FrancophonIA/ELRC3.0 huggingface dataset:
English: General disorders and administration site conditions Very common: fatigue, pain and redness at the injection site Common: fever, swelling at the injection site
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti: utrujenost, bolečina in pordelost na mestu injiciranja.
English: Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
Slovenian: Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44
English: Immune system disorders Allergic reactions including anaphylactic and anaphylactoid reactions
Slovenian: Alergijske reakcije, vključno z anafilaktično in anafilaktoidno reakcijo.
English: Skin and subcutaneous tissue disorders Rare: pruritus, rash
Slovenian: Bolezni kože in podkožja Redki: srbenje, izpuščaj.
English: Side effects that occurred during routine use of Ambirix were as follows:
Slovenian: Med rutinsko uporabo cepiva Ambirix so se pojavili naslednji neželeni učinki:
English: Infections and infestations Uncommon: upper respiratory tract infection
Slovenian: Občasni: okužba zgornjih dihal.
English: In addition, the following adverse reactions were reported during clinical trials with GlaxoSmithKline's other combined hepatitis A and hepatitis B vaccines (given as a 3 or 4 dose schedule)
Slovenian: Poleg tega so bile med kliničnimi preskušanji drugih kombiniranih cepiv družbe GlaxoSmithKline proti hepatitisu A in hepatitisu B (uporabljenih v 3 ali 4 odmerkih) opisani naslednji neželeni učinki.
English: The following adverse reactions were reported during clinical trials with Ambirix.
Slovenian: Naslednji neželeni učinki so se pojavili pri kliničnih preskušanjih s cepivom Ambirix:
English: How to store Ambirix
Slovenian: Shranjevanje cepiva Ambirix
English: month schedules were 84.8% and 92.9%, respectively.
Slovenian: 92,9 % pri drugih.
English: • swollen glands in the neck, armpit or groin (lymphadenopathy)
Slovenian: • otekle bezgavke na vratu, v pazduhah ali dimljah (limfadenopatija),
English: If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
Slovenian: V primeru potrebe po hitri zaščiti pred hepatitisom B je priporočljiva standardna shema treh odmerkov kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B. V vmesnem obdobju med prejemom drugega in tretjega odmerka kombiniranega cepiva bo tako zaščiten večji odstotek oseb, kot je po enem samem odmerku cepiva Ambirix.
English: GlaxoSmithKline Eesti OÜ Tel: +372 667 6900 estonia@gsk.com
Slovenian: GlaxoSmithKline Eesti OÜ Tel: +372 667 6900
English: United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441 customercontactuk@gsk.com
Slovenian: United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441
English: In a comparative clinical trial conducted among subjects aged from 12 years up to and including 15 years of age, 142 received two doses of Ambirix and 147 received the standard three-dose combined vaccine.
Slovenian: 15 let, jih je 142 prejelo dva odmerka cepiva Ambirix, 147 pa jih je prejelo standardno cepivo s tremi odmerki.
English: Ambirix is indicated in non-immune children and adolescents from 1 year up to and including 15 years of age for protection against hepatitis A and hepatitis B infection.
Slovenian: Cepivo Ambirix je indicirano za zaščito pred okužbo z virusom hepatitisa A in okužbo z virusom hepatitisa B pri neimuniziranih otrocih in mladostnikih od 1 do vključno 15 let starosti.
English: When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1).
Slovenian: oslovskemu kašlju - acelularno, otroški ohromelosti - inaktivirano in Haemophilusu influenzae tipa b (DTPa-IPV+Hib) ali mešanega cepiva proti ošpicam, mumpsu in rdečkam v drugem letu življenja, je bil imunski odziv na vse antigene zadovoljiv (glejte poglavje 5.1).
English: GlaxoSmithKline, S.A. Tel: + 34 902 202 700 es-ci@gsk.com
Slovenian: GlaxoSmithKline, S.A. Tel: + 34 902 202 700
English: Ambirix should not be given if any of the above apply.
Slovenian: S cepivom Ambirix se ne smete cepiti, če velja karkoli od zgoraj naštetega.
English: Skin and subcutaneous tissue disorders Erythema multiforme, lichen planus
Slovenian: Multiformni eritem, lichen planus.
English: 2D barcode carrying the unique identifier included.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznak 18.
