FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority (80%) of the patients included had a high or very high DRL (alcohol consumption >60 g/day for men and >40 g/day for women according to the WHO DRLs of alcohol consumption) at screening, of these 65% maintained a high or very high DRL between screening and randomisation.
Slovenian: Večina (80 %) vključenih bolnikov je imela visoko ali zelo visoko DRL (uživanje alkohola > 60 g/dan za moške in > 40 g/dan za ženske glede na definicijo svetovne zdravstvene organizacije (WHO) za DRL uživanja alkohola) pri presejalnem pregledu, od tega je 65 % ohranilo visoko ali zelo visoko DRL med presejalnim pregledom in randomizacijo.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Selincro in all subsets of the paediatric population for the treatment of alcohol dependence (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Selincro za vse podskupine pediatrične populacije za zdravljenje odvisnosti od alkohola (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The AUC at the no observed adverse effect level (NOAEL) for these effects was below the human exposure at the recommended clinical dose.
Slovenian: AUC na ravni brez ugotovljenih neželenih učinkov (NOAEL - no observed adverse effect level) je bila za te učinke pod izpostavljenostjo pri človeku pri priporočenem kliničnem odmerku.
English: Selincro is available in packs of 7, 14, 28, 42, 49 or 98 tablets in blister cards.
Slovenian: Zdravilo Selincro je na voljo v pakiranjih po 7, 14, 28, 42, 49 ali 98 tablet v pretisnih omotih.
English: Selincro works by affecting processes in the brain that are responsible for your urge to continue drinking.
Slovenian: Zdravilo Selincro deluje z vplivom na procese v možganih, ki so odgovorni za vašo potrebo po pitju.
English: There are no or limited data (fewer than 300 pregnancy outcomes) from the use of nalmefene in pregnant women.
Slovenian: Podatkov o uporabi nalmefena pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
English: There is no clinically relevant pharmacokinetic drug-drug interaction between nalmefene and alcohol.
Slovenian: Ni klinično pomembnega farmakokinetičnega medsebojnega delovanja zdravil med nalmefenom in alkoholom.
English: The frequencies of the adverse reactions in Table 1 were calculated based on three randomised, double-blind, placebo-controlled studies in patients with alcohol dependence.
Slovenian: Pogostnost neželenih učinkov v preglednici 1 je bila izračunana na podlagi treh randomiziranih, dvojno slepih, s placebom nadzorovanih študij pri bolnikih z odvisnostjo od alkohola.
English: If you require emergency medical attention, tell your doctor that you are taking Selincro.
Slovenian: Če potrebujete nujno zdravniško pomoč, obvestite svojega zdravnika, da jemljete zdravilo Selincro.
English: - In vivo studies have demonstrated that nalmefene reduces alcohol consumption, possibly by modulating cortico-mesolimbic functions.
Slovenian: - Študije in vivo so pokazale, da nalmefen zmanjšuje uživanje alkohola, verjetno z uravnavanjem kortiko-mezolimbičnih funkcij.
English: Table 1 Frequencies of adverse reactions System Organ Class
Slovenian: Preglednica 1: Pogostnosti neželenih učinkov Organski sistem
English: Data from the nonclinical studies, the clinical studies, and the literature do not suggest any form of dependence or abuse potential with Selincro.
Slovenian: Podatki iz nekliničnih študij, kliničnih študij in literature ne kažejo na nobeno obliko odvisnosti ali potencial za zlorabo zdravila Selincro.
English: These medicines include certain types of cough and cold medicines, certain medicines for diarrhoea and strong pain killers.
Slovenian: Med ta zdravila sodijo določene vrste zdravil proti kašlju in prehladu, določena zdravila proti driski in močna sredstva proti bolečinam.
English: If you and your doctor have decided that your immediate goal is abstinence (not drinking any alcohol), you should not take Selincro because Selincro is indicated for reduction of alcohol consumption.
Slovenian: Če ste se vi in vaš zdravnik odločila, da je vaš neposredni cilj abstinenca od alkohola (popolno odpovedovanje alkoholu), potem zdravila Selincro ne smete jemati, ker je zdravilo Selincro indicirano za zmanjšanje uživanja alkohola.
