FrancophonIA/ELRC3.0 huggingface dataset:
English: In a rabbit embryo-foetal developmental toxicity study, effects on foetuses in terms of reduced foetal weight and delayed ossification, but no major abnormalities were seen.
Slovenian: V študiji embriofetalne razvojne toksičnosti pri kuncih so bili opaženi učinki na zarodkih v smislu zmanjšanja telesne mase ploda in zapoznele osifikacije, vendar brez večjih anomalij.
English: At the next visit, Selincro may be initiated in patients who continued to have a high DRL (see section 5.1) over this two-week period, in conjunction with psychosocial intervention focused on treatment adherence and reducing alcohol consumption.
Slovenian: Pri naslednjem obisku se lahko zdravilo Selincro uvede bolnikom, ki imajo še naprej visoko DRL (glejte poglavje 5.1) v tem dvotedenskem obdobju, skupaj s psihosocialno intervencijo osredotočeno na večje vztrajanje pri zdravljenju in zmanjšanje uživanja alkohola.
English: No in vivo drug-drug interaction studies have been conducted.
Slovenian: In vivo študije interakcij z drugimi zdravili niso bile opravljene.
English: A small proportion of nalmefene is converted to nalmefene 3-O-sulphate by sulphation and to nornalmefene by CYP3A4/5.
Slovenian: Majhen delež nalmefena se s sulfoniranjem pretvori v nalmefen 3-O-sulfat in s CYP3A4/5 v nornalmefen.
English: Nalmefene is rapidly absorbed after a single oral administration of 18.06 mg, with a peak concentration (Cmax) of 16.5 ng/ml after approximately 1.5 hours and an exposure (AUC) of 131 ng*h/ml.
Slovenian: Nalmefen se hitro absorbira po enkratnem peroralnem odmerku 18,06 mg, pri čemer doseže največjo koncentracijo (Cmax) 16,5 ng/ml po približni 1,5 uri in izpostavljenost (AUC) 131 ng*h/ml.
English: The patient should be closely monitored for symptoms of respiratory depression as a result of the opioid administration and for other adverse reactions.
Slovenian: Bolnik mora biti pod skrbnim nadzorom, saj se lahko pojavijo simptomi depresije dihanja kot posledica uporabe opioidov ter drugi neželeni učinki.
English: Therefore, caution should be exercised when prescribing Selincro to patients with mild or moderate hepatic or mild or moderate renal impairment, for example, by more frequent monitoring.
Slovenian: Zato je potrebna previdnost pri predpisovanju zdravila Selincro bolnikom z blago do zmerno okvaro jeter ali blago do zmerno okvaro ledvic, na primer s pogostejšim spremljanjem.
English: Based on in vitro studies, no clinically relevant interactions between nalmefene, or its metabolites, and concomitantly administered medicinal products metabolised by the most common CYP450 and UGT enzymes or membrane transporters are anticipated.
Slovenian: Na podlagi študij in vitro klinično pomembnih medsebojnih interakcij med nalmefenom ali njegovimi presnovki in drugimi zdravili, ki se jemljejo sočasno in se presnavljajo prek CYP450 in encimov UGT ali membranskih prenašalcev, ni pričakovati.
English: Metabolism by glucuronide conjugation is the primary mechanism of clearance for nalmefene, with renal excretion being the main route of elimination of nalmefene and its metabolites.
Slovenian: Presnova s konjugacijo z glukuronsko kislino je primarni mehanizem izločanja nalmefena, izločanje skozi ledvice pa je glavna pot izločanja nalmefena in njegovih presnovkov.
English: Co-administration with medicinal products that are potent inhibitors of the UGT2B7 enzyme (for example, diclofenac, fluconazole, medroxyprogesterone acetate, meclofenamic acid) may significantly increase the exposure to nalmefene.
Slovenian: Sočasno uporaba z zdravili, ki so močni zaviralci encima UGT2B7 (npr. diklofenak, flukonazol, medroksiprogesteron acetat, meklofenaminska kislina) lahko znatno povečajo izpostavljenost nalmefenu.
