FrancophonIA/ELRC3.0 huggingface dataset:
English: Evaluated in patients with MEGE-MRI assessments performed (n = 32 for KANUMA; n = 25 for placebo).
Slovenian: Ocenjeno pri bolnikih z opravljeno preiskavo z MEGE-MRI (n=32 za zdravilo KANUMA; n=25 za placebo).
English: Driving and using machines KANUMA has no or negligible influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo KANUMA ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: The recommended dose is 1 mg per kg body weight once every other week through a drip into a vein.
Slovenian: Priporočeni odmerek je 1 mg na kg telesne mase vsak drugi teden v obliki kapalne infuzije v veno.
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.
Slovenian: Podatki v preglednici 2 opisujejo neželene učinke, o katerih so poročali pri otrocih in odraslih, ki so v kliničnih študijah prejemali sebelipazo alfa v odmerku 1 mg/kg enkrat vsak drugi teden.
English: Very common Agitation b, irritability b
Slovenian: Psihiatrične motnje zelo pogosti vznemirjenje b, razdražljivost b
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.
Slovenian: Nadomeščanje aktivnosti encima LAL vodi v zmanjšanje vsebnosti jetrnih maščob in transaminaz ter omogoča presnovo holesterolnih estrov in trigliceridov v lizosome, kar povzroči zmanjšanje lipoproteinov majhne gostote (LDL-lowdensity lipoprotein) holesterola in lipoproteinov visoke gostote (HDL-high-density lipoprotein) holesterola, trigliceridov in zvišanje ravni HDL holesterola.
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.
Slovenian: Ti poročani znaki in simptomi, ki so se pojavili pri dveh ali več bolnikih, so vključevali bolečino v trebuhu, agitacijo, mrzlico, drisko, ekcem, preobčutljivost, razdražljivost, laringealni edem, navzeo, edem, bledico, pruritus, pireksijo/zvišano telesno temperaturo, izpuščaj, tahikardijo, urtikarijo in bruhanje.
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.
Slovenian: Pri bolnikih, ki so zdravilo KANUMA prejemali v dvojno slepem obdobju, so se zmanjšane ravni ALT ohranile prvih 20 tednov zdravljenja (slika 1), nadaljnja izboljšanja pa so opazili pri parametrih maščob, vključno z ravnmi LDL-holesterola in HDLholesterola.
English: Table 1: Recommended infusion volumes (1 mg/kg dose)* Weight range (kg)
Slovenian: Preglednica 1: Priporočena količina za infundiranje (odmerek 1 mg/kg)* Razpon telesne mase (kg)
English: A statistically significant improvement in multiple endpoints was observed in the sebelipase alfatreated group as compared to the placebo group at the completion of the 20-week double-blind period of the study, as shown in Table 3.
Slovenian: V skupini, zdravljeni s sebelipazo alfa, so v primerjavi s skupino s placebom ob koncu 20-tedenskega dvojno slepega obdobja študije opazili statistično značilno izboljšanje več opazovanih dogodkov, kot prikazuje preglednica 3.
English: In LAL-CL03, 4 of 7 evaluable infants (57%) developed ADA during treatment with KANUMA.
Slovenian: V študiji LAL-CL03 so se pri 4 od 7 dojenčkov, ki jih je bilo mogoče oceniti (57%), med zdravljenjem z zdravilom KANUMA razvila ADA.
English: , abdominal pain b,e abdominal distension, nausea b e
Slovenian: , bolečine v trebuhu b,e abdominalna distenzija, navzeab e
English: • Summary of Product Characteristics
Slovenian: • povzetek glavnih značilnosti zdravila,
English: If the infusion reaction is severe, your doctor may stop the infusion of KANUMA in the vein and start giving appropriate medical treatment.
Slovenian: Če je reakcija na infuzijo resna, lahko zdravnik z infundiranjem zdravila KANUMA v veno preneha in začne dajati ustrezna zdravila.
English: KANUMA has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Slovenian: Zdravilo KANUMA je treba razredčiti z natrijevim kloridom 9 mg/ml (0,9%) raztopino za infundiranje z aseptično tehniko.
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.
Slovenian: V skladu z opažanji pri bolnikih, zdravljenih z zdravilom KANUMA v dvojno slepem obdobju, je uvedba zdravljenja z zdravilom KANUMA v odprtem obdobju povzročila hitro izboljšanje ravni ALT in parametrov maščob, vključno z ravnmi LDLholesterola in HDL-holesterola.
