FrancophonIA/ELRC3.0 huggingface dataset:
English: Gently massage the base of the ear for 30 seconds to allow distribution of the solution.
Croatian: Nježno masirajte bazu uha 30 sekundi kako biste omogućili da se otopina raspodjeli.
English: If symptoms develop, seek medical advice and show the package leaflet or the label to the physician.
Croatian: Ako se pojave simptomi, treba potražiti savjet liječnika i pokazati mu uputu ili etiketu.
English: Compatibility with ear cleaners, other than saline solution, has not been demonstrated.
Croatian: Kompatibilnost s drugim sredstvima za čišćenje uha, osim fiziološke otopine, nije dokazana.
English: Pack sizes: 2, 10 or 20 tubes.
Croatian: 15. OSTALE INFORMACIJE Veličina pakovanja: 2, 10 ili 20 tuba.
English: Decreased in vitro susceptibility to terbinafine has been reported for strains of Malassezia pachydermatis which form biofilms.
Croatian: Smanjena in vitro osjetljivost na terbinafin zabilježena je za sojeve Malassezia pachydermatis koji formiraju biofilm.
English: Do not use during pregnancy and lactation.
Croatian: Ne smije se primjenjivati tijekom graviditeta i laktacije.
English: Caution should be taken to prevent the veterinary medicinal product from getting into the eyes of the dog being treated e.g. by restraining the dog's head to prevent shaking (see section 4.9).
Croatian: Treba voditi računa da se spriječi da veterinarsko-medicinski proizvod ne dospije u oči psa koji se liječi npr. treba obuzdati glavu psa da se spriječi otresanje glavom (vidi odjeljak 4.9).
English: Caution should be taken to prevent the veterinary medicinal product from getting into the eyes of the dog being treated e.g. by restraining the dog's head to prevent shaking (see section “advice on correct administration”).
Croatian: Treba voditi računa da se spriječi da veterinarsko-medicinski proizvod dospije u oči psa koji se liječi npr. treba obuzdati glavu psa da se spriječi otresanje glavom (vidi odjeljak Savjeti za ispravnu primjenu).
English: Clean and dry the external ear canal before administering the product.
Croatian: Očistite i osušite vanjski slušni kanal prije primjene proizvoda.
English: Prolonged and intensive use of topical corticosteroid preparations is known to trigger systemic effects, including suppression of adrenal function (see section 4.10).
Croatian: Poznato je da produljena i intenzivna lokalna primjena kortikosteroida izaziva sistemske učinke, uključujući supresiju funkcije nadbubrežne žlijezde (vidi djeljak 4.10).
English: The most prominent effects were consistent with glucocorticoid administration; specific observations included suppression of the adrenal cortical response to ACTH-stimulation, decreased adrenal weight and atrophy of the adrenal cortex, decreased absolute lymphocyte and eosinophil counts, increased absolute neutrophil count, increased liver weight with hepatocellular enlargement/cytoplasmic change, and decreased thymus weight.
Croatian: Najistaknutiji učinci bili su dosljedni primjeni glukokortikoida; posebna opažanja uključivala su supresiju adrenalnog kortikalnog odgovora na stimulaciju ACTH, smanjenu adrenalnu masu i atrofiju adrenalnog korteksa, smanjen apsolutan broj limfocita i eozinofila, povećan apsolutan broj neutrofila, povećanu masu jetre s hepatocelularnim povećanjem/citoplazmatskom promjenom i smanjenu masu timusa.
English: Insert the applicator nozzle into the affected external ear canal and squeeze the entire contents into the ear.
Croatian: Umetnite aplikator u vanjski slušni kanal bolesnog uha i ispraznite cijeli sadržaj.
English: Florfenicol resistance genes detected in staphylococci include cfr and fexA.
Croatian: Geni za rezistenciju otkriveni kod stafilokoka uključuju cfr i fexA.
English: Ataxia, internal ear disorder, nystagmus, emesis, application site erythema, hyperactivity, anorexia and application site inflammation were reported very rarely in spontaneous (pharmacovigilance) reports.
Croatian: Ataksija, poremećaji unutarnjeg uha, nistagmus, povraćanje, eritem na mjestu aplikacije, hiperaktivnost, anoreksija i upala na mjestu aplikacije zabilježeni su vrlo rijetko.
English: The main findings observed at the 1X dose were decreases in cortical response to ACTH stimulation, decreased absolute lymphocyte and eosinophil counts, and decreased adrenal weight.
Croatian: Glavna otkrića primijećena kod doze 1X su smanjenje kortikalnog odgovora na ACTH stimulaciju, smanjenje apsolutnog broja limfocita i eozinofila i smanjenje težine nadbubrežne žlijezde.
English: Single-use sealed laminated tube containing 1 ml solution, with polypropylene cap and separate LDPE applicator nozzle packed in a transparent plastic blister.
Croatian: Jednodozna laminirana tuba s poklopcem koja sadrži 1 mL otopine, s polipropilenskom kapicom i posebnim LDPE aplikatorom u prozirnom plastičnom blisteru.
English: This combination is intended for the treatment of acute otitis when mixed infections caused by Staphylococcus pseudintermedius susceptible to florfenicol and Malassezia pachydermatis susceptible to terbinafine have been demonstrated.
Croatian: Ova kombinacija je namijenjena za liječenje akutne upale vanjskog uha kada je dokazana mješovita infekcija sa Staphylococcus pseudintermedius osjetljivim na florfenikol i Malassezia pachydermatis osjetljivom na terbinafin.
English: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324
Croatian: KVP Pharma + Veterinär Produkte GmbH
English: In case of accidental skin contact, wash exposed skin thoroughly with water.
Croatian: U slučaju nehotičnog kontakta, izložene dijelove kože treba temeljito isprati vodom.
English: Re-evaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment.
Croatian: Ukoliko je došlo do gubitka sluha ili znakova vestibularne disfunkcije tijekom liječenja potrebno je ponovo pregledati psa.
English: Auricular administration of up to five times the recommended dose at biweekly intervals for a total of three treatments was generally well tolerated.
Croatian: Primjena u uho peterostruke preporučene doze u dvotjednim razmacima, sveukupno u tri primjene, općenito se dobro podnosi.
English: In case of exposure to the eye, rinse with plenty of water.
Croatian: U slučaju da dospije u oko treba ga isprati obilno vodom.
English: Clean with saline solution and dry the external ear canal before administering the product.
Croatian: Očistite fiziološkom otopinom i osušite vanjski slušni kanal prije primjene proizvoda.
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic).
Croatian: Veterinarsko-medicinski proizvod je fiksna kombinacija tri djelatne tvari (kortikosteroida,
English: Mean peak plasma concentrations (Cmax) were low with 1.73 ng/ml florfenicol, 0.35 ng/ml mometasone furoate and 7.83 ng/ml terbinafine HCl reached at the tmax of 24 h, 0.5 h and 20 h after treatment, respectively.
Croatian: Srednje maksimalne koncentracije u plazmi (Cmax) bile su niske s 1,73 ng/ml florfenikola, 0,35 ng/ml mometazon furoata i 7,83 ng/ml terbinafin HCl postignutim u tmax od 24
English: Target animal safety was not studied in dogs under 4 kg bodyweight.
Croatian: Neškodljivost kod ciljnih vrsta nije ispitana kod pasa lakših od 4 kg.
English: In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog gutanja odmah potražite savjet liječnika i pokažite mu uputu ili etiketu.
English: Prolonged and intensive use of topical corticosteroid preparations is known to trigger systemic effects, including suppression of adrenal function.
Croatian: Poznato je da produljena i intenzivna lokalna primjena kortikosteroida izaziva sistemske učinke, uključujući supresiju funkcije nadbubrežne žlijezde.
English: Use of the veterinary medicinal product deviating from the instructions given in the Summary of Product Characteristics (SPC) may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.
Croatian: Primjena veterinarsko-medicinskog proizvoda koja se razlikuje od uputa danih u Sažetku opisa svojstava (SPC) može povećati prevalenciju bakterija otpornih na florfenikol i gljivica otpornih na terbinafin te može smanjiti učinkovitost liječenja drugim antibioticima i antifungicima.
English: Avoid ingestion of the product including hand-to-mouth exposure.
Croatian: Treba izbjegavati gutanje uključujući i kontakt ruku s ustima.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Blister
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: Use of the veterinary medicinal product deviating from the instructions given in the package leaflet may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.
Croatian: Primjena veterinarsko-medicinskog proizvoda koja se razlikuje od uputa danih u Sažetku opisa svojstava može povećati prevalenciju bakterija otpornih na florfenikol i gljivica otpornih na terbinafin te može smanjiti učinkovitost liječenja drugim antibioticima i antifungicima.
English: Terbinafine hydrochloride: 16.7 mg, equivalent to terbinafine base: 14.9 mg Mometasone furoate: 2.2 mg
Croatian: Terbinafin hidroklorid: 16,7 mg, ekvivalentno terbinafinskoj bazi: 14,9 mg Mometazon furoat: 2,2 mg
English: In animals with a history of recurrent otitis externa, the underlying causes of the condition such as allergy or anatomical conformation of the ear must be addressed in order to avoid ineffective treatment with a veterinary medicinal product.
Croatian: Kod životinja s povijesti recidiva upale vanjskog uha, potrebno je odrediti primarni uzrok koji može biti alergija ili anatomska građa uha kako bi se izbjeglo neučinkovito liječenje s veterinarsko-medicinskim proizvodom.
English: Ear drops, solution.
Croatian: Kapi za uho, otopina
English: One dose (1 ml) contains 16.7 mg florfenicol, 16.7 mg terbinafine hydrochloride (equivalent to 14.9 mg terbinafine base) and 2.2 mg mometasone furoate.
Croatian: Jedna doza (1 mL) sadržava 16,7 mg florfenikola, 16,7 mg terbinafin hidroklorida (ekvivalentno 14,9 mg baze terbinafina) i 2,2 mg mometazon furoata.
English: FexA codes for a membrane associated efflux system (affecting both florfenicol and chloramphenicol efflux) and is found in chromosomes as well as in plasmids.
Croatian: (koji utječe na efluks florfenikola i kloramfenikola) i pronađen je u kromosomima kao i u plazmidima.
English: PACKAGE LEAFLET: Neptra ear drops solution for dogs
Croatian: UPUTA O VMP: Neptra kapi za uho, otopina za pse
English: Neptra ear drops solution for dogs
Croatian: Neptra kapi za uho, otopina za pse
English: While holding the single-use container in an upright position, remove the cap. Use the upper end of the cap to completely break the seal and then remove cap from the single-use container.
Croatian: Pomoću gornjeg djela kapice probušite membranu i zatim uklonite kapicu s jednodoznog spremnika.
English: Bayer Animal Health GmbH 51368 Leverkusen Germany
Croatian: 51368 Leverkusen Njemačka
English: 1 dose (1 ml): 16.7 mg terbinafine hydrochloride, 16.7 mg florfenicol, 2.2 mg mometasone furoate
Croatian: 1 doza (1 mL): 16,7 mg terbinafin hidloklorida, 16,7 mg florfenikola, 2,2 mg mometazon furoata FARMACEUTSKI
English: Water, purified
Croatian: Makrogol 8000 Voda, pročišćena
English: Screw the applicator nozzle onto the single-use container.
Croatian: Pričvrstite aplikator na jednodozni spremnik.
English: 24106 Kiel
Croatian: Projensdorfer Str. 324, 24106 Kiel
English: Do not use if the ear drum is perforated.
Croatian: Ne primjenjivati u slučaju perforacije bubnjića.
English: Neptra ear drops solution for dogs terbinafine hydrochloride/florfenicol/mometasone furoate
Croatian: Neptra kapi za uho, otopina za pse Terbinafin hidroklorid/florfenikol/mometazon furoat
English: Neptra ear drops solution for dogs florfenicol/terbinafine hydrochloride/mometasone furoate
Croatian: Neptra kapi za uho, otopina za pse florfenikol/terbinafin hidroklorid/mometazon furoat
English: It selectively inhibits the early synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis (MIC90 of 1 μg/ml).
Croatian: Selektivno inhibira ranu sintezu ergosterola koji je esencijalna komponenta stanične stjenke kvasca i gljivica, uključujući Malassezia pachydermatis (MIC90 od 1 μg/ml).Terbinafin hidroklorid ima drugačiji način djelovanja od azolnih antimikotika, stoga nema unakrižne rezistencije s azolnim antimikoticima.
English: is low (MIC90 > 128 µg/ml).
Croatian: In vitro djelovanje florfenikola na Pseudomonas spp. prilično je nisko (MIC90 > 128 µg/ml).
English: Administration by a veterinarian surgeon or under their close supervision.
Croatian: Proizvod smije primijeniti veterinar ili se mora primijeniti pod strogim nadzorom veterinara.
English: Neptra ear drops for dogs terbinafine hydrochloride, florfenicol, mometasone furoate (EN or Latin)
Croatian: Neptra kapi za uho za pse terbinafini hydrochloridum, florfenicolum, mometasoni furoas
English: Auricular use.
Croatian: Primjena u uho.
English: Propylene carbonate Propylene glycol Ethanol (96 per cent) Macrogol 8000
Croatian: Etanol (96%)
English: For the treatment of acute canine otitis externa or acute exacerbations of recurrent otitis caused by mixed infections of susceptible strains of bacteria sensitive to florfenicol (Staphylococcus pseudintermedius) and fungi sensitive to terbinafine (Malassezia pachydermatis).
Croatian: Za liječenje akutne upale vanjskog slušnog kanala kod pasa ili akutnog pogoršanja recidiva upale vanjskog slušnog kanala, uzrokovane mješovitim infekcijama s bakterijama osjetljivim na florfenikol
English: 16.7 mg terbinafine hydrochloride, 16.7 mg florfenicol, 2.2 mg mometasone furoate
Croatian: 16,7 mg terbinafin hidroklorida, 16,6 mg florfenikola, 2,2 mg mometazon furoata SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
English: Marketing authorisation holder: Bayer Animal Health GmbH 51368 Leverkusen Germany
Croatian: Bayer Animal Health GmbH
English: Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324, 24106 Kiel
Croatian: Projensdorfer Str. 324 24106 Kiel NJEMAČKA
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Njemačka BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET
English: EMA/537274/2017
Croatian: EMA/537274/2017 EMEA/H/C/004724
English: The risk of such reactions decreases in subsequent infusions.
Croatian: Rizik od takvih reakcija smanjuje se tijekom kasnijih infuzija.
English: Previously known as Tuxella.
Croatian: Prethodno poznat pod nazivom Tuxella.
English: The full EPAR for Rituzena can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Rituzena nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The name of the product was changed to Rituzena on 4 August 2017.
Croatian: Ime lijeka izmijenjeno je u Rituzena 4. kolovoza 2017.
English: Patients with GPA or MPA must also not receive Rituzena if they have severe heart problems.
Croatian: Bolesnici s bolestima GPA ili MPA ne smiju primati lijek Rituzena ako imaju ozbiljne probleme sa srcem.
English: The European Commission granted a marketing aithorisation valid throughout the European Union for Tuxella on 13 July 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je na snazi za lijek Tuxella u Europskoj uniji od 13. srpnja 2017.
English: What is Rituzena and what is it used for?
Croatian: Što je Rituzena i za što se koristi?
English: This means that Rituzena is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: Drugim riječima, lijek Rituzena vrlo je sličan biološkom lijeku (poznatom kao „referentni lijek”) koji je već odobren u Europskoj uniji (EU).
English: This is a summary of the European public assessment report (EPAR) for Rituzena.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Rituzena.
English: In this study improvement was seen in 96% of cases (67 of 70 patients) with Rituzena and 90% (63 of 70 patients) with Rituxan.
Croatian: U tom ispitivanju zabilježeno je poboljšanje u 96 % slučajeva (67 od 70 bolesnika) koji su uzimali lijek Rituzena i 90 % (63 od 70 bolesnika) koji su uzimali lijek Rituxan.
English: Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare and severe brain infection known as progressive multifocal leukoencephalopathy (PML).
Croatian: Druge ozbiljne nuspojave uključuju ponovnu aktivaciju hepatitisa B (ponovno javljanje virusne upale jetre zbog hepatitisa B) te rijetku i ozbiljnu upalu mozga poznatu kao progresivna multifokalna leukoencefalopatija (PML).
English: Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine to reduce fever).
Croatian: Prije svake infuzije bolesniku je potrebno dati antihistaminik (kako bi se spriječile alergijske reakcije) i antipiretik (lijek protiv vrućice).
English: (MPA), which are inflammatory conditions of the blood vessels.
Croatian: (MPA), upalnih stanja krvnih žila.
English: Rituzena is a ‘biosimilar medicine'.
Croatian: Rituzena je „biosličan lijek”.
English: Depending on the condition it is used to treat, Rituzena may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids).
Croatian: Ovisno o bolesti koja se liječi, Rituzena se može primjenjivati uz kemoterapiju (drugi lijekovi za rak) ili lijekove koji se koriste za upalne poremećaje (kortikosteroidi).
English: The study showed that Rituzena 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 Rituzena and 73% (43 of 59 patients) with MabThera.
Croatian: Ispitivanje je pokazalo da lijekovi Rituzena i MabThera imaju usporedive učinke na simptome artritisa: udio bolesnika s 20 % poboljšanja u ocjeni simptoma (ACR20) nakon 24 tjedna primjene lijeka Rituzena iznosio je 74 % (114 od 155 bolesnika), u odnosu na 73 % (43 od 59 bolesnika) koji su uzimali lijek MabThera.
English: The most common serious side effects are infusion reactions, infections and, in cancer patients, heart-related problems.
Croatian: Najčešće ozbiljne nuspojave su reakcije na infuziju, infekcije te, kod bolesnika koji boluju od raka, srčani problemi.
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in most cancer patients and in more than 1 in 10 GPA or MPA patients at the time of the first infusion.
Croatian: Najčešće nuspojave rituksimaba su reakcije povezane s infuzijom (kao što su vrućica, drhtavica i zimica), koje se pojavljuju kod većine bolesnika oboljelih od raka i kod više od 1 na 10 osoba koje boluju od GPA i MPA bolesti nakon prve infuzije.
English: What are the risks associated with Rituzena?
Croatian: Koji su rizici povezani s lijekom Rituzena?
English: Doctors prescribing Rituzena for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Croatian: Liječnici koji propisuju lijek Rituzena dobit će edukativne materijale koji ih podsjećaju na potrebu primjene lijeka samo infuzijom u venu.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Rituzena has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Rituzena ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek MabThera te se u tijelu raspoređuje na isti način.
English: Because Rituzena is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Rituzena.
Croatian: Budući da je lijek Rituzena biosličan lijek, ispitivanja učinkovitosti i sigurnosti rituksimaba provedena za lijek MabThera nije potrebno ponavljati za lijek Rituzena.
English: It is not intended to provide practical advice on how to use Rituzena.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Rituzena.
English: Therefore, the Agency's view was that, as for MabThera, the benefit outweighs the identified risk and it recommended that Rituzena be given marketing authorisation.
Croatian: Stoga je mišljenje Agencije da, kao i kod lijeka MabThera, koristi nadmašuju utvrđene rizike te je preporučila davanje odobrenja za stavljanje lijeka Rituzena u promet.
English: Rituzena should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Croatian: Osim toga, lijek Rituzena potrebno je davati pod pomnim nadzorom iskusnog zdravstvenog radnika u ustanovi gdje je oprema za reanimaciju bolesnika odmah dostupna.
English: The active substance in Rituzena, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells).
Croatian: Djelatna tvar u lijeku Rituzena, rituksimab, je monoklonsko protutijelo (vrsta bjelančevine) osmišljeno za prepoznavanje bjelančevine pod nazivom CD20 koja je prisutna na površini B-stanica (vrste bijelih krvnih stanica) i vezivanje na nju.
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Croatian: Kada se rituksimab veže na bjelančevinu CD20, uzrokuje umiranje B-stanica, što pomaže u bolesnika s limfomom i KLL-om kod kojih su B-stanice postale kancerogene.
English: In GPA and MPA, destroying the B cells lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing
Croatian: U bolesnika s bolestima GPA i MPA uništavanjem B-stanica smanjuje se proizvodnja protutijela za koja se smatra da imaju važnu ulogu u napadu na krvne žile i uzrokovanju upale.
English: The company that markets Rituzena will provide doctors and patients using the medicine for noncancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Croatian: Tvrtka koja lijek Rituzena stavlja u promet, liječnicima i bolesnicima koji koriste lijek za bolesti koje nisu zloćudne dostavit će edukativni materijal, uključujući informacije o potrebi davanja lijeka na mjestima opremljenima aparatima za reanimaciju te o riziku od upale, uključujući PML.
English: Rituzena must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients.
Croatian: Lijek Rituzena ne smiju upotrebljavati osobe koje su preosjetljive (alergične) na rituksimab, mišje bjelančevine ili bilo koji drugi sastojak lijeka.
English: It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein.
Croatian: Lijek je dostupan kao koncentrat za otopinu koja se daje kao infuzija (drip) u venu.
English: The reference medicine for Rituzena is MabThera.
Croatian: Referentni lijek za lijek Rituzena je MabThera.
English: What measures are being taken to ensure the safe and effective use of
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rituzena?