FrancophonIA/ELRC3.0 huggingface dataset:
English: In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomized to receive the ethanolic sublingual solution of buprenorphine at 8 mg/day (a dose which is roughly comparable to a dose of 12 mg/day of buprenorphine/naloxone), or two relatively low doses of active control, one of which was low enough to serve as an alternative to placebo, during a 3 to10 day induction phase, a 16-week maintenance phase and a 7-week detoxification phase.
Croatian: U dvostruko slijepom ispitivanju s dvije kontrole na paralelnim skupinama, u kojem se uspoređivala etanolna otopina buprenorfina s aktivnom kontrolom punog agonista, 162 ispitanika su randomizirana primati sublingvalno 8 mg/dan etanolne otopine buprenorfina (doza koja je ugrubo usporediva s dozom od 12 mg/dan buprenorfina/naloksona), ili dvije relativno niske doze aktivne kontrole, od kojih je jedna bila dovoljno niska da služi kao alternativa placebu, tijekom 3 do 10 dana faze uvođenja, 16 tjedana faze održavanja i 7 tjedana faze detoksikacije.
English: o naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine.
Croatian: o Naltrekson i nalmefen su antagonisti opioida koji mogu blokirati farmakološke učinke buprenorfina.
English: There are no adequate data from the use of Suboxone in pregnant women.
Croatian: Nema podataka o primjeni lijeka Suboxone u trudnica.
English: Clinical data confirm that CYP3A4 is responsible for the Ndealkylation of buprenorphine.
Croatian: Klinički podaci potvrđuju da je CYP3A4 odgovoran za N-dealkilaciju buprenorfina.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati ovaj lijek posavjetujte se sa svojim liječnikom.
English: 6.2 Incompatibilities Not applicable.
Croatian: 6.2 lnkompatibilnosti
English: Dosage adjustment and maintenance therapy
Croatian: Prilagođavanje doze i terapija održavanja
English: The safety and efficacy of buprenorphine/naloxone in elderly patients over 65 years of age have not been established.
Croatian: Sigurnost i djelotvornost buprenorfina/naloksona u bolesnika starijih od 65 godina nije ustanovljena.
English: Use of an opioid antagonist (i.e., naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioid agents.
Croatian: Preporučuje se uporaba antagonista opioida (tj. naloksona), usprkos umjerenom učinku koji taj antagonist može imati u otklanjanju respiratornih simptoma predoziranja buprenorfinom, u usporedbi s njegovim učincima na pune agoniste opioida.
English: Efficacy and safety data for buprenorphine/naloxone are primarily derived from a one-year clinical trial, comprising a 4-week randomised double blind comparison of buprenorphine/naloxone, buprenorphine and placebo followed by a 48 week safety study of buprenorphine/naloxone.
Croatian: Podaci o djelotvornosti i sigurnosti buprenorfina/naloksona prvenstveno su dobiveni iz jednogodišnjeg kliničkog ispitivanja, koje se sastojalo od četverotjedne randomizirane dvostruko slijepe usporedbe buprenorfina/naloksona, buprenorfina i placeba nakon čega je slijedilo 48 tjedana ispitivanja sigurnosti primjene buprenorfina/naloksona.
English: A patient who is under-dosed with buprenorphine/naloxone may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.
Croatian: Bolesnik koji je subdoziran buprenorfinom/naloksonom može reagirati na nekontrolirane simptome ustezanja tako da se sam liječi opioidima, alkoholom ili drugim sedativnim hipnoticima poput benzodiazepina.
English: Withdrawal symptoms may also be associated with sub-optimal dosing.
Croatian: Simptomi ustezanja lijeka također mogu biti povezani sa suboptimalnim doziranjem.
English: Bronchospasm Respiratory depression
Croatian: Bronhospazam Respiratorna depresija
English: Buprenorphine and its metabolites are excreted in human breast milk.
Croatian: Buprenorfin i njegovi metaboliti se izlučuju u majčino mlijeko.
English: A peri-postnatal study has not been conducted with buprenorphine/naloxone; however, maternal oral administration of buprenorphine at high doses during gestation and lactation resulted in difficult parturition (possible as a result of the sedative effect of buprenorphine), high neonatal mortality and a slight delay in the development of some neurological functions (surface righting reflex and startle response) in neonatal rats.
Croatian: Nije provedeno peripostnatalno ispitivanje buprenorfina/naloksona; međutim, peroralna primjena visokih doza buprenorfina u ženki tijekom gestacije i laktacije rezultirala je otežanim okotom (vjerojatno posljedica sedativnog učinka buprenorfina), visokim neonatalnim mortalitetom i blago odgođenim razvojem nekih neuroloških funkcija (refleks uspravljanja i reakcija trzanja) u novorođenih štakora.
English: 3 - Starting from the edge where the seal is lifted, pull back the foil on the back to remove the tablet.
Croatian: 3 - Počevši od ruba na kojem je folija odignuta, povucite foliju sa stražnjeg dijela blistera kako bi izvadili tabletu.
English: A dietary dose of 100 ppm (estimated exposure approximately 2.4x for buprenorphine at a human dose of 24 mg buprenorphine/naloxone based on AUC, plasma levels of naloxone were below the limit of detection in rats) had no adverse effect on fertility in females.
Croatian: Davanje lijeka Suboxone s hranom u dozi od 100 ppm (procijenjena izloženost odgovara onoj od oko 2,4x vrijednosti za buprenorfin pri dozi za ljude od 24 mg buprenorfina/naloksona na temelju AUC, a razine naloksona u plazmi bile su ispod granice detekcije u štakora) nije imala nikakvih štetnih učinaka na plodnost u ženki.
English: Other medicines and Suboxone Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • adrenocortical disorder (e.g. Addison's disease)
Croatian: • problema sa štitnom žlijezdom • adrenokortikalni poremećaj (npr. Addisonovu bolest)
English: This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-dependent people who accidentally or deliberately take it.
Croatian: Ovaj lijek može uzrokovati tešku, moguće i sa smrtnim ishodom, respiratornu depresiju (smanjena sposobnost disanja) u djece i osoba koje nisu ovisne ako ga slučajno ili namjerno uzmu.
English: During the days after you start treatment, your doctor may increase the dose of Suboxone you take according to your needs.
Croatian: Nakon početka liječenja, liječnik Vam može povisiti dozu lijeka Suboxone prema Vašim potrebama.
English: Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see Warnings and precautions).
Croatian: Pogrešna primjena ovog lijeka putem ubrizgavanja može uzrokovati simptome ustezanja, infekcije, druge kožne reakcije i potencijalno ozbiljne probleme s jetrom (vidjeti dio “Upozorenja i mjere opreza”).
English: 28 sublingual tablets
Croatian: 7 sublingvalnih tableta 28 sublingvalnih tableta
English: What do you need to know before you take Suboxone
Croatian: Što morate znati prije nego počnete uzimati Suboxone
English: • Breathing problems
Croatian: • Problemi s disanjem
English: A carcinogenicity study with buprenorphine/naloxone was conducted in rats at doses of 7, 30 and 120 mg/kg/day, with estimated exposure multiples of 3 to 75 times, based on a human daily sublingual dose of 16 mg calculated on a mg/m² basis.
Croatian: Ispitivanje kancerogenosti buprenorfina/naloksona provedeno je na štakorima s dozama od 7, 30 i 120 mg/kg/dan, čime su štakori bili izloženi 3 do 75 puta višoj dozi, s obzirom na dnevnu sublingvalnu dozu za ljude od 16 mg izračunatu na temelju mg/m2.
English: General warnings relevant to the administration of opioids Opioids may produce orthostatic hypotension in ambulatory patients.
Croatian: Opća upozorenja vezana uz primjenu opioida Opioidi mogu izazvati ortostatsku hipotenziju u vanbolničkih bolesnika.
English: Therefore the potential to overdose with a full agonist exists, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining.
Croatian: Stoga postoji mogućnost predoziranja punim agonistom, naročito kad se pokušavaju poništiti učinci parcijalnog agonista buprenorfina ili kad su razine buprenorfina u plazmi u opadanju.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/
English: Symptoms of overdose may include feeling sleepy and uncoordinated with slowed reflexes, blurred vision, and/or slurred speech.
Croatian: Simptomi predoziranja mogu obuhvaćati osjećaj pospanosti, slabu koordinaciju s usporenim refleksima, zamagljeni vid i/ili nerazgovjetan govor.
English: In this trial, 326 heroin-addicted subjects were randomly assigned to either buprenorphine/naloxone 16 mg per day, 16 mg buprenorphine per day or placebo.
Croatian: U ovom ispitivanju, 326 ispitanika ovisnih o heroinu randomizirano je na 16 mg/dan buprenorfina/naloksona, 16 mg/dan buprenorfina, ili placebo.
English: Slow or difficult breathing, liver injury with or without jaundice, hallucinations, swelling of face and throat or life threatening allergic reactions, drop in blood pressure on changing position from sitting or lying down to standing.
Croatian: Usporeno ili otežano disanje, oštećenje jetre s ili bez žutice, halucinacije, natečenost lica i ždrijela ili po život opasne alergijske reakcije, pad krvnog tlaka pri promjeni položaja iz sjedećeg ili ležećeg u uspravni.
English: Do not use this medicine after the expiry date which is stated on the carton.
Croatian: Ne upotrebljavajte ovaj lijek nakon isteka roka trajanja koji je naveden na pakiranju.
English: Naloxone is an antagonist at -opioid receptors.
Croatian: Nalokson je antagonist µ-opioidnih receptora.
English: If you or someone else takes too much of this medicine, you must go or be taken immediately to an emergency centre or hospital for treatment as overdose with Suboxone may cause serious and lifethreatening breathing problems.
Croatian: Ako uzmete više lijeka Suboxonea nego što ste trebali Ako se Vi ili netko drugi predozira ovim lijekom, odmah treba otići ili biti odvezen u ambulantu hitne pomoći ili bolnicu zbog liječenja jer predoziranje lijekom Suboxone može uzrokovati ozbiljne i životno ugrožavajuće poteškoće s disanjem.
English: This product may cause drowsiness, dizziness, or impaired thinking, especially during treatment induction and dose adjustment.
Croatian: Ovaj lijek može izazvati pospanost, omaglicu ili umanjiti sposobnost razmišljanja, osobito tijekom početka liječenja i prilagodbe doze.
English: Co-administration during buprenorphine/naloxone treatment is contraindicated due to the potentially dangerous interaction that may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms (see section 4.3).
Croatian: Njihova istodobna primjena za vrijeme liječenja buprenorfinom/naloksonom je kontraindicirana zbog potencijalno opasnih interakcija koje bi mogle naglo uzrokovati duge i intenzivne simptome ustezanja od opioida (vidjeti dio 4.3).
English: Dansom Lane
Croatian: Dansom Lane, Hull,
English: • if you have serious liver problems
Croatian: • ako imate ozbiljne probleme s jetrom
English: Name and address of the manufacturer responsible for batch release Reckitt Benckiser Healthcare (UK) Ltd
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Reckitt Benckiser Healthcare
English: Alcohol may increase drowsiness and may increase the risk of respiratory failure if taken with Suboxone.
Croatian: Alkohol može pojačati omamljenost i rizik od zatajenja disanja ako se uzima s lijekom Suboxone.
English: Also tell your doctor immediately if you experience side effects such as:
Croatian: Također se odmah obratite svojem liječniku ako primijetite nuspojave poput:
English: N-dealkylbuprenorphine is a -opioid agonist with weak intrinsicactivity.
Croatian: N-dealkilbuprenorfin je µ-opioidni agonist sa slabom intrinzičkom aktivnošću.
English: Do not take Suboxone
Croatian: Nemojte uzimati Suboxone
English: No dose modification based on renal function is required but caution is recommended when dosing subjects with severe renal impairment (see Section 4.3).
Croatian: Nije potrebna prilagodba doze vezano uz funkciju bubrega, ali se preporučuje oprez kad se doza primjenjuje u osoba s teškim oštećenjem funkcije bubrega (vidjeti dio 4.3).
English: To minimize the risk of misuse, abuse and diversion, physicians should take appropriate precautions when prescribing and dispensing buprenorphine, such as to avoid prescribing multiple refills early in treatment, and to conduct patient follow-up visits with clinical monitoring that is appropriate to the patient's needs.
Croatian: Da bi se smanjio rizik pogrešne uporabe, zlouporabe lijeka i uporabe lijeka u svrhe za koje nije namijenjen, liječnici moraju poduzeti odgovarajuće mjere opreza pri propisivanju i davanju buprenorfina, poput izbjegavanja propisivanja višestrukih količina lijeka na početku liječenja te provođenja praćenja stanja bolesnika kliničkim praćenjem sukladno potrebama bolesnika.
English: The medicinal product is metabolized in the liver, primarily by glucuronide conjugation, and excreted in the urine.
Croatian: Ovaj se lijek metabolizira u jetri, primarno konjugacijom s glukuronskom kiselinom, a izlučuje se urinom.
English: Effect of hepatic impairment on pharmacokinetic parameters of buprenorphine and naloxone following SUBOXONE administration (change relative to healthy subjects)
Croatian: Tablica 2. Utjecaj oštećenja jetre na farmakokinetičke parametre buprenorfina i naloksona nakon primjene lijeka SUBOXONE (relativna promjena u odnosu na zdrave ispitanike)
English: Plasma levels of buprenorphine increased with the sublingual dose of buprenorphine/naloxone.
Croatian: Razine buprenorfina u plazmi povećale su se sublingvalnom primjenom buprenorfina/naloksona.
