natgillin/translations-raw huggingface dataset:
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. 
V mnogih primerih lahko k temu prispevajo že obstoječe okvare mitohondrijev (genetska bolezen, abnormalnosti jetrnih encimov, okužba z virusom hepatitisa B ali C, zloraba alkohola, anoreksija, sočasna uporaba drugih morebitno hepatotoksičnih zdravil) in sočasna uporaba zdravil za injiciranje.
14.0-fold increase 
14,0- kratno povečanje
United Kingdom. 
Velika Britanija ali
Clinical data confirm that CYP3A4 is responsible for the N 
Klinični podatki potrjujejo, da je za N-dealkilacijo buprenorfina odgovoren CYP3A4.
Medical withdrawal 
Medicinska odtegnitev
The safety and efficacy of buprenorphine/naloxone in children below the age of 15 years have not been established. 
Varnost in učinkovitost buprenorfina/naloksona pri otrocih, starih do 15 let, nista dokazani.
Nervous system disorders 
Depresija osrednjega živčnega sistema
6.5 Nature and contents of container 7 tablets in blister packs Paper/Aluminium/Nylon/Aluminium/PVC. 
7 tablet v pretisnih omotih iz papirja/aluminija/najlona/aluminija/PVC.
Caution is recommended when dosing patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.2 and 5.2). 
Pri odmerjanju pri bolnikih s hudo okvaro ledvic se priporoča previdnost (očistek kreatinina < 30 ml/min) (glejte poglavji 4.2 in 5.2).
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. 
Na splošno se je pri bolnikih s hudo okvarjenim delovanjem jeter plazemska izpostavljenost buprenorfinu povečala približno 3-krat, plazemska izpostavljenost naloksonu pa 14-krat.
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 podlagi izkušenj z morfijem lahko sočasna uporaba zaviralcev monoaminooksidaze (MAOI) poveča učinke opioidov (glejte poglavje 4.5).
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. 
Prvi odmerek buprenorfina/naloksona je treba vzeti šele, ko se pojavijo simptomi odtegnitve, vendar ne manj kot 24 ur po tem, ko je bolnik nazadnje uporabil odmerek metadona.
Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4 and 5.2). 
Pri odmerjanju pri bolnikih s hudo okvaro ledvic se priporoča previdnost (očistek kreatinina < 30 ml/min) (glejte poglavji 4.4 in 5.2).
Tell your doctor if you have any liver problems before you start treatment with Suboxone. 
Če imate težave z jetri, o tem pred začetkom zdravljenja z zdravilom Suboxone obvestite svojega zdravnika.
Tell your doctor if you are pregnant or intend to become pregnant. 
Če ste noseči ali nameravate zanositi, morate o tem obvestiti svojega zdravnika.
barbiturates (used to cause sleep or sedation) such as Phenobarbital, secobarbital tranquilisers (used to cause sleep or sedation) such as chloral hydrate. 
- Barbiturati (ki se uporabljajo za lažje spanje ali pomiritev), kot sta fenobarbital in sekobarbital.
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 Za bolnike, ki so odvisni od heroina ali kratkotrajno delujočih opioidov, je treba prvi odmerek buprenorfina/naloksona dati, ko se pojavijo znaki odtegnitve, vendar ne manj kot 6 ur po tem, ko bolnik uporabi zadnji odmerek opioidov.
Each sublingual tablet contains 156.64 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 
Ena podjezična tableta vsebuje 156,64 mg laktoze (v obliki monohidrata) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
(see section 4.3 and 5.2). 
(glejte poglavje 6),
Hepatitis Hepatitis acute Jaundice Hepatic necrosis Hepatorenal syndrome 
Bolezni jeter, žolčnika in žolčevodov hepatitis akutni hepatitis zlatenica nekroza jeter hepatorenalni sindrom
How to take Suboxone 
Kako jemati zdravilo Suboxone
Each sublingual tablet contains 168 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 
Ena podjezična tableta vsebuje 168 mg laktoze (v obliki monohidrata) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Each sublingual tablet contains 42 mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 
Ena podjezična tableta vsebuje 42 mg laktoze (v obliki monohidrata) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
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. 
