natgillin/translations-raw huggingface dataset:
Antal og procentdel af patienter med udvalgte hændelser i det placebo- kontrollerede studium
Number and percentage of patients with selected adverse events in the placebo- controlled study
Foretrukket
Preferred
Placebo%
Naglazyme Placebo%
term
Term
(patienter)
% (pts)
(pt.)
(pts)
Infektioner og parasitære sygdomme
Infections & Infestations
16 (3)
16 (3)
Gastroenteritis
Gastroenteritis
Nervesystemet
Nervous system disorders Eye Disorders
Conjunctivitis Almindelig
Areflexia Conjunctivitis Corneal opacity
Corneal opacitet Almindelig Meget
Common Common Common Very
11 (2)
11 (2) 21 (4) 11 (2)
0 (0)
0 (0) 0 (0) 0 (0)
Øre og labyrint
Ear & Labyrinth Disorders Vascular Disorders
Øresmerte
Ear pain Hypertension
almindelig
common Common
42 (8)
42 (8) 11 (2)
20 (4)
20 (4) 0 (0)
Vaskulære sygdomme
Respiratory, Thoracic, & Mediastinal
11 (2)
Very
0 (0)
Disorders
Dyspnø Apnø Nasal
Dyspnoea Apnoea Nasal
almindelig Almindelig
common Common
21 (4) 5 (1)
21 (4) 5 (1)
10 (2) 0 (0)
10 (2) 0 (0)
kongestion Abdominal
congestion
Almindelig Meget
Common Very
Mave- tarmkanalen
Gastrointestinal Disorders
smerte
Abdominal pain Umbilical
Navlebrok
hernia
Hud og subkutane væv
Skin & Subcutaneous Tissue Disorders
Almene symptomer og reaktioner på
General Disorders & Administration Site
administrationsstedet
Conditions
Brystsmerte Rigors Ubehag
Chest pain Rigors Malaise
Infusionsreaktioner, karakteriseret ved et tilbagevendende mønster af symptomer, der optræder under infusion med Naglazyme, blev observeret hos 30 (56%) af de 54 patienter, der blev behandlet med Naglazyme i samtlige kliniske studier.
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.
Reaktionerne begyndte så tidligt som i uge 6 og så sent som i uge 55 i studiebehandlingen og optrådte under flere infusioner, men dog ikke altid i på hinanden følgende uger.
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.
De hyppigste symptomer fra disse infusionsreaktioner omfattede feber, kulderystelser/ rigors, udslæt og urticaria; men der blev også indberettet hypotension, kvalme, opkastning, dyspnø, bronkospasme, retrosternal smerte, abdominal smerte, hovedpine, ubehag, respiratorisk stress, angioneurotiske ødemer og smerte i led.
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.
52/ 54 patienter (96%) behandlet med Naglazyme i samtlige studier var positive for antistoffer over for galsulfase.
52/ 54 patients (96%) treated with Naglazyme across studies were positive for antibodies to galsulfase.
Den kliniske signifikans af antistoffer over for galsulfase er ikke kendt.
The clinical significance of antibodies to galsulfase is not known.
Der er ikke rapporteret tilfælde af overdosering med Naglazyme.
No case of overdose with Naglazyme has been reported.
Fordøjelseskanal - og metabolismeprodukter - enzymer, ATC- kode:
Alimentary tract and metabolism products - enzymes, ATC code:
Dette lægemiddel er godkendt under ” særlige omstændigheder ”.
This medicinal product has been authorised under "Exceptional Circumstances".
MPS VI er en heterogen og multisystemisk lidelse, karakteriseret ved mangel på N- acetylgalactoasamine 4- sulfatase, en lysosomal hydrolase som katalyserer hydrolysen af sulfat- delen af glycosaminoglycan, dermatansulfat.
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.
Nedsat eller manglende N- acetylgalactosamine 4- sulfatase aktivitet resulterer i akkumulation af dermatansulfat i mange celletyper og væv.
Reduced or absent N-acetyl galactosamine 4-sulfatase activity results in the accumulation of dermatan sulfate in many cell types and tissues.
Renfremstillet galsulfase, en rekombinant form af human N- acetylgalactosamine 4- sulfatase, er et glykoprotein med en molekylærvægt på cirka 56 kD.
Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD.
Galsulfase består af 495 aminosyrer efter spaltning af N- terminus.
Galsulfase is comprised of 495 amino acids after cleavage of the N-terminus.
Molekylet indeholder 6 N- linkede oligosaccharid modifikationssteder.
The molecule contains 6 N-linked oligosaccharide modification sites.
Efter intravenøs infusion fjernes galsulfase hurtigt fra kredsløbet og optages af celler ind i lysosomer, højst sandsynlig via mannose- 6 fosfat receptorer.
After intravenous infusion, galsulfase is rapidly removed from the circulation and taken up by cells into lysosomes, most likely via mannose-6 phosphate receptors.
De tre kliniske studier udført med Naglazyme fokuserede på at vurdere de systemiske manifestationer af MPS VI såsom udholdenhed, bevægelighed i led, ledsmerte og – stivhed, obstruktion af de øvre luftveje, manuel behændighed og synsskarphed.
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.
Sikkerheden og effekten af Naglazyme blev undersøgt i et randomiseret, dobbeltblind, placebo - kontrolleret fase 3 studium med 39 MPS VI patienter i alderen fra 5 til 29 år.
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.
Patienterne modtog enten 1 mg/ kg galsulfase eller placebo hver uge i løbet af i alt 24 uger.
Patients received either 1 mg/ kg of galsulfase or placebo every week for a total of 24 weeks.
De sekundære endepunkter var hastigheden af hvor mange trin patienten kunne gå op ad i tre minutter samt den urinære glycosaminoglycan udskillelse fra behandlede patienter sammenlignet med placebo- gruppen ved uge 24.
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.
38 patienter blev efterfølgende rekrutteret i et forlænget forsøg med åben etiket, hvor de modtog 1 mg/ kg galsulfase hver uge.
Thirty-eight patients subsequently enrolled in an Open Label extension study where they received 1 mg/ kg of galsulfase every week.
Efter 24 ugers behandling oplevede Naglazyme- behandlede patienter en 92 ± 40 m forbedring i den afstand, de kunne gå i løbet af 12 minutter, i forhold til patienter i placebo- gruppen (p = 0, 025).
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).
Behandlede patienter oplevede en forbedring på 5, 7 trin per minut i den 3 minutter lange trappe- test i forhold til patienter i placebo- gruppen.
Treated patients experienced a 5.7 stair per minute improvement in the 3 Minute Stair Climb relative to placebo-treated patients.
Behandlede patienter oplevede desuden en gennemsnitlig reduktion i urinær glycosaminoglycan udskillelse på 238 ± 17, 8 μg/ mg kreatinin ± SE efter 24 ugers behandling i forhold til patienter i placebo- gruppen.
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.
GAG resultaterne nærmede sig normalområdet i henhold til alder i den Naglazyme- behandlede gruppe.
GAG results approached the normal range for age in the Naglazyme treatment group.
Farmakokinetikken af galsulfase blev evalueret hos 13 patienter med MPS VI, som modtog 1 mg/ kg galsulfase som en 4 timers infusion.
The pharmacokinetics of galsulfase were evaluated in 13 patients with MPS VI who received 1 mg/ kg of galsulfase as a 4 hour infusion.
Efter 24 ugers behandling var middel (± Standard Deviation [SD]) maksimumplasmakoncentrationen (Cmax) 2. 357 (± 1. 560) ng/ ml, og middel (± SD) areal under plasmakoncentration- tidskurven (AUC0- t) var 5. 860 (± 4. 184) h × ng/ ml.
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
Middel (± SD) distributionsvolumenet (Vz) var 316 (± 752) ml/ kg, og middel (± SD) plasmaclearance (CL) var 7, 9 (± 14, 7) ml/ min/ kg.
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.
Middel (± SD) eliminationshalveringstiden (t1/ 2) var 22, 8 (± 10, 7) minutter ved uge 24.
The mean (± SD) elimination half-life (t1/ 2) was 22.8 (± 10.7) minutes at Week 24.
4. 2).
Renal elimination of galsulfase is considered a minor pathway for clearance (see section 4.2).
Peri - og postnatal toksicitet er ikke blevet undersøgt.
Peri- and post-natal toxicity has not been investigated.
Natriumklorid Natriumfosfat monobasisk monohydrat Natriumfosfat dibasisk heptahydrat Polysorbat 80 Vand til injektioner
Sodium chloride Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Polysorbate 80 Water for injections
Kemisk og fysisk brugsstabilitet er blevet påvist i op til 4 dage ved stuetemperatur (23°C - 27°C).
Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23°C - 27°C).
Hvis det ikke anvendes omgående, er brugsopbevaringstid og – forhold brugerens ansvar, og det bør normalt ikke strække sig ud over 24 timer ved 2°C – 8°C efterfulgt af op til 24 timer ved stuetemperatur (23°C - 27°C) under administration.
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.
6. 3.
7 For storage conditions of the diluted medicinal product, see section 6.3.
Hætteglas (type I glas) med en prop (silikoniseret chlorobutylgummi) og forsegling (aluminium) med en flip- off hætte (polypropylen).
Vial (type I glass) with a stopper (siliconized chlorobutyl rubber) and a seal (aluminium) with a flip- off cap (polypropylene).
1 og 6 hætteglas.
1 and 6 vials.
Koncentratet til infusionsvæsken skal fortyndes med natriumklorid 9 mg/ ml (0, 9%) infusionsopløsning ved brug af aseptisk teknik.
The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ ml (0.9%) solution for infusion using aseptic technique.
Det anbefales, at den fortyndede Naglazyme opløsning administreres til patienterne ved brug af et infusionssæt, der er udstyret med et 0, 2 µm in- line filter.
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.
6. 7 Forberedelse til Naglazyme infusion (der skal anvendes aseptisk teknik)
6.7 Preparation of the Naglazyme Infusion (Aseptic Technique is to be used)
Et volumen natriumklorid 9 mg/ ml (0, 9%) infusionsopløsning, lig med det totale volumen Naglazyme der skal tilføres, trækkes ud af en 250 ml infusionspose og kasseres.
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.
100 ml infusionsposer skal overvejes til patienter, som er følsomme over for væske- overload, og som vejer mindre end 20 kg; i dette tilfælde bør infusionshastigheden (ml/ min) nedsættes således, at den totale varighed ikke bliver mindre end 4 timer.
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.
Naglazyme volumenet tilføres langsomt til natriumklorid 9 mg/ ml (0, 9%) infusionsopløsningen.
The volume of Naglazyme is to be slowly added to the sodium chloride 9 mg/ ml (0.9%) solution for infusion.
BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL Storbritannien
BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL United Kingdom
8 8.
8 8.
24, januar, 2006
24 January 2006
FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
10 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Catalent UK Packaging Ltd Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX Storbritannien
Catalent UK Packaging Ltd Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX United Kingdom
Indehaveren af markedsføringstilladelsen forpligter sig til at gennemføre de undersøgelser og yderligere lægemiddelovervågningsaktiviteter, der er beskrevet detaljeret i lægemiddelovervågningsplanen.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
11 Særlige forpligtelser:
11 Specific Obligations:
SO2 001. 3 Med henblik på at evaluere de langsigtede sikkerheds - og effektdata fra Naglazyme behandlingen vil der blive gennemført et klinisk overvågningsprogram (Clinical Surveillance Program - CSP).
SO2 001.3 To evaluate the long-term safety and efficacy data from Naglazyme treatment a Clinical Surveillance Program (CSP) will be conducted.
Inden for CSP vil der blive gennemført sub- studier, der skal:
Substudies will be conducted within the CSP that will:
Evaluere virkningen af Naglazyme på graviditet og amning 2.
Interim results will be provided in the CSP Annual Reports.
Evaluere sikkerheden og effekten af Naglazyme hos 10 børn under 5 år, der har været behandlet med en dosis på 1 mg/ kg i mindst ét år.
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.
CSP- dataene vil blive analyseret årligt, og resultaterne vil blive indsendt som årlige rapporter.
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.
Andre målinger (urin- GAG, antistoffer) vil blive vurderet hyppigere.
Other measures (urinary GAG, antibodies) are assessed more frequently.
Svær og alvorlig levertoksicitet vil blive vurderet i periodiske, opdaterede sikkerhedsindberetninger (Periodic Safety Update Reports – PSUR) men også ved analyse af disse uønskede hændelser i CSP- databasen.
Severe and serious liver toxicities will be assessed through the PSUR but also through analysis of these events in the CSP database.
Forsøgspersoner, som er rekrutteret i programmet, vil regelmæssigt få indsamlet urinær glycosaminoglycan samt prøver for IgG- antistoffer, som specificeret i Aktivitetsplanen.
Subjects enrolled in the program will have urinary glycosaminoglycan and samples for IgG antibodies routinely collected as specified in the Schedule of Activities.
Højere antistofniveauer (> 10 OD/ ul) vil blive sammenlignet med forsøgspersonens urin- GAG værdier med henblik på at vurdere den potentielle indflydelse på effekten.
Higher antibody levels (> 10OD/ uL) will be compared with the subject ’ s urinary GAG values with a view to assess potential impacts on efficacy.
De forsøgspersoner, hvis prøver har en konsekvent stigning i urin- GAG værdierne sammen med høje antistofniveauer, vil få deres antistofprøver vurderet for tegn på neutraliserende aktiviteter.
Samples from those subjects who have a consistent increase in urinary GAG values together with high antibody levels will have their antibody samples assessed for evidence of neutralizing activities.
Prøver for IgG- antistof vil blive indsamlet med specifikke intervaller.
Samples for IgG antibody will be collected at specific intervals.
Hvis en læge mistænker en IgE- medieret reaktion, rådes han/ hun ifølge protokollen til at anmode om, at indehaveren af markedsføringstilladelsen gennemfører prøver til at bekræfte tilstedeværelse af IgE- antistof.
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.
Denne protokol er blevet udarbejdet i USA og vil i slutningen af september 2005 blive indsendt til etiske komiteer i flere EU- lande (Storbritannien, Tyskland, Frankrig, Portugal, Italien) med kendte MPS VI- patienter.
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.
SOB 002 Med henblik på at evaluere de langsigtede sikkerheds - og effektdata fra Naglazyme- behandlingen vil der blive gennemført et klinisk overvågningsprogram (Clinical Surveillance Program - CSP).
SOB 002 To evaluate the long-term safety and efficacy data from Naglazyme treatment a Clinical Surveillance Program (CSP) will be conducted.
Evaluere virkningen af Naglazyme på graviditet og amning 2.
Evaluate the effect of Naglazyme on pregnancy and lactation.
Der vil blive indsamlet detaljerede oplysninger om klinisk status ved forsøgspersonens indtræden i forsøget samt på årlig basis i mindst 15 år.
Other measures (urinary GAG, antibodies) are assessed more frequently.
Endelig CSP forsøgsrapport:
Final CSP Study Report:
Svær og alvorlig levertoksicitet vil blive vurderet i periodiske, opdaterede sikkerhedsindberetninger (Periodic Safety Update Reports – PSUR) men også ved analyse af disse uønskede hændelser i CSP- databasen.
12 urinary GAG values together with high antibody levels will have their antibody samples assessed for evidence of neutralizing activities.
SO2 003. 2 Flere tiltag vil blive implementeret til vurdering af Naglazyme dosen.
SO2 003.2 Several measures will be implemented to assess the Naglazyme dose.
SO2 004. 2 Alle patienterne i de kliniske forsøg modtager på nuværende tidspunkt det produkt, der er fremstillet ved brug af den kommercielle proces.
SO2 004.2 All clinical trial patients are currently receiving the product manufactured by the commercial process.
GAG og antistofprøver bliver fortsat indsamlet ifølge de protokolspecifikke intervaller.
GAG and antibody samples continue to be collected at protocol-specified intervals.
Indehaveren af markedsføringstilladelsen vil endvidere tilvejebringe denne analyse i de kliniske forsøgsrapporter for hvert af disse forsøg, når de er fuldført.
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.
15 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE (ÆSKE)
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Naglazyme 1 mg/ ml koncentrat til infusionsvæske, opløsning Galsulfase
Naglazyme 1 mg/ ml concentrate for solution for infusion Galsulfase
ANGIVELSE AF AKTIV STOF/ AKTIVE STOFFER
STATEMENT OF ACTIVE SUBSTANCE(S)
Natriumklorid Natriumfosfat monobasisk monohydrat Natriumfosfat dibasisk heptahydrat Polysorbat 80 Vand til injektioner
Sodium chloride Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80 Water for injections
1 hætteglas med koncentrat til infusionsvæske, opløsning 6 hætteglas med koncentrat til infusionsvæske, opløsning 5 mg/ 5 ml
1 vial of concentrate for solution for infusion 6 vials of concentrate for solution for infusion 5 mg/ 5 ml
Intravenøs anvendelse Læs indlægsseddel inden brug
Intravenous use Read the package leaflet before use.
MM/ ÅÅÅÅ
EXP MM/ YYYY
Kun til engangsbrug Evt. ubrugt opløsning skal bortskaffes
For single use only Any unused solution should be discarded
EU/ 1/ 05/ 324/ 001 1 hætteglas EU/ 1/ 05/ 324/ 002 6 hætteglas
EU/ 1/ 05/ 324/ 001 1 vial EU/ 1/ 05/ 324/ 002 6 vials
17 MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER (1, 5 ml klart HÆTTEGLAS)
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Naglazyme, 1 mg/ ml koncentrat til infusionsvæske, opløsning Intravenøs anvendelse
Naglazyme, 1 mg/ ml Concentrate for solution for infusion Intravenous use
Læs denne indlægsseddel grundigt inden De/ du begynder at bruge medicinen
Read all of this leaflet carefully before you start using this medicine.
- Lægen har ordineret Naglazyme til Dem/ dig personligt.
- This medicine has been prescribed for you.
Naglazymes virkning og hvad De/ du skal bruge det til 2.
What Naglazyme is and what it is used for 2.
Det skal De/ du vide, før De/ du begynder at bruge Naglazyme 3.
Before you take Naglazyme 3.
Sådan skal De/ du bruge Naglazyme 4.
How to take Naglazyme 4.
Sådan opbevarer De/ du Naglazyme 6.
How to store Naglazyme 6.
NAGLAZYMES VIRKNING OG HVAD DE/ DU SKAL BRUGE DET TIL
WHAT NAGLAZYME IS AND WHAT IT IS USED FOR
Galsulfase er en form af det humane enzym N- acetylgalactosamine 4- sulfatase og er fremstillet ved rekombinant DNA teknologi.
Galsulfase is a form of the human enzyme N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology.
Det anvendes til enzymsubstitutionsbehandling hos patienter med Mucopolysaccharidose VI (MPS VI; Maroteaux- Lamy syndrom, en aflejringssygdom, hvor niveauet af N- acetylgalactosamine 4- sulfatase enzymaktivitet mangler eller er lavere end normalt.
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.
Hvis De/ du lider af MPS VI aflejringssygdom, resulterer den reducerede eller manglende N- acetylgalactosamine 4- sulfatase aktivitet i akkumulation af substrater i de fleste celletyper og væv.
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.
Naglazyme er indiceret til langvarig enzymsubstitutionsbehandling hos patienter med bekræftet diagnose af Mucopolysaccharidose VI (MPS VI; N- acetylgalactosamine 4- sulfatase mangel).
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).
DET SKAL DE/ DU VIDE, FØR DE/ DU BEGYNDER AT BRUGE NAGLAZYME
BEFORE YOU USE NAGLAZYME
Brug ikke Naglazyme:
Do not use Naglazyme
- Hvis De/ du er overfølsom (allergisk) over for galsulfase eller et af de øvrige indholdsstoffer.
- If you are allergic (hypersensitive) to galsulfase or any of the other ingredients of Naglazyme.
Vær ekstra forsigtig med at bruge Naglazyme:
Take special care with Naglazyme
- Hvis De/ du udvikler en infusionsrelateret reaktion, mens De/ du bliver behandlet med
- If you develop an infusion-associated reaction while being treated with Naglazyme, you should
4).
contact your physician immediately (see section 4)
- Hvis De/ du har feber, eller hvis De/ du har vanskelighed ved at trække vejret, bør De/ du tale
- If you have a fever, or if you are having difficulty breathing, talk with your doctor about
med Deres/ din læge om at udskyde Deres/ din Naglazyme infusion.
delaying your Naglazyme infusion.
- Som med ethvert intravenøst proteinprodukt er der mulighed for, at der kan forekomme
If severe allergic or
Hvis der optræder svære allergiske eller anafylaktiske reaktioner, kan det overvejes omgående at afbryde infusionen med Naglazyme, og Deres/ din læge vil påbegynde en passende behandling.
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.
20 Nedsat nyre - og leverfunktion:
20 Kidney and liver insufficiency: