natgillin/translations-raw huggingface dataset:
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).
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).
Tell your doctor immediately if you have any signs of infection (such as redness or inflammation) at the site of insertion or removal.
Ako Vam se pojave ikakvi znakovi infekcije (kao što su crvenilo ili upala) na mjestu ugradnje ili uklanjanja, odmah obavijestite liječnika.
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.
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.
These adverse reactions are presented by MedDRA system organ class, preferred term, and frequency.
Te su nuspojave prikazane prema MedDRA-inoj klasifikaciji organskih sustava, preporučenim pojmovima i učestalosti.
Sixmo implants are intended to be in place for 6 months and provide a continuous delivery of buprenorphine.
Sixmo namijenjeni su tome da tijekom 6 mjeseci od ugradnje osiguravaju neprekidnu isporuku buprenorfina.
Buprenorphine has the potential to be abused and is prone to criminal diversion.
Pogrešna primjena i nedopuštena uporaba Kod buprenorfina postoji mogućnost zlouporabe i nedopuštene uporabe u kriminalne svrhe.
Removal of Sixmo implants
Uklanjanje implantata Sixmo Implantati
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.
Spektar abnormalnosti obuhvaća sve od prolaznih asimptomatskih povišenja jetrenih transaminaza do opisa slučajeva zatajenja jetre, nekroze jetre,
LIST OF EXCIPIENTS Excipient: Ethylene vinyl acetate copolymer
Pomoćna tvar: etilenvinilacetat kopolimer
Schedule an appointment for the sutures to be removed.
Dogovorite sljedeći pregled zbog uklanjanja šava.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedan implantat sadrži 74,2 mg buprenorfina u obliku buprenorfin hidroklorida.
Figure 12
Slika 12
• constipation, nausea, vomiting, diarrhoea
• zatvor, mučnina, povraćanje, proljev
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).
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).
The following factors should be considered when determining clinical stability and suitability for Sixmo treatment:
Kad se određuje klinička stabilnost i prikladnost za liječenje implantatom Sixmo, potrebno je razmotriti sljedeće čimbenike:
• The holder of this card uses a buprenorphine only opioid dependence treatment called Sixmo.
• Vlasnik ove kartice liječi se od ovisnosti o opioidima implantatima
• sterile ruler
• sterilno ravnalo
Verify the location of the implants by palpation.
Ponovno palpacijom provjerite mjesto na kojem se nalaze implantati.
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***
manje često depresija, smanjeni libido, poremećaj spavanja, apatija, euforično raspoloženje, smanjen doživljaj orgazma, nemir, razdražljivost, ovisnost***, agitacija***, abnormalno razmišljanje***
Having the patient flex the biceps muscle may facilitate identification of the site (Figure 2).
Mjesto ugradnje lakše će se prepoznati ako bolesnik napne biceps (slika 2).
• thin adhesive strip around 6 mm wide (butterfly strip)
• tanka samoljepiva kirurška traka širine oko 6 mm (leptirasta traka)
• increased or decreased weight, including abnormal weight gain
• povišena ili snižena tjelesna težina, uključujući neuobičajeno dobivanje na težini • dehidracija, pojačan apetit
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
Sixmo u promet i/ili zabilježene uz druge lijekove koji sadrže buprenorfin Klasifikacija organskog sustava
Figure 17
Slika 17
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.
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.
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.
(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.
• #15 blade scalpel
• skalpel oštrice br.15
• abnormal sensation such as prickling, “pins and needles”, tingling and itchiness
• neuobičajeni osjeti kao što su bockanje, trnci, žmarci i svrbež
Apply a pressure bandage with sterile gauze to minimize bruising.
Stavite kompresijski zavoj sa sterilnom gazom kako biste smanjili nastanak modrice.
Counsel the patient on proper aseptic wound care.
Objasnite mu kako da na ispravan, aseptični način njeguje ranu.
Subcutaneous insertion is essential to confirm proper placement by palpation.
Nakon supkutane ugradnje, palpacijom se mora potvrditi da su implantati pravilno postavljeni.
