natgillin/translations-raw huggingface dataset:
What measures are being taken to ensure the safe and effective use of Vimizim? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vimizim?
The company will also set up a registry to assess the long-term benefits and risks of Vimizim. 
Prav tako bo družba vzpostavila register za oceno dolgoročnih koristi in tveganj, povezanih z zdravilom Vimizim.
If the enzyme is not present, or only present in very small quantities, GAGs cannot be broken down and they build up in bones and organs. 
Če tega encima ni ali če je prisoten le v zelo majhnih količinah, se glikozaminoglikani ne morejo razgraditi in se kopičijo v kosteh in organih.
This is a summary of the European public assessment report (EPAR) for Vimizim. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vimizim.
This causes the signs of the disease, the most noticeable being short bones, difficulty moving and breathing, clouding of the eyes and hearing loss. 
To povzroči znake bolezni, med katerimi so najopaznejši kratke kosti, težave pri gibanju in dihanju, zamotnitev oči ter izguba sluha.
What benefits of Vimizim have been shown in studies? 
Kakšne koristi je zdravilo Vimizim izkazalo v študijah?
In addition, the company that makes Vimizim must ensure that all healthcare professionals expected to prescribe or use the medicine are provided with educational material, informing them of how the medicine should be used and the risk of severe allergic reactions. 
Poleg tega mora družba, ki izdeluje zdravilo Vimizim, zagotoviti, da bodo vsi zdravstveni delavci, ki naj bi predpisovali ali uporabljali zdravilo, prejeli izobraževalno gradivo, s katerim se jih bo seznanilo z načinom uporabe zdravila in tveganjem za hude alergijske reakcije.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vimizim's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Vimizim večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee also considered that the safety profile of Vimizim appears manageable and serious side effects are uncommon, but further long-term safety data are to be collected. 
Odbor je prav tako menil, da je varnostni profil zdravila Vimizim obvladljiv in da resni neželeni učinki niso pogosti, vendar pa se morajo pridobiti dodatni podatki o dolgoročni varnosti.
The most common side effects with Vimizim (which may affect more than 1 in 10 people) are infusionrelated reactions, including headache, nausea (feeling sick), vomiting, fever, chills and abdominal pain (stomach ache). 
Najpogostejši neželeni učinki zdravila Vimizim (ki lahko prizadenejo več kot 1 osebo od 10) so reakcije, povezane z infundiranjem, ki vključujejo glavobol, navzeo (slabost), bruhanje, povišano telesno temperaturo, mrzlico in bolečine v trebuhu (bolečine v želodcu).
The medicine can only be obtained with a prescription and should be given by an appropriately trained healthcare professional. 
Izdaja zdravila je le na recept, dajati pa ga mora ustrezno usposobljen zdravstveni delavec.
A risk management plan has been developed to ensure that Vimizim is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Vimizim je bil pripravljen načrt obvladovanja tveganj.
Elosulfase alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce the enzyme. 
Elosulfaza alfa se pridobiva z metodo, imenovano „tehnologija rekombinantne DNA“: izdelajo jo celice, v katere so vstavili gen (DNA), s pomočjo katerega lahko tvorijo ta encim.
Serious but uncommon infusion-related reactions include anaphylaxis (severe allergic reaction). 
Resne, vendar ne pogoste reakcije, povezane z infundiranjem, vključujejo anafilakso (hudo alergijsko reakcijo).
Patients may also be given a medicine to prevent fever. 
Bolniki lahko prejmejo tudi zdravilo za preprečevanje zvišanja telesne temperature.
The summary of the opinion of the Committee for Orphan Medicinal Products for Vimizim 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 Vimizim je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
What are the risks associated with Vimizim? 
Kakšna tveganja so povezana z zdravilom Vimizim?
The replacement enzyme helps to break down GAGs and stop them building up in cells, thereby improving the symptoms of MPS IVA. 
Nadomestni encim pomaga razgraditi glikozaminoglikane in prepreči njihovo kopičenje v celicah, s čimer izboljša simptome MPS IVA.
It is used to treat patients with mucopolysaccharidosis type IVA (MPS IVA, also known as Morquio A syndrome). 
Uporablja se za zdravljenje bolnikov z mukopolisaharidozo tipa IVA (MPS IVA, ki jo imenujemo tudi Morquijev sindrom tipa A).
Enzyme replacement therapy provides patients with the enzyme they are lacking. 
Encimsko nadomestno zdravljenje bolnikom zagotovi encim, ki jim ga primanjkuje.
Because the number of patients with MPS IVA is low, the disease is considered ‘rare', and Vimizim was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009. 
Ker je bolnikov z MPS IVA malo, velja ta bolezen za redko, zato je bilo zdravilo Vimizim 24. julija 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Why is Vimizim approved? 
Zakaj je bilo zdravilo Vimizim odobreno?
It is not intended to provide practical advice on how to use Vimizim. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Treatment with Vimizim should be supervised by a doctor experienced in MPS IVA or similar diseases. 
Zdravljenje z zdravilom Vimizim mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem MPS IVA ali podobnih bolezni.
What is Vimizim and what is it used for? 
Kaj je zdravilo Vimizim in za kaj se uporablja?
The CHMP concluded that, following 6 months of treatment, Vimizim was shown to be effective at improving the distance patients could walk in six minutes, and this was accompanied by other beneficial effects, including improved ability to carry out daily activities. 
Odbor CHMP je zaključil, da se je zdravilo Vimizim po 6 mesecih zdravljenja izkazalo za učinkovito pri izboljšanju razdalje, ki so jo bolniki lahko prehodili v šestih minutah, poleg tega pa so opazili še druge koristne učinke, vključno z izboljšanjem sposobnosti opravljanja vsakodnevnih dejavnosti.
Before receiving Vimizim, the patient should be given a medicine to prevent an allergic reaction to Vimizim. 
Preden bolnik prejme zdravilo Vimizim, mora dobiti zdravilo za preprečevanje alergijske reakcije na zdravilo Vimizim.
Vimizim has been investigated in one main study involving 176 patients with MPS IVA, which compared Vimizim with placebo (a dummy treatment). 
Zdravilo Vimizim so raziskali v eni glavni študiji s 176 bolniki z MPS IVA, v kateri so zdravilo Vimizim primerjali s placebom (zdravilom brez zdravilne učinkovine).
The main measure of effectiveness was the change in the distance patients could walk in six minutes after 6 months of treatment. 
Glavno merilo učinkovitosti je bila sprememba razdalje, ki so jo bolniki po 6 mesecih zdravljenja lahko prehodili v šestih minutah.
Study results also suggested that the medicine could improve how well patients breathe or climb stairs, and in children, how well they grew. 
Rezultati študije so pokazali tudi, da lahko zdravilo pri bolnikih izboljša dihanje in zmožnost hoje po stopnicah ter izboljša rast pri otrocih.
Before treatment, the patients could walk on average just over 200 metres in six minutes. 
Bolniki so pred zdravljenjem v povprečju lahko prehodili nekaj več kot 200 metrov v šestih minutah.
For more information about treatment with Vimizim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Vimizim preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The full EPAR and risk management plan summary for Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Vimizim sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This disease is caused by the lack of an enzyme called N-acetylgalactosamine-6-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs). 
Bolezen povzroča pomanjkanje encima, imenovanega N-acetilgalaktozamin-6-sulfataza, ki je potreben za razgradnjo snovi v telesu, imenovanih glikozaminoglikani (GAG).
After 6 months, patients treated with the recommended dose of Vimizim could walk an extra 37 metres on average in six minutes, compared with an increase of 14 metres in patients receiving placebo. 
Po 6 mesecih so bolniki, zdravljeni s priporočenim odmerkom zdravila Vimizim, v povprečju lahko prehodili dodatnih 37 metrov v šestih minutah, medtem ko se je pri bolnikih, ki so prejemali placebo, razdalja podaljšala za 14 metrov.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vimizim, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vimizim in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Vimizim must not be used in patients who have experienced life-threatening allergic reactions to elosulfase alfa or any of the other ingredients in Vimizim. 
Zdravilo Vimizim se ne sme uporabljati pri bolnikih, ki so imeli smrtno nevarne alergijske reakcije na elosulfazo alfa ali katero koli drugo sestavino zdravila Vimizim.
The active substance in Vimizim, elosulfase alfa, is a copy of the human enzyme N-acetylgalactosamine-6-sulfatase. 
Zdravilna učinkovina v zdravilu Vimizim, elosulfaza alfa, je kopija humanega encima N-acetilgalaktozamin-6-sulfataze.
