FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Instructions for use - reconstitution, dilution and administration
Croatian: Upute za uporabu - rekonstitucija, razrjeđivanje i primjena
English: Contents of the pack and other information What Fabrazyme contains
Croatian: Sadržaj pakiranja i druge informacije Što Fabrazyme sadrži
English: - if you are allergic to agalsidase beta or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na agalzidazu beta ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The reconstituted solution must be diluted further (see section 6.6).
Croatian: Rekonstituirana otopina mora se dodatno razrijediti (vidjeti dio 6.6).
English: It is supplied as a powder which will be mixed with sterile water before it is given (see information for Health Care Professionals at the end of this leaflet).
Croatian: Dolazi u obliku praška koji se prije primjene miješa sa sterilnom vodom (vidjeti informacije za zdravstvene djelatnike na kraju ove upute).
English: Tell your doctor if you use any medicines containing chloroquine, amiodarone, benoquin or gentamicin.
Croatian: Obavijestite svog liječnika ako uzimate neki lijek koji sadrži klorokin, amiodaron, benokvin ili gentamicin.
English: It is characterised by the deficiency of α-galactosidase.
Croatian: Karakterizira je nedostatak α-galaktozidaze.
English: The pH of the reconstituted solution is approximately 7.0.
Croatian: vrijednost rekonstituirane otopine je otprilike 7,0.
English: White to off-white lyophilised cake or powder.
Croatian: Bijeli do bjelkasti liofilizirani kolačić ili prašak.
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.
Croatian: Trenutno dostupni podaci su opisani u dijelovima 5.1 i 5.2, ali nije moguće preporučiti režim doziranja za djecu u dobi od 5 do 7 godina.
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).
Croatian: To je postignuto u 47 od 49 bolesnika (96%) za koje su bili dostupni podaci u 6. mjesecu te u 8 od 8 bolesnika (100%) za koje su bili dostupni podaci na kraju ispitivanja (do ukupno 5 godina liječenja).
English: Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.
Croatian: Fabrazyme je indiciran u odraslih, djece i adolescenata u dobi od 8 i više godina.
English: If you have missed an infusion of Fabrazyme, please contact your doctor.
Croatian: Ako ste propustili infuziju lijeka Fabrazyme, molimo obratite se svom liječniku.
English: Your doctor may decide to lower the infusion rate or give you additional medicines to prevent such reactions from occurring.
Croatian: Liječnik može odlučiti smanjiti brzinu infuzije ili Vam može propisati dodatne lijekove za sprječavanje pojave takvih reakcija.
English: As with any intravenous protein medicinal product, allergic-type hypersensitivity reactions are possible.
Croatian: Kao i kod svakog drugog intravenskog proteinskog lijeka, moguće su alergijske reakcije preosjetljivosti.
English: Subsequent infusions may need to occur in a clinical setting.
Croatian: Daljnje infuzije će se možda morati primjenjivati u kliničkom okruženju.
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.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti jednokratne doze, toksičnosti ponovljenih doza i toksičnosti za embrij/plod.
English: The safety and efficacy of Fabrazyme in children aged 0 to7 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Fabrazyme u djece u dobi od 0 do 7 godina još nisu ustanovljene.
English: In some patients initially treated at the recommended dose, and whose dose was later reduced for an extended period, some symptoms of Fabry disease were reported more frequently.
Croatian: U nekih bolesnika, koji su na početku liječeni preporučenom dozom, a kasnije dulje vrijeme smanjenom dozom lijeka, češće su prijavljeni neki simptomi Fabryjeve bolesti.
English: This result was consistent across renal, cardiac and cerebrovascular events.
Croatian: Navedeni je rezultat bio konzistentan za bubrežne, srčane i cerebrovaskularne događaje.
English: What Fabrazyme looks like and contents of the pack
Croatian: Kako Fabrazyme izgleda i sadržaj pakiranja
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.
Croatian: Iako nije provedeno posebno ispitivanje za procjenu učinka na neurološke znakove i simptome, rezultati također ukazuju na to da se enzimskom nadomjesnom terapijom može ublažiti bol i povećati kvaliteta života bolesnika.
English: Reconstituted and diluted solutions
Croatian: Rekonstituirana i razrijeđena otopina
English: If you are treated with Fabrazyme, you may develop infusion associated reactions.
