FrancophonIA/ELRC3.0 huggingface dataset:
English: • Breast cancer which has spread to other parts of the body (this is called “metastatic” breast cancer).
Croatian: Rak dojke • Rak dojke koji se proširio na druge dijelove tijela (to se naziva metastatski rak dojke).
English: Pazenir is a white to yellow powder for dispersion for infusion.
Croatian: Pazenir je prašak bijele do žute boje za disperziju za infuziju.
English: Overall Survival
Croatian: Sveukupno preživljenje
English: Each medicinal product was administered on Day 1 of each 21-day cycle.
Croatian: Svaki lijek davan je 1. dana svakog 21-dnevnog ciklusa.
English: The exact total dosing volume of 5 mg/ml dispersion required for the patient should be calculated and the appropriate amount of reconstituted Pazenir should be injected into an empty, sterile, PVC or non-PVC type intravenous bag.
Croatian: Treba izračunati točan ukupni volumen doziranja disperzije od 5 mg/ml potreban za bolesnika i odgovarajuću količinu rekonstituiranog lijeka Pazenir ubrizgati u praznu, sterilnu, PVC ili ne-PVC
English: The median time to improvement by at least 1 grade was 21 days, and the median time to improvement from Grade 3 peripheral neuropathy to Grade 0 or 1 was 29 days.
Croatian: Medijan vremena do poboljšanja za najmanje 1 stupanj bio je 21 dan, a medijan vremena do poboljšanja periferne neuropatije s 3. stupnja na 0. ili 1. stupanj bio je 29 dana.
English: Dose adjustments during treatment of breast cancer
Croatian: Prilagodbe doze tijekom liječenja raka dojke
English: The solution should not be injected directly onto the powder as this will result in foaming.
Croatian: Otopinu nemojte injicirati izravno na prašak jer će nastati pjena.
English: After first reconstitution the dispersion should be used immediately.
Croatian: Nakon prve rekonstitucije, potrebno je odmah primijeniti disperziju.
English: Erlotinib should not be coadministered with Pazenir plus gemcitabine (see section 4.5).
Croatian: Erlotinib se ne smije primjenjivati zajedno s kombinacijom Pazenir plus gemcitabin (vidjeti dio 4.5).
English: Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases.
Croatian: Šezdeset i četiri posto bolesnika imalo je pogoršano opće stanje (ECOG 1 ili 2) pri ulasku u ispitivanje; 79% imalo je visceralne metastaze, a 76% imalo je > 3 sijela metastaza.
English: Treat with same doses as patients with normal hepatic function.
Croatian: Liječenje treba provoditi dozama jednakim onima za bolesnike s normalnom jetrenom funkcijom.
English: Pazenir is an albumin-bound nanoparticle formulation of paclitaxel, which may have substantially different pharmacological properties compared to other formulations of paclitaxel (see sections 5.1 and 5.2).
Croatian: Pazenir je paklitaksel u obliku nanočestica vezanih na albumin koji može imati znatno drugačija farmakološka svojstva u usporedbi s drugim oblicima paklitaksela (vidjeti dijelove 5.1 i 5.2).
English: The use of medical devices containing silicone oil as a lubricant (i.e. syringes and IV bags) to reconstitute and administer Pazenir may result in the formation of proteinaceous strands.
Croatian: Uporaba medicinskih proizvoda koje sadrže silikonsko ulje kao lubrikant (tj. štrcaljke i intravenske vrećice) za rekonstituciju i primjenu lijeka Pazenir može rezultirati stvaranjem proteinskih vlakana.
English: Male patients treated with Pazenir are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment.
Croatian: Muškim bolesnicima liječenim lijekom Pazenir savjetuje se da koriste učinkovitu kontracepciju i da izbjegavaju začeće djeteta tijekom i do šest mjeseci nakon završetka liječenja.
