FrancophonIA/ELRC3.0 huggingface dataset:
English: Withdraw the cannula until the hub is flush with the obturator, then twist the obturator clockwise to lock onto the cannula (Figure 12).
Croatian: Povlačite kanilu sve dok ne bude ispunjena opturatorom, a zatim zakrenite opturator u smjeru kazaljke na satu da se pričvrsti za kanilu (slika 12).
English: • a history of connective tissue disease such as scleroderma • a history of recurrent methicillin-resistant Staphylococcus aureus infections (MRSA)
Croatian: • u anamnezi imate ponavljajuće infekcije uzrokovane bakterijom Staphylococcus aureus rezistentnom na meticilin (MRSA)
English: Adverse drug reactions were categorized as implant or non-implant adverse reactions.
Croatian: Nuspojave su bile kategorizirane kao nuspojave implantata ili nuspojave djelatne tvari.
English: • rash, rash pustular, skin lesion
Croatian: • osip, pustulozni osip, kožna lezija
English: The efficacy and safety of buprenorphine in elderly patients > 65 years has not been established.
Croatian: Djelotvornost i sigurnost buprenorfina u starijih bolesnika u dobi
English: Mean plasma buprenorphine concentrations up to day 28 are based on data from the relative bioavailability study PRO-810 (which had intensive PK sampling), while concentrations after day 28 are based on pooled data from studies PRO-805, PRO-806, PRO-807 and PRO-811.
Croatian: Srednje vrijednosti koncentracija buprenorfina u plazmi do 28. dana temelje se na podacima iz ispitivanja relativne bioraspoloživosti PRO-810 (u kojem se provodilo intenzivno uzimanje uzoraka za farmakokinetičku analizu), dok su koncentracije nakon 28. dana bile temeljene na objedinjenim podacima iz ispitivanja PRO-805, PRO-806, PRO-807 i PRO-811.
English: Reproductive system and breast disorders uncommon dysmenorrhoea, erectile dysfunction
Croatian: Poremećaji reproduktivnog sustava i dojki manje često dismenoreja, erektilna disfunkcija
English: • Avoid moving implants around under the skin or gain a lot of weight after insertion of Sixmo as this may make it difficult to locate implants.
Croatian: Sixmo izbjegavajte pomicati implantate ispod kože ili se jako udebljati jer to može otežati pronalaženje mjesta na kojem se nalaze implantati.
English: Mean steady-state plasma buprenorphine concentrations were consistent across all clinical studies, at approximately 0.5 to 1 ng/mL (with the 4-implant dose), and were maintained for approximately 20 weeks (week 4 through week 24) in a 24-week treatment period.
Croatian: Srednja vrijednost koncentracije buprenorfina u plazmi u stanju dinamičke ravnoteže bila je slična u svim kliničkim ispitivanjima i iznosila je približno 0,5-1 ng/ml (uz dozu 4 implantata), a održala se tijekom približno 20 tjedana
English: The concomitant use of monoamine oxidase inhibitors (MAOI) might produce an exaggeration of the effects of opioids, based on experience with morphine (see section 4.5).
Croatian: Na temelju iskustva s morfinom, istodobna primjena inhibitora monoaminoksidaze (MAO) mogla bi pojačati učinke opioida (vidjeti dio 4.5).
English: Metabolites of buprenorphine accumulate in patients with renal failure.
Croatian: Metaboliti buprenorfina nakupljaju se u bolesnika s bubrežnim zatajenjem.
English: Implants should be removed under aseptic conditions, whereby the following equipment is needed:
Croatian: Za ugradnju implantata u aseptičkim uvjetima potrebna je sljedeća oprema:
English: Table 5: Implant breakage in Sixmo double-blind Phase 3 studies Current technique and training PRO-806
Croatian: Tablica 5: Lomljenje implantata Sixmo u dvostruko slijepim ispitivanjima faze 3
English: Plasma concentrations of buprenorphine after insertion of Sixmo are highest during the first 24 to 48 hours.
Croatian: Sixmo najviše su tijekom prvih 24-48 sati.
English: This should be stopped 12 to 24 hours before insertion of the next set of Sixmo implants.
Croatian: Tu primjenu treba prekinuti 12-24 sata prije ugradnje sljedećeg kompleta implantata Sixmo.
English: Vascular disorders common hot flush, vasodilatation**, hypertension**
Croatian: Krvožilni poremećaji često navale vrućine, vazodilatacija**, hipertenzija**
English: • signs of intoxication or overdose appear (miosis, lip cyanosis, sedation, bradycardia,
Croatian: • ako se pojave znakovi intoksikacije ili predoziranja (mioza, cijanoza usana, sedacija, bradikardija, hipotenzija, respiratorna depresija);
English: After insertion of the implants, the doctor will apply a sterile gauze with a pressure bandage to minimize bruising.
Croatian: Nakon ugradnje implantata liječnik će staviti sterilnu gazu s kompresijskim zavojem da bi smanjio podljev.
English: Investigations common alanine aminotransferase increased uncommon aspartate aminotransferase increased, weight decreased, blood lactate dehydrogenase increased, gamma-glutamyl-transferase increased, weight increased, blood alkaline phosphatase decreased, amylase increased, blood bicarbonate increased, blood bilirubin increased, blood cholesterol decreased, blood glucose increased, haematocrit decreased, haemoglobin decreased, lipase increased, lymphocyte count decreased, mean cell haemoglobin increased, mean cell volume abnormal, monocyte count increased, neutrophil count increased, platelet count decreased, red blood cell count decreased
Croatian: Pretrage često povišena vrijednost alanin aminotransferaze manje često povišena vrijednost aspartat aminotransferaze, smanjena tjelesna težina, povišena vrijednost laktat dehidrogenaze u krvi, povišena vrijednost gama-glutamiltransferaze, povećana tjelesna težina, snižena vrijednost alkalne fosfataze, povišena vrijednost amilaze, povišena vrijednost bikarbonata u krvi, povišena vrijednost bilirubina u krvi, snižena vrijednost kolesterola u krvi, povišena vrijednost glukoze u krvi, sniženi hematokrit, sniženi hemoglobin, povišena vrijednost lipaze, snižen broj limfocita, povećana srednja vrijednost hemoglobina u eritrocitu, poremećena srednja vrijednost volumena eritrocita, povećan broj monocita, povećan broj neutrofila, snižen broj trombocita, snižen broj eritrocita
English: • Please note that an ultrasound and MRI facilities need to be available to the clinical site at which the insertion and removal of Sixmo occurs.
Croatian: • Napominjemo da na klinici gdje se ugrađuju i uklanjaju implantati Sixmo moraju biti dostupni uređaji za ultrazvuk i magnetsku rezonanciju (MR).
English: Step 3: Put on sterile gloves and check the function of the implant applicator by removing the obturator from the cannula and relocking it. Clean the insertion site with an antiseptic solution, such as chlorhexidine.
Croatian: Korak 3: Navucite sterilne rukavice i provjerite funkciju aplikatora implantata tako što ćete izvaditi opturator iz kanile i onda ga vratiti i pričvrstiti.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Sachet
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: Buprenorphine is extensively metabolized in the liver and increased plasma levels were found to be increased in patients with moderate and severe hepatic impairment.
Croatian: Buprenorfin se opsežno metabolizira u jetri i u bolesnika s umjerenim i teškim oštećenjem jetrene funkcije pronađene su povišene razine u plazmi.
English: • One applicator is used to insert all four implants.
Croatian: • Za ugradnju sva četiri implantata koristi se jedan aplikator.
English: Place an adhesive bandage over the incision.
Croatian: Preko incizije stavite flaster.
English: Implants for repeat treatment should be inserted subcutaneously as soon as possible after removal of the previous implants, preferably on the same day.
Croatian: Nakon uklanjanja prethodnih implantata, implantate za ponovno liječenje treba ugraditi supkutano čim prije, po mogućnosti isti dan.
English: In case toxicity or overdose symptoms are observed, the removal of the implants and transition to a medicinal product that allows dose adjustment are required.
Croatian: U slučaju da se opaze simptomi toksičnosti ili predoziranja, potrebno je ukloniti implantate i prebaciti bolesnika na lijek kod kojeg je moguća prilagodba doze.
English: Opioids may produce orthostatic hypotension in ambulatory patients.
Croatian: Opioidi mogu izazvati ortostatsku hipotenziju u bolesnika koji nisu vezani za krevet.
English: In case toxicity or overdose symptoms develop, the removal of the implants and transition to a medicinal product that allows dose adjustment are required.
Croatian: U slučaju da se razviju znakovi i simptomi toksičnosti ili predoziranja, implantate se mora ukloniti i bolesnika prebaciti na lijek koji omogućuje prilagodbu doze.
English: • Implants are located under the skin, at the inner side of the upper arm.
Croatian: • Implantati su smješteni potkožno s unutarnje strane nadlaktice.
English: Alternatively, replacement implant(s) may be inserted in the contralateral arm.
Croatian: Druga je mogućnost ugraditi zamjenski implantat (ili više njih) u suprotnu ruku.
English: Buprenorphine given under the tongue will be stopped 12 to 24 hours before insertion of Sixmo implants.
Croatian: Primjena buprenorfina koji se daje pod jezik prekinut će se 12-24 sata prije ugradnje implantata Sixmo.
English: In the analysis of the CDF (weeks 1 to 16), a statistically significant difference between treatments (p=0.0361) was seen, which was in favour of Sixmo.
Croatian: U analizi KFD-a (od 1. do 16. tjedna) opažena je statistički značajna razlika između terapija
English: One applicator is used to insert all four implants.
Croatian: Za ugradnju sva četiri implantata koristi se jedan aplikator.
English: Modification of the Sixmo dose is not required in patients with renal impairment.
Croatian: Nije potrebna prilagodba doze implantata Sixmo u bolesnika s oštećenjem bubrežne funkcije.
English: A mass balance study of buprenorphine showed complete recovery of radiolabel in urine (30%) and faeces (69%) collected up to 11 days after dosing.
Croatian: (30%) i stolici (69%) prikupljenima do 11. dana nakon doziranja.
English: Higher doses may be required for analgesic effect.
Croatian: Za analgetski učinak mogu biti potrebne više doze pa stoga uz primjenu opioida postoji veća mogućnost toksičnosti.
English: Step 13: The patient should lie on their back, with the implant arm flexed at the elbow and externally rotated, so that the hand is positioned next to the head.
Croatian: Korak 13.: Bolesnik mora ležati na leđima, a ruka u koju će se ugraditi implantat mora biti savijena u laktu i rotirana prema van, tako da mu šaka bude pozicionirana pokraj glave.
English: PATIENT ALERT CARD
Croatian: Kartica s upozorenjima za bolesnika
English: Study PRO-806 had two co-primary endpoints, which were the CDF of the percentage of urine samples that were negative for illicit opioids for Weeks 1 to 24 in the Sixmo and placebo groups (coprimary 1), and the CDF of the percentage of urine samples that were negative for illicit opioids for Weeks 1 to 24 in the Sixmo and placebo groups, with imputation based on illicit drug self-report data (co-primary 2).
Croatian: Sixmo i skupini koja je primala placebo (1. primarna mjera), a druga KFD postotka uzoraka mokraće koji su bili negativni na nedopuštene opioide od 1. do 24. tjedna u skupini s implantatima Sixmo i i skupini koja je primala placebo uz imputaciju na temelju samoprijavljenih podataka o uporabi nedopuštenih droga (2. primarna mjera).
English: Tell your doctor immediately if you have any signs of infection (such as redness or inflammation) at the site of insertion or removal.
Croatian: Ako Vam se pojave ikakvi znakovi infekcije (kao što su crvenilo ili upala) na mjestu ugradnje ili uklanjanja, odmah obavijestite liječnika.
English: Most frequent implant adverse reactions were implant site pain, implant site pruritus, implant site haematoma, implant site haemorrhage, implant site erythema and implant site rash.
Croatian: Najčešće nuspojave implantata bile su bol na mjestu implantata, svrbež na mjestu implantata, hematom na mjestu implantata, krvarenje na mjestu implantata, eritem na mjestu implantata i osip na mjestu implantata.
English: These adverse reactions are presented by MedDRA system organ class, preferred term, and frequency.
Croatian: Te su nuspojave prikazane prema MedDRA-inoj klasifikaciji organskih sustava, preporučenim pojmovima i učestalosti.
English: Sixmo implants are intended to be in place for 6 months and provide a continuous delivery of buprenorphine.
Croatian: Sixmo namijenjeni su tome da tijekom 6 mjeseci od ugradnje osiguravaju neprekidnu isporuku buprenorfina.
English: Buprenorphine has the potential to be abused and is prone to criminal diversion.
Croatian: Pogrešna primjena i nedopuštena uporaba Kod buprenorfina postoji mogućnost zlouporabe i nedopuštene uporabe u kriminalne svrhe.
English: Removal of Sixmo implants
Croatian: Uklanjanje implantata Sixmo Implantati
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Croatian: Spektar abnormalnosti obuhvaća sve od prolaznih asimptomatskih povišenja jetrenih transaminaza do opisa slučajeva zatajenja jetre, nekroze jetre,
English: LIST OF EXCIPIENTS Excipient: Ethylene vinyl acetate copolymer
Croatian: Pomoćna tvar: etilenvinilacetat kopolimer
English: Schedule an appointment for the sutures to be removed.
Croatian: Dogovorite sljedeći pregled zbog uklanjanja šava.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan implantat sadrži 74,2 mg buprenorfina u obliku buprenorfin hidroklorida.
English: Figure 12
Croatian: Slika 12
English: • constipation, nausea, vomiting, diarrhoea
Croatian: • zatvor, mučnina, povraćanje, proljev
English: Retract the applicator, bevel-up, until the distal marking of the cannula is visible at the incision opening (the sharp tip remaining in the subcutaneous space).
Croatian: Sada aplikator, s urezanom oznakom koja gleda prema gore, izvlačite sve dok u otvoru incizije ne ugledate distalnu oznaku na kanili (oštri vrh ostaje u supkutanom prostoru).
English: The following factors should be considered when determining clinical stability and suitability for Sixmo treatment:
Croatian: Kad se određuje klinička stabilnost i prikladnost za liječenje implantatom Sixmo, potrebno je razmotriti sljedeće čimbenike:
English: • The holder of this card uses a buprenorphine only opioid dependence treatment called Sixmo.
Croatian: • Vlasnik ove kartice liječi se od ovisnosti o opioidima implantatima
English: • sterile ruler
Croatian: • sterilno ravnalo
English: Verify the location of the implants by palpation.
Croatian: Ponovno palpacijom provjerite mjesto na kojem se nalaze implantati.
English: Psychiatric disorders common insomnia, anxiety, hostility**, nervousness**, paranoia** uncommon depression, libido decreased, sleep disorder, apathy, euphoric mood, orgasmic sensation decreased, restlessness, irritability, drug dependence***, agitation***, thinking abnormal***
Croatian: manje često depresija, smanjeni libido, poremećaj spavanja, apatija, euforično raspoloženje, smanjen doživljaj orgazma, nemir, razdražljivost, ovisnost***, agitacija***, abnormalno razmišljanje***
English: Having the patient flex the biceps muscle may facilitate identification of the site (Figure 2).
Croatian: Mjesto ugradnje lakše će se prepoznati ako bolesnik napne biceps (slika 2).
English: • thin adhesive strip around 6 mm wide (butterfly strip)
Croatian: • tanka samoljepiva kirurška traka širine oko 6 mm (leptirasta traka)
English: • increased or decreased weight, including abnormal weight gain
Croatian: • povišena ili snižena tjelesna težina, uključujući neuobičajeno dobivanje na težini • dehidracija, pojačan apetit
English: Table 1: Adverse reactions reported in clinical studies and from post-marketing data with Sixmo and/or reported with other buprenorphine product System organ class
Croatian: Sixmo u promet i/ili zabilježene uz druge lijekove koji sadrže buprenorfin Klasifikacija organskog sustava
English: Figure 17
Croatian: Slika 17
English: Step 1: The patient should lie on their back, with the intended arm flexed at the elbow and externally rotated, so that the hand is positioned next to the head.
Croatian: Korak 1: Bolesnik mora ležati na leđima, a ruka u koju će se ugraditi implantat mora biti savijena u laktu i rotirana prema van, tako da mu šaka bude pozicionirana pokraj glave.
English: This study enrolled 84 patients in the Sixmo group and 89 patients in the sublingual buprenorphine group, with a median age (range) of 36 (21 to 63) years and 37 (22 to 64) years in the Sixmo and sublingual buprenorphine groups, respectively.
Croatian: (raspon) od 36 (od 21 do 63) godina u skupini kojoj je ugrađen Sixmo i 37 (od 22 do 64) godina u skupini koja je primala sublingvalni buprenorfin.
English: • #15 blade scalpel
Croatian: • skalpel oštrice br.15
English: • abnormal sensation such as prickling, “pins and needles”, tingling and itchiness
Croatian: • neuobičajeni osjeti kao što su bockanje, trnci, žmarci i svrbež
English: Apply a pressure bandage with sterile gauze to minimize bruising.
Croatian: Stavite kompresijski zavoj sa sterilnom gazom kako biste smanjili nastanak modrice.
English: Counsel the patient on proper aseptic wound care.
Croatian: Objasnite mu kako da na ispravan, aseptični način njeguje ranu.
English: Subcutaneous insertion is essential to confirm proper placement by palpation.
Croatian: Nakon supkutane ugradnje, palpacijom se mora potvrditi da su implantati pravilno postavljeni.
English: • urinary hesitation, urge to urinate, urinating more frequently with little urinary output
Croatian: • otežan početak mokrenja, urinarna urgencija (neodgodiv poriv na mokrenje), češće mokrenje malih količina mokraće
English: Place a small adhesive bandage over the insertion site.
Croatian: Mjesto incizije prekrijte malim flasterom.
English: Number (%) of patients with broken implant(s) N=number of patients with data available.
Croatian: N=broj bolesnika s dostupnim podacima
English: • medicines which calm, induce sleep or relax muscles, with active substance names ending with “azepam” This combination may result in death due to breathing depression.
Croatian: • lijekove za smirenje, spavanje ili opuštanje mišića, s djelatnim tvarima čiji nazivi završavaju na
English: • migraine, tremor
Croatian: • migrena, tremor (nevoljno drhtanje)
English: • Liver damage, including liver failure, has been reported when using buprenorphine.
Croatian: • Za vrijeme primjene buprenorfina zabilježeno je oštećenje jetre, uključujući zatajenje jetre.
English: Study PRO-805 (ITT)
Croatian: tjedna, ispitivanje PRO-805 (ITT) Postotak negativnih rezultata
English: Infection may occur at the site of the insertion or removal.
Croatian: Na mjestu ugradnje ili uklanjanja može nastati infekcija.
English: Equipment for subcutaneous insertion of Sixmo
Croatian: Oprema za supkutanu ugradnju implantata Sixmo
English: Rare but serious complications, including nerve damage and migration resulting in embolism and death, may result from improper insertion of drug implants in the upper arm. Additional complications may include local migration, protrusion, expulsion and implant breakage after insertion or during removal.
Croatian: Rijetke, ali ozbiljne komplikacije uključujući oštećenje živca i migraciju s posljedičnom embolijom i smrću mogu biti posljedica neispravne ugradnje implantata s lijekom u nadlakticu.
English: • dizziness, drowsiness
Croatian: • omaglica, omamljenost
English: Figure 14
Croatian: Slika 14
English: Sublingual buprenorphine should be discontinued 12 to 24 hours prior to insertion of four Sixmo implants.
Croatian: Primjenu sublingvalnog buprenorfina treba prekinuti 12-24 sata prije ugradnje četiri implantata Sixmo.
English: For patients returning for subsequent treatment with Sixmo, preparations should be made to perform both the removal and insertion of Sixmo at the same visit.
Croatian: Sixmo potrebno je napraviti pripreme i za uklanjanje i za ugradnju implantata Sixmo kod istog dolaska.
English: Especially, inform your doctor during Sixmo treatment before using:
Croatian: Osobito obavijestite liječnika tijekom liječenja implantatima
English: This product may cause dizziness, somnolence or sedation especially at the start of treatment.
Croatian: Ovaj lijek može uzrokovati omaglicu, somnolenciju ili sedaciju,
English: • reduced kidney function
Croatian: • smanjenu bubrežnu funkciju
English: Sublingual buprenorphine should be discontinued 12 to 24 hours prior to subcutaneous insertion of Sixmo implants.
Croatian: Primjenu sublingvalnog buprenorfina treba prekinuti 12-24 sata prije supkutane ugradnje implantata Sixmo.
English: There should be at least 5 mm between the incision and the implant when the implant is properly positioned.
Croatian: Kad je implantat ispravno postavljen, između incizije i implantata treba biti najmanje 5 mm.
English: IMPORTANT INFORMATION Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Croatian: VAŽNE INFORMACIJE Svaki implantat sadrži 74,2 mg buprenorfina u obliku buprenorfin hidroklorida.
English: Do not drink alcohol during Sixmo treatment, as it increases the sedative effect.
Croatian: Nemojte piti alkohol za vrijeme liječenja implantatima
English: Prior to initiating Sixmo therapy, the patient's medical and treatment history, including use of nonopioid psychoactive substances, needs to be reviewed, in order to ensure that Sixmo treatment can be safely initiated.
Croatian: uključujući uzimanje neopioidnih psihoaktivnih tvari, kako bi se osiguralo da se sigurno može započeti liječenje implantatima Sixmo.
English: • 1 implant applicator
Croatian: • 4 implantata Sixmo • 1 aplikator implantata
English: Instructions for removal of Sixmo
Croatian: Upute za uklanjanje implantata Sixmo
English: • mosquito forceps
Croatian: • hvataljka po Mosquitu
English: Patients who elect to discontinue Sixmo treatment should be monitored for withdrawal syndrome, with consideration given to use of a tapering dose of sublingual buprenorphine.
Croatian: Sixmo treba pratiti zbog mogućeg sindroma ustezanja te razmotriti postupno snižavanje doze sublingvalnog buprenorfina.
English: ITT=intent-to-treat, SL BPN = sublingual buprenorphine Buprenorphine was not included in urine toxicology assessments.
Croatian: ITT=populacija planirana za liječenje (engl. intent-to-treat), SL BPN=sublingvalni buprenorfin
English: There are no prospective data with Sixmo beyond two treatment cycles, and there is no experience with inserting Sixmo implants into other sites of the arm, sites other than the upper arm or re-insertion into previously-used sites.
Croatian: Sixmo na druga mjesta na ruci ili na neka druga mjesta osim nadlaktice, kao ni s ponovnom ugradnjom u već korištena mjesta.
English: • breathing depression, yawning
Croatian: • depresija disanja, zijevanje
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant
Croatian: NAZIV LIJEKA Sixmo 74,2 mg implantat
English: Frequency Adverse reactions Infections and infestations common viral infection, bronchitis**, infection**, influenza**, pharyngitis**, rhinitis** uncommon cellulitis, skin infection, peritonsillar abscess, rash pustular, urinary tract infection, vulvovaginal mycotic infection, implant site infection*, implant site abscess*
Croatian: Infekcije i infestacije često virusna infekcija, bronhitis**, infekcija**, influenca**, faringitis**, rinitis** manje često celulitis, kožna infekcija, peritonzilarni apsces,
English: • slow heartbeat, abnormal heart rhythm that starts in the atrial chambers of the heart
Croatian: • iscjedak iz oka, zamagljen vid, poremećaj suzenja • usporen rad srca, poremećen srčani ritam koji počinje u srčanim pretklijetkama
English: Patients who develop hepatic impairment while being treated with Sixmo should be monitored for signs and symptoms of toxicity or overdose.
Croatian: Sixmo treba pratiti zbog moguće pojave znakova i simptoma toksičnosti ili predoziranja.