Vimizim is available as a concentrate to be made into a solution for infusion (drip) into a vein. 
Zdravilo Vimizim je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalno infuzijo) v veno.
For practical information about using Vimizim, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Vimizim naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Other information about Vimizim 
Druge informacije o zdravilu Vimizim
For the full list of all side effects reported with Vimizim, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vimizim, glejte navodilo za uporabo.
Vimizim is an enzyme replacement therapy. 
Vimizim je zdravilo za encimsko nadomestno zdravljenje.
Vimizim is a medicine that contains the active substance elosulfase alfa. 
Vimizim je zdravilo, ki vsebuje zdravilno učinkovino elosulfazo alfa.
How does Vimizim work? 
Kako zdravilo Vimizim deluje?
How is Vimizim used? 
Kako se zdravilo Vimizim uporablja?
Bioavailability was shown to be approximately 70%. 
Ugotovljeno je bilo, da je biološka razpoložljivost približno 70 %.
Plasma protein binding is high (~99%). 
Vezava na plazemske beljakovine je visoka (~ 99 %).
ATCvet code: QP53BX03. 
Oznaka ATCvet: QP53BX03
Do not use in dogs or cats under 14 weeks of age. 
Ne uporabite pri psih in mačkah, mlajših od 14 tednov.
Administer with food. 
Dajajte s hrano.
The duration of efficacy may be reduced if the dose is administered on an empty stomach. 
Trajanje učinkovitosti se lahko skrajša, če se odmerek daje na prazen želodec.
These effects are caused primarily by activation of nicotinic acetylcholine receptors (nAChRs). 
Te učinke povzroča večinoma aktivacija nikotinskih acetilholinskih receptorjev (nAChRs).
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Antidota ni.
Use with caution in dogs and cats with pre-existing epilepsy. 
Previdno uporabljajte pri psih in mačkah z obstoječo epilepsijo.
Furthermore, a reduction of food intake was observed in females, however a significant reduction in their bodyweight was not observed. 
Poleg tega so pri samicah opazili zmanjšan vnos hrane, vendar pa bistvenega zmanjšanja njihove telesne mase niso opazili.
In case of adverse clinical signs, the animal should be treated symptomatically. 
V primeru neželenih kliničnih znakov je treba žival zdraviti simptomatsko.
Pharmacotherapeutic group: other ectoparasiticides for systemic use. 
FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: drugi ektoparazitiki za sistemsko uporabo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/02/2011. 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11/02/2011
In very rare cases, blindness, impaired vision and other eye disorders were observed. 
V zelo redkih primerih so opazili slepoto, slabovidnost in ostala obolenja oči.
Keep the blister in the outer carton to protect from light. 
Pretisni omot shranjujte v zunanji ovojnini, za zaščito pred svetlobo.
Children should not come into contact with the veterinary medicinal product. 
Otroci ne smejo priti v stik s tem zdravilom za uporabo v veterinarski medicini.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD). 
To zdravilo za uporabo v veterinarski medicini se lahko uporablja kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe (flea allergy dermatitis - FAD).
Regular monthly treatments with Comfortis break the fleas' life cycle and may be needed to control the flea population in contaminated households. 
Redna mesečna zdravljenja z zdravilom Comfortis prekinejo življenjski cikel bolhe in so morda potrebna za obvladovanje populacije bolh v kontaminiranem gospodinjstvu.
In the majority of cases, vomiting was transient, mild and did not require symptomatic treatment. 
V večini primerov je bilo bruhanje prehodno in blago ter ga ni bilo treba simptomatsko zdraviti.
AUC and Cmax values were higher in fed than fasted cats. 
Vrednosti AUC in Cmax so bile višje pri nahranjenih kot pa pri teščih mačkah.
Spinosad has been shown to be a substrate for P-glycoprotein (PgP). 
Ugotovljeno je bilo, da je spinosad substrat za P-glikoprotein (PgP).
All dogs and cats within the household should be treated. 
Zdraviti se mora vse pse in mačke v gospodinjstvu.
Spinosad could therefore interact with other PgP-substrates (for example, digoxin, doxorubicin) and possibly enhance adverse reactions from such molecules or compromise efficacy. 
Spinosad bi lahko zato medsebojno deloval z drugimi PgP-substrati (na primer z digoksinom ali doksorubicinom) in morebiti okrepil neželene učinke teh molekul ali zmanjšal učinkovitost.