Ker se buprenorfin in nalokson v veliki meri presnavljata, sta bili po enkratnem odmerjanju plazemski ravni pri bolnikih z zmerno in hudo okvaro jeter za obe učinkovini višji.
Citric acid anhydrous Sodium citrate 
Brezvodna citronska kislina Natrijev citrat
Mild Hepatic Impairment (Child-Pugh Class A) (n=9) 
Blaga okvara jeter (Child-Pugh razred A) (n=9)
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na poseben recept in le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
What Suboxone contains 
Kaj vsebuje zdravilo Suboxone
It is recommended that patients receiving buprenorphine/naloxone should be closely monitored if inducers (e.g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered. 
Če bolniki sočasno z buprenorfinom/naloksonom prejemajo induktorje (npr. fenobarbital, karbamazepin, fenitoin, rfirampicin), jih je treba pozorno spremljati.
EU/1/06/359/002 2 mg sublingual tablets 28 
EU/1/06/359/002 2 mg podjezične tablete 28
PACK OF 7 and 28 TABLETS 16 mg STRENGTH 
PAKET 7 in 28 TABLET Z JAKOSTJO 16 mg
11.3-fold increase 
11,3- kratno povečanje
Uncommon side effects (may effect up to 1 in 100 people): 
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
• naltrexone and nalmefene (drugs used to treat addiction disorders) may prevent the therapeutic effects of Suboxone. 
• Naltrekson in nalmefen (zdravili za zdravljenje odvisnosti) lahko preprečita zdravilne učinke zdravila Suboxone.
Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy. 
Pred začetkom zdravljenja se priporoča izvesti izhodiščne teste delovanja jeter in stanja okuženosti s hepatitisom.
Suboxone contains lactose. 
Zdravilo Suboxone vsebuje laktozo.
3 - Starting from the edge where the seal is lifted, pull back the foil on the back to remove the tablet. 
3 - Tableto iz omota vzamete tako, da folijo potegnete nazaj.
EU/1/06/359/004 8 mg sublingual tablets 28 
EU/1/06/359/004 8 mg podjezične tablete 28
1.7-fold increase 
1,7-kratno povečanje
Buprenorphine/naloxone may cause severe, possibly fatal, respiratory depression in children and nondependent persons in case of accidental or deliberate ingestion. 
Če bi buprenorfin/nalokson nenamerno ali namenoma zaužili otroci ali druge osebe, ki niso odvisniki, lahko povzroči resno in potencialno smrtno respiratorno depresijo.
2.8-fold increase 
2,8- kratno povečanje
Very common side effects (may effect more than one in 10 people): 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Taking Suboxone 
Jemanje zdravila Suboxone
Buprenorphine, when taken orally, undergoes first-pass metabolism with N-dealkylation and glucuroconjugation in the small intestine and the liver. 
Buprenorfin pri peroralnem jemanju najprej preide skozi presnovo prvega prehoda z N-dealkilacijo in glukurokonjugacijo v tankem črevesu in jetrih.
Suboxone 16 mg/4 mg sublingual tablets are white round biconvex tablets of 10.5 mm with “N16” debossed on one side. 
Suboxone 16 mg/4 mg podjezične tablete so bele okrogle bikonveksne tablete premera 10,5 mm, ki imajo na eni strani oznako »N16«.
Suboxone 8 mg/2 mg sublingual tablets are white hexagonal biconvex tablets of 11 mm with “N8” debossed on one side. 
Suboxone 8 mg/2 mg podjezične tablete so bele heksagonalne bikonveksne tablete premera 11 mm, ki imajo na eni strani oznako »N8«.
Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicinal product is not safeguarded against theft. 
Zloraba buprenorfina, ki je ne zagreši ciljni bolnik, pač pa druga oseba, predstavlja dodatno tveganje za nove od mamil odvisne posameznike, ki uporabljajo buprenorfin kot primarno zdravilo za zlorabo.
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. 
Kljub zmernemu učinku, ki ga lahko ima na preprečevanje učinkov buprenorfina na dihalne simptome v primerjavi z njegovimi učinki na popolne antagoniste opioidnih receptorjev, se priporoča uporaba opioidnih antagonistov (tj. naloksona).
Moderate Hepatic Impairment (Child-Pugh Class B) (n=8) 
Zmerna okvara jeter (Child-Pugh razred B) (n=8)
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 osebe, ki so bile naključno razporejene v katero koli od zdravljenj z zdravilno učinkovino, se je odmerjanje začelo z 8 mg buprenorfina prvi dan, ki mu je sledilo 16 mg (dvakrat 8 mg) buprenorfina drugi dan. Tretji dan so osebe, ki so bile naključno razporejene v skupino za prejemanje buprenorfina/naloksona, prešle na tablete s kombinacijo učinkovin.
o Furthermore, adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine/naloxone. 
o Poleg tega je pri bolnikih, ki jemljejo buprenorfin/nalokson in prejemajo polne opioidne agoniste, težko doseči zadostno analgezijo.
2.7-fold increase 
2,7- kratno povečanje
Suboxone 2 mg/0.5 mg sublingual tablets are white hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side. 
Suboxone 2 mg/0,5 mg podjezične tablete so bele heksagonalne bikonveksne tablete premera 6,5 mm, ki imajo na eni strani oznako »N2«.
o the concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine. 
o Izkušnje z morfijem kažejo, da sočasna uporaba zaviralcev monoaminooksidaze (MAOI) lahko poudari učinke opioidov.
Severe Hepatic Impairment (Child-Pugh Class C) (n=8) 
Huda okvara jeter (Child-Pugh razred C) (n=8)
Decreased appetite Hyperglycaemia Hyperlipidaemia Hypoglycaemia 
Presnovne in prehranske motnje zmanjšan apetit hiperglikemija hiperlipidemija hipoglikemija
Weight loss, swelling (hands and feet), drowsiness, anxiety, nervousness, tingling, depression, decreased sexual drive, increase in muscle tension, abnormal thinking, increased tearing (watering eyes) or other tearing disorder, blurred vision, flushing, increased blood pressure, migraines, runny nose, sore throat and painful swallowing, increased cough, upset stomach or other stomach discomfort, diarrhoea, abnormal liver function, flatulence, vomiting, rash, itching, hives, pain, joint pain, muscle pain, leg cramps (muscle spasm), difficulty in getting or keeping an erection, urine abnormality, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu-like symptoms, feeling of general discomfort, accidental injury caused by loss of alertness or co-ordination, faintness and dizziness. 
Izguba telesne mase, otekanje (roke in noge), zaspanost, tesnoba, nervoza, ščemenje, depresija, zmanjšano spolno poželenje, povečanje napetosti mišic, nenormalno razmišljanje, močnejše solzenje (solzne oči) ali druge motnje solzenja, zamegljen vid, zardevanje, povečan krvni tlak, migrene, izcedek iz nosu, vneto grlo in boleče požiranje, povečano kašljanje, razdražen želodec ali neugodje v želodcu, diareja, nenormalno delovanje jeter, napihnjenost, bruhanje, izpuščaj, srbenje, koprivnica, bolečina, bolečina v sklepih, bolečina v mišicah, krči v nogah (mišični krči), težave z erekcijo in njenim ohranjanjem, nenormalen urin, bolečina v trebuhu, bolečina v hrbtu, šibkost, okužba, mrzlica, bolečina v prsih, povišana telesna temperatura, gripi podobni simptomi, občutek splošnega nelagodja, nezgodne poškodbe zaradi motenj zbranosti ali koordinacije, vrtoglavost in omotica.
