FrancophonIA/ELRC3.0 huggingface dataset:
English: Of these 309 patients, 107 patients were treated for an additional 6 months in extension studies (i.e. for 2 implant cycles).
Slovenian: Od teh 309 bolnikov so 107 bolnikov zdravili še dodatnih 6 mesecev v okviru nadaljevalnih študij (tj. s cikla implantatov).
English: Despite the use of an open-label comparator arm, this endpoint is considered robust, as it is based on urine toxicology.
Slovenian: Kljub uporabi odprtega primerjalnega kraka ta opazovani dogodek velja za robustnega, saj temelji na toksikoloških ocena urina.
English: You may fell dizzy, drowsy and less alert.
Slovenian: Lahko boste omotični, zaspani in manj pozorni.
English: • reduced consciousness
Slovenian: • zmanjšana zavest,
English: Side effects can occur with the following frequencies: Common, may affect up to 1 in 10 people
Slovenian: Neželeni učinki se lahko pojavijo z naslednjo pogostnostjo: Pogosti, pojavijo se lahko pri največ 1 od 10 bolnikov
English: Prescription opioids * For 1 patient (0.8%) primary opioid of abuse was “other”.
Slovenian: Opioidi na recept * Za 1 bolnika (0,8 %) je bil primarni zlorabljani opioid naveden kot „drugi“.
English: • head injury or other circumstances where the pressure in the head may be increased
Slovenian: • poškodbo glave ali druge okoliščine, kjer lahko pride do povišanega tlaka v glavi,
English: Key instruction for proper insertion
Slovenian: Glavna navodila za pravilno vstavitev
English: Number (%) of patients with broken implant(s) N=number of patients with data available.
Slovenian: Število (%) bolnikov z zlomljenim/zlomljenimi implantatom/implantati n = število bolnikov, pri katerih so bili podatki na voljo.
English: The implants should only be removed by a doctor who is familiar with the procedure.
Slovenian: Implantate sme odstraniti le zdravnik, ki je seznanjen s postopkom.
English: Instead, patients who feel the need for supplemental dosing should be seen and evaluated promptly.
Slovenian: Namesto tega je treba bolnike, ki se jim zdi, da potrebujejo dodatne odmerke, pregledati in ustrezno oceniti.
English: • are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na buprenorfin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: • Alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine.
Slovenian: • alkoholnimi pijačami ali zdravili, ki vsebujejo alkohol, saj alkohol poveča sedacijski učinek buprenorfina.
English: In the worst case, it can result in breathing stopping, heart failure and death.
Slovenian: V najslabšem primeru se dihanje lahko ustavi, lahko pride do odpovedi srca in smrti.
English: The basis for successful use and subsequent removal of Sixmo is a correct and carefully performed subcutaneous insertion of the implants in accordance with the instructions.
Slovenian: Osnova za uspešno uporabo in zatem odstraniev zdravila Sixmo je pravilna in skrbno izvedena subkutana vstavitev implantatov v skladu z navodili.
English: If you cannot feel each of the four implants, or doubt their presence, use other methods to confirm the presence of the implant.
Slovenian: Če ne zatipate vsakega od štirih implantatov ali dvomite o njihovi prisotnosti, uporabite kakšno drugo metodo za preverjanje prisotnosti implantata.
English: Inform your doctor immediately if you think you have an infection at the implant site or if the implant starts to come out.
Slovenian: Zdravnika takoj obvestite, če menite, da imate okužbo na mestu implantata ali če implantat začne izstopati.
English: PROCEDURAL INFORMATION Insertion date:
Slovenian: PODATKI O POSTOPKU Datum vstavitve:
English: Avoid grapefruit juice to prevent possible side effects.
Slovenian: Ne pijte soka grenivke, da preprečite morebitne neželene učinke.
English: No published information is available regarding a potential effect of buprenorphine on male and female fertility.
Slovenian: Na voljo ni novenih objavljenih informacij v zvezi z morebitnimi učinki buprenorfina na plodnost pri moških in ženskah.
English: This risk increases when additionally using alcohol or other substances.
Slovenian: To tveganje se še poveča ob sočasni uporabi alkohola ali drugih snovi.
English: Inform your doctor immediately if the above symptoms occur, or go to the nearest hospital and bring this leaflet and your Patient Alert Card with you.
Slovenian: Če se pojavijo ti simptomi, o tem takoj obvestite zdravnika ali pojdite v najbližjo bolnišnico in ta navodila ter opozorilno kartico za bolnika prinesite s seboj.
English: The doctor will monitor you until the implant is replaced to evaluate for withdrawal symptoms.
Slovenian: Zdravnik vas bo spremljal, dokler implantat ne bo zamenjan, da bo ocenjeval simptome odtegnitve.
English: 1 single use applicator
Slovenian: 1 aplikator za enkratno uporabo
English: The implant applicator (disposable) and its parts are shown in Figure 1.
Slovenian: Aplikator za implantate (za enkratno uporabo) in njegovi deli so prikazani na sliki 1.
English: Implants inserted more deeply than subcutaneous (deep insertion) may not be palpable and the localisation and/or removal may be difficult.
Slovenian: Implantatov, ki so vstavljeni globlje kot subkutano (globoka vstavitev) morda ne bo mogoče zatipati in bosta lokalizacija in/ali odstranitev otežena.
English: The removed implant contains a significant amount of residual buprenorphine.
Slovenian: Odstranjeni implantat vsebuje znatno količino preostalega buprenorfina.
English: These underlying factors including confirmation of viral hepatitis status must be taken into consideration before prescribing Sixmo and during treatment.
Slovenian: Te osnovne dejavnike, vključno s potrditvijo stanja virusnega hepatitisa, je treba upoštevati pred predpisovanjem zdravila Sixmo in med zdravljenjem.
English: The same technique is employed for the removal of protruding or partially expelled implants.
Slovenian: Enaka tehnika se uporablja za odstranjevanje ven štrlečih ali delno iztisnjenih implantatov.
English: When pregnant rats were exposed to buprenorphine through osmotic minipumps from gestation day 7 onwards, maternal food and water consumption was reduced on gestation days 7 to 20.
Slovenian: Ko so bile breje podgane preko osmotskih mini črpalk izpostavljene buprenorfinu od 7. dneva brejosti naprej, je bila pri samicah od 7. do 20. dneva brejosti poraba hrane in vode manjša.
English: Physicians should also be informed about risks and complications of this procedure (i.e. implant migration, protrusion, expulsion, and nerve damage).
Slovenian: Zdravnike je treba obvestiti tudi o tveganjih in zapletih tega postopka (tj. migracija, protruzija, ekspulzija implantata in poškodovanje živcev).
English: Step 14: Put on sterile gloves.
Slovenian: 14. korak: Nadenite si sterilne rokavice.
English: • the patient experiences severe or intolerable side effects (including severe precipitated withdrawal);
Slovenian: • če se pri bolniku pojavijo hudi ali nevzdržni neželeni učinki (vključno s hudimi odtegnitvenimi simptomi);
English: Higher doses may be required for analgesic effect.
Slovenian: Za učinek analgezije bodo morda potrebni večji odmerki.
English: If you feel the need for additional buprenorphine doses, contact your doctor straight away.
Slovenian: Če menite, da potrebujete dodatne odmerke buprenorfina, se takoj posvetujte z zdravnikom.
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 in klinične izkušnje so pokazale, da buprenorfin lahko povzroča odvisnost, vendar v manjši meri kot popolni agonist, npr. morfin.
English: This risk is increased with the concomitant abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.
Slovenian: To tveganje se poveča s sočasno zlorabo buprenorfina in alkohola ter drugih snovi, zlasti benzodiazepinov.
English: In 3 patients treated in clinical studies, and in 1 patient treated during post-marketing, implants or fragments could not be located and were, therefore, not removed at the end of the treatment.
Slovenian: Pri 3 bolnikih v kliničnih študijah in pri 1 bolniku po začetku trženja zdravila ni bilo mogoče najti implantatov ali njegovih delcev in zato ob koncu zdravljenja niso bili odstranjeni.
English: • consistency in participation in recommended behavioural therapy/peer support programme
Slovenian: • stalno sodelovanje v priporočeni vedenjski terapiji/programih medsebojne podpore,
English: They are removed by the end of the sixth month.
Slovenian: Na koncu obdobja 6 mesecev se odstranijo.
English: Buprenorphine can influence the ability to drive and use machines and may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Buprenorfin lahko vpliva na sposobnost vožnje in upravljanja strojev ter lahko poslabša mentalne ali fizične sposobnosti, ki so potrebne za opravljanje potencialno nevarnih nalog, kot je vožnja avtomobila ali upravljanje strojev.
English: If localisation and a second removal attempt are not performed on the same day as the initial removal attempt, the wound should be closed with sutures in the interim.
Slovenian: Če lokalizacije in drugega poskusa odstranitve ne opravite isti dan kot prvi poskus odstranitve, je treba rano začasno zapreti s šivi.
English: Hepatitis and hepatic events
Slovenian: Hepatitis in jetrni dogodki
English: NAME OF THE MARKETING AUTHORISATION HOLDER L. Molteni & C. dei F.lli Alitti
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM L. Molteni & C. dei F.lli Alitti
English: Particularly, this occurs when additionally using alcohol, other opioids or certain medicines which calm, induce sleep or relax muscles.
Slovenian: To se zgodi predvsem pri sočasni uporabi alkohola, drugih opioidov ali določenih zdravil za pomiritev, uspaval ali zdravil, ki sproščajo mišice.
English: Maternal exposure to buprenorphine increased perinatal mortality and caused a delay in some development milestones in neonatal rats.
Slovenian: Izpostavljenost mater buprenorfinu je povečala perinatalno umrljivost in povzročila zakasnitve pri nekaterih razvojnih mejnikih novoskotenih podgan.
English: The recommended visit schedule for most patients is a frequency of no less than once-monthly for continued counselling and psychosocial support.
Slovenian: Priporočeni urnik kontrolnih pregledov je pri večini bolnikov vsak enkrat mesečno, da imajo stalno na voljo svetovanje in psihosocialno podporo.
English: • breathing difficulties, breathing slowly
Slovenian: • težave z dihanjem, počasno dihanje.
English: • The replacement implant(s) should be inserted in same arm either medially or laterally to in situ implants.
Slovenian: • Nadomestni(-e) implantat(-e) je treba vstaviti v isto roko medialno ali lateralno glede na implantate in situ.
English: Its activity in opioid maintenance treatment is attributed to its slowly reversible properties at the µ receptors which, over a prolonged period, minimises the need for use of other opioids.
Slovenian: Njegova aktivnost pri opioidnem vzdrževalnem zdravljenju se pripisuje njegovim počasi reverzibilnim lastnostim na μ-opioidnih receptorjih, ki lahko prek daljšega obdobja zmanjša potrebo po drugih opioidih.
English: • Substances like buprenorphine may cause pinpoint pupils, change consciousness or the way you feel pain.
Slovenian: • Snovi, kot je buprenorfin, lahko povzročijo zoženje zenic, spremembo zavesti ali načina, kako občutite bolečino.
English: In rare cases, implants or partial implants could not be localized and were, therefore, not removed (see section 4.2).
Slovenian: V redkih primerih implantatov ali delov implantatov ni mogoče lokalizirati in posledično tudi ne odstraniti (glejte poglavje 4.2).
English: • increased level of a liver enzyme, alanine aminotransferase, in blood tests
Slovenian: • povišane vrednosti jetrnih encimov, alanin-aminotransferaze, pri krvnih pregledih,
English: It consists of four implants individually packaged into laminated foil sachets and one individually packaged sterile disposable applicator.
Slovenian: Vsebuje štiri implantate, ki so posamično pakirani v laminiranih vrečicah iz folije, in en posamično pakiran sterilen aplikator za enkratno uporabo.
English: Treat these patients with a non-opioid analgesic whenever possible.
Slovenian: Kadar je mogoče, te bolnike zdravite z neopioidnimi analgetiki.
English: • The active substance is buprenorphine.
Slovenian: • Učinkovina je buprenorfin.
English: If liver problems are suspected your doctor will carry out tests to decide if treatment should be stopped.
Slovenian: Če sumite na težave z jetri, bo zdravnik opravil teste, da bo odločil, ali je treba zdravljenje prekiniti.
English: Almost all of the dose was accounted for in terms of buprenorphine, norbuprenorphine, and two unidentified buprenorphine metabolites.
Slovenian: Skoraj ves odmerek je bil zajet v obliki buprenorfina, norbuprenorfina in dveh neprepoznanih presnovkov buprenorfina.
English: If infected, it should be treated appropriately and be determined if remaining implants need to be removed.
Slovenian: Če je mesto okuženo, ga je treba ustrezno zdraviti in oceniti, ali je treba odstraniti preostale implantate.
English: The CDF results for co-primary endpoint 2 were fundamentally the same as for endpoint 1 (p < 0.0001).
Slovenian: Rezultati CDF za primarni sočasno opazovani dogodek 2 so bili v osnovi enaki kot za opazovani dogodek 1 (p < 0,0001).
English: • asthma or other breathing problems
Slovenian: • astmo ali druge težave z dihanjem,
English: In particular, patients may experience somnolence for up to one week after subcutaneous insertion; therefore, they should be cautioned about driving or operating hazardous machinery especially during this time period.
Slovenian: Bolniki lahko do en teden po subkutani vstavitvi občutijo zaspanost, zato jih je treba opozoriti o nevarnostih vožnje ali upravljanja strojev zlasti v tem obdobju.
English: • The safety concerns associated with SIXMO therapy (i.e. potential life-threatening interactions with other, concomitant therapies)
Slovenian: • zadržke glede varnosti zdravljenja z zdravilom Sixmo (tj. morebitne življenje ogrožujoče interakcije z drugimi sočasnimi zdravili).
English: Implants for repeat treatment should be inserted subcutaneously as soon as possible after removal of the previous implants, preferably on the same day.
Slovenian: Implantate za ponovljeno zdravljenje je treba vstaviti subkutano čim prej po odstranitvi prejšnjih implantatov, po možnosti še isti dan.
English: • cold sweat, dry skin
Slovenian: • mrzel pot, suha koža,
English: Step 11: Apply pressure to the incision site for approximately five minutes if necessary.
Slovenian: 11. korak: Približno pet minut pritiskajte na mesto reza, če je to potrebno.
English: NOTE: Be sure to inject the local anaesthetic deep to the centre of the implants; this will effectively lift the implants toward the skin, facilitating removal of the implants.
Slovenian: OPOMBA: Lokalni anestetik je treba injicirati globoko v sredino implantatov; na ta način se bodo implantati učinkovito dvignili proti koži, kar olajša njihovo odstranjevanje.
English: Stop immediately once the proximal marking on the cannula has disappeared into the incision (Figures 7 and 8).
Slovenian: Takoj se ustavite, ko proksimalna oznaka na kanili izgine v rez (sliki 7 in 8).
English: • Substances like buprenorphine may cause a sudden drop in blood pressure, causing dizziness when getting up quickly.
Slovenian: • Snovi, kot je buprenorfin, lahko povzročijo nenaden padec krvnega tlaka, ki povzroči omotico, če hitro vstanete.
English: Your doctor will also give you a Patient Alert Card that provides the
Slovenian: Zdravnik vam bo izročil tudi opozorilno kartico za bolnika, na kateri so navedeni
English: • infection or any problems with wound healing
Slovenian: • okužba ali druge težave s celjenjem rane,
English: The insertion site should be examined one week following implant insertion and regularly thereafter for signs of infection or any problems with wound healing, including evidence of implant extrusion from the skin as well as misuse or abuse.
