natgillin/translations-raw huggingface dataset:
Bag (ethyl vinyl acetate)
Vrečka (etil vinil acetat)
Zero degree days
1 vrečka Nič dnevnih stopinj
MA 01701 United States
MA 01701 Združene države Amerike
Date of first authorisation: 03 August 2001 Date of last renewal: 03 August 2006
Datum prve odobritve: 3. avgust 2001 Datum zadnjega podaljšanja: 3. avgust 2006
Antibody status should be regularly monitored.
Stanje protiteles je treba redno spremljati.
Not known (frequency cannot be estimated from the available data):
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
ATC code: A16AB04.
Oznaka ATC: A16AB04.
Genotoxic and carcinogenic potential are not expected.
Genotoksičnosti in kancerogenosti ni pričakovati.
The current medical standards for emergency treatment are to be observed.
Upoštevati morate veljavne medicinske standarde za urgentno zdravljenje.
Talk to your doctor first.
Najprej se posvetujte z zdravnikom.
Because this condition is slowly progressive, early detection and treatment is critical to achieve the best outcomes.
Ker je to stanje počasi napredujoče, je za doseganje najboljših izidov pomembno zgodnje odkritje in zdravljenje.
Studies with regard to other stages of the development have not been carried out.
Študije vpliva na druge stopnje razvoja niso bile opravljene.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products in the same infusion.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili v isti infuziji.
The frequency of these reactions decreased over time.
Pogostnost teh reakcij je sčasoma upadla.
• sudden swelling of the face or throat
• nenadno zatekanje obraza ali grla
Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake „EXP“.
You may need to be given additional medicines to prevent such reactions from occurring.
Morda boste za preprečevanje nastanka takih reakcij potrebovali dodatna zdravila.
These reported symptoms resemble the natural course of Fabry disease.
Ti simptomi so bili podobni naravnemu poteku Fabryjeve bolezni.
Your doctor may advise that you can be treated at home provided you meet certain criteria.
Zdravnik vam bo morda svetoval zdravljenje na domu, če izpolnjujete določena merila.
Results were similar between the two treatment groups.
Rezultati med terapevtskima skupinama so bili podobni.
Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na razvoj zarodka/plodu (glejte poglavje 5.3).
This leaflet was last revised in Other sources of information
Navodilo je bilo nazadnje revidirano dne Drugi viri informacij:
These patients should be treated with caution when re-administering agalsidase beta (see section 4.8).
Te bolnike bi morali pri ponovnemu dajanju agalzidaze beta obravnavati previdno (glejte poglavje 4.8).
The majority of these reactions can be attributed to the formation of IgG antibodies and/or complement activation.
Večino teh reakcij lahko pripišemo nastanku protiteles IgG in/ali aktivaciji komplementa.
Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.
Zdravilo Fabrazyme je indicirano pri odraslih, otrocih in mladostnikih, starih 8 let in več.
The reconstituted solution must be diluted further (see section 6.6).
Rekonstituirano raztopino je treba dodatno redčiti (glejte poglavje 6.6).
For the purpose of this table, ≥1% is defined as reactions occurring in 2 or more patients.
Za to preglednico je vrednost ≥1% opredeljena kot učinek, do katerega je prišlo pri dveh ali več bolnikih.
Plasma GL-3 levels rapidly normalised with treatment and remained normal through 5 years.
Nivoji plazemskega GL-3 so se z zdravljenjem hitro normalizirali in so ostali normalni tekom 5 let.
Intravenous use.
intravenska uporaba.
• red eyes
• rdeče oči
- if you are allergic to agalsidase beta or any of the other ingredients of this medicine (listed in section 6).
- Če ste alergični na agalzidazo beta ali katero koli sestavino tega zdravila (navedene v poglavju 6).
Each vial of Fabrazyme is intended for single use only.
Vsaka viala zdravila Fabrazyme je namenjena le enkratni uporabi.
