FrancophonIA/ELRC3.0 huggingface dataset:
English: c Severe infections are those requiring or prolonging hospitalisation.
Croatian: c Teške infekcije su one koje zahtijevaju ili produljuju hospitalizaciju.
English: Continued follow-up is recommended.
Croatian: Preporučuje se kontinuirano praćenje.
English: If the tests show anything that might affect you (or your child), the doctor will treat you as appropriate.
Croatian: Ako testovi pokažu išta što bi moglo utjecati na Vas (ili Vaše dijete), liječnik će Vas liječiti na odgovarajući način.
English: All these patients had previously taken PEG-ADA.
Croatian: Svi ti bolesnici prethodno su primali PEG-ADA.
English: The most commonly reported adverse reaction was pyrexia.
Croatian: Najčešće prijavljena nuspojava bila je pireksija.
English: Patients can develop autoimmunity.
Croatian: Bolesnici mogu razviti autoimunost.
English: No dose adjustment is expected to be required.
Croatian: Ne očekuje se da će biti potrebno prilagoditi dozu.
English: Manufacturer MolMed SpA 58 Via Olgettina
Croatian: MolMed SpA 58 Via Olgettina
English: If you have any questions about symptoms or side effects, or if any symptoms concern you
Croatian: Ako imate bilo kakvih pitanja o svojim simptomima ili nuspojavama ili ako Vas bilo koji simptom zabrinjava
English: 0.33-1 >1-2 >2-3 >3-4 >4-5 >5-6 >6-7 >7-8 Total
Croatian: n/p 0,33-1 >1-2 >2-3 >3-4 >4-5 >5-6 >6-7 >7-8 Ukupno
English: Because it is given soon after it is made, the final results of some of these tests will not be ready before the medicine is given.
Croatian: Budući da se daje ubrzo nakon što se proizvede, konačni rezultati nekih od tih testova neće biti dostupni prije primjene lijeka.
English: If you are pregnant or breast-feeding, if you think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, recite to svom liječniku prije nego primite ovaj lijek.
English: What is done
Croatian: Što se radi
English: Contents of the pack and further information
Croatian: Sadržaj pakiranja i druge informacije
English: The infusion rate should not exceed 5 ml/kg/h.
Croatian: Brzina infuzije ne smije biti veća od 5 ml/kg/h.
English: Patients should be closely monitored for potential catheter-related events.
Croatian: Bolesnike treba pomno nadzirati zbog mogućih događaja povezanih s kateterima.
English: Severe infections n
Croatian: Teške infekcije n
English: Interim registry reports shall be submitted every 2 years.
Croatian: Interim izvješća o registru podnosit će se svake 2 godine.
English: For more information on what happens before and during treatment, see section 3, How Strimvelis is given.
Croatian: Za više informacija o tome što se događa prije i tijekom liječenja pogledajte dio 3.
English: The period of administration is approximately 20 minutes (see section 6.6).
Croatian: Vrijeme primjene iznosi približno 20 minuta (vidjeti dio 6.6).
English: The presence of the transgene leads to increased expression of ADA.
Croatian: Prisutnost transgena dovodi do povećane ekspresije enzima ADA.
English: As this medicine will be given by a qualified doctor, they are responsible for correct disposal of the product.
Croatian: Budući da će ovaj lijek primijeniti kvalificiran liječnik, on je odgovoran za pravilno odlaganje lijeka.
English: Inserting a new gene into the DNA could cause leukaemia.
Croatian: Umetanje novoga gena u DNK može uzrokovati leukemiju.
English: Why
Croatian: Zašto
English: What Strimvelis is and what it is used for 2.
Croatian: Što je Strimvelis i za što se koristi 2.
English: When Strimvelis treatment cannot be completed
Croatian: Kada se liječenje lijekom Strimvelis ne može dovršiti
English: • high blood pressure (hypertension)*
Croatian: • visok krvni tlak (hipertenzija)*
English: The MAH shall complete, within the stated timeframe, the below measure:
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedenu mjeru:
English: Before Strimvelis is made, the doctor will do tests to make sure that you (or your child) are not carrying certain infections (see section 2).
Croatian: Prije nego što se Strimvelis proizvede, liječnik će provesti pretrage kako bi se uvjerio da Vi (ili Vaše dijete) nemate određene infekcije (pogledajte dio 2.).
English: Non-immunological manifestations of ADA-SCID may not respond to Strimvelis.
Croatian: Neimunološke manifestacije ADA-SCID-a možda neće odgovoriti na Strimvelis.
English: History of previous gene therapy.
Croatian: Prethodna genska terapija.
English: The majority of mice showed reconstitution of the haematopoietic system by the end of the study.
Croatian: Većina miševa ostvarila je rekonstituciju hematopoetskog sustava do kraja ispitivanja.
English: After you (or your child) have been treated with Strimvelis, you or your child will not be able to donate blood, organs or tissues at any time in future.
Croatian: Nakon što ste Vi (ili Vaše dijete) bili liječeni lijekom Strimvelis, Vi ili Vaše dijete nećete više nikada moći darovati krv, organe ni tkiva.
English: The long term effects and durability of response to Strimvelis on ADA-SCID are unknown (see section 5.1).
Croatian: Dugoročni učinci i trajanje odgovora na Strimvelis kod ADA-SCID-a nisu poznati (vidjeti dio 5.1).
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants , ATC code: not yet assigned
Croatian: Farmakoterapijska skupina: Imunostimulatori, ostali imunostimulatori, ATK oznaka: nije još dodijeljena
English: Eighty three percent were white (56% Caucasian/European heritage and 28% Arabic/North African heritage), 11% African American/African, and 6% Asian.
Croatian: Osamdeset i tri posto ispitanika bili su bijelci (56% bijele rase/europskog podrijetla, a 28% arapskog/sjevernoafričkog podrijetla), 11% Afroamerikanci/Afrikanci, a 6% Azijci.
English: If busulfan AUC exceeds 4000 nanograms/ml*h (974 µmol/L.minute), the dose should be appropriately reduced based on the AUC.
Croatian: Ako AUC busulfana premaši 4000 nanograma/ml*h (974 µmol/l.min), dozu treba u odgovarajućoj mjeri smanjiti na temelju AUC-a.
English: The bags must be kept in the outer container until ready to use.
Croatian: Vrećice se moraju čuvati u vanjskom spremniku dok sve ne bude spremno za njihovu primjenu.
English: • weakness and pain in the feet and hands (Guillain-Barré syndrome)
Croatian: • slabost i bol u stopalima i šakama (Guillain-Barréov sindrom)
English: What Strimvelis looks like and contents of the pack
Croatian: Kako Strimvelis izgleda i sadržaj pakiranja
English: Given the small patient population and size of the cohorts, adverse reactions in the table do not provide a complete perspective on the nature and frequency of these events.
Croatian: S obzirom na malu populaciju bolesnika i veličinu kohorti, nuspojave navedene u tablici ne pružaju cjelovit uvid u prirodu i učestalost tih događaja.
English: Use of Strimvelis in patients older than those previously studied should be carefully considered and reserved only for occasions where all other reasonable treatment options have been exhausted.
Croatian: Strimvelis u bolesnika starijih od dosad ispitivane populacije treba pažljivo razmotriti i rezervirati samo za one slučajeve u kojima su sve druge razumne terapijske mogućnosti iscrpljene.
English: The ones marked * may be related to busulfan.
Croatian: Nuspojave označene zvjezdicom (*) mogu biti povezane s primjenom busulfana.
English: - The other ingredient is sodium chloride (see section 2, Strimvelis contains sodium).
Croatian: - Drugi sastojak je natrijev klorid (pogledajte dio 2., „Strimvelis sadrži natrij“).
English: In addition, the allergy related adverse reactions in the table were reported mostly during the 3 month to 3 year follow-up period.
Croatian: Osim toga, nuspojave povezane s alergijom navedene u tablici također su prijavljene uglavnom tijekom razdoblja praćenja u trajanju od 3 mjeseca do 3 godine.
English: Busulfan plasma levels should be measured after the first dose of each day by serial blood sampling using an appropriate method.
Croatian: Vrijednosti busulfana u plazmi treba odrediti nakon prve doze svakog dana serijskim uzorkovanjem krvi primjenom odgovarajuće metode.
English: A 4-month biodistribution study was performed in mice.
Croatian: Provedeno je 4-mjesečno ispitivanje biodistribucije u miševa.
English: The total busulfan dose is 4 mg/kg, divided into 8 doses of 0.5 mg/kg.
Croatian: Ukupna doza busulfana je 4 mg/kg, podijeljeno na 8 doza od 0,5 mg/kg.
English: Following successful engraftment in the patient, the effects of the product are expected to be life-long.
Croatian: Nakon uspješnog usađivanja bolesniku, očekuje se da će učinci lijeka biti doživotni.
English: People with ADA-SCID cannot produce enough of an enzyme called adenosine deaminase (ADA) because the gene to make it is faulty.
Croatian: Osobe koje imaju ADA-SCID ne mogu proizvesti dovoljno enzima koji se zove adenozin deaminaza (ADA) jer je gen za njegovo stvaranje neispravan.
English: The physician should monitor and/or treat the patient as appropriate.
Croatian: Liječnik mora nadzirati i/ili liječiti bolesnika sukladno potrebama.
English: Long-term follow-up
Croatian: Dugoročno praćenje
English: • decreases in the number of red or white blood cells (anaemia, neutropenia)*
Croatian: • smanjenje broja crvenih ili bijelih krvnih stanica (anemija, neutropenija)*
English: This information is provided in the Patient Alert Card.
Croatian: Te informacije navedene su u Kartici s upozorenjima za bolesnika.
English: Current or previous history of leukaemia or myelodysplasia.
Croatian: Postojeća ili prijašnja leukemija ili mijelodisplazija.
English: In clinical trials of gene therapy for other diseases (not ADA-SCID), some patients developed leukaemia or other cancers of the blood system.
Croatian: U kliničkim ispitivanjima genske terapije za druge bolesti (ne ADA-SCID), u nekih su se bolesnika razvili leukemija ili drugi oblici raka krvnog sustava.
English: The nature of Strimvelis is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Croatian: Priroda lijeka Strimvelis je takva da se na njega ne mogu primijeniti konvencionalna ispitivanja farmakokinetike, apsorpcije, distribucije, metabolizma i eliminacije.
English: They are all caused by the immune system becoming over-active and attacking the body's own tissues.
Croatian: Sve ih uzrokuje prekomjerna aktivnost imunološkog sustava, koji počinje napadati tkiva u vlastitom tijelu.
English: In some cases the patient may be unable to receive Strimvelis because of manufacturing issues.
Croatian: U nekim slučajevima bolesnik možda neće moći primiti Strimvelis zbog problema u proizvodnji.
English: Patient 10 had no baseline value for T-lymphocytes.
Croatian: Bolesnik 10 nije imao početnu vrijednost za T-limfocite.
English: The MAH shall plan to include regular progress reports of the registry in the PSUR and provide interim study reports every 2 years until the registry finishes.
Croatian: Nositelj odobrenja uključivat će redovita izvješća o napretku registra u PSUR-ove i dostavljati interim izvješća o ispitivanju svake 2 godine do zaključenja registra.
English: Immune reconstitution
Croatian: Imunološka rekonstitucija
English: • if there was a delay in the medicine reaching the clinic where treatment is being carried out.
Croatian: • ako je došlo do kašnjenja u dostavi lijeka u kliniku u kojoj se liječenje provodi
English: What Strimvelis is and what it is used for
Croatian: Što je Strimvelis i za što se koristi
English: With this condition the immune system does not work properly to defend the body against infections.
Croatian: Kod te bolesti imunološki sustav ne radi kako bi trebao da obrani tijelo od infekcija.
English: In those patients treated in the pivotal study, the rate of severe infections declined throughout the follow-up period (Table 2).
Croatian: U tih bolesnika liječenih u pivotalnom ispitivanju, stopa teških infekcija smanjivala se tijekom čitavog razdoblja praćenja (Tablica 2).
English: • increases in liver enzymes*
Croatian: • povišene vrijednosti jetrenih enzima*
English: No clinical data on exposed pregnancies are available.
Croatian: Nema dostupnih kliničkih podataka o izloženim trudnoćama.
English: Do not use this medicine after the expiry date and time (EXP) which is stated on the container label and infusion bag label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti (datuma i vremena) (EXP) navedenog na naljepnici spremnika i naljepnici infuzijske vrećice.
English: Median values at 3 years post gene therapy were below the normal range.
Croatian: Medijani vrijednosti 3 godine nakon genske terapije bili su ispod raspona normalnih vrijednosti.
English: Milan Italy
Croatian: Milano Italija
English: Milan ITALY
Croatian: Milano ITALIJA
English: The median age across the program was 1.7 years (range 0.5 to 6.1) and 61% were males.
Croatian: Medijan dobi u cjelokupnom programu iznosio je 1,7 godina (raspon: od 0,5 do 6,1), a 61% ispitanika bilo je muškog spola.
English: Negative test results are required on at least 3 sequential occasions over a period of at least 4 weeks, after completion of treatment for hepatitis C, with the final test conducted no more than 3 days prior to cell harvest.
Croatian: Negativni rezultati ispitivanja potrebni su u najmanje 3 uzastopna testiranja tijekom razdoblja od najmanje 4 tjedna nakon završetka liječenja hepatitisa C, a zadnji test treba biti obavljen najkasnije 3 dana prije prikupljanja stanica.
English: Patient 8 withdrew from the study before 3 year visit, and thus had no data for T-lymphocytes and dAXP.
Croatian: Bolesnik 8 povukao se iz ispitivanja prije posjeta u 3. godini i stoga za njega nisu postojali podaci za T-limfocite i dAXP.
English: Patients who previously received PEG-ADA had this treatment withdrawn 10 to 22 days prior to Strimvelis therapy.
Croatian: Bolesnicima koji su prethodno primali PEG-ADA ta je terapija prekinuta 10 do 22 dana prije liječenja lijekom Strimvelis.
English: Strimvelis is a type of medicine called a gene therapy.
Croatian: Strimvelis je jedna vrsta lijeka koji se naziva genskom terapijom.
English: Strimvelis should only be administered after consultation with the patient and/or family.
Croatian: Strimvelis se smije primijeniti tek nakon razgovora s bolesnikom i/ili njegovom obitelji.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1097/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1097/001
English: Work surfaces and material which have potentially been in contact with Strimvelis must be decontaminated with appropriate disinfectant.
Croatian: Radne površine i materijali koji su možda bili u doticaju s lijekom Strimvelis moraju se dekontaminirati odgovarajućim dezinfekcijskim sredstvom.
English: Strimvelis is not tested for transmissible infectious agents.
Croatian: Strimvelis se ne testira na prenosive infektivne agense.
English: Patient ID:
Croatian: Identitet bolesnika:
English: In some cases, it might not be possible to go ahead with the planned treatment with Strimvelis.
Croatian: U nekim slučajevima možda neće biti moguće provesti planirano liječenje lijekom Strimvelis.
English: Positive test for human immunodeficiency virus (HIV) or presence of any other transmissible infectious agent listed in the current EU Cell and Tissue Directive prior to bone marrow harvest.
Croatian: Pozitivan nalaz virusa humane imunodeficijencije (HIV) ili prisutnost bilo kojeg drugog prenosivog infektivnog agensa navedenog u trenutno važećoj Direktivi EU-a o stanicama i tkivima prije prikupljanja koštane srži
English: It is recommended that an intravenous antihistamine be administered 15-30 minutes before the infusion of Strimvelis.
Croatian: Preporučuje se primijeniti intravenski antihistaminik 15 - 30 minuta prije infuzije lijeka Strimvelis.
English: • red or purple dots on the skin, bleeding under the skin (immune thrombocytopenic purpura)
Croatian: • crvene ili ljubičaste točkice na koži, krvarenje ispod kože (imuna trombocitopenična purpura)
English: Strimvelis can only be made if the doctor can collect enough of the right kind of cells from the patient's own bone marrow.
Croatian: Strimvelis se može proizvesti samo ako liječnik uspije prikupiti dovoljnu količinu odgovarajuće vrste stanica iz bolesnikove koštane srži.
English: Carcinogenicity studies have not been conducted as no adequate animal model was available to evaluate the tumourigenic potential of Strimvelis due to the inability to achieve long-term engraftment of transduced cells in mice.
Croatian: Nisu provedena ispitivanja kancerogenosti jer nije bio dostupan odgovarajući životinjski model na kojem bi se ocijenio tumorogeni potencijal lijeka Strimvelis zbog nemogućnosti postizanja dugotrajnog usađivanja transduciranih stanica u miševa.
English: Patients are expected to enrol in a post-treatment registry and will be followed-up long term.
Croatian: Od bolesnika se očekuje da se uključe u registar liječenih bolesnika i da ih se dugoročno prati.
English: Patients treated within the pivotal study
Croatian: Bolesnici liječeni u pivotalnom ispitivanju
English: • wheezing, difficulty breathing (asthma)
Croatian: • piskanje pri disanju, otežano disanje (astma)
English: Only filters intended for use with transfusion sets should be used to prevent inadvertent removal of cells from the product.
Croatian: Treba koristiti samo filtre namijenjene za uporabu sa setovima za transfuziju, kako bi se spriječilo nehotično uklanjanje stanica iz lijeka.
English: e At baseline 9 of 11 (82%) patients had dAXP <100 nmol/ml.
Croatian: e Na početku ispitivanja, 9 od 11 (82%) bolesnika imalo je dAXP < 100 nmol/ml.
English: One subject treated in a pilot study did not have PEG-ADA re-introduction data, and thus was excluded from the intervention-free survival in the integrated population.
Croatian: Za jednog ispitanika liječenog u pilot ispitivanju nisu postojali podaci o ponovnom uvođenju PEG-ADA i stoga on nije bio uključen u analizu preživljenja bez intervencije u integriranoj populaciji.
English: ADA activity remained increased throughout the duration of the 3 year follow up.
Croatian: ostala je povećana tijekom čitavog 3-godišnjeg razdoblja praćenja.
English: Another subject needed transient PEG-ADA administration due to an autoimmune event (see section 4.4).
Croatian: Još je jednom ispitaniku bila potrebna privremena primjena PEG-ADA zbog autoimunog događaja (vidjeti dio 4.4).
English: The MAH will also evaluate intervention-free survival.
Croatian: Nositelj odobrenja također će ocijeniti i preživljenje bez intervencije.
English: If the product contains less than 2 million CD34+ cells/kg, the treating physician should make a decision whether to proceed with administration, based on an individual benefit risk assessment.
Croatian: Ako lijek sadrži manje od 2 milijuna CD34+ stanica/kg, nadležni liječnik treba odlučiti hoće li nastaviti s njegovom primjenom na temelju ocjene koristi i rizika za pojedinog bolesnika.
English: • the treatment sample, 4 to 5 days before.
Croatian: • uzorak za liječenje, 4 do 5 dana prije primjene lijeka.
English: Hypersensitivity to the product or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na lijek ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Local biosafety guidelines applicable should be followed (see section 4.2).
Croatian: Treba se pridržavati primjenjivih nacionalnih smjernica za biosigurnost (vidjeti dio 4.2).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 May 2016
Croatian: Datum prvog odobrenja: 26. svibanj 2016.
English: Reproductive and developmental toxicity studies were not performed.
Croatian: Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti.
English: Patients who have previously tested positive for hepatitis C can be treated with Strimvelis, provided they demonstrate absence of ongoing infection using a nucleic acid test with a limit of quantification of ≤15 international units/ml.
Croatian: Bolesnici koji su prethodno bili pozitivni na hepatitis C mogu se liječiti lijekom Strimvelis pod uvjetom da je dokazana odsutnost infekcije primjenom testa nukleinske kiseline s limitom kvantifikacije od ≤15 internacionalnih jedinica/ml.
English: Some patients have had to resume long-term enzyme replacement therapy and/or receive a stem cell transplant (see section 5.1).
Croatian: Neki su bolesnici morali nastaviti dugoročno liječenje nadomjesnom enzimskom terapijom i/ili primiti presadak matičnih stanica (vidjeti dio 5.1).
English: Store at 15-30°C.
Croatian: Čuvati na temperaturi od 15 do 30°C.
English: The safety of Strimvelis was evaluated in 18 subjects, with a median duration of follow-up of 7 years.
Croatian: Sigurnost lijeka Strimvelis ocjenjivala se u 18 ispitanika, uz medijan trajanja praćenja od 7 godina.
English: Local biosafety guidelines applicable should be followed.
Croatian: Treba se pridržavati primjenjivih nacionalnih smjernica za biosigurnost.
English: Strimvelis is a cloudy to clear, colourless to pink dispersion of cells for infusion, which is supplied in one or more infusion bags.
Croatian: Strimvelis je mutna do bistra, bezbojna do ružičasta disperzija stanica za infuziju, koja dolazi u jednoj ili više infuzijskih vrećica.
English: Local biosafety guidelines applicable for such products should be followed (see section 6.6).
Croatian: Treba se pridržavati nacionalnih smjernica za biosigurnost koje su primjenjive na takve lijekove (vidjeti dio 6.6).
English: T-lymphocyte (CD3+) and NK (CD56+) cell counts improved following treatment with Strimvelis.
Croatian: Broj T-limfocita (CD3+) i NK (CD56+) stanica poboljšao se nakon liječenja lijekom Strimvelis.
English: Strimvelis should be administered once only.
Croatian: Strimvelis se smije primijeniti samo jedanput.
English: A transfusion administration set with filter should be used.
Croatian: Potrebno je koristiti set za transfuziju s filtrom.
English: Strimvelis is intended for autologous use only (see section 4.4).
Croatian: Strimvelis je namijenjen isključivo za autolognu primjenu (vidjeti dio 4.4).
English: → Talk to your doctor or nurse.
Croatian: Obratite se svom liječniku ili medicinskoj sestri.
English: Read all of this leaflet carefully before you (or your child) are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što Vi (ili Vaše dijete) primite ovaj lijek jer sadrži
English: Strimvelis is given…
Croatian: Strimvelis se primjenjuje...
English: Retroviral insertion sites (RIS) have been detected adjacent to or within CCND2 and LMO2 and there is a potential risk of leukaemic transformation following treatment with Strimvelis.
Croatian: Mjesta insercije retrovirusa (engl. retroviral insertion sites, RIS) pronađena su uz ili unutar gena CCND2 i LMO2 te postoji mogući rizik od leukemijske transformacije nakon liječenja lijekom Strimvelis.
English: Adverse events related to the use of central venous catheters (CVCs) have been reported (e.g., serious CVC infections and thrombosis in the device).
Croatian: Prijavljeni su štetni događaji povezani s uporabom centralnih venskih katetera (CVK) (npr. ozbiljne infekcije na mjestu CVK-a, tromboza u uređaju).
English: Strimvelis is transported directly to the medical facility where the infusion will be administered.
Croatian: Strimvelis se isporučuje izravno u zdravstvenu ustanovu u kojoj će se primijeniti infuzija.
English: Before and during Strimvelis treatment
Croatian: Prije i u vrijeme primjene lijeka Strimvelis Kada
English: There were no adverse effects on survival, haematological parameters or histopathology of major organs, apart from body weight loss and atrophy in the testes and ovaries consistent with administration of busulfan.
Croatian: Nije bilo štetnih učinaka na preživljenje, hematološke parametre niti histopatologiju glavnih organa, osim smanjenja tjelesne težine te atrofije testisa i jajnika, što je u skladu s primjenom busulfana.
English: Unused medicine must be disposed of in compliance with the local biosafety guidelines.
Croatian: Neiskorišten lijek mora se zbrinuti u skladu s nacionalnim smjernicama za biosigurnost.