FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall ensure that in each Member State where Kanuma is marketed, all healthcare professionals who are expected to use Kanuma have access to the educational material.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da bodo imeli vsi zdravstveni delavci v vsaki državi članici, kjer je zdravilo Kanuma v prometu in za katere se pričakuje, da bodo uporabljali zdravilo Kanuma, dostop do izobraževalnega gradiva.
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
Slovenian: Razredčeno raztopino je treba bolniku dati z infuzijskim kompletom z majhno vezavo beljakovin, opremljenim z vgrajenim filtrom velikosti 0,2 μm z majhno vezavo beljakovin, s površino večjo kot 4,5 cm2, ki je na voljo, da se prepreči zamašitev filtra.
English: If you or your child experiences symptoms like these, seek immediate medical attention.
Slovenian: Če vi ali vaš otrok doživita tovrstne simptome, poiščite takojšnjo zdravniško pomoč.
English: Patients have developed anti-drug antibodies (ADA) to sebelipase alfa.
Slovenian: Pri bolnikih so se razvila protitelesa proti zdravilu (ADA-anti-drug antibodies) na sebelipazo alfa.
English: After dilution: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C to 8°C, or up to 12 hours below 25°C.
Slovenian: Po redčenju: Kemična in fizikalna stabilnost med uporabo je bila dokazana za do 24 ur pri 2 °C do 8 °C ali za do 12 ur pod 25 °C.
English: Renal elimination of sebelipase alfa is considered a minor pathway for clearance.
Slovenian: Izločanje sebelipaze alfa skozi ledvice je manj pomembna pot očistka.
English: If you or your child has an egg allergy or a history of allergies to eggs, tell your doctor or nurse (see You must not be given KANUMA).
Slovenian: Če sta vi oziroma vaš otrok alergična na jajca ali ste imeli alergije na jajca v preteklosti, je treba to povedati zdravniku ali medicinski sestri (glejte poglavje Zdravila KANUMA ne smete prejeti).
English: What KANUMA looks like and contents of the pack KANUMA is supplied as a concentrate for solution for infusion.
Slovenian: Izgled zdravila KANUMA in vsebina pakiranja Zdravilo KANUMA je na voljo kot koncentrat za raztopino za infundiranje.
English: P-value d
Slovenian: Vrednost d
English: Dose escalation to 3 mg/kg once weekly was associated with additional improvements in weight gain, lymphadenopathy and serum albumin.
Slovenian: Večanje odmerka na 3 mg/kg enkrat na teden je bilo povezano z dodatnim izboljšanjem v pridobivanju telesne mase, limfadenopatiji in serumskem albuminu.
English: There are no clinical data on the effects of sebelipase alfa on fertility.
Slovenian: Ni kliničnih podatkov o vplivu sebelipaze alfa na plodnost.
English: As a precautionary measure, it is preferable to avoid use of sebelipase alfa during pregnancy.
Slovenian: Kot previdnostni ukrep se uporaba sebelipaze alfa med nosečnostjo ne priporoča.
English: Study LAL-CL08: an open-label, Phase 2 study in infants with rapidly progressive LAL Deficiency to explore long-term safety and efficacy data.
Slovenian: Študija LAL-CL08: odprta študija faze II pri dojenčkih s hitro napredujočim pomanjkanjem LAL za raziskovanje podatkov o dolgoročni varnosti in
English: Sebelipase alfa binds to cell surface receptors via glycans expressed on the protein and is subsequently internalized into lysosomes.
Slovenian: Sebelipaza alfa se veže na receptorje na površini celice s pomočjo glianov, izraženih na beljakovini, in se nato internalizira v lizosome.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of sebelipase alfa.
Slovenian: Posledično se ne pričakuje, da bi okvarjeno delovanje jeter vplivalo na farmakokinetiko sebelipaze alfa.
English: In a separate open-label study (LAL-CL01/LAL-CL04) in adult patients with LAL deficiency, improvements in serum transaminase and lipid levels were sustained through the 104-week treatment period.
Slovenian: V ločeni odprti študiji (LAL-CL01/LAL-CL04) pri odraslih bolnikih s pomanjkanjem LAL so se izboljšanja serumskih transaminaz in ravni maščob ohranile do konca 104-tedenskega obdobja zdravljenja.
English: You must not be given KANUMA: - if you or your child has experienced life-threatening allergic reactions to sebelipase alfa that cannot be managed when you or your child receives the medicine again, or to egg or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila KANUMA vam ne smejo dati: če ste vi sami ali je vaš otrok doživel življenjsko nevarne alergijske reakcije na sebelipazo alfa, ki jih ob ponovnem jemanju zdravila ne bo mogoče nadzirati, ali na jajca ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The pharmacokinetics of sebelipase alfa in children and adults were determined using a population pharmacokinetic analysis of 65 patients with LAL deficiency who received intravenous infusions of KANUMA at 1 mg/kg once every other week in LAL-CL02.
