FrancophonIA/ELRC3.0 huggingface dataset:
English: A double-blind, double-dummy, multicentre, randomized, parallel-group study compared the efficacy and safety of nebulised beclometasone dipropionate and beclometasone dipropionate administered with metered-dose inhalation in 151 patients, aged 6-16 years, with moderate to severe asthma for 4 weeks.
Croatian: U dvostruko slijepom, multicentričnom, randomiziranom ispitivanju s dvostrukim placebom, s paralelnim skupinama uspoređena je djelotvornost i sigurnost beklometazondiproprionat suspenzije u atomizatoru i beklometazondiproprionata, stlačenog inhalata primijenjenog preko odmjernog ventila u 151 bolesnika u dobi od 6-16 godina s umjerenom do teškom astmom u razdoblju od 4 tjedna.
English: Psychomotor hyperactivity, sleep disorders anxiety, depression, aggressiveness, behavioural changes (predominantly in children)
Croatian: depresija, agresivnost, bihevioralne promjene (uglavnom u djece)
English: It must be recommended that patients rinse their mouth with water immediately after inhalation to reduce the frequency of oral candidiasis.
Croatian: Bolesnicima se mora preporučiti da odmah nakon inhalacije isperu usta vodom kako bi se smanjila učestalost oralne kandidijaze.
English: Beclometasone dipropionate (BDP) is a pro-drug that is hydrolysed via esterase enzymes to an active metabolite beclometasone monopropionate (B17MP) the most abundant metabolite in plasma.
Croatian: Beklometazondipropionat (BDP) je prolijek koji se hidrolizira putem enzima esteraza u aktivni metabolit beklometazonmonopropionat (B17MP), najzastupljeniji metabolit u plazmi.
English: HOW TO STORE {INVENTED NAME}
Croatian: Kako primjenjivati {NOVOIZUMLJENO IME}
English: Once the nebuliser bowl cap is inserted, the nebuliser should be shaken gently to mix the content.
Croatian: Jednom kada je umetnut zatvarač spremnika atomizatora, atomizator se treba nježno protresti kako bi se sadržaj izmiješao.
English: Turn on the nebuliser.
Croatian: Uključite atomizator.
English: Once half the content is used, reinsert the cap upside down by pushing it onto the container.
Croatian: Nakon što iskoristite polovicu sadržaja, vratite jezičac u obrnutom položaju natrag potiskujući ga na ampulu.
English: The unit dose ampoule should be used according to the following instructions:
Croatian: Ampulu jedinične doze treba primijeniti prema sljedećim uputama:
English: The systemic pharmacodynamic effects of beclometasone dipropionate and its active metabolite B17MP is assessed by measuring the effects on hypothalamopituitary adrenal (HPA)-axis function.
Croatian: Sistemski farmakodinamički učinci beklometazondipropionata i njegovog aktivnog metabolita B17MP ocijenjeni su mjerenjem učinaka na funkciju osovine hipotalamus hipofiza-kora nadbubrežne žlijezde (HPA osovine).
English: Regular follow-up is essential to review the treatment response.
Croatian: Za ocjenu terapijskog odgovora, ključno je redovito praćenje bolesnika.
English: Open the ampoule by rotating the flap as indicated by the arrow (Figure D).
Croatian: Otvorite ampulu zakretanjem gornjeg spljoštenog dijela (jezičca) kako pokazuje strelica (slika D).
English: The benefits of the corticosteroid treatment and the possible risks on the growth suppression must be carefully weighed against one another.
Croatian: Mora se pažljivo ocijeniti omjer koristi od liječenja kortikosteroidima i mogućih rizika od supresije rasta.
English: The vial closed in this way must be stored at 2-8°C (in the refrigerator) and pour the content into the nebuliser up to the graduation mark indicated on the sides of the ampoule.
Croatian: Ampula zatvorena na ovaj način mora se čuvati na 2 °C do 8 °C (u hladnjaku) te se sadržaj mora uliti u atomizator do oznake gradacije naznačene na bočnim stranama ampule.
English: Then put the top on the nebuliser bowl and shake gently to mix the contents.
