FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Arm A UFH/enox +GP IIb/IIIa inhibitor (N=4,603)
Slovenian: Krak A UFH/enoks + zaviralec GPIIb/IIIa (N=4.603)
English: Serious adverse reactions were reported more frequently in the heparin plus GP IIb/IIIa group than the bivalirudin treated group.
Slovenian: Neželeni učinki so bili pogostejši pri skupini bolnikov, zdravljenih s heparinom in zaviralcem GP IIb/IIIa, kot pri skupini, zdravljeni z bivalirudinom.
English: 2% in patients receiving bivalirudin versus 1.9% in patients receiving UFH plus GP IIb/IIIa inhibitor (p=0.1553).
Slovenian: 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).
English: - if you have, or have had, difficulty with your blood clotting (a low platelet count).
Slovenian: - 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.
English: Angiox 250 mg powder for concentrate for solution for injection or infusion bivalirudin
Slovenian: Angiox 250 mg prašek za koncentrat za raztopino za injiciranje ali infundiranje bivalirudin
English: Major bleeding occurred most frequently at the sheath puncture site.
Slovenian: Večje krvavitve so se najpogosteje pojavile na mestu vboda.
English: Bival + GP IIb/IIIa inhibitor (N=2,924)
Slovenian: bival + zaviralec GP IIb/IIIa (N=2.924)
English: The ACUITY Trial (Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI))
Slovenian: Študija ACUITY (Pacienti z nestabilno angino/ miokardnim infarktom brez zvišanja intervala ST (UA/NSTEMI))
English: ACUITY Trial (Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI)
Slovenian: Študija ACUITY (Bolniki z nestabilno angino/ miokardnim infarktom brez zvišanja intervala ST (UA/NSTEMI)
English: The reconstituted/diluted solution should be inspected visually for particulate matter and discolouration.
Slovenian: Preglejte, ali rekonstituirana/razredčena raztopina vsebuje delce in ali je barvno spremenjena.
English: ACUITY scale major bleeding
Slovenian: Večja krvavitev po lestvici ACUITY
English: In ACUITY, bleeding data were collected separately from adverse reactions.
Slovenian: Trombociti, krvavitev in koagulacija V ACUITY so bili podatki o krvavitvah zbrani ločeno od neželenih učinkov.
English: 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.
Slovenian: 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.
English: Gum bleeding (uncommon, may affect up to 1 in 100 people) is usually not serious.
Slovenian: Krvavitev dlesni (občasno, pojavi se lahko pri največ 1 od 100 ljudi).
English: 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.
Slovenian: 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.
English: After dilution 1 ml contains 5 mg bivalirudin.
Slovenian: Po razredčitvi 1 ml vsebuje 5 mg bivalirudina.
English: Arm B bival +GP IIb/IIIa inhibitor (N=4,604)
Slovenian: Krak B bival + zaviralec GPIIb/IIIa (N=4.604)
English: Epistaxis, Haemoptysis, Pharyngeal haemorrhage
Slovenian: Bolezni ledvic in sečil hematurija
English: Lyophilised powder: Do not store above 25C.
Slovenian: Razredčena raztopina: Shranjujte pri temperaturi do 25°C.
English: • 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.
Slovenian: • 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.
English: Store in a refrigerator (2C-8C).
Slovenian: oC. Shranjujte v hladilniku (2
English: The infusion may be followed by an infusion at a lower dose of 0.25 mg/kg body weight
Slovenian: Infuziji lahko sledi infuzija z manjšim odmerkom 0,25 mg/kg telesne mase, ki traja še 4-12 ur.
English: Do not store above 25C.
Slovenian: Shranjujte pri temperaturi do 25
English: Check with the doctor if you are unsure.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom.
English: Arm B bival +GP IIb/IIIa inhibitor (N=2,924)
Slovenian: Krak B bival + zaviralec GPIIb/IIIa (N=2.924)
English: Famotidine
Slovenian: Dojenje
English: Add 5 ml sterile water for injections to one vial of Angiox and swirl gently until completely dissolved and the solution is clear.
Slovenian: Vialo zdravila Angiox nežno vrtite tako dolgo, da se prašek popolnoma raztopi in je raztopina bistra.
English: An increase in the activated clotting time (ACT) may be used as an indication that a patient has received bivalirudin.
Slovenian: Kot znak, da je bolnik prejel bivalirudin, se lahko uporablja zvečan aktivirani čas strjevanja krvi (ACT- activated clotting time).
