FrancophonIA/ELRC3.0 huggingface dataset:
English: Benepali is available in packs containing 4 pre-filled syringes, multipacks comprising 2 cartons, each containing 4 pre-filled syringes and multipacks comprising 6 cartons, each containing 4 pre-filled syringes.
Croatian: Benepali je dostupan u pakiranju koje sadrži 4 napunjene štrcaljke, višekratnom pakiranju koji sadrži 2 kutije, svaka s 4 napunjene štrcaljke i višekratnom pakiranju koje sadrži 6 kutija, svaka s 4 napunjene štrcaljke.
English: Responses at Week 12
Croatian: Dvostruko slijepi klinički odgovori u 12. tjednu
English: A single-use pre-filled syringe contains one 25 mg dose of Benepali.
Croatian: Napunjena štrcaljka za jednokratnu uporabu koja sadrži jednu dozu Benepalija od 25 mg.
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin.
Croatian: Primjena u odraslih bolesnika (u dobi od 18 ili više godina) Reumatoidni artritis, psorijatični artritis i aksijalni spondioloartritis uključujući ankilozantni spondilitis Uobičajena doza je 25 mg primijenjeno dvaput tjedno ili 50 mg jednom tjedno injekcijom pod kožu.
English: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients.
Croatian: Šest zloćudnih bolesti je zabilježeno u bolesnika liječenih etanerceptom u kliničkim ispitivanjima trajanja dužeg od 2 godine u 351 bolesnika s ankilozantnim spondilitisom.
English: Benepali is not indicated for use in children and adolescents weighing less than 62.5 kg.
Croatian: Benepali nije indiciran za primjenu u djece i adolescenata tjelesne težine manje od 62,5 kg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 12 (3 PACKS OF 4 PRE-FILLED SYRINGES) (WITH BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE OD 12 (3 PAKIRANJA PO 4 NAPUNJENE ŠTRCALJKE) (S PLAVIM OKVIROM)
English: Paediatric Plaque Psoriasis Outcomes at 12 Weeks
Croatian: Pedijatrijska plak psorijaza (u dobi od 6 godina ili više)
English: Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis
Croatian: Aksijalni spondiloartritis bez radiografskih dokaza
English: Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
Croatian: • Vrlo često (mogu se javiti kod više od 1 na 10 osoba): Infekcije (uključujući prehlade, upalu sinusa, bronhitis, infekcije mokraćnih putova i infekcije kože); reakcije na mjestu primjene injekcije (uključujući krvarenje, modrice, crvenilo, svrbež, bol i oticanje).
English: Recapping could lead to a needle stick injury.
Croatian: Vraćanjem poklopca na iglu možete se ubosti.
English: • Do not use the pre-filled syringe past the expiration date.
Croatian: • Nemojte koristiti napunjenu brizgalicu kojoj je istekao rok valjanosti.
English: A single-use pre-filled syringe contains one 50 mg dose of Benepali.
Croatian: Napunjena brizgalica za jednokratnu uporabu koja sadrži jednu dozu Benepalija od 50 mg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON WITHIN MULTIPACK (4 PRE-FILLED PENS) (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU MEĐUKUTIJA UNUTAR VIŠESTRUKOG PAKIRANJA (4 NAPUNJENE BRIZGALICE) (BEZ PLAVOG OKVIRA)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (25 mg PRE-FILLED SYRINGE)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (25 mg NAPUNJENA ŠTRCALJKA)
English: - The other ingredients are sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate,
Croatian: - Pomoćne tvari su saharoza, natrijev klorid, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat i voda za injekcije.
English: Teл.
Croatian: tj.
English: ● You should not use Benepali if you have an infection.
Croatian: Ako imate infekciju, ne smijete primjenjivati Benepali.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (25 mg PRE-FILLED SYRINGE)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (25 mg NAPUNJENA ŠTRCALJKA)
English: Biogen Hungary Kft. Tel.: + 36 (0)6 1 848 04 64
Croatian: Tel.: + 36 (0)6 1 848 04 64
English: You can let go of the skin that you are pinching after the needle is completely inserted.
Croatian: Nakon što potpuno uvedete iglu u kožu možete otpustiti nabor kože.
English: A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Benepali to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Croatian: Prije propisivanja Benepalija u osoba koje već neko vrijeme boluju, ili su nedavno oboljele, ili u kojih postoji povećana opasnost od razvoja demijelinizirajuće bolesti, preporučuje se pažljivo procijeniti odnos rizika i koristi, uključujući neurološku procjenu.
English: 50 mg solution for injection in pre-filled syringe
Croatian: 50 mg otopina za injekciju u napunjenoj brizgalici
English: Etanercept + Methotrexate (n = 231)
Croatian: + Metotreksat (n = 231)
English: Genesis Pharma (Cyprus) Ltd
Croatian: Biogen Idec (Ireland) Ltd.
English: Pancytopenia* Aplastic anaemia*
Croatian: Aplastična anemija*
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis The usual dose is 50 mg once a week as an injection under the skin.
Croatian: Primjena u odraslih bolesnika (u dobi od 18 ili više godina) Reumatoidni artritis, psorijatični artritis i aksijalni spondioloartritis uključujući ankilozantni spondilitis Uobičajena doza je 50 mg primijenjeno jednom tjedno injekcijom pod kožu.
English: Benepali 50 mg solution for injection in pre-filled syringe.
Croatian: Benepali 50 mg otopina za injekciju u napunjenoj štrcaljki.
English: Etanercept 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Croatian: U procjeni erozije nakon 12 i 24 mjeseca, etanercept u dozi od 25 mg je bio značajno superioran metotreksatu.
English: Among patients with psoriatic arthritis who received etanercept, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Croatian: Klinički odgovor u bolesnika sa psorijatičnim artritisom koji su primali etanercept zamijećen je u vrijeme prve kontrole (4. tjedna) i održan je tijekom svih 6 mjeseci liječenja.
English: Each syringe contains 25 mg etanercept.
Croatian: Jedna napunjena štrcaljka sadrži 25 mg etanercepta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (25 mg 2 PRE-FILLED SYRINGES) WITHOUT BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (25 mg 2 NAPUNJENE ŠTRCALJKE) BEZ PLAVOG OKVIRA
English: Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 50 mg once weekly.
Croatian: Alternativno, može se primijeniti 50 mg dva puta tjedno do najviše 12 tjedana, nakon čega slijedi, ako je potrebno, liječenje dozom od 50 mg primijenjeno jednom tjedno.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (50 mg 2 PRE-FILLED PENS) WITHOUT BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (50 mg 2 NAPUNJENE BRIZGALICE) BEZ PLAVOG OKVIRA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (50 mg PRE-FILLED PEN)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (50 mg NAPUNJENA BRIZGALICA)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (50 mg PRE-FILLED SYRINGE)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA (50 mg NAPUNJENA BRIZGALICA)
English: Benepali is available in packs containing 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes.
Croatian: Benepali je dostupan u pakiranju koje sadrži 4 napunjene štrcaljke i višestrukom pakiranju koje sadrži 12 napunjenih štrcaljki (3 pakiranja, s 4 napunjene štrcaljke).
English: or listlessness, seek medical attention immediately.
Croatian: Nakon toga se preporučuje odmah primijeniti lijek.
English: Benepali 25 mg solution for injection in pre-filled syringe.
Croatian: NAZIV LIJEKA Benepali 25 mg otopina za injekciju u napunjenoj štrcaljki.
English: Disposal:
Croatian: Zbrinjavanje:
English: Benepali is administered by an injection under the skin (subcutaneous use).
Croatian: Način i put primjene Benepali se daje injekcijom pod kožu (supkutano).
English: Benepali is available in packs containing 4 pre-filled pens and multipacks containing 12 (3 packs of 4) pre-filled pens.
Croatian: Benepali je dostupan u pakiranju koje sadrži 4 napunjene brizgalice i višestrukom pakiranju koje sadrži 12 napunjenih brizgalica (3 pakiranja s 4 napunjene brizgalice).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (50 mg PRE-FILLED SYRINGE)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (50 mg NAPUNJENA ŠTRCALJKA)
English: The possibility exists for TNF-antagonists, including etanercept, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Croatian: Budući da je TNF medijator upale te mijenja stanični imunološki odgovor, za sve antagoniste TNF-a, uključivši etanercept, postoji mogućnost utjecaja na obrambene reakcije bolesnika protiv infekcija i zloćudnih bolesti.
