natgillin/translations-raw huggingface dataset:
Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, see section 6.6.
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 6.6.
There is evidence suggesting that all grade (US National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Obstajajo dokazi, da je proteinurija vseh stopenj (US National Cancer InstituteCommon Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) lahko povezana z odmerkom.
The incidence of these reactions in some clinical trials of bevacizumab is common (up to 5% in bevacizumab-treated patients).
Incidenca teh reakcij pri nekaterih kliničnih preskušanjih bevacizumaba je pogosta (do 5 % pri bolnikih, zdravljenih z bevacizumabom).
• decreased number of red cells in the blood,
• zmanjšano število rdečih krvnih celic,
5-Fluorouracil
5-fluorouracil i.v.
The dose of MVASI needed depends on your body weight and the kind of cancer to be treated.
Potrebni odmerek zdravila MVASI je odvisen od telesne mase in vrste raka, ki ga zdravimo.
What you need to know before you use MVASI
Kaj morate vedeti, preden boste uporabili zdravilo MVASI
Your doctor should advise you about using contraception during treatment with MVASI and for at least 6 months after the last dose of MVASI.
Vaš zdravnik vam bo svetoval uporabo primerne kontracepcije med zdravljenjem z zdravilom MVASI in še najmanj 6 mesecev po njegovem zadnjem odmerku.
Information on foetal malformations observed in the post-marketing setting are provided in sections 4.6 and 4.8.
Podatki o malformacijah ploda, ki so jih opazili v obdobju po prihodu zdravila na trg, so vključeni v poglavji 4.6 ter 4.8.
• infection, and in particular infection in the blood or bladder,
• okužbo, še posebej krvi ali mehurja,
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 bevacizumab 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 bevacizumabom.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
• MVASI increases the risk of having protein in your urine especially if you already have high blood pressure.
• zdravilo MVASI poveča tveganje za pojav beljakovin v seču, še posebej, če že imate visok krvni tlak.
Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab-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 bevacizumabom.
• sores in the mouth and the tube from the mouth to the stomach, which may be painful and cause difficulty swallowing,
• vnetje v ustih in cevi med usti in želodcem, ki je lahko boleče in povzroča težave pri požiranju,
• changes in speech,
• motnje v govoru,
Intravitreal use
Intravitrealna uporaba
Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.
Končno celokupno analizo so opravili, ko je 46,7 % bolnic umrlo (s podatki zbranimi do 31. marca 2013).
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.
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.
• if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with MVASI (bevacizumab), in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
• pred invazivnimi posegi v zobozdravstvu in oralni kirurgiji povejte svojemu zobozdravniku, da se zdravite z zdravilom MVASI (bevacizumabom), še posebej, če prejemate ali ste prejemali injekcije difosfonata v kri.
It is recommended that the treatment with MVASI in addition to erlotinib is continued until disease progression.
Priporočamo, da se zdravljenje z zdravilom MVASI kot dodatek erlotinibu nadaljuje do napredovanja bolezni.
• MVASI may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
• zdravilo MVASI lahko poveča tveganje za razvoj neobičajne povezave ali prehoda med dvema organoma ali žilami.
Leucovorin on day 1 and 2
2 h levkovorin 1. in 2. dan
A high proportion of patients (approximately 62%) went on to receive a variety of non-protocol specified anti-cancer therapies, which may have impacted the analysis of overall survival.
Velik del bolnikov (približno 62 %) je prejemal različna zdravila za zdravljenje novotvorb, ki niso bila določena v protokolu študije, kar je lahko vplivalo na analizo celokupnega preživetja.
• lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),
• lezije v dlesnih z izpostavljeno čeljustnico, ki se ne pozdravijo in so lahko povezane z bolečino in vnetjem okoliških tkiv (za nadaljnja priporočila glejte spodaj),
Stopping your treatment with MVASI may stop the effect on tumour growth.
Prenehanje zdravljenja z zdravilom MVASI lahko ustavi učinek na rast tumorja.
Patients with untreated CNS metastases were routinely excluded from clinical trials with bevacizumab, based on imaging procedures or signs and symptoms.
Bolniki z nezdravljenimi zasevki v osrednjem živčevju so bili rutinsko izključeni iz kliničnih preskušanj z bevacizumabom, glede na postopke slikanj ali znake in simptome.
