FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are dependent upon heroin or a short acting opioid, your first dose of Zubsolv should be taken when signs of withdrawal appear, but not less than 6 hours after you last used opioids
Slovenian: Če ste odvisni od heroina ali kratkotrajno delujočega opioida, morate prvi odmerek zdravila Zubsolv vzeti, ko se pojavijo znaki odtegnitve, vendar ne manj kot 6 ur po tem, ko ste vzeli zadnji odmerek opioida.
English: • Dependence
Slovenian: • Odvisnost
English: They must not be taken at the same time as Zubsolv treatment because you may experience a sudden onset of prolonged and intense withdrawal.
Slovenian: Ne smete ju jemati sočasno z zdravilom Zubsolv, ker se lahko pri vas nenadoma pojavijo dolgotrajni in močni odtegnitveni simptomi;
English: Naloxone is an antagonist at μ-opioid receptors.
Slovenian: Nalokson je antagonist na ravni μ-opioidnih receptorjev.
English: • anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine
Slovenian: • protiretrovirusna zdravila (za zdravljenje okužbe s HIV), kot so ritonavir, nelfinavir in indinavir lahko okrepijo učinke tega zdravila;
English: These types of medicines will reduce your alertness levels making it dangerous for you to drive and use machines.
Slovenian: Te vrste zdravil zmanjšajo pozornost, zaradi česar pod njihovim vplivom vožnja in upravljanje strojev nista varna.
English: • 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
Slovenian: • Bolniki, ki so odvisni od heroina ali kratkotrajno delujočih opioidov, morajo prvi odmerek buprenorfina/naloksona vzeti, ko se pojavijo znaki odtegnitve, vendar ne manj kot 6 ur po tem,
English: • some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole and certain antibiotics, may extend the effects of this medicine
Slovenian: • nekateri antimikotiki (za zdravljenje glivičnih okužb), kot so ketokonazol, itrakonazol in nekateri antibiotiki lahko podaljšajo čas učinkovanja tega zdravila;
English: • Blood pressure
Slovenian: • Krvni tlak
English: Intravenous or intranasal misuse of Zubsolv is expected to be less likely than buprenorphine alone since the naloxone in Zubsolv can precipitate withdrawal in individuals dependent on heroin, methadone, or other opioid agonists.
Slovenian: Intravenska ali intranazalna napačna uporaba zdravila Zubsolv je manj verjetna kot napačna uporaba samo buprenorfina, saj lahko nalokson v zdravilu Zubsolv sproži odtegnitev pri bolnikih, ki so odvisni od heroina, metadona ali drugih opioidnih agonistov.
English: Not all strengths and pack-sizes may be marketed.
Slovenian: Na trgu morda ni vseh navedenih jakosti in pakiranj.
English: Following oral administration, naloxone is barely detectable in plasma; following sublingual administration of buprenorphine/naloxone, plasma naloxone concentrations are low and decline rapidly.
Slovenian: Po peroralni aplikaciji je nalokson komaj zaznaven v plazmi; po uporabi buprenorfina/naloksona pod jezikom so koncentracije naloksona v plazmi nizke in se hitro zmanjšujejo.
English: Buprenorphine/naloxone may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Slovenian: Buprenorfin/nalokson lahko povzroča zaspanost, zlasti pri jemanju skupaj z alkoholom ali depresivi centralnega živčnega sistema (kot so pomirjevala, sedativi ali hipnotiki) (glejte poglavje 4.5).
English: If naloxone is used, the long duration of action of buprenorphine should be taken into consideration when determining the length of treatment and medical surveillance needed to reverse the effects of an overdose.
Slovenian: Ob uporabi naloksona je treba pri določanju dolžine zdravljenja in zdravniškega nadzora, ki je potreben za preprečitev učinkov prevelikega odmerjanja, upoštevati dolgotrajnost delovanja buprenorfina.
