FrancophonIA/ELRC3.0 huggingface dataset:
English: Some of these infusion related side effects were serious or life-threatening.
Croatian: Neke od ovih nuspojava povezanih s infuzijom bile su ozbiljne ili opasne po život.
English: Death typically occurs due to cardiac and/or respiratory failure before the age of one year.
Croatian: Smrt obično nastupa zbog srčanog i/ili respiratornog zatajenja prije navršene prve godine života.
English: Pack sizes of 1, 10 or 25 vials.
Croatian: Veličine pakiranja od 1, 10 ili 25 bočica.
English: Take care when driving or using any tools or machines shortly after infusion of Myozyme, since you may experience dizziness.
Croatian: Budite oprezni prilikom vožnje ili uporabe bilo kakvih alata ili strojeva nedugo nakon infuzije lijeka Myozyme jer možete iskusiti omaglicu.
English: • Abnormal breathing sounds, including a whistling sound
Croatian: • neuobičajeni zvukovi pri disanju, uključujući zvuk zviždanja
English: Using these medicines to suppress the immune system may further increase this risk.
Croatian: Uzimanje lijekova za supresiju imunološkog sustava, može dodatno povećati rizik.
English: The recommended dosage of Myozyme in children and adolescents is the same as in adults.
Croatian: Preporučena doza lijeka Myozyme u djece i adolescenata ista je kao i u odraslih.
English: • Swelling and thickening of the skin at infusion site in case of leakage of the product outside blood vessels
Croatian: • oticanje i otvrdnuće kože na mjestu infuzije u slučaju istjecanja lijeka izvan krvnih žila
English: Pompe disease is a rare, progressive and fatal metabolic myopathy with an estimated global incidence of 1 in 40,000 births.
Croatian: Pompeova bolest je rijetka, progresivna i smrtonosna metabolička miopatija, čija se globalna incidencija procjenjuje na 1 od 40 000 rođene djece.
English: • Low level of oxygen in the blood
Croatian: • niska razina kisika u krvi
English: Reconstitution and dilution should be performed in accordance with good practice rules, particularly for the respect of asepsis.
Croatian: Rekonstituciju i razrjeđivanje treba provesti u skladu s odredbama dobre prakse, osobito s obzirom na asepsu.
English: Mean plasma elimination half-life (t1/2) was 2.75 hours for the two dose groups.
Croatian: Srednje poluvrijeme eliminacije iz plazme (t1/2) bilo je 2,75 sati za obje dozne skupine.
English: Pregnancy and breast-feeding and fertility
Croatian: Trudnoća i dojenje i plodnost
English: Determine the number of vials to be reconstituted based on the individual patient's dose regimen (mg/kg) and remove the required vials from the refrigerator in order to allow them to reach room temperature (approximately 30 minutes).
Croatian: Odredite broj bočica koje treba rekonstituirati na temelju režima doziranja pojedinog bolesnika (mg/kg) i izvadite ih iz hladnjaka da se ugriju na sobnu temperaturu (oko 30 minuta).
English: IARs are described in section 4.8.
Croatian: Reakcije povezane s infuzijom opisane su u dijelu 4.8.
English: 50 mg of powder in a vial (Type 1 glass) with a stopper (siliconised butyl) and a seal (aluminium) with a flip-off cap (plastic).
Croatian: 50 mg praška u bočici (staklo tipa 1) s čepom (silikonizirana butilna guma) i zaštitnim zatvaračem (aluminij) sa “flip-off” kapicom (plastika).
English: Patients should be closely monitored and all cases of IARs, delayed reactions and possible immunological reactions should be reported to the marketing authorisation holder.
Croatian: Bolesnike treba pomno nadzirati, a sve slučajeve reakcija povezanih s infuzijom, odgođenih reakcija i mogućih imunoloških reakcija treba prijaviti nositelju odobrenja.
English: 4 Additional adverse reactions from post-marketing, expanded access programs and non-controlled clinical trials.
Croatian: 4 Dodatne reakcije iz razdoblja nakon stavljanja lijeka u promet, programa proširenih pristupa i nekontroliranih kliničkih ispitivanja.
