natgillin/translations-raw huggingface dataset:
The adverse reactions listed in this section fall into the following frequency categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
● This medicine increases the risk of having protein in your urine especially if you already have high blood pressure.
● To zdravilo poveča tveganje za pojav beljakovin v urinu, zlasti če že imate visok krvni tlak.
There were no grade 4 or 5 hypertension events.
Hipertenzije stopnje 4 ali 5 ni bilo.
Table 6 Treatment regimens in trial NO16966 (mCRC)
Preglednica 6 Sheme zdravljenja v preskušanju NO16966 (mCRC)
Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Hudi neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) vključujejo:
Therefore, caution should be exercised before initiating therapy in these patients.
Zato je pred uvedbo zdravljenja pri teh bolnikih potrebna previdnost.
Data are unadjusted for the differential time on treatment.
Podatki niso prilagojeni glede na različno trajanje zdravljenja.
Name and address of the manufacturer of the biological active substance Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
Ime in naslov izdelovalca biološke učinkovine Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
No specific studies in animals have been conducted to evaluate the effect on fertility.
Specifičnih študij na živalih za oceno vpliva na plodnost niso izvedli.
*Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm
*Analiza celokupnega preživetja na podlagi kliničnih podatkov na dan 31. januarja 2007 **Primarna analiza na podlagi kliničnih podatkov na dan 31. januarja 2006 glede na kontrolno skupino
intravenous bolus injection immediately after leucovorin
injekcija v bolusu takoj po levkovorinu
* if specified, the frequency has been derived from clinical trial data
* kjer je pogostnost navedena, so jo pridobili iz podatkov iz kliničnih preskušanj
• abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,
• nenormalno visok krvni tlak v krvnih žilah pljuč, zaradi česar mora desna stran srca delati močneje kot običajno,
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.
Izrazi predstavljajo skupino neželenih učinkov, ki opisujejo medicinski pojem in ne posamezno stanje ali priporočeni izraz po MedDRA (Medical Dictionary for Regulatory Activites - medicinski slovar za regulatorne aktivnosti).
● any severe bleeding.
● kakršnakoli huda krvavitev.
Manufacturer Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
Izdelovalec Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Irska
Day 1, prior to FOLFOX-4, every 2 weeks
1. dan, pred shemo FOLFOX-4, vsaka 2 tedna
Studies to evaluate the mutagenic and carcinogenic potential of bevacizumab have not been performed.
Študij za ovrednotenje mutagenega in kancerogenega potenciala bevacizumaba niso izvedli.
This does not necessarily mean that these side effects were strictly caused by bevacizumab.
To ne pomeni nujno, da je te neželene učinke povzročil izključno bevacizumab.
These could be signs and symptoms of bone damage in the jaw (osteonecrosis).
To so lahko znaki in simptomi poškodbe kosti v čeljusti (osteonekroza).
Bevacizumab is not approved for use in patients under the age of 18 years.
Bevacizumaba niso odobrili za uporabo pri bolnikih, mlajših od 18 let.
There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly-diagnosed high-grade glioma.
Na voljo ni dovolj podatkov, da bi lahko določili varnost in učinkovitost bevacizumaba pri otrocih z novo diagnosticiranim gliomom visoke stopnje.
It is important that your doctor knows if you have ever received anthracyclines (for example doxorubicin, a specific type of chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease.
Pomembno je, da zdravnik ve, če ste že kdaj prejeli antracikline (na primer doksorubicin, specifično vrsto kemoterapije, ki jo uporabljajo za zdravljenje nekaterih vrst raka), če so vam obsevali prsni koš ali če imate srčno bolezen.
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 uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki viale poleg oznake ''EXP''.
● if you undergo surgery.
● če boste imeli kirurški poseg.
• a negative effect on a woman's ability to have children (see the paragraphs below the list of side effects for further recommendations),
• negativen učinek na zmožnost zanositve pri ženski (za nadaljnja priporočila glejte odstavke pod seznamom neželenih učinkov),
Prior hormonal therapy for the treatment of metastatic disease was allowed.