English: A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Croatian: Za liječenje djece s juvenilnim idiopatskim artritisom tjelesne težine ispod 25 kg bile bi prikladnije bočice etanercepta jačine 10 mg.
English: Please consult your doctor before you or the child receive any vaccines.
Croatian: Vi ili dijete primite bilo koje cjepivo, molimo posavjetujte se sa svojim liječnikom.
English: Contents of the pack and other information What Benepali contains
Croatian: Kako čuvati Benepali Sadržaj pakiranja i druge informacije Upute za primjenu (vidjeti na poleđini)
English: 25 mg etanercept administered twice weekly is the recommended dose.
Croatian: Preporučena doza je 25 mg etanercepta primijenjeno dvaput tjedno.
English: Neoplasms benign, malignant and
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine
English: Tel: + 39 (0)6 899 701 50
Croatian: Biogen Italia s.r.l. Tel: + 39 (0)6 899 701 50
English: Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Croatian: • Često (mogu se javiti u do 1 na 10 osoba): Alergijske reakcije; vrućica; osip; svrbež, nastanak protutijela na vlastito tkivo (autoprotutijela).
English: Benepali 50 mg solution for injection in pre-filled syringe etanercept
Croatian: NAZIV LIJEKA Benepali 50 mg otopina za injekciju u napunjenoj brizgalici etanercept
English: Etanercept has been reported to be excreted in human milk following subcutaneous administration.
Croatian: Nakon supkutane primjene etanercept se izlučuje u majčino mlijeko u ljudi.
English: Benepali 25 mg solution for injection in pre-filled syringe etanercept
Croatian: NAZIV LIJEKA Benepali 25 mg otopina za injekciju u napunjenoj štrcaljki etanercept
English: Benepali is available in packs containing 4 pre-filled pens and multipacks comprising 3 cartons, each containing 4 pre-filled pens.
Croatian: Benepali je dostupan u pakiranju koje sadrži 4 napunjene brizgalice i višestrukom pakiranju koje sadrži 3 kutije sa po 4 napunjene brizgalice.
English: Each pre-filled syringe contains 50 mg of etanercept.
Croatian: Jedna napunjena brizgalica sadrži 50 mg etanercepta.
English: Package leaflet: Information for the user Benepali 25 mg solution for injection in pre-filled syringe etanercept This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Benepali 25 mg otopina za injekciju u napunjenoj štrcaljki etanercept
English: Benepali is not indicated for use in children and adolescents who weigh less than 62.5 kg.
Croatian: Djeca i adolescenti Benepali nije indiciran za primjenu u djece i adolescenata tjelesne težine manje od 62,5 kg.
English: Administration of Benepali should be discontinued if a patient develops a serious infection.
Croatian: U slučaju razvoja ozbiljne infekcije primjena Benepalija mora se obustaviti.
English: Τηλ: + 357 22 00 04 93
Croatian: Genesis Pharma (Cyprus) Ltd Τηλ: + 357 22 00 04 93
English: Benepali is available in packs containing 4 pre-filled syringes and multipacks comprising 3 cartons, each containing 4 pre-filled syringes.
Croatian: Benepali je dostupan u pakiranju koje sadrži 4 napunjene štrcaljke i višestrukom pakiranju koje sadrži 3 kutije sa po 4 napunjene štrcaljke.
English: The solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein.
Croatian: Otopina bi trebala biti bistra do blago opalescentna, bezbojna ili svijetložuta i može sadržavati male prozirne ili bijele čestice proteina.
English: Merkel cell carcinoma (see section 4.4)
Croatian: Merkelovih stanica (vidjeti dio 4.4
English: It should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein.
Croatian: Trebala bi biti bistra do blago opalescentna, bezbojna ili svijetložuta i može sadržavati male bijele ili gotovo prozirne čestice proteina.
English: Class
Croatian: OBLIK
English: The medicine should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein.
Croatian: Otopina treba bi biti bistra do blago opalescentna, bezbojna ili svijetložuta i može sadržavati male bijele ili gotovo prozirne čestice proteina.
English: Benepali.
Croatian: napadaj
English: Package leaflet: Information for the user Benepali 50 mg solution for injection in pre-filled syringe etanercept This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Benepali 50 mg otopina za injekciju u napunjenoj štrcaljki etanercept
English: Biogen Poland Sp. z o.o.
