natgillin/translations-raw huggingface dataset:
Vorinostat MSD was to be used in patients whose cancer was progressive (getting worse), persistent (not responding to treatment) or recurrent (kept on coming back), and had not responded to at least two other systemic (whole-body) treatments.
Zdravilo Vorinostat MSD naj bi se uporabljalo pri bolnikih, katerih rak je napredovalen (se slabša), trdovraten (se ne odziva na zdravljenje) ali ponavljajoč ter se ni odzval na najmanj dve drugi sistemski (celostni) zdravljenji.
Because Vorinostat MSD was not compared with any other treatment, its safety and effectiveness could not be adequately assessed.
Ker zdravilo Vorinostat MSD niso primerjali z nobenim drugim zdravljenjem, njegove varnosti in učinkovitosti ni mogoče ustrezno oceniti.
Vorinostat MSD was designated as an orphan medicinal product on 21 June 2004.
Zdravilo Vorinostat MSD je bilo 21. junija 2004 določeno kot zdravilo sirota.
CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin.
CTCL je redka oblika limfoma (raka limfnega tkiva), pri katerem nekatere bele krvne celice (T celice) rastejo v koži.
Based on the review of the initial documentation, the Committee prepares a list of questions at day 120, which is sent to the company.
Na podlagi pregleda začetne dokumentacije CHMP pripravi seznam vprašanj (120. dan), ki ga pošlje družbi.
The effects of Vorinostat MSD were first tested in experimental models before being studied in humans.
Učinki zdravila Vorinostat MSD so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Once the company has supplied responses to the questions, the Committee reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Ko družba predloži odgovore na vprašanja, jih CHMP pregleda in lahko pred izdajo svojega mnenja na 180. dan postopka zastavi morebitna druga vprašanja.
In particular, the CHMP was concerned about the risk of thromboembolic events (problems caused by the formation of clots in the blood vessels) in patients taking Vorinostat MSD.
CHMP je bil zlasti zaskrbljen glede tveganja za tromboembolične dogodke (težave, ki jih povzroči tvorjenje strdkov v krvnih žilah) pri bolnikih, ki so jemali zdravilo Vorinostat MSD.
Questions and answers on the withdrawal of the marketing application for Vorinostat MSD
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Vorinostat MSD
The company presented the results of one main study in which 74 adults with advanced CTCL were given Vorinostat MSD.
Družba je predstavila rezultate ene glavne študije, pri katerih je 74 odraslih z napredovalnim kožnim T-celičnim limfomom prejelo zdravilo Vorinostat MSD.
On 13 February 2009 Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vorinostat MSD, for the treatment of adults with advanced cutaneous T-cell lymphoma.
Družba Merck Sharp & Dohme Limited je dne 13. februarja 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Vorinostat MSD, namenjenim za zdravljenje odraslih z napredovalnim kožnim T-celičnim limfomom.
Vorinostat MSD was not compared with any other treatment.
Zdravila Vorinostat MSD niso primerjali z nobenim drugim zdravljenjem.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the Committee had some concerns and was of the provisional opinion that Vorinostat MSD could not have been approved for the treatment of advanced CTCL.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Vorinostat MSD ni mogoče odobriti za zdravljenje napredovalnega kožnega T-celičnega limfoma.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Vorinostat MSD?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Vorinostat MSD?
Vorinostat MSD is a medicine that contains the active substance vorinostat.
Vorinostat MSD je zdravilo, ki vsebuje zdravilno učinkovino vorinostat.
The active substance in Vorinostat MSD, vorinostat, blocks the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Zdravilna učinkovina v zdravilu Vorinostat MSD, vorinostat, zavira delovanje beljakovin, imenovanih histonske deacetilaze, ki so vključene v proces aktiviranja in deaktiviranja genov v celicah.
The company informed the CHMP that there are no consequences on patients currently included in clinical trials, compassionate use programmes or named patient programmes with Vorinostat MSD.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Vorinostat MSD oziroma programih s posamezno imenovanimi bolniki.
Therefore, at the time of the withdrawal, the Committee's view was that a benefit of Vorinostat MSD had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da koristi zdravila Vorinostat MSD niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
What is Vorinostat MSD?
Kaj je zdravilo Vorinostat MSD?
