natgillin/translations-raw huggingface dataset:
The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Vimizim are provided with an Educational pack.
Imetnik dovoljenja za promet mora zagotoviti, da bodo do takrat, ko bo dal zdravilo na trg, vsi zdravstveni delavci, za katere je pričakovati, da bodo uporabljali in/ali predpisovali zdravilo Vimizim, prejeli izobraževalni paket.
Table 1: Recommended infusion volumes and rates*
Preglednica 1: Priporočene količine in hitrosti infundiranja*
(CI95, 4.0, 40.9) (p = 0.0174)
(IZ95, 4,0, 40,9) (p = 0,0174)
The educational material for Healthcare Professionals should be a step by step dosing and administration guide that includes information on the following key elements:
• izobraževalno gradivo za zdravstvene delavce Izobraževalno gradivo za zdravstvene delavce mora biti navodilo za postopno odmerjanje in dajanje, ki vključuje informacije o naslednjih ključnih elementih:
The European Medicines Agency has deferred the obligation to submit the results of studies with Vimizim in one or more subsets of the paediatric population in MPS IVA.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Vimizim za eno ali več podskupin pediatrične populacije z boleznijo MPS IVA.
The majority of patients who received Vimizim during clinical studies were in the paediatric and adolescent age range (5 to 17 years).
Večina bolnikov, ki je med kliničnimi študijami prejela zdravilo Vimizim, je bila v pediatričnem ali adolescentnem starostnem obdobju (od 5 do 17 let).
There are no data on the use of Vimizim in pregnant women.
Podatkov o uporabi zdravila Vimizim pri nosečnicah ni.
(CI95, -2.1, 4.4) (p = 0.4935)
(IZ95, -2,1, 4,4) (p = 0,4935)
Your doctor may also give you additional medicines to manage any allergic reactions (e.g. antihistamines and/or corticosteroids).
Zdravnik vam tudi lahko uvede dodatna zdravila za obvladovanje vseh alergijskih reakcij (npr. antihistaminike in/ali kortikosteroide).
The total volume of the infusion should be delivered over approximately 4 hours (see Table 1).
Celoten odmerek za infundiranje se da v približno 4 urah (glejte preglednico 1).
Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.
Bolnikom z dedno intoleranco na fruktozo (HFI - hereditary fructose intolerance) ne smete dajati tega zdravila, razen če je nujno potrebno.
Pack sizes: 1 vial
Velikost pakiranja: 1 viala
However, patients with positive neutralizing antibodies responses had decreased total clearance (CL) values and prolonged t1/2.
Vendar se je pri bolnikih s pozitivnimi odzivi nevtralizirajočih protiteles zmanjšala skupna vrednost očistka (CL) in čas t1/2 se je podaljšal.
Treatment has been shown to improve walking and to reduce the levels of keratan sulphate in the body.
Zdravilo dokazano izboljša hojo in zniža raven keratansulfata v telesu.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryofoetal development (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na nosečnost ali razvoj zarodka/plodu (glejte poglavje 5.3).
N 58 6-Minute walk test (meters) Mean SD
N 58 Šestminutni test hoje (metri) Povprečje ± SD
What Vimizim is and what it is used for
Kaj je zdravilo Vimizim in za kaj ga uporabljamo
An infusion reaction is any side effect, including an allergic reaction, occurring during the infusion or within a day following infusion (see section 4).
Z infuzijo povezana reakcija je vsak neželeni učinek, vključno z alergijsko reakcijo, ki se pojavi med infundiranjem ali v enem dnevu po prejemu infuzije (glejte poglavje 4).
A detailed history with regard to HFI symptoms has to be taken for each patient prior to being given this medicinal product.
Pri vsakem bolniku je treba pred dajanjem tega zdravila vzeti podrobno anamnezo glede simptomov HFI.
If you experience such a reaction, you should immediately contact your doctor.
Če opazite tako reakcijo, takoj obvestite zdravnika.
The appropriate number of vials is removed from the refrigerator.
Iz hladilnika vzemite ustrezno število vial.
The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator in advance in order to allow them to reach 23C - 27C.
