FrancophonIA/ELRC3.0 huggingface dataset:
English: The newly formed bone grows into the matrix, which then degrades.
Croatian: Novoformirana kost raste u matricu, koja zatim degradira.
English: In addition, the company that markets Inductos will make sure that educational material is available in all Member States for all healthcare professionals expected to use the medicine.
Croatian: Nadalje, tvrtka koja stavlja Inductos u promet osigurat će dostupnost edukacijskih materijala u svim državama članicama za sve zdravstvene djelatnike za koje se očekuje da će ih koristiti.
English: The matrix is then cut, if needed, to the correct size before use.
Croatian: Matrica se zatim prije uporabe izrezuje na ispravnu veličinu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inductos on 9 September 2002.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Inductos vrijedi na prostoru Europske unije od 9. rujna 2002.
English: • patients diagnosed with or being treated for cancer;
Croatian: • bolesnicima kojima je dijagnosticiran ili koji se liječe od raka;
English: • patients with an inadequate blood supply at the fracture site;
Croatian: • bolesnicima s neprimjerenom opskrbom krvlju u mjestu frakture;
English: What measures are being taken to ensure the safe and effective use of Inductos?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Inductos?
English: Dibotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Croatian: Dibotermin alfa je proizveden metodom poznatom pod nazivom "tehnologija rekombinantne DNK": proizvode ju stanice koje su zaprimile gen (DNK) koji im zatim omogućuje stvaranje dibotermin alfa.
English: This is a summary of the European public assessment report (EPAR) for Inductos.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Inductos.
English: Other information about Inductos
Croatian: Ostale informacije o lijeku Inductos
English: It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Croatian: To je kopija proteina naziva morfogenetski protein 2 (BMP-2), kojeg tijelo prirodno proizvodi i pomaže s formiranjem novog koštanog tkiva.
English: In this type of surgery, Inductos can be used instead of an autogenous bone graft (bone taken from one part of a person's body and placed in another part of the body).
Croatian: U ovom tipu kirurškog zahvata, Inductos se može koristiti umjesto autogenog presatka kosti (kosti uzete iz jednog dijela tijela osobe i stavljene u drugi dio tijela).
English: For more information about treatment with Inductos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Inductos pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Inductos is used together with approved medical devices that correct the position of the spine.
Croatian: Inductos se koristi zajedno s odobrenim medicinskim proizvodima koji ispravljaju položaj kralježnice.
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 Inductos.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Inductos.
English: Inductos has been studied in 450 patients with a fractured tibia.
Croatian: Inductos je ispitan u 450 bolesnika s frakturom tibije.
English: Inductos is made up into a solution before use, applied to the matrix and left for at least 15 minutes (but no more than two hours).
Croatian: Prije uporabe treba pripremiti otopinu lijeka Inductos, primijeniti otopinu na matricu i ostaviti na najmanje 15 minuta (no ne više od dva sata).
English: This material will include information on the risk of heterotopic ossification and the potential risk of medication errors and incorrect use of Inductos.
Croatian: Ovi materijali će obuhvatiti informacije o riziku heterotopične osifikacije te potencijalnom riziku pogreška pri primjeni lijeka i neispravnoj primijeni Inductos.
English: Of the patients in the standard care group, 46% needed a further intervention within a year to repair their fracture, while the proportion was 26% for those also receiving Inductos.
Croatian: Od svih bolesnika koji su bili u grupi koja je primala standardnu skrb, u 46% bolesnika bila je potrebna dodatna intervencija unutar godine dana kako bi se popravila njihova fraktura u odnosu na 26% onih koji su primili Inductos.
English: The most common side effects with Inductos (seen in more than 1 patient in 10) are radiculopathic events (problems occurring at or near the root of the nerve, along the spine, resulting in pain, weakness, numbness, or difficulty controlling specific muscles) when used in spine surgery, and localised infection when used in tibia fracture surgery.
