natgillin/translations-raw huggingface dataset:
Myalepta 3 mg powder for solution for injection Using a 1 mL syringe with a 21-gauge or smaller diameter needle, withdraw 0.6 mL of water for injection. 
Myalepta 3 mg prašek za raztopino za injiciranje Z 1-mililitrsko brizgo z iglo premera 21 G ali manj izvlecite 0,6 ml vode za injekcije.
o Hypoglycaemia with concomitant use of insulin and other antidiabetics may occur. 
o Pri bolnikih, ki sočasno jemljejo insulin in druga zdravila za sladkorno bolezen, se lahko pojavi hipoglikemija.
Rotation of injection sites is recommended in patients co-administering insulin (or other subcutaneous medicinal products) and Myalepta. 
- Pri bolnikih, ki sočasno prejemajo insulin (ali druga subkutana zdravila) in zdravilo
• chest infection 
• okužbe v prstnem košu
You should not use Myalepta if you are pregnant or might become pregnant. 
Če ste noseči ali bi lahko zanosili, ne uporabljajte zdravila Myalepta.
• swelling of your face, lips, tongue or throat 
• otekanje obraza, ustnic, jezika ali v grla • bolečine v trebuhu, siljenje na bruhanje (navzea) in bruhanje
Both males and females > 40 kg 
Moški in ženske > 40 kg
After reconstitution with 0.6 mL water for injections (see section 6.6), each mL contains 5 mg of metreleptin. 
Po redčenju z 0,6 ml vode za injekcije (glejte poglavje 6.6) en ml vsebuje 5 mg metreleptina.
Table 4 Required administration syringe per Myalepta dose Syringe 
Preglednica 4 Potrebna brizga na odmerek zdravila Myalepta Brizga
• Move the vial gently in a circle (swirling motion) 
• Pri tem nežno krožite z vialo (vrtite).
The individual patient dose = 0.9 mg. A dose increment of 0.02 mg/kg increases the daily dose to 0.08 mg/kg = 1.2 mg. Total daily volume to be injected is total dose in mg/5, in this case it is 1.2 mg/5 = 0.24 mL which equals 24 units on the 0.3 mL insulin syringe. 
Skupni dnevni volumen za injiciranje je celotni odmerek v mg/5, ki je v tem primeru 1,2 mg/5 = 0,24 ml, kar je enako 24 enotam na 0,3-mililitrski insulinski brizgi.
• Insert the 3 mL syringe needle into the vial, through the rubber seal. 
• Vstavite iglo 3-mililitrske brizge v vialo skozi gumijasto tesnilo.
After reconstitution, the solution must be administered immediately and cannot be stored for later use. 
Po pripravi si morate raztopino injicirati takoj je ne smete hraniti za poznejšo uporabo.
• feeling sick (nausea) or being sick (vomiting) 
• siljenje na bruhanje (navzea) in bruhanje • driska
- Monitoring of blood glucose in patients on concomitant insulin therapy, especially those on high doses, or insulin secretagogues and combination treatment is warranted. 
- Pri bolnikih, ki sočasno prejemajo insulin, predvsem visoke odmerke, ali bolnikih, ki jemljejo insulinske sekretagoge in kombinacijo zdravil, je treba pozorno spremljati glukozo v krvi.
The once daily dose of Myalepta can be increased by increments as shown in Table 6 to a maximum daily dose. 
*Opomba: Začetne odmerke in prirastke odmerka je treba zaokrožiti navzdol na najbližjih 0,01 ml Enkratni dnevni odmerek zdravila Myalepta se lahko povečuje v korakih, kot je prikazano v tabeli 6, do največjega dnevnega odmerka.
• One 1 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder 
• eno 1-mililitrsko brizgo z iglo premera 21G, dolgo 40 mm, za topljenje praška;
• Patients/carers training material The Guide/training material for patients/carers shall contain the following key elements: o Reminders on key prescribing information content, including indicated population, posology, warnings and precautions, and other safety- related information which is key to safe use of the product. 
o Opomnike o ključnih informacijah za predpisovanju vključno s populacijo za katero je zdravilo indicirano, odmerjanjem, opozorili in previdnostnimi ukrepi ter ostalimi informacijami, povezanimi z varnostjo, ki so ključne za varno uporabo zdravila.
