natgillin/translations-raw huggingface dataset:
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).
To je lahko tudi posledica virusnih okužb (kronični hepatitis C), zlorabe alkohola, anoreksije ali jemanja drugih zdravil, ki lahko škodujejo jetrom (glejte poglavje 4).
Buprenorphine/naloxone is contraindicated in patients with severe hepatic impairment (see section 4.3 and 5.2).
Buprenorfin/nalokson je kontraindiciran pri bolnikih s hudo okvaro jeter (glejte poglavji 4.3 in 5.2).
In patients with severe hepatic insufficiency the use of buprenorphine/naloxone is contraindicated.
Pri bolnikih s hudo okvarjenim delovanjem jeter je uporaba buprenorfina/naloksona kontraindicirana.
Opioids should be used with caution in patients with myxoedema, hypothyroidism, or adrenal cortical insufficiency (e.g., Addison's disease).
Pri uporabi opioidov pri bolnikih z miksedemom, hipotiroidizmom ali adrenokortikalno insuficienco (na primer Addisonova bolezen) je potrebna previdnost.
If the patient vomits, care must be taken to prevent aspiration of the vomitus.
Če bolnik bruha, je treba paziti, da izbljuvka ne vdiha.
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 ne bi sprožili odtegnitvenih simptomov, smete uvesti zdravljenje z buprenorfinom/naloksonom ali samo z buprenorfinom šele, ko se pojavijo objektivni in jasni znaki odtegnitve (kot na primer število točk, ki nakazuje blago do zmerno odtegnitev na uradni klinični lestvici odtegnitve od opioidov (COWSClinical Opioid Withdrawal Scale)).
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJE
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.
Če ste odvisni od heroina ali kratkotrajno delujočega opioida, morate prvi odmerek zdravila Suboxone vzeti, ko se pojavijo znaki odtegnitve, vendar ne manj kot 6 ur po tem, ko ste vzeli zadnji opioid.
• anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine.
• Protiretrovirusna zdravila (za zdravljenje HIV-a), kot so ritonavir, nelfinavir in indinavir, lahko okrepijo učinke tega zdravila,
Table 1: Treatment-related adverse reactions reported in clinical trials and post-marketing surveillance of buprenorphine/naloxone
Preglednica 1: Z zdravljenjem povezani neželeni učinki, o katerih so poročali v kliničnih raziskavah in po prihodu buprenorfina/naloksona na trg
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).
V primerih namerne intravenske napačne uporabe zdravil so nekatere neželene dogodke bolj pripisali napačni uporabi zdravila kot samemu zdravilu in poročali o lokalnih reakcijah, ki so včasih septične (absces, celulitis), in potencialno resnem akutnem hepatitisu in drugih akutnih okužbah, na primer pljučnica in endokarditis (glejte poglavje 4.4).
What Suboxone looks like and contents of the pack
Izgled zdravila Suboxone in vsebina pakiranja
To avoid precipitating withdrawal, induction with buprenorphine/naloxone should be undertaken when objective signs of withdrawal are evident (see section 4.2).
Za preprečitev odtegnitvenega sindroma morate uvajanje zdravljenja z buprenorfinom/naloksonom izvajati, ko so opazni objektivni znaki odtegnitve (glejte poglavje 4.2).
Suboxone sublingual tablets should be used with caution in patients with moderate hepatic impairment (See section 4.3 and 5.2).
Zdravilo Suboxone podjezične tablete je treba uporabljati previdno pri bolnikih z zmerno okvaro jeter (glejte poglavji 4.3 in 5.2).
Magnesium stearate Acesulfame potassium Natural lemon and lime flavour
Magnezijev stearat Kalijev acesulfam Naravna aroma limone in limete
Side effects reported with Suboxone
Neželeni učinki, o katerih so poročali pri zdravilu Suboxone
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.
Ker je lahko farmakokinetika buprenorfina/naloksona pri bolnikih z okvaro jeter spremenjena, se pri bolnikih z blago do zmerno okvaro jeter priporoča nižje začetne odmerke in previdno prilagajanje odmerka.
The first dose of Suboxone should be taken when signs of withdrawal appear, but not less than 24 hours after you last used methadone.
Prvi odmerek zdravila Suboxone je treba vzeti, ko se pojavijo znaki odtegnitve, vendar ne manj kot 24 ur po tem, ko vzamete zadnji odmerek metadona.
The tablet is to be placed under the tongue until completely dissolved.
Tableto je treba namestiti pod jezik, kjer se mora popolnoma raztopiti.
Do not swallow or consume food or any drink until the tablet is completely dissolved.
Hrane oziroma katere koli pijače ne smete pogoltniti ali zaužiti, dokler se tableta popolnoma ne raztopi.
Naloxone is an antagonist at -opioid receptors.
Nalokson je antagonist na ravni µ-opioidnih receptorjev.
Buprenorphine is a partial agonist at the µ (mu)-opiate receptor and chronic administration produces dependence of the opioid type.
Buprenorfin je delni agonist (mu) µ-opiatnega receptorja, tako da kronično dajanje povzroča opioidno odvisnost.
N-dealkylbuprenorphine is a -opioid agonist with weak intrinsicactivity.
N-dealkilbuprenorfin je agonist µ-opioidnih receptorjev s šibkim intrinzičnim delovanjem.
NAME OF THE MARKETING AUTHORISATION HOLDER Indivior Europe Limited
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Indivior Europe Limited
Like all medicines, Suboxone can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
• some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole, certain antibiotics, may extend the effects of this medicine.
• Nekatera protiglivične zdravilne učinkovine (za zdravljenje glivičnih okužb), kot so ketokonazol, itrakonazol in nekateri antibiotiki, lahko podaljšajo učinkovanje tega zdravila.
Sublingual use
Podjezična uporaba
Buprenorphine is an opioid partial agonist/antagonist which binds to the  and  (kappa) opioid receptors of the brain.
Buprenorfin je delni agonist/antagonist opioidnih receptorjev, ki se lahko veže na µ- in (kapa) κopioidne receptorje v možganih.
The dose of buprenorphine or the CYP3A4 inducer may need to be adjusted accordingly.
Morda bo potreba ustrezna prilagoditev odmerka buprenorfina ali induktorja CYP3A4.
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
Pri bolnikih, ki so znatno zasvojeni z zdravili, lahko začetno dajanje buprenorfina povzroči odtegnitveni sindrom, podoben odtegnitvenemu sindromu, ki je povezan z naloksonom (glejte poglavji 4.2 in 4.4).
A patient who is under-dosed with buprenorphine/naloxone may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.
Bolnik, ki ne prejema zadostnih odmerkov buprenorfina/naloksona, se lahko ob nenadzorovanih sindromih odtegnitve še naprej samozdravi z opioidi, alkoholom ali drugimi sedativi in uspavali, kot so benzodiazepini.
The recommended starting dose for adults and adolescents over the age of 15 years is one to two tablets of Suboxone 2 mg/0.5 mg. An additional one to two tablets of the Suboxone 2 mg/0.5 mg may be administered on day 1 depending on your needs.
Priporočen začetni odmerek pri odraslih in mladostnikih, starih več kot 15 let, je ena do dve tableti zdravila Suboxone 2 mg/0,5 mg. Na 1. dan lahko glede na svoje potrebe vzamete dodatno eno ali dve tableti zdravila Suboxone 2 mg/0,5 mg.
For patients who may require a lower buprenorphine dose, buprenorphine 0.4 mg may be used.
Pri bolnikih, ki lahko potrebujejo manjši odmerek buprenorfina, lahko uporabite buprenorfin 0,4 mg. Zaradi morebitnega relapsa je treba spremljati bolnike po medicinski odtegnitvi.
• if you are allergic (hypersensitive) to buprenorphine, naloxone or any of the other ingredients of this medicine (see section 6)
• če ste alergični (preobčutljivi) na buprenorfin, nalokson ali katero koli sestavino tega zdravila
Indivior Europe Limited Telephone 0808 234 9243
Telefon: 0800 807 15
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: