FrancophonIA/ELRC3.0 huggingface dataset:
English: The calculated amount of syringes should be filled from the thawed vials, and they should be labelled and placed in a container protected from light suitable for transportation to the room where the patient will undergo the intramuscular injections.
Croatian: Iz odmrznutih bočica treba napuniti izračunati broj štrcaljki, koje treba označiti i položiti u spremnik zaštićen od svjetlosti i prikladan za prijevoz do sobe gdje će bolesnik primiti intramuskularne injekcije.
English: Volumes per injection site must not exceed 0.5 ml.
Croatian: Volumeni po injekciji ne smiju biti veći od 0,5 ml.
English: The assay to be used in the study needs to be agreed.
Croatian: Test koji će se koristiti u ispitivanju mora biti odobren.
English: Your doctor will weigh up the benefits to you against the risks to your baby of taking Glybera whilst you are pregnant.
Croatian: Liječnik će razmotriti omjer između koristi za vas i rizika za dijete pri uporabi Glybere u trudnoći.
English: Glybera will only be given to you if you show detectable levels of LPL protein in your blood.
Croatian: Glyberu smijete primati samo ako se kod Vas pronađu utvrdive razine proteina LPL u krvi.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glybera in all subsets of the paediatric population in the treatment of lipoprotein lipase deficiency (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Glybera u svim podskupinama pedijatrijske populacije u liječenju nedostatka lipoproteinske lipaze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • It is important that you fully understand the benefits and risks associated with the treatment by discussing with your doctor
Croatian: • Važno je da se posavjetujete s liječnikom i da potpuno razumijete koristi i rizike povezane s liječenjem,
English: Very limited data on pregnancies exposed to Glybera is available.
Croatian: Trudnoća Raspoloživi podaci o trudnicama koje su izložene Glyberi vrlo su ograničeni.
English: Shedding was assessed in the clinical studies by collecting saliva, urine and semen.
Croatian: Izlučivanje virusa je procijenjeno u kliničkim ispitivanjima uzimanjem sline, urina i sperme.
English: Upon intramuscular injection, the patient will receive multiple injections of 0.5 ml (one injection per syringe), distributed over the muscles of both upper and lower legs, under aseptic conditions such as iodine.
Croatian: Pri intramuskularnom injiciranju, bolesnik će primiti višestruke injekcije od 0,5 ml (jedno injiciranje po štrcaljki), raspoređene po mišićima natkoljenica i potkoljenica, u aseptičkim uvjetima, na primjer uporabom joda.
English: Glybera is administered as a one-time series of intramuscular injections in the legs.
Croatian: Glybera se primjenjuje kao jednokratni niz intramuskularnih injekcija u noge.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu .
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Unused medicine must be disposed of in compliance with the local rules for genetically modified organisms.
Croatian: Neiskorišteni lijek mora se zbrinuti sukladno lokalnim propisima za genetski modificirane organizme.
English: The instructions for use, handling and disposal are given in section 6.6.
Croatian: Za uputu o uporabi, rukovanju i zbrinjavanju, vidjeti dio 6.6.
English: 2) Educational material for physicians and other healthcare professionals involved in the treatment of patients with Glybera including the following key safety elements:
Croatian: 2) Edukacijski materijal za liječnike i druge zdravstvene djelatnike uključene u liječenje bolesnika Glyberom, uključujući sljedeće ključne sigurnosne elemente:
English: They only last a short time.
Croatian: One ubrzo nestanu.
English: 3) Educational materials for patients treated with Glybera including the following key safety elements:
Croatian: 3) Edukacijski materijal za bolesnike koji se liječe Glyberom, uključujući sljedeće ključne sigurnosne elemente:
English: Assessment of immune response at baseline, 6 months and 12 months in at least 12 newly treated patients.
Croatian: Ocjena početnih vrijednosti imunološkog odgovora, nakon 6 mjeseci i nakon 12 mjeseci u najmanje 12 novoliječenih bolesnika.
English: Glybera is used to treat a specific inherited condition known as “lipoprotein lipase deficiency (LPLD)”.
Croatian: Glybera se koristi za liječenje specifičnog nasljednog stanja koji se naziva „nedostatak lipoproteinske lipaze (LPLD)“.
English: Alipogene tiparvovec is produced using insect cells and recombinant baculovirus technology.
Croatian: Alipogen tiparvovek je dobiven uporabom stanica insekta i rekombinantne bakulovirusne tehnologije.
English: Pre-clinical studies with doses ten times the recommended dose (1 x 1013 gc/kg) did not lead to any general systemic untoward signs or symptoms.
Croatian: Pretklinička ispitivanja s dozama koje su bile deset puta veće od preporučene doze (1 x 1013 gk/kg) nisu pokazala nepoželjne opće znakove ili simptome.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava:navedenog u Dodatku V.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: Glybera contains alipogene tiparvovec, a gene therapy product that works by delivering a gene into the body to correct a genetic deficiency.
Croatian: Glybera sadrži alipogen tiparvovek, produkt genske terapije, koja djeluje na način da unosi gen u tijelo i time ispravlja genetski manjak.
English: No interaction studies other than preclinical and clinical studies with mycophenolate mofetil and ciclosporin have been performed.
Croatian: Nisu provedena ispitivanja interakcija, izuzev pretkliničkih i kliničkih ispitivanja s mofetilmikofenolatom i ciklosporinom.
English: Anti-platelet or other anti-coagulant medicinal products must not be taken for at least one week before the leg injections or one day after the injection (see section 4.3).
Croatian: Antitrombocitni ili drugi antikoagulantni lijekovi ne smiju se primjenjivati najmanje jedan tjedan prije ili jedan dan nakon injiciranja u noge (vidjeti dio 4.3).
English: It belongs to a group of medicines called lipid modifying agents.
Croatian: Pripada skupini lijekova koji modificiraju lipide.
English: Like all medicines, Glybera can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, Glybera može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Oral contraceptive use is contraindicated in LPLD patients (see section 4.3) as this may exacerbate the underlying disease.
Croatian: Uporaba oralnih kontraceptiva kontraindicirana je u bolesnika s LPLD-om (vidjeti dio 4.3), jer može pogoršati postojeću bolest.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING Pharmacovigilance system
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Farmakovigilancijski sustav
English: After administration of Glybera to the participants, the highest vector DNA concentrations were detected in the serum, with clearance by one to two logs per week.
Croatian: Nakon primjene Glybere u ispitanika, najveće koncentracije DNK vektora pronađene su u serumu, s klirensom za jedan do dva logaritma tjedno.
English: Glybera is injected as a one-time series into the muscle of the lower extremities where it is taken up by myocytes.
Croatian: Glybera se injicira kao jednokratni niz u mišiće donjih ekstremiteta gdje je preuzimaju miociti.
English: It is important that at the time of first Glybera administration, your body's immune (defence) system is not activated.
Croatian: Važno je da se Vaš imunološki (obrambeni) sustav ne aktivira u trenutku prve primjene Glybere.
English: Furthermore, Glybera allows expression of the LPL protein in injected muscle which is reflected by the improvement of postprandial chylomicron (CM) metabolism observed in a small subset of patients.
Croatian: Osim toga, Glybera omogućuje ekspresiju proteina LPL u mišiću u koji je injicirana, na što ukazuje poboljšanje u postprandijalnom metabolizmu hilomikrona koji je opažen u manjoj podskupini bolesnika.
English: The diagnosis of LPLD has to be confirmed by genetic testing.
Croatian: Dijagnozu LPLD-a treba potvrditi genetičkim testiranjem.
English: In half of the subjects a T-cell response to the vector was seen.
Croatian: U polovice ispitanika opažen je odgovor T-limfocita na vektor.
English: • Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with Glybera at the time of injection and for at least one week before or one day after the injection.
Croatian: • Antitrombocitni ili drugi antikoagulantni lijekovi ne smiju se primjenjivati istodobno s Glyberom u trenutku injiciranja i najmanje jedan tjedan prije ili jedan dan nakon injekcije.
English: This information is also provided in the Glybera Patient's Alert Card.
Croatian: Te informacije sadrži i kartica Glybere s upozorenjima za bolesnika.
English: After treatment with Glybera do not donate blood, organs, tissues and cells for transplantation to avoid spreading cells that contain your medicine.
Croatian: Nakon liječenja Glyberom ne smijete darivati krv, organe, tkiva i stanice za transplantaciju kako biste spriječili širenje stanica koje sadrže taj lijek.
English: The studies should be performed according to an agreed protocol.
Croatian: Ispitivanja se moraju provesti u skladu s odobrenim protokolom.
English: - if your immune system does not work properly - if you have an increased bleeding risk and or muscle disease
Croatian: - ako imate povećani rizik od krvarenja i/ili bolest mišića;
English: Vials should be visually inspected for particulate matter and colour.
Croatian: Bočice je potrebno pregledati na prisutnost čestica i boje.
English: Patient Code number:
Croatian: Šifra bolesnika:
English: Re-evaluation of immune responses from all patients enrolled in study CT-AMT-011-01 by using a validated assay method should also be provided.
Croatian: Također se mora predložiti ponovna procjena imunoloških odgovora kod svih bolesnika uključenih u ispitivanje CT-AMT-011-01, uporabom validirane metode testiranja.
English: Study CT-AMT-011-03 was a combined retrospective and prospective study of subjects who had taken part in studies CT-AMT-10-01, CT-AMT-11-01, CT-AMT-11-02.
Croatian: Ispitivanje CT-AMT-011-03 bilo je kombinirano retrospektivno i prospektivno ispitivanje sudionika u ispitivanjima CT-AMT-10-01, CT-AMT-11-01, CT-AMT-11-02.
English: Upon treatment four weeks prior to mating, no maternal, foetal and developmental toxicity was seen in mice.
Croatian: Tijekom liječenja četiri tjedna prije parenja, u miševa nije opažena toksičnosti za majke, plod ili razvoj.
English: The Marketing Authorisation Holder should be informed immediately.
Croatian: O tome je potrebno odmah obavijestiti nositelja odobrenja za stavljanje lijeka u promet.
English: No data on re-administration of Glybera are available, therefore Glybera should not be re-administered.
Croatian: Nema podataka o ponovnoj primjeni Glybere, zato se Glybera ne smije ponovno primjenjivati.
English: The elements of the vector were chosen such that expression of the LPL S447X gene is promoted, by co-opting the expression machinery of the cell and the myocytes produce the protein product of the transgene LPL S447X without the vector being able to reproduce itself.
Croatian: Elementi vektora odabrani su tako da se pospješi ekspresija gena LPL S447X, s preuzimanjem staničnih mehanizama ekspresije te miociti proizvode proteinski produkt transgena LPL S447X, bez mogućnosti da se sam vektor reproducira.
English: Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with Glybera at the time of injection.
Croatian: Antitrombocitni ili drugi antikoagulantni lijekovi ne smiju se primjenjivati istodobno s Glyberom u trenutku injiciranja.
English: • Guidelines for the safe handling, administration and disposal of Glybera
Croatian: • Smjernice za sigurno rukovanje, primjenu i zbrinjavanje Glybere
English: Hair growth abnormal, Palmar-plantar erythrodysaesthesia syndrome, Rash
Croatian: Abnormalan rast dlaka, sindrom palmarnoplantarne eritrodizestezije, osip
English: Glybera has minor influence on the ability to drive and use machines¸ dizziness was commonly observed after Glybera administration (see section 4.8).
Croatian: Glybera malo utječe na sposobnost upravljanja vozilima i rada sa strojevima, no nakon primjene Glybere često je zapažena omaglica (vidjeti dio 4.8).
English: Glybera should only be used when the diagnosis of LPLD has been confirmed by an adequate genetic test (see section 5.1).
Croatian: Glybera se mora primjenjivati samo ako je dijagnoza LPLD potvrđena odgovarajućim genetskim testiranjem (vidjeti dio 5.1).
English: Doctors shall be encouraged also to enrol patients with familial LPLD who are not treated with Glybera.
Croatian: Liječnici će se poticati da u registar uključuju i bolesnike s obiteljskim LPLD-om koji nisu liječeni Glyberom.
English: One patient developed myoglobinuria in association with raised serum creatine kinase activity.
Croatian: Kod jednog se bolesnika javila mioglobinurija povezana s povećanom aktivnosti serumske keratin kinaze.
English: In clinical trials with Glybera, antibodies against the adeno-associated virus (AAV) protein shell were present prior to treatment, in 18 out of 27 subjects; anti-AAV antibodies appeared or increased after Glybera administration, in all of the subjects.
Croatian: U kliničkim ispitivanjima Glybere, kod 18 od 27 ispitanika bila su prisutna protutijela na proteinsku ovojnicu adeno-asociranog virusa (AAV) prije liječenja; nakon primjene Glybere, u svih ispitanika pojavila su se ili povećala protutijela na AAV.
English: Compared to pre-administration, a transient and variable reduction in median triglyceride levels was recorded for all patients.
Croatian: U usporedbi s razdobljem prije injiciranja, kod svih bolesnika zabilježeno je prolazno i varijabilno smanjenje medijana razina triglicerida.
English: After this time, triglyceride levels reverted back to baseline.
Croatian: Nakon tog razdoblja, razine triglicerida vratile su se na početne vrijednosti.
English: These medicines should not be taken for at least one week before the leg injections or one day after you have had the injections.
Croatian: Te lijekove ne smijete uzimati najmanje jedan tjedan prije ubrizgavanja u nogu ili jedan dan nakon toga.
English: The lowest number of copies was found in the brain, lung, heart and non-injected groups of muscle.
Croatian: Najmanji broj kopija otkriven je u mozgu, plućima, srcu i u skupinama mišića u koje lijek nije injiciran.
English: You need to take this into consideration if you are on a controlled sodium diet.
Croatian: O tome trebate voditi računa ako ste na dijeti s ograničenim unosom natrija.
English: • pain in leg(s) (pain in extremity)
Croatian: • bol u nozi (nogama) (bol u udu)
English: Glybera therapy will be overseen by a doctor who is specialised in the treatment of patients affected by your condition and will be administered to you by an appropriately qualified and trained doctor or nurse.
Croatian: Terapiju Glyberom nadzirat će liječnik koji je specijaliziran za liječenje bolesnika koji boluju od Vaše bolesti, i primjenjivat će je prikladno kvalificiran i osposobljen liječnik ili medicinska sestra.
English: The amount of sodium and potassium that you may receive depends on the number of injections that you need; your doctor will work this out depending on your weight.
Croatian: Količina natrija i kalija koju primate ovisi o broju injekcija koje su Vam potrebne, koji će izračunati liječnik na temelju
English: This is an open-label study of alipogene tiparvovec at a fixed dose of 1x1012 gc/ kg body weight administered by a single series of intramuscular injections.
Croatian: To je otvoreno ispitivanje alipogen tiparvoveka s fiksnom dozom 1 x 1012 gk/kg tjelesne težine, koja je primijenjena u jednom nizu intramuskularnih injekcija.
English: Glybera is authorised for single treatment only and should not be re-administered.
Croatian: Glybera je odobrena samo za jednokratno liječenje i ne smije se ponovno primjenjivati.
English: Obligation to conduct post-authorisation measure
Croatian: Obaveza provođenja mjera nakon davanja odobrenja
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan and the Efficacy Follow-up Plan as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP.
Croatian: Podnošenje PSUR-a za lijek treba pratiti šestomjesečni ciklus do drugačije dogovorenog od strane
English: o information on the signs and symptoms of a reduction/loss of efficacy o the use of the events diary and what should be recorded
Croatian: o informacije o znakovima i simptomima smanjenja/gubitka djelotvornosti;
English: Subjects also received a daily oral dose of 3 mg/kg/day cyclosporine and 2 g/day of mycophenolate mofetil starting three days before administration of alipogene tiparvovec through week 12.
Croatian: Ispitanici su primali također dnevnu peroralnu dozu od 3 mg/kg/dan ciklosporina i 2 g/dan mofetilmikofenolata, što je započelo tri dana prije primjene alipogen tiparvoveka i trajalo do 12. tjedna.
English: Small amounts of blood will be drawn before treatment, 6 months and 12 months after treatment to measure how your body's immune (defence) system is responding to the treatment with Glybera.
Croatian: Prije liječenja te 6 mjeseci i 12 mjeseci nakon liječenja uzet će Vam se uzorak male količine krvi, čime će se izmjeriti kako Vaš imunološki (obrambeni) sustav odgovara na liječenje s Glyberom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA
English: The aim of this open label, dose escalating study was to assess the safety profile and reduction of fasting plasma triglyceride (TG) levels after 12 weeks post Glybera administration in 14 LPLD patients.
Croatian: Cilj otvorenog ispitivanja s postupnim povećavanjem doze bio je ocijeniti sigurnosni profil i smanjenje razina triglicerida (TG) u plazmi natašte 12 tjedana nakon injiciranja Glybere u 14 bolesnika s LPLD-om.
English: Muscle biopsies obtained up to 52 weeks after administration of Glybera show an infiltrate of lymphocytes and macrophages.
Croatian: Biopsije mišića, koje su napravljene do 52 tjedna nakon primjene Glybere pokazuju infiltraciju limfocita i makrofaga.
English: • Advice on the need to continue on a low-fat diet and avoid drinking alcohol
Croatian: • Savjete o potrebi za nastavljanjem dijete s niskim sadržajem masnoća i potrebi za izbjegavanjem alkohola
English: • A medicine impacting blood coagulation e.g. acetylsalicylic acid (e.g.aspirin), a substance present in many medicines used to relieve pain and lower fever, as well as medicines used to prevent blood clotting eg anticoagulants such as warfarin, heparin.
Croatian: • lijekove koji utječu na zgrušavanje krvi, npr. acetilsalicilna kiselina (npr. aspirin), koja je prisutna u mnogim lijekovima za ublažavanje bolova i snižavanje povišene tjelesne temperature, kao i lijekove koji se uzimaju za sprječavanje zgrušavanja krvi, npr.
English: Alipogene tiparvovec contains the human lipoprotein lipase (LPL) gene variant LPLS447X in a vector.
Croatian: Alipogen tiparvovek sadrži humani gen za lipoproteinsku lipazu, varijanta LPLS447X u vektoru.
English: Burning sensation, Dizziness, Formication, Presyncope
Croatian: Osjećaj žarenja, omaglica, mravinjanje, presinkopa
English: Dyspnoea exertional, Pulmonary embolism
Croatian: Dispneja pri naporu, plućna embolija
English: Male patients must use condoms for at least 12 months after injection with Glybera.
Croatian: Muški bolesnici moraju upotrebljavati prezervative najmanje 12 mjeseci nakon ubrizgavanja Glybere.
English: Refer to local biosafety guidelines applicable for handling and disposal of medicinal products containing genetically-modified organisms.
Croatian: Pridržavajte se lokalnih smjernica za biološku sigurnost koje su primjenjive za rukovanje i zbrinjavanje lijekova koji sadrže genetski modificirane organizme.
English: Glybera is not usually recommended for use during pregnancy.
Croatian: Ne preporučuje se koristiti Glyberu tijekom trudnoće.
English: High levels of vector DNA were observed up to 12 months after dosing in the target tissue for Glybera, injected leg muscle, but not in non-injected muscle.
Croatian: Visoke razine DNA vektora opažene su do 12 mjeseci nakon doziranja u ciljnom tkivu na koje je bila usmjerena Glybera, u injiciranom mišiću noge, dok nisu opažene u mišićima gdje lijek nije bio injiciran.
English: • bruises in the upper and lower leg muscle due to the injections.
Croatian: • modrice u mišićima natkoljenice i potkoljenice zbog injekcija.
English: The dose per injection site is 1.5 x 1012 gc, or 0.5 ml of solution for injection.
Croatian: Doza po mjestu injiciranja je 1,5 x 1012 gk, ili 0,5 ml otopine za injiciranje.
English: Limited data are available in diabetic patients.
Croatian: Malo je raspoloživih podataka o bolesnicima s dijabetesom.
English: The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Croatian: Nositelj odobrenja u svakom će pakiranju priložiti i karticu s upozorenjima za bolesnika čiji tekst je uključen u Dodatku III.
English: Number of 1 ml syringes (each filled) with 0.5 ml)
Croatian: Broj štrcaljki od 1 ml (svaka napunjena sa 0,5 ml)
English: Patients are advised to continue to follow a low-fat diet and refrain from alcohol consumption.
Croatian: Bolesnicima se savjetuje da nastave svoju dijetu s niskim sadržajem masnoća i da ne konzumiraju alkohol.
English: • Information about the signs and symptoms to be monitored after treatment including:
Croatian: • Informacije o postupku liječenja Glyberom • Informacije o znakovima i simptomima koje treba pratiti nakon liječenja, uključujući:
English: An appropriate CE marked test or full gene sequencing should be used to confirm the diagnosis.
Croatian: Za potvrđivanje dijagnoze mora se koristiti odgovarajući test s oznakom CE ili potpuno sekvenciranje gena.
English: Recipients of Glybera may display a rise in serum creatine kinase activity that becomes evident about 2 weeks after administration, peaks at around 8 weeks and then returns to baseline by week 26.
Croatian: U bolesnika koji primaju Glyberu može doći do povećanja aktivnosti serumske keratin kinaze što se očituje oko 2 tjedna nakon primjene, s vršnom vrijednosti oko 8. tjedna, a zatim se do 26. tjedna vraća na početne vrijednosti.
English: To calculate the number of injection sites and the number of syringes, the patient's weight is determined to the nearest whole kg.
Croatian: Pri izračunu broja mjesta injiciranja i broja štrcaljki, tjelesna težina bolesnika zaokruži se na najbliži cijeli kilogram.
English: To ensure intramuscular injection, ultrasound or electrophysiological guidance of injections is advised.
Croatian: Kako bi se osiguralo intramuskularno injiciranje, preporučuje se ultrazvučni ili elektrofiziološki nadzor injiciranja.