Croatian: Najčešće nuspojave Inductos (mogu se javiti u više od 1 na 10 osoba) su radikulopatijski događaji (problemi koji nastupaju u ili blizini korijena živca, uz kralježnicu, što rezultira boli, slabošću, utrnućem ili poteškoćama pri kontroliranju određenih mišića) ako se koriste u kiruškom zahvatu na kralježnici, i lokalizirane infekcije ako se koriste u kirurškom zahvatu za popravak frakture tibije.
English: The main measure of effectiveness was fusion of the vertebrae confirmed by X-ray, and improvement in the pain and disability reported by the patient, measured two years after surgery.
Croatian: Glavna mjera djelotvornosti bila je fuzija kralješka potvrđena rendgenskim zrakama, te poboljšanje u boli i invaliditetu prijavljeno od strane bolesnika, izmjereno dvije godine nakon kirurškog zahvata.
English: A risk management plan has been developed to ensure that Inductos is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Inductos.
English: The main measure of effectiveness was the number of patients who did not need further treatment for their fractured tibia (such as a bone graft or changes to the nail used to fix the bones together) in the year following surgery.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika kojima nije bila potrebna daljnja terapija za liječenje frakture tibije (poput koštanog prestaka ili promjene u čavlu korištenom za fiksiranje kostiju) u godini nakon kirurškog zahvata.
English: Additional studies and analysis of data from the published literature showed that Inductos was more effective than bone graft at inducing fusion of the lower back vertebrae, irrespective of the surgical technique or the type of approved medical device used to hold the bone in position.
Croatian: Dodatna ispitivanja i analiza podataka iz objavljene literature pokazala su da je Inductos djelotvorniji od koštanog prestaka u poticanju fuzije lumbalne kralježnice, bez obzira na primijenjenu kiruršku tehniku ili tip odobrenih medicinskih proizvoda koji su korišteni za držanje kosti u mjestu.
English: The replacement dibotermin alfa acts in same way as BMP-2 produced naturally by the body.
Croatian: Zamjenski dibotermin alfa djeluje na isti način kao BMP-2 proizveden prirodnim putem od strane tijela.
English: It is only used when the nail to fix the bone does not need ‘reaming' (drilling to make room for nail placement).
Croatian: Koristi se samo u slučajevima kada nije potrebno ponovno "ciljanje" čavla za fiksiranje kosti (bušenje kako bi se napravilo mjesta za postavljanje čavla).
English: Inductos is used in adults who have been treated for at least six months for back pain due to a damaged disc but have not had an operation.
Croatian: Inductos se koristi u odraslih osoba koje su liječene u posljednjih šest mjeseci protiv boli u leđima uslijed ozljede diska, no nisu imale kirurški zahvat.
English: Inductos is used in addition to standard treatment and care.
Croatian: Inductos se koristi kao dodatak standardnom liječenju i skrbi.
English: Inductos should be used by a qualified surgeon.
Croatian: Inductos mora upotrebljavati kirurg s odgovarajućim kvalifikacijama.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Inductos are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Inductos nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (collagen sponge).
Croatian: Komplet se sastoji od praška koji sadrži djelatnu tvar, dibotermin alfa, otapala i matrice (kolagenske spužve).
English: Inductos is used to help new bone develop.
Croatian: Inductos se koristi kao pomoć u razvoju nove kosti.
English: In patients with a fractured tibia, using Inductos in addition to standard care was more effective than standard care alone in reducing the risk of treatment failure.
Croatian: U bolesnika s frakturom tibije, primjena Inductos uz standardnu skrb bila je djelotvornija od primjene samo standardne skrbi u smanjivanju rizika od neuspješne terapije.
English: For lower back spine fusion, the damaged disc between the vertebrae is removed and replaced with one or more medical devices and Inductos.
Croatian: Za fuziju lumbalne kralježnice, uklanja se oštećeni disk između kralješka te se zamjenjuje s jednim ili više medicinskih proizvoda i kompletom Inductos.
English: The medical devices fix the position of the vertebrae, and Inductos encourages bone to grow between the two vertebrae to join them permanently in the correct position.
