natgillin/translations-raw huggingface dataset:
In the 3 studies, between 87% and 94% of patients treated with Xydalba were cured, compared with between 91% and 93% of patients treated with any of the two comparators.
V navedenih treh študijah je ozdravelo od 87 do 94 % bolnikov, ki so jih zdravili z zdravilom Xydalba, v primerjavi z 91 do 93 % bolnikov, ki so jih zdravili z enim od obeh primerjalnih zdravil.
In all the studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.
Glavno merilo učinkovitosti v vseh študijah je bilo število bolnikov, pri katerih je bila okužba po zdravljenju ozdravljena.
The European Commission granted a marketing authorisation valid throughout the European Union for Xydalba on 19 February 2015.
Evropska komisija je dovoljenje za promet z zdravilom Xydalba, veljavno po vsej Evropski uniji, izdala 19. februarja 2015.
What measures are being taken to ensure the safe and effective use of Xydalba?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xydalba?
Xydalba is given once a week by an infusion lasting 30 minutes.
Zdravilo Xydalba se daje enkrat tedensko v obliki infuzije, ki traja 30 minut.
The full EPAR and risk management plan summary for Xydalba 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) in povzetek načrta obvladovanja tveganj za zdravilo Xydalba sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Patients who received vancomycin and responded to treatment had the option to switch to linezolid after 3 days.
Bolniki, ki so prejemali vankomicin in so se odzvali na zdravljenje, so lahko po treh dneh prešli na jemanje linezolida.
This is a summary of the European public assessment report (EPAR) for Xydalba.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xydalba.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xydalba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Xydalba večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It works by preventing certain bacteria from making their own cell walls, thereby killing the bacteria.
Deluje tako, da prepreči, da bi si določene bakterije zgradile celične stene, s čimer jih uniči.
In light of the need for new antibiotics targeting multi-resistant bacteria, the CHMP concluded that Xydalba, which showed activity against certain bacteria resistant to other antibiotics, could be a valuable alternative treatment option.
Odbor je ob upoštevanju potrebe po novih antibiotikih, ki delujejo proti večkratno odpornim bakterijam, zaključil, da je zdravilo Xydalba, ki se je izkazalo za učinkovito proti nekaterim bakterijam, odpornim proti drugim antibiotikom, lahko dragocena nadomestna možnost zdravljenja.
A risk management plan has been developed to ensure that Xydalba is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Xydalba je bil pripravljen načrt obvladovanja tveganj.
The active substance in Xydalba, dalbavancin, is a type of antibiotic called glycopeptide.
Zdravilna učinkovina v zdravilu Xydalba, dalbavancin, je vrsta antibiotika, ki ga imenujemo glikopeptid.
What benefits of Xydalba have been shown in studies?
Kakšne koristi je zdravilo Xydalba izkazalo v študijah?
Before using Xydalba, doctors should consider official guidance on the appropriate use of antibiotics.
Preden zdravnik predpiše zdravilo Xydalba, mora upoštevati uradne smernice za ustrezno uporabo antibiotikov.
What are the risks associated with Xydalba?
Kakšna tveganja so povezana z zdravilom Xydalba?
What is Xydalba and what is it used for?
Kaj je zdravilo Xydalba in za kaj se uporablja?
It contains the active substance dalbavancin.
Vsebuje zdravilno učinkovino dalbavancin.
Xydalba was at least as effective as vancomycin or linezolid at curing the infection.
Zdravilo Xydalba je bilo pri ozdravljenju okužbe vsaj tako učinkovito kot vankomicin ali linezolid.
Other information about Xydalba
Druge informacije o zdravilu Xydalba
The most common side effects with Xydalba (which may affect between 1 and 3 people in 100) are nausea (feeling sick), diarrhoea and headache.
Najpogostejši neželeni učinki zdravila Xydalba (ki lahko prizadenejo od 1 do 3 osebe od 100) so navzeja (slabost), glavobol, driska in glavobol.