Currently available data are described in sections 5.1 and 5.2 but no recommendation on posology can be made in children aged 5 to 7 years.
Podatki, ki so trenutno na voljo, so opisani v poglavjih 5.1 in 5.2, toda priporočil za odmerjanje pri otrocih v starosti od 0 do 7 let ni mogoče dati.
It is characterised by the deficiency of α-galactosidase.
Zanjo je značilno pomanjkanje encima α-galaktozidaze.
The pH of the reconstituted solution is approximately 7.0.
pH vrednost rekonstituirane raztopine je približno 7,0.
• Additional risk minimisation measures
• Dodatni ukrepi za zmajševanje tveganj
Fabrazyme pharmacokinetics was also evaluated in two paediatric studies.
Farmakokinetika zdravila Fabrazyme je bila ocenjena v dveh pediatričnih študijah.
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
Sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction.
Sedeminšestdeset odstotkov (67 %) bolnikov je imelo vsaj eno reakcijo, povezano z infuzijo.
The elimination half-life was dose independent and ranged from 45 to 100 minutes.
Razpolovni čas izločanja je bil odvisen od odmerka in je bil od 45 do 100 minut.
Renal function, as measured by glomerular filtration rate and serum creatinine, as well as proteinuria, remained stable in the majority of the patients.
Delovanje ledvic, merjeno s hitrostjo glomerularne filtracije in serumskim kreatininom, kot tudi proteinurija, so ostali stabilni pri večini bolnikov.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 10 VIALS)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (1 VIALA, 5 VIAL, 10 VIAL)
Although no specific study has been conducted to assess the effect on the neurological signs and symptoms, the results also indicate that patients may achieve reduced pain and enhanced quality of life upon enzyme replacement therapy.
Čeprav ni bilo izvedene posebne študije za ocenitev učinka na nevrološke znake in simptome, rezultati kažejo, da po encimskem nadomestnem zdravljenju pri bolnikih lahko pride do zmanjšanja bolečin in izboljšanja kvalitete življenja.
Clearance of GL-3 was also achieved in several other cell types from the kidney.
Očistek GL-3 je bil dosežen tudi pri nekaterih drugih vrstah ledvičnih celic.
If you suffer from Fabry disease a fat substance, called globotriaosylceramide (GL-3), is not removed from the cells of your body and starts to accumulate in the walls of the blood vessels of your organs.
Če imate Fabryjevo bolezen, se maščobna snov globotriaozilceramid (GL-3) ne odstranjuje iz telesnih celic in se začne kopičiti v stenah krvnih žil vaših organov.
Your doctor may decide to lower the infusion rate or give you additional medicines to prevent such reactions from occurring.
Vaš zdravnik bo morda presodil, da je treba zmanjšati hitrost infundiranja ali da morate prejemati dodatna zdravila za preprečevanje pojavljanja takšnih reakcij.
Efficacy and safety of Fabrazyme was evaluated in two studies with children, one dose-finding study, two double-blind placebo-controlled studies, and one open-label extension study in both male and female patients.
Klinična učinkovitost in varnost Učinkovitost in varnost zdravila Fabrazyme je bila ovrednotena z dvema študijama pri otrocih, eno študijo ugotavljanja odmerka, dvema dvojno slepima s placebom nadzorovanima študijama in eno razširjeno študijo odprtega tipa pri moških in ženskih bolnikih.
Do not invert, swirl or shake the vial.
Viale ne obračajte, vrtite ali pretresajte.
This clearance was achieved in 69% (20/29) of the Fabrazyme treated patients, but in none of the placebo patients (p<0.001).
Očistek je bil dosežen pri 69 % (20/29) bolnikov, zdravljenih z zdravilom Fabrazyme, in pri nobenem od tistih, ki so prejemali placebo (p<0,001).
Use Aseptic Technique
Uporabite aseptično tehniko.
Adverse reactions were mostly mild to moderate in severity:
Po jakosti so bili neželeni učinki večinoma blagi do zmerni:
The rate of clinical events was substantially lower among Fabrazyme-treated patients compared to placebo-treated patients (risk reduction = 53% intent-to-treat population (p=0.0577); risk reduction = 61 % per-protocol population (p=0.0341)).
Stopnja kliničnih dogodkov je bila precej nižja pri bolnikih, zdravljenih z zdravilom Fabrazyme, kot pri bolnikih, zdravljenih s placebom (zmanjšanje tveganja = 53 % populacija namenjena za zdravljenje (p=0,0577); zmanjšanje tveganja = 61 % protokolna populacija (p=0,0341)).
The results of these studies indicate that Fabrazyme treatment at 1 mg/kg every other week provides clinical benefit on key clinical outcomes in patients with early and advanced Fabry disease.
Rezultati teh študij pomenijo, da zdravljenje z zdravilom Fabrazyme 1 mg/kg vsak drugi teden zagotavlja klinično prednost pri ključnih kliničnih izidih pri bolnikih z zgodnjo in razvito obliko Fabryjeve bolezni.
Infusion associated reactions
Reakcije, povezane z infuzijo
This finding was further supported by a statistically significant decrease in GL-3 inclusions in kidney, heart and skin combined and in the individual organs in patients treated with agalsidase beta compared to placebo patients (p<0.001).
Ta izsledek je bil podprt tudi s statistično občutnim zmanjšanjem skupnega števila inkluzij GL-3 v ledvicah, srcu in koži ter v posameznih organih bolnikov, zdravljenih z agalzidazo beta, v primerjavi s tistimi, ki so prejemali placebo (p<0,001).
In clinical trials doses up to 3 mg/kg body weight were used.
V kliničnih preskušanjih so uporabljali odmerke do 3 mg/kg telesne mase.
Remove the airspace within the infusion bag to minimize the air/liquid interface.
Odstranite zrak iz infuzijske vrečke, da čimbolj zmanjšate medsebojno delovanje zraka/tekočine.
In clinical trials, sixty seven percent (67 %) of the patients experienced at least one infusionassociated reaction (see section 4.8).
V kliničnih preskušanjih je sedeminšestdeset odstotkov (67 %) bolnikov imelo vsaj eno reakcijo, povezano z infuzijo (glejte poglavje 4.8).
Plasma GL-3 was cleared in a dose dependent manner, but was less consistent at the dose of 0.3 mg/kg.
Iz plazme se je GL-3 odstranjeval v odvisnosti od odmerka, vendar pa je bil ta učinek manj konsistenten pri odmerku 0,3 mg/kg.
In the postmarketing setting, experience was gained in patients who initiated treatment at a dose of 1 mg/kg every 2 weeks and subsequently received a reduced dose for an extended period.
V obdobju trženja zdravila so bile pridobljene izkušnje z bolniki, ki so začeli zdravljenje z odmerkom 1 mg/kg vsake dva tedna, nato pa so prejemali zmanjšan odmerek daljše obdobje.
This result was consistent across renal, cardiac and cerebrovascular events.
Ta rezultat se je ujemal pri ledvičnih, srčnih in cerebrovaskularnih primerih.
Before further dilution, visually inspect the reconstituted solution in each vial for particulate matter and discoloration.
Pred nadaljnjim redčenjem vizualno preglejte rekonstituirano raztopino v vsaki viali, da ugotovite delce in obarvanje.
There is a theoretical risk of decreased agalsidase beta activity.
Obstaja teoretično tveganje zmanjšane aktivnosti agalzidaze beta.
Patients with antibodies to r-hαGAL have a greater potential to experience infusion-associated reactions (IARs), which are defined as any related adverse event occurring on the infusion day.
Bolniki s protitelesi proti r-hαGAL imajo večjo možnost, da bodo imeli reakcije, povezane z infuzijo, ki so opredeljene kot kakršenkoli neželeni učinek, ki se pojavi na dan infuzije.
Fabry disease is an inherited heterogeneous and multisystemic progressive disease, that affects both males and females.
Fabryjeva bolezen Fabryjeva bolezen je dedna heterogena in multisistemska progresivna bolezen, ki prizadene tako moške kot ženske.
In addition, infusion-associated reactions were dose dependent.
Tudi reakcije, povezane z infuzijo, so bile odvisne od odmerka.
In a limited number of patients IgE antibodies were demonstrated (see section 4.4).
Pri omejenem številu bolnikov so dokazali protitelesa IgE (glejte poglavje 4.4).
Over time, the majority of seropositive patients in clinical trials demonstrated either a downward trend in titers (based on a ≥ 4-fold reduction in titer from the peak measurement to the last measurement) (40% of the patients), tolerised (no detectable antibodies confirmed by 2 consecutive radioimmunoprecipitation (RIP) assays) (14% of the patients) or demonstrated a plateau (35% of the patients).
Sčasoma je večina seropozitivnih bolnikov v kliničnih preskušanjih izkazala padajoči (na osnovi ≥ 4 kratnega zmanjšanja titra od največje meritve do zadnje meritve) (40 % bolnikov) tolerirano (s pomočjo 2 zaporednih testov radioimunske percipitacije (RIP) ni bilo zaznati protiteles) (14 % bolnikov) oziroma je bil prikazan plato (35 % bolnikov).
Do not shake or excessively agitate the infusion bag.
Infuzijske vrečke ne tresite ali pretirano pretresajte.
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 taking this medicine.
Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujtez zdravnikom ali farmacevtom, preden vzamete to zdravilo.
As with any intravenous protein medicinal product, allergic-type hypersensitivity reactions are possible.
Kot pri vsakem intravenskem beljakovinskem zdravilu so tudi pri uporabi zdravila Fabrazyme možne alergijske preobčutljivostne reakcije.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Za navodila glede rekonstitucije in raztapljanja zdravila pred dajanjem, glejte poglavje 6.6.
• hyperthermia
• hipertermija
Do not use filter needles and avoid foaming.
Ne uporabljajte filtrirnih igel in preprečite nastajanje pene.
If you use more Fabrazyme than you should
Če uporabite večji odmerek zdravila Fabrazyme, kot bi smeli
Pregnancy There are no adequate data from the use of agalsidase beta in pregnant women.
Nosečnost Ni zadostnih podatkov o uporabi agalzidaze beta pri nosečnicah.
The safety and efficacy of Fabrazyme in children aged 0 to7 years have not yet been established.
Varnost in učinkovitost zdravila Fabrazyme pri otrocih v starosti od 0 do 7 let še nista dokazani.
Do not drive or use machines if you experience dizziness, sleepiness, vertigo or fainting during or shortly after administration of Fabrazyme (see section 4).
Ne vozite avtomobila ali upravljajte s stroji, če se pri vas pojavi omotica, zaspanost, vrtoglavica ali omedlevica med dajanjem ali v kratkem času po uporabi zdravila Fabrazyme (glejte poglavje 4 ).
In the first placebo-controlled clinical trial, Fabrazyme was effective in clearing GL-3 from the vascular endothelium of the kidney after 20 weeks of treatment.
V prvem kliničnem preskušanju, nadzorovanem s placebom, je bilo zdravilo Fabrazyme učinkovito pri odstranjevanju GL-3 iz ledvičnega žilnega endotelija po 20 tednih zdravljenja.
Reduced or absent αgalactosidase activity results in the accumulation of GL-3 in the lysosomes of many cell types including the endothelial and parenchymal cells, ultimately leading to life-threatening clinical deteriorations as a result of renal, cardiac and cerebrovascular complications.
