natgillin/translations-raw huggingface dataset:
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). 
Dugoročna primjena buprenorfina u zadnjem tromjesečju trudnoće može izazvati sindrom ustezanja u novorođenčeta (npr. hipertoniju, neonatalni tremor, neonatalnu agitaciju, mioklonus ili konvulzije).
• Keep the tablets in place under the tongue until they have completely dissolved. 
• Držite tablete na mjestu pod jezikom sve dok se potpuno ne otope.
Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence. 
Istodobna primjena antagonista opioida (naltrekson, nalmefen) za liječenje ovisnosti o alkoholu ili opioidima.
Combining buprenorphine with naloxone in Suboxone is intended to deter misuse and abuse of the buprenorphine. 
Kombiniranje buprenorfina s naloksonom u lijeku Suboxone namijenjeno je odvraćanju od pogrešne uporabe i zlouporabe buprenorfina.
- 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. 
- Drugi sastojci su laktoza hidrat, manitol, kukuruzni škrob, povidon K30, bezvodna citratna kiselina, natrijev citrat, magnezijev stearat, acesulfamkalij i prirodna aroma limuna i limete.
Buprenorphine is an opioid partial agonist/antagonist which binds to the  and  (kappa) opioid receptors of the brain. 
Buprenorfin je parcijalni agonist/antagonist opioida koji se veže za µ i κ (kappa) opioidne receptore u mozgu.
Renal elimination may be prolonged since 30 % of the administered dose is eliminated by the renal route. 
Oštećenje bubrega Eliminacija bubrezima može biti produljena, jer se 30% primijenjene doze eliminira putem bubrega.
Not Known 
Manje često Nepoznato
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. 
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.
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. 
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.
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)). 
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)).
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). 
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)).
How to take Suboxone 
Kako uzimati Suboxone
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. 
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.
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. 
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.
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. 
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,
Sudden withdrawal syndrome caused by taking Suboxone too soon after use of illicit opioids, drug withdrawal syndrome in newborn. 
Iznenadni sindrom ustezanja uzrokovan preranim uzimanjem lijeka Suboxone nakon primjene zabranjenih opioida, sindrom ustezanja lijeka u novorođenčadi.
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. 
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.
Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy. 
Prije početka terapije preporučuje se napraviti i dokumentirati osnovne pretrage funkcije jetre i status virusnog hepatitisa.
Abrupt discontinuation of treatment is not recommended as it may result in a withdrawal syndrome that may be delayed in onset. 
Ne preporučuje se nagli prekid terapije, jer on može uzrokovati sindrom ustezanja lijeka koji može imati odgođeni nastup.
The dose can be made up from multiple Suboxone tablets of different strengths, which may be taken all at the same time or in two divided portions; the second portion to be taken directly after the first portion has dissolved. 
Doza koja može biti sačinjena od više Suboxone tableta različitih jačina, može se uzeti istovremeno ili u dva podijeljena dijela; drugi dio treba uzeti odmah nakon što se prvi dio otopi.
Drug withdrawal syndrome neonatal (see section 4.6) 
Neonatalni sindrom ustezanja (vdjeti dio 4.6)
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. 
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.
Insomnia (inability to sleep), constipation, nausea, excessive sweating, headache, drug withdrawal syndrome 
Nesanica (nemogućnost spavanja), zatvor stolice, mučnina, znojenje, glavobolja, sindrom ustezanja lijeka
It is unknown whether naloxone is excreted in human breast milk. 
Nije poznato izlučuje li se nalokson u majčino mlijeko.
Suboxone should be used cautiously when co-administered with: 
Suboxone treba primjenjivati uz oprez kod istovremene primjene s:
The dose of buprenorphine or the CYP3A4 inducer may need to be adjusted accordingly. 
U skladu s tim potrebno je prilagoditi dozu buprenorfina ili induktora CYP3A4.
Table 3 summarizes the results from a clinical trial in which the exposure after single-dose administration of Suboxone 2.0/0.5mg (buprenorphine/naloxone) sublingual tablet was determined in healthy subjects, and in subjects with hepatic impairment. 
Tablica 2. objedinjuje rezultate kliničkog ispitivanja u kojem je izloženost nakon primjene jednokratne doze lijeka Suboxone 2,0/0,5 mg (buprenorfin/nalokson) sublingvalne tablete određena u zdravih osoba i u osoba s oštećenjem jetre.
Each sublingual tablet contains 156.64 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 
Svaka sublingvalna tableta sadrži 156,64 mg laktoze (kao monohidrat) Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
If you are dependent upon heroin or a short acting opioid, your first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 6 hours after you last used opioids. 
Ako ste ovisni o heroinu ili kratkodjelujućim opioidima, prvu dozu lijeka Suboxone trebate uzeti kad se pojave znakovi ustezanja, no ne ranije od 6 sati od zadnjeg uzimanja opioida.