Croatian: Zatim stavite poklopac na spremnik atomizatora i nježno protresite kako bi se sadržaj izmiješao.
English: The systemic absorption of the main active metabolite B17MP arises from both lung deposition and oral absorption of the swallowed dose.
Croatian: Do sistemske apsorpcije glavnog aktivnog metabolita B17MP dolazi i iz odlaganja u plućima i oralne apsorpcije progutanog dijela doze.
English: Cataract**, glaucoma**
Croatian: Poremećaji oka katarakta**, glaukom**
English: Use the ampoules within 3 months from the first opening of the pouch.
Croatian: Upotrijebite ampule unutar 3 mjeseca od prvog otvaranja vrećice.
English: No evidence of teratogenic effects in pregnant women using inhaled beclometasone was observed according to published data.
Croatian: Prema objavljenim podacima, nisu opaženi teratogeni učinci u trudnica koje su primjenjivale inhalacijski beklometazon.
English: • thrush in the mouth, tongue and throat.
Croatian: • gljivična infekcija kandidom u ustima, na jeziku i u grlu.
English: The ampoule should be used according to the following instructions:
Croatian: Ampulu treba primijeniti prema sljedećim uputama:
English: The container closed in this way must be stored at 2-8 C (in the refrigerator) and the remaining quantity has to be used within 12 hours after first opening.
Croatian: Ampula zatvorena na ovaj način mora se čuvati na 2 °C do 8 °C (u hladnjaku), a preostala količina mora se primijeniti unutar 12 sati nakon prvog otvaranja.
English: No evidence of carcinogenicity was observed in a 95-week study in rats treated by inhalation.
Croatian: U ispitivanju na štakorima liječenima inhalacijom tijekom 95 tjedana nije bilo dokaza kancerogenosti.
English: The starting dose of nebulised beclometasone dipropionate should take into account the frequency and severity of symptoms.
Croatian: Kod određivanja početne doze beklometazondipropionat suspenzije za atomizator treba uzeti u obzir učestalost i težinu simptoma.
English: The decision to start nebulised beclometasone dipropionate for treatment of recurrent wheezing in children up to 5 years of age should be determined by the severity and frequency of wheezing episodes.
Croatian: Odluka da se liječenje rekurentnog zviždanja u plućima u djece u dobi do 5 godina započne beklometazondipropionat suspenzijom u atomizatoru treba biti donesena ovisno o težini i učestalosti epizoda zviždanja u plućima.
English: Laryngitis, pharyngitis
Croatian: Infekcije i infestacije laringitis, faringitis
English: It is important that you use your dose as advised by your doctor.
Croatian: Ako primijenite više lijeka {NOVOIZUMLJENO IME} nego što ste trebali: Važno je da primjenjujete svoju dozu kako Vas je savjetovao Vaš liječnik.
English: Driving and using machines {INVENTED NAME} is unlikely to affect your ability to drive and use machines.
Croatian: Nije vjerojatno da će {NOVOIZUMLJENO IME} utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: {See ANNEX I of referal}
Croatian: {Vidjeti PRILOG I.}
English: Hypersensitivity reactions with the following manifestations: angioedema, rash, urticaria, pruritus,
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti sa sljedećim manifestacijama: angioedem, osip,
English: Pharmacotherapeutic group: Other drugs for obstructive airway diseases, inhalants; Glucocorticoids ATC code: R03 BA01.
Croatian: Farmakoterapijska skupina: ostali inhalacijski lijekovi za opstruktivne bolesti dišnih putova; glukokortikoidi
English: Paradoxical bronchospasm may occur after dosing.
Croatian: Nakon doziranja može doći do paradoksalnog bronhospazma.
English: {INVENTED NAME} contains the active substance beclometasone dipropionate.
Croatian: {NOVOIZUMLJENO IME} sadrži djelatnu tvar beklometazondipropionat.
English: Growth retardation* (in children and adolescents), bone density decreased*
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva zaostajanje u rastu* (kod djece i adolescenata), smanjenje gustoće kostiju*
English: The affinity of beclometasone dipropionate and its main active metabolite, beclometasone monopropionate (B17MP), for the human glucocorticoid receptor has been determined.
