FrancophonIA/ELRC3.0 huggingface dataset:
English: In one of these studies, performed in adult male patients, after an initial dose of 1.0 mg/kg every 2 weeks for 6 months, 0.3 mg/kg every 2 weeks may maintain clearance of GL-3 in certain cell types in some patients; however, the long term clinical relevance of these findings has not been established (see section 5.1).
Slovenian: V eni od študij, ki je bila narejena pri odraslih bolnikih moškega spola, lahko po začetnem odmerku 1,0 mg/kg vsaka 2 tedna v trajanju 6 mesecev, 0,3 mg/kg vsaka 2 tedna vzdržuje očistek GL-3 pri nekaterih vrstah celic in pri nekaterih bolnikih; vendar pa dolgoročne klinične pomembnosti teh izsledkov niso ugotovili (glejte poglavje 5.1).
English: No unexpected safety issues were encountered in patients with an increase in exposure after seroconversion.
Slovenian: Pri bolnikih s povečano izpostavljenostjo po serokonverziji ni prišlo do nepričakovanih spornih varnostnih vprašanj.
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.
Slovenian: Ocene GL-3 v endoteliju površinskih kožnih kapilar so se med zdravljenjem zmanjšale na nič ali so ostale nič na vseh časovnih točkah od izhodišča dalje pri 19 od 27 bolnikov, ki so študijo dokončali brez povečanja odmerka.
English: • infusion site reaction
Slovenian: • reakcija na mestu infundiranja
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.
Slovenian: Potem počasi vbrizgajte rekonstituirano raztopino neposredno v 0,9 % raztopino natrijevega klorida za intravensko uporabo (ne v preostali zrak) do končne koncentracije med 0,05 mg/ml in 0,7 mg/ml.
English: • difficulty in breathing
Slovenian: • težave pri dihanju
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.
Slovenian: Zdravilo Fabrazyme vsebuje zdravilno učinkovino agalzidaza beta in se uporablja kot encimska nadomestna terapija pri Fabryjevi bolezni, pri kateri bodisi ni encima α-galaktozidaze, ali pa je količina tega encima manjša od normalne.
English: In this trial, the initial rechallenge administration was at a low dose and a lower infusion rate (1/2 the therapeutic dose at 1/25 the initial standard recommended rate).
Slovenian: V tem preskušanju so začetno ponovno izzivalno dajanje izvajali ob manjšem odmerku in manjši hitrosti infundiranja (1/2 terapevtskega odmerka pri 1/25
English: Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Slovenian: Pred dodajanjem rekonstituirane količine zdravila Fabrazyme, potrebne za bolnikov odmerek, je priporočljivo odstraniti enako količino 0,9 % raztopine natrijevega klorida za intravensko uporabo iz infuzijske vrečke.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bo vse zdravstveno osebje, za katero se predvideva, da bodo predpisovali/uporabljali zdravilo Fabrazyme, prejelo izobraževalno gradivo s ciljem pospeševanja usposabljanja bolnikov/negovalcev ter vodenja zdravnikov pri ocenjevanju in izbiranju bolnikov ter organizacijskih zahtevah za infundiranje na domu.
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.
Slovenian: Ko bolnik tako infuzijo dobro prenaša, lahko odmerek povečate do terapevtskega odmerka 1 mg/kg, hitrost infundiranja pa lahko počasi večate s titracijo navzgor, v skladu s prenašanjem bolnika.
English: Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).
Slovenian: Zdravilo Fabrazyme je indicirano za dolgoročno encimsko nadomestno terapijo pri bolnikih s potrjeno diagnozo Fabryjeve bolezni (pomanjkanje α-galaktozidaze A).
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.
Slovenian: Po intravenski aplikaciji agalzidaze beta pri odraslih s trajanjem infundiranja približno 300 minut in pri odmerku 1 mg/kg telesne mase na vsaka 2 tedna so bile srednje vrednosti Cmax plazemske koncentracije od 2.000 do 3.500 ng/ml, medtem ko je bila vrednost AUCinf od 370 do 780 µg min/ml.
English: The reconstituted solution contains 5 mg agalsidase beta per ml, and appears as a clear colourless solution.
Slovenian: Rekonstituirana raztopina vsebuje 5 mg agalzidaze beta na ml in je videti kot bistra brezbarvna raztopina.
English: Patients experiencing adverse events during the home infusion need to immediately stop the infusion process and seek the attention of a healthcare professional.
Slovenian: Bolniki, pri katerih se med infundiranjem doma pojavijo neželeni dogodki, morajo prekiniti infundiranje in se posvetovati z zdravstvenim osebjem.
English: • fast breathing
Slovenian: • hitro dihanje
English: However, at the lower dose, IgG antibodies may play a role with respect to GL-3 clearance in some patients.
Slovenian: Vendar pa imajo lahko pri nekaterih bolnikih, pri nizkih odmerkih, protitelesa IgG pomembno vlogo na očistek GL-3.
English: A reduction in GL-3 was observed in kidney, heart, skin and plasma at all doses.
Slovenian: Pri vseh odmerkih so ugotavljali zmanjšanje količine GL-3 v ledvicah, srcu, koži in 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.
Slovenian: To naredite tako, da kapljice vode za injekcije dodajate s počasnim spuščanjem po notranjosti viale in ne neposredno na liofilizirano sredico.
English: Fabrazyme may get into breast milk.
Slovenian: Zdravilo Fabrazyme lahko prehaja v materino mleko.
English: Very common symptoms (may affect more than 1 in 10 people) include chills, fever, feeling cold, nausea, vomiting, headache and abnormal feelings in the skin such as burning or tingling.
Slovenian: Zelo pogosti (se lahko pojavijo pri več kot 1 osebi od 10) so mrzlica, zvišana telesna temperatura, občutek mraza, občutek siljenja na bruhanje, bruhanje, glavobol in nenormalen občutek v koži (pekoč občutek ali mravljinci).
English: This was achieved in 47 of the 49 patients (96%) with available information at month 6, and in 8 of the 8 patients (100%) with available information at the end of the study (up to a total of 5 years of treatment).
Slovenian: 6. meseca, in pri 8 od 8 bolnikov (100 %) s podatki, ki so bili na voljo ob koncu študije (do največ 5 let zdravljenja).
English: No interaction studies and no in vitro metabolism studies have been performed.
Slovenian: Raziskave medsebojnega delovanja in presnove in vitro niso bile opravljene.
English: Limited information from clinical trials suggests that the safety profile of Fabrazyme treatment in paediatric patients ages 5-7, treated with either 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks is similar to that of patients (above the age of 7) treated at 1.0 mg/kg every 2 weeks.
Slovenian: Omejeni podatki iz kliničnih študij nakazujejo, da je varnostni profil zdravljenja z zdravilom Fabrazyme pri pediatričnih bolnikih, starih od 5 do 7 let, zdravljenih z 0,5 mg/kg vsaka 2 tedna ali 1,0 mg/kg vsake 4 tedne, podoben tistemu pri bolnikih (nad starostjo 7 let), zdravljenih z 1,0 mg/kg vsaka 2 tedna.
English: Clearance of GL-3 in the superficial skin vascular endothelium was achieved in all patients who had accumulated GL-3 at baseline.
Slovenian: Očistek GL-3 v žilnem endoteliju vrhnje plasti kože so dosegli pri vseh bolnikih, ki so GL-3 kopičili v osnovi.
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.
Slovenian: Ker je agalzidaza beta (r-hαGAL) rekombinantni protein, pričakujemo tvorjenje protiteles IgG pri bolnikih z majhno ali neobstoječo preostalo encimsko aktivnostjo.
English: Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of patients (see section
Slovenian: O reakcijah, ki so nakazovale akutno preobčutljivost (tipa I), so poročali pri majhnem številu bolnikov (glejte poglavje 4.4).
English: • low heart rate due to conduction disturbances
Slovenian: • počasno bitje srca zaradi motenj v prevajanju
English: If you are treated with Fabrazyme, you may develop infusion associated reactions.
Slovenian: Pri zdravljenju z zdravilom Fabrazyme lahko pride do reakcij, povezanih z infuzijo.
English: • bronchospasm
Slovenian: • bronhospazem
English: • decreased sensitivity to pain
Slovenian: • zmanjšana občutljivost za bolečino
English: Additional symptoms included mild or moderate dyspnoea, hypoxia (oxygen saturation decreased), throat tightness, chest discomfort, flushing, pruritus, urticaria, face oedema, angioneurotic oedema, rhinitis, bronchospasm, tachypnoea, wheezing, hypertension, hypotension, tachycardia, palpitations, abdominal pain, nausea, vomiting, infusion-related pain including pain at the extremities, myalgia, and headache.
Slovenian: Dodatni simptomi so bili blaga ali zmerna dispneja, hipoksija (zmanjšana nasičenost s kisikom), stiskanje v grlu, neugodje v prsih, navali vročine, pruritus, urtikarija, obrazni edem, angionevrotični edem, rinitis, bronhospazem, tahipneja, sopihajoče in piskajoče dihanje, hipertenzija, hipotenzija, tahikardija, palpitacije, trebušne bolečine, navzea, bruhanje, bolečine zaradi infuzije, vključno z bolečinami v udih, mialgijo in glavobolom.
English: Fabrazyme treatment should be supervised by a physician experienced in the management of patients with Fabry disease or other inherited metabolic diseases.
Slovenian: Zdravljenje z zdravilom Fabrazyme mora potekati pod nadzorom zdravnika, izkušenega v zdravljenju bolnikov s Fabryjevo boleznijo ali drugimi dednimi presnovnimi boleznimi.
English: White to off-white lyophilised cake or powder.
Slovenian: Bela do sivkastobela, liofilizirana sredica ali prašek.
English: Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.
Slovenian: Zdravilo Fabrazyme je indicirano za uporabo v obliki dolgoročne encimske nadomestne terapije pri bolnikih s potrjeno diagnozo Fabryjeve bolezni.
English: There is no experience with the use of Fabrazyme in pregnant women.
Slovenian: Izkušenj z uporabo zdravila Fabrazyme pri nosečih ženskah ni.
English: • (mottled purplish) skin discoloration
Slovenian: • (lisasto vijolično) obarvanje kože
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
Slovenian: EU/1/01/188/001 Fabrazyme 35 mg 1 viala praška za koncentrat za raztopino za infundiranje EU/1/01/188/002 Fabrazyme 35 mg 5 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/003 Fabrazyme 35 mg 10 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/004 Fabrazyme 5 mg 1 viala praška za koncentrat za raztopino za infundiranje EU/1/01/188/005 Fabrazyme 5 mg 5 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/006 Fabrazyme 5 mg 10 vial praška za koncentrat za raztopino za infundiranje
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.
Slovenian: Začetna hitrost infundiranja ne sme preseči 0,25 mg/min (15 mg/uro), da zmanjšamo pojavljanje morebitnih infuzijskih reakcij na najmanjšo možno mero.
English: No changes in dose are necessary for patients with kidney disease.
Slovenian: Pri bolnikih z ledvičnimi boleznimi ni potrebna sprememba odmerka.
English: Infusion associated reactions consisted most often of fever and chills.
Slovenian: Reakcije, povezane z infuzijo Reakciji, povezani z infuzijo, sta najpogosteje zvišana telesna temperatura in mrzlica.
English: No clinical studies have been performed in children 0-4 years old.
Slovenian: Pri otrocih, starih od 0 do 4 leta, ni bilo opravljenih kliničnih študij.
English: How to use Fabrazyme
Slovenian: Kako uporabljati zdravilo Fabrazyme
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.
Slovenian: V eni od teh študij, je bilo 15 pediatričnih bolnikov, starih od 8,5 do 16 let s telesno maso od 27,1 do 64,9 kg, za katere so bili na voljo farmakokinetični podatki, zdravljenih z odmerkom 1,0 mg/kg vsaka 2 tedna.
English: Studies have not been performed to examine the effects of Fabrazyme on fertility.
Slovenian: Študije o učinkih zdravila Fabrazyme na plodnost niso bile opravljene.
English: Fabrazyme is supplied as a white to off-white powder.
Slovenian: Zdravilo Fabrazyme je dobavljeno kot bel do sivkastobel prašek.
English: The educational pack should contain the following:
Slovenian: Izobraževalno gradivo za bolnike mora vsebovati informacije o naslednjih ključnih elementih:
English: The recommended dose of Fabrazyme for adults is 1 mg/kg body weight, once every 2 weeks.
Slovenian: Priporočeni odmerek zdravila Fabrazyme za odrasle je 1 mg/kg telesne mase, enkrat na vsaka 2 tedna.
English: Adverse reactions only reported during the Post Marketing period are also included in the table below at a frequency category of “not known” (cannot be estimated from the available data).
Slovenian: V preglednici spodaj so v kategoriji »neznana« (ni mogoče oceniti iz razpoložljivih podatkov) zajeti tudi neželeni učinki, o katerih se je poročalo samo med obdobjem po začetku trženja.
English: The recommended dose of Fabrazyme is 1 mg/kg body weight administered once every 2 weeks as an intravenous infusion.
Slovenian: Priporočeni odmerek zdravila Fabrazyme je 1 mg/kg telesne mase in ga dajemo enkrat na vsaka 2 tedna v obliki intravenske infuzije.
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.
Slovenian: letno biopsijo ledvic so opravili v podskupini 6 bolnikov: ocene GL-3 v endoteliju ledvičnih kapilar so se pri vseh zmanjšale na nič, učinki na GL-3 v podocitih pa so bili zelo različni; zmanjšanje so zabeležili pri 3 bolnikih.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VIALA
English: • skin discoloration
Slovenian: • obarvanje kože
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.
Slovenian: - Da je zdravnik, ki predpiše zdravilo Fabrazyme, odgovoren za ustrezno usposabljanje nezdravstvenega osebja, kot je bolnik v primeru samodajanja ali negovalec v primeru uporabe zdravila na domu, če lečeči zdravnik presodi, da je to primerno.
English: After patient tolerance is established, the infusion rate may be increased gradually with subsequent infusions.
Slovenian: Ko enkrat ugotovite, da bolnik dobro prenaša infuzijo, lahko hitrost infundiranja postopoma povečujete pri naslednjih infuzijah.
English: If you have missed an infusion of Fabrazyme, please contact your doctor.
Slovenian: Če niste prejeli odmerka zdravila Fabrazyme, se obrnite na zdravnika.
English: Infections and infestations nasopharyngitis rhinitis
Slovenian: Infekcijske in parazitske bolezni nazofaringitis rinitis
English: Very common adverse reactions included chills, pyrexia, feeling cold, nausea, vomiting, headache and paraesthesia.
Slovenian: Zelo pogosti neželeni učinki so bili mrzlica, pireksija, občutek mraza, navzea, bruhanje, glavobol in parestezija.
English: Determine the total volume of sodium chloride 0.9% solution for infusion (between 50 and 500 ml) based on the individual dose.
Slovenian: Na osnovi individualnega odmerka določite celotni volumen 0,9 % raztopine natrijevega klorida za infuzijo (med 50 in 500 ml).
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: If you experience any serious side effect, you should contact your doctor immediately.
Slovenian: Če opazite kateri koli resen neželeni učinek, o tem nemudoma obvestite zdravnika.
English: What Fabrazyme looks like and contents of the pack
Slovenian: Izgled zdravila Fabrazyme in vsebina pakiranja
English: The occurrence of an adverse reaction in a single patient is defined as uncommon in light of the relatively small number of patients treated.
Slovenian: Glede na majhno število zdravljenih bolnikov se pojav neželenega učinka pri enem bolniku upošteva za občasnega.
English: Studies have not been conducted to assess the potential effects of Fabrazyme on impairment of fertility.
Slovenian: Študije za oceno morebitnega škodljivega vpliva zdravila Fabrazyme na plodnost še niso bile opravljene.
English: • syncope
Slovenian: • sinkopa
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.
Slovenian: Za odmerke, manjše od 35 mg, uporabite najmanj 50 ml, za odmerke med 35 in 70 mg uporabite najmanj 100 ml, za odmerke med 70 in 100 mg uporabite najmanj 250 ml in za odmerke, ki presegajo 100 mg, uporabite le 500 ml. Nežno obrnite ali nalahko gnetite infuzijsko vrečko, da zmešate razredčeno raztopino.
English: Severe life-threatening allergic reactions (“anaphylactoid reactions”) have been reported in some patients.
Slovenian: Pri nekaterih bolnikih so poročali o hudih, življenjsko nevarnih alergijskih reakcijah („anafilaktične reakcije“).
English: No data are available in children 0 to 4 years No dose adjustment is necessary for children 8-16 years
Slovenian: Za otroke od 8. do 16. leta starosti prilagajanje odmerka ni potrebno.
English: Immune system disorders anaphylactoid reaction
Slovenian: Bolezni imunskega sistema anafilaktičn a reakcija
English: Incidence of adverse reactions with Fabrazyme treatment System organ class
Slovenian: Pogostnost neželenih učinkov pri zdravljenju z zdravilom Fabrazyme
English: • rhinitis
Slovenian: • rinitis
English: • nasopharyngitis
Slovenian: • nazofaringitis
English: Based on its metabolism, agalsidase beta is an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Slovenian: Na podlagi njene presnove je malo verjetno, da bi imela agalzidaza beta kakšno medsebojno delovanje z drugimi zdravili s pomočjo posredovanja citokroma P450.
English: • pain at the extremities
Slovenian: • bolečine v sklepih
English: EU/1/01/188/004 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 10 vials of powder for concentrate for solution for infusion
Slovenian: EU/1/01/188/004 1 viala praška za koncentrat za raztopino za infundiranje EU/1/01/188/005 5 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/006 10 vial praška za koncentrat za raztopino za infundiranje
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.
Slovenian: Počasi izvlecite 1,0 ml (kar ustreza 5 mg) rekonstituirane raztopine iz vsake viale do celotne količine, ki je potrebna za bolnikov odmerek.
English: • upper respiratory tract congestion
Slovenian: • kongestija zgornjega dela dihal
English: EU/1/01/188/001 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 10 vials of powder for concentrate for solution for infusion
Slovenian: EU/1/01/188/0011 viala praška za koncentrat za raztopino za infundiranje EU/1/01/188/002 5 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/003 10 vial praška za koncentrat za raztopino za infundiranje
English: After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta.
Slovenian: Po rekonstituciji s 7,2 ml vode za injekcije vsebuje vsaka viala zdravila Fabrazyme 5 mg/ml (35 mg/7 ml) agalzidaze beta.
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, single dose toxicity, repeated dose toxicity and embryonal/foetal toxicity.
Slovenian: Predklinični podatki na osnovi študij farmakološke varnosti, toksičnosti enkratnih odmerkov, toksičnosti pri ponavljajočih se odmerkih in toksičnosti za zarodek oz. plod ne kažejo posebnega tveganja za ljudi.
English: One vial of powder contains 5 mg of agalsidase beta.
Slovenian: Ena viala vsebuje 5 mg agalzidaze beta.
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.
Slovenian: 14 žensk), zdravljenih z najmanj eno infuzijo zdravila Fabrazyme v odmerku 1 mg/kg vsaka 2 tedna do največ 5 let, so navedeni v spodnji preglednici po organskih sistemih in po pogostnosti (zelo pogosti: > 1/10, pogosti: ≥ 1/100 do < 1/10 in občasni: ≥ 1/1.000 do < 1/100).
English: The frequency of IARs decreased over time.
Slovenian: Pogostnost reakcij, povezanih z infuzijo, je s časom upadla.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: One vial of powder contains 35 mg of agalsidase beta.
Slovenian: Ena viala vsebuje 35 mg agalzidaze beta.
English: Use of Fabrazyme during pregnancy is not recommended.
Slovenian: Uporaba zdravila Fabrazyme v času nosečnosti ni priporočljiva.
English: Any unused solution should be discarded.
Slovenian: Vso neuporabljeno raztopino zavrzite.
English: - Regular review of the administration by the patient and/or caregiver needs to be performed to ensure maintenance of optimal practice.
Slovenian: - Da se zagotovi ohranjanje optimalne prakse, so potrebni redni pregledi dajanja zdravila s strani bolnika in/ali negovalca.
English: Genzyme Europe B.V. Paasheuvelweg 25
Slovenian: Genzyme Europe B.V.
English: The reconstituted solution cannot be stored and should be promptly diluted.
Slovenian: Rekonstituirana in razredčena raztopina Rekonstituirane raztopine ne shranjujte, ampak jo takoj razredčite.