English: Abrupt discontinuation of treatment is not recommended as it may result in withdrawal syndrome with delayed onset.
Slovenian: Nenadna prekinitev zdravljenja ni priporočljiva, saj lahko povzroči odtegnitveni sindrom, ki se lahko pojavi z zamikom.
English: Misuse, abuse and diversion
Slovenian: Napačna uporaba, zloraba in preusmeritev uporabe
English: Table 3 summarizes the results from a clinical trial in which the exposure after single-dose administration of buprenorphine/naloxone sublingual tablet was determined in healthy subjects, and in subjects with hepatic impairment.
Slovenian: Preglednica 3 povzema rezultate iz kliničnega preskušanja, v katerem je bila določena izpostavljenost buprenorfinu/naloksonu v podjezični tableti po enkratnem odmerjanju pri zdravih osebah in pri bolnikih z okvaro jeter.
English: What you need to know before you take Zubsolv Do not take Zubsolv if you:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zubsolv Ne jemljite zdravila Zubsolv:
English: Whilst you may notice that most of the table disintegrates within 40 seconds, it may take 5 to 10 minutes for the entire table to disappear from your mouth
Slovenian: Večji del tablete se raztopi v 40 sekundah, vendar lahko traja od 5 do 10 minut, da tableta popolnoma izgine v vaših ustih.
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Slovenian: Spekter nenormalnih izvidov se giblje od prehodnega asimptomatskega zvišanja jetrnih transaminaz do odpovedi jeter, jetrne nekroze, hepatorenalnega sindroma, hepatične encefalopatije in smrti.
English: In this trial, 326 heroin-addicted subjects were randomly assigned to either buprenorphine/naloxone 16 mg per day, 16 mg buprenorphine per day or placebo.
Slovenian: V tem preskušanju so 326 odvisnikov od heroina naključno razporedili v skupino, ki je prejemala 16 mg buprenorfina/naloksona na dan, skupino, ki je prejemala 16 mg buprenorfina na dan, ali skupino, ki je prejemala placebo.
English: Modification of the buprenorphine/naloxone dose is not required in patients with renal impairment.
Slovenian: Spreminjanje odmerka buprenorfina/naloksona pri bolnikih z okvaro ledvic ni potrebno.
English: Buprenorphine is metabolised by 14-N-dealkylation and glucuroconjugation of the parent molecule and the dealkylated metabolite.
Slovenian: Buprenorfin se presnavlja s 14-N-dealkilacijo in z glukuronidno konjugacijo matične molekule ter dealkiliranega presnovka.
English: • Naltrexone and nalmefene (drugs used to treat addictive disorders) as they may prevent the therapeutic effects of Zubsolv.
Slovenian: • naltrekson in nalmefen (zdravili za zdravljenje odvisnosti), saj lahko preprečita zdravilne učinke zdravila Zubsolv.
English: What Zubsolv is and what it is used for
Slovenian: Kaj je zdravilo Zubsolv in za kaj ga uporabljamo
English: The other ingredients are mannitol, citric acid anhydrous, sodium citrate, microcrystalline cellulose, croscarmellose sodium, sucralose, levomenthol, colloidal anhydrous silica and sodium stearyl fumarate.
Slovenian: Druge sestavine zdravila so manitol, brezvodna citronska kislina, natrijev citrat, mikrokristalna celuloza, premreženi natrijev karmelozat, sukraloza, levomentol, brezvodni koloidni silicijev dioksid in natrijev stearilfumarat.
English: 2.9 mg / 0.71 mg 30 months 5.7 mg / 1.4 mg 4 years
Slovenian: 2,9 mg/0,71 mg 30 mesecev 5,7 mg/1,4 mg 4 leta
English: • acne, hair loss, dry or scaling skin, skin nodule
Slovenian: • akne, izpadanje las, suha koža ali luščenje kože, kožni vozliči,
English: If you stop taking Zubsolv
Slovenian: Če ste prenehali jemati zdravilo Zubsolv
English: 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.
