natgillin/translations-raw huggingface dataset:
** 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.
** 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,
Imiglucerase is a modified form of the human enzyme acid β-glucosidase produced by recombinant DNA technology.
Imigluceraza je modificirana oblika humanega encima kisla β-glukozidaza, proizvedena z rekombinantno tehnologijo DNK.
These skeletal manifestations include bone marrow infiltration, osteonecrosis, bone pain and bone crises, osteopenia and osteoporosis, pathological fractures, and growth impairment.
Le-te vključujejo infiltracijo kostnega mozga, osteonekrozo, bolečine v kosteh in kostne krize, osteopenijo in osteoporozo, patološke zlome in motnje rasti.
People with Gaucher disease have low levels of an enzyme called acid β-glucosidase.
Ljudje z Gaucherjevo boleznijo imajo nizko raven encima, ki se imenuje kisla β-glukozidaza.
Dizziness, headache, paraesthesia*
Omotica, glavobol, parestezija*
Patients who have developed antibodies or symptoms of hypersensitivity to Ceredase (alglucerase) should be treated with caution when administering Cerezyme (imiglucerase).
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).
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.
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.
It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles.
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.
Pulmonary hypertension is a known complication of Gaucher disease.
Pljučna hipertenzija je znan zaplet pri Gaucherjevi bolezni.
In patients dosages up to 240 U/kg body weight once every two weeks have been used.
Bolniki so prejemali odmerke do 240 enot/kg telesne mase enkrat na vsaka dva tedna.
Contents of the pack and other information What Cerezyme contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Cerezyme
What Cerezyme looks like and contents of the pack
Izgled zdravila Cerezyme in vsebina pakiranja
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
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
Your dose will be specific to you.
Odmerek bo prilagojen vam.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem in ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Pack sizes: 1, 5 or 25 vials per carton.
Velikosti pakiranja: 1, 5 ali 25 vial v škatli iz kartona.
This should lead to improvement in the safe and effective use of Cerezyme.
Na ta način se lahko izboljša varnost in učinkovitost uporabe zdravila Cerezyme.
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.
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.
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.
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.
Dosages may be rounded to the nearest full vial, as long as the monthly administered dosage remains substantially unaltered.
Odmerke lahko zaokrožite na najbližjo vsebnost polne viale, kadar sprememba bistveno ne vpliva na odmerek, ki ga bolnik prejme v enem mesecu.
Anaphylactoid reactions
Preobčutljivostne reakcije
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.
Cilj registra je izboljšanje razumevanja Gaucherjeve bolezni in ocenitev učinkovitosti encimsko nadomestnega zdravljenja, in posledično izboljšanje varne in učinkovite uporabe zdravila Cerezyme.
Use Aseptic Technique
Uporabljajte aseptično tehniko Priprava raztopine
• hepatomegaly or splenomegaly
• hepatomegalija ali splenomegalija.
Urticaria/angioedema*, pruritus*, rash*
Bolezni kože in podkožja Urtikarija/angioedem*, pruritus*, izpuščaj*
Cautious use of Cerezyme during pregnancy and breastfeeding is recommended.
Med nosečnostjo in dojenjem je priporočljiva previdna uporaba zdravila Cerezyme.
Infusion of Cerezyme by the patient or caregiver at home requires training by a health care professional in a clinical setting.
Bolnika ali njegovega negovalca morajo pred dajanjem infuzije zdravila Cerezyme doma za to usposobiti zdravstveni strokovnjaki v kliničnem okolju.
Plasma clearance ranged from 9.8 to 20.3 ml/min/kg, (mean ± S.D, 14.5 ± 4.0 ml/min/kg).
20,3 ml/min/kg (srednja vrednost ± SD 14,5 ± 4,0 ml/min/kg).
Infusion rate increases should occur under supervision of a health care professional.
Zviševanje hitrosti infundiranja naj nadzoruje strokovni zdravstveni delavec.
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
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
If you have missed an infusion, please contact your doctor.
Če ste izpustili infuzijo, se posvetujte s svojim zdravnikom.
Cerezyme decreases chitotriosidase, a biomarker for glucosylceramide accumulation in macrophages and response to treatment.
Zdravilo Cerezyme zniža vrednosti hitotriozidaze, ki je biološki označevalec za kopičenje glukozilceramida v makrofagih in za odziv na zdravljenje.
It is suggested that patients suspected of a decreased response to the treatment be monitored periodically for IgG antibody formation to imiglucerase.
Priporočamo, da pri bolnikih, pri katerih sumite na slabši odziv na zdravljenje, občasno preverjate nastajanje protiteles IgG proti imiglucerazi.
Pack sizes: 1 or 25 vials per carton.
Velikosti pakiranja: 1 ali 25 vial v škatli iz kartona.
