FrancophonIA/ELRC3.0 huggingface dataset:
English: Animal studies have not shown any harmful effect on fertility and reproduction.
Croatian: Ispitivanja na životinjama nisu pokazala nikakav štetan učinak na plodnost i reprodukciju.
English: SCENESSE is administered subcutaneously under aseptic conditions as described below.
Croatian: SCENESSE se primjenjuje supkutano u aseptičkim uvjetima kako je niže opisano.
English: Pharmacokinetic data for afamelanotide or any of its metabolites are very limited.
Croatian: Farmakokinetički podaci za afamelanotid ili bilo koji njegov metabolit vrlo su ograničeni.
English: - Have the patient sit in a comfortable position or lie on his/her back with the upper part of the body slightly raised.
Croatian: - Bolesnik neka sjedne u udoban položaj ili neka legne na leđa s blago podignutim gornjim dijelom tijela.
English: A second study on embryo-fetal development in Lister-Hooded rats did not achieve sufficient exposure.
Croatian: Drugo ispitivanje embrio-fetalnog razvoja u ListerHooded štakora nije postiglo dovoljnu izloženost.
English: No pharmacokinetic information is available on any of its metabolites (active or inactive).
Croatian: Nema dostupnih farmakokinetičkih podataka o bilo kojim metabolitima (aktivnima ili neaktivnima).
English: Do not administer a new implant unless it has been unequivocally confirmed that the first one had not been inserted.
Croatian: Ne postavljajte novi implantat osim ako nije sa sigurnošću utvrđeno da prvi implantat nije umetnut.
English: This is recommended to be performed every 6 months.
Croatian: Ovakva se kontrola preporuča svakih 6
English: In most clinical studies afamelanotide plasma levels were below the limit of quantitation by day 10.
Croatian: U većini kliničkih ispitivanja razine afamelanotida u plazmi bile su ispod granice kvantifikacije do 10. dana.
English: Your doctor will need to regularly check your skin (full body) to monitor changes in moles (e.g. darkening) or other skin abnormalities.
Croatian: Vaš će liječnik morati redovito pregledavati Vašu kožu (cijelog tijela) kako bi nadzirao promjene u madežima (primjerice tamnjenje) ili druge abnormalnosti kože.
English: EPP is a condition in which patients have an increased sensitivity to sunlight, which can cause toxic effects such as pain and burning.
Croatian: EPP je stanje u kojem bolesnik ima povećanu osjetljivost na sunčevu svjetlost, koja može uzrokovati toksične učinke poput boli i pečenja.
English: It has been demonstrated that EPP patients receiving afamelanotide had more exposure to direct sunlight (10:00 to 18:00 hours) during a 180 day trial period compared to placebo recipients (p=0.044; afamelanotide arithmetic mean: 115.6 h, median 69.4h; placebo mean 60.6h, median 40.8h).
Croatian: Dokazano je da su bolesnici s EPP-om koji su primali afamelanotid imali više izlaganja izravnoj sunčevoj svjetlosti (10:00 do 18:00 sati) tijekom razdoblja ispitivanja od 180 dana u usporedbi s bolesnicima koji su primali placebo (p=0,044; aritmetička sredina za afamelanotid: 115,6 h, medijan 69,4h; aritmetička sredina za placebo 60,6h, medijan 40,8h).
English: Three implants per year are recommended, depending on the length of protection required.
Croatian: Preporučuju se tri implantata godišnje, ovisno o duljini potrebne zaštite.
English: By increasing the amount of eumelanin, SCENESSE can help to delay the onset of pain due to skin photosensitivity (sensitive to sunlight).
Croatian: Povećavajući količinu eumelanina, SCENESSE može pomoći u odgodi nastupanja boli uslijed fotoosjetljivosti kože (osjetljivosti na sunčevu svjetlost).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with SCENESSE in one or more subsets of the paediatric population in erythropoietic protoporphyria (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka SCENESSE u jednoj ili više podskupina pedijatrijske populacije u eritropoetskoj protoporfiriji (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: SCENESSE should not be used during pregnancy and in women of childbearing potential not using effective contraception.
Croatian: SCENESSE se ne smije primjenjivati tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju.
English: Talk to your doctor before receiving SCENESSE if you have or have ever had: - heart problems or severe breathing problems; - gastrointestinal problems; - diabetes;
Croatian: Obratite se svom liječniku prije nego što primite SCENESSE ako imate ili ste ikada imali: - srčane probleme ili teške probleme s disanjem - probleme s probavnim sustavom - dijabetes
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data)
Croatian: i < 1/100); rijetko (≥1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Plasma levels of afamelanotide are maintained over a number of days.