Croatian: Biogen Netherlands B.V.
English: Biogen Netherlands B.V. Tel: + 31 (0)20 808 02 70
Croatian: Biogen Pharma d.o.o. Tel: + 386 (0)1 888 81 07
English: Package leaflet: Information for the user Benepali 50 mg solution for injection in pre-filled pen etanercept This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Benepali 50 mg otopina za injekciju u napunjenoj brizgalici etanercept
English: Excipients:
Croatian: eritem,
English: ● If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss,
Croatian: Ako se kod Vas pojave simptomi koji ukazuju na postojanje infekcije, poput vrućice, upornog kašlja, gubitka tjelesne težine ili bezvoljnosti, odmah se obratite liječniku.
English: There have been post-marketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking etanercept.
Croatian: U bolesnika koji su primali etanercept nakon stavljanja u promet zabilježena su pogoršanja bolesti kongestivnog zatajenja srca, sa i bez ustanovljivih pospješujućih čimbenika.
English: Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord);
Croatian: Ozbiljne infekcije (uključujući upalu pluća, infekciju dubokih slojeva kože, infekciju zglobova, infekciju krvi i infekcije na različitim mjestima); pogoršanje kongestivnog zatajenja srca; smanjenje broja crvenih krvnih stanica; smanjenje broja bijelih krvnih stanica; smanjen broj neutrofila (vrsta bijelih krvnih stanica); nizak broj krvnih pločica; rak kože (osim melanoma);
English: Benepali 50 mg solution for injection in pre-filled pen.
Croatian: Benepali 50 mg otopina za injekciju u napunjenoj brizgalici.
English: 25 mg/0.5 ml
Croatian: 25 mg 2 x tj.
English: Tel: + 420 228 884 152
Croatian: Česká republika Biogen (Czech Republic) s.r.o. Tel: + 420 228 884 152
English: PHARMACEUTICAL FORM AND CONTENTS
Croatian: OBLIK I SADRŽAJ Otopina za injekciju
English: PC SN NN
Croatian: Icepharma hf.
English: Method and route of administration
Croatian: OZNAČIVANJE I UPUTA O LIJEKU
English: Each pre-filled syringe contains 25 mg of etanercept.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna štrcaljka sadrži 25 mg etanercepta.
English: United Kingdom Clinigen Healthcare Ltd. Pitcairn House, Crown Square First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW
Croatian: Pitcairn House, Crown Square First Avenue, Burton-onTrent, Staffordshire,
English: Annex I List of medicinal products and presentations
Croatian: Popis naziva i farmaceutskih oblika, jačina i puteva primjene
English: These occur in more than 1 in 10 people.
Croatian: Te nuspojave nastupaju u više od 1 na 10 osoba.
English: The full EPAR for Ocrevus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Ocrevus nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ocrevus is used in two types of patients:
Croatian: Ocrevus se primjenjuje u dvjema skupinama bolesnika:
English: The first two infusions are given two weeks apart and subsequent infusions are given every six months.
Croatian: Prve dvije infuzije daju se s razmakom od dva tjedna, a naknade infuzije svakih šest mjeseci.
English: What is Ocrevus and what is it used for?
Croatian: Što je Ocrevus i za što se koristi?
English: Ocrevus ocrelizumab
Croatian: Ocrevus okrelizumab
English: If reactions occur during an infusion it may be stopped or given more slowly.
Croatian: Ako se tijekom infuzije pojave reakcije, ona se može prekinuti ili davati sporije.
English: The patient should be monitored during the infusion and for at least an hour afterwards, and facilities to manage severe reactions should be readily available.
Croatian: Potreban je nadzor bolesnika tijekom infuzije i barem jedan sat nakon nje, a oprema za upravljanje teškim reakcijama mora biti lako dostupna.
English: What measures are being taken to ensure the safe and effective use of Ocrevus?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ocrevus?
English: Before each infusion, the patient is given other medicines (a corticosteroid and an antihistamine) to help to prevent potentially dangerous reactions.
Croatian: Bolesnik prije svake infuzije dobiva druge lijekove (kortikosteroid i antihistaminik) koji pomažu u sprječavanju potencijalno opasnih reakcija.
English: Why is Ocrevus approved?
Croatian: Zašto je Ocrevus odobren?
