natgillin/translations-raw huggingface dataset:
Common Common Common Very
pogosti pogosti
Ear pain Hypertension
motnost roženice
common Common
pogosti zelo
Respiratory, Thoracic, & Mediastinal
Bolezni dihal, prsnega koša in mediastinalnega
Disorders
prostora
Dyspnoea Apnoea Nasal
dispneja apneja
common Common
pogosti pogosti
congestion
nosna kongestija bolečine v
Common Very
pogosti zelo
Abdominal pain Umbilical
trebuhu popkovna kila
30 (6)
30 (6) 0 (0)
Skin & Subcutaneous Tissue Disorders
Bolezni kože in podkožja
General Disorders & Administration Site
Splošne težave in spremembe na mestu
Conditions
aplikacije
Chest pain Rigors Malaise
bolečina v prsih okorelost utrujenost
Infusion reactions, characterized by a recurring pattern of symptoms occurring during Naglazyme infusion, were observed in 30 (56%) of the 54 patients treated with Naglazyme across all clinical studies.
Z infuzijo povezane reakcije, opredeljene s ponavljajočim se vzorcem simptomov, ki so se pojavili med infuzijo Naglazyma, so bile opažene pri 30 (56%) od 54 bolnikov, zdravljenih z Naglazymom v postopku kliničnega preizkušanja.
Reactions began as early as Week 6 and as late as Week 55 of study drug treatment, and occurred during multiple infusions though not always in consecutive weeks.
Reakcije so se začele najprej 6. teden in najpozneje 55. teden kliničnega preizkušanja zdravila in so se pojavile ob večkratni infuziji, čeprav ne vedno v zaporednih tednih.
The most common symptoms of these infusion reactions included fever, chills/ rigors, rash, and urticaria, although hypotension, nausea, vomiting, dyspnoea, bronchospasm, retrosternal pain, abdominal pain, headache, malaise, respiratory stress, angioneurotic oedema and joint pain were also reported.
Najpogostejši simptomi teh reakcij so vključevali povišano telesno temperaturo, mrzlico/ okorelost, izpuščaj in urtikarijo, čeprav so poročali tudi o hipotenziji, slabosti, bruhanju, dispneji, bronhospazmu, bolečinah za prsnico, bolečinah v trebuhu, glavobolu, utrujenosti, respiratornem stresu, angionevrotičnem edemu in bolečinah v sklepih.
52/ 54 patients (96%) treated with Naglazyme across studies were positive for antibodies to galsulfase.
52 od 54 (96%) bolnikov, ki so bili v kliničnih preizkušanjih zdravljeni z Naglazymom, je razvilo protitelesa proti galsulfazi.
The clinical significance of antibodies to galsulfase is not known.
Klinični pomen protiteles na galsulfazo ni znan.
No case of overdose with Naglazyme has been reported.
Ni poročil o primerih prevelikega odmerjanja Naglazyma.
Several patients have received their total dose of Naglazyme at approximately twice the recommended infusion rate without apparent adverse events.
Nekaj bolnikov je brez očitnih neželenih učinkov prejelo svoj celotni odmerek Naglazyma pri hitrosti infuzije, ki je bila približno dvakrat hitrejša od priporočene.
Alimentary tract and metabolism products - enzymes, ATC code:
Druga zdravila za bolezni prebavil in presnove – encimi, oznaka ATC:
This medicinal product has been authorised under "Exceptional Circumstances".
Zdravilo je pridobilo dovoljenje za promet v „ izjemnih okoliščinah “.
MPS VI is a heterogeneous and multisystemic disorder characterized by the deficiency of N-acetylgalactoasamine 4-sulfatase, a lysosomal hydrolase which catalyses the hydrolysis of sulfate moiety of the glycosaminoglycan, dermatan sulfate.
MPS VI je heterogena in multisistemska motnja, za katero je značilen primanjkljaj N- acetilgalaktozamin- 4- sulfataze, lizosomalne hidrolaze, ki katalizira hidrolizo sulfatnega dela glikozaminoglikana, dermatan sulfata.
Reduced or absent N-acetyl galactosamine 4-sulfatase activity results in the accumulation of dermatan sulfate in many cell types and tissues.
Primanjkljaj ali odsotnost N- acetil- galaktozamin- 4- sulfataze vodi v kopičenje dermatan sulfata v mnogih tipih celic in v tkivih.
Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD.
Prečiščena galsulfaza, rekombinantna oblika humane N- acetilgalaktozamin- 4- sulfataze, je glikoprotein z molekulsko maso približno 56 kD.
Galsulfase is comprised of 495 amino acids after cleavage of the N-terminus.
Galsulfaza vsebuje po cepitvi na N- terminalnem delu 495 aminokislin.
After intravenous infusion, galsulfase is rapidly removed from the circulation and taken up by cells into lysosomes, most likely via mannose-6 phosphate receptors.
Po intravenski infuziji se galsulfaza hitro odstrani iz krvnega obtoka in preide v lizosome v celicah, večinoma preko manoza- 6- fosfatnih receptorjev.
The three clinical studies performed with Naglazyme focused on assessing the systemic manifestations of MPS VI such as endurance, joint mobility, joint pain and stiffness, upper airway obstruction, manual dexterity and visual acuity.
Tri klinične raziskave, izvedene z Naglazymom, so se osredotočile na ocenitev sistemskih manifestacij MPS VI kot so vzdržljivost, gibljivost sklepov, bolečina v sklepih in otrdelost sklepov, obstrukcija zgornjih dihalnih poti, ročna spretnost in ostrina vida.
The safety and efficacy of Naglazyme was assessed in a randomised, double blind, placebo controlled, phase 3 study of 39 MPS VI patients, ranging in age from 5 to 29 years.
Varnost in učinkovitost Naglazyma je bila ocenjena v randomizirani, dvojno slepi, s placebom nadzorovani klinični raziskavi faze III na 39 bolnikih z MPS VI v starosti od 5 do 29 let.
The majority of the patients presented with short stature, impaired endurance, and musculoskeletal symptoms.
Večina bolnikov je imela majhno postavo, okrnjeno vzdržljivost in mišično- kostne simptome.
Patients received either 1 mg/ kg of galsulfase or placebo every week for a total of 24 weeks.
Bolniki so 24 tednov vsak teden prejeli bodisi galsulfazo v odmerku 1mg/ kg telesne mase, bodisi placebo.
Thirty-eight patients subsequently enrolled in an Open Label extension study where they received 1 mg/ kg of galsulfase every week.
38 bolnikov je bilo nato vključenih v odprto nadaljevalno študijo, v kateri so vsak teden prejeli galsulfazo v odmerku 1 mg/ kg.
Following 24 weeks of therapy, Naglazyme-treated patients experienced a 92 ± 40 m improvement in the distance walked in 12 minutes relative to placebo-treated patients (p = 0.025).
Po 24 tednih zdravljenja so z Naglazymom zdravljeni bolniki v primerjavi s placebo skupino dosegli 92 ± 40 m izboljšanje razdalje, prehojene v 12 minutah.
Treated patients experienced a 5.7 stair per minute improvement in the 3 Minute Stair Climb relative to placebo-treated patients.
Zdravljeni bolniki so v primerjavi s placebo skupino dosegli za 5, 7 stopnic na minuto boljši rezultat v triminutnem testu hoje po stopnicah.
Treated patients also experienced a mean decrease in urinary glycosaminoglycan excretion of 238 ± 17.8 μ g/ mg creatinine ± SE following 24 weeks of treatment relative to placebo-treated patients.
Zdravljeni bolniki so v primerjavi s placebo skupino po 24 tednih zdravljenja izločali manj glikozaminoglikanov v urinu, in sicer povprečno za 238 ± 17, 8 μg kreatinina ± SE.
GAG results approached the normal range for age in the Naglazyme treatment group.
Rezultati GAG so se v skupini, zdravljeni z Naglazymom, približali normalnim vrednostim za določeno starost.
The pharmacokinetics of galsulfase were evaluated in 13 patients with MPS VI who received 1 mg/ kg of galsulfase as a 4 hour infusion.
