FrancophonIA/ELRC3.0 huggingface dataset:
English: Excessive touching of the implants or insertion site shortly after insertion may increase the chance of infection.
Croatian: Pretjerano dodirivanje implantata ili mjesta ugradnje neposredno nakon ugradnje može povećati šansu za infekciju.
English: Step 18: Disposal of Sixmo implants should be in accordance with local requirements as it contains buprenorphine.
Croatian: Korak 18: Implantati Sixmo moraju se zbrinuti u skladu s nacionalnim propisima jer sadrže buprenorfin.
English: Clean the removal site with an antiseptic solution, such as chlorhexidine.
Croatian: Očistite mjesto ugradnje antiseptičkom otopinom, kao što je klorheksidin.
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 (see section 4.4).
Croatian: Stoga postoji mogućnost predoziranja potpunim agonistima, osobito kada se pokušava nadjačati učinke parcijalnog agonista buprenorfina ili kad razine buprenorfina u plazmi opadaju (vidjeti dio 4.4).
English: • phenobarbital, carbamazepine, phenytoin: medicines to treat epilepsy and other illnesses
Croatian: • fenobarbital, karbamazepin, fenitoin: lijekovi za liječenje epilepsije i drugih bolesti
English: Study PRO-806 included an open-label comparator arm with sublingual buprenorphine (12 to 16 mg/day).
Croatian: Ispitivanje PRO-806 uključilo je skupinu koja je na otvoren način primala sublingvalni buprenorfin kao komparator (12-16 mg na dan).
English: After determining that anaesthesia is adequate and effective, make a shallow incision 2.5 to 3 mm in length at incision site marking.
Croatian: Nakon što utvrdite da je nastupila odgovarajuća i učinkovita anestezija, napravite plitku inciziju duljine 2,5-3 mm na mjestu označenom kao mjesto incizije.
English: • fatigue, chills, weakness, increased muscle tone
Croatian: • umor, zimice, slabost, povećan tonus mišića
English: If you stop Sixmo treatment your doctor will monitor you for withdrawal symptoms.
Croatian: Ako se prestanete liječiti implantatima Sixmo, liječnik će Vas pratiti zbog mogućih simptoma ustezanja.
English: Bring it to the inserting doctor to determine whether the full implant has been expelled.
Croatian: Donesite je liječniku koji je ugradio implantate kako bi mogao utvrditi je li izbačen cijeli implantat.
English: Sixmo is contraindicated in patients with severe hepatic impairment.
Croatian: Sixmo je kontraindiciran u bolesnika s teškim oštećenjem jetrene funkcije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (kit)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija (set)
English: Patients who may not be investigated using a magnetic resonance imaging (MRI) scan must not be allowed to receive Sixmo.
Croatian: Bolesnici koje se ne može pregledati magnetskom rezonancijom (MR) ne smiju primiti Sixmo.
English: Clean the incision site.
Croatian: Obrišite mjesto incizije.
English: In the case of non-palpable implants, removal should be performed under ultrasound guidance (following their localisation).
Croatian: U slučaju da se implantati ne mogu napipati, njihovo uklanjanje treba provesti pod kontrolom ultrazvuka (nakon što se utvrdi gdje se nalaze).
English: Step 15: Pick up the skin edge with Adson single toothed tissue forceps and separate the tissues above and below the visible implant, using an iris scissors or a curved mosquito forceps (Figure 16).
Croatian: Korak 15: Odignite rub kože pomoću kirurške pincete po Adsonu i odvojite tkivo iznad od tkiva ispod vidljivih implantata pomoću iris škarica ili zakrivljene hvataljke po Mosquitu (slika 16).
English: • surgical marker
Croatian: • kirurški marker
English: The clinical experience with Sixmo in non-Caucasian patients is currently limited.
Croatian: Nebjelačka populacija Kliničko iskustvo s implantatima Sixmo u nebjelačkih bolesnika trenutno je ograničeno.
English: • restlessness, excitement, excitability, abnormal thoughts
Croatian: • nemir, uzbuđenje, razdražljivost, abnormalne misli
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.
Croatian: Nuspojave povezane s mjestom ugradnje implantata suvremenim (i komercijalno korištenim) tehnikama ugradnje i uklanjanja zabilježene su u 25,9% bolesnika u dvostruko slijepim ispitivanjima i
English: • Opioid antagonists: naltrexone and nalmefene can block the pharmacological effects of buprenorphine.
Croatian: • Opioidni antagonisti: naltrekson i nalmefen mogu blokirati farmakološke učinke buprenorfina.
English: If the implant is encapsulated, or you see dimpling, use the scalpel to shave the adhering tissue to release the implant.
Croatian: Ako je inkapsuliran ili opazite malo uleknuće, upotrijebite skalpel da biste odvojili tkivo koje prianja uz implantat kako biste ga oslobodili.
English: • A number of cases of death due to breathing depression have been reported while on buprenorphine.
Croatian: • Zabilježen je određeni broj smrtnih slučajeva zbog depresije disanja u osoba koje su bile na buprenorfinu.
English: There is no suspicion of carcinogenicity based on the clinical use of buprenorphine.
Croatian: Ne sumnja se na kancerogenost buprenorfina na temelju njegove kliničke primjene.
English: If the implants cannot be located, the doctor may use ultrasound or a type of scan called magnetic resonance imaging (MRI).
Croatian: Ako se ne može utvrditi mjesto na kojem se nalaze implantati, liječnik se može poslužiti ultrazvukom ili vrstom slikovnog pregleda pod nazivom magnetska rezonancija (MR).
English: • infection or any problems with wound healing
Croatian: • znakova infekcije ili nekih problema s cijeljenjem rane
English: Prior to the launch of SIXMO in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Croatian: Prije stavljanja lijeka SIXMO u promet u pojedinoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora s nadležnim nacionalnim tijelom dogovoriti sadržaj i oblik edukacijskih materijala, uključujući načine priopćavanja, oblike distribucije i sve druge vidove programa.
English: • aprepitant: a medicine to prevent nausea and vomiting
Croatian: • aprepitant: lijek za sprječavanje mučnine i povraćanja
English: The partial opioid agonist properties of buprenorphine may precipitate opioid withdrawal signs and symptoms in persons who are currently physically dependent on full opioid agonists - such as heroin, morphine, or methadone - before the effects of the full opioid agonist have subsided.
Croatian: Svojstvo buprenorfina da djeluje kao parcijalni opioidni agonist može dovesti do pojave znakova i simptoma ustezanja od opioida u osoba koje su trenutno fizički ovisne o potpunim opioidnim agonistima, kao što su heorin, morfin ili metadon, prije nego što učinci potpunog opioidnog agonista oslabe.
English: Do not force the implant beyond the end of the cannula with the obturator.
Croatian: Nemojte pomoću opturatora na silu potiskivati implantat iza kraja kanile.
English: • That the card-holder is using SIXMO (buprenorphine only opioid-dependence treatment via SC implant located at the inner side of the upper arm)
Croatian: • da vlasnik kartice koristi SIXMO (liječenje ovisnosti o opioidima supkutanim implantatom koji sadrži samo buprenorfin i smješten je na unutarnjoj strani nadlaktice)
English: Sixmo should be used with caution in patients with asthma or other breathing problems.
Croatian: Sixmo treba primjenjivati s oprezom u bolesnika s astmom ili drugim problemima s disanjem.
English: All patients receiving Sixmo should be monitored for conditions indicative of diversion, or progression of opioid dependence and addictive behaviours suggesting the need for more intensive and structured treatment for substance use.
Croatian: Sve bolesnike kojima se ugradi Sixmo potrebno je pratiti zbog stanja koja ukazuju na nedopuštenu uporabu ili progresiju ovisnosti o opioidima i ovisničko ponašanje koje ukazuje na potrebu za intenzivnijim i strukturiranijim liječenjem ovisnosti.
English: Using aseptic technique, place the sterile equipment on the sterile field of the instrument stand.
Croatian: Primjenom aseptične tehnike, položite sterilne instrumente na sterilnu površinu kolica za instrumente.
English: The opioid antagonist naloxone is a specific antidote to respiratory depression resulting from opioid overdose.
Croatian: Antagonist opioida nalokson specifičan je antidot kod respiratorne depresije koja je posljedica predoziranja opioidima.
English: • cellulitis, skin infection, boil
Croatian: • celulitis, infekcija kože, gnojni čir
English: Anaesthetise the insertion area at the incision site and just under the skin, along the planned insertion channels, by injecting 5 mL lidocaine 1% with adrenaline 1:100,000.
Croatian: Anestezirajte područje ugradnje na mjestu incizije i neposredno ispod kože, duž planiranih kanalića ugradnje, ubrizgavanjem 5 ml 1%tnog lidokaina s adrenalinom 1:100 000.
English: • Infection may occur at the site of the insertion or removal of the implant.
Croatian: • Infekcija se može razviti na mjestu ugradnje ili uklanjanja implantata.
English: • other stomach and bowel disorders, tooth disorder
Croatian: • drugi želučani i crijevni poremećaji, poremećaj zubiju
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
Croatian: Smrtni su slučajevi zabilježeni i uz istodobnu primjenu buprenorfina i drugih depresora poput alkohola i drugih opioida.
English: • Patients who have contraindications for MRI should be not allowed to receive the implant.
Croatian: • Bolesnicima koji imaju kontraindikacije za MR ne smije se dopustiti da prime implantat.
English: Therefore, use these medicines during Sixmo treatment only on doctor's advice and at the prescribed dosage.
Croatian: Sixmo samo prema savjetu liječnika i u propisanoj dozi.
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.
Croatian: Sixmo temelji se na ispravnoj i pažljivo provedenoj supkutanoj ugradnji implantata u skladu s uputama.
English: PHARMACEUTICAL FORM AND CONTENTS 1 implant
Croatian: OBLIK I SADRŽAJ 1 implantat
English: Your doctor will examine the insertion site one week following implant insertion and at a minimum once-monthly thereafter for signs of:
Croatian: Liječnik će pregledati mjesto ugradnje tjedan dana nakon ugradnje implantata, a nakon toga najmanje jedanput mjesečno zbog moguće pojave:
English: Criteria for the use of supplemental sublingual buprenorphine It is possible that a subset of patients may require occasional supplemental sublingual buprenorphine support to achieve full control of opioid withdrawal symptoms and cravings, e.g. at times of personal stress or crisis.
Croatian: Kriteriji za primjenu dodatnih doza sublingvalnog buprenorfina Postoji mogućnost da će u jednog dijela bolesnika povremeno trebati primijeniti dodatnu dozu sublingvalnog buprenorfina da bi se postigla potpuna kontrola simptoma ustezanja i žudnje za opioidima, npr. u razdobljima stresa ili osobnih kriza.
English: If implants are placed too deeply (intramuscular or in the fascia) this may lead to neural or vascular injury upon insertion or removal.
Croatian: Preduboko postavljanje implantata (intramuskularno ili u fasciju) može dovesti do neurološke ili vaskularne ozljede kod ugradnje ili uklanjanja.
English: • latest date on which the implant must be removed Keep this card in a safe place, since the information on the card may make it easier to carry out removal.
Croatian: Čuvajte tu karticu na sigurnom mjestu jer će informacije na kartici olakšati izvođenje uklanjanja.
English: The mean doses per week in Sixmo subjects in PRO-805 and PRO-806 studies were 5.16 mg and 3.16 mg, with relatively low mean days of use per week of 0.45 and 0.31, respectively.
Croatian: Srednja vrijednost doza tjedno u ispitanika liječenih implantatima Sixmo u ispitivanjima PRO-805 i PRO-806 iznosila je 5,16 mg odnosno 3,16 mg, uz relativno nisku srednju vrijednost broja dana uzimanja tjedno od 0,45 odnosno 0,31.
English: In a pharmacokinetic study with sublingual buprenorphine, buprenorphine plasma levels were found to be higher and the half-life was found to be longer in patients with moderate and severe hepatic impairment, but not in patients with mild hepatic impairment (see section 5.2).
Croatian: U farmakokinetičkom ispitivanju sa sublingvalnim buprenorfinom pronađeno je da su razine buprenorfina u plazmi bile više, a njegov poluvijek dulji u bolesnika s umjerenim i teškim oštećenjem jetrene funkcije, ali ne i u bolesnika s blagim oštećenjem jetrene funkcije (vidjeti dio 5.2).
English: Verify that patients have completed an appropriate induction period with sublingual buprenorphine or buprenorphine/naloxone, or are already clinically stable on buprenorphine or buprenorphine/naloxone before inserting Sixmo implants (see section 4.2).
Croatian: Provjerite jesu li bolesnici završili odgovarajuću fazu indukcije sublingvalnim buprenorfiom ili buprenorfinom/naloksonom ili jesu li već klinički stabilni na buprenorfinu ili buprenorfinu/naloksonu prije ugradnje implantata Sixmo (vidjeti dio 4.2).
English: The same technique is employed for the removal of protruding or partially expelled implants.
Croatian: Ista se tehnika koristi za uklanjanje implantata koji izviruju iz kože ili su djelomično istisnuti.
English: Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence
Croatian: Istodobna primjena antagonista opioida (naltreksona, nalmefena) za liječenje ovisnosti o alkoholu ili opioidima.
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.
Croatian: Zbog dugog poluvijeka buprenorfina, treba razmotriti nadziranje stanja fetusa nekoliko posljednjih dana trudnoće da se spriječi rizik od respiratorne depresije ili sindroma ustezanja u novorođenčadi.
English: • Similarly, inducers of CYP3A4 (e.g. phenobarbital, carbamazepine, phenytoin, rifampin) may have the potential to reduce buprenorphine plasma concentrations because of increased metabolism of buprenorphine to norbuprenorphine.
Croatian: • Slično tome, induktori CYP3A4 (kao što su fenobarbital, karbamazepin, fenitoin, rifampin) mogu potencijalno smanjiti koncentracije buprenorfina u plazmi zbog pojačanog metabolizma buprenorfina u norbuprenorfin.
English: • reactions at the implant site pain, itching procedural site reaction, such as pain during the insertion procedure bruising, skin reddening, scar bleeding
Croatian: • reakcije na mjestu implantata bol, svrbež reakcije na mjestu ugradnje povezane s postupkom, kao što je bol tijekom postupka ugradnje modrice, crvenilo kože, ožiljak krvarenje
English: Renal elimination plays a relatively small role (approximately 30%) in the overall clearance of buprenorphine and buprenorphine plasma concentrations were not increased in patients with renal impairment.
Croatian: Eliminacija bubrezima ima relativno malu ulogu (približno 30%) u cjelokupnom klirensu buprenorfina i koncentracije buprenorfina u plazmi nisu bile povišene u bolesnika s oštećenjem bubrežne funkcije.
English: The dissociation of buprenorphine from the µ-opioid receptors is expected to take up to several days after discontinuation of Sixmo treatment, which will prevent withdrawal symptoms immediately after removal of Sixmo.
Croatian: Očekuje se da će za odvajanje buprenorfina od µ-opioidnih receptora trebati nekoliko dana nakon prestanka liječenja implantatom Sixmo, što će spriječiti pojavu simptoma ustezanja neposredno nakon uklanjanja implantata Sixmo.
English: Prior to entry into acute studies PRO-805, PRO-806, PRO-810 and TTP-400-02-01, patients were treatment naïve adults, with moderate to severe opioid dependency.
Croatian: Prije ulaska u akutno ispitivanja PRO-805, PRO-806, PRO-810 i TTP-400-02-01, ti odrasli bolesnici prethodno nisu bili liječeni i imali su umjerenu do tešku ovisnost o opioidima.
English: Patients who have contraindications for MRI.
Croatian: Bolesnici koji imaju kontraindikacije za MR.
English: In both studies adult patients with opioid dependence who were new entrants to buprenorphine treatment were treated over 24 weeks with 4 Sixmo or 4 placebo implants.
Croatian: U oba su ispitivanja odrasli bolesnici s ovisnošću o opioidima koji su prvi put počeli s liječenjem buprenorfinom bili liječeni tijekom 24 tjedna pomoću 4 implantata Sixmo i 4 placebo implantata.
English: The manifestations of acute buprenorphine overdose include pinpoint pupils, sedation, hypotension, respiratory depression and death.
Croatian: Manifestacije akutnog predoziranja buprenorfinom uključuju suženje zjenica, sedaciju, hipotenziju, respiratornu depresiju i smrt.
English: Serious complications from insertion and removal of Sixmo implants
Croatian: Ozbiljne komplikacije ugradnje i uklanjanja implantata Sixmo
English: After the initial buprenorphine peak, the plasma buprenorphine concentrations decreased slowly and steady-state plasma buprenorphine concentrations were reached by approximately week 4.
Croatian: Nakon početne vršne vrijednosti buprenorfina, koncentracije buprenorfina u plazmi sporo su se snižavale i postigle su stanje dinamičke ravnoteže nakon približno 4 tjedna.
English: If continued treatment is desired at the end of the first six-month treatment cycle, a new set of 4 Sixmo implants may be administered following removal of the old implants for one additional treatment cycle of six months.
Croatian: Ako je na kraju prvog šestomjesečnog ciklusa liječenja poželjan nastavak liječenja, nakon uklanjanja starih implantata može se primijeniti novi komplet od 4 implantata Sixmo za jedan dodatni ciklus liječenja u trajanju od šest mjeseci.
English: Buprenorphine has a mean elimination half-life from plasma ranging from 24 to 48 hours.
Croatian: Srednja vrijednost poluvijeka eliminacije buprenorfina iz plazme kreće se u rasponu od 24 do 48 sati.
English: After Sixmo implant insertion, an initial buprenorphine peak was observed and the median Tmax occurred at 12 hours after insertion.
Croatian: Sixmo opažena je početna vršna vrijednost buprenorfina, a medijan Tmax nastupio je 12 sati nakon ugradnje.
English: Long-term administration of buprenorphine during the last three months of pregnancy may cause a withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions).
Croatian: Dugoročna primjena buprenorfina tijekom posljednja tri mjeseca trudnoće može uzrokovati sindrom ustezanja u novorođenčeta (npr. hipertoniju, neonatalni tremor, neonatalnu agitaciju, mioklonus ili konvulzije).
English: When a hepatic event is suspected, liver function evaluation is required, including consideration whether to discontinue treatment with Sixmo.
Croatian: Kad se sumnja na događaj povezan s jetrom, potrebno je procijeniti funkciju jetre, kao i razmotriti da li prekinuti liječenje implantatima Sixmo.
English: The MAH shall ensure that in each MS where SIXMO is marketed, all physicians expected to insert / remove SIXMO subcutaneous (SC) implant are provided with an educational programme, aiming at preventing / minimising the important identified risk of implant protrusion / (spontaneous) expulsion, the important potential risks of damage to nerves or blood vessels during insertion / removal procedure, (dislocation and) migration / missing (partial) implant.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će da se u svakoj državi članici u kojoj je SIXMO u prometu, svim liječnicima za koje se očekuje da će ugrađivati/uklanjati supkutane implantate SIXMO osigura edukacijski program, s ciljem sprječavanja/minimiziranja važnih utvrđenih rizika za protruziju/(spontanu) ekspulziju implantata, važnih mogućih rizika oštećenja živaca ili krvnih žila tijekom postupka ugradnje uklanjanja te (dislokacije i) migracije/nepronalaženja
English: • If an implant comes out after insertion, take the following steps: Schedule an appointment with the inserting doctor as soon as possible.
Croatian: • Ako implantat nakon ugradnje bude istisnut van, poduzmite sljedeće korake: Čim prije zakažite pregled kod liječnika koji je ugradio implantate.
English: Sixmo is not recommended during pregnancy, nor in women of childbearing age not using contraception.
Croatian: Sixmo se ne preporučuje tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Patients with a history of keloid or hypertrophic scar formation should not undergo subcutaneous insertion, as difficulties in retrieving the implant are possible.
Croatian: Bolesnici sa stvaranjem keloida ili hipertrofičnih ožiljaka u anamnezi ne smiju biti podvrgnuti supkutanoj ugradnji, jer je moguće otežano izvlačenje implantata.
English: Both buprenorphine and norbuprenorphine can further undergo glucuronidation by UDPglucuronosyltransferases.
Croatian: I buprenorfin i norbuprenorfin mogu dalje prolaziti glukuronidaciju putem UDP-glukuronoziltransferaza.
English: In the post-marketing setting, 2 cases were reported where Sixmo implants had locally migrated from the insertion site.
Croatian: Nakon stavljanja lijeka u promet zabilježena su 2 slučaja lokalne migracije implantata Sixmo s mjesta ugradnje.
English: • tonsil complications
Croatian: • komplikacije s tonzilama
English: Insert one implant into the cannula (Figure 9), re-insert the obturator, and gently push the obturator forward (mild resistance should be felt) until the obturator stop line is level with the bevel-up stop marking, which indicates the implant is positioned at the tip of the cannula (Figure 10).
Croatian: Umetnite jedan implantat u kanilu (slika 9), ponovno uvedite opturator i nježno ga potisnite prema naprijed (treba se osjetiti slabi otpor) dok linija za zaustavljanje na opturatoru ne dođe u ravninu s urezanom oznakom za zaustavljanje na držaču kanile, što označava da se implantat sada nalazi na vršku (slika 10).
English: Implants should be inserted in the inner side of the opposite upper arm, following the insertion steps below to locate the appropriate insertion site.
Croatian: Implantate treba ugraditi s unutarnje strane suprotne nadlaktice, slijedeći korake za ugradnju opisane u nastavku kako bi se odredilo odgovarajuće mjesto ugradnje.
English: • the patient experiences lack of efficacy, as evidenced by lasting withdrawal symptoms that require repeated management with sublingual buprenorphine
Croatian: • ako bolesnik osjeća da nisu djelotvorni, što dokazuju dugotrajni simptomi ustezanja zbog kojih je potrebno stalno ponavljati primjenu sublingvalnog buprenorfina.
English: Because buprenorphine levels cannot be adjusted during Sixmo treatment, Sixmo is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (sections 4.3, 4.4 and 5.2).
Croatian: Sixmo razine buprenorfina ne mogu prilagođavati, implantati Sixmo kontraindicirani su u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh C) (dijelovi 4.3, 4.4 i 5.2).
English: • certain medicines to treat depression or Parkinson's disease, called monoamine oxidase inhibitors, such as phenelzine, isocarboxazid, iproniazid and tranylcypromine
Croatian: • određene lijekove za liječenje depresije ili Parkinsonove bolesti, pod nazivom inhibitori monoaminooksidaze, kao što su fenelzin, izokarboksazid, iproniazid i tranilcipromin.