natgillin/translations-raw huggingface dataset:
Injury, poisoning and procedural complications 
Poškodbe in zastrupitve in zapleti pri posegih pogosti padec občasni padec
• Lack of energy. 
• izguba energije, • nespečnost,
Imnovid with dexamethasone only 
Zdravilo Imnovid samo z deksametazonom
Pom+Btz+LD-Dex (N = 281) 
Povzetek celotnih podatkov učinkovitosti Pom+Btz+NO-deks (N = 281)
• Rashes. 
• vsadek,
Titanium dioxide (E171) Indigotine (E132) Brilliant blue FCF (E133) White ink 
Imnovid 4 mg trde kapsule želatina titanov dioksid (E171) indigotin (E132) brilijantno modro FCF (E133) belo črnilo
A total of 559 patients were enrolled and randomised in the study: 281 in the Pom+Btz+LD-Dex arm and 278 in the Btz+LD-Dex arm. 54% of patients were male with median age for the overall population of 68 years (min, max: 27, 89 years). 
V študijo je bilo vključenih in randomiziranih skupaj 559 bolnikov: 281 v skupino Pom+Btz+NO-deks in 278 v skupino Btz+NO-deks.
Imnovid 1 mg hard capsules pomalidomide 
Imnovid 1 mg trde kapsule pomalidomid
Deep vein thrombosis Hypotension Hypertension 
Žilne bolezni pogosti globoka venska tromboza hipotenzija hipertenzija pogosti hipotenzija hipertenzija občasni globoka venska tromboza
Hepatobiliary disorders Uncommon Hepatitis 
Infekcijske in parazitske bolezni neznana pogostnost reaktivacija hepatitisa B
• Hives (urticaria). 
• zasoplost (dispnea),
Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 4 gelatin hard capsule. 
Temno moder neprozoren pokrovček in rumeno neprozorno telo z belim natisom "POML" in črnim natisom "1 mg", velikost 4, želatinasta trda kapsula.
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132) and yellow iron oxide (E172) and white and black ink. 
• Ovojnica kapsule vsebuje: želatino, titanov dioksid (E171), indigotin (E132), rumeni železov oksid (E172) ter belo in črno črnilo;
• some antifungals such as ketaconazole 
• nekatere antimikotike, kot je ketokonazol,
Mannitol (E421) Starch, pregelatinised Sodium stearyl fumarate 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Vsebina kapsule manitol (E421) škrob, predgelirani natrijev stearilfumarat
• Each capsule contains 1 mg of pomalidomide. 
• Ena kapsula vsebuje 1 mg pomalidomida.
Pomalidomide crossed the placenta and was detected in foetal blood following administration to pregnant rabbits, see section 5.3. 
Pomalidomid prehaja skozi posteljico in je bil zaznan v krvi zarodkov po dajanju brejim kunkam.
Imnovid 2 mg hard capsules: Dark blue opaque cap and orange opaque body, with “POML 2 mg” written on them. 
Imnovid 2 mg trde kapsule: temnomoder neprozoren pokrovček in oranžno neprozorno telo z napisom "POML 2 mg" na njih.
Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules pomalidomide 
Imnovid 1 mg trde kapsule Imnovid 2 mg trde kapsule Imnovid 3 mg trde kapsule Imnovid 4 mg trde kapsule
Imnovid 3 mg hard capsules: Dark blue opaque cap and green opaque body, with “POML 3 mg” written on them. 
Imnovid 3 mg trde kapsule: temnomoder neprozoren pokrovček in zeleno neprozorno telo z napisom "POML 3 mg" na njih.
• Constipation, diarrhoea or nausea. 
• zaprtje, driska ali slabost s siljenjem na bruhanje,
Imnovid 2 mg hard capsule: 
Imnovid 2 mg trda kapsula:
• Adverse event reporting forms 
• obrazce za poročanje o neželenih učinkih.
Hepatic disorders 
Hematološki dogodki
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), brilliant blue FCF 
• Ovojnica kapsule vsebuje: želatino, titanov dioksid (E171), indigotin (E132), briljantno modro FCF (E133) in belo črnilo.
Imnovid 4 mg hard capsules 
Imnovid 4 mg trde kapsule
• Each capsule contains 3 mg of pomalidomide. 
• Ena kapsula vsebuje 3 mg pomalidomida.
