natgillin/translations-raw huggingface dataset:
What is Valebo? 
Kaj je zdravilo Valebo?
Blocking the action of these cells leads to less bone loss. 
Z zaviranjem delovanja teh celic se zmanjša izguba kostne mase.
Alfacalcidol is a type of vitamin D (a ‘vitamin D analogue'), which is required for calcium absorption and normal bone formation. 
Alfakalcidol je vrsta vitamina D (t. i. „analog vitamina D“), ki je nujen za absorpcijo kalcija in normalno tvorbo kosti.
However, although alfacalcidol has been shown in some clinical studies to reduce the risk of falls in older people, the Committee considered that this information should be included under section 5.1 of the summary of product characteristics (and not in section 4.1). 
Vendar pa je kljub temu, da je alfakalcidol v nekaterih kliničnih študijah dokazano zmanjšal tveganje za padce pri starejših, menil, da morajo biti informacije o tem navedene v poglavju 5.1 povzetka glavnih značilnosti zdravila (namesto v poglavju 4.1).
The grounds for the referral was a concern raised by Spain that appropriate data had not been submitted to support a statement which was to be included in the indication for Valebo (in section 4.1 of the summary of product characteristics) that alfacalcidol reduces the rate of falls in older people. 
Podlaga za napotitev so bili pomisleki Španije, da niso bili predloženi ustrezni podatki, ki bi podprli trditev, ki naj bi bila vključena v indikacijo za zdravilo Valebo (v poglavje 4.1 povzetka glavnih značilnosti zdravila) in ki navaja, da alfakalcidol zniža stopnjo padcev pri starejših osebah.
Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s. 
Alendronska kislina je difosfonat, ki se za zdravljenje osteoporoze uporablja od sredine 90. let prejšnjega stoletja.
It is to be used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. 
Uporabljalo naj bi se za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah v obdobju po menopavzi.
It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. 
Deluje tako, da zavira delovanje osteoklastov, tj. celic, ki sodelujejo pri razgradnji kostnega tkiva.
Alfacalcidol has been used for many years in women who have been through the menopause. 
Alfakalcidol se že vrsto let uporablja pri ženskah v obdobju po menopavzi.
Valebo is a combination of tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol. 
Zdravilo Valebo je kombinacija tablet, ki vsebujejo 70 mg alendronske kisline, in kapsul, ki vsebujejo 1 mikrogram alfakalcidola.
Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol) EMA/793424/2013 rev.1 
Vprašanja in odgovori o zdravilu Valebo in povezanih imenih (tablete, ki vsebujejo 70 mg alendronske kisline, in kapsule, ki vsebujejo 1 mikrogram alfakalcidola) EMA/793424/2013 rev. 1
Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol) 
Vprašanja in odgovori o zdravilu Valebo in povezanih imenih (tablete, ki vsebujejo 70 mg alendronske kisline, in kapsule, ki vsebujejo 1 mikrogram alfakalcidola)
TEVA Pharma B.V. submitted Valebo to the German medicines regulatory agency for a decentralised procedure. 
je nemški regulativni agenciji za zdravila predložila vlogo za začetek decentraliziranega postopka za zdravilo Valebo.
Suspension (stem cells): 1 ml 
Suspenzija (matične celice): 1 ml
Horses Intraarticular use Vial (plastic) 
Intraartikularna uporaba viala (plastična)
1 vial of stem cell suspension 
1 viala suspenzije matičnih celic nič dni
EU (MA) number 
Številka (EU) dovoljenja za promet
Zero days 
Konji
Packaging Content 
Pot uporabe Pakiranje Vsebina Velikost pakiranja
Oral use bottle (HDPE) 
Peroralna uporaba Plastenka (HDPE)
483 mg/g Granules 
483 mg/g Zrnca
174g 
174 g 1 plastenka + odmerna žlička
It must not be used in women who are more than three months pregnant. 
Zdravila ne smejo uporabljati ženske, ki so noseče več kot tri mesece.
The European Commission granted a marketing authorisation valid throughout the European Union for Imprida HCT to Novartis Europharm Limited on 15 October 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Imprida HCT, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 15. oktobra 2009.
It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. 
Zavira posebne kanalčke na površini celic, imenovane kalcijevi kanalčki, skozi katere v celico običajno vstopajo kalcijevi ioni.
Because the combination of the three active substances has been in use for a number of years, the company presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets. 
Ker se je kombinacija treh zdravilnih učinkovin uporabljala več let, je družba predstavila študije, ki kažejo, da se tableta, ki vsebuje vse tri učinkovine, enako absorbira v telesu kot posamezne tablete.
It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg and 10/320/25 mg. 
Na voljo je v obliki tablet, ki vsebujejo amlodipin, valsartan in hidroklorotiazid v naslednjih količinah: 5/160/12,5 mg, 10/160/12,5 mg, 5/160/25 mg; 10/160/25 mg in 10/320/25 mg.
Other information about Imprida HCT: 
Druge informacije o zdravilu Imprida HCT:
Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a body hormone called angiotensin II. 
Valsartan je antagonist receptorja angiotenzina II, kar pomeni, da zavira delovanje telesnega hormona, imenovanega angiotenzin II.
The Committee recommended that Imprida HCT be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Imprida HCT odobri dovoljenje za promet.
Imprida HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning. 
Zdravilo Imprida HCT se jemlje peroralno v odmerku ene tablete enkrat na dan ob isti uri po možnosti zjutraj.
What benefit has Imprida HCT shown during the studies? 
Kakšne koristi je zdravilo Imprida HCT izkazalo med študijami?
The main study showed the benefit of the highest strength of Imprida HCT in lowering the blood pressure. 
Glavna študija je pokazala koristnost uporabe največjega odmerka zdravila Imprida HCT pri zniževanju krvnega tlaka.
The three active substances in Imprida HCT are anti-hypertensive medicines that are already in use in the European Union (EU). 
Tri zdravilne učinkovine v zdravilu Imprida HCT so zdravila proti zvišanemu krvnemu tlaku, ki se že uporabljajo v Evropski uniji (EU).
Treatment with the highest strength of Imprida HCT was more effective at treating hypertension than dual combinations containing any of the two active substances. 
Zdravljenje z največjim odmerkom zdravila Imprida HCT je bilo bolj učinkovito pri zdravljenju hipertenzije kot zdravljenje z dvojnimi kombinacijami, ki so vsebovale katero od dveh zdravilnih učinkovin.
For all doses, Imprida HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately. 
Pri vseh odmerkih je zdravilo Imprida HCT izpolnilo tudi zahteve, s katerimi je bilo dokazano, da je primerljivo s kombinacijami posameznih zdravilnih učinkovin, vzetih ločeno.
The dose of Imprida HCT to be used is the same as the doses of three individual active substances that the patient was taking before. 
Odmerek zdravila Imprida HCT mora biti enak odmerkom treh posameznih zdravilnih učinkovin, ki jih je bolnik prejemal pred tem.
The Committee for Medicinal Products for Human Use (CHMP) noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Imprida HCT which combines the three substances in a single tablet. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je opozoril, da bi bolnikom, ki tri zdravilne učinkovine že prejemajo ločeno, zdravljenje verjetno bolj ustrezalo, če bi jemali zdravilo Imprida HCT, pri katerem so tri zdravilne učinkovine prisotne v eni tableti.
For the full list of all side effects reported with Imprida HCT, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Imprida HCT, glejte navodilo za uporabo.
The daily dose of Imprida HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide. 
Dnevni odmerek zdravila Imprida HCT ne sme biti večji od 10 mg amlodipina, 320 mg valsartana in 25 mg hidroklorotiazida.
Imprida HCT should not be used in people who may be hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Imprida HCT. 
Zdravila Imprida HCT ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilne učinkovine, druge sulfonamide, derivate dihidropiridina ali katero koli drugo sestavino zdravila Imprida HCT.
The most common side effects with Imprida HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention). 
Najpogostejši neželeni učinki zdravila Imprida HCT (opaženi pri 1 od 10 bolnikov izmed 100) so hipokaliemija (nizka raven kalija v krvi), omotičnost, glavobol, hipotenzija (nizek krvni tlak), dispepsija (zgaga), polakisurija (neobičajno pogosto uriniranje), utrujenost in edem (zadrževanje tekočine).
The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Imprida HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively. 
Povprečno znižanje krvnega tlaka je bilo okrog 39,7/24,7 mmHg pri bolnikih, ki so prejemali zdravilo Imprida HCT, v primerjavi z 32/19,7 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/hidroklorotiazid, 33,5/21,5 mmHg pri bolnikih, ki so prejemali kombinacije valsartan/amlodipin, in 31,5/19,5 mmHg pri bolnikih, ki so prejemali kombinacije hidroklorotiazid/amlodipin.
When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. 
Ko kalcijevi ioni vstopijo v celice mišic v stenah žil, se te začnejo krčiti.
Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). 
Angiotenzin II je učinkovit vazokonstriktor (snov, ki zožuje žile).
What is the risk associated with Imprida HCT? 
Kakšna tveganja so povezana z zdravilom Imprida HCT?
Imprida HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide. 
Zdravilo Imprida HCT se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih, pri katerih je krvni tlak že ustrezno nadzorovan z uporabo kombinacije amlodipina, valsartana in hidroklorotiazida.
Imprida HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide. 
Zdravilo Imprida HCT je zdravilo, ki vsebuje tri zdravilne učinkovine amlodipin, valsartan in hidroklorotiazid.
The full EPAR for Imprida HCT can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Imprida HCT je na voljo tukaj.
Finally, Imprida HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms. 
Zdravila Imprida HCT ne smejo uporabljati bolniki s hipokaliemijo (nizko ravnjo kalija v krvi), hiponatriemijo (nizko ravnjo natrija v krvi) in hiperkalciemijo (visoko ravnjo kalcija v krvi), ki se ne odzivajo na zdravljenje, ter bolniki s simptomatsko hiperurikemijo (visoko koncentracijo sečne kisline v krvi).
Imprida HCT amlodipine, valsartan and hydrochlorothiazide EPAR summary for the public 
Imprida HCT amlodipin, valsartan in hidroklorotiazid
The CHMP therefore decided that Imprida HCT's benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide. 
CHMP je torej zaključil, da so koristi zdravila Imprida HCT pri zdravljenju esencialne hipertanzije pri odraslih, pri katerih je krvni tlak že ustrezno nadzorovan s kombinacijo amlodipina, valsartana in hidroklorotiazida, večje od z njim povezanih tveganj.
It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique). 
Prav tako zdravila ne smejo uporabljati osebe, ki imajo obolenja jeter ali žolčnika (zlatenica), hude ledvične okvare, anurijo (nezmožnost izločanja urina) ali bolniki na dializi (tehniki čiščenja krvi).
Why has Imprida HCT been approved? 
Zakaj je bilo zdravilo Imprida HCT odobreno?
In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Imprida HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide). 
Poleg tega je bila izvedena glavna študija, v kateri so proučevali 2 271 bolnikov z zmerno do hudo hipertenzijo, ki prejemajo največji odmerek zdravila Imprida HCT (320 mg valsartana, 10 mg amlodipina in 25 mg hidroklorotiazida) Bolniki so osem tednov prejemali bodisi zdravilo Imprida HCT bodisi eno od treh kombinacij, ki vsebujejo le dve zdravilni učinkovini.
What is Imprida HCT? 
Kaj je zdravilo Imprida HCT?
What is Imprida HCT used for? 
Za kaj se zdravilo Imprida HCT uporablja?
How has Imprida HCT been studied? 
Kako je bilo zdravilo Imprida HCT raziskano?
How is Imprida HCT used? 
Kako se zdravilo Imprida HCT uporablja?
How does Imprida HCT work? 
Kako zdravilo Imprida HCT deluje?
Further information on Hulio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Hulio so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
After 24 weeks, a 20% improvement in symptoms was seen in 74% of Hulio-treated patients (270 of 363) and 76% of Humira treated patients (271 of 358). 
Po 24 tednih so 20-odstotno izboljšanje simptomov opazili pri 74 % (270 od 363) bolnikov, zdravljenih z zdravilom Hulio, in 76 % (271 od 358) bolnikov, zdravljenih z zdravilom Humira.
An alert card will also be given to patients. 
Sočasno bodo bolniki prejeli opozorilno kartico.
This means that Hulio 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 Hulio? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hulio?
An overview of Hulio and why it is authorised in the EU 
Pregled zdravila Hulio in zakaj je odobreno v EU
Other information about Hulio 
Druge informacije o zdravilu Hulio
After training, patients or their carers may inject Hulio if their doctor considers it appropriate. 
Bolniki ali njihovi skrbniki lahko po opravljenem usposabljanju sami injicirajo zdravilo Hulio, če zdravnik meni, da je to zanje primerno.
As for all medicines, data on the use of Hulio are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Hulio stalno spremljajo.
What benefits of Hulio have been shown in studies? 
Kakšne koristi zdravila Hulio so se pokazale v študijah?
Side effects reported with Hulio are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Hulio, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Hulio authorised in the EU? 
Zakaj je bilo zdravilo Hulio odobreno v EU?
Hulio is a medicine that acts on the immune system and is used to treat the following conditions: 
Hulio je zdravilo, ki učinkuje na imunski sistem in se uporablja za zdravljenje naslednjih bolezni:
The company that markets Hulio must provide educational packs for doctors who prescribe the medicine. 
Podjetje, ki trži zdravilo Hulio, mora pripraviti izobraževalno gradivo za zdravnike, ki zdravilo predpisujejo.
Hulio is available as a solution for injection under the skin in a vial or pre-filled syringe or pen and is usually given every 2 weeks. 
Zdravilo Hulio je na voljo v obliki raztopine za injiciranje pod kožo v viali ali napolnjeni injekcijski brizgi ali peresniku in se običajno daje vsaka dva tedna.
Hulio is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments. 
Zdravilo Hulio se večinoma uporablja pri odraslih, pri katerih je bolezen huda, zmerno huda ali se poslabšuje, oziroma kadar bolnik ne more prejemati drugega zdravljenja.
What are the risks associated with Hulio? 
Kakšna tveganja so povezana z zdravilom Hulio?
The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight. 
Odmerek in pogostnost injiciranja sta odvisna od bolezni, ki se zdravi, pri otrocih pa se odmerek običajno izračuna na podlagi telesne mase otroka.
Hulio 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 Hulio se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj krvi po telesu).
What is Hulio and what is it used for? 
Kaj je zdravilo Hulio in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hulio 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 Hulio upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The active substance in Hulio, 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 v zdravilu Hulio, 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 Hulio is used to treat. 
TNF sodeluje pri povzročanju vnetij in je prisoten v visokih koncentracijah pri bolnikih z boleznimi, za katere se zdravilo Hulio uporablja.
Like other medicines of its class, Hulio 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 lahko tudi zdravilo Hulio 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.
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 (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals). 
Drugi redki resni neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 1 000) so nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podobna obolenja (pri katerih imunski sistem napada bolnikova lastna tkiva, to pa povzroča vnetje in poškodbe organov) in Stevens-Johnsonov sindrom (smrtno nevarno reakcijo z gripi podobnimi simptomi in bolečim izpuščajem, ki prizadene kožo, usta, oči in spolovila).
The reference medicine for Hulio is Humira. 
Referenčno zdravilo za zdravilo Hulio je zdravilo Humira.
All these data were considered sufficient to conclude that Hulio 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 Hulio pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Humira.
For more information on the use of Hulio 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 Hulio pri vseh navedenih boleznih, vključno s tem, kdaj se lahko uporablja pri otrocih, glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain. 
Najpogostejši neželeni učinki adalimumaba (opaženi pri več kot 1 bolniku od 10 so okužbe (vključno z okužbami nosu, grla in sinusov), reakcije na mestu injiciranja (rdečina, srbenje, krvavenje, bolečina ali oteklina), glavobol ter bolečine v mišicah in kosteh.
Hulio can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Hulio is used. 
Predpisovanje in izdaja zdravila Hulio je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katere se zdravilo Hulio uporablja.
• non-infectious uveitis (inflammation of the layer beneath the white of the eyeball). 
• neinfekcijskega uveitisa (vnetja sloja pod beločnico očesa).
Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab. 
Zdravniki specialisti za očesne bolezni, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo adalimumaba.
Because Hulio is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Hulio. 
Zdravilo Hulio je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti adalimumaba, ki so že bile izvedene z zdravilom Humira, z zdravilom Hulio ni treba ponavljati.
• 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, Hulio 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 Hulio po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Humira in da se po telesu enako prenaša.