English: Ear haemorrhage
Slovenian: Okvara jeter
English: Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI)
Slovenian: Bolniki z nestabilno angino/ miokardnim infarktom brez zvišanja intervala ST (UA/NSTEMI)
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja ekhimoza izpuščaj, urtikarija
English: Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience
Slovenian: Neželeni učinki bivalirudina iz preskušanj HORIZONS, ACUITY,
English: Peritoneal haemorrhage, Retroperitoneal haematoma, Vomiting
Slovenian: Bolezni dihal, torakalne in mediastinalne bolezni epitaksa, hemoptiza, faringealna krvavitev pulmonalna krvavitev, dispneja a
English: • 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.
Slovenian: 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.
English: Haloperidol lactate
Slovenian: 10 mg/ml haloperidolijev laktat
English: Major bleeding rates in clinical trials of bivalirudin 30 day endpoints for intent-to
Slovenian: **p < 0,001 Preglednica 6: Delež večjih krvavitev kot opazovanih dogodkov v 30-dnevnem kliničnem preskušanju z bivalirudinom pri vključeni (intent-to-treat) populaciji
English: Reconstituted solution: Store in a refrigerator (2-8C).
Slovenian: Liofiliziran prašek: Shranjujte pri temperaturi do 25 C. Rekonstituirana raztopina: Shranjujte v hladilniku (2
English: Patients receiving acetylsalicylic acid & clopidogrel as per protocol* Arm A UFH/enox +GP IIb/IIIa inhibitor (N=2,842)
Slovenian: Krak A UFH/enoks + zaviralec GPIIb/IIIa (N=2.842)
English: Talk to your doctor before using Angiox.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Angiox se posvetujte z zdravnikom.
English: - If you have any further questions, ask your doctor.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom.Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečine v hrbtu, bolečine v dimljah
English: Catheter thrombosis, Vascular pseudoaneurysm
Slovenian: tromboza, vključno s poročili o smrtnem izidu, arteriovenska fistula, katetrska tromboza, vaskularni psevdoanevrizem utesnitveni sindrom a, b
English: Treatment should be stopped if bleeding is observed or suspected.
Slovenian: V primeru krvavitve ali suma na krvavitev prekinite zdravljenje.
English: • severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients 4.4 Special warnings and precautions for use
Slovenian: • hudo ledvično okvaro (GFR < 30 ml/min) in pri dializnih bolnikih
English: Pulmonary haemorrhage Dyspnoea a
Slovenian: Bolezni živčevja glavobol možganska krvavitev
English: Sandwich, Kent CT13 9NJ United Kingdom
Slovenian: Sandwich, Kent CT13 9NJ Velika Britanija
English: via Isonzo, 71 04100 Latina Italy
Slovenian: via Isonzo, 71 04100 Latina Italija
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
English: Pfizer Gyógyszerkereskedelmi Kft. Alkotás St 53
Slovenian: Pfizer Gyógyszerkereskedelmi Kft. Alkotás u. 53.
English: United Kingdom Pfizer Limited Ramsgate Road
Slovenian: Velika Britanija Pfizer Limited Ramsgate Road
English: Member State (in EEA)
Slovenian: Država članica EU/EGP
English: Pfizer ApS, Lautrupvang 8, 2750 Ballerup Denmark
Slovenian: Pfizer ApS, Lautrupvang 8, 2750 Ballerup Danska
English: 2909 LD, Capelle a/d Ijssel The Netherlands
Slovenian: Capelle a/d Ijssel Nizozemska
English: Acipimox Olbetam 250 mg kemény kapszula
Slovenian: Olbetam 250 mg Kemény kapszula
English: Luxembourg PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles
Slovenian: Luksemburg PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles
English: Acipimox Olbetam 250 mg Capsules 250 mg capsule
Slovenian: Olbetam 250 mg Capsules
English: Marketing authorisaton holder INN Invented name
Slovenian: Izmišljeno ime
English: 1123 Budapest
Slovenian: Budapest Madžarska
English: Belgium PFIZER S.A. Boulevard de la Plaine 17 1050 Ixelles
Slovenian: Boulevard de la Plaine 17 1050 Ixelles
English: The Netherlands Pfizer B.V. Rivium Westlaan 142
Slovenian: Pfizer B.V.
English: Acipimox Olbetam - Kapseln
Slovenian: Olbetam - Kapseln 250 mg
English: Atlantic salmon (Salmo salar)
Slovenian: Atlantski losos (Salmo salar)
English: --1 5.1 - 9.4 μg pUK-SPDV-poly2#1 DNA plasmid
Slovenian: --1 5,1-9,4 μg plazmidne DNK pUK-SPDV-poly2#1
English: Bag (ethyl vinyl acetate)
Slovenian: Vrečka (etil vinil acetat)
English: Zero degree days
Slovenian: 1 vrečka Nič dnevnih stopinj
English: MA 01701 United States
Slovenian: MA 01701 Združene države Amerike
English: Date of first authorisation: 03 August 2001 Date of last renewal: 03 August 2006
Slovenian: Datum prve odobritve: 3. avgust 2001 Datum zadnjega podaljšanja: 3. avgust 2006
English: Antibody status should be regularly monitored.
Slovenian: Stanje protiteles je treba redno spremljati.
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: ATC code: A16AB04.
Slovenian: Oznaka ATC: A16AB04.
English: Genotoxic and carcinogenic potential are not expected.
Slovenian: Genotoksičnosti in kancerogenosti ni pričakovati.
English: The current medical standards for emergency treatment are to be observed.
Slovenian: Upoštevati morate veljavne medicinske standarde za urgentno zdravljenje.
English: Talk to your doctor first.
Slovenian: Najprej se posvetujte z zdravnikom.
English: Because this condition is slowly progressive, early detection and treatment is critical to achieve the best outcomes.
Slovenian: Ker je to stanje počasi napredujoče, je za doseganje najboljših izidov pomembno zgodnje odkritje in zdravljenje.
English: Studies with regard to other stages of the development have not been carried out.
Slovenian: Študije vpliva na druge stopnje razvoja niso bile opravljene.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same infusion.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili v isti infuziji.
English: The frequency of these reactions decreased over time.
Slovenian: Pogostnost teh reakcij je sčasoma upadla.
English: • sudden swelling of the face or throat
Slovenian: • nenadno zatekanje obraza ali grla
English: Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake „EXP“.
English: You may need to be given additional medicines to prevent such reactions from occurring.
Slovenian: Morda boste za preprečevanje nastanka takih reakcij potrebovali dodatna zdravila.
English: These reported symptoms resemble the natural course of Fabry disease.
Slovenian: Ti simptomi so bili podobni naravnemu poteku Fabryjeve bolezni.
English: Your doctor may advise that you can be treated at home provided you meet certain criteria.
Slovenian: Zdravnik vam bo morda svetoval zdravljenje na domu, če izpolnjujete določena merila.
English: Results were similar between the two treatment groups.
Slovenian: Rezultati med terapevtskima skupinama so bili podobni.
English: Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na razvoj zarodka/plodu (glejte poglavje 5.3).
English: 1105 BP Amsterdam The Netherlands
Slovenian: 1105 BP Amsterdam Nizozemska
English: This leaflet was last revised in Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne Drugi viri informacij:
English: These patients should be treated with caution when re-administering agalsidase beta (see section 4.8).
Slovenian: Te bolnike bi morali pri ponovnemu dajanju agalzidaze beta obravnavati previdno (glejte poglavje 4.8).
English: The majority of these reactions can be attributed to the formation of IgG antibodies and/or complement activation.
Slovenian: Večino teh reakcij lahko pripišemo nastanku protiteles IgG in/ali aktivaciji komplementa.
English: Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.
Slovenian: Zdravilo Fabrazyme je indicirano pri odraslih, otrocih in mladostnikih, starih 8 let in več.
English: The reconstituted solution must be diluted further (see section 6.6).
Slovenian: Rekonstituirano raztopino je treba dodatno redčiti (glejte poglavje 6.6).
English: For the purpose of this table, ≥1% is defined as reactions occurring in 2 or more patients.
Slovenian: Za to preglednico je vrednost ≥1% opredeljena kot učinek, do katerega je prišlo pri dveh ali več bolnikih.
English: Plasma GL-3 levels rapidly normalised with treatment and remained normal through 5 years.
Slovenian: Nivoji plazemskega GL-3 so se z zdravljenjem hitro normalizirali in so ostali normalni tekom 5 let.
English: Intravenous use.
Slovenian: intravenska uporaba.
English: • red eyes
Slovenian: • rdeče oči
English: - if you are allergic to agalsidase beta or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - Če ste alergični na agalzidazo beta ali katero koli sestavino tega zdravila (navedene v poglavju 6).
English: Each vial of Fabrazyme is intended for single use only.
Slovenian: Vsaka viala zdravila Fabrazyme je namenjena le enkratni uporabi.
English: 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.
Slovenian: 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.
English: It is characterised by the deficiency of α-galactosidase.
Slovenian: Zanjo je značilno pomanjkanje encima α-galaktozidaze.
English: The pH of the reconstituted solution is approximately 7.0.
Slovenian: pH vrednost rekonstituirane raztopine je približno 7,0.
English: • Additional risk minimisation measures
Slovenian: • Dodatni ukrepi za zmajševanje tveganj
English: Fabrazyme pharmacokinetics was also evaluated in two paediatric studies.
Slovenian: Farmakokinetika zdravila Fabrazyme je bila ocenjena v dveh pediatričnih študijah.
English: 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.
Slovenian: 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.
English: Sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction.
Slovenian: Sedeminšestdeset odstotkov (67 %) bolnikov je imelo vsaj eno reakcijo, povezano z infuzijo.
English: The elimination half-life was dose independent and ranged from 45 to 100 minutes.
Slovenian: Razpolovni čas izločanja je bil odvisen od odmerka in je bil od 45 do 100 minut.
English: Renal function, as measured by glomerular filtration rate and serum creatinine, as well as proteinuria, remained stable in the majority of the patients.
Slovenian: Delovanje ledvic, merjeno s hitrostjo glomerularne filtracije in serumskim kreatininom, kot tudi proteinurija, so ostali stabilni pri večini bolnikov.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 10 VIALS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (1 VIALA, 5 VIAL, 10 VIAL)
English: 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.
Slovenian: 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.
English: Clearance of GL-3 was also achieved in several other cell types from the kidney.
Slovenian: Očistek GL-3 je bil dosežen tudi pri nekaterih drugih vrstah ledvičnih celic.
English: 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.
Slovenian: 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.
English: Your doctor may decide to lower the infusion rate or give you additional medicines to prevent such reactions from occurring.
Slovenian: Vaš zdravnik bo morda presodil, da je treba zmanjšati hitrost infundiranja ali da morate prejemati dodatna zdravila za preprečevanje pojavljanja takšnih reakcij.
English: 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.
Slovenian: 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.
English: Do not invert, swirl or shake the vial.
Slovenian: Viale ne obračajte, vrtite ali pretresajte.
English: This clearance was achieved in 69% (20/29) of the Fabrazyme treated patients, but in none of the placebo patients (p<0.001).
Slovenian: 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).
English: Use Aseptic Technique
Slovenian: Uporabite aseptično tehniko.
English: Adverse reactions were mostly mild to moderate in severity:
Slovenian: Po jakosti so bili neželeni učinki večinoma blagi do zmerni:
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)).
Slovenian: 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)).
English: 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.
Slovenian: 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.
English: Infusion associated reactions
Slovenian: Reakcije, povezane z infuzijo
English: This finding was further supported by a statistically significant decrease in GL-3 inclusions in kidney, heart and skin combined and in the individual organs in patients treated with agalsidase beta compared to placebo patients (p<0.001).
Slovenian: Ta izsledek je bil podprt tudi s statistično občutnim zmanjšanjem skupnega števila inkluzij GL-3 v ledvicah, srcu in koži ter v posameznih organih bolnikov, zdravljenih z agalzidazo beta, v primerjavi s tistimi, ki so prejemali placebo (p<0,001).
English: In clinical trials doses up to 3 mg/kg body weight were used.
Slovenian: V kliničnih preskušanjih so uporabljali odmerke do 3 mg/kg telesne mase.
English: Remove the airspace within the infusion bag to minimize the air/liquid interface.
Slovenian: Odstranite zrak iz infuzijske vrečke, da čimbolj zmanjšate medsebojno delovanje zraka/tekočine.
English: In clinical trials, sixty seven percent (67 %) of the patients experienced at least one infusionassociated reaction (see section 4.8).
Slovenian: V kliničnih preskušanjih je sedeminšestdeset odstotkov (67 %) bolnikov imelo vsaj eno reakcijo, povezano z infuzijo (glejte poglavje 4.8).
English: Plasma GL-3 was cleared in a dose dependent manner, but was less consistent at the dose of 0.3 mg/kg.
Slovenian: Iz plazme se je GL-3 odstranjeval v odvisnosti od odmerka, vendar pa je bil ta učinek manj konsistenten pri odmerku 0,3 mg/kg.