English: Genzyme Flanders bvba, Cipalstraat 8, 2440 Geel, Belgium Name and address of the manufacturers responsible for batch release Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Croatian: Genzyme Flanders bvba, Cipalstraat 8, 2440 Geel, Belgija Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: • Difficulty in breathing (including shortness of breath)
Croatian: • poteškoće s disanjem (uključujući nedostatak zraka)
English: In studies doctors have used medicines to suppress the immune system to reduce the production of antibodies.
Croatian: Liječnici su u ispitivanjima koristili lijekove za supresiju imunološkog sustava kako bi se smanjilo stvaranje antitijela.
English: • Cold extremities (e.g. hands, feet)
Croatian: • hladni udovi (npr. šake, stopala)
English: Due to the rarity of the condition and the limited experience to date, the effect of IgG antibody formation on safety and efficacy is currently not fully established.
Croatian: Zbog rijetkosti ove bolesti i trenutačno ograničenog iskustva, učinak stvaranja IgG protutijela na sigurnost i djelotvornost lijeka još nije u potpunosti utvrđen.
English: This effect was partly attributable to maternal toxicity, as a significant decrease in feed consumption and body weight gain was observed.
Croatian: Ovaj učinak može se djelomično pripisati toksičnosti za majku jer je primijećen značajno smanjenje unosa hrane te prinosa tjelesne težine.
English: The powder is white to off-white.
Croatian: Prašak je bijel do bjelkast.
English: • Swelling of the face, swelling of the throat or severe combined swelling of the face, throat and tongue due to a severe allergic reaction
Croatian: • oticanje lica, oticanje grla ili teško kombinirano oticanje lica, grla i jezika zbog teške alergijske reakcije
English: Do not shake or excessively agitate the infusion bag.
Croatian: Nemojte tresti ni prekomjerno mućkati infuzijsku vrećicu.
English: • Sudden constriction of bronchi restricting air going in and out the lungs (bronchospasm)
Croatian: • iznenadno suženje bronha koje ograničava ulazak i izlazak zraka iz pluća (bronhospazam)
English: These three studies with Myozyme (with a follow up of at least 3 years in two studies and a median of 23 months in the other study) suggested stabilisation or improvement of motor function and stabilisation of pulmonary function.
Croatian: Ova tri ispitivanja s lijekom Myozyme (s razdobljem praćenja od najmanje 3 godine u dva ispitivanja i medijanom od 23 mjeseca u preostalom ispitivanju) upućivala su na stabilizaciju ili poboljšanje motoričkih funkcija i stabilizaciju plućne funkcije.
English: Treated Patients
Croatian: Liječeni bolesnici
English: This enzyme helps the body control levels of glycogen (a type of carbohydrate).
Croatian: Taj enzim pomaže tijelu u kontroli razine glikogena (vrste ugljikohidrata).
English: Table 4: Change from baseline: efficacy outcomes in the placebo-controlled study
Croatian: Tablica 4: Promjena od početne vrijednosti: rezultati djelotvornosti u placebom kontroliranom ispitivanju
English: The primary endpoint of the pivotal trial was the proportion of patients who were alive.
Croatian: Primarna mjera ishoda pivotalnog ispitivanja bio je udio živih bolesnika.
English: Mild and transient effects may not require medical treatment or discontinuation of the infusion.
Croatian: Blagi i prolazni učinci ne moraju nužno iziskivati liječenje ili prekid infuzije.
English: Because you have Pompe disease, there is a risk that you get a severe infection of your airways or lungs.
Croatian: Budući da imate Pompeovu bolest, postoji opasnost da ćete dobiti tešku infekciju dišnih puteva ili pluća.
English: However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C when stored under protection from light.
Croatian: Međutim, dokazana je kemijska i fizikalna stabilnost razrijeđenog lijeka tijekom 24 sata na temperaturi od 2°C do 8°C, kada se čuva zaštićen od svjetlosti.
English: The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 50 mg) from each vial.
Croatian: Rekonstituirani volumen omogućuje precizno uzimanje doze od 10,0 ml (jednako 50 mg) iz svake bočice.
English: The totality of the data suggests that early diagnosis and treatment at an early stage of disease may be critical to achieve the best outcomes in these infantile onset patients.
Croatian: Ukupni podaci u načelu pokazuju da rana dijagnoza i liječenje u ranim fazama bolesti mogu biti od presudne važnosti za postizanje najboljih rezultata u ovih bolesnika s infantilnim oblikom bolesti.
English: Medical or healthcare professionals are encouraged to register patients who are diagnosed with Pompe disease at www.PompeRegistry.com.
Croatian: Liječnike i zdravstvene radnike potiče se da bolesnike s dijagnozom Pompeove bolesti registriraju na internetskoj adresi www.PompeRegistry.com.
English: However, muscle function only improved in wheelchair independent patients and in those with less pronounced muscle weakness.
Croatian: Međutim, mišićna funkcija se poboljšala samo kod bolesnika neovisnih o invalidskim kolicima i onih s manje izraženom slabošću mišića.
English: Instructions for proper use
Croatian: Upute za ispravnu primjenu
English: Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related effects”).
Croatian: Nuspojave su se uglavnom javljale dok su bolesnici primali lijek ili neposredno nakon toga („učinci povezani s infuzijom“).
English: Name and address of the manufacturers of the biological active substance Genzyme Corporation 45, 51, 76, 74 and 80 New York Avenue, Framingham, MA 01701, United States
Croatian: Genzyme Corporation 45, 51, 76, 74 and 80 New York Avenue, Framingham, MA 01701, Sjedinjene
English: Infusion Associated Reactions
Croatian: Reakcije povezane s infuzijom
English: • Pain or local reaction at the site of the drip
Croatian: • bol ili lokalna reakcija na mjestu infuzije
English: • Low blood pressure
Croatian: • nizak krvni tlak
English: Add the water for injections by slow drop-wise addition down the side of the vial and not directly onto the lyophilised cake.
Croatian: Dodajte vodu za injekcije sporim kapanjem niz stijenku bočice, a ne izravno na liofilizirani kolačić.
English: If you are given more Myozyme than you should
Croatian: Ako primijenite više lijeka Myozyme nego što ste trebali
English: People with Pompe disease have low levels of an enzyme called alpha-glucosidase.
Croatian: Osobe s Pompeovom bolešću imaju niske vrijednosti enzima koji se zove alfa-glukozidaza.
English: Some patients have experienced infusion related side effects in the form of flu-like symptoms, which lasted for a few days after completion of the infusion.
Croatian: Neki bolesnici imali su nuspojave povezane s infuzijom u obliku simptoma nalik gripi koji su trajali nekoliko dana nakon završetka infuzije.
English: Motor development is often completely arrested, or if motor milestones are achieved, they are subsequently lost.
Croatian: Motorički razvoj često je potpuno zaustavljen ili se motoričke vještine, ako su već stečene, gube s razvojem bolesti.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Croatian: Farmakoterapijska skupina: Ostali lijekovi za probavni trakt i metabolizam, enzimi.
English: Confidence Interval p-value
Croatian: 95%-tni interval pouzdanosti p-vrijednost
English: It is recommended to start the administration of the diluted solution within three hours.
Croatian: Preporučuje se razrijeđenu otopinu primijeniti u roku od tri sata.
English: Preclinical data did not reveal any significant adverse findings (see section 5.3).
Croatian: Neklinički podaci nisu ukazali ni na kakve značajne štetne učinke (vidjeti dio 5.3).
English: Alglucosidase alfa may be excreted in breast milk.
Croatian: Alglukozidaza alfa se može izlučivati u majčino mlijeko.
English: 1 Reactions reported in 39 infantile-onset patients in 2 clinical trials.
Croatian: 1 Reakcije prijavljene u 39 bolesnika s infantilnim oblikom bolesti u 2 klinička ispitivanja.
English: It is postulated that Myozyme will restore lysosomal GAA activity resulting in stabilisation or restoration of cardiac and skeletal muscle function (including respiratory muscles).
Croatian: Pretpostavlja se da bi Myozyme mogao obnoviti lizosomsku aktivnost GAA-a i tako dovesti do stabilizacije ili obnove funkcije srca i skeletnih mišića (uključujući respiratorne mišiće).
English: However, high and sustained IgG antibody titres also occur in some CRIM-positive patients.
Croatian: Međutim, visok i postojan titar IgG protutijela javlja se i u nekih CRIM-pozitivnih bolesnika.
English: Hypersensitivity/Anaphylactic reactions
Croatian: Preosjetljivost/anafilaktičke reakcije
English: Due to the bloodbrain barrier effect and the enzyme's size, uptake of alglucosidase alfa in the central nervous system is unlikely.
Croatian: S obzirom na učinak krvno-moždane barijere i veličinu enzima, nije vjerojatna pohrana alglukozidaze alfa u središnjem živčanom sustavu.
English: Mannitol (E421)
Croatian: • manitol (E421)
English: Your doctor should consider the risks and benefits of re-administering Myozyme.
Croatian: Liječnik mora procijeniti koristi i rizike ponovne primjene lijeka Myozyme.
English: ITI regimens may need to be tailored to individual patient needs (see section 5.1).
Croatian: Režime doziranja za indukciju imunološke tolerancije će možda biti potrebno prilagoditi individualnim potrebama bolesnika (vidjeti dio 5.1).
English: If you experience swelling of your lower limbs or generalized swelling, please inform your doctor.
Croatian: Ako primijetite oticanje donjih udova ili generalizirano oticanje, obavijestite svog liječnika.
English: • Increased sweating
Croatian: • pojačano znojenje
English: In two additional open-label clinical trials with Myozyme with a follow-up of 24 months, ten patients with severe late-onset Pompe disease (moderate to severe motor impairment and assisted ventilation) showed a variable response on measures of motor and respiratory functions, mostly in the form of a modest improvement (AGLU03105, AGLU04107).
Croatian: U dva dodatna otvorena klinička ispitivanja s lijekom Myozyme, s periodom paćenja od 24 mjeseca, deset bolesnika s teškim kasnim oblikom Pompeove bolesti (umjereno do teško motoričko oštećenje i ventilacijska potpora) pokazali su varijabilan odgovor na vrijednosti motoričke i respiratorne funkcije, većinom u obliku umjerenog poboljšanja (AGLU03105, AGLU04107).
English: No significant adverse findings on embryofoetal development were observed in a mouse and a rabbit embryofoetal study and no significant adverse findings were observed in a mouse fertility and early embryonic development study.
Croatian: Nisu uočeni značajni štetni učinci na embriofetalni razvoj u embriofetalnim ispitivanjima u miševa i kunića, niti su uočeni značajni štetni učinci u ispitivanjima plodnosti i ranog embrionalnog razvoja u miševa.
English: Because there are no data available on effects in neonates exposed to alglucosidase alfa via breast milk, it is recommended to stop breast-feeding when Myozyme is used.
Croatian: Budući da nema dostupnih podataka o učincima na novorođenčad izloženu alglukozidazi alfa putem majčinog mlijeka, preporučuje se prekinuti dojenje tijekom liječenja lijekom Myozyme.
English: Glycogen provides the body with energy, but in Pompe disease the levels of glycogen can get too high.
Croatian: Glikogen opskrbljuje tijelo energijom, ali njegove vrijednosti mogu u bolesnika s Pompeovom bolešću postati previsoke.
English: The final infusion solution should be administered as close to preparation time as possible.
Croatian: Gotovu otopinu za infuziju treba primijeniti što prije nakon pripreme.
English: If you have missed an infusion, please contact your doctor.
Croatian: Ako ste propustili jednu infuziju, obavijestite o tome svog liječnika.
English: Psychiatric disorders common Agitation not known
Croatian: Psihijatrijski poremećaji često agitacija nepoznato agitacija nemir
English: Due to the small patient population, an adverse reaction reported in 2 patients is classified as common.
Croatian: Zbog male populacije bolesnika nuspojava prijavljena u 2 bolesnika klasificira se kao česta.
English: After 104 weeks of treatment, 14 of 21 patients (66.7%) were alive and 1 patient was alive but had discontinued from the study.
Croatian: Nakon 104 tjedna liječenja na životu je bilo 14 od 21 bolesnika (66,7%), a 1 je bolesnik bio živ ali je istupio iz ispitivanja.
English: The objectives of the “Pompe Registry” are to enhance the understanding of Pompe disease and to monitor patients and their response to enzyme replacement therapy over time, with the ultimate goal of improving clinical outcomes for these patients.
Croatian: Svrha je registra unaprijediti razumijevanje Pompeove bolesti te pratiti bolesnike i njihov odgovor na enzimsko nadomjesno liječenje tijekom vremena, s krajnjim ciljem poboljšanja kliničkog ishoda za te bolesnike.
English: However, there was no apparent association between inhibition of uptake and the co-primary efficacy endpoints (see section 4.4).
Croatian: Međutim, nije bilo primjetne povezanosti između inhibicije pohrane i dviju primarnih mjera ishoda ispitivanja djelotvornosti (vidjeti dio 4.4).
English: If you have experienced life-threatening allergic (hypersensitive) reactions to alglucosidase alfa or any of the other ingredients of this medicine (listed in section 6) and re-administration of the medicine was not successful.
Croatian: Ako ste imali po život opasnu alergijsku reakciju (reakciju preosjetljivosti) na alglukozidazu alfa ili na neki drugi sastojak ovog lijeka (naveden u dijelu 6) i ako je ponovna primjena lijeka bila neuspješna.
English: Table 5: Alglucosidase alfa pharmacokinetics after a single dose and after 12 and 52 weeks of therapy
Croatian: Tablica 5: Farmakokinetika alglukozidaze alfa nakon jedne doze te nakon 12 i 52 tjedana liječenja
English: Linearity/non linearity Pharmacokinetics were dose proportional and did not change over time.
Croatian: Farmakokinetika je bila razmjerna dozi i nije se mijenjala s vremenom.
English: Because dizziness has been reported as an infusion associated reaction, this may affect the ability to drive and use machines on the day of the infusion.
Croatian: Budući da je kao reakcija povezana s infuzijom prijavljena omaglica, ona bi mogla utjecati na sposobnost upravljanja vozilima i rada sa strojevima na dan primanja infuzije.
English: Median
Croatian: medijan
English: Patients with Pompe disease are at increased risk of respiratory infections due to the progressive effects of the disease on the respiratory muscles.
Croatian: Kod oboljelih od Pompeove bolesti postoji rizik od respiratornih infekcija zbog progresivnih učinaka bolesti na respiratorne mišiće.
English: 6-Minute Walk Test Distance (meters)
Croatian: Daljina u šestominutnom testu hoda (6-MWT) (metri)
English: Myozyme treatment should be supervised by a physician experienced in the management of patients with Pompe disease or other inherited metabolic or neuromuscular diseases.
Croatian: Liječenje lijekom Myozyme mora nadzirati liječnik s iskustvom u liječenju bolesnika s Pompeovom bolešću ili drugih nasljednih metaboličkih ili neuromuskularnih bolesti.
English: You may need to be given pre-treatment medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or to reduce fever (antipyretics).
Croatian: Možda ćete prethodno morati primiti lijekove kako bi se spriječila alergijska reakcija (npr. antihistaminike i/ili kortikosteroide) ili snizila vrućica (antipiretike).
English: After 52 weeks all patients continued treatment for a total duration of more than 3 years (168 weeks with a median of 121 weeks).
Croatian: Nakon 52 tjedna svi su bolesnici nastavili liječenje u ukupnom trajanju od više od 3 godine (168 tjedana s medijanom od 121 tjedna).
English: Class, presented by frequency categories: very common (≥1/10), common (≥1/100 to<1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known
Croatian: (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Myozyme contains an artificial enzyme called alglucosidase alfa - this can replace the natural enzyme which is lacking in Pompe disease.
Croatian: Myozyme sadrži umjetni enzim koji se naziva alglukozidaza alfa - on može nadomjestiti prirodni enzim koji nedostaje bolesnicima s Pompeovom bolešću.
English: The late-onset form of Pompe disease manifests during infancy, childhood, adolescence or even adulthood and is much less rapidly progressive than the infantile-onset form.
Croatian: Kasni oblik Pompeove bolesti manifestira se tijekom ranog djetinjstva, djetinjstva, adolescencije ili čak u odrasloj dobi, a napreduje mnogo sporije od infantilnog oblika.
English: In these patients renal biopsy showed immune complex deposition.
Croatian: U tih je bolesnika biopsija bubrega ukazala na odlaganje imunih kompleksa.
English: If you are treated with Myozyme, you may experience an infusion-associated reaction while you are being given the medicine or during the hours following the infusion.
Croatian: Ako se liječite lijekom Myozyme, možete dobiti reakciju povezanu s infuzijom tijekom davanja lijeka ili u satima nakon infuzije.
English: There is no experience of the use of Myozyme in pregnant women.
Croatian: Ne postoje iskustva o primjeni lijeka Myozyme u trudnica.
English: Therefore, these patients should be monitored more closely during administration of Myozyme.
Croatian: Stoga te bolesnike treba pažljivije nadzirati tijekom primjene lijeka Myozyme.
English: If you forget to use Myozyme
Croatian: Ako ste zaboravili primijeniti Myozyme
English: What Myozyme looks like and contents of the pack
Croatian: Kako Myozyme izgleda i sadržaj pakiranja
English: After 52 weeks of treatment, 16 of 21 patients (76.2%) treated with Myozyme were alive.
Croatian: Nakon 52 tjedna liječenja na životu je bilo 16 od 21 bolesnika (76,2%) liječenih lijekom Myozyme.
English: The current medical standards for emergency treatment of anaphylactic reactions are to be observed.
Croatian: Treba se pridržavati važećih medicinskih normi koje se odnose na hitno liječenje anafilaktičkih reakcija.
English: Your doctor should consider discontinuation of the administration of Myozyme and initiate appropriate medical treatment.
Croatian: Vaš liječnik mora razmotriti prekid primjene lijeka Myozyme i započeti odgovarajuće liječenje.
English: Myozyme is indicated in adults and paediatric patients of all ages.
Croatian: Myozyme je indiciran u odraslih i pedijatrijskih bolesnika svih dobi.
English: A limited number of the IgG positive patients evaluated tested positive for inhibitory effects on in vitro testing.
Croatian: Malen broj procijenjenih IgG pozitivnih bolesnika imao je pozitivan nalaz testa na inhibitorne učinke in vitro.
English: Subjects were aged 6 months or less at the onset of treatment.
Croatian: Ispitanici su na početku liječenja imali 6 mjeseci ili manje.
English: The clinical presentation of Pompe disease can be described as a spectrum of disease which ranges from a rapidly-progressing infantile-onset form (onset of symptoms of Pompe disease typically within the first year of life and a very short expected life-span) to a less rapidly-progressing late-onset form.
Croatian: Klinička prezentacija Pompeove bolesti može se opisati kao spektar bolesti u rasponu od brzo napredujućeg infantilnog oblika (simptomi Pompeove bolesti obično nastupaju u prvoj godini života i očekivani životni vijek je vrlo kratak) do kasnog oblika bolesti koji napreduje sporije.
English: Recurrent reactions consisting of flu-like illness or a combination of events such as fever, chills, myalgia, arthralgia, pain, or fatigue occurring post-infusion and lasting usually for a few days, have been observed in some patients treated with alglucosidase alfa.
Croatian: Ponavljajuće reakcije koje su se manifestirale kao bolest nalik gripi ili kao kombinacija pojava poput groznice, zimice, mijalgije, artralgije, boli ili umora te su se javile nakon primljene infuzije, obično u trajanju od nekoliko dana, zabilježene su u nekih bolesnika liječenih alglukozidazom alfa.