Za zdravljenje metastatske bolezni so dovolili predhodno hormonsko zdravljenje.
● if you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
● če ste alergični na bevacizumab ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6).
The secondary endpoint of Overall Survival (OS) was not mature.
Sekundarni opazovani dogodek, celokupno preživetje (OS), ni bil dokončen.
Low albumin and high tumour burden are generally indicative of disease severity.
Majhne vrednosti albumina in veliko tumorsko breme sta splošna pokazatelja resnosti bolezni.
In patients who have previously received or are receiving intravenous bisphosphonates invasive dental procedures should be avoided, if possible.
Pri bolnikih, ki so predhodno prejemali ali trenutno prejemajo intravenske bisfosfonate, se je treba, če je le mogoče, izogibati invazivnim zobozdravstvenim posegom.
● This medicine may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
● To zdravilo lahko povzroči okužbe in zmanjša število vaših nevtrofilcev (vrsta krvnih celic, ki so pomembne za zaščito pred bakterijami).
When Zirabev is injected directly into the eye (unapproved use), the following side effects may occur:
Če zdravilo Zirabev injiciramo neposredno v oko (neodobrena uporaba), se lahko pojavijo naslednji neželeni učinki:
Elderly patients No dose adjustment is required in the elderly.
Starejši bolniki Pri starejših bolnikih odmerka ni treba prilagajati.
However, the increase in the primary endpoint of overall survival by 2 months was not significant (HR= 0.91).
Vendar pa podaljšanje celokupnega preživetja, tj. primarnega opazovanega dogodka, za 2 meseca ni bilo pomembno (HR = 0,91).
● your doctor will decide when you should be given your next dose of Zirabev.
● bo zdravnik odločil o tem, kdaj boste prejeli naslednji odmerek zdravila Zirabev.
Information on foetal malformations observed in the post marketing setting are provided in section 4.6 Fertility, Pregnancy and Lactation and 4.8 Undesirable Effects.
Podatki o malformacijah ploda, ki so jih opazili v obdobju trženja, so navedeni v poglavjih 4.6 ''Plodnost, nosečnost in dojenje'' ter 4.8 ''Neželeni učinki''.
Symptoms usually resolve or improve within days after treatment discontinuation, although some patients have experienced some neurologic sequelae.
Simptomi ponavadi izzvenijo ali se izboljšajo v nekaj dneh po prekinitvi zdravljenja, kljub temu pa so nekateri bolniki imeli nevrološke posledice.
The population pharmacokinetics were analysed in adult and pediatric patients to evaluate the effects of demographic characteristics.
Z analizo populacijske farmakokinetike so pri odraslih in pediatričnih bolnikih ovrednotili vpliv demografskih značilnosti.
Zirabev use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Uporaba zdravila Zirabev ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let, saj varnosti in koristi zdravila pri tej populaciji bolnikov še niso dokazali.
Efficacy results for study ML18147 (ITT population)
Preglednica 9 Rezultati učinkovitosti v študiji ML18147 (populacija ITT)
The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/ml to 16.5 mg/ml.
Koncentracija končne raztopine bevacizumaba mora biti v razponu od 1,4 do 16,5 mg/ml.
Before initiating Zirabev, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo zdravila Zirabev je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
● The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
● Tveganje za pojav krvnih strdkov v arterijah (vrsta krvne žile) se lahko poveča, če ste starejši od 65 let, imate sladkorno bolezen ali če ste v preteklosti že imeli krvne strdke v arterijah.
Description of selected serious adverse reactions
Opis izbranih resnih neželenih učinkov
● presence of protein in your urine accompanied by swelling of your body,
● prisotnost beljakovin v urinu, ki jo spremlja otekanje telesa,
In most cases hypertension was controlled adequately using standard antihypertensive treatment appropriate for the individual situation of the affected patient.
V večini primerov so hipertenzijo ustrezno obvladali s standardnim antihipertenzivnim zdravljenjem, primernim za posameznega bolnika v dani situaciji.