English: HAB vaccine
Slovenian: Žilne bolezni
English: For the 289 subjects evaluable for immunogenicity, seroprotection rates (SP in the table below) against hepatitis B were significantly higher at months 2 and 6 with the three-dose vaccine than with Ambirix.
Slovenian: Slednje je vsebovalo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B. Pri 289 osebah, pri katerih je bila ovrednotena imunogenost, je bil v 2. in 6. mesecu odstotek serozaščite (SP v spodnji tabeli) proti hepatitisu B signifikantno višji po cepljenju s tremi odmerki cepiva kot pa po cepljenju s cepivom Ambirix.
English: Very common (These may occur with more than 1 in 10 doses of the vaccine) :
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 odmerkov cepiva):
English: • fits or seizures
Slovenian: Bolezni kože in podkožja
English: GlaxoSmithKline AS Tlf: + 47 22 70 20 00 firmapost@gsk.no
Slovenian: Tlf: + 47 22 70 20 00 firmapost@gsk.no
English: • numbness or weakness of the arms and legs (neuropathy)
Slovenian: • omrtvičenost ali šibkost rok in nog (nevropatija),
English: Musculoskeletal and connective tissue disorders Arthritis, muscular weakness
Slovenian: Artritis, mišična šibkost.
English: GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
Slovenian: GlaxoSmithKline Latvia SIA Tel: + 371 67312687
English: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30 Finland.tuoteinfo@gsk.com
Slovenian: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30
English: • Clinical trial data
Slovenian: • Podatki iz kliničnih preskušanj
English: General disorders and administration site conditions Immediate injection site pain, stinging and burning sensation
Slovenian: Splošne težave in spremembe na mestu aplikacije Takojšnja bolečina na mestu vboda, občutek zbadanja in pekoč občutek.
English: Blood and lymphatic system disorders Rare: lymphadenopathy
Slovenian: Bolezni krvi in limfatičnega sistema
English: Vaccine group
Slovenian: Skupina glede na cepljenje
English: Hepatitis A virus (inactivated)1,2
Slovenian: 1 odmerek (1 ml): Virus hepatitisa A (inaktivirani)1,2
English: No data on concomitant administration of Ambirix with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatki o sočasnem dajanju cepiva Ambirix in specifičnih imunoglobulinov proti hepatitisu A ali imunoglobulinov proti hepatitisu B niso bili pridobljeni.
English: Contents of the pack and other information
Slovenian: Shranjevanje cepiva Ambirix Vsebina pakiranja in dodatne informacije
English: It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
Slovenian: Možno je, da so osebe v času cepljenja že v inkubacijskem obdobju okužbe s hepatitisom A ali hepatitisom B. Ni znano, če v takšnih primerih cepivo Ambirix preprečuje hepatitis A in hepatitis B.
English: Cases of overdose with GlaxoSmithKline's combined hepatitis A and hepatitis B vaccine have been reported during post-marketing surveillance.
Slovenian: Med obdobjem postmarketinškega spremljanja so bili opisani primeri prevelikega odmerjanja kombiniranega cepiva proti hepatitisu A in hepatitisu B družbe GlaxoSmithKline.
English: Hepatobiliary disorders Abnormal liver function tests
Slovenian: Nenormalni testi jetrne funkcije.
English: • abnormal test results relating to the liver
Slovenian: • nenormalni izvidi preiskav jeter,
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe 1 pre-filled syringe
Slovenian: Suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (1 ml)
English: Additional side effects that occurred during routine use of very similar combined or individual hepatitis A and hepatitis B vaccines were as follows:
Slovenian: Med rutinsko uporabo zelo podobnih kombiniranih ali enokomponentnih cepiv proti hepatitisu A in hepatitisu B so poročali o naslednjih dodatnih neželenih učinkih:
English: • aching muscles (myalgia)
Slovenian: • okužba zgornjih dihal, • boleče mišice (mialgija).
English: Your doctor will run blood tests to see whether more injections are needed to help you be better protected.
Slovenian: To pomeni, da morda ne boste zaščiteni proti enemu ali obema virusoma hepatitisa A in B. Vaš zdravnik bo izvedel krvne preiskave, da bi ugotovil, ali so potrebne dodatne injekcije, ki bi pomagale, da bi bili bolje zaščiteni.
