natgillin/translations-raw huggingface dataset:
Elimination of buprenorphine is bi- or tri-exponential, and has a mean half-life from plasma of 32 hours.
Eliminacija buprenorfina je dvojno ali trikratno eksponentna in ima v plazmi razpolovni čas 32 ur.
If you have the impression that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist.
Če imate občutek, da je zdravilo Suboxone premočno ali prešibko, se posvetujte s svojim zdravnikom ali farmacevtom.
After a satisfactory stabilisation has been achieved, if the patient agrees, the dosage may be reduced gradually to a lower maintenance dose; in some favourable cases, treatment may be discontinued.
Ko pri bolniku dosežete zadovoljivo stabilizacijo, lahko, če se bolnik strinja, odmerek počasi zmanjšate na nižji vzdrževalni odmerek; v nekaterih ugodnih primerih lahko zdravljenje prekinete.
The dose on Monday and Wednesday should be twice the individually titrated daily dose, and the dose on Friday should be three times the individually titrated daily dose, with no dose on the intervening days.
Odmerek zdravila v ponedeljek in sredo mora biti dvakrat večji od individualno prilagojenega dnevnega odmerka, odmerek v petek pa trikrat večji od individualno prilagojenega dnevnega odmerka, na vmesne dni pa bolnik ne sme prejeti nobenega odmerka.
Patients should be cautioned about driving or operating hazardous machinery in case buprenorphine/naloxone may affect their ability to engage in such activities.
Bolniki morajo biti previdni pri vožnji ali upravljanju nevarnih strojev, ker lahko buprenorfin/nalokson vpliva na njihovo sposobnost delovanja pri takih dejavnostih.
When taken during pregnancy, particularly late pregnancy, medicines like Suboxone may cause drug withdrawal symptoms including problems with breathing in your newborn baby.
Pri jemanju v nosečnosti, še posebej v pozni nosečnosti, lahko zdravila, kot je Suboxone, povzročijo odtegnitvene simptome, vključno s težavami z dihanjem pri novorojenčkih.
There are no adequate data from the use of Suboxone in pregnant women.
Ustreznih podatkov o uporabi zdravila Suboxone pri nosečnicah ni.
Respiratory depression as a result of central nervous system depression is the primary symptom requiring intervention in the case of overdose because it may lead to respiratory arrest and death.
Respiratorna depresija, ki je poglavitni simptom posledice depresije osrednjega živčnega sistema, zahteva ukrepanje, če pride do prevelikega odmerjanja, saj lahko povzroči zastoj dihanja in smrt.
Some people have died from respiratory failure (inability to breathe) because they misused this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.
Nekateri ljudje so umrli zaradi odpovedi dihanja (nesposobnost dihanja), ker so zlorabili to zdravilo ali so ga vzeli v kombinaciji z drugimi depresivi osrednjega živčnega sistema, kot so alkohol, benzodiazepini (pomirjevala) ali drugi opioidi.
Dose titration in steps of 2-8 mg buprenorphine is guided by reassessment of the clinical and psychological status of the patient, and should not exceed a maximum single daily dose of 24 mg buprenorphine.
Prilagajanje odmerka v korakih od 2 do 8 mg buprenorfina se vodi s pomočjo ponovnega ocenjevanja kliničnega in psihološkega stanja bolnika in ne sme preseči največjega posameznega odmerka 24 mg buprenorfina.
Taking the wrong dose of benzodiazepines may cause death due to respiratory failure (inability to breathe).
Napačen odmerek benzodiazepinov lahko povzroči smrt zaradi dihalne odpovedi (nezmožnosti dihanja).
Depending upon the findings, the medicinal product may be discontinued cautiously so as to prevent withdrawal symptoms and to prevent a return to illicit drug use.
Odvisno od ugotovitev lahko zdravnik prekine uporabo zdravila, tako da ne povzročite sindroma odtegnitve in prepreči povratek bolnika k uporabi nezakonitih drog.
• a urinary disorder (especially linked to enlarged prostrate in men)
• motenj uriniranja (pri moških še zlasti v povezavi s povečano prostato),
If taken together with alcohol or central nervous system depressants, the effect is likely to be more pronounced (see sections 4.4 and 4.5).
Če se zdravilo jemlje skupaj z alkoholom ali depresivi osrednjega živčnega sistema, bo učinek verjetno bolj izrazit (glejte poglavji 4.4 in 4.5).
Symptomatic treatment of respiratory depression, and standard intensive care measures, should be implemented.
Uvesti je treba simptomsko zdravljenje respiratorne depresije in standardno intenzivno nego.
