natgillin/translations-raw huggingface dataset:
In patients dosages up to 240 U/kg body weight once every two weeks have been used.
U bolesnika su primijenjene doze do 240 U/kg tjelesne težine jedanput svaka dva tjedna.
Each vial of Cerezyme is for single use only.
Jedna bočica lijeka Cerezyme namijenjena je isključivo za jednokratnu uporabu.
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.
<1/10), manje često (≥1/1000 i <1/100) i rijetko (≥1/10 000 i <1/1000)).
This may contribute to skeletal disease burden in Gaucher disease.
To može pridonijeti opterećenju koštane bolesti u sklopu Gaucherove bolesti.
The ICGG Gaucher Registry
ICGG registar bolesnika s Gaucherovom bolešću
The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap.
Zatvarač se sastoji od silikoniziranog butilnog čepa s "flip-off" kapicom s evidencijom otvaranja.
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.
Uz početnu dozu od 60 U/kg tjelesne težine primijenjenu jedanput svaka 2 tjedna došlo je do poboljšanja hematoloških i visceralnih pokazatelja unutar 6 mjeseci terapije, a nastavak primjene je ili zaustavio napredovanje ili doveo do poboljšanja koštane bolesti.
What you need to know before you are given Cerezyme.
Što morate znati prije nego počnete primite Cerezyme
The recommended dose is 60 units/kg body weight given once every 2 weeks.
Preporučena doza je 60 jedinica/kg tjelesne težine, a primjenjuje se jedanput svaka 2 tjedna.
Unopened vials: Store in a refrigerator (2°C - 8°C)
Neotvorene bočice: Čuvati u hladnjaku (2°C - 8°C)
Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ICGG Gaucher Registry” (see section 5.1).
Liječnike i zdravstvene djelatnike potiče se upisati bolesnike s Gaucherovom bolešću, uključujući i one s kroničnim neuropatskim manifestacijama bolesti, u “ICGG registar bolesnika s Gaucherovom bolešću” (vidjeti dio 5.1).
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).
Liječenje lijekom Cerezyme u dozi od 60 U/kg tjelesne težine jedanput svaka 2 tjedna dovelo je do smanjenja bolova u kostima već nakon 3 mjeseca, smanjenja koštanih kriza unutar 12 mjeseci i poboljšanja mineralne gustoće kosti nakon 24 mjeseca liječenja (Sims i sur., 2008.).
Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „Rok valjanosti“.
In pregnant Gaucher patients and those intending to become pregnant, a risk-benefit treatment assessment is required for each pregnancy.
U bolesnica s Gaucherovom bolešću koje su trudne ili planiraju zatrudnjeti potrebno je procijeniti odnos rizika i koristi liječenja u svakoj trudnoći.
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 jedinica 1 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/002 Cerezyme 200 jedinica 25 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/003 Cerezyme 400 jedinica 1 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/004 Cerezyme 400 jedinica 5 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/005 Cerezyme 400 jedinica 25 bočica s praškom za koncentrat za otopinu za infuziju
It is suggested that patients suspected of a decreased response to the treatment be monitored periodically for IgG antibody formation to imiglucerase.
Preporučuje se bolesnike, u kojih se sumnja na smanjeni odgovor na liječenje, periodički provjeravati stvaraju li IgG protutijela na imiglucerazu.
Onset of such symptoms has occurred during or shortly after infusions.
Nastupili su tijekom infuzije ili neposredno nakon nje.
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 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/002 25 bočica s praškom za koncentrat za otopinu za infuziju
Pack sizes: 1 or 25 vials per carton.
Veličine pakiranja: 1 ili 25 bočica u kutiji.
Patients with Gaucher disease may also have a low grade inflammatory profile.
Bolesnici s Gaucherovom bolešću također mogu imati upalu niskog stupnja.
Gaucher disease is a rare recessively inherited metabolic disorder that results from a deficiency of the lysosomal enzyme acid β-glucosidase.
Gaucherova bolest je rijedak recesivno nasljedan metabolički poremećaj koji nastaje uslijed nedostatka lizosomalnog enzima kisele β-glukozidaze.
Hypersensitivity
Reakcije preosjetljivosti
Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
Na temelju režima doziranja u pojedinog bolesnika odredite broj bočica koje treba rekonstituirati te ih izvadite iz hladnjaka.
After reconstitution, promptly dilute vials and do not store for subsequent use.
Nakon rekonstitucije odmah razrijedite sadržaj bočica i nemojte ih spremati za kasniju uporabu.
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.
Prašak za koncentrat za otopinu za infuziju mora se rekonstituirati s vodom za injekcije, razrijediti 0,9%-tnom otopinom natrijevog klorida za intravensku primjenu, a zatim primijeniti intravenskom infuzijom.
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).
U ispitivanju u kojem su sudjelovale 2 kohorte bolesnika liječenih medijanom doze od 80 U/kg tjelesne težine svaka 4 tjedna te medijanom doze od 30 U/kg tjelesne težine svaka 4 tjedna, među bolesnicima s opterećenjem koštane srži ≥ 6, smanjenje zbroja za 2 boda nakon 24 mjeseca liječenja lijekom Cerezyme postigao je veći broj bolesnika u kohorti koja je primala višu dozu (33%; n=22)
** 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 modificirani oblik ljudske kisele β-glukozidaze koja se proizvodi tehnologijom rekombinantne DNK na staničnoj kulturi sisavaca, odnosno jajnika kineskog hrčka (engl.
Vomiting, nausea, abdominal cramping, diarrhoea
Povraćanje, mučnina, grčevi u abdomenu, proljev
Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ICGG Gaucher Registry”.
Liječnike i zdravstvene djelatnike potiče se upisati bolesnike s Gaucherovom bolešću, uključujući i one s kroničnim neuropatskim manifestacijama bolesti, u “ICGG registar bolesnika s Gaucherovom bolešću”.
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).
X-ray absorptiometry, DXA) u 342 bolesnika, nakon 8 godina liječenja je normalna mineralna gustoća kosti postignuta uz dozu lijeka Cerezyme od 60 U/kg tjelesne težine jedanput svaka 2 tjedna, no ne i s nižim dozama od 15 i 30 U/kg tjelesne težine jedanput svaka 2 tjedna (Wenstrup i sur., 2007.).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 25 VIALS)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE (1 BOČICA, 25 BOČICA)
Cerezyme is a white to off-white powder.
Cerezyme je bijeli ili bjelkasti prašak.
Infusion rate increases should occur under supervision of a health care professional.
Povećanje brzine infuzije mora nadgledati zdravstveni djelatnik.
How Cerezyme is given
Kako se Cerezyme primjenjuje
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PRILOG II. A. PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
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.
Među njima su bili svrbež, navale crvenila, koprivnjača/lokalizirano oticanje kože ili sluznice usta ili grla, nelagoda u prsnom košu, ubrzani otkucaji srca, plavičasta koža, nedostatak zraka, trnci, osjećaj bockanja, žarenja ili utrnulost kože, pad krvnog tlaka i bol u leđima.
Cerezyme contains sodium
Cerezyme sadrži natrij
To be taken into consideration by patients on a controlled sodium diet.
O tome treba voditi računa u bolesnika koji su na dijeti s kontroliranim unosom natrija.
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 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/004 5 bočica s praškom za koncentrat za otopinu za infuziju EU/1/97/053/005 25 bočica s praškom za koncentrat za otopinu za infuziju
Flushing*, hypotension*
Navale crvenila*, hipotenzija*
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.
Najčešće manifestacije bolesti su hepatosplenomegalija, trombocitopenija, anemija i koštana patologija.
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 jedinica dolazi u obliku praška za koncentrat za otopinu za infuziju (u bočici, pakiranja od 1, 5 ili 25 bočica).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.
Cerezyme is supplied as a white to off-white powder.
Cerezyme je bijeli do bjelkasti prašak.
Imiglucerase
Razrjeđivanje
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 jedinica dolazi u obliku praška za koncentrat za otopinu za infuziju (u bočici, pakiranja od 1 ili 25 bočica).
Any unused solution should be discarded.
Neupotrijebljena otopina se mora zbrinuti.
It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles.
Da bi se uklonile čestice proteina preporučuje se razrijeđenu otopinu primjenjivati kroz “in-line” filter male sposobnosti vezanja proteina s porama veličine 0,2 µm.
The efficacy of Cerezyme on neurological symptoms of chronic neuronopathic Gaucher patients has not been established and no special dosage regimen can be recommended for these manifestations (see section 5.1).
Gaucherovom bolešću nije utvrđena i zato se za te manifestacije ne može preporučiti poseban režim doziranja (vidjeti dio 5.1).
Cerezyme decreases chitotriosidase, a biomarker for glucosylceramide accumulation in macrophages and response to treatment.
biokemijski pokazatelj kumulacije glukozilceramida u makrofagima i odgovora na liječenje.
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.
U odraslih bolesnika sa stabilnom rezidualnom Gaucherovom bolešću tipa 1 ispitana je terapija održavanja svaka 4 tjedna (Q4) istom kumulativnom dozom kao i kod primjene lijeka svaka 2 tjedna (Q2).
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.
Samo razrijeđena otopina može se čuvati do 24 sata, i to na hladnom (2°C - 8°C) i tamnom mjestu.
• Guide for Healthcare Professionals Treating Patients with Gaucher Disease.
• Priručnika za bolesnike s Gaucherovom bolešću koji primaju infuziju kod kuće • Vodiča za zdravstvene radnike koji liječe bolesnike s Gaucherovom bolešću
After reconstitution it is a clear, colourless liquid, free from foreign matter.
Nakon rekonstitucije, otopina je bistra, bezbojna tekućina i ne sadrži vidljive čestice.
Excipients: For the full list of excipients, see section 6.1.
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
The reconstituted solution contains 40 units imiglucerase per ml.
Rekonstituirana otopina sadrži 40 jedinica imigluceraze po ml.
Use Aseptic Technique
Primijenite aseptički postupak Rekonstitucija
Do not use this medicine after the expiry date printed on the labelling after the letters “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake "Rok valjanosti".
A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease.
U liječenju nekih ili svih neneuroloških manifestacija bolesti učinkovitim su se pokazali brojni režimi doziranja.
After reconstitution, the solution contains 0.62 mmol sodium (200 U/5 mL).
Nakon rekonstitucije, otopina sadrži 0,62 mmol natrija (200 U/5 ml).
Patients should be advised to discontinue infusion of the product and contact their physician if these symptoms occur.
Bolesnici se moraju savjetovati da u slučaju pojave spomenutih simptoma prekinu infuziju i jave se svom liječniku.
The reconstituted volume is 10.6 ml.
Volumen rekonstituirane otopine je 10,6 ml. pH vrijednost rekonstituirane otopine iznosi približno 6,1.
After reconstitution, the solution contains 1.24 mmol sodium (400 U/10 mL).
Nakon rekonstitucije, otopina sadrži 1,24 mmol natrija (400 U/10 ml).
Before further dilution, visually inspect the reconstituted solution in each vial for foreign particles and discoloration.
Prije daljnjeg razrjeđivanja treba vizualno pregledati je li rekonstituirana otopina u bočici promijenila boju i ima li u njoj vidljivih čestica.
Intravenous use Read the package leaflet before use.
Prije uporabe pročitajte uputu o lijeku.
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 jedinica prašak za koncentrat za otopinu za infuziju Ovaj lijek sadrži natrij i primjenjuje se u 0,9%-tnoj otopini natrijevog klorida za intravensku primjenu (vidjeti dio 6.6).
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 jedinica prašak za koncentrat za otopinu za infuziju Ovaj lijek sadrži natrij i primjenjuje se u 0,9%-tnoj otopini natrijevog klorida za intravensku primjenu (vidjeti dio 6.6).
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.
Promjene u odnosu na početne vrijednosti hemoglobina, trombocita, volumena jetre i slezene, koštane krize te bolesti kostiju činile su unaprijed definiranu kompozitnu mjeru ishoda.
Immune system disorders Hypersensitivity reactions
Poremećaji imunološkog sustava
One vial contains 200 units of imiglucerase.
Jedna bočica sadrži 200 jedinica imigluceraze.
This medicine contains sodium and is administered in 0.9% sodium chloride intravenous solution.
Ovaj lijek sadrži natrij i primjenjuje se u 0,9%-tnoj otopini natrijevog klorida za intravensku primjenu.
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.
Odluka da se bolesnik prebaci na primjenu infuzije kod kuće smije se donijeti tek nakon procjene i preporuke liječnika specijalista koji liječi bolest.
The reconstituted volume allows accurate withdrawal of 5.0 ml (equal to 200 units) from each vial.
Volumen rekonstituirane otopine omogućuje uzimanje točno 5,0 ml (jednako količini od 200 jedinica) otopine iz svake bočice.
Cerezyme 200 Units Powder for concentrate for solution for infusion Cerezyme 400 Units Powder for concentrate for solution for infusion
Cerezyme 200 jedinica prašak za koncentrat za otopinu za infuziju Cerezyme 400 jedinica prašak za koncentrat za otopinu za infuziju
The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 400 units) from each vial.
Volumen rekonstituirane otopine omogućuje uzimanje točno 10,0 ml (jednako količini od 400 jedinica) otopine iz svake bočice.
Mannitol, sodium citrate (to adjust pH), citric acid monohydrate (to adjust pH), polysorbate 80.
6.1 Popis pomoćnih tvari manitol natrijev citrat (za podešavanje pH) citratna kiselina hidrat (za podešavanje pH) polisorbat 80
- The other ingredients are: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
- Drugi sastojci su: manitol, natrijev citrat, citratna kiselina hidrat, polisorbat 80.
After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (200 U/5 ml).
Nakon rekonstitucije otopina sadrži 40 jedinica (približno 1,0 mg) imigluceraze po ml (200 U/5 ml).
Withdraw 5.0 ml reconstituted solution from each vial and combine the withdrawn volumes.
Povucite 5,0 ml rekonstituirane otopine iz svake bočice i pomiješajte ih.
The pH of the reconstituted solution is approximately 6.1.
Volumen rekonstituirane otopine je 5,3 ml. pH vrijednost rekonstituirane otopine iznosi približno 6,1.
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.
Cerezyme kako bi se osigurala kontrola osnovne Gaucherove bolesti kao i procijenila potreba za dodatnim specifičnim lijekovima za plućnu hipertenziju.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 25 VIALS)
VANJSKO PAKIRANJE (1 BOČICA, 5 BOČICA, 25 BOČICA)
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.
tnoj otopini natrijevog klorida za intravensku primjenu zadržava kemijsku stabilnost ako se čuva do 24 sata pri temperaturi od 2°C do 8°C, zaštićen od svjetlosti.
Contents of the pack and other information .
Kako se Cerezyme čuva Sadržaj pakiranja i druge informacije
Withdraw 10.0 ml reconstituted solution from each vial and combine the withdrawn volumes.
Povucite 10,0 ml rekonstituirane otopine iz svake bočice i pomiješajte ih.
Excipients: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
Pomoćne tvari: manitol, natrijev citrat, citratna kiselina hidrat i polisorbat 80.
After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml).
Nakon rekonstitucije otopina sadrži 40 jedinica (približno 1,0 mg) imigluceraze po ml (400 U/10 ml).
Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose.
Vaš odgovor na lijek kako bi bio siguran da uzimate primjerenu dozu.
Infusion site discomfort, infusion site burning, infusion site swelling, injection site sterile abscess, chest discomfort*, fever, rigors, fatigue
Nelagoda na mjestu primjene infuzije, žarenje na mjestu primjene infuzije, oticanje na mjestu primjene infuzije, sterilni apsces na mjestu injiciranja, nelagoda u prsištu*,
The usual frequency of infusion is once every 2 weeks; this is the frequency of infusion for which the most data are available.
Za tu učestalost infuzija je dostupno najviše podataka.
Cerezyme 400 Units powder for concentrate for solution for infusion 3 years
Cerezyme 400 jedinica prašak za koncentrat za otopinu za infuziju 3 godine
One vial contains 400 units of imiglucerase.
Jedna bočica sadrži 400 jedinica imigluceraze.
After reconstitution, each vial of Cerezyme contains 200 units of imiglucerase in 5.0 ml (40 units per ml).
Nakon rekonstitucije jedna bočica lijeka Cerezyme sadrži 200 jedinica imigluceraze u 5,0 ml (40 jedinica po ml).
Cerezyme 400 Units powder for concentrate for solution for infusion The reconstituted solution contains 40 units imiglucerase per ml.
Cerezyme 400 jedinica prašak za koncentrat za otopinu za infuziju Rekonstituirana otopina sadrži 40 jedinica imigluceraze po ml.
Package leaflet: Information for the user Cerezyme 200 Units powder for concentrate for solution for infusion
Uputa o lijeku: Informacije za korisnika Cerezyme 200 jedinica prašak za koncentrat za otopinu za infuziju imigluceraza
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).
Razlika nije bila statistički značajna na temelju 95% CI (-0,231, 0,060).
Cerezyme 200 Units powder for concentrate for solution for infusion Each vial contains 200 units* of imiglucerase**.
Cerezyme 200 jedinica prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 200 jedinica* imigluceraze**.
Cerezyme 200 Units powder for concentrate for solution for infusion 2 years
Cerezyme 200 jedinica prašak za koncentrat za otopinu za infuziju 2 godine
25 vials of powder for concentrate for solution for infusion.
25 bočica s praškom za koncentrat za otopinu za infuziju.
Cerezyme 200 Units powder for concentrate for solution for infusion The reconstituted solution contains 40 units imiglucerase per ml.
Cerezyme 200 jedinica prašak za koncentrat za otopinu za infuziju Rekonstituirana otopina sadrži 40 jedinica imigluceraze po ml.
Package leaflet: Information for the user Cerezyme 400 Units powder for concentrate for solution for infusion
Uputa o lijeku: Informacije za korisnika Cerezyme 400 jedinica prašak za koncentrat za otopinu za infuziju imigluceraza
There is no information on the effect of Cerezyme on brain-based symptoms of patients with chronic neuronopathic Gaucher disease.
Djelotvornost lijeka Cerezyme na neurološke simptome u bolesnika s kroničnom neuropatskom
After reconstitution, each vial of Cerezyme contains 400 units of imiglucerase in 10.0 ml (40 units per ml).
Nakon rekonstitucije jedna bočica lijeka Cerezyme sadrži 400 jedinica imigluceraze u 10,0 ml (40 jedinica po ml).
Arthralgia, backache*
Artralgija, bol u leđima*
• thrombocytopenia
• trombocitopeniju
Dyspnoea*, coughing*
Dispneja*, kašalj*