FrancophonIA/ELRC3.0 huggingface dataset:
English: Most events were reported at similar rates between Vaniqa and vehicle.
Slovenian: pri postmenopavzalnih ženskah zdravljenih z zdravilom Vaniqa v primerjavi z vehiklom.
English: Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy.
Slovenian: Če po štirih mesecih zdravljenja ne pride do izboljšanja stanja, zdravljenje prekinite.
English: The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment.
Slovenian: Osem tednov po prekinitvi zdravljenja se lahko bolezen ponovi v enaki jakosti kot pred zdravljenjem.
English: Vaniqa is a cream which is white to off white in colour.
Slovenian: Zdravilo Vaniqa je bela do umazano bela krema v tubah s 15 g, 30 g in 60 g kreme.
English: It may take 8 weeks before you see results.
Slovenian: Lahko, da boste rezultate zdravljenja opazili šele po 8 tednih zdravljenja.
English: Package leaflet: Information for the user Vaniqa 11.5% cream
Slovenian: Navodilo za uporabo Vaniqa 11,5 % krema eflornitin
English: Breast-feeding
Slovenian: OVOJNINAH TUBE
English: There were two main studies involving 103 adults and one involving 55 children.
Slovenian: Opravljeni sta bili dve glavni študiji, v kateri so bili vključeni 103 odrasli, in ena študija, ki je zajela 55 otrok.
English: The European Commission granted a marketing authorisation valid throughout the EU for Busilvex on 9 July 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Busilvex, veljavno po vsej Evropski uniji, izdala 9. julija 2003.
English: This is called ‘myeloablation'.
Slovenian: Temu pravimo „mieloablacija“.
English: The full EPAR for Busilvex 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 Busilvex je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Busilvex.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Busilvex.
English: In children up to 17 years of age, the recommended dose
Slovenian: Pri otrocih do 17. leta starosti je
English: This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Slovenian: Tovrstna presaditev se uporablja pri bolnikih, ki potrebujejo zamenjavo krvotvornih celic, ker imajo bolezen krvi (na primer redko vrsto anemije) ali krvnega raka.
English: Busilvex can affect fertility in both sexes.
Slovenian: Zdravilo Busilvex lahko vpliva na plodnost obeh spolov.
English: This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (or ‘stem') cells (cells that make other types of cell).
Slovenian: To pomeni, da uničujejo celice, še zlasti hitro razvijajoče se celice, kot so na primer rakave ali progenitorske (ali „matične“) celice (celice, ki tvorijo druge vrste celic).
English: These substances are ‘cytotoxic'.
Slovenian: Te učinkovine so „citotoksične“.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Busilvex.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: For more information about treatment with Busilvex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Busilvex preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Because of this, female patients should not become pregnant during treatment and for up to six months afterwards, and male patients are advised not to father a child during and for up to six months after treatment with Busilvex.
Slovenian: Zaradi tega bolnice ne smejo zanositi med zdravljenjem in do šest mesecev po njem, moškim pa se svetuje, da med zdravljenjem in do šest mesecev po njem ne spočnejo otroka.
English: This helps the transplanted cells to ‘engraft' (when they start to grow and produce normal blood cells).
Slovenian: To pomaga presajenim celicam, da se „primejo“ (začnejo rasti in proizvajati normalne krvne celice).
English: Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Slovenian: Vsaka infuzija traja dve uri, bolnik pa jo prejme vsakih šest ur štiri dni zapored pred zdravljenjem s ciklofosfamidom ali melfalanom in presaditvijo.
English: The data from the published studies showed that Busilvex in combination with fludarabine was effective as a ‘reduced-intensity' conditioning treatment, with complete engraftment achieved in 80 to 100% of patients.
Slovenian: Podatki iz objavljenih študij so pokazali, da je bilo zdravilo Busilvex v kombinaciji s fludarabinom učinkovito kot pripravljalno zdravljenje z zmanjšano jakostjo, saj je bilo popolno prijetje doseženo pri 80 do 100 % bolnikov.
English: When used in combination with fludarabine, the recommended dose of Busilvex is 3.2 mg per kilogram given once a day as a three-hour infusion immediately after fludarabine, for 2 or 3 consecutive days.