Vorinostat MSD was expected to be used to treat adults with advanced cutaneous T-cell lymphoma (CTCL).
Zdravilo Vorinostat MSD naj bi se uporabljalo za zdravljenje odraslih z napredovalnim kožnim Tceličnim limfomom (CTCL).
In CTCL, Vorinostat MSD was expected to stop the genes that suppress the division and growth of the tumour cells from being turned off at the appropriate times.
Pri napredovalnem kožnem T-celičnem limfomu naj bi zdravilo Vorinostat MSD preprečilo genom, ki zavirajo delitev in rast tumornih celic, deaktiviranje v ustreznem času.
How is Vorinostat MSD expected to work?
Kako naj bi zdravilo Vorinostat MSD delovalo?
What was Vorinostat MSD expected to be used for?
Za kaj naj bi se zdravilo Vorinostat MSD uporabljalo?
This will help to protect against the diseases caused by these viruses.
To prispeva k obrambi pred boleznimi, ki jih ti virusi povzročajo.
The women were followed up for up to four years after the first dose of the vaccines.
Ženske so spremljali do štiri leta po prejemu prvega odmerka cepiva.
The antibodies help to destroy the virus.
Protitelesa pomagajo uničiti virus.
The European Commission granted a marketing authorisation valid throughout the European Union for Cervarix on 20 September 2007.
Evropska komisija je dovoljenje za promet s cepivom Cervarix, veljavno po vsej Evropski uniji, izdala 20. septembra 2007.
The vaccine is given as an injection into the shoulder muscle.
Cepivo se injicira v ramensko mišico.
The full EPAR for Cervarix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo Cervarix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
A similar study was carried out in girls aged 9 to 14 years of age.
Podobno študijo so izvedli pri deklicah, starih od 9 do 14 let.
However, the second and third doses can be given after longer gaps if necessary.
Drugi in tretji odmerek se lahko po potrebi prejmeta tudi v daljšem razmiku.
What measures are being taken to ensure the safe and effective use of Cervarix?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe cepiva
If necessary, the second dose can be given between 5 and 13 months after the first dose.
Po potrebi se lahko drugi odmerek da 5 do 13 mesecev po prvem.
It is recommended that individuals who receive the first dose of Cervarix should complete the course of vaccination.
Priporočeno je, da osebe, ki prejmejo prvi odmerek cepiva Cervarix, tudi dokončajo shemo cepljenja.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cervarix have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo cepiva Cervarix, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
This document is a summary of the European public assessment report (EPAR) for Cervarix.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za cepivo Cervarix.
For more information about treatment with Cervarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju s cepivom Cervarix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For the prevention of anal lesions and cancer, four studies were carried out.
Za preprečevanje lezij in raka na zadnjiku so bile izvedene štiri študije.
Cervarix is given according to official recommendations.
Cepivo Cervarix se daje v skladu z uradnimi priporočili.
The most common side effects with Cervarix (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection including pain, redness and swelling, and fatigue (tiredness).
Najpogostejši neželeni učinki cepiva Cervarix (opaženi pri več kot 1 bolniku od 10) so glavobol, mialgija (bolečine v mišicah), reakcije na mestu injiciranja, vključno z bolečino, pordelostjo in oteklino, ter utrujenost.
• cancer of the cervix (neck of the womb) or anus;
• rak cerviksa (materničnega vratu) ali anusa;
When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Ko bolnik prejme cepivo, začne imunski sistem tvoriti protitelesa proti beljakovinam L1.
The studies looking at the levels of antibodies in males showed that their levels were similar to those in females.
Študije, v katerih so proučili ravni protiteles pri moških, so pokazale, da so bile te podobne kot pri ženskah.
People aged 9 to 14 years can be given two doses, six months apart.
Osebe, stare med 9 in 14 let, lahko prejmejo dva odmerka v razmiku šestih mesecev.
There are more than 100 types of papillomavirus, some of which are associated with genital and anal cancers.
Obstaja več kot 100 genotipov virusov papiloma, od katerih nekatere povezujejo z rakom genitalnega in analnega predela.
The CHMP decided that Cervarix's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi cepiva Cervarix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Other information about Cervarix
Druge informacije o cepivu Cervarix
Cervarix was compared with another vaccine that is not active against HPV (in this case, a vaccine against hepatitis A virus).
Cepivo Cervarix so primerjali z drugim cepivom, ki ne učinkuje proti virusu HPV (v tem primeru je šlo za cepivo proti virusu hepatitisa A).
What benefit has Cervarix shown during the studies?
Kakšne koristi je cepivo Cervarix izkazalo med študijami?
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 Cervarix.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to cepivo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Cervarix is used in males and females from the age of 9 years to protect against the following conditions caused by certain types of the human papillomavirus (HPV):
Cepivo Cervarix se uporablja pri moških in ženskah, starejših od devet let, za zaščito pred naslednjimi vrstami obolenj, ki jih povzročajo posamezni tipi humanega papilomavirusa (HPV):
To support the use in boys and men, two other studies compared the development of protective antibodies in males versus females.
Da bi podprli uporabo cepiva pri dečkih in moških, so izvedli dve drugi študiji, v katerih so primerjali razvoj zaščitnih protiteles pri moških v primerjavi z ženskami.
It is a suspension for injection that contains purified proteins for two types of the human papillomavirus (types 16 and 18).
Gre za suspenzijo za injiciranje, ki vsebuje prečiščene beljakovine za dva genotipa humanih virusov papiloma (genotipa 16 in 18).
Cervarix is a vaccine.
Zdravilo Cervarix je cepivo.
Cervarix is given as two or three doses depending on age.
Cepivo Cervarix se glede na starost daje v dveh ali treh odmerkih.
Papillomaviruses are viruses that cause warts and abnormal tissue growth.
Virusi papiloma so virusi, ki povzročajo bradavice in nenormalno rast tkiva.
The vaccine is ‘adsorbed', which means that the virus-like particles and the MPL are fixed onto an aluminium compound, to stimulate a better immune response.
Cepivo je adsorbirano, kar pomeni, da so virusu podobni delci ter MPL vezani na aluminijevo spojino, kar spodbudi boljši imunski odziv.
HPV types 16 and 18 cause approximately 70% of cervical cancers and 90% of anal cancers.
Tipa 16 in 18 humanega papilomavirusa sta povzročitelja približno 70 % vseh primerov raka materničnega vratu in 90 % raka zadnjika.
People aged 15 and above are given three doses.
Osebe, starejše od 15 let, prejmejo tri odmerke.
Cervarix contains purified L1 proteins for HPV types 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by cells into which a gene (DNA) has been introduced that makes the cells able to produce the L1 proteins.
Cepivo Cervarix vsebuje prečiščene beljakovine L1 za tipa 16 in 18 humanega virusa papiloma, ki jih proizvajajo z metodo, znano kot tehnologija rekombinantne DNK, pri kateri je v kvasovke vstavljen gen (DNK), kar jim omogoča tvorjenje beljakovin L1.
Cervarix was more effective than the comparator vaccine in preventing abnormal cell growth in the cervix.
Cepivo Cervarix je bilo pri preprečevanju neobičajne rasti celic na materničnem vratu učinkovitejše od primerjalnega cepiva.
What is Cervarix?
Kaj je Cervarix?
The study also showed that Cervarix can provide protection against infection or lesions linked to some other HPV types.
Študija je poleg tega pokazala, da lahko cepivo Cervarix zagotovi tudi zaščito pred okužbami ali lezijami, povezanimi z nekaterimi drugimi genotipi virusa HPV.
For the prevention of anal lesions and cancer, the studies that compared either 2 doses or 3 doses of Cervarix with another HPV vaccine authorised for anal cancer showed that antibody levels in women and girls were similar or better with Cervarix than with the other vaccine.
Kar zadeva preprečevanje lezij in raka zadnjika so študije, v katerih so primerjali bodisi dva ali pa tri odmerke cepiva Cervarix z drugim cepivom HPV, odobrenim za rak zadnjika, pokazale, da so bile ravni protiteles pri ženskah in deklicah pri cepivu Cervarix podobne ali boljše kot pri drugem cepivu.
The vaccine is made using an ‘adjuvant system' that contains MPL, a purified lipid (a fat-like substance) extracted from bacteria, which enhances the response of the immune system to the vaccine.
Cepivo se proizvaja ob uporabi sistema adjuvansov, ki vsebuje MPL, tj. prečiščen lipid (snov, podobno maščobam), pridobljen iz bakterij, ki okrepi odziv imunskega sistema na cepivo.