Spinosad therefore has a different mode of action to other flea control or insect control products. 
Spinosad ima zato drugačen način delovanja kot druga sredstva za obvladovanje bolh ali izdelki za obvladovanje insektov.
The veterinary medicinal product may safely be given at monthly intervals at the recommended dose. 
To zdravilo za uporabo v veterinarski medicini se lahko varno daje v mesečnih intervalih v priporočenem odmerku.
Do not use in case of known hypersensitivity to the active substance or to any of the excipients. 
Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino ali na katero koli pomožno snov.
The incidence of vomiting observed after the first and second treatments was higher (8%) in dogs dosed at the upper end of the dose band. 
Pojavnost bruhanja, ki so jo opazili po prvem in drugem zdravljenju, je bila višja (8 %) pri psih, ki so prejeli odmerek na zgornji meji odmerjanja.
Fleas may persist for a period of time after administration of the product due to the emergence of adult fleas from pupae already in the environment. 
Bolhe se lahko pojavijo tudi v obdobju po dajanju zdravila zaradi razvoja odraslih bolh iz ličink, ki so že v okolju.
It does not interact with known binding sites of other nicotinic or GABAergic insecticides such as neonicotinides (imidacloprid or nitenpyram), fiproles (fipronil), milbemycins, avermectins (e.g. selamectin) or cyclodienes, but through a novel insecticidal mechanism. 
Ne deluje medsebojno z znanimi mesti vezave drugih nikotinskih ali GABA-ergičnih insekticidov, kot so neonikotinidi (imidakloprid ali nitenpiram), fiproli (fipronil), milbemicini, avermektini (npr. selamektin) ali ciklodieni, ampak s povsem novim insekticidnim mehanizmom.
The product starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment in dogs, and in cats within 24 hours. 
Zdravilo začne bolhe ubijati v 30 minutah po dajanju; 100 % bolh pogine/so v fazi poginjanja pri psih v 4 urah po dajanju zdravila, pri mačkah pa v 24 urah.
Seizures were rare adverse reactions. 
Konvulzije so bile redek neželeni učinek.
If fleas reappear in the fourth week, the treatment interval can be shortened by up to 3 days in dogs. 
Če se bolhe četrti teden ponovno pojavijo, lahko interval dajanja pri psih skrajšate za do 3 dni.
Treatment and prevention of flea infestations (Ctenocephalides felis). 
Zdravljenje in preprečevanje infestacij z bolhami (Ctenocephalides felis).
The recommended dosage regimen should be followed. 
Upoštevajte priporočeno tabelo odmerjanja.
However there was no evidence in the clinical observations and clinical chemistry parameters that indicated any loss in organ function. 
Vendar klinična opažanja in klinični kemijski parametri niso pokazali slabšega delovanja organov.
The veterinary medicinal product should be administered with food or immediately after feeding. 
Zdravilo za uporabo v veterinarski medicini se daje s hrano ali takoj po obroku.
As the safety of this for suckling puppies and kittens has not been established, the product should only be used during pregnancy and lactation according to the benefit/risk assessment by the responsible veterinarian. 
Ker ni dokazov o varnosti za pasje in mačje mladiče, ki se dojijo, se lahko to zdravilo med brejostjo ali laktacijo uporablja le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
At doses of approximately 2.5 times the recommended dose, spinosad caused vomiting in the vast majority of dogs. 
Pri odmerkih, ki so približno 2,5-krat večji od priporočenega, je spinosad povzročil bruhanje pri veliki večini psov.
The use of the product in smaller dogs and smaller cats is therefore not recommended. 
Zato uporaba tega zdravila pri manjših psih in mačkah ni priporočljiva.
Other commonly observed adverse reactions in cats were diarrhoea and anorexia. 
Druga neželena učinka, ki so ju pri mačkah pogosto opazili, sta bili driska in anoreksija.
Cardboard box containing blister, each containing 3 or 6 chewable tablets. 
Kartonska škatla vsebuje pretisni omot s 3 ali 6 žvečljivimi tabletami.
PACKAGE SIZE 3 tablets 
VELIKOST PAKIRANJA 3 tablete
There is no antidote available. 
Antidota ni.
In cats, the full 4 week gap between treatments should be maintained, even if fleas reappear (due to an occasional slightly reduced persistent efficacy) before the end of the 4 weeks. 
Pri mačkah je treba upoštevati 4-tedenski razmik med zdravljenji, tudi če se bolhe znova pojavijo (zaradi občasne rahlo zmanjšane učinkovitosti) pred potekom 4 tednov.
The preventive effect against re-infestations is a result of the activity against adult fleas and the reduction in their production of eggs. 
Preprečevalni učinek proti ponovnim infestacijam je rezultat delovanja proti odraslim bolham in manjšega nastajanja jajčec.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini, za oznako »EXP«.
Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings, which should be treated in case of massive infestation and at the beginning of the treatment with a suitable insecticide and vacuumed regularly. 
Bolhe domačih živali pogosto infestirajo košaro, ležišče in prostore, kjer žival redno počiva, kot so preproge in oblazinjena pohištva; te morate v primeru hude infestacije in ob začetku zdravljenja obdelati z ustreznim insekticidom in jih redno sesati.
If vomiting occurs within an hour of administration and the tablet is visible, re-dose the animal with another full dose to ensure maximum effectiveness of the product. 
Če v eni uri po dajanju zdravila pride do bruhanja in v njem opazite tableto, dajte živali še enkrat polni odmerek, da zagotovite največjo učinkovitost zdravila.
In lactating bitches, spinosad is excreted in the colostrum/milk. 
Pri doječih psicah se spinosad izloča v kolostrum/mleko.
The recommended dosage regimen should be followed (see section 4.10 for information regarding overdose). 
Upoštevajte priporočeno tabelo odmerjanja (za informacije o prekomernem odmerjanju glejte poglavje
Vomiting is most likely caused by a local effect on the small intestines. 
Bruhanje najverjetneje povzroči lokalni učinek na tanko črevo.
Cat bodyweight (kg) 
Telesna masa mačke (kg)
MANUFACTURER'S BATCH NUMBER Lot 
IZDELOVALČEVA ŠTEVILKA SERIJE
In pregnant dogs (bitches), the safety of spinosad has not been sufficiently established. 
Pri brejih psicah varnost spinosada ni bila dokazana v zadostni meri.
The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product. 
Preprečevalni učinek proti ponovnim infestacijam je rezultat adulticidnega delovanja in manjšega nastajanja jajčec, ki traja še do 4 tedne po enkratni uporabi tega zdravila.
Insecticidal activity against new infestations persists for up to 4 weeks. 
Insekticidna aktivnost pred ponovno infestacijo traja do 4 tedne.
The safety of the product in male dogs and male cats used for breeding has not been determined. 
Varnost zdravila pri pasjih in mačjih samcih, namenjenih za vzrejo, ni bila ugotovljena.
Phospholipidosis (vacuolation of the cells of the liver, adrenal gland and lung) also occurred. 
Pojavila se je tudi fosfolipidoza (vakuolizacija celic jeter, nadledvične žleze in pljuč).
Phospholipidosis (vacuolation of lymphoid tissue) also occurred; although this was not related to clinical signs in dogs treated up to 6 months. 
Pojavila se je tudi fosfolipidoza (vakuolizacija limfoidnega tkiva), čeprav to ni bilo povezano s kliničnimi znaki pri psih,
In cats, the full 4 week gap between treatments should be maintained, even if fleas reappear before the end of the 4 weeks. 
Pri mačkah je treba upoštevati 4-tedenski razmik med zdravljenji, tudi če se bolhe znova pojavijo pred potekom 4 tednov.
Spinosad comprises spinosyn A and spinosyn D. The insecticidal activity of spinosad is characterised by nervous excitation leading to muscle contractions and tremors, prostration, paralysis and rapid death of the flea. 
Spinosad je sestavljen iz spinosina A in spinosina D. Za insekticidno aktivnost spinosada je značilno živčno vzdraženje, ki povzroči krčenje mišic in tremorje, izčrpanost, paralizo in hitro smrt bolh.
In adult cats, the AUC increased over 3 consecutive months of dosing with 75 mg spinosad/kg bodyweight, after which steady state was achieved; however, no clinical impact occurred as a result of this. 
Pri odraslih mačkah se je vrednost AUC v treh zaporednih mesecih zdravljenja z odmerkom 75 mg/kg telesne mase povišala, potem pa stabilizirala, vendar to ni imelo nobenega kliničnega učinka.