English: Other medicines and Selincro
Slovenian: Druga zdravila in zdravilo Selincro
English: - In vitro studies have demonstrated that nalmefene is a selective opioid receptor ligand with antagonist activity at the μ and δ receptors and partial agonist activity at the κ receptor.
Slovenian: - Študije in vitro so pokazale, da je nalmefen selektivni ligand opioidnih receptorjev z antagonističnim delovanjem na receptorje μ in δ ter delno agonističnim delovanjem na receptorje κ.
English: Patients taking opioid agonists (such as opioid analgesics, opioids for substitution therapy with opioid agonists (e.g. methadone) or partial agonists (e.g. buprenorphine)) (see section 4.4).
Slovenian: Bolniki, ki jemljejo opioidne agoniste (kot so opioidni analgetiki, opioidi za nadomestno zdravljenje z opioidnimi agonisti (npr. metadon) ali delnimi agonisti (npr. buprenorfin)) (glejte poglavje 4.4).
English: What Selincro is and what it is used for What you need to know before you take Selincro How to take Selincro
Slovenian: Kaj je zdravilo Selincro in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Selincro Kako jemati zdravilo Selincro Možni neželeni učinki
English: What you need to know before you take Selincro
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Selincro
English: No clinically relevant changes were seen in tmax or elimination half-life for any of the groups.
Slovenian: Klinično pomembne spremembe pri tmax ali razpolovna doba izločanja niso bile vidne pri nobeni skupini.
English: a Analysis treats patients who withdrew as non-responder b ≥70% reduction from baseline in TAC at Month 6 (28-day period) c 0 to 4 HDDs/month at Month 6 (28-day period)
Slovenian: a analizirani zdravljeni bolniki, ki so prekinili sodelovanje v študiji zaradi ne-odziva b ≥ 70 % zmanjšanje od izhodišča v TAC pri 6. mesecu (28-dnevno obdobje) c 0 to 4 HDDs/mesec pri 6. mesecu 6 (28-dnevno obdobje)
English: Few cases of side effects of seeing, hearing or sensing things that are not there or feeling detached from oneself have been reported.
Slovenian: Poročali so o nekaj primerih stranskih učinkov kot so videnje, slišanje ali občutenje stvari, ki jih ni ali občutek odmaknjenosti od sebe.
English: Caution should be exercised if Selincro is prescribed to patients with current psychiatric comorbidity such as major depressive disorder.
Slovenian: Potrebna je previdnost pri predpisovanju zdravila Selincro bolnikom s sočasno prisotnimi psihiatričnimi obolenji kot je velika depresivna motnja.
English: Limited data are available for Selincro in the 1-month run-out period.
Slovenian: Omejeni podatki so na voljo za zdravilo Selincro v enomesečnem zaključnem obdobju.
English: Patients for whom recent use of opioids is suspected.
Slovenian: Bolniki, pri katerih obstaja sum nedavne uporabe opioidov.
English: There is limited experience in patients with a history of seizure disorders, including alcohol withdrawal seizures.
Slovenian: Izkušnje so omejene pri bolnikih z epileptičnimi motnjami v anamnezi, vključno z epileptičnimi napadi v sklopu odtegnitve od alkohola.
English: In patients with moderate hepatic impairment, exposure increased 2.9 times for AUC and 1.7 times for Cmax, while oral clearance decreased by approximately 60%.
Slovenian: Pri bolnikih z zmerno okvaro jeter se je izpostavljenost povečala za 2,9-krat za AUC in 1,7-krat za Cmax, peroralni očistek pa se je zmanjšal za okoli 60 %.
English: Patients with a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, and delirium tremens).
Slovenian: Bolniki z nedavnim akutnim sindromom odtegnitve od alkohola (ki vključujejo halucinacije, epileptične napade in alkoholni delirij) v anamnezi.