Slovenian: Mesto vstavitve je treba pregledati en teden po vstavitvi implantata in redno tudi kasneje, kjer je treba biti pozoren na znake okužbe ali kakršnih koli težav s celjenjem rane, vključno z znaki za ekstruzijo implantata iz kože ter znake nepravilne uporabe oziroma zlorabe.
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: Implant site related adverse reactions with the current (and commercially used) insertion and removal techniques were reported in 25.9% and 14.1% of patients in the double-blind and extension studies, respectively.
Slovenian: O neželenih učinkih na mestu implantata po trenutni (in komercialno uporabljeni) tehniki vstavitve in odstranjevanja so poročali pri 25,9 % bolnikov v dvojno slepih in 14,1 % bolnikov v nadaljevalnih študijah.
English: The insertion and removal of Sixmo should take place in a setting that allows for insertion under aseptic conditions, where the patient is able to lie on their back.
Slovenian: Vstavljanje in odstranjevanje zdravila Sixmo mora potekati v okolju, ki omogoča vstavljanje v aseptičnih pogojih in kjer bolnik lahko leži na hrbtu.
English: • If the patient returns the expelled implant, it should be measured to ensure that the entire implant was expelled (26.5 mm in length).
Slovenian: • Če bolnik iztisnjeni implantat vrne, je treba implantat izmeriti za potrditev, da se je izločil celoten implantat (dolžine 26,5 mm).
English: The safety of Sixmo was evaluated in five Phase 3 studies (3 double-blind and placebo and/or activecontrolled studies, and two open-label extension studies).
Slovenian: Varnost zdravila Sixmo je bila ocenjena v petih študijah 3. faze (3 dvojno slepe, s placebom in/ali aktivno kontrolo nadzorovane študije, ter 2 odprti nadaljevalni študiji).
English: • Misuse and abuse: If buprenorphine is abused it can lead to overdose and death.
Slovenian: • Nepravilna uporaba oziroma zloraba: Če buprenorfin zlorabljate, lahko pride do prevelikega odmerjanja in smrti.
English: The remaining partial implant should be removed using the techniques described in section 4.2 under “Instructions for removal of Sixmo”.
Slovenian: Preostali delni implantat je treba odstraniti s tehnikami, ki so opisane v poglavju 4.2 pod naslovom „Navodila za odstranjevanje implantatov Sixmo“.
English: Do not drive or perform dangerous activities until you are certain Sixmo does not reduce your ability in such activities.
Slovenian: Ne vozite in ne opravljajte nevarnih opravil, dokler niste prepričani, da zdravilo Sixmo ne zmanjšuje vaše sposobnosti za opravljanje teh aktivnosti.
English: This may be related to existing reduced liver function and ongoing injecting drug use.
Slovenian: To je lahko povezano z obstoječim delovanjem jeter in sočasno uporabo drog, ki se injicirajo.
English: • lack of a white blood cell type called neutrophils
Slovenian: • pomanjkanje belih krvničk, ki jih imenujemo nevtrofilci,
English: In the post-marketing setting, 2 cases were reported where Sixmo implants had locally migrated from the insertion site.
Slovenian: V obdobju po začetku trženja so poročali o 2 primerih, kjer so se implantati Sixmo lokalno premaknili z mesta vstavitve.
English: In the majority of patients, heroin was the primary opioid of use.
Slovenian: Pri večini bolnikov je bil primarni uporabljeni opioid heroin.
English: Abuse of buprenorphine poses a risk of overdose and death.
Slovenian: Zloraba buprenorfina predstavlja tveganje prevelikega odmerjanja in smrti.
English: You must be on a stable buprenorphine dose of between 2 to 8 mg per day, given under the tongue.
Slovenian: Morate prejemati stabilen odmerek buprenorfina 2 do 8 mg na dan, ki se daje pod jezik.
English: Step 18: Disposal of Sixmo implants should be in accordance with local requirements as it contains buprenorphine.
Slovenian: 18. korak: Implantate Sixmo je treba zavreči v skladu z lokalnimi zahtevami, saj implantat vsebuje buprenorfin.