Croatian: Određen je afinitet beklometazondipropionata i njegovog glavnog aktivnog metabolita beklometazonmonopropionata (B17MP) za ljudske glukokortikoidne receptore.
English: If only half dose of {INVENTED NAME} 800 micrograms is needed, reinsert the cap upside down by pushing it onto the vial.
Croatian: Ako je potrebno samo pola doze lijeka {NOVOIZUMLJENO IME} od 800 mikrograma, vratite jezičac u obrnutom položaju natrag potiskujući ga na ampulu.
English: Bone thinning and eye problems, which include clouding of the lens of the eye (cataract), increase in pressure in the eye (glaucoma) have been reported.
Croatian: Prijavljeno je stanjivanje kostiju i problemi s očima koji uključuju zamućenje leće oka (mrenu) i povišen očni tlak
English: After the first opening of the ampoule, store in a refrigerator (2°C - 8°C).
Croatian: Nakon prvog otvaranja ampule, čuvati u hladnjaku (2°C - 8°°C).
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING POUCH
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: There is an approximately linear increase in systemic exposure of the active metabolite B17MP with increasing inhaled dose.
Croatian: Sistemska izloženost aktivnom metabolitu B17MP raste približno linearano s porastom inhalirane doze.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {INVENTED NAME} 400 mcg
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA {NOVOIZUMLJENO IME} 400 μg
English: • feeling tired.
Croatian: • osjećaj umora.
English: In terms of safety, no change in the values of morning salivary cortisol was detected (Papi et al., 2009).
Croatian: U pogledu sigurnosti, nisu utvrđene promjene u vrijednostima kortizola u jutarnjoj slini.
English: 400-800 micrograms twice daily (total daily dose: 800 - 1600 micrograms)
Croatian: 400-800 mikrograma dva puta dnevno (ukupna dnevna doza: 800 - 1600 mikrograma)
English: {INVENTED NAME} should not be injected or administered orally.
Croatian: {NOVOIZUMLJENO IME} se ne smije ubrizgavati niti primjenjivati kroz usta.
English: 800-1,600 micrograms twice daily (total daily dose: 1600 - 3200 micrograms)
Croatian: 800-1600 mikrograma dva puta dnevno (ukupna dnevna doza: 1600 - 3200 mikrograma)
English: CLENIL and associated names (see Annex I) 400 micrograms nebuliser suspension CLENIL and associated names (see Annex I) 800 micrograms nebuliser suspension
Croatian: CLENIL i pridružena imena (vidjeti Prilog I.) 400 mikrograma suspenzija za atomizator CLENIL i pridružena imena (vidjeti Prilog I.) 800 mikrograma suspenzija za atomizator
English: For 800 micrograms ampoule only: after the first opening of the ampoule, store it in a refrigerator (2°C8°C).
Croatian: Samo za ampule od 800 mikrograma: nakon prvog otvaranja ampule, čuvati u hladnjaku (2°C - 8°°C).
English: The quantity of sterile sodium chloride 9 mg/ml (0.9%) solution required should be added.
Croatian: Treba dodati potrebnu količinu sterilne otopine natrijeva klorida od 9 mg/ml
English: Because growth retardation and damage to the unborn child cannot be excluded upon prolonged treatment with corticosteroids (such as beclometasone dipropionate contained in {INVENTED NAME}) during pregnancy, your doctor will decide whether your disease requires treatment with {INVENTED NAME}.
Croatian: Budući da se zastoj u rastu i štetno djelovanje na nerođeno dijete ne mogu isključiti nakon dugotrajnog liječenja kortikosteroidima (kao što je beklometazondipropionat koji se nalazi u lijeku
English: DATE OF REVISION OF THE TEXT [to be completed nationally]
Croatian: DATUM REVIZIJE TEKSTA
English: In patients with asthma, {INVENTED NAME} must be used regularly on a daily basis; the duration of treatment should be defined on the basis of symptoms.
Croatian: U bolesnika s astmom, {NOVOIZUMLJENO IME} se mora primjenjivati redovito na dnevnoj bazi;
English: During nebulisation
Croatian: Tijekom inhalacije
English: 4.7 Effects on ability to drive and use machines {INVENTED NAME} has no or negligible influence on the ability to drive or use machines.
Croatian: {NOVOIZUMLJENO IME} ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: For 800 micrograms ampoule: after the first opening of the ampoule, store it in a refrigerator (2-8°C).
Croatian: Za ampule od 800 mikrograma: nakon prvog otvaranja ampule, čuvati u hladnjaku (2°C - 8°°C).
English: Do not use the ampoule after 3 months from the date of first opening the pouch.
Croatian: Ampule nemojte koristiti ako je od prvog otvaranja vrećice prošlo više od 3 mjeseca.
English: The other ingredients are polysorbate 20, sorbitan laurate, sodium chloride, water for injections.
Croatian: Pomoćne tvari su polisorbat 20, sorbitanlaurat, natrijev klorid, pročišćena voda.
English: The ampoule closed in this way must be stored at 2-8◦C (in the refrigerator) and the remaining quantity has to be used within 12
Croatian: Ampula zatvoren na ovaj način mora se čuvati na 2 °C do 8 °C (u hladnjaku), a preostala količina mora se primijeniti unutar 12 sati nakon prvog otvaranja.
English: • If you have an infection of nasal and paranasal cavities you have to be treated with suitable therapies,
Croatian: • Ako imate infekciju nosne šupljine i sinusa morate se liječiti odgovarajućim terapijama iako to ne predstavlja specifičnu kontraindikaciju za primjenu lijeka {NOVOIZUMLJENO IME}.
English: Following intravenous dosing, the disposition of BDP and its active metabolite, B17MP, are characterised by high plasma clearance (150 and 120 L/h respectively), with a small volume of distribution at steady state for BDP (20 L) and larger tissue distribution for its active metabolite (424 L).
Croatian: 120 l/h), malim volumenom distribucije u stanju dinamičke ravnoteže za BDP (20 l) i većom distribucijom u tkiva za njegov aktivni metabolit (424 l).
English: LIST OF EXCIPIENTS Excipients: polysorbate 20, sorbitan laurate, sodium chloride, water for injections
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: polisorbat 20, sorbitanlaurat, natrijev klorid, pročišćena voda
English: If only half dose of {INVENTED NAME} 800 micrograms is needed, hold the ampoule upside down, ensuring that the graduation mark is clearly visible and apply moderate pressure.
Croatian: Ako je potrebno samo pola doze lijeka {NOVOIZUMLJENO IME} od 800 mikrograma, prekorenite ampulu, pobrinite se da je mjerna oznaka jasno vidljiva te primijenite umjereni pritisak i pažljivo istisnite sadržaj dok razina suspenzije u ampuli ne dosegne mjernu oznaku i nimalo dalje.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {INVENTED NAME} 800 mcg
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA {NOVOIZUMLJENO IME} 800 µg
English: • sore throat (pharyngitis, laryngitis).
Croatian: • grlobolja (upala ždrijela ili grkljana).
English: Follow the manufacturer's instructions for cleaning your nebuliser.
Croatian: Čišćenje: Za čišćenje atomizatoa slijedite upute proizvođača.
English: Adrenal suppression**
Croatian: Endokrini poremećaji adrenalna supresija**
English: For inhalation use.
Croatian: Poslije inhalacije
English: • 800-1600 micrograms twice daily which correspond to a total daily amount of 1600-3200 micrograms.
Croatian: • 800-1600 mikrograma dvaput dnevno što odgovara ukupnoj dnevnoj dozi od 1600 do 3200
English: Rare side effects (may affect up to 1 in 1000people):
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba):
English: Nausea, dyspepsia
Croatian: koprivnjača, svrbež
English: The pharmacokinetics of BDP in patients with renal or hepatic impairment has not been studied; however, as BDP undergoes a very rapid metabolism via esterase enzymes present in intestinal fluids, serum, lungs and liver to originate more polar products B21MP, B17MP and BOH, hepatic impairment is not expected to modify the pharmacokinetics and safety profile of BDP.
Croatian: plućima i jetri pri čemu nastaju polarniji produkti B21MP, B17MP i BOH, ne očekuje se da će oštećenje funkcije jetre mijenjati farmakokinetiku i sigurnosni profil BDP-a.
English: Patients should be advised to have such relief medicinal product readily available.
Croatian: Bolesnicima treba savjetovati da imaju takav lijek za trenutno ublažavanje simptoma uz sebe.
English: Wheezing
Croatian: Nuspojava
English: Oral candidiasis
Croatian: Vrlo često oralna kandidijaza
English: CLENIL and associated names (see Annex I) 800 micrograms nebuliser suspension
Croatian: NAZIV LIJEKA CLENIL i pridružena imena (vidjeti Prilog I.) 800 mikrograma suspenzija za atomizator
English: CLENIL and associated names (see Annex I) 400 micrograms nebuliser suspension
Croatian: NAZIV LIJEKA CLENIL i pridružena imena (vidjeti Prilog I.) 400 mikrograma suspenzija za atomizator
English: Instructions for use: Use the ampoule according to the following instructions:
Croatian: Ampulu primijenite prema sljedećim uputama:
English: Each 1 ml ampoule contains 400 micrograms beclometasone dipropionate.
Croatian: Svaka ampula od 1 ml sadrži 400 mikrograma beklometazondipropionata.
English: You should see your doctor as soon as possible if you experience these symptoms.
Croatian: Ako Vam se pojave ovi simptomi trebate se obratiti liječniku što je prije moguće.
English: Beclometasone dipropionate can be used during breast-feeding.
Croatian: Beklometazondipropionat se može primjenjivati tijekom dojenja.
English: {INVENTED NAME} must be administered by inhalation from a suitable device (jet nebuliser) according to your doctor instructions.
Croatian: (atomizator s mlaznicom) u skladu s uputama liječnika.
English: • maintenance treatment of asthma, when the use of pressurised metered dose or dry powder inhalers is unsatisfactory or inappropriate, in adults and children up to 18 years of age;
Croatian: {NOVOIZUMLJENO IME} je indiciran u: - terapiji održavanja u liječenju astme, kada primjena stlačenog inhalata ili praška inhalata nije zadovoljavajuća ili nije primjerena, u odraslih i djece u dobi do 18 godina; - liječenju rekurentnog zviždanja u plućima u djece u dobi do 5 godina (vidjeti dijelove 4.2 i 4.4, Pedijatrijska populacija)
English: Each 2 ml ampoule contains 800 micrograms beclometasone dipropionate.
Croatian: Svaka ampula od 2 ml sadrži 800 mikrograma beklometazondipropionata.
English: Each ampoule contains 400 micrograms beclometasone dipropionate suspension in 1 ml.
Croatian: Svaka ampula sadrži 400 mikrograma bezvodnog beklometazondipropionata u 1 ml.
English: {INVENTED NAME} is not indicated to relieve acute asthma symptoms for which an inhaled shortacting beta 2-agonists is required.
Croatian: Liječenje astme obično treba slijediti stupnjeviti pristup i odgovor bolesnika treba pratiti klinički i testovima za mjerenje plućne funkcije. {NOVOIZUMLJENO IME} nije indiciran za trenutno ublažavanje akutnih simptoma astme za što su potrebni inhalacijski kratkodjelujući beta 2-agonisti.
English: Each ampoule contains 800 micrograms beclometasone dipropionate suspension in 2 ml.
Croatian: Svaka ampula sadrži 800 mikrograma bezvodnog beklometazondipropionata u 2 ml.
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.
English: After nebulisation
Croatian: Prijavljivanje nuspojava
English: {INVENTED NAME} 800 micrograms
Croatian: 16. PODACI NA BRAILLEOVOM PISMU {NOVOIZUMLJENO IME} 800 mikrograma
English: 5 ampoules containing 1 ml suspension each
Croatian: OBLIK I SADRŽAJ Suspenzija za atomizator 5 ampula s 1 ml suspenzije u svakoj.
English: 4.8 Undesirable effects
Croatian: 4.3 Kontraindikacije
English: You can used {INVENTED NAME} 800 micrograms ampoule to get 400 micrograms (half the content) using the graduation mark as described below.
Croatian: mikrograma (polovica sadržaja) koristeći mjernu oznaku kako je opisano u nastavku.
English: Each polyethylene ampoule contains 800 micrograms beclometasone dipropionate suspension in 2 ml.
Croatian: Svaka polietilenska ampula sadrži 2 ml suspenzije s 800 mikrograma beklometazondipropionata.
English: Each polyethylene ampoule contains 400 micrograms beclometasone dipropionate suspension in 1 ml.
Croatian: Svaka polietilenska ampula sadrži 1 ml suspenzije s 400 mikrograma beklometazondipropionata.
English: 400 micrograms ampoule is for single use.
Croatian: Ampula sa suspenzijom koja sadrži 400 mikrograma beklometazondipropionata predviđena je za jednokratnu uporabu.
English: {INVENTED NAME} 400 micrograms
Croatian: 16. PODACI NA BRAILLEOVOM PISMU {NOVOIZUMLJENO IME} 400 mikrograma
English: Psychiatric disorders
Croatian: Psihijatrijski poremećaji psihomotorna hiperaktivnost,
English: Starting from the top, then in the middle (Figure B).
Croatian: 2. Pažljivo odvojite novu ampulu od stripa, najprije od vrhu, zatim u sredini (slika B),
English: Nebulised beclometasone dipropionate was evaluated in 276 children aged 1-4 years with frequent wheezing in a randomized, double-blind, 12-week controlled trial.
Croatian: U randomiziranom, dvostruko slijepom, kontroliranom ispitivanju u trajanju od 12 tjedana, beklometazondiproprionat suspenzija u atomizatoru ocijenjena je u 276 djece u dobi od 1- 4 godine s učestalim zviždanjem u plućima.
English: Sorbitan laurate Sodium chloride Water for injections
Croatian: 6.1 Popis pomoćnih tvari polisorbat 20 sorbitanlaurat natrijev klorid pročišćena voda
English: Method of administration {INVENTED NAME} is for inhalation use only.
Croatian: {NOVOIZUMLJENO IME} je namijenjen samo za primjenu u dišne putove.
English: beclometasone dipropionate
Croatian: prsišta i sredoprsja kašalj
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji probavnog sustava mučnina, dispepsija
English: The full EPAR for Blitzima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Blitzima nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It must also not be used in patients with a severe infection or a severely weakened immune system.
Croatian: Ne smije se koristiti u bolesnika s teškom upalom ili jako oslabljenim imunosnim sustavom.
English: This means that Blitzima is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: To znači da je Blitzima vrlo sličan biološkom lijeku (također poznat kao „referentni lijek“) koji je već odobren u Europskoj uniji (EU).
English: Patients with GPA or MPA must also not receive Blitzima if they have severe heart problems.
Croatian: Bolesnici s bolestima GPA ili MPA ne smiju primati lijek Blitzima ako imaju ozbiljne probleme sa srcem.
English: What is Blitzima and what is it used for?
Croatian: Što je Blitzima i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Blitzima?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Blitzima?
English: In this study improvement was seen in 96% of cases (67 of 70 patients) with Blitzima and 90% (63 of 70 patients) with Rituxan.
Croatian: U tom je ispitivanju zabilježeno poboljšanje u 96 % slučajeva (67 od 70 bolesnika) koji su uzimali lijek Blitzima i 90 % (63 od 70 bolesnika) koji su uzimali lijek Rituxan.
English: This is a summary of the European public assessment report (EPAR) for Blitzima.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Blitzima.
English: The study showed that Blitzima and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Blitzima and 73% (43 of 59 patients) with MabThera.
Croatian: Ispitivanje je pokazalo da lijekovi Blitzima i MabThera imaju usporedive učinke na simptome artritisa: udio bolesnika s 20 % poboljšanja u ocjeni simptoma (ACR20) nakon 24 tjedna primjene lijeka Blitzima iznosio je 74 % (114 od 155 bolesnika), u odnosu na 73 % (43 od 59 bolesnika) koji su uzimali lijek MabThera.