Število vial, ki jih je treba razredčiti, se določi na podlagi bolnikove telesne mase in vnaprej vzame iz hladilnika, da lahko do priprave dosežejo temperaturo 23 °C-27 °C.
You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Preden boste dobili zdravilo, morate zdravniku povedati, če imate vi (ali vaš otrok) HFI ali če vaš otrok ne sme več uživati sladke hrane ali pijače, ker mu je slabo, bruha ali ima neprijetne neželene učinke, kot so napenjanje, želodčni krči ali driska.
The safety and efficacy of Vimizim was assessed in a randomised, double-blind, placebo-controlled, Phase 3 clinical study of 176 patients with MPS IVA, ranging in age from 5 to 57 years.
Varnost in učinkovitost zdravila Vimizim sta bili ocenjeni v randomizirani, dvojno slepi, s placebom nadzorovani klinični študiji 3. faze pri 176 bolnikih z MPS IVA, starih od 5 do 57 let.
Model-based mean‡ (95%CI) p-value
Modelirano povprečje‡ (95 % IZ) vrednost p
What you need to know before you are given Vimizim 3.
Kaj morate vedeti, preden boste dobili zdravilo Vimizim 3.
The evaluation of the peri- and postnatal development study in rats is hampered due to subsequent administration of DPH, and therefore of limited relevance.
Vrednotenje v študiji peri- in postanatalnega razvoja pri podganah je oteženo zaradi nadaljnjega dajanja difenhidramina (DPH) in zato nima velikega pomena.
It is not known whether elosulfase alfa is excreted in human breast milk, but systemic exposure via breast milk is not expected.
Ni znano, ali se tudi pri ljudeh elosulfaza alfa izloča v materino mleko, vendar sistemska izpostavljenost pri dojenju ni pričakovana.
Despite the alteration of the pharmacokinetics profile, presence of neutralizing antibodies did not affect pharmacodynamics, efficacy, or safety of the patients who were treated with elosulfase alfa.
Kljub spremembam profila farmakokinetike prisotnost nevtralizirajočih protiteles ne vpliva na farmakodinamiko, učinkovitost ali varnost pri bolnikih, ki se zdravijo z elosulfazo alfa.
Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with elosulfase alfa.
Dolgotrajne študije na živalih, ki bi ovrednotile rakotvorni potencial, ali študije, ki bi ovrednotile mutageni potencial elosulfaze alfa, niso bile izvedene.
The infusion bag is gently rotated to ensure proper distribution of Vimizim.
Infuzijsko vrečko je treba rahlo zasukati, da se zagotovi ustrezna porazdelitev zdravila Vimizim.
The primary and secondary endpoints were evaluated at Week 24 (see Table 3).
Primarni in sekundarni opazovani dogodki so bili ovrednoteni 24. teden po začetku zdravljenja (glejte preglednico 3).
Re-administration after a severe reaction should be carried out with caution and close monitoring by the treating physician.
Vnovično dajanje po pojavu hudih reakcij je treba opraviti previdno in lečeči zdravnik ga mora natančno spremljati.
You must not receive Vimizim - if you have experienced life-threatening allergic reactions to elosulfase alfa or any of the other ingredients of this medicine (listed in section 6).
Ne smete prejeti zdravila Vimizim: - če ste imeli življenjsko nevarno alergijsko reakcijo na elosulfazo alfa ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
From a microbiological safety point of view, the diluted solution should be used immediately.
Vendar je z mikrobiološkega stališča treba pripravljeno raztopino uporabiti takoj.
Pharmacokinetic parameter
Farkamokinetični parameter
The dose you receive is based on your body weight.
Odmerek, ki ga prejmete, se določi na podlagi vaše telesne mase.
Table 3: Results from placebo-controlled clinical study at 2 mg per kg per week
Preglednica 3: Rezultati s placebom nadzorovane klinične študije pri odmerku 2 mg na kg telesne mase enkrat tedensko
Warnings and precautions - If you are treated with Vimizim, you may develop infusion reactions.
Opozorila in previdnostni ukrepi - Če se zdravite z zdravilom Vimizim, se lahko pri vas razvijejo z infuzijo povezano reakcije.
Anaphylaxis and severe allergic reactions have been reported in clinical studies.
O anafilaksi in hudih alergijskih reakcijah so poročali v kliničnih študijah.
Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion reactions”).
Neželene učinke so večinoma opazili pri bolnikih med dajanjem zdravila ali kmalu po dajanju zdravila (»z infuzijo povezani neželeni učinki«).
If you experience any difficulty swallowing, talking, severe shortness of breath or wheezing, swelling of the face or lips, dizziness or weak pulse; these may represent symptoms of a severe allergic reaction and you should tell your doctor immediately.
Če opazite težave pri požiranju, govorjenju, hudo zasoplost ali sopenje, otekanje obraza ali ustnic, omotico ali šibek utrip, kar so lahko simptomi hude alergijske reakcije, o tem takoj obvestite zdravnika.
You should not receive Vimizim during pregnancy unless clearly necessary.
Zdravila Vimizim ne smete prejemati med nosečnostjo, razen če je nujno potrebno.
Dizziness was reported during Vimizim infusions; if dizziness occurs after the infusion, the ability to drive and use machines may be affected.
Med infuzijami zdravila Vimizim so poročali o omotici; če se po infuziji pojavi omotica, lahko vpliva na sposobnost vožnje in upravljanje s stroji.
No effect on fertility was observed in animals.
Pri živalih niso opazili vpliva na plodnost.
In patients < 5 years of age, the overall safety profile of Vimizim at 2 mg/kg/week was consistent with the safety profile of Vimizim observed in older children.
Pri bolnikih < 5 let starosti je bil splošni profil varnosti zdravila Vimizim pri 2 mg/kg/teden skladen s profilom varnosti zdravila Vimizim, ki so ga opazili pri starejših otrocih.
Do not heat or microwave vials.
Vial ne segrevajte v mikrovalovni pečici ali kakor koli drugače.
Each 5 ml vial contains 8 mg sodium and 100 mg sorbitol (E420).
Ena 5-mililitrska viala vsebuje 8 mg natrija in 100 mg sorbitola (E420).
Week 0 Mean (SD)
Teden 0 Povprečje (SD)
In clinical studies, doses of elosulfase alfa were explored up to 4 mg/kg per week and no specific signs or symptoms were identified following the higher doses.
V kliničnih študijah so raziskali elosulfazo alfa v odmerku do 4 mg/kg na teden in po višjih odmerkih niso ugotovili nobenih specifičnih znakov ali simptomov.
Treatment should be supervised by a physician experienced in the management of patients with MPS IVA or other inherited metabolic diseases.
Zdravljenje mora nadzorovati zdravnik z izkušnjami pri zdravljenju bolnikov s sindromom MPS IVA ali drugimi dednimi boleznimi presnove.
The treatment benefit to the child compared to the associated risks must be fully evaluated prior to treatment.
Pred zdravljenjem je treba v celoti oceniti korist zdravljenja za otroka in povezana tveganja.
IRs may include allergic reactions.
Z infuzijo povezane reakcije lahko vključujejo alergijske reakcije.
The accumulation leads to widespread cellular, tissue, and organ dysfunction.
Kopičenje vodi v široko razširjene okvare celic, tkiv in organov.
At Week 22, the mean AUC0-t and Cmax increased by 181% and 192%, respectively, when compared to Week 0
V 22. tednu se je v primerjavi s tednom 0 povprečna vrednost AUC0-t povečala za 181 % in povprečna vrednost Cmax za 192 %.
Approximately 80% of patients developed neutralizing antibodies capable of inhibiting the elosulfase alfa from binding to the cationindependent mannose-6-phosphate receptor.
Približno 80 % bolnikov je razvilo nevtralizirajoča protitelesa, ki zavirajo vezavo elosulfaze alfa na od kationov neodvisni receptor za manozo-6-fosfat.
This medicine replaces the natural enzyme N-acetylgalactosamine-6-sulfatase which is lacking in MPS IVA patients.
To zdravilo nadomešča naravni encim N-acetilgalaktozamin-6-sulfataza, ki ga bolniki z MPS IVA nimajo dovolj.
Vimizim contains an enzyme called elosulfase alfa, which belongs to a group of medicines known as enzyme replacement therapies.
Zdravilo Vimizim vsebuje encim, imenovan elosulfaza alfa, ki pripada skupini zdravil za encimsko nadomestno zdravljenje.
• Summary of Product Characteristics and Patient Information Leaflet
• povzetek glavnih značilnosti zdravila in navodilo za uporabo za bolnika
After the first 52 weeks of treatment the normalised standing height z-score was -1.9 (±1.62).
Po 52 tednih zdravljenja je bil normaliziran zrezultat stojne višine -1,9 (±1,62).
Week 22 Mean (SD)
Teden 22 Povprečje (SD)
Clinical studies performed with Vimizim assessed the impact of treatment on the systemic manifestations of MPS IVA in various domains including endurance, respiratory function, growth velocity, and mobility, as well as urine KS.
V kliničnih študijah, izvedenih z zdravilom Vimizim, so ocenjevali vpliv zdravljenja na sistemske manifestacije MPS IVA na različnih področjih, kot so vzdržljivost, dihalna funkcija, hitrost rasti, gibljivost in ravni KS v urinu.
As a precautionary measure, it is preferable to avoid the use of Vimizim during pregnancy, unless clearly necessary.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Vimizim bolje izogibati, razen če je nujno potrebna.
Anaphylaxis and severe allergic reactions
Anafilaksa in hude alergijske reakcije
What you need to know before you are given Vimizim
Kaj morate vedeti, preden boste dobili zdravilo Vimizim
Mucopolysaccharidoses comprises a group of lysosomal storage disorders caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAG).
Mukopolisaharidoza vključuje skupino motenj lizosomskega shranjevanja, ki jih povzroča pomanjkanje specifičnih lizosomskih encimov, potrebnih za razgradnjo glikozaminoglikanov (GAG).
Male and female patients had comparable elosulfase alfa clearance, and clearance did not trend with age or weight at week 22.
Bolniki in bolnice so imeli primerljiv očistek elosulfaze alfa, pri čemer se očistek v 22. tednu ni spremenil glede na starost ali telesno maso.
The most serious side effects were severe allergic reactions (seen uncommonly - may affect up to 1 in 100 people) and mild to moderate vomiting (seen very commonly - may affect more than 1 in 10 people).
Najresnejši neželeni učinki so bili hude alergijske reakcije (občasni - lahko se pojavijo pri največ 1 od 100 oseb) in blago do zmerno bruhanje (pogosti - lahko se pojavijo pri več kot 1 od 10 oseb).
Discuss with your doctor if the benefits of taking Vimizim are greater than the potential risk to your newborn while breast-feeding.
Posvetujte se z zdravnikom, ali prednosti zdravljenja z zdravilom Vimizim odtehtajo morebitno tveganje za novorojenčka med dojenjem.
Each vial of Vimizim is intended for single use only.
Vsaka viala z zdravilom Vimizim je samo za enkratno uporabo.
Your doctor or nurse will give Vimizim to you by an infusion into a vein.
Zdravilo Vimizim vam bo dal zdravnik ali sestra v obliki infuzije v veno.
Elosulfase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Elosulfaza alfa je beljakovina, zato je pričakovano, da se po presnovni poti razgradi s hidrolizo peptidov.
IRs were generally mild or moderate, and the frequency was higher during the first 12 weeks of treatment and tended to occur less frequently with time.
Z infuzijo povezane reakcije so v splošnem blage do zmerne in njihova pogostnost, ki je večja v prvih dvanajstih tednih zdravljenja, običajno sčasoma upade.
The data in Table 2 below describes adverse reactions from clinical studies in patients treated with Vimizim.
Podatki v preglednici 2 opisujejo neželene učinke iz kliničnih študij z bolniki, zdravljenimi z zdravilom Vimizim.
The medicine has to be diluted before being given.
Zdravilo je treba pred dajanjem razredčiti.