A list of bacteria against which Xydalba is active can be found in the summary of product characteristics (also part of the EPAR).
Seznam bakterij, proti katerim je zdravilo Xydalba učinkovito, je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
For more information about treatment with Xydalba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Xydalba preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Why is Xydalba approved?
Zakaj je bilo zdravilo Xydalba odobreno?
For the full list of all side effects and restrictions with Xydalba, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Xydalba glejte navodilo za uporabo.
Xydalba is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Zdravilo Xydalba je antibiotik, ki se uporablja pri odraslih za zdravljenje akutnih (kratkotrajnih) bakterijskih okužb kože in kožnih struktur (podkožnega tkiva), kot so celulitis (vnetje globokega podkožnega tkiva), kožni abscesi in okužbe ran.
Xydalba was compared with vancomycin (another glycopeptide) or with linezolid (an antibiotic that can be taken by mouth) in three main studies involving a total of around 2,000 patients with serious infections of the skin and soft tissue under the skin, such as cellulitis, skin abscesses and wound infections.
Zdravilo Xydalba so primerjali z vankomicinom (drugim glikopeptidom) ali linezolidom (antibiotikom, ki se lahko jemlje peroralno) v treh glavnih študijah, v katerih je sodelovalo skupno približno 2 000 bolnikov z resnimi okužbami kože in mehkega podkožnega tkiva, kot so celulitis, abscesi kože in okužbe rane.
For practical information about using Xydalba, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Xydalba naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Dalbavancin has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA))
Dalbavancin je dokazano učinkovit proti bakterijam (na primer proti na meticilin odporni bakteriji Staphylococcus aureus (MRSA)), proti katerim običajni antibiotiki ne delujejo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xydalba, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Xydalba is available as a powder to be made up into a solution for infusion (drip) into a vein and can only be obtained with a prescription.
Zdravilo Xydalba je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno in se izdaja le na recept.
It is not intended to provide practical advice on how to use Xydalba.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Xydalba's safety profile is comparable to that of other antibiotics of the glycopeptide class; side effects affecting hearing and kidney function, which are typical for glycopeptides, have not been shown with the proposed regimens of Xydalba in the clinical trials.
Varnostni profil zdravila Xydalba je primerljiv z varnostnim profilom drugih glikopeptidnih antibiotikov, pri čemer v kliničnih preskušanjih ob zdravljenju z zdravilom Xydalba po predlaganih režimih niso opazili neželenih učinkov na sluh in delovanje ledvic, ki so sicer značilni za glikopeptide.
How is Xydalba used?
Kako se zdravilo Xydalba uporablja?
How does Xydalba work?
Kako zdravilo Xydalba deluje?
The dose of Xydalba needs to be reduced in patients with severely impaired kidney function.
Pri bolnikih s hudo okvaro delovanja ledvic je odmerek včasih treba zmanjšati.
The main measure of effectiveness was the rate of implantation and pregnancy.
Glavno merilo učinkovitosti je bil delež vsaditev in nosečnosti.
What measures are being taken to ensure the safe and effective use of Rekovelle?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rekovelle?
The full EPAR for Rekovelle 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 zdravilo Rekovelle je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is not intended to provide practical advice on how to use Rekovelle.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What benefits of Rekovelle have been shown in studies?
Kakšne koristi je zdravilo Rekovelle izkazalo v študijah?
The frequency of side effects may decrease with repeated treatment cycles.
Pogostnost neželenih učinkov se s ponavljanjem ciklov zdravljenja lahko zmanjša.
After the first injection, the woman or their partner may be able to give the injections themselves, if they have been trained and have access to expert advice.
Po prvi injekciji si injekcijo lahko daje ženska sama oziroma njen partner, če sta bila za to usposobljena in imata dostop do izvedenskega svetovanja.
This is a summary of the European public assessment report (EPAR) for Rekovelle.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rekovelle.
What is Rekovelle and what is it used for?
Kaj je zdravilo Rekovelle in za kaj se uporablja?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rekovelle's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Rekovelle večje od z njim povezanih tveganj in priporočil, da se odobri za uporabo v EU.
The dose can then be modified in subsequent cycles according to the woman's response.
Odmerek se nato v naslednjih ciklih prilagodi glede na odziv ženske.
The safety profile of Rekovelle was considered acceptable and similar to that of GONAL-f.
Varnostni profil zdravila Rekovelle je bil ocenjen kot sprejemljiv in je podoben varnostnemu profilu zdravila GONAL-f.
Rekovelle is given by injection under the skin once a day for several consecutive days during the woman's menstrual cycle starting on day 2 or 3 of the cycle and is continued until sufficient eggs have developed.
Zdravilo Rekovelle se daje z injekcijo pod kožo enkrat na dan več dni zaporedoma v času menstrualnega cikla s pričetkom na 2. ali 3. dan cikla in se nadaljuje, dokler se ne razvije dovolj jajčec.
Other information about Rekovelle
Druge informacije o zdravilu Rekovelle
What are the risks associated with Rekovelle?
Kakšna tveganja so povezana z zdravilom Rekovelle?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rekovelle have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Why is Rekovelle approved?
Zakaj je bilo zdravilo Rekovelle odobreno?
The study showed that Rekovelle was as effective as GONAL-f at stimulating the ovaries: around 31% of women (204 out of 665) treated with Rekovelle became pregnant compared with around 32% of women (209 out of 661) treated with GONAL-f. Implantation rates were also similar: around 35% with Rekovelle versus around 36% with GONAL-f.
Študija je pokazala, da je zdravilo Rekovelle enako učinkovito kot zdravilo GONAL-f pri stimulaciji jajčnikov: zanosilo je približno 31 % žensk (204 od 665), zdravljenih z zdravilom Rekovelle, v primerjavi s približno 32 % žensk (209 od 661), zdravljenih z zdravilom GONAL-f.
The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika z izkušnjami z zdravljenjem težav s plodnostjo.
For more information about treatment with Rekovelle, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Rekovelle preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling sick) and tiredness and ovarian hyperstimulation syndrome (OHSS).
Najpogostejši neželeni učinki zdravila Rekovelle (ki se lahko pojavijo pri od 1 do 10 bolnic od 100) so glavobol, neugodje in bolečina v medeničnem predelu, ki lahko izhaja iz jajčnikov, slabost (siljenje na bruhanje) in utrujenost ter sindrom hiperstimulacije jajčnikov.
The starting dose of Rekovelle depends on the woman's bodyweight and on the blood level of the anti-Müllerian hormone (a hormone which indicates how well the ovaries will respond to stimulation).
Začetni odmerek zdravila Rekovelle je odvisen od telesne mase ženske in ravni antiMüllerjevega hormona (hormona, ki kaže, kako dobro se bodo jajčniki odzvali na stimulacijo) v krvi.
How is Rekovelle used?
Kako se zdravilo Rekovelle uporablja?
For practical information about using Rekovelle, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Rekovelle naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
In severe cases OHSS may lead to difficulty breathing and problems with blood clotting.
V resnih primerih lahko sindrom hiperstimulacije jajčnikov privede do težav z dihanjem in motenj strjevanja krvi.
Rekovelle was compared with GONAL-f (follitropin alfa), another fertility medicine, in one study involving 1,326 women who were undergoing controlled ovarian stimulation for IVF or ICSI.
Zdravilo Rekovelle so primerjali z zdravilom GONAL-f (folitropin alfa), tj. drugim zdravilom za zdravljenje neplodnosti, v študiji, ki je vključevala 1 326 žensk v postopku nadzorovane stimulacije jajčnikov za IVF ali ICSI.
Rekovelle must not be used in women with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Zdravilo Rekovelle se ne sme uporabljati pri ženskah s tumorji na hipofizi ali hipotalamusu, z rakom dojk, maternice ali jajčnikov.