Suboxone sublingual tablets should be used with caution in patients with moderate hepatic impairment (See section 4.3 and 5.2). 
Suboxone sublingvalne tablete moraju se primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetre (vidjeti dijelove 4.3 i 5.2).
o 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. 
induktorima CYP3A4: Istodobna primjena induktora CYP3A4 s buprenorfinom može sniziti koncentraciju buprenorfina u plazmi te potencijalno rezultirati suboptimalnim liječenjem ovisnosti o opioidima buprenorfinom.
Patients should be monitored for signs and symptoms of precipitated opioid withdrawal, toxicity or overdose caused by increased levels of naloxone and/or buprenorphine. 
Bolesnici moraju biti pod nadzorom zbog znakova i simptoma ustezanja opioida, toksičnosti ili predoziranja uzrokovanih povišenom razinom naloksona i/ili buprenorfina.
Severe Hepatic Impairment (Child-Pugh Class C) (n=8) 
Teško oštećenje jetre (Child-Pughov stupanj C) (n=8)
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. 
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.
Buprenorphine is a partial agonist at the µ (mu)-opiate receptor and chronic administration produces dependence of the opioid type. 
Buprenorfin je parcijalni agonist µ (mi)-opioidnih receptora i kronična primjena dovodi do ovisnosti opioidnog tipa.
Overall, buprenorphine plasma exposure increased approximately 3-fold in patients with severely impaired hepatic function, while naloxone plasma exposure increased 14-fold with severely impaired hepatic function. 
Sveukupno, izloženost buprenorfinu u plazmi povećana je približno 3 puta, a izloženost naloksona u plazmi povećana je 14 puta u bolesnika s teškim oštećenjem funkcije jetre.
The first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 24 hours after you last used methadone. 
Prvu dozu lijeka Suboxone trebate uzeti kad se pojave znakovi ustezanja, no ne ranije od 24 sata od zadnjeg uzimanja metadona.
In cases of intravenous drug misuse, some adverse experiences are attributed to the act of misuse rather than the medicinal product and include local reactions, sometimes septic (abscess, cellulitis), and potentially serious acute hepatitis, and other acute infections such as pneumonia, endocarditis have been reported (see section 4.4). 
U slučajevima intravenske zlouporabe lijeka, neke nuspojave su prije povezane s činom zloupotrebe, nego s lijekom i zabilježene su lokalne reakcije, ponekad septičke (apsces, celulitis), i potencijalno ozbiljan akutni hepatitis te druge akutne infekcije kao što su pneumonija, endokarditis (vidjeti dio 4.4).
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
U slučaju bilo pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.
For subjects randomized to either active treatment, dosing began with 8 mg of buprenorphine on Day 1, followed by 16 mg (two 8 mg) of buprenorphine on Day 2. 
Za ispitanike randomizirane u jednu od dvije skupine koje su primale djelatnu tvar, doziranje je započelo s 8 mg buprenorfina 1. dana, a 2. dana ispitanici su dobili 16 mg (dvaput po 8 mg) buprenorfina.
For example, a patient stabilised to receive a daily dose of 8 mg buprenorphine may be given 16 mg buprenorphine on alternate days, with no dose on the intervening days. 
Na primjer, bolesniku čije je stanje stabilno uz dnevnu dozu od 8 mg buprenorfina može se dati 16 mg buprenorfina svaki drugi dan, bez primjene lijeka u međuvremenu.
Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent persons. 
U ispitivanjima kliničke farmakologije primjećeni su “učinci plafona” uz opioidne agoniste u osoba ovisnih o opioidima.
Mild Hepatic Impairment (Child-Pugh Class A) (n=9) 
Blago oštećenje jetre (Child-Pughov stupanj A) (n=9)
Keep out of the sight and reach of children and other household members. 
Kako čuvati Suboxone Držite izvan pogleda i dosega djece ili drugih članova kućanstva.
Each sublingual tablet contains 168 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 
Svaka sublingvalna tableta sadrži 168 mg laktoze (kao monohidrat) Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
28 tablets in blister packs Paper/Aluminium/Nylon/Aluminium/PVC. 
7 tableta u papir/aluminij/najlon/aluminij/PVC blister pakiranju . 28 tableta u papir/aluminij/najlon/aluminij/PVC blister pakiranju.
Caution is recommended when dosing patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.2 and 5.2). 
Preporučuje se oprez prilikom doziranja bolesnika s teškim oštećenjima bubrega (klirens kreatinina <30 ml/min) (vidjeti dijelove 4.2 i 5.2).
A patent airway and assisted or controlled ventilation must be assured. 
Potrebno je osigurati prohodnost dišnih puteva te asistirano ili kontrolirano disanje.
• anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine. 
• antiretrovirotici (koriste se za liječenje HIV-a) poput ritonavira, nelfinavira i indinavira mogu povećati učinke ovog lijeka.
Uncommon side effects (may effect up to 1 in 100 people): 
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba):
Suboxone contains lactose. 
Suboxone sadrži laktozu.
• if you are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence. 
• ako uzimate naltrekson ili nalmefen za liječenje ovisnosti o alkoholu ili opioidima.
Common side effects (may effect up to 1 in 10 people): 
Česte nuspojave (mogu se javiti u do 1 na 10 osoba):
6.3 Shelf life 3 years. 
6.3 Rok valjanosti
Patients requiring a titrated daily dose> 8 mg buprenorphine/day may not find this regimen adequate. 
Za bolesnike kojima je potrebna titrirana dnevna doza >8 mg buprenorfina /dan ovakav režim doziranja možda neće biti prikladan.
The first dose of buprenorphine/naloxone should be taken only when signs of withdrawal appear, but not less than 24 hours after the patient last used methadone. 
Prvu dozu buprenorfina/naloksona treba uzeti tek kad se pojave znakovi ustezanja, ali ne prije nego što je proteklo najmanje 24 sata nakon što je bolesnik zadnji put uzeo metadon.
• naltrexone and nalmefene (drugs used to treat addiction disorders) may prevent the therapeutic effects of Suboxone. 
• Naltrekson i nalmefen (lijekovi koji se koriste za liječenje poremećaja ovisnosti) mogu spriječiti terapijsko djelovanje lijeka Suboxone.
Table 1: Treatment-related adverse reactions reported in clinical trials and post-marketing surveillance of buprenorphine/naloxone 
Tablica 1: Nuspojave vezane uz liječenje, prijavljene u kliničkim ispitivanjima i nuspojave zabilježene nakon stavljanja buprenorfina/naloksona u promet
The effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone were evaluated in a post-marketing study. 
Učinak oštećenja jetre na farmakokinetiku buprenorfina i naloksona procijenjen je u post marketinškom ispitivanju.
11.3-fold increase 
Povećanje od 11,3 puta
The concomitant use of monoamine oxidase inhibitors (MAOI) might produce an exaggeration of the effects of opioids, based on experience with morphine (see section 4.5). 
Na temelju iskustva s morfijem, istovremena primjena inhibitora monoaminooksidaze (MAOI) može pojačati učinke opioida (vidjeti dio 4.5).
If you get any side effects, talk to your doctor. 
• Ako primijetite bilo koju nuspojavu, obavijestite Vašeg liječnika.
Suboxone contains lactose 
Suboxone sadrži laktozu
• some antifungal agents (used to treat fungal infections) such as ketoconzaole, itraconazole, certain antibiotics may extend the effects of this medicine. 
• neki antifungalni lijekovi (koriste se za liječenje gljivica) poput ketokonazola, itrakonazola i određenih antibiotika mogu produljiti učinke ovog lijeka.
• if you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of this medicine (see section 6) 
• ako ste alergični (preosjetljivi) na buprenorfin, nalokson ili bilo koji drugi sastojak ovog lijeka
Dietary administration of buprenorphine in the rat at dose levels of 500 ppm or greater produced a reduction in fertility demonstrated by reduced female conception rates. 
Davanjem buprenorfina/naloksona zajedno s hranom u štakora pri dozi od 500 ppm ili višoj smanjila se plodnost, što se pokazalo smanjenjem stopa začeća u ženki štakora.
Buprenorphine/naloxone is contraindicated in patients with severe hepatic impairment (see section 4.3 and 5.2). 
Buprenorfin/nalokson kontraindiciran je u bolesnika s teškim oštećenjem jetre (vidjeti dijeloveo 4.3 i 5.2).
o For patients dependent upon heroin or short-acting opioids, the first dose of buprenorphine/naloxone should be taken when signs of withdrawal appear, but not less than 6 hours after the patient last used opioids. 
o Bolesnici ovisni o heroinu ili kratkodjelujućim opioidima, prvu dozu buprenorfina/naloksona trebaju uzeti kad se pojave znakovi ustezanja, ali ne prije nego što je proteklo 6 sati nakon zadnjeg uzimanja opioida.
In patients with severe hepatic insufficiency the use of buprenorphine/naloxone is contraindicated. 
U bolesnika s teškim oštećenjem jetre primjena buprenorfina/naloksona je kontraindicirana.
Treatment must be under the supervision of a physician experienced in the management of opiate dependence/addiction. 
4.2 Doziranje i način primjene Liječenje se mora odvijati pod nadzorom liječnika s iskustvom u liječenju ovisnosti o opioidima/ovisnosti.