If you experience symptoms that affect your vision or concentration, or your ability to react, do not drive and use machines until symptoms disappear.
Če se pri vas pojavijo simptomi, ki vplivajo na vid ali koncentracijo oziroma na vašo sposobnost odzivanja, ne vozite ali uporabljajte strojev, dokler simptomi ne izginejo.
• 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 pozdravi in je lahko povezana z bolečino in vnetjem okoliških tkiv (za nadaljnja priporočila glejte odstavke pod seznamom neželenih učinkov),
In addition, an independent review of the primary endpoint was also conducted.
Dodatno so izvedli neodvisno preverjanje primarnega opazovanega dogodka.
Long term effects of the treatment with bevacizumab on fertility are unknown.
Dolgoročni učinki zdravljenja z bevacizumabom na plodnost niso znani.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1344/001 100 mg/4 ml vial EU/1/18/1344/002 400 mg/16 ml vial
EU/1/18/1344/001 100 mg/4 ml viala EU/1/18/1344/002 400 mg/16 ml viala
After discontinuation of bevacizumab treatment, ovarian function recovered in 86.2% of these evaluable women.
Po prekinitvi zdravljenja z bevacizumabom se je delovanje jajčnikov obnovilo pri 86,2 % žensk, ki jih je bilo mogoče oceniti.
Monitoring of blood pressure is generally recommended during therapy.
Med zdravljenjem je na splošno priporočljivo spremljanje krvnega tlaka.
For further information on proteinuria see section 4.4 and Proteinuria in section 4.8.
Za dodatne informacije glede proteinurije glejte poglavje 4.4 in ''Proteinurija'' v poglavju 4.8.
These clinically significant reactions have therefore been included in Table 2 within the column entitled “Frequency Not Known.”
Ti klinično pomembni neželeni učinki so zato v preglednici 2 razvrščeni v stolpec ''Neznana pogostnost''.
A cross-trial comparison of the efficacy and safety data is limited by differences between these studies, most notably in patient populations, previous bevacizumab exposure and chemotherapy regimens.
Primerjava podatkov o učinkovitosti in varnosti med študijama je omejena zaradi razlik med njima, še posebej glede populacije bolnikov, predhodne izpostavljenosti bevacizumabu in kemoterapevtskih shem.
Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only
primarno analizo so opravili s podatki, ki so jih zajeli do 12. decembra 2012, in velja za končno analizo nadaljnjo analizo so opravili s podatki, ki so jih zajeli do 7. marca 2014; vse p-vrednosti so navedene samo v opisne namene
● if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Zirabev, in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
● če imate načrtovano invazivno zdravljenje zob ali zobozdravstveni poseg, povejte zobozdravniku, da se zdravite z zdravilom Zirabev, zlasti če prejemate ali ste prejeli tudi injekcijo bisfosfonata v kri.
The dose of Zirabev needed depends on your body weight and the kind of cancer to be treated.
Potrebni odmerek zdravila Zirabev je odvisen od vaše telesne mase in vrste raka, ki ga bomo zdravili.
Zirabev may also cause changes in laboratory tests carried out by your doctor.
Zdravilo Zirabev lahko povzroči tudi spremembe izvidov laboratorijskih preiskav, ki jih opravi zdravnik.
Major or massive pulmonary haemorrhage/haemoptysis can occur suddenly and up to two thirds of the serious pulmonary haemorrhages resulted in a fatal outcome.
Večja ali obsežna krvavitev v pljučih/hemoptiza se lahko pojavi nenadoma in pri do dveh tretjinah resnih krvavitev v pljučih je prišlo do smrtnega izida.
The safety of reinitiating bevacizumab therapy in patients previously experiencing PRES is not known.
Varnost ponovne uvedbe zdravljenja z bevacizumabom pri bolnikih, pri katerih se je v preteklosti že pojavil PRES, ni znana.
The addition of bevacizumab to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Dodajanje bevacizumaba shemi FOLFOX-4 je statistično pomembno podaljšalo preživetje.