OHSS is when a woman's ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain.
Sindrom hiperstimulacije jajčnikov se pojavi, kadar se ženska čezmerno odzove na stimulacijo, povzroča pa simptome, kot so bruhanje, driska in bolečina.
Rekovelle is available as a solution for injection, contained in a cartridge to be used with Rekovelle injection pen.
Zdravilo Rekovelle je na voljo v obliki raztopine za injiciranje v vložku, ki se uporablja skupaj z injekcijskim peresnikom Rekovelle.
The active substance in Rekovelle, follitropin delta, is a copy of the natural hormone called folliclestimulating hormone (FSH) which plays a key role in fertility in women by stimulating the production of eggs in the ovaries.
Zdravilna učinkovina v zdravilu Rekovelle, folitropin delta, je imitacija naravnega hormona, imenovanega folikle stimulirajoči hormon (FSH), ki ima zaradi spodbujanja nastajanja jajčec v jajčnikih glavno vlogo pri ženski plodnosti.
Giving extra stimulation with Rekovelle helps increase the number of eggs produced in the ovaries, which means that more eggs can then be collected and fertilised in the laboratory.
Z dodatno stimulacijo s pomočjo zdravila Rekovelle se poveča število jajčec, ki nastanejo v jajčnikih, kar pomeni, da se lahko odvzame in v laboratoriju oplodi več jajčec.
It is used to stimulate the ovaries to produce several eggs at the time, which can then be collected and fertilised in the laboratory.
Uporablja se za spodbujanje jajčnikov, da v njih nastane več jajčec hkrati, ki jih nato odvzamejo in oplodijo v laboratoriju.
Rekovelle must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian syndrome, or when there is unexplained bleeding from the vagina.
Zdravilo Rekovelle se ne sme uporabljati, če imate povečane jajčnike ali ciste, ki niso posledica sindroma policističnih jajčnikov, ali imate krvavitve iz nožnice brez znanega vzroka.
For the full list of all side effects reported with Rekovelle, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rekovelle, glejte navodilo za uporabo.
Rekovelle contains the active substance follitropin delta.
Zdravilo Rekovelle vsebuje zdravilno učinkovino folitropin delta.
The CHMP considered that Rekovelle was effective in obtaining several eggs at the same time following stimulation in women undergoing fertility treatment.
Odbor CHMP je menil, da je zdravilo Rekovelle pri ženskah, ki se zdravijo zaradi neplodnosti, učinkovito pri pridobivanju več jajčec hkrati po stimulaciji.
Rekovelle is a medicine given to women who are having fertility treatments such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).
Rekovelle je zdravilo, ki se daje ženskam, ki se zdravijo zaradi neplodnosti, na primer z zunajtelesno oploditvijo jajčne celice (IVF) ali neposrednim vnosom semenčice v citoplazmo jajčne celice (ICSI).
How does Rekovelle work?
Kako zdravilo Rekovelle deluje?
The application was withdrawn at ‘day 120'.
Družba je vlogo umaknila na „120.
The summary of the opinion of the Committee for Orphan Medicinal Products for Tekinex can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Povzetek mnenja Odbora za zdravila sirote za zdravilo Tekinex je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Tekinex was not compared directly with any other treatment.
Zdravila Tekinex niso neposredno primerjali z nobeno drugo vrsto zdravljenja.
The CHMP also had concerns about the doses used in the study and the criteria used for measuring the medicine's effectiveness.
CHMP je imel tudi zadržke glede odmerkov, ki so jih uporabili v študiji, in meril, uporabljenih za merjenje učinkovitosti zdravila.
The effects of Tekinex were first tested in experimental models before being studied in humans.
Učinki zdravila Tekinex so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
dan.“ To pomeni, da je CHMP ocenil začetno dokumentacijo, ki jo je predložila, in sestavil seznam vprašanj.
The company had not yet responded to the questions at the time of the withdrawal.
Ob umiku vloge družba še ni odgovorila na vprašanja.
