FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used to treat opioid dependence in adults who are also receiving medical, social and psychological support.
Croatian: Primjenuje se za liječenje ovisnosti o opioidima u odraslih koji također dobivaju medicinsku, socijalnu i psihološku potporu.
English: Note: Do not push the obturator.
Croatian: Napomena: Nemojte potiskivati opturator.
English: • This medicine can cause dependence, but at a lower level than other substances such as morphine.
Croatian: • Ovaj lijek može uzrokovati ovisnost, ali u manjoj mjeri nego druga sredstva, poput morfina.
English: • Present this card to your doctor, dentist or surgeon before any medical treatment or surgery.
Croatian: • Pokažite ovu karticu liječniku, stomatologu ili kirurgu prije bilo kakvog liječenja ili kirurškog zahvata.
English: Patient name:
Croatian: Ime i prezime bolesnika:
English: In the worst case, it can result in breathing stopping, heart failure and death.
Croatian: U najgorem slučaju, to može dovesti do prestanka disanja, zatajenja srca i smrti.
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.
Croatian: Odmah obavijestite svog liječnika ako se pojave gore navedeni simptomi ili otiđite u najbiližu bolnicu i ponesite sa sobom ovu uputu o lijeku i Vašu karticu s upozorenjima za bolesnika.
English: If you feel the need for additional buprenorphine doses, contact your doctor straight away.
Croatian: Ako osjećate da su Vam potrebne dodatne doze buprenorfina, odmah se obratite liječniku.
English: Generally, other buprenorphine treatments/formulations are considered more appropriate in this situation.
Croatian: Općenito se drugačije liječenje buprenorfinom / formulacijama buprenorfina u toj situaciji smatra primjerenijim.
English: PROCEDURAL INFORMATION Insertion date:
Croatian: INFORMACIJE O POSTUPKU Datum ugradnje:
English: Breakage rates decreased in studies using the current technique and training.
Croatian: Stope lomljenja u ispitivanjima smanjile su se uz korištenje najnovije tehnike i obuke.
English: • Contact your doctor if you experience any unusual symptoms, such as breathing problems, head injury, increased pressure in the head.
Croatian: • Obratite se svom liječniku ako osjetite bilo kakve neobične simptome, kao što su problemi s disanjem, ozljeda glave ili povišen tlak u glavi.
English: Weeks 1 to 16
Croatian: 1. do 16. tjedna
English: • high blood pressure, feeling heartbeat
Croatian: • visoki krvni tlak, osjećaj lupanja srca
English: Talk to your doctor before using Sixmo if you have:
Croatian: Obratite se svom liječniku prije nego primite Sixmo ako imate:
English: • Alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine.
Croatian: • alkoholnim pićima ili lijekovima koji sadrže alkohol jer alkohol pojačava sedativni učinak buprenorfina.
English: Instead, patients who feel the need for supplemental dosing should be seen and evaluated promptly.
Croatian: Umjesto toga, bolesnike koji osjećaju da im je potrebna dodatna doza mora se odmah primiti na pregled i procijeniti.
English: Medicinal product subject to special and restricted medical prescription.
Croatian: Lijek se izdaje na poseban i ograničeni recept.
English: The implants should only be removed by a doctor who is familiar with the procedure.
Croatian: Implantate smije ukloniti samo liječnik koji poznaje postupak.
English: Sixmo implants are not radiopaque and cannot be seen by X-ray or CT scan.
Croatian: Implantati Sixmo nisu radiološki neprozirni pa se ne vide na rendgenskim ili CT snimkama.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1369/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1369/001
English: They are removed by the doctor at the end of the sixth month.
Croatian: Uklanja ih liječnik na kraju tih šest mjeseci.
English: • depression, euphoria
Croatian: • depresija, euforija
English: Buprenorphine is approximately 96% protein bound, primarily to alpha and beta globulin.
Croatian: Približno je 96% buprenorfina vezano za proteine plazme, prvenstveno za alfa i beta globulin.
English: • are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na buprenorfin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
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.
Croatian: Ispitivanja na životinjama, kao i kliničko iskustvo, pokazala su da buprenorfin može izazvati ovisnost, ali na nižoj razini nego potpuni agonist, npr. morfin.
English: Step 12: Complete the Patient Alert Card and give it to the patient to keep.
Croatian: Korak 12: Ispunite karticu s upozorenjima za bolesnika i dajte je bolesniku.
English: • The incision site should be inspected for infection.
Croatian: • Mjesto incizije treba pregledati zbog moguće infekcije.
English: The syndrome may be milder and more protracted than that from short acting full μ-opioid agonists.
Croatian: Taj sindrom može biti blaži i dugotrajniji od onog uzrokovanog kratkodjelujućim potpunim μ-opioidnim agonistima.
English: No published information is available regarding a potential effect of buprenorphine on male and female fertility.
Croatian: Nema dostupnih objavljenih informacija o mogućem učinku buprenorfina na mušku i žensku plodnost.
English: New implants will be inserted in the other arm.
Croatian: Novi implantati bit će ugrađeni u drugu ruku.
English: L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A, Strada Statale 67,
Croatian: Molteni & C. dei F.lli Alitti Soc.Es.S.p.A, Strada Statale 67,
English: If you cannot feel each of the four implants, or doubt their presence, use other methods to confirm the presence of the implant.
Croatian: Ako ne možete napipati svaki od četiri implantata ili niste sigurni jesu li tu, upotrijebite druge metode da biste potvrdili prisutnost implantata.
English: What Sixmo contains
Croatian: Što Sixmo sadrži
English: There is no experience of reimplantation beyond 12 months.
Croatian: Nema iskustva s ponovnom ugradnjom implantata nakon 12 mjeseci.
English: • head injury or other circumstances where the pressure in the head may be increased
Croatian: • ozljedu glave ili druge poremećaje kod kojih može biti povećan tlak unutar glave
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.
Croatian: Kad su gravidne ženke štakora bile izložene buprenorfinu kroz osmotske minipumpe od 7. dana gestacije nadalje, smanjeno su uzimale hranu i vodu od 7. do 20. dana gestacije.
English: • period without episodes of hospitalisations (addiction or mental health issues), emergency room visits, or crisis interventions
Croatian: • razdoblje bez epizoda hospitalizacije (zbog ovisnosti ili problema mentalnog zdravlja), dolazaka na hitnu pomoć ili kriznih intervencija
English: The safety and efficacy of Sixmo in children under 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost implantata Sixmo u djece mlađe od 18 godina nisu još ustanovljene.
English: This endpoint was considered to be of clinical relevance in the targeted indication.
Croatian: Ta se mjera ishoda smatrala klinički važnom za ciljnu indikaciju.
English: What you need to know before you use Sixmo
Croatian: Što morate znati prije nego počnete primjenjivati Sixmo
English: • evidence of implant coming out of the skin
Croatian: • znakova da implantat izlazi iz kože
English: The recommended visit schedule for most patients is a frequency of no less than once-monthly for continued counselling and psychosocial support.
Croatian: Preporučena učestalost dolazaka na pregled za većinu bolesnika je najmanje jedanput mjesečno zbog daljnjeg savjetovanja i psihosocijalne podrške.
English: • local anaesthetic, such as 1% lidocaine with adrenaline 1:100,000
Croatian: • lokalni anestetik, kao što je 1%-tni lidokain s adrenalinom 1:100 000
English: If you have more Sixmo than you need
Croatian: Ako imate više implantata Sixmo nego što Vam je potrebno
English: Severe respiratory insufficiency
Croatian: Teška respiratorna insuficijencija
English: • rifampicin: a medicine to treat tuberculosis or certain other infections
Croatian: • rifampicin: lijek za liječenje tuberkuloze ili određenih drugih infekcija
English: Key instruction for proper insertion
Croatian: Glavne upute za ispravnu ugradnju
English: Step 11: Apply pressure to the incision site for approximately five minutes if necessary.
Croatian: Korak 11: Po potrebi primijenite pritisak na mjesto incizije tijekom približno pet minuta.
English: The implant time was 24 weeks.
Croatian: Implantat je ostao ugrađen 24 tjedna.
English: If infected, it should be treated appropriately and be determined if remaining implants need to be removed.
Croatian: Ako je inficirano, potrebno je provesti odgovarajuće liječenje i utvrditi trebaju li preostali implantati biti uklonjeni.
English: L. Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A. Strada Statale 67
Croatian: Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A. Strada Statale 67
English: • lack of a white blood cell type called neutrophils
Croatian: • nedostatak jedne vrste bijelih krvnih stanica pod nazivom neutrofili
English: Inform your doctor immediately if you think you have an infection at the implant site or if the implant starts to come out.
Croatian: Odmah obavijestite liječnika ako mislite da imate infekciju na mjestu implantata ili ako implantat počne izlaziti iz kože.
English: What Sixmo looks like and contents of the pack
Croatian: Kako Sixmo izgleda i sadržaj pakiranja
English: Physicians should also be informed about risks and complications of this procedure (i.e. implant migration, protrusion, expulsion, and nerve damage).
Croatian: Liječnici također moraju biti obaviješteni o rizicima i komplikacijama ovog postupka (tj. migraciji, protruziji, ekspulziji implantata i oštećenju živaca).
English: Higher than normal doses and repeated administration may be necessary.
Croatian: Možda će biti potrebno primijeniti više doze od normalnih i ponavljati primjenu.
English: The nature of the syndrome may vary depending upon the mother's drug use history.
Croatian: Priroda sindroma može varirati ovisno o ovisničkoj anamnezi majke.
English: Your doctor will also give you a Patient Alert Card that provides the
Croatian: Liječnik će vam također dati karticu s upozorenjima za bolesnika na kojoj su navedeni
English: Particularly, this occurs when additionally using alcohol, other opioids or certain medicines which calm, induce sleep or relax muscles.
Croatian: To se događa osobito kad se dodatno uzimaju alkohol, drugi opioidi ili određeni lijekovi za smirenje, spavanje ili opuštanje mišića.
English: 6-month removal date:
Croatian: Datum uklanjanja nakon 6 mjeseci:
English: NAME OF THE MARKETING AUTHORISATION HOLDER L. Molteni & C. dei F.lli Alitti
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET L. Molteni & C. dei F.lli Alitti
English: The removed implant contains a significant amount of residual buprenorphine.
Croatian: Uklonjeni implantat sadrži značajnu količinu preostalog buprenorfina.
English: Other medicines and Sixmo
Croatian: Drugi lijekovi i Sixmo
English: If the treatment is continued, hepatic function should be monitored closely.
Croatian: Ako se liječenje nastavi, potrebno je pažljivo pratiti jetrenu funkciju.
English: • asthma or other breathing problems
Croatian: • astmu ili druge probleme s disanjem
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.
Croatian: Pazite da ubrizgate lokalni anestetik duboko ispod sredina implantata; to će učinkovito podići implantate prema koži, što će olakšati njihovo uklanjanje.
English: Sixmo is not recommended for children under 18 years.
Croatian: Sixmo se ne preporučuje u djece mlađe od 18 godina.
English: You must be on a stable buprenorphine dose of between 2 to 8 mg per day, given under the tongue.
Croatian: Morate biti na stabilnoj dozi buprenorfina između 2 i 8 mg na dan, koja se daje pod jezik.
English: • increased level of a liver enzyme, alanine aminotransferase, in blood tests
Croatian: • povišene razine jetrenog enzima alanin aminotransferaze na krvnim pretragama
English: Maternal exposure to buprenorphine increased perinatal mortality and caused a delay in some development milestones in neonatal rats.
Croatian: Maternalna izloženost buprenorfinu povećala je perinatalni mortalitet i uzrokovala odgođeno postizanje određenih razvojnih faza u novookoćenih štakora.
English: • 5 mL syringe with 25G×1.5" needle (0.5×38 mm)
Croatian: • štrcaljka od 5 ml s iglom od 25G×1,5" (0,5×38 mm)
English: • adequate lighting, such as headlamp
Croatian: • odgovarajuće osvjetljenje, poput čeone svjetiljke
English: Uncommon, may affect up to 1 in 100 people
Croatian: Manje često, mogu se javiti u do 1 na 100 osoba
English: Each dose consists of 4 implants.
Croatian: Jedna doza sastoji se od 4 implantata.
English: In the majority of patients, heroin was the primary opioid of use.
Croatian: U većine je bolesnika heroin bio primarni opioid zlouporabe.
English: • two X-plant clamps (vasectomy fixation clamps with 2.5 mm ring diameter)
Croatian: • dvije hvataljke X-plant (vazektomijske fiksacijske hvataljke s promjerom prstena od 2,5 mm)
English: Do not drive or perform dangerous activities until you are certain Sixmo does not reduce your ability in such activities.
Croatian: Nemojte voziti ili obavljati opasne radnje dok ne budete sigurni da Vam Sixmo ne smanjuje sposobnost obavljanja takvih radnji.
English: • the patient experiences severe or intolerable side effects (including severe precipitated withdrawal);
Croatian: • ako bolesnik ima jake ili nepodnošljive nuspojave (uključujući teški precipitirani sindrom ustezanja);
English: This risk is increased with the concomitant abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.
Croatian: Taj je rizik povećan kod istodobne zlouporabe buprenorfina i alkohola i drugih supstancija, osobito benzodiazepina.
English: Step 17: After removal of all implants, clean the incision site.
Croatian: Korak 17: Nakon što uklonite sve implantate, obrišite mjesto incizije.
English: If liver problems are suspected your doctor will carry out tests to decide if treatment should be stopped.
Croatian: slučaju sumnje na probleme s jetrom, liječnik će Vam provesti pretrage kako bi odlučio treba li prekinuti liječenje.
English: Opioids should be administered with caution to elderly or debilitated patients.
Croatian: Opioide treba primjenjivati s oprezom starijim ili oslabljenim bolesnicima.
English: Pups exposed to buprenorphine only during the prenatal period had a similar body weight compared with controls in the first 3 postnatal weeks.
Croatian: Mladunčad izložena buprenorfinu samo tijekom prenatalnog razdoblja imala je sličnu tjelesnu težinu u usporedbi s kontrolama u prva 3 postnatalna tjedna.
English: The closer the implants lie to each other at the time of insertion, the more easily they can be removed.
Croatian: Što implantati budu postavljeni bliže jedan drugom u vrijeme ugradnje, to će ih biti lakše ukloniti.
English: • decreased sexual desire, decreased orgasmic sensation
Croatian: • smanjena seksualna želja, smanjen doživljaj orgazma
English: Sixmo is provided in a carton.
Croatian: Sixmo je pakiran u kutiji.
English: It consists of four implants individually packaged into laminated foil sachets and one individually packaged sterile disposable applicator.
Croatian: Sastoji se od četiri implantata pojedinačno pakirana u vrećice od laminirane folije i jednog zasebno pakiranog sterilnog aplikatora za jednokratnu uporabu.
English: Patients may experience somnolence, especially in the first week following insertion of the implants and should be cautioned in this respect (see section 4.7).
Croatian: Bolesnici mogu osjetiti somnolenciju, osobito u prvom tjednu nakon ugradnje implantata, i na to ih treba upozoriti (vidjeti dio 4.7).
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.
Croatian: U 3 bolesnika liječena u kliničkim ispitivanjima i u 1 bolesnika liječenog nakon stavljanja lijeka u promet nije se moglo utvrditi mjesto na kojem se nalaze implantati ili dijelovi implantata pa stoga nisu bili uklonjeni na kraju liječenja.
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.
Croatian: Opioidima izazvana mioza, promjene u razini svijesti ili promjene u percepciji bola kao simptoma bolesti mogu utjecati na procjenu bolesnikova stanja ili zamaskirati dijagnozu ili klinički tijek istodobno prisutne bolesti.
English: Mark the channel tracks where each implant will be inserted by drawing 4 lines - with each line 40 mm long.
Croatian: Označite mjesta kanalića u koje će se ugraditi svaki pojedini implantat tako što ćete nacrtati 4 crte, svaku duljine 40 mm.
English: Treat these patients with a non-opioid analgesic whenever possible.
Croatian: Kad god je to moguće, liječite ove bolesnike neopioidnim analgeticima.
English: The mortality index was significantly increased in the buprenorphine groups.
Croatian: Indeks mortaliteta bio je značajno povećan u skupinama koje su primale buprenorfin.
English: Frequency categories are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The CDF results for co-primary endpoint 2 were fundamentally the same as for endpoint 1 (p < 0.0001).
Croatian: Rezultati KFD-a za 2. primarnu mjeru ishoda bili su temeljno isti kao i za 1. mjeru ishoda (p < 0,0001).
English: This may be related to existing reduced liver function and ongoing injecting drug use.
Croatian: To može biti povezano s već smanjenom jetrenom funkcijom i intravenskim uzimanjem droga.
English: Step 14: Put on sterile gloves.
Croatian: Korak 14: Navucite sterilne rukavice.
English: In rare cases, implants or partial implants could not be localized and were, therefore, not removed (see section 4.2).
Croatian: U rijetkim se slučajevima nije moglo utvrditi mjesto gdje se nalaze implantati ili dijelovi implantata pa stoga nisu bili uklonjeni (vidjeti dio 4.2).
English: • pressure bandage around 8 cm wide
Croatian: • kompresijski zavoj širine približno 8 cm
English: Almost all of the dose was accounted for in terms of buprenorphine, norbuprenorphine, and two unidentified buprenorphine metabolites.
Croatian: Gotovo cijelu dozu činili su buprenorfin, norbuprenorfin i dva neidentificirana metabolita buprenorfina.
English: Advise the patient on proper care of the insertion site.
Croatian: Bolesniku savjetujte kako da ispravno njeguje mjesto ugradnje.
English: There was a greater occurrence of resorptions and an increase in the number of stillbirths.
Croatian: Češće se događala resporpcija ploda i povećao se broj mrtvorođenih.
English: If buprenorphine is administered to some non-opioid dependent individuals, who are not tolerant to the effects of opioids, potentially fatal respiratory depression may occur.
Croatian: Ako se buprenorfin primjenuje nekim osobama koje nisu ovisne o opioidima, koje nemaju toleranciju na učinke opioida, može nastupiti respiratorna depresija s potencijalno smrtnim ishodom.
English: The reduced level of alertness can make driving and using machines hazardous (see section 4.7).
Croatian: Zbog snižene razine budnosti može biti opasno upravljati vozilima i raditi na strojevima (vidjeti dio 4.7).
English: In this study, approximately 75% of patients reported prescription opioids as the primary opioid of abuse, and 21% of patients reported heroin as the primary opioid of abuse.
Croatian: U tom je ispitivanju približno 75% bolesnika prijavilo ovisnost o opioidnim lijekovima koji se izdaju na recept kao primarni opioid zlouporabe, dok je 21% prijavilo heroin kao primarni opioid uporabe.
English: Buprenorphine and its metabolites are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely.
Croatian: Buprenorfin i njegovi metaboliti se izlučuju u majčino mlijeko u tolikoj mjeri da su učinci na dojenu novorođenčad/dojenčad vjerojatni.
English: • vulvovaginal fungal infection
Croatian: • vulvovaginalna gljivična infekcija
English: The formation of norbuprenorphine was initially found to be performed by CYP3A4; subsequent studies also demonstrated the involvement of CYP2C8.
Croatian: Isprva je pronađeno da se stvaranje norbuprenorfina odvija putem CYP3A4; kasnija ispitivanja pokazala su da je u to uključen i CYP2C8.
English: Despite the use of an open-label comparator arm, this endpoint is considered robust, as it is based on urine toxicology.
Croatian: Unatoč uporabi skupine koja je na otvoren način primala komparator, ova mjera ishoda smatra se pouzdanom jer se temelji na toksikološkim nalazima mokraće.
English: Sixmo contains the active substance buprenorphine, which is a type of opioid medicine.
Croatian: Sixmo sadrži djelatnu tvar buprenorfin, što je vrsta opioidnog lijeka.
English: These underlying factors including confirmation of viral hepatitis status must be taken into consideration before prescribing Sixmo and during treatment.
Croatian: Ove se podležeće čimbenike, uključujući i potvrdu statusa virusnog hepatitisa, mora uzeti u obzir prije propisivanja implantata Sixmo i tijekom liječenja.
English: Number (%) of broken implants
Croatian: Broj (%) slomljenih implantata Broj (%) bolesnika sa slomljenim implantatom (implantatima)
English: The remaining partial implant should be removed using the techniques described in section 4.2 under “Instructions for removal of Sixmo”.
Croatian: Preostali dio implantata treba ukloniti pomoću tehnika opisanih u dijelu 4.2 pod „Upute za uklanjanje implantata Sixmo“.
English: These are very common or common adverse reactions with buprenorphine.
Croatian: To su vrlo česte ili česte nuspojave buprenorfina.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Sixmo in all subsets of the paediatric population for the maintenance treatment of opioid dependence (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Sixmo u svim podskupinama pedijatrijske populacije za terapiju održavanja kod ovisnosti o opioidima (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If the implants are inserted deeply, it is possible that neurovascular injury may occur.
Croatian: Ako se implantati ugrade duboko, moguć je nastanak neurovaskularne ozljede.
English: • reduced consciousness
Croatian: • snižena razina svijesti
English: Furthermore, after establishment of non-inferiority, superiority of Sixmo over sublingual buprenorphine was tested and established (p=0.034).
Croatian: Nadalje, nakon ustanovljene neinferiornosti ispitana je i ustanovljena superiornost implantata Sixmo u odnosu na sublingvalni buprenorfin (p=0,034).
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.
Croatian: Bolesnici osobito mogu osjetiti somnolenciju do tjedan dana nakon supkutane ugradnje; stoga ih se mora upozoriti da osobito u tom razdoblju ne upravljaju vozilima i ne rade na opasnim strojevima.
English: The implants will be inserted through a small 2.5 to 3 mm subcutaneous incision.
Croatian: Implantati se uvode kroz malu supkutanu inciziju od 2,5 do 3 mm.