FrancophonIA/ELRC3.0 huggingface dataset:
English: * 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
Croatian: ** Zabilježeno uz drugi odobreni lijek koji sadrži samo buprenorfin *** Samo podaci nakon stavljanja lijeka u promet
English: • inflammation of the airways in the lungs, throat or inner lining of the nose
Croatian: • upala dišnih puteva u plućima, grla ili sluznice nosa • pojačano znojenje, loše osjećanje
English: Do not use these medicines during Sixmo treatment as they can cause a sudden onset of prolonged, intense withdrawal symptoms.
Croatian: Sixmo jer mogu uzrokovati naglu pojavu dugotrajnih i jakih simptoma ustezanja.
English: • Name and contact details of the treating physician
Croatian: • ime nadležnog liječnika i kontakt podaci
English: • Adson single tooth tissue forceps
Croatian: • kirurška pinceta po Adsonu
English: Retreatment with Sixmo implants
Croatian: Ponovno liječenje implantatima Sixmo
English: Mean (SE)
Croatian: Srednja vrijednost (SE)
English: Please note: Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it.
Croatian: Napomena: u slučaju nehotične izloženosti u djece, buprenorfin može prouzročiti tešku respiratornu depresiju s mogućim smrtnim ishodom.
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant (buprenorphine)
Croatian: NAZIV LIJEKA Sixmo 74,2 mg implantat (buprenorfin)
English: Treatment must be under the supervision of a healthcare professional experienced in the management of opioid dependence/addiction.
Croatian: 4.2 Doziranje i način primjene Liječenje se mora provoditi pod nadzorom liječnika s iskustvom u liječenju ovisnosti o opioidima.
English: 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.
Croatian: Sixmo također treba primijeniti s oprezom bolesnicima s anamnezom bolesti vezivnog tkiva (npr.
English: • Substances like buprenorphine may cause pinpoint pupils, change consciousness or the way you feel pain.
Croatian: 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.
English: Equipment for removal of Sixmo
Croatian: Oprema za uklanjanje implantata Sixmo
English: Treatment with Sixmo implants
Croatian: Liječenje implantatima Sixmo
English: Implant
Croatian: OBLIK Implantat
English: • dilated pupils
Croatian: • proširene zjenice
English: Instructions for subcutaneous insertion of Sixmo
Croatian: Upute za supkutanu ugradnju implantata Sixmo
English: Do not breast-feed during Sixmo treatment, as buprenorphine passes into breast milk.
Croatian: Sixmo jer buprenorfin prelazi u majčino mlijeko.
English: • fainting
Croatian: • flasteri
English: 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.
Croatian: Sixmo nakon što se izvade stari implantati, po mogućnosti istog dana.
English: • medicines to treat HIV infections with active substance names ending in “navir”, such as ritonavir, nelfinavir, amprenavir, fosamprenavir
Croatian: • 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,
English: Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Croatian: Jedan implantat sadrži 74,2 mg buprenorfina u obliku buprenorfin hidroklorida.
English: • abnormal mean cell volume
Croatian: • poremećena srednja vrijednost volumena crvenih krvnih stanica
English: • are using naltrexone or nalmefene to treat alcohol or opioid dependence
Croatian: • ako uzimate naltrekson ili nalmefen za liječenje ovisnosti o alkoholu ili opojnim drogama • ako Vam se pojačano stvara ožiljno tkivo.
English: 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.
Croatian: Upravljanje vozilima i strojevima Buprenorfin može smanjiti sposobnost upravljanja vozilima i rada strojevima; osobito tijekom prvih
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant buprenorphine
Croatian: NAZIV LIJEKA Sixmo 74,2 mg implantat buprenorfin
English: • abnormal function of the bile duct
Croatian: • poremećenu funkciju žučovoda
English: Reconfirm the location of the implants by palpation.
Croatian: Palpacijom utvrdite mjesto na kojem se nalaze implantati.
English: • drug dependence
Croatian: • ovisnost o drogi
English: • pregnancy
Croatian: • trudnoća
English: • migration of implant(s), device breakage or expulsion
Croatian: • pomicanje jednog ili više implantata, lomljenje ili izbacivanje implantata
English: 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).
Croatian: što je uglavnom bilo pripisano neispravnoj tehnici ugradnje (vidjeti dio 4.4).
English: Surgical intervention is necessary for removing an implant that has migrated.
Croatian: Implantat koji je migrirao mora se ukloniti kirurškom intervencijom.
English: Before administering Sixmo implants
Croatian: Prije primjene implantata Sixmo
English: • sterile fenestrated drape
Croatian: • sterilna prekrivka s otvorom
English: Side effects can occur with the following frequencies: Common, may affect up to 1 in 10 people
Croatian: Često, mogu se javiti u do 1 na 10 osoba
English: 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.
Croatian: U analizi KFD-a (1. primarna mjera ishoda) opažena je statistički značajna razlika između terapija
English: Table 4: Percentage of Opioid-Negative Urine Samples for Weeks 1 to 24, Study PRO-806
Croatian: Tablica 4: Postotak uzoraka mokraće negativnih na opioide od 1. do 24. tjedna, ispitivanje
English: • the patient experiences withdrawal symptoms, e.g. sweating, lacrimation, yawning, nausea,
Croatian: Nadležni liječnik treba razmotriti primjenu dodatnih doza sublingvalnog buprenorfina: • ako bolesnik ima simptome ustezanja, npr. znojenje, suzenje, zijevanje, mučninu, povraćanje,
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).
Croatian: CYP3A4, drugim opioidima i u slučajevima oštećenja funkcije jetre (vidjeti dijelove 4.4 i 4.5).
English: Plasma buprenorphine concentrations after Sixmo are illustrated in figure 3.
Croatian: Sixmo prikazane su u slici 3.
English: 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.
Croatian: Ako se implantati za ponovno liječenje ne ugrade istog dana kad su uklonjeni prethodni implantati, osobu treba održavati na fiksnoj dozi sublingvalnog buprenorfina od
English: 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
Croatian: 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***
English: Expulsion of the implant
Croatian: Nakon ugradnje implantata
English: Percentage of negative results
Croatian: Postotak bolesnika
English: hypercapnia, pre-existing respiratory depression or kyphoscoliosis [curvature of spine leading to potential shortness of breath]).
Croatian: (npr. kroničnom opstruktivnom plućnom bolešću, plućnim srcem, smanjenom respiratornom rezervom, hipoksijom, hiperkapnijom, već prisutnom respiratornom depresijom ili kifoskoliozom
English: • Your doctor should examine the insertion site for infections and wound problems: one week after implant insertion and at least once a month thereafter
Croatian: • Liječnik Vam treba pregledati mjesto ugradnje zbog mogućih infekcija i problema s ranom:
English: 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
Croatian: Poremećaji probavnog sustava često konstipacija, mučnina, povraćanje, proljev, bol u abdomenu, poremećaj probavnog sustava**, poremećaj zubiju**
English: • in case of patient's self-reported heroin use, other opioid use or craving and/ or urine samples positive for opioids
Croatian: tahikardiju, hipertenziju, piloerekciju, proširene zjenice; • u slučaju da mu bolesnik kaže da je uzeo heroin, neki drugi opioid ili ima žudnju za opioidima,
English: Driving and using machines
Croatian: Najnovija tehnika i obuka
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).
Croatian: Korak 9: Dok prethodno umetnuti implantat držite kažiprstom na mjestu, podalje od oštrog vrška,
English: Primary opioid of abuse, n (%)
Croatian: Buprenorfin u plazmi (ng/ml)
English: Package size blister (PVC/alu) 336 (4 packs of 84) hard capsules blister (PVC/alu) 84 hard capsules
Croatian: 200 mg kapsula, tvrda Za primjenu kroz usta blister (PVC/Al) 336 (4 kutije sa 84) tvrdih kapsula
English: Within 1 month of Commission Decision.
Croatian: U roku od 1 mjeseca od Odluke Komisije.
English: Annex IV Conditions to the marketing authorisation(s)
Croatian: Prilog IV. Uvjeti odobrenja za stavljanje u promet
English: These should be submitted to the National Competent Authorities:
Croatian: Treba ih dostaviti nacionalnim nadležnim tijelima:
English: The clinical study report should be submitted to the relevant National Competent Authorities:
Croatian: Izvješće o kliničkom o ispitivanju treba dostaviti odgovarajućim nacionalnim nadležnim tijelima:
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: nakon ispitivanja korisnica i uzimajući u obzir doprinos lokalnih predstavnika bolesnika.
English: 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:
Croatian: 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:
English: The MAHs of oral retinoids containing acitretin, alitretinoin or isotretinoin shall develop and submit educational materials according to the agreed key elements.
Croatian: Nositelji odobrenja za stavljanje u promet retinoida acitretina, alitretinoina i izotretinoina za peroralnu primjenu moraju izraditi i dostaviti edukacijske materijale u skladu s dogovorenim ključnim elementima.
English: In order to assess the effectiveness of the updated risk minimisation measures in women of childbearing potential resulting from this referral procedure, MAH(s) of oral retinoids acitretin, alitretinoin and isotretinoin should conduct and submit the results of a drug utilisation study (DUS).
Croatian: Kako bi se procijenila učinkovitost ažuriranih mjera za smanjenje rizika u žena u reproduktivnoj dobi koji proizlaze iz ovog postupka upućivanja nositelji odobrenja za stavljanje u promet retinoida acitretina, alitretinoina i izotretinoina za peroralnu primjenu trebaju provesti ispitivanje potrošnje lijeka i dostaviti dobivene rezultate.
English: A visual reminder on the outer package to warn patients about the harm to unborn baby and the need for effective contraception when using the medicinal product should be implemented in all medicinal products-containing oral retinoids acitretin, alitretinoin and isotretinoin.
Croatian: Na vanjsko pakiranje svih lijekova koji sadrže retinoide acitretin, alitretinoin i izotretinoin za peroralnu primjenu potrebno je staviti vizualni podsjetnik kako bi se bolesnice upozorile na štetnost za nerođeno dijete te potrebu primjene učinkovite kontracepcije za vrijeme uzimanja lijeka.
English: 25 mg Film-coated tablet
Croatian: Unutarnje pakovanje Veličina pakovanja
English: EU/1/07/383/001 Januvia
Croatian: Broj (EU) odobrenja
English: Page 2 of 2
Croatian: Put primjene
English: The programme may last up to approximately a year.
Croatian: Program može trajati do otprilike godinu dana.
English: However, knowledge on the long-term effect of the medicine is limited.
Croatian: No, saznanja o dugoročnom djelovanju lijeka su ograničena.
English: This summary was last updated in 07-2014.
Croatian: Sažetak je posljednji put ažuriran 07. 2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ChondroCelect on 5 October 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek ChondroCelect vrijedi na prostoru Europske unije od 5. listopada 2009.
English: The full EPAR for ChondroCelect can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek ChondroCelect nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The defects were on the femoral condyle and were between 1 and 5 cm2 in size.
Croatian: Oštećenja su se nalazila na femoralnom kondilu i bila su veličine između 1 i 5 cm2.
English: ChondroCelect is a medicine that is prepared specially for each individual patient and can only be used to treat the particular patient it was prepared for.
Croatian: ChondroCelect je lijek koji se priprema posebno za svakog pojedinog bolesnika i može se koristiti samo za liječenje određenog bolesnika za kojeg je pripremljen.
English: Patients treated with ChondroCelect should follow specific rehabilitation programme, including physiotherapy.
Croatian: Bolesnici liječeni lijekom ChondroCelect moraju se pridržavati specifičnog rehabilitacijskog programa, uključujući fizioterapiju.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Croatian: Riječ je o vrsti lijeka koja sadrži stanice ili tkiva koja su izmijenjena kako bi se mogla koristiti za liječenje, regeneraciju ili zamjenu tkiva.
English: First, a biopsy (a small sample) is taken from the patient's cartilage in the knee.
Croatian: Kao prvo, biopsija (mali uzorak) se uzima iz hrskavice koljena bolesnika.
English: Cartilage in the knee can be damaged because of an accident, such as a fall, or because they wear off.
Croatian: Do oštećenja hrskavice u koljenu može doći uslijed nesreće, poput pada ili zbog istrošenosti.
English: This is a summary of the European public assessment report (EPAR) for ChondroCelect.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek ChondroCelect.
English: These cells repair the defects in the knee by producing new cartilage.
Croatian: Ove stanice popravljaju oštećenja u koljenu stvarajući novu hrskavicu.
English: The main measures of effectiveness were how well the defects had healed after one year and the change in the patients' Knee Injury and Osteoarthritis Outcome Score (KOOS) after one and three years of treatment.
Croatian: Glavne mjere djelotvornosti bile su stupanj zacijeljenosti oštećenja nakon jedne godine i promjena u rezultatu ishoda mjerenja nakon oštećenje koljena i osteoartritisa (Knee Injury and Osteoarthritis Outcome Score - KOOS) nakon jedne i tri godina liječenja.
English: ChondroCelect must not be used in people who are hypersensitive (allergic) to any of the other ingredients or to bovine serum (cow's blood).
Croatian: ChondroCelect se ne smije koristiti u osoba koje su preosjetljive (alergične) na bilo koju pomoćnu tvar ili goveđi serum (kravlju krv).
English: The KOOS was measured by patients rating the severity of their symptoms.
Croatian: KOOS su izmjerili bolesnici koji su ocjenjivali i težinu svojih simptoma.
English: ChondroCelect was compared with microfracture (a type of surgery used to treat defects in cartilage) in one main study involving 118 adult patients with symptoms caused by defects in their knee cartilage.
