FrancophonIA/ELRC3.0 huggingface dataset:
English: to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from available data).
Slovenian: <1/1.000), zelo redki (<1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Depending on your condition, the dose of Zubsolv may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Slovenian: Glede na vaše stanje lahko odmerek zdravila Zubsolv še naprej zmanjšujete pod skrbnim zdravniškim nadzorom, dokler ga na koncu ne prenehate jemati.
English: What Zubsolv is and what it is used for 2.
Slovenian: Kaj je zdravilo Zubsolv in za kaj ga uporabljamo 2.
English: Only open the blister immediately before taking the dose.
Slovenian: Pretisni omot odprite tik preden vzamete odmerek.
English: Zubsolv is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.
Slovenian: Zdravilo Zubsolv se uporablja pri odraslih ali mladostnikih, starejših od 15 let, ki prejemajo tudi medicinsko, socialno in psihološko podporo.
English: If the treatment is continued, hepatic function should be monitored closely.
Slovenian: Če se zdravljenje nadaljuje, je treba pozorno spremljati delovanje jeter.
English: Both Cmax and AUC of buprenorphine increased with the increase in dose, although the increase was less than dose-proportional.
Slovenian: Vrednosti Cmax in AUC buprenorfina sta se povečali s povečanjem odmerka, čeprav je bilo povečanje manjše kot sorazmerno z odmerkom.
English: Keep this medicine in a safe place to protect it from theft.
Slovenian: Zdravilo hranite na varnem mestu, kjer je zaščiteno pred krajo.
English: Do not take Zubsolv together with alcohol.
Slovenian: Zdravila Zubsolv ne smete vzeti skupaj z alkoholom.
English: This leaflet was last revised in.
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: What you need to know before you take Zubsolv 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Zubsolv 3.
English: This product can cause withdrawal symptoms if you take it less than six hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone.
Slovenian: To zdravilo lahko povzroči odtegnitvene simptome, če ga vzamete manj kot šest ur po uporabi kratkotrajno delujočega opioida (npr. morfija, heroina) ali manj kot 24 ur po tem, ko uporabite dolgotrajno delujoč opioid, kot je metadon.
English: Due to the lack of data in adolescents (age 15 - <18 years), patients in this age group should be more closely monitored during treatment.
Slovenian: Uporaba pri mladostnikih (starih od 15 do <18 let) Zaradi pomanjkanja podatkov o uporabi pri mladostnikih (starih od 15 do <18 let) je treba med zdravljenjem bolnike v tej starostni skupini spremljati bolj natančno.
English: A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Slovenian: Poročali so o številnih primerih smrti zaradi respiratorne depresije, zlasti pri uporabi buprenorfina v kombinaciji z benzodiazepini (glejte poglavje 4.5) ali kadar buprenorfin ni bil uporabljen skladno z navodili za predpisovanje.
English: • Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam.
Slovenian: • benzodiazepini (za zdravljenje tesnobe ali motenj spanja), kot so diazepam, temazepam, alprazolam.
English: Patients must be warned to store the blister safely, to never open the blister in advance, to keep them out of the sight and reach of children and other household members, and not to take this medicine in front of children.
Slovenian: Bolnike posvarite, naj pretisni omot shranjujejo na varnem mestu in ga nikoli ne odpirajo vnaprej, zdravilo naj shranjujejo zunaj pogleda in dosega otrok in drugih članov gospodinjstva ter naj zdravila ne jemljejo v prisotnosti otrok.
English: This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-opioid dependent people.
Slovenian: To zdravilo lahko povzroči hudo, morda celo smrtno respiratorno depresijo (zmanjšana zmožnost dihanja) pri otrocih in tistih, ki niso odvisni od opioidov.
English: A doctor's assessment of your readiness for treatment will guide the timing of your first Zubsolv dose.
Slovenian: Zdravnikova ocena vaše primernosti za zdravljenje bo narekovala čas za vaš prvi odmerek zdravila
English: This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft.
