natgillin/translations-raw huggingface dataset:
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.
Sublingual tablet White hexagonal biconvex tablets of 11 mm with “N8” debossed on one side.
Sublingvalna tableta Bijele heksagonalne bikonveksne tablete promjera 11 mm s "N8" utisnutim na jednoj strani.
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 sublingvalne tablete su bijele, okrugle, bikonveksne tablete promjera 10,5 mm s “N16” utisnutim na jednoj strani.
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.
Preporučena početna doza u odraslih i adolescenata starijih od 15 godina je jedna do dvije tablete lijeka Suboxone od 2 mg/0,5 mg.
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 sublingvalne tablete su bijele, heksagonalne, bikonveksne tablete promjera 6,5 mm s “N2” utisnutim na jednoj strani.
If you have been taking methadone or a long acting opioid, the dose of methadone should ideally be reduced to below 30 mg/day before beginning Suboxone therapy.
Ako uzimate metadon ili dugodjelujući opioid, idealno dozu metadona treba sniziti na manje od
o other central nervous system depressants, other opioid derivatives (e.g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase central nervous system depression.
o drugim depresorima središnjeg živčanog sustava, drugim derivatima opioida (npr. metadon, analgetici i antitusici), određenim antidepresivima, sedativnim antagonistima H1-receptora,
Hull,
(rifampicin).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7 and 28 TABLETS 2 mg STRENGTH
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PAKIRANJE OD 7 i 28 TABLETA JAČINE 2 mg
Sublingual tablet White round biconvex tablets of 10.5 mm with “N16” debossed on one side.
Sublingvalna tableta Bijele okrugle bikonveksne tablete promjera 10,5 mm s "N16" utisnutim na jednoj strani.
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 sublingvalne tablete su bijele, heksagonalne, bikonveksne tablete promjera 11 mm s “N8” utisnutim na jednoj strani.
1.2-fold increase
Povećanje od 1,2-puta
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7 and 28 TABLETS 8 mg STRENGTH
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PAKIRANJE OD 7 i 28 TABLETA JAČINE 8 mg
2.7-fold increase
Povećanje od 2,7 puta
Taking Suboxone
Uzimanje lijeka Suboxone
Haematuria Nephrolithiasis Urinary retention
Albuminurija Dizurija Hematurija Nefrolitijaza Retencija urina
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7 and 28 TABLETS 2 mg STRENGTH
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7 i 28 TABLETA JAČINE 2 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7 and 28 TABLETS 8 mg STRENGTH
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE OD 7 i 28 TABLETA JAČINE 8 mg
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/001 2 mg sublingual tablets 7
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/359/001 7 sublingvalnih tableta od 2 mg
How to store Suboxone
Moguće nuspojave Kako čuvati Suboxone
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/003 8 mg sublingual tablets 7
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/359/003 7 sublingvalnih tableta od 8 mg
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/359/001
Very common side effects (may effect more than one in 10 people):
Nuspojave zabilježene s lijekom Suboxone Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
o Furthermore, adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine/naloxone.
o Nadalje, kad se puni agonist opioida primjenjuje u bolesnika koji primaju buprenorfin/nalokson, možda će biti teško postići dostatnu analgeziju.
Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane,
(UK) Ltd,
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.
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.
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.
Dodatno se može uzeti jedna ili dvije tablete lijeka Suboxonea od 2 mg/0,5 mg prvog dana, ovisno o Vašim potrebama.
INFORMATION IN BRAILLE Suboxone 16 mg/4 mg sublingual tablets
Suboxone 16 mg/4 mg sublingvalne tablete
Package leaflet: Information for the user Suboxone 16 mg/4 mg sublingual tablets buprenorphine / naloxone
UPUTA O LIJEKU: PODACI ZA KORISNIKA Suboxone 16 mg/4 mg sublingvalne tablete buprenorfin/nalokson
INFORMATION IN BRAILLE Suboxone 2 mg/0.5 mg sublingual tablets
Suboxone 2 mg/0,5 mg sublingvalne tablete
Patients should be cautioned about driving or operating hazardous machinery in case buprenorphine/naloxone may affect their ability to engage in such activities.
Bolesnike treba upozoriti da buprenorfin/nalokson može utjecati na njihovu sposobnost upravljanja vozilima i rada na teškim strojevima.
Sublingual tablet White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side.
Bijele heksagonalne bikonveksne tablete promjera 6,5 mm s "N2" utisnutim na jednoj strani.
Each sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate).
Svaka sublingvalna tableta sadrži 16 mg buprenorfina (kao hidroklorid) i 4 mg naloksona (kao hidroklorid dihidrat).
HU8 7DS
HU8 7DS Ujedinjeno Kraljevstvo ili
Each 2 mg/0.5 mg sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
Svaka sublingvalna tableta od 2 mg/0,5 mg sadrži 2 mg buprenorfina (u obliku buprenorfinklorida) i 0,5 mg naloksona (u obliku naloksonklorid dihidrata).
AUTHORISATION
Postupanje
NAME OF THE MEDICINAL PRODUCT Suboxone 8 mg/2 mg sublingual tablets
Suboxone 8 mg/2 mg sublingvalne tablete
Package leaflet: Information for the user Suboxone 8 mg/2 mg sublingual tablets buprenorphine / naloxone
UPUTA O LIJEKU: PODACI ZA KORISNIKA Suboxone 8 mg/2 mg sublingvalne tablete buprenorfin/nalokson
Each sublingual tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate).
