FrancophonIA/ELRC3.0 huggingface dataset:
English: Cutaneous, Articular Syndrome (CINCA) - Muckle-Wells Syndrome (MWS) - Familial Cold Autoinflammatory Syndrome (FCAS)
Croatian: Familial Cold Autoinflammatory Syndrome - FCAS)
English: The safety and efficacy of Kineret in patients with neutropenia have not been evaluated.
Croatian: Sigurnost i djelotovornost Kinereta u bolesnika s neutropenijom nije utvrđena.
English: Kineret 100 mg/0.67 ml injection Anakinra
Croatian: Kineret 100 mg/0,67 ml injekcija anakinra s.c.
English: Mild thrombocytopenia has also been observed in CAPS patients.
Croatian: Blaga trombocitopenija zabilježena je i u bolesnika s CAPS-om.
English: • The prescribed dose of Kineret
Croatian: • Propisanu dozu Kinereta
English: Clinical efficacy and safety in Still's disease
Croatian: Klinička djelotvornost i sigurnost u Stillovoj bolesti
English: Solution for injection in pre-filled syringe 7 GRADUATED pre-filled syringes This box containing 7 pre-filled syringes is part of a 28-multipack.
Croatian: Ova kutija sadrži 7 napunjenih štrcaljki te je dio višestrukog pakiranja od 28 štrcaljki.
English: Each graduated pre-filled syringe contains 100 mg of anakinra.
Croatian: Svaka kalibrirana napunjena štrcaljka sadrži 100 mg anakinre.
English: With careful monitoring, Kineret treatment can be continued also during a serious infection.
Croatian: Liječenje Kineretom može se nastaviti i tijekom ozbiljnih infekcija, ali uz pažljivo praćenje.
English: Kineret is a sterile unpreserved solution.
Croatian: Kineret je sterilna otopina bez konzervansa.
English: In addition cases of non-infectious hepatitis, including occasional events of acute liver failure, have been reported in patients with Still's disease during Kineret treatment.
Croatian: Nadalje, u bolesnika sa Stillovom bolešću tijekom liječenja Kineretom prijavljeni su slučajevi neinfektivnog hepatitisa, uključujući povremeno i slučajeve akutnog zatajenja jetre.
English: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
Croatian: Kineret 100 mg/0,67 ml otopina za injekciju u napunjenoj štrcaljki.
English: Patients are usually well-controlled by maintaining the recommended starting dose (1-2 mg/kg/day).
Croatian: Doza održavanja kod blagog CAPS-a (FCAS, blagi MWS) Bolest se obično može dobro kontrolirati održavanjem preporučene početne doze (1-2 mg/kg/dan).
English: Talk to your doctor before using Kineret: - if you have a history of recurring infections, or if you suffer from asthma.
Croatian: - ako imate ponavljajuće infekcije u povijesti bolesti ili patite od astme.
English: In a clinical study including 43 adult and paediatric patients (36 patients aged 8 months to < 18 years) with severe CAPS (NOMID/CINCA and MWS), a clinical response to anakinra was seen within 10 days after initiation of treatment in all patients and was sustained for up to 5 years with the continued administration of Kineret.
Croatian: U kliničkom ispitivanju koje je uključivalo 43 odraslih i pedijatrijskih ispitanika (36 ispitanika bilo je u dobi od 8 mjeseci do < 18 godina) s teškim oblikom CAPS-a (NOMID/CINCA i MWS)
English: Package leaflet: Information for the user Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe
Croatian: Uputa o lijeku: Informacije za korisnika Kineret 100 mg/0,67 ml otopina za injekciju u napunjenoj štrcaljki anakinra
English: Combined anakinra and methotrexate treatment demonstrates a statistically and clinically significant reduction in the severity of the signs and symptoms of RA in patients who have had an inadequate response to methotrexate alone (38% vs. 22% responders as measured by ACR20 criteria).
Croatian: Kombinirano liječenje anakinrom i metotreksatom pokazuje statistički i klinički značajno smanjenje težine znakova i simptoma RA u bolesnika koji su imali neodgovarajući odgovor na sam metotreksat
English: These have shown no deleterious effect on joint cartilage.
Croatian: Rendgenske snimke nisu pokazale štetni učinak na hrskavicu zgloba.
English: Uncommon (≥ 1/1,000 to < 1/100) Allergic reactions including anaphylactic reactions, angioedema, urticaria and pruritus
Croatian: Alergijske reakcije koje uključuju anafilaktičke reakcije, angioedem, urtikariju i pruritus
English: The 50 patients who achieved a clinical response after a 12-week open-label run-in were randomized to Kineret (25 patients) or placebo (25 patients), administered daily for an additional 16 weeks.