Croatian: Razine afamelanotida u plazmi održavaju se tijekom nekoliko dana.
English: SCENESSE should not be used during breastfeeding.
Croatian: SCENESSE se ne smije primjenjivati tijekom dojenja.
English: Since available data in treatment of the elderly are limited, afamelanotide should not be used in patients over 70 years of age.
Croatian: Budući da su dostupni podaci o liječenju starijih osoba ograničeni, afamelanotid se ne smije primjenjivati u bolesnika starijih od 70 godina.
English: If the skin changes noted are consistent with skin cancer or its precursors, or are ambiguous to the porphyria specialist, dermatology specialist consultation should be sought.
Croatian: Ako su uočene promjene kože konzistetne s rakom kože ili njegovim prekursorima, ili su nejasne liječniku specijalistu za porfiriju, potrebno je potražiti savjet specijalista za dermatologiju.
English: This is an expected response to this medicine, and the darkening will slowly fade unless another implant is used.
Croatian: To je očekivan odgovor na ovaj lijek, te će tamnjenje polako izblijediti osim ako se ne primijeni novi implantat.
English: One implant is administered every 2 months prior to expected and during increased sunlight exposure, e.g. from spring to early autumn.
Croatian: Jedan implantat se primijeni svaka 2 mjeseca prije očekivanog i tijekom povećanog izlaganja suncu, primjerice od proljeća do rane jeseni.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/969/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/969/001
English: Do not use SCENESSE
Croatian: Nemojte primjenjivati SCENESSE
English: It presumably undergoes hydrolysis within a short time; its metabolites' pharmacokinetics and pharmacodynamics are not understood yet.
Croatian: Pretpostavlja se da hidroliza nastupa u kratkom vremenu; još uvijek nisu poznate farmakokinetika i farmakodinamika njegovih metabolita.
English: In repeated dose toxicity studies, the only finding of relevance was an increase in melanin pigmentation in the dog, which is consistent with the active substance's pharmacological activity.
Croatian: U ispitivanju toksičnosti ponovljenih doza, jedini značajan nalaz bilo je povećanje melaninske pigmentacije u pasa, što je konzistentno s farmakološkim djelovanjem djelatne tvari.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 December 2014
Croatian: Datum prvog odobrenja: 22. prosinca 2014.
English: Before inserting this medicine, your doctor may decide to give you a local anaesthetic to numb the area where the implant is to be inserted.
Croatian: Prije umetanja ovoga lijeka, Vaš se liječnik može odlučiti za primjenu lokalne anestezije kao bi otupio područje u koje se umeće implantat.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • U roku od 60 dana od ostvarenja važnog cilja (u smislu farmakovigilancije ili smanjenja rizika)
English: Do not change the sun protection measures you normally follow to manage your EPP and according to your skin phototype (UV sensitivity).
Croatian: Ne mijenjajte mjere zaštite od sunca kojih se normalno pridržavate za zbrinjavanje svog EPP-a i u skladu s Vašim fototipom kože (UV osjetljivost).
English: There is a risk of feeling drowsy and tired when using this medicine, especially within 72 hours of administration.
Croatian: Postoji rizik od osjećaja omamljenosti i umora tijekom korištenja ovoga lijeka, posebice unutar 72 sata od primjene.
English: 6.6 Special precautions for disposal and other handling For instructions on correct administration and preparation see section 4.2.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Za upute o ispravnoj primjeni i pripremi pogledajte dio 4.2.
English: Animal studies are insufficient with respect to developmental toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama su nedostatna za donošenje zaključka o razvojnoj toksičnosti (vidjeti dio 5.3).
English: As an oligopeptide with a short half-life, afamelanotide is expected to be rapidly hydrolysed into shorter peptide fragments and into its individual amino acids.
Croatian: Budući da je afamelanotid oligopeptid s kratkim poluvijekom, očekuje se njegova brza hidroliza u kraće fragmente peptida i u pojedinačne aminokiseline.
English: The MAH shall ensure that in each Member State where SCENESSE is marketed, all healthcare professionals who are expected to use the product are provided with the following educational package and trained:
Croatian: Nositelj odobrenja će osigurati da u svakoj državi članici u kojoj se lijek SCENESSE stavlja u promet, svi zdravstveni djelatnici za koje se očekuje da će primjenjivati lijek dobiju sljedeći edukacijski paket i prođu obuku:
English: Data on possible interactions or effects in special populations, e.g. in patients with hepatic or renal impairment are not available.
