natgillin/translations-raw huggingface dataset:
[The sentence below should be inserted only where the marketing authorisation currently includes indications for the epilepsy and/or bipolar disorder].
[Spodnji stavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo epilepsija in/ali bipolarna motnja.]
[The paragraph below should be included in this section where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
[Spodnji stavek je treba vstaviti v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov]
Do not stop taking your medicine until your doctor tells you to. [The text below should be inserted in all indications].
Ne prenehajte jemati zdravila, dokler vam tega ne naroči zdravnik.
[The following sentence should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks] In women planning to become pregnant or who are pregnant valproate therapies should be stopped.
[Spodnji odstavek je treba vključiti v to poglavje v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov] Zdravljenje z zdravilom <Izmišljeno ime> sme uvesti in nadzorovati le specialist, ki ima izkušnje z vodenjem migrene.
Further information on Bavencio can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bavencio.
Nadaljnje informacije za zdravilo Bavencio so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/bavencio.
If no reactions have occurred by the fourth infusion, the treating doctor may decide to stop giving these medicines before subsequent infusions.
Če do četrte infuzije ne pride do nobene reakcije, se lahko lečeči zdravnik odloči, da bo ta zdravila pred naslednjimi infuzijami nehal dajati.
Bavencio received a conditional marketing authorisation valid throughout the European Union on 18 September 2017.
Za zdravilo Bavencio je bilo 18. septembra 2017 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Bavencio?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bavencio?
The European Medicines Agency decided that Bavencio's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Bavencio večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
As for all medicines, data on the use of Bavencio are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Bavencio stalno spremljajo.
Patients with MCC that has spread and come back after initial treatment with chemotherapy have very limited treatment options.
Bolniki s KMC, ki se je razširil in se po začetnem zdravljenju s kemoterapijo znova pojavil, imajo zelo omejene možnosti zdravljenja.
Although the response rates to Bavencio are not outstanding, the duration of the response (at least 6 months) is important for these patients, since the responses seen with chemotherapy medicines are of shorter duration.
Čeprav stopnja odziva na zdravilo Bavencio ni izjemna, je za te bolnike trajanje odziva (vsaj šest mesecev) pomembno, saj je trajanje odzivov, opaženih pri kemoterapevtskih zdravilih, krajše.
Other information about Bavencio
Druge informacije o zdravilu Bavencio
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bavencio have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Bavencio upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Why is Bavencio authorised in the EU?
Zakaj je bilo zdravilo Bavencio odobreno v EU?
An overview of Bavencio and why it is authorised in the EU
Pregled zdravila Bavencio in zakaj je odobreno v EU
Side effects reported with Bavencio are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Bavencio, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
In both its uses, Bavencio is given in a dose of 800 mg once every 2 weeks as an infusion (drip) into a vein that lasts around 1 hour..
Pri obeh vrstah uporabe se zdravilo Bavencio daje v odmerku 800 mg enkrat vsake dva tedna z infundiranjem (kapalno infuzijo) v veno, ki traja približno eno uro.
Longer follow-up was needed to draw a reliable conclusion on how well patients given Bavencio and axitinib survive overall.
Potrebno je daljše nadaljnje opazovanje, da bi lahko prišli do zanesljivega zaključka o tem, kako dobro je na splošno preživetje bolnikov, ki so prejemali zdravilo Bavencio in aksitinib.
Treatment should continue as long as the patient benefits from it or side effects become unacceptable.
Zdravljenje se nadaljuje, dokler bolniku koristi oziroma do pojava nesprejemljivih neželenih učinkov.
The side effects of the combination were consistent with what was expected, and were considered acceptable given the nature of the condition being treated.
Neželeni učinki kombinacije so sorazmerni s pričakovanimi in veljajo za sprejemljive glede na zdravljeno bolezen.
For more information about using Bavencio, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Bavencio glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What is Bavencio and what is it used for?
Kaj je zdravilo Bavencio in za kaj se uporablja?
What benefits of Bavencio have been shown in studies?
Kakšne koristi zdravila Bavencio so se pokazale v študijah?
Although the dose of Bavencio in these studies was based on the patients' body weight, the company also supplied supporting data to show that Bavencio could be given in a standard dose, regardless of weight.
Čeprav je odmerek zdravila Bavencio v teh študijah temeljil na telesni masi bolnikov, je podjetje predložilo tudi podporne podatke, iz katerih je razvidno, da se zdravilo Bavencio lahko daje v standardnem odmerku, ne glede na telesno maso.
What are the risks associated with Bavencio?
Kakšna tveganja so povezana z zdravilom Bavencio?
In addition, early data from an ongoing study indicate that the majority of patients who have not had previous chemotherapy also respond to treatment with Bavencio, with a similar duration of response.
Poleg tega zgodnji podatki iz potekajoče študije kažejo, da se večina bolnikov, ki se predhodno niso zdravili s kemoterapijo, tudi odziva na zdravljenje z zdravilom Bavencio, pri čemer je trajanje odziva podobno.
The company that markets Bavencio will issue educational materials for patients containing important information about possible side effects of Bavencio, particularly immune-related reactions, and how to manage them.
Podjetje, ki trži zdravilo Bavencio, bo izdalo izobraževalno gradivo za bolnike, v katerem bodo navedene pomembne informacije o možnih neželenih učinkih zdravila Bavencio, še posebej reakcije, povezane z imunskim sistemom, in načini njihovega obvladovanja.
For MCC, Bavencio has been given ‘conditional approval'.
Za zdravljenje KMC je zdravilo Bavencio pridobilo „pogojno dovoljenje za promet“.
The average time patients lived without their disease getting worse was around 13 months in those given Bavencio and axitinib versus 8 months in those given sunitinib.
Povprečni čas, ko so bolniki živeli brez poslabšanja bolezni, je bil približno 13 mesecev pri tistih, ki so prejemali zdravilo Bavencio in aksitinib, v primerjavi z osmimi meseci pri bolnikih, ki so prejemali sunitinib.
The active substance in Bavencio, avelumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand-1' (PD-L1), which is present on the surface of many cancer cells.
Učinkovina v zdravilu Bavencio, avelumab, je monoklonsko protitelo, vrsta beljakovine, zasnovane tako, da prepozna beljakovino, imenovano „ligand 1 za receptor programirane celične smrti 1“ (PD-L1), ki je prisotna na površini številnih rakavih celic, in se veže nanjo.
Bavencio can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the treatment of cancer.
Predpisovanje in izdaja zdravila Bavencio je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
PD-L1 usually attaches to cells of the immune (defence) system called T cells, preventing the T cells from attacking the cancer cells.
PD-L1 se veže na celice imunskega (obrambnega) sistema, imenovane celice T, katerim preprečuje, da bi napadle rakave celice.
By attaching to PD-L1, Bavencio prevents the cancer cells from switching off the T cells, thereby increasing the ability of the T cells to kill the cancer cells.
Z vezavo na PD-L1 zdravilo Bavencio prepreči, da bi rakave celice onemogočile delovanje celic T, s čimer poveča sposobnost celic T za uničevanje rakavih celic.
The safety of Bavencio for this use is considered acceptable and side effects manageable with the additional measures put in place.
Varnost zdravila Bavencio pri tej uporabi velja za sprejemljivo, neželeni učinki pa za obvladljive, če so vzpostavljeni dodatni ukrepi.
Since Bavencio has been granted a conditional approval for MCC, the company that markets the medicine will provide further data from the ongoing study of patients who did not receive chemotherapy before starting treatment with Bavencio.
Ker je zdravilo Bavencio pridobilo pogojno dovoljenje za promet za zdravljenje KMC, bo podjetje, ki ga trži, zagotovilo nadaljnje podatke iz potekajoče študije o bolnikih, ki pred začetkom zdravljenja z zdravilom Bavencio niso prejemali kemoterapije.
Serious side effects include immune-related and infusion-related reactions, anaemia (low red blood cell counts), difficulty breathing and abdominal pain.
Hudi neželeni učinki vključujejo reakcije, povezane z imunskim sistemom in infuzijo, anemijo (nizko število rdečih krvnih celic), težave z dihanjem in bolečine v trebuhu.
Bavencio is a cancer medicine used to treat adults with Merkel cell carcinoma (MCC), a type of skin cancer, when the cancer has spread to other parts of the body.
Bavencio je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih s karcinomom Merklovih celic (KMC), vrsto kožnega raka, ki se je razširil na druge dele telesa.
In a main study involving 886 patients with advanced RCC, who had not been previously treated, Bavencio infusion in combination with axitinib by mouth was compared with standard treatment using another cancer medicine, sunitinib.
V glavni študiji, v katero je bilo vključenih 886 bolnikov z napredovalim KLC, ki predhodno niso bili zdravljeni, so infundiranje zdravila Bavencio v kombinaciji z aksitinibom, vzetim peroralno, primerjali s standardnim zdravljenjem z drugim zdravilom za zdravljenje raka, in sicer s sunitinibom.
In a main study involving 88 patients with metastatic MCC who had received previous treatment with chemotherapy (cancer medicines), around 33% of patients (29 out of 88) were considered to have had a reduction in tumour size or no sign of it after treatment with the medicine; in most of these patients, the response lasted for at least 6 months.
V glavni študiji, ki je vključevala 88 bolnikov z metastatskim KMC, predhodno zdravljenih s kemoterapijo (zdravili za zdravljenje raka), se je po zdravljenju z zdravilom Bavencio pri približno 33 % (29 od 88) bolnikov tumor zmanjšal ali izginil; pri večini teh bolnikov je odziv trajal vsaj šest mesecev.
For the full list of side effects and restrictions of Bavencio, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Bavencio glejte navodilo za uporabo.
What information is still awaited for Bavencio?
Katere informacije o zdravilu Bavencio še pričakujemo?
Before the first 4 infusions of Bavencio, the patient receives an antihistamine and paracetamol to help prevent infusion-related reactions, such as reddening of the skin, chills, fever, back or abdominal (belly) pain, allergic reactions and difficulty breathing.
Bolnik pred prvimi štirimi infuzijami zdravila Bavencio prejme antihistaminik in paracetamol za preprečevanje reakcij, povezanih z infuzijo, kot so pordelost kože, mrzlica, povišana telesna temperatura, bolečine v hrbtu ali trebuhu, alergijske reakcije in težave z dihanjem.
In patients with advanced RCC, Bavencio plus axitinib has been shown to improve the length of time patients survive without their disease getting worse, when compared with sunitinib, though how long patients survive overall remains to be shown.
Pri bolnikih z napredovalim KLC je zdravilo Bavencio v kombinaciji z aksitinibom v primerjavi s sunitinibom podaljšalo čas preživetja bolnikov brez poslabšanja bolezni, vendar je treba še dokazati, kako dolgo preživijo na splošno.
How does Bavencio work?
Kako zdravilo Bavencio deluje?
When Bavencio is used with axitinib the most common side effects of the combination, which may affect more than 1 in 5 people, are diarrhoea, high blood pressure, tiredness, nausea, dysphonia (hoarseness), decreased appetite, hypothyroidism (reduced thyroid function), cough, headache, breathing difficulties and arthralgia (joint pain).
Kadar se zdravilo Bavencio uporablja z aksitinibom, so najpogostejši neželeni učinki te kombinacije, ki lahko prizadenejo več kot 1 osebo od 5, driska, visok krvni tlak, utrujenost, navzeja, disfonija (hripavost), zmanjšan apetit, hipotiroizem (zmanjšano delovanje ščitnice), kašelj, glavobol, težave z dihanjem in artralgija (bolečine v sklepih).
Early results from an ongoing study looking at the effects of Bavencio in patients with metastatic MCC who had not received previous chemotherapy showed that the overall response rate at the time of analysis was 62% (18 out of 29 patients).
Pri opazovanju učinkov zdravila Bavencio pri bolnikih z metastatskim KMC, ki predhodno niso bili zdravljeni s kemoterapijo, so zgodnji rezultati potekajoče študije pokazali, da je stopnja skupnega odziva v času analize znašala 62 % (18 od 29 bolnikov).
Bavencio has been shown to be of benefit in one main study that showed the cancer shrank in patients with MCC and one that showed patients with RCC could live longer without their disease getting worse.
Zdravilo Bavencio se je izkazalo koristno v eni glavni študiji, kjer se je rak pri bolnikih s KMC zmanjšal, v drugi glavni študiji pri bolnikih z KLC pa so bolniki živeli dlje brez poslabšanja bolezni.
Treatment may need to be delayed or stopped if certain side effects occur.
Če se pojavijo nekateri neželeni učinki, bo zdravljenje morda treba ustaviti ali prekiniti.
Bavencio is also used in combination with another cancer medicine, axitinib, for the initial treatment of patients with advanced renal cell carcinoma (RCC, a cancer of the kidney).
Uporablja se tudi v kombinaciji z drugim zdravilom za zdravljenje raka, aksitinibom, za začetno zdravljenje bolnikov z napredovalim karcinomom ledvičnih celic (KLC, rakom ledvic) Zdravilo Bavencio vsebuje učinkovino avelumab.
The most common side effects with Bavencio used alone (which may affect more than 1 in 10 people) include tiredness, nausea (feeling sick), diarrhoea, decreased appetite, constipation, infusion-related reactions, weight loss and vomiting.
Najpogostejši neželeni učinki zdravila Bavencio, uporabljenega samostojno, (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so utrujenost, navzeja (siljenje na bruhanje), driska, zmanjšan apetit, zaprtost, z infuzijo povezane reakcije, izguba telesne mase in bruhanje.
How is Bavencio used?
Kako se zdravilo Bavencio uporablja?
Drink plenty of water
Pijte veliko vode
Each cycle was 28 days.
Vsak cikel je trajal 28 dni.
For the first 4 weeks you will get a new pack each week.
prvih 4 tednih boste vsak teden dobili novo pakiranje.
It also slows down the worsening of the disease.
Upočasni tudi poslabšanje bolezni.
This is because it has not been studied in these age groups.
To pa zato, ker njegove uporabe pri teh starostnih skupinah niso preučevali.
• you think you may have an infection or have had a long-lasting or repeated infection
• menite, da bi lahko imeli okužbo ali pa ste v preteklosti imeli dolgotrajno ali ponavljajočo okužbo,
Overall Survivale
Celokupno preživetjee
Date of first authorisation: 5 December 2016 Date of latest renewal: 6 September 2018
Datum prve odobritve: 5. december 2016 Datum zadnjega podaljšanja: 6. september 2018
This may affect your ability to father a child.
To lahko vpliva na vašo sposobnost, da zaplodite otroka.
This is because they can increase the amount of venetoclax in your blood.
To pa zato, ker lahko povečajo količino venetoklaksa v krvi.
Blood tests may also show
Krvne preiskave lahko pokažejo tudi
This is to see if you can continue to take this medicine safely.
To je zato, da se ugotovi, ali lahko še naprej varno jemljete to zdravilo.
NE=not evaluable.
NE=ni možno oceniti (not evaluable).
The prophylaxis measures listed below should be followed.
Upoštevati je treba spodaj navedene ukrepe za profilakso.
Reversibility of this finding has not been demonstrated.
Reverzibilnost te spremembe ni dokazana.
17p deletion status was determined based on central laboratory test results.
Status delecije 17p je določen na osnovi rezultatov osrednjih laboratorijskih testov.
A risk to the breast-feeding child cannot be excluded.
Tveganja za dojene otroke ni mogoče izključiti.
Take the tablets and this leaflet with you.
Vzemite tablete in to navodilo s seboj.
Do not stop taking this medicine unless your doctor tells you to.
Ne prenehajte jemati tega zdravila, razen če vam zdravnik ne naroči tako.
In CLL, the lymphocytes multiply too quickly and live for too long, so that there are too many of them in the blood.
Pri KLL se limfociti množijo prehitro in živijo predolgo, tako da jih je v krvi preveč.
Grade ≥3a
Stopnja ≥3a
Alternative treatments should be considered.
Treba je razmisliti o alternativnih zdravljenjih.
Response assessments were performed at 8 weeks, 24 weeks, and every 12 weeks thereafter.
Odziv so ocenili po 8 in 24 tednih, nato pa vsakih 12 tednov.
More intensive measures should be employed as overall risk increases.
Ob povečanju celokupnega tveganja je treba uporabiti bolj intenzivne ukrepe.
Electrolyte abnormalities should be corrected promptly.
Nepravilnosti elektrolitov je treba popraviti takoj.
It is important to follow all of the instructions in the ‘how to take' section of the leaflet.
Pomembno je, da sledite navodilom v poglavju ‘Kako jemati' navodila za uporabo.
IRC assessed
Ocena IRC
Hospitalisation should be considered for subsequent dose increases based on reassessment of risk.
O hospitalizaciji je treba razmisliti pri naslednjih povečanjih odmerka, in sicer na podlagi ponovne ocene tveganja.
The population estimate for the terminal phase elimination half-life of venetoclax was approximately 26 hours.
Populacijska ocena eliminacijskega razpolovnega časa terminalne faze venetoklaksa je približno 26 ur.
Complete blood counts should be monitored throughout the treatment period.
Skozi celotno obdobje zdravljenja je treba spremljati kompletno krvno sliko.
• lower number of red blood cells
• manjše število rdečih krvnih celic
Efficacy results are shown in Table 6.
Rezultati učinkovitosti so prikazani v preglednici 6.
After approximately 3 months of daily dosing in dogs, venetoclax caused progressive white discoloration of the hair coat, due to loss of melanin pigment in the hair.
Po približno 3 mesecih vsakodnevne uporabe pri psih je venetoklaks povzročil progresivno belo razbarvanje dlake zaradi izgube melaninskega barvila v dlaki.
The tablets should not be chewed, crushed, or broken before swallowing.
Tablet se ne sme žvečiti, drobiti ali lomiti, preden se jih pogoltne.
• During the first 5 weeks of treatment, you should take the tablets in the morning to help you follow-up with blood tests, if needed.
• v prvih 5 tednih zdravljenja jemljite tablete zjutraj, da se boste lažje dogovorili glede krvnih preiskav, če bo potrebno.
Low white blood cell count can increase your risk for infection.
Majhno število belih krvnih celic lahko poveča tveganje za okužbo.
Blocking this protein helps to kill and lower the number of cancer cells.
Zaviranje te beljakovine pomaga pri ubijanju in zmanjševanju števila rakavih celic.
• severe infection in the blood (sepsis)
• huda okužba krvi (sepsa)
Live vaccines should not be administered during treatment and thereafter until B-cell recovery.
Živih cepiv se ne sme dajati med zdravljenjem in pozneje, vse do povrnitve celic B.
Investigator assessment (N=158)b
Ocena raziskovalca (N = 158)b
The safety and efficacy of venetoclax in children aged less than 18 years have not been established.
Varnost in učinkovitost venetoklaksa pri otrocih, starih manj kot 18 let, nista bili dokazani.
• ritonavir for HIV infection.
• ritonavir pri okužbi s HIV.
Results of subgroup analyses
Rezultati analize podskupin
When your Venclyxto dose has been increased to the full standard dose, check with your doctor if you can start taking these medicines again.
Ko bo odmerek zdravila Venclyxto povečan do celotnega standardnega odmerka, s svojim zdravnikom preverite, če lahko znova začnete jemati ta zdravila.
The estimated PFS rate at 6 months post treatment was 92%.
Ocenjena vrednost PFS 6 mesecev po zdravljenju je bila 92 %.
- you are allergic to the active substance venetoclax or any of the other ingredients of this medicine (listed in section 6).
- ste alergični na učinkovino venetoklaks ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Additional efficacy results for the pre-specified primary analysis are shown in Table 5 and Figure 2 and Figure 3.
Dodatni rezultati učinkovitosti za vnaprej določeno primarno analizo so prikazani v preglednici 5, na sliki 2 in sliki 3.
Table 2: Dose modification for TLS and other toxicities
Preglednica 2: Prilagoditev odmerka zaradi TLS in drugih toksičnosti
Frequency (all grades)a
Pogostnost (vse stopnje)a
Summary of safety profile
Povzetek varnostnega profila zdravila
This will help to remove cancer cell breakdown products from your blood through your urine.
To bo pomagalo, da se produkti razgradnje rakavih celic iz krvi odstranjujejo z urinom.
Your doctor will gradually increase the dose over the next 4 weeks to the full standard dose.
Zdravnik vam bo v naslednjih štirih tednih postopoma povečal odmerek do celotnega standardnega odmerka.
Your doctor, pharmacist or nurse will do blood tests to check for TLS.
Zdravnik, farmacevt ali medicinska sestra vam bodo opravili krvne preiskave za ugotavljanje TLS.
Unstratified hazard ratio is displayed on the X-axis with logarithmic scale.
Nerazčlenjeno razmerje tveganja je prikazano na osi X z logaritmično lestvico.
Time to next anti-leukaemic therapy Number of events (%)
Čas do naslednjega zdravljenja levkemije Število dogodkov (%)
Dose at interruption (mg)
Odmerek ob prekinitvi (mg)
Patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics.
Bolnike je treba oceniti glede tveganja in dobiti morajo ustrezno profilakso za TLS, vključno s hidracijo in antihiperurikemiki.
This is because serious and life-threatening effects can occur when Venclyxto is taken with these medicines:
To je zato, ker se lahko pojavijo resni in življenje ogrožajoči učinki, če se zdravilo Venclyxto vzame s temi zdravili:
Arm B (idelalisib failures) (N=36)
Skupina B (neuspeh z idelalisibom) (N = 36)
Both B- and T-cells were affected, but the most significant decreases occurred with B-cells.
Prizadete so bile tako celice B kot celice T, toda najpomembnejše je bilo zmanjšanje števila celic B.
There are no adequate and well-controlled data from the use of venetoclax in pregnant women.
Ni dovolj ustreznih in dobro preverjenih podatkov o uporabi venetoklaksa pri nosečnicah.
Venclyxto should not be used in children and adolescents.
Zdravila Venclyxto se pri otrocih in mladostnikih ne sme uporabljati.