FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no clinically relevant changes from baseline in pain scores in either the methylnaltrexone bromide or placebo-treated patients.
Croatian: Nisu opažene klinički značajne promjene od početnih vrijednosti stupnjevanja boli ni kod bolesnika liječenih metilnaltreksonbromidom ni kod bolesnika koji su primali placebo.
English: Each vial contains 0.6 mL of solution.
Croatian: Svaka bočica sadrži 0,6 ml otopine.
English: Consequently, no meaningful change in AUC of methylnaltrexone bromide, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine.
Croatian: U skladu s tim, nije opažena značajna promjena niti AUC metilnaltreksonbromida niti Cmax,
English: The dose is normally given every 48 hours (every two days) as an injection under the skin.
Croatian: Doza se obično daje svakih 48 sati
English: In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 mL of solution) for those weighing 62 to 114 kg.
Croatian: do 114 kg, doza metilnaltreksonbromida mora se smanjiti s 12 mg na 8 mg (0,4 ml otopine).
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/011
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/011
English: The mean percentage of methylnaltrexone bromide resulting in any RFBM within 4 hours were 28.9% and 30.2% respectively for the once daily and every other day dose groups compared with 9.4% and 9.3% respectively for the corresponding placebo regimen (p < 0.001).
Croatian: Prosječni postotak metilnaltreksonbromida koji je doveo do pražnjenja crijeva bez primjene dodatnog laksativa, unutar 4 sata iznosio je 28,9% za skupinu koja je uzimala lijek jedanput dnevno, odnosno 30,2% za kupinu koja je uzimala lijek svaki drugi dan u usporedbi s 9,4%, odnosno
English: Do not use Relistor
Croatian: Ako prestanete uzimati Relistor
English: Cases of a hole developing in the bowel wall (gastrointestinal perforation) have been reported in patients using Relistor.
Croatian: U bolesnika koji su uzimali ovaj lijek opisani su slučajevi gastrointestinalne perforacije, tj. puknuća crijeva.
English: 0.6 mL (12 mg) More than 114 kg 0.15 mg/kg
Croatian: kg) ili 12 mg (0,6 ml otopine) (za bolesnike koji teže 62 - 114 kg).
English: It is used for patients when other medicines for constipation, called laxatives, have not worked well enough.
Croatian: (zatvor), tzv. laksativi, nisu imali dovoljno dobar učinak.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja ili mjere opreza pri uporabi Teški simptomi i simptomi koji se pogoršavaju
English: NAME OF THE MEDICINAL PRODUCT Relistor 8 mg solution for injection in pre-filled syringe Methylnaltrexone bromide
Croatian: Relistor 8 mg otopina za injekciju u napunjenoj štrcaljki metilnaltreksonbromid
English: Look for the needle tip inside the vial.
Croatian: Provjerite da li je vrh igle u bočici.
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg/0.6 mL solution for injection Methylnaltrexone bromide
Croatian: Relistor 12 mg/0,6 ml otopina za injekciju Metilnaltreksonbromid
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Relistor 8 mg injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Relistor 8 mg injekcija metilnaltreksonbromid s.c.
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg solution for injection in pre-filled syringe Methylnaltrexone bromide
Croatian: Relistor 12 mg otopina za injekciju u napunjenoj štrcaljki metilnaltreksonbromid
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/007
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/009
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/009
English: Hold the vial on the work surface with the other hand so that it can not slip off. You will feel a slight resistance as the needle passes through the stopper.
Croatian: Prilikom prolaska igle kroz čep osjetit ćete blagi otpor.
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/005
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/002
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/001
English: Gather the supplies you will need for your injection:
Croatian: Složite sve predmete koji su Vam potrebni za injekciju: Napunjenu štrcaljku Relistora
English: Dizziness may occur and this may have an effect on the ability to drive and use machines (see section 4.8).
Croatian: Metilnaltreksonbromid malo utječe na sposobnost upravljanja vozilima i rada na strojevima.Može se javiti omaglica, koja može utjecati na sposobnost upravljanja vozilima i rada na strojevima (vidjeti dio
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/006
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/006
English: • Please also talk to your doctor if you have a colostomy, a tube in your abdomen (peritoneal catheter), or suffer from diverticular disease or faecal impaction as this medicine should be used carefully in these circumstances.
Croatian: • Molimo također se savjetujte sa svojim liječnikom ukoliko imate kolostomiju, cjevčicu u trbuhu
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/008
English: Τηλ: +39 02 828 77 050 e-mail: mail.it@sobi.com
Croatian: Swedish Orphan Biovitrum S.r.l. Τηλ: +39 02 828 77 050 e-mail: mail.it@sobi.com
English: A total of 460 patients (methylnaltrexone bromide
Croatian: 0,4 ml otopine (8 mg metilnaltreksonbromida)
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/004
English: 2 sterile 1 mL injection syringes with retractable injection needle 4 alcohol swabs
Croatian: 2 bočice od 0,6 ml 2 sterilne štrcaljke za injekciju od 1 ml s iglom za injekciju na uvlačenje
English: - Please talk to your doctor if you experience stomach ache which continues, nausea, (feeling sick) or vomiting (being sick) that is new or becomes worse.
Croatian: (ukoliko Vam je “zlo”) ili povraćanje, novonastalo ili pogoršano.
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/463/003
English: 10 March 2014
Croatian: 10. ožujka 2014.
English: The European Commission issued a decision on 10 March 2014.
Croatian: Europska komisija donijela je odluku 10. ožujka 2014.
English: Outcome of a procedure under Article 29(4) of Directive 2001/83/EC
Croatian: Ishod postupka u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ
English: What is Valebo?
Croatian: Što je Valebo?
English: On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Valebo.
Croatian: Dana 19. prosinca 2013. godine Europska agencija za lijekove završila je arbitražni postupak nakon neslaganja među državama članicama Europske unije (EU) u vezi s odobrenjem za stavljanje u promet lijeka Valebo.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom).
Croatian: Ovo je postupak tijekom kojeg je jedna država članica („referentna država članica”, u ovom slučaju Njemačka) ocijenila lijek radi izdavanja odobrenja za stavljanje lijeka u promet koje će biti valjano u ovoj državi kao i u ostalim državama članicama („države članice uključene u postupak”, u ovom slučaju Austrija, Belgija, Bugarska, Danska, Francuska, Mađarska, Irska, Nizozemska, Portugal, Slovačka, Slovenija, Španjolska i Ujedinjena Kraljevina).
English: Why was Valebo reviewed?
Croatian: Zašto je proveden pregled lijeka Valebo?
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 28 February.
Croatian: No, države članice nisu uspjele postići sporazum, pa je njemačka regulatorna agencija za lijekove uputila predmet CHMP-u na arbitražu 28. veljače.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Valebo outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da koristi od lijeka Valebo nadmašuju s njim povezane rizike, te da se odobrenje za stavljanje lijeka u promet može izdati u Njemačkoj i sljedećim državama članicama EU-a: Austriji, Belgiji, Bugarskoj, Danskoj, Francuskoj, Mađarskoj, Irskoj, Nizozemskoj, Portugalu, Slovačkoj, Sloveniji, Španjolskoj i Ujedinjenoj Kraljevini.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Valebo should be granted marketing authorisation in all concerned Member States for the treatment of postmenopausal women with osteoporosis.
Croatian: Na temelju ocjene trenutno dostupnih podataka i znanstvene rasprave provedene unutar Povjerenstva, CHMP je zaključio da za lijek Valebo treba izdati odobrenje za stavljanje lijeka u promet u svim državama članicama uključenim u postupak za liječenje žena u postmenopauzi s osteoporozom.
English: TEVA Pharma B.V. submitted Valebo to the German medicines regulatory agency for a decentralised procedure.
Croatian: Tvrtka TEVA Pharma B.V. dostavila je lijek Valebo njemačkoj regulatornoj agenciji za lijekove za potrebe decentraliziranog postupka.
English: 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).
Croatian: No, iako je u pojedinim kliničkim ispitivanjima dokazano da alfakalcidol smanjuje rizik od padova u starijih osoba, Povjerenstvo smatra da se ova informacija treba uključiti u dio 5.1 Sažetka opisa svojstava proizvoda (a ne u dio 4.1).
English: Alfacalcidol is a type of vitamin D (a ‘vitamin D analogue'), which is required for calcium absorption and normal bone formation.
Croatian: Alfakalcidol je tip vitamina D („analog vitamina D”) koji je potreban za apsorpciju kalcija i normalno formiranje kostiju.
English: Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s.
Croatian: Alendronatna kiselina je bifosfat koji se koristi za liječenje osteoporoze od sredine 1990.-ih.
English: It is to be used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Croatian: Koristi se za liječenje osteoporoze (bolesti koja čini kosti lomljivima) u žena koje su prošle menopauzu.
English: Blocking the action of these cells leads to less bone loss.
Croatian: Inhibiranjem djelovanja ovih stanica uzrokuje smanjenje gubitka koštane mase.
English: 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.
Croatian: Osnovu za upućivanje predstavlja razlog za zabrinutost koji je iznijela Španjolska, tj. da nisu dostavljeni odgovarajući podaci u prilog izjavi koja je trebala biti uključena u indikaciju za lijek Valebo (u dijelu 4.1 Sažetka opisa svojstava lijeka) da alfakalcidol smanjuje postotak padova u starijih osoba.
English: It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Croatian: Usporava djelovanje osteoklasta, stanica koje su uključene u razgradnju koštanog tkiva.
English: Alfacalcidol has been used for many years in women who have been through the menopause.
Croatian: Alfakalcidol se primjenjivao dugi niz godina u žena koje su prošle menopauzu.
English: Valebo is a combination of tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol.
Croatian: Valebo je kombinacija tableta koje sadrže 70 mg alendronatne kiseline i kapsula koje sadrže 1 μg alfakalcidola.
English: Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol)
Croatian: Pitanja i odgovori o lijeku Valebo i srodnim nazivima (tablete koje sadrže 70 mg alendronatne kiseline i kapsule koje sadrže 1 μg alfakalcidola)
English: Suspension (stem cells): 1 ml
Croatian: Suspenzija (matične stanice): 1 ml
English: Packaging Content
Croatian: Put primjene Pakiranje Sadržaj
English: 1 vial of stem cell suspension
Croatian: 1 bočica suspenzije matičnih stanica
English: EU (MA) number
Croatian: Broj EU odobrenja
English: Invented name
Croatian: Novoizum ljeno ime
English: Horses Intraarticular use Vial (plastic)
Croatian: Bočica (plastična)
English: These packs will include information on the safety of the medicine.
Croatian: Ti će paketi sadržavati informacije o sigurnosti lijeka.
English: Further information on Hulio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Hulio možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 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).
Croatian: Nakon 24 tjedna zabilježeno je 20 % poboljšanja simptoma u 74 % bolesnika liječenih lijekom Hulio (270 od 363) te u 76 % bolesnika liječenih lijekom Humira (271 od 358).
English: An alert card will also be given to patients.
Croatian: Bolesnici će također dobiti karticu s upozorenjima.
English: 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.
Croatian: Doza i učestalost injekcije ovisi o stanju koje je potrebno liječiti, a doza za djecu obično se izračunava na osnovi tjelesne težine djeteta.
English: This means that Hulio is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, Hulio je vrlo sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u EU-u.
English: After training, patients or their carers may inject Hulio if their doctor considers it appropriate.
Croatian: Nakon obuke bolesnici ili njihovi njegovatelji mogu injektirati lijek Hulio ako to njihov liječnik smatra primjerenim.
English: What is Hulio and what is it used for?
Croatian: Što je Hulio i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Hulio?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Hulio?
English: Hulio is a medicine that acts on the immune system and is used to treat the following conditions:
Croatian: Hulio je lijek koji djeluje na imunosni sustav te se koristi za liječenje sljedećih stanja:
English: The reference medicine for Hulio is Humira.
Croatian: Referentni lijek za lijek Hulio je Humira.
English: Other information about Hulio
Croatian: Ostale informacije o lijeku Hulio
English: 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.
Croatian: Kao i drugi lijekovi u tom razredu, Hulio može utjecati na sposobnost imunosnog sustava da se bori protiv infekcija i raka, pa su zabilježeni slučajevi ozbiljnih infekcija i raka krvi u bolesnika koji su liječeni adalimumabom.
English: The company that markets Hulio must provide educational packs for doctors who prescribe the medicine.
Croatian: Tvrtka koja stavlja lijek Hulio u promet mora dostaviti edukacijske pakete za liječnike koji propisuju taj lijek.
English: In addition, Hulio was as effective as Humira in a study involving 730 patients with rheumatoid arthritis that was not adequately controlled with the medicine methotrexate.
Croatian: Osim toga, lijek Hulio bio je jednako djelotvoran kao lijek Humira u ispitivanju u kojem je sudjelovalo 730 bolesnika s reumatoidnim artritisom koji se nije mogao odgovarajuće kontrolirati primjenom metotreksata.
English: 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).
Croatian: Hulio se ne smije primjenjivati u bolesnika s aktivnom tuberkulozom ili drugim teškim infekcijama ni u bolesnika s umjerenim do teškim zatajenjem srca (nesposobnost srca da pumpa dovoljne količine krvi u tijelu).
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Croatian: Vezivanjem na TNF adalimumab inhibira njegovo djelovanje te tako smanjuje upalu i druge simptome bolesti.
English: Side effects reported with Hulio are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Hulio pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: An overview of Hulio and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Hulio i zašto je odobren u EU-u
English: 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.
Croatian: Budući da je lijek Hulio biosličan lijek, ispitivanja učinkovitosti i sigurnosti adalimumaba provedena za lijek Humira nije potrebno ponavljati za lijek Hulio.
English: 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.
Croatian: Hulio je dostupan kao otopina za potkožnu injekciju u bočici ili napunjenoj štrcaljki ili brizgalici te se obično primjenjuje svaka dva tjedna.
English: 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.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Hulio ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Humira te se u tijelu raspoređuje na isti način.
English: What are the risks associated with Hulio?
Croatian: Koji su rizici povezani s lijekom Hulio?
English: Why is Hulio authorised in the EU?
Croatian: Zašto je lijek Hulio odobren u EU-u?
English: 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).
Croatian: Druge rijetke ozbiljne nuspojave (koje se mogu javiti u manje od 1 na 1000 osoba) obuhvaćaju poremećaj u kojemu koštana srž više ne proizvodi krvne stanice, poremećaje živaca, lupus i poremećaje slične lupusu (pri čemu imunosni sustav bolesnika napada tkiva u vlastitom organizmu, uzrokujući upalu i oštećenja organa) i Stevens-Johnsonov sindrom (po život opasna reakcija sa simptomima sličnima gripi i bolnim osipom koji zahvaća kožu, usta, oči i genitalije).
English: As for all medicines, data on the use of Hulio are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Hulio kontinuirano se prate.
English: 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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Hulio također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: 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.
Croatian: Hulio se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju bolesti za koje se Hulio koristi.
English: Hulio contains the active substance adalimumab and is a ‘biosimilar medicine'.
Croatian: Hulio sadrži djelatnu tvar adalimumab te je „biosličan lijek”.
English: 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.
Croatian: Najčešće nuspojave povezane s adalimumabom (zabilježene u više od 1 na 10 bolesnika) jesu infekcije (uključujući infekcije nosa, ždrijela i sinusa), reakcije na mjestu primjene injekcije (crvenilo, svrbež, krvarenje, bol ili oticanje), glavobolja i bol u mišićno-koštanom sustavu.
English: 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).
Croatian: Djelatna tvar u lijeku Hulio, adalimumab, monoklonsko je protutijelo (vrsta bjelančevine) namijenjeno prepoznavanju i vezivanju za tvar u tijelu zvanu faktor tumorske nekroze (TNF).
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
Croatian: • poliartikularnog juvenilnog idiopatskog artritisa i aktivnog artritisa povezanog s entezitisom (obje su rijetke bolesti koje uzrokuju upalu zglobova)
English: • 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;
Croatian: • aksijalnog spondiloartritisa (upale kralježnice koja uzrokuje bolove u leđima), uključujući ankilozantni spondilitis, te kad rendgenska snimka ne pokazuje bolest, no postoje jasni znaci upale
English: Hulio is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments.
Croatian: Hulio se ponajprije primjenjuje u odraslih osoba za ozbiljno do umjereno ozbiljno stanje bolesti ili stanje koje se pogoršava, odnosno kad bolesnici ne mogu primiti drugu terapiju.
English: 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.
Croatian: Za više informacija o primjeni lijeka Hulio za sva stanja, kao i kada se može primjenjivati u djece, pogledajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Therefore, the Agency's view was that, as for Humira, the benefit of Hulio outweighs the identified risk and it can be authorised.
Croatian: Stoga je stav Agencije da korist od lijeka Hulio, kao i od lijeka Humira, nadmašuje identificirani rizik te da lijek može biti odobren.