Slovenian: Bolnik, ki ne prejema zadostnih odmerkov buprenorfina/naloksona, se lahko ob nenadzorovanih sindromih odtegnitve še naprej samozdravi z opioidi, alkoholom ali drugimi sedativi in hipnotiki, kot so benzodiazepini.
English: All strengths will be available as packs of 7, 28, and 30 tablets presented in aluminium blisters.
Slovenian: Vse jakosti so na voljo v pakiranjih po 7, 28, in 30 tablet v aluminijastih pretisnih omotih.
English: The first dose of Zubsolv should be taken when signs of withdrawal appear, but not less than 24 hours after you last used methadone
Slovenian: Prvi odmerek zdravila Zubsolv je treba vzeti šele, ko se pojavijo simptomi odtegnitve, vendar ne manj kot 24 ur po tem, ko ste vzeli zadnji odmerek metadona.
English: Fold the packet along the dotted line.
Slovenian: Prepognite omot po črtkani črti.
English: Induction
Slovenian: Indukcija
English: Naloxone has a mean half-life from plasma of 1.2 hours.
Slovenian: Povprečni plazemski razpolovni čas naloksona je 1,2 ure.
English: Other medicines and Zubsolv
Slovenian: Druga zdravila in zdravilo Zubsolv
English: Buprenorphine and its metabolites are excreted in human milk.
Slovenian: Buprenorfin in njegovi presnovki se izločajo v materino mleko.
English: In cases of intravenous drug misuse, some adverse reactions are attributed to the act of misuse rather than the medicinal product.
Slovenian: Opis izbranih neželenih učinkov V primerih napačne intravenske uporabe zdravil so nekatere neželene učinke pripisali napačni uporabi zdravila bolj kot samemu zdravilu.
English: • migraines, dizziness, fainting, increase in muscle tension, tingling, drowsiness
Slovenian: • migrene, omotica, omedlevica, povečanje napetosti mišic, ščemenje, zaspanost,
English: Patients should be monitored for signs and symptoms of opioid withdrawal, toxicity or overdose caused by increased levels of naloxone and/or buprenorphine.
Slovenian: Bolnike je treba spremljati glede znakov in simptomov opioidne odtegnitve, toksičnosti ali prevelikega odmerjanja, ki so posledica povečane koncentracije naloksona in/ali buprenorfina.
English: A reduction of the buprenorphine/naloxone dose may be needed.
Slovenian: Morda bo potrebno zmanjšanje odmerka buprenorfina/naloksona.
English: A peri-postnatal study has not been conducted with buprenorphine/naloxone; however, maternal oral administration of buprenorphine at high doses during gestation and lactation resulted in difficult parturition (possible as a result of the sedative effect of buprenorphine), high neonatal mortality and a slight delay in the development of some neurological functions (surface righting reflex and startle response) in neonatal rats.
Slovenian: vendar pa je peroralno dajanje velikih odmerkov buprenorfina materi med gestacijo in laktacijo povzročilo težave pri kotenju (morda zaradi sedativnega učinka buprenorfina), visoko neonatalno umrljivost in rahel zastoj v razvoju nekaterih nevroloških funkcij (refleks površinskega vzravnanja in odziv zdrznjenja) pri novoskotenih podganah.
English: In patients 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 4.4).
Slovenian: Pri bolnikih, ki so izrazito odvisni od drog, lahko začetno dajanje buprenorfina povzroči odtegnitveni sindrom, podoben odtegnitvenemu sindromu, ki je povezan z naloksonom (glejte poglavji 4.2 in 4.4).
English: There are small deviations in buprenorphine dose proportionality exposure parameters as well as deviations from strict compositional proportionality for the three lower strengths (2.9/0.71, 1.4/0.36, and 0.7/0.18 mg) compared to the three higher dose presentations.
Slovenian: Pri parametrih sorazmernosti izpostavljenosti glede na odmerek buprenorfina so majhna odstopanja; odstopanja obstajajo tudi od stroge sorazmernosti sestave za tri manjše jakosti (2,9 mg/0,71 mg, 1,4 mg/0,36 mg in 0,7 mg/0,18 mg) v primerjavi s tremi večjimi odmerki.
English: Regular blood tests may be conducted by your doctor to monitor the condition of your liver.
Slovenian: Zdravnik se lahko odloči, da bo stanje vaših jeter spremljal z rednimi krvnimi testi.
English: To avoid precipitating withdrawal, induction with buprenorphine/naloxone 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).
Slovenian: Da ne bi sprožili odtegnitvenih simptomov, smete zdravljenje z buprenorfinom/naloksonom uvesti šele, ko se pojavijo objektivni in jasni znaki odtegnitve (na primer število točk, ki nakazuje blago do zmerno odtegnitev na uradni klinični lestvici odtegnitve od opioidov (COWS - Clinical Opioid Withdrawal Scale)).
English: 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.
Slovenian: V mnogih primerih so lahko vzrok ali lahko k temu prispevajo že obstoječe okvare mitohondrijev (genetska bolezen, nenormalnosti jetrnih encimov, okužba z virusom hepatitisa B ali C, zloraba alkohola, anoreksija, sočasna uporaba drugih potencialno hepatotoksičnih zdravil) in sočasna uporaba drog za injiciranje.
English: “8.6” on one side
Slovenian: 8,2 mm z oznako »8.6« na eni strani
English: Treatment must be under the supervision of a physician experienced in the management of opioid dependence/addiction.
Slovenian: Zdravljenje mora potekati pod nadzorom zdravnika, ki ima izkušnje z obvladovanjem odvisnosti od opioidov oziroma z zasvojenostjo z opioidi.
English: Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
Slovenian: Zaviralci encima CYP3A Zdravila, ki zavirajo encim CYP3A4, lahko privedejo do povečanih koncentracij buprenorfina.
English: • rapid or slow heartbeat, myocardial infarction (heart attack), palpitations, chest tightness
Slovenian: • hitro ali počasno utripanje srca, miokardni infarkt (srčna kap), palpitacije, tiščanje v prsih,
English: Buprenorphine/naloxone is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 5.2).
Slovenian: Buprenorfin/nalokson je kontraindiciran pri bolnikih s hudo okvaro jeter (glejte poglavji 4.3 in 5.2).
English: Pack-size of 28 (4 x 7) tablets.
Slovenian: Velikost pakiranja po 28 (4 × 7) tablet.
English: 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.
Slovenian: Prehransko dajanje buprenorfina pri podganah v odmerku 500 delcev na milijon ali več je povzročilo zmanjšanje plodnosti, ki je bilo dokazano z zmanjšano pogostnostjo zanositve pri samicah.
English: • protein in your urine, urinary tract infection, difficulty urinating, painful or difficult urination,
Slovenian: • beljakovine v urinu, okužba sečil, težave pri uriniranju, boleče ali oteženo uriniranje, kri v urinu, ledvični kamni,
English: • eye inflammation or infection, small pupil size
Slovenian: • vnetje ali okužba oči, majhne zenice,
English: Pack-size of 7 (1 x 7) tablets.
Slovenian: Velikost pakiranja po 7 (1 × 7) tablet.
English: • Liver damage
Slovenian: • Poškodbe jeter
English: 6 hours after the patient last used opioids.
Slovenian: ko je bolnik uporabil zadnji odmerek opioidov.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ and κ (kappa) opioid receptors of the brain.
Slovenian: Buprenorfin je delni agonist/antagonist opioidnih receptorjev, ki se lahko veže na μ- in κ(kapa)opioidne receptorje v možganih.
English: If infusion is not possible, repeated dosing with naloxone may be required.
Slovenian: Če infuzija ni mogoča, bo morda potrebno večkratno odmerjanje naloksona.
English: 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 (see section 5.2).
Slovenian: Ker je lahko farmakokinetika buprenorfina/naloksona pri bolnikih z okvaro jeter spremenjena, se pri bolnikih z blago do zmerno okvaro jeter priporočajo manjši začetni odmerki in previdno prilagajanje odmerka (glejte poglavje 5.2).
English: A carcinogenicity study with buprenorphine/naloxone was conducted in rats at doses of 7, 30 and 120 mg/kg/day, with estimated dose multiples of 3 to75 times, based on a Zubsolv equivalent human daily sublingual dose of 11.4 mg of buprenorphine calculated on a mg/m² basis.
Slovenian: Študijo karcinogenosti z buprenorfinom/naloksonom so izvedli pri podganah v odmerkih 7, 30 in 120 mg/kg/dan, kar je ocenjen 3- do 75-kratnik izpostavljenosti pri ljudeh na osnovi dnevnega podjezičnega odmerka 11,4 mg buprenorfina, enakovrednega odmerku zdravila Zubsolv, in izračunanega v mg/m².
English: Do not breast-feed whilst taking this medicine, since Zubsolv passes into breast milk.
Slovenian: Dokler jemljete to zdravilo, ne dojite, saj se zdravilo Zubsolv izloča v materino mleko.
English: In patients with severe hepatic insufficiency the use of buprenorphine/naloxone is contraindicated (see section 4.3).
Slovenian: Pri bolnikih s hudo okvarjenim delovanjem jeter je uporaba buprenorfina/naloksona kontraindicirana (glejte poglavje 4.3).
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Buprenorphine may precipitate symptoms of withdrawal in patients dependent upon methadone.
Slovenian: Buprenorfin lahko pri bolnikih, ki so odvisni od metadona, sproži simptome odtegnitve.
English: Plasma levels of buprenorphine increased with the sublingual dose of buprenorphine/naloxone.
Slovenian: Plazemske koncentracije buprenorfina so se povečale s podjezičnim odmerkom buprenorfina/naloksona.
English: What Zubsolv looks like and contents of the pack
Slovenian: Izgled zdravila Zubsolv in vsebina pakiranja
English: During the initiation of treatment, daily supervision of dosing is recommended to ensure proper sublingual placement of the dose and to observe patient response to treatment as a guide to effective dose titration according to clinical effect.
Slovenian: Med uvajanjem zdravljenja se priporoča vsakodnevno nadzorovanje odmerjanja, da se zagotovi pravilna namestitev odmerka pod jezik in se opazuje odziv bolnika na zdravljenje, kar pripomore k učinkovitemu prilagajanju odmerka kliničnemu učinku.
English: It is unknown whether naloxone/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se nalokson oziroma njegovi presnovki izločajo v materino mleko.
English: Naloxone exposure was not higher from Zubsolv at any of the tested dose levels.
Slovenian: Pri nobenem preskušanem odmerku izpostavljenost naloksonu ni bila višja kot pri zdravilu Zubsolv.
English: • 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.
Slovenian: analgetiki in antitusiki), določenimi antidepresivi, sedativnimi agonisti receptorja H1, barbiturati, anksiolitiki, ki niso benzodiazepini, nevroleptiki, klonidinom in sorodnimi substancami, saj te kombinacije povečajo depresijo centralnega živčnega sistema.
English: Opioids should be administered with caution to elderly or debilitated patients.
Slovenian: Pri dajanju opioidov starejšim ali oslabelim osebam je potrebna previdnost.
English: Patients should be monitored during dose titration.
Slovenian: Med prilagajanjem odmerka je treba bolnike nadzirati.
English: Patients who are positive for viral hepatitis, receiving concomitant medicinal products (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury.
Slovenian: Pri bolnikih, ki so pozitivni na virusni hepatitis in sočasno prejemajo druga zdravila (glejte poglavje 4.5), in/ali pri bolnikih z motenim delovanjem jeter obstaja tveganje za pospešeno poškodbo jeter.
English: If the patient vomits, care must be taken to prevent aspiration of the vomitus.
Slovenian: Če bolnik bruha, je treba paziti, da izbljuvka ne vdihne.
English: The lowest dose studied represented exposure multiples of 1x for buprenorphine and 5 x for naloxone at the maximum human therapeutic dose calculated on a mg/m² basis.
Slovenian: Najmanjši preiskovan odmerek je ustrezal večkratniku izpostavitve 1-krat za buprenorfin in 5-krat za nalokson pri največjem terapevtskem odmerku za ljudi, izračunanem v mg/m².
English: • abnormal liver function, weight loss
Slovenian: • nenormalno delovanje jeter, izguba telesne mase,
English: When administered orally or sublingually in usual doses to patients experiencing opioid withdrawal, naloxone exhibits little or no pharmacological effect because of its almost complete first pass metabolism.
Slovenian: Pri dajanju običajnih odmerkov naloksona peroralno ali podjezično bolnikom z odtegnitvijo opioidov ima majhen farmakološki učinek oziroma ta učinek sploh ni prisoten, ker se skoraj popolnoma presnovi že pri prvem prehodu.
English: Naloxone is metabolised in the liver, primarily by glucuronide conjugation, and excreted in the urine.
Slovenian: Nalokson se presnavlja v jetrih, za kar je pretežno odgovoren proces glukuronidne konjugacije, in se izloča z urinom.
English: If a patient is changed between buprenorphine or buprenorphine and naloxone containing products, dose adjustments may be necessary due to the potential differences in bioavailability (see sections 4.4 and 5.2).
Slovenian: Ob prehodu bolnika z drugega zdravila, ki vsebuje buprenorfin ali buprenorfin in nalokson, bodo zaradi potencialnih razlik v biološki uporabnosti morda potrebne prilagoditve odmerka (glejte poglavji 4.4 in 5.2).
English: • Drowsiness
Slovenian: • Zaspanost
English: Do not take any other medicines whilst taking Zubsolv without first talking to your doctor, especially:
Slovenian: Med zdravljenjem z zdravilom Zubsolv ne uporabljajte nobenega drugega zdravila, ne da bi se prej posvetovali z zdravnikom; zlasti to velja za naslednja zdravila:
English: The intention of the naloxone component is to deter intravenous misuse.
Slovenian: Namen sestavine nalokson je odvračanje od intravenske zlorabe.
English: Opioids may elevate cerebrospinal fluid pressure, which may cause seizures, so opioids should be used with caution in patients with head injury, intracranial lesions, other circumstances where cerebrospinal pressure may be increased, or history of seizure.
Slovenian: Ker lahko opioidi povečajo tlak cerebrospinalne tekočine, kar lahko povzroči epileptične napade, jih je treba pri bolnikih s poškodbami glave, intrakranialnimi lezijami, drugimi stanji, ki lahko privedejo do povečanja tlaka cerebrospinalne tekočine, ali pri bolnikih z anamnezo epileptičnih napadov uporabljati previdno.
English: 0.7 mg / 0.18 mg 2 years
Slovenian: 0,7 mg/0,18 mg 2 leti
English: Very common side effects (may affect more than one in 10 people):
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: The tablet is to be placed under the tongue until completely dissolved.
Slovenian: Tableto je treba položiti pod jezik, kjer se mora popolnoma raztopiti.
English: Patients already treated with CYP3A4 inhibitors should have their dose of buprenorphine/naloxone titrated carefully since a reduced dose may be sufficient in these patients (see section 4.5).
Slovenian: CYP3A4, je treba odmerek buprenorfina/naloksona previdno prilagajati, saj lahko pri teh bolnikih zadostuje že manjši odmerek (glejte poglavje 4.5).
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI