FrancophonIA/ELRC3.0 huggingface dataset:
English: DEX (6 mg/m 2/day, PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 1-56 Methotrexate (20 mg/m 2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
Croatian: = u mišić, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6-merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA = natrijev 2-merkaptoetan sulfonat, iii = ili dok vrijednost MTX-a ne bude <0,1 μM, Gy = Gray
English: Reinduction block 1 (3 weeks)
Croatian: Reindukcijska terapija 1 (3 tjedan)
English: 200 mg/m
Croatian: (doza od 340 mg/m²)
English: Breast-feeding
Croatian: Cerebralni edem*
English: monthly for 13 months;
Croatian: VCR 2 mg i.v. mjesečno tijekom 13 mjeseci;
English: Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision
Croatian: Edem kapaka, pojačano suzenje, konjunktivalno krvarenje, konjunktivitis, suhe oči, zamagljen vid
English: Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules
Croatian: Imatinib medac 100 mg tvrde kapsule Imatinib medac 400 mg tvrde kapsule
English: 9/l) and thrombocytopenias (platelet count < 50 x 10
Croatian: 9/l) i trombocitopenija (broj trombocita <50 x 10
English: • Rash.
Croatian: • osip
English: VCR (1.5 mg/m 2/day, IV): days 1, 29
Croatian: VCR (1,5 mg/m², i.v.): dani 1, 29
English: Imatinib medac 100 mg hard capsules Size “3” hard capsules with orange body and cap. Imatinib medac 400 mg hard capsules Size “00” hard capsules with caramel body and cap.
Croatian: Imatinib medac 100 mg tvrde kapsule Tvrde kapsule veličine “3” narančastog tijela i kapice.
English: Each 100 mg hard capsule of Imatinib medac contains 100 mg imatinib (as mesilate).
Croatian: Svaka tvrda kapsula Imatinib medaca od 100 mg sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: The dose of
Croatian: NAZIV LIJEKA
English: Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172)
Croatian: Ovojnica kapsule želatina željezov oksid, žuti (E172) titanijev dioksid (E171) željezov oksid, crveni (E172)
English: 9/l) and thrombocytopenia (platelet count < 10 x 10
Croatian: 9/l) i trombocitopenija (broj trombocita <10 x 10
English: (24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
Croatian: DEX 40 mg/dan na dane 1-4 i 11-14, izmjenjivano s MTX 1 g/m² i.v. (24 h), dan 1, Ara-C 1 g/m² i.v. (2 h, svakih 12 h), dani 2-3 (ukupno
English: Remission induction DEX 10 mg/m oral, days 6-7, 13-16; i.v.
Croatian: Indukcija remisije DEX 10 mg/m² peroralno, dani 6-7, 13-16; VCR 1 mg i.v., dani 7, 14;
English: Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate).
Croatian: Svaka tvrda kapsula Imatinib medaca od 400 mg sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: G-CSF (5 μg/kg, SC): days 34-43
Croatian: MESNA i.v.: dani 29-33 G-CSF (5 μg/kg, s.c.): dani 34-43
English: IV or PO q6h x 6 doses)iii:
Croatian: 6 sati x 6 doza)iii: dani 2 i 3
English: (3 h), days 1-4; Mitoxantrone 10 mg/m i.v.
Croatian: Ara-C 1000 mg/m²/12 h i.v.(3 h), dani 1-4; mitoksantron 10 mg/m² i.v. dani 3-5;
English: • paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+)
Croatian: • pedijatrijskih bolesnika s novodijagnosticiranom kroničnom mijeloičnom leukemijom (KML) s pozitivnim Philadelphia (Ph+) kromosomom (bcr-abl), u kojih se transplantacija koštane srži ne smatra prvom linijom liječenja,
English: (n = 5), 340 mg/m2/day (n = 7) and 570 mg/m 2/day (n = 5).
Croatian: Bolesnici su liječeni dozama imatiniba od 260 mg/m²/dan (n=5), 340 mg/m²/dan (n=9), 440 mg/m²/dan (n=7), te 570 mg/m²/dan (n=5).
English: Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172)
Croatian: Ovojnica kapsule želatina željezov oksid, žuti (E172) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni E172)
English: 2/day, IV): days 1, 8 and 15 2/day bolus, IV): days 1 and 2 2/dose q12h x 4 doses, iv): Days 3 and 4 2, IM): day 4 G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15 2/day, PO): days 1-7 and 15-21
Croatian: ARA-C (3 g/m²/doza svakih 12 sati x 4, i.v.): dani 2 i 3 G-CSF (5 μg/kg, s.c.): dani 4-13 ili do porasta ABN >1500 nakon najniže izmjerene vrijednosti
English: Imatinib medac 400 mg hard capsules Capsule content
Croatian: Imatinib medac 400 mg tvrde kapsule imatinib
English: Imatinib medac 100 mg hard capsules Capsule content
Croatian: Imatinib medac 100 mg tvrde kapsule imatinib
English: Renal failure chronic Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki Manje često:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg of imatinib (as mesilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: • Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
Croatian: • teška glavobolja, slabost ili paraliza udova ili lica, otežan govor, iznenadni gubitak svijesti
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 400 mg of imatinib (as mesilate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tvrda kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: Table 1 Tabulated summary of adverse reactions Infections and infestations
Croatian: Terapijska indikacija Toksični učinci: neutropenija i
English: Haematological adverse reactions
Croatian: Hematološke nuspojave
English: (1 h), days 28-31, 35-38, 42-45;
Croatian: Ara-C 75 mg/m² i.v. (1 h), dani 28-31, 35-38, 42-45; 6-MP 60 mg/m² peroralno, dani 26-46
English: Mild
Croatian: Umjereni
English: Avascular necrosis/hip necrosis*, growth retardation in children* Renal and urinary disorders
Croatian: Avaskularna nekroza/nekroza kuka*, zastoj u rastu kod djece* Poremećaji bubrega i mokraćnog sustava Manje često:
English: months (range 24 days - 60 months).
Croatian: Ti su bolesnici primali imatinib za medijan od 47 mjeseci (raspon 24 dana - 60 mjeseci).
English: Eye disorders
Croatian: • oslabljen sluh
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Croatian: • mučnina, nedostatak zraka, nepravilni otkucaji srca, zamućenje mokraće, umor i/ili osjećaj nelagode u zglobovima udruženi s poremećenim nalazima laboratorijskih pretraga (npr. visoke razine kalija, mokraćne kiseline i kalcija te niske razine fosfora u krvi).
English: ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Croatian: Ara-C 2x 2 g/m² i.v. (3 h, svakih 12 h), dan 5
English: Chest pain, malaise
Croatian: Bol u prsnom košu, malaksalost
English: 9/l.
Croatian: 9/l) bila između 4 i
English: • Mouth ulcers.
Croatian: • čirevi u ustima
English: Gastrointestinal disorders Very common: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain
Croatian: Mučnina, proljev, povraćanje, dispepsija, bol u trbuhu
English: G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Croatian: MESNA (360 mg/m²/doza svaka 3 sata x 8 doza/dan, i.v.): dani 1-5 G-CSF (5 μg/kg, s.c.): dani 6-15 ili do porasta ABN >1500 nakon najniže izmjerene vrijednosti i.t. metotreksat (prilagođeno dobi): SAMO dan 1
English: Frequency categories are defined using the following convention: very common
Croatian: Pretrage Vrlo često: Često:
English: Imatinib medac 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Imatinib medac 100 mg tvrde kapsule Svaka tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib.
Croatian: Uz imatinib su uočeni slučajevi oštećenja jetre, uključujući zatajenje jetre i jetrenu nekrozu.
English: Methotrexate (5 g/m over 24 hours, IV): days 1 and 15 at hour 36, IV; 15 mg/m
Croatian: Metotreksat (5 g/m² kroz 24 sata, i.v.): dani 1 i 15
English: Nervous system disorders
Croatian: Konfuzno stanje Poremećaji živčanog sustava Vrlo često:
English: Ara-C 1,000 mg/m2/12 h i.v.
Croatian: CP 500 mg/m² i.v.(1 h) dan 1;
English: Weakness, pyrexia, anasarca, chills, rigors
Croatian: Slabost, vrućica, anasarka, zimica, tresavica
English: Flushing, haemorrhage
Croatian: Pancitopenija, febrilna neutropenija
English: 9/l, no blood blasts, BM blasts < 5 % and no extramedullary disease] NEL: Same criteria as for CHR but ANC ≥ 1 x 10
Croatian: NEL: Isti kriteriji kao za CHR, ali je ABN ≥1 x 10
English: (0.5 h), days 7, 8, 14, 15; i.v., days 22-25, 29-32
Croatian: Ara-C 60 mg/m² i.v., dani 22-25, 29-32
English: Clinical studies in chronic myeloid leukaemia
Croatian: Pedijatrijska kronična faza KML-a
English: The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
Croatian: Za odrasle bolesnike s Ph+ ALL-om preporučena doza imatiniba iznosi 600 mg/dan.