It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a blue plastic flip-off cap. 
Zdravilo je dobavljeno kot beli prašek v stekleni viali z gumijastim zamaškom in aluminijastim tesnilom z modro plastično zaporko.
12) Insert the needle of the 1 mL syringe containing the 0.6 mL of water for injection all the way into the Myalepta vial containing the powder. 
12) Vstavite iglo 1-mililitrske brizge, v kateri sta 0,6 ml vode za injekcije, do konca v vialo s praškom zdravila Myalepta.
Cases of T-cell lymphoma have been reported in clinical studies in patients taking Myalepta. 
V kliničnih študijah so poročali o primerih pojava T-celičnega limfoma med uporabo zdravila Myalepta.
For doses of: ≤ 1.5 mg /≤ 0.3 mL volume daily 
Za odmerke: ≥ 1,5 mg /≥ 0,3 ml dnevno
• Pull up until the top rim of the plunger lines up with the black 0.6 mL line. 
• Vlecite ga navzgor, dokler ne bo zgornji rob bata poravnan s črno črto za 0,6 ml.
• diabetes 
• sladkorna bolezen
21 gauge 40 mm needle 
40 mm igla
12) Insert the needle of the 3 mL syringe containing the 2.2 mL of water for injection all the way into the Myalepta vial containing the powder. 
12) Vstavite iglo 3-mililitrske brizge, v kateri sta 2,2 ml vode za injekcije, do konca v vialo s praškom zdravila Myalepta.
It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a white plastic flip-off cap. 
Zdravilo je dobavljeno kot beli prašek v stekleni viali z gumijastim zamaškom in aluminijastim tesnilom z belo plastično zaporko.
12) Insert the needle of the 3 mL syringe containing the 1.1 mL of water for injection all the way into the Myalepta vial containing the powder. 
12) Vstavite iglo 3-mililitrske brizge, v kateri sta 1,1 ml vode za injekcije, do konca v vialo s praškom zdravila Myalepta.
• One 3 mL syringe with a 21 gauge, 40 mm needle for dissolving the powder 
• eno 3-mililitrsko brizgo z iglo premera 21G, dolgo 40 mm, za topljenje praška;
It is a white powder supplied in a glass vial with a rubber stopper and an aluminium seal with a red plastic flip-off cap. 
Zdravilo je dobavljeno kot beli prašek v stekleni viali z gumijastim zamaškom in aluminijastim tesnilom z rdečo plastično zaporko.
• Pull up until the top rim of the plunger lines up with the black 1.1 mL line. 
• Vlecite ga navzgor, dokler ne bo zgornji rob bata poravnan s črno črto za 1,1 ml.
• Insert the 1 mL syringe needle into the vial, through the rubber seal. 
• Vstavite iglo 1-mililitrske brizge v vialo skozi gumijasto tesnilo.
• who have generalised lipodystrophy (the whole of your body does not have enough fatty tissue) It is used, when other treatments have been ineffective, in adults, and adolescents 12 years or over: 
Uporablja se, če so bile druge oblike zdravljenja neučinkovite, pri odraslih in mladostnikih, starih 12 let ali več:
Myalepta 11.3 mg powder for injection metreleptin 
Myalepta 11,3 mg prašek za raztopino za injiciranje metreleptin
*Global post marketing experience 
in iz izkušenj po začetku trženja zdravila
Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/red plastic flip-off cap. 
Myalepta 3 mg prašek za raztopino za injiciranje Steklena viala tipa I (3 ml) z gumijastim zamaškom iz klorobutila ter aluminijastim tesnilom/rdečo plastično zaporko.
• going to the toilet to pass urine more often 
• pogosteje odvajanje vode
Abrupt interruption and/or non-compliance with metreleptin dosing was suspected to have contributed to the occurrence of pancreatitis in 2 patients. 
Obstaja možnost, da sta pri 2 bolnikih za pojav pankreatitisa bila odgovorna nenadna prekinitev in/ali nepravilno odmerjanje metreleptina.
- Rotation of injection sites is recommended in patients co administering insulin (or other SC medicinal products) and Myalepta. 
Pri bolnikih, ki hkrati jemljejo insulin (ali druga subkutana zdravila) in zdravilo Myalepta, se priporoča rotacija mest injiciranja.
o Loss of efficacy, potentially due to neutralising antibodies, may occur in patients on Myalepta therapy. 
o Pri bolnikih, ki se zdravijo z zdravilom Myalepta, lahko pride do zmanjšanja učinkovitosti, najverjetneje zaradi nevtralizirajočih protiteles.
Myalepta 5.8 mg powder for injection metreleptin 
Myalepta 5,8 mg prašek za raztopino za injiciranje metreleptin
SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM
Myalepta 3 mg powder for solution for injection 1.0 mL 
Myalepta 3 mg prašek za raztopino za injiciranje 1,0 ml premer 21G
• Remove the needle guard. 
• Odstranite varovalo za iglo.
When discontinuing Myalepta in patients with risk factors for pancreatitis (e.g. history of pancreatitis, severe hypertriglyceridaemia), tapering of the dose over a two-week period is recommended in conjunction with a low-fat diet. During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicinal products as needed. 
anamneza pankreatitisa, huda hipertrigliceridemija), se priporoča postopno zmanjšanje odmerka v obdobju dveh tednov, hkrati z dieto z malo maščobami.
Myalepta 3 mg powder for injection metreleptin 
Myalepta 3 mg prašek za raztopino za injiciranje metreleptin
• Pull up until the top rim of the plunger lines up with the black 2.2 mL line. 
• Vlecite ga navzgor, dokler ne bo zgornji rob bata poravnan s črno črto za 2,2 ml.
Talk to your doctor, pharmacist or nurse before using Myalepta if: 
Pred začetkom uporabe zdravila Myalepta se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
No formal pharmacokinetic studies were conducted in patients with hepatic impairment. 
Pri bolnikih z okvaro jeter formalnih farmakokinetičnih študij niso izvedli.
Rounded amount of solution 
Zaokrožen volumen raztopine
Myalepta 3 mg powder for solution for injection. 
Myalepta 3 mg prašek za raztopino za injiciranje
Type I glass vial (3 mL) with a chlorobutyl rubber stopper and an aluminium seal/blue plastic flip-off cap. 
Myalepta 5,8 mg prašek za raztopino za injiciranje Steklena viala tipa I (3 ml) z gumijastim zamaškom iz klorobutila ter aluminijastim tesnilom/modro plastično zaporko.
Each vial contains 3 mg of metreleptin After reconstitution, each mL contains 5 mg of metreleptin (5 mg/mL) 
Po rekonstituciji en ml vsebuje 5 mg metreleptina (5 mg/ml).
Large dose reductions of 50% or more of baseline insulin requirements may be needed in the first 2 weeks of treatment. 
2 tednih zdravljenja bo morda treba odmerek zmanjšati tudi do 50 % ali več glede na potrebe pred začetkom zdravljenja.
Myalepta 5.8 mg powder for solution for injection. 
Myalepta 5,8 mg prašek za raztopino za injiciranje
25 kg patient is initiated at 0.012 mL/kg = 0.3 mL of Myalepta solution to inject 
Individualni odmerek za bolnika = 1,5 mg Bolnik, ki tehta 25 kg, na začetku prejme 0,012 ml/kg = 0,3 ml raztopine Myalepta za injiciranje
• You will be given the 1 mL syringe to use if your daily dose is more than 1.5 mg up to 5 mg, 
• 1-mililitrsko brizgo boste prejeli, če je vaš dnevni odmerek več kot 1,5 mg do 5 mg, kar je v prostornini več kot 0,3 ml in do 1,0 ml raztopine Myalepta.
When properly mixed, the Myalepta reconstituted solution should be clear, colourless, and free of clumps or dry powder, bubbles or foam. 
brezbarvna in brez grud ali suhega praška, zračnih mehurčkov ali pene.
Peak serum leptin (endogenous leptin and metreleptin) concentration (Cmax) occurred approximately 4.0 hours after subcutaneous administration of single doses ranging from 0.1 to 0.3 mg/kg in healthy adult subjects. 
4,0 ure po subkutanem odmerjanju enkratnih odmerkov od 0,1 do 0,3 mg/kg pri zdravih odraslih osebah.
2.2 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin. 
Po raztopitvi vsebine viale v 2,2 mililitrih vode za injekcije en mililiter vsebuje 5 miligramov metreleptina.
1.1 millilitres of water for injections, each millilitre contains 5 milligrams of metreleptin. 
Po raztopitvi vsebine viale v 1,1 mililitrih vode za injekcije en mililiter vsebuje 5 miligramov metreleptina.
30 gauge 13 mm needle 
1,0 ml premer 30G 13 mm igla
No formal pharmacokinetic studies were conducted in patients with renal impairment. 
Pri bolnikih z okvaro ledvic formalnih farmakokinetičnih študij niso izvedli .
Pull the plunger down carefully • Pull it down until the top rim of the plunger lines up with the black 0.6 mL line. 
• Vlecite ga navzdol, dokler ne bo zgornji rob bata poravnan s črno črto za 0,6 ml.
Pull the plunger down carefully • Pull it down until the top rim of the plunger lines up with the black 1.1 mL line. 
• Vlecite ga navzdol, dokler ne bo zgornji rob bata poravnan s črno črto za 1,1 ml.
● thigh 
• kašelj • zasoplost
This will include for example instructions for handling possible ADRs o Allergic reactions can occur with Myalepta use. 
o Med zdravljenjem z zdravilom Myalepta se lahko pojavijo alergijske reakcije.
Pull the plunger down carefully • Pull it down until the top rim of the plunger lines up with the black 2.2 mL line. 
• Vlecite ga navzdol, dokler ne bo zgornji rob bata poravnan s črno črto za 2,2 ml.
Across two completed clinical studies (NIH 991265/20010769 and FHA101), there were 52 paediatric patients (4 in the subgroup of partial LD patients and 48 with generalised LD) enrolled and exposed to metreleptin. 
52 pediatričnih bolnikov (4 v podskupini bolnikov s parcialno LD in 48 z generalizirano LD), ki so bili izpostavljeni metreleptinu.
There was evidence of improvement in renal and hepatic function in patients with generalised LD treated with metreleptin. 
Pri bolnikih z generalizirano LD, zdravljenih z metreleptinom, so bili vidni znaki izboljšanja v delovanju ledvic in jeter.
• One injection syringe with a much shorter needle for injecting the solution under your skin The size of this syringe will be chosen by your doctor, nurse or pharmacist for your dose of Myalepta. 
Velikost te brizge izbere zdravnik, medicinska sestra ali farmacevt glede na vaš odmerek zdravila Myalepta.
Always use a new ampoule or vial of water for injection each time when preparing to dissolve Myalepta powder. 
Vsakič, ko pripravljate prašek zdravila Myalepta za raztapljanje, uporabite novo ampulo ali vialo vode za injekcije.
How to store Myalepta 
Shranjevanje zdravila Myalepta
• Do not over-tighten the needle. 
• Pazite, da igle ne pritrdite premočno.
● Presence of diabetes mellitus, or 
● sladkorna bolezen ali
o Serious and severe infections secondary to the appearance of NAb may occur. 
o Zaradi nevtralizirajočih protiteles se lahko pojavijo resne in hude okužbe.
• a glass ampoule 
• stekleni ampuli
After IV administration, metreleptin clearance was shown to be 79.6 mL/kg/h in healthy volunteers. 
dajanju metreleptina je bilo izločanje metreleptina pri zdravih prostovoljcih
● back of the upper arm 
• zadnja stran nadlahti.
“Instructions for Use” (section 7) for more information on reading and using the different syringes. 
Več informacij o odčitanju in uporabi različnih brizg najdete v "priročniku za uporabo"
STATEMENT OF ACTIVE SUBSTANCE(S) 
SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI
o The need of compliance with treatment due to the risk of pancreatitis when medication is abruptly stopped. 
*Globalne izkušnje po začetku trženja zdravila Akutni pankreatitis zaradi prekinitve jemanja metreleptina
21 gauge 40 mm needle Myalepta 5.8 mg powder for solution for injection 3.0 mL 
Myalepta 3 mg prašek za raztopino za injiciranje Myalepta 5,8 mg prašek za raztopino za injiciranje Myalepta 11,3 mg prašek za raztopino za injiciranje
Needle gauge and length Myalepta dose range to be administered 
Razpon odmerka zdravila Myalepta za uporabo
o T-cell lymphoma - Acquired LDs are associated with autoimmune disorders. 
- Pridobljene lipodistrofije so povezane z avtoimunskimi boleznimi.
B. PACKAGE LEAFLET 
Prelomna točka
Among 15 patients in the partial LD subgroup who had a baseline TG level 5.65 mmol/L or greater and data available at Month 12, the mean (SD) baseline triglyceride level was 27.6 mmol/L (32.88) and the mean percent reduction in TGs at Month 12 was 53.7%. 
P SD = standardna deviacija Med 15 bolniki v podskupini s parcialno LD, ki so imeli izhodiščno raven TG 5,65 mmol/l ali več in po 12 mesecih razpoložljive podatke, je bila povprečna (SD) izhodiščna raven trigliceridov
The efficacy and safety of treatment with metreleptin was evaluated in an open-label, single-arm study (Study NIH 991265/20010769) in patients with congenital or acquired generalised LD or familial or acquired partial LD. 
(študija NIH 991265/20010769) pri bolnikih s prirojeno ali pridobljeno generalizirano LD ali familiarno ali pridobljeno parcialno LD.
Arthralgia, Myalgia 
OVOJNINAH VIALA
Eighteen patients completed the study. 
Osemnajst bolnikov je zaključilo študijo.
Over time the number of these reactions decreased. 
Sčasoma se je število teh reakcij zmanjšalo.
Some of these reactions may be severe. 
Nekatere od teh reakcij so lahko resne.
Not known (frequency cannot be estimated from the available data) 
Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
2 Both groups exceeded the minimal clinically important difference (-0.24) 
2 Obe skupini sta prekoračili najnižjo klinično pomembno razliko (-0,24)
ATC code: A16AB05. 
Oznaka ATC: A16AB05.
• bluish color of the skin (due to lower levels of oxygen in the blood) 
• modrikasta barva kože (zaradi nižjih vrednosti kisika v krvi)
Aldurazyme was well tolerated at both dosages. 
Aldurazyme so dobro tolerirali pri obeh odmerkih.
• cold hands or feet 
• mrzle dlani ali stopala
The type of IARs was similar to those seen in other clinical studies. 
Vrste reakcij ob infuziji so bile podobne tistim, ki so jih opazili v drugih kliničnih študijah.
This patient tested positive for IgE. 
Pri tem bolniku je bil test z IgE pozitiven.
Date of latest renewal: 10 June 2008 
Datum prve odobritve: 10. junij 2003 Datum zadnjega podaljšanja: 10. junij 2008
• increased body temperature 
• povišana telesna temperatura
• cold sweat, heavy sweating 
• hladen znoj, močno znojenje
CHAQ/HAQ Disability Index 2 
CHAQ/HAQ indeks invalidnosti2
The majority of these reactions were mild or moderate in intensity. 
Večina teh reakcij je bila blagih ali zmernih.
The activity unit (U) is defined as the hydrolysis of one micromole of substrate (4-MUI) per minute. 
Enota aktivnosti (e) je opredeljena kot hidroliza enega mikromola substrata (4-MUI) na minuto.
• influenza like illness 
• gripi podobna bolezen
Remove the required vials from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature (below 30˚C). 
Potrebne viale vzemite iz hladilnika približno 20 minut pred uporabo, da dosežejo sobno temperaturo (pod 30 ˚C).
If you are allergic (hypersensitive) to laronidase or any of the other ingredients of this medicine (listed in section 6). 
Če ste alergični (preobčutljivi) za laronidazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Cmax showed an increase over time. 
Vrednost Cmax je sčasoma naraščala.
Three clinical trials were performed with Aldurazyme to assess its efficacy and safety. 
Z zdravilom Aldurazyme so bila opravljena tri klinična preskušanja za ocenitev njegove učinkovitosti in varnosti.
Genotoxic and carcinogenic potential are not expected. 
Ne pričakujemo, da bi zdravilo lahko imelo genotoksičen ali karcinogen potencial.
Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal/foetal development, parturition and postnatal development (see section 5.3). 
Študije na živalih ne kažejo na neposredne ali posredne škodljive učinke na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3.)
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
You may be given additional medication such as antihistamines and paracetamol to help prevent allergic-type reactions. 
Lahko boste dobili dodatno zdravilo, kot so antihistaminiki ali paracetamol, za pomoč pri preprečevanju alergičnih reakcij.
The total volume of the administration should be delivered in approximately 3-4 hours. 
Celoten odmerek zdravila morate prejeti v približno 3-4 urah.
• leakage of the drug into the surrounding tissue at the site of injection, which may cause swelling or redness 
• prepuščanje zdravila v okoliško tkivo na mestu injiciranja, kar lahko povzroči otekanje ali rdečino
Patients were enrolled with a Forced Vital Capacity (FVC) less than 80% of the predicted value and had to be able to stand for 6 minutes and to walk 5 meters. 
Sodelovali so bolniki s forsirano vitalno kapaciteto (FVC) manj kot 80 % od predvidene vrednosti ter so bili zmožni stati 6 minut in prehoditi 5 metrov.
Phase 3, 26 weeks of treatment compared to placebo p value Confidence interval 
3. faza, 26 tednov zdravljenja V primerjavi s placebom vrednost p
Paediatric population No dose adjustment is necessary for the paediatric population. 
Prilagajanje odmerka za pediatrično populacijo ni potrebno.
In addition 60 patients in the Phase 2 and 3 studies were tested for in-vitro neutralising effects. 
Poleg tega so bili pri 60 bolnikih v drugi in tretji fazi študije opravljeni preizkusi za in-vitro nevtralizacijske učinke.
The mean urinary GAG level declined by 50% at Week 13 and was reduced by 61% at the end of the study. 
Srednja vrednost GAG v urinu se je znižala za 50 % v 13. tednu in za 61 % ob zaključku študije.
The clinical significance of this finding is unknown since there were no consistent relationships between IgG antibody level and clinical efficacy endpoints. 
Ni znana klinična pomembnost teh rezultatov, ker ni bilo doslednega odnosa med vrednostjo IgG protiteles in končnimi točkami klinične učinkovitosti.
What Aldurazyme is and what is it used for 
Kaj je zdravilo Aldurazyme in za kaj ga uporabljamo
Several patients showed an increase in height (n=7) and weight (n=3) for age Z-score. 
Pri več bolnikih smo opazili povečano višino (n=7) in težo (n=3) za starost Zštetja.
Pharmacotherapeutic group: Enzymes. 
Farmakoterapevtska skupina: encimi.
AUC∞ (h•U/ml) 0.930 ± 0.214 CL (ml/min/kg) 1.96 ± 0.495 Vz (l/kg) 
AUC (h•E/ml) 0,930 ± 0,214 CL (ml/min/kg) 1,96 ± 0,495 Vz (l/kg)
Following 26 weeks of therapy, Aldurazyme-treated patients showed improved respiratory function and walking ability as compared to placebo as indicated below. 
Po 26 tednih zdravljenja se je pri bolnikih, ki so prejemali zdravilo Aldurazyme, izboljšala dihalna funkcija in zmožnost hoje v primerjavi s placebom, kot je prikazano spodaj.
The pharmacokinetic profile in patients less than 5 years old was similar to that of older and less severely affected patients. 
Farmakokinetični profil pri bolnikih, mlajših od 5 let, je bil podoben profilu manj prizadetih starejših bolnikov.
There was a rapid reduction in the excretion of urinary GAG (µg/mg creatinine) within the first 4 weeks, which was maintained through the remainder of the study. 
Hitro znižanje v izločanju GAG v urinu (µg/mg kreatinina) se je pojavilo v roku prvih 4 tednov in se nadaljevalo do zaključka študije.
These reactions may be particularly severe if you have a pre-existing MPS I-related upper airway obstruction. 
Te reakcije so lahko še posebno resne, če ste že prej imeli z MPS I povezano obstrukcijo zgornjih dihalnih poti.
Other side effects include the following: 
Drugi neželeni učinki so:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2) 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le pod omejenimi pogoji in na recept (Glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)