor if you are using platinum- or taxane-based therapies for lung or metastatic breast cancer.
Obvestite svojega zdravnika, če za zdravljenje pljučnega raka ali metastatskega raka dojk prejemate zdravila, ki vsebujejo platino ali taksane.
Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines.
Adjuvantno kemoterapijo je prejelo 65 % bolnikov, od tega 19 % taksane in 49 % antracikline.
Overall approximately 34% of patients were FIGO Stage III optimally debulked with gross residual disease, 40% Stage III sub-optimally debulked, and 26% were Stage IV patients.
Celokupno je približno 34 % bolnic imelo po FIGO klasifikaciji bolezen stadija III, z opravljeno optimalno citoredukcijo, s preostankom bolezni; 40 % jih je imelo bolezen stadija III, z opravljeno suboptimalno citoredukcijo in 26 % je imelo bolezen stadija IV.
Therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed.
Zdravljenja ne smemo začeti, če je od večje operacije minilo manj kot 28 dni ali dokler se kirurška rana popolnoma ne zaceli.
If you are considering having children you should discuss this with your doctor before your treatment starts.
V primeru, da razmišljate o zanositvi, se posvetujte s svojim zdravnikom, preden začnete z zdravljenjem.
The primary endpoint was PFS based on investigator's assessment of disease progression based on radiological scans or CA 125 levels, or symptomatic deterioration per protocol.
Primarni cilj študije je bil preživetje brez napredovanja bolezni, ki temelji na oceni raziskovalca o napredovanju bolezni glede na radiološki posnetek ali določitvi vrednosti CA 125 oziroma na simptomatsko poslabšanje glede na protokol.
Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with Avastin (analyses shown in Table 7), consistent with the statistically significant benefit observed in the pooled analysis.
Sekundarne analize preživetja brez napredovanja bolezni, ki so temeljile na ocenah odgovora ob zdravljenju (¢on-treatment¢), so potrdile signifikantno superiorno klinično korist za bolnike, ki so jih zdravili z zdravilom Avastin (analiza prikazana v preglednici 7), kar je v skladu s statistično signifikantno koristjo, ki so jo opazili v združenih analizah podatkov.
Investigator assessment
Ocena raziskovalca
For further information please refer to Table 3 'Adverse reactions reported in post-marketing setting.'
a Za nadaljnje informacije, prosimo, glejte preglednico 3 »Neželeni učinki, o katerih so poročali po prihodu zdravila na trg«.
In both studies, bevacizumb exposure trended lower as body weight decreased.
V obeh študijah se je izpostavljenost bevacizumabu z manjšanjem telesne mase zmanjševala.
Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells.
Mehanizem delovanja Bevacizumab se veže na vaskularni endotelijski rastni faktor (VEGF - vascular endothelial growth factor), ki je ključni dejavnik vaskulogeneze in angiogeneze, in s tem zavira vezavo VEGF na njegova receptorja Flt-1 (VEGFR-1) in KDR (VEGFR-2) na površini endotelijskih celic.
Most patients were FIGO Stage IIIC or Stage IV.
Večina bolnic je imela stadij IIIC ali IV po klasifikaciji FIGO.
Statistically significant improvements in progression-free survival and objective response rate were also observed (see Table 8).
Opazili so tudi statistično značilna izboljšanja v preživetju brez napredovanja bolezni in objektivnem odgovoru na zdravljenje (glejte preglednico 8).
Reactions (frequency*)
Neželeni učinki (pogostnost*)
Day 1, prior to XELOX, q 3 weeks
1. dan, pred XELOX, vsake 3 tedne
No incompatibilities between Avastin and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Med zdravilom Avastin in polivinil kloridom ali poliolefinskimi vrečkami ali infuzijskimi seti ni bilo inkompatibilnosti.
The overall safety profile of Avastin is based on data from over 5,700 patients with various malignancies, predominantly treated with Avastin in combination with chemotherapy in clinical trials.