Croatian: Ako se liječite lijekom Fabrazyme, mogu se razviti reakcije povezane s infuzijom.
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).
Croatian: Nuspojave prijavljene nakon stavljanja lijeka u promet također su navedene u tablici pod kategorijom učestalosti "nepoznato" (ne može se procijeniti iz dostupnih podataka).
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.
Croatian: Ako bolujete od Fabryjeve bolesti, masna tvar zvana globotriaozilceramid (GL-3) ne uklanja se iz stanica tijela nego se počinje nakupljati u stijenkama krvnih žila organa.
English: An infusionassociated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4).
Croatian: Reakcija povezana s infuzijom je svaka nuspojava koja se javlja tijekom infuzije ili do kraja dana u kojem je infuzija primijenjena (vidjeti dio 4).
English: Avoid forceful impact of the water for injections on the powder and avoid foaming.
Croatian: Izbjegavajte naglo izlijevanje vode za injekcije na prašak i izbjegavajte pjenjenje.
English: Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Croatian: Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: Patients with advanced renal disease
Croatian: Bolesnici s uznapredovalom bolešću bubrega
English: Doses up to 3 mg/kg body weight have shown to be safe.
Croatian: Doze do 3 mg/kg tjelesne težine pokazale su se sigurnima.
English: Agalsidase beta
Croatian: agalzidaze beta.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće javiti kod svakoga.
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.
Croatian: Djelotvornost i sigurnost lijeka Fabrazyme procijenjena je u dva ispitivanja s djecom, jednom ispitivanju radi utvrđivanja doze, dva dvostruko slijepa, placebom kontrolirana ispitivanja te u jednom otvorenom produžetku ispitivanja s bolesnicima muškog i ženskog spola.
English: Fabrazyme should not be used during pregnancy unless clearly necessary.
Croatian: Fabrazyme se ne smije primjenjivati tijekom trudnoće, osim ako nije neophodno.
English: The majority of these reactions can be attributed to the formation of IgG antibodies and/or complement activation.
Croatian: Većina navedenih reakcija može se pripisati stvaranju IgG protutijela i/ili aktiviranju komplemenata.
English: If severe allergic or anaphylactic-type reactions occur, immediate discontinuation of the administration of Fabrazyme should be considered and appropriate treatment initiated.
Croatian: Ako se pojave alergijske ili anafilaktičke reakcije, treba razmotriti trenutni prekid primjene lijeka Fabrazyme i započeti odgovarajuće liječenje.
English: The majority of patients developed IgG antibodies to r-hαGAL, typically within 3 months of the first infusion with Fabrazyme.
Croatian: U većine su se bolesnika razvila IgG protutijela na r-hαGAL, obično unutar 3 mjeseca nakon prve infuzije lijeka Fabrazyme.
English: Plasma GL-3 was cleared in a dose dependent manner, but was less consistent at the dose of 0.3 mg/kg.
Croatian: Klirens GL-3 iz plazme ovisio je o dozi, ali je bio manje konzistentan kod doze od 0,3 mg/kg.
English: Infusion associated reactions consisted most often of fever and chills.
Croatian: Reakcije povezane s infuzijom najčešće su bile vrućica i zimica.
English: In clinical trials, sixty seven percent (67 %) of the patients experienced at least one infusionassociated reaction (see section 4.8).
Croatian: U kliničkim je ispitivanjima šezdeset i sedam posto (67%) bolesnika doživjelo barem jednu reakciju povezanu s infuzijom (vidjeti dio 4.8).
English: Infusion associated reactions
Croatian: Reakcije povezane s infuzijom
English: The reconstituted solution must be further diluted.
Croatian: Pripremljena otopina mora se dodatno razrijediti.
English: Sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction.
Croatian: U šezdeset i sedam posto (67%) bolesnika javila se barem jedna reakcija povezana s infuzijom.
English: In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related reactions”).
Croatian: U kliničkim su ispitivanjima nuspojave uglavnom zabilježene tijekom primjene lijeka ili nedugo nakon toga ("reakcije povezane s infuzijom").
English: If not used immediately, in-use storage and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika.
English: Agalsidase beta is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Croatian: Agalzidaza beta je protein i očekuje se da će se metabolički razgraditi peptidnom hidrolizom.
English: Package sizes: 1, 5 and 10 vials per carton.
Croatian: Veličine pakiranja: 1, 5 i 10 bočica u kutiji.
English: • influenza-like illness
Croatian: • bolest nalik gripi
English: Adverse reactions were mostly mild to moderate in severity:
Croatian: Nuspojave su uglavnom bile blagog do umjerenog intenziteta:
English: List of other side effects:
Croatian: Popis ostalih nuspojava:
English: If you experience a reaction like this, you should tell your doctor immediately.
Croatian: Ako doživite takvu reakciju, odmah o tome obavijestite svoga liječnika.
English: Renal function, as measured by glomerular filtration rate and serum creatinine, as well as proteinuria, remained stable in the majority of the patients.
Croatian: Bubrežna funkcija, mjerena brzinom glomeluralne filtracije i vrijednošću kreatinina u serumu te proteinurijom, ostala je stabilna u većine bolesnika.
English: No interaction studies and no in vitro metabolism studies have been performed.
Croatian: Nisu provedena ispitivanja interakcija ni ispitivanja metabolizma in vitro.
English: The decision to have a patient move to home infusion should be made after evaluation and recommendation by the treating physician.
Croatian: Odluka da se bolesnika prebaci na primjenu infuzije kod kuće smije se donijeti tek nakon procjene i preporuke nadležnog liječnika.
English: In clinical trials doses up to 3 mg/kg body weight were used.
Croatian: U kliničkim ispitivanjima primjenjivane su doze do 3 mg/kg tjelesne težine.
English: These patients should be treated with caution when re-administering agalsidase beta (see section 4.8).
Croatian: U tih bolesnika kod ponovne primjene agalzidaze beta liječenje treba provoditi uz oprez (vidjeti dio 4.8).
English: Another double-blind, placebo-controlled study of 82 patients was performed to determine whether Fabrazyme would reduce the rate of occurrence of renal, cardiac, or cerebrovascular disease or death.
Croatian: Provedeno je još jedno dvostruko slijepo, placebom kontrolirano ispitivanje s 82 bolesnika kako bi se utvrdilo može li Fabrazyme smanjiti stopu bubrežnih, srčanih ili cerebrovaskularnih bolesti odnosno smrti.
English: Plasma GL-3 levels rapidly normalised with treatment and remained normal through 5 years.
Croatian: Razine GL-3 u plazmi brzo su se normalizirale s liječenjem i ostale na normalnoj razini tijekom 5 godina.
English: Dose and infusion rate should remain constant while at home, and not be changed without supervision of a healthcare professional.
Croatian: Kad se infuzija primjenjuje kod kuće, doza i brzina moraju biti konstantne i ne smiju se mijenjati bez nadzora zdravstvenog djelatnika.
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).
Croatian: Ovaj nalaz dodatno podupire statistički značajno smanjenje inkluzija GL-3 u bubrezima, srcu i koži zajedno te u pojedinačnim organima u bolesnika liječenih agalzidazom beta u usporedbi s bolesnicima koji su primali placebo (p < 0,001).
English: Life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients listed in section 6.1.
Croatian: Po život opasna preosjetljivost (anafilaktička reakcija) na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: In the first placebo-controlled clinical trial, Fabrazyme was effective in clearing GL-3 from the vascular endothelium of the kidney after 20 weeks of treatment.
Croatian: U prvom placebom kontroliranom kliničkom ispitivanju Fabrazyme je učinkovito pročistio GL-3 iz krvožilnog endotela bubrega nakon 20 tjedana liječenja.
English: Remove the airspace within the infusion bag to minimize the air/liquid interface.
Croatian: Uklonite zrak iz infuzijske vrećice da bi kontakt između zraka i tekućine bio što manji.
English: Uncommon (may affect up to 1 in 100 people): • tremor
Croatian: Manje česte (mogu se javiti u manje od 1 na 100 osoba): • nevoljno drhtanje
English: Each vial of Fabrazyme is intended for single use only.
Croatian: Jedna bočica lijeka Fabrazyme namijenjena je isključivo za jednokratnu uporabu.
English: This clearance was achieved in 69% (20/29) of the Fabrazyme treated patients, but in none of the placebo patients (p<0.001).
Croatian: Takav je klirens postiglo 69% (20/29) bolesnika liječenih lijekom Fabrazyme, no niti jedan bolesnik koji je primao placebo (p < 0,001).
English: Because there are no data available on effects in neonates exposed to agalsidase beta via breast milk, it is recommended to stop breast-feeding when Fabrazyme is used.
Croatian: Budući da nema podataka o učincima izlaganja novorođenčadi agalzidazi beta putem majčinog mlijeka, preporučuje se prekinuti dojenje tijekom primjene lijeka Fabrazyme.
English: The risks and benefits of Fabrazyme in children aged 5 to 7 years have not yet been established and therefore no dose can be recommended for this age group.
Croatian: Rizici i koristi lijeka Fabrazyme u djece u dobi od 5 do 7 godina još nisu ustanovljeni pa se za tu dobnu skupinu ne može preporučiti doza.
English: Fabrazyme is given through a drip into a vein (by intravenous infusion).
Croatian: Fabrazyme se daje kapanjem (dripom) u venu (intravenskom infuzijom).
English: Investigations oxygen saturation decreased
Croatian: Pretrage smanjena saturacija kisikom
English: After IgG seroconversion, there was no apparent change in CL (+24% and +6%, resp.), while Vss was 1.8 and 2.2 fold higher, with the net effect being a small decrease in Cmax (up to -34% and -11%, resp.) and no change in AUC (-19% and6%, resp.).
Croatian: Nakon IgG serokonverzije nije bilo vidljive promjene CL-a (redom +24% odnosno +6%), dok je Vss bio 1,8 odnosno 2,2 puta viši s neto učinkom malog smanjenja Cmax vrijednosti (do -34% odnosno -11%) i bez promjene AUC vrijednosti (-19% odnosno
English: Adverse reaction terminology is based upon the Medical Dictionary for Regulatory Activities (MedDRA)
Croatian: Terminologija nuspojava temelji se na medicinskom rječniku za regulatorne poslove
English: • Home infusion manual for healthcare professionals
Croatian: • priručnik za primjenu infuzije kod kuće za zdravstvene djelatnike
English: In some of these patients, an increase of some of the following symptoms was spontaneously reported: pain, paraesthesia and diarrhoea, as well as cardiac, central nervous system and renal manifestations.
Croatian: U nekih od tih bolesnika spontano je prijavljeno povećanje nekih od sljedećih simptoma: boli, parestezije i proljeva te manifestacija na srcu, središnjem živčanom sustavu i bubrezima.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 10 VIALS)
Croatian: VANJSKO PAKIRANJE (1 BOČICA, 5 BOČICA, 10 BOČICA)
English: If you forget to use Fabrazyme
Croatian: Ako ste zaboravili primijeniti Fabrazyme
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, enzimi.
English: Agalsidase beta may be excreted in milk.
Croatian: Agalzidaza beta može se izlučivati u mlijeko.
English: The closure consists of a siliconised butyl stopper and an aluminium seal with a plastic flip-off cap.
Croatian: Zatvarač se sastoji od silikoniziranog butilnog čepa i aluminijskog zaštitnog zatvarača s plastičnom "flip-off" kapicom.
English: The infusion-associated reactions were managed by a reduction in the infusion rate together with the administration of non-steroidal anti-inflammatory medicinal products, antihistamines and/or corticosteroids.
Croatian: Reakcije povezane s infuzijom ublažene su smanjenjem brzine infuzije u kombinaciji s primjenom nesteroidnih protuupalnih lijekova, antihistaminika i/ili kortikosteroida.
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.
Croatian: Rezultati tih ispitivanja ukazuju na to da liječenje lijekom Fabrazyme u dozi od 1 mg/kg svaki drugi tjedan poboljšava ključne pokazatelje kliničkog ishoda u bolesnika s ranom i uznapredovalom Fabryjevom bolešću.
English: Patients experiencing adverse events during the home infusion need to immediately stop the infusion process and seek the attention of a healthcare professional.
Croatian: Bolesnici u kojih se tijekom primanja infuzije pojave nuspojave moraju odmah prekinuti infuziju i potražiti pomoć zdravstvenog djelatnika.
English: The reconstituted solution cannot be stored and should be promptly diluted; only the diluted solution can be held for up to 24 hours at 2°C-8°C.