Farmakokinetika galsulfaze je bila ovrednotena na 13 bolnikih z MPS VI, ki so prejeli galsulfazo v odmerku 1 mg/ kg telesne mase v obliki 4- urne infuzije.
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
Po 24 tednih zdravljenja je bila povprečna (± standardni odklon [SD – » standard deviation «]) najvišja plazemska koncentracija 2, 357 (±1, 560)
6 the plasma concentration-time curve (AUC0-t) was 5,860 (± 4,184) h × ng/ ml.
6 ng/ ml in povprečna (±SD) površina pod plazemsko koncentracijsko krivuljo (AUC0- t) 5, 860 (±4, 184) h x ng/ ml.
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.
Povprečni (±SD) volumen porazdelitve je znašal 316 (± 752) ml/ kg in povprečni plazemski očistek (Cl) je znašal 7, 9 (± 14, 7) ml/ min/ kg.
The mean (± SD) elimination half-life (t1/ 2) was 22.8 (± 10.7) minutes at Week 24.
Povprečni (±SD) razpolovni čas izločanja (t1/ 2) v tednu 24 je bil 22, 8 (± 10, 7) minut.
Renal elimination of galsulfase is considered a minor pathway for clearance (see section 4.2).
Izločanje skozi ledvice velja za manj pomembno pot za očistek galsulfaze (glejte poglavje 4. 2).
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.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti posameznega odmerka, toksičnosti ponavljajočih se odmerkov ali vpliva na splošno reproduktivno sposobnost ali razvoj zarodka/ ploda pri podganah ali kuncih niso pokazali posebnega tveganja za ljudi.
Diluted solutions:
Razredčene raztopine:
Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23°C - 27°C).
Dokazano je bilo, da je pripravljena raztopina pri sobni temperaturi (23 °C – 27 °C) kemijsko in fizikalno stabilna do 4 dni.
From a microbiological safety point of view, Naglazyme should be used immediately.
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja pripravljene raztopine odgovoren uporabnik.
If not used immediately, in-use storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2°C - 8°C followed by up to 24 hours at room temperature (23°C - 27°C) during administration.
Praviloma shranjevanje ne sme presegati 24 ur pri temperaturi 2 °C – 8 °C in nadaljnjih 24 ur pri sobni temperaturi (23 °C – 27 °C) v fazi dajanja zdravila.
7 For storage conditions of the diluted medicinal product, see section 6.3.
Za pogoje shranjevanja raztopljenega zdravila glejte poglavje 6. 3.
1 and 6 vials.
Škatlica vsebuje 1 ali 6 vial.
The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ ml (0.9%) solution for infusion using aseptic technique.
Koncentrat za raztopino za infundiranje mora biti po aseptičnem postopku razredčen z izotonično raztopino natrijevega klorida 9 mg/ ml (0, 9%) za infundiranje.
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.
Priporočljivo je, da se razredčena raztopina Naglazyma aplicira bolnikom z infuzijskim setom, ki je opremljen z 0, 2 μm "in- line" filtrom (navpična izvedba).
6.7 Preparation of the Naglazyme Infusion (Aseptic Technique is to be used)
6. 7 Priprava Naglazyme raztopine za infundiranje (po aseptičnem postopku)
A volume of the sodium chloride 9 mg/ ml (0.9%) solution for infusion is to be withdrawn and discarded from a 250 ml infusion bag equal to the total volume of Naglazyme to be added.
Iz 250 ml vsebnika z raztopino natrijevega klorida 9 mg/ ml (0, 9%) za infundiranje se potegne in zavrže takšen volumen raztopine natrijevega klorida 9 mg/ ml (0, 9%), kot znaša celoten, na telesno maso bolnika preračunani volumen Naglazyma.
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.
Za bolnike, ki so občutljivi na volumsko preobremenitev in tehtajo manj kakor 20 kg, je treba uporabiti vsebnik s 100 ml infuzijske raztopine natrijevega klorida in v tem primeru zmanjšati hitrost infuzije tako, da celotna infuzija ne traja manj kot 4 ure.
The volume of Naglazyme is to be slowly added to the sodium chloride 9 mg/ ml (0.9%) solution for infusion.
Volumen Naglazyma je treba počasi dodajati infuzijski raztopini natrijevega klorida 9 mg/ ml (0, 9%).
BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL United Kingdom
BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL Združeno kraljestvo
24 January 2006
24 januar 2006
10 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
10 A IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
BioMarin Pharmaceutical Inc., 46 Galli Drive, Novato, CA 94949 United States of America
BioMarin Pharmaceutical Inc., 46 Galli Drive, Novato, CA 94949 Združene države Amerike
Catalent UK Packaging Ltd Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX United Kingdom
Catalent UK Packaging Ltd Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX Velika Britanija
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance.
11 Specific Obligations:
11 Posebne zahteve:
SO2 001.3 To evaluate the long-term safety and efficacy data from Naglazyme treatment a Clinical Surveillance Program (CSP) will be conducted.
SO2 001. 3 Izvedena bo ocean podatkov dolgoročne varnosti in učinkovitosti zdravljenja z zdravilom Naglazyme (Clinical Surveillance Program – CSP).
Evaluate the safety and efficacy of Naglazyme in 10 children less than 5 years of age will be treated with the 1 mg/ kg dose for at least one year.
Za ocenitev varnosti in učinkovitosti zdravila Naglazyme bo 10 otrok, starih manj kot 5 let starosti, zdravljenih z odmerkom 1 mg/ kg vsaj eno leto.
Information will also be collected on clinical status, adverse events, assessments of immunogenicity and potential effects on antibody formation The CSP data will be analysed at yearly intervals and results will be submitted as annual reports.
Podatki CSP se bodo analizirali v letnih intervalih, rezultati pa bodo predloženi kot letna poročila.
Severe and serious liver toxicities will be assessed through the PSUR but also through analysis of these events in the CSP database.
S PSUR- om, pa tudi z analizo teh dogodkov v podatkovni bazi CSP se bo ocenila resna in huda toksičnost za jetra.
Subjects enrolled in the program will have urinary glycosaminoglycan and samples for IgG antibodies routinely collected as specified in the Schedule of Activities.
Kot je določeno v seznamu aktivnosti, se bodo bolnikom, vključenim v program, redno jemali vzorci glikozaminoglikana v urinu in vzorci za protitelesa IgG.
Higher antibody levels (> 10OD/ uL) will be compared with the subject ’ s urinary GAG values with a view to assess potential impacts on efficacy.
Višje ravni protiteles (> 10OD/ uL) bodo primerjane z vrednostmi GAG v urinu tega bolnika z namenom oceniti morebitni vpliv na učinkovitost.
Samples for IgG antibody will be collected at specific intervals.
Vzorci za protitelesa IgG se bodo jemali na določen interval.
This protocol has been initiated in the United States and will be submitted to Ethics Committees in several EU countries (UK, Germany, France, Portugal, Italy) with known MPS VI patients at the end of September 2005.
Ta protokol se je začel izvajati v Združenih državah Amerike in bo predložen Odborom za etiko v številnih državah EU (VB, Nemčija, Francija, Portugalska, Italija) z znanimi bolniki MPS VI ob koncu septembra 2005.
SOB 002 To evaluate the long-term safety and efficacy data from Naglazyme treatment a Clinical Surveillance Program (CSP) will be conducted.
SOB 002 Izvedena bo ocean podatkov dolgoročne varnosti in učinkovitosti zdravljenja z zdravilom Naglazyme (Clinical Surveillance Program – CSP).
Subjects enrolled in the program will have urinary glycosaminoglycan and samples for IgG antibodies routinely collected as specified in the Schedule of Activities.
Kot je določeno v seznamu aktivnosti, se bodo bolnikom, vključenim v program, redno jemali vzorci glikozaminoglikana v urinu in vzorci za
Final CSP Study Report:
Končno študijsko poročilo CPS:
12 urinary GAG values together with high antibody levels will have their antibody samples assessed for evidence of neutralizing activities.
Višje ravni protiteles (> 10OD/ uL) bodo primerjane z vrednostmi GAG v urinu tega bolnika z namenom oceniti morebitni vpliv na učinkovitost.
Samples for IgG antibody will be collected at specific intervals.
Vzorci bolnikov, pri katerih se ugotovi stalna porast vrednosti GAG v urinu in visoke ravni protiteles, se bodo ocenili v zvezi z nevtralizacijo učinka zdravila.
SO2 003.2 Several measures will be implemented to assess the Naglazyme dose.
SO2 003. 2 Uvedeni bodo številni ukrepi za oceno odmerka zdravila Naglazyme.
SO2 004.2 All clinical trial patients are currently receiving the product manufactured by the commercial process.
SO2 004. 2 Vsi bolniki v okviru kliničnega preskušanja trenutno prejemajo zdravilo, izdelano v tržne namene.
GAG and antibody samples continue to be collected at protocol-specified intervals.
Še naprej poteka zbiranje vzorcev GAG in protiteles v časovnih presledkih, določenih v protokolu.
The MAH commits to analysing the data from patients who have received clinical and then commercial process product to determine if there was any change to safety (antibody formation) or efficacy parameters stemming from the transition to commercial material and will provide this analysis in the clinical study reports for each of these studies when complete.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo za vsako od teh študij po njihovem zaključku analiziral podatke bolnikov, ki so prejemali zdravilo izdelano za klinična preizkušanja in nato zdravilo, izdelano v tržne namene, da se ugotovijo morebitne spremembe v varnosti (nastajanje protiteles) ali v parametrih učinkovitosti zaradi prehoda na komercialno zdravilo.
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
15 PODATKI NA ZUNANJI OVOJNINI (ŠKATLA)
Naglazyme 1 mg/ ml concentrate for solution for infusion Galsulfase
Naglazyme 1mg/ ml koncentrat za raztopino za infundiranje galsulfaza
Sodium chloride Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80 Water for injections
Natrijev klorid Natrijev hidrogenfosfat monohidrat Natrijev dihidrogenfosfat heptahidrat Polisorbat 80 Voda za injekcije
1 vial of concentrate for solution for infusion 6 vials of concentrate for solution for infusion 5 mg/ 5 ml
1 viala koncentrata za raztopino za infundiranje 6 vial koncentrata za raztopino za infundiranje 5 mg/ 5 ml
Intravenous use Read the package leaflet before use.
Intravenska uporaba Pred uporabo preberite priloženo navodilo.
EXP MM/ YYYY
Uporabno do:
Store in a refrigerator Do not freeze
Shranjujte v hladilniku Ne zamrzujte.
For single use only Any unused solution should be discarded
Vso neporabljeno raztopino je treba zavreči.
EU/ 1/ 05/ 324/ 001 1 vial EU/ 1/ 05/ 324/ 002 6 vials
EU/ 1/ 05/ 324/ 001 1 viala EU/ 1/ 05/ 324/ 002 6 vial
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH (prozorna 1, 5 ml viala)
Naglazyme, 1 mg/ ml Concentrate for solution for infusion Intravenous use
Naglazyme, 1 mg/ ml koncentrat za raztopino za infundiranje Intravenska uporaba
EXP MM/ YYYY
Upor. do:
Naglazyme 1 mg/ ml concentrate for solution for infusion Galsulfase
Naglazyme 1 mg/ ml koncentrat za raztopino za infundiranje Galsulfaze
What Naglazyme is and what it is used for 2.
Kaj je zdravilo Naglazyme in za kaj ga uporabljamo 2.
Before you take Naglazyme 3.
Kaj morate vedeti, preden boste uporabili zdravilo Naglazyme 3.
How to take Naglazyme 4.
Kako uporabljati zdravilo Naglazyme 4.
How to store Naglazyme 6.
Shranjevanje zdravila Naglazyme 6.
WHAT NAGLAZYME IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO NAGALZYME IN ZA KAJ SGA UPORABLJAMO
Galsulfase is a form of the human enzyme N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology.
