FrancophonIA/ELRC3.0 huggingface dataset:
English: From baseline to week 48, the mean reductions for ALT and AST were -34.0 U/l and -44.5 U/l, respectively.
Croatian: Od početka do 48. tjedna, srednja vrijednost smanjenja ALT-a bila je -34,0 U/l, a AST-a -44,5 U/l.
English: Table 1: Recommended infusion volumes (1 mg/kg dose)* Weight range (kg)
Croatian: Tablica 1: Preporučeni volumeni infuzije (doza od 1 mg/kg)* Raspon težine (kg)
English: It is not known whether sebelipase alfa is excreted in human milk.
Croatian: Nije poznato izlučuje li se sebelipaza alfa u majčino mlijeko.
English: If not used immediately, the diluted solution may be stored up to 24 hours at 2°C to 8°C or up to 12 hours below 25°C.
Croatian: Ako se ne primijeni odmah, razrijeđena otopina može se čuvati do 24 sata na temperaturi od 2 °C do 8 °C ili do 12 sati na temperaturi ispod 25 °C.
English: There is a lack of data in patients with severe hepatic impairment.
Croatian: Nedostaju podaci o bolesnicima s teškim oštećenjem jetre.
English: Sixty-five of 66 patients entered the open-label period (up to 130 weeks) at a KANUMA dose of 1 mg/kg once every other week.
Croatian: Šezdeset i pet od 66 bolesnika ušlo je u razdoblje otvorenog ispitivanja (do 130 tjedana) uz dozu KANUME od 1 mg/kg jednom svaki drugi tjedan.
English: Transient hypercholesterolaemia, transient hypertriglyceridaemia
Croatian: Prolazna hiperkolesterolemija, prolazna hipertrigliceridemija
English: , oedema, fatigue, infusion site induration, pyrexia
Croatian: , edem, umor, induracija na mjestu primjene infuzije, pireksija
English: How KANUMA is given
Croatian: Kako se KANUMA daje
English: LAL deficiency is an autosomal recessive lysosomal storage disorder characterised by a genetic defect resulting in a marked decrease or loss in activity of the lysosomal acid lipase (LAL) enzyme.
Croatian: Nedostatak LAL-a je autosomno recesivna lizosomska bolest nakupljanja karakterizirana genetskim oštećenjem koje uzrokuje značajno smanjenje ili gubitak aktivnosti enzima lizosomske kisele lipaze (LAL).
English: At the time of initial ADA positivity, 3 patients were receiving a dose of 1 mg/kg once weekly and 1 patient was receiving a dose of 3 mg/kg once weekly.
Croatian: U vrijeme početne pozitivne reakcije na ADA, 3 bolesnika primala su dozu od 1 mg/kg jednom tjedno, a 1 bolesnik je primao dozu od 3 mg/kg jednom tjedno.
English: If treated with KANUMA, you or your child may experience a side effect while you or your child is being given the medicine or during the hours following the infusion (see section 4).
Croatian: Ako se Vi ili Vaše dijete liječite KANUMOM možete osjetiti nuspojave za vrijeme davanja lijeka ili u satima nakon infuzije (vidjeti dio 4).
English: This medicinal product contains 33 mg sodium per vial and is administered in sodium chloride 9 mg/ml (0.9%) solution for infusion (see section 6.6).
Croatian: Ovaj lijek sadrži 33 mg natrija po bočici i daje se u otopini natrijevog klorida za infuziju od 9 mg/ml (0,9%) (vidjeti dio 6.6).
English: Each vial of KANUMA is intended for single use only.
Croatian: Svaka bočica KANUME namijenjena je samo za jednokratnu primjenu.
English: LAL-CL03 was a multicentre, open-label, single-arm study of KANUMA in 9 patients with LAL deficiency with growth failure or other evidence of rapidly progressive disease prior to 6 months of age.
Croatian: Ispitivanje LAL-CL03 bilo je multicentrično, otvoreno ispitivanje KANUME u jedne skupine od 9 bolesnika s nedostatkom LAL-a i zastojem u rastu ili drugim dokazom brzo progresivne bolesti prije dobi od 6 mjeseci.
English: In the liver, this accumulation leads to hepatomegaly, increased hepatic fat content, transaminase elevation signaling chronic liver injury, and progression to fibrosis, cirrhosis, and complications of end stage liver disease.
