natgillin/translations-raw huggingface dataset:
The most common side effects with Zelboraf (which may affect more than 3 in 10 patients) include arthralgia (joint pain), tiredness, rash, photosensitivity reaction (sunburn-like reactions following exposure to light), nausea and vomiting (feeling sick and being sick), alopecia (hair loss), diarrhoea, headache, pruritus (itching), skin papilloma (warts) and hyperkeratosis (thickening and toughening of the skin).
Najpogostejši neželeni učinki zdravila Zelboraf (ki se lahko pojavijo pri več kot 3 od 10 bolnikov) so artralgija (bolečine v sklepih), utrujenost, izpuščaji, fotosenzibilna reakcija (reakcije, podobne sončnim opeklinam, ki so posledica izpostavljenosti svetlobi), navzeja (siljenje na bruhanje) in bruhanje, alopecija (izpadanje las), driska, glavobol, pruritus (srbenje), papilom na koži (bradavice) in hiperkeratoza (zadebelitev in otrditev kože).
Why is Zelboraf authorised in the EU?
Zakaj je bilo zdravilo Zelboraf odobreno v EU?
The Agency considered the side effects to be manageable and included recommendations for doctors to help reduce the risks in the product information.
Agencija je menila, da so neželeni učinki obvladljivi in v informacije o zdravilu dodala priporočila za zdravnike, ki naj bi prispevala k zmanjšanju tveganj.
Side effects reported with Zelboraf are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Zelboraf, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Zelboraf can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.
Predpisovanje in izdaja zdravila Zelboraf je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem raka.
An overview of Zelboraf and why it is authorised in the EU
Pregled zdravila Zelboraf in zakaj je odobreno v EU
Treatment should be continued until the disease worsens or the side effects become too severe.
Z zdravljenjem je treba nadaljevati, dokler se bolezen ne poslabša ali dokler neželeni učinki ne postanejo prehudi.
What are the risks associated with Zelboraf?
Kakšna tveganja so povezana z zdravilom Zelboraf?
For more information about using Zelboraf, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Zelboraf glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
With regard to its risks, in the main study around half of the patients taking Zelboraf experienced a severe side effect and about one fifth developed cutaneous squamous cell carcinoma.
Glede z njim povezanih tveganj se je v glavni študiji pri približno polovici bolnikov, ki so jemali zdravilo Zelboraf, pojavil resen neželeni učinek, približno pri eni petini pa se je razvil ploščatocelični karcinom kože.
The first dose is taken in the morning and the second dose in the evening around 12 hours later.
Priporočeni odmerek je 960 mg (štiri tablete) dvakrat na dan. Prvi odmerek je treba vzeti zjutraj, drugi odmerek pa zvečer, približno 12 ur pozneje.
Zelboraf is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.
Zelboraf je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih z melanomom (vrsto kožnega raka), ki se je razširil na druge dele telesa ali ga ni mogoče kirurško odstraniti.
Zelboraf is only for patients whose melanoma tumour cells have a specific mutation (genetic change) called ‘BRAF V600'.
Zdravilo Zelboraf se uporablja samo za bolnike, pri katerih imajo tumorske celice melanoma posebno mutacijo (gensko spremembo), imenovano „BRAF V600“.
The most common serious side effects include another type of skin cancer called ‘cutaneous squamous cell carcinoma', which is commonly treated by local surgery, keratoacanthoma (benign skin tumour), rash, arthralgia and change in liver test results (increased gamma-glutamyltransferase [GGT]).
Najpogostejši resni neželeni učinki so druga vrsta kožnega raka, imenovana ploščatocelični karcinom kože, ki se uspešno zdravi z lokalno operacijo, keratoakantom (benigni kožni tumor), izpuščaji, artralgija in spremembe v izvidih jetrnih testov (zvišanje gama-glutamiltransferaze [GGT]).
The Agency noted that Zelboraf had been convincingly shown to improve overall survival and to delay the worsening of ‘BRAF V600 positive' melanoma which has spread or cannot be surgically removed.
Agencija ugotavlja, da je zdravilo Zelboraf prepričljivo dokazalo, da izboljšuje celokupno preživetje in odlaga poslabšanje melanoma s pozitivno BRAF V600 mutacijo, ki se je razširil ali ga ni mogoče kirurško odstraniti.
Before starting treatment a test must be carried out to make sure that the patient's tumours have the BRAF V600 mutation.
Pred začetkom zdravljenja je treba narediti test, ki potrdi mutacijo BRAF V600 v tumorskih celicah bolnika.
For the full list of side effects and restrictions with Zelboraf, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Zelboraf glejte navodilo za uporabo.
In melanoma tumours with the BRAF V600 mutation, an abnormal form of BRAF is present which plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
V tumorjih melanoma z mutacijo BRAF V600 je prisotna neobičajna oblika beljakovine BRAF, ki vpliva na razvoj raka tako, da omogoča nenadzorovano deljenje tumorskih celic.
The study showed that patients taking Zelboraf lived on average for 13.2 months compared with 9.9 months for patients on dacarbazine, and it took on average 5.3 months for the disease to worsen in the Zelboraf group compared with 1.6 months in the dacarbazine group.
Študija je pokazala, da so bolniki, ki so jemali zdravilo Zelboraf, v povprečju živeli 13,2 meseca, medtem ko so bolniki, ki so jemali dakarbazin, živeli 9,9 meseca.
The active substance in Zelboraf, vemurafenib, is an inhibitor of BRAF, a protein involved in stimulating cell division.
Učinkovina v zdravilu Zelboraf, vemurafenib, je zaviralec BRAF, beljakovine, ki sodeluje pri spodbujanju delitve celic.
By blocking the action of the abnormal BRAF, Zelboraf helps to slow down the growth and spread of the cancer.
Zdravilo Zelboraf z zaviranjem delovanja neobičajne beljakovine BRAF prispeva k upočasnitvi rasti in širjenja raka.
Patients were to receive either medicine until their disease got worse or their
Bolniki so posamezno zdravilo prejemali, dokler se bolezen ni poslabšala ali je zdravljenje zanje postalo preveč toksično.
How is Zelboraf used?
Kako se zdravilo Zelboraf uporablja?
How does Zelboraf work?
Kako zdravilo Zelboraf deluje?
Zelboraf was compared with the cancer medicine dacarbazine in a main study involving 675 patients with melanoma containing the BRAF V600 mutation whose tumours had spread or could not be surgically removed.
Zdravilo Zelboraf so v glavni študiji, ki je vključevala 675 bolnikov z melanomom, ki je vseboval mutacijo BRAF V600, pri katerih se je tumor razširil ali ga ni bilo mogoče kirurško odstraniti, primerjali z zdravilom proti raku dakarbazin.
Zelboraf contains the active substance vemurafenib.
Vsebuje učinkovino vemurafenib.
The preliminary review was concluded on 8th of February 2018.
Začasni pregled je bil zaključen 8. februarja 2018.
Three out of those four cases of serious liver injury were reported to the competent authorities before November 2017.
Trije od teh štirih primerov resne poškodbe jeter so bili pristojnim organom sporočeni pred novembrom 2017.
Nevertheless, the review of cumulatively reported post-marketing cases does not allow a firm conclusion at this stage.
Pregled kumulativno prijavljenih primerov iz obdobja trženja v tej fazi kljub temu ne omogoča trdnega zaključka.
Patients overcoming such threshold should be closely monitored after discontinuation of the treatment.
Bolnike, ki presežejo ta prag, je treba po opustitvi zdravljenja natančno spremljati.
Acknowledging the uncertainty regarding background incidence and the information in the reported cases, the seriousness of the reported cases raises concern.
Ob priznavanju nejasnosti o osnovni incidenci in informacij v primerih, o katerih so poročali, vzbuja zaskrbljenost resnost prijavljenih primerov.
The adequacy of these provisional measures will be reviewed as part of the ongoing Article 20.
Presoja ustreznosti teh začasnih ukrepov bo opravljena kot del potekajočega postopka iz člena 20.
An in depth assessment is needed to firmly establish factors that may have caused the reported serious hepatic injuries.
Potrebna je tudi poglobljena ocena, s katero bi trdno določili dejavnike, ki so lahko povzročili resne poškodbe jeter, o katerih so poročali.
However, there are a few cases of serious hepatic injury, where no other obvious explanation has been identified, despite uncertainty in relation to possible confounding.
Vendarle pa obstaja nekaj primerov resnih poškodb jeter, pri katerih kljub nejasnosti v povezavi z možnimi zavajajočimi dejavniki ni bilo mogoče prepoznati nobene očitne razlage.
It is therefore too early to conclude that the risk of hepatotoxicity is associated with the use of Esmya for all cases.
Zato je prezgodaj za zaključek, da je tveganje za hepatotoksičnost povezano z uporabo zdravila Esmya pri vseh primerih.
Although firm conclusions cannot be drawn that these cases were caused by Esmya, the available data raise serious concerns.
Čeprav ni mogoče sprejeti trdnega zaključka, da je te primere povzročilo zdravilo Esmya, razpoložljivi podatki vzbujajo resne pomisleke.
A fourth case of hepatic liver failure leading to transplantation was reported on 30th of January 2018.
Četrti primer odpovedi jeter, ki je privedla do presaditve, je bil sporočen 30. januarja 2018.
On 30 November 2017 the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Esmya and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Evropska komisija je zato 30. novembra 2017 na podlagi farmakovigilančnih podatkov sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in odbor PRAC zaprosila, naj oceni vpliv zgornjih pomislekov na razmerje med tveganji in koristmi zdravila Esmya ter izda priporočilo o tem, ali naj se ustrezna dovoljenja za promet z zdravilom ohranijo, spremenijo, začasno umaknejo ali odvzamejo.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Esmya (Ulipristal acetate), in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) N0 726/2004.
• Odbor PRAC je upošteval postopek iz člena 20 Uredbe (ES) št. 726/2004, ki je bil sprožen na podlagi farmakovigilančnih podatkov za zdravilo Esmya (ulipristalacetat), zlasti zaradi potrebe po uvedbi začasnih ukrepov v skladu s členom 20(3) Uredbe (ES) št. 726/2004.
Even though it is unclear at this stage whether monitoring of transaminases would necessarily prevent further severe cases, liver function monitoring is expected to be an important measure to detect liver injury during treatment, and likely reduce the incidence of severe cases.
Čeprav v tej fazi ni jasno, ali bi spremljanje transaminaz nedvomno preprečilo nadaljnje hude primere, se pričakuje, da bo spremljanje delovanja jeter pomembno pripomoglo k prepoznavi poškodbe jeter med zdravljenjem in verjetno zmanjšalo incidenco hudih primerov.
Liver monitoring should also be performed up to four weeks after the discontinuation of the treatment.
Poleg tega je treba spremljanje delovanja jeter nadaljevati do štiri tedne po prenehanju zdravljenja.
In addition to these, a preliminary assessment of a recently reported case of liver transplantation with fatal outcome was performed.
Poleg tega je bila opravljena preliminarna ocena nedavno prijavljenega primera presaditve jeter s smrtnim izidom.
The absence of findings in clinical trials has to be interpreted with caution as abnormal values of ALT/AST was an exclusion criterion as per protocols
Odsotnost izsledkov v kliničnih preskušanjih je treba razlagati previdno, saj so bile nenormalne vrednosti encimov ALT/AST po protokolih izključitveno merilo.
The Committee, as a consequence, recommends the variations of the terms of the marketing authorisation for Esmya.
Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom Esmya.
These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 procedure.
Ti začasni ukrepi ne posegajo v izid potekajočega pregleda v okviru postopka v skladu s členom 20.
Patients exhibiting signs and symptoms suggestive of liver injury should promptly contact a healthcare professional.
Bolniki z znaki in simptomi, ki kažejo na poškodbe jeter, morajo nemudoma stopiti v stik z zdravstvenim delavcem.
Taking into account this new case and the totality of the reported cases, a preliminary review and assessment of all the data available was performed by PRAC, to consider if provisional measures were needed while the issue is being furtherly reviewed.
Ob upoštevanju tega novega primera in skupnega števila sporočenih primerov je odbor PRAC opravil predhodni pregled in oceno vseh razpoložljivih podatkov, da bi ocenil, ali so med nadaljnjim pregledom zadeve potrebni začasni ukrepi.
In addition, PRAC considers that involvement of Esmya in at least two of the four transplantation cases reported and in two additional less serious cases, is at least plausible.
Odbor PRAC poleg tega meni, da je povezava z zdravilom Esmya in vsaj dvema od štirih prijavljenih primerov presaditve in dvema dodatnim manj resnima primeroma verjetna.
• Furthermore, PRAC recommended that a healthcare professional communication should be disseminated to inform healthcare professionals about the precautionary measures, awaiting the outcome of the full review of Esmya.
• Odbor PRAC je poleg tega priporočil, da se zdravstvenim delavcem sporočijo informacije o previdnostnih ukrepih med čakanjem na izid celovitega pregleda zdravila Esmya.
• The PRAC recommends that no new patients should be treated with the medicinal product while the review is ongoing.
• Odbor PRAC priporoča, da se med potekom pregleda z zdravilom ne zdravi noben nov bolnik.
In addition, several other cases of hepatic impairment associated with the use of the product were reported.
Poleg tega so poročali o več drugih primerih okvar jeter, povezanih z uporabo tega zdravila.
The threshold of transaminases elevation for patients not included in clinical trials, which is two times the upper limit of normal, should be considered as the threshold in which the discontinuation of treatment is recommended.
Prag zvišanja transaminaz pri bolnikih, ki niso vključeni v klinična preskušanja, je dvakratnik normalne vrednosti, zato ga je treba upoštevati kot prag, pri katerem se priporoča opustitev zdravljenja.
In addition, for patients currently under treatment, a monitoring of serum transaminases levels should to be performed at least monthly and immediately in case of incidence of signs and symptoms of liver injury.
Poleg tega je treba pri bolnikih, ki se trenutno zdravijo s tem zdravilom, meriti ravni transaminaz v serumu vsaj mesečno, v primeru pojava znakov in simptomov poškodbe jeter pa jih je treba izmeriti nemudoma.
PRAC concluded that the use of Esmya could potentially be associated with a risk of serious liver injury.
Odbor PRAC je zaključil, da bi bila lahko uporaba zdravila Esmya povezana s tveganjem za resno poškodbo jeter.
Follow-up information on this case was also reviewed by the PRAC, as well as additional information provided by the Marketing Authorisation Holder while the review was ongoing.
Odbor PRAC je pregledal tudi nadaljnje informacije o tem primeru in dodatne informacije, ki jih je predložil imetnik dovoljenja za promet z zdravilom, ko je potekal pregled.
Given the estimated exposure to Esmya of approximately 175,000 patient years, the number of cases of subacute severe liver impairment leading to liver transplantation with Esmya is higher than expected (4 transplantation cases among 175,000 patient years - a total of 7 cases with severe liver impairment among 175,000 patient years; although causality is uncertain for some of these cases).
Glede na ocenjeno izpostavljenost zdravilu Esmya približno 175 000 bolnik-let se zdi število primerov subakutne hude okvare jeter, ki je privedla do presaditve jeter, pri zdravilu Esmya višje od pričakovanega (štirje primeri presaditve na 175 000 bolnik-let - skupno sedem primerov s hudo okvaro jeter na 175 000 bolnik-let; čeprav je vzročnost za nekatere od teh primerov negotova).
The current recommendation relates only to provisional measures recommended by the PRAC for Esmya based on the preliminary data available at this time.
Trenutno poročilo se nanaša zgolj na ukrepe, ki jih odbor PRAC za zdravilo Esmya priporoča na podlagi predhodnih podatkov, ki so ob tem času na voljo.
The PRAC considered the duration of treatment with Esmya, the timelines of the current scientific evaluation and the patients that are currently under treatment.
Odbor PRAC je upošteval trajanje zdravljenja z zdravilom Esmya, časovni načrt potekajočega znanstvenega vrednotenja in bolnike, ki se trenutno zdravijo s tem zdravilom.
The provisional measures proposed by PRAC also include the limitation of use of the medicinal product in patients that are currently under therapeutic treatment.
Začasni ukrepi, ki jih je predlagal odbor PRAC, vključujejo tudi omejitev uporabe zdravila pri bolnikih, ki se z njim trenutno zdravijo terapevtsko.
• PRAC recommended monitoring of the liver function at least monthly of patients under treatment as well as up to four weeks after the discontinuation of the treatment.
• Odbor PRAC je priporočil, da se pri bolnikih, ki se zdravijo s tem zdravilom, delovanje jeter preverja vsaj enkrat na mesec in še do štiri tedne po prenehanju zdravljenja.
The possible causal relationship between Esmya and acute liver failure of those three cases prompted an in-depth investigation of this risk and its impact on the benefit risk balance of Esmya is warranted.
Možna vzročna zveza med zdravilom Esmya in akutno odpovedjo jeter v teh treh primerih je sprožila poglobljeno raziskavo tega tveganja in njegovega vpliva na razmerje med tveganji in koristmi.
The PRAC considered the potential risk of hepatotoxicity of the product, together with the fact that Esmya is a symptomatic treatment and not curative, that has the potential to reduce the need for surgical intervention.
Odbor PRAC je upošteval možno tveganje za hepatotoksičnost zdravila in dejstvo, da se zdravilo Esmya uporablja za simptomatsko in ne kurativno zdravljenje, ki lahko zmanjša potrebo za kirurški poseg.
These investigations should occur immediately in case a patient shows signs or symptoms compatible with liver injury.
Te preiskave je treba v primeru, če bolnik kaže znake ali simptome, ki nakazujejo na poškodbo jeter, opraviti nemudoma.
Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Zdravilo Esmya (ulipristalacetat, 5 mg) je odobreno po centraliziranem postopku in je indicirano za predoperacijsko in intermitentno zdravljenje zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi.
• During the ongoing review of safety and efficacy data in relation to the overall risk of liver injury with Esmya, the PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya.
• Med potekajočim pregledom podatkov o varnosti in učinkovitosti v povezavi s splošnim tveganjem zdravila Esmya za poškodbo jeter je odbor PRAC pregledal vse trenutno dostopne podatke iz obdobja trženja in iz kliničnih preskušanj ter odgovore, ki jih je o primerih resne poškodbe jeter, o kateri so poročali v povezavi z zdravilom Esmya, predložil imetnik dovoljenja za promet z zdravilom.
The therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on results from another study providing data for up to 4 intermittent treatment courses of 3 months each with ulipristal acetate along with data for repeated treatment courses from the previous studies.
Terapevtska indikacija za intermitentno zdravljenje zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi je temeljila na rezultatih druge študije, kjer so zbrali podatke za do štiri trimesečna intermitentna zdravljenja z ulipristalacetatom ter podatke o ponovljenih zdravljenjih iz prejšnjih študij.
Given the estimated exposure to Esmya of approximately 175,000 patient years, the number of cases of subacute severe liver impairment leading to liver transplantation with Esmya appears higher than expected, although background incidence on drug induced liver injury is uncertain.
Glede na ocenjeno izpostavljenost zdravilu Esmya približno 175.000 bolnik-let se zdi število primerov subakutne hude okvare jeter, ki je privedla do presaditve jeter, pri zdravilu Esmya višje od pričakovanega, čeprav je osnovna incidenca z zdravili povzročene poškodbe jeter nejasna.
Considering all these factors, in order to recommend the measure that would be the most proportionate, the PRAC concluded to provisionally limit the use of the medicinal product to patients that are currently under therapeutic treatment.
Da bi priporočil ukrep, ki bi bil najbolj sorazmeren, je odbor PRAC ob upoštevanju vseh teh dejavnikov sklenil, da porabo zdravila začasno omeji na bolnike, ki se z njim trenutno zdravijo terapevtsko.
The impact of the new safety findings in the currently authorised indications of Esmya cannot be evaluated with certainty at present in view of the limited data available.
Ker so na voljo samo omejeni podatki, vpliva novih izsledkov o varnosti pri trenutno odobrenih indikacijah za zdravilo Esmya trenutno ni mogoče z gotovostjo ovrednotiti.
In patients suffering from heavy menstrual bleeding associated with uterine fibroids, repeated 3-month treatment courses with ulipristal acetate provide a medical alternative to surgery and have the potential to reduce the need for surgical intervention.
Pri bolnicah, ki so imele močno menstruacijsko krvavitev, povezano z materničnimi fibroidi, je večkratno trimesečno zdravljenje z ulipristalacetatom pomenilo alternativo kirurškemu zdravljenju in možnost za zmanjšanje potrebe po kirurškem posegu.
In view of the above, the Committee considers that the benefit-risk balance of Esmya remains favourable subject to the agreed provisional measures.
Odbor je glede na zgoraj navedeno menil, da je razmerje med tveganji in koristmi zdravila Esmya še naprej ugodno, če se upoštevajo dogovorjene začasne spremembe informacij o zdravilu.
The clinical efficacy of ulipristal acetate in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on short-term studies demonstrating the ability of the active substance to reduce fibroid-related bleeding, anaemia and fibroid size if administered in a daily dose of 5 mg for up to three months.
Klinična učinkovitost ulipristalacetata pri predoperacijskem zdravljenju zmernih do hudih simptomov materničnih fibroidov pri odraslih ženskah v rodni dobi temelji na kratkotrajnih študijah, ki so pokazale zmožnost zdravilne učinkovine za zmanjševanje s fibroidi povezanih krvavitev, anemije in velikosti fibroidov ob trimesečnem vsakodnevnem dajanju 5-miligramskega odmerka.