After reconstitution and dilution, the preparation is administered by intravenous infusion.
Način uporabe Po rekonstituciji in razredčitvi (se pripravek aplicira z intravenskim infundiranjem.
Gaucher disease is a rare recessively inherited metabolic disorder that results from a deficiency of the lysosomal enzyme acid β-glucosidase.
Mehanizem delovanja Gaucherjeva bolezen je redka, recesivno podedovana presnovna motnja, ki je posledica pomanjkanja lizosomskega encima kisla β-glukozidaza.
In an ICGG Gaucher Registry analysis of a large cohort of patients (n=528) with Gaucher disease type 1, a time- and dose-dependent effect for Cerezyme was observed for haematological and visceral parameters (platelet count, haemoglobin concentration, spleen and liver volume) within the dose range of 15, 30 and 60 U/kg body weight once every 2 weeks.
Pri analizi Gaucherjevega registra Mednarodne sodelovalne skupine za Gaucherjevo bolezen (International Collaborative Gaucher Group (ICGG) Gaucher Registry) velike skupine bolnikov (n=528) z Gaucherjevo boleznijo tipa 1, so pri hematoloških in visceralnih parametrih (število trombocitov, koncentracija hemoglobina, volumen vranice in jeter) v razponu odmerkov 15, 30 in 60
Unopened vials: Store in a refrigerator (2°C - 8°C)
Neodprte viale: Shranjujte v hladilniku (2 °C - 8 °C)
It is supplied as a powder which will be mixed with sterile water before it is given.
Na razpolago je v obliki praška, ki se pred dajanjem zmeša s sterilno vodo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 25 VIALS)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (1 VIALA, 5 VIAL, 25 VIAL)
Cerezyme, 400 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1, 5 or 25).
Cerezyme, 400 enot, je na voljo v obliki praška za koncentrat za raztopino za infundiranje (v vialah, pakiranih po 1, 5 ali 25).
But, if you suffer with any shortness of breath you should tell your doctor.
Če imate kakršnokoli obliko kratke sape, obvestite svojega zdravnika.
Mannitol, sodium citrate (to adjust pH), citric acid monohydrate (to adjust pH), polysorbate 80.
Manitol, natrijev citrat (za uravnavanje pH), citronska kislina monohidrat (za uravnavanje pH), polisorbat 80.
Your doctor may advise that you can be treated at home provided you meet certain criteria.
Če izpolnjujete določene kriterije, vam zdravnik lahko svetuje, da se zdravite doma.
The most frequent disease manifestations are hepatosplenomegaly, thrombocytopenia, anaemia, and skeletal pathology, The skeletal abnormalities are frequently the most debilitating and disabling features of Gaucher disease.
Najbolj pogosti bolezenski znaki so hepatosplenomegalija, trombocitopenija, anemija in patologija skeleta.
EU/1/97/053/003 1 vial of powder for concentrate for solution for infusion EU/1/97/053/004 5 vials of powder for concentrate for solution for infusion EU/1/97/053/005 25 vial of powder for concentrate for solution for infusion
EU/1/97/053/003 1 viala praška za koncentrat za raztopino za infundiranje EU/1/97/053/004 5 vial praška za koncentrat za raztopino za infundiranje EU/1/97/053/005 25 vial praška za koncentrat za raztopino za infundiranje
This medicine contains sodium and is administered in 0.9% sodium chloride intravenous solution.
To zdravilo vsebuje natrij in se aplicira v 0,9 % intravenski raztopini natrijevega klorida.
Glucosylceramide is a natural substance in the body, made of sugar and fat.
Glukozilceramid je naravna snov v telesu,
• Guide for Healthcare Professionals Treating Patients with Gaucher Disease.
Cerezyme • Priročnik za zdravstveno osebje, ki obravnava bolnike z Gaucherjevo boleznijo
Disease management should be directed by physicians knowledgeable in the treatment of Gaucher disease.
Nadzor in zdravljenje bolezni mora voditi zdravnik, ki ima izkušnje z zdravljenjem Gaucherjeve bolezni.
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
To zdravilo vsebuje natrij in se aplicira v 0,9 % intravenski raztopini natrijevega klorida (glejte poglavje 6.6).
The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Z 0,9 % raztopino natrijevega klorida za intravensko uporabo razredčeno zdravilo je kemično stabilno 24 ur pri temperaturi od 2 do 8 ºC in zaščiteno pred svetlobo; mikrobiološka neoporečnost zdravila pa zavisi od uporabe aseptične tehnike pri pripravi in redčenju raztopine.
To be taken into consideration by patients on a controlled sodium diet.
To je pomembno upoštevati pri bolnikih, ki so na dieti z nadzorovano količino natrija.
Cerezyme 200 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1 or 25).
Cerezyme, 200 enot, je na voljo v obliki praška za koncentrat za raztopino za infundiranje (v vialah, pakiranih po 1 ali 25).
Excipients: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
Pomožne snovi: manitol, natrijev citrat, citronska kislina monohidrat, polisorbat 80.
It can occur whether the patient is treated with Cerezyme or not.
Pojavi se lahko neodvisno od prejemanja zdravila Cerezyme.
Cerezyme contains sodium
Zdravilo Cerezyme vsebuje natrij
The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion.
Prašek za koncentrat za raztopino za infundiranje raztopimo z vodo za injekcije in raztopino razredčimo z 0,9 % raztopino natrijevega klorida za intravensko uporabo.
Infusion site discomfort, infusion site burning, infusion site swelling, injection site sterile abscess, chest discomfort*, fever, rigors, fatigue
pekoča bolečina na mestu aplikacije, otekanje na mestu aplikacije, sterilni absces na mestu aplikacije, neugodje v prsih*, zvišana telesna temperatura, okorelost, utrujenost
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 25 VIALS)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (1 VIALA, 25 VIAL)
Cerezyme 400 Units powder for concentrate for solution for infusion This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje natrij in se aplicira v intravenski 0,9 % raztopini natrijevega klorida (glejte poglavje 6.6).
Patients with Gaucher disease may also have a low grade inflammatory profile.
Pri bolnikih z Gaucherjevo boleznijo lahko opazimo tudi nizko stopnjo vnetja.
Initial doses of 60 U/kg of body weight once every 2 weeks have shown improvement in haematological and visceral parameters within 6 months of therapy and continued use has either stopped progression of or improved bone disease.
tedna so se hematološki in visceralni parametri zboljšali v 6 mesecih, nadaljnje zdravljenje pa je bodisi zaustavilo napredovanje bolezni kosti ali zboljšalo njeno bolezensko stanje.
After reconstitution, the solution contains 1.24 mmol sodium (400 U/10 mL).
Po rekonstituciji vsebuje raztopina 1,24 mmol natrija (400 e/10 mL).
After reconstitution, the solution contains 0.62 mmol sodium (200 U/5 mL).
Po rekonstituciji vsebuje raztopina 0,62 mmol natrija (200 e/5 mL).
Treatment with Cerezyme at a dose of 60 U/kg body weight once every 2 weeks, showed improvement in bone pain as early as 3 months, decrease in bone crises within 12 months, and improvement in bone mineral density after 24 months of treatment (Sims et al, 2008).
mesecih in izboljšanja mineralne gostote kosti po 24 mesecih zdravljenja (Sims et al, 2008).
Infusion of Cerezyme at home may be considered for patients who are tolerating their infusions well for several months.. Decision to have patient move to home infusion should be made after evaluation and recommendation by the treating physician.
Odločitev, da bolnik začne dobivati infuzije doma, se lahko sprejme po ovrednotenju in priporočilu s strani lečečega zdravnika.
Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
Število vial se določi na podlagi bolnikove individualne sheme odmerjanja.
Cerezyme 200 Units powder for concentrate for solution for infusion This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje natrij in se aplicira v intravenski 0,9 % raztopini natrijevega klorida (glejte poglavje 6.6).
After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (200 U/5 ml).
Po rekonstituciji vsebuje raztopina 40 enot (približno 1,0 mg) imigluceraze na ml (200 e/5 ml).
Please contact your doctor if you would like to be treated at home.
Če se želite zdraviti doma, se posvetujte s svojim zdravnikom.
Before further dilution, visually inspect the reconstituted solution in each vial for foreign particles and discoloration.
Preden raztopino nadalje razredčite, preverite vsako vialo, ali raztopina ne vsebuje delcev in ali ni obarvana.
sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Z 0,9 % raztopino natrijevega klorida za intravensko uporabo razredčeno zdravilo je kemično stabilno 24 ur pri temperaturi od 2 do 8ºC in zaščiteno pred svetlobo; mikrobiološka neoporečnost zdravila pa zavisi od uporabe aseptične tehnike pri pripravi in redčenju raztopine.
Therefore no conclusions on the effect of enzyme replacement therapy on the neurological manifestations of the disease can be drawn.
Učinkovitost zdravila Cerezyme pri nevroloških manifestacijah bolezni ni bila raziskana, zato ne moremo sklepati o učinku encimsko nadomestnega zdravljenja pri nevroloških manifestacijah bolezni.
Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualization of dose according to the patient's needs and therapeutic response.
Za individualizacijo odmerkov glede na bolnikove potrebe in odziv na zdravljenje je treba skrbno nadzirati nosečnost in klinične manifestacije Gaucherjeve bolezni.
One vial contains 200 units of imiglucerase.
Ena viala vsebuje 200 enot imigluceraze.
How Cerezyme is given
Kako vam bo zdravilo Cerezyme dano
Flushing*, hypotension*
hipotenzija*
One vial contains 400 units of imiglucerase.
Ena viala vsebuje 400 enot imigluceraze.
After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml).
Po rekonstituciji vsebuje raztopina 40 enot (približno 1,0 mg) imigluceraze na ml (400 e/10 ml).
Dyspnoea*, coughing*
Dispneja*, kašljanje*
Imiglucerase
- srbenje
After reconstitution, promptly dilute vials and do not store for subsequent use.
Raztopino, pripravljeno z vodo za injekcije, takoj razredčite in je ne shranjujte za naslednjo uporabo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL / VIAL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
After reconstitution, each vial of Cerezyme contains 400 units of imiglucerase in 10.0 ml (40 units per ml).
Po pripravi raztopine ena viala zdravila Cerezyme vsebuje 400 enot imigluceraze v 10,0 ml (40 enot na ml).
The non-neurological manifestations of Gaucher disease include one or more of the following conditions:
Pri ne-nevroloških manifestacijah Gaucherjeve bolezni se pojavlja eden ali več naslednjih simptomov: • anemija, ko smo izključili druge vzroke zanjo, kot npr. pomanjkanje železa,
Cerezyme is supplied as a white to off-white powder.
Zdravilo Cerezyme je na voljo kot bel do belkast prašek.
Patients diagnosed with pulmonary hypertension, in particular, should receive adequate doses of Cerezyme to ensure control of underlying Gaucher disease as well as be evaluated for the need of additional pulmonary hypertension specific treatments.
Za bolnike z diagnozo pljučne hipertenzije še posebno velja, da morajo prejemati ustrezne odmerke zdravila
Cerezyme 200 Units Powder for concentrate for solution for infusion Cerezyme 400 Units Powder for concentrate for solution for infusion
Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje
Patients should be advised to discontinue infusion of the product and contact their physician if these symptoms occur.
Če se našteti simptomi pojavijo, moramo infundiranje prekiniti, bolnik pa naj se posvetuje z zdravnikom.
Cerezyme 200 Units powder for concentrate for solution for infusion Each vial contains 200 units* of imiglucerase**.
Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 200 enot* imigluceraze**.
Arthralgia, backache*
Artralgija, bolečine v hrbtu*
After reconstitution, each vial of Cerezyme contains 200 units of imiglucerase in 5.0 ml (40 units per ml).
Po pripravi raztopine ena viala zdravila Cerezyme vsebuje 200 enot imigluceraze v 5,0 ml (40 enot na ml).
Cerezyme 200 Units powder for concentrate for solution for infusion 2 years
Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje 2 leti
Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ICGG Gaucher Registry”.
vključno s tistimi s kroničnimi nevronopatskimi manifestacijami bolezni, v register 'ICGG Gaucher
Cerezyme 400 Units powder for concentrate for solution for infusion 3 years
Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje 3 leta
Any unused solution should be discarded.
Neuporabljeno raztopino zavrzite.
Cerezyme 400 Units powder for concentrate for solution for infusion Each vial contains 400 units* of imiglucerase**.
Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 400 enot* imigluceraze**.
25 vials of powder for concentrate for solution for infusion.
25 vial praška za koncentrat za raztopino za infundiranje.
How Cerezyme is stored
Shranjevanje zdravila Cerezyme
There are no cases of overdose of Cerezyme reported.
Če ste uporabili večji odmerek zdravila Cerezyme, kot bi smeli Ni poročil o primerih prevelikega odmerjanja.
The reconstituted volume allows accurate withdrawal of 5.0 ml (equal to 200 units) from each vial.
Volumen pripravljene raztopine v eni viali zadošča za natančni odvzem nominalnega volumna, ki je 5,0 ml (ustreza 200 enotam).
The product diluted in 0.9%
Plazemski očistek je znašal 9,8 do
The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 400 units) from each vial.
Volumen pripravljene raztopine v eni viali zadošča za natančni odvzem nominalnega volumna, ki je 10,0 ml (ustreza 400 enotam).
In a study investigating 2 cohorts of patients treated with a median dose of 80 U/kg body weight every 4 weeks and a median dose of 30 U/kg body weight every 4 weeks, among the patients with bone marrow burden score ≥ 6, more patients in the higher dose cohort (33%; n=22) achieved a decrease in the score of 2 points after 24 months of Cerezyme treatment compared with patients in the lower dose cohort (10%; n=13) (de Fost et al, 2006).
V študiji z 2 skupinama bolnikov, ki so jih zdravili s povprečnim odmerkom v višini 80 enot/kg telesne mase na vsake 4 tedne in povprečnim odmerkom v višini 30 enot/kg telesne mase na vsake 4