FrancophonIA/ELRC3.0 huggingface dataset:
English: • have severe breathing problems
Slovenian: • če imate hude težave z dihanjem;
English: Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence
Slovenian: Sočasna uporaba antagonistov opioidov (naltrekson, nalmefen) za zdravljenje odvisnosti od alkohola ali opioidov
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Sixmo za vse podskupine pediatrične populacije pri vzdrževalnem zdravljenju odvisnosti od opioidov
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.
Slovenian: Priporočljivo je, da je zdravstveni strokovnjak med celotnim postopkom vstavljanja v sedečem položaju, tako da lahko s strani jasno vidi mesto vstavitve in premikanje igle tik pod kožo.
English: • fatigue, chills, weakness, increased muscle tone
Slovenian: • utrujenost, mrzlica, šibkost, povečanje mišičnega tonusa,
English: Patients receiving Sixmo should be closely monitored for signs of toxicity if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole and itraconazole, or macrolide antibiotics).
Slovenian: Bolnike, ki uporabljajo zdravilo Sixmo, je treba pozorno spremljati glede znakov toksičnosti, če sočasno jemljejo močne zaviralce encima CYP3A4 (npr. zaviralce proteaze, kot so ritonavir, nelfinavir ali indinavir, ali azolske antimikotike, kot so ketokonazol in itrakonazol, ali makrolidne antibiotike).
English: • pain and dysfunction of chewing muscles and joints called temporomandibular joint syndrome
Slovenian: • bolečina in nedelovanje žvečilnih mišic in sklepov, kar imenujemo sindrom temporomandibularnega sklepa,
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.
Slovenian: Primarni opazovani dogodek je bil delež bolnikov z odzivom, opredeljenih kot bolniki, ki so uporabljali prepovedane opioide manj kot 2 od 6 mesecev, na podlagi rezultatov urinskih testov in bolnikovega samoporočanja.
English: Non-palpable implants must be located prior to attempted removal.
Slovenian: Implantate, ki jih ne morete zatipati, je treba najprej poiskati, preden se lotite postopka odstranjevanja.
English: In a pharmacokinetic study with sublingual buprenorphine, buprenorphine plasma levels were found to be higher and the half-life was found to be longer in patients with moderate and severe hepatic impairment, but not in patients with mild hepatic impairment (see section 5.2).
Slovenian: V farmakokinetični študiji podjezičnega buprenorfina so bile pri bolnikih z zmerno do hudo okvaro jeter ugotovljene višje ravni buprenorfina v plazmi in daljša razpolovna doba, česar pa niso opazili pri bolnikih z blago okvaro jeter (glejte poglavje 5.2).
English: Name and address of the manufacturer of the active substance
Slovenian: Ime in naslov izdelovalca biološke učinkovine
English: Sixmo is contraindicated in patients with severe hepatic impairment.
Slovenian: Zdravilo Sixmo je kontraindicirano pri bolnikih s hudo okvaro jeter.
English: • An appointment for the patient should be scheduled to return to the inserting healthcare professional as soon as possible.
Slovenian: • Bolniku je treba čim prej dati termin pri zdravstvenem strokovnjaku, ki izvaja postopek vsaditve.
English: • cellulitis, skin infection, boil
Slovenian: • celulitis, okužba kože, tur,
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.
Slovenian: Ko se prepričate, da je anestezija ustrezna in učinkovita, s skalpelom naredite rez dolžine 7 do 10 mm vzporedno z osjo roke,
English: Supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary oedema as indicated.
Slovenian: Pri obvladovanju cirkulatornega šoka in pljučnega edema je treba uporabiti podporne ukrepe (vključno s kisikom, vazopresorimi sredstvi), kot je indicirano.
English: Infection may occur at the site of the insertion or removal.
Slovenian: Na mestu vstavitve ali odstranjevanja se lahko pojavi okužba.
English: Having the patient flex the biceps muscle may facilitate identification of the site (Figure 2).
Slovenian: Če bolnik napne dvoglavo mišico, je lažje prepoznati mesto vstavitve (slika 2).
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).