Croatian: 16 tjedana dnevno primale Kineret (25 ispitanika) ili placebo (25 ispitanika).
English: It may contain some translucent-to-white particles of protein.
Croatian: Može sadržavati neke prozirne do bijele čestice bjelančevina.
English: Uncommon side effects (may affect up to 1 in 100 people): - Serious allergic reactions including swelling of the face, tongue or throat, trouble swallowing or breathing, suddenly feeling fast pulse or sweating and itchy skin or rash.
Croatian: - Ozbiljne alergijske reakcije uključujući oticanje lica, jezika ili grla, poteškoće u gutanju ili disanju, iznenadni osjećaj ubrzanog pulsa ili znojenje te svrbež kože ili osip.
English: The patient reminder card shall contain the following key messages:
Croatian: • Savjete kako liječiti reakcije na mjestu injiciranja Kartica s podsjetnikom za bolesnike sadržavat će sljedeće ključne obavijesti:
English: In addition to the evaluation of clinical symptoms and inflammatory markers in severe CAPS, assessments of inflammation of the CNS, including the inner ear (MRI or CT, lumbar puncture, and audiology) and eyes (ophthalmological assessments) are recommended after an initial 3 months of treatment, and thereafter every 6 months, until effective treatment doses have been identified.
Croatian: CT, lumbalna punkcija i audiologija) i oči (oftalmološki pregled), a potom svakih 6 mjeseci dok se ne utvrdi učinkovita doza liječenja.
English: • The patient reminder card
Croatian: • Kartica s podsjetnikom za bolesnike
English: The absolute bioavailability of anakinra after a 70 mg subcutaneous bolus injection in healthy subjects (n = 11) is 95%.
Croatian: Apsolutna bioraspoloživost anakinre nakon supkutane bolusne injekcije od 70 mg u zdravih ispitanika
English: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe Anakinra
Croatian: Kineret 100 mg/0,67 ml otopina za injekciju u napunjenoj štrcaljki anakinra
English: There are limited amount of data from the use of anakinra in pregnant women.
Croatian: Podaci o primjeni anakinre u trudnica su ograničeni.
English: During post-marketing use case reports of MAS in Kineret treated patients with Still's disease have been received.
Croatian: Tijekom postmarketinške primjene prijavljeni su slučajevi MAS-a u bolesnika sa Stillovom bolešću liječenih Kineretom.
English: The adverse reactions table below therefore applies to Kineret treatment of RA, CAPS and Still's disease.
Croatian: Tablica nuspojava u nastavku se stoga odnosi na liječenje Kineretom bolesnika s RA, CAPS-om i Stillovom bolešću.
English: Each 0.67 ml graduated pre-filled syringe contains 100 mg of anakinra.
Croatian: Svaka kalibrirana napunjena štrcaljka od 0,67 ml sadrži 100 mg anakinre.
English: Adverse reactions data in CAPS patients are based on an open-label study of 43 patients with NOMID/CINCA treated with Kineret for up to 5 years, with a total Kineret exposure of 159.8 patient years.
Croatian: NOMID/CINCA-om liječenih Kineretom tijekom do 5 godina, pri čemu je ukupna izloženost Kineretu iznosila 159,8 bolesnik godina.
English: Still's Disease
Croatian: Maligne bolesti
English: Sodium hydroxide Water for injections
Croatian: polisorbat 80, natrijev hidroksid i voda za injekcije.
English: Only clear, colourless-to-white solutions that may contain some product-related translucent-to-white amorphous particles should be injected.
Croatian: Smije se injicirati samo bistra, bezbojna do bijela otopina za injekciju koja može sadržavati neke prozirne do bijele amorfne čestice porijeklom od lijeka.
English: In Kineret treated CAPS patients, there is a risk for disease flares when discontinuing Kineret treatment.
Croatian: Kineretom postoji rizik od ponovnog izbijanja bolesti nakon prekida liječenja Kineretom.
English: Injection site reaction Uncommon (≥ 1/1,000 to < 1/100) Rash
Croatian: Poremećaji imunološkog sustava Manje često (≥ 1/1000 i
English: • Patient and caregiver information pack
Croatian: • Informacijski paket za bolesnike i njegovatelje
English: You should position the syringe in one hand with the needle pointing straight upwards as shown in Figure B. Put your thumb on the plunger rod and push slowly until you see a tiny liquid drop at the tip of the needle.
Croatian: Štrcaljku stavite u jednu ruku tako da je igla usmjerena ravno prema gore kako je prikazano na slici B.
English: How to store Kineret
Croatian: Moguće nuspojave Kako čuvati Kineret
English: 0.67 ml of solution for injection in a graduated pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber) and 29 gauge needle.
Croatian: 0,67 ml otopine za injekciju u kalibriranoj napunjenoj štrcaljki (staklo tipa I) sa čepom klipa
English: At the same time point, 7 of 12 in the Kineret treated group were classified as ACRpedi50 and 5 of 12 as ACRpedi70 responders compared to none in the placebo group.
Croatian: od 12 bolesnika kao bolesnici s odgovorom ACRpedi70 u usporedbi s nijednim bolesnikom u skupini koja je primala placebo.
English: Also persistent low-grade fever, weight loss, and persistent cough can be signs of an infection.
Croatian: Znakovi infekcije također mogu biti stalna blago povišena tjelesna temperatura, gubitak težine i uporan kašalj.
English: A corresponding decrease in creatinine clearance was seen in the hepatic failure population.
Croatian: Sukladno tome utvrđen je smanjeni klirens kreatinina u populaciji s dekompenzacijom jetre.
English: Kineret treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of RA, CAPS and Still's disease, respectively.
Croatian: 4.2 Doziranje i način primjene Liječenje Kineretom treba započeti i nadzirati liječnik specijalist iskusan u dijagnosticiranju i liječenju
English: There may be some translucent-to-white particles of protein in the solution.
Croatian: U otopini mogu postojati neke prozirne do bijele čestice bjelančevina.
English: • a pre-filled syringe of Kineret
Croatian: • vanjski dio nadlaktica
English: Citric acid, anhydrous Sodium chloride Disodium edetate dihydrate Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari citratna kiselina, bezvodna natrijev klorid dinatrijev edetat dihidrat polisorbat 80 natrijev hidroksid voda za injekcije
English: Patients with trisomy 21 seem to be overrepresented.
Croatian: Čini se da veći udio ovih bolesnika čine bolesnici s trisomijom 21. Nije ustanovljena uzročna povezanost s Kineretom.
English: Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still's disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
Croatian: Kineret je indiciran u odraslih, adolescenata, djece i dojenčadi u dobi od 8 mjeseci i starije s tjelesnom težinom od najmanje 10 kg ili više za liječenje Stillove bolesti, uključujući sistemski juvenilni idiopatski artritis (engl.
English: - The other ingredients are anhydrous citric acid, sodium chloride, disodium edetate dihydrate, polysorbate 80 and sodium hydroxide and water for injections.
Croatian: - Drugi sastojci su bezvodna citratna kiselina, natrijev klorid, dinatrijev edetat dihidrat,
English: Immune system disorders
Croatian: Neonatal-Onset Multisystem Inflammatory
English: Your doctor will have to decide if you can still be given Kineret; - if you have a history of increased levels of liver enzymes; - if you require vaccinations.
Croatian: Liječnik će odlučiti da li još uvijek možete primati Kineret;
English: In clinical studies in RA patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
Croatian: U kliničkim ispitivanjima u bolesnika s reumatoidnim artritisom trombocitopenija je prijavljena u 1,9%
English: Anakinra
Croatian: Chronic
English: Very common side effects (may affect more than 1 in 10 people): - Redness, swelling, bruising or itching at the injection site.
Croatian: - Svrbež kože ili osip Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
English: Malignancies
Croatian: Trombocitopenija
English: Kineret was studied in a single randomized, blinded multi-center trial in 86 patients with polyarticular course JIA (ages 2-17 years) receiving a dose of 1 mg/kg subcutaneously daily, up to a maximum dose of 100 mg.
Croatian: 86 bolesnika s poliartikularnim JIA (dob 2-17 godina) koji su primali dozu od 1 mg/kg dnevno supkutanom injekcijom, do maksimalne doze od 100 mg. 50 bolesnika u kojih je postignut klinički odgovor nakon 12 tjedana otvorene, početne faze ispitivanja randomizirani su u skupine koje su daljnjih
English: This is a type of cytokine (an immunosuppressive agent) that is used to treat: - Rheumatoid Arthritis (RA) - Cryopyrin-Associated Periodic Syndromes (CAPS) which includes the following autoinflammatory diseases: - Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also called Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA), - Muckle-Wells Syndrome (MWS), - Familial Cold Autoinflammatory Syndrome (FCAS) - Still´s disease including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD)
Croatian: Neonatal-Onset Multisystem Inflammatory Disease - NOMID) ili takozvani kronični infantilni neurološki, kutani i zglobni sindrom
English: Pull straight as shown in Figure A. Do not touch the needle or push the plunger.
Croatian: Nemojte dodirivati iglu ili gurati klip.
English: (~35 times the recommended dose in RA) over a 72 hour treatment period.
Croatian: U ispitivanjima sepse, 1015 bolesnika primilo je Kineret u dozama do 2 mg/kg/sat intravenski (~35 puta više od preporučene doze za bolesnike s RA) tijekom razdoblja liječenja od 72 sata.
English: The therapeutic response is primarily reflected by reduction in clinical symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.
Croatian: bol u zglobovima i glavobolja, ali i u razini upalnih markera u serumu (CRP/SAA razine) ili u ponovnom izbijanju bolesti.
English: The median steady-state dose-normalized anakinra concentration in SJIA patients over 28 weeks was comparable to that observed in RA patients.
Croatian: SJIA tijekom 28 tjedana bio je usporediv s onim uočenim u bolesnika s RA.
English: • Contact details of their physician
Croatian: • Kontakt podatke bolesnikova liječnika
English: In RA patients the most common and consistently reported treatment-related adverse reactions associated with Kineret were ISRs.
Croatian: Najčešće i dosljedno prijavljene nuspojave povezane s liječenjem Kineretom u bolesnika s RA bile su reakcije na mjestu primjene (engl.
English: Hearing and visual acuity did not deteriorate further during anakinra treatment.
Croatian: Tijekom liječenja anakinrom nije došlo do pogoršanja oštrine sluha i vida.
English: Hyperlink reference not valid.http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: The safety and efficacy have been demonstrated in a published randomized controlled study in 24 SJIA patients treated with Kineret for up to 1 year.
Croatian: Sigurnost i djelotvornost dokazane su u objavljenom randomiziranom kontroliranom ispitivanju u
English: Mechanism of action
Croatian: OKVIRA)
English: Breast-feeding
Croatian: Interleukin-1
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 7 PRE-FILLED SYRINGES AS AN INTERMEDIATE PACK (WITHOUT BLUE BOX)
Croatian: ŠTRCALJKI KAO MEĐUPAKIRANJE (BEZ PLAVOG
English: SC
Croatian: Slika C
English: Two medicines are bioequivalent when they produce the same levels of the active substances in the body.
Croatian: Dva su lijeka bioekvivalentna ako u tijelu proizvode iste razine djelatne tvari.
English: There are no ongoing clinical trials or compassionate use programmes.
Croatian: Trenutačno nema kliničkih ispitivanja ili programa milosrdnog davanja su u tijeku.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the time required to generate the supporting data makes this product unviable.
Croatian: U dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da vrijeme koje je potrebno za prikupljanje popratnih podataka čini proizvod neodrživim.
English: The company informed the CHMP that this withdrawal has no consequences for patients.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike zbog povlačenja.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the medicine could not have been approved based on the data presented by the company.
Croatian: U skladu s navedenim, u vrijeme povlačenja, CHMP je smatrao kako lijek nije moguće odobriti na temelju podataka koje je tvrtka dostavila.
English: It was expected to reduce the risk of fractures (broken bones) in the spine and the hip.
Croatian: Lijek je trebao smanjiti rizik od fraktura (prijeloma kostiju) kralješnice i kuka.
English: Alendronic acid reduces the loss of bone tissue and colecalciferol, also known as vitamin D3, increases the absorption of calcium and formation of bone.
Croatian: Alendronska kiselina smanjuje gubitak koštanog tkiva, a kolekalciferol, poznat i kao vitamin D3, povećava apsorpciju kalcija i formiranje kostiju.
English: On 27 May 2016, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Alendronic Acid/Colecalciferol Mylan, for the treatment of postmenopausal osteoporosis in women at risk of vitamin D deficiency.
Croatian: Dana 27. svibnja 2016. tvrtka Mylan SAS službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Alendronska kiselina/kolekalciferol Mylan, za liječenje postmenopauzalne osteoporoze u žena s rizikom od nedostatka vitamina D.
English: This means that Alendronic Acid/Colecalciferol Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Fosavance.
Croatian: To znači da je lijek Alendronska kiselina/kolekalciferol Mylan trebao biti sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Fosavance.
English: Because Alendronic Acid/Colecalciferol Mylan is a generic medicine, the company had presented results of a study to determine that Alendronic Acid/Colecalciferol Mylan is bioequivalent to the reference medicine, Fosavance.
Croatian: Budući da je lijek Alendronska kiselina/kolekalciferol Mylan generički lijek, tvrtka je predstavila rezultate ispitivanja kako bi se utvrdilo da je lijek Alendronska kiselina/kolekalciferol Mylan bioekvivalentan referentnom lijeku Fosavance.
English: The CHMP also considered that data from the study do not convincingly establish that Alendronic Acid/Colecalciferol Mylan is sufficiently similar to the reference medicine, Fosavance.
Croatian: CHMP je također smatrao da na osnovi podataka iz ispitivanja nije uvjerljivo utvrđeno da je lijek Alendronska kiselina/kolekalciferol Mylan u dovoljnoj mjeri sličan referentnom lijeku Fosavance.
English: Alendronic Acid/Colecalciferol Mylan was to be used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of insufficient vitamin-D levels.
Croatian: Lijek Alendronska kiselina/kolekalciferol Mylan trebao se koristiti za liječenje osteoporoze (bolesti koja kosti čini lomljivima) u žena u postmenopauzi s rizikom od preniskih razina vitamina D.
English: Alendronic Acid/Colecalciferol Mylan was developed as a ‘generic medicine'.
Croatian: Lijek Alendronska kiselina/kolekalciferol Mylan razvijen je kao „generički lijek”.
English: Alendronic Acid/Colecalciferol Mylan is a medicine that contains two active substances: alendronic acid and colecalciferol.
Croatian: Alendronska kiselina/kolekalciferol Mylan lijek je koji sadrži dvije djelatne tvari, alendronsku kiselinu i kolekalciferol.
English: What is Alendronic Acid/Colecalciferol Mylan?
Croatian: Što je Alendronska kiselina/kolekalciferol Mylan?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Alendronic Acid/Colecalciferol Mylan could not have been approved for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja CHMP je smatrao da postoje problemi te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Alendronska kiselina/kolekalciferol Mylan za liječenje postmenopauzalne osteoporoze u žena s rizikom od nedostatka vitamina D. CHMP je izrazio zabrinutost zbog nesigurnosti u pogledu načina na koji je ispitivanje bioekvivalencije provedeno.
English: Alendronic Acid/Colecalciferol Mylan is expected to work in the same way as the reference medicine, Fosavance.
Croatian: Lijek Alendronska kiselina/kolekalciferol Mylan trebao je djelovati na isti način kao i referentni lijek, Fosavance.
English: How is Alendronic Acid/Colecalciferol Mylan expected to work?
Croatian: Kako je lijek Alendronska kiselina/kolekalciferol Mylan trebao djelovati?
English: What was Alendronic Acid/Colecalciferol Mylan expected to be used for?
Croatian: Za što se lijek Alendronska kiselina/kolekalciferol Mylan trebao koristiti?
English: What is Adlumiz?
Croatian: Što je Adlumiz?
English: 15 September 2017 EMA/599030/2017 EMEA/H/C/003847
Croatian: EMA/599030/2017 EMEA/H/C/003847
English: It was to be available as 100 mg tablets to be taken by mouth.
Croatian: Trebao je biti dostupan u obliku tableta od 100 mg koje se uzimaju kroz usta.
English: Activation of the receptor causes release of substances in the body which are expected to act in the brain to increase appetite and prevent weight loss.
Croatian: Aktivacija receptora uzrokuje otpuštanje tvari u tijelu za koje se očekuje da će djelovanjem u mozgu povećati apetit i spriječiti gubitak tjelesne težine.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Croatian: Nakon razmatranja razloga za ovaj zahtjev, CHMP je preispitao prvotno mišljenje i potvrdio odbijanje odobrenja za stavljanje lijeka u promet dana 14. rujna 2017.
English: In addition, following an inspection at clinical study sites, CHMP considered that the safety data on the medicine had not been recorded adequately.
Croatian: Osim toga, nakon inspekcije lokacija kliničkog ispitivanja, CHMP je smatrao da sigurnosni podatci o lijeku nisu zabilježeni na odgovarajući način.
English: This meant that a thorough evaluation of potential risks with Adlumiz was not possible.
Croatian: To je značilo da nije bila moguća detaljna procjena mogućih rizika lijeka Adlumiz.
English: Refusal of the marketing authorisation for Adlumiz (anamorelin hydrochloride) EMA/599030/2017
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Adlumiz (anamorelin hidroklorid) EMA/599030/2017
English: The company that applied for authorisation is Helsinn Birex Pharmaceuticals Ltd.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka Helsinn Birex Pharmaceuticals Ltd.
English: The company presented results of two main studies involving a total of around 1,000 non-small cell lung cancer patients with cachexia.
Croatian: Tvrtka je dostavila rezultate dvaju glavnih ispitivanja na ukupnom broju od otprilike 1000 bolesnika oboljelih od raka pluća nemalih stanica s kaheksijom.