English: *This data is based on Clinical Study Report: CA012-0 Addendum dated Final (23 March-2005) a Chi-squared test b Log-rank test
Croatian: *Ovi se podaci temelje na Izvješću kliničkog ispitivanja: CA012-0, konačna dopuna datirana 23. ožujka 2005.
English: It is hypothesised that this enhanced transendothelial caveolar transport is mediated by the gp-60 albumin receptor, and that there is enhanced accumulation of paclitaxel in the area of tumour due to the albumin-binding protein Secreted Protein Acidic Rich in Cysteine (SPARC).
Croatian: Pretpostavlja se da je ovaj povećani transendotelni kaveolarni prijenos posredovan albuminskim receptorom gp-60 te da postoji povećana akumulacija paklitaksela u području tumora zbog izlučenog kiselog proteina bogatog cisteinom (SPARC od engl. secreted protein acidic and rich in cysteine) koji na sebe veže albumin.
English: Based on the published literature, in vitro studies of binding to human serum proteins, (using paclitaxel at concentrations ranging from 0.1 to 50 µg/ml), indicate that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel.
Croatian: Na temelju objavljene literature, in vitro ispitivanja vezanja za ljudske serumske proteine (primjenom paklitaksela u koncentracijama od 0,1 do 50 µg/ml) pokazuju da prisutnost cimetidina, ranitidina, deksametazona ili difenhidramina nije utjecala na vezanje paklitaksela za proteine.
English: Neurotoxicity to paclitaxel was evaluated through improvement by one grade for patients experiencing Grade 3 peripheral neuropathy at any time during therapy.
Croatian: Neurotoksičnost paklitaksela procijenjena je na temelju poboljšanja za jedan stupanj u bolesnika s 3. stupnjem periferne neuropatije, u bilo kojem trenutku tijekom terapije.
English: • Diminished muscular coordination or difficulty in reading, increased or decreased tears, loss of eyelashes
Croatian: • smanjena koordinacija mišića ili poteškoće pri čitanju, pojačano ili smanjeno suzenje, gubitak trepavica
English: • Changes in heart rate or rhythm, heart failure
Croatian: • promjene u brzini otkucaja srca ili u srčanom ritmu, zatajenje srca
English: Gastrointestinal Toxicity:
Croatian: Gastrointestinalna toksičnost:
English: • Skin reaction to another agent or lung inflammation following radiation
Croatian: • kožna reakcija na drugi lijek ili upala pluća nakon ozračivanja
English: In addition, paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Croatian: Pored toga, paklitaksel inducira abnormalne nizove ili "snopove" mikrotubula kroz stanični ciklus te umnaža astere mikrotubula tijekom mitoze.
English: If a hypersensitivity reaction occurs, the medicinal product should be discontinued immediately, symptomatic treatment should be initiated, and the patient should not be rechallenged with paclitaxel.
Croatian: U slučaju razvoja reakcije preosjetljivosti potrebno je odmah prekinuti uporabu lijeka i započeti simptomatsko liječenje, a tom se bolesniku ne smije ponovno u terapiju uvesti paklitaksel.
English: Paclitaxel belongs to a group of medicines called “taxanes” used in cancer.
Croatian: Paklitaksel pripada skupini lijekova zvanih taksani, koji se koriste za liječenje raka.
English: In the very elderly (≥75 years) who received Pazenir and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation including haematologic toxicities, peripheral neuropathy, decreased appetite and dehydration.
Croatian: U bolesnika visoke starosti (≥ 75 godina) koji su primali Pazenir u kombinaciji s gemcitabinom bila je veća incidencija ozbiljnih nuspojava i nuspojava koje su dovele do prekida liječenja, uključujući hematološke toksičnosti, perifernu neuropatiju, smanjeni apetit i dehidraciju.
English: Grade 2 or 3
Croatian: 2. ili 3. stupnja
English: For treatment of metastatic breast cancer, Pazenir is usually given once every three weeks (on day 1 of a 21-day cycle).
Croatian: Za liječenje metastatskog raka dojke, Pazenir obično se daje jednom svaka tri tjedna (1. dana svakog
English: • Decreased liver function, increased size of liver
Croatian: • smanjena jetrena funkcija, uvećana jetra
English: • Albumin is the part of the medicine that helps paclitaxel dissolve in the blood and get across the walls of the blood vessels into the tumour.
Croatian: • Albumin je sastavni dio lijeka koji pomaže otapanje paklitaksela u krvi te prodiranje paklitaksela kroz stijenke krvnih žila u tumor.
English: • Pain in the muscles
Croatian: • bol u mišićima
English: Paclitaxel has minor or moderate influence on the ability to drive and use machines.
Croatian: Paklitaksel malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: ULN) (see section 5.2).
Croatian: (vidjeti dio 5.2).
English: The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate), see section 2 “Pazenir contains sodium”.
Croatian: Drugi sastojak je ljudski albumin (koji sadrži natrij, natrijev kaprilat i N-acetil DL triptofanat), vidjeti dio 2 „Pazenir sadrži natrij“.
English: MedDRA = Medical Dictionary for Regulatory Activities.
Croatian: MedDRA = skraćenica za Medical Dictionary for Regulatory Activities; Rječnik medicinskih pojmova za regulatorne poslove.
English: Each ml of concentrate contains 0.183 mmol sodium, which is 4.2 mg of sodium.
Croatian: Jedan ml koncentrata sadrži 0,183 mmol natrija, što odgovara 4,2 mg natrija.
English: Albumin is known to mediate endothelial caveolar transcytosis of plasma constituents, and in vitro studies demonstrated that the presence of albumin enhances transport of paclitaxel across endothelial cells.
Croatian: Poznato je da albumin posreduje u endotelnoj kaveolarnoj transcitozi sastojaka plazme, a in vitro ispitivanja pokazala su da prisutnost albumina povećava prijenos paklitaksela kroz endotelne stanice.
English: Table 2: Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma Cycle Day
Croatian: Tablica 2: Promjene doze zbog neutropenije i/ili trombocitopenije na početku ciklusa ili tijekom ciklusa u bolesnika s adenokarcinomom pankreasa Dan ciklusa
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed before treatment is considered (see section 4.4).
Croatian: Bolesnike s adenokarcinomom pankreasa u dobi od 75 i više godina valja pažljivo procijeniti prije razmatranja liječenja (vidjeti dio 4.4).
English: • if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Pazenir (listed in section 6);
Croatian: • ako ste alergični (preosjetljivi) na paklitaksel ili neki drugi sastojak lijeka Pazenir (naveden u dijelu 6); • ako dojite;
English: The second trial utilised a dose of 300 mg/m2 as a 30 minute infusion in 63 patients with metastatic breast cancer.
Croatian: U drugom je ispitivanju korištena doza od 300 mg/m2 kao 30-minutna infuzija u 63 bolesnika s metastatskim rakom dojke.
English: If the dispersion contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Croatian: Ako disperzija dođe u dodir s kožom, kožu je potrebno odmah temeljito oprati vodom i sapunom.
English: The key secondary endpoints were progression- free survival (PFS) and overall response rate (ORR), both assessed by independent, central, blinded radiological review using RECIST guidelines (Version 1.0).
Croatian: Ključni sekundarni ishodi bili su preživljenje bez progresije bolesti (PFS) i stopa sveukupnog odgovora (ORR), a oba ishoda procijenjena su slijepom neovisnom središnjom radiološkom procjenom na temelju smjernica RECIST (verzija 1.0).
English: At the clinical dose range of 80 to 300 mg/m2, the mean plasma clearance of paclitaxel ranges from 13 to 30 L/h/m2, and the mean terminal half-life ranges from 13 to 27 hours.
Croatian: Pri kliničkom rasponu doze od 80 do 300 mg/m2, srednja je vrijednost plazmatskog klirensa paklitaksela u rasponu od od 13 do 30 L/h/m2, a prosječni završni poluvijek od 13 do 27 sati.
English: This information is presented below.
Croatian: Ovi podaci prikazani su u nastavku.
English: The safety and efficacy of human serum albumin-paclitaxel nanoparticles in children and adolescents aged 0-17 years has not been established.
Croatian: Sigurnost i djelotvornost paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma u djece i adolescenata u dobi od 0 do 17 godina nisu još ustanovljene.
English: Results for overall response rate and time to disease progression, and progression-free survival and survival for patients receiving > 1st-line therapy, are shown below.
Croatian: Rezultati ukupne stope odgovora i vrijeme do progresije bolesti te preživljenja bez progresije bolesti i preživljenja za bolesnike koji su primali > 1. linije liječenja prikazani su u nastavku.
English: • if you experience breathing problems, like shortness of breath or dry cough.
Croatian: • ako Vam se pojave tegobe s disanjem poput nedostatka zraka ili suhog kašlja.
English: The results show that mild hepatic impairment (total bilirubin >1 to ≤1.5 x ULN) has no clinically important effect on pharmacokinetics of paclitaxel.
Croatian: Rezultati pokazuju da blago oštećenje jetrene funkcije (ukupni bilirubin od > 1 do ≤ 1,5 x GGN) nema klinički važan učinak na farmakokinetiku paklitaksela.
English: • medicines used to help you lower blood lipid levels (e.g. gemfibrozil)
Croatian: • lijekovi koji pomažu sniziti razine lipida u krvi (npr. gemfibrozil)
English: Anaemia (Hb < 10 g/dl) was observed in 46% of patients on human serum albumin-paclitaxel nanoparticles, and was severe (Hb < 8 g/dl) in three cases.
Croatian: Anemija (Hb < 10 g/dl) je opažena u 46% bolesnika koji su primali paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma i bila je teška (Hb < 8 g/dl) u tri slučaja.
English: Day 15: If Day 8 doses were reduced:
Croatian: 15. dan: Ako su doze 8. dana bile smanjene:
English: Peripheral Neuropathy:
Croatian: Periferna neuropatija:
English: The use of specialized di(2-ethylhexyl)phthalate (DEHP)-free solution containers or administration sets is not necessary to prepare or administer Pazenir infusions.
Croatian: Uporaba posebnih spremnika ili kompleta za primjenu otopine bez di(2-etilheksil)ftalata (DEHP) nije nužna za pripremu ili primjenu infuzije lijeka Pazenir.
English: Common: Febrile neutropenia Rare: Pancytopenia
Croatian: Često: febrilna neutropenija Rijetko: pancitopenija
English: Paclitaxel and/or its metabolites were excreted into the milk of lactating rats (see section 5.3).
Croatian: Paklitaksel i/ili njegovi metaboliti izlučivali su se u mlijeko ženki štakora u laktaciji (vidjeti dio 5.3).
English: Pharmacokinetic/pharmacodynamic modeling indicates that there is no correlation between hepatic function (as indicated by the baseline albumin or total bilirubin level) and neutropenia after adjusting for human serum albumin-paclitaxel nanoparticles exposure.
Croatian: Farmakokinetičko/farmakodinamičko modeliranje pokazuje da ne postoji korelacija između jetrene funkcije (kako pokazuje početna razina albumina ili ukupnog bilirubina) i neutropenije nakon podešavanja za izloženost paklitakselu u obliku nanočestica vezanih na albumin iz ljudskog seruma.
English: Pharmacokinetic data are insufficient for patients with severe renal impairment and not available for patients with end stage kidney disease.
Croatian: Farmakokinetički podaci o bolesnicima s teškim oštećenjem bubrežne funkcije nisu dostatni, a nema ih za bolesnike s završnim stadijem bubrežne bolesti.
English: Reduce to next lower dose levela; discontinue treatment if ADR persists
Croatian: Smanjiti na sljedeću nižu razinu dozaa; prekinuti liječenje ako su nuspojave i dalje prisutne
English: Dose adjustments during treatment of pancreatic adenocarcinoma
Croatian: Prilagodbe doza tijekom liječenja adenokarcinoma pankreasa
English: The solution should be directed onto the inside wall of the vial.
Croatian: Otopinu treba usmjeriti na unutarnju stijenku bočice.
English: Alternative light-protection may be used in the clean room.
Croatian: U čistoj sobi može se koristiti drugi način zaštite od svjetlosti.
English: 4.6 Fertility, pregnancy and breast-feeding
Croatian: 4.6 Plodnost, trudnoća i dojenje
English: Patients who experience severe neutropenia (neutrophil count < 500 cells/mm3 for a week or longer) or severe sensory neuropathy during Pazenir therapy should have the dose reduced to 220 mg/m2 for subsequent courses.
Croatian: Bolesnicima koji su razvili tešku neutropeniju (broj neutrofila < 500 stanica/mm3 tijekom tjedan dana ili dulje) ili tešku senzornu neuropatiju tijekom liječenja lijekom Pazenir treba smanjiti dozu na 220 mg/m2 u narednim ciklusima liječenja.
English: Closely monitor all patients for signs and symptoms of pneumonitis.
Croatian: Sve bolesnike treba pažljivo nadzirati zbog pojave znakova i simptoma pneumonitisa.
English: Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume human serum albumin-paclitaxel nanoparticlesat a reduced dose.
Croatian: Od bolesnika kojima je liječenje prekinuto zbog periferne neuropatije, 44% (31/70 bolesnika) moglo je nastaviti liječenje paklitakselom u obliku nanočestica vezanih na albumin iz ljudskog seruma pri smanjenoj dozi.
English: Pharmacokinetic data are not available for patients with total bilirubin >5 x ULN or for patients with metastatic adenocarcinoma of the pancreas (see section 4.2).
Croatian: Nisu dostupni farmakokinetički podaci za bolesnike s ukupnim bilirubinom > 5 x GGN, kao ni za bolesnike s metastatskim adenokarcinomom pankreasa (vidjeti dio 4.2).
English: Treatment effects on OS favoured the human serum albumin-paclitaxel nanoparticles/gemcitabine arm across the majority of pre-specified subgroups (including gender, KPS, geographic region, primary location of pancreatic cancer, stage at diagnosis, presence of liver metastases, presence of peritoneal carcinomatosis, prior Whipple procedure, presence of biliary stent at baseline, presence of pulmonary metastases, and number of metastatic sites).
Croatian: Učinci liječenja na sveukupno preživljenje bili su u prilog skupine koja je primala paklitaksel u obliku nanočestica vezanih na albumin iz ljudskog seruma/gemcitabin u većini unaprijed određenih podskupina (uključujući spol, KPS, zemljopisnu regiju, primarno mjesto karcinoma pankreasa, stadij prilikom dijagnoze, prisutnost metastaza jetre, prisutnost peritonejske karcinomatoze, prethodni Whippleov postupak, prisutnost bilijarnog stenta na početku, prisutnost plućnih metastaza i broj metastaznih mjesta).
English: 26.5 [18.98, 34.05] (n = 132) 13.2 [7.54, 18.93] (n = 136) 0.006a
Croatian: Stopa odgovora [95% CI] (%) > 1. linije terapije 26,5 [18,98; 34,05] (n = 132) 13,2 [7,54; 18,93] (n = 136)
English: Talk to your doctor or nurse before using Pazenir
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije primjene lijeka Pazenir:
English: Based on population pharmacokinetic analysis, the total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel.
Croatian: Na temelju analize populacijske farmakokinetike, ukupni volumen distribucije iznosi približno 1741 l;
English: Each ml of Pazenir contains approximately 4.2 mg of sodium.
Croatian: Svaki ml lijeka Pazenir sadrži približno 4,2 mg natrija.
English: Pazenir in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Croatian: Pazenir je indiciran u kombinaciji s karboplatinom kao prva linija liječenja raka pluća nemalih stanica u odraslih bolesnika koji nisu kandidati za potencijalno kurativni kirurški zahvat i/ili terapiju zračenjem.
English: Uncommon: Contusion Rare: Radiation recall phenomenon, radiation pneumonitis
Croatian: Manje često: kontuzija Rijetko: pojava recidiva kožnih reakcija izazvanih zračenjem, radijacijski pneumonitis
English: • medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
Croatian: • lijekovi za liječenje HIV-a i SIDA-e (npr. ritonavir, sakvinavir, indinavir, nelfinavir, efavirenz, nevirapin)
English: The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of human serum albumin-paclitaxel nanoparticles after > 6 courses of treatment was not evaluated and remains unknown.
Croatian: Prirodni tijek izlječenja periferne neuropatije u odnosu na početno stanje zbog kumulativne toksičnosti paklitaksela u obliku nanočestica vezanih na albumin iz ljudskog seruma nakon > 6 ciklusa liječenja nije procijenjen i ostaje nepoznat.
English: • a medicine called clopidogrel used to prevent blood clots
Croatian: • lijek pod nazivom klopidogrel koji se koristi za sprječavanje stvaranja krvnih ugrušaka.
English: In the comparator treatment arm, gemcitabine monotherapy was administered to patients (N = 430) in accordance with the recommended dose and regimen.
Croatian: U usporednoj skupini bolesnicima je primijenjen gemcitabin kao monoterapija (N = 430) u skladu s preporučenom dozom i režimom doziranja.
English: • Pain and swelling in the nose, skin infections, infection due to catheter line
Croatian: • bol i otečenost nosa, kožne infekcije, infekcije uzrokovane kateterom
English: Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
Croatian: Primjena paklitaksela istodobno s lijekovima za koje je utvrđeno da induciraju bilo CYP2C8 ili CYP3A4 (primjerice, rifampicin, karbamazepin, fenitoin, efavirenz, nevirapin) ne preporučuje se jer djelotvornost može biti kompromitirana zbog manje izloženosti paklitakselu.
English: Day 15: If Day 8 doses were withheld:
Croatian: 15. dan: Ako su doze 8. dana bile obustavljene:
English: Monitor patients closely for signs and symptoms of pneumonitis.
Croatian: Bolesnike treba pažljivo nadzirati zbog pojave znakova i simptoma pneumonitisa.
English: • medicines used to treat seizures (epilepsy) (e.g. carbamazepine, phenytoin)
Croatian: • lijekovi za liječenje napadaja (u epilepsiji) (npr. karbamazepin, fenitoin)
English: Frequencies are defined as: 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).
Croatian: (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: Paclitaxel at doses below the human therapeutic dose was associated with low fertility when administered prior and during mating in male and female rats and foetal toxicity in rats.
Croatian: Paklitaksel se u dozama nižim od terapijskih doza za čovjeka povezuje s niskom plodnošću kada se primjenjuje prije i tijekom parenja u mužjaka i ženki štakora, te s fetalnom toksičnošću u štakora.
English: Paclitaxel and/or its metabolites were excreted into the milk of lactating rats.
Croatian: Paklitaksel i/ili njegovi metaboliti izlučivali su se u mlijeko ženki štakora u laktaciji.
English: • Pazenir is also used together with a medicine called carboplatin if you have the most common type of lung cancer, called “non-small cell lung cancer”.
Croatian: Rak pluća • Pazenir također se koristi s lijekom pod nazivom karboplatin ako imate najčešći oblik raka pluća koji se naziva “rak pluća nemalih stanica”.
English: What you need to know before you use Pazenir Do not use Pazenir
Croatian: Što morate znati prije nego počnete primjenjivati Pazenir
English: Survival Rate % (95% CI) at
Croatian: Stopa preživljenja % (95% CI) u
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2