Celotni varnostni profil zdravila Avastin temelji na podatkih več kot 5700 bolnikov z različnimi malignimi boleznimi, ki so se v kliničnih preskušanjih večinoma zdravili z zdravilom Avastin v kombinaciji s kemoterapijo.
The addition of Avastin to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Dodatek zdravila Avastin k zdravljenju po shemi FOLFOX-4 je statistično značilno podaljšal preživetje.
• feeling of numbness or tingling in hands or feet,
· občutek otrplosti ali zbadanja v dlaneh ali nogah,
The majority of the patients in each treatment arm (74% and 71%) had poorly differentiated (Grade 3) primary tumours at baseline.
Večina bolnic v vsaki skupini (74 % in 71 %) je imela pred začetkom zdravljenja slabo diferenciran (stopnje 3) primarni tumor.
After discontinuation of bevacizumab treatment, ovarian function recovered in the majority of patients.
Po prekinitvi zdravljenja z bevacizumabom se je delovanje jajčnikov izboljšalo pri večini bolnic.
It is recommended that the treatment with Avastin in addition to erlotinib is continued until disease progression.
Priporočamo, da se zdravljenje z zdravilom Avastin kot dodatek erlotinibu nadaljuje do napredovanja bolezni.
It is therefore not authorised to be used in this way.
Niso ga pripravili za injiciranje v oko, zato njegova uporaba na ta način ni odobrena.
Very common (affects more than 1 user in 10) side effects, which were not severe, include:
Zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov) neželeni učinki, ki pa niso bili hudi, vključujejo:
During the trial, of the patients who received trial treatment, 32.2% (136/422) of patients received 7-12 administrations of Avastin and 21.1% (89/422) of patients received 13 or more administrations of Avastin.
Med preskušanjem je od bolnikov, ki so prejemali zdravilo v preskušanju, 32,2 % bolnikov (136/422) prejelo 7 do 12 odmerkov zdravila Avastin, 21,1 % (89/422) bolnikov pa je prejelo 13 ali več odmerkov zdravila Avastin.
The patient characteristics were similar across the trial arms.
V vseh preiskovanih skupinah so bile karakteristike bolnikov podobne.
Table 22 Efficacy results1,2 from study GOG-0213 Primary Endpoint
Preglednica 22 Rezultati učinkovitosti1,2 iz študije GOG-0213 Primarni opazovani dogodek
The concentrate is a clear, colourless to pale brown liquid in a glass vial with a rubber stopper.
Koncentrat je bistra, brezbarvna do rahlo rjava tekočina v stekleni viali z gumijastim zamaškom.
1, the drug could be delivered as a 1-hour infusion.
Po prvem ciklusu se lahko zdravilo daje kot 1-urna infuzija.
In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
4.4 Posebna opozorila in previdnostni ukrepi Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime in številko serije uporabljenega zdravila jasno zabeležiti (navesti) v bolnikovo kartoteko.
For the posology and method of administration of erlotinib, please refer to the full erlotinib prescribing information.
Za odmerjanje in način uporabe erlotiniba, prosimo, glejte celotni povzetek glavnih značilnosti erlotiniba.
An exploratory multivariate Cox regression model using backward selection indicated that the following baseline prognostic factors were strongly associated with survival independent of treatment: gender, white blood cell count, platelets, body weight loss in the 6 months prior to trial entry, number of metastatic sites, sum of longest diameter of target lesions, Motzer score.
S pomočjo eksplorativnega multivariantnega Coxovega regresijskega modela s selekcijo nazaj so ugotovili, da so naslednji izhodiščni napovedni dejavniki močno povezani s preživetjem, neodvisno od zdravljenja: spol, število belih krvnih celic, trombocitov, izguba telesne mase 6 mesecev pred vstopom v preskušanje, število metastatskih mest, vsota najdaljših premerov tarčnih lezij, rezultat po Motzerju.
● Avastin may increase the risk of developing serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing.
· zdravilo Avastin lahko poveča tveganje za nastanek resnih okužb kože ali globljih plasti pod kožo, še posebej, če se vam je stena črevesja preluknjala ali ste imeli težave pri celjenju ran.
● It is possible that Avastin can increase the risk of bleeding in your lungs, including coughing or spitting blood.
· možno je, da lahko zdravilo Avastin poveča tveganje za krvavitve v pljučih, vključno s kašljanjem in izpljuvanjem krvi.
The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution for injection.
Potrebno količino bevacizumaba je potrebno odvzeti in jo razredčiti do ustreznega volumna za aplikacijo z 9 mg/ml (0,9-%) raztopino natrijevega klorida za injiciranje.
An increased incidence of post-operative bleeding or wound healing complication occurring within 60 days of major surgery was observed if the patient was being treated with Avastin at the time of surgery.
Povečano incidenco za pooperativno krvavitev ali zaplet pri celjenju ran, ki se pojavi v 60 dneh po večji operaciji, so opazili v primerih, ko se je bolnik v času operacije zdravil z zdravilom Avastin.
Of the 722 patients in the trial, the majority of patients had HER2-negative disease (90%), with a small number of patients with unknown (8%) or confirmed HER2-positive status (2%), who had previously been treated with or were considered unsuitable for trastuzumab therapy.
Od 722 bolnikov v preskušanju je večina bolnikov imela HER-2 negativno bolezen (90 %), manjše število bolnikov pa je imelo neznan (8 %) ali potrjen HER-2 pozitivni status (2 %).
The occurrence of those events varied in type and severity, ranging from free air seen on the plain abdominal X-ray, which resolved without treatment, to intestinal perforation with abdominal abscess and fatal outcome.
Pojavljanje teh neželenih dogodkov se je razlikovalo po vrsti in resnosti: od prostega zraka, vidnega na nativnem rentgenogramu, ki je spontano izvenel, do perforacije črevesja z abdominalnimi abscesi in smrtnim izidom.
● if you have problems with wound healing following surgery,
· če imate težave s celjenjem ran po operaciji, · če boste operirani,
Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only
2 Analizo po spremljanju so opravili s podatki, zajetimi do 7. marca 2014; vse vrednosti p so napisane samo za deskriptivne namene.
You must not breast-feed your baby during treatment with Avastin and for at least 6 months after the last dose of Avastin, as this medicine may interfere with the growth and development of your baby.
Med zdravljenjem z zdravilom Avastin in še najmanj 6 mesecev po njegovem zadnjem odmerku otroka ne smete dojiti, ker lahko to zdravilo vpliva na rast in razvoj vašega otroka.
Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Bolečina v ustih, zobeh in/ali čeljusti, otekline ali mehurji v ustih, otrplost ali občutek teže v čeljusti ali razmajanost zoba.
In most clinical trials of Avastin, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
V večino kliničnih preskušanj z zdravilom Avastin bolniki, ki so imeli kongestivno srčno popuščanje pred pričetkom zdravljenja (NYHA - New York Heart Association II-IV), niso bili vključeni, zato informacije o tveganju za kongestivno srčno popuščanje pri tej populaciji niso na voljo.
Avastin in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Zdravilo Avastin v kombinaciji z interferonom alfa 2-a v prvi liniji zdravljenja napredovalega in/ali metastatskega raka ledvičnih celic (BO17705)
a Interferon alfa-2a 9 MIU 3x/week b
a interferon alfa-2a 9 mio 3x/teden b bevacizumab 10 mg/kg vsake 2 tedna
0.65 (p < 0.0001) 95% CI (0.56; 0.76)
0,65 (p < 0,0001) 95-% interval zaupanja (0,56; 0,76)
Progression-free survival (PFS)
Preživetje brez napredovanja bolezni (PFS)
Keep the vial in the outer carton
Vialo shranjujte v zunanji ovojnini
In adults, the results showed no significant difference in the pharmacokinetics of bevacizumab in relation to age.
Rezultati so pokazali, da pri odraslih ni značilnih razlik v farmakokinetiki bevacuzimaba glede na starost.
Description of selected serious adverse reactions
Opis določenih resnih neželenih učinkov