FrancophonIA/ELRC3.0 huggingface dataset:
English: Name and address of the manufacturer of the biological active substance MolMed SpA
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: Hypothyroidism Autoimmune thyroiditis
Croatian: Endokrini poremećaji hipotireoza autoimuni tireoiditis
English: Strimvelis goes through a range of tests before it is used.
Croatian: Prije primjene, Strimvelis prolazi kroz niz testova.
English: It is not known whether the ingredients of Strimvelis can pass into breast milk.
Croatian: Nije poznato mogu li se sastojci lijeka Strimvelis izlučiti u majčino mlijeko.
English: If it is possible that you could become pregnant, you must use a barrier contraceptive (such as condoms) during treatment and for at least 6 months afterwards.
Croatian: Ako postoji mogućnost da zatrudnite, morate koristiti mehaničku metodu kontracepcije (poput prezervativa)
English: NAME OF THE MEDICINAL PRODUCT Strimvelis 1-10 million cells/ml dispersion for infusion.
Croatian: NAZIV LIJEKA Strimvelis 1-10 milijuna stanica/ml disperzija za infuziju.
English: • blood test results positive for antineutrophil cytoplasmic antibody and smooth muscle antibody
Croatian: • pozitivni nalazi krvnih pretraga na antineutrofilna citoplazmatska protutijela i protutijela na glatke mišiće
English: No data from clinical studies are available regarding overdose of Strimvelis.
Croatian: Nema dostupnih podataka iz kliničkih ispitivanja o predoziranju lijekom Strimvelis.
English: Post treatment
Croatian: Nakon liječenja
English: Gently agitate the infusion bag to re-disperse any cellular aggregates, administer using a transfusion administration set with filter to remove any remaining cellular aggregates.
Croatian: Nježno protresite infuzijsku vrećicu da bi se moguće nakupine stanica ponovno disperzirale, a zatim primijenite njezin sadržaj uz pomoć seta za transfuziju s filtrom kako bi se uklonile eventualne preostale nakupine stanica.
English: No immunogenicity testing has been conducted with Strimvelis.
Croatian: Nije provedeno ispitivanje imunogenosti lijeka Strimvelis.
English: Strimvelis is intended solely for autologous use and should never be administered to any patient other than the original CD34+ cell donor.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Strimvelis je namijenjen isključivo za autolognu primjenu i nikada se ne smije primijeniti u nijednog drugog bolesnika osim onoga koji je bio izvorni davatelj CD34+ stanica.
English: B cell function: All 12 subjects treated in the pivotal study were receiving IVIG therapy at the time of screening, and 7 subjects (58%) had discontinued IVIG use during 0-3 years follow-up after gene therapy.
Croatian: IVIG-om u trenutku probira, a 7 ispitanika (58%) prekinulo je primjenu IVIG-a tijekom razdoblja praćenja od 0 do 3 godine nakon genske terapije.
English: Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Croatian: Nuspojave u nastavku navedene su prema MedDRA klasifikaciji organskih sustava i učestalosti.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Strimvelis 1-10 million cells/ml dispersion for infusion.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Strimvelis 1-10 milijuna stanica/ml disperzija za infuziju.
English: The infusion bags are provided in a closed container.
Croatian: Infuzijske vrećice dolaze u zatvorenom spremniku.
English: This medicinal product contains 0.15 mmol sodium per ml.
Croatian: Ovaj lijek sadrži 0,15 mmol natrija po ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NAVESTI NA VANJSKOM I UNUTARNJEM PAKIRANJU VANJSKI SPREMNIK
English: It will be stored, to be given to the patient as replacement stem cells if Strimvelis cannot be given or does not work (see ‘When Strimvelis treatment cannot be completed' in section 2)
Croatian: Te će se stanice čuvati kako bi se primjenile u bolesniku kao nadomjesne matične stanice u slučaju da se Strimvelis ne može primijeniti ili ako ne bude djelotvoran (pogledajte odlomak 'Kada se liječenje lijekom
English: b Based on the 3 year post-treatment period for survival and severe infections, and the data collected at the 3 year visit for T-lymphocytes and dAXP.
Croatian: b Preživljenje i teške infekcije: na temelju 3-godišnjeg razdoblja nakon liječenja; T-limfociti i dAXP: podaci su prikupljeni pri posjetu nakon 3 godine.
English: by a drip into a vein.
Croatian: ukapavanjem u venu.
English: Bag No.:
Croatian: Vrećica br.:
English: Effects on male and female fertility have not been evaluated in animal studies.
Croatian: U ispitivanjima na životinjama nisu se ocjenjivali učinci na plodnost mužjaka i ženki.
English: Results at 3 years for the ITT population in the pivotal study*
Croatian: Rezultati nakon 3 godine u populaciji koju se namjeravalo liječiti (engl. intent-to-treat, ITT) u pivotalnom ispitivanju*
English: Also contains sodium chloride.
Croatian: POPIS POMOĆNIH TVARI Također sadrži natrijev klorid.
English: Strimvelis is made specially from the patient's own cells.
Croatian: Strimvelis se posebno proizvodi iz bolesnikovih vlastitih stanica.
English: The identity of the patient must be matched with the essential unique patient information on the primary and/or outer container prior to infusion.
Croatian: Identitet bolesnika mora se prije infuzije usporediti s osnovnim jedinstvenim informacijama o bolesniku navedenima na primarnom i/ili vanjskom spremniku.
English: • reduced numbers of blood cells (autoimmune haemolytic anaemia, autoimmune aplastic anaemia)
Croatian: • smanjen broj krvnih stanica (autoimuna hemolitička anemija, autoimuna aplastična anemija)
English: • inflamed liver (autoimmune hepatitis)
Croatian: • upala jetre (autoimuni hepatitis)
English: Posology The recommended dose range of Strimvelis is between 2 and 20 million CD34+ cells/kg.
Croatian: Preporučena doza lijeka Strimvelis kreće se u rasponu od 2 do 20 milijuna CD34+ stanica/kg.
English: Findings that TREC (T cell receptor excision circles) in peripheral blood lymphocytes were increased above baseline (median 141, range 56 to 1542 copies/100ng DNA) at Years 1 and maintained to 3 post-treatment and that all subjects had evidence of polyclonal V-beta chains at one or more time points following gene therapy provides further supportive evidence of functional T cell development.
Croatian: od 56 do 1542 kopija/100 ng DNK) nakon godinu dana i da su se ta povišenja održala do 3 godine nakon liječenja te da su svi ispitanici imali dokaze poliklonskih V-beta lanaca u jednoj ili više vremenskih točaka nakon genske terapije dodatno potvrđuju razvoj funkcionalnih T stanica.
English: It can only be given in a specialised hospital, and by a doctor who is experienced in treating patients with ADA-SCID and in using this type of medicine.
Croatian: Smije se primijeniti samo u specijaliziranoj bolnici, a primjenjuje ga liječnik koji ima iskustva s liječenjem bolesnika oboljelih od
English: There have been cases where treatment with Strimvelis has been unsuccessful.
Croatian: Liječenje lijekom Strimvelis u nekim je slučajevima bilo neuspješno.
English: The MAH will review the occurrence of angioedema, anaphylactic reactions, systemic allergic events and severe cutaneous adverse reactions during the FU period, particularly in those patients who had unsuccessful response and received ERT or SCT.
Croatian: anafilaktičkih reakcija, sistemskih alergijskih događaja i teških kožnih nuspojava tijekom razdoblja praćenja, osobito u onih bolesnika koji nisu uspješno odgovorili na liječenje i koji su primili nadomjesnu enzimsku terapiju ili presadak matičnih stanica.
English: The educational materials should address the following safety concerns/key elements: Autoimmunity, Unsuccessful response to gene therapy, and Malignancy due to insertional oncogenesis (e.g. leukaemia, myelodysplasia).
Croatian: autoimunitet, neuspješan odgovor na gensku terapiju i malignost zbog insercijske onkogeneze (na primjer leukemije, mijelodisplazije).
English: 6 hours.
Croatian: 6.3 Rok valjanosti 6 sati.
English: Prior to launch of Strimvelis in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for parents/carers and health professionals,
Croatian: Prije stavljanja lijeka Strimvelis u promet u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora s nadležnim nacionalnim tijelom dogovoriti sadržaj i format edukacijskih materijala za roditelje/skrbnike i zdravstvene radnike, pojedinosti izdavanja lijeka na ograničen recept i kontroliran pristup/obrazac pristanka za primjenu lijeka, uključujući medije komunikacije, modalitete distribucije i sve druge aspekte programa.
English: Orchard Therapeutics (Netherlands) BV Prins Bernhardplein 200, 1097 JB Amsterdam, the Netherlands
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Orchard Therapeutics (Netherlands) BV Prins Bernhardplein 200,
English: The safety and efficacy of Strimvelis in children less than six months of age or over 6 years 1 month has not been established (see section 4.4).
Croatian: Sigurnost i djelotvornost lijeka Strimvelis u djece mlađe od 6 mjeseci i one starije od 6 godina i
English: The effect on breast-fed infants of administration of Strimvelis to their mothers has not been studied.
Croatian: Nije se ispitivao učinak lijeka Strimvelis na dojenčad nakon njegove primjene majkama.
English: Patients should be closely monitored for the occurrence of severe and opportunistic infections, immune reconstitution parameters and the need for replacement intravenous immunoglobulin (IVIG); in case of lack of response, it is recommended to introduce other ADA-SCID treatments under the supervision of a physician.
Croatian: Bolesnike treba pažljivo nadzirati zbog moguće pojave teških i oportunističkih infekcija, parametara imunološke rekonstitucije i potrebe za nadomjesnom terapijom intravenskim imunoglobulinom
English: The final clinical study report should be submitted after the 50th patient has 15 year follow-up visit; Q4 2037.
Croatian: Završno izvješće o kliničkom ispitivanju treba dostaviti nakon što 50. bolesnik odradi posjet nakon
English: Strimvelis is used to treat a serious condition called ADA-SCID (Adenosine Deaminase-Severe Combined Immune Deficiency).
Croatian: Strimvelis se koristi za liječenje ozbiljne bolesti koja se zove teška kombinirana imunodeficijencija uzrokovana nedostatkom adenozin deaminaze ili ADA-SCID (engl.
English: Cases of skin papillomas, abnormal serum protein electrophoresis and one case each of lipofibroma, pulmonary mass and decreased T-cell V beta repertoire were reported.
Croatian: Prijavljeni su slučajevi kožnih papiloma, odstupanja u nalazima elektroforeze serumskih proteina i po jedan slučaj lipofibroma, mase u plućima i smanjenja
English: How Strimvelis is given
Croatian: Kako se Strimvelis primjenjuje
English: • if there were not enough of the right type of cells to make the medicine
Croatian: • ako nije bilo dovoljno odgovarajuće vrste stanica za proizvodnju lijeka • ako je došlo do onečišćenja lijeka tijekom njegove proizvodnje
English: The infusion bag is placed inside a closed outer container.
Croatian: Infuzijska vrećica stavlja se u zatvoren vanjski spremnik.
English: Exp.: {DD MMM YY} {hh:mm} BATCH NUMBER, DONATION AND PRODUCT CODES
Croatian: BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA
English: Strimvelis should be used with caution in patients older than 6 years and 1 month and younger than 6 months as there are no data from clinical trials in these age ranges.
Croatian: Strimvelis treba primjenjivati uz oprez u bolesnika starijih od 6 godina i 1 mjeseca te onih mlađih od
English: Year 3/ 3 Years Post-Treatmentb
Croatian: 3. godina/3 godine nakon liječenjab
English: Following administration, a saline filled 50 ml syringe should be used to flush the bag through.
Croatian: Nakon primjene, vrećicu treba isprati uz pomoć štrcaljke volumena 50 ml napunjene fiziološkom otopinom.
English: Antineutrophil cytoplasmic antibody positive, smooth muscle antibody positive aAdverse reactions considered potentially related to busulfan conditioning
Croatian: Pretrage povišene vrijednosti jetrenih enzimaa, pozitivan nalaz na antinuklearna protutijela pozitivan nalaz na antineutrofilna citoplazmatska protutijela, pozitivan nalaz na protutijela na glatke mišiće aNuspojave za koje se smatra da bi mogle biti povezane s kondicioniranjem busulfanom Opis odabranih nuspojava
English: It is unknown whether Strimvelis is excreted in human milk.
Croatian: Nije poznato izlučuje li se Strimvelis u majčino mlijeko.
English: Strimvelis must be administered in a specialist transplant centre, by a physician with previous experience in the treatment and management of patients with ADA-SCID and in the use of autologous CD34+ ex vivo gene therapy products.
Croatian: Strimvelis se mora primijeniti u specijalističkom transplantacijskom centru i mora ga primijeniti liječnik koji već ima iskustva u liječenju i zbrinjavanju bolesnika s ADA-SCID-om te primjeni ex vivo pripravljenih genskih lijekova s autolognim CD34+ stanicama.
English: Strimvelis will be administered at a specialist transplant centre, and by physicians with previous experience in the treatment and management of patients with ADA-SCID and the use of autologous CD34+ ex vivo gene therapy products.
Croatian: Strimvelis će se primijeniti u specijalističkom transplantacijskom centru i primijenit će ga liječnik koji već ima iskustva u liječenju i zbrinjavanju bolesnika s ADA-SCID-om te primjeni ex vivo pripravljenih genskih lijekova s autolognim CD34+ stanicama.
English: No evidence of causality to the product has been established.
Croatian: Nisu ustanovljeni dokazi uzročne povezanosti s lijekom.
English: Strimvelis is not expected to interact with the hepatic cytochrome P-450 family of enzymes or drug transporters.
Croatian: Ne očekuje se da će Strimvelis ulaziti u interakcije s jetrenim enzimima iz obitelji citokroma
English: • inflamed itchy skin (atopic dermatitis, eczema)
Croatian: • upaljena koža koja svrbi (atopijski dermatitis, ekcem) • povišena tjelesna temperatura (pireksija)
English: An antihistamine medicine may be given to make it less likely that you will react to the infusion
Croatian: Približno 15 do 30 minuta prije liječenja može se primijeniti antihistaminik kako bi se smanjila vjerojatnost nastupa reakcije na infuziju
English: However, vector insertions into chromosomal regions previously associated with leukaemia in comparable trials of gene therapy in Wiskott Aldrich Syndrome, X-SCID and Chronic Granulomatous Disease have been documented.
Croatian: Međutim, u usporedivim ispitivanjima genske terapije kod Wiskott-Aldrichova sindroma, spolno vezane teške kombinirane imunodeficijencije (engl. X-linked severe combined immunodeficiency, X-SCID) i kronične granulomatozne bolesti zabilježeni su slučajevi insercije vektora u kromosomske regije koje se povezuju s leukemijom.
English: T-lymphocyte (x106/l) n median (range) % subjects with venous RBC dAXP <100 nmol/ml after Strimvelisd n
Croatian: T-limfociti (x 106/l) n medijan (raspon)
English: Strimvelis has not been studied in patients with hepatic impairment.
Croatian: Strimvelis se nije ispitivao u bolesnika s oštećenjem jetrene funkcije.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INFUSION BAG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: What you need to know before you (or your child) are given Strimvelis 3.
Croatian: Što morate znati prije nego Vi (ili Vaše dijete) primite Strimvelis 3.
English: This should be taken into consideration by patients on a controlled sodium diet.
Croatian: O tome moraju voditi računa bolesnici na dijeti s ograničenim unosom natrija.
English: Package leaflet: Information for the patient or carer Strimvelis 1-10 million cells/ml dispersion for infusion Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Croatian: Uputa o lijeku: Informacije za bolesnika ili skrbnika Strimvelis 1-10 milijuna stanica/ml disperzija za infuziju stanična frakcija obogaćena autolognim CD34+ stanicama koja sadrži CD34+ stanice transducirane retrovirusnim vektorom koji kodira sekvencu cDNK humane adenozin deaminaze
English: The identity of the patient must be matched with the essential unique patient information on the infusion bag(s) and/or outer container prior to infusion.
Croatian: Identitet bolesnika mora se prije infuzije usporediti s osnovnim jedinstvenim informacijama o bolesniku navedenima na infuzijskoj vrećici/vrećicama i/ili vanjskom spremniku.
English: The 3 month hospitalisation period immediately post gene therapy was excluded from the calculation d dAXP=dAMP+dADP+dATP.
Croatian: d dAXP=dAMP+dADP+dATP.
English: * Including data from one patient collected post intervention with PEG-ADA (>3 months treatment) or hematopoietic stem cell transplantation a Based on the entire pre-treatment period for severe infections (retrospectively collected), and the data collected at the baseline visit for T-lymphocytes.
Croatian: % ispitanika s vrijednošću RBC dAXP u venskoj krvi < 100 nmol/ml nakon primjene lijeka Strimvelisd n nije primjenjivoe * Uključujući podatke za jednog bolesnika prikupljene nakon intervencije primjenom PEG-ADA (≥ 3 mjeseca liječenja) ili presađivanja hematopoetskih matičnih stanica a Teške infekcije: na temelju čitavog razdoblja prije liječenja (retrospektivno prikupljanje); T-limfociti: podaci su prikupljeni pri posjetu na početku ispitivanja.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva atopijski dermatitis, ekcem
English: Before infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the Strimvelis infusion bag(s) and/or container (see sections 4.4 and 6.6).
Croatian: Prije infuzije mora se potvrditi da bolesnikov identitet odgovara osnovnim jedinstvenim informacijama o bolesniku navedenima na infuzijskoj vrećici/vrećicama i/ili spremniku lijeka
English: An autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence with a concentration of 1-10 million CD34+ cells/ml.
Croatian: Stanična frakcija obogaćena autolognim CD34+ stanicama koja sadrži CD34+ stanice transducirane retrovirusnim vektorom koji kodira sekvencu cDNK humane adenozin deaminaze u koncentraciji od 1-10 milijuna CD34+ stanica/ml.
English: Name and address of the manufacturer responsible for batch release MolMed SpA
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Strimvelis is an autologous cellular therapy.
Croatian: Strimvelis se primjenjuje kao terapija autolognim stanicama.
English: Autoimmune haemolytic anaemia, autoimmune aplastic anaemia, autoimmune thrombocytopenia
Croatian: Poremećaji krvi i limfnog sustava anemijaa neutropenijaa autoimuna hemolitička anemija, autoimuna aplastična anemija,
English: An autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells.
Croatian: Stanična frakcija obogaćena autolognim CD34+ stanicama koja sadrži CD34+ stanice transducirane retrovirusnim vektorom koji kodira sekvencu cDNK humane adenozin deaminaze (ADA) iz humanih hematopoetskih matičnih/progenitorskih (CD34+) stanica.
English: Precautions to be taken before manipulating or administering the product
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Ovaj lijek sadrži genetski modificirane stanice.
English: No. of severe infections
Croatian: Broj teških infekcija 29
English: The finished product is composed of one or more ethylene vinyl acetate (EVA) bags which contain an autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence.
Croatian: Gotov lijek sastoji se od jedne ili više etilenvinilacetatnih (EVA) vrećica koje sadrže staničnu frakciju obogaćenu autolognim CD34+ stanicama koja sadrži CD34+ stanice transducirane retrovirusnim vektorom koji kodira sekvencu cDNK humane ADA-e.
English: Autoimmune hepatitis
Croatian: autoimuna trombocitopenija
English: Blood and lymphatic system disorders
Croatian: Krvožilni poremećaji hipertenzijaa
English: LIST OF EXCIPIENTS
Croatian: Broj ispitanika
English: • underactive thyroid gland (hypothyroidism)
Croatian: • nedovoljno aktivna štitnjača (hipotireoza)
English: • inflamed thyroid gland (autoimmune thyroiditis)
Croatian: • upaljena štitnjača (autoimuni tireoiditis)
English: How to store Strimvelis
Croatian: Kako se Strimvelis primjenjuje.
English: Backup sample of stem cells collected to be stored as a backup (see above)
Croatian: Najmanje 3 tjedna prije liječenja uzima se rezervni uzorak matičnih stanica koji se čuva kao rezerva (vidjeti u prethodnom odlomku)
English: The infusion bag(s) is/are placed inside a closed outer container.
Croatian: Infuzijska vrećica/e stavlja/ju se u zatvoren vanjski spremnik.
English: Rate of severe infections per person year * Excluding data from one patient collected from the time of intervention with PEG-ADA (>3 months treatment) or hematopoietic stem cell transplantation.
Croatian: *Isključeni su podaci za jednog bolesnika prikupljeni nakon intervencije primjenom PEG-ADA (≥ 3 mjeseca liječenja) ili presađivanja hematopoetskih matičnih stanica; n/p - nije primjenjivo 5.2 Farmakokinetička svojstva
English: Treatment failure was observed in a patient treated in the clinical trials with <2 millions CD34+cell/kg.
Croatian: U kliničkim je ispitivanjima zabilježen terapijski neuspjeh u jednog bolesnika liječenog dozom od < 2 milijuna
English: x 106 METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: Strimvelis should not be administered to women who are breast-feeding.
Croatian: Strimvelis se ne smije primijeniti u dojilja.
English: The majority were reported during the 3 month to 3 year follow-up period and resolved, with the exception of hypothyroidism and positive ANA tests.
Croatian: Većina ih je prijavljena tijekom razdoblja praćenja u trajanju od 3 mjeseca do 3 godine i većina ih se povukla,
English: Strimvelis should not be given to you if you are pregnant.
Croatian: Ne smijete primiti Strimvelis ako ste trudni.
English: interval)
Croatian: Doziranje
English: - The active substance is autologous (the patient's own) CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence.
Croatian: Sadržaj pakiranja i druge informacije Što Strimvelis sadrži - Djelatna tvar je stanična frakcija obogaćena autolognim (uzetim od samog bolesnika) CD34+ stanicama koja sadrži CD34+ stanice transducirane retrovirusnim vektorom koji kodira sekvencu cDNK humane ADA-e.
English: n/a - not applicable.
Croatian: Preživljenje n nije primjenjivo 12
English: You should not be given Strimvelis if you are breast-feeding.
Croatian: Ne smijete primiti Strimvelis ako dojite.
English: Treatment sample of stem cells collected to make Strimvelis (see above)
Croatian: Približno 4 do 5 dana prije liječenja uzima se uzorak matičnih stanica za liječenje za proizvodnju lijeka Strimvelis (vidjeti u prethodnom odlomku)
English: Anaemiaa Neutropeniaa
Croatian: Aktivnost enzima ADA
English: • if the medicine got contaminated while it was being made
Croatian: OD LIJEKA, AKO JE POTREBNO
English: The frequency categories used are:
Croatian: Korištene kategorije učestalosti su: vrlo često > 1/10 često
English: (pomalidomide)
Croatian: (pomalidomid)
English: The recommended starting dose is 4 mg once a day, taken at the same time each day.
Croatian: Preporučena početna doza iznosi 4 mg jednom dnevno i uzima se u isto vrijeme svakog dana.
English: Previously known as Pomalidomide Celgene.
Croatian: Prethodno poznat kao Pomalidomide Celgene.
English: What is Imnovid and what is it used for?
Croatian: Što je Imnovid i za što se primjenjuje?