Slovenian: Farmakokinetiko sebelipaze alfa pri otrocih in odraslih so določili s pomočjo analize populacijske farmakokinetike pri 65 bolnikih s pomanjkanjem LAL, ki so prejemali intravenske infuzije zdravila KANUMA v odmerku 1 mg/kg enkrat na vsak drugi teden v študiji LAL-CL02.
English: Efficacy was assessed by comparing the survival experience of KANUMA-treated patients who survived past 12 months of age in LAL-CL03 with a historical cohort of untreated infants presenting with LAL deficiency with similar clinical characteristics.
Slovenian: Učinkovitost so ocenili s primerjavo izkušnje preživetja pri bolnikih, zdravljenih z zdravilom KANUMA, ki so preživeli več kot 12 mesecev starosti v LAL-CL03 z zgodovinsko kohorto nezdravljenih dojenčkov, ki so imeli pomanjkanje LAL s podobnimi kliničnimi značilnostmi.
English: Evaluated in patients with abnormal baseline values (n = 36 for KANUMA; n = 29 for placebo).
Slovenian: Ocenjeno pri bolnikih z abnormalnimi izhodiščnimi vrednostmi (n=36 za zdravilo KANUMA; n=29 za placebo).
English: What KANUMA is and what it is used for What you need to know before you are given KANUMA How KANUMA is given
Slovenian: Kaj je zdravilo KANUMA in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo KANUMA Kako se daje zdravilo KANUMA Možni neželeni učinki
English: If you or your child experiences a severe infusion reaction like this, seek immediate medical attention.
Slovenian: Če vi ali vaš otrok doživite tovrstno hudo reakcijo na infuzijo, poiščite takojšnjo zdravniško pomoč.
English: If you or your child has an infusion reaction you or your child may be given additional medicines to treat or help prevent future reactions.
Slovenian: Če imata vi oziroma ima vaš otrok reakcijo na infuzijo, bosta vi oziroma vaš otrok morda prejela dodatna zdravila za zdravljenje ali preprečevanje reakcij v prihodnje.
English: Paired liver biopsies at baseline and week 20 were available in a subset of patients (n = 26).
Slovenian: Parne jetrne biopsije ob izhodišču in v 20. tednu so bile na voljo za podskupino bolnikov (n=26).
English: The educational material is aimed to encourage healthcare professionals to enrol patients in the prospective disease and clinical outcome registry of patients with Lysosomal Acid Lipase (LAL) Deficiency to monitor for efficacy and safety of Kanuma (LAL Deficiency Registry), with particular regard to hypersensitivity reactions, including anaphylaxis, and anti-drug antibodies (ADA) development impacting response to drug.
Slovenian: Izobraževalno gradivo je namenjeno spodbujanju zdravstvenih strokovnjakov, da bolnike vključijo v prihodnji register bolezni in kliničnih izidov za bolnike s pomanjkanjem lizozomalne kisle lipaze (LAL), da bi omogočili spremljanje učinkovitosti in varnosti zdravila Kanuma (Register o pomanjkljivosti LAL), s posebnim poudarkom na preobčutljivostnih reakcijah, vključno z anafilaksijo, in na razvoju protiteles proti zdravilu (ADA), ki vplivajo na odziv na zdravilo.
English: Lipid accumulation in the intestinal wall leads to malabsorption and growth failure.
Slovenian: Kopičenje maščob v črevesni steni povzroči malabsorpcijo in zaostanek v rasti.
English: LAL deficiency registry
Slovenian: Register o pomanjkanju LAL
English: There are no data from the use of sebelipase alfa in pregnant women.
Slovenian: Podatkov o uporabi sebelipaze alfa pri nosečnicah ni.
English: KANUMA treatment should be supervised by a healthcare professional experienced in the management of patients with LAL deficiency, other metabolic disorders, or chronic liver diseases.
Slovenian: Zdravljenje z zdravilom KANUMA mora nadzirati zdravstveni delavec z izkušnjami pri zdravljenju bolnikov s pomanjkanjem LAL, drugimi presnovnimi boleznimi ali kroničnimi boleznimi jeter.
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.
Slovenian: V jetrih povzroči to kopičenje hepatomegalijo, povečano vsebnost jetrnih maščob, zvišano raven transaminaz, ki kaže na kronično poškodbo jeter, in napredovanje do fibroze, ciroze in zapletov bolezni jeter v končnem stadiju.
