natgillin/translations-raw huggingface dataset:
Appropriate additional information regarding posologies adaptation should be implemented in the SmPC depending on the strength of the formulations
V Povzetek glavnih značilnosti zdravila je treba vključiti ustrezne dodatne informacije o prilagajanju odmerjanja zdravila glede na jakost formulacij.
Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.
Zaradi tveganja za pojav nehotenih mišičnih krčev, zdravljenje ne sme trajati več kot 3 mesece.
A minimal interval of 24 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
Časovni razmik med posameznimi odmerki zdravila mora biti najmanj 24 ur, tudi v primeru bruhanja ali zavrnitve odmerka (glejte poglavje 4.4).
For formulations which cannot be used to administer a 5mg dose {Tradename} is not suitable for use in children weighing less than 61 kg.
Zdravilo Xyz ni primerno za uporabo pri otrocih, katerih telesna masa je nižja od 61 kg.
- to prevent delayed nausea and vomiting that may occur after chemotherapy - to prevent nausea and vomiting caused by radiotherapy - to treat nausea and vomiting including nausea and vomiting which may occur with a migraine.
- preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja, - preprečevanje z radioterapijo povzročene slabosti in bruhanja, - zdravljenje slabosti in bruhanja, vključno s slabostjo in bruhanjem, ki nastopita zaradi migrene; V primeru migrene se metoklopramid lahko uporablja v kombinaciji s peroralnimi zdravili proti bolečinam, da bodo le-ta delovala bolj učinkovito.
A minimal interval of 12 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
Časovni razmik med posameznimi odmerki zdravila mora biti najmanj 12 ur, tudi v primeru bruhanja ali zavrnitve odmerka (glejte poglavje 4.4).
General disorders and administra- tion site conditions Common Asthenia
Pogosti diareja Splošne težave in spremembe na mestu aplikacije Pogosti astenija
Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms.
V primeru pojava ekstrapiramidnih simptomov je treba zdravljenje z metoklopramidom nemudoma prekiniti.
Not known Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia (see section 4.4); Atrioventricular block,
Neznana srčni zastoj, ki se pojavi kmalu po injiciranju in se lahko pojavi po bradikardiji (glejte poglavje 4.4); atrioventrikularni blok, sinusni zastoj, zlasti pri intravenskih farmacevtskih oblikah; elektrokardiogram: podaljšan interval QT; torsade de pointes
The dose should be reduced if you have severe liver problems.
Če imate hude težave z jetri, bo odmerek potrebno zmanjšati.
- you have bleeding, obstruction or a tear in your stomach or gut.
- če imate krvavitev, zaporo ali predrtje v želodcu ali črevesju, - če imate ali bi lahko imeli redek tumor nadledvične žleze, ki se nahaja v bližini ledvic
A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
Časovni razmik med posameznimi odmerki zdravila mora biti najmanj 6 ur, tudi v primeru bruhanja ali zavrnitve odmerka (glejte poglavje 4.4).
The recommended single dose is 15 mg, repeated up to twice daily.
Priporočeni enkratni odmerek je 15 mg, ki ga prejmete največ dvakrat na dan. 30 mg jakost
Driving and using machines For all routes of administration
Vpliv na sposobnost upravljanja vozil in strojev Velja za vse načine uporabe zdravila.
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by intravenous route.
Priporočeni odmerek je od 0,1 do 0,15 mg/kg telesne mase, ki ga bolnik prejme največ trikrat na dan, intravensko.
Summary of Product Characteristics
Vse farmacevtske oblike
Uncommon (may affect up to 1 in 100 people) raised levels of a hormone called prolactin in the blood which may cause: milk production in men, and women who are not breast-feeding irregular periods hallucination decreased level of consciousness slow heartbeat (particularly with intravenous route) allergy
• povečane ravni hormona, imenovanega prolaktin v krvi, kar lahko vodi k proizvajanju mleka pri moških in ženskah, ki ne dojijo,
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken by mouth (oral route).
Priporočeni odmerek je od 0,1 do 0,15 mg/kg telesne mase, ki ga prejmete največ trikrat na dan in ga zaužijete (peroralna uporaba).
Hepatic impairment
Občasni halucinacije
You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Za peroralne farmacevtske oblike s takojšnjim sproščanjem Med jemanjem posameznih odmerkov metoklopramida morate počakati najmanj 6 ur, tudi v primeru bruhanja ali zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
For formulations which can be used to administer a 5mg dose {Tradename} is not suitable for use in children weighing less than 30 kg.
Zdravilo Xyz ni primerno za uporabo pri otrocih, katerih telesna masa je nižja od 30 kg.
The time interval of at least 24 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Med posameznimi odmerki metoklopramida je potrebno upoštevati časovni razmik, in sicer najmanj 24 ur, kot je navedeno v poglavju 4.2, tudi v primeru bruhanja in zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
Oral route
Peroralna uporaba
The time interval of at least 12 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Med posameznimi odmerki metoklopramida je potrebno upoštevati časovni razmik, in sicer najmanj 12 ur, kot je navedeno v poglavju 4.2, tudi v primeru bruhanja in zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
The time interval of at least 6 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Med posameznimi odmerki metoklopramida je potrebno upoštevati časovni razmik, in sicer najmanj 6 ur, kot je navedeno v poglavju 4.2, tudi v primeru bruhanja in zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
Dosing table
Tabela za odmerjanje
Very common
Zelo pogosti somnolenca
For all formulations - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk - Confirmed or suspected pheochromocytoma, due to the risk of severe hypertension episodes - History of neuroleptic or metoclopramide-induced tardive dyskinesia - Epilepsy (increased crises frequency and intensity) - Parkinson's disease - Combination with levodopa or dopaminergic agonists (see section 4.5) - Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5
Zdravilo Xyz je pri odraslih bolnikih indicirano za: - preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja, - preprečevanje z radioterapijo povzročene slabosti in bruhanja - simptomatsko zdravljenje slabosti in bruhanja, vključno s slabostjo in bruhanjem pri akutni migreni; Metoklopramid se lahko uporablja v kombinaciji s peroralnimi analgetiki za izboljšanje absorpcije analgetikov pri akutni migreni.
How to take {Tradename}
Kako jemati zdravilo Xyz
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route.
Priporočeni odmerek je od 0,1 do 0,15 mg/kg telesne mase, ki ga bolnik prejme največ trikrat na dan, peroralno.
Uncommon Bradycardia, particularly with intravenous formulation
• omedlevica (zlasti pri intravenski uporabi zdravila),
Common Diarrhoea
Žilne bolezni
Other medicines and {Tradename} For all routes of administration
Druga zdravila in zdravilo Xyz Velja za vse načine uporabe zdravila.
Management
Zdravljenje
You must wait at least 12 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Za peroralne farmacevtske oblike s podaljšanim sproščanjem z jakostjo 15 mg Med jemanjem posameznih odmerkov metoklopramida morate počakati najmanj 12 ur, tudi v primeru bruhanja ali zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
This overview was last updated in June 2018.
Ta povzetek je bil nazadnje posodobljen junija 2018.
The side effects were seen in the first week after use of the medicine.
Neželene učinke so opazili v prvem tednu po uporabi zdravila.
improvement in lameness was considered relevant and positive effects lasted over a period of one year.
Izboljšanje šepavosti je bilo ocenjeno kot pomembno, pozitivni učinki pa so trajali eno leto.
Further information on Arti-Cell Forte can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Arti-Cell Forte so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Arti-Cell Forte received a marketing authorisation valid throughout the EU on 29 March 2019.
Zdravilo Arti-Cell Forte je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 29. marca 2019.
The European Medicines Agency decided that Arti-Cell Forte's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Arti-Cell Forte večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The addition of the EAP to the stem cells after thawing and just before injection of the medicine increases the viability (ability to live) of the stem cells.
Dodatek EAP matičnim celicam po odtalitvi in tik pred injiciranjem zdravila poveča viabilnost (zmožnost preživetja) matičnih celic.
It consists of two vials which are supplied frozen: one vial contains the active substance and a second vial contains equine allogeneic plasma (EAP) which is the liquid part of blood.
Sestavljeno je iz dveh vial, ki sta ob dobavi zamrznjeni: ena viala vsebuje učinkovino, druga pa konjsko alogensko plazmo (EAP), ki je tekoči del krvi.
Other information about Arti-Cell Forte
Druge informacije o zdravilu Arti-Cell Forte
The stem cells have been prepared by being taken from blood from donor horses and grown in the laboratory to increase their numbers; they are treated so that they develop into cartilage cells which help to protect cartilage.
Matične celice so bile pripravljene tako, da so bile odvzete iz krvi konjev darovalcev in gojene v laboratoriju, da se je njihovo število povečalo; obdelane so tako, da se razvijejo v hrustančne celice, kar pripomore k zaščiti hrustanca.
Liquid nitrogen containers should be handled by properly trained personnel only.
Z vsebniki s tekočim dušikom sme ravnati samo ustrezno usposobljeno osebje.
Accidental self-injection can cause pain, local inflammatory reactions and swelling at the injection site which may last for several weeks and possibly cause fever.
Nenamerno samoinjiciranje lahko povzroči bolečino, lokalne vnetne reakcije in otekanje na mestu injiciranja, kar lahko traja več tednov in lahko povzroči povišano telesno temperaturo.
In order to prepare the injection, the content of both vials, once thawed, are mixed and then injected only by a veterinarian directly into the affected joint.
Za pripravo injekcije se po odtalitvi zmeša vsebina obeh vial, ki jo nato neposredno v prizadeti sklep injicira izključno veterinar.
Before withdrawing the vials from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or goggles should be worn.
Pred odvzemom vial iz posode s tekočim dušikom mora oseba nositi zaščitno opremo, ki jo sestavljajo rokavice, dolgi rokavi in obrazna maska oziroma zaščitna očala.
EMA/410964/2018
pridobljene iz periferne krvi) EMA/410964/2018
In a field study involving horses with a history of lameness lasting 2 to 6 months, 50 horses were treated with Arti-Cell Forte and 25 received a placebo (dummy injection) of saline in one fetlock joint.
V terenski študiji, ki je vključevala konje z anamnezo šepavosti s trajanjem od 2 do 6 mesecev, so 50 konjev zdravili z zdravilom Arti-Cell Forte, 25 pa jih je prejemalo placebo (zdravilo brez učinkovine) s fiziološko raztopino v en bicljev sklep.
It contains stem cells which are obtained from equine blood.
Vsebuje matične celice, pridobljene iz konjske krvi.
The medicine is available as an injection and can only be obtained with a prescription.
Zdravilo je na voljo v obliki injekcije, njegovo predpisovanje in izdaja pa je le na recept.
All horses received intravenous ketoprofen, a medicine to relieve pain and inflammation, at the time of treatment.
Vsi konji so ob času zdravljenja intravensko prejemali ketoprofen, zdravilo za lajšanje bolečin in vnetja.
For more information about using Arti-Cell Forte, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Arti-Cell Forte glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
The most common side effects with Arti-Cell Forte (which may affect more than 1 in 10 horses) are mild increases in lameness, injection site reactions such as swelling and mild increases in temperature at the injection site.
Najpogostejši neželeni učinki zdravila Arti-Cell Forte (ki lahko prizadenejo več kot 1 konja od 10) so blago povečanje šepavosti, reakcije na mestu injiciranja, kot je oteklina, in blago povišanje temperature na mestu injiciranja.
The vials containing equine mesenchymal stem cells and equine allogeneic plasma can be stored and transported either frozen or in liquid nitrogen containers.
Viale, ki vsebujejo mezenhimske matične celice in konjsko alogensko plazmo, je treba shranjevati in prevažati v zamrznjeni obliki ali v vsebnikih s tekočim dušikom.
Why is Arti-Cell Forte authorised in the EU?
Zakaj je zdravilo Arti-Cell Forte odobreno v EU?
This product contains chondrogenic induced equine mesenchymal stem cells and EAP.
To zdravilo vsebuje hondrogeno inducirane konjske mezenhimske matične celice in EAP.
An overview of Arti-Cell Forte and why it is authorised in the EU
Pregled zdravila Arti-Cell Forte in zakaj je odobreno v EU
What are the risks associated with Arti-Cell Forte?
Kakšna tveganja so povezana z zdravilom Arti-Cell Forte?
The withdrawal period for meat from horses treated with Arti-Cell Forte is ‘zero' days, which means that there is no mandatory waiting time.
Karenca za meso konjev, zdravljenih z zdravilom Arti-Cell Forte, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
What is Arti-Cell Forte and what is it used for?
Kaj je zdravilo Arti-Cell Forte in za kaj se uporablja?
What benefits of Arti-Cell Forte have been shown in studies?
Kakšne koristi je zdravilo Arti-Cell Forte izkazalo v študijah?
The stem cells in the active substance (mesenchymal stem cells) are treated so that they develop into cartilage cells.
Matične celice v učinkovini (mezenhimske matične celice) so obdelane tako, da se razvijejo v hrustančne celice.
Arti-Cell Forte is a veterinary medicine used to treat mild to moderate lameness linked to non-infective joint inflammation in horses.
Arti-Cell Forte je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje blage do zmerne šepavosti, povezane z neinfektivnim vnetjem sklepov, pri konjih.
The handling of liquid nitrogen should take place in a wellventilated area.
Delo s tekočim dušikom mora potekati v dobro zračenem prostoru.
How does Arti-Cell Forte work?
Kako zdravilo Arti-Cell Forte deluje?
How is Arti-Cell Forte used?
Kako se zdravilo Arti-Cell Forte uporablja?
Six weeks after treatment 68% of the horses treated with Arti-Cell Forte had a lameness score reduction by 2 or 3 lameness grades compared to none of the horses in the control group.
zdravljenih z zdravilom Arti-Cell Forte, rezultat šepavosti zmanjšal za 2 ali 3 stopnje šepavosti, pri konjih iz kontrolne skupine pa do takega izboljšanja ni prišlo pri nobenem konju.
Further information on Hyrimoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Hyrimoz so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Hyrimoz and 63% with Humira.
Delež bolnikov, pri katerih so se simptomi po 16 tednih zdravljenja zmanjšali za vsaj 75 %, je bil pri zdravilu Hyrimoz 68 %, pri zdravilu Humira pa 63 %.
This means that Hyrimoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
What measures are being taken to ensure the safe and effective use of Hyrimoz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hyrimoz?
An overview of Hyrimoz and why it is authorised in the EU
Pregled zdravila Hyrimoz in zakaj je odobreno v EU
As for all medicines, data on the use of Hyrimoz are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Hyrimoz stalno spremljajo.
Hyrimoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.
Zdravilo Hyrimoz je na voljo v obliki raztopine za injiciranje pod kožo v napolnjeni injekcijski brizgi ali peresniku in se običajno daje vsaka dva tedna.
What benefits of Hyrimoz have been shown in studies?
Kakšne koristi zdravila Hyrimoz so se pokazale v študijah?
Why is Hyrimoz authorised in the EU?
Zakaj je bilo zdravilo Hyrimoz odobreno v EU?
Other information about Hyrimoz
Druge informacije o zdravilu Hyrimoz
Side effects reported with Hyrimoz are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Hyrimoz, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hyrimoz have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Hyrimoz upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Hyrimoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Zdravilo Hyrimoz se večinoma uporablja pri odraslih, katerih bolezen je huda ali zmerno huda ali pa se poslabšuje oziroma kadar bolnik ne more prejemati drugega zdravljenja.
The company that markets Hyrimoz must provide educational packs for doctors who prescribe the medicine.
Podjetje, ki trži zdravilo Hyrimoz, mora pripraviti izobraževalno gradivo za zdravnike, ki zdravilo predpisujejo.
Hyrimoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Zdravilo Hyrimoz se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali pri bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj krvi po telesu).
What is Hyrimoz and what is it used for?
Kaj je zdravilo Hyrimoz in za kaj se uporablja?
The active substance in Hyrimoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Učinkovina zdravila Hyrimoz, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna snov, imenovano tumorje nekrotizirajoči faktor (TNF), in se veže nanjo.
TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hyrimoz is used to treat.
TNF sodeluje pri povzročanju vnetij in je v visokih koncentracijah prisoten pri bolnikih z boleznimi, za katere se zdravilo Hyrimoz uporablja.
All these data were considered sufficient to conclude that Hyrimoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Hyrimoz pri odobrenih načinih uporabe z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Humira.
What are the risks associated with Hyrimoz?
Kakšna tveganja so povezana z zdravilom Hyrimoz?
Like other medicines of its class, Hyrimoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Tako kot druga zdravila iz istega razreda tudi zdravilo Hyrimoz lahko vpliva na obrambno sposobnost imunskega sistema proti okužbam in raku; pri bolnikih, ki prejemajo adalimumab, so bili namreč zabeleženi nekateri primeri resnih okužb in krvnega raka.
For more information on the use of Hyrimoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Hyrimoz pri vseh navedenih boleznih, vključno s tem, kdaj se lahko uporablja pri otrocih, glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Drugi redki resni neželeni učinki (ki se lahko pojavijo pri največ 1 od 1 000 bolnikov) vključujejo nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podobna obolenja (pri katerih imunski sistem napada bolnikova lastna tkiva, kar povzroča vnetje in poškodbe organov) ter Stevens-Johnsonov sindrom (hudo kožno obolenje).
Hyrimoz is a medicine that acts on the immune system and is used to treat the following conditions:
Zdravilo Hyrimoz učinkuje na imunski sistem in se uporablja za zdravljenje naslednjih bolezni:
Because Hyrimoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Hyrimoz.
Zdravilo Hyrimoz je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti adalimumaba, ki so že bile izvedene z zdravilom Humira, z zdravilom Hyrimoz ni treba ponavljati.
The reference medicine for Hyrimoz is Humira.
Referenčno zdravilo za zdravilo Hyrimoz je zdravilo Humira.
• axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
• aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu), vključno z ankilozirajočim spondilitisom, in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki vnetja;
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hyrimoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Hyrimoz po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Humira in da se po telesu enako porazdeli.