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
Slovenian: spahovanje driska koprivnica izpuščaj bruhanje srbenje rdeča otekla koža rdeča otekla koža zvišana telesna temperatura oteklost mrzlica hitro dihanje premalo kisika v krvi hiter srčni utrip razdražljivost
English: Improvement in growth occurs as a result of substrate reduction in the intestine.
Slovenian: Posledica zmanjšanja substrata v črevesju je izboljšanje rasti.
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).
Slovenian: Če se vi sami oziroma se vaš otrok zdravi z zdravilom KANUMA, lahko vi oziroma vaš otrok doživita neželene učinke med dajanjem zdravila ali v urah, ki sledijo infuziji (glejte poglavje 4).
English: The solution should be mixed gently, and not be shaken.
Slovenian: Raztopino je treba nežno premešati, ni pa je dovoljeno stresati.
English: Very common = Reported in ≥ 1 patient receiving KANUMA
Slovenian: Zelo pogosti = o njih so poročali pri ≥ 1 bolniku, ki je dobival zdravilo KANUMA
English: KANUMA is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.
Slovenian: Zdravilo KANUMA je indicirano za dolgotrajno nadomestno encimsko zdravljenje pri bolnikih vseh starosti s pomanjkanjem lizosomske kisle lipaze (LAL-lysosomal acid lipase).
English: Each vial of 10 ml contains 20 mg sebelipase alfa.
Slovenian: Ena viala z 10 ml vsebuje 20 mg sebelipaze alfa.
English: Hypersensitivity reactions including anaphylaxis
Slovenian: Preobčutljivostne reakcije, vključno z anafilakso
English: If interrupted, the infusion may be resumed at a slower rate with increases as tolerated.
Slovenian: Po prekinitvi je možno infundiranje nadaljevati počasneje, z večanjem hitrosti glede na to, kako bolnik prenaša zdravilo.
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.
Slovenian: Na podlagi nerazdelčne analize podatkov za odrasle (LAL-CL01/LAL-CL-04) je kazalo, da je farmakokinetika sebelipaze alfa nelinearna in da je povečanje, ki so ga opazili med odmerki 1 in 3 mg/kg večje kot z odmerkom sorazmerno povečanje v izpostavljenosti.
English: MedDRA preferred term
Slovenian: Priporočeni izraz po MedDRA
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.
Slovenian: Podatki v preglednici 1 opisujejo neželene učinke, o katerih so poročali pri dojenčkih, ki so v kliničnih študijah prejemali zdravilo KANUMA v odmerkih do 3 mg/kg na teden.
English: The active substance is sebelipase alfa.
Slovenian: Zdravilna učinkovina je sebelipaza alfa.
English: Mechanism of action Sebelipase alfa is a recombinant human lysosomal acid lipase (rhLAL).
Slovenian: Sebelipaza alfa je rekombinantna humana lizosomska kisla lipaza (rhLAL-recombinant human lysosomal acid lipase).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 2 mg sebelipase alfa*.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 2 mg sebelipaze alfa (sebelipasum alfa)*.
English: In the spleen, LAL deficiency results in splenomegaly, anemia, and thrombocytopenia.
Slovenian: V vranici povzroči pomanjkanje LAL splenomegalijo, anemijo in trombocitopenijo.
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
Slovenian: O njih so v dvojno slepem obdobju študije LAL-CL02 poročali z enako pogostnostjo pri bolnikih, ki so dobivali zdravilo KANUMA ali placebo, ali pogosteje pri bolnikih, ki so dobivali placebo c
English: a. The number of vials to be diluted for infusion should be determined based on the patient's weight and prescribed dose.
Slovenian: a. Na podlagi bolnikove telesne mase in predpisanega odmerka je treba določiti število vial, ki jih je treba razredčiti za infundiranje.
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
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Register o pomanjkanju LAL: Neintervencijski, multicentrični, bodoči register bolezni in kliničnih izidov pri bolnikih s pomanjkanjem lizozomalne kisle lipaze za nadaljnje razumevanje bolezni, njenega napredovanja in vseh morebitnih zapletov, ter za ocenjevanje dolgoročne učinkovitosti (normalizacija delovanja jeter) in varnosti zdravila Kanuma (zlasti glede preobčutljivostnih reakcij, vključno z anafilaksijo, in razvoja protiteles protui zdravilu, ki potencialno vplivajo na odziva na zdravilo) v skladno z dogovorjenim protokolom.
