FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic modelling and simulation of rat data suggests that, when co-administered with febuxostat, the clinical dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose in order to avoid possible haematological effects (see section 4.4 and 4.5).
Slovenian: Farmakokinetično modeliranje in simulacija podatkov, pridobljenih pri podganah, kaže, da je treba kliničen odmerek merkaptopurina/azatioprina ob sočasnem jemanju s febuksostatom, zmanjšati na 20 % ali manj prvotno predpisanega odmerka, da se izognemo morebitnim hematološkim učinkom (glejte poglavji 4.4 in 4.5).
English: Film coating
Slovenian: Filmska obloga:
English: Febuxostat is eliminated by both hepatic and renal pathways.
Slovenian: Febuksostat se izloča tako preko jeter kot ledvic.
English: Modelling and simulation analysis of data from a pre-clinical study in rats indicates that, in case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to 20% or less of the previously prescribed dose (see section 4.4 and 5.3).
Slovenian: Modeliranje in simulacija analiznih podatkov predklinične študije, izvedene na podganah, v primeru sočasnega jemanja s febuksostatom kažejo, da je treba odmerek merkaptopurina/azatioprina zmanjšati na 20 % ali manj prvotno predpisanega odmerka (glejte poglavji 4.4 in 5.3).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Zdravilo Febuksostat Krka vsebuje laktozo in natrij Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Other medicines and Febuxostat Krka
Slovenian: Druga zdravila in zdravilo Febuksostat Krka
English: In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03;95% CI 0.871.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
Slovenian: V preskušanju CARES iz obdobja trženja (glejte poglavje 5.1 za bolj podroben opis študije), je bila stopnja MACE (Major Adverse Cardiovascular Events) v skupini, ki je prejemala febuksostat podobna kot v skupini, ki je prejemala alopurinol (razmerje ogroženosti [HR - hazard ratio] 1,03; 95% interval zaupanja [IZ] 0,87-1,23), vendar je bil delež srčno-žilnih smrti večji v skupini zdravljeni s febuksostatom (4,3% v primerjavi z 3,2% bolnikov; HR 1,34; 95% IZ 1,03-1,73).
English: Population pharmacokinetic/pharmacodynamic analyses were conducted in 211 patients with hyperuricaemia and gout, treated with febuxostat 40-240 mg QD.
Slovenian: Analize populacijske farmakokinetike/farmakodinamike so bile izvedene pri 211 bolnikih s hiperurikemijo in protinom, zdravljenih s febuksostatom 40-240 mg enkrat na dan. Na splošno se parametri farmakokinetike febuksostata, ocenjeni v teh analizah, ujemajo s tistimi, ki so jih pridobili pri zdravih osebah, kar kaže, da so zdrave osebe ustrezne za oceno farmakokinetike/farmakodinamike pri bolnikih s protinom.
English: Febuxostat Krka 80 mg tablets febuxostat
Slovenian: Febuksostat Krka 80 mg tablete febuksostat
English: Febuxostat Krka 120 mg tablets febuxostat
Slovenian: Febuksostat Krka 120 mg tablete febuksostat
English: Febuxostat Krka works by reducing uric acid levels.
Slovenian: Zdravilo Febuksostat Krka zmanjšuje ravni sečne kisline.
English: Pancytopenia, thrombocytopenia, agranulocytosis*
Slovenian: Bolezni krvi in limfnega sistema Redki pancitopenija, trombocitopenija, agranulocitoza*
English: Possible symptoms of allergic reactions might be: - rash including severe forms (e.g. blisters, nodules, itchy, exfoliative rash), itchiness - swelling of limbs or face - difficulties in breathing - fever with enlarged lymph nodes - but also serious life threatening allergic conditions with cardiac and circulatory arrest.
Slovenian: srbenje - otekanje okončin in obraza - oteženo dihanje - zvišana telesna temperatura s povečanimi bezgavkami - in tudi resna, življenjsko nevarna alergijska stanja z zastojem srca in s krvožilnim zastojem.
English: Febuxostat Krka 120 mg film-coated tablets
Slovenian: Febuksostat Krka 120 mg filmsko obložene tablete
English: Titanium dioxide (E171) Talc
Slovenian: polivinilalkohol makrogol 3350 titanov dioksid (E171) smukec rumeni železov oksid (E172)
English: study, and showed that febuxostat was significantly more efficacious in lowering serum urate levels to < 6 mg/dL compared to allopurinol 300 mg/200 mg in patients who had gout with mild to moderate renal impairment (65% of patients studied).
