natgillin/translations-raw huggingface dataset:
The full EPAR for Selincro 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 Selincro je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
As a guide: a bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g alcohol.
Kot vodilo: steklenica vina (750 ml; 12 vol. % alkohola) vsebuje približno 70 g alkohola, steklenica piva (330 ml; 5 vol. % alkohola) pa vsebuje približno 13 g alkohola.
At the patient's initial visit to their doctor, the patient's overall health, alcohol dependence, and level of alcohol consumption (based on patient reporting) will be evaluated.
Ob prvem obisku bolnika pri zdravniku se ovrednoti njegovo splošno zdravstveno stanje, odvisnost od alkohola in stopnjo uživanja alkohola (na podlagi bolnikovega poročanja).
This is a summary of the European public assessment report (EPAR) for Selincro.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Selincro.
The main measures of effectiveness were the reduction in the number of heavy drinking days and the average daily alcohol consumption after six months of treatment.
Glavno merilo učinkovitosti je bilo zmanjšanje števila dni prekomernega pitja in povprečne količine dnevno zaužitega alkohola po šestih mesecih zdravljenja.
Thereafter, the patient will be asked to record his or her alcohol consumption for approximately two weeks.
Zatem se bolnika pozove, da približno dva tedna beleži svoje uživanje alkohola.
The most common side effects (seen in more than 1 patient in 10) were nausea (feeling sick), dizziness, insomnia (difficulty sleeping) and headache.
Najpogostejši neželeni učinki zdravila (opaženi pri več kot 1 od 10 bolnikov) so bili navzea (slabost), omotica, nespečnost (težave s spanjem) in glavobol.
It should only be used together with psychosocial support (counselling) and only in people who do not have physical withdrawal symptoms and who do not require immediate detoxification.
Uporablja se lahko samo sočasno s psihosocialno podporo (svetovanjem) in samo pri bolnikih, ki nimajo fizičnih odtegnitvenih simptomov in ne potrebujejo takojšnje detoksifikacije.
The effects of Selincro were first tested in experimental models before being studied in humans.
Učinki zdravila Selincro so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The patient should take one Selincro tablet by mouth ‘as needed', which means when there is a risk that they would start drinking.
Bolnik mora vzeti eno tableto zdravila Selincro peroralno „po potrebi“, tj. ko obstaja tveganje, da bi bolnik začel piti alkohol.
For more information about treatment with Selincro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Selincro preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Selincro was compared with placebo (a dummy treatment) in two main studies involving 1,322 men and women with alcohol dependence.
Zdravilo Selincro so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, ki sta vključevali 1 322 moških in žensk z odvisnostjo od alkohola.
If the patient has started drinking without Selincro, a tablet should be taken as soon as possible.
Če je bolnik začel piti alkohol, ne da bi vzel zdravilo Selincro, mora vzeti tableto v najkrajšem možnem času.
The CHMP decided that Selincro's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Selincro večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The active substance in Selincro, nalmefene, attaches to certain opioid receptors in the brain.
Zdravilna učinkovina v zdravilu Selincro, nalmefen, se veže na nekatere opioidne receptorje v možganih.
Opioid receptors play a role in addiction and, by attaching to them and modifying their activity, nalmefene helps reduce the urge to drink in people accustomed to large amounts of alcohol.
Opioidni receptorji imajo pomembno vlogo pri zasvojenosti, zato nalmefen, ki se veže nanje in spremeni njihovo delovanje, pomaga zmanjšati potrebo po pitju pri bolnikih, ki so navajeni uživati velike količine alkohola.
Selincro does not prevent the intoxicating effects of alcohol.
Zdravilo Selincro ne preprečuje učinkov zastrupitve z alkoholom.
Selincro must not be used in people who are hypersensitive (allergic) to nalmefene or any of its other ingredients.
Zdravila Selincro ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) nalmefen ali katero koli drugo sestavino zdravila.
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 Selincro.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Selincro, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
All patients also received counselling to help them reduce their drinking and keep to their treatment.
Vsi bolniki so bili deležni tudi svetovanja, ki naj bi jim pomagalo zmanjšati pitje alkohola in držati se zdravljenja.
It must also not be used in patients with severe liver or kidney impairment or a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures (fits) and tremors).
Prav tako ga ne smejo uporabljati bolniki s hudo okvaro jeter ali ledvic in bolniki z nedavnim akutnim sindromom odtegnitve alkohola (ki vključuje halucinacije, epileptične napade (krče) in tremor).
In these patients, after six months, the number of heavy drinking days a month with Selincro fell from 23 to 10 in the first study and from 23 to 11 in the second.
Pri teh bolnikih se je po šestih mesecih jemanja zdravila Selincro število dni prekomernega pitja na mesec v prvi študiji zmanjšalo s 23 na 10, v drugi pa s 23 na 11.
Treatment must also include counselling to help the patient reduce their drinking and keep to their treatment.
Zdravljenje mora vključevati tudi svetovanje, ki bolniku pomaga zmanjšati pitje alkohola in se držati zdravljenja.
Before starting treatment with Selincro, the patient is asked to record their level of alcohol consumption over a two week period.
Pred začetkom zdravljenja z zdravilom Selincro mora bolnik dva tedna beležiti stopnjo uživanja alkohola.
What benefit has Selincro shown during the studies?
Kakšne koristi je zdravilo Selincro izkazalo med študijami?
Other information about Selincro
Druge informacije o zdravilu Selincro
Significant improvements, usually observed within the first four weeks of treatment, were seen in patients who were already consuming more than 60 g of alcohol per day (for men) or more than 40 g of per day (for women).
Pomembna izboljšanja, ki se običajno pojavijo v prvih štirih tednih zdravljenja, so opazili pri bolnikih, ki so že uživali več kot 60 g alkohola na dan (za moške) oziroma več kot 40 g na dan (za ženske).
Selincro was shown to be more effective than placebo in reducing the number of heavy drinking days and daily alcohol consumption.
Zdravilo Selincro je bilo učinkovitejše od placeba pri zmanjšanju števila dni prekomernega pitja in količine dnevno zaužitega alkohola.
It must not be used in patients taking opioid medicines, in patients who have a current or recent addiction to opioids, patients with acute opioid withdrawal symptoms, or in patients suspected to have used opioids recently.
Zdravila ne smejo uporabljati bolniki, ki jemljejo opioidna zdravila, bolniki s trenutno ali nedavno odvisnostjo od opioidov, bolniki z akutnimi simptomi odtegnitve opioidov in bolniki, pri katerih obstaja sum nedavne uporabe opioidov.
At the next visit (after the two weeks), Selincro may be started if the patient continues to have a high level of alcohol consumption (above 60 g per day for men and 40 g per day for women).
Pri naslednjem obisku (po dveh tednih) se lahko pri bolniku uvede zdravilo Selincro, če je njegova stopnja uživanja alkohola še vedno visoka (več kot 60 g na dan za moške in 40 g na dan za ženske).
What is the risk associated with Selincro?
Kakšna tveganja so povezana z zdravilom Selincro?
Selincro is used to help reduce alcohol consumption in adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women).
Zdravilo Selincro se uporablja za pomoč pri zmanjševanju uživanja alkohola pri odraslih z odvisnostjo od alkohola, ki uživajo več kot 60 g alkohola na dan (za moške) oziroma več kot 40 g na dan (za ženske).
Caution is advised if Selincro is prescribed for more than one year.
Če je zdravilo Selincro predpisano za več kot eno leto, je potrebna previdnost.
Selincro is medicine that contains the active substance nalmefene.
Selincro je zdravilo, ki vsebuje zdravilno učinkovino nalmefen.
Why has Selincro been approved?
Zakaj je bilo zdravilo Selincro odobreno?
Selincro can only be obtained by prescription.
Izdaja zdravila Selincro je le na recept.
Daily alcohol consumption with Selincro fell from 102 g to 44 g in the first study and from 113 g to 43 g in the second.
Količina dnevno zaužitega alkohola se je po jemanju zdravila Selincro v prvi študiji zmanjšala s 102 g na 44 g, v drugi pa s 113 g na 43 g. Izboljšanja so bila v primerjavi s placebom večja za približno 2,7 do 3,7 dni prekomernega pitja na mesec in za približno 10 do 18 g alkohola na dan.
How has Selincro been studied?
Kako je bilo zdravilo Selincro raziskano?
What is Selincro used for?
Za kaj se zdravilo Selincro uporablja?
How does Selincro work?
Kako zdravilo Selincro deluje?
What is Selincro?
Kaj je zdravilo Selincro?
The CHMP noted that Selincro was shown to be effective in reducing alcohol consumption in men drinking more than 60 g and women drinking more than 40 g a day.
CHMP je menil, da se je zdravilo Selincro izkazalo za učinkovito pri zmanjševanju uživanja alkohola pri moških, ki uživajo več kot 60 g, in pri ženskah, ki uživajo več kot 40 g alkohola na dan. Neželeni učinki, o katerih so poročali v študijah, niso vzbudili večjih pomislekov glede varnosti.
How is Selincro used?
Kako se zdravilo Selincro uporablja?
You may need medical help.
Morda boste potrebovali zdravstveno pomoč.
This means you should:
To pomeni, da se morate:
Symptoms you should be aware of
Simptomi, na katere morate biti pozorni
Date of first authorisation: 24 May 2018 Date of latest renewal: 13 March 2019
Datum prve odobritve: 24. maj 2018 Datum zadnjega podaljšanja: 13. marec 2019
• wear clothing that covers your head, arms and legs
• zaščititi z oblačili, ki pokrivajo vašo glavo, roke in noge.
CI: Confidence interval
IZ: Interval zaupanja
The results should be interpreted with caution due to the limited representation of some subgroup phenotypes.
Rezultate je treba tolmačiti previdno zaradi omejene zastopanosti nekaterih fenotipov v podskupinah.
This is because it may harm your unborn baby.
Škoduje namreč lahko vašemu nerojenemu otroku.
• Do not stop taking this medicine without talking to your doctor first.
• Ne prenehajte jemati tega zdravila, ne da bi se prej pogovorili z zdravnikom.
Therefore, use in this patient population is not recommended.
Zato se uporaba pri tej populaciji bolnic ne priporoča.
Median overall survival was not achieved in this population.
Mediano celokupno preživetje pri tej populaciji ni bilo doseženo.
A risk to the newborns/infants cannot be excluded.
Tveganja za novorojenčke/dojenčke ne moremo izključiti.
Patients, n
Bolnice, n
• Talk to your doctor or pharmacist about the most effective methods of contraception.
- Pogovorite se z zdravnikom ali farmacevtom o najučinkovitejših metodah kontracepcije.
The safety and efficacy of Rubraca in children or adolescents aged less than 18 years have not been established.
Varnost in učinkovitost zdravila Rubraca pri otrocih ali mladostnikih, mlajših od 18 let, nista bili dokazani.
Take care if you feel tired or feel sick (nauseous).
Bodite previdni, če se počutite utrujeni ali če vam je slabo.
NA: Not Achieved
NA: Ni doseženo (not achieved).
• It is important to keep taking Rubraca every day - as long as your doctor prescribes it for you.
• Pomembno je, da zdravilo Rubraca jemljete vsak dan, toliko časa, kot vam je to predpisal zdravnik.
Your doctor may also do weekly tests, if you have low blood cell counts for a long time.
Zdravnik lahko izvaja tudi tedenske preiskave, če imate nizko število krvnih celic dlje časa.
Censoring N (%)
Cenzorirano N (%)
Treatment was continued until disease progression or unacceptable toxicity.
Zdravljenje je trajalo do napredovanja bolezni ali do nesprejemljive toksičnosti.
• if you are allergic to rucaparib or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na rukaparib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Your doctor or nurse will perform blood tests to check your blood cell-counts:
Zdravnik ali medicinska sestra bosta izvedla krvne preiskave, da bosta preverila število krvnih celic v vaši krvi:
See section 5.2.
Glejte poglavje 5.2.
The signs and symptoms of low blood cell counts include fever, infection, bruising or bleeding.
Znaki in simptomi nizkega števila krvnih celic vključujejo vročino, okužbo, podplutbe ali krvavitev.
At the time of the analysis of PFS, OS data were not mature (with 22% of events).
V času analize PFS podatki o OS še niso bili zaključeni (z 22 % dogodkov).
A total of 32% of patients were in complete response (CR) to their most recent therapy.
Skupaj 32 % bolnic je bilo popolnoma odzivnih (CR) v njihovem zadnjem zdravljenju.
If you have certain side effects your doctor may recommend a lower dose, or temporarily stop your treatment.
Če se pri vas pojavijo določeni neželeni učinki, vam lahko zdravnik priporoči nižji odmerek ali pa začasno prekine zdravljenje.
• Take the tablets once in the morning and once in the evening, approximately 12 hours apart.
- Vzemite en odmerek tablet zjutraj in enega zvečer, s približno 12-urnim razmakom.
Mechanism of action and pharmacodynamics effects
Mehanizem delovanja in farmakodinamični učinki
An analysis of progression-free survival (PFS) was also performed.
Opravili so tudi analizo preživetja brez napredovanja bolezni (PFS - progression-free survival).
Efficacy results from all patients treated are summarized in Table 5.
Rezultati učinkovitosti pri vseh zdravljenih bolnicah so povzeti v Preglednici 5.
Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Takoj obvestite zdravnika, če opazite katerega koli od naslednjih neželenih učinkov, saj boste morda potrebovali nujno zdravniško pomoč:
Pharmacokinetics in specific populations
Farmakokinetika pri posebnih populacijah
This means you take a total of 1,200 mg each day.
To pomeni, da vsak dan skupno vzamete 1.200 mg zdravila.
IRR- assessment for the ITT population supported the primary endpoint.
Ocena IRR za populacijo ITT je podprla primarni opazovani dogodek.
These increases in serum creatinine were clinically asymptomatic.
Ta povišanja ravni kreatinina v serumu so bila klinično asimptomatska.
These reactions are manageable with routine medical treatment and/or dose adjustment for more severe cases.
Te učinke je mogoče obvladovati z rutinskim zdravljenjem in/ali prilagoditvijo odmerka pri hujših primerih.
Take care in direct sunlight
Na neposredni sončni svetlobi bodite previdni.
It is important to proactively manage these events to avoid prolonged or more severe events of nausea/vomiting which have the potential to lead to complications such as dehydration or hospitalisation.
Te dogodke je pomembno proaktivno obvladovati, da se izognemo dolgotrajnim ali hujšim dogodkom navzee/bruhanja, ki lahko privedejo do zapletov, kot sta dehidracija ali hospitalizacija.
BRCA status based on a local test was known for some patients at the time of enrollment.
Status BRCA na podlagi lokalnih testov je bil za nekatere bolnice znan v času vključitve.
These may be signs and symptoms that Rubraca is affecting your stomach.
To so lahko znaki in simptomi, da zdravilo Rubraca vpliva na vaš želodec.
Primary Efficacy N=106
N = 106
• red blood-cells, white blood-cells, or platelets.
• rdečih krvnih celic, belih krvnih celic ali krvnih ploščic.
Efficacy results are summarised in Table 4 and Figure 1.
Rezultati za učinkovitost so povzeti v Preglednici 4 in na sliki 1.
These findings occurred at exposures below those observed in patients treated at the recommended dose, and were largely reversible within 4 weeks of cessation of dosing.
Ti izsledki so se pojavili pri izpostavljenostih, nižjih od tistih, ki so jih opazili pri bolnicah, zdravljenih s priporočenim odmerkom, in so bili v veliki meri reverzibilni v 4 tednih po prekinitvi odmerjanja.
Investigator Assessment
Ocena raziskovalca
In the event of suspected overdose, physicians should follow general supportive measures and should treat symptomatically.
V primeru suma na preveliko odmerjanje morajo zdravniki uporabiti splošne podporne ukrepe in simptomatsko zdravljenje.
The absolute oral bioavailability at 600 mg has not been determined.
Absolutne peroralne biološke uporabnosti pri odmerku 600 mg niso ugotovili.
There are limited clinical data in patients aged 75 or over.
Klinični podatki o bolnicah, starih 75 let ali več, so omejeni.
Although no cases were reported during therapy in patients who received placebo, one case has been reported in a placebo - treated patient during the long term safety follow up.
Čeprav med zdravljenjem pri bolnicah, ki so prejemale placebo, niso poročali o nobenem primeru, so o enem primeru pri bolnici, ki se je zdravila s placebom, poročali med dolgoročnim spremljanjem varnosti.
The majority of adverse reactions were mild to moderate (Grade 1 or 2).
Večina neželenih učinkov je bila blagih do zmernih (stopnje 1 ali 2).
The only serious adverse reaction occurring in > 2% of patients was anaemia (5%).
Edini resen neželeni učinek, ki se je pojavil pri > 2 % bolnic, je bil anemija (5 %).
The doses should be taken approximately 12 hours apart.
Med odmerkoma naj bo približno 12-urni razmak.
Rucaparib may only be used in patients with severe renal impairment if the potential benefit outweighs the risk.
Rukaparib se sme pri bolnicah s hudo okvaro ledvic uporabljati le, če morebitne koristi odtehtajo tveganja.
For the platinum-refractory population (N=7), there were no responders.
Med populacijo, neodzivno na platino (N=7), ni bilo odzivnih bolnic.
Patients with changes (mutations) in genes called BRCA are at risk of developing a number of types of cancer.
Pri bolnicah s spremembami (mutacijami) genov, imenovanih BRCA, obstaja tveganje za pojav številnih vrst raka.
These events occurred within the first few weeks of treatment with rucaparib, were reversible, and were rarely associated with increases in bilirubin.
Ti dogodki so se pojavili v prvih tednih zdravljenja z rukaparibom, bili so reverzibilni in redko povezani s povišanji bilirubina.
The primary efficacy outcome measure of both studies was objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1.
