natgillin/translations-raw huggingface dataset:
It is not known whether Vimizim is excreted in breast milk.
Ni znano, ali se zdravilo Vimizim izloča v materino mleko.
Table 4: Pharmacokinetic properties
Preglednica 4: Farmakokinetične lastnosti
In clinical studies, spinal/cervical cord compression (SCC) was observed both in patients receiving Vimizim and patients receiving placebo.
V kliničnih študijah so o kompresiji hrbtenjače/vratne hrbtenice poročali pri bolnikih, ki so prejemali zdravilo Vimizim, in bolnikih, ki so prejemali placebo.
Other very common adverse reactions were diarrhoea, mouth and throat pain, dizziness and trouble breathing.
Drugi zelo pogosti neželeni učinki so driska, bolečine v ustih in grlu, omotica ter težave z dihanjem.
Total infusion volume (ml)
Skupna prostornina za infundiranje (ml)
This medicinal product contains 8 mg sodium per vial, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult, and is administered in sodium chloride 9 mg/ml (0.9%) solution for infusion (see section 6.6).
Zdravilo vsebuje 8 mg natrija na vialo, kar ustreza 0,4 % največjega dnevnega vnosa za odraslega, ki ga priporoča SZO, tj. 2 g natrija, in se daje v raztopini natrijevega klorida 9 mg/ml (0,9 %) za infuzijo (glejte poglavje 6.6).
Table 2: Adverse reactions in patients treated with Vimizim
Preglednica 2: Neželeni učinki pri bolnikih, zdravljenih z zdravilom Vimizim
Available reproductive data in animals have shown excretion of elosulfase alfa in milk.
Razpoložljivi podatki iz študij o vplivu na razmnoževanje pri živalih potrjujejo, da se elosulfaza alfa izloča v mleko.
How to store Vimizim 6.
Kako dajati zdravilo Vimizim 4.
The recommended dose is 2 mg per kg.
Priporočeni odmerek je 2 mg na kg telesne mase.
MedDRA System organ class
MedDRA organski sistem
BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork Ireland
BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork Irska
The diluted solution is to be mixed gently prior to infusion.
Razredčeno raztopino je treba pred pričetkom infuzije rahlo zmešati.
Common side effects observed was muscle pain.
Pogosti neželeni učinki, ki so jih opazili, so bile bolečine v mišicah.
The safety and efficacy of Vimizim in patients older than 65 years has not been established, and no alternative treatment regimen can be recommended in these patients.
Varnosti in učinkovitosti zdravila Vimizim pri bolnikih, starejših od 65 let, niso ugotavljali.
Diarrhoea, vomiting, oropharyngeal pain, upper abdominal pain, abdominal pain, nausea
Driska, bruhanje, orofaringealna bolečina, bolečine v zgornjem delu trebuha, bolečine v trebuhu, navzea
Each vial contains 5 mg elosulfase alfa in 5 ml of solution (1 mg/ml).
Ena viala vsebuje 5 mg elosulfaze alfa v 5 ml raztopine (1 mg/ml).
Patients should be monitored for signs and symptoms of SCC (including back pain, paralysis of limbs below the level of compression, urinary and faecal incontinence) and given appropriate clinical care.
Bolnike je treba spremljati in v primeru pojava znakov in simptomov kompresije hrbtenjače/vratne hrbtenice (vključno z bolečinami v hrbtu, paralizo okončin pod ravnjo kompresije, inkotinenco urina in blata) zagotoviti ustrezno klinično nego.
Reproduction studies have been performed in rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or reproductive performance.
Študije o vplivu na razmnoževanje pri podganah z do 10-krat večjimi odmerki kot pri človeku niso pokazale vpliva na plodnost ali sposobnost razmnoževanja.
The recommended dose of elosulfase alfa is 2 mg/kg of body weight administered once a week.
Priporočeni odmerek elosulfaze alfa je 2 mg/kg telesne mase enkrat tedensko.
The assessment of adverse reactions is based on the exposure of 176 patients with MPS IVA, ages 5 to 57 years old to 2 mg/kg elosulfase alfa once a week (n=58), 2 mg/kg elosulfase alfa once every other week (n=59), or placebo (n=59) in a randomised, double-blind, placebo-controlled study.
