FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration during buprenorphine treatment is contraindicated due to the potentially dangerous interaction that may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms (see section 4.3).
Croatian: Njihova je istodobna primjena tijekom liječenja buprenorfinom kontraindicirana zbog mogućih opasnih interakcija koje mogu dovesti do nagle pojave dugotrajnih i jakih simptoma ustezanja od opioida (vidjeti dio 4.3).
English: Cardiac disorders common palpitations** uncommon atrial flutter, bradycardia
Croatian: Srčani poremećaji često palpitacije** manje često undulacija atrija, bradikardija
English: A standard battery of genotoxicity tests conducted on extracts of Sixmo and ethylene vinyl acetate (EVA) placebo implants was negative.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Standardna baterija testova za ispitivanje genotoksičnosti provedena na ekstraktima implantata Sixmo i placebo implantata od etilenvinilacetata (EVA) bila je negativna.
English: Buprenorphine undergoes N-dealkylation to its major pharmacologically active metabolite norbuprenorphine and subsequent glucuronidation.
Croatian: Biotransformacija Buprenorfin prolazi N-dealkilaciju, čime nastaje njegov glavni, farmakološki aktivan metabolit norbuprenorfin, a poslije toga glukuronidaciju.
English: Insertion and removal of the Sixmo implants must be performed by a physician who is competent in minor surgery and has been trained to conduct the insertion and removal procedure.
Croatian: Ugradnju i uklanjanje implantata Sixmo mora provesti liječnik kvalificiran za izvođenje malog kirurškog zahvata te je educiran za izvođenje postupka ugradnje i uklanjanja.
English: • breathing difficulties, breathing slowly
Croatian: • otežano disanje, usporeno disanje.
English: Each Sixmo implant is packaged individually into a PET/LDPE/Alu/LDPE-peelable foil laminate sachet.
Croatian: Svaki implantat Sixmo pakiran je pojedinačno u laminiranu vrećicu od PET/LDPE/Alu/LDPE folije koja se može otvoriti odlijepljivanjem.
English: Close the incision with sutures.
Croatian: Zatvorite inciziju šavima.
English: Step 6: While lifting, gently advance the applicator subcutaneously along the channel marking on the skin.
Croatian: Korak 6: Dok podižete kožu, nježno uvodite aplikator supkutano duž oznaka za kanaliće na koži.
English: When used during pregnancy, particularly late pregnancy, buprenorphine may cause withdrawal symptoms, including breathing problems, in the newborn baby.
Croatian: Kad se primjenjuje tijekom trudnoće, osobito tijekom kasne trudnoće, buprenorfin može u novorođenčeta uzrokovati simptome ustezanja, uključujući probleme s disanjem.
English: Implants inserted more deeply than subcutaneous (deep insertion) may not be palpable and the localisation and/or removal may be difficult.
Croatian: Implantati koji se ugrade dublje nego supkutano (duboka ugradnja) možda se neće moći napipati, što može otežati utvrđivanje mjesta na kojem se nalaze i njihovo uklanjanje.
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.
Croatian: Ako se utvrđivanje mjesta implantata i drugi pokušaj uklanjanja ne provedu istog dana kad i prvi postupak uklanjanja, ranu u međuvremenu treba zatvoriti šavima.
English: Table 2: Patient characteristics in the studies PRO-805 and PRO-806 Study PRO-805
Croatian: Tablica 2: Značajke bolesnika u ispitivanjima PRO-805 i PRO-806 Ispitivanje PRO-805
English: Cases of acute hepatic injury (including fatal cases) have been reported with the active substance buprenorphine in opioid-dependent addicts both in clinical trials and in post marketing adverse reaction reports.
Croatian: Slučajevi akutnog oštećenja jetre (uključujući smrtne slučajeve) kod primjene djelatne tvari buprenorfin u osoba s ovisnošću o opioidima zabilježeni su i u kliničkim ispitivanjima i u prijavama nuspojava nakon stavljanja lijeka u promet.
English: There are no or limited data from the use of buprenorphine in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni buprenorfina u trudnica ograničeni.
English: The majority of patients (around 80%) in both studies were adequately treated with 4 implants; around 20% of patients required a dose increase with a fifth implant.
Croatian: Većina bolesnika (oko 80%) u oba ispitivanja bila je odgovarajuće liječena pomoću 4 implantata; oko
English: Retention in treatment was high, with 96.4% of Sixmo patients and 94.4% of sublingual buprenorphine patients completing the study.
Croatian: Ostanak u liječenju bio je velik i ispitivanje je završilo 96,4% bolesnika s implantatima Sixmo i 94,4% bolesnika koji su primali sublingvalni buprenorfin.
English: Patients requiring opioid therapy for analgesia may be treated with a high-affinity full opioid analgesic under the supervision of a healthcare professional, with particular attention to respiratory function.
Croatian: Bolesnici kojima je potrebna opioidna terapija za analgeziju mogu se pod nadzorom liječnika liječiti opioidnim analgetikom koji je potpuni agonist opioidnih receptora visokog afiniteta vezanja, s time da osobitu pozornost treba posvetiti respiratornoj funkciji.
English: The MAH shall also ensure that in each MS where SIXMO is marketed, each patient being prescribed this SC implant receives from the treating physician the Patient Information Leaflet (PIL) and a (wallet-sized) patient alert card, to be carried out at all times while on SIXMO treatment, and presented to other health care professionals (HCP) before any medical treatment / intervention is carried out.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet također će osigurati da u svakoj državi članici u kojoj je SIXMO u prometu svaki bolesnik kojem se propiše ovaj supkutani implantat dobije od nadležnog liječnika uputu o lijeku i karticu s upozorenjima za bolesnika (koja stane u novčanik) koju će za vrijeme liječenja implantatima SIXMO stalno nositi sa sobom i pokazati je drugim zdravstvenim radnicima prije provođenja bilo kakvog medikamentoznog liječenja / medicinske intervencije.
English: Apply liquid adhesive to the skin margins and allow to dry before closing the incision with the thin adhesive strip around 6 mm wide (butterfly strip).
Croatian: Nanesite tekuće ljepilo na rubove kože i ostavite da se osuši prije zatvaranja incizije tankom samoljepivom trakom širine oko 6 mm (leptirasta traka).
English: The implants will be positioned in a close fan-shaped distribution 4 to 6 mm apart, with the fan opening towards the shoulder (Figure 3).
Croatian: Implantati će biti postavljeni u razmaku od 4 do 6 mm i raspoređeni u obliku uske lepeze koja se širi prema ramenu (slika 3).
English: Nevertheless, it is possible to extract the buprenorphine from the Sixmo implant.
Croatian: Ipak, buprenorfin se može izvući iz implantata Sixmo.
English: hypotension, respiratory depression);
Croatian: bradikardija, hipotenzija, respiratorna depresija).
English: You may remove the pressure bandage after 24 hours and the adhesive bandage after five days.
Croatian: Kompresijski zavoj možete ukloniti nakon 24 sata, a flaster nakon pet dana.
English: Step 5: Lower the applicator to a horizontal position; lift the skin up with the tip of the applicator, but keep the cannula in the subcutaneous connective tissue (Figure 6).
Croatian: Korak 5: Spustite aplikator u vodoravni položaj; podignite kožu vrškom aplikatora, ali neka kanila ostane u potkožnom vezivnom tkivu (slika 6).
English: • fever, feeling cold, discomfort
Croatian: • vrućica, osjećaj hladnoće, nelagoda
English: PHARMACEUTICAL FORM AND CONTENTS 4 implants
Croatian: OBLIK I SADRŽAJ 4 implantata
English: • It is recommended that the healthcare professional is in a seated position during the entire insertion procedure so that the insertion site and the movement of the needle under the skin can be clearly seen from the side.
Croatian: • Liječniku se preporučuje da sjedi tijekom cijelog postupka ugradnje, tako da sa strane može jasno vidjeti mjesto ugradnje i pomicanje igle pod kožom.
English: Identify the insertion site, which is at the inner side of the upper arm, about 80 to 100 mm (8 to 10 cm) above the medial epicondyle, in the sulcus between the biceps and triceps muscle.
Croatian: Pronađite mjesto ugradnje, koje se nalazi na unutarnjoj strani nadlaktice, oko 80-100 mm (8-10 cm) iznad medijalnog epikondila, u sulkusu između bicepsa i tricepsa.
English: It has a relatively wide therapeutic window as a consequence of its partial agonist/antagonist properties, which attenuates suppression of cardiovascular and respiratory function.
Croatian: Zbog svojih svojstava parcijalnog agonista/antagonista ima relativno širok terapijski raspon, što smanjuje supresivno djelovanje na kardiovaskularnu i respiratornu funkciju.
English: Buprenorphine can cause fatal breathing problems in non-dependent people or children.
Croatian: Buprenorfin može uzrokovati probleme s disanjem koji mogu dovesti do smrti u osoba koje nisu ovisne ili u djece.
English: The primary efficacy endpoint in both studies was the cumulative distribution function (CDF) of the percentage of urine samples that were negative for illicit opioids (as evaluated through thrice weekly urine toxicology and patient self-reported opioid use).
Croatian: Primarna mjera ishoda u pogledu djelotvornosti u oba ispitivanja bila je kumulativna funkcija distribucije (KFD) postotka uzoraka mokraće koji su bili negativni na nedopuštene droge (procijenjeno prema toksikološkim nalazima mokraće tri puta tjedno i samoprijavljenoj uporabi opioida u bolesnika).
English: The implants should be positioned in a fan-shaped distribution at least 5 mm from the incision, and palpable after placement.
Croatian: Implantate treba rasporediti u obliku lepeze najmanje 5 mm od incizije i implantati moraju biti opipljivi nakon ugradnje.
English: Improper removal carries risk of implant-site infection and implant breakage.
Croatian: Nepravilno uklanjanje nosi rizik od infekcije na mjestu implantata i pucanja implantata.
English: The primary endpoint was proportion of responders, defined as patients with no more than 2 of 6 months with evidence of illicit opioid use based on a composite of both urine and self-report results.
Croatian: Primarna mjera ishoda bila je udio ispitanika s odgovorom definiranim kao uporaba nedopuštenih opioida tijekom najviše 2 od 6 mjeseci dokazana na temelju kompozitne mjere sastavljene od rezultata analize mokraće i upitnika za samoprocjenu.
English: Hepatitis and hepatic events
Croatian: Hepatitis i događaji povezani s jetrom
English: At steady state, a small decrease in buprenorphine concentrations was also recorded between week 4 and week 24.
Croatian: U stanju dinamičke ravnoteže bilo je zabilježeno i malo smanjenje koncentracija buprenorfina između 4. i 24. tjedna.
English: • If it is not possible to palpate the remaining implant, an ultrasound or MRI should be performed per techniques described in section 4.2 under “Instructions for removal of Sixmo”.
Croatian: • Ako nije moguće napipati preostali dio implantata, treba napraviti pregled ultrazvukom ili MRom prema tehnikama opisanima u dijelu 4.2 pod “ Upute za uklanjanje implantata Sixmo”.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ (mu) and κ (kappa)
Croatian: Buprenorfin je parcijalni opioidni agonist/antagonist koji se veže za μ (mu) i κ (kappa) receptore u mozgu.
English: Generally, concentrations were comparable to the trough buprenorphine concentration of 8 mg per day sublingual buprenorphine.
Croatian: koncentracije su bile usporedive s najnižim koncentracijama buprenorfina kod doze od 8 mg na dan sublingvalnog buprenorfina.
English: Please note: Buprenorphine can cause severe, possibly fatal, breathing depression (shortness of breath or stops breathing) in children who are accidentally exposed to it.
Croatian: Napomena: buprenorfin može uzrokovati tešku depresiju disanja s mogućim smrtnim ishodom (nedostatkom daha ili prestankom disanja) u djece koja mu nehotice budu izložena.
English: They are removed by the end of the sixth month.
Croatian: Uklanjanju se na kraju tog šestomjesečnog razdoblja.
English: • instrument stand covered with sterile drape
Croatian: • kolica za instrumente pokrivena sterilnom prekrivkom
English: Sixmo is formulated as a diversion and abuse deterrent formulation.
Croatian: Sixmo ima formulaciju koja sprječava nedopuštenu uporabu i zlouporabu.
English: Using the surgical marker, mark the location of the implants and the location of the incision.
Croatian: Kirurškim markerom označite mjesto na kojem se nalaze implantati i mjesto incizije.
English: • consistency in participation in recommended behavioural therapy/peer support programme
Croatian: • dosljedno sudjelovanje u preporučenoj bihevioralnoj terapiji / grupi za samopomoć i uzajamnu podršku
English: In clinical studies and from post-marketing data 7 cases of clinically relevant implant breakage (breakage associated with an adverse reaction) were observed.
Croatian: U kliničkim ispitivanjima i prema podacima nakon stavljanja lijeka u promet opaženo je 7 slučajeva klinički važnog lomljenja implantata (pucanje povezano s nuspojavom).
English: Step 8: While holding the obturator in place on the arm, retract the cannula along the obturator, leaving the implant in place (Figure 11).
Croatian: Korak 8: Dok držite opturator na istom mjestu na ruci, povucite kanilu unatrag duž opturatora, ostavljajući implantat na mjestu (slika 11).
English: In a subset of patients, Sixmo implants broke during implant removal.
Croatian: U podskupini bolesnika došlo je do lomljenja implantata Sixmo tijekom njihova uklanjanja.
English: Study PRO-806
Croatian: Ispitivanje PRO-806
English: CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.
Croatian: Inhibitori CYP3A4 mogu inhibirati metabolizam buprenorfina, što dovodi do povišenja vrijednosti Cmax i AUC-a buprenorfina i norbuprenorfina.
English: The healthcare professional should review the patient's treatment history for concomitant use of CYP3A4 inhibitors prior to initiating Sixmo treatment to determine suitability (see section 4.5).
Croatian: Liječnik treba u povijesti liječenja bolesnika provjeriti je li bolesnik već istodobno primao inhibitore CYP3A4 prije početka liječenja implantatima Sixmo, kako bi odredio prikladnost tog liječenja (vidjeti dio 4.5).
English: Each dose consists of four implants, for subcutaneous insertion in the inner side of the upper arm.
Croatian: Jedna doza sastoji se od četiri implantata koji se ugrađuju supkutano s unutarnje strane nadlaktice.
English: The physician educational programme, provided in conjunction with the Summary of Product Characteristics (SmPC), should include lecture slides and a detailed, face to face, step-by step description and live demonstration of the surgical procedure for SIXMO insertion and removal.
Croatian: Edukacijski program za liječnike, koji se osigurava zajedno sa sažetkom opisa svojstava lijeka, mora uključiti prezentaciju s predavanja (slajdove), detaljni opis svakog koraka licem u lice i uživo demonstraciju kirurškog zahvata ugradnje i uklanjanja implantata SIXMO.
English: • period free from opioid drug abuse
Croatian: • razdoblje bez zlouporabe opioida
English: If pregnancy occurs during treatment with Sixmo the benefit to the patient should be weighed against the risk to the foetus.
Croatian: Sixmo nastupi trudnoća, potrebno je procijeniti korist za bolesnicu u odnosu na rizik za fetus.
English: General precautions relevant to the administration of opioids
Croatian: Opće mjere opreza važne kod primjene opioida
English: • reactions at the implant site infection, including wound infection rash, scaring reduced healing swollen area containing pus
Croatian: • reakcije na mjestu implantata infekcija, uključujući infekciju rane osip, ožiljak usporeno cijeljenje otečeno područje s gnojnim sadržajem
English: Sixmo is contraindicated in patients with a history of keloid or hypertrophic scar formation at the site where Sixmo would be implanted, as difficulties in retrieving the implant are possible (see section
Croatian: Sixmo je kontraindiciran u bolesnika s anamnezom stvaranja keloida ili hipertrofičnih ožiljaka na mjestu gdje bi se ugradio Sixmo jer su moguće poteškoće s uklanjanjem implantata (vidjeti dio 4.3).
English: If another set of implants is not inserted on the same day as the previous set is removed: A dose of between 2 and 8 mg buprenorphine daily, given under the tongue, is recommended until repeat treatment occurs.
Croatian: Ako se drugi komplet implantata ne ugradi istog dana kad se uklonio prethodni komplet: Preporučuje se primijeniti dozu između 2 i 8 mg buprenorfina dnevno, pod jezik, do ponovnog liječenja implantatima.
English: In many cases the presence of pre-existing hepatic impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicines) and ongoing injecting drug use may have a causative or contributory role.
Croatian: U mnogim su slučajevima to mogli uzrokovati ili tome pridonijeti već postojeće oštećenje jetre (genetska bolest, abnormalnosti jetrenih enzima, infekcija virusom hepatitisa B ili hepatitisa C, alkoholizam, anoreksija, istodobna primjena drugih potencijalno hepatotoksičnih lijekova) i aktualna intravenska uporaba droga.
English: It is recommended that the healthcare professional is in a seated position during the entire insertion procedure so that the insertion site and the movement of the needle just under the skin can be clearly seen from the side.
Croatian: Liječniku se preporučuje da sjedi tijekom cijelog postupka ugradnje, tako da sa strane može jasno vidjeti mjesto ugradnje i pomicanje igle neposredno ispod kože.
English: Do not use Sixmo if you:
Croatian: Nemojte primjenjivati Sixmo:
English: After one subcutaneous insertion in each arm (for a total of two treatments cycles), most patients should be transitioned back to their previous sublingual buprenorphine dose (i.e. the dose from which they were transferred to Sixmo treatment) for continued treatment.
Croatian: Nakon što su implantati bili supkutano ugrađeni u svaku ruku (za ukupno dva ciklusa liječenja), većinu bolesnika treba prebaciti na prethodnu dozu sublingvalnog buprenorfina (tj. dozu s koje su prebačeni na liječenje implantatima Sixmo) zbog nastavka liječenja.
English: Although some patients may require occasional supplemental dosing with buprenorphine, patients should not be provided with prescriptions for sublingual buprenorphine-containing products for asneeded use.
Croatian: Iako nekim bolesnicima može povremeno trebati dodatna doza buprenorfina, ne smije im se dati recept za lijek koji sadrži sublingvalni buprenorfin da ga uzmu po potrebi.
English: 4.5 Interaction with other medicinal products and other forms of interaction Buprenorphine should not be administered together with:
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Properly placed implants are those placed just under the skin, using the implant applicator, about 80 to 100 mm (8 to 10 cm) above the medial epicondyle, in the sulcus between the biceps and triceps muscle of the inner side of the upper arm.
Croatian: Ispravno ugrađeni implantati su oni postavljeni pomoću aplikatora implantata neposredno ispod kože, oko 80 do 100 mg (8-10 cm) iznad medijalnog epikondila, u sulkusu između bicepsa i tricepsa na unutarnjoj strani nadlaktice.
English: • reduced sense of touch or sensation
Croatian: • smanjen osjet dodira ili osjetljivost na podražaj
English: Patients previously treated with sublingual buprenorphine or sublingual buprenorphine + naloxone, must be on stable doses between 2 to 8 mg/day for at least 30 days and deemed clinically stable by the treating healthcare professional.
Croatian: Bolesnici prethodno liječeni sublingvalnim buprenorfinom ili sublingvalnim buprenorfinom u kombinaciji s naloksonom moraju biti na stabilnoj dozi između 2 mg i 8 mg na dan tijekom najmanje 30 dana i, prema procjeni nadležnog liječnika, klinički stabilni.
English: Sixmo is a white/off-white to pale yellow rod-shaped implant, 26.5 mm long and 2.4 mm in diameter.
Croatian: Sixmo je bijeli/gotovo bijeli do blijedožuti implantat u obliku štapića, duljine 26,5 mm i promjera 2,4 mm.
English: Mark the insertion site with the surgical marker.
Croatian: Označite mjesto ugradnje kirurškim markerom.
English: • Implant insertion and six-month removal date(s)
Croatian: • datum(e) ugradnje i uklanjanja implantata nakon šest mjeseci
English: • sleep disorder, disinterest
Croatian: • poremećaj spavanja, ravnodušnost
English: Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
Croatian: Sixmo je indiciran kao nadomjesna terapija u liječenju ovisnosti o opioidima u klinički stabilnih odraslih bolesnika kojima, u sklopu medicinskog, socijalnog i psihološkog liječenja, nije potrebno više od 8 mg na dan sublingvalno primjenjenog buprenorfina.
English: Adverse reactions (implant and non-implant) reported are listed in the following table.
Croatian: Zabilježene nuspojave (implantata i djelatne tvari) navedene su u tablici u nastavku.
English: Two additional randomised, double-blind, placebo-controlled Phase 3 studies provide supportive data on efficacy and PK (Studies PRO-805 and PRO-806).
Croatian: Dva dodatna randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze 3 pružila su podatke koji potkrijepljuju djelotvornost i farmakokinetiku (ispitivanja PRO-805 i PRO-806).
English: Apply the sterile drape to the patient's arm. Anaesthetise the incision site and the subcutaneous space containing the implants (for example, by injecting 5 to 7 mL lidocaine 1% with adrenaline 1:100,000).
Croatian: Anestezirajte mjesto incizije i potkožno tkivo u kojem se nalaze implantati (na primjer, ubrizgavanjem 5-7 ml 1%-tnog lidokaina s adrenalinom 1:100 000).
English: Patients with mild to moderate hepatic impairment (Child-Pugh A and B) should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine (miosis, lip cyanosis, sedation, bradycardia, hypotension, respiratory depression).
Croatian: Bolesnike s blagim do umjerenim oštećenjem jetrene funkcije (Child-Pugh A i B) treba pratiti zbog moguće pojave znakova i simptoma toksičnosti ili predoziranja uzrokovanih povišenim razinama buprenorfina (mioza, cijanoza usana, sedacija, bradikardija, hipotenzija, respiratorna depresija).
English: Patients with mild to moderate hepatic impairment should be monitored for signs and symptoms of toxicity, or overdose caused by increased levels of buprenorphine (see section 4.2).
Croatian: Bolesnike s blagim do umjerenim oštećenjem jetrene funkcije treba pratiti zbog mogućih znakova i simptoma toksičnosti ili predoziranja uzrokovanih povišenim razinama buprenorfina (vidjeti dio 4.2).
English: In study PRO-805, the primary endpoint was the CDF of the percentage of urine samples that were negative for illicit opioids over weeks 1 to 16, while the CDF over weeks 17 to 24 was evaluated as secondary endpoint.
Croatian: U ispitivanju PRO-805, primarna mjera ishoda bio je KFD postotka uzoraka mokraće koji su bili negativni na nedopuštene droge tijekom razdoblja od 1. do 16. tjedna, dok se KFD od 17. do 24. tjedna ocjenjivao kao sekundarna mjera ishoda.
English: Opioids should be used with caution in patients with myxoedema, hypothyroidism or adrenal cortical insufficiency (e.g. Addison's disease).
Croatian: Opioide treba primjenjivati s oprezom u bolesnika s miksedemom, hipotireozom ili insuficijencijom kore nadbubrežne žlijezde (npr. Addisonovom bolešću).