Intravenous or intranasal misuse of Suboxone is expected to be less likely than buprenorphine alone since the naloxone in Suboxone can precipitate withdrawal in individuals dependent on heroin, methadone, or other opioid agonists. 
Suboxone nego samog buprenorfina, s obzirom da nalokson u lijeku Suboxone može izazvati simptome ustezanja u pojedinaca ovisnih o heroinu, metadonu ili drugim agonistima opioida.
This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines with the ability to harm your liver (see section 4). 
zlouporabom alkohola, anoreksijom ili primjenom drugih lijekova koji imaju sposobnost oštećivanja Vaše jetre (pogledajte dio 4).
The reduced level of alertness can make driving and using machines hazardous. 
Smanjenje pažnje povećava rizik pri upravljanju vozilima i strojevima.
1.6-fold increase 
Povećanje od 1,6 puta
Table 3. 
3 godine.
Do not breast-feed whilst taking this medicine, since Suboxone passes into breast milk. 
S obzirom da se ovaj lijek izlučuje u majčino mlijeko, nemojte dojiti dok uzimate Suboxone.
What you need to know before you take Suboxone 
Što morate znati prije nego počnete uzimati Suboxone Nemojte uzimati Suboxone
Both active substances of Suboxone, buprenorphine and naloxone, are extensively metabolized in the liver, and the plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment. 
Obje djelatne tvari lijeka Suboxone, buprenorfin i nalokson, opsežno se metaboliziraju u jetri i utvrđeno je da su njihove izmjerene razine u plazmi više u bolesnika s umjerenim i teškim oštećenjem jetre.
• any kidney disease. 
• bilo koju bolest bubrega
Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine. 
Lijekovi koji inhibiraju enzim CYP3A4 mogu dovesti do povišenih koncentracija buprenorfina, zbog čega može biti potrebno sniziti dozu buprenorfina/naloksona.
Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir or azole antifungals such as ketoconazole or itraconazole, macrolide antibiotics). 
Bolesnike koji primaju Suboxone treba pažljivo nadzirati, jer u njih će možda biti potrebno sniziti dozu lijeka Suboxone ako se kombinira s jakim inhibitorima CYP3A4 (npr. inhibitori proteaze, kao što su ritonavir,
Diarrhoea Dyspepsia Flatulence Vomiting 
Dispepsija Flatulencija
1.7-fold increase 
Povećanje od 1,7 puta
• Diagnosis of unrelated medical conditions This medicine may mask pain symptoms that could assist in the diagnosis of some diseases. 
Ovaj lijek može zamaskirati bol koja ukazuje na neke bolesti.
Buprenorphine/naloxone has minor to moderate influence on the ability to drive and use machines when administered to opioid dependent patients. 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada na strojevima Buprenorfin/nalokson malo do umjereno utječe na sposobnost upravljanja vozilima i rad na strojevima kad se primjenjuje u bolesnika ovisnih o opioidima.
To avoid precipitating withdrawal, induction with buprenorphine/naloxone should be undertaken when objective signs of withdrawal are evident (see section 4.2). 
Da bi se izbjeglo izazivanje simptoma ustezanja opioida, uvođenje buprenorfina/naloksona treba se poduzeti nakon očitih objektivnih simptoma ustezanja lijeka (vidjeti dio 4.2).
In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a drug withdrawal syndrome similar to that associated with naloxone (see sections 4.2 and 
U bolesnika s izraženom ovisnosti o lijeku, početna primjena buprenorfina može uzrokovati sindrom ustezanja od lijeka sličan onom uzrokovanom primjenom naloksona (vidjeti dijelove 4.2 i 4.4).
o the concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine. 
o na temelju iskustva s morfijem, istovremena primjena inhibitora monoaminooksidaze (MAOI) može pojačati učinke opioida.
EU/1/06/359/004 8 mg sublingual tablets 28 
EU/1/06/359/004 28 sublingvalnih tableta od 8 mg
EU/1/06/359/002 2 mg sublingual tablets 28 
EU/1/06/359/002 28 sublingvalnih tableta od 2 mg
Since both buprenorphine and naloxone are extensively metabolized, plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment after single-dose administration. 
S obzirom da se buprenorfin i nalokson opsežno metaboliziraju u jetri, njihova izmjerena razina u plazmi bila je viša u bolesnika s umjerenim i teškom oštećenjem jetre nakon primijenjene jednokratne doze.
Buprenorphine/naloxone may cause severe, possibly fatal, respiratory depression in children and nondependent persons in case of accidental or deliberate ingestion. 
Ovaj lijek može uzrokovati ozbiljnu, moguće i sa smrtnim ishodom, respiratornu depresiju (smanjena sposobnost disanja) u djece i osoba koje nisu ovisne ako ga slučajno ili namjerno upotrijebe.