Vrednotenje neželenih učinkov temelji na izpostavitvi 176 bolnikov z MPS IVA, starih od 5 do 57 let, elosulfazi alfa v odmerku 2 mg/kg enkrat tedensko (n = 58), elosulfazi alfa v odmerku 2 mg/kg vsak drug teden (n = 59) ali odmerku placeba (n = 59) v randomizirani, dvojno slepi in s placebom nadzorovani študiji.
* Infusion rate may be increased as tolerated by patient.
* Hitrost infundiranja lahko povečate glede na toleranco bolnika.
The other ingredients are: sodium acetate trihydrate, sodium dihydrogen phosphate monohydrate, arginine hydrochloride, sorbitol, polysorbate 20, and water for injections (see section 2 under ‘Vimizim contains sodium and sorbitol (E420)').
Druge sestavine zdravila so natrijev acetat trihidrat, natrijev dihidrogenfosfat monohidrat, argininijev klorid, sorbitol, polisorbat 20 in voda za injekcije (glejte poglavje 2 »Zdravilo Vimizim vsebuje natrij in sorbitol (E 420)«).
The sulfatase activity deficiency results in the accumulation of the GAG substrates, KS and chondroitin 6 sulphate (C6S), in the lysosomal compartment of cells throughout the body.
Zmanjšana dejavnost sulfataze vodi v kopičenje substratov GAG, KS in hondroitin-6-sulfata (C6S) v lizosomih, ki so prisotni v celicah telesa.
If severe IRs occur, immediately stop the infusion and initiate appropriate treatment.
Če se pojavijo hude z infuzijo povezane reakcije, je treba takoj prenehati z infundiranjem in uvesti ustrezno zdravljenje.
PHARMACEUTICAL FORM Concentrate for solution for infusion (Sterile concentrate).
Zdravilo Vimizim je na voljo v obliki koncentrata za raztopino za infundiranje (sterilnega koncentrata).
Do not use Vimizim if the solution is discoloured or it contains visible particles.
Ne uporabite zdravila Vimizim, če je raztopina spremeni barvo ali vsebuje vidne delce.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
The diluted solution should be used immediately.
Pripravljeno raztopino je treba nemudoma porabiti.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology evaluating central nervous, respiratory and cardiovascular systems, single-dose and repeated-dose toxicity in rats and monkeys or fertility and embryo-foetal development in rats or rabbits.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti vpliva na centralni živčni sistem, dihalni sistem in srčno-žilni sistem ter toksičnosti posameznega odmerka in ponavljajočih se odmerkov pri podganah in opicah ali vpliva na plodnost in razvoj zarodka/ploda pri podganah ali kuncih ne kažejo posebnega tveganja za človeka.
An infusion set equipped with an in-line 0.2 μm filter can be used.
Uporabite lahko infuzijski komplet, opremljen z 0,2-µm linijskim filtrom.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg elosulfase alfa*.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 1 mg elosulfaze alfa*.
• Patient weight (kg) multiplied by 2 (mg/kg) = Patient dose (mg)
• Bolnikova telesna masa (kg), pomnožena z vrednostjo 2 (mg/kg) = odmerek za bolnika
No correlations were found between higher antibody titres or neutralizing antibody positivity and reductions in efficacy measurements or occurrence of anaphylaxis or other hypersensitivity reactions.
Korelacije med višjimi titri protiteles ali prisotnostjo nevtralizirajočih protiteles in zmanjšanjem v meritvah učinkovitosti ali pojavom anafilakse ali drugih preobčutljivostnih reakcij niso opazili.
The recommended dose regimen for adults and children is 2 mg/kg body weight given once every week through a drip into a vein (intravenous infusion).
Priporočeni odmerek za odrasle in otroke je 2 mg/kg telesne mase enkrat tedensko, dan prek infuzije v žilo (z intravensko infuzijo).
Symptoms of allergic reaction include rash, itching or hives on the skin (seen commonly - may affect up to 1 in 10 people).
Simptomi alergijskih reakcij so bili izpuščaj, srbečica ali koprivnica (pogosti - lahko se pojavijo pri največ 1 od 10 oseb).
The baseline mean (±SD) normalised standing height z-score was - 1.6 (±1.61).
Ob izhodišču je bil povprečen (±SD) normaliziran z-rezultat stojne višine -1,6 (±1,61).
Enzyme uptake by cells into lysosomes is mediated by cation independent mannose-6-phosphate receptors leading to restored GALNS activity and clearance of KS and C6S.
Privzem encimov v lizosome celic omogočajo od kationov neodvisni receptorji za manozo-6-fosfat, kar vodi v obnovitev dejavnosti GALNS ter očistek substratov KS in C6S.
Other medicines and Vimizim Please tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
This medicinal product contains 100 mg sorbitol in each vial which is equivalent to 40 mg/kg.
Zdravilo vsebuje 100 mg sorbitola na vialo, kar ustreza 40 mg/kg.
concentrate for solution for infusion 1 vial
koncentrat za raztopino za infundiranje 1 viala
A total of 173 patients subsequently enrolled in an extension study in which patients received 2 mg/kg of elosulfase alfa every week or 2 mg/kg every other week, and then all were switched to 2 mg/kg every week upon availability of the Week 24 results.
Skupaj 173 bolnikov je bilo nato vključenih v podaljšanje študije, v katerem so bolniki vsak teden prejemali elosulfazo alfa v odmerku 2 mg/kg telesne mase ali vsak drugi teden v odmerku 2 mg/kg telesne mase, ko pa so bili na voljo rezultati v 24. tednu, so vsi bolniki prejemali zdravilo v odmerku 2 mg/kg telesne mase enkrat tedensko.
This medicine contains 100 mg sorbitol in each 5 ml vial which is equivalent to 40 mg/kg.
To zdravilo vsebuje 100 mg sorbitola v eni 5-ml viali, kar je enako 40 mg/kg.
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2C - 8C followed by up to 24 hours at 23C - 27C.
Fizikalna in kemijska obstojnost za uporabo pripravljene raztopine je bila dokazana za obdobje 24 ur pri temperaturi od 2 °C-8 °C in nadalje za največ 24 ur pri temperaturi od 23 °C-27 °C.
It is used to treat adults and children with mucopolysaccharidosis type IVA (MPS IVA disease, also known as Morquio A Syndrome).
Uporablja se za zdravljenje bolezni mukopolisaharidoza tipa IVA (bolezen MPS IVA, znana tudi pod imenom Morquijev sindrom tipa A) pri odraslih in otrocih.
Impact of antibodies on elosulfase alfa pharmacokinetics was assessed.
Ovrednoten je bil učinek protiteles na farmakokinetiko elosulfaze alfa.
The recommended dose regimen is 2 mg/kg body weight administered once every week through a drip into a vein (by intravenous infusion).
Priporočeni odmerek je 2 mg/kg telesne mase enkrat tedensko prek infuzije v žilo (z intravensko infuzijo).
The results from the every other week regimen in the distance walked in 6 minutes or in stairs climbed per minute were comparable to placebo.
Rezultati v razdalji, prehojeni v šestminutnem testu hoje, in številu stopnic, prehojenih v eni minuti, za skupino, ki je prejemala zdravilo vsak drugi teden, so primerljivi z rezultati skupine, ki je prejemala placebo.
Clear glass vial (Type I) with a butyl rubber stopper and a flip-off crimp seal (aluminium) with a plastic cap.
Viala iz prozornega stekla (tipa I) z zamaškom iz butilne gume ter aluminijasto dvižno zaporko s plastičnim pokrovčkom.
At Week 104 mean (±SD) normalised standing height z-score was -3.1 (±
104. teden pa je bil povprečni (±SD) normalizirani z-rezultat stojne višine -3,1 (±1,13).
No association was apparent between the total antibody titre and elosulfase clearance.
Med celokupnim titrom protiteles in očistkom elosulfaze ni bilo očitne povezave.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vimizim 1 mg/ml sterile concentrate elosulfase alfa
IME ZDRAVILA IN POT(I) UPORABE Vimizim 1 mg/ml sterilni koncentrat elosulfaza alfa i.v.
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
• the calculation of the dose and of the volume of infusion
• izračun odmerkov in prostornine infuzije,
Patients who could walk more than 30 meters (m) but less than 325 m in a 6 Minute Walk Test (MWT) at baseline were enrolled in the study.
V študijo so bili vključeni bolniki, ki so v šestminutnem testu hoje na začetku zdravljenja lahko prehodili več kot 30 metrov (m) in manj kot 325 metrov (m).
Elosulfase alfa is intended to provide the exogenous enzyme N-acetylgalactosamine-6-sulfatase that will be taken up into the lysosomes and increase the catabolism of the GAGs KS and C6S.
Elosulfaza alfa je namenjena proizvodnji eksogenega encima N-acetilgalaktozamin-6sulfataza, ki preide v lizosome in povečuje razgradnjo substratov GAG, KS in C6S.
Infusion rate may be increased as tolerated by patient.
Hitrost infundiranja lahko povečate glede na toleranco bolnika.
Vimizim 1 mg/ml concentrate for solution for infusion elosulfase alfa
Vimizim 1 mg/ml koncentrat za raztopino za infundiranje elosulfaza alfa
The modelled treatment effect for the percent change in urine KS, compared to placebo, was -40.7 % (CI95, -49.0, -32.4; p<0.0001) for the 2 mg/kg per week regimen.
Modelirani učinek zdravljenja v deležu spremembe ravni KS v urinu je v primerjavi s placebom znašal -40,7 % (IZ95, -49,0, -32,4; p < 0,0001) pri odmerku 2 mg/kg telesne mase enkrat na teden.
Very common side effects include symptoms of infusion reactions such as headache, nausea, fever, chills and stomach ache.
Zelo pogosti neželeni učinki so z infuzijo povezani simptomi, kot so glavobol, siljenje na bruhanje, povišana telesna temperatura, mrzlica in bolečine v trebuhu.
The number of vials to be diluted is based on the individual patient's weight.
Število vial, ki jih je treba razredčiti, se določi na podlagi bolnikove telesne mase.
Therefore, appropriate medical support must be readily available when elosulfase alfa is administered.
Zato je pri dajanju elosulfaze alfa potrebna takojšnja razpoložljivost ustrezne zdravniške pomoči.
Patients received elosulfase alfa 2 mg/kg every week (n=58) or 2 mg/kg every other week (n=59), or placebo (n=59) for a total of 24 weeks.
Bolniki so skupaj 24 tednov prejemali elosulfazo alfa bodisi vsak teden v odmerku 2 mg/kg telesne mase (n = 58) bodisi vsak drugi teden v odmerku 2 mg/kg telesne mase (n = 59) ali pa so prejemali placebo (n = 59).
Sodium acetate trihydrate Sodium dihydrogen phosphate monohydrate Arginine hydrochloride Sorbitol (E 420)
Natrijev acetat trihidrat natrijev dihidrogenfosfat monohidrat argininijev klorid sorbitol (E 420) polisorbat 20 voda za injekcije
Infusion reactions
Z infuzijo povezane reakcije
Vimizim is slowly added to the infusion bag using care to avoid agitation.
Zdravilo Vimizim je treba počasi in previdno dodajati v infuzijsko vrečko, da se prepreči pretresanje.
The secondary endpoints were the change from baseline in the 3 Minute Stair Climb Test (MSCT) and urine KS levels at Week 24.
Sekundarna opazovana dogodka sta bili sprememba v številu prehojenih stopnic v triminutnem testu hoje po stopnicah in raven keratansulfata v urinu v 24. tednu glede na izhodišče.
Renal elimination of elosulfase alfa is considered a minor pathway for clearance.
Izločanje skozi ledvice velja za manj pomembno pot očistka elosulfaze alfa.
The Vimizim solution should be clear to slightly opalescent and colourless to pale yellow.
Raztopina zdravila Vimizim mora biti bistra do rahlo opalescentna in brezbarvna do bledo rumena.
Serious IRs were observed in clinical studies and included anaphylaxis, hypersensitivity and vomiting.
Med resnimi, z infuzijo povezanimi reakcijami, ki so jih opazili v kliničnih študijah, so bili anafilaksa, preobčutljivost in bruhanje.
All patients developed antibodies to elosulfase alfa in clinical studies.
V kliničnih študijah so vsi bolniki razvili protitelesa proti elosulfazi alfa.
• Patient dose (mg) divided by 1 (mg/ml concentrate of Vimizim) = Total number of ml of
• Odmerek za bolnika (mg), deljen z 1 (mg/ml koncentrata zdravila Vimizim) = skupna količina zdravila Vimizim v ml
The primary endpoint was the change from baseline in the 6 MWT distance compared to placebo at Week 24.
Primarni opazovani dogodek je bila sprememba v razdalji, prehojeni v šestminutnem testu hoje, v 24. tednu glede na izhodišče in v primerjavi s placebom.
The difference was greatest between the placebo group and the weekly treatment group for all endpoints.
V vseh kazalcih učinkovitosti je bila razlika največja med skupino, ki je prejemala placebo, in skupino, ki je prejemala zdravilo enkrat tedensko.
What Vimizim contains
Kaj vsebuje zdravilo Vimizim
The modelled treatment effect in stairs climbed per minute, compared to placebo, was 1.1 stairs/minute (CI95, -2.1, 4.4; p=0.4935) for the 2 mg/kg per week regimen.
Modelirani učinek zdravljenja v smislu števila stopnic, prehojenih v eni minuti, v primerjavi s placebom, je bil 1,1 stopnice/minuto (IZ95, -2,1, 4,4; p = 0,4935) pri odmerku 2 mg/kg telesne mase enkrat na teden.
The active substance is elosulfase alfa.
Zdravilna učinkovina je elosulfaza alfa.
Management of IRs should be based on the severity of the reaction and include slowing or temporary interruption of the infusion and/or administration of additional antihistamines, antipyretics, and/or corticosteroids.
Če se pojavijo z infuzijo povezane reakcije, je treba glede na njihovo izraženost ustrezno zmanjšati hitrost infundiranja, začasno prekiniti infundiranje in/ali dodati antihistaminike, antipiretike in/ali kortikosteroide.
• the calculation of the infusion rate
• izračun hitrosti infuzije,
Sustained improvements in efficacy measures and reductions in urine keratan sulphate (KS) over time were observed across studies, despite the presence of anti elosulfase alfa antibodies.
Med študijami so bila kljub prisotnosti protiteles proti elosulfazi alfa sčasoma opažena trajna izboljšanja v meritvah učinkovitosti in znižanju ravni keratansulfata (KS) v urinu.
Vimizim must be diluted prior to administration.
Zdravilo Vimizim je treba pred dajanjem razredčiti.
Each ml of concentrate contains 1 mg elosulfase alfa.
En ml koncentrata vsebuje 1 mg elosulfaze alfa.
Administration of Vimizim should be carried out by an appropriately trained healthcare professional with the ability to manage medical emergencies.
Zdravilo Vimizim da bolniku ustrezno usposobljen zdravstveni delavec, ki je usposobljen tudi za nudenje nujne medicinske pomoči.
NAME OF THE MEDICINAL PRODUCT Vimizim 1 mg/ml concentrate for solution for infusion
IME ZDRAVILA Vimizim 1 mg/ml koncentrat za raztopino za infundiranje
Respiratory, thoracic, and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
• Total amount (ml) Vimizim divided by 5 ml per vial = Total number of vials 2.
• Skupna količina (ml) zdravila Vimizim, deljena s 5 ml na vialo = skupno število vial 2.
Intravenous use after dilution
intravenska uporaba po redčenju
How to store Vimizim
Kako dajati zdravilo Vimizim
Before withdrawing Vimizim from the vial, each vial is visually inspected for particulate matter and discoloration.
Preden povlečete zdravilo Vimizim iz viale, morate vsako vialo pregledati in preveriti, ali so v njej delci in ali je raztopina spremeni barvo.
The modelled treatment effect in the distance walked in 6 minutes, compared to placebo, was 22.5 m (CI95, 4.0, 40.9; p=0.0174) for the 2 mg/kg per week regimen.
Modelirani učinek zdravljenja v smislu razdalje, prehojene v šestminutnem testu hoje, v primerjavi s placebom, je bil 22,5 m (IZ95, 4,0, 40,9; p = 0,0174) pri odmerku 2 mg/kg telesne mase enkrat na teden.
The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles.
V bistrem do rahlo opalescentnem in brezbarvnem do bledo rumenem koncentratu ne sme biti vidnih delcev.
Home administration under the supervision of an appropriately trained healthcare professional may be considered for patients who are tolerating their infusions well.
Pri bolnikih, ki infuzijo dobro prenašajo, je možno razmisliti o dajanju zdravila doma pod nadzorom ustrezno usposobljenega zdravstvenega delavca.
• Total amount (ml) Vimizim divided by 5 ml per vial = Total number of vials
• Skupna količina (ml) zdravila Vimizim, deljena s 5 ml na vialo = skupno število vial
Pack sizes: 1 vial of 5 ml
Velikosti pakiranja: 1 5-ml viala
Preparation of the Vimizim infusion (Use aseptic technique)
Priprava raztopine zdravila Vimizim za infundiranje (po aseptičnem postopku)
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi, oznaka ATC:A16AB12.
The majority of adverse reactions in clinical studies were IRs, which are defined as reactions occurring after initiation of infusion until the end of the day following the infusion.
Te so opredeljene kot reakcije, ki se pojavijo po začetku infundiranja in trajajo do konca naslednjega dne po infundiranju.
Because of the potential for hypersensitivity reactions with elosulfase alfa, patients should receive antihistamines with or without antipyretics 30 to 60 minutes prior to start of infusion (see section 4.4).
30 do 60 minut pred začetkom infuzije morajo bolniki prejeti antihistaminike z antipiretiki ali brez njih, saj obstaja možnost za pojav preobčutljivostnih reakcij, povezanih z infundiranjem elosulfaze alfa (glejte poglavje 4.4).
Diluted Vimizim solution is to be administered to patients using an infusion set.
Razredčena raztopina zdravila Vimizim se daje bolnikom z infuzijskim kompletom.
When diluted with 250 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion; the initial rate will be 6 ml/hr.
Če je zdravilo razredčeno z 250 ml natrijevega klorida 9 mg/ml (0,9 %), mora biti začetna hitrost infundiranja 6 ml/uro.
Patients weighing less than 25 kg should receive a total volume of 100 ml.
Bolniki, ki tehtajo manj kot 25 kg, morajo prejeti skupno prostornino 100 ml.
When diluted in 250 ml, the initial infusion rate should be 6 ml/hr.
Če je zdravilo razredčeno z 250 ml vehikla, mora biti začetna hitrost infundiranja 6 ml/uro.
* One patient in the Vimizim group dropped out after 1 infusion ‡ Model-based mean of Vimizim versus placebo, adjusted for baseline
* En bolnik iz skupine, ki je prejemala zdravilo Vimizim, je po prvi infuziji odstopil od preskušanja.
This medicine contains 8 mg sodium (main component of cooking/table salt) in each 5 ml vial.
Zdravilo Vimizim vsebuje natrij in sorbitol (E 420) To zdravilo vsebuje 8 mg natrija (glavna sestavina kuhinjske/namizne soli) v eni 5-ml viali.
Each vial of 5 ml contains 5 mg elosulfase alfa.
Ena 5ml viala vsebuje 5 mg elosulfaze alfa.
The clear to slightly opalescent and colourless to pale yellow solution must be free of visible particles.
Bistra do rahlo opalescentna in brezbarvna do bledo rumena raztopina mora biti brez vidnih delcev.
• Patients weighing less than 25 kg should receive a total volume of 100 ml.
• Bolniki, ki tehtajo manj kot 25 kg, morajo prejeti skupno prostornino 100 ml.
No accumulation of elosulfase alfa in plasma was evident following weekly dosing
Po odmerjanju enkrat tedensko ni bilo opaziti kopičenja elosulfaze alfa v plazmi.
The diluted solution is administered to patients using an infusion set.
Razredčena raztopina se daje bolnikom z uporabo infuzijskega kompleta.
It is not known if Vimizim impacts human fertility.
Vpliv zdravila Vimizim na plodnost pri ljudeh ni znan.
When diluted with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion; the initial rate will be 3 ml/hr.
Če je zdravilo razredčeno s 100 ml natrijevega klorida 9 mg/ml (0,9 %), mora biti začetna hitrost infundiranja 3 ml/uro.
Do not use if the solution is discoloured or if there is particulate matter in the solution.
Raztopine ne uporabljajte, če je spremeni barvo ali če so v njej prisotni delci.
An infusion bag containing sodium chloride 9 mg/ml (0.9 %) solution for infusion is obtained suitable for intravenous administration.
Pripravi se infuzijska vrečka z raztopino natrijevega klorida 9 mg/ml (0,9 %), ki je primerna za intravensko dajanje.