English: A study with IV administration suggested that there were no relevant changes in the pharmacokinetics in the elderly as compared to non-elderly adults (see sections 4.2 and 4.4).
Slovenian: Študija z intravenskim vnosom je pokazala, da ni pomembnih sprememb v farmakokinetiki pri starejših v primerjavi z drugimi odraslimi (glejte poglavji 4.2 in 4.4).
English: Caution is advised if Selincro is co-administered with a potent UGT2B7 inhibitor (see section 4.5).
Slovenian: Potrebna je previdnost, če zdravilo Selincro sočasno uporabljamo z močnim zaviralcem UGT2B7 (glejte poglavje 4.5).
English: The most common adverse reactions were nausea, dizziness, insomnia, and headache.
Slovenian: Najpogostejši neželeni učinki so bili slabost, omotica, nespečnost in glavobol.
English: The film-coated tablet should not be divided or crushed because nalmefene may cause skin sensitisation when in direct contact with the skin (see section 5.3).
Slovenian: Filmsko obložene tablete ne smete razpolavljati ali drobiti, saj lahko nalmefen pri neposrednem stiku s kožo povzroči preobčutljivost kože (glejte poglavje 5.3).
English: - This medicine does not require any special storage conditions.
Slovenian: - Za shranjevanje tega zdravila niso potrebna posebna navodila.
English: No specific study with oral dosing has been conducted in patients ≥65 years of age.
Slovenian: Pri bolnikih, starih 65 let ali več, ni bila opravljena nobena posebna študija s peroralnimi odmerki.
English: Post-hoc efficacy analysis in patients who maintained a high or very high DRL at randomisation In Study 1, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (50% versus 32%, respectively).
Slovenian: Post hoc analiza učinkovitosti pri bolnikih, ki so ohranili visoko ali zelo visoko DRL pri randomizaciji V študiji 1 je bil delež bolnikov, ki so prekinili sodelovanje v študiji večji v Selincro skupini kot v placebo skupini (50 % proti 32 %, glede na vrstni red).
English: Film-coated tablet (tablet) White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with “S” on one side
Slovenian: Bela, ovalna, bikonveksna, 6,0 mm x 8,75 mm filmsko obložena tableta z vtisnjeno oznako "S" na eni strani.
English: In Study 2, the proportion of patients who withdrew was higher in the Selincro group than in the placebo group (30% versus 28%, respectively).
Slovenian: V študiji 2 je bil delež bolnikov, ki so prekinili sodelovanje v študiji večji v Selincro skupini kot v placebo skupini (30 % proti 28 %, glede na vrstni red).
English: Nalmefene is an opioid system modulator with a distinct μ, δ, and κ receptor profile.
Slovenian: Nalmefen je modulator opioidnega sistema z značilnimi profilom delovanja na receptorjih μ, δ in κ.
English: Tachycardia Palpitations
Slovenian: Tahikardija Palpitacije
English: Occupancy data obtained in a PET study after single and repeated daily dosing with 18.06 mg nalmefene show 94% to 100% receptor occupancy within 3 hours after dosing, which suggests that nalmefene readily crosses the blood-brain barrier.
Slovenian: Podatki o zasedenosti receptorjev, ki so bili pridobljeni v študiji s pozitronsko emisijsko tomografije (PET) po enkratnem in ponovljenem dnevnem odmerku 18,06 mg nalmefena, kažejo 94 % do 100 % zasedenost receptorjev v 3 urah po vnosu odmerka, kar kaže na to, da nalmefen dobro prehaja skozi krvno-možgansko pregrado.
English: For the inactive major metabolite nalmefene 3-O-glucuronide, the AUC and Cmax were up to 5.1 times and 1.8 times higher in patients with severe renal impairment, respectively (see sections 4.3 and 4.4).
Slovenian: Za glavni neaktivni metabolit nalmefena 3-O-glukuronid je bila pri bolnikih s hudo okvaro ledvic AUC do 1,8-krat večja in Cmax do 5,1-krat večja (glejte poglavji 4.3 in 4.4).
