FrancophonIA/ELRC3.0 huggingface dataset:
English: In children, Cerezyme has been shown to enable normal pubertal development, and to induce catch-up growth, leading to normal height and bone mineral density in adulthood.
Slovenian: Izkazalo se je, da zdravilo Cerezyme pri otrocih omogoča normalni razvoj v puberteti in povzroči dohitevanje rasti, kar vodi do normalne višine in mineralne gostote kosti pri odraslih.
English: The mixed solution in the vial cannot be stored and should be promptly diluted in an infusion bag; only the diluted solution can be held for up to 24 hours if it is kept cool (2°C - 8°C) and in the dark.
Slovenian: Zmešane raztopine v viali ni možno hraniti in jo je treba takoj razredčiti v infuzijski vrečki; samo razredčeno raztopino je možno hraniti do 24 ur v hladnem (2 °C - 8 °C) in temnem prostoru.
English: In Gaucher disease glucosylceramide levels can get too high.
Slovenian: Pri Gaucherjevi bolezni so lahko ravni glukozilceramida previsoke.
English: Patients who have undergone a splenectomy have an increased risk of pulmonary hypertension.
Slovenian: Pri bolnikih z izvedeno splenektomijo je prisotno povišano tveganje za pljučno hipertenzijo.
English: * An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β-D-glucopyranoside (pNP-Glc) per minute at 37°C.
Slovenian: *1 enota encima (e.) je količina encima, ki v 1 minuti katalizira hidrolizo 1 mikromola sintetičnega substrata para-nitrofenil β-D-glukopiranozida (pNP-Glc) pri temperaturi 37 °C.
English: Patients experiencing adverse events during the infusion need to immediately stop the infusion process and seek the attention of a healthcare professional.
Slovenian: Bolniki, ki doživijo neželene dogodke med infuzijo, naj takoj prekinejo z infundiranjem ter poiščejo pomoč zdravstvenega osebja.
English: Foetal demise has been reported rarely, although it is not clear whether this related to the use of Cerezyme or to the underlying Gaucher disease.
Slovenian: Redko poročajo o smrti plodu, vendar ni jasno ali v povezavi z uporabo zdravila Cerezyme ali z osnovno Gaucherjevo boleznijo.
English: At subsequent administrations, infusion rate may be increased but should not exceed 1 unit per kg body weight per minute.
Slovenian: Pri nadaljnjih infuzijah zdravila Cerezyme se lahko hitrost zviša, vendar naj ne preseže 1 enote na kg telesne mase na minuto.
English: Instructions for proper use Cerezyme is given through a drip into a vein (by intravenous infusion).
Slovenian: Navodila za pravilno uporabo Zdravilo Cerezyme se daje kot kapalna infuzija v veno (z intravenskim infundiranjem).
English: If you experience any of these symptoms, please tell your doctor immediately.
Slovenian: Če opazite kateregakoli od teh simptom nemudoma obvestite svojega zdravnika.
English: In individuals with Gaucher disease, glucosylceramide degradation is insufficient, leading to accumulation of large quantities of this substrate within the lysosomes of macrophages (termed ‘Gaucher cells'), leading to widespread secondary pathology.
Slovenian: Pri osebah z Gaucherjevo boleznijo je razgradnja glukozilceramida nezadostna, kar povzroči kopičenje velikih količin tega substrata v lizosomih makrofagov (imenovanih „Gaucherjeve celice“), kar pripelje do razširjene sekundarne patologije.
English: What you need to know before you are given Cerezyme Do not use Cerezyme
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Cerezyme Ne uporabljajte zdravila Cerezyme:
English: Cerezyme 400 U
Slovenian: Cerezyme 400 enot
English: Gaucher cells are typically found in liver, spleen and bone marrow and occasionally in lung, kidney and intestine.
Slovenian: Gaucherjeve celice so značilno prisotne v jetrih, vranici in kostnem mozgu ter občasno tudi v pljučih, ledvicah in črevesju.
English: Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease.
Slovenian: Zdravilo Cerezyme (imigluceraza) je indicirano za dolgotrajno encimsko nadomestno zdravljenje bolnikov s potrjeno diagnozo ne-nevronopatske (tip 1) ali kronično nevronopatske (tip 3) Gaucherjeve bolezni, ki kažejo klinično pomembne ne-nevrološke manifestacije te bolezni.
English: Your patient data will be registered anonymously- nobody will know it is information about you.
Slovenian: Vaši podatki o bolniku bodo vpisani anonimno, zato teh podatkov ne bo možno povezati z vami.
English: Similarly, in an ICGG Gaucher Registry analysis of bone mineral density using dual-energy X-ray absorptiometry (DXA) in 342 patients, after 8 years of treatment normal bone mineral density was achieved with a Cerezyme dose of 60 U/kg body weight once every 2 weeks, but not with lower doses of 15 and 30 U/kg body weight once every 2 weeks (Wenstrup et al, 2007).
Slovenian: Podobno je analiza Gaucherjevega registra ICGG za mineralno gostoto kosti, z uporabo dvoenergetske rentgenske absorpciometrije (dual-energy X-ray absorptiometry, DXA) pri 342 bolnikih, pokazala, da je bila po 8-ih letih zdravljenja dosežena normalna mineralna gostota kosti z odmerkom zdravila Cerezyme v višini 60 enot/kg telesne mase enkrat na vsaka 2 tedna, vendar pa ne pri nižjih odmerkih v višini 15 in 30 enot/kg telesne mase na vsaka 2 tedna (Wenstrup et al, 2007).
English: Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Slovenian: Bolnice, ki imajo Gaucherjevo bolezen in zanosijo, lahko med nosečnostjo in v poporodnem obdobju doživijo obdobje povečanega delovanja bolezni.
English: In children, Gaucher disease can lead to growth retardation and delayed puberty.
Slovenian: Pri otrocih lahko Gaucherjeva bolezen vodi do upočasnjene rasti in zapoznele pubertete.
English: Cerezyme contains the active substance imiglucerase and is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleed easily (due to low numbers of plateletsa type of blood cell), spleen or liver enlargement or bone disease.
Slovenian: Zdravilo Cerezyme vsebuje zdravilno učinkovino imiglucerazo in se uporablja za zdravljenje bolnikov, pri katerih so potrdili diagnozo Gaucherjeve bolezni tipa 1 ali tipa 3 in ki kažejo znake bolezni, kot so: anemija (nizko število rdečih krvničk), nagnjenost h krvavitvam (zaradi nizkega števila trombocitov - vrste krvnih celic), povečanja vranice ali jeter ali bolezen kosti.
English: Due to the heterogeneity and the multi-systemic nature of Gaucher disease, dosage should be individualised for each patient based on a comprehensive evaluation of all clinical manifestations of the disease.
Slovenian: Odmerjanje Zaradi genske raznolikosti Gaucherjeve bolezni in obolelosti več telesnih sistemov moramo odmerjanje individualno prilagajati za vsakega bolnika glede na celovito oceno vseh kliničnih simptomov bolezni.
English: Onset of such symptoms has occurred during or shortly after infusions.
Slovenian: Takšni simptomi so se začeli med infundiranjem ali kmalu po njem.
English: The reconstituted volume is 10.6 ml.
Slovenian: Volumen pripravljene raztopine je 10,6 ml.
English: Cerezyme contains no preservatives.
Slovenian: Zdravilo Cerezyme ne vsebuje konzervansov.
English: Imiglucerase (recombinant macrophage targeted acid ß-glucosidase) replaces the deficient enzyme activity, hydrolysing glucosylceramide, thus correcting initial pathophysiology and preventing secondary pathology.
Slovenian: Imigluceraza (rekombinantna, na makrofage usmerjena kisla β-glukozidaza) nadomesti nezadostno encimsko aktivnost tako, da hidrolizira glukozilceramid ter s tem popravi prvotno patološko fiziologijo in prepreči sekundarno patologijo.
English: Eighty-nine percent of Q4- and 100% of Q2-treated patients met the therapeutic goals-based endpoint; the difference was not statistically significant based on the 95% CI (-0.231, 0.060).
Slovenian: Devetinosemdeset odstotkov od Q4- in 100 % od Q2-zdravljenih bolnikov je doseglo na ciljih zdravljenja temelječo končno točko; razlika na osnovi 95 % IZ (-0.231, 0.060) ni bila statistično značilna.
English: The pH of the reconstituted solution is approximately 6.1.
Slovenian: Njen pH je približno 6,1.
English: The reconstituted volume is 5.3 ml.
Slovenian: Volumen pripravljene raztopine je 5,3 ml.
English: Dose and infusion rate should remain constant while at home, and not be changed without supervision of a health care professional.
Slovenian: Odmerek in hitrost infuzije naj doma ostaneta enaka, spreminjata se lahko le pod nadzorom zdravstvenega osebja.
English: The recommended dose is 60 units/kg body weight given once every 2 weeks.
Slovenian: Priporočen odmerek je 60 enot/kg telesne mase enkrat vsaka 2 tedna.
English: There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease.
Slovenian: Ni podatkov o učinku zdravila Cerezyme na simptome, povezane z možgani, pri bolnikih s kronično nevronopatsko Gaucherjevo boleznijo.
English: It is not known whether Cerezyme passes via the placenta to the developing foetus.
Slovenian: Ni znano, ali zdravilo Cerezyme prehaja preko placente do razvijajočega plodu.
English: This enzyme breaks down glucosylceramide, a key component of the lipid structure of cell membranes, into glucose and ceramide.
Slovenian: Navedeni encim razgradi glukozilceramid, ki je ključna sestavina lipidne strukture celičnih membran, v glukozo in ceramid.
English: Cerezyme is an artificial enzyme called imiglucerase - this can replace the natural enzyme acid β-glucosidase which is lacking or not active enough in patients with Gaucher disease.
Slovenian: Cerezyme je umetni encim, ki se imenuje imigluceraza in lahko nadomesti naravni encim kisla β-glukozidaza, ki pri bolnikih z Gaucherjevo boleznijo manjka ali pa ni dovolj aktiven.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja raztopljenega zdravila glejte poglavje 6.3.
English: Routine evaluation to detect the presence of pulmonary hypertension after diagnosis of Gaucher disease and over time is recommended.
Slovenian: Priporočajo se redni pregledi za ugotovitev prisotnosti pljučne hipertenzije takoj po diagnozi Gaucherjeve bolezni in pozneje.
English: Cerezyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.
Slovenian: Zdravilo Cerezyme se uporablja samo pod nadzorom zdravnika, ki je ustrezno usposobljen za zdravljenje Gaucherjeve bolezni.
English: The volume of distribution corrected for weight ranged from 0.09 to 0.15 l/kg (mean ± S.D 0.12 ± 0.02 l/kg).
Slovenian: Telesni masi prilagojen volumen porazdelitve je bil v območju 0,09 do 0,15 l/kg (srednja vrednost ± SD 0,12 ± 0,02 l/kg).
English: The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works.
Slovenian: Namen registra je izboljšati razumevanje Gaucherjeve bolezni in preveriti učinkovitost delovanja encimske nadomestne terapije, kot je na primer Cerezyme.
English: Cerezyme reduces resting energy expenditure rate.
Slovenian: Cerezyme zniža stopnjo porabe energije v mirovanju.
English: MARKETING AUTHORISATION NUMBERS
Slovenian: ŠTEVILKE DOVOLJENJA ZA PROMET
English: Administration of doses as low as 15 U/kg of body weight once every 2 weeks has been shown to improve haematological parameters and organomegaly, but not bone parameters.
Slovenian: Zdravljenje z zelo majhnimi odmerki, po 15 enot/kg telesne mase enkrat vsaka 2 tedna, je zboljšalo hematološke parametre in organomegalijo, ne pa tudi kostnih parametrov.
English: - The active substance is imiglucerase.
Slovenian: - Zdravilna učinkovina je imigluceraza.
English: If you experience a reaction like this, you should tell your doctor immediately.
