FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake "Rok valjanosti".
English: Do not drive or use machines if you experience dizziness, sleepiness, vertigo or fainting during or shortly after administration of Fabrazyme (see section 4).
Croatian: Nemojte upravljati vozilima ni raditi na strojevima ako osjetite omaglicu, pospanost, vrtoglavicu ili nesvjesticu tijekom ili nedugo nakon primjene lijeka Fabrazyme (vidjeti dio 4).
English: • increased sensitivity to pain
Croatian: • povećana osjetljivost na bol
English: Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development (see section 5.3).
Croatian: Istraživanja na životinjama ne ukazuju na izravne niti neizravne štetne učinke na razvoj zametka/ploda
English: Clearance of GL-3 was also achieved in several other cell types from the kidney.
Croatian: Klirens GL-3 postignut je i u nekoliko drugih vrsta bubrežnih stanica.
English: After intravenous infusion, agalsidase beta is rapidly removed from the circulation and taken up by vascular endothelial and parenchymal cells into lysosomes, likely through the mannose-6 phosphate, mannose and asialoglycoprotein receptors.
Croatian: Nakon intravenske infuzije agalzidaza beta se brzo uklanja iz krvotoka jer je stanice krvožilnog endotela i parenhimske stanice prenose u svoje lizozome, vjerojatno putem manoza-6-fosfatnih, manoznih i azialoglikoproteinskih receptora.
English: • low heart rate due to conduction disturbances
Croatian: • spori otkucaji srca zbog smetnji provođenja impulsa
English: The initial infusion rate should be no more than 0.25 mg/min (15 mg/hour) to minimise the potential occurrence of infusion-associated reactions.
Croatian: Početna brzina infuzije ne smije biti veća od 0,25 mg/min (15 mg/sat) kako bi se mogućnost pojave reakcija povezanih s infuzijom svela na najmanju moguću mjeru.
English: However, the effect of Fabrazyme treatment on the kidney function was limited in some patients with advanced renal disease.
Croatian: Međutim, učinak liječenja lijekom Fabrazyme na bubrežnu funkciju bio je ograničen u nekih bolesnika s uznapredovalom bolešću bubrega.
English: Both baseline and 5-year kidney biopsies were obtained in a subset of 6 patients: in all, kidney capillary endothelium GL-3 scores were reduced to zero but highly variable effects were observed in podocyte GL-3, with a reduction in 3 patients.
Croatian: Biopsije bubrega na početku i nakon 5 godina su pribavljene u podskupini od 6 bolesnika: u svih su vrijednosti GL-3 u endotelu kapilara bubrega bile smanjene na nulu, ali primjećeni su visoko varijabilni rezultati u GL-3 vrijednostima u podocitima, sa smanjenjem u 3 bolesnika.
English: Immune system disorders anaphylactoid reaction
Croatian: Poremećaji imunološkog sustava anafilaktoidna reakcija
English: Infections and infestations nasopharyngitis rhinitis
Croatian: Infekcije i infestacije nazofaringitis rinitis
English: No clinical studies have been performed in children 0-4 years old.
Croatian: U djece u dobi od 0 do 4 godine nisu provedena klinička ispitivanja.
English: • red eyes
Croatian: • crvenilo očiju
English: For doses lower than 35 mg use a minimum of 50 ml, for doses 35 to 70 mg use a minimum of 100 ml, for doses 70 to 100 mg use a minimum of 250 ml and for doses greater than 100 mg use only 500 ml.
Croatian: Za doze manje od 35 mg uzmite najmanje 50 ml, za doze od 35 do 70 mg najmanje 100 ml, za doze od 70 do 100 mg najmanje 250 ml, a za doze iznad 100 mg uzmite isključivo
English: In an additional study, 21 male patients were enrolled to follow GL3 clearance in kidney and skin tissues at an alternative dosing regimen.
Croatian: U dodatno ispitivanje uključen je 21 bolesnik muškog spola, a pratio se klirens GL3 iz tkiva bubrega i kože kod primjene alternativnog režima doziranja.
English: A reduction in GL-3 was observed in kidney, heart, skin and plasma at all doses.
