natgillin/translations-raw huggingface dataset:
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.
Raziskave vpliva zdravila Naglazyme na razmnoževanje, ki so bile opravljene pri podganah in kuncih z odmerki do 3 mg/kg/dan, niso dokazale zmanjšane plodnosti ali škodljivih posledic za zarodek ali plod.
In case of a mild or moderate IAR, treatment with antihistamines and paracetamol should be considered and/or a reduction in the infusion rate to half the rate at which the reaction occurred.
V primeru blage ali zmerne IAR je treba razmisliti o zdravljenju z antihistaminiki in paracetamolom in/ali zmanjšati hitrost infuzije na polovično hitrost od tiste, pri kateri se je reakcija pojavila.
• Bluish skin
• bledica kože
Naglazyme should not be used during pregnancy unless clearly necessary.
Zdravila Naglazyme ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
EU/1/05/324/001 1 vial EU/1/05/324/002 6 vials
EU/1/05/324/002 6 vial
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 zdravila Naglazyme pri hitrosti infuzije, ki je bila približno dvakrat hitrejša od priporočene.
Galsulfase is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Galsulfaza je beljakovina, zato je pričakovano, da se po presnovni poti razgradi s hidrolizo beljakovin.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Clear type 1, 5 ml VIAL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH prozorna 1,5 ml viala
Bradycardia, tachycardia, cyanosis
Srčne bolezni bradikardija, tahikardija, cianoza neznana
Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD. Galsulfase is comprised of 495 amino acids after cleavage of the N-terminus.
Prečiščena galsulfaza, rekombinantna oblika humane N-acetilgalaktozamin-4-sulfataze, je glikoprotein z molekulsko maso približno 56 kD. Galsulfaza vsebuje po cepitvi na N-terminalnem delu 495 aminokislin.
A comprehensive antibody analysis based on data from three clinical studies has been carried out in 48 patients.
Pri 48 bolnikih so izvedli celovito analizo protiteles na osnovi podatkov iz treh kliničnih študij.
Interim results will be provided in the annual re-assessment reports.
Vmesni rezultati bodo predloženi v letnem poročilu o ponovni oceni.
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.
Primarni kazalec učinkovitosti je bilo število metrov, prehojenih v 12 minutah v 24. tednu v primerjavi s prehojenim izhodiščnim številom metrov na začetku zdravljenja.
Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion associated reactions”).
Neželeni učinki, ki so jih opazili v glavnem pri bolnikih med dajanjem zdravila ali tik za tem (»neželeni učinki, povezani z infundiranjem«).
• Shock
• šok
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.
There have been post-marketing reports of patients treated with Naglazyme who experienced the onset or worsening of SCC requiring decompression surgery.
Obstajajo poročila iz obdobja trženja za bolnike, zdravljene z zdravilom Naglazyme, ki so doživeli nastanek ali poslabšanje kompresije hrbtenice/hrbtenjače, zaradi česar je bil potreben dekompresijski poseg.
PSURs The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Imetnik dovoljenja za promet z zdravilom bo še naprej oddajal letna periodična poročila o varnosti, razen če CHMP ne določi drugače.
When you experience such a reaction, you should immediately contact your doctor.
Če opazite tako reakcijo, takoj obvestite svojega zdravnika.
The solution is to be mixed gently before infusion.
Raztopino je treba pred pričetkom infuzije rahlo pretresti.
Store in a refrigerator Do not freeze
DRUGI PODATKI Shranjujte v hladilniku Ne zamrzujte
How to store this medicine
Shranjevanje tega zdravila
People with MPS VI disease have either a low level, or no level, of an enzyme called N-acetylgalactosamine 4-sulfatase, which breaks down specific substances (glycosaminoglycans) in the body.
Osebe z MPS VI imajo bodisi nizko vrednost ali pa sploh nimajo encima, ki se imenuje N-acetilgalaktozamin 4-sulfataza, ki razgrajuje določene snovi (glikozaminoglikane) v telesu.
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.
In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol and/or corticosteroids) and a reduction of the infusion rate to 50% - 25% of the rate at which the previous reaction occurred.
V primeru ponovitve zmerne IAR ali ponovni posamezni hudi IAR je treba razmisliti o premedikaciji bolnika (z antihistaminiki in paracetamolom in/ali kortikosteroidi) in zmanjšati hitrost infuzije na 50% - 25% hitrosti, pri kateri se je pojavila prejšnja reakcija.
One vial of 5 ml contains 5 mg galsulfase.
Ena 5 ml viala vsebuje 5 mg galsulfaze.
Preparation of the Naglazyme infusion (aseptic technique is to be used) 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.
Priprava zdravila Naglazyme raztopine za infundiranje (po aseptičnem postopku) Število vial, ki jih bo treba razredčiti, se določi na osnovi bolnikove telesne mase in vzame iz hladilnika približno 20 minut pred pripravo, da lahko do priprave dosežejo sobno temperaturo.
The recommended dose regimen for galsulfase is 1 mg/kg body weight administered once every week as an intravenous infusion over 4 hours.
Priporočen režim odmerjanja za galsulfazo je 1 mg/ kg telesne mase enkrat tedensko v obliki 4-urne intravenske infuzije.
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 zdravilom Naglazyme, 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.
Marketing Authorization Holder BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Imetnik dovoljenja za promet z zdravilom BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Talk to your doctor if you have kidney or liver insufficiency.
Povejte svojemu zdravniku, če imate motnje v delovanju ledvic ali jeter.
For single use only Any unused solution should be discarded
Vso neporabljeno raztopino je treba zavreči
• Cloudy eyes
• motne oči
The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles.
Bistra do rahlo opalescentna in brezbarvna do bledo rumena raztopina mora biti brez vidnih delcev.
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.
Čeprav je pri večjem deležu bolnikov z visokimi ravnmi skupnih protiteles prišlo do ponavljajočih, z infuzijo povezanih reakcij, pa na osnovi ravni protiteles proti galsulfazi ni bilo moč sklepati na pogostost in na resnost teh reakcij.
- The active substance is galsulfase.
- Zdravilna učinkovina je galsulfaza.
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 zdravilom Naglazyme zdravljeni bolniki v primerjavi s placebo skupino dosegli 92  40 m izboljšanje razdalje, prehojene v 12 minutah.
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA MM/YYYY
The safety and efficacy of Naglazyme in patients older than 65 years has not been established, and no alternative dose regimen can be recommended in these patients.
Varnosti in učinkovitosti zdravila Naglazyme pri bolnikih, starejših od 65 let, niso ugotavljali.
How this medicine works
Kako to zdravilo deluje
Only clear and colourless solutions without visible particles should be used.
Uporabiti se sme samo bistro in brezbarvno raztopino brez vidnih delcev.
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.
Pri bolnikih, ki so občutljivi na vnos prevelikega volumna tekočine in tehtajo manj kot 20 kg, pridejo v poštev 100 ml infuzijske vrečke; v tem primeru je treba hitrost infuzije (ml/min) zmanjšati tako, da celotni postopek infundiranja traja najmanj 4 ure.
Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Galsulfaza je rekombinantna oblika humane N-acetilgalaktozamin-4-sulfataze in je izdelana z rekombinantno DNA tehnologijo z uporabo sesalske celične kulture ovarijskih celic kitajskega hrčka (CHO).
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.
Zdravljeni bolniki so v primerjavi s placebo skupino po 24 tednih zdravljenja izločali manj glikozaminoglikanov v urinu, in sicer povprečno za 238  17,8 g kreatinina ( standardna napaka [SE - »standard error«]).
Common symptoms of infusion reactions were pruritus, vomiting, abdominal pain, nausea, hypertension, headache, chest pain, erythema, cough, hypotension, angioedema, respiratory distress, tremor, conjunctivitis, malaise, bronchospasm and arthralgia.
Pogosti simptomi reakcij na infundiranje so bili pruritus, bruhanje, bolečina v trebuhu, navzea, hipertenzija, glavobol, bolečina v prsnem košu, eritem, kašelj, hipotenzija, angioedem, dihalna stiska, tremor, konjunktivitis, splošno slabo počutje, bronhospazem in artralgija.
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.
All patients treated with NAGLAZYME (59/59) reported at least one AE.
Vsi bolniki, zdravljeni z zdravilom NAGLAZYME (59/59), so poročali o vsaj enem neželenem učinku.
Diluted solutions: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23C - 27C).
Razredčene raztopine: Dokazano je bilo, da je pripravljena raztopina pri sobni temperaturi (23 C27 C) kemijsko in fizikalno stabilna do 4 dni.
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.
Pharyngitis1, gastroenteritis1
Infekcijske in parazitske bolezni faringitis1, gastroenteritis1
Other medicines and Naglazyme
Druga zdravila in zdravilo Naglazyme
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg galsulfase.
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 1 mg galsulfaze.
Common side effects (these may affect up to 1 in 10 people):
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept
- The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate, sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections.
- Pomožne snovi so: natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, polisorbat 80, voda za injekcije.
Your doctor or nurse will administer Naglazyme to you.
Zdravilo Naglazyme vam bo dal vaš zdravnik ali sestra.
A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Treatment with Naglazyme showed improvement, or lack of worsening, of facial dysmorphism.
Ob zdravljenju z Naglazymom je bilo opaziti izboljšanje oz. ni prišlo do poslabšanja kraniofacialnega dismorfizma.
• Increased heart rate
• hitrejši srčni utrip
If you experience any reaction like this, please tell your doctor immediately.
Če opazite take reakcije, o tem takoj obvestite zdravnika.
Serious adverse reactions included laryngeal edema, apnoea, pyrexia, urticaria, respiratory distress, angioedema, asthma and anaphylactoid reaction.
Hudi neželeni učinki so vključevali edem grla, apnejo, pireksijo, urtikarijo, dihalno stisko, angioedem, astmo in anafilaktoidno reakcijo.
METHOD OF ADMINISTRATION Read the package leaflet before use
POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo
Administration of Naglazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Naglazyma se da bolniku v ustrezni klinični ustanovi, ki je opremljena z ustrezno opremo za nudenje nujne medicinske pomoči.
• Pain (including ear, abdominal, joint, chest pain)
• bolečine (vključno z bolečino v ušesih,
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 sposobnost razmnoževanja ali razvoj zarodka/ploda pri podganah ali kuncih niso pokazali posebnega tveganja za ljudi.
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%).
• Decreased heart rate
• upočasnjen srčni utrip
Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80
Natrijev hidrogenfosfat monohidrat, Natrijev dihidrogenfosfat heptahidrat, Polisorbat 80,
• Cough
• kašelj
If not used immediately, in-use storage times and conditions are the responsibility of the user and must 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 C27 C) v fazi dajanja zdravila.
Very common adverse reactions are those with a frequency of 1/10.
Neželeni učinki so našteti v skladu s dogovorom o navedbi pogostnosti po MedDRA. Zelo pogosti neželeni učinki so tisti, ki se pojavijo pri 1/10 bolnikov.
GAG results approached the normal range for age in the Naglazyme treatment group.
Rezultati GAG so se v skupini, zdravljeni z zdravilom Naglazyme, približali normalnim vrednostim za določeno starost.
Galsulfase is recombinant human N-acetylgalactosamine 4-sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
Galsulfaza je rekombinantna oblika humane Nacetilgalaktozamin-4-sulfataze, ki jo pridobijo iz gensko spremenjenih ovarijskih celic kitajskega hrčka (CHO).
Subjects enrolled in the program will have urinary glycosaminoglycan and samples for total 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 skupna protitelesa.
Angioeodema1, rash1, urticaria, pruritus Very Common Erythema
Bolezni kože in podkožja angioedem1, izpuščaj1, urtikarija, pruritus zelo pogosti eritem pogosti
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.
Ob aplikaciji Naglazyma je približno 30 - 60 minut pred pričetkom infuzije za zmanjšanje tveganja za razvoj IAR priporočljiva premedikacija bolnikov (antihistaminiki z ali brez antipiretikov).
• Bulging belly button
• zamašen nos • izbokel popek
Preparation of the Naglazyme Infusion (Use Aseptic Technique)
Priprava Naglazyme raztopine za infundiranje (po aseptičnem postopku)
Musculoskeletal and Connective Tissue Disorders
Bolezni mišično-skeletnega sistema artralgija zelo pogosti
• Low blood-oxygen
• nizka raven kisika v krvi
Do not take Naglazyme if it contains visible particles.
Ne vzemite zdravila Naglazyme, če opazite vidne delce.
• When new information is received that may impact on the current Safety
• ob prejemu novih informacij, ki bi lahko vplivale na trenutno varnostno spedifikacijo , farmakovigilančni načrt ali dejavnosti za zmanjšanje tveganja;
Before dilution, each vial is to be inspected for particulate matter and discolouration.