Glavno merilo izida učinkovitosti je v obeh študijah predstavljala stopnja objektivnega odziva (objective response rate - ORR), kot jo je ocenil raziskovalec glede na merila RECIST, različica 1.1.
Other minor metabolites accounted for 13.8% of the radioactivity in plasma.
Drugi manjši presnovki so predstavljali 13,8 % radioaktivnosti v plazmi.
Treatment with rucaparib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Zdravljenje z rukaparibom mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
Following repeated twice daily dosing, the accumulation based on AUC ranged from 3.5 to 6.2 fold.
Po večkratnem odmerjanju dvakrat na dan je bilo kopičenje glede na vrednost AUC od 3,5- do 6,2-kratno.
Age, race, and body weight
Starost, rasa in telesna masa
The food effect on PK was not considered clinically significant.
Učinek hrane na farmakokinetiko se ne šteje za klinično pomembnega.
Recommended dose adjustments Dose reduction
Priporočene prilagoditve odmerkov Zmanjšanje odmerkov Odmerek
Grade 4
Stopnja 4
• every month during treatment with Rubraca
• vsak mesec med zdravljenjem z zdravilom Rubraca
• You can take the tablets with or without food.
- Tablete lahko vzamete s hrano ali brez nje.
They may stop treatment with Rubraca until your blood cell counts improve.
Odloči se lahko za prekinitev zdravljenja z zdravilom Rubraca, dokler se število celic v vaši krvi ne izboljša.
Pregnant women should be informed of the potential risk to a foetus.
Nosečnice je treba opozoriti na potencialno tveganje za plod.
Greater sensitivity of some elderly patients (≥ 65 years of age) to adverse events cannot be ruled out.
Večje občutljivosti za neželene učinke pri nekaterih starejših bolnicah (≥ 65 let) ni mogoče izključiti.
Breast-feeding (see section 4.6)
Dojenje (glejte poglavje 4.6)
It is used after the cancer has responded to previous chemotherapy treatments.
Uporabljamo ga potem, ko se je rak odzval na predhodna zdravljenja s kemoterapijo.
Demographics, baseline disease characteristics, and prior treatment history were generally well balanced between the rucaparib and placebo arms.
Demografski podatki, značilnosti bolezni v izhodišču in zgodovina predhodnih zdravljenj so bili na splošno dobro uravnoteženi med skupinama, ki sta prejemali rukaparib in placebo.
Four (5.1%) of 79 platinum sensitive patients overall had progressive disease as best response.
Pri štirih (5,1 %) od skupaj 79 na platino občutljivih bolnic je bil najboljši odziv progresivna bolezen.
Steady state was achieved after 1 week of dosing.
Stanje dinamičnega ravnovesja je bilo doseženo po 1-tedenskem odmerjanju zdravila.
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX55
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX55
The overall safety profile of rucaparib is based on data from 937 patients in clinical trials in ovarian cancer treated with rucaparib monotherapy.
Celoten varnostni profil rukapariba temelji na podatkih o 937 bolnicah v kliničnih preskušanjih za raka jajčnikov, zdravljenih z monoterapijo rukapariba.
Rubraca blocks an enzyme that repairs damaged DNA in the cancer cells, resulting in their death.
Zdravilo Rubraca blokira encim, ki popravlja poškodovano DNK v rakavih celicah, in tako povzroči njihovo smrt.
In repeat-dose toxicity studies of up to 3 months duration in rats and dogs, the target organs were the gastrointestinal, haematopoietic, and lymphopoietic systems.
V študijah toksičnosti s ponavljajočimi odmerki pri podganah in psih, ki so trajale do 3 mesece, so bili ciljni organi gastrointestinalni, hematopoetski in limfopoetski sistemi.
Increases in serum aminotransferases (AST/ALT)
Povišanja aminotransferaz v serumu (AST/ALT)
All patients had potential contributing factors for the development of MDS/AML; in all cases, patients had received previous platinumcontaining chemotherapy regimens and/or other DNA damaging agents.
Vse bolnice so imele dejavnike, ki bi lahko pripomogli k razvoju MDS/AML; v vseh primerih so bolnice v preteklosti prejemale kemoterapevtske režime zdravljenja s platino in/ali druga zdravila, ki poškodujejo DNA.
Complete response % Partial response %
Popolni odziv %
The clinical relevance MRP2 and MRP3 interaction in the gut is not known.
Klinični pomen interakcije MRP2 in MRP3 v prebavilih ni znan.
Central BRCA testing was performed retrospectively after patients were enrolled.
Osrednje testiranje BRCA je bilo opravljeno retrospektivno po vključitvi bolnic.