Croatian: To nakupljanje u jetri uzrokuje hepatomegaliju, povećanje količine masti u jetri, povišenu razinu transaminaza koja upućuje na kronično oštećenje jetre, te progresiju do fibroze, ciroze i komplikacija završnog stadija bolesti jetre.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 2 mg sebelipase alfa*.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 2 mg sebelipaze alfa (sebelipase alfa)*.
English: Based on these data, the pharmacokinetics of sebelipase alfa appeared to be nonlinear with a greater than dose-proportional increase in exposure observed between the 1 and 3 mg/kg dose.
Croatian: Temeljeno na navedenim podacima, čini se da je farmakokinetika sebelipaze alfa nelinearna, s porastom izloženosti većim od onog proporcionalnog dozi uočenim za doze između 1 i 3 mg/kg.
English: In clinical studies, 21 of 106 (20%) KANUMA-treated patients, including 9 of 14 (64%) infants and 12 of 92 (13%) children and adults, experienced signs and symptoms either consistent with or that may be related to a hypersensitivity reaction.
Croatian: U kliničkim ispitivanjima, u 21 od 106 (20%) bolesnika liječenih KANUMOM, uključujući 9 od 14 (64%) dojenčadi i 12 od 92 (13%) djece i odraslih, javili su se znakovi i simptomi u skladu s reakcijom preosjetljivosti ili koji bi s njom mogli biti povezani.
English: For study entry, patients were required to have ALT levels of ≥1.5 X upper limit of normal (ULN).
Croatian: Uvjet za ulazak bolesnika u ispitivanje bila je razina ALT-a ≥ 1,5 puta iznad gornje granice normale (GGN).
English: Sebelipase alfa catalyses the lysosomal hydrolysis of cholesteryl esters and triglycerides to free cholesterol, glycerol and free fatty acids.
Croatian: Sebelipaza alfa katalizira lizosomsku hidrolizu kolesterolskih estera i triglicerida na slobodni kolesterol, glicerol i slobodne masne kiseline.
English: KANUMA has no or negligible influence on the ability to drive and use machines.
Croatian: KANUMA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Lysosomal acid lipase (LAL) deficiency
Croatian: Nedostatak lizosomske kisele lipaze (LAL)
English: AUCss = Area under the plasma concentration time curve at steady-state Cmax = Maximum concentration
Croatian: AUCss = površina ispod krivulje plazmatske koncentracije i vremena u stanju dinamičke ravnoteže Cmax = maksimalna koncentracija Tmax = vrijeme do postizanja maksimalne koncentracije CL = klirens Vc = središnji volumen distribucije T1/2 = poluvijek
English: Table 1: Adverse reactions reported in infants c receiving KANUMA
Croatian: Tablica 1: Nuspojave zabilježene u dojenčadi c koja su primala KANUMU
English: The active substance is sebelipase alfa.
Croatian: Djelatna tvar je sebelipaza alfa.
English: Lipid accumulation in the intestinal wall leads to malabsorption and growth failure.
Croatian: Nakupljanje lipida u stijenci crijeva vodi do malapsorpcije i zastoja u rastu.
English: In patients who had received KANUMA during the double-blind period, reductions in ALT levels during the first 20 weeks of treatment were maintained and further improvements were seen in lipid parameters including LDL-cholesterol and HDL-cholesterol levels.
Croatian: U bolesnika koji su primali KANUMU tijekom dvostruko slijepog razdoblja održane su smanjene razine ALT-a postignute tijekom prvih 20 tjedana liječenja i zabilježena su daljnja poboljšanja parametara lipida, uključujući razine LDL i HDL kolesterola.
English: Animal studies show no evidence of impaired fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala štetan učinak na plodnost (vidjeti dio 5.3).
English: • Information on how to manage patients experiencing severe hypersensitivity reactions including anaphylaxis.
Croatian: • Informacije o zbrinjavanju bolesnika s teškom reakcijom preosjetljivosti, uključujući anafilaksiju.
English: If the infusion reaction is severe, your doctor may stop the infusion of KANUMA in the vein and start giving appropriate medical treatment.
Croatian: Ako je infuzijska reakcija teška, Vaš će liječnik možda zaustaviti infuziju KANUME u venu i započeti odgovarajuće liječenje.
English: Evaluated in patients with MEGE-MRI assessments performed (n = 32 for KANUMA; n = 25 for placebo).
Croatian: Procijenjeno u bolesnika u kojih je učinjena procjena pomoću MEGE-MR-a (n=32 za KANUMU; n=25 za placebo).
English: How to store KANUMA
Croatian: Kako čuvati KANUMU
English: These reported signs and symptoms occurring in two or more patients included abdominal pain, agitation, chills, diarrhoea, eczema, hypertension, irritability, laryngeal oedema, nausea, oedema, pallor, pruritus, pyrexia/body temperature increased, rash, tachycardia, urticaria, and vomiting.
Croatian: Zabilježeni znakovi i simptomi koji su se javili u dva ili više bolesnika uključivali su bol u abdomenu, agitaciju, zimicu, proljev, ekcem, hipertenziju, iritabilnost, edem larinksa, mučninu, edem, bljedilo, pruritus, pireksiju/povišenu tjelesnu temperaturu, osip, tahikardiju, urtikariju i povraćanje.
English: Diarrhoea b,e
Croatian: Proljev b,e
English: In LAL-CL03, 4 of 7 evaluable infants (57%) developed ADA during treatment with KANUMA.
Croatian: U ispitivanju LAL-CL03, 4 od 7 (57%) dojenčadi pogodne za procjenu razvilo je ADA tijekom liječenja KANUMOM.
English: Other medicines and KANUMA Tell your doctor if you or your child are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ako Vi ili Vaše dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: It is used to treat patients of all ages with lysosomal acid lipase deficiency (LAL deficiency).
Croatian: Koristi se za liječenje bolesnika svih dobi s nedostatkom lizosomske kisele lipaze (nedostatak LAL-a).
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of sebelipase alfa.
Croatian: Posljedično se ne očekuje utjecaj oštećenja jetrene funkcije na farmakokinetiku sebelipaze alfa.
English: The data in Table 2 describe adverse reactions reported in children and adults who received sebelipase alfa in clinical studies at a dose of 1 mg/kg once every other week.
Croatian: Podaci u Tablici 2 opisuju nuspojave zabilježene u djece i odraslih koji su u kliničkim ispitivanjima primali sebelipazu alfa u dozi od 1 mg/kg jednom svaki drugi tjedan.
English: Based on a noncompartmental analysis of data from adults (LAL-CL01/LAL-CL-04), the pharmacokinetics of sebelipase alfa appeared to be nonlinear with a greater than dose-proportional increase in exposure observed between the 1 and 3 mg/kg dosages.
Croatian: Temeljeno na analizi podataka za odrasle (LAL-CL01/LAL-CL-04) bez uključivanja odjeljaka, čini se da je farmakokinetika sebelipaze alfa nelinearna, s porastom izloženosti većim od onog proporcionalnog dozi uočenim za doze između 1 i 3 mg/kg.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: Consistent with what was observed in KANUMA-treated patients during the double-blind period, initiation of treatment with KANUMA during the open-label period produced rapid improvements in ALT levels and in lipid parameters including LDL-cholesterol and HDL-cholesterol levels.
Croatian: U skladu s onim što je uočeno u bolesnika liječenih KANUMOM tijekom dvostruko slijepog razdoblja, započinjanje liječenja KANUMOM tijekom razdoblja otvorenog ispitivanja izazvalo je brzo poboljšanje razina ALT-a i parametara lipida, uključujući razine LDL i HDL kolesterola.
English: The recommended starting dose in infants (< 6 months of age) presenting with rapidly progressive LAL deficiency is 1 mg/kg administered as an intravenous infusion once weekly.
Croatian: Preporučena početna doza za dojenčad (< 6 mjeseci starosti) s kliničkom slikom brzo progresivnog nedostatka LAL-a je 1 mg/kg primijenjeno kao intravenska infuzija jednom tjedno.
English: No patients developed antibodies that inhibited in vitro enzyme activity and one patient developed antibodies that inhibited cellular uptake of the enzyme in vitro.