English: Sebelipase alfa catalyses the lysosomal hydrolysis of cholesteryl esters and triglycerides to free cholesterol, glycerol and free fatty acids.
Slovenian: Sebelipaza alfa katalizira lizosomsko hidrolizo holesterolnih estrov in trigliceridov v prosti holesterol, glicerol in proste maščobne kisline.
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.
Slovenian: V študiji LAL-CL02 se je pri 5 od 35 otrok in odraslih, ki jih je bilo možno oceniti (14%) in so v 20-tedenskem dvojno slepem obdobju študije dobivali zdravilo KANUMA, razvila ADA.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity in rats and monkeys, or fertility, embryo-foetal and peri- and postnatal development in rats and rabbits.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih pri podganah in opicah ali plodnosti ter embrio-fetalnega in peri- in postnatalnega razvoja pri podganah in kuncih ne kažejo posebnega tveganja za človeka.
English: Other medicines and KANUMA Tell your doctor if you or your child are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, če vi sami oziroma vaš otrok jemljeta, sta pred kratkim jemala ali pa bosta morda začela jemati katero koli drugo zdravilo.
English: Primary Endpoint Normalisation of ALT
Slovenian: Primarni opazovani dogodek Normalizacija vrednosti ALT
English: There is a lack of data in patients with renal impairment.
Slovenian: Podatki za bolnike z okvaro ledvic so pomanjkljivi.
English: For diluted solutions, immediate use is recommended.
Slovenian: Priporoča se, da razredčeno raztopino takoj uporabite.
English: Table 1: Adverse reactions reported in infants c receiving KANUMA
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali pri dojenčkih c, ki so prejemali zdravilo
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.
Slovenian: Pri treh bolnikih od 106 (3%) bolnikov, zdravljenih z zdravilom KANUMA v kliničnih študijah, vključno pri 1 od 14 (7 %) dojenčkov in 2 od 92 (2 %) otrok ter odraslih, so se pojavili znaki in simptomi, skladni z anafilakso.
English: Two patients were determined to be positive for antibodies that inhibit in vitro enzyme activity and cellular uptake of the enzyme.
Slovenian: Pri dveh bolnikih se je ugotovilo, da sta pozitivna na protitelesa, ki in vitro zavirajo aktivnost encima in celični privzem encima.
English: Very common Diarrhoea, gastro-oesophageal reflux disease, retching, vomiting b
Slovenian: Bolezni prebavil zelo pogosti driska, gastro-ezofagealna refluksna bolezen, spahovanje, bruhanje b
English: Animal studies show no evidence of impaired fertility (see section 5.3).
Slovenian: Študije na živalih niso pokazale vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine (učinkovin)
English: P-values are from Fisher's exact test for normalisation endpoints and Wilcoxon rank-sum test for all other endpoints.
Slovenian: d Vrednosti P so iz Fisherjevega testa natančnosti za opazovane dogodke normalizacije in
English: How KANUMA works
Slovenian: Kako deluje zdravilo KANUMA
English: How KANUMA is given
Slovenian: Kako se daje zdravilo KANUMA
English: There is a lack of data in patients with severe hepatic impairment.
Slovenian: Podatki za bolnike s hudo okvaro jeter so pomanjkljivi.
English: Deficient LAL enzyme activity results in the lysosomal accumulation of cholesteryl esters and triglycerides.
Slovenian: Pomanjkanje encima LAL povzroči lizosomsko kopičenje holesterolnih estrov in trigliceridov.
English: LDL-cholesterol, mean % change from baseline non-HDL-cholesterol, mean % change from baseline Normalisation of AST
Slovenian: Sekundarni opazovani dogodki LDL-holesterol, povprečna sprememba v % od izhodišča ne-HDL-holesterol, povprečna sprememba v % od izhodišča
English: Common side effects reported in children and adolescents (4 to 18 years old) and adults are: severe allergic reaction (anaphylactic reaction)
Slovenian: Pogosti neželeni učinki, o katerih so poročali pri otrocih in mladostnikih (starih od 4 do 18 let) in odraslih, so:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION KANUMA 2 mg/ml sterile concentrate sebelipase alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE KANUMA 2 mg/ml sterilni koncentrat sebelipasum alfa i.v.
English: If you or your child gets any side effects, talk to your doctor.
Slovenian: Če pri sebi ali svojem otroku opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: Infants presenting with LAL deficiency
Slovenian: Dojenčki s pomanjkanjem LAL
English: Therefore, appropriate medical support must be readily available when sebelipase alfa is administered.
Slovenian: Zato mora biti pri dajanju sebelipaze alfa takoj na voljo ustrezna zdravstvena oskrba.
English: Hyperaemia e, hypotension
Slovenian: Žilne bolezni pogosti hiperemija e, hipotenzija
English: It is a solution that is clear to slightly opalescent, and colourless to slightly coloured.
Slovenian: Raztopina je bistra do nekoliko motna in brezbarvna do nekoliko obarvana.
English: Trisodium citrate dihydrate Citric acid monohydrate Human serum albumin Water for injections
Slovenian: 6.1 Seznam pomožnih snovi trinatrijev citrat dihidrat citronska kislina monohidrat humani serumski albumin voda za injekcije
English: There is limited information of sebelipase alfa pharmacokinetics in non-Caucasian ethnic groups.
Slovenian: Informacije o farmakokinetiki sebelipaze alfa so pri drugih etničnih skupinah, razen pri belcih, omejene.
English: ADA titres decreased to undetectable levels during continued treatment in all patients.
Slovenian: Pri vseh bolnikih so se titri ADA z nadaljevanjem zdravljenja zmanjšali do nezaznavnih ravni.
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK UPORABE Pred uporabo preberite navodilo za uporabo!
English: Administration of KANUMA to infants with confirmed multiple-organ failure should be at the discretion of the treating physician.
Slovenian: Dajanje zdravila Kanuma dojenčkom (starim < 6 mesecev) s potrjeno odpovedjo več organov je dovoljeno po presoji lečečega zdravnika.
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.
Slovenian: Znaki in simptomi so vključevali nelagodje v prsnem košu, pordelost očesne veznice, dispnejo, generaliziran in srbeč izpuščaj, hiperemijo, blag edem veke, rinorejo, resno dihalno stisko, tahikardijo, tahipnejo in urtikarijo.
English: e. Up to 10 ml of solution should be slowly withdrawn from each vial and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: e. Iz vsake viale je treba počasi vsrkati do 10 ml raztopine in jo razredčiti z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za infundiranje.
English: Reported in ≥ 2 patients receiving KANUMA
Slovenian: O njih so poročali pri ≥ 2 bolnikih, ki sta dobivala zdravilo KANUMA
English: KANUMA contains the active substance sebelipase alfa.
Slovenian: Zdravilo KANUMA vsebuje zdravilno učinkovino sebelipaza alfa.
English: There is limited information on the impact of anti-drug antibodies on sebelipase alfa pharmacokinetics.
Slovenian: Informacije o vplivu protiteles proti zdravilu na farmakokinetiko sebelipaze so omejene.
English: d. Do not use if the solution is cloudy, or if foreign particulate matter is present.
Slovenian: d. Ne uporabite raztopine, ki je motna ali v kateri plavajo delci.
English: ≥ 18 years old N=18 Week 0 Week 22* Week 0 Week 22* Week 0 Week 22* AUCss (ng∙hr/mL) 1133.8 941.6 1436.4 1453.6 1989.3 1861.0 Cmax (ng/mL) Tmax (hr) CL (L/hr) Vc (L) T1/2 (hr) * Week 22 for placebo patients reset to Week 0, i.e. first week of active treatment.
Slovenian: ≥ 18 let starosti n=18 0. teden 22. teden* 0. teden 22. teden* 0. teden 22. teden*
English: Each vial contains 20 mg of sebelipase alfa in 10 ml (2 mg/ml).
Slovenian: Vsaka viala vsebuje 20 mg sebelipaze alfa (2 mg/ml).
English: KANUMA 2 mg/ml concentrate for solution for infusion sebelipase alfa
Slovenian: KANUMA 2 mg/ml koncentrat za raztopino za infundiranje sebelipaza alfa (sebelipasum alfa)
English: Very common Hypotonia
Slovenian: Bolezni živčevja zelo pogosti hipotonija
English: Diarrhoea b,e
Slovenian: Bolezni prebavil pogosti driska b,e
English: What KANUMA contains
Slovenian: Kaj vsebuje zdravilo KANUMA
English: Very common Hypertension, pallor b
Slovenian: Žilne bolezni zelo pogosti hipertenzija, bledica b
English: MedDRA System organ class
Slovenian: KANUMA Organski sistem po MedDRA
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih pogosti reakcije, povezane z infundiranjem c a
English: Very common Tachycardia b
Slovenian: Srčne bolezni zelo pogosti tahikardija b
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.
Slovenian: Pri nobenem bolniku se niso razvila protitelesa, ki in vitro zavirajo aktivnost encima.
English: A 1-hour infusion may be considered after patient tolerability is established.
Slovenian: Ko se ugotovi, da bolnik zdravilo prenaša, se lahko razmisli o 1-urni infuziji.
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.
Slovenian: Priporočeni odmerek za otroke in odrasle s pomanjkanjem LAL je 1 mg/kg dan v obliki intravenske infuzije enkrat vsak drugi teden.
English: Urticaria, rashc,e (including rash papular and rash pruritic), prurituse, eczema e
Slovenian: (vključno s papularnim in pruritičnim izpuščajem), pruritus e, ekcem e
English: KANUMA 2 mg/ml concentrate for solution for infusion
Slovenian: KANUMA 2 mg/ml koncentrat za raztopino za infundiranje
English: KANUMA contains sodium
Slovenian: Zdravilo KANUMA vsebuje natrij
English: Very common Respiratory distress, wheezing, cough, rhinitis, nasal congestion, sneezing
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti dihalna stiska, zasoplost, kašelj, rinitis, zamašen nos, kihanje
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 20 mg sebelipase alfa in 10 ml of solution (2 mg/ml)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 20 mg sebelipaze alfa v 10 ml raztopine (2 mg/ml)
English: See Table 5 for recommended total infusion volumes by weight range.
Slovenian: Za priporočeno skupno količino za infundiranje glede na razpon telesne mase glejte preglednico 5.
English: Transient hypercholesterolaemia, transient hypertriglyceridaemia
Slovenian: Presnovne in prehranske motnje pogosti prehodna hiperholesterolemija, prehodna hipertrigliceridemija
English: Nervous system disorders
Slovenian: Bolezni živčevja pogosti omotica
English: No dosing adjustment is recommended in patients with renal or hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of sebelipase alfa.
Slovenian: Na podlagi trenutnega znanja o farmakokinetiki in farmakodinamiki sebelipaze alfa prilagajanje odmerkov pri bolnikih z okvaro ledvic ali jeter ni potrebno.
English: Trisodium citrate dihydrate (see leaflet for further information) Citric acid monohydrate
Slovenian: Pomožne snovi: trinatrijev citrat dihidrat (glejte navodilo za uporabo za več informacij) citronska kislina monohidrat humani serumski albumin voda za injekcije
English: Menorrhagia
Slovenian: Imunogenost
English: Obligation to conduct post-authorisation measures The MAH shall complete, the measures described below:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: How to store KANUMA
Slovenian: Shranjevanje zdravila KANUMA
English: Table 2: Adverse reactions reported in children and adultsd receiving KANUMA MedDRA System organ class
Slovenian: Starost ob prvem odmerku: 1 do 6 mesecev Preglednica 2: Neželeni učinki, o katerih so poročali pri otrocih in odraslih d, ki so prejemali zdravilo KANUMA Organski sistem po MedDRA
English: See Table 1 for recommended total infusion volumes by weight range.
Slovenian: Za priporočeno skupno količino za infundiranje glede na razpon telesne mase glejte preglednico 1.
English: Age at first dose: 4 to 58 years e
Slovenian: Starost ob prvem odmerku: 4 do 58 let e O njih so poročali pri ≥ 2 bolnikih, ki sta dobivala zdravilo KANUMA
English: Dose adjustments may be considered based on how well you or your child responds to treatment.
Slovenian: Glede na vaš oziroma otrokov odziv na zdravljenje se lahko razmisli o prilagoditvi odmerka.
English: Dose escalation to 3 mg/kg once weekly should be considered based on clinical response.
Slovenian: Na podlagi kliničnega odziva se lahko razmisli o povečevanju odmerka na 3 mg/kg enkrat na teden.