natgillin/translations-raw huggingface dataset:
Both major and minor bleeds were significantly less frequent with bivalirudin alone than the heparin plus GP IIb/IIIa inhibitor and bivalirudin plus GP IIb/IIIa inhibitor groups. 
V skupini, v kateri se je uporabil samo bivalirudin, so bile večje in manjše krvavitve znatno redkejše kot v skupini s heparinom in inhibitorjem GP IIb/IIIa, ter skupini z bivalirudinom in inhibitorjem GP IIb/IIIa.
Bival + GP IIb/IIIa inhibitor 
Bival + zaviralec GP IIb/IIIa
6.1 List of excipients 
6.1 Seznam pomožnih snovi Manitol
• Shortness of breath 
• hitro bitje srca
Angiox 250 mg powder for concentrate bivalirudin 
Angiox 250 mg prašek za koncentrat bivalirudin intravenozna uporaba
Unplanned revasc. 
Neuporabljeno raztopino zavrzite.
heparin  GP IIb/IIIa inhibitor (N=2,882) 
heparin + inhibitor GP IIb/IIIa (N=2.882)
• 0.5 mg/kg body weight for the intravenous injection, followed by an infusion into vein of 1.75 mg/kg body weight, per hour for the duration of the PCI. 
• 0,5 mg/kg telesne mase za intravensko injekcijo, ki ji sledi infundiranje v veno 1,75 mg/kg telesne mase na uro za čas trajanja PCI.
Intravenous infusion lines should be primed with bivalirudin to ensure continuity of drug infusion after delivery of the bolus. 
Da se zagotovi stalna infuzija zdravila po infuziji bolusa, morajo biti intravenske infuzijske linije napolnjene z bivalirudinom.
In STEMI patients the infusion of 1.75 mg/kg body weight/hour should be continued for up to 4 hours post-PCI and continued at a reduced dose of 0.25 mg/kg/h for an additional 4 - 12 hours as clinically necessary (see section 4.4). 
Pri bolnikih s STEMI je treba infundiranje 1,75 mg/kg telesne mase/h nadaljevati še največ 4 ure po PCI in nato še, v skladu s kliničnimi potrebami, 4-12 ur z infundiranjem zmanjšanega odmerka 0,25 mg/kg/h (glejte poglavje 4.4).
• severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients. 
• hudo ledvično okvaro (GFR < 30 ml/min) in dializnih bolnikih.
Intraocular haemorrhage 
Očesne bolezni intraokularna krvavitev
• If you are taking blood thinners or medicines to prevent blood clots (anticoagulants or antithrombotics e.g. warfarin, dabigatran, apixaban, rivaroxaban, acetylsalicylic acid, 
(antikoagulanti ali antitrombotiki npr. varfarin, dabigatran, apiksaban, rivaroksaban,
ACUITY major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site haemorrhage requiring radiological or surgical intervention, ≥5 cm diameter haematoma at puncture site, reduction in haemoglobin concentration of ≥4 g/dl without an overt source of bleeding, reduction in haemoglobin concentration of ≥3 g/dl with an overt source of bleeding, re-operation for bleeding, use of any blood product transfusion. 
Večja krvavitev je bila v študiji ACUITY opredeljena kot: intrakranialna, retroperitonealna, intraokularna, krvavitev na mestu pristopa, ki zahteva radiološko ali kirurško intervencijo, hematom na mestu vboda s premerom 5 cm ali več, zmanjšanje koncentracije hemoglobina za 4 g/dl ali več brez očitnega vira krvavitve, zmanjšanje koncentracije hemoglobina za 3 g/dl ali več pri očitnem viru krvavitve, ponovna operacija zaradi krvavitve ali uporaba kakršne koli transfuzije krvnih proizvodov.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema znižane vrednosti hemoglobina trombocitopenija, anemija
Bival alone (N=2,911) % 
Samo bival (N=2.911)
The approved adult weight-based intravenous bolus dose of 0.75 mg/kg followed by an infusion of 1.75 mg/kg/hour was studied and pharmacokinetic/pharmacodynamic analysis found a response similar to that of adults, although weight-normalized clearance (ml/min/kg) of bivalirudin was higher in neonates than in older children and decreased with increasing age. 
Farmakokinetična/farmakodinamična analiza je pokazala, da je odziv podoben kot pri odraslih, čeprav je bil očistek bivalirudina, normaliziran glede na telesno maso (ml/min/kg), večji pri novorojenčkih kot pri starejših otrocih in se je s starostjo manjšal.
Haemorrhage 
• zadihanost
• with chest pain due to heart disease (acute coronary syndromes - ACS) 
o z bolečinami v prsih zaradi srčne bolezni (akutni koronarni sindrom - AKS) o ki imajo kirurški poseg za zdravljenje blokad v žilah (angioplastika ali perkutana koronarna
Quadruple endpoint Triple endpoint* Components: Death Myocardial Infarction Major bleeding** (based on nonTIMI criteria - see section 4.8) Urgent revascularisation * excludes major bleeding component. 
Miokardni infarkt Večja krvavitev** (na osnovi ne-TIMI kriterijev - glejte poglavje
Bleeding has been observed in some reports of overdose. 
Pri nekaterih primerih prevelikega odmerjanja so se pojavile krvavitve.
Ischaemic Components All cause death 
Kompozita ishemije Smrt
REPLACE-2 major bleeding was defined as the occurrence of any of the following: intracranial haemorrhage, retroperitoneal haemorrhage, blood loss leading to a transfusion of at least two units of whole blood or packed red blood cells, or bleeding resulting in a haemoglobin drop of more than 3 g/dl, or a fall in haemoglobin greater than 4 g/dl (or 12% of haematocrit) with no bleeding site identified. 
Večja krvavitev je bila v študiji REPLACE-2 opredeljena kot: intrakranialna krvavitev, retroperitonealna krvavitev, izguba krvi, ki vodi do transfuzije vsaj dveh enot krvi ali zapakiranih krvnih celic ali krvavitev, ki povzroči zmanjšanje koncentracije hemoglobina za 3 g/dl ali več ali padec hemoglobina za 4 g/dl ali več (ali 12% hematokrita) brez očitnega mesta krvavitve.
Arm A UFH/enox +GP IIb/IIIa inhibitor (N=4,603) 
Krak A UFH/enoks + zaviralec GPIIb/IIIa (N=4.603)
Serious adverse reactions were reported more frequently in the heparin plus GP IIb/IIIa group than the bivalirudin treated group. 
Neželeni učinki so bili pogostejši pri skupini bolnikov, zdravljenih s heparinom in zaviralcem GP IIb/IIIa, kot pri skupini, zdravljeni z bivalirudinom.
2% in patients receiving bivalirudin versus 1.9% in patients receiving UFH plus GP IIb/IIIa inhibitor (p=0.1553). 
Pogostnost tromboze stenta med 24 urami in 30 dnevi je bila 1,2% pri bolnikih, ki so prejemali bivalirudin, ter 1,9% pri bolnikih, ki so prejemali UFH in zaviralec GP IIb/IIIa (p=0,1553).
- if you have, or have had, difficulty with your blood clotting (a low platelet count). 
- če imate ali ste imeli težave s strjevanjem krvi (majhno število trombocitov), - če imate zelo visok krvni tlak, - če imate okužbo srčnega tkiva, - če imate hude težave z ledvicami ali če potrebujete ledvično dializo.
Angiox 250 mg powder for concentrate for solution for injection or infusion bivalirudin 
Angiox 250 mg prašek za koncentrat za raztopino za injiciranje ali infundiranje bivalirudin
Major bleeding occurred most frequently at the sheath puncture site. 
Večje krvavitve so se najpogosteje pojavile na mestu vboda.
Bival + GP IIb/IIIa inhibitor (N=2,924) 
bival + zaviralec GP IIb/IIIa (N=2.924)
The ACUITY Trial (Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI)) 
Študija ACUITY (Pacienti z nestabilno angino/ miokardnim infarktom brez zvišanja intervala ST (UA/NSTEMI))
ACUITY Trial (Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI) 
Študija ACUITY (Bolniki z nestabilno angino/ miokardnim infarktom brez zvišanja intervala ST (UA/NSTEMI)
The reconstituted/diluted solution should be inspected visually for particulate matter and discolouration. 
Preglejte, ali rekonstituirana/razredčena raztopina vsebuje delce in ali je barvno spremenjena.
ACUITY scale major bleeding 
Večja krvavitev po lestvici ACUITY
In ACUITY, bleeding data were collected separately from adverse reactions. 
Trombociti, krvavitev in koagulacija V ACUITY so bili podatki o krvavitvah zbrani ločeno od neželenih učinkov.
The infusion of 1.75 mg/kg body weight/hour may be continued for up to 4 hours post-PCI and at a reduced dose of 0.25 mg/kg body weight/hour for an additional 4 - 12 hours as clinically necessary. 
Infundiranje 1,75 mg/kg telesne mase/h se lahko nadaljuje še največ 4 ure po PCI in nato še, v skladu s kliničnimi potrebami, 4-12 ur z infundiranjem zmanjšanega odmerka 0,25 mg/kg/h.
Gum bleeding (uncommon, may affect up to 1 in 100 people) is usually not serious. 
Krvavitev dlesni (občasno, pojavi se lahko pri največ 1 od 100 ljudi).
Major bleeding was defined as the occurrence of any of the following: intracranial haemorrhage, retroperitoneal haemorrhage, blood loss leading to a transfusion of at least two units of whole blood or packed red blood cells, or bleeding resulting in a haemoglobin drop of more than 3 g/dl, or a fall in haemoglobin greater than 4 g/dl (or 12% of haematocrit) with no bleeding site identified. 
Večja krvavitev je opredeljena kot pojav naslednjega: intrakranialna krvavitev, retroperitonealna krvavitev, izguba krvi, ki pripelje do transfuzije najmanj dveh enot celih ali pakiranih krvnih celic ali krvavitev, katere rezultat je zmanjšanje koncentracije hemoglobina za več kot 3 g/dl, ali zmanjšanje koncentracije hemoglobina za več kot 4 g/dl (ali 12 % hematokrita) brez očitnega vira krvavitve.
After dilution 1 ml contains 5 mg bivalirudin. 
Po razredčitvi 1 ml vsebuje 5 mg bivalirudina.
Arm B bival +GP IIb/IIIa inhibitor (N=4,604) 
Krak B bival + zaviralec GPIIb/IIIa (N=4.604)
Epistaxis, Haemoptysis, Pharyngeal haemorrhage 
Bolezni ledvic in sečil hematurija
Lyophilised powder: Do not store above 25C. 
Razredčena raztopina: Shranjujte pri temperaturi do 25°C.
• 0.75 mg/kg body weight as an intravenous injection, followed immediately by an infusion (drip) into vein of 1.75 mg/kg body weight, per hour for at least the duration of the PCI. 
• 0,75 mg/kg telesne mase v obliki intravenske injekcije, ki ji sledi infundiranje (kapljično) v veno 1,75 mg/kg telesne mase na uro, ki traja vsaj toliko kot PCI.
Store in a refrigerator (2C-8C). 
oC. Shranjujte v hladilniku (2
The infusion may be followed by an infusion at a lower dose of 0.25 mg/kg body weight 
Infuziji lahko sledi infuzija z manjšim odmerkom 0,25 mg/kg telesne mase, ki traja še 4-12 ur.
Do not store above 25C. 
Shranjujte pri temperaturi do 25
Check with the doctor if you are unsure. 
Če ste negotovi, se posvetujte s svojim zdravnikom.
Arm B bival +GP IIb/IIIa inhibitor (N=2,924) 
Krak B bival + zaviralec GPIIb/IIIa (N=2.924)
Famotidine 
Dojenje
Add 5 ml sterile water for injections to one vial of Angiox and swirl gently until completely dissolved and the solution is clear. 
Vialo zdravila Angiox nežno vrtite tako dolgo, da se prašek popolnoma raztopi in je raztopina bistra.
An increase in the activated clotting time (ACT) may be used as an indication that a patient has received bivalirudin. 
Kot znak, da je bolnik prejel bivalirudin, se lahko uporablja zvečan aktivirani čas strjevanja krvi (ACT- activated clotting time).
Ear haemorrhage 
Okvara jeter
Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI) 
Bolniki z nestabilno angino/ miokardnim infarktom brez zvišanja intervala ST (UA/NSTEMI)
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja ekhimoza izpuščaj, urtikarija
Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience 
Neželeni učinki bivalirudina iz preskušanj HORIZONS, ACUITY,
Peritoneal haemorrhage, Retroperitoneal haematoma, Vomiting 
Bolezni dihal, torakalne in mediastinalne bolezni epitaksa, hemoptiza, faringealna krvavitev pulmonalna krvavitev, dispneja a
• Approved dose in patients undergoing percutaneous coronary intervention (PCI): The licensed and approved dosing regimen of Angiox is an intravenous (IV) bolus injection of 0.75 mg/kg body weight followed immediately by an intravenous infusion at 1.75 mg/kg/hour for at least the duration of the PCI. 
Bolniki, pri katerih se bo izvedla PCI, vključno z bolniki z miokardnim infarktom z zvišanjem intervala ST (STEMI), pri katerih se bo izvedla primarna PCI Priporočeni odmerek bivalirudina pri bolnikih, pri katerih se bo izvedla PCI, je intravenski bolus 0,75 mg/kg telesne mase, ki mu takoj sledi intravensko infundiranje s hitrostjo 1,75 mg/kg telesne mase/h vsaj v času trajanja postopka.
Haloperidol lactate 
10 mg/ml haloperidolijev laktat
Major bleeding rates in clinical trials of bivalirudin 30 day endpoints for intent-to 
**p < 0,001 Preglednica 6: Delež večjih krvavitev kot opazovanih dogodkov v 30-dnevnem kliničnem preskušanju z bivalirudinom pri vključeni (intent-to-treat) populaciji
Reconstituted solution: Store in a refrigerator (2-8C). 
Liofiliziran prašek: Shranjujte pri temperaturi do 25 C. Rekonstituirana raztopina: Shranjujte v hladilniku (2
Patients receiving acetylsalicylic acid & clopidogrel as per protocol* Arm A UFH/enox +GP IIb/IIIa inhibitor (N=2,842) 
Krak A UFH/enoks + zaviralec GPIIb/IIIa (N=2.842)
Talk to your doctor before using Angiox. 
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Angiox se posvetujte z zdravnikom.
- If you have any further questions, ask your doctor. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom.Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
Musculoskeletal and connective tissue disorders 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečine v hrbtu, bolečine v dimljah
Catheter thrombosis, Vascular pseudoaneurysm 
tromboza, vključno s poročili o smrtnem izidu, arteriovenska fistula, katetrska tromboza, vaskularni psevdoanevrizem utesnitveni sindrom a, b
Treatment should be stopped if bleeding is observed or suspected. 
V primeru krvavitve ali suma na krvavitev prekinite zdravljenje.
• severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients 4.4 Special warnings and precautions for use 
• hudo ledvično okvaro (GFR < 30 ml/min) in pri dializnih bolnikih
Pulmonary haemorrhage Dyspnoea a 
Bolezni živčevja glavobol možganska krvavitev
Sandwich, Kent CT13 9NJ United Kingdom 
Sandwich, Kent CT13 9NJ Velika Britanija
via Isonzo, 71 04100 Latina Italy 
via Isonzo, 71 04100 Latina Italija
Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States 
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
United Kingdom Pfizer Limited Ramsgate Road 
Velika Britanija Pfizer Limited Ramsgate Road
Member State (in EEA) 
Država članica EU/EGP
Marketing authorisaton holder INN Invented name 
Izmišljeno ime
1123 Budapest 
Budapest Madžarska
--1 5.1 - 9.4 μg pUK-SPDV-poly2#1 DNA plasmid 
--1 5,1-9,4 μg plazmidne DNK pUK-SPDV-poly2#1
Bag (ethyl vinyl acetate) 
Vrečka (etil vinil acetat)
Zero degree days 
1 vrečka Nič dnevnih stopinj
MA 01701 United States 
MA 01701 Združene države Amerike
Date of first authorisation: 03 August 2001 Date of last renewal: 03 August 2006 
Datum prve odobritve: 3. avgust 2001 Datum zadnjega podaljšanja: 3. avgust 2006
Antibody status should be regularly monitored. 
Stanje protiteles je treba redno spremljati.
Not known (frequency cannot be estimated from the available data): 
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
ATC code: A16AB04. 
Oznaka ATC: A16AB04.
Genotoxic and carcinogenic potential are not expected. 
Genotoksičnosti in kancerogenosti ni pričakovati.
The current medical standards for emergency treatment are to be observed. 
Upoštevati morate veljavne medicinske standarde za urgentno zdravljenje.
Talk to your doctor first. 
Najprej se posvetujte z zdravnikom.
Because this condition is slowly progressive, early detection and treatment is critical to achieve the best outcomes. 
Ker je to stanje počasi napredujoče, je za doseganje najboljših izidov pomembno zgodnje odkritje in zdravljenje.
Studies with regard to other stages of the development have not been carried out. 
Študije vpliva na druge stopnje razvoja niso bile opravljene.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same infusion. 
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili v isti infuziji.
The frequency of these reactions decreased over time. 
Pogostnost teh reakcij je sčasoma upadla.
• sudden swelling of the face or throat 
• nenadno zatekanje obraza ali grla
Do not use this medicine after the expiry date which is stated on the label after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake „EXP“.
You may need to be given additional medicines to prevent such reactions from occurring. 
Morda boste za preprečevanje nastanka takih reakcij potrebovali dodatna zdravila.
These reported symptoms resemble the natural course of Fabry disease. 
Ti simptomi so bili podobni naravnemu poteku Fabryjeve bolezni.
Your doctor may advise that you can be treated at home provided you meet certain criteria. 
Zdravnik vam bo morda svetoval zdravljenje na domu, če izpolnjujete določena merila.
Results were similar between the two treatment groups. 
Rezultati med terapevtskima skupinama so bili podobni.
Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development (see section 5.3). 
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na razvoj zarodka/plodu (glejte poglavje 5.3).
This leaflet was last revised in Other sources of information 
Navodilo je bilo nazadnje revidirano dne Drugi viri informacij:
These patients should be treated with caution when re-administering agalsidase beta (see section 4.8). 
Te bolnike bi morali pri ponovnemu dajanju agalzidaze beta obravnavati previdno (glejte poglavje 4.8).
The majority of these reactions can be attributed to the formation of IgG antibodies and/or complement activation. 
Večino teh reakcij lahko pripišemo nastanku protiteles IgG in/ali aktivaciji komplementa.
Fabrazyme is indicated in adults, children and adolescents aged 8 years and older. 
Zdravilo Fabrazyme je indicirano pri odraslih, otrocih in mladostnikih, starih 8 let in več.
The reconstituted solution must be diluted further (see section 6.6). 
Rekonstituirano raztopino je treba dodatno redčiti (glejte poglavje 6.6).
For the purpose of this table, ≥1% is defined as reactions occurring in 2 or more patients. 
Za to preglednico je vrednost ≥1% opredeljena kot učinek, do katerega je prišlo pri dveh ali več bolnikih.
Plasma GL-3 levels rapidly normalised with treatment and remained normal through 5 years. 
Nivoji plazemskega GL-3 so se z zdravljenjem hitro normalizirali in so ostali normalni tekom 5 let.
Intravenous use. 
intravenska uporaba.
• red eyes 
• rdeče oči
- if you are allergic to agalsidase beta or any of the other ingredients of this medicine (listed in section 6). 
- Če ste alergični na agalzidazo beta ali katero koli sestavino tega zdravila (navedene v poglavju 6).
Each vial of Fabrazyme is intended for single use only. 
Vsaka viala zdravila Fabrazyme je namenjena le enkratni uporabi.
Currently available data are described in sections 5.1 and 5.2 but no recommendation on posology can be made in children aged 5 to 7 years. 
Podatki, ki so trenutno na voljo, so opisani v poglavjih 5.1 in 5.2, toda priporočil za odmerjanje pri otrocih v starosti od 0 do 7 let ni mogoče dati.
It is characterised by the deficiency of α-galactosidase. 
Zanjo je značilno pomanjkanje encima α-galaktozidaze.
The pH of the reconstituted solution is approximately 7.0. 
pH vrednost rekonstituirane raztopine je približno 7,0.
• Additional risk minimisation measures 
• Dodatni ukrepi za zmajševanje tveganj
Fabrazyme pharmacokinetics was also evaluated in two paediatric studies. 
Farmakokinetika zdravila Fabrazyme je bila ocenjena v dveh pediatričnih študijah.
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
Sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction. 
Sedeminšestdeset odstotkov (67 %) bolnikov je imelo vsaj eno reakcijo, povezano z infuzijo.
The elimination half-life was dose independent and ranged from 45 to 100 minutes. 
Razpolovni čas izločanja je bil odvisen od odmerka in je bil od 45 do 100 minut.
Renal function, as measured by glomerular filtration rate and serum creatinine, as well as proteinuria, remained stable in the majority of the patients. 
Delovanje ledvic, merjeno s hitrostjo glomerularne filtracije in serumskim kreatininom, kot tudi proteinurija, so ostali stabilni pri večini bolnikov.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 10 VIALS) 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (1 VIALA, 5 VIAL, 10 VIAL)
Although no specific study has been conducted to assess the effect on the neurological signs and symptoms, the results also indicate that patients may achieve reduced pain and enhanced quality of life upon enzyme replacement therapy. 
Čeprav ni bilo izvedene posebne študije za ocenitev učinka na nevrološke znake in simptome, rezultati kažejo, da po encimskem nadomestnem zdravljenju pri bolnikih lahko pride do zmanjšanja bolečin in izboljšanja kvalitete življenja.
Clearance of GL-3 was also achieved in several other cell types from the kidney. 
Očistek GL-3 je bil dosežen tudi pri nekaterih drugih vrstah ledvičnih celic.
If you suffer from Fabry disease a fat substance, called globotriaosylceramide (GL-3), is not removed from the cells of your body and starts to accumulate in the walls of the blood vessels of your organs. 
Če imate Fabryjevo bolezen, se maščobna snov globotriaozilceramid (GL-3) ne odstranjuje iz telesnih celic in se začne kopičiti v stenah krvnih žil vaših organov.
Your doctor may decide to lower the infusion rate or give you additional medicines to prevent such reactions from occurring. 
Vaš zdravnik bo morda presodil, da je treba zmanjšati hitrost infundiranja ali da morate prejemati dodatna zdravila za preprečevanje pojavljanja takšnih reakcij.
Efficacy and safety of Fabrazyme was evaluated in two studies with children, one dose-finding study, two double-blind placebo-controlled studies, and one open-label extension study in both male and female patients. 
Klinična učinkovitost in varnost Učinkovitost in varnost zdravila Fabrazyme je bila ovrednotena z dvema študijama pri otrocih, eno študijo ugotavljanja odmerka, dvema dvojno slepima s placebom nadzorovanima študijama in eno razširjeno študijo odprtega tipa pri moških in ženskih bolnikih.
Do not invert, swirl or shake the vial. 
Viale ne obračajte, vrtite ali pretresajte.
This clearance was achieved in 69% (20/29) of the Fabrazyme treated patients, but in none of the placebo patients (p<0.001). 
Očistek je bil dosežen pri 69 % (20/29) bolnikov, zdravljenih z zdravilom Fabrazyme, in pri nobenem od tistih, ki so prejemali placebo (p<0,001).
Use Aseptic Technique 
Uporabite aseptično tehniko.
Adverse reactions were mostly mild to moderate in severity: 
Po jakosti so bili neželeni učinki večinoma blagi do zmerni:
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)). 
Stopnja kliničnih dogodkov je bila precej nižja pri bolnikih, zdravljenih z zdravilom Fabrazyme, kot pri bolnikih, zdravljenih s placebom (zmanjšanje tveganja = 53 % populacija namenjena za zdravljenje (p=0,0577); zmanjšanje tveganja = 61 % protokolna populacija (p=0,0341)).
The results of these studies indicate that Fabrazyme treatment at 1 mg/kg every other week provides clinical benefit on key clinical outcomes in patients with early and advanced Fabry disease. 
Rezultati teh študij pomenijo, da zdravljenje z zdravilom Fabrazyme 1 mg/kg vsak drugi teden zagotavlja klinično prednost pri ključnih kliničnih izidih pri bolnikih z zgodnjo in razvito obliko Fabryjeve bolezni.
Infusion associated reactions 
Reakcije, povezane z infuzijo