Slovenian: To zdravilo je lahko tarča ljudi, ki zlorabljajo zdravila na recept, zato ga je treba hraniti na varnem mestu, kjer je zaščiteno pred krajo.
English: Your treatment is prescribed and monitored by doctors who are experienced in the treatment of drug dependence.
Slovenian: Vaše zdravljenje predpišejo in spremljajo zdravniki, ki imajo izkušnje z zdravljenjem odvisnosti od mamil.
English: • insomnia (inability to sleep)
Slovenian: • nespečnost (nezmožnost spanja),
English: Never open in advance as the tablet is sensitive to moisture
Slovenian: Embalaže nikoli ne odpirajte predčasno, saj je tableta občutljiva na vlago.
English: Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist e.g. morphine.
Slovenian: Študije na živalih kot tudi klinične izkušnje so pokazale, da lahko buprenorfin povzroči odvisnost, ki pa ni tako močna kot pri polnih agonistih, npr. morfinu.
English: Therefore, breastfeeding should be discontinued during treatment with Zubsolv.
Slovenian: Zato je treba med zdravljenjem z zdravilom Zubsolv prenehati z dojenjem.
English: Therefore, multiples of the three lower dose presentations of Zubsolv should not be used to substitute for any of the three higher dose Zubsolv presentations.
Slovenian: Zato se večkratnik treh manjših odmerkov zdravila Zubsolv ne sme uporabiti kot nadomestilo za katerega koli od treh večjih odmerkov zdravila Zubsolv.
English: 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.
Slovenian: V preglednici 1 je naveden povzetek neželenih učinkov, o katerih so poročali v glavnih kliničnih preskušanjih, v katerih je 342 od 472 bolnikov (72,5 %) poročalo o neželenih učinkih, in neželenih učinkov, o katerih so poročali v izkušnjah po začetku trženja zdravila.
English: • have kidney problems • have recently suffered a head injury or brain disease
Slovenian: • če imate težave z ledvicami, • če ste nedavno utrpeli poškodbe glave ali bolezen možganov,
English: Sublingual use.
Slovenian: Podjezična uporaba.
English: Tell your doctor if you are pregnant or intend to become pregnant.
Slovenian: Če ste noseči ali načrtujete zanositev,
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: • menstrual or vaginal problems, abnormal ejaculation
Slovenian: • menstrualne ali vaginalne težave, nenormalna ejakulacija,
English: Dosage adjustments may therefore be necessary.
Slovenian: Zaradi tega bodo morda potrebne prilagoditve odmerka.
English: Your doctor may increase the dose of Zubsolv you take according to your needs.
Slovenian: Zdravnik vam bo morda povečal odmerek zdravila Zubsolv glede na vaše potrebe.
English: Warnings and precautions • Misuse, abuse and diversion
Slovenian: Opozorila in previdnostni ukrepi • Napačna uporaba, zloraba in preusmeritev uporabe
English: PVC/OPA/Al/PVC // Al/PET/Paper child resistant blister cards.
Slovenian: Za otroke varni pretisni omoti iz PVC/OPA/Al/PVC // Al/PET/papirja.
English: Some medicines may increase the side effects of Zubsolv and may sometimes cause very serious reactions.
Slovenian: Nekatera zdravila lahko povečajo neželene učinke zdravila Zubsolv in imajo lahko včasih zelo hude neželene učinke.
English: Symptomatic treatment of respiratory depression and standard intensive care measures should be implemented.
Slovenian: Uvesti je treba simptomatsko zdravljenje respiratorne depresije in standardno intenzivno nego.
English: Renal elimination plays a relatively small role (~30 %) in the overall clearance of buprenorphine/naloxone.
Slovenian: Izločanje skozi ledvice ima relativno majhno vlogo (~30 %) pri celotnem očistku buprenorfina/naloksona.
English: 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 Zubsolv may cause serious and life-threatening breathing problems.
Slovenian: 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 lahko prevelik odmerek zdravila Zubsolv povzroči resne in smrtno nevarne težave z dihanjem.