Croatian: Rekonstituirana otopina ne može se čuvati i mora se odmah razrijediti; samo se razrijeđena otopina može čuvati do 24 sata na temperaturi od 2°C do 8°C.
English: Agalsidase beta is a recombinant form of human α-galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture.
Croatian: Agalzidaza beta je rekombinantni oblik ljudske α-galaktozidaze A, a proizvodi se tehnologijom rekombinantne DNK na staničnoj kulturi sisavaca, odnosno jajnika kineskog hrčka (engl.
English: Cardiac Disorders tachycardia, palpitations, bradycardia sinus bradycardia --
Croatian: Srčani poremećaji tahikardija, palpitacije, bradikardija sinusna bradikardija --
English: Determine the total volume of sodium chloride 0.9% solution for infusion (between 50 and 500 ml) based on the individual dose.
Croatian: Odredite ukupni volumen 0,9% otopine natrijevog klorida za infuziju (između 50 i 500 ml) na temelju pojedinačne doze.
English: Fabry disease is an inherited heterogeneous and multisystemic progressive disease, that affects both males and females.
Croatian: Fabryjeva bolest Fabryjeva bolest je nasljedna heterogena i višesustavna progresivna bolest koja pogađa i muškarce i žene.
English: Patients with antibodies to r-hαGAL have a greater potential to experience infusion-associated reactions (IARs), which are defined as any related adverse event occurring on the infusion day.
Croatian: U bolesnika s protutijelima na r-hαGAL postoji veća vjerojatnost od pojave reakcija povezanih s infuzijom koje se definiraju kao bilo koja povezana nuspojava koja se pojavi na dan infuzije.
English: The diluted solution can be held for up to 24 hours at 2°C - 8°C.
Croatian: Razrijeđena se otopina može čuvati do 24 sata na temperaturi 2°C - 8°C.
English: Vss ranged from 8.3-40.8 l, plasma clearance from 119-345 ml/min and the mean elimination half-life from 80-120 minutes.
Croatian: Vrijednost Vss iznosila je od 8,3 do 40,8 l, klirens iz plazme od 119 do 345 ml/min, a srednje poluvrijeme eliminacije od 80 do 120 minuta.
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Croatian: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska
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.
Croatian: Vrlo česti simptomi (mogu se javiti u više od 1 na 10 osoba) uključuju zimicu, vrućicu, osjećaj hladnoće, mučninu, povraćanje, glavobolju i neuobičajene osjete na koži, poput žarenja ili trnaca.
English: Reduced or absent αgalactosidase activity results in the accumulation of GL-3 in the lysosomes of many cell types including the endothelial and parenchymal cells, ultimately leading to life-threatening clinical deteriorations as a result of renal, cardiac and cerebrovascular complications.
Croatian: Smanjena aktivnost α-galaktozidaze ili njezin potpuni izostanak dovodi do kumulacije GL-3 u lizosomima mnogih vrsta stanica, uključujući stanice endotela i parenhimske stanice, što u konačnici dovodi do po život opasnih kliničkih pogoršanja kao posljedice bubrežnih, srčanih i cerebrovaskularnih komplikacija.
English: The educational material for patients should include information on the following key elements: - The prescribing physician may decide that Fabrazyme may be administered at home.
Croatian: Edukacijski materijal za bolesnike mora sadržavati informacije o sljedećim ključnim elementima: - Liječnik propisivač može donijeti odluku o primjeni lijeka Fabrazyme kod kuće.
English: Gently invert or lightly massage the infusion bag to mix the diluted solution.
Croatian: Lagano preokrenite ili protrljajte infuzijsku vrećicu kako biste promiješali razrijeđenu otopinu.
English: The marketing authorisation holder (MAH) shall agree the details of the educational programme for Fabrazyme home infusion with the National Competent Authorities prior to implementing the programme nationally.
Croatian: Nositelj odobrenja obvezuje se u suradnji s nacionalnim nadležnim tijelima dogovoriti podrobnosti programa edukacije za kućnu primjenu infuzije lijeka Fabrazyme prije provedbe programa na nacionalnoj razini.
English: What you need to know before you use Fabrazyme Do not use Fabrazyme
Croatian: Što morate znati prije nego počnete primjenjivati Fabrazyme