FrancophonIA/ELRC3.0 huggingface dataset:
English: The maximum daily dose is 17.2 mg.
Croatian: Maksimalna dnevna doza je 17,2 mg.
English: Do not take any other medicines whilst taking Zubsolv without first talking to your doctor, especially:
Croatian: Nemojte uzimati bilo koje druge lijekove dok uzimate Zubsolv bez prethodnog razgovora sa svojim liječnikom, osobito:
English: These may be symptoms of liver damage
Croatian: Ovo mogu biti simptomi oštećenja jetre
English: Never open in advance as the tablet is sensitive to moisture
Croatian: Nikada ga nemojte otvarati unaprijed jer je tableta osjetljiva na vlagu
English: Symptomatic treatment of respiratory depression and standard intensive care measures should be implemented.
Croatian: Treba provesti simptomatsko liječenje depresije disanja i standardne mjere intenzivne skrbi.
English: What Zubsolv looks like and contents of the pack
Croatian: Kako Zubsolv izgleda i sadržaj pakiranja
English: Subjects were seen daily in the clinic (Monday through Friday) for dosing and efficacy assessments.
Croatian: Ispitanici su se svakodnevno javljali u kliniku (od ponedjeljka do petka) radi procjena doziranja i djelotvornosti liječenja.
English: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Croatian: Nadomjesno liječenje ovisnosti o opioidima u okviru medicinskog, socijalnog i psihološkog liječenja.
English: If you take more Zubsolv than you should
Croatian: Ako uzmete više lijeka Zubsolv nego što ste trebali
English: • Do not chew or swallow the tablets, as the medicine will not work and you may get withdrawal symptoms
Croatian: • Nemojte žvakati ili gutati tablete, jer lijek neće djelovati i možete imati simptome ustezanja.
English: Patients should be monitored during dose titration.
Croatian: Bolesnike je potrebno nadzirati tijekom titracije doze.
English: This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative medicines when you take Zubsolv.
Croatian: Do ovog može doći češće u prvih nekoliko tjedana liječenja kada Vam se mijenja doza, no također se može pojaviti ako uz Zubsolv konzumirate alkohol ili uzimate druge sedative.
English: How to remove the tablet from the blister
Croatian: Kako izvaditi tabletu iz blistera
English: • some medicines may decrease the effect of Zubsolv.
Croatian: • neki lijekovi mogu smanjiti učinke lijeka Zubsolv.
English: Do not give this medicine to anyone else.
Croatian: Nemojte davati ovaj lijek drugim osobama.
English: The dose on Monday and Wednesday should be twice the individually titrated daily dose, and the dose on Friday should be three times the individually titrated daily dose, with no dose on the intervening days.)
Croatian: Doza koja se daje ponedjeljkom i srijedom treba biti dvostruko viša od individualno titrirane dnevne doze, a doza petkom treba biti tri puta viša od individualno titrirane dnevne doze, bez primjene doze u međuvremenu.)
English: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥/10,000
Croatian: Vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i
English: Respiratory depression as a result of central nervous system depression is the primary symptom requiring intervention in the case of overdose because it may lead to respiratory arrest and death.
Croatian: Depresija disanja kao rezultat depresije središnjeg živčanog sustava je glavni simptom zbog kojeg je potrebna intervencija u slučaju predoziranja jer može dovesti do respiratornog aresta i smrti.
English: Do not drive, use any tools or machines, or perform dangerous activities until you know how this medicine affects you.
Croatian: Nemojte upravljati vozilima, koristiti se alatima ili upravljati strojevima ili obavljati rizične aktivnosti dok ne znate kako ovaj lijek utječe na Vas.
English: During your treatment, the doctor may adjust the dose, depending upon your response.
Croatian: Tijekom liječenja, liječnik može prilagođavati dozu ovisno o Vašem odgovoru.
English: Similar to control
Croatian: Slično kontrolnoj skupini
English: Tell your doctor as soon as possible if you miss a dose.
Croatian: Obavijestite svog liječnika čim prije ako ste propustili dozu.
English: Some medicines may increase the side effects of Zubsolv and may sometimes cause very serious reactions.
Croatian: Neki lijekovi mogu povećati nuspojave lijeka Zubsolv te mogu ponekad uzrokovati vrlo ozbiljne reakcije.
English: Do not swallow.
Croatian: Ne progutati.
English: Undesirable effects were based on the known pharmacological activity of opioid agonistic and/or antagonistic substances.
Croatian: Neželjeni učinci temeljili su se na poznatom farmakološkom djelovanju opioidnih agonista i/ili antagonističkih tvari.
English: 7 sublingual tablets 28 sublingual tablets 30 sublingual tablets
Croatian: 7 sublingvalnih tableta 28 sublingvalnih tableta 30 sublingvalnih tableta
English: Clear signs of withdrawal should be evident before taking your first dose of Zubsolv.
Croatian: Jasni znakovi ustezanja trebaju biti vidljivi prije uzimanja vaše prve doze Zubsolva.
English: • alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7)
Croatian: • alkoholnim pićima ili lijekovima koji sadrže alkohol, jer alkohol pojačava sedativni učinak buprenorfina (vidjeti dio 4.7).
English: Dosage adjustment and maintenance therapy
Croatian: Prilagodba doze i terapija održavanja
English: Tell your doctor immediately or seek urgent medical attention if you experience serious side effects, such as:
Croatian: Odmah obavijestite svojeg liječnika ili potražite hitnu medicinsku pomoć ako primijetite nuspojave, kao što su:
English: Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist e.g. morphine.
Croatian: Ispitivanja na životinjama, kao i kliničko iskustvo, pokazala su da buprenorfin može izazvati ovisnost, no znatno manje razine od punog agonista, npr. morfija.
English: Statistically significant increases in the incidence of benign testicular interstitial (Leydig's) cell adenomas were observed in all dosage groups.
Croatian: Statistički značajno povećanje incidencije benignih adenoma intersticijskih (Leydigovih) stanica testisa primijećeno je u svim doznim skupinama.
English: The absorption of buprenorphine is followed by a rapid distribution phase (distribution half-life of 2 to 5 hours).
Croatian: Nakon apsorpcije buprenorfina slijedi faza brze distribucije (poluvrijeme distribucije od 2 do 5 sati).
English: The frequency of possible side effects listed below is defined using the following convention:
Croatian: Učestalost mogućih nuspojava navedenih u nastavku definirana je na sljedeći način:
English: medicine dependence, exaggerated feeling of well-being, feelings of hostility
Croatian: ovisnost o lijekovima, pretjerani osjećaj da ste dobro, osjećaj neprijateljstva
English: Severe respiratory insufficiency.
Croatian: Teška respiratorna insuficijencija.
English: If you feel that the effect of Zubsolv is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako imate dojam da je učinak lijeka Zubsolv prejak ili preslab, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: General supportive measures should be initiated, including close monitoring of respiratory and cardiac status of the patient.
Croatian: Potrebno je započeti opće suportivne mjere, uključujući strogu kontrolu respiratornog i kardijalnog statusa bolesnika.
English: Withdrawal symptoms may also be associated with sub-optimal dosing.
Croatian: Simptomi ustezanja također mogu biti povezani sa suboptimalnim doziranjem.
English: Taking the wrong dose of benzodiazepines may cause death due to respiratory failure (inability to breathe).
Croatian: Uzimanje pogrešne doze benzodiazepina može uzrokovati smrt zbog zatajenja disanja (nemogućnosti disanja).
English: • abnormal dreams, agitation, loss of interest, depersonalisation (not feeling like yourself),
Croatian: • neuobičajeni snovi, uznemirenost, gubitak interesa, depersonalizacija (ne osjećate se svoji),
English: Do not take Zubsolv together with alcohol.
Croatian: Ne uzimajte lijek Zubsolv zajedno s alkoholom.
English: Regular blood tests may be conducted by your doctor to monitor the condition of your liver.
Croatian: Vaš liječnik može provoditi redovite krvne pretrage kako bi nadzirao stanje
English: Zubsolv can also cause withdrawal symptoms if you stop taking it abruptly.
Croatian: Zubsolv može također uzrokovati simptome ustezanja ako ga naglo prestanete uzimati.
English: Buprenorphine/naloxone should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Croatian: Buprenorfin/nalokson bi za vrijeme trudnoće trebalo koristiti isključivo ako potencijalna korist nadmašuje potencijalnu opasnost za fetus.
English: This may involve taking a combination of different strengths, but your daily dose should not exceed 17.2mg of buprenorphine.
Croatian: To može uključiti uzimanje kombinacije različitih jačina, ali Vaša dnevna doza ne smije prijeći 17,2 mg buprenorfina.
English: • Take the dose once a day or as advised by your doctor.
Croatian: • Uzmite dozu jednom dnevno prema uputama liječnika.
English: Zubsolv sublingual tablets have a higher bioavailability than conventional sublingual tablets.
Croatian: Sublingvalne tablete Zubsolv imaju veću bioraspoloživost od konvencionalnih sublingvalnih tableta.
English: Tell your doctor if you have any liver problems before you start treatment with Zubsolv.
Croatian: Obavijestite svog liječnika ako imate bilo kakvih problema s jetrom prije nego počnete liječenje lijekom Zubsolv.
English: Your doctor will prescribe the correct dose for you.
Croatian: Liječnik će Vam propisati ispravnu dozu.
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 Zubsolv may cause serious and life-threatening breathing problems.
Croatian: 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 Zubsolv može uzrokovati ozbiljne i životno ugrožavajuće poteškoće s disanjem.
English: (buprenorphine/naloxone)
Croatian: (buprenorfin/nalokson)
English: Use of multiples of the three lower dose presentations of Zubsolv to substitute for any of the three higher dose presentations (in for example cases where the higher dose presentations are temporarily not available) is not recommended (see section 5.2).
Croatian: Višestruka primjena tri najniže doze Zubsolva kao zamjena za bilo koju od tri najviše doze (primjerice u slučajevima kad više doze nisu privremeno dostupne) se ne preporučuje (vidjeti dio 5.2).
English: • drop in blood pressure on changing position from sitting or lying down to standing
Croatian: • pad krvnog tlaka prilikom promjene položaja iz sjedanja ili ležanja u stajanje
English: Patients requiring a titrated daily dose > 5.7 mg buprenorphine /day may not find this regimen adequate.
Croatian: Za bolesnike kojima je potrebna titrirana dnevna doza >5,7 mg buprenorfina/dan ovakav režim doziranja možda neće biti prikladan.
English: What you need to know before you take Zubsolv 3.
Croatian: Što morate znati prije nego počnete uzimati Zubsolv 3.
English: The effectiveness of buprenorphine, 8 mg per day was similar to that of the moderate active control dose, but equivalence was not demonstrated.
Croatian: Učinkovitost buprenorfina u dozi od 8 mg dnevno bila je slična onoj aktivne kontrole s umjerenom dozom, iako ekvivalencija nije dokazana.
English: Patients must be warned to store the blister safely, to never open the blister in advance, to keep them out of the sight and reach of children and other household members, and not to take this medicine in front of children.
Croatian: Bolesnici se moraju upozoriti da blister čuvaju na sigurnom, da blister nikada ne otvaraju unaprijed, da ga čuvaju izvan pogleda i dohvata djece i drugih članova domaćinstva te da ne uzimaju lijek pred djecom.
English: Elimination of buprenorphine is bi- or tri-exponential, and has a mean half-life from plasma of 32 hours.
Croatian: Eliminacija buprenorfina je dvo- ili tro-eksponencijalna i ima srednji poluvijek u plazmi od 32 sata.
English: Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Croatian: Liječenje je namijenjeno za uporabu u odraslih i adolescenata starijih od 15 godina koji su pristali na liječenje ovisnosti.
English: This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft.
Croatian: Ovaj lijek može biti meta osobama koji zlouporabljuju propisivane lijekove te se mora držati na sigurnom mjestu zbog zaštite od krađe.
English: Therefore the dose in mg can differ between products.
Croatian: Zato se doza u mg može razlikovati između lijekova.
English: A doctor's assessment of your readiness for treatment will guide the timing of your first Zubsolv dose.
Croatian: Liječnička procjena vaše spremnosti za liječenje će odrediti vašu prvu dozu Zubsolva.
English: • have kidney problems • have recently suffered a head injury or brain disease
Croatian: • ako ste nedavno zadobili ozljedu glave ili imali bolest mozga
English: Naloxone has a mean half-life from plasma of 1.2 hours.
Croatian: Nalokson ima srednju vrijednost poluvijeka u plazmi od 1,2 sata.
English: No developmental toxicity was observed in rabbits at maternally toxic doses.
Croatian: Nije primijećena razvojna toksičnost u kunića pri maternalno toksičnim dozama.
English: Therefore, breastfeeding should be discontinued during treatment with Zubsolv.
Croatian: Stoga dojenje treba prekinuti za vrijeme liječenja lijekom Zubsolv.
English: Zubsolv is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Croatian: Zubsolv se koristi za liječenje ovisnosti o opioidima (narkoticima) kao što su heroin ili morfin kod ovisnika o drogama koji su pristali na liječenje ovisnosti.
English: Both Cmax and AUC of buprenorphine increased with the increase in dose, although the increase was less than dose-proportional.
Croatian: I Cmax i AUC buprenorfina povećali su se s povišenjem doze, iako povećanje nije bilo proporcionalno dozi, nego manje.
English: Patients should be monitored following medical withdrawal because of the potential for relapse.
Croatian: Bolesnike je potrebno nadzirati nakon ustezanja lijeka od strane liječnika zbog mogućnosti pojave relapsa.
English: - have serious breathing problems - have serious liver problems
Croatian: - ako imate ozbiljne poteškoće s disanjem - ako imate ozbiljne probleme s jetrom
English: If the treatment is continued, hepatic function should be monitored closely.
Croatian: Ako se nastavi s liječenjem, treba pažljivo pratiti funkciju jetre.
English: Therefore, multiples of the three lower dose presentations of Zubsolv should not be used to substitute for any of the three higher dose Zubsolv presentations.
Croatian: Stoga ne treba upotrebljavati višestruke tri najniže doze Zubsolva kao zamjenu za nijednu od tri najviše doze Zubsolva.
English: Elderly No pharmacokinetic data in elderly patients are available.
Croatian: Nema dostupnih podataka o farmakokinetici u starijih bolesnika.
English: Table 1 summarises adverse reactions reported from pivotal clinical trials in which, 342 of 472 patients (72.5 %) reported adverse reactions and adverse reactions reported during post-marketing surveillance.
Croatian: Tablica 1 sažeto prikazuje nuspojave zabilježene tijekom ključnih kliničkih ispitivanja u kojima su 342 od 472 bolesnika (72,5%) prijavila nuspojave i nuspojave zabilježene nakon stavljanja lijeka u promet.
English: These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin)
Croatian: To su lijekovi koji se koriste za liječenje epilepsije (poput karbamazepina i fenitoina) i lijekovi koji se koriste za liječenje tuberkuloze (rifampicin)
English: Peak plasma concentrations are achieved approximately 90 minutes after sublingual administration.
Croatian: Vršne koncentracije u plazmi postižu se približno 90 minuta nakon sublingvalne primjene.
English: No recommendation on posology can be made.
Croatian: Nije moguće dati preporuku o doziranju.
English: • Starting treatment of Zubsolv whilst dependent on heroin:
Croatian: • Početak liječenja lijekom Zubsolv dok ste ovisni o heroinu:
English: Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines while taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their physician (see section 4.4)
Croatian: Bolesnike treba upozoriti da je iznimno opasno samoprimjenjivati nepropisane benzodiazepine tijekom uzimanja ovog lijeka, a također ih treba upozoriti da uzimaju benzodiazepine zajedno s ovim lijekom isključivo prema uputama njihovog liječnika (vidjeti dio 4.4).
English: N-dealkylbuprenorphine is a μ-opioid agonist with weak intrinsic activity.
Croatian: N-dealkilbuprenorfin je μ-opioidni agonist sa slabom intrinzičkom aktivnošću.
English: Depending on your condition, the dose of Zubsolv may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Croatian: Ovisno o Vašem stanju, sa snižavanjem doze lijeka Zubsolv se može nastaviti pod pažljivim liječničkim nadzorom, sve do trenutka kad se eventualno može prekinuti.
English: This product may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.
Croatian: Ovaj lijek može uzrokovati iznenadan pad Vašeg krvnog tlaka, uzrokujući osjećaj omaglice ako prebrzo ustajete iz sjedećeg ili ležećeg položaja.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: The availability of six different tablet strengths supports individual dose titration and tapering.
Croatian: Dostupnost šest različitih jačina tableta omogućava titraciju i snižavanje pojedinačnih doza.
English: Physicians must warn patients that the sublingual route is the only effective and safe route of administration for this medicinal product (see section 4.4).
Croatian: Liječnici moraju upozoriti bolesnike da je sublingvalni put primjene jedini djelotvoran i siguran put primjene ovog lijeka (vidjeti dio 4.4).
English: Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit.
Croatian: Buprenorfin se može pogrešno rabiti ili zlouporabiti na sličan način kao i drugi opioidi, zakoniti ili zabranjeni.
English: A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Croatian: Prijavljeni su smrtni slučajevi zbog depresije disanja, osobito kad se buprenorfin rabio u kombinaciji s benzodiazepinima (vidjeti dio 4.5) ili kad se buprenorfin nije rabio u skladu s propisanim uputama.
English: Zubsolv disintegrates usually within 40 seconds, however it may take 5 to 10 minutes for the patient to feel complete tablet disappearance from the mouth.
Croatian: Zubsolv se obično raspada u roku od 40 sekundi, međutim može proteći 5 do 10 minuta prije nego što bolesnik osjeti da je tableta potpuno nestala iz usta.
English: The risks of using Zubsolv in pregnant women are not known.
Croatian: Rizici uzimanja lijeka Zubsolv u trudnica nisu poznati.
English: Opioid-induced miosis, changes in the level of consciousness, or changes in the perception of pain as a symptom of disease may interfere with patient evaluation or obscure the diagnosis or clinical course of concomitant disease.
Croatian: Mioza potaknuta opioidima, promjene u razini svijesti ili promjene u percepciji boli kao simptoma bolesti mogu utjecati na procjenu bolesnika ili zasjeniti dijagnozu ili klinički tijek prateće bolesti.
English: Zubsolv can be a target for people who abuse prescription medicine.
Croatian: Zubsolv može biti meta osobama koje zloupotrebljavaju lijekove koji se izdaju na recept.
English: After a period of successful treatment, you may agree with your doctor to reduce the dose gradually to a lower maintenance dose.
Croatian: Nakon uspješnog liječenja, možete se složiti s Vašim liječnikom da se doza postupno snizi na nižu dozu održavanja.
English: • Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam.
Croatian: • Benzodiazepine (koriste se za liječenje tjeskobe ili poremećaja spavanja) poput diazepama, temazepama, alprazolama.
English: Buprenorphine was titrated to maintenance dose by Day 3; active control doses were titrated more gradually.
Croatian: Do 3. dana buprenorfin je titriran do doze održavanja; doze aktivnih kontrola titrirale su se postupnije.
English: The diagnosis of opioid-related toxicity should be reconsidered if there is still failure to respond after a total of 10 mg of naloxone has been administered.
Croatian: Dijagnozu toksičnosti povezane s opoidima potrebno je ponovno razmotriti ako bolesnik i dalje ne reagira ni nakon primjene ukupno 10 mg naloksona.
English: These include local reactions, sometimes septic (abscess, cellulitis), potentially serious acute hepatitis, and other acute infections such as pneumonia, endocarditis (see section 4.4).
Croatian: Te su nuspojave uključivale lokalne reakcije, ponekad septičke (apsces, celulitis), i potencijalno ozbiljan akutni hepatitis te druge akutne infekcije kao što su pneumonija, endokarditis (vidjeti dio 4.4).
English: Following intravenous administration, naloxone is rapidly distributed (distribution half-life ~ 4 minutes).
Croatian: Nakon intravenske primjene, nalokson se brzo distribuira (poluvrijeme distribucije ~ 4 minute).
English: What Zubsolv is and what it is used for
Croatian: Što je Zubsolv i za što se koristi
English: Opioids should be administered with caution to elderly or debilitated patients.
Croatian: Opioide je potrebno primjenjivati uz oprez u starijih i oslabljenih bolesnika.
English: • Place the tablets under the tongue
Croatian: • Stavite lijek ispod jezika
English: These types of medicines will reduce your alertness levels making it dangerous for you to drive and use machines.
Croatian: Te vrste lijekova smanjuju Vašu razinu pažnje što Vam otežava upravljanje vozilima i strojevima.
English: The 0.7mg / 0.18mg strength is intended to be used to fine tune the dose for patients especially during tapering of treatment or in case of tolerability issues during titration.
Croatian: Jačina doze od 0,7 mg / 0,18 mg namijenjena je za precizno usklađivanje doze za bolesnike, pogotovo tijekom smanjenja terapijske doze ili u slučaju problema s podnošenjem lijeka tijekom titracije.
English: This product can cause withdrawal symptoms if you take it less than six hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone.
Croatian: Ovaj lijek može uzrokovati simptome ustezanja ako ga uzmete u manje od šest sati otkad ste zadnji put uzeli kratkodjelujući opioid (npr. morfij, heroin) ili u manje od 24 sata nakon što ste uzeli dugodjelujući opioid poput metadona.