FrancophonIA/ELRC3.0 huggingface dataset:
English: Also, scan or input the details of the implant procedure into the patient's medical records.
Croatian: Također skenirajte i unesite podatke o postupku ugradnje implantata u zdravstveni karton bolesnika.
English: • nefazodone: a medicine to treat depression
Croatian: • nefazodon: lijek za liječenje depresije
English: Therefore, breastfeeding should be discontinued during treatment with Sixmo.
Croatian: Stoga dojenje treba prekinuti za vrijeme liječenja lijekom Sixmo.
English: • If the patient returns the expelled implant, it should be measured to ensure that the entire implant was expelled (26.5 mm in length).
Croatian: • Ako bolesnik donese izbačeni implantat, treba ga izmjeriti kako biste bili sigurni da je izbačen cijeli implantat (duljine 26,5 mm).
English: Of these 309 patients, 107 patients were treated for an additional 6 months in extension studies (i.e. for 2 implant cycles).
Croatian: U produžecima ispitivanja, 107 od ovih 309 bolesnika bilo je liječeno još dodatnih 6 mjeseci (tj. tijekom 2 ciklusa implantata).
English: Pups born tended to weigh less on postnatal day 1 compared with controls.
Croatian: Okoćena mladunčad pokazivala je tendenciju manje težine 1. postnatalnog dana u usporedbi s kontrolama.
English: • The patient should be instructed to place the implant in a glass jar with a lid, store it safely away from others, especially children, and bring it to the healthcare professional to determine whether the full implant has been expelled.
Croatian: • Bolesniku treba savjetovati da stavi implantat u staklenku s poklopcem i spremi je na sigurno mjesto podalje od drugih, osobito djece, te da je donese liječniku kako bi mogao odrediti je li bio izbačen cijeli implantat.
English: • verapamil, diltiazem, amiodarone: medicines to treat high blood pressure and heart disorders
Croatian: • verapamil, diltiazem, amiodaron: lijekovi za liječenje visokog krvnog tlaka i srčanih poremećaja
English: The safety of Sixmo was evaluated in five Phase 3 studies (3 double-blind and placebo and/or activecontrolled studies, and two open-label extension studies).
Croatian: Sixmo procijenjena je u pet ispitivanja faze 3 (3 dvostruko slijepa i placebom i/ili aktivnim komparatorom kontrolirana ispitivanja te dva otvorena produžetka ispitivanja).
English: Suitable methods for location include ultrasound with a high frequency linear array transducer (10 MHz or greater) or, in case ultrasound is not successful, magnetic resonance imaging (MRI).
Croatian: Pogodne metode za utvrđivanje mjesta gdje se nalaze implantati uključuju ultrazvuk s linearnom sondom visoke frekvencije (10 MHz ili veće) ili, u slučaju da ultrazvuk ne bude uspješan, slikovni prikaz magnetskom rezonancijom (MR).
English: Sublingual buprenorphine N=119
Croatian: Sublingvalni buprenorfin N=119
English: • clarithromycin, erythromycin, troleandomycin: medicines to treat bacterial infections
Croatian: • klaritromicin, eritromicin, troleandomicin: lijekovi za liječenje bakterijskih infekcija
English: Patient characteristics in these studies are shown below.
Croatian: Značajke bolesnika u tim ispitivanjima prikazane su u daljnjem tekstu.
English: • swelling, including tissue swelling in arms, legs or face caused by excess fluid
Croatian: • oticanje, uključujući oticanje tkiva na rukama, nogama ili licu prouzročeno prekomjernom tekućinom
English: • drug withdrawal syndrome, such as sweating, feeling hot and cold
Croatian: • sindrom ustezanja od droge, kao što je znojenje, osjećaj vrućine i hladnoće
English: • Substances like buprenorphine may cause a sudden drop in blood pressure, causing dizziness when getting up quickly.
Croatian: • Tvari poput buprenorfina mogu uzrokovati iznenadni pad krvnog tlaka, što uzrokuje omaglicu kod brzog ustajanja.
English: These risks and the patient's stability in treatment for opioid dependence should be considered when determining whether Sixmo is appropriate for the patient.
Croatian: Potrebno je uzeti u obzir ove rizike i stabilnost bolesnika koji se liječi od ovisnosti o opioidima kad se određuje je li Sixmo prikladan za bolesnika.
English: In this analysis, the percentage of opioid negative urines in the sublingual buprenorphine group was very similar to the results in the Sixmo group (33% versus 31%), and non-inferiority of Sixmo to sublingual buprenorphine was shown.
Croatian: U ovoj analizi, postotak uzoraka mokraće negativnih na opioide u skupini koja je primala sublingvalni buprenorfin bio je sličan rezultatima u skupini koja je dobila Sixmo (33% naspram 31%), a neinferiornost implantata Sixmo prema sublingvalnom buprenorfinu je dokazana.
English: Supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary oedema as indicated.
Croatian: Potporne mjere (uključujući kisik i vazopresore) moraju se primijeniti u zbrinjavanju cirkulacijskog šoka i plućnog edema, kako je indicirano.
English: This risk increases when additionally using alcohol or other substances.
Croatian: Taj se rizik povećava kad se istodobno uzimaju alkohol ili druga sredstva.
English: If opioid therapy is required as part of anaesthesia, patients should be continuously monitored in an anaesthesia care setting by persons not involved in the conduct of the surgical or diagnostic procedure.
Croatian: Ako je opioidnu terapiju potrebno primijeniti u sklopu anestezije, bolesnici trebaju neprekidno biti pod anesteziološkim nadozorom osoba koje nisu uključene u provođenje kirurškog ili dijagnostičkog postupka.
English: You may fell dizzy, drowsy and less alert.
Croatian: Možete osjećati omaglicu, omamljenost i smanjenu budnost.
English: • The replacement implant(s) should be inserted in same arm either medially or laterally to in situ implants.
Croatian: • Zamjenski implantat (ili više njih) treba ugraditi u istu ruku medijalno ili lateralno od implantata in situ.
English: Name and address of the manufacturer of the active substance
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: The doctor will monitor you until the implant is replaced to evaluate for withdrawal symptoms.
Croatian: Liječnik će Vas pratiti do zamjene implantata kako bi mogao procijeniti simptome ustezanja.
English: • mental condition, chracterised by delusions and irrationality
Croatian: • mentalno stanje karakterizirano sumanutim mislima i iracionalnošću
English: Stop immediately once the proximal marking on the cannula has disappeared into the incision (Figures 7 and 8).
Croatian: Zaustavite se čim proksimalna oznaka na kanili nestane ispod ruba incizije (slike 7 i 8).
English: Patients not adequately treated with the 4 implant dose could receive a fifth implant.
Croatian: Bolesnici koji nisu bili odgovarajuće liječeni dozom iz 4 implantata mogli su dobiti peti implantat.
English: • Always keep this card with you while on treatment.
Croatian: • Dok traje liječenje, uvijek nosite ovu karticu sa sobom.
English: The insertion site should be examined one week following implant insertion and regularly thereafter for signs of infection or any problems with wound healing, including evidence of implant extrusion from the skin as well as misuse or abuse.
Croatian: Mjesto ugradnje treba pregledati tjedan dana nakon ugradnje implantata te redovito nakon toga zbog mogućih znakova infekcije ili problema sa zarastanjem rane, uključujući znakove ekstruzije implantata iz kože, pogrešne primjene i zlouporabe.
English: It must be handled with adequate security and accountability for proper disposal in accordance with local requirements.
Croatian: Njime je potrebno rukovati uz odgovarajuće mjere sigurnosti i na odgovoran ga način ispravno zbrinuti u skladu s nacionalnim propisima.
English: • The safety concerns associated with SIXMO therapy (i.e. potential life-threatening interactions with other, concomitant therapies)
Croatian: • sigurnosna pitanja povezana s terapijom implantatima SIXMO (tj. moguće životno opasne interakcije s drugim istodobono primijenjenim terapijama)
English: Exploratory surgery without knowledge of the exact location of all implants is strongly discouraged.
Croatian: Eksplorativni kirurški zahvat bez poznavanja točnog mjesta svih implantata nikako se ne preporučuje.
English: Generally, breakage was not perceived as a safety concern to the patient by the investigator.
Croatian: Uglavnom, ispitivač nije smatrao lomljenje implantata razlogom za zabrinutost u pogledu sigurnosti za bolesnika.
English: Median (Range)
Croatian: Medijan (raspon)
English: The demonstration of efficacy relies primarily on study PRO-814, a randomized, double-blind and active-controlled Phase 3 study in adult patients who met DSM-IV-TR criteria for opioid dependence and who were clinically stabilised on sublingual buprenorphine.
Croatian: Dokaz djelotvornosti temelji se prvenstveno na ispitivanju PRO-814, randomiziranom, dvostruko slijepom ispitivanju faze 3 s aktivnom kontrolom u odraslih bolesnika koji su ispunjavali kriterije DSM-IV-TR za ovisnost o opioidima i bili klinički stabilizirani na sublingvalnom buprenorfinu.
English: Non-palpable implants must be located prior to attempted removal.
Croatian: Implantati koji se ne mogu palpirati moraju biti locirani prije pokušaja uklanjanja.
English: Buprenorphine may cause drowsiness, particularly when taken together with alcohol or CNS depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Croatian: Buprenorfin može uzrokovati omamljenost, osobito kad se uzima zajedno s alkoholom ili depresorima SŽS-a (kao što su trankvilizanti, sedativi ili hipnotici) (vidjeti dio 4.5).
English: Do not blot or wipe away.
Croatian: Nemojte tapkanjem sušiti ili brisati to mjesto.
English: • The active substance is buprenorphine.
Croatian: • Djelatna tvar je buprenorfin.
English: Pharmacotherapeutic group: Other nervous system drugs, Drugs used in opioid dependence, ATC code: N07BC01
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: ostali lijekovi s djelovanjem na živčani sustav, lijekovi za liječenje ovisnosti, ATK oznaka: N07BC01
English: After determining the anaesthesia is adequate and effective, make a 7 to 10 mm incision with a scalpel, parallel to the axis of the arm, between the second and third implants.
Croatian: Nakon što utvrdite da je nastupila odgovarajuća i učinkovita anestezija, napravite skalpelom inciziju duljine 7-10 mm, paralelno s osi ruke, između drugog i trećeg implantata.
English: Its activity in opioid maintenance treatment is attributed to its slowly reversible properties at the µ receptors which, over a prolonged period, minimises the need for use of other opioids.
Croatian: Njegovo djelovanje u terapiji održavanja opioidima pripisuje se njegovim sporim reverzibilnim svojstvima na µ receptorima, što tijekom duljeg razdoblja smanjuje potrebu za uzimanjem drugih opioda na najmanju moguću mjeru.
English: The insertion and removal of Sixmo should take place in a setting that allows for insertion under aseptic conditions, where the patient is able to lie on their back.
Croatian: Ugradnja i uklanjanje implantata Sixmo moraju se provesti u okruženju koje omogućuje ugradnju pod aseptičkim uvjetima, gdje bolesnik može ležati na leđima.
English: Excessive palpation shortly after insertion of the implants may increase the chance of infection.
Croatian: Pretjerana palpacija neposredno nakon ugradnje implantata može povećati šansu za infekciju.
English: • Opioid analgesics: Adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine.
Croatian: • Opioidni analgetici: odgovarajuću analgeziju može biti teško postići kad se bolesnicima koji primaju buprenorfin primjenjuje potpuni opioidni agonist.
English: Instruction for location of implants prior to removal
Croatian: Upute za utvrđivanje mjesta implantata prije njihova uklanjanja
English: Clinical efficacy and safety with Sixmo
Croatian: Klinička djelotvornost i sigurnost implantata Sixmo
English: The patient alert card should mention:
Croatian: kartici s upozorenjima za bolesnika mora biti navedeno sljedeće:
English: CI=confidence interval, ITT=intent-to-treat, N=number of subjects, SE=standard error
Croatian: CI=raspon pouzdanosti, ITT=planirani za liječenje (engl. intent-to-treat), N=broj ispitanika, SE=standardna pogreška
English: Opioids may elevate cerebrospinal fluid pressure, which may cause seizures, so opioids should be used with caution in patients with head injury, intracranial lesions, other circumstances where cerebrospinal pressure may be increased, or history of seizure.
