FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using any medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: Follow applicable local or international guidelines for prophylaxis (See also section 4.5).
Croatian: Pridržavajte se lokalnih ili međunarodnih smjernica za profilaksu (vidjeti također dio 4.5).
English: The dose you will need is dependent on your weight and is calculated by your doctor.
Croatian: Doza koja Vam je potrebna ovisi o Vašoj tjelesnoj težini, a izračunat će je Vaš liječnik.
English: All interventional studies continued into long term follow up studies.
Croatian: Svim intervencijskim ispitivanjima uslijedila su dugotrajna ispitivanja praćenja.
English: Once thawed, the medicinal product should not be re-frozen.
Croatian: Kada se lijek odmrzne, ne smije se ponovno zamrzavati.
English: • Information on the need to avoid pregnancy
Croatian: • Informacije o potrebi sprječavanja trudnoće
English: As expected, all animals developed antibodies to the AAV protein shell.
Croatian: Kao što je bilo očekivano, sve su životinje razvile protutijela na proteinsku ovojnicu AAV-a.
English: Non-clinical biodistribution
Croatian: Neklinička biodistribucija
English: Very common (may affects more than 1 in 10 people)
Croatian: Vrlo često (mogu se javiti kod više od 1 na 10 osoba)
English: Diabetes mellitus is common in patients who have the most severe symptoms of LPLD.
Croatian: Diabetes mellitus je uobičajen kod bolesnika koji imaju najteže simptome LPLD-a.
English: The most commonly reported adverse reaction is pain in extremity occurring in approximately one third of patients.
Croatian: Najčešće prijavljena nuspojava bila je bol u ekstremitetu, koja se pojavila u približno trećini bolesnika.
English: These effects were dose-dependent but showed regression with time.
Croatian: Ti su učinci bili ovisni o dozi, ali su nakon određenog vremena pokazali regresivnu dinamiku.
English: Read it carefully and follow the related
Croatian: Pažljivo je pročitajte i pridržavajte se navedenih uputa.
English: Local biosafety guidelines applicable for such products should be followed (see section 6.6).
Croatian: Moraju se pratiti lokalne smjernice za biološku sigurnost, koje vrijede za takve lijekove (vidjeti dio 6.6).
English: • If you do become pregnant during treatment with Glybera, tell your doctor.
Croatian: • Ako tijekom liječenja Glyberom zatrudnite, obavijestite svog liječnika.
English: If any of the above applies to you, or if you are unsure of any of the above, please talk to your doctor before you receive Glybera.
Croatian: Ako se nešto od navedenog odnosi na Vas, ili niste sigurni u nešto od navedenog, obratite se svom liječniku prije nego primite Glyberu.
English: Contents of the pack and other information What Glybera contains
Croatian: Sadržaj pakiranja i druge informacije Što Glybera sadrži
English: This medicine has been authorised under "exceptional circumstances”.
Croatian: Ovaj lijek je odobren u „iznimnim okolnostima”.
English: The registry should be performed according to an agreed protocol.
Croatian: Registar se mora provoditi u skladu s odobrenim protokolom.
English: It is important that you ask your doctor about the side effects of these other medicines.
Croatian: Važno je da upitate liječnika o nuspojavama tih drugih lijekova.
English: Please ask your doctor for more information about the exact immunosuppressant medicine you will be taking.
Croatian: Liječnika zamolite za više informacija o stvarnom imunosupresivnom lijeku koji ćete uzimati.
English: - You have been given a patient card by your doctor.
Croatian: - Liječnik Vam je dao karticu za bolesnika.
English: PSUR/ annual reassessment
Croatian: PSUR/godišnja procjena
English: Syringes must not be used more than once.
Croatian: Štrcaljke se smiju koristiti samo jednom.