English: The side effects reported with Selincro were mainly mild or moderate, occurred at the beginning of treatment and lasted for a few hours to a few days.
Slovenian: Neželeni učinki, o katerih so poročali pri uporabi zdravila Selincro, so bili v glavnem blagi ali zmerni, pojavili pa so se na začetku zdravljenja in trajali nekaj ur ali dni.
English: If you have started drinking alcohol without taking Selincro, take one tablet as soon as possible.
Slovenian: Če ste začeli piti alkohol, ne da bi vzeli zdravilo Selincro, morate vzeti eno tableto v najkrajšem možnem času.
English: Caution should be exercised when prescribing Selincro to patients with elevated ALAT or ASAT (>3 times ULN) as these patients were excluded from the clinical development programme.
Slovenian: Potrebna je previdnost pri predpisovanju zdravila Selincro bolnikom s povišano vrednostjo alanin aminotransferaze (ALAT) ali aspartat aminotransferaze (ASAT) (> 3-kratna zgornja meja normalnih vrednosti (ULN - Upper Limit of Normal), saj so bili ti bolniki izključeni iz programa kliničnega razvoja.
English: Confusional state and, rarely, hallucinations and dissociation were reported in the clinical studies.
Slovenian: V kliničnih študijah so poročali o zmedenosti ter redkeje o halucinacijah in disociaciji.
English: In patients with mild hepatic impairment, exposure increased 1.5 times and oral clearance decreased by approximately 35%.
Slovenian: Pri bolnikih z blago okvaro jeter se je izpostavljenost povečala za 1,5-krat, peroralni očistek pa se je zmanjšal za okoli 35 %.
English: From distribution, metabolism, and excretion data, it appears that nalmefene has a high hepatic extraction ratio.
Slovenian: Podatki o porazdelitvi, presnovi in izločanju kažejo, da ima nalmefen visoko jetrno ekstrakcijsko razmerje.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Selincro therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
Slovenian: Odločite se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Selincro, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: If the patient has started drinking alcohol without taking Selincro, the patient should take one tablet as soon as possible.
Slovenian: Če je bolnik začel piti alkohol, ne da bi vzel zdravilo Selincro, mora vzeti eno tableto v najkrajšem možnem času.
English: Pharmacokinetic data after oral administration of nalmefene to patients with severe hepatic impairment are not available (see sections 4.3 and 4.4).
Slovenian: Farmakokinetični podatki po peroralnem vnosu nalmefena pri bolnikih s hudo okvaro jeter niso na voljo (glejte poglavja 4.3 in 4.4.
English: You may experience acute opioid withdrawal symptoms (such as feeling sick, vomiting, shakiness, sweating and anxiety) - if you experience, or suspect you are experiencing opioid withdrawal symptoms - if your liver or kidney function is poor - if you are experiencing or have recently experienced several alcohol withdrawal symptoms
Slovenian: Pojavijo se lahko akutni opioidni odtegnitveni simptomi (kot so slabost, bruhanje, tresenje, potenje in tesnoba) - če se pojavijo ali sumite, da so se pojavili odtegnitveni simptomi pri odvisnosti od opoidov - če imate oslabljeno delovanje jeter ali ledvic - če imate ali ste pred kratkim doživeli več odtegnitvenih simptomov od alkohola (kot so videnje,
English: If you take more Selincro than you should
Slovenian: Če ste vzeli večji odmerek zdravila Selincro, kot bi smeli
English: Selincro is not for patients for whom the treatment goal is immediate abstinence.
Slovenian: Zdravilo Selincro ni primerno za bolnike, katerih cilj je takojšnja vzpostavitev abstinence od alkohola.
English: In fertility studies in rats, no effects were observed for nalmefene on fertility, mating, pregnancy, or sperm parameters.
Slovenian: V študijah o vplivu na sposobnost razmnoževanja pri podganah niso zasledili nobenih vplivov nalmefena na plodnost, sposobnost razmnoževanja, nosečnost ali parametre semena.
English: Management of an overdose should be observational and symptomatic.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika opazovati in zdraviti simptomatsko.
English: Selincro is not recommended if you are pregnant.
Slovenian: Zdravilo Selincro ne uporabljajte, če ste noseči.
English: Each film-coated tablet contains 18.06 mg nalmefene (as hydrochloride dihydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 18,06 mg nalmefena (v obliki nalmefenijevega klorida dihidrata).
English: Hallucination (including hallucination auditory, hallucination tactile, hallucination visual, and somatic hallucination)
Slovenian: Halucinacije (vključno s slušnimi, tipnimi, vidnimi halucinacijami in halucinacijami telesnega občutka) Disociacija
English: Selincro contains lactose
Slovenian: Zdravilo Selincro vsebuje laktozo
English: Conversely, concomitant administration with a UGT inducer (for example, dexamethasone, phenobarbital, rifampicin, omeprazole) may potentially lead to subtherapeutic nalmefene plasma concentrations.
Slovenian: Nasprotno, lahko sočasno uporaba UGT induktorjev (npr. deksametazon, fenobarbital, rifampicin, omeprazol) privede do subterapevtskih koncentracij nalmefena v plazmi.
English: Administration of a single oral dose of nalmefene 18.06 mg to patients with mild, moderate or severe renal impairment, classified using the estimated glomerular filtration rate, resulted in an increased exposure to nalmefene relative to that in healthy subjects.
Slovenian: Enkratni odmerek nalmefena 18,06 mg je pri bolnikih z blago, zmerno ali hudo okvaro ledvic, razvrščenih na podlagi ocene hitrosti glomerulne filtracije, povzročil povečano izpostavljenost nalmefenu v primerjavi z zdravimi osebami.
English: Caution should be exercised when prescribing Selincro to patients ≥65 years of age (see sections 4.2 and 5.2).
Slovenian: Potrebna je previdnost pri predpisovanju zdravila Selincro bolnikom, starim 65 let ali več (glejte poglavji 4.2 in 5.2).
English: Elderly (≥65 years of age) No dose adjustment is recommended for this patient population (see sections 4.4 and 5.2).
Slovenian: Starejši (≥65 let) Za to skupino bolnikov ni priporočenega prilaganja odmerka (glejte poglavji 4.4 in 5.2).
English: The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration (a few hours to a few days).
Slovenian: Večina teh učinkov je bila blagih ali zmernih, povezanih z začetkom zdravljenja in kratkotrajnih (od nekaj ur do nekaj dni).
English: Microcrystalline cellulose Lactose, anhydrous Crospovidone, type A Magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza brezvodna laktoza krospovidon tipa A magnezijev stearat
English: Titanium dioxide (E171)
Slovenian: Obloga tablete hipromeloza makrogol 400 titanov dioksid (E171)
English: What Selincro looks like and contents of the pack
Slovenian: Izgled zdravila Selincro in vsebina pakiranja
English: If you forget to take Selincro
Slovenian: Če ste pozabili vzeti zdravilo Selincro
English: Other side effects (cannot be estimated from the available data) - seeing, hearing or sensing things that are not there - feeling detached from oneself - swelling of face, lips, tongue or throat - hives - itching - rash - redness of skin - muscle pain - prolonged erection (priapism)
Slovenian: Drugi neželeni učinki (ni mogoče oceniti iz razpoložljivih podatkov): - videnje, slišanje ali občutenje stvari, ki jih ni - občutek odmaknjenosti od sebe - otekanje obraza, ustnic, jezika ali grla
English: The nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, or carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti ali kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Angioedema Urticaria Pruritus Rash
Slovenian: Angioedem Urtikarija Pruritus Izpuščaj Eritem
English: - Selincro is for oral use.