Slovenian: Študija PRO-806 je imela dva primarna sočasno opazovana dogodka - CDF odstotka vzorcev urina, ki so bili negativni na prepovedane opioide, od 1. do 24. tedna v skupini z zdravilom Sixmo in skupini s placebom (primarni sočasno opazovani dogodek 1), in CDF odstotka vzorcev urina, ki so bili negativni na prepovedane opioide, od 1. do 24. tedna v skupini z zdravilom Sixmo in skupini s placebom na podlagi podatkov samoporočanja o jemanju prepovedanih drog (primarni sočasno opazovani dogodek 2).
English: If the implants are inserted deeply, it is possible that neurovascular injury may occur.
Slovenian: Če so implantati vstavljeni globoko, lahko pride do poškodb živcev ali žilja.
English: Table 2: Patient characteristics in the studies PRO-805 and PRO-806 Study PRO-805
Slovenian: Preglednica 2: Značilnosti bolnikov v študijah PRO-805 in PRO-806
English: Step 9: Redirect the applicator to the next channel marking, while stabilizing the previously inserted implant with your index finger, away from the sharp tip (Figure 13).
Slovenian: 9. korak: Aplikator preusmerite na naslednji označeni kanal, pri tem pa predhodno vstavljeni implantat držite s kazalcem proč od ostre konice (slika 13).
English: Patients who may not be investigated using a magnetic resonance imaging (MRI) scan must not be allowed to receive Sixmo.
Slovenian: Bolniki, pri katerih preiskava z magnetnoresonančnim slikanjem (MRI) ni dovoljena, ne smejo uporabljati zdravila Sixmo.
English: Anaesthetise the insertion area at the incision site and just under the skin, along the planned insertion channels, by injecting 5 mL lidocaine 1% with adrenaline 1:100,000.
Slovenian: Mesto vstavitve in predel tik pod kožo vzdolž predvidenih kanalov za vstavljanje anestezirajte tako, da injicirate 5 ml 1 % lidokaina z adrenalinom 1 : 100.000.
English: Sixmo is not recommended for children under 18 years.
Slovenian: Otroci in mladostniki Zdravilo Sixmo ni priporočljivo za otroke, mlajše od 18 let.
English: Retention in treatment was high, with 96.4% of Sixmo patients and 94.4% of sublingual buprenorphine patients completing the study.
Slovenian: Stopnja vztrajanja bolnikov v programu zdravljenja je bila visoka - 96,4 % bolnikov v skupini z zdravilom Sixmo in 94,4 % bolnikov v skupini s podjezičnim buprenorfinom.
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.
Slovenian: Pozor: buprenorfin lahko povzroči hudo, lahko celo usodno, depresijo dihanja (kratko sapo ali prenehanje dihanja) pri otrocih, ki so buprenorfinu nehote izpostavljeni.
English: Blood and lymphatic system disorders uncommon lymphadenopathy, neutropenia
Slovenian: Bolezni krvi in limfatičnega sistema občasni limfadenopatija, nevtropenija
English: The implants should be positioned in a fan-shaped distribution at least 5 mm from the incision, and palpable after placement.
Slovenian: Implantati morajo biti pahljačasto razporejeni vsaj 5 mm stran od reza in morajo biti po namestitvi otipljivi.
English: In each of the two studies, the proportion of subjects requiring supplemental SL BPN was significantly higher in the placebo group than in the Sixmo group (90.9% and 66.7% of subjects, with mean days of use per week of 2.17 and 1.27, in PRO-805 and PRO-806, respectively).
Slovenian: V vsaki od obeh študij je bil delež preiskovancev, ki so potrebovali dodatni SL BPN, pomembno višji v skupini, ki je dobivala placebo, kot v skupini, ki je dobila zdravilo Sixmo (90,9 % proti 66,7 % preiskovancev, s povprečnim številom dni uporabe na teden 2,17 v študiji PRO-805 oziroma 1,27 v študiji PRO-806).
English: Do not breast-feed during Sixmo treatment, as buprenorphine passes into breast milk.
Slovenian: • Dojenje Med uporabo zdravila Sixmo ne dojite, ker buprenorfin prehajata v materino mleko.
English: • instrument stand covered with sterile drape
Slovenian: • instrumentarska mizica, prekrita s sterilno prevleko,
English: The implants will then be inserted under the skin in the inner side of the upper arm.
Slovenian: Implantate bo nato vstavil pod kožo na notranjo stran nadlakti.
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.
Slovenian: Implantate Sixmo sme vstavljati in odstranjevati le zdravnik, ki je pristojen za izvajanje manjših kirurških posegov in je usposobljen za izvajanje postopkov vstavljanja in odstranjevanja.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ (mu) and κ (kappa)
Slovenian: Buprenorfin je delni agonist/antagonist opioidov, ki se veže na receptorje μ (mu) in κ (kapa) v možganih.
English: If implant(s) or implant fragment(s) are not removed during a removal attempt, the patient should undergo imaging for localisation as soon as is feasible with the subsequent removal attempt performed on the same day as localisation.
Slovenian: Če med postopkom odstranjevanja implantata/implantatov ali delcev implantata ne morete odstraniti, je bolnika treba slikati za določitev položaja čim prej, ko je mogoče, in še isti dan znova poskusiti s postopkom odstranjevanja.
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.
Slovenian: Pri bolnikih, ki pridejo zaradi nadaljevanja zdravljenja z zdravilom Sixmo, se je treba pripraviti tako na odstranitev kot tudi vstavitev novih implantatov Sixmo v sklopu enega obiska.
English: However, pups exposed to opioids postnatally exhibited significant body weights reductions.
Slovenian: Se je pa pri mladičih, ki so bili opioidom izpostavljeni v ponatalnem obdobju, telesna masa pomembno zmanjšala.
English: Therefore, a higher potential for toxicity exists with opioid administration.
Slovenian: Zato obstaja večja verjetnost za toksičnost pri dajanju opioidov.
English: If the implant is encapsulated, or you see dimpling, use the scalpel to shave the adhering tissue to release the implant.
Slovenian: Če je implantat vraščen ali pogreznjen, s skalpelom odstranite prilepljeno tkivo, da sprostite implantat.
English: Patients with a history of keloid or hypertrophic scar formation should not undergo subcutaneous insertion, as difficulties in retrieving the implant are possible.
Slovenian: Pri bolnikih, ki imajo v anamnezi keloidno ali hipertrofično brazgotinjenje, subkutana vstavitev ni dovoljena, saj bi se pri odstranjevanju implantatov lahko pojavile težave.
English: • are using naltrexone or nalmefene to treat alcohol or opioid dependence
Slovenian: • če uporabljate naltrekson ali nalmefen za zdravljenje odvisnosti od alkohola ali opioidov;
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 Huda respiratorna insuficienca
English: Please note: Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it.
Slovenian: Pomnite: Buprenorfin lahko povzroči hudo, lahko celo usodno, depresijo dihanja pri otrocih, ki so mu nehote izpostavljeni.
English: • painful period, erectile dysfunction
Slovenian: • boleča menstruacija, motnje erekcije,
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).
Slovenian: Bolnike z blago do zmerno okvaro jeter (Child-Pugh A in B) je treba spremljati glede znakov in simptomov toksičnosti ali prevelikega odmerjanja, ki ga povzročajo povišane ravni buprenorfina (mioza, cianoza ustnic, sedacija, bradikardija, hipotenzija, depresija dihanja).
English: These are very common or common adverse reactions with buprenorphine.
Slovenian: To so zelo pogosti ali pogosti neželeni učinki pri jemanju buprenorfina.
English: • medicines to treat HIV infections with active substance names ending in “navir”, such as ritonavir, nelfinavir, amprenavir, fosamprenavir
Slovenian: • zdravila za zdravljenje okužbe s HIV, ki vsebujejo učinkovino, katere ime se konča na „navir“, kot so ritonavir, nelfinavir, amprenavir, fosamprenavir;
English: You may remove the pressure bandage after 24 hours and the adhesive bandage after five days.
Slovenian: Kompresijski povoj lahko odstranite po 24 urah, obliž pa po petih dneh.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo v vseh državah članicah, kjer se zadravilo Sixmo trži, vsak bolnik, ki prejme ta podkožni implantat, od lečečega zdravnika prejel navodilo za uporabo za bolnika in opozorilno kartica za bolnika (v velikosti, primerni za v denarnico), ki jo mora imeti pri sebi ves čas med zdravljenjem z zdravilom Sixmo in jo pokazati drugim zdravstvenim delavcem pred vsakim zdravljenjem/posegom.
English: Patients treated with CYP inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, verapamil, diltiazem, amiodarone, amprenavir, fosamprenavir, aprepitant, fluconazole, erythromycin and grapefruit juice) should be monitored for signs and symptoms of toxicity or overdose (miosis, lip cyanosis, sedation, bradycardia, hypotension, respiratory depression).
Slovenian: Bolnike, ki se zdravijo z zaviralci encima CYP (npr. ritonavir, ketokonazol, itrakonazol, troleandomicin, klaritromicin, nelfinavir, nefazodon, verapamil, diltiazem, amiodaron, amprenavir, fosamprenavir, aprepitant, flukonazol, eritromicin in sok grenivke) je treba spremljati glede zankov in simptomov toksičnosti ali prevelikega odmerjanja (mioza, cianoza ustnic, sedacija, bradikardija, hipotenzija, depresija dihanja).
English: • abnormal mean cell volume
Slovenian: • nenormalen povprečni celični volumen,
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).
Slovenian: 5. korak: Aplikator spustite v vodoravni položaj, s konico aplikatorja dvignite kožo tako, da bo kanila še naprej v subkutanem vezivnem tkivu (slika 6).
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.
Slovenian: Spekter nenormalnih izvidov se giblje od prehodnega asimptomatskega zvišanja jetrnih transaminaz do odpovedi jeter, jetrne nekroze, hepatorenalnega sindroma, hepatične encefalopatije in smrti.
English: CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine.
Slovenian: Zaviralci CYP3A4 lahko zavrejo presnovo buprenorfina, kar povzroči povečanje vrednosti Cmax in AUC buprenorfina in norbuprenorfina.
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.
Slovenian: Bolnike, ki se odločijo za prekinitev zdravljenja z zdravilom Sixmo, je treba spremljati glede odtegnitvenega sindroma in pri tem razmisliti o zmanjšanem odmerku podjezičnega buprenorfina.
English: Prior to the launch of SIXMO in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Pred prihodom zdravila SIXMO na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega gradiva, vključno sredstvi obveščanja, načini razdeljevanja in drugimi vidiki programa.
English: Step 15: Pick up the skin edge with Adson single toothed tissue forceps and separate the tissues above and below the visible implant, using an iris scissors or a curved mosquito forceps (Figure 16).
Slovenian: 15. korak: S kirurško pinceto Adson privzdignite rob kože in ločite tkivo nad vidnim implantatom in tkivo pod njim, pri tem pa uporabite kratke škarje ali ukrivljene hemostatske prijemalke (slika 16).
English: hypercapnia, pre-existing respiratory depression or kyphoscoliosis [curvature of spine leading to potential shortness of breath]).
Slovenian: hiperkapnijo, obstoječo respiratorno depresijo ali kifoskoliozo [ukrivljenost hrbtenice, ki povzroča kratko sapo]) uporabljati previdno.
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.
Slovenian: Ta študija je vključevala 84 bolnikov v skupini, ki je dobila zdravilo Sixmo, in 89 bolnikov, ki so prejeli podjezični buprenorfin, mediana starosti (razpon) je v skupini z zdravilom Sixmo znašala 36 (21 do
English: Sixmo implants are intended to be in place for 6 months of treatment and provide a sustained delivery of buprenorphine.
Slovenian: Implantati Sixmo so predvideni za vstavitev za 6 mesecev zdravljenja in stalno dovajajo buprenorfin.
English: Appropriate precautions, such as the conduct of patient follow-up visits according to the patient's needs and the treating physician's clinical judgement, should be taken during Sixmo treatment.
Slovenian: Med zdravljenjem z zdravilom Sixmo je treba izvesti ustrezne previdnostne ukrepe, kot je izvajanje spremljevalnih obiskov bolnika v skladu z bolnikovimi potrebami in klinično presojo lečečega zdravnika.
English: • increased or decreased weight, including abnormal weight gain
Slovenian: • povečanje ali zmanjšanje telesne mase, vključno z nenormalnim povečanjem telesne mase,
English: A key secondary endpoint in Study PRO-806 was the difference in proportions of urine samples that were negative for opioids over 24 weeks for Sixmo versus sublingual buprenorphine.
Slovenian: Ključni sekundarni opazovani dogodek v študiji PRO-806 je bila razlika v deležih vzorcev urina, ki so bili v 24 tednih negativni za opioide v skupini z zdravilom Sixmo v primerjavi s skupino, ki je jemala podjezični buprenorfin.
English: Step 7: While holding the cannula in place, unlock the obturator and remove the obturator.
Slovenian: 7. korak: Medtem ko kanilo držite pri miru, odklenite mandren in ga odstranite.
English: • consistency in compliance with clinic visit requirements
Slovenian: • stalno izpolnjevanje zahtev v okviru kontrolnih pregledov,
English: Buprenorphine has the potential to be abused and is prone to criminal diversion.
Slovenian: Zloraba in preusmerjanje uporabe Buprenorfin ima potencial, da se ga zlorablja in preusmerja v kaznivo uporabo.
English: • sleeplessness, anxiety, hostility, nervousness
Slovenian: • nespečnost, tesnoba, sovražnost, živčnost,
English: Also, scan or input the details of the implant procedure into the patient's medical records.
Slovenian: Prav tako v bolnikovo zdravstveno kartoteko zabeležite oz. vnesite podatke o postopku implantacije.
English: Only a healthcare professional who is competent in minor surgery and is trained in the insertion of Sixmo should perform the procedure, using only the implant applicator, with the recommended local anaesthetic available.
Slovenian: Postopek lahko izvede samo zdravstveni strokovnjak, ki je pristojen za izvajanje manjših kirurških posegov in je usposobljen za vstavljanje zdravila Sixmo, pri tem postopku pa mora uporabljati aplikator za implantate in imeti na voljo priporočeni lokalni anestetik.
English: • latest date on which the implant must be removed Keep this card in a safe place, since the information on the card may make it easier to carry out removal.
Slovenian: To kartico shranite na varnem mestu, ker informacije na kartici lahko olajšajo odstranjevanje implantatov.
English: General precautions relevant to the administration of opioids
Slovenian: Splošna opozorila, ki se nanašajo na dajanje opioidov
English: • Infection may occur at the site of the insertion or removal of the implant.
Slovenian: • Na mestu vstavitve ali odstranjevanja implantata se lahko pojavi okužba.
English: • That the card-holder is using SIXMO (buprenorphine only opioid-dependence treatment via SC implant located at the inner side of the upper arm)
Slovenian: • imetnik te kartice uporablja zdravilo Sixmo (zdravilo za zdravljenje odvisnosti od opioidov, ki vsebuje samo buprenorfin, v obliki podkožnega implantata na notranji strani nadlakti);
English: Therefore, breastfeeding should be discontinued during treatment with Sixmo.
Slovenian: Med zdravljenjem z zdravilom Sixmo je treba prenehati z dojenjem.
English: Place a small adhesive bandage over the insertion site.
Slovenian: Čez mesto vstavitve namestite manjši obliž.
English: Healthcare professionals should consider the potential role and contribution of buprenorphine when given in conjunction with other CNS depressant medicinal products, CYP3A4 inhibitors, other opioids and in cases of hepatic impairment when determining whether the implants should be removed (see sections 4.4 and 4.5).
Slovenian: Zdravstveni strokovnjaki morajo pri odločanju glede odstranitve implantatov upoštevati potencialno vlogo in prispevek buprenorfina, kadar se uporablja v kombinaciji z drugimi depresorji centralnega živčnega sistema, zaviralci encima CYP3A4, drugimi opioidi in v primerih okvare jeter (glejte poglavji 4.4 in 4.5).
English: How to use Sixmo
Slovenian: Kako uporabljati zdravilo Sixmo
English: Sixmo is formulated as a diversion and abuse deterrent formulation.
Slovenian: Zdravilo Sixmo je formulirano tako, da odvrača od preusmerjanja in zlorabe.
English: • reduced sense of touch or sensation
Slovenian: • zmanjšan občutek dotika ali zmanjšane čutne zaznave,
English: • sutures, such as 4-0 Prolene™ with an FS-2 cutting needle (may be absorbable)
Slovenian: • kirurške niti, na primer 4-0 Prolene™ z rezalno iglo FS-2 (lahko je resorbilna).
English: The following factors should be considered when determining clinical stability and suitability for Sixmo treatment:
Slovenian: Pri določanju klinične stabilnosti in primernosti zdravljenja z zdravilom Sixmo je treba upoštevati naslednje dejavnike: