natgillin/translations-raw huggingface dataset:
One clinical study focussed mainly on assessing the effect of Aldurazyme on the systemic manifestations of MPS I such as poor endurance, restrictive lung disease, upper airway obstruction, reduced joint range of motion, hepatomegaly and visual impairment. 
Ena klinična študija je bila osredotočena predvsem na ocenjevanje učinka zdravila Aldurazyme na sistemske znake mukopolisaharidoze I, kot so slaba vzdržljivost, , restriktivna pljučna bolezen, obstrukcija zgornjih dihalnih poti, zmanjšan obseg gibanja sklepov, hepatomegalija in poslabšanje vida.
In case of a single severe IAR, the infusion should be stopped until the symptoms are resolved and treatment with antihistamines and paracetamol/ibuprofen should be considered. 
Če se pojavi enkratna težka reakcija ob infuziji, morate zdravljenje z infuzijo prekiniti, dokler so simptomi prisotni, in razmisliti o zdravljenju z antihistaminiki ter s paracetamolom ali ibuprofenom.
It is recommended that the diluted Aldurazyme solution be administered to patients using an infusion set equipped with an 0.2 µm in-line filter. 
Priporočamo, da pripravljeno raztopino zdravila Aldurazyme infundirate z uporabo kompleta za infuzijo, opremljenega z 0,2 µm vmesnim filtrom.
Although patients representing the full range of the disease spectrum were enrolled, the majority of the patients were of the intermediate phenotype, with only one patient exhibiting the severe phenotype. 
Bolniki, ki so sodelovali v študiji, so sicer predstavljali celoten spekter bolezni, vendar jih je večina imela srednji fenotip bolezni, samo en bolnik pa težjo obliko.
Preparation of the Aldurazyme Infusion (Use Aseptic Technique) Determine the number of vials to be diluted based on the individual patient's weight. 
Priprava infuzije zdravila Aldurazyme (z uporabo aseptične tehnike) Število vial, ki jih boste uporabili, določite glede na bolnikovo maso.
It is not known whether Aldurazyme appears in breast milk. 
Ni znano, ali se zdravilo Aldurazyme izloča v materino mleko.
The concentrate for solution for infusion has to be diluted before administration and is for intravenous use (see information for health care professionals). 
Navodila za uporabo - priprava raztopine in uporaba Koncentrat za pripravo raztopine za infundiranje je pred uporabo treba razredčiti; namenjen je intravenski uporabi (glejte informacije za zdravstveno osebje).
The initial infusion rate of 2 U/kg/h may be gradually increased every fifteen minutes, if tolerated, to a maximum of 43 U/kg/h. 
Začetna hitrost infuzije 2 e/kg/h se lahko postopoma povečuje vsakih petnajst minut, če to dobro prenašate, do največje hitrosti 43 e/kg/h.
Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs). 
Motnje v shranjevanju mukopolisaharidov povzroča pomanjkanje specifičnih lizosomskih encimov, potrebnih za katabolni metabolizem glikozaminoglikanov.
In clinical studies IARs were usually manageable by slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol or ibuprofen), thus enabling the patient to continue treatment. 
V kliničnih študijah so reakcije ob infuziji navadno uspeli ublažiti s počasnejšim infundiranjem in (predhodnim) zdravljenjem z antihistaminiki in/ali antipiretiki (paracetamolom ali ibuprofenom), tako da je bolnik lahko nadaljeval zdravljenje.
Administration of Aldurazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available. 
Zdravilo Aldurazyme se mora uporabljati v ustreznem kliničnem okolju, kjer je na razpolago oprema za oživljanje za primere, ko je potrebna nujna zdravniška oskrba.
Very common symptoms (may affect more than 1 in 10 people) which were not serious include headache, nausea, abdominal pain, rash, joint disease, joint pain, back pain, pain in arms or legs, flushing, fever, chills, increased heart rate, increased blood pressure, and reaction at the infusion site. 
Zelo pogosti simptomi (pojavijo se lahko pri več kot 1 od 10 bolnikov), ki niso resni, so: glavobol, slabost, bolečine v trebuhu, izpuščaji, bolezni sklepov, bolečine v sklepih, hrbtu, rokah ali nogah, navali vročine, vročina, mrzlica, povečan srčni utrip, zvišan krvni tlak in reakcija na mestu infuzije.
For instruction on dilution of the medicinal product before administration, see section 6.6. 
Za navodila glede redčenja zdravila pred dajanjem, glejte poglavje 6.6.
However, severe systemic allergic reaction (anaphylactic reaction) has been observed in patients during or up to 3 hours after Aldurazyme infusions. 
Vendar so pri bolnikih med infuzijami zdravila Aldurazyme ali do 3 ure po njih opazili hudo sistemsko alergično (anafilaktično) reakcijo.
What Aldurazyme looks like and contents of the pack Aldurazyme is supplied as a concentrate for solution for infusion. 
Izgled zdravila Aldurazyme in vsebina pakiranja Zdravilo Aldurazyme je v obliki koncentrata za pripravo raztopine za infundiranje.
What Aldurazyme contains - The active substance is laronidase. 
Kaj vsebuje zdravilo Aldurazyme - Zdravilna učinkovina je laronidaza.
5 ml concentrate for solution in a vial (type I glass) with a stopper (siliconised chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene). 
5 ml koncentrata za pripravo raztopine v viali (steklo vrste I) z zamaškom iz silikonizirane klorobutilne gume, aluminijastim tesnilom in polipropilensko zaporko Flip-Off.
A single patient with pre-existing airway compromise developed a severe reaction three hours from the start of the infusion (at week 62 of treatment) consisting of urticaria and airway obstruction, requiring tracheostomy. 
Pri bolniku z že obstoječo boleznijo dihal je tri ure po začetku infuzije (v 62. tednu zdravljenja) prišlo do hude reakcije v obliki koprivnice in oviranega pretoka zraka, zaradi katere je bila potrebna traheostomija.
Aldurazyme should not be administered simultaneously with chloroquine or procaine due to a potential risk of interference with the intracellular uptake of laronidase. 
Zdravila Aldurazyme ne smete dajati sočasno s klorokinom ali prokainom, ker obstaja nevarnost pojava motenj v znotrajceličnem privzemu laronidaze.
Due to the small patient population, an ADR reported in a single patient is classified as common. 
Zaradi majhnega vzorca bolnikov je bil neželeni učinek zdravila, ki se je pojavil pri enem samem bolniku, označen kot pogost.
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included. 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA ODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Marketing Authorisation Holder: Genzyme Europe B.V. 
Imetnik dovoljenja za promet z zdravilom: Genzyme Europe B.V.
If these reactions occur, immediate discontinuation of Aldurazyme is recommended and appropriate medical treatment should be initiated. 
Če pride do teh reakcij, priporočamo takojšnjo prekinitev zdravljenja z zdravilom Aldurazyme in ustrezne zdravstvene ukrepe.
Additionally, a few patients who had a prior history of severe MPS I- related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm, respiratory arrest, and facial oedema (see section 4.4). 
Poleg tega so se pri nekaj bolnikih, ki so imeli zaradi MPS I hudo prizadeta zgornja dihala in pljuča, pojavile hude reakcije, vključno z bronhospazmom, zastankom dihanja in obraznim edemom (glejte poglavje 4.4).
Patients with absent to low antibody levels showed a robust reduction in urinary GAG level, whereas patients with high antibody titers showed variable reduction in urinary GAG. 
Pri bolnikih brez protiteles ali z nizkimi vrednostmi protiteles so se GAG vrednosti v urinu izrazito znižale, medtem ko so se pri bolnikih z visokimi titri protiteles vrednosti GAG v urinu različno nižale.
Percent Predicted FVC (percentage point) 
Interval zaupanja predvideni odstotek FVC
Aldurazyme treatment should be supervised by a physician experienced in the management of patients with MPS I or other inherited metabolic diseases. 
Zdravljenje z zdravilom Aldurazyme mora nadzorovati zdravnik, ki ima izkušnje pri zdravljenju bolnikov z mukopolisaharidozo tipa I ali drugimi dednimi boleznimi presnove.
You should not be given Aldurazyme 
Ne smete prejeti zdravila Aldurazyme
With initial administration of Aldurazyme or upon re-administration following interruption of treatment, it is recommended that patients be administered pre-treatment medicines (antihistamines and/or antipyretics) approximately 60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs. 
Ob začetku uporabe zdravila Aldurazyme ali ob ponovni uporabi po prekinitvi zdravljenja priporočamo predhodno zdravljenje bolnika z antihistaminiki in/ali antipiretiki (približno 60 minut pred infuzijo), kar bo zmanjšalo možnosti pojava reakcij ob infuziji.
MedDRA System Organ Class 
razred organskega sistema (po MedDRA)
Based on its metabolism, laronidase is an unlikely candidate for Cytochrome P450 mediated interactions. 
Glede na metabolizem laronidaze ni verjetno, da bi pri uporabi te učinkovine prišlo do interakcij, povezanih s citokromom P450.
MPS I is a heterogeneous and multisystemic disorder characterised by the deficiency of α-L-iduronidase, a lysosomal hydrolase which catalyses the hydrolysis of terminal α-L-iduronic residues of dermatan sulfate and heparan sulfate. 
Mukopolisaharidoza tipa I je heterogena in multisistemska motnja, za katero je značilno pomanjkanje -L-iduronidaze, lizosomske hidrolaze, ki katalizira hidrolizo -L-iduronskih ostankov dermatan sulfata in heparan sulfata.
SUMMARY OF PRODUCT CHARACTERISTICS 
PRILOGA POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity and toxicity to reproduction. 
Neklinični podatki, na osnovi običajnih študij farmakološke varnosti,, toksičnosti enojnega odmerka, toksičnosti pri ponavljajočih se odmerkih in vpliva na sposobnost razmnoževanja, ne kažejo posebnega tveganja za človeka.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/253/001 1 Vial 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/253/001 1 Viala
EU/1/03/253/002 10 Vials 
EU/1/03/253/002 10 Vial
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C). 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 C - 8 C).
It is a solution that is clear to slightly opalescent, and colourless to pale yellow. 
Raztopina je bistra do rahlo opalescentna, brezbarvna do bledo rumene barve.
Infusion 26 Mean± SD 
Infuzija 26 Srednja vrednost ± SD
There is not enough experience of the use of Aldurazyme in pregnant women. 
Z uporabo zdravila Aldurazyme pri nosečnicah ni dovolj izkušenj.
MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands. 
Imetnik dovoljenja za promet Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska.
Driving and using machines The effects on the ability to drive and to use machines have not been studied. 
Vpliv na sposobnost upravljanja vozil in strojev Študije vpliva na sposobnost upravljanja vozil in strojev niso bile opravljene.
Post-marketing experience of infusion-associated reactions revealed reporting of cyanosis, hypoxia, tachypnoea, pyrexia, vomiting, chills and erythema, in which some of these reactions were severe. 
V obdobju trženja so pri infundiranju zaznali pojave cianoze, hipoksije, tahipneje, pireksije, bruhanja, mrzlice in eritema; nekatere od teh reakcij so bile resne.
ADRs to Aldurazyme reported during a Phase 2 study in a total of 20 patients, under 5 years of age and mainly of the severe phenotype, treated up to 12 months are listed below. 
Neželeni učinki zdravila Aldurazyme, zabeleženi v drugi fazi študije pri 20 bolnikih, mlajših od 5 let in v glavnem s hujšo obliko fenotipa, zdravljenih do 12 mesecev, so navedeni v spodnji preglednici.
EU/1/03/253/003 25 Vials 
EU/1/03/253/003 25 Vial
Determine the total volume of infusion based on the individual patient's weight, either 100 ml (if body weight is less or equal than 20 kg) or 250 ml (if body weight is more than 20 kg) of sodium chloride 9 mg/ml (0.9%) solution for infusion. 
Če bolnik tehta 20 kg ali manj, za infundiranje uporabite 100 ml, in če tehta nad 20 kg, 250 ml raztopine natrijevega klorida 9 mg/ml (0,9%).
If not used immediately, in-use storage should not be longer than 24 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions. 
Z mikrobiološkega varnostnega stališča je treba proizvod porabiti takoj, sicer pa lahko raztopino hranite največ 24 ur pri temperaturi med 2 C in 8 C, če ste jo pripravili v nadzorovanih in potrjeno aseptičnih pogojih.
Infusion 12 Mean ± SD 
Infuzija 12 Srednja vrednost ± SD
25 vials of concentrate for solution for infusion. 
25 vial s koncentratom za raztopino za infundiranje.
There are inadequate data on the use of Aldurazyme in pregnant women. 
Ni natančnih podatkov o uporabi zdravila Aldurazyme pri nosečnicah.
To be taken into consideration by patients on a controlled sodium diet. 
Opozorilo morajo upoštevati bolniki, ki sledijo dieti z omejeno količino natrija.
Infusion 1 Mean ± SD 
Infuzija 1 Srednja vrednost ± SD
The clear to slightly opalescent and colourless to pale yellow solution should be free of visible particles. 
Bistra do rahlo opalescentna, brezbarvna do bledo rumena raztopina ne sme vsebovati vidnih delcev.
What you need to know before you are given Aldurazyme 
Kaj morate vedeti, preden boste uporabili zdravilo Aldurazyme
Aldurazyme should not be mixed with other medicinal products in the same infusion. 
Raztopine za infundiranje z zdravilom Aldurazyme ne smete mešati z drugimi zdravili.
Sodium phosphate monobasic monohydrate, Sodium phosphate dibasic heptahydrate, Polysorbate 80, 
Natrijev dihidrogenfosfat monohidrat, Natrijev hidrogenfosfat heptahidrat, Polisorbat 80,
Patients who have developed antibodies or symptoms of IARs should be treated with caution when administering Aldurazyme (see sections 4.3 and 4.8). 
Aldurazyme uporabljajte previdno pri bolnikih, ki imajo protitelesa ali znake reakcij ob infuziji (glejte poglavje 4.3 in 4.8).
- The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections. 
- Pomožne snovi so natrijev klorid, monohidrat natrijevega dihidrogenfosfata, heptahidrat natrijevega hidrogenfosfata, polisorbat 80, voda za injekcije.
Store in a refrigerator (2°C - 8°C). 
Shranjujte v hladilniku (2 C - 8 C).
Method of administration Aldurazyme is to be administered as an intravenous infusion. 
Način uporabe Zdravilo Aldurazyme se daje v obliki intravenske infuzije.
The recommended dose group had the fewest number of patients who experienced ADRs and IARs. 
V skupini, ki je prejemala priporočeni odmerek, je bilo najmanjše število bolnikov z neželenimi učinki zdravila ali reakcijami ob infuziji.
In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol/ibuprofen and/or corticosteroids) and a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the previous reaction occurred. 
V primeru ponavljajočih se zmernih reakcij ali ponovni nevarnosti po enkratni težki reakciji ob infuziji, bo morda potrebno predhodno zdravljenje (z antihistaminiki, paracetamolom ali ibuprofenom in/ali kortikosteroidi) in zmanjšanje hitrosti infundiranja na četrtino do polovico hitrosti, pri kateri se je pojavila prejšnja reakcija.
Pack sizes: 1, 10 and 25 vials. 
Škatlica vsebuje 1, 10 ali 25 vial.
Shoulder flexion Range Of Motion (degrees) 
Indeks apneja/hipopneja (IAH) obseg gibanja ramena (stopinje)
The number of these reactions decreased the longer that patients were on Aldurazyme. 
Dlje kot so bili bolniki na terapiji z zdravilom Aldurazyme, manjše je bilo število teh reakcij.
10 vials of concentrate for solution for infusion. 
10 vial s koncentratom za raztopino za infundiranje.
The patients were scheduled to receive Aldurazyme 100 U/kg weekly infusions for a total duration of 52 weeks. 
Bolniki so 52 tednov tedensko prejemali infuzije zdravila Aldurazyme po 100 e/kg.
Patients received either 100 U/kg of Aldurazyme or placebo every week for a total of 26 weeks. 
Študija je trajala 26 tednov in bolniki so vsak teden prejeli 100 e/kg zdravila Aldurazyme ali placeba.
In this 26-week open label study, 33 MPS I patients received 1 of 4 dose regimens of Aldurazyme: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks; or 300 U/kg IV every 2 weeks. 
V tej 26-tedenski odprti študiji je 33 bolnikov z MPS I prejemalo 1 izmed 4 režimov odmerjanja: 100 e/kg i.v.
An infusion-associated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4 “Possible Side Effects”). 
To so kakršnikoli neželeni učinki, ki se pojavijo med infundiranjem ali do konca dneva, ko ste prejeli infuzijo (glejte poglavje 4.
If you experience any reaction like this, you should contact your doctor immediately. 
Če ste opazili kakršne koli reakcije, podobne spodaj navedenim, nemudoma obvestite svojega zdravnika.
Before dilution, visually inspect each vial for particulate matter and discoloration. 
Pred pripravo raztopine si pozorno oglejte vsako vialo, ali vsebuje drobne delce in ali je vsebina razbarvana.
How to store Aldurazyme 
Kako boste prejeli zdravilo Aldurazyme
The infusion can be restarted with a reduction of the infusion rate to 1/2 - 1/4 the rate of the infusion at which the reaction occurred. 
V nadaljevanju lahko dajete bolniku infuzijo s hitrostjo, ki je za četrtino do polovico manjša od hitrosti, ob kateri je prišlo do reakcije.
If you are treated with Aldurazyme, you may develop infusion-associated reactions. 
Med zdravljenjem z zdravilom Aldurazyme se lahko pojavijo z infuzijo povezane reakcije.
One ml of the solution in the vial contains 100 U of laronidase. 
En ml raztopine v viali vsebuje 100 enot (e) laronidaze.
• swelling of the neck 
• otekanje vratu
Talk to your doctor before using Aldurazyme. 
Pred začetkom uporabe zdravila Aldurazyme se posvetujte s svojim zdravnikom.
The recommended dosage regimen of Aldurazyme is 100 U/kg body weight given once every week as an intravenous infusion. 
Pri zdravilu Aldurazyme priporočamo uporabo enkrat tedensko z odmerki 100 e/kg telesne mase v obliki intravenske infuzije.
Infusion-associated reactions 
Reakcije ob infuziji
Withdraw the required volume from the Aldurazyme vials and combine the withdrawn volumes. 
Iz vial z zdravilom Aldurazyme odmerite potrebne količine zdravila in jih zmešajte.
This can replace the natural enzyme which is lacking in MPS I disease. 
Aldurazyme je umetni encim laronidaza, ki lahko nadomesti naravni encim, ki ni prisoten pri bolezni MPS I.
A few patients who had a prior history of severe MPS I related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm (airway constriction), respiratory arrest, and swelling of the face. 
Nekaj bolnikov s predhodnimi pojavi hude MPS I, povezane z zgornjimi dihali in pljuči, je imelo resne reakcije, vključno s bronhospazmom (zoženjem dihalnih poti), zastojem dihanja in oteklino obraza.Pogostnosti bronhospazma in zastoja dihanja nista znani.
Aldurazyme contains sodium 
Zdravilo Aldurazyme vsebuje natrij
In a phase 4 study 33 MPS I patients received 1 of 4 dose regimens: 100 U/kg IV every week (recommended dose), 200 U/kg IV every week, 200 U/kg IV every 2 weeks or 300 U/kg IV every 2 weeks. 
V 4. fazi študije je 33 bolnikov z MPS I prejemalo 1 izmed 4 režimov odmerjanja: 100 e/kg i.v.
Urinary GAG levels decreased by 77% and 66% in the Placebo/Aldurazyme and Aldurazyme/Aldurazyme groups, respectively; at the end of the study one-third of the patients (15 of 45) had reached normal urinary GAG levels. 
Vrednosti GAG v urinu so se znižale za 77 % pri placebo/Aldurazyme skupini oziroma 66 % pri Aldurazyme/Aldurazyme skupini.
MedDRA Preferred term 
prednostni izraz (po MedDRA)
The recommended dosage regimen of Aldurazyme is 100 U/kg body weight administered once every week. 
Priporočeni režim odmerjanja je pri zdravilu Aldurazyme enkrat tedensko z odmerkom 100 e/kg telesne mase.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 100 U of laronidase. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml vsebuje 100 e laronidaze.
Preclinical data did not reveal any significant adverse finding (see section 5.3). 
Kliničnih podatkov o vplivu laronidaze na plodnost ni. Neklinični podatki ne kažejo pomembnih neželenih učinkov (glejte poglavje 5.3).
The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique. 
Raztopino za infundiranje pripravite tako, da koncentrat razredčite s fiziološko raztopino (0,9 % natrijev klorid) z uporabo aseptične tehnike.
In case of a mild or moderate IAR, treatment with antihistamines and paracetamol/ibuprofen should be considered and/or a reduction in the infusion rate to half the infusion rate at which the reaction occurred. 
Ob pojavu blage ali zmerne reakcije ob infuziji poskusite zdraviti bolnika z antihistaminiki in paracetamolom ali ibuprofenom in/ali za polovico zmanjšati hitrost infundiranja, ob kateri je prišlo do reakcije.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Aldurazyme 100 U/ml concentrate for solution for infusion laronidase 
IME ZDRAVILA IN POT (I) UPORABE Aldurazyme, 100 e/ml koncentrat za raztopino za infundiranje laronidaza
METHOD OF ADMINISTRATION Read the package leaflet before use. 
POSTOPEK UPORABE Pred uporabo natančno preberite priloženo navodilo!
It is recommended to stop breast-feeding during treatment with Aldurazyme. 
Med zdravljenjem z zdravilom Aldurazyme priporočamo, da dojenje prekinete.
Patients treated with Aldurazyme may develop infusion-associated reactions (IARs), defined as any related adverse event occurring during the infusion or until the end of the infusion day (see section 4.8). 
To so kakršnikoli z infuzijo povezani neželeni dogodki, ki se pojavijo med infundiranjem ali do konca dneva, ko je bolnik prejel infuzijo (glejte poglavje 4.8).
OTHER 
- NL
The most frequent adverse drug reactions (ADRs) were: headache, nausea, abdominal pain, rash, arthralgia, backpain, pain at extremity, flushing, pyrexia, infusion site reactions, blood pressure increased, oxygen saturation decreased, 
izpuščaji, artlargija, bolečine v hrbtu, bolečine v udih, navali vročine, pireksija, reakcije na mestih infuzije, zvišani krvni tlak, zmanjšana nasičenost s kisikom, tahikardija in mrzlica.
Do not use vials exhibiting particles or discoloration. 
Ne uporabljajte vial, če je koncentrat razbarvan ali če v njem opazite majhne delce.
• dizziness 
• ščemenje
Tachycardia 
laronidaza
Withdraw and discard a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added. 
Iz vrečke za infuzijo odstranite in zavrzite količino 0,9% raztopine natrijevega klorida (9 mg/ml), ki je enaka količini zdravila Aldurazyme, ki ga boste dodali.
Some of the IARs were severe. 
Nekatere od IARs (reakcij, povezane z infuzijami) so bile resne.
Respiratory, thoracic and mediastinal disorders 
Okvarjeno delovanje ledvic in jeter
If you get any side effects, talk to your doctor or pharmacist. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom,farmacevtom ali medicinsko sestro.
NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion 
IME ZDRAVILA Aldurazyme, 100 e/ml koncentrat za raztopino za infundiranje.
Dosage 
mediana
- If you have any further questions, ask your doctor or your pharmacist. 
Morda ga boste želeli ponovno prebrati - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
Mix the solution for infusion gently. 
• Raztopino previdno premešajte.
• diarrhoea 
• nemirnost
Musculoskeletal pain 
• bolečine v mišicah
Prior to use visually inspect the solution for particulate matter. 
Pred uporabo si pozorno oglejte, ali raztopina vsebuje drobne delce.