The most common symptoms of IRs (occurring in ≥ 10% of patients treated with Vimizim and ≥ 5% more when compared to placebo) were headache, nausea, vomiting, pyrexia, chills and abdominal pain.
Najpogostejši simptomi z infuzijo povezanih reakcij (ki prizadenejo ≥ 10 % bolnikov, ki prejmejo zdravilo Vimizim, in ≥ 5 % več bolnikov v primerjavi s tistimi, ki prejmejo placebo) vključujejo glavobol, navzeo, bruhanje, pireksijo, mrzlico in bolečine v trebuhu.
In an open-label study, 15 paediatric patients with MPS IVA under the age of 5 years (9 months to <5 years) received 2 mg/kg of Vimizim once a week for 52 weeks.
V odprti študiji je 15 pediatričnih bolnikov z MPS IVA, starih manj kot 5 let (9 mesecev do < 5 let), 52 tednov prejemalo 2 mg/kg zdravila Vimizim enkrat na teden.
- If you experience back pain, numbness in your arms or legs, or lack of control over passing urine or stools, you should immediately contact your doctor.
- Če se pri vas pojavijo bolečine v hrbtu, otrplost v rokah ali nogah ali nenadzorovano izločanje urina ali blata, morate o tem takoj obvestiti zdravnika.
Consequently, impaired liver function is not expected to affect the pharmacokinetics of elosulfase alfa.
Posledično se ne pričakuje, da bi okvarjeno delovanje jeter vplivalo na farmakokinetiko elosulfaze alfa.
MPS IVA is characterised by the absence or marked reduction in N-acetylgalactosamine-6-sulfatase activity.
Za MPS IVA sta značilna odsotnost ali bistveno zmanjšanje dejavnosti N-acetilgalaktozamin-6sulfataze.
In additional extension studies, patients receiving elosulfase alfa 2 mg/kg every week, showed maintenance of initial improvement in endurance and sustained reduction of urinary KS up to 156 weeks.
V dodatnih podaljšanjih študije so pri bolnikih, ki so vsak teden prejemali elosulfazo alfa v odmerku 2 mg/kg telesne mase, opazili ohranjanje začetnega izboljšanja vzdržljivosti in trajanje znižanja ravni KS v urinu do 156 tednov.
All patients were treated with antihistamines prior to each infusion.
Vsi bolniki so pred vsakim infundiranjem prejeli antihistaminike.
*Elosulfase alfa is a recombinant form of human N-acetylgalactosamine-6-sulfatase (rhGALNS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology.
*Elosulfaza alfa je rekombinantna oblika humane N-acetilgalaktozamin-6-sulfataze (rhGALNS) in je izdelana z rekombinantno DNA-tehnologijo z uporabo celične kulture ovarijskih celic kitajskega hrčka.
Tmax, minute¶ * AUC0-t, area under the plasma concentration-time curve from time zero to the time of last measurable concentration; † Cmax, observed maximum plasma concentration; ‡ CL, total clearance of elosulfase alfa after intravenous administration; § t1/2, elimination half-life; ¶ Tmax, time from zero to maximum plasma concentration
AUC0-t, minute • µg/ml* Cmax, µg/ml† CL, ml/minuto/kg‡ t1/2, minute§ Tmax, minute¶ * AUC0-t, površina pod krivuljo koncentracije v plazmi v odvisnosti od časa od ničelne vrednosti časa do zadnje merjene koncentracije; † Cmax, zabeležena najvišja koncentracija v plazmi; ‡ CL, celokupni očistek elosulfaze alfa po intravenskem dajanju; § t1/2, razpolovni čas izločanja; ¶ Tmax, čas od ničelne koncentracije v plazmi do najvišje koncentracije v plazmi.
For patients who have experienced allergic reactions during infusion, caution should be exercised upon re-administration.
Pri bolnikih, ki so med infundiranjem zdravila doživeli alergijsko reakcijo, je potrebna previdnost pri ponovnem dajanju.
Patients should receive antihistamines with or without antipyretics prior to infusion (see section 4.2).
Bolniki morajo pred infundiranjem prejeti antihistaminike z antipiretiki ali brez njih (glejte poglavje 4.2).
Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.
Zdravilo Vimizim je indicirano za zdravljenje mukopolisaharidoze tipa IVA (Morquijev sindrom tipa A, MPS IVA) pri bolnikih vseh starosti.
For instructions for dilution of the medicinal product prior to administration, see section 6.6.
Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 6.6.
Vimizim has minor influence on the ability to drive and use machines.
Zdravilo Vimizim ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
If these reactions occur, immediately stop the infusion and initiate appropriate medical treatment.
Če se pojavijo te reakcije, takoj prenehajte z infundiranjem in uvedite ustrezno zdravljenje.
They accumulate in the tissues interfering with their normal function and causing the symptoms of MPS IVA, such as difficulty walking, trouble breathing, short height, and hearing loss.
Tako se nabirajo v tkivih in ovirajo njihovo normalno delovanje ter povzročajo simptome bolezni MPS IVA, kot so otežena hoja in dihanje, nizka telesna višina in izguba sluha.
Step 1 Initial infusion rate 0-15 minutes (ml/hr)
1. korak Začetna stopnja infundiranja 0-15 minut (ml/uro)
Due to lack of human data, Vimizim should only be administered to breast-feeding woman if the potential benefit is considered to outweigh the potential risk to the infant.
Zaradi pomanjkanja podatkov pri ljudeh se sme zdravilo Vimizim dajati doječim materam samo takrat, kadar prednosti zdravljenja matere odtehtajo morebitno tveganje za dojenčka.
The number of vials to be diluted based on the individual patient's weight and the recommended dose of 2 mg/kg is determined, using the following calculation:
Število vial, ki jih je treba razredčiti, se določi na podlagi bolnikove telesne mase in priporočenega odmerka 2 mg na kg telesne mase z naslednjim izračunom:
The pharmacokinetic parameters of elosulfase alfa were evaluated in 23 patients with MPS IVA who received weekly intravenous infusions of 2 mg/kg of elosulfase alfa over approximately 4 hours for 22 weeks and the parameters at Week 0 and Week 22 were compared.
Farmakokinetične parametre elosulfaze alfa so ovrednotili pri 23 bolnikih z MPS IVA, ki so 22 tednov enkrat tedensko prejemali 2 mg elosulfaze alfa/kg telesne mase v obliki približno 4-urne intravenske infuzije, pri čemer so primerjali parametre v tednih 0 in 22.
Based on the severity of the side effect, your doctor may slow or temporarily interrupt the infusion and/ or give you additional medicines to reduce the effects of a severe allergic reaction (e.g. antihistamines and/or corticosteroids) or to reduce fever (antipyretics).
Glede na resnost neželenega učinka bo zdravnik morda upočasnil ali začasno prekinil infuzijo in/ali vam dal dodatna zdravila, ki bodo zmanjšala hudo alergijsko reakcijo (npr. antihistaminike in/ali kortikosteroide) ali znižala povišano telesno temperaturo (antipiretike).
IgE antibodies against elosulfase alfa were detected in ≤ 10% of treated patients and have not consistently been related to anaphylaxis or other hypersensitivity reactions and/or treatment withdrawal.
Pri ≤ 10 % zdravljenih bolnikov so odkrili protitelesa IgE proti elosulfazi alfa, ki pa niso bila dosledno povezana z anafilakso ali drugimi preobčutljivostnimi reakcijami in/ali prenehanjem zdravljenja.
The total volume of the infusion is determined by the patient's body weight.
Skupna količina infuzije se določi na podlagi bolnikove telesne mase.
The calculated volume of Vimizim from the appropriate number of vials is slowly withdrawn using caution to avoid excessive agitation.
Izračunano prostornino zdravila Vimizim je treba počasi in previdno povleči iz ustreznega števila vial, da se prepreči čezmerno pretresanje.
Life-threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Življenjsko nevarna preobčutljivost (anafilaktična reakcija) na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).
No impairment of fertility has been observed in nonclinical studies (see section 5.3) with elosulfase alfa.
V nekliničnih študijah z elosulfazo alfa zmanjšanje plodnosti ni bilo opaženo (glejte poglavje 5.3).