Slovenian: Če se take reakcije pojavijo, to nemudoma sporočite svojemu zdravniku.
English: At initial infusions, Cerezyme should be administered at a rate not exceeding 0.5 unit per kg body weight per minute.
Slovenian: Pri začetnih infuzijah zdravila Cerezyme naj hitrost ne presega 0,5 enot na kg telesne mase na minuto.
English: Cerezyme 200 U
Slovenian: Cerezyme 200 enot
English: After reconstitution it is a clear, colourless liquid, free from foreign matter.
Slovenian: Po rekonstituciji je tekočina čista in brezbarvna, brez primesi.
English: Both pregnancy and lactation are known to stress maternal calcium homeostasis and to accelerate bone turnover.
Slovenian: Tako za nosečnost kot za dojenje je znano, da povzročata motnje v homeostazi kalcija pri materah in pospešujeta spremembe v kosteh.
English: Adverse reactions are listed by system organ class and frequency (common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)) in the table below.
Slovenian: (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100) in redki (≥1/10.000 to <1/1.000)).
English: This enzyme helps the body control levels of glucosylceramide.
Slovenian: pomočjo tega encima telo nadzira ravni glukozilceramida.
English: If not used immediately, in-use storage and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C under protection from light.
Slovenian: V nasprotnem primeru uporabnik sam prevzame odgovornost za hranjenje med uporabo in pogoje pred uporabo - čas hranjenja naj ne bo daljši od 24 ur pri temperaturi 2°C - 8°C zaščiteno pred svetlobo.
English: Sixty-three percent of Q4- and 81% of Q2treated patients met the composite endpoint at Month 24; the difference was not statistically significant based on the 95% CI (-0.357, 0.058).
Slovenian: Triinšestdeset odstotkov Q4- in 81 % od Q2-zdravljenih bolnikov je doseglo sestavljeno končno točko v 24. mesecu; razlika na osnovi 95 % IZ (-0.357, 0.958) ni bila statistično značilna.
English: If a patient experiences a reaction suggestive of hypersensitivity, subsequent testing for imiglucerase antibodies is advised.
Slovenian: Če doživi bolnik reakcijo, ki opozarja na preobčutljivost, je priporočljivo izvesti test za odkrivanje protiteles za imiglucerazo.
English: Talk to your doctor or pharmacist before using Cerezyme: - if you are treated with Cerezyme, you may experience an allergic reaction while you are being given the medicine or shortly after.
Slovenian: Pred začetkom uporabe zdravila Cerezyme se posvetujte z zdravnikom ali farmacevtom: - Pri prejemanju zdravila Cerezyme se lahko pojavijo alergijske reakcije med ali tik po prejemu zdravila.
English: ** Imiglucerase is a modified form of human acid β-glucosidase and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture, with mannose modification for targeting macrophages.
Slovenian: ** Imigluceraza je modificirana oblika humanega encima kisla β-glukozidaza in je proizvedena s tehnologijo rekombinantne DNK iz celične kulture jajčnika kitajskega hrčka (Chinese Hamster Ovary,
English: Imiglucerase is a modified form of the human enzyme acid β-glucosidase produced by recombinant DNA technology.
Slovenian: Imigluceraza je modificirana oblika humanega encima kisla β-glukozidaza, proizvedena z rekombinantno tehnologijo DNK.
English: These skeletal manifestations include bone marrow infiltration, osteonecrosis, bone pain and bone crises, osteopenia and osteoporosis, pathological fractures, and growth impairment.
Slovenian: Le-te vključujejo infiltracijo kostnega mozga, osteonekrozo, bolečine v kosteh in kostne krize, osteopenijo in osteoporozo, patološke zlome in motnje rasti.
English: People with Gaucher disease have low levels of an enzyme called acid β-glucosidase.
Slovenian: Ljudje z Gaucherjevo boleznijo imajo nizko raven encima, ki se imenuje kisla β-glukozidaza.
English: Dizziness, headache, paraesthesia*
Slovenian: Omotica, glavobol, parestezija*
English: Patients who have developed antibodies or symptoms of hypersensitivity to Ceredase (alglucerase) should be treated with caution when administering Cerezyme (imiglucerase).
Slovenian: Pri bolnikih, pri katerih so se v preteklosti razvila protitelesa za zdravilo Ceredase (alglucerazo) ali preobčutljivost zanj, je potrebna previdnost, kadar jim predpišemo zdravljenje z zdravilom Cerezyme (imiglucerazo).
English: These have included itching, flushing, hives/localised swelling of the skin or lining of the mouth or throat, chest discomfort, increased heart rate, bluish skin, breathlessness, a sensation of tingling, pricking, burning or numbness of the skin, fall in blood pressure and backache.
Slovenian: Zajemajo srbenje, oblivanje, izpuščaj/lokalno oteklost kože ali obloženost ust ali grla, nelagodje v prsih, povišan srčni utrip, modrikavo kožo, zasoplost, občutek zbadanja, ščemenja, skelenja ali otopelosti kože, padec krvnega pritiska in bolečine v hrbtu.
English: It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles.
Slovenian: Priporočljivo je, da razredčeno raztopino dajete skozi 0,2 µm filter v cevni liniji za vezanje proteinov z nizko molekulsko maso, s katerim odstranite vse proteinske delce.
English: Pulmonary hypertension is a known complication of Gaucher disease.
Slovenian: Pljučna hipertenzija je znan zaplet pri Gaucherjevi bolezni.
English: In patients dosages up to 240 U/kg body weight once every two weeks have been used.
Slovenian: Bolniki so prejemali odmerke do 240 enot/kg telesne mase enkrat na vsaka dva tedna.
English: Contents of the pack and other information What Cerezyme contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Cerezyme
English: What Cerezyme looks like and contents of the pack
Slovenian: Izgled zdravila Cerezyme in vsebina pakiranja
English: EU/1/97/053/001 Cerezyme 200 Units 1 vial of powder for concentrate for solution for infusion EU/1/97/053/002 Cerezyme 200 Units 25 vials of powder for concentrate for solution for infusion EU/1/97/053/003 Cerezyme 400 Units 1 vial of powder for concentrate for solution for infusion EU/1/97/053/004 Cerezyme 400 Units 5 vials of powder for concentrate for solution for infusion EU/1/97/053/005 Cerezyme 400 Units 25 vials of powder for concentrate for solution for infusion
Slovenian: EU/1/97/053/001 Cerezyme 200 enot 1 viala praška za koncentrat za raztopino za infundiranje EU/1/97/053/002 Cerezyme 200 enot 25 vial praška za koncentrat za raztopino za infundiranje EU/1/97/053/003 Cerezyme 400 enot 1 viala praška za koncentrat za raztopino za infundiranje EU/1/97/053/004 Cerezyme 400 enot 5 vial praška za koncentrat za raztopino za infundiranje EU/1/97/053/005 Cerezyme 400 enot 25 vial praška za koncentrat za raztopino za infundiranje
English: Your dose will be specific to you.
Slovenian: Odmerek bo prilagojen vam.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem in ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Pack sizes: 1, 5 or 25 vials per carton.
Slovenian: Velikosti pakiranja: 1, 5 ali 25 vial v škatli iz kartona.
English: This should lead to improvement in the safe and effective use of Cerezyme.
Slovenian: Na ta način se lahko izboljša varnost in učinkovitost uporabe zdravila Cerezyme.
English: Changes from baseline in hemoglobin, platelets, liver and spleen volumes, bone crisis, and bone disease comprised a predefined composite endpoint; achievement or maintenance of established Gaucher disease therapeutic goals for the hematologic and visceral parameters comprised an additional endpoint.
Slovenian: Sestavljena končna točka je zajemala spremembe osnovnih vrednosti hemoglobina, trombocitov, volumnov jeter in vranice, kostnih kriz in kostne bolezni; dodatna končna točka je zajemala doseganje ali vzdrževanje ciljev zdravljenja ustaljene Gaucherjeve bolezni v hematoloških in visceralnih parametrih.
English: Cerezyme reduces spleen and liver size, improves or normalises thrombocytopenia and anaemia, improves or normalises bone mineral density and bone marrow burden, and reduces or eliminates bone pain and bone crises.
Slovenian: izboljša ali normalizira trombocitopenijo in anemijo, izboljša ali normalizira mineralno gostoto kosti in obremenitev kostnega mozga ter zniža ali odstrani bolečine v kosteh in kostne krize.
English: Dosages may be rounded to the nearest full vial, as long as the monthly administered dosage remains substantially unaltered.
Slovenian: Odmerke lahko zaokrožite na najbližjo vsebnost polne viale, kadar sprememba bistveno ne vpliva na odmerek, ki ga bolnik prejme v enem mesecu.
English: Anaphylactoid reactions
Slovenian: Preobčutljivostne reakcije
English: The objectives of the “ICGG Gaucher Registry” are to enhance the understanding of Gaucher disease and to evaluate the effectiveness of enzyme replacement therapy, ultimately leading to improvement in the safe and efficacious use of Cerezyme.
Slovenian: Cilj registra je izboljšanje razumevanja Gaucherjeve bolezni in ocenitev učinkovitosti encimsko nadomestnega zdravljenja, in posledično izboljšanje varne in učinkovite uporabe zdravila Cerezyme.
English: Use Aseptic Technique
Slovenian: Uporabljajte aseptično tehniko Priprava raztopine
English: • hepatomegaly or splenomegaly
Slovenian: • hepatomegalija ali splenomegalija.
English: Urticaria/angioedema*, pruritus*, rash*
Slovenian: Bolezni kože in podkožja Urtikarija/angioedem*, pruritus*, izpuščaj*
English: Cautious use of Cerezyme during pregnancy and breastfeeding is recommended.
Slovenian: Med nosečnostjo in dojenjem je priporočljiva previdna uporaba zdravila Cerezyme.
English: Infusion of Cerezyme by the patient or caregiver at home requires training by a health care professional in a clinical setting.
Slovenian: Bolnika ali njegovega negovalca morajo pred dajanjem infuzije zdravila Cerezyme doma za to usposobiti zdravstveni strokovnjaki v kliničnem okolju.
English: Plasma clearance ranged from 9.8 to 20.3 ml/min/kg, (mean ± S.D, 14.5 ± 4.0 ml/min/kg).
Slovenian: 20,3 ml/min/kg (srednja vrednost ± SD 14,5 ± 4,0 ml/min/kg).
English: Infusion rate increases should occur under supervision of a health care professional.
Slovenian: Zviševanje hitrosti infundiranja naj nadzoruje strokovni zdravstveni delavec.
English: EU/1/97/053/001 1 vial of powder for concentrate for solution for infusion EU/1/97/053/002 25 vials of powder for concentrate for solution for infusion
Slovenian: EU/1/97/053/001 1 viala praška za koncentrat za raztopino za infundiranje EU/1/97/053/002 25 vial praška za koncentrat za raztopino za infundiranje
English: If you have missed an infusion, please contact your doctor.
Slovenian: Če ste izpustili infuzijo, se posvetujte s svojim zdravnikom.
English: Cerezyme decreases chitotriosidase, a biomarker for glucosylceramide accumulation in macrophages and response to treatment.
Slovenian: Zdravilo Cerezyme zniža vrednosti hitotriozidaze, ki je biološki označevalec za kopičenje glukozilceramida v makrofagih in za odziv na zdravljenje.
English: It is suggested that patients suspected of a decreased response to the treatment be monitored periodically for IgG antibody formation to imiglucerase.
Slovenian: Priporočamo, da pri bolnikih, pri katerih sumite na slabši odziv na zdravljenje, občasno preverjate nastajanje protiteles IgG proti imiglucerazi.
English: Pack sizes: 1 or 25 vials per carton.
Slovenian: Velikosti pakiranja: 1 ali 25 vial v škatli iz kartona.
English: After reconstitution and dilution, the preparation is administered by intravenous infusion.
Slovenian: Način uporabe Po rekonstituciji in razredčitvi (se pripravek aplicira z intravenskim infundiranjem.