English: Additional side effects that have been reported during clinical trials with very similar combined hepatitis A and hepatitis B vaccines, include:
Slovenian: Med kliničnimi preskušanji z zelo podobnimi kombiniranimi cepivi proti hepatitisu A in hepatitisu B so poročali o naslednjih dodatnih neželenih učinkih:
English: Missing a dose
Slovenian: Izpuščeni odmerek
English: • If you/your child gets any side effects, talk to your doctor, nurse or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: How much is given
Slovenian: Koliko cepiva se uporabi
English: • Ambirix may not protect you from being ill if you have already caught the hepatitis A or B virus.
Slovenian: • Cepivo Ambirix vas morda ne bo zaščitilo pred boleznijo, če ste se že okužili z virusom hepatitisa A ali B. • Cepivo Ambirix vas lahko pomaga zaščititi le pred okužbo z virusom hepatitisa A ali B, ne more pa preprečiti drugih okužb jeter, čeprav so lahko znaki teh okužb podobni tistim pri okužbi z virusom hepatitisa A ali B.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije
English: Tel: + 43 1 970 75-0 at.info@gsk.com
Slovenian: Tel. +370 5 264 90 00 info.lt@gsk.com
English: 1330 Rixensart
Slovenian: 1330 Rixensart Belgija
English: NAME OF THE MEDICINAL PRODUCT Ambirix - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Slovenian: Ambirix - suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
English: Protection against hepatitis B infections may not be obtained until after the second dose (see section Therefore: - Ambirix should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course.
Slovenian: - Ambirix se lahko uporablja le, če je tveganje za okužbo z virusom hepatitisa B med potekom cepljenja relativno majhno.
English: General disorders and administration site conditions Common: malaise, injection site reaction Rare: chills, influenza like illness
Slovenian: Splošne težave in spremembe na mestu aplikacije Pogosti: splošno slabo počutje, reakcija na mestu injiciranja.
English: The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines.
Slovenian: Po zaključku osnovnega cepljenja s cepivom Ambirix so doseženi titri protiteles proti površinskemu antigenu virusa hepatitisa B (anti-HBs) in proti virusu hepatitisa A (anti-HAV) primerljivi s tistimi, ki se jih doseže po cepljenju z monovalentnimi cepivi proti hepatitisu A in hepatitisu B. Splošne smernice za obnovitveno cepljenje se torej lahko povzamejo iz izkušenj z monovalentnimi cepivi, kot sledi:
English: Metabolism and nutrition disorders
Slovenian: Infekcijske in parazitske bolezni
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 August 2002
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects vaccinated at the 0, 6 and 0, 12
Slovenian: Delež protiteles anti-HBs ≥10 mi.e./ml je bil pri osebah, cepljenih po shemi 0., 6. mesec ali 0., 12. mesec, ob tem času 84,8 % pri prvih in
English: 50 x 1 dose (1 ml)
Slovenian: 50 napolnjenih injekcijskih brizg 50 x 1 odmerek (1 ml)
English: • joint pain (arthralgia)
Slovenian: • mravljinčenje (parestezija),
English: • itching (pruritus), rash
Slovenian: • koprivnica (urtikarija).
English: NAME OF THE MEDICINAL PRODUCT Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Slovenian: Ambirix suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
English: GlaxoSmithKline s.r.o.
Slovenian: GlaxoSmithKline S.p.A.
English: • feeling drowsy
Slovenian: • omedlevica,
English: Very rare (These may occur with up to 1 in 10,000 doses of the vaccine): • hives (urticaria)
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 odmerkov cepiva): • zvišana telesna temperatura,
English: However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Slovenian: Ker pri osebah s trombocitopenijo ali z motnjami hemostaze obstaja nevarnost krvavitve po intramuskularnem dajanju, se takšnim osebam cepivo Ambirix lahko izjemoma daje subkutano.
English: Tel: + 49 (0)89 360448701 produkt.info@gsk.com
Slovenian: KG Tel: + 49 (0)89 360448701
English: GlaxoSmithKline Kft. Tel.: + 36-1-2255300
Slovenian: Tel.: + 36-1-2255300
English: Rare (These may occur with up to 1 in 1,000 doses of the vaccine) :
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10,000 odmerkov cepiva):
English: - Booster dose
Slovenian: - Obnovitveni odmerek
English: However some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
Slovenian: Pri zdravih posameznikih, ki so bili popolno osnovno cepljeni, ni bila dokazana potreba po obnovitvenem odmerku cepiva proti hepatitisu B. Nekateri uradni programi cepljenja kljub temu priporočajo obnovitveni odmerek cepiva proti hepatitisu B in jih je treba upoštevati.
English: It is used to prevent two diseases: hepatitis A and hepatitis B.
Slovenian: Cepivo Ambirix se uporablja pri od 1 do vključno 15 let starih dojenčkih, otrocih in mladostnikih za preprečevanje dveh bolezni: hepatitisa A in hepatitisa B.
English: • you need to be fully protected against hepatitis A and B infection within the next 6 monthsyour doctor may recommend a different vaccine
Slovenian: če: • morate biti popolnoma zaščiteni pred okužbo z virusom hepatitisa A in B v naslednjih
English: Anti-HBs Month 2 SP (%)
Slovenian: Anti-HBs 2. mesec
English: Uncommon (These may occur with up to 1 in 100 doses of the vaccine) :
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 odmerkov cepiva):
English: How the injection is given
Slovenian: NAPOLNJENA INJEKCIJSKA BRIZGA
English: Common (These may occur with up to 1 in 10 doses of the vaccine) :
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 odmerkov cepiva):
English: Anti-HBs Month 7 SP (%)
Slovenian: Anti-HBs 7. mesec
English: The standard primary course of vaccination consists of two doses, the first administered at the elected date and the second between 6 and 12 months after the first dose.
Slovenian: Standardno osnovno cepljenje je sestavljeno iz dveh odmerkov.
English: However, this route of administration may result in suboptimal immune response to the vaccine.
Slovenian: Pri bolnikih s trombocitopenijo ali z motnjami hemostaze se lahko cepivo izjemoma aplicira subkutano, vendar je lahko posledica takšnega načina dajanja suboptimalen imunski odziv na cepivo
English: PHARMACOLOGICAL PROPERTIES
Slovenian: FARMACEVTSKA OBLIKA
English: Anti-HBs Month 6 SP (%)
Slovenian: Anti-HBs 6. mesec
English: GlaxoSmithKline S.p.A. Tel: + 39 04 59 21 81 11
Slovenian: GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100
English: This includes medicines obtained without a prescription and herbal medicines.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: Nederland GlaxoSmithKline BV
Slovenian: Norge GlaxoSmithKline AS
English: Seropositivity rates for anti-HAV were 99.0% and seropositivity rates for anti-HBs were 99.0% at month 13 with seroprotection rates of 97.0%.
Slovenian: V klinični študiji s 102 osebama, ki so bile stare od 12 do vključno 15 let in so prejele drugi odmerek cepiva Ambirix 12 mesecev po danem prvem odmerku, je bil v 13. mesecu odstotek seropozitivnosti za anti-HAV in za anti-HBs 99,0 %, odstotek serozaščite pa 97,0 %.
English: Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Slovenian: Tel: + 421 (0)2 48 26 11 11
English: Vascular disorders Rare: hypotension
Slovenian: Redki: hipotenzija Bolezni prebavil Pogosti: driska, navzea.
English: The anti-HBs seroprotection rates (titers ≥ 10 mlU/ml) at these time points were 37.4% and 98.2% respectively.
Slovenian: Odstotek serozaščite s protitelesi anti-HBs (titer ≥ 10 i.e./l) je bil en mesec po prejemu prvega odmerka 37,4 %, po prejemu drugega odmerka čez 6 mesecev pa 98,2 %.
English: • fever
Slovenian: • bruhanje,
English: However, others can become very ill.
Slovenian: Večina odraslih popolnoma ozdravi.
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE
English: • stomach and digestive problems
Slovenian: • občutek omotičnosti, • težave z želodcem in s prebavo,
English: Gastrointestinal disorders Common: diarrhoea, nausea Uncommon: vomiting, abdominal pain*
Slovenian: Občasni: bruhanje, bolečine v trebuhu*.
English: • diarrhoea, feeling sick (nausea)
Slovenian: • driska, občutek slabosti (navzea), • reakcija na mestu injiciranja.
English: At 10 years following the initiation of a 0, 6 month schedule of Ambirix in children aged 1-15 years,
Slovenian: 10 let po cepljenju otrok, starih od 1 do 15 let, s cepivom Ambirix po shemi 0., 6. mesec so vse osebe ohranile ≥15 mi.e./ml protiteles anti-HAV.
English: Irinotecan has been authorised in the EU for a number of years for the treatment of colorectal cancer.
