FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Za zmanjšanje tveganja napačne uporabe, zlorabe in preusmeritve uporabe, morajo zdravniki upoštevati ustrezne previdnostne ukrepe pri predpisovanju in razdeljevanju buprenorfina, kot sta izogibanje večjim količinam zdravila pri ponovnem predpisovanju v zgodnjih fazah zdravljenja in naročanje bolnika na ponovne obiske s kliničnim spremljanjem glede na bolnikove potrebe.
English: Peak plasma concentrations are achieved approximately 90 minutes after sublingual administration.
Slovenian: Najvišja plazemska koncentracija se doseže približno 90 minut po podjezični uporabi.
English: 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).
Slovenian: Če se zdravilo jemlje skupaj z alkoholom ali depresivi centralnega živčnega sistema, bo učinek verjetno bolj izrazit (glejte poglavji 4.4 in 4.5).
English: Following intravenous administration, naloxone is rapidly distributed (distribution half-life ~ 4 minutes).
Slovenian: Po intravenski aplikaciji se nalokson hitro porazdeli (porazdelitveni razpolovni čas ~ 4 minute).
English: Further, no teratogenicity has been observed in either rats or rabbits.
Slovenian: Poleg tega niti pri podganah niti kuncih niso opazili teratogenosti.
English: • drop in blood pressure on changing position from sitting or lying down to standing
Slovenian: • padec krvnega tlaka ob spremembi položaja iz sedečega ali ležečega v stoječega,
English: Do not forget to advise your doctor if you take this medicine.
Slovenian: Obvestite zdravnika, če jemljete to zdravilo.
English: • severe tiredness, itching with yellowing of skin or eyes.
Slovenian: • huda utrujenost, srbenje z rumeno obarvanostjo kože ali oči.
English: Some reports of seizure, vomiting, diarrhoea, and elevated liver function tests were considered serious.
Slovenian: Nekatera poročila o epileptičnih napadih, bruhanju, driski in povečanih vrednostih preiskav jetrne funkcije so bila ocenjena kot resna.
English: During your treatment, the doctor may adjust the dose, depending upon your response.
Slovenian: Zdravnik vam bo med zdravljenjem glede na vaš odziv morda moral prilagoditi odmerek.
English: Zubsolv must not be taken together with:
Slovenian: Zdravila Zubsolv se ne sme jemati skupaj z:
English: 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).
Slovenian: Odstotek vzorcev urina, ki so jih odvzeli trikrat na teden in so bili negativni na prisotnost opioidov, ki se jih v študiji ni uporabljalo, je bil statistično višji tako za buprenorfin/nalokson glede na placebo (p < 0,0001) kot za buprenorfin glede na placebo (p < 0,0001).
English: 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.
Slovenian: Zaradi dolgega razpolovnega časa buprenorfina je treba ob koncu nosečnosti razmisliti o nekajdnevnem spremljanju novorojenčka, da se pri njem prepreči tveganje respiratorne depresije ali odtegnitvenega sindroma.
English: Remove just one section from the blister pack, tearing it along the perforated line.
Slovenian: S pretisnega omota odstranite le eno enoto tako, da jo odtrgate po perforirani črti.
English: Ongoing intravenous infusion rates should be titrated to patient response.
Slovenian: Nadaljnje hitrosti intravenske infuzije je treba prilagoditi odzivu bolnika.
English: Patients should be closely monitored during the switching period from buprenorphine or methadone to buprenorphine/naloxone since withdrawal symptoms have been reported.
Slovenian: Bolnika je treba med obdobjem prehoda z buprenorfina ali metadona na buprenorfin/nalokson skrbno spremljati, saj so poročali o pojavu simptomov odtegnitve.
English: 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 17.2 mg buprenorphine, based on AUC) (see section 5.3).
Slovenian: 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 17,2 mg buprenorfina, na podlagi vrednosti AUC) (glejte poglavje 5.3).
English: After a satisfactory stabilisation has been achieved the frequency of dosing may be decreased to dosing every other day at twice the individually titrated daily dose.
Slovenian: Ko dosežete zadovoljivo stabilizacijo, lahko pogostnost odmerjanja zmanjšate na odmerjanje vsak drugi dan z dvakratnim individualno prilagojenim dnevnim odmerkom.
English: 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.
Slovenian: Podatki o učinkovitosti in varnosti buprenorfina/naloksona so pretežno pridobljeni iz enoletnega kliničnega preskušanja, ki je vključevalo 4-tedensko randomizirano dvojno slepo primerjavo buprenorfina/naloksona, buprenorfina in placeba, ki ji je sledila 48-tedenska študija varnosti buprenorfina/naloksona.
English: This product may cause drowsiness, dizziness, or impaired thinking, especially during treatment induction and dose adjustment.
Slovenian: To zdravilo lahko povzroča zaspanost, omotico ali oteženo razmišljanje, zlasti med uvajanjem zdravljenja in v obdobju prilagajanja odmerkov.
English: • feeling sleepy and uncoordinated, have blurred vision, have slurred speech, cannot think well or clearly, or your breathing gets much slower than is normal for you
Slovenian: • občutek zaspanosti in nekoordiniranosti, zamegljen vid, nerazločen govor, nezmožnost treznega ali zbranega razmišljanja ali dihanje, ki postane veliko počasnejše, kot je sicer za vas običajno;
English: Use of multiples of the three lower dose presentations of Zubsolv to substitute for any of the three higher dose presentations (in for example cases where the higher dose presentations are temporarily not available) is not recommended (see section 5.2).
Slovenian: Odmerjanje po več tablet treh manjših odmerkov zdravila Zubslov z namenom nadomeščanja katerega od treh večjih odmerkov zdravila (na primer v primerih, ko večji odmerki zdravila začasno niso na voljo) ni priporočljivo (glejte poglavje 5.2).
English: 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.
Slovenian: Študije razmnoževanja pri peroralni aplikaciji buprenorfina : naloksona (v razmerju 1 : 1) kažejo, da se je pri podganah smrtnost zarodkov v prisotnosti toksičnosti za mater pojavila pri vseh odmerkih.
English: Your doctor will decide if your treatment should be continued with an alternative medicine.
Slovenian: Zdravnik bo presodil, ali bo pri vas nadaljeval zdravljenje s kakim drugim zdravilom.
English: Opioids have been shown to increase intracholedochal pressure, and should be used with caution in patients with dysfunction of the biliary tract.
Slovenian: Opioidi dokazano povečujejo intraholedohalni tlak, zato jih je treba pri bolnikih z nepravilnim delovanjem biliarnega trakta uporabljati previdno.
English: Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence.
Slovenian: Sočasna uporaba opioidnih antagonistov (naltreksona, nalmefena) za zdravljenje odvisnosti od alkohola ali opioidov.
English: Your doctor will prescribe the correct dose for you.
Slovenian: Zdravnik vam bo predpisal ustrezen odmerek.
English: Buprenorphine is eliminated in the faeces by biliary excretion of the glucuroconjugated metabolites (70 %), the rest being eliminated in the urine.
Slovenian: Buprenorfin se izloča z blatom prek izločanja glukuronidno konjugiranih presnovkov v žolč (70 %), ostanek pa se izloča z urinom.
English: The safety and efficacy of buprenorphine/naloxone in elderly patients over 65 years of age have not been established.
Slovenian: Varnost in učinkovitost buprenorfina/naloksona pri bolnikih, starejših od 65 let, nista bili dokazani.
English: These include local reactions, sometimes septic (abscess, cellulitis), potentially serious acute hepatitis, and other acute infections such as pneumonia, endocarditis (see section 4.4).
Slovenian: Ti neželeni učinki so vključevali lokalne reakcije, ki so bile včasih septične (absces, celulitis), potencialno resen akutni hepatitis in druge akutne okužbe, kot sta pljučnica in endokarditis (glejte poglavje 4.4).
English: This may involve taking a combination of different strengths, but your daily dose should not exceed 17.2mg of buprenorphine.
Slovenian: To lahko vključuje jemanje kombinacije različnih jakosti, vendar dnevni odmerek buprenorfina ne sme preseči 17,2 mg.
English: Combining buprenorphine with naloxone in Zubsolv is intended to deter misuse and abuse of the buprenorphine.
Slovenian: Kombiniranje buprenorfina z naloksonom v zdravilu Zubsolv je namenjeno preprečevanju napačne uporabe in zlorabe buprenorfina.
English: Naloxone can be eliminated more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms, so a continuing infusion may be necessary.
Slovenian: Nalokson se lahko izloči hitreje kot buprenorfin, zato se lahko znova pojavijo predhodno nadzorovani simptomi prevelikega odmerjanja buprenorfina, zaradi česar bo morda potrebna dolgotrajna infuzija.
English: 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.
Slovenian: Če buprenorfin prejmejo osebe, ki niso odvisne od opioidov in ne prenašajo njihovih učinkov, lahko to privede do potencialno smrtne respiratorne depresije.
English: 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.
Slovenian: Kombinacija buprenorfinijevega klorida in naloksonijevega klorida (4 : 1) 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.
English: Dosage adjustment and maintenance therapy
Slovenian: Prilagajanje odmerka in vzdrževalno zdravljenje
English: • anxiety, depression, decreased sexual drive, nervousness, abnormal thinking
Slovenian: • anksioznost, depresija, zmanjšano spolno poželenje, živčnost, nenormalno razmišljanje,
English: • difficulty in getting or keeping an erection
Slovenian: • težave z erekcijo ali njenim ohranjanjem,
English: Zubsolv disintegrates usually within 40 seconds, however it may take 5 to 10 minutes for the patient to feel complete tablet disappearance from the mouth.
Slovenian: Zdravilo Zubsolv se običajno raztopi v 40 sekundah, vendar bo morda pri bolniku trajalo 5 do 10 minut, da bo imel občutek, da je tableta v celoti izginila iz njegovih ust.
English: The safety and efficacy of buprenorphine/naloxone in children below the age of 15 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost buprenorfina/naloksona pri otrocih, mlajših od 15 let, nista bili dokazani.
English: Once the appropriate dose has been identified for a patient with a specific buprenorphine product, that product should not be exchanged with another product.
Slovenian: Ko ugotovite za bolnika ustrezen odmerek zdravila, ki vsebuje buprenorfin, ga ne smete zamenjati z drugim zdravilom.
English: Contents of the pack and other information What Zubsolv contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zubsolv
English: Regular monitoring of liver function is recommended (see section 4.4).
Slovenian: Priporoča se redno spremljanje delovanja jeter (glejte poglavje 4.4).
English: • amnesia (memory disturbance), convulsion (fits), speech disorder, tremor
Slovenian: • amnezija (motnje spomina), krči (epileptični napadi), motnje govora, tremor,
English: Stopping treatment suddenly may cause withdrawal symptoms.
Slovenian: Nenadna prekinitev zdravljenja lahko povzroči odtegnitvene simptome.
English: Do not drive, use any tools or machines, or perform dangerous activities until you know how this medicine affects you.
Slovenian: Dokler ne veste, kako zdravilo vpliva na vas, ne vozite, ne uporabljajte orodij ali strojev in ne izvajajte nevarnih dejavnosti.
English: Elimination of buprenorphine is bi- or tri-exponential, and has a mean half-life from plasma of 32 hours.
Slovenian: Eliminacija buprenorfina je dvo- ali trieksponentna in plazemski razpolovni čas znaša 32 ur.
English: Keep the tablet under your tongue until it dissolves.
Slovenian: Tableto zadržite pod jezikom, dokler se ne raztopi.
English: Starting treatment
Slovenian: Začetek zdravljenja
English: • Withdrawal symptoms
Slovenian: • Odtegnitveni simptomi
English: You may be more closely monitored by your doctor if you are below the age of 18.
Slovenian: Če ste mlajši od 18 let, vas bo morda zdravnik moral natančneje spremljati.
English: The reduced level of alertness can make driving and using machines hazardous
Slovenian: Zaradi zmanjšane pozornosti lahko postaneta nevarna tudi vožnja ali upravljanje s stroji
English: The tablet contains buprenorphine which is responsible for the treatment of opioid (narcotic) dependence.
Slovenian: Tableta vsebuje buprenorfin, ki se uporablja za zdravljenje odvisnosti od opioidov (narkotikov).
English: Signs of overdose may also include somnolence, amblyopia, miosis, hypotension, nausea, vomiting and/or speech disorders.
Slovenian: Znaki prevelikega odmerjanja lahko vključujejo tudi somnolenco, ambliopijo, miozo, hipotenzijo, navzeo, bruhanje in/ali motnje govora.
English: Tear following the direction of the arrow.
Slovenian: Odtrgajte v smeri puščice.
English: Long-term administration of buprenorphine during the last three months of pregnancy may cause withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions).
Slovenian: Dolgotrajna uporaba buprenorfina v zadnjem tromesečju nosečnosti lahko povzroči odtegnitveni sindrom pri novorojenčku (npr. hipertonija, neonatalni tremor, neonatalna agitacija, mioklonus ali konvulzije).
English: The availability of six different tablet strengths supports individual dose titration and tapering.
Slovenian: Uporabnost tablet v šestih različnih jakostih omogoča individualno prilagajanje in zmanjševanje odmerka.
English: • increased tearing (watering eyes) or other tearing disorder
Slovenian: • močnejše solzenje (solzne oči) ali druge motnje solzenja,
English: This medicine can cause drowsiness, particularly when taken together with alcohol or other central nervous system depressants (such as tranquilisers, sedatives or hypnotics).
Slovenian: To zdravilo lahko povzroča zaspanost, zlasti pri jemanju skupaj z alkoholom ali drugimi depresivi centralnega živčnega sistema (kot so pomirjevala, sedativi ali hipnotiki).
English: It also contains naloxone which is used to deter intravenous abuse of the product.
Slovenian: Vsebuje tudi nalokson, ki se uporablja za odvračanje intravenske zlorabe zdravila.
English: Symptoms of overdose may include breathing more slowly and weakly than normal, feeling more sleepy than normal, reduction in the size of the pupils, low blood pressure, feeling sick, vomit and/or slurred speech.
Slovenian: Simptomi prevelikega odmerjanja se lahko kažejo kot počasnejše in šibkejše dihanje in večji občutek zaspanosti, kot je normalno, zmanjšanje zenic, nizek krvni tlak, občutek slabosti, bruhanje in/ali nerazločen govor.
English: Stopping treatment
Slovenian: Prekinitev zdravljenja
English: No developmental toxicity was observed in rabbits at maternally toxic doses.
Slovenian: Pri kuncih niso opazili nobene razvojne toksičnosti pri odmerkih, ki so bili toksični za mater.
English: Zubsolv sublingual tablets are available in six different strengths, differentiated by shape and debossing:
Slovenian: Zdravilo Zubsolv podjezične tablete so na voljo v šestih različnih jakostih, ki se razlikujejo po obliki in vtisnjenih oznakah:
English: No dose modification based on renal function is required but caution is recommended when dosing subjects with severe renal impairment (see section 4.4).
Slovenian: Odmerka na osnovi ledvične funkcije ni treba spreminjati, priporoča pa se skrbnost pri odmerjanju osebam s hudo okvaro ledvic (glejte poglavje 4.4).
English: The most commonly reported treatment related adverse reactions reported during the pivotal clinical trials were constipation and symptoms commonly associated with drug withdrawal (i.e. insomnia, headache, nausea, hyperhidrosis and pain).
Slovenian: Z zdravljenjem najpogosteje povezani neželeni učinki, o katerih so poročali med glavnimi kliničnimi preskušanji, so bili zaprtost in simptomi, ki so običajno povezani z odtegnitvijo drog (npr. nespečnost, glavobol, navzea, hiperhidroza in bolečina).
English: Pack-size of 30 (3 x 10) tablets.
Slovenian: Velikost pakiranja po 30 (3 × 10) tablet.
English: Buprenorphine/naloxone has minor to moderate influence on the ability to drive and use machines when administered to opioid dependent patients.
Slovenian: Buprenorfin/nalokson ima blag do zmeren vpliv na sposobnost vožnje in upravljanja strojev, če se ga daje bolnikom, ki so odvisni od opioidov.
English: This product should be used with care in patients with asthma or respiratory insufficiency (e.g. chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis (curvature of spine leading to potential shortness of breath)).
Slovenian: To zdravilo je treba pri bolnikih z astmo ali respiratorno insuficienco (npr. kronično obstruktivno pljučno boleznijo, pljučnim srcem, zmanjšanim respiratornim rezervnim volumnom, hipoksijo, hiperkapnijo, obstoječo respiratorno depresijo ali kifoskoliozo (ukrivljenost hrbtenice, ki lahko povzroča težko dihanje) uporabljati previdno.
English: In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomised 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.
