FrancophonIA/ELRC3.0 huggingface dataset:
English: Zubsolv is not interchangeable with other buprenorphine products, as different buprenorphine products have different bioavailability.
Croatian: Zubsolv nije međusobno izmjenjiv s drugim lijekovima koji sadrže buprenorfin, budući da različiti lijekovi koji sadrže buprenorfin imaju različitu bioraspoloživost.
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 nisu ustanovljene.
English: Talk to your doctor before taking Zubsolv if you:
Croatian: Obratite se svom liječniku prije nego uzmete Zubsolv:
English: Your doctor will determine the best dose for you.
Croatian: Liječnik će odrediti dozu koja je za Vas najbolja.
English: On Day 3, those randomised 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: If naloxone is used, the long duration of action of buprenorphine should be taken into consideration when determining the length of treatment and medical surveillance needed to reverse the effects of an overdose.
Croatian: U slučaju korištenja naloksona, treba uzeti u obzir dugotrajnost djelovanja buprenorfina prilikom određivanja trajanja liječenja i liječničkog nadzora potrebnih da bi se otklonili učinci predoziranja.
English: Treatment must be under the supervision of a physician experienced in the management of opioid dependence/addiction.
Croatian: Liječenje se mora odvijati pod nadzorom liječnika s iskustvom u liječenju ovisnosti o opioidima/ovisnosti.
English: Regular monitoring of liver function is recommended (see section 4.4).
Croatian: Preporučuje se redovito praćenje funkcije jetre (vidjeti dio 4.4).
English: Respiratory depression
Croatian: Depresija disanja
English: This product may cause drowsiness, dizziness, or impaired thinking, especially during treatment induction and dose adjustment.
Croatian: Ovaj lijek može izazvati omamljenost, omaglicu ili umanjiti sposobnost razmišljanja, osobito tijekom početka liječenja i prilagodbe doze.
English: The primary study comparison was to assess the efficacy of buprenorphine and buprenorphine/naloxone individually against placebo.
Croatian: Primarna usporedba u ispitivanju bila je procjena djelotvornosti buprenorfina i buprenorfina/naloksona naspram placeba.
English: • naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine.
Croatian: • naltreksonom i nalmefenom jer su oni antagonisti opioida koji mogu blokirati farmakološke učinke buprenorfina.
English: • seeing or hearing things that are not there (hallucinations)
Croatian: • vidna ili slušna priviđanja (halucinacije)
English: Fold here Tear here
Croatian: Preklopiti ovdje Otrgnuti ovdje
English: Pack-size of 30 (3 x 10) tablets.
Croatian: Veličina pakiranja od 30 (3 x 10) tableta.
English: • CYP3A4 inducers: Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.
Croatian: • induktorima CYP3A4: istovremena primjena induktora CYP3A4 s buprenorfinom može sniziti koncentracije buprenorfina u plazmi te potencijalno rezultirati suboptimalnim liječenjem ovisnosti o opioidima buprenorfinom.
English: When administered orally or sublingually in usual doses to patients experiencing opioid withdrawal, naloxone exhibits little or no pharmacological effect because of its almost complete first pass metabolism.
Croatian: Kad se primjenjuje peroralno ili sublingvalno u uobičajenim dozama u bolesnika u fazi ustezanja od opioida, nalokson pokazuje mali ili nikakav farmakološki učinak zbog toga što se gotovo potpuno metabolizira pri prvom prolasku kroz jetru.
English: When initiating treatment with buprenorphine/naloxone, the physician must be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal in opioid-dependent patients, particularly if administered less than 6 hours after the last use of heroin or other short-acting opioid, or if administered less than 24 hours after the last dose of methadone.
Croatian: Pri započinjanju terapije buprenorfinom/naloksonom, liječnik mora biti svjestan parcijalnog agonističkog profila buprenorfina te da on može izazvati simptome ustezanja od lijeka u bolesnika ovisnih o opioidima, osobito ako se primijeni nakon manje od 6 sati od posljednje uporabe heroina ili drugog kratkodjelujućeg opioida, ili ako se primijeni nakon manje od 24 sata od posljednje doze metadona.
English: Influenza Infection Pharyngitis Rhinitis
Croatian: Influenca Infekcija Faringitis Rinitis
English: • excessive sweating
Croatian: • pojačano znojenje
English: However, the dose given on any one day should not exceed 17.2 mg buprenorphine.
Croatian: Međutim, sveukupna dnevna doza ne smije biti viša od 17,2 mg buprenorfina.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: What you need to know before you take Zubsolv Do not take Zubsolv if you:
Croatian: Što morate znati prije nego počnete uzimati Zubsolv Nemojte uzimati Zubsolv:
English: Naloxone exposure was not higher from Zubsolv at any of the tested dose levels.
Croatian: Izloženost naloksona nije bila veća od lijeka Zubsolv ni pri jednim ispitanim razinama doza.
English: Buprenorphine is eliminated in the faeces by biliary excretion of the glucuroconjugated metabolites (70 %), the rest being eliminated in the urine.
Croatian: Buprenorfin se nakon ekskrecije glukurokonjugiranih metabolita putem žuči eliminira stolicom (70 %), dok se ostatak eliminira urinom.
English: The most commonly reported treatment related adverse reactions reported during the pivotal clinical trials were constipation and symptoms commonly associated with drug withdrawal (i.e. insomnia, headache, nausea, hyperhidrosis and pain).
Croatian: Najčešće prijavljene nuspojave vezane uz liječenje, zabilježene tijekom ključnih kliničkih ispitivanja su konstipacija i simptomi često povezani s ustezanjem od lijeka (npr. nesanica, glavobolja, mučnina, hiperhidroza i bol).
English: Buprenorphine is metabolised by 14-N-dealkylation and glucuroconjugation of the parent molecule and the dealkylated metabolite.
Croatian: Buprenorfin se metabolizira 14-N-dealkiliranjem i glukurokonjugacijom ishodišne molekule i dealkiliranog metabolita.
English: General warnings relevant to the administration of opioids
Croatian: Opća upozorenja vezana uz primjenu opioida
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ and κ (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: 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: A dietary dose of 100 ppm (estimated exposure approximately 2.4 x for buprenorphine at a human dose of 17.2 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: Primjena s hranom u dozi od 100 ppm (procijenjena izloženost odgovara onoj od oko 2,4x vrijednosti za buprenorfin pri dozi za ljude od 17,2 mg buprenorfina/naloksona na temelju AUC vrijednosti, a razine naloksona u plazmi bile su ispod granice detekcije u štakora) nije imala nikakvih štetnih učinaka na plodnost u ženki.
English: The recommended starting dose in adults and adolescents over 15 years of age is Zubsolv 1.4 mg / 0.36 mg or 2.9 mg / 0.71 mg a day.
Croatian: Preporučena početna doza lijeka Zubsolv u odraslih i adolescenata starijih od 15 godina je 1,4 mg / 0,36 mg ili 2,9 mg / 0,71 mg dnevno.
English: Long-term administration of buprenorphine during the last three months of pregnancy may cause 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: In many cases the presence of pre-existing mitochondrial impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicines) and ongoing injecting drug use may have a causative or contributory role.
Croatian: U mnogim slučajevima prisutnost postojećih mitohondrijskih oštećenja (genetskih bolesti, abnormalnosti jetrenih enzima, infekcije virusom hepatitisa B ili C, alkoholizma, anoreksije, uz istovremenu primjenu drugih potencijalno hepatotoksičnih lijekova) i aktualna intravenska uporaba sredstava ovisnosti mogli su prouzročiti ove promjene ili im doprinijeti.
English: Serious cases of infections with potential fatal outcome may occur if Zubsolv is misused, by taking it intravenously.