Zmanjšana aktivnost ali odsotnost α-galaktozidaze povzroči kopičenje GL-3 v lizosomih številnih vrst celic, vključno z endotelijskimi in parenhimskimi celicami, kar na koncu privede do življenjsko nevarnih kliničnih poslabšanj, ki so posledica ledvičnih, srčnih ali cerebrovaskularnih zapletov.
In some patients initially treated at the recommended dose, and whose dose was later reduced for an extended period, some symptoms of Fabry disease were reported more frequently.
Pri nekaterih bolnikih, sprva zdravljenih s priporočenim odmerkom, so se po zmanjšanju odmerka za daljše obdobje nekateri simptomi Fabryjeve bolezni pojavljali pogosteje.
If severe allergic or anaphylactic-type reactions occur, immediate discontinuation of the administration of Fabrazyme should be considered and appropriate treatment initiated.
Če nastopijo hude alergijske ali anafilaktične reakcije, pretehtajte, ali je potrebna takojšnja ustavitev dajanja zdravila Fabrazyme in uvedite ustrezno zdravljenje.
Because there are no data available on effects in neonates exposed to agalsidase beta via breast milk, it is recommended to stop breast-feeding when Fabrazyme is used.
Ker ni nobenih podatkov o učinkih agalzidaze beta na novorojenčke, ki so bili zdravilu izpostavljeni prek materinega mleka, priporočamo, da mati preneha dojiti med uporabo zdravila Fabrazyme.
With careful rechallenge Fabrazyme has been re-administered to all 6 patients who tested positive for IgE antibodies or had a positive skin test to Fabrazyme in a clinical trial.
S previdnim ponovnim izzivanjem so Fabrazyme začeli znova dajati vsem 6 bolnikom, katerih testi na protitelesa IgE so bili pozitivni ali so imeli pozitivni kožni test na Fabrazyme v kliničnem preskušanju.
The diluted solution can be held for up to 24 hours at 2°C - 8°C.
Razredčeno raztopino lahko shranjujete do 24 ur pri temperaturi 2 °C - 8 °C.
Investigations oxygen saturation decreased
Preiskave zmanjšana nasičenost s kisikom
The reconstituted solution must be further diluted.
Rekonstituirano raztopino morate dodatno razredčiti.
It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles which will not lead to any loss of agalsidase beta activity.
Razredčeno raztopino je priporočljivo dajati skozi 0,2 µm linijski filter, ki veže enostavne beljakovine, da odstranite vse beljakovinske delce, kar ne bo povzročilo nikakršne izgube aktivnosti agalzidaze beta.
The majority of patients developed IgG antibodies to r-hαGAL, typically within 3 months of the first infusion with Fabrazyme.
Večina bolnikov je protitelesa IgG proti r-hαGAL začela tvoriti v 3 mesecih od prve infuzije zdravila Fabrazyme.
What Fabrazyme is and what it is used for What you need to know before you use Fabrazyme How to use Fabrazyme
Kaj je zdravilo Fabrazyme in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Fabrazyme Kako uporabljati zdravilo Fabrazyme
The risks and benefits of Fabrazyme in children aged 5 to 7 years have not yet been established and therefore no dose can be recommended for this age group.
Tveganja in koristi zdravila Fabrazyme pri otrocih, starih od 5 do 7 let, še niso potrjena, zato za to starostno skupino ni možno priporočiti odmerka.
List of other side effects:
Seznam ostalih neželenih učinkov:
Adverse reaction terminology is based upon the Medical Dictionary for Regulatory Activities (MedDRA)
Terminologija neželenih učinkov temelji na medicinskem slovarju za regulatorne aktivnosti
Please contact your doctor if you would like to be treated at home.
Posvetujte se z zdravnikom, če se želite zdraviti doma.
The educational material for healthcare professionals should include information on the following key elements: - Guidance regarding patient evaluation and selection and organisational requirements for home infusion.
Izobraževalno gradivo za zdravstveno osebje mora vsebovati informacije o naslednjih ključnih elementih: - Smernice za ocenjevanje in izbiranje bolnikov ter organizacijske zahteve za infundiranje na domu.
Dose and infusion rate should remain constant while at home, and not be changed without supervision of a healthcare professional.
Odmerek in hitrost infundiranja se doma ne smeta spremeniti brez dovoljenja zdravstvenega osebja.
After reconstitution it is a clear, colourless liquid, free from foreign matter.
Po rekonstituciji postane čista, brezbarvna tekočina brez tujkov.
An infusionassociated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4).
Reakcija, povezana z infuzijo, je vsak neželeni učinek, do katerega pride med infundiranjem ali do konca dneva, na katerega ste prejeli infuzijo (glejte poglavje 4).
Roll and tilt each vial gently.
Vsako vialo nežno zazibajte in nagnite.
If you forget to use Fabrazyme
Če ste pozabili uporabiti zdravilo Fabrazyme
• increased sensitivity to pain
• povečana občutljivost na bolečino
The safety and efficacy of Fabrazyme in patients older than 65 years have not been established and no dosage regimen can presently be recommended in these patients.
Starostniki Varnosti in učinkovitosti zdravila Fabrazyme pri bolnikih, starejših od 65 let, še niso ugotovili in zanje trenutno ne moremo priporočiti nobenega režima odmerjanja.
If you experience a reaction like this, you should tell your doctor immediately.
Če se pri vas pojavi takšna reakcija, nemudoma obvestite zdravnika.
What Fabrazyme is and what it is used for
Kaj je zdravilo Fabrazyme in za kaj ga uporabljamo
The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of α-galactosidase A.
Aminokislinsko zaporedje rekombinantne oblike, kakor tudi nukleotidno zaporedje, ki ga kodira, sta popolnoma enaka naravni obliki encima α-galaktozidaze A.
In the dose finding study, the effects of 0.3, 1.0 and 3.0 mg/kg once every 2 weeks and 1.0 and 3.0 mg/kg once every 2 days were evaluated.
V študijah za ugotavljanje odmerka so ovrednotili učinke odmerkov 0,3, 1,0 in 3,0 mg/kg enkrat na vsaka 2 tedna in odmerkov 1,0 in 3,0 mg/kg enkrat na vsaka 2 dni.
Life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients listed in section 6.1.
Smrtno nevarna preobčutljivost (anafilaktična reakcija) na zdravilno učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
Doses up to 3 mg/kg body weight have shown to be safe.
Odmerki do 3 mg/kg telesne mase so se izkazali za varne.
Tell your doctor if you use any medicines containing chloroquine, amiodarone, benoquin or gentamicin.
Obvestite zdravnika, če jemljete katero koli zdravilo, ki vsebuje klorokvin, amiodaron, monobenzon ali gentamicin.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali oziroma če razmišljate o jemanju kateregakoli drugega zdravila, tudi če ste ga dobili brez recepta.
In an additional study, 21 male patients were enrolled to follow GL3 clearance in kidney and skin tissues at an alternative dosing regimen.
V dodatni študiji je sodelovalo 21 moških bolnikov, pri katerih so opazovali očistek GL-3 v ledvicah in kožnem tkivu pri alternativnem režimu odmerjanja.
It is supplied as a powder which will be mixed with sterile water before it is given (see information for Health Care Professionals at the end of this leaflet).
Zdravilo je v obliki praška, ki ga bodo pred infundiranjem zmešali s sterilno vodo (glejte informacije za zdravstveno osebje na koncu teh navodil).Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
Agalsidase beta is a recombinant form of human α-galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture.
Agalzidaza beta je rekombinantna oblika človeškega encima α-galaktozidaze A, ki ga izdelujejo s tehnologijo rekombinantne DNA v sesalskih celičnih kulturah ovarijskih celic kitajskega hrčka
Hepatic impairment Studies in patients with hepatic insufficiency have not been performed.
Jetrna insuficienca Študije pri bolnikih z jetrno insuficienco še niso bile opravljene.