The study looked at how the patients responded to treatment based on results of blood tests taken to measure how active the cancer was.
V študiji so ugotavljali, kako se bolniki odzivajo na zdravljenje, in sicer na podlagi preiskav krvi, s katerimi so izmerili aktivnost raka.
Because the number of patients with CML is low, the disease is considered ‘rare', and Tekinex was designated an ‘orphan medicine' (a medicine used in rare diseases) on 2 September 2004.
Ker je bolnikov s KML malo, se bolezen šteje za „redko“ in zdravilo Tekinex je bilo dne 2. septembra 2004 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja za redke bolezni).
It was to be available as a powder to be made up into a solution for injection.
Na voljo naj bi bilo kot prašek za pripravo raztopine za injiciranje.
Finally, following an inspection of the study sites, the Committee noted that there were some inconsistencies in the application that could have affected the reliability of the study results.
Po pregledu mest študije pa je Odbor ugotovil nekaj neskladnosti v vlogi, ki bi lahko vplivale na zanesljivost rezultatov študije.
The company informed the CHMP that clinical trials with Tekinex will continue.
Družba je obvestila CHMP, da se bodo klinična preskušanja z zdravilom Tekinex nadaljevala.
Tekinex is a medicine that contains the active substance omacetaxine mepesuccinate.
Tekinex je zdravilo, ki vsebuje zdravilno učinkovino omacetaksin mepesukcinat.
Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Tekinex could not have been approved.
Na podlagi pregleda podatkov v času umika vloge je imel CHMP nekaj zadržkov in bil začasnega mnenja, da zdravila Tekinex ni mogoče odobriti.
The CHMP was of the view that the medicine's benefits were uncertain.
CHMP je menil, da koristi zdravila niso jasne.
There was also insufficient follow-up of the patients following treatment and the Committee was doubtful about the medicine being safe enough to be self-administered by patients as intended by the company.
Odbor je imel pomisleke, ali je varnost zdravila zadostna, da bi si ga bolniki dajali sami, kot je nameravala družba.
The active substance in Tekinex, omacetaxine, is an inhibitor of protein synthesis.
Zdravilna učinkovina v zdravilu Tekinex, omacetaksin, je zaviralec nastajanja beljakovin.
What is Tekinex?
Kaj je zdravilo Tekinex?
The way it works is unclear, but it is thought to disrupt the production of the Bcr-Abl tyrosine kinase enzyme.
Način njegovega delovanja ni jasen, vendar naj bi prekinil nastajanje encima tirozin-kinaze BCR-ABL.
On 11 January 2011, ChemGenex Europe SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tekinex intended to be used to treat patients with Philadelphia chromosome-positive chronic myeloid leukaemia who have the ‘Bcr-Abl T315I kinase domain' mutation and whose previous treatment with imatinib had failed.
Družba ChemGenex Europe SAS je dne 11. januarja 2011 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Tekinex, namenjenim zdravljenju bolnikov s kronično mieloično levkemijo, pozitivno na kromosom Philadelphia, ki imajo mutacijo „T315I domene kinaze BCR-ABL“ in pri katerih je bilo predhodno zdravljenje z imatinibom neuspešno.
The company presented results from a main study involving 66 patients with Philadelphia-positive CML and the T315I mutation, whose previous treatment with imatinib had failed.
Družba je predložila rezultate glavne študije, v katero je bilo vključenih 66 bolnikov s KML, pozitivno na kromosom Philadelphia, in mutacijo T315I, pri katerih je bilo predhodno zdravljenje z imatinibom neuspešno.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Tekinex did not outweigh its risks.
Zato je CHMP v času umika menil, da koristi zdravila Tekinex ne odtehtajo z njim povezanih tveganj.
Tekinex was therefore expected to work in Ph+ patients with the T315I mutation.
Zato so za zdravilo Tekinex pričakovali, da bo delovalo pri bolnikih s Ph+ z mutacijo T315I.