natgillin/translations-raw huggingface dataset:
• Hives • Rash • Paleness • Redness of the skin • (Facial) flushing • Increased or high blood pressure • Bluish discolouration of the skin • Fever or increased body temperature • Chills • Cough • Increased breathing rate • Increased or decreased heart rate • Vomiting • Agitation • Tremor • Swelling around the eyes • Abnormal breathing sounds
• koprivnica • izpuščaj • bledica • rdečica kože • zardevanje (obraza) • zvišan ali visok krvni tlak • modrikasto obarvanje kože • vročica ali zvišana telesna temperatura • mrzlica • kašelj • povečana hitrost dihanja • pospešen ali upočasnjen srčni utrip • bruhanje • agitacija • drhtenje • otekanje okrog oči • nenavadni zvoki dihanja • težave pri dihanju • glavobol
22 • Difficulty in breathing • Headache • Cold extremities (e. g. hands, feet) • Tingling • Pain or local reaction at the site of the drip • Dizziness • Irritability • Itchy skin • Retching • Low blood pressure • Bronchospasm • Low level of oxygen in the blood • Swelling of the face, swelling of the throat or severe combined swelling of the face, throat and tongue due to a severe allergic reaction • Swelling of the arms and legs • Feeling hot • Increased sweating • Eyes tearing • Mottled skin • Nausea • Restlessness • Wheezing • Heart stopping
22 • hladni udje (roke, noge) • mravljinčenje • bolečina ali lokalna reakcija na mestu aplikacije • omotica • razdražljivost • srbeča koža • bljuvanje • nizek krvni tlak • bronhospazem • nizka vrednost kisika v krvi • otekanje obraza, otekanje grla ali hudo kombinirano otekanje obraza, grla in jezika zaradi hude alergijske reakcije • otekanje rok in nog • občutek vročine • povečano potenje • solzenje • lisasta koža • slabost • nemir • sopenje • zaustavitev delovanja srca
Life threatening reactions, including very severe generalised allergic reactions and anaphylactic shock, have been reported in some patients.
Pri nekaterih bolnikih so poročali o življenjsko nevarnih reakcijah, vključno z zelo hudimi generaliziranimi alergijskimi reakcijami in anafilaktični šok.
HOW TO STORE MYOZYME
SHRANJEVANJE ZDRAVILA MYOZYME
Do not use after the expiry date stated on the labelling after the letters ‘ EXP’.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake » Uporabno do «.
It is recommended that Myozyme is used immediately after it has been mixed with sterile water.
Priporočeno je, da se zdravilo Myozyme uporabi takoj po mešanju s sterilno vodo.
However it can be kept for up to 24 hours if it is kept cool (2°C – 8°C) and in the dark.
Kljub temu pa se lahko shranjuje do 24 ur, če je na hladnem (2 °C – 8 °C) in temnem mestu.
What Myozyme contains
Kaj vsebuje zdravilo Myozyme
- The active substance is alglucosidase alfa 50 mg.
Zdravilna učinkovina je alglukozidaza alfa 50 mg.
- The other ingredients are
- Pomožne snovi so:
- sodium phosphate monobasic monohydrate
- monohidrat natrijevega dihidrogenfosfata
- sodium phosphate dibasic heptahydrate
- heptahidrat natrijevega hidrogenfosfata
- polysorbate 80
- polisorbat 80
What Myozyme looks like and contents of the pack Myozyme, 50 mg, is presented as a powder for concentrate for solution for infusion (in a vial- pack: sizes of 1, 10 or 25).
Izgled zdravila Myozyme in vsebina pakiranja Myozyme 50 mg je prašek za koncentrat za raztopino za infundiranje (v pakiranju z 1, 10 ali 25 vialami).
Myozyme is supplied as a white to off-white powder.
Myozyme je bel do sivkastobel prašek.
Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom
Izdelovalec Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija
Č eská Republika/ Slovenská Republika/ Slovenija Genzyme Europe B. V. organizač ní slož ka (Č eská Republika, Č eš ka, Republika Č eš ka), Tel: +420 227 133 665
Česká republika/ Slovenská Republika / Slovenija Genzyme Europe B. V. organizační složka (Česká republika, Republika Češka, Češka), Tel: +420 227 133 665
Portugal Genzyme Portugal, Tel: +351 21 422 0100
România Genzyme CEE GmbH - Reprezentanta pentru Romania Tel: +40 21 243 4228
< ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
< -------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
Myozyme has to be reconstituted with water for injections, then diluted with 9 mg/ ml (0.9%) sodium chloride solution and then administered by intravenous infusion.
