FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation , is in place and functioning before and whilst the product is on the market.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav, kako je opisano u Modulu 1.8.1. Obrasca prijave nositelja odobrenja, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
English: - The active substance is galsulfase.
Croatian: - Djelatna tvar je galsulfaza.
English: It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
Croatian: Nije poznato da li se galsulfaza izlučuje u mlijeku, tako da dojenje treba prekinuti tijekom liječenja lijekom Naglazyme.
English: GAG results approached the normal range for age in the Naglazyme treatment group.
Croatian: GAG rezultati su se približili normalnom rasponu za tu dob u grupi liječenoj Naglazyme.
English: After 24 weeks of treatment the mean ( Standard Deviation [SD]) maximum plasma concentration (Cmax) was 2,357 (± 1,560) ng/ml and the mean ( SD) area under the plasma concentration-time curve (AUC0-t) was 5,860 ( 4,184) h  ng/ml.
Croatian: Nakon 24 tjedna liječenja srednja (± standardna devijacija [SD]) maksimalna koncentracija plazme (Cmax) je bila 2,357 (± 1,560) ng/ml i srednja (± SD) površina ispod krivulje koncentracija u plazmi-vrijeme (AUC0-t) je bila 5,860 (± 4,184) h ± ng/ml.
English: Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium.
Croatian: Svaka bočica od 5 ml sadrži 0,8 mmol (18,4 mg) natrija.
English: Talk to your doctor if you have kidney or liver insufficiency.
Croatian: Razgovarajte sa svojim liječnikom ako imate zatajenje funkcije bubrega ili jetre.
English: You must not receive this medicine - If you have experienced severe or life-threatening allergic (hypersensitive) reactions to galsulfase or any of the other ingredients of Naglazyme and re-administration of the medicine was not successful.
Croatian: Ne smijete uzimati ovaj lijek - ako ste imali tešku ili po život opasnu alergijsku reakciju (reakciju preosjetljivosti) na galsulfazu ili neki drugi sastojak Naglazyme i ponovna primjena Naglazyme nije bila uspješna.
English: Evaluate the effect of Naglazyme on pregnancy and lactation.
Croatian: Procijeniti djelovanje Naglazyme-a na trudnoću i dojenje.
English: The mean ( SD) volume of distribution (Vz) was 316 ( 752) ml/kg and the mean ( SD) plasma clearance (CL) was 7.9 ( 14.7) ml/min/kg.
Croatian: Srednji (± SD) volumen distribucije (Vz) je bio 316 (± 752) ml/kg i srednji (± SD) klirens plazme (CL) je bio 7,9 (± 14,7) ml/min/kg.
English: Caution must be exercised in the management and treatment of patients with compromised airways by limitation or careful monitoring of antihistamine and other sedative medicinal product use.
Croatian: Mora se biti oprezan kod zbrinjavanja i liječenja bolesnika s kompromitiranim dišnim putovima ograničavanjem ili pažljivim praćenjem primjene antihistaminika i drugih sedativa.
English: Out of the 59 patients treated with Naglazyme in the clinical studies, 54 were tested for IgG antibodies.
Croatian: Od 59 bolesnika liječenih lijekom Naglazyme u kliničkim studijama, 54 je bilo testirano na IgG antitijela.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, repeated-dose toxicity or on general reproductive performance or embryo-foetal development in rats or rabbits.
Croatian: Nekliničke podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti jedne doze, toksičnosti ponovljene doze ili na opći reproduktivni stadij i na razvoj embrija i fetusa kod štakora i kunića.
English: The primary efficacy endpoint was the numbers of meters walked in 12 minutes at Week 24 compared to the number of meters walked at baseline.
Croatian: Primarni ishod djelotvornosti je bio broj metara prehodanih u 12 minuta u 24. tjednu, u usporedbi s brojem metara prehodanih na samom početku.
English: From a microbiological safety point of view, the product is to be used immediately.
Croatian: Sa stajališta mikrobiološke sigurnosti, lijek se mora odmah primijeniti.
English: If these reactions occur, immediate discontinuation of Naglazyme is recommended and appropriate medical treatment should be initiated.
Croatian: Ako dođe do takvih reakcija, odmah se mora prekinuti liječenje lijekom Naglazyme i započeti s odgovarajućim liječenjem.
English: The safety and efficacy of Naglazyme in patients with renal or hepatic insufficiency have not been evaluated (see section 5.2) and no alternative dose regimen can be recommended in these patients.
Croatian: Sigurnost i djelotvornost lijeka Naglazyme u bolesnika s insuficijencijom bubrega ili jetre nije procjenjivana (vidjeti dio 5.2) te se ne može preporučiti alternativni režim doziranja kod tih bolesnika.
English: Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nije bilo obavljenih studija učinaka na sposobnost vožnje i upravljanja strojevima
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će svake godine procjenjivati nove informacije o ovom lijeku te će se ova uputa obnavljati prema potrebi.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Croatian: Prema smjernicama CHMP za Sustave upravljanja rizicima za lijekove za humanu uporabu, svaka dopuna RMPa mora se podnijeti u isto vrijeme kao i odgovarajuće Periodičko izvješće o neškodljivosti lijeka (PSUR).
English: No interaction studies have been performed.
Croatian: Nisu provedena ispitivanja interakcije lijeka.
English: Higher antibody levels (≥ 65610 Dilution Fraction) will be compared with the subject's urinary GAG values with a view to assess potential impacts on efficacy.
Croatian: Više razine antitijela (≥ 65610 Dilucijska frakcija) usporedit će se s ispitanikovim vrijednostima urinarnog GAG-a s namjerom da se procijene potencijalni utjecaji na djelotvornost.
English: Naglazyme treatment should be supervised by a physician experienced in the management of patients with MPS VI or other inherited metabolic diseases.
Croatian: Liječenje lijekom Naglazyme mora nadgledati liječnik koji ima iskustva u zbrinjavanju bolesnika s MPS VI ili drugim nasljednim metaboličkim bolestima.
English: Vial (type I glass) with a stopper (siliconized chlorobutyl rubber) and a seal (aluminium) with a flipoff cap (polypropylene).
Croatian: Bočica (staklo tip I) sa čepom (silikonizirana klorobutilna guma) i zaštitnim zatvaračem (aluminij) sa „flip-off“ kapicom (polipropilen).
English: Reproduction studies have been performed in rats and rabbits at doses up to 3 mg/kg/day and have revealed no evidence of impaired fertility or harm to the embryo or foetus due to Naglazyme.
Croatian: Ispitivanja utjecaja na reprodukciju su provedena u štakora i kunića u dozama do 3 mg/kg/dan te nisu ukazala na postojanje dokaza o štetnom učinku Naglazyme na plodnost, embrij ili fetus.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 002 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Croatian: Nositelj odobrenja se obvezuje provoditi ispitivanja i dodatne aktivnosti predviđene Farmakovigilancijskim planom, kako je dogovoreno verzijom 002 Plana upravljanja rizicima (RMP) prikazanoj u Modulu 1.8.2.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Croatian: Nositelj odobrenja se obvezuje provoditi ispitivanja i dodatne aktivnosti predviđene Farmakovigilancijskim planom.
English: To evaluate the long-term safety and efficacy data from Naglazyme treatment a Clinical Surveillance Program (CSP) will be conducted.
Croatian: Kako bi se procijenili podaci o dugoročnoj sigurnosti i djelotvornosti liječenja Naglazyme-om, provest će se Program kliničkog nadzora (CSP).
English: Patients treated with Naglazyme have developed infusion-associated reactions (IARs), defined as any adverse reactions occurring during the infusion or until the end of the infusion day (see section 4.8).
Croatian: Bolesnici liječeni lijekom Naglazyme su razvili reakcije vezane uz infuziju, definirane kao bilo koje nuspojave koje se jave tijekom infuzije ili do kraja dana u kojem je infuzija primljena (vidjeti dio 4.8).
English: Do not take use this medicine after the expiry date which is stated on the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici iza EXP.
English: The initial infusion rate is adjusted so that approximately 2.5% of the total solution is infused during the first hour, with infusion of the remaining volume (approximately 97.5%) over the next 3 hours.
Croatian: Početna brzina infuzije je podešena tako da se otprilike 2,5% ukupne otopine infundira tijekom prvog sata, a infuzija preostale količine (otprilike 97,5%) tijekom slijedeća 3 sata.
English: Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1).
Croatian: Naglazyme je indiciran za dugotrajnu enzimsku nadomjesnu terapiju kod bolesnika s potvrđenom dijagnozom mukopolisaharidoze VI (MPS VI; deficijencija N-acetilgalaktozamin 4-sulfataze; Maroteaux-Lamy sindrom) (vidjeti dio 5.1).
English: Likewise, antibody development is not predictive of decreased efficacy although subjects with limited response in endurance parameters or urinary glycosaminoglycans (GAGs) tended to have higher peak anti-galsulfase titres than those with good response.
Croatian: Također, na temelju stvaranja antitijela ne može se predvidjeti smanjenje djelotvornosti iako su osobe s ograničenim odgovorom u parametrima izdržljivosti ili glikozaminoglikanima u urinu su imale tendenciju k većem titru antitijela na galsulfazu u odnosu na osobe s dobrim odgovorom.
English: Severe and serious liver toxicities will be assessed through the PSUR but also through analysis of these events in the CSP database.
Croatian: Teška i ozbiljna toksična oštećenja jetre će se procijeniti putem PSUR-a ali i kroz analizu tih događaja u bazi podataka Kliničkog programa praćenja.
English: An infusion associated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4 “Possible Side Effects”).
Croatian: Reakcija na infuziju je svaka nuspojava koja se javlja tijekom infuzije ili do kraja dana kada ste primili infuziju (vidjeti dio 4 'Moguće nuspojave').
English: Although a larger proportion of subjects with high total antibody titres experienced recurrent infusion reactions, neither frequency nor severity could be predicted based on the anti-galsulfase antibody titre.
Croatian: Iako je veći udio bolesnika s visokim ukupnim titrom antitijela doživio ponavljajuće reakcije na infuziju, ni učestalost ni težina reakcije se ne može predvidjeti na temelju titra anti-galsulfaza antitijela.
English: The recommended dose is 1 mg/kg body weight administered once every week through a drip into a vein (by intravenous infusion).
Croatian: Preporučena doza je 1 mg/kg tjelesne težine primijenjeno jednom tjedno u venu kroz infuziju (u obliku intravenske infuzije).
English: For the first hour the infusion rate will be slow (approximately 2.5% of the total solution), with the remaining volume (approximately 97.5%) being taken over the next 3 hours.
Croatian: Prvi sat će brzina infuzije biti polagana (otprilike 2,5 % ukupne otopine), a preostala količina (otprilike 97,5%) se unosi tijekom preostala 3 sata.
English: The most serious side effects were swollen face and fever (very common); longer than normal gaps between breaths, difficulty breathing, asthma and hives (common); and swelling of the tongue and throat, and serious allergic reaction to this medicine (unknown frequency).
Croatian: Najozbiljnije nuspojave bile su otečeno lice i vrućica (vrlo često); produljeni razmaci između izdisaja, poteškoće u disanju, astma i koprivnjača (često); te oticanje jezika i grla, i ozbiljne alergijske reakcije na ovaj lijek (nepoznata učestalost).
English: Data collected in the post-marketing phase will also be examined to determine if a suitable Naglazyme maintenance dose can be recommended relative to the efficacy endpoints used in the clinical studies.
Croatian: Podaci prikupljeni tijekom faze nakon plasiranja na tržište će se također ispitati kako bi se odredilo može li se preporučiti odgovarajuća doza Naglazyme za održavanje s obzirom na krajnji cilj djelotvornosti tijekom ispitivanja.
English: Patients should be monitored for signs and symptoms of spinal/cervical cord compression (including back pain, paralysis of limbs below the level of compression, urinary and faecal incontinence) and given appropriate clinical care.
Croatian: Bolesnici se moraju nadzirati radi znakova i simptoma kompresije leđne/cervikalne moždine (uključujući bol u leđima, paralizu udova ispod razine kompresije, urinarne inkontinencije ili inkontinencije stolice) i omogućiti im odgovarajuću liječničku pomoć.
English: Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs).
Croatian: Poremećaji taloženja mukopolisaharida nastaju zbog deficijencije specifičnih lizosomalnih enzima koji su potrebni za katabolizam glikozaminoglikana (GAG).
English: Treated patients also experienced a mean decrease in urinary glycosaminoglycan excretion of 238 ± 17.8 μg/mg creatinine ( Standard Error [SE]) following 24 weeks of treatment relative to placebo-treated patients.
Croatian: Kod liječenih bolesnika također je zabilježen pad srednje vrijednosti izlučivanja glikozaminoglikana urinom od 238 ± 17,8 μg/mg kreatinina (± standardna pogreška [SE]) nakon 24 tjedna liječenja, naspram bolesnika koji su dobivali placebo.
English: Naglazyme should not be used during pregnancy unless clearly necessary.
Croatian: Naglazyme se ne bi trebao koristiti tijekom trudnoće osim ako nije stvarno potrebno.
English: Treatment has been shown to improve walking and stairclimbing ability, and to reduce the levels of glycosaminoglycans in the body.
Croatian: Pokazalo se da liječenje poboljšava sposobnost hodanja i penjanja po stepenicama, te da snižava razinu glikozaminoglikana u tijelu.
English: Interim results will be provided in the annual re-assessment reports.
Croatian: Privremeni rezultati će se objaviti u godišnjim izvještajima o re-evaluaciji.
English: Interim results will be provided in the CSP Annual Reports.
Croatian: Privremeni rezultati će se objaviti u godišnjim CSP izvještajima.
English: Naglazyme should not be given during pregnancy unless clearly necessary.
Croatian: Naglazyme se ne smije davati tijekom trudnoće osim ako to nije neophodno.
English: With administration of Naglazyme it is recommended that patients be administered pre-treatment medicinal products (antihistamines with or without antipyretics) approximately 30-60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs.
Croatian: Uz primjenu lijeka Naglazyme, preporučuje se premedikacija (antihistaminici sa ili bez antipiretika) otprilike 30-60 minuta prije početka infuzije kako bi se smanjila mogućnost razvoja reakcija na infuziju.
English: How this medicine is given
Croatian: Kako se ovaj lijek daje
English: Very common adverse reactions are those with a frequency of 1/10.
Croatian: Vrlo česte nuspojave su one s učestalošću ≥1/10.
English: If you experience any reaction like this, please tell your doctor immediately.
Croatian: Ako iskusite neku od ovih reakcija, molimo odmah o tome obavijestite svog liječnika.
English: Bradycardia, tachycardia, cyanosis
Croatian: Bradikardija, tahikardija, cijanoza Nepoznato
English: For information on pre-treatment see section 4.4 and for further instructions see section 6.6.
Croatian: Za informacije o premedikaciji pogledati dio 4.4 te za daljnje upute vidjeti dio 6.6. 4.3 Kontraindikacije
English: Apnoea1, cough, respiratory distress, asthma, bronchospasm
Croatian: Apneja1, kašalj, respiratorni distres, astma, brohnospazam
English: Severe, or potentially life-threatening hypersensitivity is a contraindication to rechallenge, if hypersensitivity is not controllable.
Croatian: Teška ili potencijalno po život opasna preosjetljivost je kontraindikacija za ponovnu primjenu lijeka, ako se reakcija preosjetljivosti ne može kontrolirati.
English: Administration of Naglazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Croatian: Naglazyme se mora primjenjivati u primjerenim kliničkim uvjetima gdje bi oprema za oživljavanje, u hitnim slučajevima bila odmah dostupna.
English: Any unused product or waste material is to be disposed of in accordance with local requirements.
Croatian: Sav neiskorišten lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
English: The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature.
Croatian: Mora se odrediti broj bočica koje treba razrijediti na temelju individualne težine bolesnika te ih izvaditi iz hladnjaka otprilike 20 minuta prije, kako bi im se omogućilo da dostignu sobnu temperaturu.
English: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23C - 27C).
Croatian: Dokazana kemijska i fizikalna stabilnost u primjeni je do 4 dana na sobnoj temperaturi (23C - 27C).
English: Reduced or absent N-acetylgalactosamine 4-sulfatase activity results in the accumulation of dermatan sulfate in many cell types and tissues.
Croatian: Smanjena ili nepostojeća aktivnost N-acetil galaktozamin 4-sulfataze dovodi do sakupljanja dermatan sulfata u mnogim tipovima stanica i tkiva.
English: 100 ml infusion bags should be considered for patients who are susceptible to fluid volume overload and weigh less than 20 kg; in this case the infusion rate (ml/min) should be decreased so that the total duration remains no less than 4 hours.
Croatian: Treba koristiti infuzijske vrećice od 100 ml za bolesnike koji su podložni volumnom preopterećenju i za one koji imaju manje od 20 kg; u tom slučaju brzina infuzije (ml/min) mora biti smanjena tako da ukupno trajanje ne bude manje od 4 sata.
English: Other reactions with known frequency were reported from 59 patients treated with Naglazyme from all five clinical trials.
Croatian: Ostale reakcije s poznatom učestalosti su prijavljene u 59 bolesnika liječenih s Naglazymom u svih 5 kliničkih pokusa.
English: Due to the low number of patients in clinical trials, adverse event (AE) data from all Naglazyme studies have been pooled and reviewed in a single, clinical trial safety analysis.
Croatian: Kao posljedica malog broja bolesnika uključenih u klinička ispitivanja, podaci o štetnim događajima iz svih kliničkih ispitivanja lijeka Naglazyme su izdvojeni i obrađeni u jednoj kliničkoj studiji ispitivanja sigurnosti.
English: BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 Ireland
Croatian: BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 Irska
English: Store in a refrigerator (2C - 8C).
Croatian: Neotvorene bočice: čuvati u hladnjaku (2C - 8C).
English: Adverse reactions are listed in Table 1 by System Organ Class.
Croatian: Nuspojave lijeka su navedene u Tablici 1 prema klasifikaciju organskih sustava.
English: Severe or life-threatening hypersensitivity to the active substance or to any of the excipients, if hypersensitivity is not controllable.
Croatian: Jaka ili po život opasna preosjetljivost na djelatnu tvar ili neke od pomoćnih tvari, ako preosjetljivost nije moguće kontrolirati.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave su navedene od najozbiljnije prema najmanje ozbiljnoj.
English: Each vial of Naglazyme is intended for single use only.
Croatian: Naglazyme-a je namijenjena samo za jednokratnu upotrebu.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Croatian: Uvjete čuvanja razrijeđenog lijeka vidjeti u dijelu 6.3.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Clear type 1, 5 ml VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE Prozirna tip 1, BOČICA od 5 ml
English: It is recommended that the diluted Naglazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Croatian: Preporučuje se razrijeđenu Naglazyme otopinu dati bolesnicima putem infuzijskog seta opremljenog s 0,2 μm in-line filtrom.
English: This medicinal product contains 0.8 mmol (18.4 mg) sodium per vial and is administered in sodium chloride 9 mg/ml solution for injection (see section 6.6).
Croatian: Ovaj lijek sadrži 0,8 mmol (18,4 mg) natrija u jednoj bočici i primjenjuje se s otopinom natrij klorida 9 mg/ml za injekcije (vidjeti dio 6.6).
English: Information will also be collected on clinical status, adverse events, assessments of immunogenicity and potential effects on antibody formation.
Croatian: Informacije će se također prikupljati o kliničkom statusu, štetnim događajima, procjeni imunogenosti te potencijalnom djelovanju na stvaranje antitijela.
English: The secondary efficacy endpoints were the rate of stairs climbed in three minutes and the urinary glycosaminoglycan excretion of treated patients compared to placebo at Week 24.
Croatian: Sekundarni ishod djelotvornosti je bio broj prijeđenih stepenica u tri minute i izlučivanje glikozaminoglikana urinom u liječenih bolesnika naspram onih koji su dobivali placebo u 24. tjednu.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Croatian: • UVJETI ILI OGRANIČENJA VEZANA UZ OPSKRBU I UPORABU LIJEKA ZADANI
English: If a physician suspects an IgE mediated reaction they have been advised in the protocol to request IgE antibody presence to be conducted by the MAH.
Croatian: Ako liječnik sumnja na postojanje reakcije posredovanjem IgE, prema protokolu mu se savjetuje da zatraži od Vlasnika odobrenja za stavljanje lijeka na tržište da provjeri prisutnost IgE antitijela.
English: What Naglazyme looks like and contents of the pack
Croatian: Kako Naglazyme izgleda i sadržaj pakovanja
English: All patients treated with NAGLAZYME (59/59) reported at least one AE.
Croatian: Svi bolesnici liječeni lijekom Naglazyme (59/59) prijavili su barem jedan štetni događaj.
English: How to store this medicine
Croatian: Kako čuvati ovaj lijek
English: Naglazyme is used to treat patients with MPS VI disease (Mucopolysaccharidosis VI).
Croatian: Naglazyme se koristi za liječenje bolesnika s MPS VI (Mukopolisaharidoza VI).
English: • Bluish skin
Croatian: • Plavičasta koža
English: Common side effects (these may affect up to 1 in 10 people):
Croatian: Česte nuspojave (mogu se javiti kod 1 osobe od 10):
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of concentrate for solution for infusion 6 vials of concentrate for solution for infusion 5 mg/5 ml
Croatian: OBLIK I SADRŽAJ 1 bočica s koncentratom za otopinu za infuziju 6 bočica s koncentratom za otopinu za infuziju 5 mg/5 ml