This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-dependent people who accidentally or deliberately take it.
To zdravilo lahko povzroči hudo, morda celo usodno, depresijo dihanja (zmanjšana zmožnost dihanja) pri otrocih in tistih, ki niso odvisniki, in to zdravilo vzamejo nenamerno ali namerno.
Packed in packs of 7 and 28 tablets.
Pakirano v paketih 7 in 28 tablet.
These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin).
Ta zdravila vključujejo zdravila za zdravljenje epilepsije (kot sta karbamazepin in fenitoin) in zdravila za zdravljenje tuberkuloze (rifampicin).
Table 1 summarises adverse reactions reported from pivotal clinical trials in which, 342 of 472 patients (72.5 %) reported adverse reactions and adverse reactions reported during post-marketing surveillance.
Preglednica 1 podaja povzetek neželenih učinkov, o katerih so poročali v glavnih kliničnih raziskavah, v katerih je 342 od 472 bolnikov (72,5 %) poročalo o neželenih učinkih, in tistih, o katerih so poročali po prihodu zdravila na trg.
Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
O smrti so poročali tudi v povezavi s sočasnim dajanjem buprenorfina in drugih depresivov, kot so alkohol ali drugi opioidi.
Do not forget to advise your doctor if you take this medicine.
Obvestite svojega zdravnika, če jemljete to zdravilo.
• clonidine (used to treat high blood pressure) may extend the effects of this medicine.
• Klondin (za zdravljenje visokega krvnega tlaka) lahko podaljša čas učinkovanja tega zdravila.
Opioid-induced miosis, changes in the level of consciousness, or changes in the perception of pain as a symptom of disease may interfere with patient evaluation or obscure the diagnosis or clinical course of concomitant disease.
Mioza zaradi opioidov, spremembe v stopnji zavesti in spremembe v občutenju bolečine kot simptoma bolezni lahko vplivajo na oceno bolnika ter otežijo diagnozo oziroma zakrijejo klinični potek druge bolezni.
Peak plasma concentrations are achieved 90 minutes after sublingual administration.
Najvišja plazemska koncentracija se doseže 90 minut po uporabi pod jezikom.
Patients must be warned to store the blister safely, to never open the blister in advance, to keep them out of the reach of children and other household members, and not to take this medicine in front of children.
Bolnike posvarite, naj pretisni omot shranjujejo na varnem mestu in ga ne odpirajo vnaprej, zdravila naj shranjujejo zunaj dosega otrok in drugih članov gospodinjstva ter naj zdravila ne jemljejo v prisotnosti otrok.
Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines while taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their physician (see section 4.4).
Bolnike je treba opozoriti, da je samostojna uporaba nepredpisanih benzodiazepinov izjemno nevarna med jemanjem tega zdravila in da je uporaba benzadiazepinov sočasno s tem izdelkom dovoljena samo skladno z navodili njihovega zdravnika (glejte poglavje 4.4).
To minimize the risk of misuse, abuse and diversion, physicians should take appropriate precautions when prescribing and dispensing buprenorphine, such as to avoid prescribing multiple refills early in treatment, and to conduct patient follow-up visits with clinical monitoring that is appropriate to the patient's needs.
Za zmanjšanje tveganja napačne uporabe, zlorabe in preusmeritve uporabe, morajo zdravniki poskrbeti za ustrezne previdnostne ukrepe pri predpisovanju in razdeljevanju buprenorfina, kot so izogibanje večji količini zdravil pri ponovnem predpisovanju v zgodnjih fazah zdravljenja in naročanjem bolnika na ponovne obiske s kliničnim spremljanjem, ki je primerno potrebam bolnika.
Renal elimination may be prolonged since 30 % of the administered dose is eliminated by the renal route.
Eliminacija skozi ledvice se lahko podaljša, ker se 30 % danega odmerka izloči prek ledvic.
Following treatment induction on day one, the patient should be stabilised to a maintenance dose during the next few days by progressively adjusting the dose according to the clinical effect of the individual patient.
Po začetku zdravljenja je treba prvi dan bolnika stabilizirati na vzdrževalni odmerek v teku naslednjih nekaj dni s postopnim prilagajanjem odmerka skladno s kliničnim učinkom pri posameznem bolniku.
Buprenorphine/naloxone should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Buprenorfin/nalokson se lahko med nosečnostjo uporablja le, če potencialne koristi pretehtajo potencialno tveganje za zarodek.
Lactose monohydrate Mannitol
Laktoza monohidrat Manitol
It is unknown whether naloxone is excreted in human breast milk.
Ni znano, ali se nalokson izloča v materino mleko.
• Starting treatment of Suboxone whilst dependent on heroin
• Začetek zdravljenja z zdravilom Suboxone med odvisnostjo od heroina
• low blood pressure
• nizkega krvnega tlaka,
During your treatment, the doctor may adjust the dose, depending upon your response.
Zdravnik bo med zdravljenjem morda moral prilagoditi odmerek glede na vaš odziv.
Keep the tablet under your tongue until it dissolves.
Tableto imejte pod jezikom, dokler se ne raztopi.
Liver damage has been reported after taking Suboxone, especially when the medicine is misused.
Poročali so o poškodbah jeter po jemanju zdravila Suboxone, še posebej ob napačni uporabi zdravila.
This product may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.
To zdravilo lahko povzroči nenaden padec krvnega tlaka, kar povzroči občutek vrtoglavice, če se prehitro dvignete iz sedečega ali ležečega položaja.
Tell your doctor immediately or seek urgent medical attention if you experience side effects, such as:
Takoj se posvetujte s svojim zdravnikom ali poiščite nujno medicinsko pomoč, če se pojavijo neželeni učinki, kot so:
The frequency of possible side effects listed below is defined using the following convention: Very common (1/10), Common (1/100 to <1/10), Uncommon (1/1,000 to <1/100), Not known (cannot be estimated from available data).
Pogostnost spodaj naštetih možnih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
If the treatment is continued, hepatic function should be monitored closely.
Če bo z zdravljenjem nadaljeval, mora pozorno spremljati delovanje jeter.
If buprenorphine is administered to some non-opioid dependent individuals, who are not tolerant to the effects of opioids, potentially fatal respiratory depression may occur.
Če se buprenorfin daje osebam, ki niso odvisne od opioidov in ki niso razvile tolerance na učinke opioidov, se lahko pojavi potencialno smrtna respiratorna depresija.
CYP 3A inhibitors
Zaviralci encima CYP 3A
Due to the long half-life of buprenorphine, neonatal monitoring for several days should be considered at the end of pregnancy, to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
Zaradi dolgega razpolovnega časa buprenorfina je treba ob koncu nosečnosti razmisliti o nekajdnevnem spremljanju novorojenčka, da se prepreči tveganje respiratorne depresije ali odtegnitvenega sindroma pri novorojenčkih.
Suboxone should not be taken together with:
Zdravila Suboxone se ne sme jemati skupaj z:
Efficacy and safety data for buprenorphine/naloxone are primarily derived from a one-year clinical trial, comprising a 4-week randomised double blind comparison of buprenorphine/naloxone, buprenorphine and placebo followed by a 48 week safety study of buprenorphine/naloxone.
Podatki o učinkovitosti in varnosti buprenorfina/naloksona so pridobljeni v glavnem iz enoletnih kliničnih preskušanj, ki vključujejo 4-tedensko randomizirano dvojno slepo primerjavo buprenorfina/naloksona, buprenorfina in placeba, ki ji je sledila 48-tedenska študija varnosti buprenorfina/naloksona.
Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see Warnings and precautions).
Nepravilna uporaba tega zdravila z vbrizgavanjem lahko povzroči odtegnitvene simptome, okužbe, druge kožne reakcije in morda hude težave z jetri (glejte » Opozorila in previdnostni ukrepi«).
Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the -opioid receptors which, over a prolonged period, might minimise the need of addicted patients for drugs.
Učinkovanje buprenorfina se pripisuje njegovim počasi reverzibilnim lastnostim na µ-opioidnih receptorjih, ki lahko prek daljšega obdobja zmanjša potrebo odvisnosti bolnikov od drog.
Slow or difficult breathing, liver injury with or without jaundice, hallucinations, swelling of face and throat or life threatening allergic reactions, drop in blood pressure on changing position from sitting or lying down to standing.
Počasno ali težko dihanje, poškodba jeter z zlatenico ali brez nje, halucinacije, otekanje obraza ali grla ali življenje ogrožajoče alergijske reakcije, padec krvnega tlaka ob spremembi položaja iz sedečega v stoječega.
The combination of buprenorphine and naloxone has been investigated in acute and repeated dose (up to 90 days in rats) toxicity studies in animals.
Kombinacija buprenorfina in naloksona je bila raziskana v študijah toksičnosti pri živalih ob uporabi akutnega in večkratnega odmerka (do 90 dni pri podganah).
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
Some reports of seizure, vomiting, diarrhoea, and elevated liver function tests were considered serious.
Nekatera poročila o epileptičnih napadih, bruhanju, driski in povečanih vrednostih testov delovanja jeter so bila ocenjena kot resna.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Preobčutljivost na zdravilni učinkovini ali na katero koli pomožno snov, navedeno v poglavju 6.1.
After a time of successful treatment, you may agree with your doctor to reduce the dose gradually to a lower maintenance dose.
Po določenem času ustreznega zdravljenja se lahko s svojim zdravnikom dogovorite za počasno zmanjšanje odmerka na nižji vzdrževalni odmerek.
The expiry date refers to the last day of that month
Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Towards the end of pregnancy buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration.
Proti koncu nosečnosti lahko buprenorfin inducira respiratorno depresijo pri novorojenčku celo po kratkem času dajanja.
Prior to treatment initiation, consideration should be given to the type of opioid dependence (i.e. longor short-acting opioid), the time since last opioid use and the degree of opioid dependence.
Pred začetkom zdravljenja je treba oceniti vrsto opioidne odvisnosti (tj. dolgotrajno ali kratkotrajno delujoči opioid), čas od zadnje uporabe opioidov in stopnjo odvisnosti od opioidov.
Animal studies have shown a reduction in female fertility at high doses (systemic exposure > 2.4 times the human exposure at the maximum recommended dose of 24 mg buprenorphine, based on AUC).
Študije na živalih so pokazale zmanjšanje plodnosti pri samicah ob velikih odmerkih (sistemska izpostavljenost > 2,4-krat večja izpostavljenost kot pri ljudeh ob največjem priporočenem odmerku, ki znaša 24 mg buprenorfina na podlagi vrednosti AUC).
Patients should be clearly monitored during the switching period from buprenorphine or methadone to buprenorphine/naloxone since withdrawal symptoms have been reported.
Bolnika je treba med obdobjem prehoda iz buprenorfina ali metadona na buprenorfin/nalokson skrbno spremljati, saj so poročali o pojavu simptomov odtegnitve.
East Yorkshire HU8 7DS, United Kingdom.
East Yorkshire HU8 7DS, Velika Britanija ali
Reproduction studies by oral administration of buprenorphine: naloxone (ratio 1:1) indicated that embryolethality occurred in rats in the presence of maternal toxicity at all doses.
Študije razmnoževanja pri peroralnem jemanju buprenorfina: nalokson (razmerje 1:1) kaže, da se je smrtnost za embrio v prisotnosti materine toksičnosti pojavila pri vseh odmerkih.
The percentage of thrice-weekly urine samples that were negative for non-study opioids was statistically higher for both buprenorphine/naloxone versus placebo (p < 0.0001) and buprenorphine versus placebo (p < 0.0001).
Odstotek vzorcev, ki se jih je odvzelo trikrat na teden in so bili negativni na prisotnost opioidov, ki se jih v študiji ni uporabljajo, so bili statistično višji za buprenorfin/nalokson glede na placebo (p < 0,0001) in buprenorfin glede na placebo (p < 0,0001).
The primary study comparison was to assess the efficacy of buprenorphine and buprenorphine/naloxone individually against placebo.
S primerjavo primarnih študij so ocenili učinkovitost buprenorfina in buprenorfina/naloksona individualno glede na placebo.
They should not be taken at the same time as Suboxone treatment because you may experience a sudden onset of prolonged and intense withdrawal.
Ne smete ju jemati sočasno z zdravilom Suboxone, ker se lahko pri vas nenadno pojavijo dolgotrajni in močni odtegnitveni simptomi.
If you or someone else takes too much of this medicine, you must go or be taken immediately to an emergency centre or hospital for treatment as overdose with Suboxone may cause serious and lifethreatening breathing problems.
Če ste vzeli večji odmerek zdravila Suboxone, kot bi smeli Če vi ali kdor koli drug zaužije prevelik odmerek tega zdravila, morate takoj obiskati center za nujno medicinsko pomoč ali bolnišnico oziroma vas morajo tja prepeljati, saj preveliko odmerjanje zdravila Suboxone lahko povzroči hude in smrtno nevarne težave z dihanjem.
• adrenocortical disorder (e.g. Addison's disease)
• adrenokortikalne okvare (Addisonova bolezen).
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).
Bolnike, ki prejemajo zdravilo Suboxone, je treba pozorno spremljati, saj bo morda pri njih potrebno zmanjšati odmerek v kombinaciji z močnimi zaviralci CYP3A4 (npr. zaviralci proteaze, kot so ritonavir ali nelfinavir ali indinavir ali azolskimi antimiotiki, kot so ketokonazol ali itrakonazol, makrolidni antibiotiki).
The reduced level of alertness can make driving and using machines hazardous.
Zaradi zmanjšane pozornosti lahko postaneta nevarna tudi vožnja ali upravljanje s stroji.
Severe respiratory insufficiency
Huda respiratorna insuficienca.
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.
Če ste jemali metadon oziroma dolgotrajno delujoč opioid, je treba odmerek metadona idealno zmanjšati pod 30 mg/dan preden začnete z zdravljenjem z zdravilom Suboxon.
o naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine.
o Naltrekson in nalmefen sta opioidna antagonista, ki lahko blokirata farmakološke učinke buprenorfina.
Suboxone should be used cautiously when co-administered with:
Zdravilo Suboxone je treba uporabljati previdno pri sočasnem dajanju z:
A carcinogenicity study with buprenorphine/naloxone was conducted in rats at doses of 7, 30 and 120 mg/kg/day, with estimated exposure multiples of 3 to 75 times, based on a human daily sublingual dose of 16 mg calculated on a mg/m² basis.
Študijo karcinogenosti z buprenorfinom/naloksonom so izvedli pri podganah v odmerkih 7, 30 in 120 mg/kg/dan z ocenjenim večkratnim faktorjem od 3 do 75-krat za izpostavljenost pri ljudeh na osnovi dnevnega podjezičnega odmerka 16 mg, izračunanega na osnovi mg/m².
Some risks of misuse and abuse include overdose, spread of blood borne viral or localised and systemic infections, respiratory depression and hepatic injury.
Nekatera tveganja, ki se pojavijo zaradi napačne uporabe in zlorabe, vključujejo preveliko odmerjanje, širjenje virusnih ali lokaliziranih in sistemskih okužb, ki se prenašajo s krvjo, respiratorno depresijo in poškodbe jeter.
In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomized to receive the ethanolic sublingual solution of buprenorphine at 8 mg/day (a dose which is roughly comparable to a dose of 12 mg/day of buprenorphine/naloxone), or two relatively low doses of active control, one of which was low enough to serve as an alternative to placebo, during a 3 to10 day induction phase, a 16-week maintenance phase and a 7-week detoxification phase.
V dvojno slepi študiji z dvojnim placebom in vzporednimi skupinami, v kateri so primerjali etanolno raztopino buprenorfina z aktivno kontrolo, ki je vsebovala popoln agonist, so randomizirali 162 oseb, ki bi morale prejeti etanolno podjezično raztopino buprenorfina v količini 8 mg/dan (odmerek, ki je v grobem primerljiv z odmerkom 12 mg/dan buprenorfina/naloksona) ali dva relativno majhna odmerka aktivne kontrole, od katerih je bil en dovolj nizek, da se ga je lahko uporabljalo kot nadomestek za placebo, v času 3- do 10-dnevne indukcijske faze, 16-tedenske vzdrževalne faze in 7-tedenske detoksifikacijske faze.
A dietary dose of 100 ppm (estimated exposure approximately 2.4x for buprenorphine at a human dose of 24 mg buprenorphine/naloxone based on AUC, plasma levels of naloxone were below the limit of detection in rats) had no adverse effect on fertility in females.
Prehranski odmerek 100 ppm (ocenjena izpostavitev je približno 2,4x za buprenorfin pri odmerku za ljudi 24 mg buprenorfina/naloksona na osnovi AUC, ravni naloksona v plazmi so bile pod mejo zaznavanja pri podganah) ni imel neželenih učinkov na plodnost samic.
Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
Zdravila, ki zavirajo encim CYP3A4, lahko povzročijo povečane koncentracije buprenorfina.
• any liver disease such as hepatitis
• kakršnih koli težav z jetri, na primer hepatitisa,
• Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam.
• Benzodiazepini (za zdravljenje tesnobe ali motenj spanja), kot so diazepam, temazepam, alprazolam.
The combination (4:1) of buprenorphine hydrochloride and naloxone hydrochloride was not mutagenic in a bacterial mutation assay (Ames test), and was not clastogenic in an in vitro cytogenetic assay in human lymphocytes or in an intravenous micronucleus test in the rat.
Kombinacija (4:1) buprenorfinijevega klorida in naloksonijevega klorida ni bila mutagena pri preskusu bakterijske mutagenosti (Amesov preskus) in ni bila klastogena v citogenetski preiskavi in vitro na človeških limfocitih ali v intravenskem preskusu mikronukleusov pri podganah.
28 tablets in blister packs Paper/Aluminium/Nylon/Aluminium/PVC.
28 tablet v pretisnih omotih iz papirja/aluminija/najlona/aluminija/PVC.