Within each frequency category, adverse reactions are presented in the order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Zirabev may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Zdravilo Zirabev lahko poškoduje nerojenega otroka, saj lahko zaustavi tvorbo novih krvnih žil.
Approximately 350 patients were randomised into each of the 4 trial arms in the Part II of the trial.
V 2. delu preskušanja so v vsako od 4 skupin randomizirali približno 350 bolnikov.
You will be treated with Zirabev once every 2 or 3 weeks.
Z zdravilom Zirabev se boste zdravili vsaka 2 ali 3 tedne.
● Your doctor should record the brand name and batch number of your medication.
● Pomembno je, da tako vi kot zdravnik zabeležite lastniško ime in številko serije vašega zdravila.
The signs may include: difficulty in breathing or chest pain.
Znaki so lahko: oteženo dihanje ali bolečina v prsnem košu.
● It is possible that Zirabev can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
● Možno je, da zdravilo Zirabev povzroča preobčutljivost in/ali reakcije na infuzijo (reakcije, povezane z injiciranjem zdravila).
Relative to control arm. NR = not reached.
NR = niso dosegli (not reached).
Adverse reactions are added to the appropriate frequency category in the tables below according to the highest incidence seen in any indication.
Neželeni učinki so v spodnjih preglednicah razvrščeni v ustrezno skupino pogostnosti glede na največjo pogostnost, ki so jo opazili pri katerikoli indikaciji.
A total of 452 patients were randomised to receive either:
Skupno so randomizirali 452 bolnic na prejemanje ene od naslednjih shem:
c Based on a substudy from NSABP C-08 with 295 patients d
Na podlagi podštudije NSABP C-08 pri 295 bolnicah.
● This medicine can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
● To zdravilo lahko poveča tveganje za krvavitve ali poveča tveganje za težave pri celjenju ran po kirurškem posegu.
There were no complete responses and 2 partial responses (MacDonald criteria).
Popolnih odzivov na zdravljenje ni bilo, zabeležili pa so 2 delna odziva na zdravljenje (merila po MacDonaldu).
Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Žilne bolezni renalna trombotična mikroangiopatija, ki se lahko klinično kaže kot proteinurija (neznana) pri sočasnem zdravljenju s sunitinibom ali brez njega.
Best overall response ratea
Najboljša stopnja celokupnega odziva
These efficacy data are consistent with the results from trial AVF2107g.
Ti podatki o učinkovitosti so skladni z rezultati preskušanja AVF2107g.
• loss of body weight,
• izgubo telesne mase,
If you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine.
Če boste operirani, če je od večjega kirurškega posega minilo manj kot 28 dni ali če se vaša rana po kirurškem posegu še ni zacelila, tega zdravila ne smete prejeti.
• dry mouth in combination with thirst and/or reduced or darkened urine,
• suha usta v kombinaciji z žejo in/ali zmanjšanim izločanjem urina ali temnejšim urinom,
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 HER2-negativno bolezen (90 %), manjše število bolnikov pa je imelo neznan (8 %) ali potrjen HER2-pozitiven status (2 %); bolniki so se predhodno zdravili s trastuzumabom ali pa so bili neprimerni za zdravljenje s trastuzumabom.
After discontinuation of bevacizumab treatment, ovarian function recovered in the majority of patients.
Po prekinitvi zdravljenja z bevacizumabom se je delovanje jajčnikov pri večini bolnic obnovilo.
As maternal IgG is excreted in milk and bevacizumab could harm infant growth and development (see section 5.3), women must discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose of bevacizumab.
Ker se materini IgG izločajo v mleko in ker bevacizumab lahko škodljivo vpliva na rast in razvoj otroka (glejte poglavje 5.3), morajo ženske med zdravljenjem dojenje prekiniti in ne smejo dojiti še vsaj 6 mesecev po zadnjem odmerku bevacizumaba.
The only variables that showed statistically significant correlations with bleeding were bevacizumab therapy and squamous cell histology.
Edini spremenljivki, ki sta pokazali statistično pomembno povezavo s krvavitvijo, sta bili zdravljenje z bevacizumabom in ploščatocelična histologija.
Bevacizumab clearance was approximately 30% faster in patients with low levels of serum albumin and 7% faster in subjects with higher tumour burden when compared with a typical patient with median values of albumin and tumour burden.
Očistek bevacizumaba je bil približno 30 % hitrejši pri bolnikih z nizkimi ravnmi albumina v serumu in 7 % hitrejši pri bolnikih z velikim tumorskim bremenom v primerjavi s tipičnim bolnikom z medianimi vrednostmi albumina in tumorskega bremena.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Običajno naj shranjevanje ne bi bilo daljše od 24 ur pri temperaturi od 2 °C do 8 °C, razen če je redčenje potekalo v nadzorovanih in validiranih aseptičnih pogojih.
Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 ml of red blood) should not be treated with Zirabev.
Bolnikov z nedavno krvavitvijo v pljučih/hemoptizo (> 2,5 ml rdeče krvi), ne smemo zdraviti z zdravilom Zirabev.
The initial dose should be delivered over 90 minutes as an intravenous infusion.
Začetni odmerek je treba dati v obliki 90minutne intravenske infuzije.
Table 7 Key efficacy results for the superiority analysis (ITT population, trial NO16966) Endpoint (months)
Preglednica 7 Ključni rezultati učinkovitosti glede na analizo superiornosti (populacija ITT, preskušanje NO16966)
The pharmacokinetic data for bevacizumab are available from ten clinical trials in patients with solid tumours.
Na voljo so farmakokinetični podatki o bevacizumabu iz 10 kliničnih preskušanj pri bolnikih s solidnimi tumorji.
Median overall survival*
mediano celokupno preživetje*
You should discuss this with your doctor.
O tem se pogovorite z zdravnikom.
If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
Če imate stanje, ki povzroča trebušno vnetje (npr. divertikulitis, želodčno razjedo, s kemoterapijo povezan kolitis), se o tem pogovorite z zdravnikom.
Repeat dose toxicity studies in animals have shown that bevacizumab may have an adverse effect on female fertility (see section 5.3).
Študije toksičnosti pri ponavljajočih odmerkih na živalih so pokazale, da ima bevacizumab lahko škodljiv vpliv na plodnost žensk (glejte poglavje 5.3).
• feeling weak and having no energy,
• občutek oslabelosti in pomanjkanje energije,
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.
Zdravnika, farmacevta ali medicinsko sestro obvestite, če ste v preteklosti že kdaj imeli težave po injiciranju, kot so omotica/občutek omedlevice, 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 študijah metastatskega raka dojk, ki niso prejemali sočasnega zdravljenja z antraciklini (NCI-CTCAE v.3) (glejte poglavje 4.8).
The highest dose tested in humans (20 mg/kg of body weight, intravenous every 2 weeks) was associated with severe migraine in several patients.
Največji odmerek, ki so ga preskusili pri ljudeh (20 mg/kg telesne mase, intravensko vsaka 2 tedna), je bil pri več bolnikih povezan s hudo migreno.
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 1 kliničnem preskušanju je bila pojavnost hipertenzije stopnje ≥ 3 dvakrat večja pri bolnikih, starih > 65 let, v primerjavi s skupino mlajših bolnikov (< 65 let).
Patients should be monitored for signs and symptoms of CNS bleeding, and Zirabev treatment discontinued in cases of intracranial bleeding.
Bolnike je treba spremljati glede znakov in simptomov krvavitve v CŽS in v primerih intrakranialne krvavitve zdravljenje z zdravilom Zirabev prekiniti.
The findings ranged from asymptomatic declines in left ventricular ejection fraction to symptomatic CHF, requiring treatment or hospitalisation.
Ugotovljeni učinki so segali od asimptomatskega zmanjšanja iztisnega deleža levega prekata do simptomatskega KSP, ki je zahtevalo zdravljenje ali hospitalizacijo.
The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/kg.
Farmakokinetika bevacizumaba je bila linearna pri odmerkih v razponu od 1 do 10 mg/kg.