English: Patients who have contraindications for MRI.
Slovenian: Bolniki s kontraindikacijami za MRI
English: Do not blot or wipe away.
Slovenian: Ne pivnajte ali obrišite.
English: Suitable methods for location include ultrasound with a high frequency linear array transducer (10 MHz or greater) or, in case ultrasound is not successful, magnetic resonance imaging (MRI).
Slovenian: Med ustrezne metode za iskanje položaja spadajo ultrazvok z visokofrekvenčnim pretvornikom z linearnim nizom (10 MHz ali več) ali, če ultrazvok ni uspešen, magnetnoresonančno slikanje (MRI).
English: The closer the implants lie to each other at the time of insertion, the more easily they can be removed.
Slovenian: Manjši ko je razmik med implantati po vstavitvi, lažje jih bo odstraniti.
English: The reduced level of alertness can make driving and using machines hazardous (see section 4.7).
Slovenian: Zaradi zmanjšane pozornosti lahko vožnja in upravljanje s stroji postaneta nevarna (glejte poglavje 4.7).
English: What Sixmo is and what it is used for What you need to know before you use Sixmo How to use Sixmo
Slovenian: Kaj je zdravilo Sixmo in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Sixmo Kako uporabljati zdravilo Sixmo
English: Sixmo implants are not radiopaque and cannot be seen by X-ray or CT scan.
Slovenian: Implantati Sixmo so prepustni za rentgenske žarke in jih pri rentgenskem ali CT-slikanju ni mogoče videti.
English: It must be handled with adequate security and accountability for proper disposal in accordance with local requirements.
Slovenian: Z njimi je treba ravnati na ustrezno varen in odgovoren način ter jih pravilno zavreči v skladu z lokalnimi predpisi.
English: Before engaging driving or operating hazardous machinery patients should be reasonably certain that Sixmo does not adversely affect their ability to engage in such activities.
Slovenian: Preden se lotijo vožnje ali upravljanja strojev, morajo biti bolniki razumno prepričani, da zdravilo Sixmo ne vpliva negativno na njihovo sposobnost opravljanja takih aktivnosti.
English: Patients not adequately treated with the 4 implant dose could receive a fifth implant.
Slovenian: Bolniki, ki niso bili ustrezno zdravljeni z odmerkom 4 implantatov, so lahko prejeli peti implantat.
English: The effect of hepatic impairment on the pharmacokinetics of Sixmo has not been studied.
Slovenian: Učinka okvare jeter na farmakokinetiko zdravila Sixmo niso preučevali.
English: Step 10: Verify the presence of each implant (26.5 mm in length) by palpation of the patient's arm immediately after the insertion, as shown in Figure 14.
Slovenian: 10. korak: Potrdite prisotnost vsakega implantata (dolžine 26,5 mm) tako, da potipate bolnikovo roko tik za rezom, kot prikazuje slika 14.
English: • Your doctor should examine the insertion site for infections and wound problems: one week after implant insertion and at least once a month thereafter
Slovenian: • Zdravnik mora pregledati mesto vstavitve glede okužb in težav z rano: en teden po vstavitvi implantata in zatem vsaj enkrat na mesec.
English: There was a greater occurrence of resorptions and an increase in the number of stillbirths.
Slovenian: Pojavnost resorpcije je bila večja, prav tako je bilo večje število mrtvoskotenih mladičev.
English: Literature data indicated no genotoxic properties of buprenorphine.
Slovenian: Podatki iz literature ne navajajo genotoksičnih lastnosti buprenorfina.
English: • 100×100 mm sterile gauze
Slovenian: • sterilna gaza 100 × 100 mm,
English: • excessive sleepiness
Slovenian: • prekomerna zaspanost,
English: • slow heartbeat, abnormal heart rhythm that starts in the atrial chambers of the heart
Slovenian: • počasen srčni utrip, nenormalen srčni ritem, ki se začne v srčnih preddvorih (atrijih),
English: PHARMACEUTICAL FORM AND CONTENTS 1 implant
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 1 implantat