English: In an emergency situation when opioids must be administered to a patient taking Selincro, the amount of opioid required to obtain the desired effect may be greater than usual.
Slovenian: V nujnih primerih, ko mora bolnik, ki jemlje zdravilo Selincro, prejeti opioide, se lahko zgodi, da bo količina opioidov, potrebna za doseganje želenega učinka, večja od običajne.
English: Selincro can help you reduce the amount of alcohol you drink, and keep the reduced level of alcohol consumption.
Slovenian: Zdravilo Selincro vam lahko pomaga zmanjšati količino alkohola, ki ga spijete, in ohraniti nižjo raven uživanje alkohola.
English: The increased suicidal risk in alcohol and substances abusers, with or without accompanying depression, is not reduced by the intake of nalmefene.
Slovenian: Povečano tveganje za samomor pri odvisnikih od alkohola in drog, s spremljajočo depresijo ali brez nje, se ob jemanju nalmefena ne zmanjša.
English: No clinically relevant changes were seen in tmax for any of the groups.
Slovenian: Klinično pomembnih sprememb pri tmax niso opazili pri nobeni skupini.
English: It is unknown whether nalmefene is excreted in human milk.
Slovenian: Ni znano, ali se nalmefen izloča v materino mleko.
English: However, nalmefene 3-O-sulphate is present in concentrations less than 10% of that of nalmefene and thus considered highly unlikely to be a major contributor to the pharmacological effect of nalmefene.
Slovenian: Vendar pa je nalmefen 3-O-sulfat prisoten v koncentracijah, manjših od 10 % koncentracije nalmefena, zato je zelo malo verjetno, da pomembno prispeva k farmakološkem učinku nalmefena.
English: The film-coated tablet should be swallowed whole.
Slovenian: Filmsko obloženo tableto mora bolnik pogoltniti celo.
English: The efficacy of Selincro in reducing alcohol consumption in patients with alcohol dependence (DSMIV) was evaluated in two efficacy studies.
Slovenian: Učinkovitost zdravila Selincro pri zmanjšanju uživanja alkohola pri bolnikih z odvisnostjo od alkohola (DSM-IV) je bila ocenjena v dveh študijah učinkovitosti.
English: Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL) [see section 5.1], without physical withdrawal symptoms and who do not require immediate detoxification.
Slovenian: Zdravilo Selincro je indicirano za zmanjševanje uživanja alkohola pri odraslih bolnikih z odvisnostjo od alkohola, ki imajo visoko stopnjo tveganja za zdravje zaradi pitja (DRL - drinking risk level) [glejte poglavje 5.1], brez fizičnih odtegnitvenih simptomov ter ne potrebujejo takojšnje detoksifikacije.
English: In a study in patients diagnosed with pathological gambling, doses of nalmefene up to 90 mg/day for 16 weeks were investigated.
Slovenian: V študiji pri bolnikih z diagnozo patološkega hazardiranja so bili preiskani odmerki nalmefena do 90 mg/dan v obdobju 16 tednov.
English: The absolute oral bioavailability of nalmefene is 41%.
Slovenian: Absolutna peroralna biološka uporabnost nalmefena je 41 %.
English: In a study in patients with interstitial cystitis, 20 patients received 108 mg/day of nalmefene for more than 2 years.
Slovenian: V študiji pri bolnikih z intersticijskim cistitisom je 20 bolnikov prejemalo 108 mg/dan nalmefena več kot 2 leti.
English: As concerns the patients with high or very high DRL at baseline, 35% of patients experienced improvement due to non-pharmacological effects in the period between the initial visit (screening) and randomisation.
Slovenian: Glede bolnikov z visoko ali zelo visoko DRL v izhodišču, je 35 % bolnikov občutilo izboljšanje zaradi ne-farmakoloških učinkov v obdobju med začetnim obiskom (presejalni pregled) in randomizacijo.