Sublingual tablet White round biconvex tablets of 10.5 mm with “N16” debossed on one side. 
Bele okrogle bikonveksne tablete s premerom 10,5 mm, z oznako »N16« na eni strani.
1.2-fold increase 
1,2-kratno povečanje
1.6-fold increase 
1,6- kratno povečanje
EU/1/06/359/002 
EU/1/06/359/001 EU/1/06/359/002
Patients should not swallow or consume food or drink until the tablet is completely dissolved. 
Dokler se tableta popolnoma ne raztopi, bolnik ne sme pogoltniti ali zaužiti hrane oziroma pijače.
Sublingual tablet White hexagonal biconvex tablets of 11 mm with “N8” debossed on one side. 
Bele heksagonalne bikonveksne tablete s premerom 11 mm, z oznako »N8« na eni strani.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/001 2 mg sublingual tablets 7 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/359/001 2 mg podjezične tablete 7
Sublingual tablet White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side. 
Bele heksagonalne bikonveksne tablete s premerom 6,5 mm, z oznako »N2« na eni strani.
INFORMATION IN BRAILLE Suboxone 16 mg/4 mg sublingual tablets 
PODATKI V BRAILLOVI PISAVI Suboxone 16 mg/4 mg podjezične tablete
• any kidney disease. 
• bolezni ledvic,
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/003 8 mg sublingual tablets 7 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/359/003 8 mg podjezične tablete 7
Do not take Suboxone 
Ne jemljite zdravila Suboxone:
Swollen glands (lymph nodes), agitation, tremor, abnormal dream, excessive muscle activity, depersonalisation (not feeling like yourself), medicine dependence, amnesia (memory disturbance), loss of interest, exaggerated feeling of well-being, convulsion (fits), speech disorder, small pupil size, difficulty urinating, eye inflammation or infection, rapid or slow heartbeat, low blood pressure, palpitations, myocardial infarction (heart attack), chest tightness, shortness of breath, asthma, yawning, pain and sores in mouth, tongue discolouration, acne, skin nodule, hair loss, dry or scaling skin, inflammation of joints, urinary tract infection, abnormal blood tests, blood in urine, abnormal ejaculation, menstrual or vaginal problems, kidney stone, protein in your urine, painful or difficult urination, sensitivity to heat or cold, heat stroke, loss of appetite, feelings of hostility. 
Otekle žleze (bezgavke), razburjenost, tresenje, nenormalne sanje, čezmerna mišična aktivnost, depersonalizacija (bolnik se ne počuti pri sebi), odvisnost od zdravila, amnezija (motnje spomina), izguba zanimanja, pretiran občutek dobrega počutja, epileptični krči (napadi), motnje govora, majhne zenice, težave z uriniranjem, vnetje ali okužba oči, hitro ali počasno utripanje srca, nizek krvni tlak, palpitacije, miokardni infarkt (srčna kap), občutek tiščanja v prsih, zasoplost, astma, zehanje, bolečina in razjede v ustih, obarvanje jezika, akne, kožni vozliči, izguba las, suha koža ali luščenje kože, vnetje sklepov, okužba sečil, nenormalni izvidi krvnih testov, kri v urinu, nenormalna ejakulacija, menstrualne ali vaginalne težave, ledvični kamni, beljakovine v urinu, boleče uriniranje ali težave pri uriniranju, občutljivost na toplo ali mrzlo, vročinska kap, izguba teka, občutek sovražnosti.
INFORMATION IN BRAILLE Suboxone 2 mg/0.5 mg sublingual tablets 
PODATKI V BRAILLOVI PISAVI Suboxone 2 mg/0,5 mg podjezične tablete
Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent persons. 
Med kliničnimi farmakološkimi študijami pri osebah, odvisnih od opioidov, so opazili največje antagonistične učinke opioidnih receptorjev.