English: For patients who have signs and symptoms of the disease when they are infants, the recommended starting dose is 1 mg/kg once weekly.
Slovenian: Za bolnike, ki imajo znake in simptome bolezni kot dojenčki, je priporočeni začetni odmerek 1 mg/kg enkrat na teden.
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.
Slovenian: V času začetne pozitivnosti na ADA so 3 bolniki prejemali odmerek 1 mg/kg enkrat na teden, 1 bolnik pa je prejemal odmerek 3 mg/kg enkrat na teden.
English: Consistent with its known mechanism of action, asymptomatic increases in circulating cholesterol and triglycerides have been observed following initiation of treatment.
Slovenian: V skladu z znanim mehanizmom delovanja so po uvedbi zdravljenja opazili asimptomatsko povečanje cirkulirajočega holesterola in trigliceridov.
English: Marketing Authorisation Holder Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France
Slovenian: Imetnik dovoljenja za promet z zdravilom Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Francija
English: KANUMA has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo KANUMA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Method of administration KANUMA is for intravenous use only.
Slovenian: Način uporabe Zdravilo KANUMA je samo za intravensko uporabo.
English: KANUMA at doses up to 1 mg/kg once weekly resulted in improvements in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels and weight gain within the first several weeks of treatment.
Slovenian: Zdravilo KANUMA je v odmerkih do 1 mg/kg enkrat na teden izboljšalo ravni alaninaminotransferaze (ALT) in aspartat-aminotransferaze (AST) in pridobivanje telesne mase v prvih nekaj tednih zdravljenja.
English: During the covariate analysis of the population pharmacokinetics model for sebelipase alfa, age, body weight, and sex were not found to have a significant influence on CL and Vc of sebelipase alfa.
Slovenian: V analizi sospremenljivk populacijskega farmakokinetičnega modela za sebelipazo alfa je bilo ugotovljeno, da starost, telesna masa in spol nimajo značilnega vpliva na očistek in Vc sebelipaze alfa.
English: Due to the proteinaceous nature of the product, slight flocculation (e.g., thin translucent fibres) may be present in the vialed solution and is acceptable for use.
Slovenian: Ker je to beljakovinska raztopina, je lahko v raztopini viale prisotna flokulacija (npr. tanka prosojna vlakna), ta pa je kljub temu uporabna.
English: Sebelipase alfa is similar to the naturally occurring enzyme lysosomal acid lipase (LAL), which the body uses to breakdown fats.
Slovenian: Sebelipaza alfa je podobna encimu lizosomska kisla lipaza (LAL), ki se pojavlja naravno in ki jo uporablja telo pri razgradnji maščob.
English: LAL deficiency is a genetic disease that leads to liver damage, high blood cholesterol, and other complications due to a build-up of certain types of fats (cholesteryl esters and triglycerides).
Slovenian: Pomanjkanje LAL je genska motnja, ki povzroča poškodbe jeter, visoko raven holesterola v krvi in druge zaplete zaradi kopičenja določenih vrst maščob (holesterolnih estrov in trigliceridov).
English: If severe reactions occur, the sebelipase alfa infusion should be immediately stopped and appropriate medical treatment should be initiated.
Slovenian: Če se pojavijo hude reakcije, takoj prenehajte z infundiranjem sebelipaze alfa in uvedite ustrezno zdravljenje.
English: A further dose escalation to 5 mg/kg once weekly was allowed.
Slovenian: Dovoljeno je bilo nadaljnje večanje odmerka na 5 mg/kg enkrat na teden.
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.
Slovenian: Pomanjkanje LAL je avtosomna recesivna motnja lizosomskega skladiščenja, za katero je značilna genska okvara, ki povzroči močno zmanjšanje ali izgubo aktivnosti encima lizosomska kisla lipaza (LAL).
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.
Slovenian: LAL-CL03 je bila multicentrična, odprta študija z enim krakom za zdravilo KANUMA pri 9 bolnikih s pomanjkanjem LAL in zaostajanjem v rasti ali drugimi znaki hitrega napredovanja bolezni pred 6. mesecem starosti.
English: Those patients who developed ADA did so within the first 3 months of exposure.
Slovenian: Pri bolnikih se je ADA razvila v prvih 3 mesecih izpostavljenosti.
English: Placebo patients had persistently elevated serum transaminase and abnormal serum lipid levels during the double-blind period.
