FrancophonIA/ELRC3.0 huggingface dataset:
English: o Serious and severe infections secondary to the appearance of NAb may occur.
Slovenian: o Zaradi nevtralizirajočih protiteles se lahko pojavijo resne in hude okužbe.
English: • a glass ampoule
Slovenian: • stekleni ampuli
English: After IV administration, metreleptin clearance was shown to be 79.6 mL/kg/h in healthy volunteers.
Slovenian: dajanju metreleptina je bilo izločanje metreleptina pri zdravih prostovoljcih
English: ● back of the upper arm
Slovenian: • zadnja stran nadlahti.
English: “Instructions for Use” (section 7) for more information on reading and using the different syringes.
Slovenian: Več informacij o odčitanju in uporabi različnih brizg najdete v "priročniku za uporabo"
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI
English: o The need of compliance with treatment due to the risk of pancreatitis when medication is abruptly stopped.
Slovenian: *Globalne izkušnje po začetku trženja zdravila Akutni pankreatitis zaradi prekinitve jemanja metreleptina
English: 0.120 mL 0.12 mL
Slovenian: 0,120 ml
English: 21 gauge 40 mm needle Myalepta 5.8 mg powder for solution for injection 3.0 mL
Slovenian: Myalepta 3 mg prašek za raztopino za injiciranje Myalepta 5,8 mg prašek za raztopino za injiciranje Myalepta 11,3 mg prašek za raztopino za injiciranje
English: Needle gauge and length Myalepta dose range to be administered
Slovenian: Razpon odmerka zdravila Myalepta za uporabo
English: o T-cell lymphoma - Acquired LDs are associated with autoimmune disorders.
Slovenian: - Pridobljene lipodistrofije so povezane z avtoimunskimi boleznimi.
English: B. PACKAGE LEAFLET
Slovenian: Prelomna točka
English: 0.228 mL 0.22 mL
Slovenian: 0,228 ml
English: Among 15 patients in the partial LD subgroup who had a baseline TG level 5.65 mmol/L or greater and data available at Month 12, the mean (SD) baseline triglyceride level was 27.6 mmol/L (32.88) and the mean percent reduction in TGs at Month 12 was 53.7%.
Slovenian: P SD = standardna deviacija Med 15 bolniki v podskupini s parcialno LD, ki so imeli izhodiščno raven TG 5,65 mmol/l ali več in po 12 mesecih razpoložljive podatke, je bila povprečna (SD) izhodiščna raven trigliceridov
English: The efficacy and safety of treatment with metreleptin was evaluated in an open-label, single-arm study (Study NIH 991265/20010769) in patients with congenital or acquired generalised LD or familial or acquired partial LD.
Slovenian: (študija NIH 991265/20010769) pri bolnikih s prirojeno ali pridobljeno generalizirano LD ali familiarno ali pridobljeno parcialno LD.
English: Arthralgia, Myalgia
Slovenian: OVOJNINAH VIALA
English: Eighteen patients completed the study.
Slovenian: Osemnajst bolnikov je zaključilo študijo.
English: Over time the number of these reactions decreased.
Slovenian: Sčasoma se je število teh reakcij zmanjšalo.
English: Some of these reactions may be severe.
Slovenian: Nekatere od teh reakcij so lahko resne.
English: Not known (frequency cannot be estimated from the available data)
Slovenian: Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: 2 Both groups exceeded the minimal clinically important difference (-0.24)
Slovenian: 2 Obe skupini sta prekoračili najnižjo klinično pomembno razliko (-0,24)
English: ATC code: A16AB05.
Slovenian: Oznaka ATC: A16AB05.
English: • bluish color of the skin (due to lower levels of oxygen in the blood)
Slovenian: • modrikasta barva kože (zaradi nižjih vrednosti kisika v krvi)
English: Aldurazyme was well tolerated at both dosages.
Slovenian: Aldurazyme so dobro tolerirali pri obeh odmerkih.
English: • cold hands or feet
Slovenian: • mrzle dlani ali stopala
English: The type of IARs was similar to those seen in other clinical studies.
Slovenian: Vrste reakcij ob infuziji so bile podobne tistim, ki so jih opazili v drugih kliničnih študijah.
English: This patient tested positive for IgE.
Slovenian: Pri tem bolniku je bil test z IgE pozitiven.
English: Date of latest renewal: 10 June 2008
Slovenian: Datum prve odobritve: 10. junij 2003 Datum zadnjega podaljšanja: 10. junij 2008
English: • increased body temperature
Slovenian: • povišana telesna temperatura
English: • cold sweat, heavy sweating
Slovenian: • hladen znoj, močno znojenje
English: CHAQ/HAQ Disability Index 2
Slovenian: CHAQ/HAQ indeks invalidnosti2
English: The majority of these reactions were mild or moderate in intensity.
Slovenian: Večina teh reakcij je bila blagih ali zmernih.
English: The activity unit (U) is defined as the hydrolysis of one micromole of substrate (4-MUI) per minute.
Slovenian: Enota aktivnosti (e) je opredeljena kot hidroliza enega mikromola substrata (4-MUI) na minuto.
English: • influenza like illness
Slovenian: • gripi podobna bolezen
English: Remove the required vials from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature (below 30˚C).
Slovenian: Potrebne viale vzemite iz hladilnika približno 20 minut pred uporabo, da dosežejo sobno temperaturo (pod 30 ˚C).
English: If you are allergic (hypersensitive) to laronidase or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Če ste alergični (preobčutljivi) za laronidazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Cmax (U/ml)
Slovenian: Cmax (E/ml)
English: Cmax showed an increase over time.
Slovenian: Vrednost Cmax je sčasoma naraščala.
English: Three clinical trials were performed with Aldurazyme to assess its efficacy and safety.
Slovenian: Z zdravilom Aldurazyme so bila opravljena tri klinična preskušanja za ocenitev njegove učinkovitosti in varnosti.
English: Genotoxic and carcinogenic potential are not expected.
Slovenian: Ne pričakujemo, da bi zdravilo lahko imelo genotoksičen ali karcinogen potencial.
English: Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal/foetal development, parturition and postnatal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo na neposredne ali posredne škodljive učinke na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3.)
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: You may be given additional medication such as antihistamines and paracetamol to help prevent allergic-type reactions.
Slovenian: Lahko boste dobili dodatno zdravilo, kot so antihistaminiki ali paracetamol, za pomoč pri preprečevanju alergičnih reakcij.
English: The total volume of the administration should be delivered in approximately 3-4 hours.
Slovenian: Celoten odmerek zdravila morate prejeti v približno 3-4 urah.
English: • leakage of the drug into the surrounding tissue at the site of injection, which may cause swelling or redness
Slovenian: • prepuščanje zdravila v okoliško tkivo na mestu injiciranja, kar lahko povzroči otekanje ali rdečino
English: Patients were enrolled with a Forced Vital Capacity (FVC) less than 80% of the predicted value and had to be able to stand for 6 minutes and to walk 5 meters.
Slovenian: Sodelovali so bolniki s forsirano vitalno kapaciteto (FVC) manj kot 80 % od predvidene vrednosti ter so bili zmožni stati 6 minut in prehoditi 5 metrov.
English: Phase 3, 26 weeks of treatment compared to placebo p value Confidence interval
Slovenian: 3. faza, 26 tednov zdravljenja V primerjavi s placebom vrednost p
English: Paediatric population No dose adjustment is necessary for the paediatric population.
Slovenian: Prilagajanje odmerka za pediatrično populacijo ni potrebno.
English: In addition 60 patients in the Phase 2 and 3 studies were tested for in-vitro neutralising effects.
Slovenian: Poleg tega so bili pri 60 bolnikih v drugi in tretji fazi študije opravljeni preizkusi za in-vitro nevtralizacijske učinke.
English: 6MWT (meters)
Slovenian: 6MWT (metri)
English: The mean urinary GAG level declined by 50% at Week 13 and was reduced by 61% at the end of the study.
Slovenian: Srednja vrednost GAG v urinu se je znižala za 50 % v 13. tednu in za 61 % ob zaključku študije.
English: The clinical significance of this finding is unknown since there were no consistent relationships between IgG antibody level and clinical efficacy endpoints.
Slovenian: Ni znana klinična pomembnost teh rezultatov, ker ni bilo doslednega odnosa med vrednostjo IgG protiteles in končnimi točkami klinične učinkovitosti.
English: What Aldurazyme is and what is it used for
Slovenian: Kaj je zdravilo Aldurazyme in za kaj ga uporabljamo
English: Several patients showed an increase in height (n=7) and weight (n=3) for age Z-score.
Slovenian: Pri več bolnikih smo opazili povečano višino (n=7) in težo (n=3) za starost Zštetja.
English: Pharmacotherapeutic group: Enzymes.
Slovenian: Farmakoterapevtska skupina: encimi.
English: AUC∞ (h•U/ml) 0.930 ± 0.214 CL (ml/min/kg) 1.96 ± 0.495 Vz (l/kg)
Slovenian: AUC (h•E/ml) 0,930 ± 0,214 CL (ml/min/kg) 1,96 ± 0,495 Vz (l/kg)
English: Following 26 weeks of therapy, Aldurazyme-treated patients showed improved respiratory function and walking ability as compared to placebo as indicated below.
Slovenian: Po 26 tednih zdravljenja se je pri bolnikih, ki so prejemali zdravilo Aldurazyme, izboljšala dihalna funkcija in zmožnost hoje v primerjavi s placebom, kot je prikazano spodaj.
English: The pharmacokinetic profile in patients less than 5 years old was similar to that of older and less severely affected patients.
Slovenian: Farmakokinetični profil pri bolnikih, mlajših od 5 let, je bil podoben profilu manj prizadetih starejših bolnikov.
English: There was a rapid reduction in the excretion of urinary GAG (µg/mg creatinine) within the first 4 weeks, which was maintained through the remainder of the study.
Slovenian: Hitro znižanje v izločanju GAG v urinu (µg/mg kreatinina) se je pojavilo v roku prvih 4 tednov in se nadaljevalo do zaključka študije.
English: These reactions may be particularly severe if you have a pre-existing MPS I-related upper airway obstruction.
Slovenian: Te reakcije so lahko še posebno resne, če ste že prej imeli z MPS I povezano obstrukcijo zgornjih dihalnih poti.
English: Other side effects include the following:
Slovenian: Drugi neželeni učinki so:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le pod omejenimi pogoji in na recept (Glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: 1 The decrease in percent predicted FVC is not clinically significant over this timeframe, and absolute lung volumes continued to increase commensurate with changes in height in growing paediatric patients.
Slovenian: 1 Znižanje predvidenega odstotka FVC ni klinično pomembno v tem časovnem okviru, celotni volumen pljuč pa se je še naprej zviševal sorazmerno s spremembami v višini pediatričnih bolnikov, ki še rastejo.
English: The open label extension study showed improvement and/or maintenance of these effects up to 208 weeks in the Aldurazyme/Aldurazyme group and 182 weeks in the Placebo/Aldurazyme group as indicated in the table below.
Slovenian: Razširjena odprta študija je pokazala izboljšanje in/ali vzdrževanje navedenih učinkov do 208 tedna pri skupini, ki je prejemala Aldurazyme/Aldurazyme, in 182 tednov pri skupini, ki je prejemala placebo/Aldurazyme, kot je navedeno spodaj.
English: The occurrence of IgE antibodies was not fully explored.
Slovenian: Pojavnost protiteles IgE ni popolnoma raziskana.
English: At 182 weeks
Slovenian: vsaka 2 tedna.
English: The younger patients with the severe phenotype (< 2.5 years) and all 4 patients with the intermediate phenotype exhibited a normal rate of mental development, whereas the older patients with a severe phenotype made limited or no gains in cognition.
Slovenian: Mlajši bolniki z resnim fenotipom (< 2,5 let) in vsi 4 bolniki z vmesnim fenotipom so pokazali normalno stopnjo mentalnega razvoja, medtem ko so starejši bolniki z resnim fenotipom kazali omejen napredek ali nobenega napredka v kogniciji.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, USA Name and address of the manufacturer responsible for batch release Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, ZDA Ime in naslov izdelovalca, odgovornega za sproščanje serij Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
English: The volume of distribution decreased with continued treatment, possibly related to antibody formation and/or decreased liver volume.
Slovenian: Volumen porazdelitve se je z nadaljevanjem zdravljenja zmanjšal, kar je verjetno povezano s tvorbo protiteles in/ali pomanjšanjem jeter.
English: One study mainly assessed the safety and pharmacokinetics of Aldurazyme in patients less than 5 years old, but some efficacy measurements were included as well.
Slovenian: V eni študiji so ocenjevali predvsem varnost in farmakokinetiko zdravila Aldurazyme pri bolnikih, mlajših od 5 let, vključenih pa je bilo tudi nekaj meritev učinkovitosti.
English: Other medicines and Aldurazyme
Slovenian: Druga zdravila in zdravilo Aldurazyme
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: ADRs to Aldurazyme reported during the Phase 3 study and its extension in a total of 45 patients age 5 years and older and treated up to 4 years are listed below using the following categories of frequency: very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki zdravila Aldurazyme, o katerih so poročali v tretji fazi študije in njenem podaljšanju pri 45 bolnikih, starih 5 let in več ter zdravljenih do 4 leta, so razporejeni v spodnji preglednici po naslednjih kategorijah pogostosti: zelo pogosto (≥1/10); pogosto (≥1/100 do < 1/10), občasno (≥1/1.000 do <1/100), redko (≥1/10.000 do <1/1.000), zelo redko (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Inform your doctor if you are using medicines containing chloroquine or procaine, due to a possible risk of decreasing the action of Aldurazyme.
Slovenian: Obvestite svojega zdravnika, če jemljete zdravila s klorokvinom ali prokainom, ker obstaja možno tveganje zmanjšanja delovanja zdravila Aldurazyme.
English: All patients subsequently enrolled in an open label extension study where they all received 100 U/kg of Aldurazyme every week for an additional 3.5 years (182 weeks).
Slovenian: Pozneje so vsi bolniki sodelovali v razširjeni odprti študiji, kjer so vsi vsak teden dobivali 100 e/kg zdravila Aldurazyme dodatnih 3,5 let (182 tednov).
English: No definite benefit was shown with the higher doses over the recommended dose.
Slovenian: Niso opazili izrazitih prednosti višjih odmerkih v primerjavi s priporočenim odmerkom.
English: The safety and efficacy of Aldurazyme was assessed in a randomised, double-blind, placebo controlled, Phase 3 Study of 45 patients, ranging in age from 6 to 43 years.
Slovenian: Varnost in učinkovitost zdravila Aldurazyme je bila ocenjena v randomizirani dvojno slepi in s placebom nadzorovani tretji fazi študije na 45 bolnikih, starih od 6 do 43 let.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC,
English: Side effects were mainly seen while patients were being given the medicine or shortly after (infusionassociated reactions).
Slovenian: Neželene učinke so v glavnem opazili pri bolnikih, ko so prejeli zdravilo ali pa kmalu zatem (reakcije, povezane z infuzijo).
English: When you experience such a reaction, you should immediately contact your doctor.
Slovenian: Če doživite takšno reakcijo, morate nemudoma kontaktirati svojega zdravnika.
English: Upon study completion, all patients showed reductions in liver size and 50% (9/18) had normal liver size.
Slovenian: Po zaključku študije je bilo pri vseh bolnikih opazno zmanjšanje velikosti jeter in 50 % (9/18) je imelo normalno velika jetra.
English: Genzyme Europe B.V. - NL
Slovenian: Genzyme Europe B.V.
English: • feeling hot, feeling cold
Slovenian: • občutek vročine, občutek mraza
English: It is given to treat the non-neurological manifestations of the disease.
Slovenian: Zdravilo je namenjeno zdravljenju manifestacij bolezni, ki niso nevrološke narave.
English: To address the heterogeneity in disease manifestation across patients, using a composite endpoint that summed up clinically significant changes across five efficacy variables (percent predicted normal FVC, 6MWT distance, shoulder flexion range of motion, AHI, and visual acuity) the global response was an improvement in 26 patients (58%), no change in 10 patients (22%), and a deterioration in 9 patients (20%).
Slovenian: Heterogenost manifestacije bolezni pri bolnikih smo obravnavali z uporabo sestavljene končne vrednosti, ki je povzela klinično pomembne spremembe petih spremenljivk učinkovitosti (predvideni normalni odstotek FVC, razdalja 6 min preizkusa hoje (MWT), obseg gibanja ramena, IAH in ostrina vida); globalni odgovor je bil izboljšanje pri 26 bolnikih (58 %), brez spremembe pri 10 bolnikih (22 %) in poslabšanje pri 9 bolnikih (20 %).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 U (approximately 0.58 mg) of laronidase.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml vsebuje 100 e (približno 0,58 mg) laronidaze.
English: Four patients (three in the Phase 3 study and one in the Phase 2 study) showed marginal to low level in vitro inhibition of laronidase enzymatic activity, which did not appear to impact clinical efficacy and/or urinary GAG reduction.
Slovenian: Pri štirih bolnikih (treh iz tretje faze študije in enem iz druge faze študije) je bila opažena mejna do nizka in vitro inhibicija encimske aktivnosti laronidaze, ki ni imela očitnega vpliva na klinično učinkovitost in/ali zmanjšanje vrednosti GAG v urinu.
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.
Slovenian: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija.
English: Some of the symptoms of such a severe allergic reaction were life-threatening and included extreme difficulty breathing, swelling of the throat, low blood pressure, and low oxygen level in the body.
Slovenian: Nekateri simptomi takšne alergične reakcije so bili življenje ogrožajoči in so vključevali izjemno oteženo dihanje, otekanje žrela, nizek krvni tlak in nizko raven kisika v telesu.
English: Aldurazyme is used to treat patients with MPS I disease (Mucopolysaccharidosis I).
Slovenian: Aldurazyme se uporablja za zdravljenje bolnikov z boleznijo MPS I (mukopolisaharidoza I).
English: After intravenous infusion, laronidase is rapidly removed from the circulation and taken up by cells into lysosomes, most likely via mannose-6 phosphate receptors.
Slovenian: Po intravenski infuziji laronidaza hitro zapusti krvni obtok in celice jo zajamejo v lizosome, najverjetneje z receptorji za manozo-6-fosfat.
English: Patients treated with Aldurazyme should be closely monitored and all cases of infusion-associated reactions, delayed reactions and possible immunological reactions reported.
Slovenian: Bolnike, ki se zdravijo z zdravilom Aldurazyme, morate skrbno nadzorovati in poročati o vseh reakcijah ob infuziji, zapoznelih reakcijah ali morebitnih imunoloških reakcijah.
English: Of the 26 patients with abnormal liver volumes at pre-treatment baseline, 22 (85%) achieved a normal liver size by the end of the study.
Slovenian: Izmed 26 bolnikov z abnormalnimi volumni jeter glede na izhodiščno točko, jih je 22 (85 %) doseglo normalno velikost jeter do zaključka študije.
English: The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyse the accumulated substrate and to prevent further accumulation.
Slovenian: Osnovni cilj terapije z nadomestnimi encimi je obnovitev encimske aktivnosti na raven, ki zadošča za hidrolizo nakopičenih substratov in preprečevanje njihovega nadaljnjega kopičenja.
English: To date there are no clinical data that demonstrate any benefit on the neurological manifestations of the disorder.
Slovenian: Ni kliničnih podatkov, ki bi prikazali kakršnekoli izboljšave nevroloških manifestacij te motnje.
English: Each vial of Aldurazyme is intended for single use only.
Slovenian: Vsaka viala z zdravilom Aldurazyme je namenjena samo enkratni uporabi.
English: As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible.
Slovenian: Kot pri vseh pripravkih s proteini za intravensko uporabo obstaja možnost pojava težkih alergičnih reakcij.
English: Laronidase is a recombinant form of human α-L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Slovenian: Laronidaza je rekombinantna oblika človeške -L-iduronidaze in se proizvaja s tehnologijo rekombinacije DNA z uporabo ovarijske celične kulture kitajskih hrčkov.
English: If you are given more Aldurazyme than needed No case of overdose of Aldurazyme has been reported.
Slovenian: Če ste prejeli večji odmerek zdravila Aldurazyme, kot ga potrebujete Ni poročil o primerih prevelikega odmerjanja.
English: The majority of the related adverse events in the clinical trials were classified as infusion-associated reactions (IARs), experienced by 53% of the patients in the Phase 3 study (treated for up to 4 years) and 35% of the patients in the under 5 study (up to 1 year of treatment).
Slovenian: Večino z zdravilom povezanih neželenih dogodkov v kliničnih preskušanjih so opredelili kot reakcije, povezane z infuzijami (infusion associated reactions, IARs)), do katerih je prišlo pri 53 % bolnikov v tretji fazi študije (zdravljenje do 4 let) in 35 % bolnikov mlajših od 5 let (zdravljenje do 1 leta).
English: After intravenous administration of laronidase with an infusion time of 240 minutes and at a dose of 100 U/kg body weight pharmacokinetic properties were measured at Weeks 1, 12 and 26.
Slovenian: Po intravenski uporabi laronidaze s časom infundiranja 240 minut in z odmerkom 100 e/kg telesne mase so merili farmakokinetične lastnosti v 1., 12. in 26. tednu zdravljenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 10 VIALS, 25 VIALS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (1 VIALA, 10 VIAL, 25 VIAL)