Svaka sublingvalna tableta sadrži 8 mg buprenorfina (kao hidroklorid) i 2 mg naloksona (kao hidroklorid dihidrat).
other opioid containing medicines such as methadone, certain pain killers and cough suppressants anti-depressants (used to treat depression) such as isocarboxazide, phenelzine, selegiline, tranylcypromine and valproate may increase the effects of this medicine.
drugi opioidi koji sadrže lijekove poput metadona, određeni lijekovi protiv boli i lijekovi protiv kašlja antidepresivi (koriste se za liječenje depresije) poput izokarboksazida, fenelzina, selegilina, tranilcipromina i valproata mogu povećati učinak ovih lijekova. sedativni antagonisti H1 receptora (koriste se za liječenje alergijskih reakcija) poput difenhidramina i klorfenamina. barbiturati (koriste se za uspavljivanje ili sedaciju) poput fenobarbitala, sekobarbitala trankvilizatori (koriste se za uspavljivanje ili sedaciju) poput kloralhidrata.
Some reports of seizure, vomiting, diarrhoea, and elevated liver function tests were considered serious.
Ozbiljnim su smatrane neke prijave o epileptičkim napadajima, povraćanju,
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava na Internetska stranica: www.halmed.hr ili potražite HALMED aplikaciju putem Google Play ili Apple App Store trgovine Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
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).
Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.
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.
Gubitak tjelesne težine, oticanje (ruku i stopala), , omamljenost, tjeskoba, nervoza, trnci, depresija, smanjen seksualni nagon, povećana napetost mišića, poremećaj razmišljanja, pojačano suzenje (vodnjikave oči) ili drugi poremećaji suzenja, zamagljen vid, navale crvenila, povišen krvni tlak, migrene, curenje iz nosa, grlobolja i bolno gutanje, pojačan kašalj, nadražen želudac ili druge nelagode želuca, proljev, poremećaj jetrene funkcije, , vjetrovi, povraćanje, osip, svrbež, koprivnjača, bol, bol u zglobovima, bol u mišićima, grčevi u nogama (grč mišića), poteškoće u postizanju i održavanju erekcije, abnormalnosti mokraće, bol u trbuhu, bol u leđima, slabost, infekcije, zimica, bol u prsištu, vrućica, simptomi nalik gripi, osjećaj opće nelagode, slučajne ozljede uzrokovane gubitkom pažnje ili koordinacije, nesvjestica i omaglica.
Ireland
Croatia
Albuminuria Dysuria
Prijavljivanje nuspojava
Each 16 mg/4 mg sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate).
Svaka sublingvalna tableta od 16 mg/4 mg sadrži 16 mg buprenorfina (u obliku buprenorfinklorida) i 4 mg naloksona (u obliku naloksonklorid dihidrata).
Side effects reported with Suboxone
Nuspojave zabilježene s lijekom Suboxone
Metabolites of buprenorphine accumulate in patients with renal failure.
bolesnika sa zatajenjem bubrega nakupljaju se metaboliti buprenorfina.
It is recommended that patients receiving buprenorphine/naloxone should be closely monitored if inducers (e.g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered.
karbamazepina, fenitoina, rifampicina) preporučuje se pažljivo nadziranje bolesnika koji primaju buprenorfin/nalokson.
Package leaflet: Information for the user Suboxone 2 mg/0.5 mg sublingual tablets buprenorphine / naloxone
Uputa o lijeku: Informacija za korsnika Suboxone 2 mg/0,5 mg sublingvalne tablete buprenorfin/nalokson
Asthma Dyspnoea
Astma Dispneja Zijevanje
5 How to store Suboxone Content of the pack and other information
Sadržaj pakiranja i druge informacije Što Suboxone sadrži
Respiratory, thoracic and
Poremećaji jetre i žuči
NAME OF THE MEDICINAL PRODUCT Suboxone 8 mg/2 mg sublingual tablets buprenorphine/naloxone
Suboxone 8 mg/2 mg sublingvalne tablete buprenorfin/nalokson
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/005
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/06/359/005
MARKETING AUTHORISATION NUMBER(S) EU/1/06/359/005 16 mg sublingual tablets 7
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/359/005 7 sublingvalnih tableta od 16 mg EU/1/06/359/006 28 sublingvalnih tableta od 16 mg
NAME OF THE MEDICINAL PRODUCT Suboxone 16 mg/4 mg sublingual tablets buprenorphine/naloxone
Suboxone 16 mg/4 mg sublingvalne tablete buprenorfin/nalokson
Each 8 mg/2 mg tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate).
Svaka sublingvalna tableta od 8 mg/2 mg sadrži 8 mg buprenorfina (u obliku buprenorfinklorida) i 2 mg naloksona (u obliku naloksonklorid dihidrata).
Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
Svaka sublingvalna tableta sadrži 2 mg buprenorfina (u obliku buprenorfinklorida) i 0,5 mg naloksona (u obliku naloksonklorid dihidrata).
- The active substances are buprenorphine and naloxone.
- Djelatne tvari su buprenorfin i nalokson.
Severe hepatic impairment
Hepatitis Akutni hepatitis
NAME OF THE MEDICINAL PRODUCT Suboxone 2 mg/0.5 mg sublingual tablets buprenorphine/naloxone
Suboxone 2 mg/0,5 mg sublingvalne tablete buprenorfin/nalokson
Abdominal Pain Diarrhoea Dyspepsia Flatulence
Bol u abdomenu Proljev
1.1-fold Increase
Povećanje od 1,1 puta
Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4 and 5.2).
Preporučuje se oprez pri doziranju u bolesnika s teškim bubrežnim oštećenjem (klirens kreatinina < 30 ml/min)
Liver function test abnormal Weight decreased
Promijenjeni nalazi funkcije jetre