Croatian: Medicinski proizvodi popravljaju položaj kralježaka, a Inductos potiče rast kosti između dva kralješka kako bi kosti trajno srasle u ispravan položaj.
English: • patients with an active infection at the surgery site;
Croatian: • bolesnicima s aktivnom infekcijom u mjestu frakture;
English: Patients undergoing treatment with Inductos may be at risk of heterotopic ossification (the growth of bone in abnormal places like soft tissue); this risk is considered to be manageable with the proposed risk minimisation measures.
Croatian: Bolesnici koji se podvrgavaju terapiji kompletom fuziju jedne razine lumbalne kralježnice mogu biti izloženi riziku heterotopične osifikacije (rasta kosti na abnormalnim mjestima, poput mekanoga tkiva); ovaj se rizik smatra upravljivim uz primjenu predloženih mjera za smanjivanje rizika.
English: Inductos was compared with standard care.
Croatian: Inductos je uspoređen sa standardnom skrbi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inductos, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Inductos nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The CHMP considered that Inductos is effective in single-level lumbar spine fusion as a substitute for autogenous bone graft and for the treatment of acute tibia fractures in adults, as an adjunct to standard care.
Croatian: CHMP zaključio je da je Inductos djelotvoran u fuziji jedne razine lumbalne kralježnice kao zamjena za autogeni koštani presadak te za terapiju akutnih fraktura tibije u odraslih osoba, kao dodatak standardnoj skrbi.
English: Inductos has been studied in 279 patients having lower back spine fusion.
Croatian: Inductos je ispitan u 279 bolesnika na kojima je provedena fuzija lumbalne kralježnice.
English: When implanted, dibotermin alfa stimulates the bone tissue around the matrix to make new bone.
Croatian: Prilikom ugradnje, dibotermin alfa stimulira koštano tkivo oko matrice kako bi se proizvela nova kost.
English: In spinal fusion, Inductos was as effective as bone grafts.
Croatian: U slučaju fuzije kralježnice, Inductos je bio podjednako djelotvoran kao koštani presadak.
English: This is a type of surgery used to relieve back pain due to a damaged disc where the disc between two vertebrae (the bones in the spine) is removed and the vertebrae are fused (joined) together.
Croatian: Ovaj se tip kirurškog zahvata koristi za ublažavanje boli uslijed ozljeđenog diska u slučaju kada se disk između dva kralješka (kosti kralježnice) uklanja, te se vrši fuzija kralješka (spajanje).
English: The most severe side effect is localised oedema (swelling at the surgery site) when used in upper spine (neck) surgery.
Croatian: Najčešće nuspojave su lokalizirani edem (otok u mjestu kirurškog zahvata) ako se koristi u kirurškom zahvatu u gornjoj (vratnoj) kralježnici).
English: Why has Inductos been approved?
Croatian: Zašto je Inductos odobren?
English: Inductos is a kit for implant.
Croatian: Inductos je komplet za usadak.
English: • surgery to heal fractures (breaks) of the tibia (shin bone).
Croatian: • kirurški zahvat za liječenje fraktura (puknuća) tibije (goljenične kosti).
English: What is the risk associated with Inductos?
Croatian: Koji su rizici povezani s lijekom Inductos?
English: What is Inductos?
Croatian: Što je Inductos?
English: The active substance in Inductos, dibotermin alfa, acts on the bone structure.
Croatian: Djelatna tvar lijeka Inductos, dibotermin alfa, djeluje na strukturu kostiju.
English: For a fractured tibia, Inductos is placed around the broken bone to aid healing.
Croatian: U slučaju pucanja tibije, Inductos se stavlja oko slomljene kosti kako bi se pomoglo pri zacjeljivanju.
English: Spinal fusion using Inductos was compared with fusion using a bone graft removed from the hip during surgery.
Croatian: Fuzija kralježnice pomoću kompleta Inductos uspoređena je s fuzijom za koju je primijenjen koštani presadak koji je uzet iz kuka tijekom kirurškog zahvata.
English: What benefit has Inductos shown during the studies?
Croatian: Koje su koristi lijeka Inductos utvrđene u ispitivanjima?
English: • lower back spine fusion surgery.
Croatian: • fuziji lumbalne kralježnice.
English: For the full list of all side effects reported with Inductos, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Inductos potražite u uputi o lijeku.
English: What is Inductos used for?
Croatian: Za što se Inductos koristi?
English: For the full list of restrictions with Inductos, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Inductos potražite u uputi o lijeku.
English: How does Inductos work?
Croatian: Kako djeluje Inductos?
English: How is Inductos used?
Croatian: Kako se Inductos koristi?
English: How has Inductos been studied?
Croatian: Kako je Inductos ispitivan?
English: Scenesse has been authorised under ‘exceptional circumstances'.
Croatian: Scenesse je odobren u „iznimnim okolnostima”.
English: The number of implants per year depends on how much protection from the sun is needed.
Croatian: Broj implantata po godini ovisi o tome koliko je zaštite od sunca potrebno.
English: Scenesse afamelanotide
Croatian: Scenesse afamelanotid
English: Doctors will also be given information on the EU registry.
Croatian: Liječnicima će se također dostaviti informacije iz registra EU-a.
English: Patients should be observed for allergic reactions for 30 minutes after the injection of each implant.
Croatian: Bolesnici trebaju obratiti pozornost na alergijske reakcije unutar 30 minuta nakon injekcije svakog implantata.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Scenesse on 22 December 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Scenesse na snazi u Europskoj uniji od 22. prosinca 2014.
English: Scenesse is used to help prevent or reduce these symptoms so that these patients can lead more normal lives.
Croatian: Scenesse se koristi kao pomoć pri sprječavanju ili smanjivanju ovih simptoma tako da bolesnici mogu voditi normalnije živote.
English: What is Scenesse and what is it used for?
Croatian: Što je Scenesse i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Scenesse?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Scenesse?
English: Why is Scenesse approved?
Croatian: Zašto je Scenesse odobren?
English: Other information about Scenesse
Croatian: Ostale informacije o lijeku Scenesse
English: These affected around 1 in 5 patients and were generally mild in severity.
Croatian: Ove nuspojave uočene su kod otprilike 1 na 5 bolesnika, te su bile načelno blage u svojoj ozbiljnosti.
English: The Committee also consulted individual patients and experts on their experience with Scenesse.
Croatian: Odbor je također zatražio savjet od pojedinih bolesnika i stručnjaka o njihovom iskustvu u korištenju lijeka Scenesse.
English: Patients with EPP have high levels of a substance called protoporphyrin IX in the body.
Croatian: Bolesnici s EPP-om imaju visoke koncentracije tvari naziva protoporfirin IX u tijelu.
English: Scenesse must not be used in patients with reduced liver or kidney function.
Croatian: Scenesse se ne smije koristiti u bolesnika sa smanjenom funkcijom jetre ili bubrega.
English: Protoporphyrin IX is phototoxic and, when exposed to light, causes the painful reactions seen with this condition.
Croatian: Protoporfirin IX je fototoksičan i ako se izlaže svjetlu uzrokuje bolne reakcije uočene s ovim stanjem.
English: This is a summary of the European public assessment report (EPAR) for Scenesse.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Scenesse.
English: Daily records of exposure to sunlight between 10 am and 6 pm showed that patients treated with Scenesse spent on average 116 hours in direct sunlight without experiencing pain during the six-month period compared with 61 hours for patients treated with placebo.
Croatian: Dnevna evidencija izlaganja sunčevoj svjetlosti između 10:00 i 18:00 pokazala je da bolesnici liječeni lijekom Scenesse provode prosječno 116 sati izloženi izravnoj Sunčevoj svjetlosti bez da iskuse bol tijekom razdoblja od šest mjeseci u usporedbi sa 61 satom za bolesnike liječene placebom.
English: The most common side effects seen in studies with Scenesse were nausea (feeling sick), headache and reactions at the implant site (such as discoloration, pain and redness).
Croatian: Najčešće nuspojave uočene u ispitivanjima provedenima s lijekom Scenesse su mučnina (osjećaj slabosti), glavobolja i reakcije u mjestu implantacije (poput promjena boje, bol i crvenilo).
English: It is not intended to provide practical advice on how to use Scenesse.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Scenesse.
English: This is because it has not been possible to obtain complete information about the benefits of Scenesse, in part due to the rarity of the disease.
Croatian: Tome je razlog nemogućnost dobivanja potpunih informacija o lijeku Scenesse zbog rijetkosti bolesti.
English: Because the number of patients with EPP is low, the disease is considered ‘rare', and Scenesse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 May 2008.
Croatian: Budući da je broj bolesnika s EPP-om nizak, bolest se smatra „rijetkom” te se Scenesse označava kao lijek za liječenje rijetkih bolesti od 8. svibnja 2008.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Scenesse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Scenesse nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: A risk management plan has been developed to ensure that Scenesse is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Scenesse.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Scenesse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Scenesse dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In the study, involving 93 patients with EPP, patients were treated with either Scenesse or a placebo (a dummy treatment) over a six-month period.
Croatian: U ispitivanju, koje je obuhvatilo 93 bolesnika s EPP-om, bolesnici su liječeni lijekom Scenesse ili placebom (lažnim liječenjem) tijekom razdoblja od šest mjeseci.
English: Scenesse is an implant used to treat patients with erythropoietic protoporphyria (EPP), a rare disease that causes intolerance to light.
Croatian: Scenesse je implantat koji se koristi za liječenje bolesnika s eritropoetskom protoporfirijom (EPP), a rijetkom bolešću koja uzrokuje netoleranciju na svijetlo.
English: By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, thus helping to prevent the painful reactions.
Croatian: Stimulirajući stvaranje eumelanina u koži, Scenesse smanjuje penetraciju svjetla kroz kožu, te tako pomaže pri sprječavanju bolnih reakcija.
English: The full EPAR and risk management plan summary for Scenesse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Scenesse nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Scenesse contains the active substance afamelanotide.
Croatian: Scenesse sadrži djelatnu tvar afamelanotid.
English: Three implants per year are recommended;
Croatian: Preporučuje se tri implantata godišnje, a maksimalan broj je 4 implantata.
English: One Scenesse implant is injected under the patient's skin once every 2 months, before and during periods of high sunlight exposure, e.g. from spring to autumn.
Croatian: Jedan implantat Scenesse ubrizgava se supkutano u bolesnika svaka 2 mjeseca prije i tijekom razdoblja povećanog izlaganja suncu, primjerice od proljeća do rane jeseni.
English: The active substance in Scenesse, afamelanotide, is similar to a hormone in the body known as alphamelanocyte stimulating hormone, which stimulates the production of a brown-black pigment in the skin.
Croatian: Djelatna tvar lijeka Scenesse, afamelanotid, slična je hormonu u tijelu poznatom pod nazivom hormon koji stimulira alfa-melanocit, koji stimulira proizvodnju smeđe-crnog pigmenta u koži.
English: What are the risks associated with Scenesse?
Croatian: Koji su rizici povezani s lijekom Scenesse?
English: This pigment, known as eumelanin, is produced during exposure to sunlight to block the penetration of light into cells.
Croatian: Ovaj pigment, poznat pod nazivom eumelanin, proizvodi se tijekom izlaganja sunčevoj svjetlosti kako bi se inhibirala penetracija svjetla u stanice.
English: In patients with EPP, exposure to light can lead to symptoms such as pain and swelling of the skin, which prevent patients from being able to spend time outdoors or in places with bright light.
Croatian: U bolesnika s EPP-om, izlaganje svjetlu može rezultirati simptomima poput boli i otoka kože, što sprječava bolesnike od provođenja više vremena na otvorenom ili na mjestima s jakim osvjetljenjem.
English: What information is still awaited for Scenesse?
Croatian: Koje se još informacije očekuju o lijeku Scenesse?