Croatian: Opioidi mogu povećati tlak cerebrospinalne tekućine, što može uzrokovati napadaje, tako da je opioide potrebno primjenjivati s oprezom u bolesnika s ozljedom glave, intrakranijalnim lezijama, drugim stanjima kod kojih cerebrospinalni tlak može biti povišen ili kod napadaja u anamnezi.
English: • The healthcare professional must carefully monitor the patient until the implant is replaced to evaluate for withdrawal or other clinical indicators suggesting that supplemental sublingual buprenorphine may be needed.
Croatian: • Liječnik mora pažljivo pratiti bolesnika do zamjene implantata kako bi procijenio jesu li prisutni znakovi ustezanja ili drugi klinički pokazatelji koji ukazuju na moguću potrebu za dodatnim sublingvalnim buprenorfinom.
English: Step 10: Verify the presence of each implant (26.5 mm in length) by palpation of the patient's arm immediately after the insertion, as shown in Figure 14.
Croatian: Korak 10: Neposredno nakon ugradnje provjerite prisutnost svakog implantata (duljine 26,5 mm) palpacijom ruke bolesnika, kako je prikazano na slici 14.
English: The implant applicator (disposable) and its parts are shown in Figure 1.
Croatian: Aplikator implantata (za jednokratnu uporabu) i njegovi dijelovi prikazani su na slici 1.
English: • painful period, erectile dysfunction
Croatian: • bolne menstruacije, erektilna disfunkcija
English: • 100×100 mm sterile gauze
Croatian: • sterilna gaza dimenzija 100×100 mm
English: • small bleeds beneath the skin
Croatian: • sitna krvarenja pod kožom
English: • pain and dysfunction of chewing muscles and joints called temporomandibular joint syndrome
Croatian: • bol i poremećena funkcija žvakačih mišića i zglobova pod nazivom sindrom temporomandibularnog zgloba
English: Renal elimination may be prolonged since 30% of the administered dose is eliminated by the renal route.
Croatian: Eliminacija bubrezima može biti produljena jer se 30% primijenjene doze eliminira putem bubrega.
English: Before engaging driving or operating hazardous machinery patients should be reasonably certain that Sixmo does not adversely affect their ability to engage in such activities.
Croatian: Prije nego što počnu upravljati vozilima ili raditi na opasnim strojevima, bolesnici moraju biti u razumnoj mjeri sigurni da Sixmo nema štetan utjecaj na njihovu sposobnost obavljanja takvih radnji.
English: Due to the inflexibility with regard to dose increases and to the increased dose requirements during pregnancy, Sixmo is not considered to be an optimal treatment choice for pregnant women, therefore treatment with Sixmo should not be started in pregnant women.
Croatian: Zbog nemogućnosti povećavanja doze i potrebe za povišenom dozom tijekom trudnoće, Sixmo se ne smatra optimalnim izborom liječenja u trudnica pa se stoga liječenje implantatima
English: The safety and efficacy of Sixmo was investigated in 3 double-blind Phase 3 clinical studies in which a total of 309 patients were treated with Sixmo for up to 6 months (1 implant cycle).
Croatian: Sixmo ispitane su u 3 dvostruko slijepa klinička ispitivanja faze 3 u kojima je ukupno 309 bolesnika bilo liječeno implantatima Sixmo u trajanju do 6 mjeseci (1 ciklus implantata).
English: Patients should be warned that it is extremely dangerous to selfadminister non-prescribed benzodiazepines while taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their healthcare professional (see section 4.4).
Croatian: Bolesnike treba upozoriti da je krajnje opasno vlastitom odlukom istodobno s ovim lijekom uzimati benzodiazepine koji im nisu propisani, te ih se također treba upozoriti da benzodiazepine uzimaju istodobno s ovim lijekom samo prema uputama njihovog liječnika (vidjeti dio 4.4).
English: There are no or limited data on effects of buprenorphine on human fertility (see section 5.3).
Croatian: Nema podataka ili su podaci o učincima buprenorfina na plodnost u ljudi ograničeni (vidjeti dio 5.3).
English: Clean removal site with alcohol pad prior to marking the skin.
Croatian: Obrišite mjesto uklanjanja alkoholnim tupferom prije nego što nacrtate oznake na koži.
English: Buprenorphine can influence the ability to drive and use machines and may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Buprenorfin može utjecati na sposobnost upravljanja vozilima i rada sa strojevima te može narušiti mentalne ili fizičke sposobnosti potrebne za izvođenje potencijalno opasnih radnji kao što su upravljanje vozilom ili strojevima.
English: During clinical pharmacologic studies in opioid-dependent patients, buprenorphine shows ceiling effects on a number of PD and safety parameters.
Croatian: Tijekom kliničkih farmakoloških ispitivanja u bolesnika s ovisnošću o opioidima, buprenorfin pokazuje gornju granicu djelovanja (engl. ceiling effect) u mnogim farmakodinamičkim i sigurnosnim parametrima.
English: • antiseptic solution, such as chlorhexidine
Croatian: • antiseptička otopina, kao što je klorheksidin
English: However, pups exposed to opioids postnatally exhibited significant body weights reductions.
Croatian: Međutim, mladunčad postnatalno izložena opiodima imala je značajno smanjenu tjelesnu težinu.
English: Sixmo is not recommended for patients over 65 years.
Croatian: Sixmo se ne preporučuje u bolesnika u dobi iznad 65 godina.
English: • have acute alcoholism or alcohol delirium caused by withdrawal from alcohol
Croatian: • ako imate akutni alkoholizam ili alkoholni delirij uzrokovan ustezanjem od alkohola
English: • Monoamine oxidase inhibitors (MAOI): Possible exacerbation of the effects of opioids, based on experience with morphine.
Croatian: • Inhibitori monoaminoksidaze (MAOI): moguće egzacerbacije učinaka opioida, na temelju iskustva s morfinom.
English: Towards the end of pregnancy buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration.
Croatian: Prema kraju trudnoće buprenorfin može izazvati respiratornu depresiju u novorođenčeta, čak i nakon kratkog razdoblja primjene.
English: Clinical studies of Sixmo did not include patients over 65 years and, therefore, the use of the product in this population is not recommended.
Croatian: Klinička ispitivanja implantata Sixmo nisu uključila bolesnike starije od 65 godina pa se stoga ne preporučuje primjena ovog lijeka u te populacije.
English: Literature data indicated no genotoxic properties of buprenorphine.
Croatian: Podaci iz literature pokazuju da buprenorfin nema genotoksična svojstva.
English: Step 2: Clean the insertion site with an alcohol pad.
Croatian: Korak 2: Obrišite mjesto ugradnje alkoholnim tupferom.
English: Before inserting Sixmo, your doctor will give you a local anaesthetic to numb the area.
Croatian: Sixmo liječnik će Vam dati lokalni anestetik da bi umrtvio to područje.
English: • The insertion and removal of Sixmo should take place under aseptic conditions.
Croatian: • Ugradnja i uklanjanje implantata Sixmo moraju se provesti u aseptičkim uvjetima.
English: Use the sterile gauze and apply gentle pressure to the incision site, for five minutes, to ensure haemostasis.
Croatian: Upotrijebite sterilnu gazu i nježno pritisnite mjesto incizije na pet minuta, radi hemostaze.
English: • CYP3A4 inhibitors and inducers: Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when Sixmo is given concurrently with medicinal products that affect CYP3A4 activity.
Croatian: • Inhibitori i induktori CYP3A4: buprenorfin se metabolizira do norbuprenorfina prvenstveno putem CYP3A4; stoga mogu nastati potencijalne interakcije kad se uz Sixmo istodobno daju lijekovi koji utječu na aktivnost CYP3A4.
English: Ostravska 29/305
Croatian: TEVA Czech Industries s.r.o. Ostravska 29/305
English: • Misuse and abuse: If buprenorphine is abused it can lead to overdose and death.
Croatian: • Pogrešna primjena i zlouporaba: Zlouporaba buprenorfina može dovesti do predoziranja i smrti.
English: In this double-blind and double-dummy study, patients maintained on doses of sublingual buprenorphine of 8 mg/day or less were transferred to 4 Sixmo implants (and daily sublingual placebo), or sublingual buprenorphine 8 mg/day or less (and 4 placebo implants).
Croatian: U tom dvostruko slijepom ispitivanju s dvostrukim placebom, bolesnici na dozi održavanja sublingvalnim buprenorfinom od 8 mg na dan ili nižom bili su prebačeni na 4 implantata Sixmo (i svakodnevni sublingvalni placebo) ili sublingvalni buprenorfin u dozi od 8 mg na dan ili nižoj (i 4 placebo implantata).
English: Abuse of buprenorphine poses a risk of overdose and death.
Croatian: Zlouporaba buprenorfina predstavlja rizik od predoziranja i smrti.
English: The incision should be made parallel to the axis of the arm, between the second and third implants, to access the subcutaneous space (Figure 15).
Croatian: Inciziju treba napraviti paralelno s osi ruke, između drugog i trećeg implantata, kako bi se pristupilo supkutanom prostoru (slika 15).
English: If spontaneous expulsion of the implant occurs after insertion, the following steps should be taken:
Croatian: Ako nakon ugradnje nastupi spontana ekspulzija implantata, potrebno je poduzeti sljedeće korake:
English: Exploratory surgery without knowledge of the exact location of all implants is strongly discouraged (see section 4.4).
Croatian: Eksplorativni kirurški zahvat bez poznavanja točnog mjesta svih implantata nikako se ne preporučuje (vidjeti dio 4.4).
English: The opioid therapy must be provided by healthcare professionals trained in the use of anaesthetic medicinal products and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation.
Croatian: Opioidnu terapiju moraju davati liječnici obučeni u primjeni anestetičkih lijekova i zbrinjavaju respiratornih učinaka jakih opioida, osobito uspostavljanja i održavanja prohodnosti dišnih puteva i potpomognute ventilacije.
English: Sixmo should be used only in patients who are opioid tolerant.
Croatian: Sixmo se smije primijeniti samo u bolesnika koji podnose opioide.
English: • reduced adrenal gland function, such as Addison's disease
Croatian: • smanjenu aktivnost štitne žlijezde • smanjenu funkciju nadbubrežnih žlijezda, kao što je Addisonova bolest
English: In urine, most of the buprenorphine and norbuprenorphine was conjugated (buprenorphine: 1% free and 9.4% conjugated; norbuprenorphine: 2.7% free and 11% conjugated).
Croatian: U mokraći su buprenorfin i norbuprenorfin većinom bili u konjugiranom obliku (buprenorfin: 1% slobodan i 9,4% konjugiran; norbuprenorfin: 2,7% slobodan i 11% konjugiran).
English: MOLTeNI-2019-01 - A prospective, observational (non-interventional), postauthorisation safety cohort study to evaluate the incidence of the breakages and insertion/removal complications of buprenorphine implants (Sixmo) in the routine clinical care
Croatian: MOLTeNI-2019-01 - Prospektivno, opservacijsko (neintervencijko) kohortno ispitivanje sigurnosti primjene nakon stavljanja u promet radi procjene incidencije lomljenja implantata s buprenorfinom (Sixmo) i komplikacija pri njihovoj ugradnji/uklanjanju u rutinskoj kliničkoj praksi
English: In faeces, almost all of the buprenorphine and norbuprenorphine were free (buprenorphine: 33% free and 5% conjugated; norbuprenorphine: 21% free and 2% conjugated).
Croatian: U stolici su gotovo sav buprenorfin i norbuprenorfin bili u slobodnom obliku (buprenorfin: 33% slobodan i 5% konjugiran; norbuprenorfin: 21% slobodan i 2% konjugiran).