Zdravilo Myozyme je treba rekonstituirati z vodo za injekcije, razredčiti z 9 mg/ ml (0, 9%) raztopino natrijevega klorida in nato uporabiti za intravensko infundiranje.
Therefore, a 0.2 micron low protein binding in-line filter should be used for administration.
Zato je treba na cevki uporabiti 0, 2- mikronski filter, ki veže nizkomolekularne beljakovine.
It was demonstrated that the use of a 0.2 micron in-line filter removes visible particles and does not result in an apparent loss of protein or activity.
Dokazali so, da se z uporabo 0, 2- mikronskega filtra odstranijo vidni delci in ne pride do očitne izgube beljakovin ali aktivnosti.
Determine the number of vials to be reconstituted based on the individual patient’ s dose regimen (mg/ kg) and remove the required vials from the refrigerator in order to allow them to reach room temperature (approximately 30 minutes).
Število vial za rekonstituiranje določite na podlagi režima odmerjanja (mg/ kg) pri posameznem bolniku in nato potrebne viale vzemite iz hladilnika, da bodo dosegle sobno temperaturo (približno 30 minut).
As Myozyme does not contain a preservative, each vial of Myozyme is for single use only.
Ker zdravilo Myozyme ne vsebuje konzervansa, je vsaka viala zdravila Myozyme namenjena le enkratni uporabi.
Use Aseptic Technique
• Rekonstitucija
• Reconstitution Reconstitute each 50 mg vial of Myozyme with 10.3 ml water for injections.
Vsako 50 mg vialo zdravila Myozyme rekonstituirajte z 10, 3 ml vode za injekcije.
Add the water for injections by slow drop-wise addition down the side of the vial and not directly onto the lyophilized cake.
Vodo za injekcije dodajajte s počasnim spuščanjem kapljic po steni viale in ne neposredno na liofilizirano sredico.
The reconstituted volume is 10.5 ml containing 5 mg enzyme/ ml, and appears as a clear, colourless to pale yellow solution which may contain particles in the form of thin white strands or translucent fibres.
Rekonstituirana vsebina je 10, 5 ml s 5 mg encima/ ml in je videti kot bistra brezbarvna do bledorumena raztopina, ki lahko vsebuje delce v obliki tankih belih nitk ali prosojnih vlaken.
• Dilution When reconstituted as above, the reconstituted solution in the vial contains 5 mg alglucosidase alfa per ml.
Po zgoraj opisani rekonstituciji rekonstituirana raztopina v viali vsebuje 5 mg alglukozidaze alfa na ml.
The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 50 mg) from each vial.
Rekonstituirana količina omogoča natančen odvzem 10, 0 ml (enakovredno 50 mg) iz vsake viale.
Also remove an equal volume of 0.9% sodium chloride, that will be replaced with
Odstranite tudi enako količino 0, 9% natrijevega klorida, ki ga bo nadomestil rekonstituiran Myozyme.
• Administration It is recommended to start the administration of the diluted solution within three hours.
Priporočljivo je, da začnete z dajanjem razredčene raztopine v treh urah.
The recommended dosage regimen of Myozyme is 20 mg/ kg of body weight administered once every 2 weeks as an intravenous infusion.
Priporočen odmerek zdravila Myozyme je 20 mg/ kg telesne mase in ga dajemo enkrat na 2 tedna kot intravensko infuzijo.
It is recommended that the infusion begin at an initial rate of 1 mg/ kg/ hr and be gradually increased by 2 mg/ kg/ hr every 30 minutes if there are no signs of IARs (Infusion Associated Reactions) until a maximum rate of 7 mg/ kg/ hr is reached.
Priporočljiva začetna stopnja infundiranja je 1 mg/ kg/ uro in jo postopno povečujemo za 2 mg/ kg/ uro vsakih 30 minut, če ni prisotnih znakov infuzijskih reakcij, dokler ni dosežena najvišja stopnja 7 mg/ kg/ uro.
Naglazyme is a solution for infusion (drip into a vein).
Zdravilo Naglazyme je raztopina za infundiranje (kapalno infuzijo v veno).
It contains the active substance galsulfase.
Vsebuje zdravilno učinkovino galsulfazo.
Naglazyme is used to treat patients who have mucopolysaccharidosis VI (MPS VI or Maroteaux-Lamy syndrome).
Zdravilo Naglazyme se uporablja za zdravljenje bolnikov z mukopolisaharidozo VI (MPS VI ali Maroteaux- Lamy sindrom).
This disease is caused by the lack of an enzyme called arylsulfatase B, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
To bolezen povzroča pomanjkanje encima, imenovanega arilsulfataza B, ki je potreben za razgradnjo snovi v telesu, imenovane glikozaminoglikani (GAG).
Because the number of patients with MPS VI is low, the disease is considered ‘ rare’, and Naglazyme was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 14 February 2001.
Ker je bolnikov z MPS VI malo, velja bolezen za redko, zato je bilo zdravilo Naglazyme dne 14. februarja 2001 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Naglazyme is given as a four-hour infusion once a week.
Zdravilo Naglazyme se daje v obliki štiriurne infuzije enkrat tedensko.
Although patients under five years of age were not included in the main study of Naglazyme, it is important that they are treated if they have a severe form of MPS VI.
Čeprav bolniki, mlajši od pet let, niso bili vključeni v glavno študijo zdravila Naglazyme, je pomembno, da prejemajo zdravljenje, če imajo hudo obliko MPS VI.
The active substance in Naglazyme, galsulfase, is a copy of the human enzyme arylsulfatase B.
Zdravilna učinkovina zdravila Naglazyme, galsulfaza, je kopija človeškega encima arilsulfataze B.
Naglazyme helps to break down the GAGs and stop them building up in the cells.
Zdravilo Naglazyme pomaga razgraditi glikozaminoglikane in preprečuje njihovo kopičenje v celicah.
This can improve the symptoms of MPS VI, including how far people with the disease can walk.
S tem se izboljšajo simptomi bolezni MPS VI, vključno z dolžino razdalje, ki jo lahko prehodi bolnik s to boleznijo.
Galsulfase is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce the enzyme.
Galsulfazo proizvajajo z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri encim proizvede celica, ki je prejela gen (DNK), s katerim lahko tvori encim.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. europa. eu http: // www. emea. europa
How has Naglazyme been studied?
Reproduction is authorised provided the source is acknowledged Kako je bilo zdravilo Naglazyme raziskano?
In studies, the most common side effects with Naglazyme (seen in more than 1 patient in 10) were ear pain, dyspnoea (difficulty breathing), abdominal (tummy) pain, general pain and reactions to the infusion (such as fever, chills, rash and hives).
V študijah so bili najpogostejši neželeni učinki zdravila Naglazyme (opaženi pri več kot 1 bolniku od 10) bolečine v ušesih, dispneja (težave z dihanjem), bolečine v trebuhu, splošne bolečine in reakcije na infuzijo (kot so povišana telesna temperatura, mrazenje in izpuščaji.
For the full list of all side effects reported with Naglazyme, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Naglazyme, glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) decided that for patients with MPS VI, treatment with Naglazyme provides benefits such as improved mobility when compared with patients given placebo.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da zdravljenje z zdravilom Naglazyme za bolnike z MPS VI pomeni klinično korist, kot je izboljšana gibljivost, v primerjavi z bolniki, ki so prejemali placebo.
Naglazyme only slightly improves the symptoms of MPS VI, but because this disease is severe and there are no other treatments for most patients with the disease, the CHMP decided that Naglazyme’ s benefits are greater than its risks for long-term enzyme replacement therapy in patients with a confirmed diagnosis of MPS VI.
Zdravilo Naglazyme zgolj rahlo izboljša simptome MPS VI, toda ker je bolezen huda in ker za večino bolnikov ni na voljo drugega zdravljenja, je CHMP odločil, da so koristi zdravila Naglazyme pri encimskem nadomestnem zdravljenju pri bolnikih s potrjeno diagnozo MPS VI, večje od z njim povezanih tveganj.
The Committee recommended that Naglazyme be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Naglazyme odobri dovoljenje za promet z zdravilom.
Naglazyme has been authorised under ‘ Exceptional Circumstances’.
Zdravilo Naglazyme je bilo odobreno „ v izjemnih okoliščinah “.
The company that makes Naglazyme will carry out studies to look at the long-term safety and effectiveness of Naglazyme in pregnant and breast-feeding women and in children under the age of five years, to see if they develop antibodies (proteins that are produced in the body in response to Naglazyme that could affect the response to treatment) and to look at the medicine’ s side effects.
