FrancophonIA/ELRC3.0 huggingface dataset:
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja rekonstituiranog i razrijeđenog lijeka, vidjeti dio 6.3.
English: - The need to seek urgent treatment in the event of failure to gain venous access or if there is a lack of efficacy - The need to keep a diary to document each treatment received at home and to bring it at each visit
Croatian: - da bolesnik treba potražiti hitnu medicinsku pomoć ako ne može pristupiti veni ili ako primijeti nedovoljnu djelotvornost liječenja - potrebi vođenja dnevnika u koji treba bilježiti svako liječenje primijenjeno kod kuće i koji bolesnik mora ponijeti sa sobom pri svakom posjetu liječniku
English: - Regular review of the administration by the patient and/or caregiver needs to be performed to ensure maintenance of optimal practice.
Croatian: Ako lijek primjenjuje bolesnik ili njegovatelj, primjenu treba redovito provjeravati kako bi se osiguralo održavanje optimalne razine liječenja.
English: Over time, the majority of seropositive patients in clinical trials demonstrated either a downward trend in titers (based on a ≥ 4-fold reduction in titer from the peak measurement to the last measurement) (40% of the patients), tolerised (no detectable antibodies confirmed by 2 consecutive radioimmunoprecipitation (RIP) assays) (14% of the patients) or demonstrated a plateau (35% of the patients).
Croatian: (na temelju smanjenja titra od vršnog do posljednjeg mjerenja za ≥ 4 puta) (40% bolesnika), navikavanje na lijek (u 2 uzastopna radioimunoprecipitacijska (RIP) testa nisu pronađena protutijela) (14% bolesnika)
English: Slowly, withdraw 7.0 ml (equal to 35 mg) of the reconstituted solution from each vial up to the total volume required for the patient dose.
Croatian: Polako izvucite 7,0 ml (što odgovara 35 mg) rekonstituirane otopine iz svake bočice do ukupnog volumena potrebnog za dozu za bolesnika.
English: Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.
Croatian: Fabrazyme je namijenjen za dugoročnu enzimsku nadomjesnu terapiju u bolesnika s potvrđenom dijagnozom Fabryjeve bolesti.
English: Clearance of GL-3 in the superficial skin vascular endothelium was achieved in all patients who had accumulated GL-3 at baseline.
Croatian: Klirens GL-3 u endotelu površinskih kapilara kože postignut je u svih bolesnika u kojih je na početku liječenja postojala kumulacija GL-3.
English: The recommended dose of Fabrazyme for children and adolescents 8 - 16 years is 1 mg/kg body weight, once every 2 weeks.
Croatian: Preporučena doza lijeka Fabrazyme za djecu i adolescente u dobi od 8 do 16 godina je 1 mg/kg tjelesne težine, jedanput svaka 2 tjedna.
English: Patients with antibodies to r-hαGAL have a greater potential to experience infusion-associated reactions (IARs).
Croatian: U bolesnika s protutijelima na r-hαGAL veća je vjerojatnost pojave reakcija povezanih s infuzijom.
English: • fast breathing
Croatian: • ubrzano disanje
English: • feeling hot and cold
Croatian: • osjećaj vrućine i hladnoće • mišićno-koštana bol
English: Name and address of the manufacturer responsible for batch release
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: After reconstitution with 1.1 ml water for injections, each vial of Fabrazyme contains 5 mg/ml of agalsidase beta.
Croatian: Nakon rekonstitucije sa 1,1 ml vode za injekcije jedna bočica lijeka Fabrazyme sadrži 5 mg/ml agalzidaze beta.
English: If not used immediately, in-use storage and conditions are the responsibility of the user.
Croatian: vrijeme i uvjeti čuvanja su odgovornost korisnika.
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.
Croatian: Zbog relativno malog broja liječenih bolesnika pojava nuspojave u samo jednog bolesnika definirana je kao manje česta.
English: Sustained clearance of GL-3 from kidney vascular endothelium upon agalsidase beta treatment was demonstrated further in the open label extension of this trial.
Croatian: Klirens GL-3 iz bubrežnog krvožilnog endotela održao se nakon uzimanja agalzidaze beta i u otvorenom produžetku ovog ispitivanja.
English: How to use Fabrazyme
Croatian: Kako primjenjivati Fabrazyme
English: How to store Fabrazyme
Croatian: Kako čuvati Fabrazyme
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: The recommended dose of Fabrazyme for adults is 1 mg/kg body weight, once every 2 weeks.
Croatian: Preporučena doza lijeka Fabrazyme za odrasle je 1 mg/kg tjelesne težine, jedanput svaka 2 tjedna.
English: The 2 female patients had little or no GL-3 accumulation in the superficial skin vascular endothelium at baseline, making this conclusion applicable in male patients only.
Croatian: Dvije djevojčice su na početku liječenja, u endotelu površinskih krvnih žila kože, imale malo ili nimalo akumuliranog GL-3, što znači da se ovaj zaključak odnosi samo na bolesnike muškog spola.
English: Baseline CL was 77 ml/min with a Vss of 2.6 l; half-life was 55 min. After IgG seroconversion, CL decreased to 35 ml/min, Vss increased to 5.4 l, and half-life increased to 240 min.
Croatian: Nakon serokonverzije IgG-a, CL se smanjio na 35 ml/min, Vss je porastao na 5,4 l, a poluvijek se povećao na 240 minuta.
English: Marketing Authorisation Holder and Manufacturer Marketing authorisation holder
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet
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).
Croatian: dozom od 0,3 mg/kg svaka 2 tjedna može se u nekih bolesnika održati klirens GL-3 u određenim vrstama stanica; međutim, dugoročan klinički značaj tih nalaza nije utvrđen (vidjeti dio 5.1).
English: One vial of powder contains 5 mg of agalsidase beta.
Croatian: Jedna bočica praška sadrži 5 mg agalzidaze beta.
English: • exacerbated difficulty in breathing
Croatian: • pogoršanje tegoba s disanjem
English: - The treating physician will be responsible for determining which patients may be suitable for home or self-administration of Fabrazyme and for arranging for treatment at home and training the patient and/or caregiver in the appropriate skills necessary for this.
Croatian: - Odgovornost je liječnika propisivača odrediti koji bolesnici su pogodni za (samostalnu) primjenu lijeka Fabrazyme kod kuće, organizirati sve za primjenu lijeka kod kuće i poučiti bolesnika i/ili njegovatelja svim vještinama potrebnima za primjenu lijeka kod kuće.
English: In another study with 30 paediatric patients with available pharmacokinetics data, aged 5 to 18 years, treated with two lower dose regimens of 0.5 mg/kg every 2 weeks and 1.0 mg/kg every 4 weeks, mean CL was 4.6 and 2.3 ml/min/kg, respectively, mean Vss was 0.27 and 0.22 l/kg, respectively, and mean elimination half-life was 88 and 107 minutes, respectively.
Croatian: do 18 godina liječenih s dva niža režima doziranja od 0,5 mg/kg svaka 2 tjedna odnosno 1,0 mg/kg svaka 4 tjedna, srednji CL je bio redom 4,6 odnosno 2,3 ml/min/kg, srednji Vss 0,27 odnosno 0,22 l/kg i srednje poluvrijeme eliminacije 88 odnosno 107 minuta.
English: - That it is the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Fabrazyme.
Croatian: - Odgovornost je liječnika propisivača odrediti koji su bolesnici podobni za primjenu infuzije kod kuće, odnosno samostalnu primjenu lijeka Fabrazyme.
English: Do not use the solution if foreign particles are observed or if the solution is discoloured.
Croatian: Ne smijete upotrijebiti otopinu u kojoj ima stranih čestica ili ako je promijenila boju.
English: - The training to be provided to the patient and /or caregiver should address the following elements: - That it is essential to follow strictly the prescribed dose and infusion rate - Method of preparation and administration of Fabrazyme - Instructions in handling possible adverse events - Instruction to seek emergency treatment by healthcare professionals in the event of any adverse reactions during an infusion - The need to seek urgent treatment in the event of failure to gain venous access or if there is a lack of efficacy - The need to keep a diary to document each treatment received at home and to bring it at each visit - It is the responsibility of the prescribing physician to verify that all necessary skills have been acquired by the non-healthcare professional and that Fabrazyme may be safely and effectively administered at home.
Croatian: - bolesnika treba uputiti da potraži hitnu medicinsku pomoć ako ne može pristupiti veni ili ako primijeti nedovoljnu djelotvornost liječenja - potrebu vođenja dnevnika u koji treba bilježitu svako liječenje primijenjeno kod kuće i koji bolesnika mora ponijeti sa sobom pri svakom posjetu liječniku - Liječnik propisivač dužan je provjeriti je li osoba koja nije zdravstveni djelatnik savladala sve nužne vještine i jesu li zadovoljeni svi uvjeti za sigurnu i djelotvornu primjenu lijeka Fabrazyme kod kuće.
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.
Croatian: Nakon rekonstitucije sa 7,2 ml vode za injekcije jedna bočica lijeka Fabrazyme sadrži 5 mg/ml (35 mg/7 ml)
English: • increased blood pressure • joint pain
Croatian: • povišen krvni tlak
English: Use of Fabrazyme during pregnancy is not recommended.
Croatian: Ne preporučuje se primjena lijeka Fabrazyme tijekom trudnoće.
English: One vial of powder contains 35 mg of agalsidase beta.
Croatian: Jedna bočica praška sadrži 35 mg agalzidaze beta.
English: Fabrazyme 5 mg powder for concentrate for solution for infusion 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.
Croatian: Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju Prije dodavanja rekonstituiranog volumena lijeka Fabrazyme potrebnog za dozu za bolesnika, preporučuje se iz infuzijske vrećice ukloniti jednaki volumen 0,9% otopine natrijevog klorida za intravensku primjenu.
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
Croatian: EU/1/01/188/002 5 bočica s praškom za koncentrat za otopinu za infuziju EU/1/01/188/003 10 bočica s praškom za koncentrat za otopinu za infuziju
English: • pain at the extremities
Croatian: • bol u udovima
English: Genzyme Europe B.V. Paasheuvelweg 25
Croatian: Genzyme Europe B.V.-NL
English: No unexpected safety issues were encountered in patients with an increase in exposure after seroconversion.
Croatian: U bolesnika u kojih se nakon serokonverzije povećala izloženost lijeku nisu zabilježene neočekivane poteškoće povezane sa sigurnošću.
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase beta.
Croatian: Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju Jedna bočica lijeka Fabrazyme sadrži nominalnu vrijednost od 5 mg agalzidaze beta.
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.
Croatian: Malobrojni podaci iz kliničkih ispitivanja upućuju da je sigurnosni profil liječenja lijekom Fabrazyme u pedijatrijskih bolesnika u dobi od 5 do 7 godina liječenih dozom od 0,5 mg/kg svaka 2 tjedna ili dozom od
English: Incidence of adverse reactions with Fabrazyme treatment System organ class
Croatian: Incidencija nuspojava kod liječenja lijekom Fabrazyme Organski sustav Vrlo često Često
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion
Croatian: Fabrazyme 35 mg prašak za koncentrat za otopinu za infuziju Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju
English: • itching eyes
Croatian: • svrbež očiju
English: The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of α-galactosidase A.
Croatian: Niz aminokiselina rekombinantnog oblika, kao i niz nukleotida koji ga kodira,
English: Very common Common
Croatian: Manje često
English: Gastrointestinal Disorders nausea, vomiting abdominal pain, abdominal pain upper, abdominal discomfort, stomach discomfort, hypoaesthesia oral, diarrhoea dyspepsia, dysphagia --
Croatian: Poremećaji probavnog sustava mučnina, povraćanje bol u abdomenu, bol u gornjem dijelu abdomena, nelagoda u abdomenu, nelagoda u želucu, oralna hipoestezija, proljev dispepsija, disfagija --
English: Use of Fabrazyme during breastfeeding is not recommended.
Croatian: Ne preporučuje se primjena lijeka Fabrazyme tijekom dojenja.
English: • red rash
Croatian: • crveni osip
English: Patients experiencing mild or moderate infusion-associated reactions when treated with agalsidase beta during clinical trials have continued therapy after a reduction in the infusion rate (~0.15 mg/min; 10 mg/hr) and/or pre-treatment with antihistamines, paracetamol, ibuprofen and/or corticosteroids.
Croatian: (~0,15 mg/min; 10 mg/sat) i/ili prethodne primjene antihistaminika, paracetamola, ibuprofena i/ili kortikosteroida.
English: Respiratory, thoracic and mediastinal disorders dyspnoea, nasal congestion, throat tightness, wheezing, cough, dyspnoea exacerbated bronchospasm, pharyngolaryngeal pain, rhinnorhoea, tachypnoea, upper respiratory tract congestion hypoxia
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, kongestija nosa, stezanje u grlu, piskanje pri disanju, kašalj, egzacerbacija dispneje bronhospazam, faringolaringealna bol, rinoreja, tahipneja, kongestija gornjeg dišnog sustava hipoksija
English: Skin and subcutaneous tissue disorders pruritus, urticaria, rash, erythema, pruritus generalized, angioneurotic oedema, swelling face, rash maculo-papular livedo reticularis, rash erythematous, rash pruritic, skin discolouration, skin discomfort leukocytoclastic vasculitis
Croatian: Poremećaji kože i potkožnog tkiva pruritus, urtikarija, osip, eritem, generalizirani pruritus, angioneurotski edem, oticanje lica, makulopapularni osip retikularni livedo, eritematozni osip,
English: - The active substance is agalsidase beta, one vial contains 35 mg. - The other ingredients are:
Croatian: - Djelatna tvar je agalzidaza beta, jedna bočica sadrži 35 mg.
English: Any unused solution should be discarded.
Croatian: Neupotrijebljena otopina mora se zbrinuti.
English: Musculoskeletal and connective tissue disorders pain in extremity, myalgia, back pain, muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness musculoskeletal pain --
Croatian: bol u leđima, grčevi u mišićima, artralgija, stezanje u mišićima, mišićno-koštana ukočenost mišićno-koštana bol --
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Croatian: Fabrazyme 35 mg prašak za koncentrat za otopinu za infuziju Jednu bočicu lijeka Fabrazyme od 35 mg rekonstituirajte sa 7,2 ml vode za injekcije.
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.
Croatian: Prije dodavanja rekonstituiranog volumena lijeka Fabrazyme potrebnog za dozu za bolesnika, preporučuje se iz infuzijske vrećice ukloniti jednaki volumen 0,9% otopine natrijevog klorida za intravensku primjenu.
English: It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles which will not lead to any loss of agalsidase beta activity.
Croatian: Da bi se uklonile čestice proteina preporučuje se razrijeđenu otopinu primjenjivati kroz “in-line” filtar male sposobnosti vezanja proteina s porama veličine 0,2 µm.
English: Common (may affect up to 1 in 10 people): • chest pain
Croatian: Česte (mogu se javiti u manje od 1 na 10 osoba):
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Croatian: Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju Jednu bočicu lijeka Fabrazyme od 5 mg rekonstituirajte s 1,1 ml vode za injekcije.
English: • skin discoloration
Croatian: • promjena boje kože
English: However, at the lower dose, IgG antibodies may play a role with respect to GL-3 clearance in some patients.
Croatian: IgG protutijela mogu utjecati na klirens GL-3.
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).
Croatian: (1/2 terapijske doze uz 1/25 početne standardne preporučene brzine).
English: • difficulty in breathing
Croatian: • otežano disanje
English: Reconstitute each vial of Fabrazyme 35 mg with 7.2 ml water for injections.
Croatian: Jednu bočicu lijeka Fabrazyme od 35 mg rekonstituirajte sa 7,2 ml vode za injekcije.
English: • burning sensation
Croatian: • osjećaj žarenja
English: • urticaria
Croatian: • koprivnjača
English: The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to clear the accumulating substrate in the organ tissues; thereby, preventing, stabilizing or reversing the progressive decline in function of these organs before irreversible damage has occurred.
Croatian: Time se sprječava, stabilizira ili popravlja progresivno smanjenje funkcije tih organa prije nastanka nepopravljivih oštećenja.
English: • feeling hot
Croatian: • navala vrućine
English: - The active substance is agalsidase beta, one vial contains 5 mg. - The other ingredients are:
Croatian: - Djelatna tvar je agalzidaza beta, jedna bočica sadrži 5 mg.
English: Reconstitute each vial of Fabrazyme 5 mg with 1.1 ml water for injections.
Croatian: Jednu bočicu lijeka Fabrazyme od 5 mg rekonstituirajte s 1,1 ml vode za injekcije.
English: • injection site blood clotting
Croatian: • zgrušavanje krvi na mjestu primjene injekcije
English: Intravenous use.
Croatian: Za primjenu u venu.
English: 5 vials of powder for concentrate for solution for infusion.
Croatian: 5 bočica s praškom za koncentrat za otopinu za infuziju.
English: Fabrazyme 35 mg powder for concentrate for solution for infusion agalsidase beta
Croatian: Fabrazyme 35 mg prašak za koncentrat za otopinu za infuziju agalzidaza beta
English: Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 35 mg is supplied in clear Type I glass 20 ml vials.
Croatian: Fabrazyme 35 mg je dostupan u prozirnim staklenim bočicama od 20 ml (staklo tipa I).
English: 10 vials of powder for concentrate for solution for infusion.
Croatian: 10 bočica s praškom za koncentrat za otopinu za infuziju.
English: • (mottled purplish) skin discoloration
Croatian: • promjena boje kože (ljubičaste šare)
English: Nervous system disorders headache, paraesthesia dizziness, somnolence, hypoaesthesia, burning sensation, lethargy, syncope hyperaesthesia, tremor
Croatian: hipoestezija, osjećaj žarenja, letargija, sinkopa hiperestezija, tremor --
English: No changes in dose are necessary for patients with kidney disease.
Croatian: U bolesnika s bolešću bubrega nije potrebno mijenjati dozu.
English: • lower blood oxygen levels • serious inflammation of the vessels
Croatian: • niže razine kisika u krvi
English: Fabrazyme 5 mg powder for concentrate for solution for infusion agalsidase beta
Croatian: Fabrazyme 5 mg prašak za koncentrat za otopinu za infuziju agalzidaza beta
English: • oedema
Croatian: • omaglica
English: Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of patients (see section
Croatian: U malog su broja bolesnika prijavljene reakcije koje upućuju na akutnu preosjetljivost (tipa I) (vidjeti dio 4.4).
English: • musculoskeletal stiffness
Croatian: • stezanje mišića
English: General disorders and administration site conditions chills, pyrexia, feeling cold fatigue, chest discomfort, feeling hot, oedema peripheral, pain, asthenia, chest pain, face oedema, hyperthermia feeling hot and cold, influenza-like illness, infusion site pain, infusion site reaction, injection site thrombosis, malaise, oedema
Croatian: osjećaj vrućine, periferni edem, bol, astenija, bol u prsištu, oticanje lica, hipertermija osjećaj vrućine i hladnoće, bolest nalik gripi, bol na mjestu primjene infuzije, reakcija na mjestu primjene infuzije, tromboza na mjestu injekcije, malaksalost, edem
English: Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
Croatian: manitol natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat
English: Due to the limitations of the study design (small number of patients), no definitive conclusion regarding the dose maintenance regimen can be drawn, but these findings suggest that, after an initial debulking dose of 1.0 mg/kg every 2 weeks, 0.3 mg/kg every 2 weeks may be sufficient in some patients to maintain clearance of GL-3.
Croatian: Ipak, nalazi pokazuju da nakon početne doze od 1,0 mg/kg svaka 2 tjedna doza od 0,3 mg/kg svaka 2 tjedna može u nekih bolesnika biti dovoljna za održavanje klirensa GL-3.
English: Hepatic impairment Studies in patients with hepatic insufficiency have not been performed.
Croatian: Nisu provedena ispitivanja u bolesnika sa zatajivanjem jetre.
English: Ear and labyrinth disorders tinnitus, vertigo auricular swelling, ear pain
Croatian: Poremećaji uha i labirinta tinitus, vrtoglavica oticanje ušne školjke, bol u uhu
English: • increased heart beat
Croatian: • ubrzani otkucaji srca
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.
Croatian: Ostali simptomi uključivali su blagu do umjerenu dispneju, hipoksiju (smanjenu saturaciju kisikom), stezanje u grlu, nelagodu u prsištu, crvenilo praćeno osjećajem užarenosti, pruritus, urtikariju, edem lica, angioneurotski edem, rinitis, bronhospazam,
English: Infusion of Fabrazyme at home may be considered for patients who are tolerating their infusions well.
Croatian: U bolesnika koji dobro podnose infuzije može se razmotriti mogućnost primjene infuzije lijeka Fabrazyme kod kuće.
English: • decreased blood pressure • hot flush
Croatian: • naglo oticanje lica ili grla • snižen krvni tlak
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
Croatian: EU/1/01/188/004 1 bočica s praškom za koncentrat za otopinu za infuziju
English: Fabry disease
Croatian: FARMAKOLOŠKA SVOJSTVA
English: • sudden swelling of the face or throat
Croatian: • upala nosa ili ždrijela
English: • low heart rate
Croatian: • spori otkucaji srca
English: Fabrazyme 5 mg powder for concentrate for solution for infusion Fabrazyme 5 mg is supplied in clear Type I glass 5 ml vials.
Croatian: Fabrazyme 5 mg je dostupan u prozirnim staklenim bočicama od 5 ml (staklo tipa I).