Croatian: Ozbiljni slučajevi infekcija s potencijalnim smrtnim ishodom mogu se pojaviti u slučaju pogrešne, intravenske uporabe lijeka Zubsolv.
English: Buprenorphine may precipitate symptoms of withdrawal in patients dependent upon methadone.
Croatian: Buprenorfin može pospješiti simptome ustezanja u bolesnika ovisnih o metadonu.
English: Your treatment is prescribed and monitored by doctors who are experienced in the treatment of drug dependence.
Croatian: Liječenje propisuju i prate liječnici s iskustvom u liječenju ovisnosti o lijekovima.
English: Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.
Croatian: Pretrage jetrene funkcije na početku ispitivanja i dokumentacija stanja virusnog hepatitisa preporučaju se prije početka terapije.
English: Patients should be monitored for signs and symptoms of opioid withdrawal, toxicity or overdose caused by increased levels of naloxone and/or buprenorphine.
Croatian: Bolesnici trebaju biti pod nadzorom zbog znakova i simptoma ustezanja od opioida, toksičnosti ili predoziranja uzrokovanih povišenim razinama naloksona i/ili buprenorfina.
English: • some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole and certain antibiotics, may extend the effects of this medicine
Croatian: • neki antifungalni lijekovi (koriste se za liječenje gljivica) poput ketokonazola, itrakonazola i određenih antibiotika mogu produljiti učinke ovog lijeka
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 4-tjedne randomizirane dvostruko slijepe usporedbe buprenorfina/naloksona, buprenorfina i placeba nakon čega je slijedilo 48 tjedana ispitivanja sigurnosti primjene buprenorfina/naloksona.
English: Tear following the direction of the arrow.
Croatian: Otkinite u smjeru strelice.
English: Whilst you may notice that most of the table disintegrates within 40 seconds, it may take 5 to 10 minutes for the entire table to disappear from your mouth
Croatian: Iako možete primijetiti da se većina tablete raspada unutar 40 sekundi, možda ćete osjetiti potpuni nestanak tablete u ustima tek nakon 5 do 10 minuta.
English: The safety and efficacy of buprenorphine/naloxone in children below the age of 15 years have not been established.
Croatian: Sigurnost i djelotvornost buprenorfina/naloksona u djece u dobi od 15 godina nisu ustanovljene.
English: Opioids have been shown to increase intracholedochal pressure, and should be used with caution in patients with dysfunction of the biliary tract.
Croatian: Opioidi povećavaju intrakoledohalni tlak i stoga ih je potrebno koristiti uz oprez u bolesnika s disfunkcijom bilijarnog trakta.
English: Table 3: Effect of hepatic impairment on pharmacokinetic parameters of buprenorphine and naloxone following administration (change relative to healthy subjects) PK Parameter
Croatian: Tablica 3: Učinak oštećenja jetre na farmakokinetičke parametre buprenorfina i naloksona nakon primjene (relativna promjena u odnosu na zdrave ispitanike)
English: Following oral administration, naloxone is barely detectable in plasma; following sublingual administration of buprenorphine/naloxone, plasma naloxone concentrations are low and decline rapidly.
Croatian: Nakon peroralne primjene, nalokson se jedva može izmjeriti u plazmi; nakon sublingvalne primjene buprenorfina/naloksona, koncentracije naloksona u plazmi su niske i brzo se smanjuju.
English: • have poor adrenal gland function (e.g. Addison's disease)
Croatian: • ako imate slab rad nadbubrežne žlijezde (npr. Addisonovu bolest)
English: Plasma levels of buprenorphine increased with the sublingual dose of buprenorphine/naloxone.
Croatian: Razine buprenorfina u plazmi povećale su se sublingvalnom primjenom doze buprenorfina/naloksona.
English: Some reports of seizure, vomiting, diarrhoea, and elevated liver function tests were considered serious.
Croatian: Ozbiljnim su smatrane neke prijave o epileptičkim napadajima, povraćanju, proljevu i povišenim vrijednostima testova funkcije jetre.
English: Appearance
Croatian: Izgled
English: • Naltrexone and nalmefene (drugs used to treat addictive disorders) as they may prevent the therapeutic effects of Zubsolv.
Croatian: • Naltrekson i nalmefen (lijekovi koji se koriste za liječenje poremećaja ovisnosti) mogu spriječiti terapijske učinke lijeka Zubsolv.
English: Sub-optimal treatment with buprenorphine/naloxone may prompt medicine misuse by the patient, leading to overdose or treatment dropout.
Croatian: Suboptimalno liječenje buprenorfinom/naloksonom može potaknuti pogrešnu uporabu lijeka od strane bolesnika, dovodeći do predoziranja ili prekida liječenja.
English: Patients should be closely monitored during the switching period from buprenorphine or methadone to buprenorphine/naloxone since withdrawal symptoms have been reported.
Croatian: Bolesnike treba pažljivo pratiti u razdoblju prelaska s buprenorfina ili metadona na buprenorfin/nalokson s obzirom na prijavljene simptome ustezanja.
English: Symptoms of overdose may include breathing more slowly and weakly than normal, feeling more sleepy than normal, reduction in the size of the pupils, low blood pressure, feeling sick, vomit and/or slurred speech.
Croatian: Simptomi predoziranja mogu obuhvaćati sporije i slabije disanje nego inače, osjećaj veće pospanosti nego inače, sužavanje zjenica, nizak krvni tlak, osjećaj mučnine, povraćanje i/ili nerazgovjetan govor.
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 trebaju poduzeti odgovarajuće mjere opreza pri propisivanju i davanju buprenorfina, poput izbjegavanja propisivanja višestrukih količina lijeka na početku liječenja te provođenja kontrola stanja bolesnika kliničkim praćenjem sukladno potrebama bolesnika.
English: Modification of the buprenorphine/naloxone dose is not required in patients with renal impairment.
Croatian: Promjena doze buprenorfina/naloksona nije potrebna u bolesnika s oštećenjem bubrega.
English: Take-home doses were provided for weekends.
Croatian: Potrebna doza za vikend izdavana im je za uzimanje kod kuće.
English: However, when administered intravenously to opioid-dependent patients the presence of naloxone in Zubsolv produces marked opioid antagonist effects, thereby deterring intravenous abuse.
Croatian: Međutim, kad ga intravenski primjenjuju bolesnici ovisni o opioidima, prisutnost naloksona u lijeku Zubsolv izaziva izrazite učinke opioidnog antagonista, što odvraća osobe od intravenske zlouporabe.
English: Buprenorphine and its metabolites are excreted in human milk.
Croatian: Buprenorfin i njegovi metaboliti se izlučuju u majčino mlijeko.
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 je istovremena primjena za vrijeme liječenja buprenorfinom/naloksonom kontraindicirana zbog potencijalno opasne interakcije koja bi mogla naglo uzrokovati duge i intenzivne simptome ustezanja od opioida (vidjeti dio 4.3).
English: This medicine can cause drowsiness, particularly when taken together with alcohol or other central nervous system depressants (such as tranquilisers, sedatives or hypnotics).
Croatian: Ovaj lijek može uzrokovati omamljenost, osobito ako se uzme zajedno s alkoholom ili drugim depresorima središnjeg živčanog sustava (kao što su sredstva za umirenje, sedativi ili hipnotici).
English: Buprenorphine/naloxone has minor to moderate influence on the ability to drive and use machines when administered to opioid dependent patients.
Croatian: Buprenorfin/nalokson malo do umjereno utječe na sposobnost upravljanja vozilima i rad sa strojevima kad se primjenjuje u bolesnika ovisnih o opioidima.
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: • Dependence
Croatian: • Ovisnost
English: Based on retention in treatment and the percentage of thrice-weekly urine samples negative for non-study opioids, buprenorphine was more effective than the low dose of the control, in keeping heroin addicts in treatment and in reducing their use of opioids while in treatment.
Croatian: Na temelju broja ispitanika koji su ostali na liječenju i postotka uzoraka urina prikupljanih tri puta tjedno i negativnih na opioide izvan ispitivanja, buprenorfin se pokazao učinkovitijim u zadržavanju heroinskih ovisnika na liječenju i u smanjivanju njihove uporabe opioida za vrijeme liječenja, nego nisko dozirana aktivna kontrola.
English: • anxiety, depression, decreased sexual drive, nervousness, abnormal thinking
Croatian: • tjeskoba, depresija, smanjen seksualni nagon, nervoza, poremećaj razmišljanja
English: In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomised 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: • sudden withdrawal syndrome caused by taking product too soon after use of illicit opioids, drug withdrawal syndrome in newborn
Croatian: • iznenadni sindrom ustezanja uzrokovan preranim uzimanjem lijeka nakon primjene zabranjenih opioida, sindrom ustezanja lijeka u novorođenčadi.
English: Moderate Hepatic Impairment (Child-Pugh Class B) (n=8)
Croatian: Umjereno oštećenje jetre (Child-Pughov stupanj B) (n=8)
English: Naloxone is metabolised in the liver, primarily by glucuronide conjugation, and excreted in the urine.
Croatian: Nalokson se metabolizira u jetri, primarno konjugacijom s glukuronskom kiselinom, a izlučuje se urinom.
English: Buprenorphine/naloxone may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Croatian: Buprenorfin/nalokson može uzrokovati omamljenost, osobito ako se uzme zajedno s alkoholom ili depresorima središnjeg živčanog sustava (kao što su sredstva za umirenje, sedativi ili hipnotici) (vidjeti dio 4.5).
English: Zubsolv is not interchangeable with other buprenorphine products.
Croatian: Zubsolv se ne može međusobno mijenjati s drugim lijekovima buprenorfina.
English: These underlying factors must be taken into consideration before prescribing buprenorphine/naloxone and during treatment.
Croatian: Spomenuti čimbenici moraju se uzeti u obzir prije propisivanja buprenorfina/naloksona kao i tijekom samog liječenja.
English: Regular monitoring of liver function is recommended (see section 4.4)
Croatian: Preporuča se redovito praćenje jetrene funkcije (vidjeti dio 4.4)
English: Leukocytosis Leukopenia Lymphadenopathy Thrombocytopenia
Croatian: Leukocitoza Leukopenija Limfadenopatija Trombocitopenija
English: Decreased appetite Hyperglycaemia Hyperlipidaemia Hypoglycaemia
Croatian: Smanjeni apetit Hiperglikemija Hiperlipidemija Hipoglikemija
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 doziranja može se smanjiti na doziranje svaki drugi dan, s time da se daje dvostruka dnevna doza koju pojedini bolesnik inače prima.
English: Liver damage has been reported after taking buprenorphine/naloxone, especially when the medicine is misused.
Croatian: Zabilježeni su slučajevi oštećenja jetre nakon uzimanja lijeka buprenorfina/naloksona, osobito prilikom pogrešne uporabe lijeka.
English: • Liver damage
Croatian: • Oštećenje jetre
English: As buprenorphine/naloxone pharmacokinetics may be altered in patients with hepatic impairment, lower initial doses and careful dose titration in patients with mild to moderate hepatic impairment are recommended (see section 5.2).
Croatian: S obzirom na to da farmakokinetika buprenorfina/naloksona može biti izmijenjena u bolesnika s oštećenjem jetre, preporučuju se niže početne doze i pažljivo titriranje doze u bolesnika s blagim do umjerenim oštećenjem jetre (vidjeti dio 5.2).
English: • migraines, dizziness, fainting, increase in muscle tension, tingling, drowsiness
Croatian: • migrene, omaglica, nesvjestica, povećana napetost mišića, trnci, omamljenost