Upper respiratory tract infection Respiratory tract infection Lower respiratory tract infection Lung infection 
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti epistaksa intersticijska pljučna bolezen občasni epistaksa intersticijska pljučna bolezen
Common Rash 
Raven odmerka
Respiratory, thoracic and mediastinal disorders 
Bolezni jeter, žolčnika in žolčevodov občasni hepatitis
Each hard capsule contains 1 mg of pomalidomide. 
Ena trda kapsula vsebuje 1 mg pomalidomida.
• Each capsule contains 2 mg of pomalidomide. 
• Ena kapsula vsebuje 2 mg pomalidomida.
Imnovid 2 mg hard capsules pomalidomide 
Imnovid 2 mg trde kapsule pomalidomid
Unused medicinal product should be returned to the pharmacist at the end of treatment. 
Ob koncu zdravljenja morate neuporabljeno zdravilo vrniti farmacevtu.
Imnovid 3 mg hard capsule: 
Imnovid 3 mg trda kapsula:
Each hard capsule contains 4 mg of pomalidomide. 
Ena trda kapsula vsebuje 4 mg pomalidomida.
Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White and black ink 
Imnovid 1 mg trde kapsule želatina titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172) belo in črno črnilo
Imnovid 2 mg hard capsules 
Imnovid 2 mg trde kapsule
Peripheral sensory neuropathy Peripheral sensorimotor neuropathy 
Bolezni živčevja zelo pogosti periferna senzorična nevropatija omotica tremor pogosti sinkopa periferna senzorimotorična nevropatija parestezije disgevzija pogosti sinkopa periferna senzorična nevropatija periferna senzorimotorična nevropatija občasni omotica tremor
Resume at one dose level lower than previous dose. 
Nadaljujte zdravljenje z odmerkom, za eno raven manjšim od predhodnega odmerka.
Decrease by one dose level if symptoms persist. 
Če simptomi vztrajajo, zmanjšajte odmerek za eno raven.
Each hard capsule contains 3 mg of pomalidomide. 
Ena trda kapsula vsebuje 3 mg pomalidomida.
Each hard capsule contains 2 mg of pomalidomide. 
Ena trda kapsula vsebuje 2 mg pomalidomida.
Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White ink 
Imnovid 3 mg trde kapsule želatina titanov dioksid (E171) indigotin (E132) rumeni železov oksid (E172) belo črnilo
Angioedema and severe cutaneous reactions including SJS, TEN and DRESS has been reported with the use of pomalidomide. 
Pri uporabi pomalidomida so poročali o angioedemu in hudih dermatoloških reakcijah, vključno s SJS, TEN in DRESS.
Acute kidney injury Chronic kidney injury Urinary retention 
Bolezni sečil pogosti akutna okvara ledvic kronična okvara ledvic zastajanje urina pogosti akutna okvara ledvic kronična okvara ledvic zastajanje urina
Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 2 gelatin hard capsule. 
Temno moder neprozoren pokrovček in oranžno neprozorno telo z belim natisom "POML 2 mg", velikost 2, želatinasta trda kapsula.
Imnovid 3 mg hard capsules 
Imnovid 3 mg trde kapsule
What Imnovid looks like and contents of the pack Imnovid 1 mg hard capsules: Dark blue opaque cap and yellow opaque body, with “POML 1 mg” written on them. 
Imnovid 1 mg trde kapsule: temnomoder neprozoren pokrovček in rumeno neprozorno telo z napisom "POML 1 mg" na njih.
Dark blue opaque cap and green opaque body, imprinted “POML 3 mg” in white ink, size 2 gelatin hard capsule. 
Temno moder neprozoren pokrovček in zeleno neprozorno telo z belim natisom "POML 3 mg", velikost 2, želatinasta trda kapsula.
Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 2 gelatin hard capsule. 
Temno moder neprozoren pokrovček in modro neprozorno telo z belim natisom "POML 4 mg", velikost 2, želatinasta trda kapsula.
NE Two sided 95% CIb [48.1, NE] Hazard Ratio (Pom+LD-Dex:HD-Dex) [Two sided 95% CIc] Log-Rank Test Two sided P-Value d 
Razmerje tveganja (POM + NO-deks : VO-deks) [2 stranski 95 % IZc]
Imnovid 3 mg hard capsules pomalidomide 
Imnovid 3 mg trde kapsule pomalidomid
If pomalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water. 
V primeru stika pomalidomida s sluznico jo morate temeljito sprati z obilico vode.
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema pogosti pancitopenija pogosti pancitopenija
Imnovid 4 mg hard capsules pomalidomide 
Imnovid 4 mg trde kapsule pomalidomid
Very Common Muscular weakness Back pain 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva zelo pogosti mišična šibkost bolečine v hrbtu pogosti bolečine v kosteh mišični spazmi pogosti mišična šibkost bolečine v hrbtu občasni bolečine v kosteh
Common Diarrhoea Vomiting Abdominal pain Constipation 
Motnje reprodukcije in dojk pogosti bolečina v medenici pogosti bolečina v medenici
muscle aches, palpitations, tingling or numbness, dyspnoea, mood changes. 
• znižana raven kalija v krvi (hipokaliemija), ki lahko povzroči šibkost, mišične krče, bolečine v mišicah, palpitacije, mravljinčenje in odrevenelost, dispneo, spremembe razpoloženja,
Very Common Neutropenia Thrombocytopenia Leucopenia Anaemia 
Žilne bolezni pogosti globoka venska tromboza občasni globoka venska tromboza
• The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide 
• Ovojnica kapsule vsebuje: želatino, titanov dioksid (E171), indigotin (E132), rumeni železov oksid (E172) in belo črnilo.
CARTON 
VO-deks
EU/1/13/850/006 (Pack size of 14 hard capsules) EU/1/13/850/002 (Pack size of 21 hard capsules) 
EU/1/13/850/006 (velikost pakiranja 14 trdih kapsul) EU/1/13/850/002 (velikost pakiranja 21 trdih kapsul)
EU/1/13/850/008 (Pack size of 14 hard capsules) EU/1/13/850/004 (Pack size of 21 hard capsules) 
EU/1/13/850/008 (velikost pakiranja 14 trdih kapsul) EU/1/13/850/004 (velikost pakiranja 21 trdih kapsul)
EU/1/13/850/007 (Pack size of 14 hard capsules) EU/1/13/850/003 (Pack size of 21 hard capsules) 
EU/1/13/850/007 (velikost pakiranja 14 trdih kapsul) EU/1/13/850/003 (velikost pakiranja 21 trdih kapsul)
Interstitial lung disease 
Bolezni jeter
EU/1/13/850/005 (Pack size of 14 hard capsules) EU/1/13/850/001 (Pack size of 21 hard capsules) 
EU/1/13/850/005 (velikost pakiranja 14 trdih kapsul) EU/1/13/850/001 (velikost pakiranja 21 trdih kapsul)
Common Depression Insomnia 
Psihiatrične motnje zelo pogosti nespečnost pogosti depresija pogosti depresija nespečnost
90 (3 x 30) tablets (multipack) 
90 (3 × 30) filmsko obloženih tablet (večkratno pakiranje)
30 tablets 
30 filmsko obloženih tablet
London, 25 June 2009 Doc. 
London, 25. junija 2009 Sklic dok.
Factive was expected to be used to treat the following bacterial infections in adults: 
Zdravilo Factive naj bi se uporabljalo za zdravljenje naslednjih bakterijskih okužb pri odraslih:
The main measures of effectiveness for the studies were based on the number of patients who got better after treatment. 
Glavno merilo učinkovitosti za študije je temeljilo na številu bolnikov, katerih stanje se je po zdravljenju izboljšalo.
The effects of Factive were first tested in experimental models before being studied in humans. 
Učinki zdravila Factive so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Questions and answers on the withdrawal of the marketing authorisation application for Factive gemifloxacin 
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Factive gemifloksacin
The seven-day treatment was not considered acceptable because of the risk of side effects. 
Sedemdnevno zdravljenje ni štelo za sprejemljivo zaradi tveganja pojava neželenih učinkov.
It is expected to work by blocking the action of two bacterial enzymes called DNA gyrase and topoisomerase IV, which are needed to make and repair bacterial DNA. 
Delovalo naj bi zaviranjem delovanja dveh bakterijskih encimov, imenovanih DNK giraza in topoizomeraza IV, ki sta potrebna za tvorbo in popravilo bakterijske DNK.
The CHMP was concerned that Factive may be more genotoxic (harmful to the DNA, the genetic material in cells) and that it may therefore cause more damage to the DNA than other fluoroquinolones. 
CHMP je imel zadržke, da bi bilo zdravilo Factive lahko bolj genotoksično (škodljivo za DNK, genetsko gradivo v celicah) in bi zato lahko bolj poškodovalo DNK kot drugi fluorokinoloni.