The proteins are assembled in ‘virus-like particles' (structures that look like HPV, so that the body can recognise them easily).
Beljakovine tvorijo virusu podobne delce (strukture, ki so podobne humanemu papilomavirusu, tako da jih telo zlahka prepozna).
What is the risk associated with Cervarix?
Kakšna tveganja so povezana s cepivom Cervarix?
It is recommended that there is one month between the first and second doses, and five months between the second and third doses.
Priporočljivo je, da je med prvim in drugim odmerkom enomesečni, med drugim in tretjim odmerkom pa petmesečni razmik.
One study compared the level of protective antibodies developed in adult women after Cervarix use and compared it with those of another HPV vaccine already authorised for anal lesions and cancer.
V eni študiji so primerjali zaščitne ravni protiteles, ki so se razvile pri odraslih ženskah po uporabi cepiva Cervarix in jih primerjali z ravnmi pri drugem cepivu proti HPV, že odobrenem za lezije in rak zadnjika.
After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Po cepljenju je imunski sistem ob izpostavljenosti pravim virusom zmožen hitreje tvoriti protitelesa.
Data on protection against precancerous vulvar and vaginal lesions indicated that Cervarix could be effective in protecting against these lesions.
Podatki o zaščiti proti predrakavim lezijam na zunanjem in notranjem ženskem spolovilu nakazujejo, da bi lahko bilo cepivo Cervarix učinkovito pri zaščiti proti tem lezijam.
The second main study showed that two doses of Cervarix given 5 to 13 months apart were no less effective in girls aged 9 to 14 than a standard three-dose vaccination was in older subjects: all previously unprotected subjects had developed high levels of protective antibodies against virus types 16 and 18 one month after their last dose.
Druga glavna študija je pokazala, da dva odmerka cepiva Cervarix, ki se data v razmiku od 5 do 13 mesecev, nista bila nič manj učinkovita pri deklicah od 9 do 14 let kot stardardno cepljenje s tremi odmerki pri starejših: vse prej nezaščitene osebe so razvile visoke ravni zaščitnih protiteles proti virusoma tipa 16 in 18 en mesec po zadnjem odmerku.
Taken together these results suggested that the vaccine would be effective at protecting from infection with these HPV types when given from 9 years of age, and that a two-dose vaccination is suitable in those aged 9 to
Ob skupnem pregledu teh rezultatov je mogoče sklepati, da bi to cepivo učinkovito varovalo pred okužbo, povezano s tema genotipoma virusa HPV, če bi se dajalo od starosti devetih let, in da sta dva odmerka ustrezna za deklice med 9 in 14 letom starosti.
For the full list of all side effects and restrictions with Cervarix, see the package leaflet
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi cepiva Cervarix glejte navodilo za uporabo.
Five additional studies also looked at the development of antibodies in girls and women from 9 to 25 years of age who were given three doses of Cervarix.
V dodatnih petih študijah so obravnavali razvoj protiteles pri deklicah in ženskah, starih od 9 do 25 let, ki so prejele tri odmerke cepiva Cervarix.
• precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva, vagina or anus).
• predrakave lezije (neobičajna rast celic) v genitalnem predelu (cerviksu, zunanjem in notranjem ženskem spolovilu ali anusu).
The main measure of effectiveness was the development of protective antibodies against HPV types 16 and 18 one month after the last dose in previously unvaccinated subjects.
Glavno merilo učinkovitosti je bil razvoj zaščitnih ravni protiteles za virus HPV genotipov 16 in 18 en mesec po injiciranju zadnjega odmerka pri predhodno necepljenih osebah.
All papillomaviruses have a shell or ‘capsid', which is made up of distinctive proteins called ‘L1 proteins'.
Vsi virusi papiloma imajo plašč ali „kapsido“ iz beljakovin, imenovanih beljakovine L1.
Why has Cervarix been approved?
Zakaj je bilo cepivo Cervarix odobreno?
These data indicate that Cervarix could be effective in protecting against anal lesions and cancer in males and females.
Ti podatki kažejo, da bi bilo cepivo Cervarix lahko učinkovito pri varovanju proti lezijam in raku zadnjika pri moških in ženskah.