English: The long half life of methadone should be considered when starting buprenorphine/naloxone.
Croatian: Dug poluvijek metadona treba uzeti u obzir kad se započinje s liječenjem buprenorfinom/naloksonom.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal treba biti zbrinuti sukladno lokalnim propisima.
English: The combination (4:1) of buprenorphine hydrochloride and naloxone hydrochloride was not mutagenic in a bacterial mutation assay (Ames test), and was not clastogenic in an in vitro cytogenetic assay in human lymphocytes or in an intravenous micronucleus test in the rat.
Croatian: Kombinacija (4:1) buprenorfin klorida i nalokson hidroklorida nije imala mutagene učinke u ispitivanju mutagenosti na bakterijama (Amesov test) i nije bila klastogenična u citogenetičkom ispitivanju in vitro na ljudskim limfocitima ili u intravenskom mikronukleusnom testu u štakora.
English: 14.0-fold increase
Croatian: Povećanje od 14,0 puta
English: • if you have serious breathing problems
Croatian: • ako imate ozbiljne poteškoće s disanjem
English: Oedema peripheral
Croatian: Bol Periferni edem
English: After a satisfactory stabilisation has been achieved the frequency of dosing may be decreased to dosing every other day at twice the individually titrated daily dose.
Croatian: Nakon što se postigla zadovoljavajuća stabilizacija, učestalost primjene može se smanjiti na svaki drugi dan, s time da se daje dvostruka dnevna doza koju pojedini bolesnik inače prima.
English: o For patients receiving methadone, the dose of methadone should be reduced to a maximum of 30 mg/day before beginning buprenorphine/naloxone therapy.
Croatian: o Za bolesnike koji dobivaju metadon, doza metadona mora se sniziti na najviše 30 mg dnevno prije početka terapije buprenorfinom/naloksonom.
English: On Day 3, those randomized to receive buprenorphine/naloxone were switched to the combination tablet.
Croatian: 3. dana, ispitanici randomizirani u skupinu koja će primati buprenorfin/nalokson prebačeni su na kombiniranu tabletu.
English: o CYP3A4 inhibitors: an interaction study of buprenorphine with ketoconazole (a potent inhibitor of CYP3A4) resulted in increased Cmax and AUC (area under the curve) of buprenorphine (approximately 50 % and 70 % respectively) and, to a lesser extent, of norbuprenorphine.
Croatian: o inhibitorima CYP3A4: ispitivanje interakcija buprenorfina s ketokonazolom (jaki inhibitor CYP3A4) rezultiralo je povećanjem Cmax (za 50 %) i AUC (područje ispod krivulje) (za 70 %) buprenorfina, i u manjoj mjeri, norbuprenorfina.
English: Patients should be clearly monitored during the switching period from buprenorphine or methadone to buprenorphine/naloxone since withdrawal symptoms have been reported.
Croatian: Bolesnike treba strogo pratiti tijekom razdoblja prelaska s buprenorfina ili metadona na buprenorfin/nalokson s obzirom na prijavljene simptome ustezanja.
English: Long-term administration of buprenorphine during the last three months of pregnancy may cause a withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions).
Croatian: Dugoročna primjena buprenorfina u zadnjem tromjesečju trudnoće može izazvati sindrom ustezanja u novorođenčeta (npr. hipertoniju, neonatalni tremor, neonatalnu agitaciju, mioklonus ili konvulzije).
English: • Keep the tablets in place under the tongue until they have completely dissolved.
Croatian: • Držite tablete na mjestu pod jezikom sve dok se potpuno ne otope.
English: Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence.
Croatian: Istodobna primjena antagonista opioida (naltrekson, nalmefen) za liječenje ovisnosti o alkoholu ili opioidima.
English: Combining buprenorphine with naloxone in Suboxone is intended to deter misuse and abuse of the buprenorphine.
Croatian: Kombiniranje buprenorfina s naloksonom u lijeku Suboxone namijenjeno je odvraćanju od pogrešne uporabe i zlouporabe buprenorfina.
English: - The other ingredients are lactose monohydrate, mannitol, maize starch, povidone K30, citric acid anhydrous, sodium citrate, magnesium stearate, acesulfame potassium and natural lemon and lime flavour.
Croatian: - Drugi sastojci su laktoza hidrat, manitol, kukuruzni škrob, povidon K30, bezvodna citratna kiselina, natrijev citrat, magnezijev stearat, acesulfamkalij i prirodna aroma limuna i limete.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the  and  (kappa) opioid receptors of the brain.
Croatian: Buprenorfin je parcijalni agonist/antagonist opioida koji se veže za µ i κ (kappa) opioidne receptore u mozgu.
English: Renal elimination may be prolonged since 30 % of the administered dose is eliminated by the renal route.
Croatian: Oštećenje bubrega Eliminacija bubrezima može biti produljena, jer se 30% primijenjene doze eliminira putem bubrega.
English: Not Known
Croatian: Manje često Nepoznato
English: Prior to treatment initiation, consideration should be given to the type of opioid dependence (i.e. longor short-acting opioid), the time since last opioid use and the degree of opioid dependence.
Croatian: Prije početka liječenja, mora se utvrditi o kojoj se vrsti ovisnosti o opioidima radi (tj. kratkodjelujućim ili dugodjelujućim opioidima), vremenu od zadnje uporabe opioida te stupnju ovisnosti o opioidima.
English: Depending upon the findings, the medicinal product may be discontinued cautiously so as to prevent withdrawal symptoms and to prevent a return to illicit drug use.
Croatian: Ovisno o nalazima, može se prekinuti davanje lijeka, ali uz oprez, tako da se spriječi nastanak simptoma ustezanja od lijeka i povrat na zlouporabu lijeka.
English: This product should be used with care in patients with asthma or respiratory insufficiency (e.g. chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis (curvature of spine leading to potential shortness of breath)).
Croatian: Ovaj lijek treba primjenjivati uz oprez u bolesnika s astmom ili respiratornom insuficijencijom ( npr. kronična opstruktivna bolest pluća, plućno srce, smanjeni kapacitet pluća, hipoksija, hiperkapnija, prethodno postojeća depresija disanja ili kifoskolioza (iskrivljenje kralježnice koje vodi do potencijalno kratkog daha)).
English: To avoid precipitating withdrawal, induction with buprenorphine/naloxone or buprenorphine only should be undertaken when objective and clear signs of withdrawal are evident (demonstrated e.g. by a score indicating mild to moderate withdrawal on the validated Clinical Opioid Withdrawal Scale, COWS).
Croatian: Da bi se izbjeglo naglo ustezanje, buprenorfin/nalokson ili sam buprenorfin trebaju se uvesti samo kad objektivni i jasni znakovi ustezanja postanu očiti (pokazuju se, primjerice, rezultatom koji upućuje na blago do umjereno ustezanje na validiranoj Kliničkoj skali ustezanja od opioida (COWS)).
English: Pharmacokinetic Parameter Suboxone 4 mg Suboxone 8 mg Suboxone 16 mg
Croatian: Suboxone 4 mg Suboxone 8 mg Suboxone 16 mg
English: How to take Suboxone
Croatian: Kako uzimati Suboxone
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Croatian: Poremećaji su se kretali u rasponu od prolaznih asimptomatskih povišenja jetrenih transaminaza do pojedinačnih prikaza slučajeva zatajenja jetre, nekroze jetre, hepatorenalnog sindroma, hepatalne encefalopatije i smrti.
English: The lowest dose studied represented exposure multiples of 1x for buprenorphine and 5x for naloxone at the maximum human therapeutic dose calculated on a mg/m² basis.
Croatian: Najniža ispitivana doza kojoj su štakori bili izloženi odgovarala je umnošcima od 1x izloženosti za buprenorfin i 5x za nalokson pri maksimalnoj terapijskoj dozi za ljude izračunate na temelju mg/m2.
English: Some people have died from respiratory failure (inability to breathe) because they misused this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.
Croatian: Neke su osobe umrle zbog zatajenja disanja (nisu mogle disati), jer su uzele ovaj lijek na pogrešan način ili su ga uzele u kombinaciji s drugim depresorima središnjeg živčanog sustava,
English: Sudden withdrawal syndrome caused by taking Suboxone too soon after use of illicit opioids, drug withdrawal syndrome in newborn.
Croatian: Iznenadni sindrom ustezanja uzrokovan preranim uzimanjem lijeka Suboxone nakon primjene zabranjenih opioida, sindrom ustezanja lijeka u novorođenčadi.
English: However, when administered intravenously to opioid-dependent persons, the presence of naloxone in Suboxone produces marked opioid antagonist effects and opioid withdrawal, thereby deterring intravenous abuse.
Croatian: Međutim, kad ga intravenski primjenjuju osobe ovisne o opioidima, prisutnost naloksona u lijeku Suboxone izaziva izrazite učinke opioidnog antagonista i ustezanja opioida, što odvraća osobe od intravenske zlouporabe.
English: Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.
Croatian: Prije početka terapije preporučuje se napraviti i dokumentirati osnovne pretrage funkcije jetre i status virusnog hepatitisa.