The Committee also noted that the information presented did not support the use of Factive for chronic bronchitis because no studies were carried out to investigate whether Factive was better than other treatments for this type of infection and because there were problems with the studies that were performed. 
Odbor je opozoril tudi, da predstavljene informacije niso podpirale uporabe zdravila Factive za zdravljenje kroničnega bronhitisa, ker niso bile izvedene študije, s katerimi bi raziskali, ali je zdravilo Factive boljše od drugih zdravljenj za te vrste okužb, in ker so se pri opravljenih študijah pojavili problemi.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Factive? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Factive?
Factive is a medicine that contains the active substance gemifloxacin. 
Factive je zdravilo, ki vsebuje zdravilno učinkovino gemifloksacin.
When these enzymes are blocked, the bacteria cannot multiply and they eventually die. 
Ko sta ta dva encima zavrta, se bakterije ne morejo razmnoževati in sčasoma odmrejo.
• acute exacerbation (flare-up) of chronic bronchitis (inflammation of the airways in the lungs). 
• akutnega poslabšanja (ponovnih izbruhov) kroničnega bronhitisa (vnetja dihalnih poti v pljučih).
• mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital); 
• blage ali zmerne pljučnice, pridobljene izven bolnišnice (okužbe pljuč);
On 17 June 2009, Menarini International Operations Luxembourg S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Factive, for the treatment of the bacterial infections, communityacquired pneumonia and acute exacerbation of chronic bronchitis. 
Dne 17. junija 2009 je družba Menarini International Operations Luxembourg S.A. uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom Factive za zdravljenje bakterijskih okužb, pljučnice, pridobljene izven bolnišnice, in akutnega poslabšanja kroničnega bronhitisa.
The active substance in Factive, gemifloxacin, is an antibiotic belonging to the class ‘fluoroquinolones'. 
Zdravilna učinkovina zdravila Factive, gemifloksacin, je antibiotik iz skupine „fluorokinolonov“.
In four main studies, 1,874 adults with mild to moderate community-acquired pneumonia were treated for at least seven days with Factive or other antibiotics. 
V štirih glavnih študijah je bilo 1 874 odraslih z blago do zmerno pljučnico, pridobljeno izven bolnišnice, zdravljenih najmanj sedem dni z zdravilom Factive ali drugimi antibiotiki.
The application was at day 196 when the company withdrew. 
Družba je vlogo umaknila na 196. dan postopka.
The company informed the CHMP that there are no clinical trials or compassionate use programmes with Factive in Europe. 
Družba je obvestila CHMP, da klinična preizkušanja ali programi sočasne uporabe z zdravilom Factive v Evropi ne potekajo.
What is Factive? 
Kaj je zdravilo Factive?
In another study of patients with communityacquired pneumonia, 510 adults were given Factive either as a five- or seven-day treatment. 
V drugi študiji bolnikov s pljučnico, pridobljeno izven bolnišnice, je 510 odraslih prejelo zdravilo Factive bodisi med pet- ali sedemdnevnim zdravljenjem.
What was Factive expected to be used for? 
Za kaj naj bi se zdravilo Factive uporabljalo?
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Factive could not have been approved for the treatment of community acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Factive ni mogoče odobriti za zdravljenje pljučnice, pridobljene izven bolnišnice in akutnega poslabšanja kroničnega bronhitisa, ki je posledica bakterijske okužbe.
In three other main studies, 1,652 adults with acute exacerbation of chronic bronchitis were treated with Factive for five days or with other antibiotics. 
V treh preostalih glavnih študijah je bilo z zdravilom Factive ali drugimi antibiotiki pet dni zdravljenih 1 652 odraslih z akutnim poslabšanjem kroničnega bronhitisa.
The Committee was also concerned there was not enough evidence of effectiveness of Factive in patients with moderate community-acquired pneumonia when given as a five-day treatment. 
Odbor je bil imel zadržke tudi o količini dokazov o učinkovitosti zdravila Factive med petdnevnim zdravljenjem pri bolnikih z zmerno pljučnico, pridobljeno izven bolnišnice.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Factive in the treatment of community-acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection did not outweigh its risks. 
CHMP je v času umika menil, da koristi zdravila Factive za zdravljenje pljučnice, pridobljene izven bolnišnice, in akutnega poslabšanja kroničnega bronhitisa, ki je posledica bakterijske okužbe, ne odtehtajo tveganj, povezanih z njim.