English: Ocrevus must not be used in patients with active infections or severely weakened immune systems or in patients with cancer.
Croatian: Ocrevus se ne smije primjenjivati u bolesnika s aktivnim infekcijama ili jako oslabljenim imunosnim sustavom, niti u bolesnika oboljelih od raka.
English: The European Medicines Agency concluded that the benefits seen with Ocrevus outweighed its risks and recommended that it be authorised in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Ocrevus nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: This is a summary of the European public assessment report (EPAR) for Ocrevus.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ocrevus.
English: Other information about Ocrevus
Croatian: Ostale informacije o lijeku Ocrevus
English: • adults with primary progressive multiple sclerosis (PPMS), where symptoms get steadily worse over time.
Croatian: • odrasle osobe s primarno progresivnom multiplom sklerozom (PPMS), kada se simptomi tijekom vremena stalno pogoršavaju.
English: It is not intended to provide practical advice on how to use Ocrevus.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Ocrevus.
English: The most important and most frequently reported side effects with Ocrevus are infusion reactions (such as itching, rash, and difficulty breathing) and infections.
Croatian: Najvažnije i najčešće zabilježene nuspojave lijeka Ocrevus su reakcije na infuziju (kao što su svrbež, osip i otežano disanje) i infekcije.
English: What are the risks associated with Ocrevus?
Croatian: Koji su rizici povezani s lijekom Ocrevus?
English: The active substance in Ocrevus, ocrelizumab, is a monoclonal antibody designed to recognise and attach to a target called CD20 on the surface of certain types of white blood cells (so called B cells).
Croatian: Djelatna tvar u lijeku Ocrevus je okrelizumab, monoklonsko protutijelo osmišljeno za prepoznavanje ciljane tvari pod nazivom CD20 na površini određenih vrsta bijelih krvnih stanica (takozvane B-stanice) i vezivanje na nju.
English: In two studies of 1,656 patients with relapsing forms of multiple sclerosis (RMS), the average number of relapses in patients treated with Ocrevus was about half that in patients treated with another medicine interferon beta-1a (0.16 versus 0.29 relapses per year).
Croatian: U dvama ispitivanjima na 1 656 bolesnika s relapsirajućim oblicima multiple skleroze (RMS), prosječan broj relapsa u bolesnika liječenih lijekom Ocrevus bio je otprilike upola manji od broja relapsa u bolesnika koji su primali drugi lijek, interferon beta-1a (0,16 nasuprot 0,29 relapsa godišnje).
English: These white blood cells play a role in multiple sclerosis by attacking the sheaths around the nerves in the brain and spinal cord, causing inflammation and damage.
Croatian: Te bijele krvne stanice imaju ulogu u multiploj sklerozi jer napadaju ovojnice oko živaca u mozgu i leđnoj moždini, uzrokujući time upalu i oštećenja.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ocrevus have 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 Ocrevus nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Ocrevus is a medicine for treating multiple sclerosis - an inflammatory disease of the nervous system that causes symptoms such as weakness, difficulty walking and problems with vision.
Croatian: Ocrevus je lijek za liječenje multiple skleroze, upalne bolesti živčanog sustava koja uzrokuje simptome kao što su slabost, poteškoće s hodanjem i problemi s vidom.
English: Ocrevus can only be obtained with a prescription and treatment must only be started and supervised by a doctor experienced in treating diseases of the nerves.
Croatian: Ocrevus se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju bolesti živaca.
English: A third study, in 732 patients with primary progressive multiple sclerosis (PPMS), showed that fewer patients taking Ocrevus had worsening symptoms lasting 12 weeks or more (30%) compared with those taking a placebo (34%).
Croatian: U trećem ispitivanju na 732 bolesnika s primarno progresivnom multiplom sklerozom (PPMS), pogoršanje simptoma u trajanju od 12 ili više tjedana zabilježeno je u manje bolesnika koji su primali lijek Ocrevus (30 %) u usporedbi s bolesnicima koji su primali placebo (34 %).
English: By targeting the B cells, Ocrevus helps to reduce their activity and thereby relieves symptoms or slows down the worsening of the disease.
Croatian: Djelovanjem na B-stanice Ocrevus pomaže u smanjivanju njihove aktivnosti i time ublažava simptome ili usporava pogoršanje bolesti.