FrancophonIA/ELRC3.0 huggingface dataset:
English: The patients in CT-AMT-010-01 have been followed for up to 5 years (n=6) post therapy administration, those in CT-AMT-011-01 for up to 5 years (n=13), and those in CT-AMT-011-02 for up to 1 year (n=3).
Croatian: CT-AMT-010-01 praćeni su do 5 godina (n = 6) nakon primjene terapije, bolesnici u ispitivanju CTAMT-011-01 do 5 godina (n = 13), a bolesnici u ispitivanju CT-AMT-011-02 do 1 godine (n = 3).
English: • Guidance on the need to measure immune response at baseline and at 6 and 12 months after treatment
Croatian: • Smjernice o potrebi mjerenja početnih vrijednosti imunološkog odgovora i 6 te 12 mjeseci nakon liječenja
English: However in toxicity studies, no increase in tumour was identified.
Croatian: Nisu provedena ispitivanja kancerogenosti, no u ispitivanjima toksičnosti nije opaženo povećanje u učestalosti tumora.
English: Two of these clinical trials were preceded by prospective observational studies to assess fasting triglycerides (TG) level and symptoms and signs of LPLD in subjects maintained on a low fat diet.
Croatian: Dvama od navedenih kliničkih ispitivanja prethodila su prospektivna opservacijska ispitivanja u kojima je ocijenjena razina triglicerida (TG) natašte te simptomi i znakovi LPLD-a kod ispitanika na dijeti s niskim sadržajem masnoća.
English: Glybera is authorised for single treatment only.
Croatian: Glybera je odobrena samo za jednokratno liječenje.
English: If you receive two doses in one injection site by mistake this might lead to more local reaction such as bruising or sensitivity.
Croatian: Ako slučajno primite dvije doze na istom mjestu ubrizgavanja, može doći do jače lokalne reakcije, kao što je nastanak modrica ili preosjetljivost.
English: During administration of Glybera appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration.
Croatian: Tijekom primjene Glybere uvijek mora biti odmah dostupna prikladna medicinska terapija i nadzor za slučaj anafilaktičkog događaja nakon primjene.
English: Immunosuppressants (see section 5.2) Immediately prior to initiation of the immunosuppressant regimen and prior to Glybera injection the patient must be checked for symptoms of active infectious disease of any nature, and in case of such infection the start of treatment must be postponed until after the patient has recovered.
Croatian: Neposredno prije uvođenja imunosupresivne terapije i prije injiciranja Glybere, mora se provjeriti ima li bolesnik simptome aktivne infektivne bolesti bilo koje prirode, a u slučaju da takva infekcija postoji, potrebno je početak liječenja odgoditi dok bolesnik ne ozdravi.
English: This is the number of vials that must be dispensed.
Croatian: Tako je određen broj bočica koji se mora primijeniti.
English: • Guidance to ensure that patients receive the Patient Alert Card included in the pack.
Croatian: • Smjernice koje će osigurati da bolesnici prime karticu s upozorenjima za bolesnika koja je sadržana u pakiranju.
English: How to store Glybera
Croatian: Kako ćete primiti Glyberu
English: This medicinal product contains 47.5 mg sodium per administration at 27 injection sites to 105.6 mg sodium per administration at 60 injection sites.
Croatian: Lijek sadrži 47,5 mg natrija po primjeni na 27 mjesta injiciranja do 105,6 mg natrija po primjeni na 60 mjesta injiciranja.
English: Doctor Phone:
Croatian: Tel. broj liječnika:
English: It is not known whether Glybera passes into breast milk.
Croatian: Nije poznato dospijeva li Glybera u majčino mlijeko.
English: In saliva vector DNA was still detectable up to 12 weeks; in urine up to 10 weeks and in semen up to 26 weeks.
