natgillin/translations-raw huggingface dataset:
NEXGARD SPECTRA 9 mg/ 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg chewable tablets for dogs >30-60 kg afoxolaner / milbemycin oxime
NEXGARD SPECTRA 9 mg/ 2 mg tableta za žvakanje za pse 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tableta za žvakanje za pse >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tableta za žvakanje za pse >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tableta za žvakanje za pse >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tableta za žvakanje za pse >30-60 kg afoxolaner / milbemycin oxime
PACKAGE LEAFLET: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg
UPUTA O VMP: NEXGARD SPECTRA 9 mg/ 2 mg tablete za žvakanje za pse 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tablete za žvakanje za pse >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tablete za žvakanje za pse >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tablete za žvakanje za pse >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tablete za žvakanje za pse >30-60 kg
NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg
NEXGARD SPECTRA 9 mg/ 2 mg tablete za žvakanje za pse 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tablete za žvakanje za pse >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tablete za žvakanje za pse >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tablete za žvakanje za pse >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tablete za žvakanje za pse >30-60 kg
It will be given to you once every 2 weeks.
Primit ćete je jedanput svaka 2 tjedna.
ATC code: A16AB07.
ATK oznaka: A16AB07.
OTHER SPECIAL WARNING(S), IF NECESSARY
DRUGO(A) POSEBNA UPOZORENJE(A), AKO JE POTREBNO
The results are shown in Table 4.
Rezultati su prikazani u Tablici 4.
The dose you receive is based on your body weight.
Doza koju ćete primiti ovisi o Vašoj tjelesnoj težini.
Evaluation of motor function gave disparate results.
Procjena motoričkih funkcija dala je različite rezultate.
However, motor and respiratory responses to treatment have been more variable.
Međutim, motorički i respiratorni odgovori na liječenje bili su varijabilniji.
The t½ of approximately 2-3 hours was also similar in this group of patients.
Vrijednost t½ od oko 2-3 sata također je bila slična u toj skupini bolesnika.
Patient data will be anonymously collected in this Registry.
U tom će se registru podaci o bolesnicima prikupljati anonimno.
An infusionassociated reaction can sometimes be very severe.
Reakcija povezana s infuzijom katkad može biti vrlo teška.
No interactions studies have been performed.
Nisu provedena ispitivanja interakcija.
Cmax (µg/ml) AUC∞ (µg•h/ml) CL (ml/h/kg) Vss (ml/kg) Effective half-life (h)
Cmax (µg/ml) AUC∞ (µg•h/ml) CL (ml/h/kg) Vss (ml/kg) Efektivni poluvijek (h)
The total time between reconstitution and completion of the infusion should not exceed 24 hours.
Između rekonstitucije i završetka infuzije ne smije proteći više od 24 sata.
Wilcoxon-Mann-Whitney Test p-value
Wilcoxon-Mann-Whitney test p-vrijednost
One additional patient died after study end and another one after withdrawal from the study.
Jedan je dodatni bolesnik umro po završetku ispitivanja, a još jedan nakon povlačenja iz ispitivanja.
Patient response to treatment should be routinely evaluated based on a comprehensive evaluation of all clinical manifestations of the disease.
Odgovor bolesnika na liječenje treba rutinski procjenjivati na temelju sveobuhvatne procjene svih kliničkih manifestacija bolesti.
Some reactions were severe (see section 4.8).
Neke od tih reakcija bile su teške (vidjeti dio 4.8).
Patients improved following treatment interruption.
Bolesnicima se stanje popravilo nakon prekida liječenja.
Reactions generally occurred shortly after initiation of the infusion.
Reakcije su se obično javile ubrzo nakon početka infuzije.
The majority of these reactions were non-serious, mild to moderate in intensity and resolved spontaneously.
Većina tih reakcija nije bila ozbiljna, bila je blagog do umjerenog intenziteta i spontano se povukla.
What Myozyme is and what it is used for
Što je Myozyme i za što se koristi
Date of first authorisation: 29 March 2006 Date of latest renewal: 29 March 2011
Datum prvog odobrenja: 29. ožujka 2006.
• Chest pain (not in the heart)
• bol u prsnom košu (ne u srcu)
Manufacturer Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
Two patients died and did not enter into the extension study.
Dva su bolesnika umrla te nisu bila uključena u produžetak ispitivanja.
The 9 remaining patients either died (5 patients) or became invasive-ventilator dependent (4 patients).
Preostalih 9 bolesnika je ili umrlo (5 bolesnika) ili postalo ovisno o invazivnoj mehaničkoj ventilaciji (4 bolesnika).
Other medicines and Myozyme
Drugi lijekovi i Myozyme
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity.
Neklinički podaci ne ukazuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja farmakološke sigurnosti, toksičnosti pojedinačne ili ponovljenih doze.
Change from Baseline to Week 78/Last Observation*
Promjena od početnih vrijednosti do 78. tjedna /posljednje opažanje*
Median Week 78/Last Observation Mean ± s.d.
78. tjedan/posljednje opažanje prosjek ± s.d. medijan
Kaplan-Meier survival rates at 12, 24 and 36 months of age were 26%, 9% and 7%, respectively.
Stope preživljenja po Kaplan-Meieru u dobi od 12, 24 odnosno 36 mjeseci iznosile su 26%, 9% odnosno 7%.
• Increased or high blood pressure
• povišen ili visok krvni tlak
Contents of the pack and other information What Myozyme contains
Sadržaj pakiranja i druge informacije Što Myozyme sadrži
Each pack contains 1, 10 or 25 vials.
Jedno pakiranje sadrži 1, 10 ili 25 bočica.
• Temporary suspension or sudden cessation of breathing
• privremeni prekid ili nagli prestanak disanja
• polysorbate 80 (E433).
• polisorbat 80 (E433).
*Human acid α-glucosidase is produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology.
*Ljudska kisela α-glukozidaza proizvodi se na jajnim stanicama kineskog hrčka (CHO) tehnologijom rekombinantne DNK.
Use aseptic technique
Primijenite aseptičku tehniku
Remove airspace within the infusion bag.
Uklonite zrak iz infuzijske vrećice.
Mean ± s.d Median
prosjek ± s.d. medijan
It was demonstrated that the use of a 0.2 micron in-line filter removes visible particles and does not result in an apparent loss of protein or activity.
Pokazalo se da se uporabom ”in-line” filtra od 0,2 μm uklanjaju vidljive čestice, ali pritom ne dolazi do gubitka proteina ili aktivnosti.
Some of these infusion related side effects were serious or life-threatening.
Neke od ovih nuspojava povezanih s infuzijom bile su ozbiljne ili opasne po život.
Death typically occurs due to cardiac and/or respiratory failure before the age of one year.
Smrt obično nastupa zbog srčanog i/ili respiratornog zatajenja prije navršene prve godine života.
Pack sizes of 1, 10 or 25 vials.
Veličine pakiranja od 1, 10 ili 25 bočica.
Take care when driving or using any tools or machines shortly after infusion of Myozyme, since you may experience dizziness.
Budite oprezni prilikom vožnje ili uporabe bilo kakvih alata ili strojeva nedugo nakon infuzije lijeka Myozyme jer možete iskusiti omaglicu.
• Abnormal breathing sounds, including a whistling sound
• neuobičajeni zvukovi pri disanju, uključujući zvuk zviždanja
Using these medicines to suppress the immune system may further increase this risk.
Uzimanje lijekova za supresiju imunološkog sustava, može dodatno povećati rizik.
The recommended dosage of Myozyme in children and adolescents is the same as in adults.
Preporučena doza lijeka Myozyme u djece i adolescenata ista je kao i u odraslih.
• Swelling and thickening of the skin at infusion site in case of leakage of the product outside blood vessels
• oticanje i otvrdnuće kože na mjestu infuzije u slučaju istjecanja lijeka izvan krvnih žila
Pompe disease is a rare, progressive and fatal metabolic myopathy with an estimated global incidence of 1 in 40,000 births.
Pompeova bolest je rijetka, progresivna i smrtonosna metabolička miopatija, čija se globalna incidencija procjenjuje na 1 od 40 000 rođene djece.
• Low level of oxygen in the blood
• niska razina kisika u krvi
Reconstitution and dilution should be performed in accordance with good practice rules, particularly for the respect of asepsis.
Rekonstituciju i razrjeđivanje treba provesti u skladu s odredbama dobre prakse, osobito s obzirom na asepsu.
Mean plasma elimination half-life (t1/2) was 2.75 hours for the two dose groups.
Srednje poluvrijeme eliminacije iz plazme (t1/2) bilo je 2,75 sati za obje dozne skupine.
Pregnancy and breast-feeding and fertility
Trudnoća i dojenje i plodnost
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).
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).
IARs are described in section 4.8.
Reakcije povezane s infuzijom opisane su u dijelu 4.8.
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).
50 mg praška u bočici (staklo tipa 1) s čepom (silikonizirana butilna guma) i zaštitnim zatvaračem (aluminij) sa “flip-off” kapicom (plastika).
Patients should be closely monitored and all cases of IARs, delayed reactions and possible immunological reactions should be reported to the marketing authorisation holder.
Bolesnike treba pomno nadzirati, a sve slučajeve reakcija povezanih s infuzijom, odgođenih reakcija i mogućih imunoloških reakcija treba prijaviti nositelju odobrenja.
4 Additional adverse reactions from post-marketing, expanded access programs and non-controlled clinical trials.
4 Dodatne reakcije iz razdoblja nakon stavljanja lijeka u promet, programa proširenih pristupa i nekontroliranih kliničkih ispitivanja.
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
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
• Difficulty in breathing (including shortness of breath)
• poteškoće s disanjem (uključujući nedostatak zraka)
In studies doctors have used medicines to suppress the immune system to reduce the production of antibodies.
Liječnici su u ispitivanjima koristili lijekove za supresiju imunološkog sustava kako bi se smanjilo stvaranje antitijela.
• Cold extremities (e.g. hands, feet)
• hladni udovi (npr. šake, stopala)
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.
Zbog rijetkosti ove bolesti i trenutačno ograničenog iskustva, učinak stvaranja IgG protutijela na sigurnost i djelotvornost lijeka još nije u potpunosti utvrđen.
This effect was partly attributable to maternal toxicity, as a significant decrease in feed consumption and body weight gain was observed.
Ovaj učinak može se djelomično pripisati toksičnosti za majku jer je primijećen značajno smanjenje unosa hrane te prinosa tjelesne težine.
The powder is white to off-white.
Prašak je bijel do bjelkast.
• Swelling of the face, swelling of the throat or severe combined swelling of the face, throat and tongue due to a severe allergic reaction
• oticanje lica, oticanje grla ili teško kombinirano oticanje lica, grla i jezika zbog teške alergijske reakcije
Do not shake or excessively agitate the infusion bag.
Nemojte tresti ni prekomjerno mućkati infuzijsku vrećicu.
• Sudden constriction of bronchi restricting air going in and out the lungs (bronchospasm)
• iznenadno suženje bronha koje ograničava ulazak i izlazak zraka iz pluća (bronhospazam)
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.
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.
Treated Patients
Liječeni bolesnici
This enzyme helps the body control levels of glycogen (a type of carbohydrate).
Taj enzim pomaže tijelu u kontroli razine glikogena (vrste ugljikohidrata).
Table 4: Change from baseline: efficacy outcomes in the placebo-controlled study
Tablica 4: Promjena od početne vrijednosti: rezultati djelotvornosti u placebom kontroliranom ispitivanju
The primary endpoint of the pivotal trial was the proportion of patients who were alive.
Primarna mjera ishoda pivotalnog ispitivanja bio je udio živih bolesnika.
Mild and transient effects may not require medical treatment or discontinuation of the infusion.
Blagi i prolazni učinci ne moraju nužno iziskivati liječenje ili prekid infuzije.
Because you have Pompe disease, there is a risk that you get a severe infection of your airways or lungs.
Budući da imate Pompeovu bolest, postoji opasnost da ćete dobiti tešku infekciju dišnih puteva ili pluća.
However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C when stored under protection from light.
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.
The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 50 mg) from each vial.
Rekonstituirani volumen omogućuje precizno uzimanje doze od 10,0 ml (jednako 50 mg) iz svake bočice.
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.
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.
Medical or healthcare professionals are encouraged to register patients who are diagnosed with Pompe disease at www.PompeRegistry.com.
Liječnike i zdravstvene radnike potiče se da bolesnike s dijagnozom Pompeove bolesti registriraju na internetskoj adresi www.PompeRegistry.com.
However, muscle function only improved in wheelchair independent patients and in those with less pronounced muscle weakness.
Međutim, mišićna funkcija se poboljšala samo kod bolesnika neovisnih o invalidskim kolicima i onih s manje izraženom slabošću mišića.
Instructions for proper use
Upute za ispravnu primjenu
Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related effects”).
Nuspojave su se uglavnom javljale dok su bolesnici primali lijek ili neposredno nakon toga („učinci povezani s infuzijom“).
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
Genzyme Corporation 45, 51, 76, 74 and 80 New York Avenue, Framingham, MA 01701, Sjedinjene
Infusion Associated Reactions
Reakcije povezane s infuzijom
• Pain or local reaction at the site of the drip
• bol ili lokalna reakcija na mjestu infuzije
• Low blood pressure
• nizak krvni tlak
Add the water for injections by slow drop-wise addition down the side of the vial and not directly onto the lyophilised cake.
Dodajte vodu za injekcije sporim kapanjem niz stijenku bočice, a ne izravno na liofilizirani kolačić.
If you are given more Myozyme than you should
Ako primijenite više lijeka Myozyme nego što ste trebali
People with Pompe disease have low levels of an enzyme called alpha-glucosidase.
Osobe s Pompeovom bolešću imaju niske vrijednosti enzima koji se zove alfa-glukozidaza.
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.
Neki bolesnici imali su nuspojave povezane s infuzijom u obliku simptoma nalik gripi koji su trajali nekoliko dana nakon završetka infuzije.
Motor development is often completely arrested, or if motor milestones are achieved, they are subsequently lost.
Motorički razvoj često je potpuno zaustavljen ili se motoričke vještine, ako su već stečene, gube s razvojem bolesti.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Farmakoterapijska skupina: Ostali lijekovi za probavni trakt i metabolizam, enzimi.
Confidence Interval p-value
95%-tni interval pouzdanosti p-vrijednost
It is recommended to start the administration of the diluted solution within three hours.
Preporučuje se razrijeđenu otopinu primijeniti u roku od tri sata.
Preclinical data did not reveal any significant adverse findings (see section 5.3).
Neklinički podaci nisu ukazali ni na kakve značajne štetne učinke (vidjeti dio 5.3).
Alglucosidase alfa may be excreted in breast milk.
Alglukozidaza alfa se može izlučivati u majčino mlijeko.
1 Reactions reported in 39 infantile-onset patients in 2 clinical trials.
1 Reakcije prijavljene u 39 bolesnika s infantilnim oblikom bolesti u 2 klinička ispitivanja.
It is postulated that Myozyme will restore lysosomal GAA activity resulting in stabilisation or restoration of cardiac and skeletal muscle function (including respiratory muscles).
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).
However, high and sustained IgG antibody titres also occur in some CRIM-positive patients.
Međutim, visok i postojan titar IgG protutijela javlja se i u nekih CRIM-pozitivnih bolesnika.
Hypersensitivity/Anaphylactic reactions
Preosjetljivost/anafilaktičke reakcije
Due to the bloodbrain barrier effect and the enzyme's size, uptake of alglucosidase alfa in the central nervous system is unlikely.
S obzirom na učinak krvno-moždane barijere i veličinu enzima, nije vjerojatna pohrana alglukozidaze alfa u središnjem živčanom sustavu.
Mannitol (E421)
• manitol (E421)
Your doctor should consider the risks and benefits of re-administering Myozyme.
Liječnik mora procijeniti koristi i rizike ponovne primjene lijeka Myozyme.
ITI regimens may need to be tailored to individual patient needs (see section 5.1).
Režime doziranja za indukciju imunološke tolerancije će možda biti potrebno prilagoditi individualnim potrebama bolesnika (vidjeti dio 5.1).
If you experience swelling of your lower limbs or generalized swelling, please inform your doctor.
Ako primijetite oticanje donjih udova ili generalizirano oticanje, obavijestite svog liječnika.
• Increased sweating
• pojačano znojenje
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).
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).
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.
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.
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.
Budući da nema dostupnih podataka o učincima na novorođenčad izloženu alglukozidazi alfa putem majčinog mlijeka, preporučuje se prekinuti dojenje tijekom liječenja lijekom Myozyme.
Glycogen provides the body with energy, but in Pompe disease the levels of glycogen can get too high.
Glikogen opskrbljuje tijelo energijom, ali njegove vrijednosti mogu u bolesnika s Pompeovom bolešću postati previsoke.
The final infusion solution should be administered as close to preparation time as possible.
Gotovu otopinu za infuziju treba primijeniti što prije nakon pripreme.
If you have missed an infusion, please contact your doctor.
Ako ste propustili jednu infuziju, obavijestite o tome svog liječnika.
Psychiatric disorders common Agitation not known
Psihijatrijski poremećaji često agitacija nepoznato agitacija nemir
Due to the small patient population, an adverse reaction reported in 2 patients is classified as common.
Zbog male populacije bolesnika nuspojava prijavljena u 2 bolesnika klasificira se kao česta.
After 104 weeks of treatment, 14 of 21 patients (66.7%) were alive and 1 patient was alive but had discontinued from the study.
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.
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.
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.
However, there was no apparent association between inhibition of uptake and the co-primary efficacy endpoints (see section 4.4).
Međutim, nije bilo primjetne povezanosti između inhibicije pohrane i dviju primarnih mjera ishoda ispitivanja djelotvornosti (vidjeti dio 4.4).
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.
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.
Table 5: Alglucosidase alfa pharmacokinetics after a single dose and after 12 and 52 weeks of therapy
Tablica 5: Farmakokinetika alglukozidaze alfa nakon jedne doze te nakon 12 i 52 tjedana liječenja
Linearity/non linearity Pharmacokinetics were dose proportional and did not change over time.
Farmakokinetika je bila razmjerna dozi i nije se mijenjala s vremenom.
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.
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.
Median
medijan