English: In some patients, after a satisfactory stabilisation has been achieved, the frequency of dosing may be decreased to 3 times a week (for example on Monday, Wednesday and Friday.
Slovenian: Pri nekaterih bolnikih lahko po zadovoljivi stabilizaciji zmanjšate pogostnost odmerjanja na 3-krat tedensko (na primer ponedeljek,
English: However, the dose given on any one day should not exceed 17.2 mg buprenorphine.
Slovenian: Vendar pa odmerek na kateri koli posamezen dan ne sme presegati 17,2 mg buprenorfina.
English: 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.
Slovenian: Na podlagi ugotovitev se lahko uporaba zdravila previdno prekine, tako da ne povzroči sindroma odtegnitve in da se prepreči povratek bolnika k uporabi nezakonitih drog.
English: Buprenorphine/naloxone should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Slovenian: Buprenorfin/nalokson se lahko med nosečnostjo uporablja le, če potencialne koristi pretehtajo potencialno tveganje za plod.
English: Patients should be cautioned about driving or operating hazardous machinery in case buprenorphine/naloxone may affect their ability to engage in such activities.
Slovenian: Bolnike je treba opozoriti na previdnost pri vožnji ali upravljanju nevarnih strojev, saj lahko buprenorfin/nalokson vpliva na njihovo sposobnost delovanja pri takih dejavnostih.
English: Physicians are encouraged to prescribe a single tablet once daily regimen where possible to minimise risk of diversion.
Slovenian: Zdravnike se spodbuja, da predpisujejo režim odmerjanja ene tablete dnevno, da se zmanjša tveganje preusmeritve uporabe.
English: 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.
Slovenian: Mioza zaradi opioidov, spremembe v stopnji zavesti ali spremembe v občutenju bolečine kot simptom bolezni lahko vplivajo na oceno bolnika ali otežijo diagnozo oziroma zakrijejo klinični potek sočasne bolezni.
English: Therefore the dose in mg can differ between products.
Slovenian: Zato se lahko odmerek v miligramih razlikuje med različnimi zdravili.
English: The product should be used with care in patients with pre-existing breathing problems
Slovenian: Zdravilo je treba uporabljati previdno pri bolnikih z obstoječimi težavami z dihanjem.
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
Slovenian: O smrtnih primerih so poročali tudi v povezavi s sočasnim dajanjem buprenorfina in drugih depresivov, kot je alkohol ali drugi opioidi.
English: 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).
Slovenian: Zdravniki morajo bolnike opozoriti, da je podjezični način uporabe edini učinkovit in varen način uporabe tega zdravila (glejte poglavje 4.4).
English: Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the μ-opioid receptors which, over a prolonged period, might minimise the need of addicted patients for drugs.
Slovenian: Delovanje buprenorfina v vzdrževalnem zdravljenju opioidne odvisnosti se pripisuje njegovim počasi reverzibilnim lastnostim na μ-opioidnih receptorjih, ki lahko v daljšem obdobju zmanjšajo potrebo odvisnih bolnikov po drogah.
English: Store in the original package below 25°C in order to protect from moisture.
Slovenian: Shranjujte v originalni ovojnini pri temperaturi do 25 °C za zagotovitev zaščite pred vlago.
English: • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, severe hives/nettle rash.
Slovenian: • otekanje obraza, ustnic, jezika ali grla, ki lahko povzročijo težave s požiranjem ali dihanjem in hude izpuščaje/koprivnico.
English: Buprenorphine was titrated to maintenance dose by Day 3; active control doses were titrated more gradually.
Slovenian: Buprenorfin so prilagodili do vzdrževalnega odmerka do 3. dne; odmerke aktivne kontrole so prilagodili bolj postopoma.
English: 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.)
Slovenian: sreda in petek, pri čemer mora biti odmerek zdravila v ponedeljek in sredo dvakrat večji od individualno prilagojenega dnevnega odmerka, odmerek v petek trikrat večji od individualno prilagojenega dnevnega odmerka, na vmesne dni pa bolnik ne sme prejeti nobenega odmerka).
English: Prior to treatment initiation, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence.
Slovenian: 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.
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in addictive disorders, ATC code: N07BC51.
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje, zdravila, za zdravljenje zasvojenosti z opioidi, oznaka ATC: N07BC51.
English: Use of an opioid antagonist (i.e., naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioid agents.
Slovenian: Uporaba opioidnih antagonistov (tj. naloksona) se priporoča kljub njihovemu skromnemu učinku, ki ga lahko imajo na nevtralizacijo z buprenorfinom izzvanih respiratornih simptomov v primerjavi z njihovimi učinki na polne opioidne agoniste.
English: Zubsolv can be a target for people who abuse prescription medicine.
Slovenian: Zdravilo Zubsolv je lahko tarča ljudi, ki zlorabljajo zdravila na recept.
English: Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Slovenian: Zdravljenje je namenjeno odraslim in mladostnikom, starejšim od 15 let, ki so privolili v zdravljenje svoje odvisnosti.
English: • Place the tablets under the tongue
Slovenian: • Tableto položite pod jezik.
English: 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 on the individual patient.
Slovenian: Po uvedbi zdravljenja na prvi dan je treba bolnika v naslednjih nekaj dneh stabilizirati na vzdrževalni odmerek s postopnim prilagajanjem odmerka glede na klinični učinek pri posameznem bolniku.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Therefore the potential to overdose with a full agonist exists, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining
Slovenian: Posledično obstaja možnost prevelikega odmerjanja polnih agonistov, zlasti če želimo premagati delne agonistične učinke buprenorfina ali kadar plazemske koncentracije buprenorfina upadajo
English: Withdrawal symptoms may also be associated with sub-optimal dosing.
Slovenian: Simptomi odtegnitve so lahko povezani tudi z nezadostnim odmerjanjem.
English: Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see section 2, Warnings and precautions).
Slovenian: Nepravilna uporaba tega zdravila z injiciranjem lahko povzroči odtegnitvene simptome, okužbe, druge kožne reakcije in potencialne resne težave z jetri (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
English: • Starting treatment of Zubsolv whilst dependent on heroin:
Slovenian: • Začetek zdravljenja z zdravilom Zubsolv med odvisnostjo od heroina:
English: These underlying factors must be taken into consideration before prescribing buprenorphine/naloxone and during treatment.
Slovenian: Te osnovne dejavnike je treba upoštevati pred predpisovanjem buprenorfina/naloksona in med zdravljenjem z njima.
English: No recommendation on posology can be made.
Slovenian: Priporočil o odmerjanju ni mogoče dati.
English: Zubsolv sublingual tablets have a higher bioavailability than conventional sublingual tablets.
Slovenian: Zdravilo Zubsolv podjezične tablete imajo večjo biološko uporabnost kot običajne podjezične tablete.
English: This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines that can harm your liver.
Slovenian: Te so lahko tudi posledica virusnih okužb (kronični hepatitis C), zlorabe alkohola, anoreksije ali jemanja drugih zdravil, ki lahko škodujejo jetrom.
English: After a period of successful treatment, you may agree with your doctor to reduce the dose gradually to a lower maintenance dose.
Slovenian: Po določenem času uspešnega zdravljenja se lahko s svojim zdravnikom dogovorite za postopno zmanjšanje odmerka na nižji vzdrževalni odmerek.
English: Your doctor will determine the best dose for you.
Slovenian: Zdravnik bo določil najprimernejši odmerek za vas.
English: These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin)
Slovenian: Ta zdravila vključujejo zdravila za zdravljenje epilepsije (kot sta karbamazepin in fenitoin) in zdravila za zdravljenje tuberkuloze (rifampicin).
English: Towards the end of pregnancy buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration.
Slovenian: Proti koncu nosečnosti lahko buprenorfin povzroči respiratorno depresijo pri novorojenčku celo po kratkem času dajanja.
English: Renal elimination may be prolonged since 30 % of the administered dose is eliminated by the renal route.