English: If patients develop psychiatric symptoms that are not associated with treatment initiation with Selincro, and/or that are not transient, the prescriber should consider alternative causes of the symptoms and assess the need for continuing treatment with Selincro.
Slovenian: Če se pri bolnikih pojavijo psihiatrični simptomi, ki niso povezani z začetkom zdravljenja z zdravilom Selincro in/ali niso prehodni, mora zdravnik preučiti tudi druge možne vzroke za simptome in oceniti potrebo po nadaljnjem zdravljenju z zdravilom Selincro.
English: The clinical efficacy and the clinical relevance of Selincro were analysed in patients with a high or very high DRL at screening and randomisation.
Slovenian: Klinična učinkovitost in klinična pomembnost zdravila Selincro sta bili analizirani pri bolnikih z visoko in zelo visoko DRL pri presejalnem pregledu in ob randomizaciji.
English: Malaise Feeling abnormal
Slovenian: Slabo počutje Nenormalno počutje
English: - if you are allergic to nalmefene or any of the other ingredients of this medicine (listed in section 6) - if you are taking medicines containing opioids, for example, methadone or buprenorphine or pain killers (such as morphine, oxycodone or other opioids) - if you are or have recently been dependent on opioids.
Slovenian: - če ste alergični na nalmefen ali katero koli sestavino tega zdravila (navedeno v poglavju 6) - če jemljete zdravila, ki vsebujejo opioide, na primer metadon ali buprenorfin ali zdravila proti bolečinam (kot so morfij, oksikodon in drugi opioidi) - če ste ali ste pred kratkim bili odvisni od opioidov.
English: If you believe you have taken too many Selincro tablets, contact your doctor or pharmacist.
Slovenian: Če menite, da ste vzeli preveč tablet zdravila Selincro, se posvetujte s svojim zdravnikom ali farmacevtom.
English: Table 2 Pooled Responder Analysis Results in Patients with a High or Very High DRL at screening and Randomisation
Slovenian: Preglednica 2: Zbrani rezultati odzivnostne analize pri bolnikih z visoko ali zelo visoko DRL pri presejalnem pregledu in randomizaciji
English: Selincro should be temporarily discontinued for 1 week prior to the anticipated use of opioids, for example, if opioid analgesics might be used during elective surgery.
Slovenian: Zdravljenje z zdravilom Selincro je treba začasno prekiniti za 1 teden pred pričakovano uporabo opioidov, denimo v primeru uporabe opioidnih analgetikov pri kirurškem posegu.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Selincro should be initiated only in patients who continue to have a high DRL two weeks after initial assessment.
Slovenian: Zdravilo Selincro je treba uvesti le pri bolnikih, ki so dva tedna po začetni oceni imeli še naprej visoko DRL.
English: In this post-hoc target population, more patients receiving nalmefene discontinued (45%) as compared to those receiving placebo (31%).
Slovenian: V tej post-hoc ciljni populaciji je več bolnikov, ki so jemali nalmefen prekinilo sodelovanje v študiji (45 %) v primerjavi s tistimi, ki o prejemali placebo (31 %).
English: If unusually large doses are required, close observation is necessary.
Slovenian: Če so potrebni neobičajno veliki odmerki, je bolnika treba skrbno nadzorovati.
English: What Selincro is and what it is used for
Slovenian: Kaj je zdravilo Selincro in za kaj ga uporabljamo
English: Most of these adverse reactions resolved during continued treatment and did not recur upon repeated administration.
Slovenian: Večina neželenih učinkov je izginila med nadaljnjim zdravljenjem in se ni ponovno pojavila pri ponovnem jemanju zdravila.
English: Selincro with food and alcohol
Slovenian: Zdravilo Selincro skupaj s hrano in alkoholom
English: Studies in rats have shown excretion of nalmefene or its metabolites in milk.
Slovenian: Študije na podganah kažejo izločanje nalmefena ali njegovih presnovkov v mleko.
English: Studies in animals do not indicate direct harmful effects with respect to fertility, pregnancy, embryonic/foetal development, parturition, or postnatal development.