Croatian: Nema dostupnih podataka o mogućim interakcijama ili učincima u posebnim populacijama, primjerice u bolesnika s oštećenjem jetre ili bubrega.
English: The implant may be removed by a simple surgical procedure if needed.
Croatian: Implantat se može ukloniti jednostavnim kirurškim zahvatom, ako je to potrebno.
English: • The importance of recruiting and entering patients in the EU Registry,
Croatian: • Važnost regrutiranja i upisa bolesnika u EU registar, • Kako pristupiti i koristiti EU registar.
English: Three implants per year are recommended, depending on the length of effect required.
Croatian: Preporučuje se postavljanje tri implantata godišnje, ovisno o duljini potrebnog djelovanja.
English: The doctor will decide with you the most suitable time and the site for inserting the implant.
Croatian: Liječnik će donijeti odluku o najprikladnijem trenutku i mjestu za umetanje implantata.
English: The overall duration of treatment is at the specialist physician's discretion (see section 4.4).
Croatian: Cjelokupno trajanje liječenja ovisi o procjeni liječnika specijaliste (vidjeti dio 4.4.).
English: In most cases these adverse reactions are reported to be mild in severity.
Croatian: U većini slučajeva, te su prijavljene nuspojave bile blage naravi.
English: For patients with renal or hepatic impairment see sections 4.3 and 5.2.
Croatian: Za primjenu u bolesnika s oštećenjem funkcije bubrega i jetre vidjeti dijelove 4.3. i 5.2.
English: Afamelanotide has moderate influence on the ability to drive and use machines, especially within 72 hours of administration.
Croatian: Afamelanotid umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima, posebice unutar 72 sata od primjene.
English: If the implant has not been administered during the procedural steps described above, discard the implant and administer a new implant.
Croatian: Ako implantat nije postavljen tijekom prethodno opisanih koraka, odložite implantat u otpad i postavite novi implantat.
English: This results in part from afamelanotide's resistance to immediate degradation by serum or proteolytic enzymes (see section
Croatian: To je djelomično rezultat otpornosti afamelanotida na trenutnu razgradnju serumskim ili proteolitičkim enzimima (vidjeti dio 5.2).
English: No specific interaction studies have been performed with this medicinal product.
Croatian: S ovim lijekom nisu provedena posebna ispitivanja interakcija.
English: A regular full body skin examination (every 6 months) is recommended to monitor all pigmentary lesions and other skin abnormalities.
Croatian: Preporučuje se redovit pregled cijeloga tijela (svakih 6 mjeseci) s ciljem praćenja svih pigmentacijskih lezija i drugih abnormalnosti kože.
English: Following subcutaneous administration of the implant, most of the active substance is released within the first 48 hours with over 90% released by day 5.
Croatian: Nakon supkutane primjene implantata, većina djelatne tvari se otpušta unutar prvih 48 sati, a do 5.
English: - Take the packed implant out of the refrigerator and allow the medicinal product to warm up to ambient temperature.
Croatian: Upute za uporabu - Izvadite zapakirani implantat iz hladnjaka i ostavite lijek da se zagrije do temperature okoline.
English: Pharmacotherapeutic group: Emollients and protectives, protectives against UV-radiation for systemic use, ATC code: D02BB02
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Emolijenti i protektivi, protektivi protiv UV zračenja za sistemsku primjenu; ATK oznaka: D02BB02 Mehanizam djelovanja
English: The most commonly reported adverse reactions are nausea, experienced by approximately 19% of subjects who received treatment with this medicinal product, headache (20%), and implant site reactions (21%; mainly discolouration, pain, haematoma, erythema).
Croatian: Najčešće prijavljene nuspojave su mučnina, koja se javila kod otprilike 19% ispitanika koji su primili liječenje ovim lijekom, glavobolja (20%) i reakcije na mjestu implantacije (21%; uglavnom promjena boje kože, bol, hematom, eritem).
English: This can be accompanied by a darkening of the skin pigmentation in areas with melanocytes which gradually fades unless a further implant is administered.
Croatian: Ovo može biti popraćeno tamnijom pigmentacijom kože u područjima s melanocitima, koja postepeno blijede osim ako se ne primijeni novi implantat.
English: Talk to your doctor before receiving SCENESSE if you are over 70 years of age.
Croatian: Ako ste stariji od 70 godina, obratite se svom liječniku prije nego što primite SCENESSE.
English: Prior to launch in Member States, the MAH shall establish a disease registry to gather long term safety data and outcome endpoints in patients with EPP.
Croatian: Prije stavljanja lijeka u promet u državama članicama, nositelj odobrenja uspostavit će registar bolesti kako bi prikupio podatke o sigurnosti dugoročne primjene i mjerama ishoda u bolesnika s EPPom.
English: This medicine must not be used after the expiry date which is stated on the vial and the outer carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i vanjskoj kutiji.
English: Long-term safety data for afamelanotide are limited.
Croatian: Dugotrajna primjena Podaci o sigurnosti dugotrajne primjene afamelanotida su ograničeni.
English: A study in Sprague-Dawley rats showed no adverse effects on embryo-fetal development at exposures approximately 135-fold the human exposure (based on Cmax).
Croatian: Ispitivanje provedeno u Sprague-Dawley štakora nije pokazalo nikakve štetne učinke na embrio-fetalni razvoj pri izloženosti otprilike 135 puta većoj od izloženosti u ljudi (na temelju Cmax).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 implant
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 implantat
English: Administration of afamelanotide may, therefore, result in increased production of eumelanin in the skin of the EPP patient independently of exposure to sunlight or artificial UV light.
Croatian: Primjena afamelanotida može, stoga, rezultirati povećanom proizvodnjom eumelanina u koži bolesnika s EPP-om nezavisno od izlaganja sunčevoj svjetlosti ili umjetnom UV svjetlu.
English: Concomitant disorders not studied
Croatian: Istovremeni poremećaji koji nisu ispitani
English: - The other ingredient is poly (D,L-lactide-co-glycolide).
Croatian: - Drugi sastojak je poli (D,L-laktid-ko-glikolid).
English: EPP patients with fair skin may be more likely to request treatment and are more prone to developing UV light-associated skin changes, including cancer; - detect and monitor changes in pigmentary lesions, thus allowing early detection of melanoma.
Croatian: Izglednije je da će bolesnici s EPP-om koji imaju blijedu put zatražiti liječenje i da će biti skloniji razvijanju promjena kože povezanih s UV svjetlom, uključujući i rak; - otkrivanju i praćenju promjena u pigmentacijskim lezijama, koje omogućuje rano otkrivanje melanoma.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should not receive SCENESSE, since it is not known how it will affect your unborn baby or the breastfed infant.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, ne smijete primiti
English: - Select a 14 gauge (1.6 mm inner diameter) catheter with needle.
Croatian: - Odaberite kateter promjera 14 G (unutarnjeg promjera od 1,6 mm) s iglom.
English: - Using a suitable device (such as a stylet) gently push the implant down the full length of the catheter lumen.
Croatian: - Primjenom prikladnog pomagala (poput stileta) pažljivo pogurnite implantat punom dužinom lumena katetera.
English: A careful decision must be made whether to treat patients with any of these conditions with this medicinal product.
Croatian: Nužno je oprezno donijeti odluku o liječenju ovim lijekom u bolesnika s bilo kojim od prethodno navedenih stanja.
English: The MAH shall also agree the details of the controlled access programme to ensure distribution of SCENESSE only to centres where the physicians received the educational materials and have been trained.
Croatian: Nositelj odobrenja također je dužan usuglasiti detalje programa kontroliranog pristupa kako bi osigurao distribuciju lijeka SCENESSE samo u centre u kojima su liječnici zaprimili edukacijske materijale i prošli obuku.
English: SCENESSE is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Croatian: SCENESSE je indiciran za prevenciju fototoksičnosti u odraslih bolesnika s eritropoetskom protoporfirijom (EPP).
English: 4 years.
Croatian: mjeseci.
English: Afamelanotide is a melanocortin receptor agonist and binds predominantly to the melanocortin-1 receptor (MC1R).
Croatian: Afamelanotid je agonist receptora melanokortina i veže se uglavnom na receptor za melanokortin-1 (MC1R).
English: - Anaesthetise the insertion area if deemed necessary and in consultation with the patient.
Croatian: - Anestezirajte mjesto umetanja ako to smatrate potrebnim te u dogovoru s bolesnikom.
English: - if you have liver problems.
Croatian: - ako imate tegobe s bubrezima.
English: Skin monitoring
Croatian: Praćenje kože
English: The implant is absorbed by the body within 50 to 60 days after administration.
Croatian: Implantat se resorbira u tijelu unutar 50 do 60 dana od primjene.
English: Afamelanotide works in a way similar to the natural hormone, by making skin cells produce eumelanin which is a brown-black type of melanin pigment in the body.
Croatian: Afamelanotid djeluje na sličan način kao i prirodni hormon tako što potiče stanice kože da proizvode eumelanin, odnosno smeđe-crni tip pigmenta melanina u tijelu.
English: The pharmacokinetics of afamelanotide have not been fully characterised yet, i.e. distribution, metabolism or excretion are not clear.
Croatian: Farmakokinetika afamelanotida još uvijek nije u potpunosti definirana, odnosno distribucija,
English: E. SPECIFIC OBLIGATIONS TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures: Description
Croatian: Budući je ovo odobrenje za stavljanje lijeka u promet u iznimnim okolnostima, sukladno članku 14. stavku 8. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: Arrange for an early appointment with your porphyria specialist if pigmented lesions like moles grow or if other growing, non-healing, weeping, plaque-like, wart-like, or ulcerated lesions appear.
Croatian: Dogovorite rani pregled sa svojim liječnikom specijalistom za porfiriju ako pigmentirane lezije poput madeža narastu ili ako se pojave druge lezije koje rastu, ne zacjeljuju, imaju iscjedak, slične su plakovima, bradavicama ili su ulcerirane.
English: This is because patients taking such medicines may experience increased bruising or bleeding at the site of the implant.
Croatian: Razlog ovome je što bolesnik koji uzima ovakve lijekove može biti skloniji nastanku modrica ili krvarenju na mjestu primjene implantata.
English: It is unknown whether afamelanotide or any of its metabolites are excreted in breast milk.
Croatian: Nije poznato izlučuje li se afamelanotid ili njegov metabolit u majčino mlijeko.
English: Retrospective chart review study The MAH shall conduct a retrospective study comparing long term safety data and outcome endpoints in patients receiving and not receiving SCENESSE, or having discontinued SCENESSE use.
Croatian: Nositelj odobrenja provest će retrospektivno ispitivanje uspoređujući podatke o sigurnosti dugoročne primjene i mjere ishoda u bolesnika koji primaju i ne primaju lijek SCENESSE ili su prekinuli primjenu lijeka SCENESSE.
English: - Observe the patient for 30 minutes to ensure that you will notice if the patient develops an allergic or hypersensitivity reaction (immediate type).
Croatian: - Pratite bolesnika 30 minuta kako biste osigurali uočavanje pojave alergijske reakcije ili reakciju preosjetljivosti (ranog tipa) u slučaju da se javi u bolesnika.
English: Afamelanotide is used to increase the tolerance to sunlight in adults with a confirmed diagnosis of erythropoietic protoporphyria (EPP).
Croatian: Afamelanotid se koristi za povećavanje tolerancije na sunčevu svjetlost u odraslih osoba s potvrđenom dijagnozom eritropoetske protoporfirije (EPP).
English: - Disinfect the skin above the supra-iliac crest.
Croatian: - Dezinficirajte kožu iznad ilijačnog grebena.
English: If you experience discomfort and are concerned, speak to your doctor.
Croatian: Ako osjetite nelagodu i zabrinuti ste, obratite se svom liječniku.
English: Your doctor will check the expiry date before an implant is used.
Croatian: Vaš će liječnik provjeriti rok valjanosti prije primjene implantata.
English: If you are affected, do not drive or use any tools or machines.
Croatian: Ako osjećate ove simptome ne upravljajte vozilom i ne radite sa strojevima.
English: SCENESSE should only be prescribed by specialist physicians in recognised porphyria centres and administration should be performed by a physician trained and accredited by the marketing authorisation holder to administer the implant.
Croatian: SCENESSE smije propisivati samo liječnik specijalist u priznatim centrima za liječenje porfirije, a lijek treba primjenjivati liječnik obučen i ovlašten za primjenu implantata od strane nositelja odobrenja za stavljanje lijeka u promet.
English: Women who could become pregnant should use adequate contraception such as oral contraceptives, diaphragm plus spermicide, intrauterine device (also known as a coil) during treatment and for three months after the last SCENESSE implantation.
Croatian: Žene reproduktivne dobi trebaju koristiti primjerenu kontracepciju poput oralnih kontraceptiva, dijafragme u kombinaciji sa spermicidom, intrauterinog uloška (poznatog i kao spirala) tijekom liječenja i još tri mjeseca nakon posljednje ugradnje implantata SCENESSE.