Slovenian: Izločanje skozi ledvice se lahko podaljša, ker se 30 % danega odmerka izloči prek ledvic.
English: How to remove the tablet from the blister
Slovenian: Kako vzeti tableto iz pretisnega omota
English: The primary study comparison was to assess the efficacy of buprenorphine and buprenorphine/naloxone individually against placebo.
Slovenian: Primarni cilj primerjave v študiji je bil oceniti učinkovitost buprenorfina in buprenorfina/naloksona individualno glede na placebo.
English: • accidental injury caused by loss of alertness or co-ordination
Slovenian: • nezgodne poškodbe zaradi motenj zbranosti ali koordinacije.
English: If you take more Zubsolv than you should
Slovenian: Če ste vzeli večji odmerek zdravila Zubsolv, kot bi smeli
English: • Breathing problems (see also ‘Do not take Zubsolv' above ) 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.
Slovenian: • Težave z dihanjem (glejte tudi zgornje poglavje »Ne jemljite zdravila Zubsolv«) Nekateri ljudje so umrli zaradi dihalne odpovedi (nezmožnost dihanja), ker so zlorabili to zdravilo ali so ga vzeli v kombinaciji z drugimi depresivi centralnega živčnega sistema, kot so alkohol, benzodiazepini (pomirjevala) ali drugi opioidi.
English: If you feel that the effect of Zubsolv is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če imate občutek, da je zdravilo Zubsolv premočno ali prešibko, se posvetujte z zdravnikom ali farmacevtom.
English: • naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine.
Slovenian: • naltrekson in nalmefen sta opioidna antagonista, ki lahko blokirata farmakološke učinke buprenorfina.
English: • sudden withdrawal syndrome caused by taking product too soon after use of illicit opioids, drug withdrawal syndrome in newborn
Slovenian: • nenaden pojav odtegnitvenega sindroma, ki ga povzroči jemanje zdravila prekmalu po uporabi nedovoljenih opioidov, sindrom odtegnitve pri novorojenčkih,
English: When taken during pregnancy, particularly late pregnancy, medicines like Zubsolv may cause drug withdrawal symptoms including problems with breathing in your newborn baby.
Slovenian: Pri jemanju v nosečnosti, zlasti v pozni nosečnosti, lahko zdravila, kot je zdravilo Zubsolv, povzročijo odtegnitvene simptome, vključno s težavami z dihanjem pri novorojenčkih.
English: The combination of buprenorphine and naloxone has been investigated in acute and repeated dose (up to 90 days in rats) toxicity studies in animals.
Slovenian: Kombinacija buprenorfina in naloksona je bila raziskana v študijah toksičnosti pri živalih ob uporabi akutnega odmerka in ponavljajočih odmerkov (do 90 dni pri podganah).
English: The 0.7mg / 0.18mg strength is intended to be used to fine tune the dose for patients especially during tapering of treatment or in case of tolerability issues during titration.
Slovenian: Jakost 0,7 mg/0,18 mg se uporablja za natančno prilagajanje odmerka pri bolnikih, zlasti med zmanjševanjem odmerka ali v primeru težav s toleranco med prilagajanjem odmerka.
English: The diagnosis of opioid-related toxicity should be reconsidered if there is still failure to respond after a total of 10 mg of naloxone has been administered.
Slovenian: O diagnozi z opioidi povezane toksičnosti je treba znova razmisliti, če pri bolniku po odmerjanju naloksona v skupnem odmerku 10 mg še naprej ni opaziti nobenega odziva.
English: 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.
Slovenian: To zdravilo lahko povzroči nenaden padec krvnega tlaka, kar povzroči občutek omotice, če se prehitro dvignete iz sedečega ali ležečega položaja.
English: 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.
Slovenian: Medicinska odtegnitev Ko pri bolniku dosežete zadovoljivo stabilizacijo, lahko, če se bolnik strinja, odmerek postopoma zmanjšate na manjši vzdrževalni odmerek; v nekaterih ugodnih primerih lahko zdravljenje prekinete.