Slovenian: Bolniki na placebu so imeli v dvojno slepem obdobju stalno zvišane ravni serumske transaminaze in nenormalne ravni maščob v serumu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/10 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 20 mg/10 ml
English: Very common side effects reported in infants (1 to 6 months old) are: eyelid swelling agitation high blood pressure decreased muscle tone difficulty breathing wheezing paleness stuffy or swollen nose sneezing cough heartburn (reflux diseases)
Slovenian: Zelo pogosti neželeni učinki, o katerih so poročali pri dojenčkih (starih od 1 do 6 mesecev), so: otekle veke vznemirjenost visok krvni tlak zmanjšan mišični tonus težave z dihanjem sopenje bledica zamašen ali otekel nos kihanje kašelj zgaga (refluksna bolezen)
English: The other ingredients are trisodium citrate dihydrate (see section 2 under ‘KANUMA contains sodium'), citric acid monohydrate, human serum albumin, and water for injections.
Slovenian: Druge sestavine zdravila so trinatrijev citrat dihidrat (glejte poglavje 2 pod "Zdravilo KANUMA vsebuje natrij"), citronska kislina monohidrat, humani serumski albumin in voda za injekcije.
English: Four (4) of 65 patients in the open label period were dose escalated to 3 mg/kg once every other week based on clinical response.
Slovenian: Štirim (4) bolnikom od 65 je bil v odprtem obdobju odmerek povečan na 3 mg/kg vsak drugi teden glede na klinični odziv.
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.
Slovenian: Če zdravila ne uporabite takoj, lahko razredčeno zdravilo hranite do 24 ur pri 2 °C do 8 °C ali do 12 ur pod 25 °C.
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).
Slovenian: To zdravilo vsebuje 33 mg natrija na vialo in se daje v natrijevem kloridu 9 mg/ml (0,9%) raztopini za infundiranje (glejte poglavje 6.6).
English: Patients received sebelipase alfa at 0.35 mg/kg once weekly for the first 2 weeks and then 1 mg/kg once weekly.
Slovenian: Bolniki so prva 2 tedna dobivali sebelipazo alfa v odmerku 0,35 mg/kg enkrat na teden, nato pa 1 mg/kg enkrat na teden.
English: Transient hyperlipidaemia
Slovenian: Prehodna hiperlipidemija
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.
Slovenian: V kliničnih študijah je 21 od 106 (20%) bolnikov, zdravljenih z zdravilom KANUMA, vključno z 9 od 14 (64%) dojenčkov in 12 od 92 (13%) otrok in odraslih, doživelo znake in simptome, ki so bili skladni ali povezani s preobčutljivostno reakcijo.
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.
Slovenian: Priporočeni začetni odmerek pri dojenčkih (< 6 mesecev starosti) s hitro napredujočim pomanjkanjem LAL je 1 mg/kg dan v obliki intravenske infuzije enkrat na teden.
English: For instructions on the preventive measures and monitoring of hypersensitivity reactions, see section 4.4.
Slovenian: Za navodila glede preventivnih ukrepov in spremljanja preobčutljivostnih reakcij glejte poglavje 4.4.
English: Based on clinical response, dose escalation to 3 mg/kg once weekly occurred as early as 1 month and up to 20 months after starting treatment at 1 mg/kg.
Slovenian: Na podlagi kliničnega odziva so odmerek zvečali na 3 mg/kg enkrat na teden že 1 mesec po začetku zdravljenja in nato do 20 mesecev po začetku zdravljenja na 1 mg/kg.
English: Because it is a recombinant human protein, sebelipase alfa is an unlikely candidate for cytochrome P450 mediated or other drug-drug interactions.
Slovenian: Ker je sebelipaza alfa rekombinantna humana beljakovina, ni verjetno, da bi bila kandidat za medsebojno delovanje z drugimi zdravili, pri katerih posreduje citokrom P450.
English: Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with sebelipase alfa; see section 4.8.
Slovenian: Pri bolnikih, zdravljenih s sebelipazo alfa, so poročali o preobčutljivostnih reakcijah, vključno z anafilakso; glejte poglavje 4.8.
English: Body temperature increased, oxygen saturation decreased, blood pressure increased, heart rate increased, respiratory rate increased a
Slovenian: Preiskave zelo pogosti zvišana telesna temperatura, zmanjšana zasičenost s kisikom, povečan krvni tlak, pospešen srčni utrip, povečana frekvenca dihanja a
English: Prior to dilution, the solution in the vials should be inspected visually; the solution should be clear to slightly opalescent, colourless to slightly coloured (yellow).
Slovenian: Pred razredčitvijo je treba raztopino v vialah pregledati s prostim očesom; raztopina mora biti bistra do nekoliko motna, brezbarvna do nekoliko obarvana.
English: It is used to treat patients of all ages with lysosomal acid lipase deficiency (LAL deficiency).
Slovenian: Uporablja se pri zdravljenju bolnikov vseh starosti s pomanjkanjem lizosomalne kisle lipaze (pomanjkanje LAL).
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.
Slovenian: Na podlagi teh podatkov se zdi, da je farmakokinetika sebelipaze alfa nelinearna in da je povečanje v izpostavljenosti večje kot bi bilo sorazmerno z odmerkom, ki so ga opazili pri odmerku 1 in 3 mg/kg.
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.
Slovenian: Neželenih izsledkov v študijah embrio-fetalnega razvoja pri podganah in kuncih pri odmerkih, ki so bili do vsaj 10-krat večji od priporočenega odmerka pri odraslih/otrocih ter študijah plodnosti in periter postnatalnega razvoja pri podganah pri odmerkih, do 10-krat večjih kot je priporočeni odmerek pri odraslih/otrocih, niso opazili.
English: Each vial of KANUMA is intended for single use only.
Slovenian: Vsaka viala zdravila KANUMA je samo za enkratno uporabo.
English: Dyslipidemia is common with elevated LDL and triglycerides and low HDL, associated with increase liver fat content and transaminase elevations.
Slovenian: Dislipidemija je pogosta pri zvišanih ravneh LDL in trigliceridov in nizki ravni HDL, kar je povezano s povečano vsebnostjo jetrnih maščob in zvišano ravnijo transaminaz.
English: You or your child may be monitored by your doctor or nurse for an additional hour after the infusion.
Slovenian: Zdravnik bo vas oziroma vašega otroka spremljal dodatno uro po infuziji.
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
Slovenian: anafilaktična reakcija okužba sečil oteklost vek začasno povečane ravni holesterola ali trigliceridov (maščob) v krvi hiter srčni utrip tesnobnost nespečnost omotica nizek krvni tlak pordelost obraza zasoplost oteklost žrela driska bolečine v trebuhu napenjanje v trebuhu siljenje na bruhanje koprivnica izpuščaj srbenje rdeča otekla koža increased povečana menstrualna krvavitev tresenje nelagodje v prsnem košu oteklina utrujenost otrdlina okoli mesta infundiranja zvišana telesna temperatura
English: From baseline to week 48, the mean reductions for ALT and AST were -34.0 U/l and -44.5 U/l, respectively.
Slovenian: Od izhodišča do 48. tedna sta se vrednosti ALT in AST povprečno zmanjšali za -34,0 e./l oz. -44,5 e./l.
English: Your doctor or nurse will give KANUMA to you or your child by an infusion (drip) into a vein.
Slovenian: Vaš zdravnik ali medicinska sestra bo zdravilo KANUMA vam oziroma vašemu otroku dal kot infuzijo v veno.
English: Lysosomal acid lipase (LAL) deficiency
Slovenian: Pomanjkanje lizosomske kisle lipaze (LAL)
English: Table 5: Recommended infusion volumes (1 mg/kg dose)* Weight range (kg)
Slovenian: Preglednica 5: Priporočena količina za infundiranje (odmerek 1 mg/kg)* Razpon telesne mase (kg)
English: You can help by reporting any side effects you or your child may get.
Slovenian: Tudi sami lahko k temu prispevate tako, da poročate o katerem koli neželenem učinku zdravila, ki bi se utegnil pojaviti pri vašem otroku.
English: Each 10 ml vial contains 33 mg sodium.
Slovenian: Ena 10 ml viala vsebuje 33 mg natrija.
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.
Slovenian: Petinšestdeset od 66 bolnikov je bilo vključenih v odprto obdobje (do 130 tednov) z odmerkom zdravila KANUMA 1 mg/kg enkrat vsak drugi teden.
English: If the infusion reaction is severe, your doctor may stop KANUMA infusion and start giving you or your child appropriate medical treatment.
Slovenian: Če je reakcija na infuzijo resna, lahko zdravnik z infundiranjem zdravila KANUMA preneha in vam oziroma vašemu otroku začne dajati ustrezna zdravila.
English: ADA titres decreased to undetectable levels during continued treatment in 3 of the 4 patients.
Slovenian: Titri ADA so se pri 3 od 4 bolnikov z nadaljevanjem zdravljenja zmanjšali do nezaznavnih ravni.
English: Reported as part of an adverse reaction in a single patient receiving KANUMA in LAL-CL02
Slovenian: O njih so poročali kot del neželenega učinka pri enem samem bolniku, ki je v študiji LAL-CL02 dobival zdravilo KANUMA