Družba, ki izdeluje zdravilo Naglazyme, bo izvedla študije za proučitev dolgoročne varnosti in učinkovitosti zdravila Naglazyme pri nosečih in doječih ženskah ter pri otrocih, mlajših od pet let, da bi ugotovili, ali se pri njih razvijejo protitelesa (beljakovine, ki jih telo tvori v odziv na zdravilo Naglazyme in ki lahko vplivajo na odziv na zdravljenje), ter proučili neželene učinke zdravila.
It will also carry out studies to determine the best dose to give to patients on a regular long-term basis.
Izvedli bodo tudi študije za določitev najustreznejšega odmerka za bolnike ob dolgoročni redni uporabi.
What are the measures to minimise the risk associated with Naglazyme?
Kateri ukrepi zmanjšujejo tveganja, povezana z zdravilom Naglazyne?
The company that makes Naglazyme has put a plan in place to monitor the long-term safety and effectiveness of the medicine, collecting all the necessary data from patients treated with it.
Družba, ki izdeluje zdravilo Naglazyme, je za nadzor dolgoročne varnosti in učinkovitosti zdravila pripravila načrt, s katerim se zbirajo vsi potrebni podatki bolnikov, zdravljenih s tem zdravilom.
Other information about Naglazyme:
Druge informacije o zdravilu Naglazyme:
The European Commission granted a marketing authorisation valid throughout the European Union for Naglazyme to BioMarin Europe Limited on 24 January 2006.
Evropska komisija je dovoljenje za promet z zdravilom Naglazyme, veljavno po vsej Evropski uniji, odobrila družbi BioMarin Europe Limited dne 24. januarja 2006.
The summary of opinion of the Committee for Orphan Medicinal Products is available here.
Povzetek mnenja Odbora za zdravila sirote je na voljo tukaj.
The full EPAR for Naglazyme can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Naglazyme je na voljo tukaj.
Concentrate for solution for infusion Concentrate for solution for infusion
Koncentrat za pripravo raztopine za infundiranje
Intravenous use Intravenous use
Intravensko
vial (glass) vial (glass)
Viala (steklo)
1 vial 6 vial
6 vial
Naglazyme 1 mg/ ml concentrate for solution for infusion.
Naglazyme 1 mg/ ml koncentrat za raztopino za infundiranje
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).
A clear to slightly opalescent, and colourless to pale yellow solution.
Bistra do rahlo opalescentna in brezbarvna do bledo rumena raztopina.
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).
4. 1 Terapevtske indikacije
A key issue is to treat young patients aged < 5 years suffering from a severe form of the disease, even though patients < 5 years were not included in the pivotal phase 3 study.
Ključni namen je zdraviti mlade bolnike pred dopolnjenim petim letom starosti, ki trpijo za težko obliko bolezni, čeprav bolniki, mlajši od 5 let, niso bili vključeni v ključno klinično raziskavo faze III.
The recommended dosage 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 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.
Začetna hitrost infuzije naj bo prilagojena tako, da se približno 2, 5% celotne raztopine infundira v prvi uri, preostali volumen raztopine (približno 97, 5%) pa v naslednjih 3 urah.
For information on pre-treatment see section 4.4 and for further instructions see section 6.6.
Za informacije o predpripravi bolnika glejte poglavje 4. 4 in za nadaljnja navodila poglavje 6. 6.
Caution must be exercised in the management and treatment of patients with compromised airways by limitation or careful monitoring of antihistamine and other sedative medication use.
Posebno pozornost je treba posvetiti vodenju in zdravljenju bolnikov s prizadetimi dihalnimi potmi in upoštevati omejitev ali pazljivo nadzorovati uporabo antihistaminikov ali drugih pomirjeval.
Institution of positive– airway pressure during sleep as well as potential tracheostomy in clinically appropriate situations should also be considered.
2 Razmisliti je treba tudi, da se zagotoviti pozitivni tlak v dihalnih poteh med spanjem in tudi možnost traheostomije v ustreznih kliničnih situacijah.
Consider delaying Naglazyme infusions in patients who present with an acute febrile or respiratory illness.
Pri bolnikih z akutno vročinsko ali respiratorno boleznijo je treba razmisliti o zamiku infuzije Naglazyma.
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, starjših od 65 let, niso raziskali.
The safety and efficacy of Naglazyme in patients with renal or hepatic insufficiency have not been evaluated (see section 5.2).
(glejte poglavje 5. 2).
Patients treated with Naglazyme have developed infusion-associated reactions (IARs), defined as any drug-related adverse event occurring during the infusion or until the end of the infusion day (see section 4.8).
Bolniki, zdravljeni z Naglazymom, so razvili z infundiranjem zdravila povezane reakcije (IAR – » infusion- associated reaction «), definirane kot katerikoli z zdravilom povezani neželeni dogodek, ki se je pojavil med infuzijo ali do konca dne, v katerem je bila infuzija aplicirana (glejte poglavje 4. 8).
Based on data obtained during Naglazyme clinical trials, the majority of patients are expected to develop IgG antibodies to galsulfase within 4-8 weeks of treatment initiation.
Na osnovi podatkov, pridobljenih v času kliničnih preizkušanj Naglazyma, se za večino bolnikov pričakuje, da bodo razvili IgG protitelesa na galsulfazo v 4- 8 tednih po pričetku zdravljenja.
In the Naglazyme clinical trials, IARs were usually manageable by interrupting or slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/ or antipyretics (paracetamol), thus enabling the patient to continue treatment.
V fazi kliničnega preizkušanja Naglazyma so bile IAR običajno obvladljive z upočasnitvijo ali prekinitvijo infuzije in s (predhodnim) zdravljenjem bolnika z antihistaminiki in/ ali antipiretiki (paracetamolom), kar je bolniku omogočilo nadaljevanje zdravljenja.
With administration of Naglazyme it is recommended that patients be administered pre-treatment medications (antihistamines with or without antipyretics) approximately 30-60 minutes prior to the start of the infusion, to minimize 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).
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.
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%
As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible.
- 25% hitrosti, pri kateri se je pojavila prejšnja reakcija.
4.5 Interaction with other medicinal products and other forms of interaction
4. 6 Nosečnost in dojenje
No interaction studies have been performed.
Študije na živalih niso zadostne za oceno vpliva na nosečnost ali razvoj zarodka/ plodu (glejte poglavje 5. 3).
3 4.6 Pregnancy and lactation
Ni poznano, ali se galsulfaza izloča v mleko, zato je treba med zdravljenjem z Naglazymom dojenje prekiniti.
For Naglazyme, no clinical data on exposed pregnancies are available.
3 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Naglazyme should not be used during pregnancy unless clearly necessary.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
4. 8 Neželeni učinki
4.7 Effects on ability to drive and use machines
Ne glede na to, ali so prejemali Naglazyme ali placebo, so vsi bolniki v fazi III kliničnega preizkušanja doživeli neželene učinke.
No studies on the effects on the ability to drive and use machines have been performed.
Neželeni učinki, ki so se pojavili med III. fazo kliničnega preizkušanja na 39 bolnikih, ki so bili zdravljeni do 6 mesecev, so navedeni v spodnji tabeli po organskih sistemih.
All patients in the Phase 3 clinical study experienced Adverse Drug Reactions (ADRs), regardless of whether they were receiving Naglazyme or placebo.
Neželeni učinki so našteti v skladu s priporočenim dogovorom o navedbi pogostnosti:
The ADRs are listed following the recommended frequency convention.
Zelo pogosti neželeni dogodki so tisti, ki se pojavijo pri več kot 1 od 10 bolnikov.
Very common adverse events are those with a frequency of more than 1 in 10.
Pogosti dogodki se pojavijo pri več kakor 1 od 100 bolnikov.
Common events have a frequency of more than 1 in 100.
Med študijo so opazili 1 primer apneje v spanju.
4 Table 1:
4 Tabela 1:
Number and percentage of patients with selected adverse events in the placebo- controlled study
Število in odstotek bolnikov z izbranimi neželenimi učinki v placebo kontrolirani študiji
MedDRA
Naglazyme Placebo
Preferred
MedDRA
Naglazyme Placebo%
Preferenčni
System Organ Class
%
Term
%
Frequency
Organski sistem
% (pts)
izraz
(pts)
Pogostnost (bolniki) (bolniki)
Infections & Infestations
Infekcije in parazitske bolezni
Nervous system disorders Eye Disorders
Bolezni živčevja Očesne bolezni
Areflexia Conjunctivitis Corneal opacity
arefleksija konjunktivitis