Slovenian: BL = izhodi0e SEM = standadnanapaIcasrednjeTedno sečne kisline na < 6 mg/dl v primerjavi z alopurinolom 300 mg/200 mg pri bolnikih s protinom in blago do zmerno okvaro ledvic (65 % bolnikov).
English: Febuxostat Krka 80 mg film-coated tablets
Slovenian: Febuksostat Krka 80 mg filmsko obložene tablete
English: Febuxostat Krka 80 mg film-coated tablets febuxostat
Slovenian: Febuksostat Krka 80 mg filmsko obložene tablete febuksostat
English: Febuxostat Krka 120 mg film-coated tablets febuxostat
Slovenian: Febuksostat Krka 120 mg filmsko obložene tablete febuksostat
English: Febuxostat Krka works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
Slovenian: Zaradi hitrega nastopa učinka zdravila Febuksostat Krka se lahko preverjanje sečne kisline v serumu izvede že po 2 tednih.
English: Iron oxide, yellow (E172)
Slovenian: polivinilalkohol makrogol 3350 titanov dioksid (E171) smukec rdeči železov oksid (E172)
English: - abnormal liver test results - diarrhoea - headache - rash (including various types of rash, please see below under “uncommon” and “rare” sections) - nausea - increase in gout symptoms - localised swelling due to retention of fluids in tissues (oedema).
Slovenian: "redkimi"), - slabost, - povečano pojavljanje znakov protina, - lokalizirana oteklina zaradi zastajanja tekočine v tkivu (edem).
English: Prevention and treatment of hyperuricaemia in patients at risk of TLS
Slovenian: Preventiva in zdravljenje visokih vrednosti sečne kisline pri bolnikih, ki zdravijo rakava obolenja s kemoterapijo
English: How to store Febuxostat Krka
Slovenian: Kako jemati zdravilo Febuksostat Krka
English: Blood and lymphatic system disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: Febuxostat achieved the primary efficacy endpoint in 44% (80 mg QD), 45% (120 mg QD), and 60% (240 mg QD) of patients compared to 0% in the allopurinol 100 mg QD and placebo groups.
Slovenian: Pri bolnikih z okvaro ledvic, ki so bili naključno razporejeni v skupino, ki je prejemala alopurinol, je bila višina odmerka omejena na 100 mg enkrat na dan. Primarni izid učinkovitosti je bil v skupini, ki je jemala febuksostat, dosežen pri 44 % (80 mg enkrat na dan), 45 % (120 mg enkrat na dan) in 60 % (240 mg enkrat na dan) bolnikov v primerjavi z 0 % v skupinah, ki so prejemale alopurinol 100 mg enkrat na dan ali placebo.
English: - dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, diminished sense of smell (hyposmia) - abnormal ECG heart tracing, irregular or rapid heartbeats, feeling your heart beat (palpitation) - hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding
Slovenian: - Živčnost, - žeja, - zvenenje v ušesih, - zamegljen vid, spremembe vida, - izpadanje las, - razjede v ustih, - vnetje trebušne slinavke: običajni simptomi so bolečina v trebuhu, občutek siljenja na bruhanje in bruhanje, - čezmerno znojenje, - zmanjšanje telesne mase, povečanje apetita, nenadzorovana izguba apetita (anoreksija), - vnetje sklepa, ki ga običajno spremlja bolečina in oteklina (artritis), togost mišic in/ali sklepov, - nenormalno majhno število krvnih celic (belih ali rdečih celic ali krvnih ploščic), - nujna potreba po odvajanju urina, - spremembe ali zmanjšanje količine urina zaradi vnetja ledvic (tubulointersticijski nefritis), - vnetje jeter (hepatitis), - rumenkasto obarvana koža (zlatenica), - poškodba jeter, - povečane vrednosti kreatin fosfokinaze v krvi (indikator poškodbe mišic), - nenadna srčna smrt.
English: Following an 80 mg oral dose of
Slovenian: Po peroralnem odmerku 80 mg s
English: Mean (±SEM) Serum Uric Acid Level (mg/dL)
Slovenian: Občasni povečanje ščitnico stimulirajočega hormona (TSH)
English: It is not known if Febuxostat Krka may harm your unborn child. Febuxostat Krka should not be used during pregnancy.
Slovenian: Ni znano, ali zdravilo Febuksostat Krka škodljivo vpliva na nerojenega otroka.
English: small, flat red spots on the skin, flat, red area on the skin that is covered with small confluent bumps, rash, areas of redness and spots on the skin, other type of skin conditions - muscle cramp, muscle weakness, pain/ache in muscles/joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/or stiffness), pain in extremity, back pain,
Slovenian: - Rdečina kože (eritem), različni tipi izpuščajev (npr. srbeč, z belimi pikami, z mehurčki, z gnojnimi mehurčki, z odstranjevanjem kože, noricam podoben izpuščaj), razširjena rdečina kože, nekroza, mehurjasto odstopanje povrhnjice in membran sluznice, ki se kaže kot luščenje in možnost nastanka sepse (Stevens-Johnson sindrom/toksična epidermalna nekroliza).
English: In conclusion, the CHMP agrees that the responses submitted by the Applicant indicate that the issues are resolved.
Slovenian: CHMP se v zaključku strinja, da odgovori, predloženi s strani vlagatelja, kažejo, da so omenjena vprašanja rešena.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VANTAS (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA VANTAS (glejte Dodatek I)
English: The local safety of Vantas is sufficiently investigated and further comparative studies are not necessary.
Slovenian: Lokalna varnost zdravila Vantas je bila raziskana v zadostni meri, tako da nadaljnje primerjalne študije niso potrebne.
English: With an efficacy of 98-100% in serum testosterone reduction further active comparator studies are redundant and thus not necessary.
Slovenian: Zaradi 98-100 % učinkovitosti nižanja ravni testosterona so nadaljnje aktivne primerjalne študije odvečne in nepotrebne.
English: In the past, testosterone suppression was achieved by bilateral orchiectomy (surgical castration).
Slovenian: V preteklosti so supresijo testosterona dosegli z obojestransko orhiektomijo (kirurško kastracijo).
English: There is no indication that any of the members within this class differs with respect to efficacy and safety, and Vantas seems to be no exception in that respect.
Slovenian: Ni indikacij, da bi bil kateri koli od članov tega razreda drugačen z vidika učinkovitosti in varnosti, kar velja tudi za zdravilo Vantas.
English: A distinction should be made between safety aspects of androgen suppression therapy in general and the (local) safety of this product.
Slovenian: Pri tem je treba razlikovati med varnostnimi vidiki zdravljenja s supresijo moškega spolnega hormona na splošno in (lokalno) varnostjo zdravila.
English: Denmark Valera Pharmaceuticals Ireland Ltd. 25-28 North Wall Quay, Dublin, Ireland
Slovenian: Valera Pharmaceuticals Ireland Ltd.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: In principle, it is important to achieve serum testosterone concentrations as low as possible for ADT to minimize stimulation of prostate cancer cells.
Slovenian: Načeloma je pomembno doseči najmanjše možne koncentracije testosterona v serumu, da bi ADT čim manj spodbujal celice raka prostate.
English: Vantas is a new LHRH agonist and this pharmacological class was introduced for the treatment of advanced prostate cancer more than 20 years ago.
Slovenian: Zdravilo Vantas je nov agonist LHRH iz farmakološkega razreda, ki je bil za zdravljenje raka prostate v napredovalem stadiju vpeljan pred več kot 20 leti.
English: Serum testosterone concentrations that correspond to castration levels have generally been set at less than 50 ng/dL (1.7 nmol/L), given the known variability of values in reference laboratories.
Slovenian: Koncentracije testosterona v serumu, ki ustrezajo ravnem po kastraciji, so bile določene na manj kot 50 ng/dl (1,7 nmol/l), ob upoštevanju znanih odstopanj vrednosti v referenčnih laboratorijih.
English: Thus, the documented pharmacological endpoint serum testosterone < 50 ng/dL, documented for Vantas in studies 302, 301 and in addition in the Long Term Extension of Study 301 is an acceptable primary efficacy endpoint in patients with advanced prostate cancer.
Slovenian: Zato je dokumentirana farmakološka končna točka za testosteron v serumu < 50 ng/dl, ki je bila dokumentirana za zdravilo Vantas v študijah 302, 301 in poleg tega tudi v dolgotrajnem podaljšku študije 301, sprejemljiva primarna končna točka učinkovitosti pri raku prostate v napredovalem stadiju.
English: Marketing Authorisation Holder Applicant
Slovenian: Država članica Imetnik dovoljenja za promet z zdravilom
English: Androgen ablation is considered to be a palliative treatment.
Slovenian: Ablacija moškega spolnega hormona se šteje za paliativno zdravljenje.
English: The proposal of the applicant/MAH to include five pharmacovigilance safety concerns in the Risk Management Plan is endorsed (two relate specifically to the unique Vantas formulation while the other three are classified as class effects: expulsions, cellulitis, flare, osteoporosis and QT prolongation).
Slovenian: Sprejet je bil predlog vlagatelja/imetnika dovoljenja za promet z zdravilom, da v načrt za obvladovanje tveganja vključi pet vprašanj o varnosti z vidika farmakovigilance (dve se nanašata zlasti na edinstveno formulacijo zdravila Vantas, medtem ko ostala tri spadajo med učinke razreda: izključitve, celulitis, začetni dvig koncentracije testosterona (flare), osteoporoza in podaljšanje QT intervala).
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine.
English: The achievement of castrate levels of testosterone is an acceptable surrogate endpoint in hormone sensitive advanced prostate cancer which can be translated into less pain from bone metastases, improvement in urinary flow, and in some cases slowing of tumour progression, although a clear-cut survival benefit has not been demonstrated.
Slovenian: Doseganje ravni testosterona, ki so enake kot po kastraciji, je sprejemljiva nadomestna končna točka pri zdravljenju na hormone občutljivega raka prostate v naprednem stadiju in ki se lahko izrazi kot manj bolečin zaradi kostnih metastaz, izboljšanje pretoka urina in v nekaterih primerih tudi upočasnitev napredovanja tumorja, čeprav jasnega izboljšanja stopnje preživetja ni bilo mogoče dokazati.
English: The safety database seems limited, but no unexpected safety issues have occurred nor in the American post marketing surveillance neither in the trials.
Slovenian: Zbirka podatkov o varnosti je na prvi pogled omejena, vendar pa niti nadzor po uvedbi zdravila na trg v Ameriki niti preizkušanja niso razkrila nobenih nepričakovanih varnostnih zadržkov.
English: The CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure as mentioned in Annex III for Vantas.
Slovenian: CHMP je priporočil odobritev dovoljenja za promet z zdravilom, za katerega so bile končne različice Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo dosežene med postopkom koordinacijske skupine, kot je omenjeno v Dodatku III za zdravilo Vantas.
English: For the last two decades, injection of long-acting luteinizing hormone-releasing hormone agonists (LH-RHas) has been used to achieve androgen ablation.
Slovenian: V zadnjih dveh desetletjih so ablacijo moškega spolnega hormona dosegali z vbrizgavanjem dolgo delujočih agonistov hormona za sproščanje luteinizirajočega hormona (LH-RHa-ji).
English: The data from the Long Term Extension Study 301 concerning efficacy and safety are in support for both long-term efficacy and safety for patients, receiving palliative treatment of advanced prostate cancer with histrelin implant for two or more years.
Slovenian: Podatki dolgotrajnega podaljška študije 301, ki se nanašajo na učinkovitost in varnost, podpirajo tako dolgotrajno učinkovitost kot varnost pri bolnikih, ki prejemajo paliativno zdravljenje raka prostate v napredovalem stadiju s histrelinskimi vsadki že dve leti ali dlje.
English: The CHMP requests the inclusion, as proposed by the Applicant/MAH, of the five pharmacovigilance safety concerns in the Risk Management Plan as mentioned above.
Slovenian: CHMP zahteva vključitev petih vprašanj varnosti z vidika farmakovigilance v načrt za obvladovanje tveganja, kot je predlagal vlagatelj/imetnik dovoljenja za promet z zdravilom in kot so opisana zgoraj.
English: The data of the Long Term Extension of Study 301 support long-term safety for patients treated with Vantas for two or more years.
Slovenian: Podatki iz dolgotrajnega podaljška študije 301 govorijo v prid varnosti na dolgi rok pri bolnikih, ki se z zdravilom Vantas zdravijo že dve leti ali dlje.
English: ANNEX III SUMMARY OF PRODUCT CHARACHTERITICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Late in the clinical course, it is androgen independent, and is refractory to hormonal therapy.
Slovenian: Kasneje v kliničnem poteku postane pri svojem razvoju neodvisen od androgena in neodziven na hormonsko zdravljenje.
English: The safety of androgen suppression is well known and further information is not necessary for this product.
Slovenian: Varnost supresije moškega spolnega hormona je dobro znana, tako da nadaljnje informacije o varnosti zdravila niso potrebne.
English: Another LHRH agonist could be used, but this is superfluous considering the meta-analysis presented by Applicant, orchidectomy is not acceptable when reversible methods are available, DES is obsolete and non-steroidal anti-androgens may have inferior efficacy when used as monotherapy.
Slovenian: Orhidektomija ni sprejemljiva, če so na voljo reverzibilne metode, metoda z DES je zastarela, nesteroidni antiandrogen pa je lahko manj učinkovit, če se ga uporablja kot monoterapijo.
English: However, even in the androgenindependent state, prostate cancer is likely to contain subpopulations of cells that are androgen dependent.
Slovenian: Vendar pa rak prostate tudi v stadiju, ko je neodvisen od moškega spolnega hormona, po vsej verjetnosti vsebuje podskupine celic, ki ostajajo odvisne od tega hormona.
English: United Kingdom
Slovenian: Združeno kraljestvo (Velika Britanija)
English: Early in its natural cycle, prostate cancer is androgen dependent.
Slovenian: V svojih zgodnjih stadijih je rak prostate odvisen od androgena, moškega spolnega hormona.
English: Furthermore, reduction of testosterone to castrate levels has been accepted as a valid surrogate for clinical efficacy in advanced prostate cancer by the CHMP in 2004 as part of scientific advice from the SAWP.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je poleg tega po znanstvenem priporočilu Delovne skupine za znanstveno svetovanje (SAWP) sprejel zmanjšanje ravni testosterona na enake kot pri kastriranih osebah za veljaven nadomestek za klinično učinkovitost pri napredovalem stadiju raka prostate.
English: On the basis of these limited data, continued androgen suppression in men with androgenindependent prostate cancer (AIPC) is the current standard of care.
Slovenian: Na osnovi teh omejenih podatkov je trenutno veljaven standard zdravljenja pri raku prostate, ki ni odvisen od moškega spolnega hormona, neprekinjena supresija moškega spolnega hormona.
English: Member State
Slovenian: Predlagatelj
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Ukkel
Slovenian: NV AstraZeneca SA Egide Van Ophemstraat 110 1180 Ukkel
English: Luxembourg NV AstraZeneca SA Rue Egide Van Ophem 110
Slovenian: Luksemburg NV AstraZeneca SA Rue Egide Van Ophem 110
English: AstraZeneca S.p.A. Palazzo Volta Via Francesco SforzaBasiglio (Milano) 20080 Italy
Slovenian: Palazzo Volta Via Francesco SforzaBasiglio (Milano) 20080 Italy
English: United Kingdom AstraZeneca UK Limited 600 Capability Green
Slovenian: Velika Britanija AstraZeneca UK Limited 600 Capability Green
English: 2719 EE Zoetermeer The Netherlands cream; hydrophilic cutaneous use
Slovenian: Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands krema; hidrofilna
English: EMLA 5% w/w Cream lidocaine prilocaine
Slovenian: EMLA 5% w/w Cream lidokain prilokain
English: Emla krém 5% lidocaine prilocaine
Slovenian: Emla krém 5% lidokain prilokain
English: Emla Cream 5% lidocaine prilocaine
Slovenian: Emla Cream 5% lidokain prilokain
English: Czech Republic AstraZeneca UK Limited 2 Kingdom Street
Slovenian: AstraZeneca UK Limited 2 Kingdom Street W2 6BD London United Kingdom
English: The Netherlands AstraZeneca B.V. Louis Pasteurlaan 5
Slovenian: AstraZeneca B.V.
English: In addition, 81% of these bleeding episodes required only a single treatment with Advate.
Slovenian: Poleg tega je 81 % od omenjenih epizod krvavitev zahtevalo le eno zdravljenje z zdravilom Advate.
English: Hypersensitivity (allergic) reactions have been reported and may in some cases become severe.
Slovenian: Poročali so o preobčutljivostnih (alergijskih) reakcijah, ki lahko v nekaterih primerih postanejo hude.
English: The European Commission granted a marketing authorisation valid throughout the EU for Advate on 2 March 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Advate, veljavno po vsej Evropski uniji, izdala 2. marca 2004.
English: Advate is intended for either short-term or long-term use.
Slovenian: Zdravilo Advate je namenjeno za kratkotrajno ali dolgotrajno uporabo.
English: The effectiveness of Advate was rated as ‘excellent' or ‘good' in 86% of 510 new bleeding episodes.
Slovenian: Učinkovitost zdravila Advate je bila ocenjena kot „odlična“ ali „dobra“ v 86 % od 510 novih epizod krvavitev.
English: What measures are being taken to ensure the safe and effective use of Advate?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Advate?
English: The full EPAR for Advate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Advate je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Advate
Slovenian: Druge informacije o zdravilu Advate
English: The additional studies confirmed Advate's effectiveness, including in children under 6 years of age.
Slovenian: Dodatne študije so potrdile učinkovitost zdravila Advate tudi pri otrocih, mlajših od 6 let.
English: This is a summary of the European public assessment report (EPAR) for Advate.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Advate.