How is Factive expected to work? 
Kako naj bi zdravilo Factive delovalo?
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 disease is usually diagnosed in infants between one and five years of age. 
Bolezen običajno odkrijejo pri otrocih, starih od ena do pet let.
The main measure of effectiveness was how far the patients could walk after 24 weeks of treatment. 
Glavno merilo učinkovitosti je bila razdalja, ki jo je bolnik lahko prehodil po 24 tednih zdravljenja.
The recommended dose is 1 mg per kilogram bodyweight. 
Priporočeni odmerek je 1 mg na kilogram telesne mase.
This means that because the disease is rare, it has not been possible to obtain complete information about Naglazyme. 
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu.
Naglazyme galsulfase 
Naglazyme galsulfaza
After 24 weeks, the average distance walked over 12 minutes increased by 109 metres in the patients treated with Naglazyme and by 18 metres in those receiving placebo. 
Po 24 tednih je bila povprečna prehojena razdalja v 12 minutah daljša za 109 metrov pri bolnikih, ki so prejemali zdravilo Naglazyme, in za 18 metrov pri bolnikih, ki so prejemali placebo.
Before each infusion, patients should be given an antihistamine to reduce the risk of an allergic reaction. 
Pred vsako infuzijo je treba bolniku dati antihistaminik za zmanjšanje tveganja za alergijske reakcije.
It should be given where resuscitation equipment is available in case of a medical emergency. 
Dajati se mora v okolju, kjer je na voljo oprema za oživljanje v nujnem primeru.
The company is also carrying out studies to determine the best dose to give to patients on a regular longterm basis. 
Izvedli bodo tudi študije za določitev najustreznejšega odmerka za bolnike ob dolgoročni redni uporabi.
This can improve the symptoms of MPS VI, including the ability of patients to move about. 
Tako se izboljšajo simptomi MPS IV, vključno s sposobnostjo bolnikovega gibanja.
The company that makes Naglazyme is carrying out studies looking 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 pri njih nastanejo protitelesa (beljakovine, ki jih telo tvori kot odziv na zdravilo Naglazyme in ki lahko vplivajo na odziv na zdravljenje), ter proučili neželene učinke zdravila.
Naglazyme was more effective than placebo. 
Zdravilo Naglazyme je bilo učinkovitejše od placeba.
Enzyme replacement therapy provides patients with the enzyme they are lacking. 
Encimska nadomestna terapija zagotavlja bolnikom encim, ki jim ga primanjkuje.
Naglazyme is given as a four-hour infusion once a week. 
Zdravilo Naglazyme se daje v obliki štiriurne infuzije enkrat na teden.
This causes the signs of the disease, the most noticeable being a short body, a large head and difficulty moving about. 
Tako se pokažejo znaki bolezni, od katerih so najopaznejši nizka rast, velika glava in težave pri gibanju.
What benefit has Naglazyme shown during the studies? 
Kakšne koristi je zdravilo Naglazyme izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Naglazyme. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Naglazyme, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with Naglazyme? 
Kakšna tveganja so povezana z zdravilom Naglazyme?
For more information about treatment with Naglazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Naglazyme preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In studies, the most common side effects with Naglazyme (seen in more than 1 patient in 10) were ear pain, dyspnoea (difficulty breathing), abdominal pain and general pain. 
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 in splošne bolečine.
Naglazyme treatment should be supervised by a doctor who has experience in the management of patients with MPS VI or similar diseases. 
Zdravljenje z zdravilom Naglazyme mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z MPS VI ali podobnimi boleznimi.
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 ta bolezen za redko, zato je bilo zdravilo Naglazyme dne 14. februarja 2001 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
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 celica prejme gen (DNK), s katerim lahko tvori encim.
The summary of the opinion of the Committee for Orphan Medicinal Products for Nagalzyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Naglazyme je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
If the enzyme is not present, GAGs cannot be broken down and they build up in the cells. 
Če encim ni prisoten, glikozaminoglikanov ni mogoče razgraditi, zato se kopičijo v celicah.
Naglazyme has been compared with placebo (a dummy treatment) in one main study involving 39 patients with MPS VI aged between five and 29 years. 
Zdravilo Naglazyme so primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji, v kateri je sodelovalo 39 bolnikov z MPS VI, starih od pet do 29 let.