Croatian: Nijedan bolesnik nije razvio protutijela koja su inhibirala in vitro enzimsku aktivnost, a jedan je bolesnik razvio protutijela koja su in vitro inhibirala unos enzima u stanicu.
English: Administration of KANUMA to infants with confirmed multiple-organ failure should be at the discretion of the treating physician.
Croatian: Odluku o primjeni KANUME u dojenčadi s potvrđenim višestrukim zatajenjem organa treba donijeti nadležni liječnik.
English: infection of the urinary system swelling of the eyelids temporary increased cholesterol or triglyceride (fats) levels in the blood fast heartbeat anxiety sleeplessness dizziness low blood pressure redness in face shortness of breath swelling of the throat diarrhoea stomach ache stomach bloating nausea hives rash itching red swollen skin increased menstrual bleeding shivers chest discomfort swelling tiredness hardened area around the infusion site fever
Croatian: infekcija mokraćnog sustava oticanje vjeđa prolazan porast razina kolesterola i triglicerida (masnoća) u krvi brzi otkucaji srca tjeskoba nesanica omaglica nizak krvni tlak crvenilo lica nedostatak zraka oticanje grla proljev bol u trbuhu nadutost mučnina koprivnjača osip svrbež crvena otečena koža pojačano menstrualno krvarenje drhtanje nelagoda u prsištu oticanje umor otvrdnuće oko mjesta primjene infuzije vrućica
English: The data in Table 1 describe adverse reactions reported in infants who received KANUMA in clinical studies at doses up to 3 mg/kg weekly.
Croatian: Podaci u Tablici 1 opisuju nuspojave zabilježene u dojenčadi koja su u kliničkim ispitivanjima primala KANUMU u dozama do 3 mg/kg tjedno.
English: No adverse findings were observed in rat and rabbit embryofoetal development studies at doses up to at least 10 times the adult/children recommended dose and in rat fertility and peri- postnatal development studies at doses up to 10 times the adult/children recommended dose.
Croatian: U ispitivanjima embriofetalnog razvoja u štakora i kunića nisu uočeni štetni učinci ni pri dozama najmanje 10 puta većima od doza preporučenih za odrasle/djecu, a ni u ispitivanjima plodnosti te perinatalnog i postnatalnog razvoja u štakora pri dozama do 10 puta većima od doza preporučenih za odrasle/djecu.
English: Very common Agitation b, irritability b
Croatian: Agitacija b, iritabilnost t
English: Reported in ≥ 2 patients receiving KANUMA
Croatian: Zabilježeno u ≥ 2 bolesnika koji su primali KANUMU
English: In a separate study in infants, one of five evaluable patients developed antibodies that inhibit in vitro enzyme activity and cellular uptake of the enzyme.
Croatian: U posebnom ispitivanju u dojenčadi, jedan od pet bolesnika pogodnih za procjenu razvio je protutijela koja inhibiraju in vitro enzimsku aktivnost i unos enzima u stanicu.
English: Anaphylactic reaction, eyelid oedema
Croatian: Anafilaktička reakcija, edem vjeđa
English: Open-label period
Croatian: Razdoblje otvorenog ispitivanja
English: Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with sebelipase alfa; see section 4.8.
Croatian: U bolesnika liječenih sebelipazom alfa zabilježene su reakcije preosjetljivosti, uključujući anafilaksiju, vidjeti dio 4.8.
English: In LAL-CL02, 5 of 35 evaluable children and adults (14%) who were administered KANUMA during the 20-week double-blind period of the study developed ADA.
Croatian: U ispitivanju LAL-CL02, 5 od 35 (14%) djece i odraslih pogodnih za procjenu, liječenih KANUMOM tijekom 20 tjedana dvostruko slijepog razdoblja ispitivanja, razvilo je ADA.
English: Skin and subcutaneous tissue disorders Common
Croatian: Poremećaji kože i potkožnog tkiva
English: Very common Diarrhoea, gastro-oesophageal reflux disease, retching, vomiting b
Croatian: Proljev, gastroezofagealna refluksna bolest, nagon na povraćanje, povraćanje b
English: Triglycerides, mean % change from baseline HDL-cholesterol, mean % change from baseline Liver fat content c, mean % change from baseline a Proportion of patients who achieved normalisation defined as 34 or 43 U/l, depending on age and gender.
Croatian: Količina masti u jetri c, srednja vrijednost promjene od početne vrijednosti u % a Udio bolesnika koji su postigli normalizaciju definiranu kao 34 ili 43 U/l, ovisno o dobi i spolu.
English: Each vial contains 20 mg of sebelipase alfa in 10 ml (2 mg/ml).
Croatian: Jedna bočica sadrži 20 mg sebelipaze alfa u 10 ml (2 mg/ml).
English: KANUMA is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.
Croatian: KANUMA je indicirana za dugotrajnu enzimsku nadomjesnu terapiju (engl. enzyme replacement therapy, ERT) u bolesnika svih dobnih skupina s nedostatkom lizosomske kisele lipaze (engl. lysosomal acid lipase, LAL).
English: How KANUMA works
Croatian: Kako KANUMA djeluje
English: The risks and benefits of re-administering sebelipase alfa following a severe reaction should be considered.
Croatian: Nakon teške reakcije potrebno je razmotriti koristi i rizike ponovne primjene sebelipaze alfa.
English: Obligation to conduct post-authorisation measures The MAH shall complete, the measures described below:
Croatian: Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere:
English: ADA titres decreased to undetectable levels during continued treatment in all patients.
Croatian: Titar ADA se u svih bolesnika smanjio na nemjerljive razine tijekom nastavka liječenja.
English: There is limited information of sebelipase alfa pharmacokinetics in non-Caucasian ethnic groups.
Croatian: Informacije o farmakokinetici sebelipaze alfa u nebjelačkih etničkih skupina su ograničene.
English: The diluted solution should be administered to patients using a low-protein binding infusion set equipped with an in-line, low-protein binding 0.2 μm filter, with a surface area of greater than 4.5 cm2
Croatian: Razrijeđenu otopinu bolesniku treba primijeniti pomoću infuzijskog seta koji slabo veže proteine, opremljenog ugrađenim filterom od 0,2 μm koji slabo veže proteine, a ima površinu veću od 4,5 cm2 (ovisno o dostupnosti) kako bi se izbjeglo začepljenje filtera.
English: Very common Respiratory distress, wheezing, cough, rhinitis, nasal congestion, sneezing
Croatian: Respiratorni distres, zviždanje pri disanju, kašalj, rinitis, nazalna kongestija, kihanje
English: Each ml of concentrate contains 2 mg sebelipase alfa.
Croatian: Jedan ml koncentrata sadrži 2 mg sebelipaze alfa.
English: dry heaving diarrhoea hives rash vomiting itching raised rash red swollen skin fever swelling chills rapid breathing not enough oxygen in the blood fast heartbeat irritability
Croatian: nagon na povraćanje proljev koprivnjača osip povraćanje svrbež uzdignuti osip crvena otečena koža vrućica oticanje zimica ubrzano disanje nedostatak kisika u krvi brzi otkucaji srca razdražljivost
English: Each 10 ml vial contains 33 mg sodium.
Croatian: Jedna bočica od 10 ml sadrži 33 mg natrija.
English: Non-interventional post-authorisation safety study (PASS): LAL Deficiency Registry: Non-interventional, multicentre, prospective disease and clinical outcome registry of patients with Lysosomal Acid Lipase Deficiency to further understand the disease, its progression and any associated complication, and to evaluate the long-term efficacy (normalisation of hepatic function) and safety
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (PASS): Registar nedostatka LAL-a: Neintervencijski, multicentričan, prospektivni registar bolesti i kliničkog ishoda bolesnika s nedostatkom lizosomske kisele lipaze kako bi se bolje razumjela bolest, njezino napredovanje i bilo kakve pridružene komplikacije, kako bi se procijenila dugoročna djelotvornost (normalizacija funkcije jetre) i sigurnost Kanume (posebice reakcija preosjetljivosti, uključujući anafilaksiju te mogućeg utjecaja razvoja protutijela na lijek na odgovor na lijek) prema dogovorenom protokolu.
English: Each vial contains 33 mg sodium.
Croatian: Jedna bočica sadrži 33 mg natrija.
English: The recommended dose in children and adults who do not present with rapidly progressive LAL deficiency prior to 6 months of age is 1 mg/kg administered as an intravenous infusion once every other week.
Croatian: Preporučena doza u djece i odraslih u kojih nije prisutna klinička slika brzo progresivnog nedostatka LAL-a prije 6 mjeseci starosti je 1 mg/kg primijenjeno kao intravenska infuzija jednom svaki drugi tjedan.
English: Three patients of 106 (3%) patients treated with KANUMA, including 1 of 14 (7%) infants and 2 of 92 (2%) children and adults, in clinical studies experienced signs and symptoms consistent with anaphylaxis.
Croatian: U tri od 106 (3%) bolesnika, uključujući 1 od 14 (7 %) dojenčadi i 2 od 92 (2 %) djece i odraslih, liječenih KANUMOM u kliničkim ispitivanjima javili su se znakovi i simptomi u skladu s anafilaksijom.
English: This means that it replaces the missing or defective LAL enzyme in patients with LAL deficiency.
Croatian: To znači da nadomješta LAL enzim koji u bolesnika s nedostatkom LAL-a nedostaje ili je oštećen.
English: LAL enzyme activity leads to reductions in liver fat content and transaminases, and enables metabolism of cholesteryl esters and triglycerides in the lysosome, leading to reductions in lowdensity lipoprotein (LDL) cholesterol and non-high-density lipoprotein (HDL) cholesterol, triglycerides, and increases in HDL cholesterol.
Croatian: Nadomještanje enzimske aktivnosti LAL-a dovodi do smanjenja količine masti u jetri i transaminaza, omogućuje metabolizam kolesterolskih estera i triglicerida u lizosomima i tako uzrokuje smanjenje LDL kolesterola i kolesterola koji nije HDL, triglicerida te povećanje HDL kolesterola.
English: KANUMA has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Croatian: KANUMA se mora razrijediti s otopinom natrijevog klorida za infuziju od 9 mg/ml (0,9%) uz korištenje aseptične tehnike.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 10 ml VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA 10 ml
English: Each vial of 10 ml contains 20 mg sebelipase alfa.
Croatian: Jedna bočica od 10 ml sadrži 20 mg sebelipaze alfa.
English: In the spleen, LAL deficiency results in splenomegaly, anemia, and thrombocytopenia.
Croatian: Nedostatak LAL-a u slezeni uzrokuje splenomegaliju, anemiju i trombocitopeniju.
English: Signs and symptoms included chest discomfort, conjunctival injection, dyspnoea, generalised and itchy rash, hyperaemia, mild eyelid oedema, rhinorrhoea, severe respiratory distress, tachycardia, tachypnoea and urticaria.
Croatian: Znakovi i simptomi uključivali su nelagodu u prsištu, injekciju konjunktive, dispneju, generaliziran osip koji svrbi, hiperemiju, blagi edem vjeđa, rinoreju, težak respiratorni distres, tahikardiju, tahipneju i urtikariju.
English: *Sebelipase alfa is produced in egg white of transgenic Gallus by recombinant DNA (rDNA) technology.
Croatian: *Sebelipaza alfa je proizvedena u bjelanjku transgenične kokoši (lat.
English: Consistent with its known mechanism of action, asymptomatic increases in circulating cholesterol and triglycerides have been observed following initiation of treatment.
Croatian: Nakon uvođenja liječenja zabilježen je asimptomatski porast razina cirkulirajućeg kolesterola i triglicerida, što je u skladu s njenim poznatim mehanizmom djelovanja.
English: Transient hyperlipidaemia
Croatian: Prolazna hiperlipidemija
English: Infusion related reaction c a Common = Reported in ≥ 1 patient receiving KANUMA b Reported at the same frequency in patients receiving KANUMA or placebo or more frequently in patients receiving placebo during the double-blind period of LAL-CL02
Croatian: Zabilježena jednaka učestalost u bolesnika koji su primali KANUMU ili placebo ili je učestalost bila veća u bolesnika koji su primali placebo tijekom dvostruko slijepog razdoblja ispitivanja LAL-CL02
English: Dyslipidemia is common with elevated LDL and triglycerides and low HDL, associated with increase liver fat content and transaminase elevations.
Croatian: Česte su dislipidemije s povišenim LDL-om i trigliceridima te niskim HDL-om povezane s povećanjem količine masti u jetri i povišenim razinama transaminaza.