English: In the event of recurrence of ANC < 1.0 x10
Croatian: 3. U slučaju da je ABN ponovno <1,0 x10 9/l i/ili trombociti <50 x10
English: VCR (1.5 mg/m 2/day, IV): days 1, 8, and 15 DAUN (45 mg/m 2/day bolus, IV): days 1 and 2
Croatian: VCR (1,5 mg/m²/dan, i.v.): dani 1, 8, i 15
English: In the event of recurrence of ANC < 1.0 x 10
Croatian: 3. U slučaju da je ABN ponovno <1,0 x 109/l i/ili trombociti <50 x 10
English: Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Croatian: Ara-C 40 mg intratekalno, dani 1, 8, 15, 22; metilprednizolon 40 mg intratekalno, dani 1, 8, 15, 22
English: Vitreous haemorrhage* Ear and labyrinth disorders
Croatian: Hemoragična cista žutog tijela/hemoragična cista jajnika
English: The starting dose is 400 mg, to be taken as 1 capsule of 400 mg once a day.
Croatian: • Ako se liječite zbog MDS/MPD-a: Početna doza je 400 mg, a uzima se kao 1 kapsula od 400 mg jednom na dan.
English: (24 h), day 1; Etoposide 250 mg/m i.v.
Croatian: MTX 1,5 g/m² i.v. (24 h), dan 1; etopozid 250 mg/m² i.v. (1 h) dani 4-5;
English: The recommended dose of imatinib is 100 mg/day for patients with HES/CEL.
Croatian: Za bolesnike s HES/KEL-om preporučena doza imatiniba iznosi 100 mg/dan.
English: • Stomach pain with feeling sick (nausea).
Croatian: • bol u trbuhu s mučninom
English: The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis.
Croatian: Za odrasle bolesnike u blastičnoj krizi preporučena doza imatiniba iznosi 600 mg/dan.
English: Pharmacokinetics of imatinib
Croatian: Farmakokinetika imatiniba
English: Study AJP01 Induction therapy i.v.
Croatian: Studija AUS01 Indukcijskokonsolidacijska terapija
English: Further information on MabThera can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/mabthera.
Croatian: Više informacija o lijeku MabThera dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/mabthera.
English: Depending on the condition being treated, the patients can also be given other medicines.
Croatian: Ovisno o bolesti koja se liječi, bolesnicima se mogu davati i drugi lijekovi.
English: It can only be obtained with a prescription.
Croatian: Izdaje se samo na recept.
English: Before each infusion or injection, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine for fever).
Croatian: Prije svake infuzije ili injekcije bolesniku je potrebno dati antihistaminik (kako bi se spriječile alergijske reakcije) i antipiretik (lijek protiv vrućice).
English: What measures are being taken to ensure the safe and effective use of MabThera?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka MabThera?
English: In addition, the medicine should be given under the close supervision of an experienced healthcare professional and in an environment where facilities for resuscitating patients are immediately available.
Croatian: Osim toga, lijek je potrebno davati pod pomnim nadzorom iskusnog zdravstvenog radnika i u okruženju u kojem su izravno dostupni odjeli za oživljavanje bolesnika.
English: What is MabThera and what is it used for?
Croatian: Što je MabThera i za što se koristi?
English: MabThera received a marketing authorisation valid throughout the EU on 2 June 1998.
Croatian: Lijek MabThera dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 2. lipnja 1998.
English: MabThera (rituximab)
Croatian: MabThera (rituksimab)
English: The formulation injected under the skin must also not be used in patients who are allergic to a substance called hyaluronidase.
Croatian: Formulacija koja se injicira pod kožu ne smije se primjenjivati u bolesnika koji su alergični na tvar koja se naziva hijaluronidaza.
English: ‘Autoimmune' means that the disease is caused by the immune system (the body's natural defences) attacking the body's own cells.
Croatian: je bolest uzrokovana napadom imunosnog sustava (prirodne obrane tijela) na vlastite stanice tijela.
English: Some results from the main studies on the benefits of MabThera are described below:
Croatian: Neki od rezultata glavnih ispitivanja o koristi lijeka MabThera opisani su u nastavku:
English: A second study in 117 patients looked at the proportion of patients whose condition came back within 28 months.
Croatian: U drugome ispitivanju se kod 117 bolesnika istražio udio bolesnika kod kojih se bolest vratila unutar 28 mjeseci.
English: All doctors administering MabThera under the skin will also receive educational material to minimise the risk of improper use or errors.
Croatian: Svi liječnici koji primjenjuju lijek MabThera pod kožu također će dobiti edukativne materijale kako bi se rizik od nepravilne primjene ili grešaka sveo na najmanju moguću mjeru.
English: An overview of MabThera and why it is authorised in the EU
Croatian: Pregled informacija o lijeku MabThera i zašto je odobren u EU-u
English: Other information about MabThera
Croatian: Ostale informacije o lijeku MabThera
English: The European Medicines Agency decided that MabThera's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka MabThera nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: Side effects reported with MabThera are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek MabThera pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Patients with rheumatoid arthritis, GPA, MPA or pemphigus must not receive MabThera if they have severe heart problems.
Croatian: Bolesnici s reumatoidnim artritisom i bolestima GPA, MPA ili pemfigus ne smiju primati lijek MabThera ako imaju ozbiljne probleme sa srcem.
English: MabThera is a medicine used to treat the following blood cancers and inflammatory conditions:
Croatian: MabThera je lijek koji se koristi za liječenje sljedećih vrsta raka krvi i upala u odraslih:
English: MabThera is given as an infusion (drip) into a vein.
Croatian: MabThera daje se kao infizija (drip) u venu.
English: Why is MabThera authorised in the EU?
Croatian: Zašto je lijek MabThera odobren u EU-u?
English: What is the risk associated with MabThera?
Croatian: Koji su rizici povezani s lijekom MabThera?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of MabThera 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 MabThera nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Following 2 years of treatment, 90% of patients treated with MabThera and shortterm (up to 6 months) prednisone were in complete remission (meaning that skin and mucosa had healed and there were no new or old lesions) after stopping prednisone for 2 months or more, compared with 28% of patients treated with prednisone alone.
Croatian: Nakon dvije godine liječenja, 90 % bolesnika koji su primali lijek MabThera i kratkotrajno prednizon (do najviše 6 mjeseci) bili su u potpunoj remisiji (koža i sluznica su zacijelile i nisu postojale ni stare ni nove lezije) nakon što su prestali uzimati prednizon dva mjeseca ili duže u usporedbi s 28 % bolesnika koji su uzimali prednizon kao monoterapiju.
English: A maintenance study in previously untreated patients showed the likelihood for the disease to get worse was reduced by 50% for patients who received MabThera.
Croatian: Ispitivanje terapije održavanja u prethodno neliječenih bolesnika pokazalo je da se vjerojatnost pogoršanja smanjuje na 50 % u bolesnika koji primaju lijek MabThera.
English: Depending on the condition it is used to treat, MabThera may be given on its own, or with chemotherapy, methotrexate or a corticosteroid.
Croatian: Ovisno o bolesti koju liječi, MabThera se može koristiti kao monoterapija ili u kombinaciji s kemoterapijom, metotreksatom ili kortikostereoidima.
English: MabThera is available as a concentrate that is made up into the solution for infusion and as a readymade solution for the injection under the skin.
Croatian: Lijek MabThera dostupan je u obliku koncentrata od kojeg se priprema otopina za infuziju i kao gotova otopina za injekciju pod kožu.
English: MabThera must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system.
Croatian: MabThera se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na rituksimab, mišje bjelančevine ili bilo koje druge sastojke lijeka ili u bolesnika s jakom infekcijom ili značajno oslabljenim imunosnim sustavom.
English: Studies show MabThera to be effective in treating all the conditions for which it is approved.
Croatian: Ispitivanja su pokazala da je lijek MabThera učinkovit u liječenju svih bolesti za koje je dobio odobrenje.
English: As for all medicines, data on the use of MabThera are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka MabThera kontinuirano se prate.
English: These patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they experience symptoms of infection.
Croatian: Ti će bolesnici primiti i karticu s upozorenjima koju uvijek trebaju nositi sa sobom i na kojoj piše da se u slučaju simptoma infekcije odmah obrate liječniku.
English: • chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);
Croatian: • kronične limfocitne leukemije (KLL, druge vrste raka krvi koji pogađa bijele krvne stanice);
English: For more information about using MabThera, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka MabThera pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: The active substance in MabThera, rituximab, is a monoclonal antibody designed to recognise and attach to a protein called CD20 present on the surface of B-lymphocytes.
Croatian: Djelatna tvar u lijeku MabThera je rituksimab, monoklonsko protutijelo koje je osmišljeno za prepoznavanje i vezivanje na bjelančevinu naziva CD20, prisutnu na površini B-limfocita.
English: The company marketing MabThera will provide doctors and patients using the medicine for rheumatoid arthritis, GPA, MPA or pemphigus with educational material on the risk of infection including of a rare severe infection known as progressive multifocal leukoencephalopathy (PML).
Croatian: Tvrtka koja stavlja lijek MabThera u promet osigurat će liječnicima i bolesnicima koji koriste taj lijek za reumatoidni artritis, bolesti GPA, MPA i pemfigus edukativne materijale s informacijama o riziku od infekcija, uključujući informacije o riziku od rijetke i ozbiljne infekcije naziva progresivna multifokalna leukoencefalopatija (PML).
English: When rituximab attaches to CD20, it causes the death of B-lymphocytes, which helps in lymphoma and CLL (where B-lymphocytes have become cancerous) and in rheumatoid arthritis (where B-lymphocytes are involved in joint inflammation).
Croatian: Kad se rituksimab veže na bjelančevinu CD20, uzrokuje smrt B-limfocita, što pomaže u bolesnika s limfomom i KLL-om (kod kojih su B-limfociti postali kancerogeni) i bolesnika s reumatoidnim artritisom (bolesti pri kojoj su B-limfociti uključeni u upalu zglobova).
English: The company that markets MabThera will also submit reports from a study on the effectiveness of MabThera in previously diagnosed pemphigus vulgaris patients and on the long-term effects of the medicine on the progression of the disease.
Croatian: Tvrtka koja stavlja lijek MabThera u promet također će dostaviti izvješća o ispitivanju djelotvornosti lijeka MabThera u bolesnika s prethodno dijagnosticiranim običnim pemfigusom te o dugotrajnim učincima lijeka u pogledu napredovanja bolesti.
English: • In a study of 517 patients with rheumatoid arthritis, MabThera was more effective than placebo: 51% of the patients receiving MabThera had an improvement in symptoms, compared with 18% of the patients receiving placebo.
Croatian: • U ispitivanju provedenom na 517 bolesnika s reumatoidnim artritisom, lijek MabThera bio je učinkovitiji od placeba: u 51 % bolesnika koji su primali lijek MabThera došlo je do ublažavanja simptoma u usporedbi s 18 % bolesnika koji su primali placebo.
English: The most common side effects with MabThera intravenous infusions are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heart-related problems.
Croatian: Najčešće nuspojave uočene kod intravenskih infuzija lijeka MabThera su reakcije povezane s infuzijom (kao što su vrućica, zimica i drhtavica), a najčešće su teške nuspojave reakcije na infuziju, infekcije i problemi sa srcem.
English: Similar side effects are seen when MabThera is injected under the skin, with the exception of reactions around the injections site (pain, swelling and rash), which occur more frequently with the skin injections.
Croatian: Slične nuspojave uočene su kod injiciranja lijeka MabThera pod kožu, uz iznimku reakcija oko mjesta injekcije (bol, oticanje i osip) koje su kod potkožnih injekcija bile češće.
English: The study showed that only 5% of patients treated with MabThera had a relapse, compared with 29% of patients treated with azathioprine (another medicine used to treat GPA and MPA).
Croatian: Ispitivanjem se pokazalo da je kod samo 5 % bolesnika koji su primali lijek MabThera zabilježen relaps u usporedbi s 29 % bolesnika liječenih azatioprinom (još jedan lijek protiv bolesti GPA i MPA).
English: In GPA and MPA, destroying the B-lymphocytes lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Croatian: U bolesnika s bolestima GPA i MPA uništavanje Blimfocita smanjuje proizvodnju protutijela za koja se smatra da imaju važnu ulogu u napadu na krvne žile i uzrokovanje upale.