Slovenian: V EU je irinotekan že več let odobren za zdravljenje kolorektalnega raka.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.
Slovenian: Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal mnenje in dne 9. novembra 2017 potrdil zavrnitev vloge za dovoljenje za promet.
English: The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned.
Slovenian: Družba je odbor CHMP obvestila, da bodo bolniki, ki prejemajo to zdravilo v kliničnih študijah, zdravljenje še naprej prejemali, kot je bilo načrtovano.
English: The Committee considered that the data from this subgroup, which were not supported by additional studies, were not sufficient to prove the effectiveness of Onzeald, even when analysed by different methods.
Slovenian: Odbor je menil, da podatki iz te podskupine, ki niso bili podprti z dodatnimi študijami, niso zadostovali za dokazovanje učinkovitosti zdravila Onzeald, tudi če so bili analizirani z različnimi metodami.
English: In this study, Onzeald was compared with standard cancer medicines chosen by the treating doctor, and the main measure of effectiveness was overall survival (how long the patients lived).
Slovenian: Zdravljenje z zdravilom Onzeald so primerjali s standardnim zdravilom za zdravljenje raka, ki ga je izbral lečeči zdravnik, glavno merilo učinkovitosti pa je bilo celokupno preživetje (kako dolgo so bolniki živeli).
English: The claim of effectiveness relied on data from a subgroup of patients from a main study which, overall, failed to convincingly show the effectiveness of Onzeald.
Slovenian: Trditev o učinkovitosti se je opirala na podatke podskupine bolnikov iz glavne študije, ki na splošno niso uspeli prepričljivo dokazati učinkovitosti zdravila Onzeald.
English: The company presented the results of one main study involving 852 patients with breast cancer that had spread to other parts of the body who had been treated with at least 2 other cancer medicines.
Slovenian: Družba je predstavila rezultate ene glavne študije, v katero je bilo vključenih 852 bolnikov z rakom dojke, pri katerih se je rak razširil v druge dele telesa in so bili zdravljeni z vsaj dvema drugima zdraviloma za zdravljenje raka.
English: Refusal of the marketing authorisation for Onzeald (etirinotecan pegol) EMA/736863/2017
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Onzeald (etirinotekanpegol) EMA/736863/2017
English: On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Onzeald, intended for the treatment of advanced breast cancer that has spread to the brain.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 20. julija 2017 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Onzeald, namenjenim zdravljenju napredovalega raka dojke, ki se je razširil v možgane.
English: How does Onzeald work?
Slovenian: Kako zdravilo Onzeald deluje?
English: The CHMP refusal was confirmed after re-examination.
Slovenian: Zavrnitev odbora CHMP glede izdaje dovoljenja za promet je bila po ponovnem pregledu potrjena.
English: What was Onzeald expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Onzeald uporabljalo?
English: Because it is pegylated in etirinotecan pegol, the medicine is removed from the body at a slower rate, allowing the medicine to be given less often.
Slovenian: Ker je pegiliran v učinkovini etirinotekanpegol, je izločanje zdravila iz telesa upočasnjeno, zaradi česar se lahko daje manj pogosto.
English: Therefore, the CHMP was of the opinion that the study did not provide enough evidence on the benefits of Onzeald and recommended that the marketing authorisation be refused.
Slovenian: Zato je menil, da študija ni zagotovila dovolj dokazov o koristih zdravila Onzeald, in priporočil, da se dovoljenje za promet z zdravilom zavrne.
English: What is Onzeald?
Slovenian: Kaj je zdravilo Onzeald?
English: It was to be available as a powder to be made into a solution for infusion (drip) into a vein.
Slovenian: Na voljo naj bi bilo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The active substance in Onzeald, etirinotecan pegol, consists of irinotecan (a cancer medicine that belongs to the group ‘topoisomerase inhibitors') that has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: Zdravilna učinkovina v zdravilu Onzeald, etirinotekanpegol, je irinotekan (zdravilo za zdravljenje raka, ki spada v skupino „zaviralcev topoizomeraze“), ki je „pegiliran“ (vezan na spojino, imenovano polietilenglikol).
English: Irinotecan blocks topoisomerase I, an enzyme that is involved in copying cell DNA, which is needed to make new cells.
Slovenian: Irinotekan zavira encim, imenovan topoizomeraza I, ki sodeluje pri podvajanju celične DNK, ki je potrebna za nastanek novih celic.