A second main study looked at the effect of two doses of Cervarix in girls aged 9 to 14 years compared with the effect of three doses in girls and women aged 15 to 25.
V drugi glavni študiji so učinek, ki sta ga imela dva odmerka cepiva Cervarix na deklice, stare med 9 in 14 let, primerjali z učinkom, ki so ga imeli trije odmerki tega cepiva na dekleta in ženske, stare od 15 do 25 let.
For the prevention of precancerous lesions or cancer of the cervix, Cervarix has been investigated in one main study involving almost 19,000 women aged between 15 and 25 years.
Zdravilo Cervarix so za preprečevanje predrakavih lezij ali raka materničnega vratu proučevali v eni glavni študiji pri skoraj 19 000 ženskah, starih od 15 do 25 let.
In the first main study, after an average of 39 months, four of the more than 7,000 women who received Cervarix and who had not been infected with HPV types 16 or 18 before, developed precancerous lesions in the cervix linked to these HPV types.
V prvi glavni študiji so se v povprečju po 39 mesecih pri štirih od več kot 7 000 žensk, ki so prejele cepivo Cervarix in ki predhodno niso bile okužene z virusom HPV genotipov 16 ali 18, pojavile predrakave lezije na materničnem vratu zaradi teh dveh tipov virusa HPV.
The study looked at how many women, who in the vast majority had no current infection with HPV types 16 or 18 at the start of the study, went on to develop precancerous lesions in the cervix linked to infection with these types of HPV.
V študiji so ugotavljali, pri koliko ženskah, ki na začetku študije večinoma niso bile okužene z virusom HPV genotipov 16 in 18, so se pozneje pojavile predrakave lezije na materničnem vratu, povezane z okužbo s tema dvema tipoma virusa HPV.
The additional five studies also showed that all of those aged 9 years and older who were given three doses of Cervarix developed high levels of antibodies against HPV types 16 and 18.
Dodatnih pet študij je pokazalo, da so deklice, starejše od devet let, ki so prejele tri odmerke cepiva Cervarix, razvile visoko raven protiteles za virus HPV genotipov 16 in 18.
The company also presented data on protection against precancerous vulvar and vaginal lesions in patients given Cervarix.
Družba je predstavila podatke o zaščiti proti predrakavim lezijam na zunanjem ali notranjem ženskem spolovilu pri bolnicah, ki so prejele cepivo Cervarix.
What is Cervarix used for?
Za kaj se cepivo Cervarix uporablja?
How has Cervarix been studied?
Kako je bilo cepivo Cervarix raziskano?
How is Cervarix used?
Kako se cepivo Cervarix uporablja?
How does Cervarix work?
Kako cepivo Cervarix deluje?
This compared with 56 of the more than 7,000 women who received the other vaccine.
Pri tistih, ki so prejele drugo cepivo, pa so se predrakave lezije na materničnem vratu pojavile pri 56 od več kot 7 000.
Cervarix human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
Pharmaceutic al form
Farmacevtska oblika
List of the names, pharmaceutical forms, strength of the medicinal product, route of administration, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, predlagataljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
FUMOMO 50 mikrogramov/vpih pršilo za nos, suspenzija
Mommox 50 mikrogramov/vpih pršilo za nos, suspenzija
Name
(Izmišljeno) ime
United Kingdom Sandoz B.V. Veluwezoom 22
Velika Britanija Sandoz B.V.
Mommox 0,05mg/dávku 50 microgram/dose nasal spray, suspension
Mommox 0,05mg/dávku 50 mikrogramov/vpih Pršilo za nos, suspenzija
Mometasone Furoate 50micrograms/dose, nasal spray, suspension
Mometasone Furoate 50micrograms/dose, nasal spray, suspension mikrogramov/odmerek
Belgium Sandoz B.V. Veluwezoom 22
Veluwezoom 22
EU (MA) number Invented name
EU (MA) številka Izmišljeno ime Jakost Farmacevtska oblika
Packaging Content
Pakiranje Vsebina Velikost pakiranja
• Healthcare professionals have been informed in writing about these recommendations.
• Zdravstveni delavci so bili o teh priporočilih pisno obveščeni.
In particular, several manufacturing shortcomings had not been resolved.
Zlasti ni bilo odpravljenih več pomanjkljivosti pri proizvodnji.