Croatian: ChondroCelect je uspoređen s mikrofrakturom (tipom kirurškog zahvata koji se koristi za liječenje oštećenja hrskavice) u jednom glavnom ispitivanju koje je obuhvatilo 118 odraslih osoba sa simptomima koji su uzrokovali oštećenja u njihovim hrskavicama koljena.
English: After one year, when scans were performed and samples of cartilage were examined, patients who were treated with ChondroCelect showed better structural repair of their cartilage than patients treated with microfracture.
Croatian: Nakon godine dana, kada su napravljeni snimci i pregledani uzorci hrskavice, bolesnici koji su liječeni lijekom ChondroCelect pokazali su bolji strukturalni popravak hrskavica od bolesnika liječenih mikrofrakturom.
English: This means that they are cells taken from the patient, grown outside the body and can be used for implantation into the patient's cartilage.
Croatian: To znači da se stanice uzimaju iz bolesnika, uzgajaju se izvan tijela i mogu se koristiti za ugradnju u bolesnikovu hrskavicu.
English: Other information about ChondroCelect
Croatian: Ostale informacije o lijeku ChondroCelect
English: During surgery on the knee, the suspension is placed into the defect in the patient's cartilage.
Croatian: Tijekom kirurškog zahvata na koljenu, suspenzija se postavlja u oštećenje u hrskavici bolesnika.
English: What measures are being taken to ensure the safe and effective use of ChondroCelect?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka ChondroCelect?
English: This helps the patients to recover from the operation but also leaves enough time for the cartilage cells to implant themselves and for the knee to heal.
Croatian: Ovo pomaže bolesnicima pri oporavku nakon operacije, no ostavlja im i dovoljno vremena da se stanice hrskavice same ugrade te da koljeno zacijeli.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ChondroCelect.
Croatian: Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uvjete korištenja lijeka ChondroCelect.
English: Because ChondroCelect is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Croatian: Budući da je ChondroCelect lijek za naprednu terapiju, njegovo djelovanje ocijenio je Odbor za napredne terapije (Committee for Advanced Therapies - CAT).
English: ChondoCelect is a type of advanced therapy medicine called a ‘tissue engineered product'.
Croatian: ChondoCelect je vrsta lijeka za naprednu terapiju koji se naziva „lijek dobiven tkivnim inženjerstvom”.
English: For more information about treatment with ChondroCelect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom ChondroCelect pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: There was no clear evidence of a difference in the change of KOOS in patients treated with ChondroCelect and those treated with microfracture.
Croatian: Ne postoje jasni dokazi razlika u promjenama KOOS-a u bolesnika liječenih lijekom ChondroCelect i bolesnika liječenih mikrofrakturama.
English: The company is also performing an observational study to obtain more information about the safety and effectiveness of ChondroCelect.
Croatian: Tvrtka također provodi opservacijsko ispitivanje da bi prikupila informacije o sigurnoj primjeni i djelotvornosti lijeka ChondroCelect.
English: The most common side effects with ChondroCelect (seen in more than 1 patient in 10) are arthralgia (joint pain), cartilage hypertrophy (overgrowth), joint crepitation (unusual crackling sounds) and swelling of the joint.
Croatian: Najčešće nuspojave lijeka ChondroCelect (kod više od 1 na 10 osoba 10) su artralgija (bol u zglobovima), hipertrofija hrskavice (prekomjeran rast), krepitacija zgloba (neobični zvukovi pucketanja) i naticanje zgloba.
English: ChondroCelect is a suspension for implantation that contains cartilage cells.
Croatian: ChondroCelect je suspenzija za implantaciju koja sadrži stanice hrskavice.
English: ChondroCelect was also as effective as microfracture at improving symptoms.
Croatian: ChondroCelect je također bio podjednako djelotvoran kao i mikrofrakture u poboljšavanju simptoma.
English: These cells are ‘characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins'.
Croatian: Ove su stanice „karakteristične viabilne autologne stanice hrskavice razvijene ex vivo koje imaju specifične markerske proteine“.
English: A biological membrane is then used as a seal to keep the cells in place while the cartilage repairs.
Croatian: Biološka membrana se zatim koristi za fiksiranje te kako bi se stanice zadržale u mjestu tijekom popravka hrskavice.
English: The cartilage cells are then grown and expanded in the laboratory to provide enough cells to make up a suspension of cells that can be used to treat the cartilage defect.
Croatian: Stanice hrskavice se zatim uzgajaju i šire u laboratoriju kako bi se proizvelo dovoljno stanica za pripremu suspenzije stanica koja se može koristiti za liječenje oštećenja hrskavice.