Slovenian: Kadar se zdravilo uporablja v kombinaciji s fludarabinom, znaša priporočeni odmerek 3,2 mg/kg in se daje enkrat na dan kot triurna infuzija dva ali tri dni zapored neposredno po uporabi fludarabina.
English: The Committee decided that Busilvex's benefits are greater than its risks in these settings and recommended that Busilvex be given marketing authorisation.
Slovenian: Sklenil je, da so koristi zdravila Busilvex večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Since Busilvex in combination with fludarabine has been used in clinical practice for many years, data from 7 studies (involving 731 patients) which looked at the effectiveness of Busilvex and fludarabine as ‘reduced-intensity' conditioning treatment were presented.
Slovenian: Ker se zdravilo Busilvex v kombinaciji s fludarabinom že več let uporablja v klinični praksi, so bili predstavljeni podatki iz sedmih študij, v katere je bilo vključenih 731 bolnikov in v katerih so proučevali učinkovitost zdravila Busilvex in fludarabina kot pripravljalnega zdravljenja z zmanjšano jakostjo.
English: Apart from the decrease in blood cell counts, which is the intended effect of the medicine, the most serious side effects of Busilvex are infection, liver disorders including blocking of a liver vein, graft versus host disease (when the transplanted cells attack the body) and respiratory (lung) disorders.
Slovenian: Razen zmanjšanja števila krvnih celic v obtoku, kar je tudi nameravani učinek zdravila, so najresnejši neželeni učinki zdravila Busilvex okužba, motnje delovanja jeter, vključno z zaporo jetrne vene, bolezen presadka proti gostitelju (ko presajene celice napadejo telo) in pljučni zapleti.
English: Busilvex must not be used in women who are pregnant.
Slovenian: Zdravila Busilvex ne smejo uporabljati nosečnice.
English: It contains the active substance busulfan.
Slovenian: Vsebuje zdravilno učinkovino busulfan.
English: Before receiving Busilvex, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Slovenian: Preden bolniki prejmejo zdravilo Busilvex, dobijo zdravila proti konvulzijam (za preprečevanje epileptičnih napadov) in antiemetike (za preprečevanje bruhanja).
English: Other information about Busilvex
Slovenian: Druge informacije o zdravilu Busilvex
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom of Busilvex varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Busilvex is given as a central intravenous infusion (drip into a central vein in the chest).
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom priporočeni odmerek zdravila odvisen od telesne mase otroka in se giblje med 0,8 in 1,2 mg/kg.
English: What benefit has Busilvex shown during the studies?
Slovenian: Kakšne koristi je zdravilo Busilvex izkazalo med študijami?
English: In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busilvex is given right after treatment with another medicine, fludarabine.
Slovenian: Pri odraslih bolnikih, ki so upravičeni do pripravljalnega režima zdravljenja z zmanjšano jakostjo, se zdravilo Busilvex daje neposredno po zdravljenju z drugim zdravilom, fludarabinom.
English: Busulfan is used before transplantation to destroy abnormal cells and the patient's existing haematopoietic progenitor cells.
Slovenian: Zdravilo Busulfan se uporablja pred presaditvijo, da se uničijo nenormalne celice in obstoječe bolnikove krvotvorne matične celice.
English: The main measures of effectiveness were the number of patients with myeloablation and ‘engraftment' (the time for the transplanted stem cells to begin growing and for white blood cells to return to higher levels).
Slovenian: Glavni merili učinkovitosti sta bili število bolnikov z mieloablacijo in „prijetje presadka“ (čas, potreben za začetek rasti presajenih matičnih celic in povečanje števila belih krvnih telesc v obtoku).
English: The active substance in Busilvex, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Slovenian: Zdravilna učinkovina zdravila Busilvex, busulfan, spada v skupino zdravil, ki jih imenujemo „alkilirajoči citostatiki“.
English: Busilvex is used in adults and children as part of a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Slovenian: Zdravilo Busilvex se uporablja pri odraslih in otrocih kot del pripravljalnega zdravljenja pred presaditvijo krvotvornih matičnih celic (celic, ki tvorijo krvne celice).
English: Cyclophosphamide, melphalan or fludarabine are used to suppress the immune system, so that the body's natural defences are decreased.
Slovenian: Nato se za zaviranje delovanja imunskega sistema uporabi ciklofosfamid, melfalan ali fludarabin, s čimer se zmanjša naravna obramba telesa.
English: Busilvex should be used by a doctor who has experience in treatments given before transplantation.
Slovenian: Zdravilo Busilvex lahko uporablja samo zdravnik z izkušnjami z zdravljenjem, ki mu sledi presaditev.
English: For the full list of all side effects and restrictions with Busilvex, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Busilvex glejte navodilo za uporabo.
English: What is the risk associated with Busilvex?
Slovenian: Kakšna tveganja so povezana z zdravilom Busilvex?
English: When Busilvex was given in combination with cyclophosphamide or melphalan, all adults and children achieved myeloablation.
Slovenian: Kadar se je zdravilo Busilvex uporabljalo v kombinaciji s ciklofosfamidom ali melfalanom, so vsi odrasli in otroci dosegli mieloablacijo.
English: Busilvex in combination with cyclophosphamide or melphalan has been studied in patients, mainly with blood cancer, who needed transplantation of haematopoietic progenitor cells.
Slovenian: Zdravilo Busilvex v kombinaciji s ciklofosfamidom ali melfalanom je bilo raziskano večinoma pri bolnikih s krvnim rakom, ki so potrebovali presaditev krvotvornih matičnih celic.
English: Why has Busilvex been approved?
Slovenian: Zakaj je bilo zdravilo Busilvex odobreno?
English: When used in combination with cyclophosphamide or melphalan the recommended dose of Busilvex in adults is 0.8 mg per kilogram body weight.
Slovenian: Kadar se zdravilo Busilvex uporablja v kombinaciji s ciklofosfamidom ali melfalanom, znaša njegov priporočeni odmerek pri odraslih 0,8 mg na kilogram telesne mase.
English: The CHMP concluded that the effectiveness of Busilvex in combination with cyclophosphamide and melphalan for conventional conditioning, and with fludarabine for reduced-intensity conditioning had been shown; Busilvex also provides an alternative to busulfan tablets, which have disadvantages such as the large number of tablets that need to be taken.
Slovenian: CHMP je zaključil, da je bila učinkovitost zdravila Busilvex v kombinaciji s ciklofosfamidom in melfalanom pri konvencionalnem pripravljalnem zdravljenju in v kombinaciji s fludarabinom pri pripravljalnem zdravljenju z zmanjšano jakostjo dokazana in da se lahko zdravilo uporabi kot nadomestilo busulfana v tabletah, katerega pomanjkljivost je veliko število tablet, ki jih je treba zaužiti.
English: For a conventional conditioning treatment, Busilvex is given before treatment with a second medicine, cyclophosphamide, in adults, and either cyclophosphamide or an alternative medicine, melphalan, in children.
Slovenian: V okviru konvencionalnega pripravljalnega zdravljenja se zdravilo Busilvex uporabi pred začetkom zdravljenja z drugim zdravilom, in sicer pri odraslih pred ciklofosfamidom, pri otrocih pa bodisi pred ciklofosfamidom bodisi nadomestnim zdravilom, melfalanom.
English: Breast-feeding should be stopped when treatment with Busilvex is started.
Slovenian: Ženske, ki dojijo, morajo ob začetku zdravljenja z zdravilom Busilvex prenehati dojiti.
English: Busilvex is a concentrate to be made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Busilvex je koncentrat za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: On average, engraftment was reached in 10 days in adults and 11 days in children with ‘autotransplantation' (when the patient receives their own cells, harvested and stored before the transplant).
Slovenian: V primeru „avtotransplantacije“ (ko bolnik prejme svoje lastne celice, ki so bile odvzete in shranjene pred presaditvijo) je bilo prijetje v povprečju doseženo v 10 dneh pri odraslih oziroma 11 dneh pri otrocih.
English: How has Busilvex been studied?
Slovenian: Kako je bilo zdravilo Busilvex raziskano?
English: What is Busilvex?
Slovenian: Kaj je zdravilo Busilvex?
English: Engraftment was obtained in 13 days in adults and 21 days in children with ‘allotransplantation' (when the patient receives cells from a donor).
Slovenian: V primeru „alotransplantacije“ (ko bolnik prejme celice darovalca) je bilo prijetje v povprečju doseženo v 13 dneh pri odraslih oziroma 21 dneh pri otrocih.
English: How is Busilvex used?
Slovenian: Kako se zdravilo Busilvex uporablja?
English: How does Busilvex work?
Slovenian: Kako zdravilo Busilvex deluje?
English: What is Busilvex used for?
Slovenian: Za kaj se zdravilo Busilvex uporablja?
English: The recommended dose is one tablet daily.
Slovenian: Priporočeni odmerek je ena tableta na dan.
English: Further information on Pifeltro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pifeltro.
Slovenian: Nadaljnje informacije o zdravilu Pifeltro so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/pifeltro.
English: Pifeltro (doravirine)
Slovenian: Pifeltro (doravirin)
English: The European Medicines Agency therefore decided that Pifeltro's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Pifeltro večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Pifeltro?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pifeltro?
English: Pifeltro must not be used with certain medicines that may reduce its effectiveness.
Slovenian: Zdravilo Pifeltro se ne sme jemati skupaj z določenimi zdravili, ki lahko zmanjšajo njegovo učinkovitost.
English: What are the risks associated with Pifeltro?
Slovenian: Kakšna tveganja so povezana z zdravilom Pifeltro?
English: Other information about Pifeltro
Slovenian: Druge informacije o zdravilu Pifeltro
English: As for all medicines, data on the use of Pifeltro are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Pifeltro stalno spremljajo.
English: In addition, Pifeltro's side effects are mostly mild.
Slovenian: Poleg tega so neželeni učinki zdravila Pifeltro večinoma blagi.
English: Pifeltro (doravirine) EMA/821744/2018
Slovenian: Pifeltro (doravirin) EMA/661893/2018
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pifeltro have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pifeltro upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Pifeltro are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Pifeltro, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Pifeltro, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Pifeltro glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Pifeltro is available as tablets (100 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Pifeltro je na voljo v obliki tablet (100 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: Why is Pifeltro authorised in the EU?
Slovenian: Zakaj je zdravilo Pifeltro odobreno v EU?
English: An overview of Pifeltro and why it is authorised in the EU
Slovenian: Pregled zdravila Pifeltro in zakaj je odobreno v EU
English: Pifeltro helps keep the amount of HIV in the blood at a low level.
Slovenian: Zdravilo Pifeltro pomaga ohranjati nizko raven virusa HIV v krvi.
English: What benefits of Pifeltro have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Pifeltro izkazalo v študijah?
English: What is Pifeltro and what is it used for?
Slovenian: Kaj je zdravilo Pifeltro in za kaj se uporablja?
English: Pifeltro is an antiviral medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Pifeltro je protivirusno zdravilo za zdravljenje odraslih, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: The most common side effects with Pifeltro (which may affect up to 1 in 10 people) are nausea (feeling sick) and headache.
Slovenian: Najpogostejši neželeni učinki zdravila Pifeltro (ki se lahko pojavijo pri največ 1 osebi od 10) so navzeja (slabost) in glavobol.
English: It does not cure HIV infection or AIDS but, when used in combination with other antivirals, it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa v kombinaciji z drugimi protivirusnimi zdravili upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: Doravirine blocks the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Slovenian: Doravirin zavira dejavnost reverzne transkriptaze, tj. encima, ki virusu HIV omogoča razmnoževanje v okuženih celicah.
English: In a second study with 728 patients, 84% of patients treated with Pifeltro in combination with tenofovir disoproxil and lamivudine had undetectable HIV levels by 48 weeks compared with 80% of patients given a combination of efavirenz, tenofovir disoproxil and emtricitabine.
Slovenian: V drugi študiji, v kateri je sodelovalo 728 bolnikov, je 84 % bolnikov, ki so prejemali zdravilo Pifeltro v kombinaciji s dizoproksiltenofoviratom in lamivudinom, po 48 tednih zdravljenja imelo nezaznavno raven virusov HIV v krvi v primerjavi z 80 % tistih, ki so prejemali kombinacijo efavirenza, dizoproksiltenofovirata in emtricitabina.
English: The active substance in Pifeltro, doravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Slovenian: Učinkovina zdravila Pifeltro, doravirin, je nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
English: For the full list of side effects and restrictions with Pifeltro, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Pifeltro glejte navodilo za uporabo.
English: In a study of 766 patients, 83% of patients taking Pifeltro (together with either emtricitabine and tenofovir disoproxil or abacavir and lamivudine) had undetectable levels of HIV in their blood (fewer than 40 copies/ml) after 48 weeks of treatment.
Slovenian: V študiji, v kateri je sodelovalo 766 bolnikov, je 83 % tistih, ki so prejemali zdravilo Pifeltro (v kombinaciji z emtricitabinom in dizoproksiltenofoviratom ali abakavirjem in lamivudinom), po 48 tednih zdravljenja imelo nezaznavno raven virusov HIV v krvi (manj kot 40 kopij/ml).
English: The medicine is not suitable for patients who are infected with HIV that is resistant to medicines in the same class as Pifeltro (non-nucleoside reverse transcriptase inhibitors or NNRTIs).
Slovenian: Zdravilo Pifeltro ni primerno za bolnike, okužene z virusom HIV, ki je odporen na zdravila iz istega razreda kot zdravilo Pifeltro (nenukleozidni zaviralci reverzne transkriptaze, NNRTI) Zdravilo Pifeltro vsebuje učinkovino doravirin.
English: Studies showed that Pifeltro taken with other antivirals was as effective at keeping HIV infection under control as standard HIV combination treatments.
Slovenian: Študije so pokazale, da je zdravilo Pifeltro v kombinaciji z drugimi protivirusnimi zdravili enako učinkovito pri nadzorovanju okužbe z virusom HIV kot standardna kombinirana zdravljenja.
English: How is Pifeltro used?
Slovenian: Kako se zdravilo Pifeltro uporablja?
English: How does Pifeltro work?
Slovenian: Kako zdravilo Pifeltro deluje?
English: Pifeltro is used together with other antiviral medicines.
Slovenian: Uporablja se v kombinaciji z drugimi protivirusnimi zdravili.
English: This compares with 79% of patients taking standard combination of darunavir plus ritonavir (together with either emtricitabine and tenofovir disoproxil or abacavir and lamivudine).
Slovenian: V primerjavi s tem je bilo v skupini bolnikov, ki so jemali standardno kombinacijo darunavirja in ritonavirja (skupaj bodisi z emtricitabinom in dizoproksiltenofoviratom bodisi abakavirjem in lamivudinom), 79 % takšnih bolnikov.
English: Pifeltro used in combination with other antivirals is as effective as standard HIV combination treatments at keeping HIV infection under control.
Slovenian: Zdravilo Pifeltro je v kombinaciji z drugimi protivirusnimi zdravili enako učinkovito pri nadzorovanju okužbe z virusom HIV kot standardna kombinirana zdravljenja okužbe z virusom HIV.
English: 1ml (200 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Slovenian: 1 mL (200mg/ml) 12 (3 X 4) napolnjenih injekcijskih peresnikov (skupno pakiranje)
English: 1ml (200 mg/ml) 4 pre-filled syringes
Slovenian: 1 mL (200mg/ml) 4 napolnjeni injekcijski peresniki
English: 1ml (200 mg/ml) 1 pre-filled syringe
Slovenian: 1 mL (200mg/ml) 1 napolnjena injekcijska brizga
English: 1ml (200 mg/ml) 1 pre-filled pen
Slovenian: 1 mL (200mg/ml) 1 napolnjen injekcijski peresnik
English: The European Commission granted a marketing authorisation valid throughout the European Union for Avastin on 12 January 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Avastin, veljavno po vsej Evropski uniji, izdala 12. januarja 2005.
English: What measures are being taken to ensure the safe and effective use of Avastin?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Avastin?