Slovenian: Študije na živalih ne kažejo neposrednih škodljivih vplivov na plodnost, nosečnost, razvoj zarodka/plodu, porod ali razvoj po rojstvu.
English: Selincro is extensively metabolised by the liver and excreted predominantly in the urine.
Slovenian: Zdravilo Selincro se v veliki meri presnavlja v jetrih in izloča pretežno z urinom.
English: If Selincro is taken concomitantly with opioid agonists (for example, certain types of cough and cold medicinal products, certain antidiarrhoeal medicinal products, and opioid analgesics), the patient may not benefit from the opioid agonist.
Slovenian: Če se zdravilo Selincro jemlje sočasno z opioidnimi agonisti (na primer določene vrste zdravil proti kašlju in prehladu, določena zdravila proti driski in opioidni analgetiki), opioidni agonist mogoče ne bo pomagal bolniku.
English: Your doctor has prescribed Selincro because you were not able to reduce your alcohol consumption on your own.
Slovenian: Zdravnik vam je predpisal zdravilo Selincro, ker niste bili sami zmožni zmanjšati vaše uživanje alkohola.
English: Disturbance in attention Paraesthesia Hypoaesthesia
Slovenian: Motnje pozornosti Parestezija Hipestezija
English: Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.
Slovenian: Zdravilo Selincro je treba predpisati le v povezavi s stalno psihosocialno podporo, ki je osredotočena na večje vztrajanje pri zdravljenju in zmanjšanju uživanja alkohola.
English: If you continue treatment with Selincro, or start again after a break in treatment, you will probably not have side effects.
Slovenian: Če nadaljujete z zdravljenjem z zdravilom Selincro ali ponovno začnete z zdravljenjem po premoru, se neželeni učinki najverjetneje ne bodo pojavili.
English: 54% of the total dose is excreted in the urine as nalmefene 3-O-glucuronide, while nalmefene and its other metabolites are present in the urine in amounts of less than 3% each.
Slovenian: 54 % celotnega odmerka se izloči z urinom kot nalmefen 3-O-glukuronid, medtem ko je količina nalmefena in njegovih drugih presnovkov v urinu manjša od 3 %.
English: At the randomisation visit, which occurred 1 to 2 weeks later, the DRL was re-assessed and treatment with Selincro was initiated together with a psychosocial intervention (BRENDA) focused on treatment adherence and reduction of alcohol consumption.
Slovenian: Pri randomizacijskem obisku, ki se je zgodil 1 do 2 tednov kasneje je bila ponovno ocenjena DRL in uvedeno zdravljenje z zdravilom Selincro skupaj s psihosocialno intervencijo (BRENDA) osredotočeno na vztrajanje pri zdravljenju in zmanjšanju uživanja alkohola.
English: The oral clearance of nalmefene (CL/F) was estimated as 169 l/h and the terminal half-life was estimated as 12.5 hours.
Slovenian: Peroralni očistek nalmefena (CL/F) je ocenjen na 169 l/h, končna razpolovna doba pa na 12,5 ure.
English: The efficacy of Selincro was measured using two co-primary endpoints: the change from baseline to Month 6 in the monthly number of heavy drinking days (HDDs) and the change from baseline to Month 6 in the daily total alcohol consumption (TAC).
Slovenian: Učinkovitost zdravila Selincro se je izmerila z dvema primarnima opazovanima dogodkoma: s spremembo od izhodišča do 6. meseca v številu dni prekomernega pitja (HDDs - heavy drinking days) v mesecu in s spremembo od izhodišča do 6. meseca v dnevni skupni količini zaužitega alkohola (TAC - total alcohol consumption).
English: The metabolites are not considered to contribute with significant pharmacological effect on the opioid receptors in humans, except for nalmefene 3-O-sulphate, which has a potency comparable to that of nalmefene.
Slovenian: Smatra se, da presnovki nimajo pomembnega farmakološkega učinka na opioidne receptorje pri ljudeh razen nalmefen 3-O-sulfata, ki ima učinkovitost, primerljivo z nalmefenom.
English: Following oral administration, nalmefene undergoes extensive, rapid metabolism to the major metabolite nalmefene 3-O-glucuronide, with the UGT2B7 enzyme being primarily responsible for the conversion, and with the UGT1A3 and UGT1A8 enzymes as minor contributors.
Slovenian: Po peroralnem jemanju se nalmefen hitro in obsežno presnavlja v glavni presnovek nalmefen 3-O-glukuronid, pri čemer je encim UGT2B7 primarno odgovoren za pretvorbo, encima UGT1A3 in UGT1A8 pa imata manjšo vlogo.
English: If you are 65 years old or above, talk to your doctor or pharmacist before taking Selincro.
Slovenian: Če ste stari 65 let ali več, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete zdravilo Selincro.
English: Caution should be excercised when taking medicines such as diclofenac (antiinflammatory medicine used to treat, for example, muscle pain), fluconazole (antibiotic used to treat diseases caused by some types of fungus), omeprazole (medicine used to block the production of acid in the stomach), or rifampicin (antibiotic used to treat diseases caused by some types of bacteria) together with Selincro.
Slovenian: Previdnost je potrebna pri jemanju zdravil kot so diklofenak (protivnetno zdravilo za zdravljenje, na primer, bolečine v mišicah), flukonazol (antibiotik za zdravljenje bolezni, ki jih povzročajo nekatere vrste gliv), omeprazol (zdravilo, ki se uporablja za zaviranje nastajanje kisline v želodcu) ali rifampicin (antibiotik za zdravljenje bolezni, ki jih povzročajo nekatere vrste bakterij), skupaj z zdravilom Selincro.
English: - The recommended dose is one tablet on days when you think there is a risk you will drink alcohol - The maximum dose is one tablet per day.
Slovenian: - Priporočeni odmerek je ena tableta na dneve, ko menite, da obstaja tveganje, da boste pili alkohol.
English: Caution should be exercised when using medicinal products containing opioids (for example, cough medicines, opioid analgesics (see section 4.5)).
Slovenian: Potrebna je previdnost pri uporabi zdravil, ki vsebujejo opioide (na primer zdravila proti kašlju, opioidni analgetiki (glejte poglavje 4.5)).
English: Simultaneous intake of alcohol and Selincro does not prevent the intoxicating effects of alcohol.
Slovenian: Sočasen vnos alkohola in zdravila Selincro ne preprečuje učinkov zastrupitve z alkoholom.
English: The film-coating of the tablet contains: hypromellose, macrogol 400, titanium dioxide (E171).
Slovenian: Filmska obloga tablete vsebuje: hipromelozo, makrogol 400, titanov dioksid (E171).
English: Further, the Cmax and elimination half-life for nalmefene was up to 1.6 times higher in patients with severe renal impairment.
Slovenian: Poleg tega sta bili Cmax in razpolovna doba izločanja za nalmefen do 1,6-krat večji pri bolnikih s hudo okvaro ledvic.
English: An increase in still-born pups and decrease in post-natal viability of pups was observed in prepostnatal toxicity studies in rats.
Slovenian: Povečanje mrtvorojenih mladičev in zmanjšanje postnatalnega preživetja mladičev so opazili v študijah pre - in postnatalne toksičnosti pri podganah.
English: Do not take Selincro:
Slovenian: Ne jemljite zdravila Selincro:
English: Patients with a history of delirium tremens, hallucinations, seizures, significant psychiatric comorbidity, or significant abnormalities of liver function as well as those with significant physical withdrawal symptoms at screening or randomisation were excluded.
Slovenian: Bolniki z alkoholnim delirijem, halucinacijami, epileptičnimi napadi, pomembno psihiatrično komorbidnostjo ali pomembno motnjo v delovanju jeter v anamnezi, kot tudi tisti z večjimi fizičnimi odtegnitvenimi simptomi pri presejalnem pregledu ali randomizaciji, so bili izključeni.
English: Selincro is a white, oval, biconvex, film-coated tablet of 6.0 x 8.75 mm.
Slovenian: Zdravilo Selincro je bela, ovalna, bikonveksna, filmsko obložena tableta v velikosti 6,0 mm x 8,75 mm.
English: How much to take
Slovenian: Kakšen odmerek vzeti
English: Nalmefene exhibits a dose-independent linear pharmacokinetic profile in the dose interval of 18.06 mg to 72.24 mg, with a 4.4 times increase in Cmax and a 4.3 times increase in AUC0-tau (at or near steady state).
Slovenian: Nalmefen kaže od odmerka neodvisen linearni farmakokinetični profil v intervalu odmerjanja od 18,06 mg do 72,24 mg s 4,4-kratnim povečanjem Cmax in 4,3-kratnim povečanjem AUC0-tau (v stanju dinamičnega ravnotežja ali blizu njega).
English: At an initial visit, the patient's clinical status, alcohol dependence, and level of alcohol consumption (based on patient reporting) should be evaluated.
Slovenian: Pri začetnem obisku je treba ovrednotiti klinični status bolnika, odvisnost od alkohola in stopnjo uživanja alkohola (na podlagi bolnikovega poročanja).
English: Administration of high-fat food increases the total exposure (AUC) by 30% and the peak concentration (Cmax) by 50%; the time to peak concentration (tmax) is delayed by 30 min (tmax is 1.5 hours).
Slovenian: Uživanje hrane z visoko vsebnostjo maščob poveča skupno izpostavljenost (AUC) za 30 % in največjo koncentracijo (Cmax) za 50 %; čas do največje koncentracije (tmax) se podaljša za 30 min (tmax je 1,5 ure).
English: At the initial visit, the patients' clinical status, social situation, and alcohol consumption pattern were evaluated (based on patient reporting).
Slovenian: Pri začetnem obisku so bili ocenjeni klinično stanje, socialni položaj in vzorec uživanja alkohola bolnikov (na podlagi bolnikovega poročanja).
English: Selincro was prescribed as-needed, which resulted in patients taking Selincro, on average, approximately half of the days.
Slovenian: Zdravilo Selincro je bilo predpisano z režimom odmerjanja po potrebi, kar je privedlo, da so bolniki jemali zdravilo Selincro v povprečju polovico vseh dni.
English: - Swallow the tablet whole, do not crush or divide the tablet because Selincro may cause skin sensitisation when in direct contact with the skin.
Slovenian: - Tableto pogoltnite celo in je ne drobite ali razpolavljajte, saj lahko zdravilo Selincro povzroči preobčutljivost kože, če pride v neposreden stik s kožo.
English: Consequently, Selincro may have minor to moderate influence on the ability to drive and use machines and patients should exercise caution particular when starting treatment with Selincro.
Slovenian: Posledično ima lahko zdravilo Selincro blag ali zmeren vpliv na sposobnost vožnje in upravljanje strojev, zato morajo biti bolniki previdni, še zlasti na začetku zdravljenja.
English: DK-2500 Valby
Slovenian: DK-2500 Valby Danska
English: Patients with acute symptoms of opioid withdrawal.
Slovenian: Bolniki z akutnimi simptomi odtegnitve opioidov.
English: Vomiting Dry mouth Diarrhoea
Slovenian: Bruhanje Suha usta Driska
English: You may need to stop taking Selincro temporarily.
Slovenian: Morda boste morali začasno prenehati z jemanjem zdravila Selincro.
English: If opioids are needed in an emergency, the dose must always be titrated individually.
Slovenian: Če so pri nujni medicinski pomoči potrebni opioidi, je treba odmerek vedno titrirati glede na posameznega bolnika.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of nalmefene/metabolites in milk (see section 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje nalmefena/presnovkov v mleko (glejte poglavje 5.3).
English: Selincro is used for the reduction of alcohol consumption in adult patients with alcohol dependence who still have a high level of alcohol consumption 2 weeks after the first consultation with their doctor.
Slovenian: Zdravilo Selincro se uporablja za zmanjšanje uživanja alkohola pri odraslih bolnikih z odvisnostjo od alkohola, ki imajo po dveh tednih od prvega posveta s svojim zdravnikom še vedno visoko stopnjo uživanja alkohola.