• urinary hesitation, urge to urinate, urinating more frequently with little urinary output
• otežan početak mokrenja, urinarna urgencija (neodgodiv poriv na mokrenje), češće mokrenje malih količina mokraće
Place a small adhesive bandage over the insertion site.
Mjesto incizije prekrijte malim flasterom.
Number (%) of patients with broken implant(s) N=number of patients with data available.
N=broj bolesnika s dostupnim podacima
• 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.
• lijekove za smirenje, spavanje ili opuštanje mišića, s djelatnim tvarima čiji nazivi završavaju na
• migraine, tremor
• migrena, tremor (nevoljno drhtanje)
• Liver damage, including liver failure, has been reported when using buprenorphine.
• Za vrijeme primjene buprenorfina zabilježeno je oštećenje jetre, uključujući zatajenje jetre.
Study PRO-805 (ITT)
tjedna, ispitivanje PRO-805 (ITT) Postotak negativnih rezultata
Infection may occur at the site of the insertion or removal.
Na mjestu ugradnje ili uklanjanja može nastati infekcija.
Equipment for subcutaneous insertion of Sixmo
Oprema za supkutanu ugradnju implantata Sixmo
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.
Rijetke, ali ozbiljne komplikacije uključujući oštećenje živca i migraciju s posljedičnom embolijom i smrću mogu biti posljedica neispravne ugradnje implantata s lijekom u nadlakticu.
• dizziness, drowsiness
• omaglica, omamljenost
Figure 14
Slika 14
Sublingual buprenorphine should be discontinued 12 to 24 hours prior to insertion of four Sixmo implants.
Primjenu sublingvalnog buprenorfina treba prekinuti 12-24 sata prije ugradnje četiri implantata Sixmo.
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.
Sixmo potrebno je napraviti pripreme i za uklanjanje i za ugradnju implantata Sixmo kod istog dolaska.
Especially, inform your doctor during Sixmo treatment before using:
Osobito obavijestite liječnika tijekom liječenja implantatima
This product may cause dizziness, somnolence or sedation especially at the start of treatment.
Ovaj lijek može uzrokovati omaglicu, somnolenciju ili sedaciju,
• reduced kidney function
• smanjenu bubrežnu funkciju
Sublingual buprenorphine should be discontinued 12 to 24 hours prior to subcutaneous insertion of Sixmo implants.
Primjenu sublingvalnog buprenorfina treba prekinuti 12-24 sata prije supkutane ugradnje implantata Sixmo.
There should be at least 5 mm between the incision and the implant when the implant is properly positioned.
Kad je implantat ispravno postavljen, između incizije i implantata treba biti najmanje 5 mm.
IMPORTANT INFORMATION Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
VAŽNE INFORMACIJE Svaki implantat sadrži 74,2 mg buprenorfina u obliku buprenorfin hidroklorida.
Do not drink alcohol during Sixmo treatment, as it increases the sedative effect.
Nemojte piti alkohol za vrijeme liječenja implantatima
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.
uključujući uzimanje neopioidnih psihoaktivnih tvari, kako bi se osiguralo da se sigurno može započeti liječenje implantatima Sixmo.
• 1 implant applicator
• 4 implantata Sixmo • 1 aplikator implantata
Instructions for removal of Sixmo
Upute za uklanjanje implantata Sixmo
• mosquito forceps
• hvataljka po Mosquitu
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.
Sixmo treba pratiti zbog mogućeg sindroma ustezanja te razmotriti postupno snižavanje doze sublingvalnog buprenorfina.
ITT=intent-to-treat, SL BPN = sublingual buprenorphine Buprenorphine was not included in urine toxicology assessments.
ITT=populacija planirana za liječenje (engl. intent-to-treat), SL BPN=sublingvalni buprenorfin
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.
Sixmo na druga mjesta na ruci ili na neka druga mjesta osim nadlaktice, kao ni s ponovnom ugradnjom u već korištena mjesta.
• breathing depression, yawning
• depresija disanja, zijevanje
NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant
NAZIV LIJEKA Sixmo 74,2 mg implantat
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*
Infekcije i infestacije često virusna infekcija, bronhitis**, infekcija**, influenca**, faringitis**, rinitis** manje često celulitis, kožna infekcija, peritonzilarni apsces,
• slow heartbeat, abnormal heart rhythm that starts in the atrial chambers of the heart
• iscjedak iz oka, zamagljen vid, poremećaj suzenja • usporen rad srca, poremećen srčani ritam koji počinje u srčanim pretklijetkama
Patients who develop hepatic impairment while being treated with Sixmo should be monitored for signs and symptoms of toxicity or overdose.
Sixmo treba pratiti zbog moguće pojave znakova i simptoma toksičnosti ili predoziranja.
* Implant site adverse drug reaction (*) Observed as implant and non-implant site adverse drug reaction ** Reported with other approved buprenorphine only medicinal product *** Post-marketing data only
** Zabilježeno uz drugi odobreni lijek koji sadrži samo buprenorfin *** Samo podaci nakon stavljanja lijeka u promet
• inflammation of the airways in the lungs, throat or inner lining of the nose
• upala dišnih puteva u plućima, grla ili sluznice nosa • pojačano znojenje, loše osjećanje
Do not use these medicines during Sixmo treatment as they can cause a sudden onset of prolonged, intense withdrawal symptoms.
Sixmo jer mogu uzrokovati naglu pojavu dugotrajnih i jakih simptoma ustezanja.
• Name and contact details of the treating physician
• ime nadležnog liječnika i kontakt podaci
• Adson single tooth tissue forceps
• kirurška pinceta po Adsonu
Retreatment with Sixmo implants
Ponovno liječenje implantatima Sixmo
Mean (SE)
Srednja vrijednost (SE)
Please note: Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it.
Napomena: u slučaju nehotične izloženosti u djece, buprenorfin može prouzročiti tešku respiratornu depresiju s mogućim smrtnim ishodom.
NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant (buprenorphine)
NAZIV LIJEKA Sixmo 74,2 mg implantat (buprenorfin)
Treatment must be under the supervision of a healthcare professional experienced in the management of opioid dependence/addiction.
4.2 Doziranje i način primjene Liječenje se mora provoditi pod nadzorom liječnika s iskustvom u liječenju ovisnosti o opioidima.
Sixmo should also be administered with caution in patients with a history of connective tissue disease (e.g. scleroderma) or history of recurrent methicillin-resistant Staphylococcus aureus infections.
Sixmo također treba primijeniti s oprezom bolesnicima s anamnezom bolesti vezivnog tkiva (npr.
• Substances like buprenorphine may cause pinpoint pupils, change consciousness or the way you feel pain.
U takvim slučajevima upitajte svog liječnika ili ljekarnika za savjet. • Tvari poput buprenorfina mogu uzrokovati suženje zjenica, promjenu razine svijesti ili način na koji osjećate bol.
Equipment for removal of Sixmo
Oprema za uklanjanje implantata Sixmo
Treatment with Sixmo implants
Liječenje implantatima Sixmo
Implant
OBLIK Implantat
• dilated pupils
• proširene zjenice
Instructions for subcutaneous insertion of Sixmo
Upute za supkutanu ugradnju implantata Sixmo
Do not breast-feed during Sixmo treatment, as buprenorphine passes into breast milk.
Sixmo jer buprenorfin prelazi u majčino mlijeko.
• fainting
• flasteri
When the first 6-month treatment period is up, a new set of Sixmo implants may be given after removal of the old implants, preferably on the same day.
Sixmo nakon što se izvade stari implantati, po mogućnosti istog dana.
• medicines to treat HIV infections with active substance names ending in “navir”, such as ritonavir, nelfinavir, amprenavir, fosamprenavir
• lijekove za liječenje HIV-infekcije s djelatnim tvarima čiji nazivi završavaju na “navir”, kao što su ritonavir, nelfinavir, amprenavir, fosamprenavir • lijekove za liječenje gljivičnih infekcija, poput genitalnih infekcija uzrokovanih gljivicom kandidom, s djelatnim tvarima čiji nazivi završavaju na “azol”, kao što su ketokonazol,
Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Jedan implantat sadrži 74,2 mg buprenorfina u obliku buprenorfin hidroklorida.
• abnormal mean cell volume
• poremećena srednja vrijednost volumena crvenih krvnih stanica
• are using naltrexone or nalmefene to treat alcohol or opioid dependence
• ako uzimate naltrekson ili nalmefen za liječenje ovisnosti o alkoholu ili opojnim drogama • ako Vam se pojačano stvara ožiljno tkivo.
Buprenorphine may reduce the ability to drive and use machines; especially during the first 24 to 48 hours up to one week following implant insertion.
Upravljanje vozilima i strojevima Buprenorfin može smanjiti sposobnost upravljanja vozilima i rada strojevima; osobito tijekom prvih
NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant buprenorphine
NAZIV LIJEKA Sixmo 74,2 mg implantat buprenorfin
• abnormal function of the bile duct
• poremećenu funkciju žučovoda
Reconfirm the location of the implants by palpation.
Palpacijom utvrdite mjesto na kojem se nalaze implantati.
• drug dependence
• ovisnost o drogi
• pregnancy
• trudnoća
• migration of implant(s), device breakage or expulsion
• pomicanje jednog ili više implantata, lomljenje ili izbacivanje implantata
Few cases of protrusion or expulsion of implants, mainly attributed to improper insertion technique, were reported in clinical studies with Sixmo (see section 4.4).
što je uglavnom bilo pripisano neispravnoj tehnici ugradnje (vidjeti dio 4.4).
Surgical intervention is necessary for removing an implant that has migrated.
Implantat koji je migrirao mora se ukloniti kirurškom intervencijom.
Before administering Sixmo implants
Prije primjene implantata Sixmo
• sterile fenestrated drape
• sterilna prekrivka s otvorom
Side effects can occur with the following frequencies: Common, may affect up to 1 in 10 people
Često, mogu se javiti u do 1 na 10 osoba
CI=confidence interval, ITT=intent-to-treat, N=number of subjects, SE=standard error In the analysis of the CDF (co-primary endpoint 1), a statistically significant difference between treatments (p<0.0001) was seen, which was in favour of Sixmo.
U analizi KFD-a (1. primarna mjera ishoda) opažena je statistički značajna razlika između terapija
Table 4: Percentage of Opioid-Negative Urine Samples for Weeks 1 to 24, Study PRO-806
Tablica 4: Postotak uzoraka mokraće negativnih na opioide od 1. do 24. tjedna, ispitivanje
• the patient experiences withdrawal symptoms, e.g. sweating, lacrimation, yawning, nausea,
Nadležni liječnik treba razmotriti primjenu dodatnih doza sublingvalnog buprenorfina: • ako bolesnik ima simptome ustezanja, npr. znojenje, suzenje, zijevanje, mučninu, povraćanje,
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).
CYP3A4, drugim opioidima i u slučajevima oštećenja funkcije jetre (vidjeti dijelove 4.4 i 4.5).
Plasma buprenorphine concentrations after Sixmo are illustrated in figure 3.
Sixmo prikazane su u slici 3.
If implants for repeat treatment are not inserted on the same day as removal of previous implants, individuals should be maintained on a fixed dose of 2 to 8 mg/day of sublingual buprenorphine, as clinically indicated, until repeat treatment occurs.
Ako se implantati za ponovno liječenje ne ugrade istog dana kad su uklonjeni prethodni implantati, osobu treba održavati na fiksnoj dozi sublingvalnog buprenorfina od
General disorders and administration site conditions common fatigue, chills, asthenia, pain, implant site haematoma*, implant site pain*, implant site pruritus*, implant site haemorrhage*, implant site erythema*, implant site scar*, chest pain**, malaise***, drug withdrawal syndrome*** uncommon oedema peripheral, discomfort, face oedema, feeling cold, pyrexia, swelling, implant site oedema*, implant site reaction*, device expulsion*, impaired healing*, implant site
Opći poremećaji i reakcije na mjestu primjene često umor, zimica, astenija, bol, hematom na mjestu implantata*, bol na mjestu implantata*, pruritus na mjestu implantata*, krvarenje na mjestu implantata*, eritem na mjestu implantata*, ožiljak na mjestu implantata*, bol u prsnom košu**, malaksalost***, sindrom ustezanja od droge***
Expulsion of the implant
Nakon ugradnje implantata
Percentage of negative results
Postotak bolesnika
hypercapnia, pre-existing respiratory depression or kyphoscoliosis [curvature of spine leading to potential shortness of breath]).
(npr. kroničnom opstruktivnom plućnom bolešću, plućnim srcem, smanjenom respiratornom rezervom, hipoksijom, hiperkapnijom, već prisutnom respiratornom depresijom ili kifoskoliozom
• Your doctor should examine the insertion site for infections and wound problems: one week after implant insertion and at least once a month thereafter
• Liječnik Vam treba pregledati mjesto ugradnje zbog mogućih infekcija i problema s ranom:
Respiratory, thoracic and mediastinal disorders common cough**, dyspnoea** uncommon respiratory depression, yawning Gastrointestinal disorders common constipation, nausea, vomiting, diarrhoea, abdominal pain, gastrointestinal disorder**, tooth disorder** uncommon dry mouth, dyspepsia, flatulence, haematochezia
Poremećaji probavnog sustava često konstipacija, mučnina, povraćanje, proljev, bol u abdomenu, poremećaj probavnog sustava**, poremećaj zubiju**
• in case of patient's self-reported heroin use, other opioid use or craving and/ or urine samples positive for opioids
tahikardiju, hipertenziju, piloerekciju, proširene zjenice; • u slučaju da mu bolesnik kaže da je uzeo heroin, neki drugi opioid ili ima žudnju za opioidima,
Driving and using machines
Najnovija tehnika i obuka
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).
Korak 9: Dok prethodno umetnuti implantat držite kažiprstom na mjestu, podalje od oštrog vrška,
Primary opioid of abuse, n (%)
Buprenorfin u plazmi (ng/ml)
Package size blister (PVC/alu) 336 (4 packs of 84) hard capsules blister (PVC/alu) 84 hard capsules
200 mg kapsula, tvrda Za primjenu kroz usta blister (PVC/Al) 336 (4 kutije sa 84) tvrdih kapsula
Within 1 month of Commission Decision.
U roku od 1 mjeseca od Odluke Komisije.
Annex IV Conditions to the marketing authorisation(s)
Prilog IV. Uvjeti odobrenja za stavljanje u promet
These should be submitted to the National Competent Authorities:
Treba ih dostaviti nacionalnim nadležnim tijelima:
The clinical study report should be submitted to the relevant National Competent Authorities:
Izvješće o kliničkom o ispitivanju treba dostaviti odgovarajućim nacionalnim nadležnim tijelima:
The study design should aim to evaluate and quantify the effectiveness of the Risk Management Measures, and should include a pre- and post-implemented analysis and assessment.
Ispitivanje bi trebalo biti oblikovano tako da se njime ocijeni i kvantitativno odredi učinkovitost mjera za upravljanje rizikom te bi trebalo obuhvaćati prethodno i naknadno provedenu analizu i procjenu.
These materials should ensure that prescribers are informed and the patients understand and acknowledge the risks associated with oral retinoids acitretin, alitretinoin and isotretinoin in-utero exposure.
Tim bi se materijalima trebalo osigurati da su propisivači informirani te da bolesnice razumiju i prihvaćaju rizike povezane s in utero izlaganjem retinoidima acitretinu, alitretinoinu i izotretinoinu za peroralnu primjenu.
The details of the visual reminder should be agreed at national level further to a user test taking into account input from local patient representatives.
nakon ispitivanja korisnica i uzimajući u obzir doprinos lokalnih predstavnika bolesnika.
The marketing authorisation holder(s) for oral retinoids acitretin, alitretinoin and isotretinoin shall complete the below conditions, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Nositelji odobrenja za stavljanje u promet retinoida acitretina, alitretinoina i izotretinoina za peroralnu primjenu moraju ispuniti uvjete u nastavku u navedenom roku, a nadležna tijela osiguravaju ispunjavanje sljedećih uvjeta: