natgillin/translations-raw huggingface dataset:
Generally, improvements in organ systems with a faster turnover rate, such as the haematological, can be noted far more rapidly than in those with a slower turnover, such as the bone.
Na splošno se izboljšave opazijo veliko hitreje v organskih sistemih s hitrim obnavljanjem, kot je hematološki, kot pri organskih sistemih s počasnim obnavljanjem, kot je skelet.
The natural history of Gaucher disease usually shows progression, with the risk of irreversible complications arising in various organs over time.
Anamneza Gaucherjeve bolezni navadno kaže napredovanje, tekom časa pa se lahko v različnih organih pojavi tveganje nepopravljivih zapletov.
Your doctor may test if you have an allergic reaction to imiglucerase.
Vaš zdravnik lahko testira, ali se na imiglucerazo alergijsko odzovete.
Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake: "EXP".
The usual frequency of infusion is once every 2 weeks; this is the frequency of infusion for which the most data are available.
Običajna pogostost infundiranja je enkrat na vsaka 2 tedna; večina podatkov, ki so na voljo, se nanašajo na navedeno pogostost odmerjanja.
It is recommended that Cerezyme is used immediately after it has been mixed with sterile water.
Priporoča se, da zdravilo Cerezyme uporabite takoj po tem, ko ga zmešate s sterilno vodo.
A Q4 infusion regimen may be a therapeutic option for some adult patients with stable residual Gaucher disease type 1, but clinical data are limited.
Q4 režim infundiranja lahko predstavlja možnost zdravljenja za nekatere odrasle bolnike s stabilno rezidualno Gaucherjevo boleznijo tipa 1, vendar so klinični podatki omejeni.
Signs and symptoms presenting in childhood typically represent more severe Gaucher disease.
Znaki in simptomi, ki se pojavijo v otroštvu, navadno kažejo na bolj resno obliko Gaucherjeve bolezni.
Educational materials for the use of Cerezyme in home infusion, consisting of:
Izobraževalno gradivo za infundiranje zdravila Cerezyme na domu, sestavljeno iz:
Clinically, Gaucher disease is a heterogeneous phenotypic spectrum.
Klinično je Gaucherjeva bolezen heterogeni fenotipski spekter.
No animal studies have been carried out with respect to assessing the effects of Cerezyme on pregnancy, embryonal/foetal development, parturition and postnatal development.
Študije na živalih, za oceno učinkov zdravila Cerezyme na nosečnost, razvoj zarodka/plodu, porod in postnatalni razvoj, niso bile izvedene.
The rate and extent of response to Cerezyme treatment is dose-dependent.
Stopnja in obseg odziva na zdravilo Cerezyme sta odvisna od velikosti odmerka.
Other medicines and Cerezyme
Druga zdravila in zdravilo Cerezyme
Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions (see section 4.8).
Pri bolnikih s protitelesi za imiglucerazo se poveča tveganje za preobčutljivostne reakcije (glejte poglavje 4.8).
• Manual for patients with Gaucher disease who receive home infusion;
• Priročnik za bolnike z Gaucherjevo boleznijo, ki doma prejemajo infuzije zdravila
In addition, Gaucher disease has been associated with an increased risk of immunoglobulin abnormalities such as hyperimmunoglobulinemia, polyclonal gammopathy, monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma.
Poleg tega je Gaucherjeva bolezen povezana s povišanim tveganjem za imunoglobulinske nepravilnosti, kot so hiperimunoglobulinemija, poliklonska gamopatija, monoklonska gamopatija nedoločenega pomena (monoclonal gammopathy of undetermined significance, MGUS) in multipli mielom.
Maintenance therapy every 4 weeks (Q4) at the same cumulative dose as the bi-weekly (Q2) dose has been studied in adult patients with stable residual Gaucher disease type 1.
Vzdrževalno zdravljenje na vsake 4 tedne (Q4) z enakim kumulativnim odmerkom kot pri dvotedenskem odmerku (Q2) so proučevali pri odraslih bolnikih s stabilno rezidualno Gaucherjevo boleznijo tipa 1.
Gaucher disease is associated with increased morbidity and early mortality.
Gaucherjeva bolezen je povezana z zvišano stopnjo pojavnosti bolezni in zgodnjo umrljivostjo.
It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Cerezyme after 12 months of therapy.
Kaže, da se pri bolnikih, pri katerih se protitelesa IgG razvijejo, le-ta zelo verjetno razvijejo v 6 mesecih in le redko po 12 mesecih zdravljenja.
This may contribute to skeletal disease burden in Gaucher disease.
To lahko prispeva k obremenitvi bolezni skeleta pri Gaucherjevi bolezni.
It is not known whether this active substance is excreted in human milk, however, the enzyme is likely to be digested in the child's gastrointestinal tract
Ni znano, ali se ta zdravilna učinkovina izloča v materino mleko, vendar se bo encim verjetno presnovil v otrokovih prebavilih.
Tachycardia*, cyanosis*
Tahikardija*, cianoza*
Pharmacotherapeutic group: Enzymes-Imiglucerase (recombinant macrophage targeted βglucocerebrosidase), ATC code: A16AB02.
Farmakoterapevtska skupina: Encimi - imigluceraza (rekombinantna, na makrofage usmerjena βglukocerebrozidaza), ATC koda A16AB02.
Some side effects were seen primarily while patients were being given the medicine or shortly after.
Nekateri neželeni učinki so se primarno pojavili pri bolnikih med prejemanjem zdravila ali tik po tem.
This includes an increased risk of skeletal manifestations, exacerbation of cytopenia, haemorrhage, and an increased need for transfusion.
To vključuje povečano tveganje za skeletne manifestacije, poslabšanje citopenije, krvavitve in večje potrebe po transfuziji.
Cerezyme therapy reduces the requirement for splenectomy in most cases and early treatment with Cerezyme has been associated with a reduced risk of pulmonary hypertension.
Zdravljenje z zdravilom Cerezyme zniža potrebo po izvajanju splenektomije v večini primerov, zgodnje zdravljenje z zdravilom Cerezyme pa povezujejo z znižanim tveganjem za pljučno hipertenzijo.
You can ask your doctor to register your patient information into the “ICGG Gaucher Registry”.
Register “ICGG Gaucher Registry” Zdravnika lahko prosite, da vpiše vaše podatke o bolniku v „ICGG Gaucher Registry“.
Current data using a screening ELISA followed by a confirmatory radioimmunoprecipitation assay, suggest that, during the first year of therapy, IgG antibodies to imiglucerase are formed in approximately 15% of the treated patients.
Po sedanjih podatkih, na osnovi presejalnega preizkusa ELISA, kateremu je sledil potrdilni preizkus radioimunskega obarjanja, se pri približno 15 % bolnikov prvo leto zdravljenja razvijejo protitelesa IgG za imiglucerazo.
In pregnant Gaucher patients and those intending to become pregnant, a risk-benefit treatment assessment is required for each pregnancy.
Pri nosečnicah z Gaucherjevo boleznijo in tistih, ki nameravajo zanositi, je treba oceniti tveganje in koristi zdravljenja za vsako nosečnost.
The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Informacija na teh navodilih za uporabo se nanaša na vse skupine bolnikov, vključno z otroci,
Furthermore, these data indicate no malformative toxicity for the foetus by Cerezyme, although the statistical evidence is low.
Ti podatki kažejo, da Cerezyme ne povzroča toksičnih deformacij plodu, čeprav je statističnih dokazov malo.
In women receiving Cerezyme treatment continuation throughout pregnancy should be considered.
Pri ženskah, ki prejemajo zdravilo Cerezyme, bi morali premisliti o nadaljevanju zdravljenja v času nosečnosti.
Cerezyme has been shown to improve both mental and physical aspects in the quality of life of Gaucher disease.
Izkazalo se je, da zdravilo Cerezyme izboljša duševne in fizične vidike kakovosti življenja bolnikov z Gaucherjevo boleznijo.
Rare (may affect up to 1 in 1,000 people): - anaphylactoid reactions
Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov) - anafilaktične reakcije
Gaucher disease is associated with increased glucose production and increased resting energy expenditure rate, which may contribute to fatigue and cachexia.
Gaucherjeva bolezen je povezana z zvišano tvorbo glukoze in zvišano stopnjo porabe energije v mirovanju, kar lahko prispeva k utrujenosti in kaheksiji.
The patient or caregiver will be instructed in infusion technique and the keeping of a treatment diary.
Bolnik ali njegov negovalec se bosta poučila o tehniki infuzije, vodila pa bosta tudi dnevnik zdravljenja.
During 1 hour intravenous infusions of 4 doses (7.5, 15, 30, 60 U/kg) of imiglucerase, steady-state enzymatic activity was achieved by 30 minutes.
Med enournim intravenskim infundiranjem 4 odmerkov (7,5, 15, 30 in 60 enot/kg) imigluceraze se je pojavila ravnotežna encimska aktivnost po 30 minutah.
Name and address of the manufacturer of the biological active substance Genzyme Corporation, 500 Soldiers Field Road, Allston, MA 02134, USA Lonza Biologics Inc., 101 International Drive, Portsmouth, NH 03801-2815, USA Name and address of the manufacturers 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.
500 Soldiers Field Road - Allston, MA 02134, ZDA Lonza Biologics Inc., 101 International Drive, Portsmouth, NH 03801-2815, ZDA Ime in naslov izdelovalcev, odgovornih 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 morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
Patients treated with 60 U/kg body weight every 2 weeks showed a faster improvement and a greater maximum treatment effect as compared to patients receiving the lower doses.
Pri bolnikih, ki so prejemali 60 enot/kg telesne mase na vsaka 2 tedna, je prišlo do hitrejšega izboljšanja in večjega največjega učinka zdravljenja v primerjavi z bolniki, ki so prejemali nižje odmerke.
What Cerezyme is and what it is used for.
Kaj je zdravilo Cerezyme in za kaj ga uporabljamo
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.
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.
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.
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.
In Gaucher disease glucosylceramide levels can get too high.
Pri Gaucherjevi bolezni so lahko ravni glukozilceramida previsoke.
Patients who have undergone a splenectomy have an increased risk of pulmonary hypertension.
Pri bolnikih z izvedeno splenektomijo je prisotno povišano tveganje za pljučno hipertenzijo.
* 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.
*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.
Patients experiencing adverse events during the infusion need to immediately stop the infusion process and seek the attention of a healthcare professional.
Bolniki, ki doživijo neželene dogodke med infuzijo, naj takoj prekinejo z infundiranjem ter poiščejo pomoč zdravstvenega osebja.
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.
Redko poročajo o smrti plodu, vendar ni jasno ali v povezavi z uporabo zdravila Cerezyme ali z osnovno Gaucherjevo boleznijo.
At subsequent administrations, infusion rate may be increased but should not exceed 1 unit per kg body weight per minute.
Pri nadaljnjih infuzijah zdravila Cerezyme se lahko hitrost zviša, vendar naj ne preseže 1 enote na kg telesne mase na minuto.
Instructions for proper use Cerezyme is given through a drip into a vein (by intravenous infusion).
Navodila za pravilno uporabo Zdravilo Cerezyme se daje kot kapalna infuzija v veno (z intravenskim infundiranjem).
If you experience any of these symptoms, please tell your doctor immediately.
Če opazite kateregakoli od teh simptom nemudoma obvestite svojega zdravnika.
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.
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.
What you need to know before you are given Cerezyme Do not use Cerezyme
Kaj morate vedeti, preden boste prejeli zdravilo Cerezyme Ne uporabljajte zdravila Cerezyme:
Cerezyme 400 U
Cerezyme 400 enot
Gaucher cells are typically found in liver, spleen and bone marrow and occasionally in lung, kidney and intestine.
Gaucherjeve celice so značilno prisotne v jetrih, vranici in kostnem mozgu ter občasno tudi v pljučih, ledvicah in črevesju.
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.
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.
Your patient data will be registered anonymously- nobody will know it is information about you.
Vaši podatki o bolniku bodo vpisani anonimno, zato teh podatkov ne bo možno povezati z vami.
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).
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).
Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Bolnice, ki imajo Gaucherjevo bolezen in zanosijo, lahko med nosečnostjo in v poporodnem obdobju doživijo obdobje povečanega delovanja bolezni.
In children, Gaucher disease can lead to growth retardation and delayed puberty.
Pri otrocih lahko Gaucherjeva bolezen vodi do upočasnjene rasti in zapoznele pubertete.
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.
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.
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.
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.
Onset of such symptoms has occurred during or shortly after infusions.
Takšni simptomi so se začeli med infundiranjem ali kmalu po njem.
The reconstituted volume is 10.6 ml.
Volumen pripravljene raztopine je 10,6 ml.
Cerezyme contains no preservatives.
Zdravilo Cerezyme ne vsebuje konzervansov.
Imiglucerase (recombinant macrophage targeted acid ß-glucosidase) replaces the deficient enzyme activity, hydrolysing glucosylceramide, thus correcting initial pathophysiology and preventing secondary pathology.
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.
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).
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.
The pH of the reconstituted solution is approximately 6.1.
Njen pH je približno 6,1.
The reconstituted volume is 5.3 ml.
Volumen pripravljene raztopine je 5,3 ml.
Dose and infusion rate should remain constant while at home, and not be changed without supervision of a health care professional.
Odmerek in hitrost infuzije naj doma ostaneta enaka, spreminjata se lahko le pod nadzorom zdravstvenega osebja.
The recommended dose is 60 units/kg body weight given once every 2 weeks.
Priporočen odmerek je 60 enot/kg telesne mase enkrat vsaka 2 tedna.
There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease.
Ni podatkov o učinku zdravila Cerezyme na simptome, povezane z možgani, pri bolnikih s kronično nevronopatsko Gaucherjevo boleznijo.
It is not known whether Cerezyme passes via the placenta to the developing foetus.
Ni znano, ali zdravilo Cerezyme prehaja preko placente do razvijajočega plodu.
This enzyme breaks down glucosylceramide, a key component of the lipid structure of cell membranes, into glucose and ceramide.
Navedeni encim razgradi glukozilceramid, ki je ključna sestavina lipidne strukture celičnih membran, v glukozo in ceramid.
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.
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.
For storage conditions after dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja raztopljenega zdravila glejte poglavje 6.3.
Routine evaluation to detect the presence of pulmonary hypertension after diagnosis of Gaucher disease and over time is recommended.
Priporočajo se redni pregledi za ugotovitev prisotnosti pljučne hipertenzije takoj po diagnozi Gaucherjeve bolezni in pozneje.
Cerezyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.
Zdravilo Cerezyme se uporablja samo pod nadzorom zdravnika, ki je ustrezno usposobljen za zdravljenje Gaucherjeve bolezni.
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).
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).
The aims of this Registry are to increase the understanding of Gaucher disease and to check how well enzyme replacement therapy, like Cerezyme, works.
Namen registra je izboljšati razumevanje Gaucherjeve bolezni in preveriti učinkovitost delovanja encimske nadomestne terapije, kot je na primer Cerezyme.
Cerezyme reduces resting energy expenditure rate.
Cerezyme zniža stopnjo porabe energije v mirovanju.
MARKETING AUTHORISATION NUMBERS
ŠTEVILKE DOVOLJENJA ZA PROMET
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.
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.
- The active substance is imiglucerase.
- Zdravilna učinkovina je imigluceraza.
If you experience a reaction like this, you should tell your doctor immediately.
Če se take reakcije pojavijo, to nemudoma sporočite svojemu zdravniku.
At initial infusions, Cerezyme should be administered at a rate not exceeding 0.5 unit per kg body weight per minute.
Pri začetnih infuzijah zdravila Cerezyme naj hitrost ne presega 0,5 enot na kg telesne mase na minuto.
Cerezyme 200 U
Cerezyme 200 enot
After reconstitution it is a clear, colourless liquid, free from foreign matter.
Po rekonstituciji je tekočina čista in brezbarvna, brez primesi.
Both pregnancy and lactation are known to stress maternal calcium homeostasis and to accelerate bone turnover.
Tako za nosečnost kot za dojenje je znano, da povzročata motnje v homeostazi kalcija pri materah in pospešujeta spremembe v kosteh.
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.
(≥1/100 do <1/10), občasni (≥1/1.000 do <1/100) in redki (≥1/10.000 to <1/1.000)).
This enzyme helps the body control levels of glucosylceramide.
pomočjo tega encima telo nadzira ravni glukozilceramida.
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.
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.
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).
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.
If a patient experiences a reaction suggestive of hypersensitivity, subsequent testing for imiglucerase antibodies is advised.
Če doživi bolnik reakcijo, ki opozarja na preobčutljivost, je priporočljivo izvesti test za odkrivanje protiteles za imiglucerazo.
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.
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.