Pred redčenjem se je treba za vsako vialo prepričati, da ne vsebuje vidnih delcev in da ni razbarvana.
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.
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.
A brief update will be submitted as part of the Annual Reassessments.
Kratko poročilo bo predloženo v letnem poročilu o ponovni oceni.
If you have missed a Naglazyme infusion, please contact your doctor.
Če ste pozabili priti na infuzijo zdravila Naglazyme, se posvetujte s svojim zdravnikom.
Evaluate the safety and efficacy of Naglazyme in 10 children less than
Za ocenitev varnosti in učinkovitosti zdravila Naglazyme bo 10 otrok,
Very common symptoms of these infusion reactions were pyrexia, chills/rigors, rash, urticaria and dyspnoea.
Zelo pogosti simptomi teh reakcij na infundiranje so bili pireksija, mrzlica/tresavica, izpuščaj, urtikarija in dispneja.
The most common symptoms of infusion associated reactions include fever, chills, rash, hives and shortness of breath.
Najbolj pogosti simptomi reakcij, povezanih z infundiranjem, so vključevali zvišano telesno temperaturo, mrzlico, izpuščaj, koprivnico in zasoplost.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Samo za enkratno uporabo
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.
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.
Apnoea1, cough, respiratory distress, asthma, bronchospasm
zelo pogosti apneja1, kašelj, dihalna stiska, astma, bronhospazem pogosti edem grla, hipoksija, tahipneja neznana
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase
IME ZDRAVILA IN POT(I) UPORABE Naglazyme 1 mg/ml koncentrat za raztopino za infundiranje galsulfaza
The following information is intended for medical or healthcare professionals only: Naglazyme should not be mixed with other medicinal products in the same infusion, except for those mentioned below.
To zdravilo se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena spodaj.
• Poor hearing
• poslabšan sluh
• Wheezing • Skin redness
• zasoplost • rdečina kože
A clear to slightly opalescent, and colourless to pale yellow solution.
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje bistra do rahlo opalescentna in brezbarvna do bledo rumena raztopina
One ml of Naglazyme contains 1 mg galsulfase.
Vsak ml raztopine vsebuje 1 mg galsulfaze.
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 1 mg galsulfase.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsak ml raztopine vsebuje 1 mg galsulfaze.
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management System for medicinal products for human use.
V skladu s smernicami CHMP o sistemih za obvladovanje tveganja za zdravila za humano uporabo mora imetnik dovoljenja za promet predložiti posodobljen načrt RMP.
NAME OF THE MEDICINAL PRODUCT Naglazyme 1 mg/ml concentrate for solution for infusion
IME ZDRAVILA Naglazyme 1 mg/ml koncentrat za raztopino za infundiranje
Management of compromised airways
Obravnava prizadetih dihalnih poti
• Sore throat
• vnetje žrela
The most common adverse reactions were pyrexia, rash, pruritus, urticaria, chills/rigors, nausea, headache, abdominal pain, vomiting and dypsnoea.
Najpogostejši neželeni učinki so bili pireksija, izpuščaj, pruritus, urtikarija, mrzlica/tresavica, navzea, glavobol, bolečina v trebuhu, bruhanje in dispneja.
Overall, one case of sleep apnoea was experienced from all clinical studies.
Med klinično študijo so opazili 1 primer apneje v spanju.
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Dyspnoea1, nasal congestion1
Očesne bolezni konjunktivitis1, motnost roženice1
4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji
• Skin paleness
• modrikava koža
Table 1: Frequency of adverse drug reactions with Naglazyme
Preglednica 1: Pogostnost neželenih učinkov na zdravilo Naglazyme Organski sistem po MedDRA Priporočeni izraz po MedDRA Pogostnost Bolezni imunskega sistema anafilaksa, šok neznana
PACKAGE LEAFLET: INFORMATION FOR THE USER Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase
NAVODILO ZA UPORABO Naglazyme 1 mg/ml koncentrat za raztopino za infundiranje galsulfaza
There is no evidence for special considerations when Naglazyme is administered to the paediatric population.
Ni dokazov za posebne pomisleke v zvezi z uporabo zdravila Naglazyme pri otrocih.
Abdominal pain1, umbilical hernia1, vomiting, nausea
Bolezni prebavil bolečina v trebuhu1, popkovna kila1, bruhanje, navzea zelo pogosti