Croatian: Pri svim je dozama primijećeno smanjenje vrijednosti GL-3 u bubrezima, srcu, koži i plazmi.
English: This is done by slow dropwise addition of the water for injection down the inside of the vial and not directly onto the lyophilized cake.
Croatian: To se postiže polaganim ulijevanjem vode za injekcije kap po kap niz unutarnju stijenku bočice, a ne izravno na liofilizirani kolačić.
English: There is a theoretical risk of decreased agalsidase beta activity.
Croatian: Postoji teoretska mogućnost da oni umanje aktivnost agalzidaze beta.
English: • Home infusion manuals for patients
Croatian: • priručnike za primjenu infuzije kod kuće za bolesnike
English: EU/1/01/188/001 Fabrazyme 35 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 Fabrazyme 35 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 Fabrazyme 35 mg 10 vials of powder for concentrate for solution for infusion EU/1/01/188/004 Fabrazyme 5 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 Fabrazyme 5 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 Fabrazyme 5 mg 10 vials of powder for concentrate for solution for infusion
Croatian: EU/1/01/188/001 Fabrazyme 35 mg 1 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/002 Fabrazyme 35 mg 5 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/003 Fabrazyme 35 mg 10 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/004 Fabrazyme 5 mg 1 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/005 Fabrazyme 5 mg 5 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/006 Fabrazyme 5 mg 10 bočica praška za koncentrat za otopinu za infuziju
English: The safety and efficacy of Fabrazyme in patients older than 65 years have not been established and no dosage regimen can presently be recommended in these patients.
Croatian: U bolesnika starijih od 65 godina sigurnost i djelotvornost lijeka Fabrazyme nisu utvrđene pa trenutno za te bolesnike nije moguće preporučiti režim doziranja.
English: Determine the number of vials to be reconstituted based on the individual patient's weight and remove the required vials from the refrigerator in order to allow them to reach room temperature (in approximately 30 minutes).
Croatian: Na temelju tjelesne težine pojedinog bolesnika odredite broj bočica koje treba rekonstituirati i izvadite ih iz hladnjaka da se ugriju na sobnu temperaturu (otprilike 30 minuta).
English: Pregnancy There are no adequate data from the use of agalsidase beta in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni agalzidaze beta u trudnica.
English: After reconstitution it is recommended to promptly dilute the vials, to minimise protein particle formation over time.
Croatian: Nakon rekonstitucije preporučuje se odmah razrijediti sadržaj bočica kako bi se stvaranje čestica proteina s vremenom svelo na najmanju moguću mjeru.
English: • decreased mouth sensitivity
Croatian: • smanjena osjetljivost u ustima
English: Fabrazyme pharmacokinetics was also evaluated in two paediatric studies.
Croatian: Farmakokinetika lijeka Fabrazyme ocijenjena je i u dva ispitivanja s pedijatrijskom populacijom.
English: Fabrazyme is supplied as a white to off-white powder.
Croatian: Fabrazyme dolazi u obliku bijelog do bjelkastog praška.
English: Use Aseptic Technique
Croatian: Primijenite aseptički postupak
English: Renal elimination of agalsidase beta is considered to be a minor pathway for clearance.
Croatian: Eliminacija agalzidaze beta bubrezima smatra se sporednim putem klirensa.
English: • infusion site reaction
Croatian: • reakcija na mjestu primjene infuzije
English: Lower dosing regimens have been used in clinical studies.
Croatian: U kliničkim su ispitivanjima primijenjeni i niži režimi doziranja.
English: The effect of Fabrazyme treatment on the kidneys may be limited in patients with advanced renal disease.
Croatian: Učinak liječenja lijekom Fabrazyme na bubrege može biti ograničen u bolesnika s uznapredovalom bubrežnom bolešću.
English: After patient tolerance is established, the infusion rate may be increased gradually with subsequent infusions.
Croatian: Nakon što se u bolesnika utvrdi podnošljivost, brzina infuzije može se u sljedećim infuzijama postupno povećavati.
English: Fabrazyme contains the active substance agalsidase beta and is used as enzyme replacement therapy in Fabry disease, where the level of α-galactosidase enzyme activity is absent or lower than normal.
Croatian: Fabrazyme sadrži djelatnu tvar agalzidazu beta, a primjenjuje se kao enzimska nadomjesna terapija u liječenju Fabryjeve bolesti kod koje enzim α-galaktozidaza nije aktivan ili je njegova aktivnost niža od normalne.
English: Fabrazyme treatment should be supervised by a physician experienced in the management of patients with Fabry disease or other inherited metabolic diseases.
Croatian: Liječenje lijekom Fabrazyme mora nadzirati liječnik s iskustvom u liječenju bolesnika s Fabryjevom bolešću ili drugim nasljednim metaboličkim bolestima.
English: Then slowly inject the reconstituted solution directly into the 0.9% sodium chloride intravenous solution (not in any remaining airspace) to a final concentration between 0.05 mg/ml and 0.7 mg/ml.
Croatian: Zatim polako ubrizgavajte rekonstituiranu otopinu izravno u 0,9% otopinu natrijevog klorida za intravensku primjenu (ne u prostor ispunjen zrakom) do konačne koncentracije između 0,05 mg/ml i 0,7 mg/ml.
English: In the dose finding study, the effects of 0.3, 1.0 and 3.0 mg/kg once every 2 weeks and 1.0 and 3.0 mg/kg once every 2 days were evaluated.
Croatian: U ispitivanju za utvrđivanje doze procijenjeni su učinci doza od 0,3, 1,0 i 3,0 mg/kg primijenjenih jedanput svaka 2 tjedna te doza od 1,0 i 3,0 mg/kg primijenjenih jedanput svaka 2 dana.
English: The rate of clinical events was substantially lower among Fabrazyme-treated patients compared to placebo-treated patients (risk reduction = 53% intent-to-treat population (p=0.0577); risk reduction = 61 % per-protocol population (p=0.0341)).
Croatian: Stopa kliničkih događaja bila je znatno niža u bolesnika liječenih lijekom Fabrazyme nego u bolesnika koji su primali placebo (smanjenje rizika = 53% u populaciji svih uključenih bolesnika (p=0,0577);
English: Ten (10) patients met per protocol dose increase criteria, two (2) had a dose increase to the recommended dose of 1.0 mg/kg every 2 weeks.
Croatian: Destorica (10) bolesnika zadovoljila su kriterije za povišenje doze prema protokolu, a dvojici (2) bolesnika je doza povišena do preporučene doze od 1,0mg/kg svaka 2 tjedna.
English: Following an intravenous administration of agalsidase beta to adults at doses of 0.3 mg, 1 mg and 3 mg/kg body weight, the AUC values increased more than dose proportional, due to a decrease in clearance, indicating a saturated clearance.
Croatian: Nakon intravenske primjene agalzidaze beta u odraslih bolesnika u dozama od 0,3 mg, 1 mg i 3 mg/kg tjelesne težine, vrijednosti AUC-a su se zbog smanjenja klirensa povećale više nego što je razmjerno dozi, što je ukazalo na zasićeni klirens.
English: In a limited number of patients IgE antibodies were demonstrated (see section 4.4).
Croatian: U malog broja bolesnika utvrđeno je postojanje IgE protutijela (vidjeti dio 4.4).
English: In an additional 5-year open-label paediatric study, 31 male patients aged 5 to 18 years were randomized prior to the onset of clinical symptoms involving major organs and treated with two lower dose regimens of agalsidase beta, 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks.
Croatian: U dodatnom petogodišnjem otvorenom ispitivanju s pedijatrijskom populacijom, 31 muški bolesnik u dobi od 5 do 18 godina bio je ranodmiziran prije nastupa kliničkih simptoma koji su obuhvaćali veće organe i liječen s dva niža režima doziranja agalzidaze beta, 0,5 mg/kg svaka 2 tjedna ili 1,0 mg/kg svaka 4 tjedna.
English: Once a patient tolerates the infusion, the dose may be increased to reach the therapeutic dose of 1 mg/kg and the infusion rate may be increased by slowly titrating upwards, as tolerated.
Croatian: Kad se utvrdi da bolesnik dobro podnosi infuziju, doza se može povećati do terapijske doze od 1 mg/kg, a brzina infuzije može se polako titrirati naviše u skladu s podnošljivošću.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of agalsidase beta in a clinically significant way.
Croatian: Stoga se ne očekuje da bi oštećena jetrena funkcija mogla imati klinički značajan utjecaj na farmakokinetiku agalzidaze beta.
English: If you experience any serious side effect, you should contact your doctor immediately.
Croatian: Ako primijetite bilo koju ozbiljnu nuspojavu, odmah se obratite svome liječniku.
English: Superficial skin capillary endothelium GL-3 scores were reduced to zero or maintained at zero at all time points post-baseline upon treatment in 19/27 patients completing the study without a dose increase.
Croatian: Vrijednosti GL-3 u endotelu površinskih kapilara kože su bile snižene na nulu ili zadržane na nuli u svim vremenskim točkama nakon početka liječenja u 19 od 27 bolesnika, završavajući tako ispitivanje bez povišenja doze.
English: lacrimation increased eye pruritus, ocular hyperaemia
Croatian: pojačano suzenje pruritus oka, hiperemija oka
English: Do not invert, swirl or shake the vial.
Croatian: Bočicu nemojte preokretati, vrtjeti ni tresti.
English: • decreased sensitivity to pain
Croatian: • smanjena osjetljivost na bol
English: - That it is the responsibility of the prescribing physician to provide appropriate training to the non-healthcare professional, such as the patient for self-administration or a caregiver who will administer the treatment at home, if the treating physician decides that this is appropriate.
Croatian: - Odgovornost je liječnika propisivača pružiti odgovarajuću obuku o (samostalnoj) primjeni lijeka osobama koje nisu zdravstveni djelatnici, poput bolesnika ili njegovatelja koji će bolesniku primjenjivati lijek kod kuće, ako nadležni liječnik odluči da je to primjereno.
English: Studies have not been conducted to assess the potential effects of Fabrazyme on impairment of fertility.
Croatian: Nisu provedena ispitivanja kojima bi se procijenili mogući učinci lijeka Fabrazyme na smanjenje plodnosti.
English: No data are available in children 0 to 4 years No dose adjustment is necessary for children 8-16 years
Croatian: U djece u dobi od 8 do 16 godina nije potrebno prilagođavati dozu.
English: In one of these studies, 15 paediatric patients with available pharmacokinetics data, aged 8.5 to 16 years weighing 27.1 to 64.9 kg were treated with 1.0 mg/kg every 2 weeks.
Croatian: U jednom od tih ispitivanja, 15 pedijatrijskih bolesnika s dostupnim farmakokinetičkim podacima u dobi od 8,5 do 16 godina i tjelesne težine od 27,1 do 64,9 kg bilo je liječeno dozom od 1,0 mg/kg svaka 2 tjedna.
English: Following treatment with 1 mg/kg every other week for 24 weeks, a dose regimen of 0.3 mg/kg every 2 weeks for 18 months was able to maintain the clearance of cellular GL-3 in the capillary endothelium of the kidney, other kidney cell types and skin (superficial skin capillary endothelium) in the majority of patients.
Croatian: Nakon liječenja dozom od 1 mg/kg svaki drugi tjedan tijekom 24 tjedna uslijedio je režim doziranja od 0,3 mg/kg svaka 2 tjedna tijekom 18 mjeseci, kojim se u većine bolesnika uspio održati klirens staničnog GL-3 u kapilarnom endotelu bubrega, drugim tipovima bubrežnih stanica i koži (endotel površinskih kapilara kože).
English: A small number of patients have experienced reactions suggestive of immediate (Type I) hypersensitivity.
Croatian: U malog broja bolesnika pojavile su se reakcije koje upućuju na akutnu preosjetljivost (tipa I).
English: Since agalsidase beta (r-hαGAL) is a recombinant protein, the development of IgG antibodies is expected in patients with little or no residual enzyme activity.
Croatian: Budući da je agalzidaza beta (r-hαGAL) rekombinantni protein, očekuje se razvoj IgG protutijela u bolesnika u kojih je rezidualna enzimska aktivnost niska ili ne postoji.
English: Based on its metabolism, agalsidase beta is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Croatian: S obzirom na njezin metabolizam, nije vjerojatno da će agalzidaza beta sudjelovati u interakcijama s lijekovima posredovanima citokromom P450.
English: The elimination half-life was dose independent and ranged from 45 to 100 minutes.
Croatian: Poluvrijeme eliminacije nije ovisilo o dozi, a kretalo se u rasponu od 45
English: Adverse reactions reported from clinical trials with a total of 168 patients (154 males and 14 females) treated with Fabrazyme administered at a dose of 1 mg/kg every 2 weeks for a minimum of one infusion up to a maximum of 5 years are listed by System Organ Class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10 and uncommon ≥ 1/1000 to < 1/100) in the table below.
Croatian: Nuspojave prijavljene u kliničkim ispitivanjima u kojima je sudjelovalo ukupno 168 bolesnika (154 muškaraca i 14 žena) liječenih lijekom Fabrazyme u dozi od 1 mg/kg svaka 2 tjedna u rasponu od najmanje jedne infuzije do liječenja u trajanju od najviše 5 godina navedene su u tablici koja slijedi prema klasifikaciji organskih sustava i učestalosti (vrlo često ≥ 1/10; često ≥ 1/100 do < 1/10 i manje često ≥ 1/1000 do < 1/100).
English: Fabrazyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Fabry disease.
Croatian: Fabrazyme se primjenjuje samo pod nadzorom liječnika s iskustvom u liječenju Fabryjeve bolesti.
English: Fabrazyme may have a minor influence on the ability to drive or use machines on the day of Fabrazyme administration because dizziness, somnolence, vertigo and syncope may occur (see section
Croatian: Fabrazyme može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima na dan primjene lijeka zbog moguće pojave omaglice, somnolencije, vrtoglavice i sinkope (vidjeti dio 4.8).
English: With careful rechallenge Fabrazyme has been re-administered to all 6 patients who tested positive for IgE antibodies or had a positive skin test to Fabrazyme in a clinical trial.
Croatian: Uz oprez prilikom ponovnog uvođenja, Fabrazyme je ponovno primijenjen u svih 6 bolesnika koji su u kliničkom ispitivanju imali pozitivan nalaz na IgE protutijela i pozitivan rezultat kožnog testa na
English: Fabrazyme should not be administered with chloroquine, amiodarone, benoquin or gentamycin due to a theoretical risk of inhibition of intra-cellular α-galactosidase A activity.
Croatian: Fabrazyme se ne smije primjenjivati s klorokinom, amiodaronom, benokvinom ili gentamicinom zbog teoretskog rizika od inhibicije unutarstanične aktivnosti α-galaktozidaze A. 4.6 Plodnost, trudnoća i dojenje
English: Studies have not been performed to examine the effects of Fabrazyme on fertility.
Croatian: Nisu provedena ispitivanja o učincima lijeka Fabrazyme na plodnost.
English: After intravenous administration of agalsidase beta to adults with an infusion time of approximately 300 minutes and at a dose of 1 mg/kg body weight, biweekly, mean Cmax plasma concentrations ranged from 2000-3500 ng/ml, while the AUCinf ranged from 370-780 µg min/ml.
Croatian: Nakon intravenske primjene agalzidaze beta odraslim osobama uz trajanje infuzije od otprilike 300 minuta i pri dozi od 1 mg/kg tjelesne težine primijenjenoj svaka dva tjedna, srednji Cmax u plazmi kretao se u rasponu od 2000 do 3500 ng/ml, dok se vrijednost AUCinf kretala u rasponu od 370 do 780 µg min/ml.
English: Severe life-threatening allergic reactions (“anaphylactoid reactions”) have been reported in some patients.
Croatian: U nekih su bolesnika prijavljene teške i po život opasne alergijske reakcije ("anafilaktoidne reakcije").
English: Fabrazyme may get into breast milk.
Croatian: Fabrazyme se može izlučivati u majčino mlijeko.
English: Very common adverse reactions included chills, pyrexia, feeling cold, nausea, vomiting, headache and paraesthesia.
Croatian: Vrlo česte nuspojave uključivale su zimicu, pireksiju, osjećaj hladnoće, mučninu, povraćanje, glavobolju i paresteziju.
English: Roll and tilt each vial gently.
Croatian: Svaku bočicu lagano njišite i nagnite.
English: Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).
Croatian: Fabrazyme je indiciran kao dugoročna enzimska nadomjesna terapija u bolesnika s potvrđenom dijagnozom Fabryjeve bolesti (nedostatak α-galaktozidaze A).
English: In addition, infusion-associated reactions were dose dependent.
Croatian: Osim toga, o dozi su ovisile i reakcije povezane s infuzijom.
English: The recommended dose of Fabrazyme is 1 mg/kg body weight administered once every 2 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka Fabrazyme je 1 mg/kg tjelesne težine primijenjeno jedanput svaka 2 tjedna u obliku intravenske infuzije.
English: The net effect of these changes after seroconversion was an increase in exposure of 2- to 3-fold based on AUC and Cmax.
Croatian: Cmax, neto učinak navedenih promjena nakon serokonverzije bilo je dvostruko do trostruko povećanje izloženosti.
English: 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.
Croatian: Prašak za koncentrat za otopinu za infuziju mora se rekonstituirati s vodom za injekcije, razrijediti s 0,9% otopinom natrijevog klorida za intravensku primjenu i zatim primijeniti intravenskom infuzijom.
English: The reconstituted solution cannot be stored and should be promptly diluted.
Croatian: Pripremljene i razrijeđene otopine Pripremljena otopina ne može se čuvati i mora se odmah razrijediti.
English: Before further dilution, visually inspect the reconstituted solution in each vial for particulate matter and discoloration.
Croatian: Prije daljnjeg razrjeđivanja vizualno pregledajte rekonstituiranu otopinu u svakoj bočici, sadrži li čestice i je li došlo do promjene boje.
English: There is no experience with the use of Fabrazyme in pregnant women.
Croatian: Nema iskustva s primjenom lijeka Fabrazyme u trudnica.
English: In one open-label paediatric study, sixteen patients with Fabry disease (8-16 years old; 14 males, 2 females) had been treated for one year at 1.0 mg/kg every 2 weeks.
Croatian: U jednom otvorenom ispitivanju s pedijatrijskom populacijom, 16 bolesnika s Fabryjevom bolešću (u dobi od 8 do 16 godina; 14 dječaka, 2 djevojčice) lijek je primalo godinu dana u dozi od 1,0 mg/kg svaka 2 tjedna.
English: • bronchospasm
Croatian: • bronhospazam
English: Slowly, withdraw 1.0 ml (equal to 5 mg) of the reconstituted solution from each vial up to the total volume required for the patient dose.
Croatian: Polako izvucite 1,0 ml (što odgovara 5 mg) rekonstituirane otopine iz svake bočice do ukupnog volumena potrebnog za dozu za bolesnika.
English: The MAH shall ensure that all Healthcare Professional who are expected to prescribe/use Fabrazyme are provided with an educational pack aiming to facilitate the training of the patients/caregivers and also to guide prescribers regarding patient evaluation and selection and organisational requirements for home infusion.
Croatian: Nositelj odobrenja mora se pobrinuti da svi zdravstveni djelatnici, za koje se očekuje da će propisivati/primjenjivati Fabrazyme, dobiju edukacijski paket kojem je cilj olakšati obuku bolesnika/njegovatelja te liječnicima propisivačima dati smjernice za procjenu i odabir bolesnika te organizacijske uvjete koji moraju biti zadovoljeni za primjenu infuzije kod kuće.
English: The educational material for healthcare professionals should include information on the following key elements: - Guidance regarding patient evaluation and selection and organisational requirements for home infusion.
Croatian: Edukacijski materijal za zdravstvene djelatnike mora sadržavati informacije o sljedećim ključnim elementima: - Smjernice za procjenu i odabir bolesnika te organizacijske uvjete koji moraju biti zadovoljeni za primjenu infuzije kod kuće.