Slovenian: V dvojno slepi študiji z dvojnim placebom in vzporednimi skupinami, v kateri so primerjali etanolno raztopino buprenorfina z aktivno kontrolo, ki je vključevala polni agonist, so randomizirali 162 oseb, ki naj bi prejele etanolno podjezično raztopino buprenorfina v odmerku 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.
English: Orexo AB Virdings allé 32 A Uppsala
Slovenian: Virdings allé 32 A
English: Appearance
Slovenian: Izgled
English: Zubsolv is not interchangeable with other buprenorphine products, as different buprenorphine products have different bioavailability.
Slovenian: Zdravilo Zubsolv ni zamenljivo z drugimi zdravili, ki vsebujejo buprenorfin, saj imajo različna zdravila, ki vsebujejo buprenorfin, različno biološko uporabnost.
English: Table 3: Effect of hepatic impairment on pharmacokinetic parameters of buprenorphine and naloxone following administration (change relative to healthy subjects) PK Parameter
Slovenian: Preglednica 3: Učinek okvare jeter na farmakokinetične parametre buprenorfina in naloksona po jemanju (sprememba glede na zdrave osebe) FK parameter
English: Sub-optimal treatment with buprenorphine/naloxone may prompt medicine misuse by the patient, leading to overdose or treatment dropout.
Slovenian: Neoptimalno zdravljenje z buprenorfinom/naloksonom lahko spodbudi napačno uporabo zdravila pri bolniku, kar povzroči preveliko odmerjanje ali prekinitev zdravljenja.
English: N-dealkylbuprenorphine is a μ-opioid agonist with weak intrinsic activity.
Slovenian: N-dealkilbuprenorfin je agonist μ-opioidnih receptorjev s šibkim intrinzičnim delovanjem.
English: There are no adequate data from the use of buprenorphine/naloxone in pregnant women.
Slovenian: Nosečnost Na voljo ni ustreznih podatkov o uporabi buprenorfina/naloksona pri nosečnicah.
English: Statistically significant increases in the incidence of benign testicular interstitial (Leydig's) cell adenomas were observed in all dosage groups.
Slovenian: V vseh skupinah odmerjanja so opazili statistično pomembna povečanja pojavnosti benignega testikularnega adenoma intersticijskih celic (Leydigove celice).
English: Based on retention in treatment and the percentage of thrice-weekly urine samples negative for non-study opioids, buprenorphine was more effective than the low dose of the control, in keeping heroin addicts in treatment and in reducing their use of opioids while in treatment.
Slovenian: Na osnovi zadrževanja bolnikov na zdravljenju in odstotku trikrat tedenskih vzorcev urina, ki so bili negativni na opioide, ki se jih v študiji ni uporabljalo, so določili, da je bil buprenorfin bolj učinkovit pri zadrževanju odvisnikov od heroina na zdravljenju in pri zmanjšanju njihove uporabe opioidov med zdravljenjem, kot majhen odmerek kontrolnega zdravila.
English: • low blood pressure
Slovenian: • nizek krvni tlak,
English: • urine abnormality
Slovenian: • nenormalen urin,
English: Some risks to opioid misusers and abusers include overdose, spread of blood borne viral or localised and systemic infections, respiratory depression and hepatic injury.
Slovenian: Nekatera tveganja, ki se pojavijo zaradi napačne uporabe in zlorabe opioidov, vključujejo preveliko odmerjanje, širjenje virusnih ali lokaliziranih in sistemskih okužb,ki se prenašajo s krvjo, respiratorno depresijo in poškodbe jeter.
English: • CYP3A4 inducers: Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.
Slovenian: • induktorji CYP3A4: sočasna uporaba induktorjev CYP3A4 in buprenorfina lahko zmanjša plazemsko koncentracijo buprenorfina, kar lahko privede do neoptimalnega zdravljenja odvisnosti od opioidov z buprenorfinom.
English: A dietary dose of 100 ppm (estimated exposure approximately 2.4 x for buprenorphine at a human dose of 17.2 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.
Slovenian: Prehranski odmerek 100 delcev na milijon (ocenjena izpostavitev je približno 2,4-kratna za buprenorfin pri odmerku 17,2 mg buprenorfina/naloksona za ljudi na osnovi AUC, koncentracije naloksona v plazmi so bile pod mejo zaznavnosti pri podganah) ni imel neželenih učinkov na plodnost samic.