natgillin/translations-raw huggingface dataset:
The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks.
251 Bolezni živčevja se najraje pojavijo, ko z zdravljenjem pričnemo prvič, vendar se običajno v prvih nekaj tednih zmanjšajo.
Some patients have more serious symptoms that may affect mood or the
Nekateri bolniki imajo hujše simptome, ki vplivajo na njihovo razpoloženje ali zmožnost jasnega mišljenja.
242 ability to think clearly.
Nekaj bolnikov je naredilo samomor.
These problems tend to occur more often in those who have a history of mental illness.
Te težave se kot kaže pogosteje pojavljajo pri bolnikih, ki so v preteklosti že imeli duševne motnje.
- pain in the abdomen (stomach) caused by inflammation of the pancreas
bolečine v trebuhu (želodcu) zaradi vnetja trebušne slinavke
Keep out of the reach and sight of children.
252 Zdravilo shranjujte nedosegljivo otrokom!
Do not use STOCRIN after the expiry date which is stated on the bottle and on the carton after EXP.
Zdravila STOCRIN ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in na škatli poleg oznake EXP.
Ask your pharmacist how to dispose of medicines no longer required.
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, e posvetujte s farmacevtom.
• Each STOCRIN film-coated tablet contains 50 mg of the active substance efavirenz. • The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate and magnesium stearate. • The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and carnauba wax.
• Ena filmsko obložena tableta STOCRIN vsebuje kot zdravilno učinkovino 50 mg efavirenza. • Pomožne snovi v jedru tablete so: premrežen natrijev karmelozat, mikrokristalna celuloza, natrijev lavrilsulfat, hidroksipropilceluloza, laktoza monohidrat in magnezijev stearat. • Filmska obloga vsebuje: hipromelozo (E464), titanov dioksid (E171), makrogol 400, rumeni železov oksid (E172) in karnauba vosek.
STOCRIN 50 mg film-coated tablets are supplied in bottles of 30 tablets.
STOCRIN 50 mg filmsko obložene tablete so na voljo v plastenkah s 30 tabletami.
Deutschland Bristol-Myers Squibb GmbH & CO.
253 Deutschland Bristol- Myers Squibb GmbH & CO.
Lietuva UAB “Merck Sharp & Dohme” Tel.: +370 5 278 02 47 msd_lietuva@merck.com
254 Lietuva UAB “ Merck Sharp & Dohme ” Tel.: +370 5 278 02 47 msd_ lietuva@ merck. com
245 This leaflet was last approved in
Navodilo je bilo odobreno
246 PACKAGE LEAFLET:
- Navodilo shranite.
INFORMATION FOR THE USER
Morda ga boste želeli ponovno prebrati.
STOCRIN 200 mg film-coated tablets efavirenz
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Njim bi lahko celo
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.Do not pass it on to others.
škodovalo, čeprav imajo znake bolezni, podobne vašim.
2.
Kaj je zdravilo STOCRIN in za kaj ga uporabljamo 2.
WHAT STOCRIN IS AND WHAT IT IS USED FOR?
KAJ JE ZDRAVILO STOCRIN IN ZA KAJ GA UPORABLJAMO
247 Take special care with STOCRIN • STOCRIN must be taken with other medicines that act against the HIV virus.
Če boste
If STOCRIN is started because your current treatment has not prevented the virus from multiplying, another medicine you have not taken before must be started at the same time.
256 začeli z jemanjem zdravila STOCRIN zato, ker dosedanji način zdravljenja ni preprečil razmnoževanja virusa, morate hkrati začeti jemati tudi drugo protivirusno zdravilo, ki ga do sedaj še niste jemali.
-
Pri nekaterih bolnikih z napredovalo okužbo s
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
HIV (AIDS) in z oportunistično okužbo v anamnezi se lahko kmalu po začetku anti- HIV zdravljenja pojavijo znaki in simptomi vnetja, povezani s prejšnjimi okužbami.
changes in body fat.
- spremembe v telesnem maščevju.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
maščevja se lahko pojavijo pri bolnikih, ki se zdravijo s kombinacijo protiretrovirusnih zdravil.
-
Pri nekaterih bolnikih, ki se zdravijo s kombiniranim
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
protiretrovirusnim zdravljenjem, se lahko pojavi bolezen kosti, imenovana osteonekroza (odmiranje kostnega tkiva zaradi nezadostne prekrvitve kosti).
248 corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
257 Nekateri od številnih dejavnikov tveganja za pojav te bolezni so lahko trajanje kombiniranega protiretrovirusnega zdravljenja, uporaba kortikosteroidov, uživanje alkohola, hudo zmanjšanje imunskega odziva in višji indeks telesne mase.
Use in children STOCRIN 200 mg film-coated tablets can be taken by children 3 years of age and older who are able to swallow the tablets (see How to take STOCRIN).
Uporaba pri otrocih STOCRIN 200 mg filmsko obložene tablete lahko jemljejo otroci, stari 3 leta in več, ki so tableto zmožni pogoltniti (glejte Kako jemati zdravilo STOCRIN).
Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your dose of methadone.
258 Metadon, zdravilo za zdravljenje odvisnosti z opiati, ker vam bo morda zdravnik spremenil odmerek metadona.
249 Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Sertralin, zdravilo za zdravljenje depresije, ker vam bo morda zdravnik spremenil odmerek sertralina.
• STOCRIN is for oral use.
259 • STOCRIN se vzame skozi usta.
250 • The dose for children weighing less than 40 kg is calculated by body weight and is taken once daily as shown below:
Otrok ga vzame enkrat na dan, kakor je prikazano v naslednji tabeli:
The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks.
260 Bolezni živčevja se najraje pojavijo, ko z zdravljenjem pričnemo prvič, vendar se običajno v prvih nekaj tednih zmanjšajo.
These problems tend to occur
Nekateri bolniki imajo hujše simptome, ki vplivajo na njihovo razpoloženje ali zmožnost jasnega mišljenja.
251 more often in those who have a history of mental illness.
Nekaj bolnikov je naredilo samomor. Te težave se kot kaže pogosteje pojavljajo pri bolnikih, ki so v preteklosti že imeli duševne motnje.
- allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme,
alergijska reakcija (preobčutljivost), ki lahko povzroči hude kožne reakcije (multiformni eritem,
Do not use STOCRIN after the expiry date which is stated on the bottle and on the carton after EXP.
261 Zdravila STOCRIN ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in na škatli poleg oznake EXP.
The expiry date refers to the last day of that month.
Datum izteka roka uporabnsoti se nanaša na zadnji dan navedenega meseca.
252 Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
• Each STOCRIN film-coated tablet contains 200 mg of the active substance efavirenz. • The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate and magnesium stearate. • The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), and carnauba wax.
• Ena filmsko obložena tableta STOCRIN vsebuje kot zdravilno učinkovino 200 mg efavirenza. • Pomožne snovi v jedru tablete so: premrežen natrijev karmelozat, mikrokristalna celuloza, natrijev lavrilsulfat, hidroksipropilceluloza, laktoza monohidrat in magnezijev stearat. • Filmska obloga vsebuje: hipromelozo (E464), titanov dioksid (E171), makrogol 400, rumeni železov oksid (E172) in karnauba vosek.
STOCRIN 200 mg film-coated tablets are supplied in bottles of 90.
STOCRIN 200 mg filmsko obložene tablete so na voljo v plastenkah z 90 tabletami.
Deutschland Bristol-Myers Squibb GmbH & CO.
262 Deutschland Bristol- Myers Squibb GmbH & CO.
Lietuva UAB “Merck Sharp & Dohme” Tel.: +370 5 278 02 47 msd_lietuva@merck.com
263 Lietuva UAB “ Merck Sharp & Dohme ” Tel.: +370 5 278 02 47 msd_ lietuva@ merck. com
254 This leaflet was last approved in
Navodilo je bilo odobreno
255 ANNEX IV
264 DODATEK IV
GROUNDS FOR ONE ADDITIONAL RENEWAL
VZROKI ZA ENO DODATNO PODALJŠANJE DOVOLJENJA ZA PROMET
256 GROUNDS FOR ONE ADDITIONAL RENEWAL
265 VZROKI ZA ENO DODATNO PODALJŠANJE DOVOLJENJA ZA PROMET
Based on the review of the available information, the CHMP was of the opinion that the quality, the safety and the efficacy of this medicinal product continues to be adequately and sufficiently demonstrated and therefore considered that the benefit/risk balance of Stocrin remains favourable.
Na podlagi pregleda razpoložljivih informacij je CHMP mnenja, da so kakovost, varnost in učinkovitost tega zdravila še naprej ustrezno in dovolj utemeljene, in zato smatra, da razmerje koristi in tveganja za zdravilo Stocrin ostaja ugodno.
However specific safety issues related to pharmacovigilance remain, which warrant a close monitoring.
Vendar pa ostajajo določena vprašanja glede varnosti, povezana s sistemom farmakovigilance, ki opravičujejo natančen nadzor.
Overall, the number of spontaneous reports on hepatic toxicity and acute or sub-acute chronic hepatitis potentially serious and fatal presented in subjects without other known risk factors (hepatitis B/C co- infection) is a matter of concern in particular in view of the evolving therapeutic management of HIV infected patients.
Na splošno je zaskrbljujoče število spontanih poročil o toksičnosti za jetra in akutnem ali subakutnem kroničnem potencialno hudem in smrtnem hepatitisu, ki se je pojavil pri posameznikih brez drugih znanih dejavnikov tveganja (sočasna okužba s hepatitisom B/ C), še posebej z ozirom na razvoj zdravljenja z zdravili s HIV okuženih bolnikov.
As newer therapeutic options for the treatment of HIV infection become available, the benefit/risk balance should be continuously reassessed in light of the introduction of these new options into treatment regimens.
Ker prihajajo nove terapevtske možnosti za zdravljenje okužbe s HIV, je treba v luči vključitve teh novih možnosti v režim zdravljenja nenehno ponovno vrednotiti razmerje koristi in tveganja.
Based on these issues, the CHMP is of the opinion that one additional five-year renewal on the basis of pharmacovigilance grounds is required.
Na podlagi navedenega je CHMP mnenja, da je iz farmakovigilančnih vzrokov potrebno eno dodatno podaljšanje dovoljenja za promet po petih letih.
The MAH should continue to submit yearly PSURs, until otherwise specified by the CHMP.
Imetnik dovoljenja za promet mora še naprej predajati letna Periodična poročila o varnosti (PSUR- e), dokler CHMP ne določi drugače.
257
266
Suboxone are white, hexagonal, sublingual tablets (they dissolve under the tongue).
Zdravilo Suboxone so bele, šestkotne, podjezične tablete (raztopijo se pod jezikom).
Suboxone contains two active substances, buprenorphine and naloxone.
Zdravilo Suboxone vsebuje dve zdravilni učinkovini: buprenorfin in nalokson.
The tablets contain either 2 mg buprenorphine and 0.5 mg naloxone, or 8 mg buprenorphine and 2 mg naloxone.
Tablete vsebujejo bodisi 2 mg buprenorfina in 0, 5 mg naloksona ali pa 8 mg buprenorfina in 2 mg naloksona.
Suboxone is used by drug addicts who have agreed to be treated for their addiction, as a substitution treatment for the opioid drugs they normally use.
Zdravilo Suboxone se uporablja za odvisnike od mamil, ki se strinjajo z zdravljenjem odvisnosti, kot nadomestno zdravljenje namesto opioidnih mamil, ki jih običajno uporabljajo.
Opioids, also known as narcotic drugs, are drugs such as heroin or morphine.
Med opioide, ki jim pravimo tudi narkotična mamila, spadata npr. heroin in morfij.
Suboxone is used in adults and children over the age of 15, who are also receiving medical, social and psychological support.
Zdravilo Suboxone se uporablja za odrasle in otroke starejše od 15 let, ki so deležni tudi medicinske, socialne in psihološke podpore.
The medicine can only be obtained with a special prescription.
Zdravilo se dobi samo na posebni recept.
Suboxone must be used under the supervision of a doctor who has experience in the management of opioid addiction.
Zdravilo Suboxone se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem odvisnosti od opioidov.
The patient ’ s liver function must be checked before the medicine is prescribed.
Pred izdajo recepta je treba preveriti delovanje jeter.
The way Suboxone is used depends on the patient’ s status: type of addiction, state of withdrawal, and whether the patient is already using another substitution treatment such as methadone before starting Suboxone.
Način uporabe zdravila Suboxone je odvisen od statusa bolnika: vrste odvisnosti, stanja odtegnitve in ali bolnik pred uporabo zdravila Suboxone že jemlje kakšno drugo nadomestno zdravljenje, npr. metadon.
This dose is adjusted according to the patient’ s response, until the patient is stabilised.
Priporočeni začetni odmerek je ena ali dve tableti zdravila Suboxone 2 mg/ 0, 5 mg, Ta odmerek lahko prilagodimo glede na bolnikov odziv, dokler se bolnik ne stabilizira.
The dose should not be higher than 24 mg buprenorphine per day.
Odmerek ne sme biti večji od 24 mg buprenorfina dnevno.
Once the patient is stabilised, the dosage schedule can be adjusted or decreased.
Ko se bolnik stabilizira, se lahko razpored odmerkov prilagodi ali zmanjša.
For the full dosage instructions, see the Summary of Product Characteristics, also part of the EPAR.
Za celovita navodila o odmerjanju glejte Povzetek glavnih značilnosti zdravila, ki je prav tako del EPAR.
The tablets must be placed under the tongue and allowed to dissolve (this may take 5 to 10 minutes).
Tablete damo pod jezik in pustimo, da se raztopijo (to lahko traja od 5 do 10 minut).
Suboxone contains two active substances, buprenorphine, which is an opioid agonist (it acts like an opioid drug), and naloxone, which is an opioid antagonists (it counteracts the effects of opioid drugs).
Zdravilo Suboxone vsebuje dve zdravilni učinkovini: buprenorfin, ki je opioidni agonist (deluje kot opioidno mamilo), in nalokson, ki je opioidni antagonist (izniči učinke opioidnih mamil).
Buprenorphine on its own, as sublingual tablets, has been used since the mid-1990’ s as a substitution treatment for opioid addiction.
Buprenorfin se že od sredine 1990- ih let uporablja samostojno v obliki podjezičnih tablet kot nadomestno zdravljenje za odvisnost od opioidnih snovi.
But the tablets have been misused: addicts have been known to dissolve them to inject the resulting solution.
Vendar so bolniki tablete zlorabljali: ugotovljeno je bilo, da so jih odvisniki raztapljali in si vbrizgavali dobljeno raztopino.
Suboxone contains buprenorphine with naloxone, because naloxone helps prevent the misuse of the medicine.
Zdravilo Suboxone vsebuje buprenorfin skupaj z naloksonom, kar preprečuje zlorabo zdravila.
Naloxone is not absorbed orally, but if injected to an opioid addict, it causes acute withdrawal symptoms.
Če opioidni odvisnik naloksona ne zaužije, ampak si ga injicira, snov povzroči akutne odtegnitvene simptome.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Suboxone been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Suboxone raziskano?
The effects of Suboxone were first tested in experimental models before being studied in humans.
Učinki zdravila Suboxone so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
The main study of the effectiveness of Suboxone compared Suboxone to buprenorphine on its own or to placebo (dummy treatment) in 326 opioid-dependent (heroin) patients.
V glavni raziskavi učinkovitosti zdravila Suboxone, v katerih je sodelovalo skupno 326 bolnikov, odvisnih od opioidne snovi (heroina), so primerjali zdravilo Suboxone z buprenorfinom samostojno in s placebom (zdravilom brez zdravilne učinkovine).
The study lasted 4 weeks, and measured the percentage of patients who had no trace of opioids in their urine at the end of the study.
V raziskavi so merili odstotek bolnikov, ki niso imeli sledi opioidnih snovi v urinu ob koncu raziskave.
Patients also used a specially designed questionnaire to record their cravings, and the change in the questionnaire score before and at the end of the study was also measured.
Bolniki so izpolnjevali tudi posebne vprašalnike o hlepenju, zato so merili tudi spremembo v rezultatih vprašalnikov pred raziskavo in ob koncu raziskave.
What benefit has Suboxone shown during the studies?
Kakšne koristi je zdravilo Suboxone izkazalo med raziskavami?
Suboxone was more effective than placebo:
Zdravilo Suboxone je bilo učinkovitejše od placeba: negativen rezultat preiskave urina ob koncu raziskave je imelo 17, 8% bolnikov, ki so jemali zdravilo, in 5, 8% bolnikov, ki so jemali placebo.
17.8% of the patients who received the medicine had a urine sample that tested negative at the end of the study, whereas the percentage was 5.8% in patients receiving placebo.
V skupini bolnikov, ki so jemali zdravilo Suboxone, se je znižala na 29, 8.
The craving score, which was between 62.4 and 65.6 before treatment, was down to 29.8 with Suboxone (and 55.1 with placebo).
V skupini bolnikov, ki so jemali placebo, pa se je znižala na 55, 1.
The study also showed that there is no difference in the effectiveness of Suboxone when compared to buprenorphine on its own.
V raziskavi so dokazali tudi, da ni statistično značilne razlike v učinkovitosti med zdravilom Suboxone in samostojnim buprenorfinom.
The most common side-effects (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache, and withdrawal syndrome.
Najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) so bili nespečnost, zaprtost, slabost, potenje, glavobol in odtegnitveni sindrom.
For the full list of all side effects reported with Suboxone, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Suboxone, najdete v Navodilih za uporabo.
Suboxone should not be used in people who may be hypersensitive (allergic) to buprenorphine or naloxone, or to any of the other ingredients.
Zdravila Suboxone ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) buprenorfin, nalokson ali katerokoli drugo sestavino zdravila.
It should not be used in patients with severe lung insufficiency, severe liver insufficiency, or acute alcohol intoxication or delirium tremens (a condition brought on by alcohol withdrawal).
Zdravila ne smejo uporabljati bolniki s hudo pljučno pomanjkljivostjo, hudo jetrno pomanjkljivostjo, akutno zastrupitvijo z alkoholom ali delirium tremens (stanje, ki ga povzroči odtegnitev alkohola).
The Committee for Medicinal products for Human Use (CHMP) concluded that the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential for intravenous misuse.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je kombinacija opioidnega analoga z opioidnim antagonistom uveljavljena strategija zmanjševanja možnosti intravenske zlorabe.
They decided that Suboxone’ s benefits as a substitution treatment for opioid drug dependency are greater than its risks and they recommended that Suboxone be given marketing authorisation.
Odbor je mnenja, da so koristni učinki zdravila Suboxone za nadomestno zdravljenje odvisnosti od opioidnih mamil večji od z njim povezanih tveganj, zato je priporočil odobritev dovoljenja za promet z zdravilom Suboxone.
Which measures are being taken to ensure the safe use of Suboxone?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Suboxone?
The company who markets Suboxone will put together information plans for doctors and pharmacists, to ensure that they are aware of the risk of misuse, and that they report on specific safety issues with the medicine such as liver disorders and effect on newborns.
Podjetje, ki daje zdravilo Suboxone v promet, bo sestavilo informacijske načrte za zdravnike in farmacevte, da se bodo slednji zavedali tveganja za zlorabo ter poročali o specifičnih varnostnih težavah z zdravilom, kot so bolezni jeter in učinki na novorojenčke.
Other information about Suboxone:
Druge informacije o zdravilu Suboxone:
The European Commission granted a marketing authorisation valid throughout the European Union for Suboxone to SP Europe on 26 September 2006.
Evropska komisija je dovoljenje za promet z zdravilom Suboxone, veljavno po vsej Evropski uniji, odobrila družbi SP Europe dne 26. septembra 2006.
The full EPAR for Suboxone can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Suboxone je na voljo tukaj.
administration
pot uporabe
Sublingual tablet
podjezične tablete
Blister (nylon/ ALU/ PVC)
Pretisni omot (najlon/ ALU/ PVC)
NAME OF THE MEDICINAL PRODUCT
Suboxone 2 mg/ 0, 5 mg podjezične tablete
Suboxone 2 mg/ 0.5 mg sublingual tablets
2.
Each tablet contains 2 mg buprenorphine (as buprenorphine hydrochloride) and 0.5 mg naloxone (as naloxone hydrochloride dihydrate).
Vsaka tableta vsebuje 2 mg buprenorfina (v obliki buprenorfinijevega klorida) in 0, 5 mg naloksona (v obliki naloksonijevega klorida dihidrata).
Excipients: lactose 42 mg
Pomožne snovi: laktoza 42 mg
Sublingual tablet
Podjezična tableta
White hexagonal biconvex tablets, embossed with a sword logo on one side and “ N2” on the reverse side.
Bele heksagonalne, bikonveksne tablete z vtisnjenim znakom meča na eni strani in “ N2 ” na drugi strani.
Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Nadomestno zdravljenje odvisnosti od opioidov v okviru medicinskega, socialnega in psihološkega zdravljenja bolnika.
The intention of the naloxone component is to deter intravenous misuse.
Namen dodanega naloksona je ljudi odvrniti od intravenske zlorabe zdravila.
Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Zdravljenje je namenjeno uporabi pri odraslih in mladostnikih, starejših od 15 let, ki soglašajo z zdravljenjem zasvojenosti.
Treatment must be under the supervision of a physician experienced in the management of opiate dependence/ addiction.
Zdravljenje mora potekati pod nadzorom zdravnika z izkušnjami z zdravljenjem odvisnosti oz. zasvojenosti z opiati.
Each Suboxone sublingual tablet contains buprenorphine and naloxone.
Vsaka podjezična tableta zdravila Suboxone vsebuje buprenorfin in nalokson.
Suboxone containing 2 mg buprenorphine and 0.5 mg naloxone is referred to as the "2 mg" tablets.
Zdravilo Suboxone, ki vsebuje 2 mg buprenorfina in 0, 5 mg naloksona, tu imenujemo na kratko tudi "2 mg tablete".
Physicians must warn patients that the sublingual route is the only effective and safe route of administration for this medicinal product (see section 4.4).
Zdravnik mora bolnika opozoriti, da je podjezična uporaba edina učinkovita in varna pot uporabe tega zdravila (glejte poglavje 4. 4).
Suboxone sublingual tablets are to be placed under the tongue until dissolved, which usually requires 5 to 10 minutes.
Za to je običajno potrebnih od 5 do 10 minut.