Croatian: U slini je još bilo moguće pronaći DNK vektor do 12 tjedana nakon injiciranja, u urinu do 10 tjedana,
English: In mice local cellular infiltrates and signs of degeneration and regeneration without necrosis, were seen at the clinical dose in the injected muscle upon histopathological examination.
Croatian: U miševa su pri histopatološkoj analizi opaženi lokalni stanični infiltrati te znakovi degeneracije i regeneracije bez nekroze u mišiću u koji je bila injicirana klinička doza.
English: In addition, half an hour prior to Glybera injection an intravenous bolus of 1mg/kg of methylprednisolone should be administered (see section 4.4).
Croatian: Pored toga, pola sata prije injiciranja Glybere mora se primijeniti intravenski bolus s 1 mg/kg metilprednizolona (vidjeti dio 4.4).
English: Following intramuscular administration of Glybera to mice, vector DNA was transiently detected in the circulation.
Croatian: Nakon intramuskularne primjene Glybere u miševa, u krvotoku je kratkotrajno primijećen DNK vektora.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: Examples of these immunosuppressants are ciclosporin, mycophenolate mofetil.
Croatian: Primjeri imunosupresivnih lijekova su ciklosporin i mofetilmikofenolat.
English: If a vial is showing damage, syringes for the injection should not be prepared and the injection procedure should be postponed and rescheduled.
Croatian: Ako je bočica vidno oštećena ne smijete pripremiti štrcaljke za injekciju, a injiciranje treba odgoditi i bolesnika ponovno naručiti.
English: 1 ml solution in a 2 ml vial (glass) with siliconised chlorobutyl, injection stopper and flip-off seal.
Croatian: 1 ml otopine u bočici (staklo) od 2 ml s injekcijskim čepom od silikoniziranog klorobutila i odvojivim zatvaračem.
English: No dose adjustment of Glybera is required.
Croatian: Nije potrebno prilagoditi dozu Glybere.
English: Glybera contains the human LPL gene variant LPL S447X in an adeno-associated virus serotype 1 (AAV1) vector intended to target the muscle.
Croatian: Mehanizam djelovanja Glybera sadrži humani gen za lipoproteinsku lipazu varijanta LPL S447X u vektoru od adeno-asociranog virusnog serotipa 1 (AAV1) koji je usmjeren na mišić.
English: The patient's weight should be divided by 3, then without rounding up this number multiplied by 2 and rounded up to the next higher whole number.
Croatian: Bolesnikovu tjelesnu težinu treba podijeliti s 3, zatim taj broj bez zaokruživanja pomnožiti s 2 i zaokružiti na sljedeći viši cijeli broj.
English: The active substance is alipogene tiparvovec.
Croatian: - Djelatna tvar je alipogen tiparvovek.
English: Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Croatian: Meibergdreef 61, 1105 BA Amsterdam, Nizozemska.
English: Assessment of postprandial chylomicron metabolism in at least 12 patients before 12 months and 24 months after treatment with Glybera to be chosen in addition to the patients included in study CT-AMT.011.02; and eight healthy subjects in the second study.
Croatian: bolesnika prije liječenja Glyberom i 12 i 24 mjeseca nakon toga, koje treba odabrati povrh bolesnika uključenih u ispitivanju CT-AMT.011.02, te kod osam zdravih ispitanika u drugom ispitivanju.
English: Glybera is delivered in a patient-specific pack and will therefore contain the precise amount of vials per patient, calculated according to the patient's weight.
Croatian: Glybera se dostavlja u pakiranju specifičnom za bolesnika, što znači da sadrži točnu količinu bočica za jednog bolesnika, koja se izračuna na temelju njegove tjelesne težine.
English: An immune response was seen despite the use of immunosuppressants.
Croatian: Imunogenost Usprkos uporabi imunosupresivnih lijekova, zapažen je imunološki odgovor.
English: • Guidance on the aftercare of the patient including monitoring for fever
Croatian: • Smjernice o njezi bolesnika nakon injiciranja, uključujući praćenje pojave vrućice
English: Glybera therapy must be prescribed by and administered under the supervision of a physician with expertise in treating LPLD patients and in gene therapy administration, in full consultation with the patient.
Croatian: Terapija Glyberom mora biti propisana i primjenjivana pod nadzorom liječnika koji ima iskustva u liječenju bolesnika s LPLD i u primjeni genske terapije, u punom dogovoru s bolesnikom.
English: The MAH shall set up a long term surveillance programme/ disease registry to collect information on the epidemiology of the disease and the demographics, safety, and the effectiveness outcomes of patients treated with Glybera.
Croatian: Nositelj odobrenja će uspostaviti dugotrajni program praćenja/registar bolesti, u kojem će sakupljati podatke o epidemiologiji bolesti i rezultate u pogledu demografije, sigurnosti i učinkovitosti kod bolesnika koji su liječeni
English: Therefore, use of barrier contraception methods for at least 12 months following Glybera administration is recommended.
Croatian: Uporaba barijernih kontracepcijskih sredstava se zato preporučuje najmanje 12 mjeseci nakon primjene Glybere.
English: In the event two doses are administered by mistake to the identical injection site this might lead to more local reaction such as bruising or sensitivity.
Croatian: U slučaju da se na isto mjesto injiciranja greškom primijene dvije doze, to može prouzročiti težu lokalnu reakciju, kao što je nastanak modrica ili preosjetljivost.
English: Standard genetic analysis (sequencing) was used in the clinical studies of Glybera.
Croatian: U kliničkim ispitivanjima Glybere korištena je standardna genetska analiza (sekvenciranje).
English: This product contains GMO.
Croatian: Ovaj lijek sadrži GMO.
English: Male patients, including vasectomised males, are advised to practise barrier contraception methods for at least 12 months following Glybera administration.
Croatian: Kod muških bolesnika, uključujući i bolesnike koji su podvrgnuti vazektomiji, preporučuje se uporaba barijernih kontracepcijskih metoda najmanje 12 mjeseci nakon primjene Glybere.
English: What you need to know before you are given Glybera Do not receive Glybera
Croatian: Što morate znati prije nego počnete primati Glyberu
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: From three days prior to and for 12 weeks following Glybera administration an immunosuppressive regimen should be administered: ciclosporin (3 mg/kg/day) and mycophenolate mofetil (2 x 1 g/day) is recommended.
Croatian: Počevši tri dana prije primjene i tijekom 12 tjedana nakon primjene Glybere mora se primijeniti imunosupresivna terapija: preporučuje se ciklosporin (3 mg/kg/dan) i mofetilmikofenolat (2 x 1 g/dan).
English: T-cell responses against AAV were detected in approximately half of the subjects post therapy only.
Croatian: Odgovor T-limfocita na AAV otkriven je samo nakon liječenja u približno polovici ispitanika.
English: Glybera should only be used when the diagnosis of LPLD has been confirmed by an adequate genetic test.
Croatian: Glybera se smije primjenjivati samo ako je dijagnoza LPLD-a potvrđena odgovarajućim genetskim testiranjem.
English: T-cell responses were seen in roughly half of the patients without clinical sequelae.
Croatian: Odgovori T-limfocita bez kliničkih posljedica opaženi su u približno polovice bolesnika.
English: Taking these medicines before receiving or at the same time as receiving Glybera, may cause unnecessary bruising or bleeding from the injection sites.
Croatian: Glybere ili u trenutku njezinog ubrizgavanja može prouzročiti nepotrebne modrice ili krvarenje iz mjesta ubrizgavanja.
English: Posology The maximum total dose of Glybera for administration is 1 x 1012 gc/kg body weight.
Croatian: Najveća ukupna doza Glybere za primjenu je 1 x 1012 gk/kg tjelesne težine.
English: ▼ This medicinal product is subject to additional monitoring.
Croatian: Ovaj je lijek pod dodatnim praćenjem.