3.2-fold increase 
3,2- kratno povečanje
INFORMATION IN BRAILLE Suboxone 8 mg/2 mg sublingual tablets 
PODATKI V BRAILLOVI PISAVI Suboxone 8 mg/2 mg podjezične tablete
Each 2 mg/0.5 mg sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta zdravila Suboxone 2 mg/0,5 mg vsebuje 2 mg buprenorfina (v obliki klorida) in 0,5 mg naloksona (v obliki klorid dihidrata).
NAME OF THE MEDICINAL PRODUCT Suboxone 2 mg/0.5 mg sublingual tablets 
IME ZDRAVILA Suboxone 2 mg/0,5 mg podjezične tablete
Patients requiring a titrated daily dose> 8 mg buprenorphine/day may not find this regimen adequate. 
Ta režim odmerjanja morda ne bo primeren za bolnike, ki potrebujejo prilagojen dnevni odmerek > 8 mg buprenorfina/dan.
NAME OF THE MEDICINAL PRODUCT Suboxone 16 mg/4 mg sublingual tablets 
IME ZDRAVILA Suboxone 16 mg/4 mg podjezične tablete
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. 
Ugotovili so, da je plazemska raven obeh; buprenorfina in naloksona, višja pri bolnikih z zmerno in hudo okvaro jeter.
Absorption 
Buprenorfin Absorpcija
Each 16 mg/4 mg sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta zdravila Suboxone 16 mg/4 mg vsebuje 16 mg buprenorfina (v obliki klorida) in 4 mg naloksona (v obliki klorid dihidrata).
NAME OF THE MEDICINAL PRODUCT Suboxone 8 mg/2 mg sublingual tablets 
IME ZDRAVILA Suboxone 8 mg/2 mg podjezične tablete
Sudden withdrawal syndrome caused by taking Suboxone too soon after use of illicit opioids, drug withdrawal syndrome in newborn. 
Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Nenaden pojav odtegnitvenega sindroma, ki ga povzroči jemanje zdravila Suboxone prekmalu po uporabi nedovoljenih opioidov, sindrom odtegnitve pri novorojenčkih.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7 and 28 TABLETS 2 mg STRENGTH 
PODATKI NA ZUNANJI OVOJNINI PAKET 7 in 28 TABLET Z JAKOSTJO 2 mg
Talk to your doctor before taking Suboxone if you have: 
Pred začetkom jemanja zdravila Suboxone se posvetujte z zdravnikom v primeru:
PHARMACOLOGICAL PROPERTIES 
Farmakokinetični parametri
Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta vsebuje 2 mg buprenorfina (v obliki klorida) in 0,5 mg naloksona (v obliki klorid dihidrata).
Amblyopia Lacrimal disorder 
Očesne bolezni ambliopija motnje solznih žlez konjuktivitis mioza
Each 8 mg/2 mg tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta zdravila Suboxone 8 mg/2 mg vsebuje 8 mg buprenorfina (v obliki klorida) in 2 mg naloksona (v obliki klorid dihidrata).
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). 
Zaradi potencialno nevarne interakcije, ki lahko sproži pojav dolgotrajnih in intenzivnih simptomov odtegnitve od opioidov (glejte poglavje 4.3), je sočasno jemanje med zdravljenjem z buprenorfinom/naloksonom kontraindicirano.
How to store Suboxone 
Shranjevanje zdravila Suboxone
Common side effects (may effect up to 1 in 10 people): 
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
The recommended starting dose in adults and adolescents over 15 years of age is one to two Suboxone 2 mg/0.5 mg. An additional one to two Suboxone 2 mg/0.5 mg may be administered on day one depending on the individual patient's requirement. 
Dodatni ena ali dve tableti zdravila Suboxone 2 mg/0,5 mg se lahko da prvega dne, kar je odvisno od zahtev posameznega bolnika.
Each sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta vsebuje 16 mg buprenorfina (v obliki klorida) in 4 mg naloksona (v obliki klorid dihidrata).
The long half life of methadone should be considered when starting buprenorphine/naloxone. 
Ob začetku zdravljenja z buprenorfinom/naloksonom je treba upoštevati dolgo razpolovno dobo metadona.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7 and 28 TABLETS 8 mg STRENGTH 
PODATKI NA ZUNANJI OVOJNINI PAKET 7 in 28 TABLET Z JAKOSTJO 8 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7 and 28 TABLETS 16 mg STRENGTH 
PODATKI NA ZUNANJI OVOJNINI PAKET 7 in 28 TABLET Z JAKOSTJO 16 mg
1.1-fold Increase 
1,1-kratno povečanje
Each sublingual tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate). 
Ena podjezična tableta vsebuje 8 mg buprenorfina (v obliki klorida) in 2 mg naloksona (v obliki klorid dihidrata).
Suboxone can also cause withdrawal symptoms if you stop taking it abruptly. 
Če zdravilo Suboxone nehate jemati nenadoma, se lahko pojavijo odtegnitveni simptomi.
AUClast 
Nalokson
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/005 16 mg sublingual tablets 7 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/359/005 16 mg podjezične tablete 7 EU/1/06/359/006 16 mg podjezične tablete 28
STATEMENT OF ACTIVE SUBSTANCE(S) Each sublingual tablet contains 8 mg buprenorphine as buprenorphine hydrochloride and 2 mg naloxone as naloxone hydrochloride dihydrate. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena podjezična tableta vsebuje 8 mg buprenorfina v obliki buprenorfinijevega klorida in 2 mg naloksona v obliki naloksonijevega klorid dihidrata.
NAME OF THE MEDICINAL PRODUCT Suboxone 16 mg/4 mg sublingual tablets buprenorphine/naloxone 
Navodilo za uporabo Suboxone 16 mg/4 mg podjezične tablete buprenorfin/nalokson
NAME OF THE MEDICINAL PRODUCT Suboxone 8 mg/2 mg sublingual tablets buprenorphine/naloxone 
Navodilo za uporabo Suboxone 8 mg/2 mg podjezične tablete buprenorfin/nalokson
Abdominal Pain Diarrhoea Dyspepsia Flatulence Vomiting 
Bolezni prebavil zaprtost navzea bolečine v trebuhu diareja razjede v ustih obarvanje jezika dispepsija napihnjenost bruhanje
Diarrhoea Dyspepsia Flatulence Vomiting 
Žilne bolezni hipertenzija vazodilatacija hipotenzija ortostatska hipotenzija
NAME OF THE MEDICINAL PRODUCT Suboxone 2 mg/0.5 mg sublingual tablets buprenorphine / naloxone 
Navodilo za uporabo Suboxone 2 mg/0,5 mg podjezične tablete buprenorfin/nalokson
Clear signs of withdrawal should be evident before taking your first dose of Suboxone. 
Preden vzamete prvi odmerek zdravila Suboxone, morajo biti jasno vidni odtegnitveni simptomi.
NAME OF THE MEDICINAL PRODUCT Suboxone 16 mg/4 mg sublingual tablets buprenorphine / naloxone 
Suboxone 16 mg/4 mg podjezične tablete buprenorfin/nalokson
Hallucination 
Odmerjanje
3 - Starting from the edge where the seal is lifted, pull back the foil on the back to remove the tablet 
Začnite na vogalu, kjer folija ni pritrjena na omot.
Alcohol may increase drowsiness and may increase the risk of respiratory failure if taken with Suboxone. 
Zdravilo Suboxone skupaj s hrano, pijačo in alkoholom Alkohol lahko ob sočasnem uživanju z zdravilom Suboxone poveča zaspanost in poveča tveganje dihalne odpovedi.