You must not breast-feed your baby during treatment with MVASI and for at least 6 months after the last dose of MVASI, as this medicine may interfere with the growth and development of your baby.
Med zdravljenjem z zdravilom MVASI in še najmanj 6 mesecev po njegovem zadnjem odmerku otroka ne smete dojiti, ker lahko to zdravilo vpliva na rast in razvoj vašega otroka.
Objective response rate (%) in patients with measurable disease
Objektivni odgovor (%) pri bolnikih z merljivo boleznijo n Odgovor
After correcting for body weight, male patients had a higher bevacizumab clearance (+ 17%) than females.
Po prilagoditvi glede na telesno maso so imeli bolniki višji očistek bevacizumaba (+ 17 %) kot bolnice.
These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.
To vključuje zmanjšanje števila belih krvnih celic v krvi, še posebno nevtrofilcev (vrsta belih krvnih celic, ki pomaga varovati pred okužbami), prisotnost beljakovin v seču, zmanjšanje ravni kalija, natrija ali fosforja (mineral) v krvi, zvišan sladkor v krvi, zvečanje alkalne fosfataze (encim), zvečanje kreatinina v serumu (beljakovina, ki jo merijo v preiskavah krvi, da ocenijo, kako dobro delujejo vaše ledvice), zmanjšanje hemoglobina (nahaja se v rdečih krvnih celicah, ki prenašajo kisik), ki je lahko hudo.
The administration of MVASI should be temporarily discontinued
Dajanje zdravila MVASI je treba začasno opustiti
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).
In both studies, bevacizumab exposure trended lower as body weight decreased.
V obeh študijah se je izpostavljenost bevacizumabu z manjšanjem telesne mase zmanjševala.
• bleeding from the lower part of the large bowel,
• krvavitev iz spodnjega dela debelega črevesa,
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.
For further information please refer to table 3 “Adverse reactions reported in post-marketing setting”.
Za nadaljnje informacije, prosimo, glejte preglednico 3 ”Neželeni učinki, o katerih so poročali po prihodu zdravila na trg”.
• a hole in the stomach or intestines,
• luknja v želodcu ali črevesju,
Efficacy results from study BO17707 (ICON7) Progression-free survival
Rezultati učinkovitosti iz študije BO17707 (ICON7) Preživetje brez napredovanja bolezni
Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression-free survival was 8.8 months.
Med 110 bolniki, randomiziranimi v skupino 3 (5-FU/FA + bevacizumab), je bila mediana celokupnega preživetja pred ukinitvijo te skupine 18,3 meseca, mediana preživetja brez napredovanja bolezni pa 8,8 meseca.
In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file.
Za izboljšanje sledljivosti tega zdravila morata zdravnik ali farmacevt v bolnikovi dokumentaciji zabeležiti trgovsko ime in serijsko številko zdravila, ki ste ga prejeli.
95% CI for one sample binomial using Pearson-Clopper method.
95-% interval zaupanja (IZ) za binomski test enega vzorca z uporabo Pearson-Clopperjeve metode.
Efficacy results for trial E4599
Rezultati učinkovitosti za preskušanje E4599
• an abnormal tube-like connection or passage between the windpipe and the gullet, between internal organs and skin, between the vagina and any parts of the gut or between other tissues that are not normally connected (fistula), and are judged by your doctor to be severe,
• neobičajna povezava ali prehod, podoben cevi, med sapnikom in požiralnikom, med notranjimi organi in kožo, med nožnico in katerim koli delom črevesa ali med drugimi tkivi, ki normalno niso povezani (fistula), in jih vaš zdravnik oceni kot resne,
Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Tega zdravila ne smete uporabljajti po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki viale poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Depending on the dose prescribed for you, some or all of the contents of the MVASI 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 MVASI pred uporabo razredčiti z raztopino natrijevega klorida.
No adverse events leading to death occurred in either treatment arm; all deaths were attributed to disease progression.
V nobeni od zdravljenih skupin ni bilo neželenih učinkov, ki bi bili smrtni; vsi smrtni primeri so bili zaradi napredovanja bolezni.
MVASI contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
Zdravilo MVASI vsebuje zdravilno učinkovino bevacizumab, ki je humanizirano monoklonsko protitelo (vrsta beljakovine, ki jo običajno proizvaja imunski sistem, da pomaga telesu pri obrambi proti okužbam in raku).
% patients with objective response p-value
% bolnic z objektivnim odgovorom p-vrednost
MVASI is contraindicated in pregnancy (see section 4.3).
Zdravilo MVASI je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
The overall safety profile of bevacizumab is based on data from over 5,700 patients with various malignancies, predominantly treated with bevacizumab in combination with chemotherapy in clinical trials.
Celotni varnostni profil bevacizumaba temelji na podatkih več kot 5700 bolnikov z različnimi malignimi boleznimi, ki so se v kliničnih preskušanjih večinoma zdravili z bevacizumabom v kombinaciji s kemoterapijo.
The population pharmacokinetics were analysed in adult and paediatric patients to evaluate the effects of demographic characteristics.
Pri odraslih in pediatričnih bolnikih so z analizo populacijske farmakokinetike proučili vpliv demografskih značilnosti na farmakokinetiko.
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.
This is consistent with results in patients in other studies of metastatic breast cancer who did not receive concurrent anthracycline treatment (NCI-CTCAE v.3) (see section 4.8).
To je skladno z rezultati pri bolnikih v drugih preskušanjih pri metastatskemu raku dojk, ki niso prejemali sočasnega zdravljenja z antraciklini (NCICTCAE v.3) (glejte poglavje 4.8).
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion.
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje.
Efficacy results1,2 from study GOG-0213
Rezultati učinkovitosti1,2 iz študije GOG-0213
Tables 1 and 2 list adverse reactions associated with the use of bevacizumab in combination with different chemotherapy regimens in multiple indications.
V preglednicah 1 in 2 so našteti neželeni učinki, ki so povezani z uporabo bevacizumaba v kombinaciji z različnimi shemami kemoterapije pri več indikacijah.
Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensinconverting 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.
Patients should have had a life expectancy of ≥ 12 weeks and no prior radiotherapy to the pelvis or abdomen.
Bolnice so morale imeti pričakovano preživetje ≥ 12 tednov in v preteklosti niso smele prejeti radioterapije medenice ali trebuha.
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 bevacizumab 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 bevacizumabom.
The analysis of the primary endpoint showed no difference between the bevacizumab + placebo arm and the bevacizumab + erlotinib arm (median PFS 8.5 versus 9.9 months).
Analiza primarnega cilja raziskave ni pokazala razlik med skupino z bevacizumabom + placebom in skupino z bevacizumabom + erlotinibom (mediana preživetja brez napredovanja bolezni 8,5 v primerjavi z 9,9 meseca).
MVASI 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 MVASI 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.
The typical value for central volume (Vc) was 2.73 L and 3.28 L for female and male patients respectively, which is in the range that has been described for IgGs and other monoclonal antibodies.
Tipična vrednost za volumen osrednjega prostora (Vc) je bila 2,73 l pri bolnicah in 3,28 l pri bolnikih, kar je v območju, ki so ga opisali za imunoglobuline G in druga monoklonska protitelesa.
Bevacizumab in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Bevacizumab v kombinaciji z interferonom alfa 2-a v prvi liniji zdravljenja napredovalega in/ali metastatskega raka ledvičnih celic (BO17705)
In terms of safety, there was a higher overall incidence of grade 3-5 AEs in study E3200 relative to study ML18147.
Kar se tiče varnosti, je bila v študiji E3200 celokupno večja incidenca neželenih dogodkov stopnje 3-5 glede na študijo ML18147.
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.
• bleeding, including bleeding in the lungs in patients with non-small cell lung cancer,
• krvavitev, vključno s krvavitvijo v pljučih pri bolnikih z nedrobnoceličnim rakom pljuč,
• dry skin, flaking and inflammation of the skin, change in skin colour,
• suho kožo, luskavost in vnetje kože, spremembo barve kože,
• Redness of the eye, small particles or spots in your vision (floaters), eye pain,
• pordelost očesa, majhni delci ali madeži v vidnem polju (motnjave), bolečina v očesu,
IFN alfa-2a was given up to 52 weeks or until disease progression at a recommended starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
Interferon alfa-2a so prejemali do 52 tednov ali do napredovanja bolezni, priporočeni začetni odmerek je bil 9 mio i.e. trikrat na teden, dovoljeno pa ga je bilo zmanjšati v dveh korakih na 3 mio i.e. trikrat na teden.
You must not use this medicine if you are pregnant.
Če ste noseči, tega zdravila ne smete prejemati.
The concentrate is a clear to slightly opalescent, colourless to slightly yellow liquid in a glass vial with a rubber stopper.
Koncentrat je bistro do rahlo opalescentna, brezbarvna do rahlo rumena tekočina v stekleni viali z gumijastim zamaškom.
Patients should be monitored for signs and symptoms of CNS bleeding, and MVASI treatment discontinued in cases of intracranial bleeding.
Bolnike je treba spremljati za znake ali simptome krvavitev v osrednjem živčevju in zdravljenje z zdravilom MVASI v primerih intrakranialne krvavitve prekiniti.
If you stop treatment with MVASI
Če ste prenehali jemati zdravilo MVASI
5 mg/kg IV 30-90 min Day 1, prior to FOLFOX-4, every 2 weeks
30-90 min 1. dan, pred FOLFOX-4, vsaka 2 tedna
Trial results show that 94% (277 / 296) of eligible patients went on to receive single agent bevacizumab at cycle 7.
Rezultati preskušanja kažejo, da je 94 % (277/296) primernih bolnikov s 7. ciklom nadaljevalo s samostojnim zdravljenjem z bevacizumabom.
Overall approximately 34% of patients were FIGO stage III optimally debulked with gross residual disease, 40% stage III suboptimally 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.
In the majority of the occasions the necessary amount of MVASI can be diluted with 0.9% sodium chloride solution for injection to a total volume of 100 mL.
V večini primerov lahko potrebno količino zdravila MVASI razredčimo z 0,9-% raztopino natrijevega klorida za injiciranje do končnega volumna 100 ml.
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 in paediatrics 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 pri pediatrični populaciji z uporabo populacijskega farmakokinetičnega modela.
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).
Bevacizumab use has been associated with serious cases of fistulae including reactions resulting in death.
Uporaba bevacizumaba je bila povezana z resnimi primeri fistul, vključno s takimi, ki so se končali s smrtjo.
• MVASI can increase the incidence of high blood pressure.
• zdravilo MVASI lahko poveča pojavnost visokega krvnega tlaka.
The efficacy results of bevacizumab in combination with IFL-chemotherapy are displayed in table 4.
Rezultate učinkovitosti bevacizumaba v kombinaciji z IFL-kemoterapijo prikazuje preglednica 4.
• fistula: abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected, including connections between vagina and the gut in patients with cervical cancer.
• fistule: nenormalne cevaste povezave med notranjimi organi in kožo ali drugimi tkivi, ki normalno niso povezani, med drugim povezave med nožnico in črevesom pri bolnicah z rakom materničnega vratu.
MVASI is also used for the treatment of adult patients with advanced non-small cell lung cancer when cancer cells have specific mutations of a protein called epidermal growth factor receptor (EGFR).
Zdravilo MVASI uporabljamo tudi za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim rakom pljuč, ko imajo rakave celice določene mutacije beljakovine, ki se imenuje receptor epidermalnega rastnega faktorja (EGFR).
Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with bevacizumab (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 bevacizumabom (analiza prikazana v preglednici 7), kar je v skladu s statistično signifikantno koristjo, ki so jo opazili v združenih analizah podatkov.
Overall survival6
Celokupno preživetje6
• localised pus collection,
• lokalizirano nabiranje gnoja,
In most clinical trials urine protein levels of ≥ 2g/24 hrs led to stopping treatment with bevacizumab until recovery to < 2g/24 hrs.
V večini kliničnih preskušanj so koncentracije beljakovin v seču ≥ 2 g/24 ur povzročile prekinitev zdravljenja z bevacizumabom, dokler ni prišlo do zmanjšanja < 2 g/24 ur.
Bevacizumab 10 mg/kg was given every 2 weeks until disease progression.
Bevacizumab so prejemali v odmerku 10 mg/kg vsaka dva tedna do napredovanja bolezni.
Most patients were FIGO stage IIIC or stage IV.
Večina bolnic je imela stadij IIIC ali IV po klasifikaciji FIGO.
Efficacy results for study ML18147 (ITT population)
Rezultati učinkovitosti za študijo ML18147 (populacija bolnikov, ki so jo nameravali zdraviti)
Efficacy results for trial BO17705
Rezultati učinkovitosti preskušanja BO17705
Fistulae have also been reported in post-marketing experience.
O fistulah so poročali tudi v obdobju po prihodu zdravila na trg.