English: Only clear and colourless solutions without visible particles should be used.
Croatian: Smijete koristiti samo bistru i bezbojnu otopinu bez vidljivih čestica.
English: Clinical pharmacokinetics and shedding
Croatian: Klinička farmakokinetika i izlučivanje virusa
English: After time, residual vector DNA levels remained high in the injected muscle and inguinal lymph nodes while decreasing steadily in the other organs.
Croatian: Nakon određenog vremena, rezidualne razine DNK vektora ostale su visoke u injiciranom mišiću i u preponskim limfnim čvorovima, dok su se u drugim organima ravnomjerno snižavale.
English: Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions.
Croatian: Glybera je indicirana za odrasle bolesnike s dijagnosticiranom obiteljskom deficijencijom lipoproteinske lipaze (LPLD) i teškim ili ponavljanim upalama gušterače usprkos ograničenom unosu masnoće prehranom.
English: • Hypersensitivity to the active substance or any of the excipients of Glybera listed in section
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari Glybere navedenih u dijelu 6.1.
English: - if you are allergic to alipogene tiparvovec or to any of the other ingredients of Glybera (listed in section 6 ‘Further information').
Croatian: - ako ste alergični na alipogen tiparvovek ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: From the triglyceride data the 1 x 1012 gc/kg dose appears the most optimal.
Croatian: Na temelju podataka o trigliceridima čini se da je najoptimalnija doza 1 x 1012 gk/kg.
English: The treatment should be monitored by measuring neutralising antibodies and T-Cell response against AAV1 and LPLS447X at baseline as well as 6 and 12 months after treatment.
Croatian: Liječenje treba pratiti određivanjem neutralizirajućih protutijela i odgovora T-limfocita na AAV1 i LPLS447X na početku liječenja, kao i 6 i 12 mjeseci nakon liječenja.
English: Glybera should under no circumstances be administered intravascularly (see section 4.4).
Croatian: Glybera se ne smije nikada injicirati intravaskularno (vidjeti dio 4.4).
English: 1) on efficacy data such as biochemical markers as part of normal practice and frequency and severity of pancreatitis and 2) on safety including immunogenicity against Glybera and LPL.
Croatian: 1) podacima o djelotvornosti, kao što su biokemijski markeri kao dio normalne prakse i učestalosti te težine pankreatitisa;
English: This is the number of injection sites and the total number of syringes (each filled with 0.5ml) needed to administer a volume of 0.5ml per injection site for the patient's treatment.
Croatian: Tako dobijete broj mjesta injiciranja i ukupan broj potrebnih štrcaljki (svaka napunjena sa 0,5 ml) potrebnih za primjenu volumena od 0,5ml po mjestu injiciranja za liječenje bolesnika.
English: This is the number of injection sites and the total number of syringes (each filled with 0.5ml) required for the patient's treatment.
Croatian: Tako se dobije broj mjesta injiciranja i ukupan broj potrebnih štrcaljki (svaka napunjena sa 0,5 ml) za liječenje bolesnika.
English: In addition, half an hour prior to Glybera injection an intravenous bolus of 1mg/kg of methylprednisolone should be administered.
Croatian: Pored toga, pola sata prije injiciranja Glybere treba primijeniti intravenski bolus s 1 mg/kg metilprednizolona.
English: In clinical studies a transient reduction in triglycerides for up to 12 weeks in individual patients could be observed.
Croatian: U kliničkim ispitivanjima, u pojedinih bolesnika opaženo je prolazno smanjenje triglicerida u trajanju do 12 tjedana.
English: No T-cell response to LPL was detected in any subject.
Croatian: Ni kod jednog ispitanika nije otkriven odgovor T-limfocita na LPL.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Croatian: odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Store frozen at -25°C to -15°C.
Croatian: Čuvajte zamrznuto pri temperaturi od -25 °C do -15 °C.
English: It contains genetically modified organisms.
Croatian: Sadrži genetski modificirane organizme.
English: The final outer carton contains a variable number of casings according to the patient specific dose required.
Croatian: Vanjska kutija sadrži različiti broj omota ovisno o potrebnoj dozi za određenog bolesnika.
English: The product contains less than 1 mmol (39 mg) potassium per administration of 27-60 injection sites ; i.e. essentially potassium-free.
Croatian: Lijek sadrži manje od 1 mmol (39 mg) kalija po primjeni na 27-60 mjesta injiciranja, tj. sadrži zanemarivu količinu kalija.
English: Preparation of Glybera for administration
Croatian: Priprema Glybere za primjenu
English: Glybera is used to treat adult patients diagnosed with lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions.
Croatian: Glybera se koristi u odraslih bolesnika s dijagnosticiranim nedostatkom lipoproteinske lipaze (LPLD) i teškim ili ponavljanim upalama gušterače usprkos ograničenom unosu masnoće prehranom.
English: The patient-specific pack contains a variable number of casings based on the patient's body weight.
Croatian: Pakiranje specifično za bolesnika sadrži različiti broj omota ovisno o tjelesnoj težini bolesnika.
English: All patients treated with Glybera shall be enrolled in the registry.
Croatian: U registar će biti uključeni svi bolesnici liječeni Glyberom.
English: This will fade after a short time.
Croatian: Ta boja će brzo nestati.
English: Symptomatic and supportive treatment, as deemed necessary by the treating physician, is advised in case of overdose.
Croatian: U slučaju predoziranja, preporučuje se simptomatsko i suportivno liječenje koje treba odrediti liječnik.
English: Abdominal pain.Nausea, Constipation
Croatian: Bol u abdomenu, mučnina, konstipacija
English: The other ingredients are, disodium phosphate, potassium chloride, potassium dihydrogen phosphate, sodium chloride, sucrose, and water for injections.
Croatian: - Drugi sastojci su natrijev hidrogenfosfat, kalijev klorid, kalijev dihidrogenfosfat, natrijev klorid,
English: Chills, Injection site pain, Oedema peripheral, Pyrexia
Croatian: Umor, hipertermija Zimica, bol na mjestu injiciranja, periferni edem, pireksija
English: Elevations in serum creatine kinase activity
Croatian: Povećana aktivnost serumske keratin kinaze
English: No neutralising assay was used.
Croatian: Test neutralizacije nije korišten.
English: The treatment should be monitored by measuring neutralising antibodies and T-Cell response against AAV1 and LPLS447X and T-Cell response at baseline as well as 6 and 12 months after treatment.
Croatian: Liječenje se mora pratiti određivanjem neutralizirajućih protutijela i odgovora T-limfocita na AAV1 i LPLS447X te određivanjem odgovora T-limfocita na početku terapije, kao i nakon 6 i 12 mjeseci liječenja.
English: After the amount of Glybera to be administered has been calculated (see section 4.2) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Croatian: Nakon izračuna količine Glybere koju treba primijeniti (vidjeti dio 4.2), uzmite odgovarajući broj bočica za jednokratnu uporabu iz zamrzivača i pričekajte da se odmrznu na sobnoj temperaturi (15 oC
English: Additional monitoring tests
Croatian: Dodatne pretrage za praćenje bolesnika
English: Once thawed, the medicinal product must be used immediately; if not used immediately, the vials should be stored in a refrigerator at 2ºC to 8ºC, and protected from light for a maximum of 8 hours.
Croatian: Kada se lijek odmrzne, mora se iskoristiti odmah; ako se ne iskoristi odmah, bočice se smiju čuvati najduže 8 sati u hladnjaku pri temperaturi od 2 ºC do 8 ºC, a pritom moraju biti zaštićene od svjetlosti.
English: If not stored in a refrigerator the medicinal product can be stored in syringes at not more than 25°C, and protected from light for a maximum of 8 hours.
Croatian: Ako se lijek ne čuva u hladnjaku, smije se najduže 8 sati čuvati u štrcaljkama zaštićenima od svjetlosti pri temperaturi do najviše 25 °C.
English: People diagnosed with lipoprotein lipase deficiency are advised to be careful with their diet, both before and after Glybera therapy; they should not drink alcohol.
Croatian: Preporučuje se da osobe s dijagnosticiranim nedostatkom lipoproteinske lipaze pridržavaju dijete prije liječenja Glyberom i nakon toga; i moraju izbjegavati alkohol.
English: The first 2 patients enrolled received a dose of 3 x 1011 gc/kg, the next 4 patients received a dose of 3 x 1011 gc/kg with immunosuppressant regiment (oral ciclosporin and oral mycophenolate mofetil from the day after Glybera administration until Week 12) and the final 8 patients received a dose of 1 x 1012gc/kg with immunosuppressant regiment.
Croatian: Prva 2 bolesnika uključena u ispitivanje primila su dozu od 3 x 1011 gk/kg, sljedeća 4 bolesnika primila su dozu od 3 x 1011 gk/kg s imunosupresivnom terapijom (peroralni ciklosporin i peroralni mofetilmikofenolatom počevši od dana nakon injiciranja
English: Assessment of each individual subject's risk profile prior to Glybera administration is advised.
Croatian: Prije primjene Glybere preporučuje se procjena profila rizika svakog pojedinog bolesnika.
English: Cell and tissue donation
Croatian: Darivanje stanica i tkiva
English: Diabetic patients
Croatian: Bolesnici s dijabetesom
English: • Guidance on the selection of suitable patients for treatment with Glybera including: o the need for genetic testing to be performed prior to the initiation of treatment in order to identify the patients who are eligible for treatment o that patients should not be taking anti-platelet or other anti-coagulation medicinal products at the time of injection o the need to exclude infection before starting immunosuppressant treatment o the need for all patients to be entered into a long term surveillance programme
Croatian: • Smjernice o odabiru prikladnih bolesnika za liječenje Glyberom, uključujući: o potrebu za genetskim testiranjem, koje treba obaviti prije početka liječenja, kako bi se identificirali bolesnici koji su prikladni za liječenje;
English: There is limited experience in the use of Glybera in patients with renal or hepatic impairment.
Croatian: Iskustvo s primjenom Glybere u bolesnika s bubrežnim ili jetrenim oštećenjem je ograničeno.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Glyberu Lijek čuvajte izvan pogleda i dohvata djece.
English: In case of contraindication for such procedure deep sedation is advised instead.
Croatian: Ako je ona kontraindicirana, preporučuje se duboka sedacija.
English: Present this card to health care professionals (doctor, nurse) upon consultation or hospitalization!
Croatian: U slučaju odlaska k liječniku ili prijema u bolnicu, tu karticu pokažite zdravstvenom djelatniku (liječniku, medicinskoj sestri)!
English: With the exception of a case of fever (39.9 °C) in study CT-AMT-011-01 which reversed within a day, no Glybera or immunosuppression related serious adverse events occurred.
Croatian: Nisu se pojavile ozbiljne nuspojave povezane s Glyberom ili imunosupresijom, izuzev jednog slučaja vrućice (39,9 °C) u ispitivanju CT-AMT-011-01, koja je nestala unutar jednog dana.
English: Each vial of alipogene tiparvovec contains 1 ml of solution, containing 3 x 1012 genome copies (gc).
Croatian: Jedna bočica alipogen tiparvoveka sadrži 1 ml otopine, koja sadrži 3 x 1012 genomskih kopija (gk).
English: Do not take oral contraceptives as they have the potential to worsen your disease; Use condoms so that as little Glybera as possible may be passed to/from your partner.
Croatian: Koristite prezervative, na taj će način na/s Vašeg partnera prijeći što manje Glybere.
English: Immunogenicity
Croatian: • Imunodeficijencija