Slovenian: - Zdravilo Selincro je za peroralno uporabo.
English: Limited clinical data are available on the use of Selincro in patients ≥65 years of age with alcohol dependence.
Slovenian: O uporabi zdravila Selincro pri bolnikih, starih 65 let ali več, z odvisnostjo od alkohola, so na voljo omejeni klinični podatki.
English: The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration.
Slovenian: Večina teh učinkov je bila blagih ali zmernih, povezanih z začetkom zdravljenja in kratkotrajnih.
English: If you are breast-feeding, you and your doctor should make a decision whether to discontinue breastfeeding or to discontinue Selincro therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to you.
Slovenian: Če dojite, se morate vi in vaš zdravnik odločiti med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom Selincro, pri čemer je treba pretehtati prednost dojenja za otroka in prednost zdravljena za vas.
English: Hepatic impairment
Slovenian: Omotica Glavobol
English: If you stop taking Selincro
Slovenian: Če ste prenehali jemati zdravilo Selincro
English: The tablet core: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), magnesium stearate.
Slovenian: Jedro tablete: mikrokristalna celuloza, brezvodna laktoza, krospovidon tipa A, magnezijev stearat.
English: The majority of these reactions were mild or moderate, occurred at the beginning of treatment and lasted for a few hours to a few days.
Slovenian: Večina teh učinkov je bila blagih ali zmernih, pojavili pa so se na začetku zdravljenja in so trajali nekaj ur do nekaj dni.
English: Selincro 18 mg tablet nalmefene
Slovenian: Selincro 18 mg tablete nalmefen
English: Nornalmefene is further converted to nornalmefene 3-O-glucuronide and nornalmefene 3O-sulphate.
Slovenian: 3-O-glukuronid in nornalmefen 3-O-sulfat.
English: Administration of a single dose of nalmefene 18.06 mg to patients with mild or moderate hepatic impairment increased exposure relative to that in healthy subjects.
Slovenian: Pri enkratnem odmerku nalmefena 18,06 mg pri bolnikih z blago ali zmerno okvaro jeter se je izpostavljenost povečala podobno kot pri zdravih osebah.
English: How to take Selincro
Slovenian: Kako jemati zdravilo Selincro
English: (such as seeing, hearing or sensing things that are not there, seizures and shakiness)
Slovenian: slišanje ali občutenje stvari, ki jih ni, epileptični napadi in tresenje)
English: Adverse reactions such as disturbance in attention, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur following administration of nalmefene (see section 4.8).
Slovenian: Po dajanju nalmefena se lahko pojavijo neželeni učinki, kot so motnje pozornosti, nenormalno počutje, navzea, omotica, somnolenca, nespečnost in glavobol (glejte poglavje 4.8).
English: Selincro 18 mg film-coated tablets
Slovenian: Selincro 18 mg filmsko obložene tablete
English: - Do not use this medicine after the expiry date (EXP) that is printed on the blister and carton.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
English: Selincro 18 mg film-coated tablets nalmefene
Slovenian: Selincro 18 mg filmsko obložene tablete nalmefen
English: Both studies were randomised, double-blind, parallel-group and placebo-controlled, and after 6 months of treatment, patients who received Selincro were re-randomised to receive either placebo or Selincro in a 1-month run-out period.
Slovenian: Šest mesecev po zdravljenju so bili bolniki, ki so prejemali zdravilo Selincro, ponovno randomizirani in so mesec dni prejemali bodisi placebo bodisi zdravilo Selincro.
English: Selincro contains the active substance nalmefene.
Slovenian: Zdravilo Selincro vsebuje zdravilno učinkovino nalmefen.
English: The patient's response to treatment and the need for continued pharmacotherapy should be evaluated on a regular
Slovenian: Odziv bolnika na zdravljenje in potrebo po nadaljnji farmakoterapiji je treba ovrednotiti na redni (npr. mesečni) osnovi (glejte poglavje 5.1).