English: • Guidance on the need for immunosuppressive administration prior to and after treatment
Croatian: • Smjernice o potrebi imunosupresivne terapije prije i nakon liječenja
English: • Oral contraceptives (see section 2 ‘Do not receive Glybera')
Croatian: • oralne kontraceptive (pogledajte dio 2 „Glyberu ne smijete primiti“).
English: EXP Shelf life after first opening in the syringes: 8 hours (if space permitted)
Croatian: Rok valjanosti Rok valjanosti nakon prvog otvaranja štrcaljki: 8 sati (ako prostor to dozvoljava)
English: In lipoprotein lipase deficiency, this enzyme is missing due to a genetic defect.
Croatian: Pri nedostatku lipoproteinske lipaze, taj enzim je odsutan zbog genetskog poremećaja.
English: Strict compliance with dietary fat restriction was difficult.
Croatian: Strogo pridržavanje ograničenog unosa masnoća u prehrani bilo je teško.
English: Other medicines and Glybera
Croatian: Drugi lijekovi i Glybera
English: • Oral contraceptive use (see section 4.6).
Croatian: • Uporaba oralnih kontraceptiva (vidjeti dio 4.6).
English: Glybera is not recommended for use in children and adolescents under 18 years of age.
Croatian: Glybera se ne preporučuje za primjenu u djece i adolescenata ispod 18 godina starosti.
English: Lipoprotein lipase (LPL) is a naturally occurring substance in the body (known as an enzyme) that controls the level of certain fats in the blood.
Croatian: Lipoproteinska lipaza (LPL) je prirodno prisutna tvar u tijelu (poznata kao enzim), koja nadzire razinu određenih masnoća u krvi.
English: One patient was diagnosed with pulmonary embolism 7 weeks after therapy.
Croatian: Kod jednog bolesnika je postavljena dijagnoza plućne embolije 7 tjedana nakon terapije.
English: The safety and efficacy of Glybera in children and adolescents below 18 years has not been established.
Croatian: Sigurnost i djelotvornost Glybere u djece i adolescenata ispod 18 godina starosti nisu ustanovljene.
English: Given the small patient population and size of the cohorts, captured adverse reactions and serious adverse reactions do not provide a complete perspective on the nature and frequency of these events.
Croatian: S obzirom na malu populaciju bolesnika i veličinu kohorti, opažene nuspojave i ozbiljne nuspojave ne predstavljaju potpunu sliku o značaju i učestalosti tih događaja.
English: See also section 3, ‘How Glybera is used'.
Croatian: Vidjeti također dio 3. „Kako primjenjivati Glyberu“.
English: Although there is no fully adequate animal model to address the tumourigenic potential, the available toxicological data do not suggest any concern for tumourigenicity
Croatian: Iako za davanje odgovora o onkogenom potencijalu ne postoji potpuno odgovarajući životinjski model, raspoloživi toksikološki podaci ne ukazuju ni na kakve probleme s onkogenosti.
English: Due to the large number of individual injections that you will receive during the Glybera therapy session, you will be given either a regional anaesthetic into the spine (which will numb your legs only), or a more localised anaesthetic before you are given the Glybera injections.
Croatian: Zbog velikog broja pojedinačnih injekcija koje ćete primiti tijekom primjene terapije Glyberom, dobit ćete regionalni anestetik u kralježnicu (koji će umrtviti samo noge), ili više lokaliziran anestetik prije nego primite injekcije Glybere.
English: • Patients with increased bleeding risk (such as thrombocytopenia) and muscle disease (such as myositis), must not be treated in view of the large number of intramuscular injections
Croatian: • Bolesnici s povećanim rizikom od krvarenja (kao što je trombocitopenija) i s bolešću mišića (kao što je miozitis) ne smiju se liječiti zbog velikog broja potrebnih intramuskularnih injekcija.
English: Local pain or sensitivity may be managed by symptomatic treatment such as administration of local or systemic pain relievers.
Croatian: Lokalna bol ili preosjetljivost mogu se zbrinuti simptomatskim liječenjem, kao što je primjena lokalnih ili sistemskih sredstava za ublažavanje bolova.