Galsulfaza je rekombinantna oblika humane N- acetilgalaktozamin- 4- sulfataze in je izdelana z rekombinantno DNA tehnologijo.
It is used for enzyme replacement therapy in Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome), a storage disorder where the level of N- acetylgalactosamine 4-sulfatase enzyme activity is absent or lower than normal.
Uporablja se za encimsko nadomestno zdravljenje pri bolnikih z mukopolisaharidozo VI (MPS VI; Maroteaux- Lamy sindrom), motnjo presnove, kjer je raven aktivnosti encima N- acetilgalaktozamin- 4- sulfataze manjša kakor normalno ali pa je encim neaktiven.
If you suffer from the MPS VI storage disorder, the reduced or absent N-acetylgalactosamine 4-sulfatase activity results in the accumulation of substrates in most cell types and tissue.
Če trpite zaradi presnovne motnje MPS VI, zmanjšana aktivnost ali neaktivnost N- acetil - galaktozamin- 4- sulfataze vodi v kopičenje substratov v večini tipov celic in v tkivu.
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).
Naglazyme je indiciran za dolgotrajno encimsko nadomestno zdravljenje pri bolnikih s potrjeno diagnozo mukopolisaharidoze VI (MPS VI; pomanjkanje N- acetilgalaktozamin- 4- sulfataze).
BEFORE YOU USE NAGLAZYME
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO NAGLAZYME
Do not use Naglazyme
Ne uporabljajte zdravila Naglazyme
- If you are allergic (hypersensitive) to galsulfase or any of the other ingredients of Naglazyme.
- Če ste alergični na (preobčutljivi za) galsulfazo ali katerokoli sestavino zdravila Naglazyme.
Take special care with Naglazyme
Bodite posebej pozorni pri uporabi zdravila Naglazyme:
- If you develop an infusion-associated reaction while being treated with Naglazyme, you should
- Če med zdravljenjem z Naglazymom razvijete z infundiranjem zdravila povezano reakcijo,
contact your physician immediately (see section 4)
takoj obvestite svojega zdravnika (glejte poglavje 4).
- If you have a fever, or if you are having difficulty breathing, talk with your doctor about
- Če imate vročino ali težave z dihanjem se pogovorite z zdravnikom o odlogu infuzije
delaying your Naglazyme infusion.
Naglazyma.
If severe allergic or
- Kakor pri vsakem drugem intravenskem beljakovinskem produktu je mogoče, da pride do
anaphylactic reactions occur, immediate discontinuation of the administration of Naglazyme may be considered and an appropriate treatment will have to be initiated by your physician.
Če se pojavi huda alergična ali anafilaktična reakcija, bo morda treba infuzijo takoj prekiniti, vaš zdravnik pa bo moral uvesti ustrezno zdravljenje.
The safety and efficacy of Naglazyme in children below the age of 5 years and in patients older than 65 years have not been established.
Varnosti in učinkovitosti Naglazyma pri otrocih, mlajših od 5 let, in pri bolnikih, starejših od 65 let, niso raziskali.
20 Kidney and liver insufficiency:
20 Motnje v delovanju ledvic in jeter:
The safety and efficacy of Naglazyme in patients with renal or hepatic insufficiency have not been evaluated.
Varnosti in učinkovitosti Naglazyma pri bolnikih z motnjami v delovanju ledvic ali jeter niso ovrednotili.
Using other medicines There are no known interactions with other medicinal products.
Uporaba drugih zdravil Poznanih interakcij z drugimi zdravili ni.
Using Naglazyme with food and drink Naglazyme is given via intravenous infusion, therefore no interaction with food and drink is expected.
Uporaba zdravila Naglazyme s hrano in pijačo Naglazyme se uporablja v obliki intravenske infuzije, zato interakcije s hrano in pijačo niso pričakovane.
Pregnancy Naglazyme should not be used during pregnancy unless clearly necessary.
Nosečnost Zdravila Naglazyme ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Breast-feeding It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
Dojenje Ni poznano, ali se galsulfaza izloča v mleko, zato je treba med zdravljenjem z Naglazymom dojenje prekiniti.