English: • Use appropriate barrier contraception such as condoms to avoid becoming pregnant during treatment and for at least 12 months after treatment.
Croatian: • Upotrebljavajte prikladnu fizičku kontracepciju, kao što su prezervativi, da spriječite trudnoću tijekom liječenja i najmanje 12 mjeseci nakon toga.
English: Patients experiencing dizziness are advised to not drive or use machines.
Croatian: Bolesnike kod kojih se pojavi omaglica treba savjetovati da ne upravljaju vozilima i ne rade sa strojevima.
English: Treatment with Glybera does not eliminate attacks of acute pancreatitis.
Croatian: Prehrana Liječenje Glyberom ne uklanja atake akutnog pankreatitisa.
English: 1105 BA Amsterdam The Netherlands
Croatian: 1105 BA Amsterdam Nizozemska
English: • Information on the need for long term follow-up for Glybera, including the registry
Croatian: • Informacije o potrebi za dugotrajnim praćenjem liječenja Glyberom, uključujući registar
English: • Information on the use of Glybera and avoidance of pregnancy.
Croatian: • Informacije o uporabi Glybere i sprječavanju trudnoće
English: All but two patients received immunosuppressant for 12 weeks.
Croatian: Svi bolesnici, izuzev dvojice, primali su imunosupresivnu terapiju tijekom 12 tjedana.
English: Your doctor should give you a copy of the patient information leaflet (like this one) for the immunosuppressants you will need to take.
Croatian: Liječnik Vam mora dati primjerak uputa za uporabu (poput ovoga) za imunosupresivne lijekove koje ćete morati uzimati.
English: The clinical relevance of the antibody response is unknown (see section 4.2 on re-administration).
Croatian: Klinički značaj odgovora protutijela nije poznat (vidjeti dio 4.2 o ponovnoj primjeni).
English: Work surfaces and material which have potentially been in contact with Glybera must be decontaminated with appropriate virucidal disinfectants with activity for non-enveloped viruses (such as hypochlorite and chlorine releasers) for at least 10 minutes.
Croatian: Radne površine i materijal koji su možda došli u kontakt s Glyberom moraju se najmanje 10 minuta dekontaminirati odgovarajućim virucidnim sredstvima za dezinfekciju koja djeluju na viruse bez ovojnice (kao što su sredstva koja oslobađaju hipoklorit i klor).
English: What Glybera looks like and contents of the pack
Croatian: Kako Glybera izgleda i sadržaj pakiranja
English: Except for the site of injection, the highest vector DNA copy numbers were found in the liver and blood.
Croatian: Osim na mjestu injiciranja, najveći broj kopija DNK vektora otkriven je u jetri i krvi.
English: Liver and kidney function, cytochrome P450 polymorphisms and ageing are not expected to influence the clinical efficacy or safety of Glybera.
Croatian: Ne očekuje se da će funkcija jetre i bubrega, polimorfizmi citokroma P450 ili starenje utjecati na kliničku djelotvornost ili sigurnost
English: Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza „Rok valjanosti“ ili oznake „EXP”.
English: The educational pack for healthcare professionals must be agreed with the National Competent Authorities prior to distribution and consist of the following components:
Croatian: Edukacijski materijal za zdravstvene djelatnike mora prije distribucije odobriti nadležno državno tijelo i mora sadržati sljedeće komponente:
English: Number of injection sites
Croatian: Broj mjesta injiciranja
English: What Glybera is and what it is used for What you need to know before you are given Glybera
Croatian: Što je Glybera i za što se koristi Što morate znati prije nego počnete primati Glyberu
English: No drug-related serious adverse events occurred and no dose-limiting toxicity was observed.
Croatian: Nisu se pojavili ozbiljni štetni događaji povezani s lijekom i nije opažena toksičnost koja bi zahtijevala ograničenje doze.
English: Upon injection, Glybera was well tolerated in all animal studies performed with no notable clinical signs.
Croatian: Nakon injiciranja, lijek Glybera su životinje dobro podnijele u svim ispitivanjima provedenima na životinjama i nisu opaženi nikakvi klinički značajni znakovi.
English: To avoid any injection of particles from the stopper due to two withdrawals, one needle for the withdrawal from the vial (to be left inside the stopper) and a separate needle for each syringe must be used.
Croatian: Kako bi se izbjeglo injiciranje čestica iz čepa uslijed dva izvlačenja, moraju se koristiti jedna igla za izvlačenje iz bočice (koja se ostavlja u čepu) i zasebna igla za svaku štrcaljku.
English: Examples of typical dose schedules based on the body weight of patients are shown in the table below:
Croatian: Primjeri tipičnih rasporeda doze na temelju tjelesne težine pacijenata prikazani su u donjoj tablici:
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će svake godine procjenjivati sve nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
English: For each injection site, one syringe of 1 ml with clear volume marks of 0.5 ml must be used.
Croatian: Za svako mjesto injiciranja mora se koristiti štrcaljka od 1 ml s jasnim oznakama volumena od 0,5 ml.
English: Lipoprotein lipase is a key ‘first step' enzyme in the metabolism of lipoproteins following fat intake with diet.
Croatian: Lipoproteinska lipaza je ključni enzim „prvog koraka“ u metabolizmu lipoproteina nakon unosa masnoća s prehranom.
English: In addition to being given Glybera, you will be given other medicines called immunosuppressants (see section 3 ‘How Glybera is used').
Croatian: Pored Glybere, primit ćete i druge lijekove, koje nazivamo imunosupresivnim lijekovima (pogledajte dio 3. „Kako primjenjivati Glyberu“).
English: Women of childbearing potential must be advised to use reliable barrier contraception methods in accordance with the guidelines for immunosuppressants for a minimum of 12 months from the start of therapy (9 months following cessation of immunosuppressants).
Croatian: Žene reproduktivne dobi treba savjetovati da koriste pouzdane fizičke kontracepcijske metode u skladu sa smjernicama za imunosupresivne lijekove najmanje 12 mjeseci od početka liječenja (9 mjeseci nakon završetka uzimanja imunosupresivnih lijekova).
English: LPL protein mass should be measured in a blood sample from the patient against a control sample from healthy volunteers.
Croatian: Masu proteina LPL treba izmjeriti u krvnom uzorku bolesnika i usporediti s kontrolnim uzorkom zdravih dobrovoljaca.
English: Glybera is expected to be degraded by endogenous protein and DNA catabolic pathways.
Croatian: Očekuje se da će se Glybera razgraditi kataboličkim putevima endogenih proteina i DNK.
English: Treated patients should not donate blood, organs, tissues and cells for transplantation.
Croatian: Liječeni bolesnici ne smiju darivati krv, organe, tkiva i stanice za transplantaciju.
English: Blue Box
Croatian: Plavi okvir
English: This medicine contains genetically modified organisms and must be disposed of according to local rules for such medicines.
Croatian: Ovaj lijek sadrži genetski modificirane organizme, zato se mora zbrinuti sukladno lokalnim propisima za takve lijekove.
English: Important information about some of the ingredients of Glybera
Croatian: Važne informacije o nekim sastojcima Glybere
English: There is the theoretical risk that the co-administration of the immunosuppressant regime leads to longer persistence of virus DNA in serum and as well to longer shedding in saliva, urine and semen.
Croatian: Postoji teoretska opasnost da istodobna primjena imunosupresivne terapije uzrokuje duže perzistiranje DNK virusa u serumu te duže izlučivanje virusa u slini, urinu i spermi.
English: After thawing, each vial should be gently inverted twice to ensure even mixing.
Croatian: Nakon odmrzavanja, potrebno je svaku bočicu dvaput nježno preokrenuti kako biste omogućili ravnomjerno miješanje.
English: In gonads and reproductive organs, vector DNA copies were found at low levels.
Croatian: U gonadama i reprodukcijskim organima razine kopija DNK vektora bile su niske.
English: Each preformed transparent sealed plastic casing contains either 2 or 3 individual vials with a liquid absorbing sheet.
Croatian: Jedan oblikovan, proziran, zatvoren plastični omot sadrži 2 ili 3 pojedinačne bočice s listom za upijanje tekućine.
English: Information for health care professionals: The holder of this card has received Glybera, a gene therapy medicinal product for familial lipoprotein lipase deficiency, containing genetically modified organisms.
Croatian: Informacije za zdravstvene djelatnike: Vlasnik ove kartice je primio Glyberu, namijenjenu genskoj terapiji kod obiteljskog nedostatka lipoproteinske lipaze, koja sadrži genetski modificirane organizme.
English: Five eligible subjects were included in the study with all subjects receiving alipogene tiparvovec.
Croatian: U studiju je bilo uključeno pet prikladnih ispitanika, koji su svi primali alipogen tiparvovek.
English: The MAH shall agree the details of a restricted access programme with the National Competent Authorities and must implement such programme nationally prior to launch.
Croatian: Nositelj odobrenja će se o pojedinostima programa s ograničenim pristupom dogovoriti s nadležnim državnim tijelom i morat će taj program provesti nacionalno prije stavljanja lijeka na tržište.
English: Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX10.
Croatian: Farmakoterapijska skupina: pripravci koji modificiraju lipide, drugi pripravci koji modificiraju lipide, ATK oznaka: C10AX10.
English: • It is important that you tell your doctor if you have an active infection of any sort before you take the medicines you will be given to reduce your body's defences (immunosuppressants) and before you receive Glybera.
Croatian: • Važno je da liječnika obavijestite ako imate bilo kakvu aktivnu infekciju prije nego primite lijekove koji smanjuju otpornost tijela (imunosupresivne lijekove) i prije nego primite
English: No clinical data on the effect of Glybera on fertility are available.
Croatian: Nema kliničkih podataka o djelovanju Glybere na plodnost.
English: The holder should not donate blood, organs or tissues and should use barrier contraception at least 12 months after Glybera treatment.
Croatian: Vlasnik kartice ne smije darivati krv, organe ili tkiva i mora upotrebljavati barijernu kontracepciju najmanje 12 mjeseci nakon liječenja Glyberom.
English: Pain in extremity Arthritis, Limb discomfort, Muscle spasms, Muscle strain, Musculoskeletal stiffness, Myalgia, Muscle pain, Neck pain, Sensation of heaviness, Acute myositis and chronic myositis
Croatian: Bol u ekstremitetu Artritis, nelagoda u udu, mišićni spazmi, istegnuće mišića, mišićno-koštana ukočenost, mialgija, bol u mišićima, bol u vratu, osjećaj težine, akutni miozitis i kronični miozitis
English: 15 years follow-up is recommended for every patient treated.
Croatian: Kod svakog liječenog bolesnika preporučuje se praćenje u trajanju od 15
English: Dose of immunosuppressant may need to be adjusted.
Croatian: Možda će biti potrebno prilagoditi dozu imunosupresivnog lijeka.
English: Glybera shall only be supplied if the healthcare professionals involved in the treatment of a patient have received the educational pack and if the prescriber confirms that the patient agrees to participate in the registry.
Croatian: Glybera će biti dostavljena samo ako su zdravstveni djelatnici, uključeni u liječenje bolesnika, primili edukacijski materijal i ako liječnik koji propisuje lijek potvrdi da se bolesnik slaže sa sudjelovanjem u registru.
English: The indication is restricted to patients with detectable levels of LPL protein (see section 4.4).
Croatian: Indikacija je ograničena na bolesnike s utvrđenim razinama proteina LPL (vidjeti dio 4.4).
English: Immunosuppressant co-treatment did not influence the biodistribution pattern neither at low dose nor at high dose in mice.
Croatian: Istodobna imunosupresivna terapija nije utjecala na uzorak biodistribucije ni u malim ni u velikim dozama u miševa.
English: All patients treated with Glybera should be enrolled in the registry and systematic data collection carried out to enrich the database:
Croatian: Sve bolesnike koji se liječe Glyberom mora se uključiti u registar te sustavno sakupljati podatke radi obogaćivanja baze podataka:
English: Glybera contains sodium and potassium.
Croatian: Glybera sadrži natrij i kalij.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Croatian: Prema smjernicama CHMP za Sustave upravljanja rizicima za lijekove za humanu uporabu, svaka dopuna RMPa mora se podnijeti u isto vrijeme kao i odgovarajuće Periodičko izvješće o neškodljivosti lijeka (PSUR)
English: Re-administration of Glybera after this first treatment session is not recommended.
Croatian: Ponovna primjena Glybere nakon te prve terapije nije preporučljiva.
English: Serum creatine kinase
Croatian: Serumska kreatin kinaza
English: The levels of Glybera vector DNA found in gonads were measurable but lower than in other non-target organs.
Croatian: Razine DNK vektora Glybere koje su otkrivene u gonadama bile su mjerljive, ali niže nego u ostalim nezahvaćenim organima.
English: A demonstrable improvement of postprandial CM metabolism was shown in 5/5 patients up to week 14 and in 3/3 patients who were followed up to 52 weeks.
Croatian: Dokazivo poboljšanje u postprandijalnom metabolizmu hilomikrona pokazalo se kod 5/5 bolesnika do 14. tjedna i kod 3/3
English: Muscle biopsies taken half a year post administration demonstrated long-term expression of the LPL gene and the presence of biologically active LPL protein.
Croatian: Biopsije mišića, koje su napravljene pola godine nakon injiciranja, pokazale su dugotrajnu ekspresiju gena LPL i prisutnost biološki aktivnog proteina LPL.
English: Doctor name:
Croatian: Ime liječnika:
English: The patients enrolled in clinical studies (CT-AMT-010-01, CT-AMT 01101, CT-AMT 011-02) should be followed up in the LPLD registry.
Croatian: Bolesnici uključeni u klinička ispitivanja (CT-AMT-010-01, CT-AMT 01101, CT-AMT 011-02) moraju biti praćeni u registru LPLD.
English: Spinal anaesthesia and multiple intramuscular injections may further increase the risk of (thrombo) embolic events at and shortly after administration of Glybera.
Croatian: Spinalna anestezija i višekratne intramuskularne injekcije mogu dodatno povećati rizik od (trombo) embolijskih događaja tijekom i odmah nakon primjene Glybere.
English: In a follow-up period of up to 3 years after treatment, there was a decreasing trend in the incidence and severity of pancreatitis in the 12 patients who had multiple attacks during their life time.
Croatian: U razdoblju praćenja koje je trajalo do 3 godine nakon liječenja, opažen je trend smanjenja incidencije i težine pankreatitisa kod 12 bolesnika koji su u životu imali višekratne napade pankreatitisa.
English: In addition, patients, who have been treated with Glybera in a clinical trial shall be enrolled in the registry at the end of the trial.
Croatian: Nadalje, bolesnici koji su liječeni Glyberom u kliničkom ispitivanju bit će uključeni u registar na kraju ispitivanja.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the medicinal product is on the market.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav prikazan u Modulu 1.8.1 odobrenja za stavljanje lijeka u promet, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
English: Glybera should only be administered to patients with an LPL protein mass of at least 5% of normal.
Croatian: Glybera se smije primjenjivati samo kod bolesnika s masom proteina LPL koja je najmanje 5% od normalne vrijednosti.