FrancophonIA/ELRC3.0 huggingface dataset:
English: Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1).
Croatian: Benlysta je indicirana kao dodatna terapija u odraslih bolesnika s aktivnim sistemskim eritematoznim lupusom (SLE) s pozitivnim autoprotutijelima, koji imaju visok stupanj aktivnosti bolesti (npr.
English: • container with a tight-fitting lid for pen disposal (not included in the pack).
Croatian: • gazu ili pamučnu vatu (nije uključeno u pakiranje) • spremnik koji se može čvrsto zatvoriti, za odlaganje brizgalice (nije uključen u pakiranje).
English: • Do not remove the needle cap until immediately before the injection.
Croatian: • Nemojte ukloniti zatvarač igle do neposredno prije injekcije.
English: The 120 mg single-use vial of belimumab is reconstituted with 1.5 ml of water for injections to yield a final concentration of 80 mg/ml belimumab.
Croatian: Bočica od 120 mg belimumaba za jednokratnu uporabu rekonstituira se s 1,5 ml vode za injekcije kako bi se postigla konačna koncentracija od 80 mg/ml belimumaba.
English: Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile Parma
Croatian: GlaxoSmithKline Manufacturing S.P.A. Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile Parma
English: There was a higher proportion of paediatric patients achieving an SRI response in patients receiving Benlysta compared with placebo.
Croatian: SRI odgovor bio je veći među onima koji su primali lijek Benlysta nego među onima koji su primali placebo.
English: The safety and efficacy of Benlysta administered intravenously have been studied in black patients.
Croatian: U bolesnika crne rase ispitivale su se sigurnost i djelotvornost formulacije lijeka Benlysta za intravensku primjenu.
English: In patients who experience such symptoms, treatment discontinuation should be considered.
Croatian: U bolesnika kod kojih se razviju takvi simptomi treba ocijeniti rizik i korist nastavka liječenja lijekom Benlysta.
English: The 400 mg single-use vial of belimumab is reconstituted with 4.8 ml of water for injections to yield a final concentration of 80 mg/ml belimumab.
Croatian: Bočica od 400 mg belimumaba za jednokratnu uporabu rekonstituira se s 4,8 ml vode za injekcije kako bi se postigla konačna koncentracija od 80 mg/ml belimumaba.
English: Powder for concentrate for solution for infusion 1 vial
Croatian: Prašak za koncentrat za otopinu za infuziju
English: Benlysta pre-filled pen parts
Croatian: Dijelovi Benlysta napunjene brizgalice
English: 400 mg vial
Croatian: 400 mg bočica
English: Inspect the Benlysta solution
Croatian: Pregledajte otopinu lijeka Benlysta
English: • Do not remove the ring cap until immediately before the injection.
Croatian: • Nemojte ukloniti zatvarač s prstenom do neposredno prije injekcije.
English: Benlysta 400 mg powder for concentrate for solution for infusion.
Croatian: Benlysta 400 mg prašak za koncentrat za otopinu za infuziju
English: Background medicinal products included corticosteroids (76%; >7.5 mg/day 46%), immunosuppressives (56%), and anti-malarials (63%).
Croatian: Osnovno liječenje uključivalo je kortikosteroide (76%; 46% bolesnika je primalo dozu >7,5 mg/dan),
English: bronchitis, and diarrhoea.
Croatian: pruritus i dispneju.
English: Instructions for use and handling - reconstitution, dilution and administration In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Croatian: Upute za korištenje i rukovanje - rekonstitucija, razrjeđivanje i primjena
English: Needle cap
Croatian: SELENA-SLEDAI
English: Patients experiencing a severe flare (%) Observed treatment difference vs. placebo (%) Time to severe flare [Hazard ratio (95% CI)]
Croatian: Vrijeme do teške egzacerbacije [omjer hazarda (95% CI)]
English: GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Croatian: GlaxoSmithKline d.o.o. Tel: + 385 1 6051 999
English: Benlysta 200 mg solution for injection in pre-filled syringe.
Croatian: Benlysta 200 mg otopina za injekciju u napunjenoj štrcaljki.
English: • Benlysta pre-filled syringe
Croatian: • Benlysta napunjenu brizgalicu
English: Rarely, less severe delayed reactions to Benlysta can also occur, usually 5 to 10 days after an injection.
Croatian: Rijetko se kod primjene lijeka Benlysta mogu javiti i manje teške, odgođene reakcije, koje obično nastupaju 5 - 10 dana nakon injekcije, a uključuju simptome poput osipa, mučnine, umora, bolova u mišićima, glavobolje ili oticanja lica.
English: Your doctor will decide if you need to stop using Benlysta.
Croatian: Prestanak liječenja lijekom Benlysta Liječnik će odlučiti trebate li prekinuti liječenje lijekom Benlysta.
English: Benlysta pre-filled syringe
Croatian: Benlysta napunjena štrcaljka
English: The 400 mg single-use vial of Benlysta is reconstituted with 4.8 ml of water for injections to yield a final concentration of 80 mg/ml belimumab.
Croatian: Jednokratna bočica lijeka Benlysta od 400 mg rekonstituira se s 4,8 ml vode za injekcije, kako bi se postigla konačna koncentracija od 80 mg/ml belimumaba.
English: • Push the plunger all the way down until all of the solution is injected.
Croatian: • Pritisnite klip do kraja, dok ne injicirate svu otopinu. (Slika 8) Slika 8
English: • Hold the prefilled syringe by the body, and with the needle facing away from you.
Croatian: • Uhvatite napunjenu štrcaljku za tijelo i usmjerite iglu od sebe. (Slika 6a)
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Benlysta 200 mg solution for injection in pre-filled syringe belimumab
Croatian: Benlysta 200 mg otopina za injekciju u napunjenoj brizgalici belimumab
English: Subgroup analysis of the primary endpoint demonstrated that the greatest benefit was observed in patients with higher disease activity at baseline including patients with SELENA SLEDAI scores ≥ 10 or patients requiring steroids to control their disease or patients with low complement levels.
Croatian: Analiza primarne mjere ishoda prema podskupinama pokazala je da je najveća korist uočena u bolesnika s višom aktivnošću bolesti na početku ispitivanja, uključujući bolesnike sa SELENA
English: Do not shake.
Croatian: Ne tresite bočicu.
English: ≥1/1,000 to <1/100
Croatian: Manje često ≥ 1/1000 i <1/100 Rijetko
English: Pre-filled pen
Croatian: Napunjena brizgalica
English: The 120 mg single-use vial of Benlysta is reconstituted with 1.5 ml of water for injections to yield a final concentration of 80 mg/ml belimumab.
Croatian: Jednokratna bočica lijeka Benlysta od 120 mg rekonstituira se s 1,5 ml vode za injekcije, kako bi se postigla konačna koncentracija od 80 mg/ml belimumaba.
English: Some vaccines should not be given just before or during treatment with Benlysta
Croatian: Neka cjepiva se ne bi smjela primjenjivati neposredno prije ili za vrijeme liječenja lijekom Benlysta • ako Vam lupus zahvaća bubrege ili živčani sustav
English: Alcohol swab
Croatian: Tupfer natopljen alkoholom
English: Teл.
Croatian: Benlysta.
English: Pre-filled syringe Each 1-ml pre-filled syringe contains 200 mg of belimumab.
Croatian: Napunjena štrcaljka Jedna napunjena štrcaljka od 1 ml sadrži 200 mg belimumaba.
English: Benlysta 120 mg powder for concentrate for solution for infusion Benlysta 400 mg powder for concentrate for solution for infusion belimumab This medicine is subject to additional monitoring.
Croatian: Benlysta 120 mg prašak za koncentrat za otopinu za infuziju Benlysta 400 mg prašak za koncentrat za otopinu za infuziju
English: Grey stopper
Croatian: Sivi zaustavnik
English: Each 1 ml pre-filled syringe contains 200 mg belimumab.
Croatian: Jedna napunjena brizgalica od 1 ml sadrži 200 mg belimumaba.
English: ‘Infusion or injection-related systemic reactions' covers a group of terms and can manifest as a range of symptoms including bradycardia, myalgia, headache, rash, urticaria, pyrexia, hypotension, hypertension, dizziness, and arthralgia.
Croatian: ‘Sistemske reakcije povezane s primjenom infuzije ili injekcije' obuhvaćaju skupinu termina te se mogu manifestirati kao niz simptoma uključujući bradikardiju, mialgiju,
English: Mechanism of action
Croatian: Assessment Group)
English: Benlysta pre-filled pen
Croatian: Benlysta napunjena brizgalica
English: Migraine
Croatian: Dojenje
English: Each 1 ml pre-filled syringe contains 200 mg belimumab
Croatian: Jedna napunjena brizgalica od 1 ml sadrži 200 mg belimumaba
English: Benlysta 120 mg powder for concentrate for solution for infusion.
Croatian: Benlysta 120 mg prašak za koncentrat za otopinu za infuziju belimumab i.v.
English: They include symptoms such as rash, feeling sick, tiredness, muscle aches, headache, or facial swelling.
Croatian: glavobolju, osip, urtikariju, pireksiju, hipotenziju, hipertenziju, omaglicu i artralgiju.
English: ≤7.5 mg/day during Weeks 40 through 52, was 18.2% in the group receiving Benlysta and 11.9% in the group receiving placebo (p=0.0732).
Croatian: Postotak bolesnika koji su na početku ispitivanja primali više od 7,5 mg prednizona (ili ekvivalenta) na dan, a kojima je prosječna doza kortikosteroida bila smanjena za barem 25% u odnosu na početnu vrijednost, na dozu ekvivalentnu ≤ 7,5 mg prednizona na dan tijekom 40. - 52. tjedna, iznosio je 18,2% u skupini koja je primala lijek Benlysta te 11,9% u skupini koja je primala placebo (p=0,0732).
English: Hypersensitivity reactions*
Croatian: Poremećaji imunološkog sustava često reakcije preosjetljivosti*
English: Leucopenia
Croatian: Sljedivost
English: Inspect the Benlysta solution visually for particulate matter and discoloration prior to administration.
Croatian: Prije primjene vizualno pregledajte otopinu lijeka Benlysta radi čestica ili promjene boje.
English: However, higher rates of nausea, vomiting and diarrhoea were observed in obese patients.
Croatian: No, u pretilih bolesnika uočene su veće stope mučnine, povraćanja i proljeva.
English: Prepare and inspect the pre-filled syringe Allow to come to room temperature
Croatian: Pričekajte da se ugrije na sobnu temperaturu
English: Step-by-step instructions for using the pre-filled pen
Croatian: Upute za uporabu napunjene brizgalice korak po korak
English: България
Croatian: Irska
English: Suicidal behaviour, suicidal ideation
Croatian: Psihijatrijski poremećaji često depresija manje često suicidalno ponašanje, suicidalne misli
English: Severe flares over 52 weeks Patients experiencing a severe flare (%) Observed treatment difference vs. placebo (%) Time to severe flare [Hazard ratio (95% CI)]
Croatian: Teške egzacerbacije tijekom 52 tjedna Bolesnici s teškom egzacerbacijom (%)
English: Benlysta 200 mg solution for injection in pre-filled pen.
Croatian: Benlysta 200 mg otopina za injekciju u napunjenoj brizgalici.
English: Infections and infestations
Croatian: Trudnoća i dojenje
English: Histidine monohydrochloride Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari argininklorid histidin histidinklorid polisorbat 80 natrijev klorid voda za injekcije
English: This takes about 1 hour.
Croatian: To traje oko 1 sat.
English: • If you are under 18 years of age.
Croatian: • ako ste mlađi od 18 godina.
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Croatian: Nadopunjeni RMP treba dostaviti: • Na zahtjev Europske agencije za lijekove;
English: Children and adolescents below the age of 18 years.
Croatian: Djeca i adolescenti mlađi od 18 godina.
English: • Increase or decrease in your blood pressure (your doctor or nurse will notice this if they are monitoring your blood pressure).
Croatian: • povišen ili snižen krvni tlak (liječnik ili medicinska sestra će to primijetiti ukoliko prate Vaš krvni tlak).
English: AFFIRM study: Main features and results
Croatian: Ispitivanje AFFIRM: osnovne značajke i rezultati
English: Effects on laboratory tests
Croatian: Utjecaji na laboratorijske testove
English: These medicines reduce the activity of your body's immune system.
Croatian: Ti lijekovi smanjuju aktivnost imunološkog sustava Vašeg tijela.
English: This reduces nerve damage caused by MS.
Croatian: Tako smanjuje oštećenje živaca koje uzrokuje MS.
English: Two years
Croatian: Dvije godine
English: − An unexplained fever
Croatian: − neobjašnjivu vrućicu
English: Symptoms of serious infections including:
Croatian: Simptome ozbiljnih infekcija uključujući:
English: These results were obtained from a post hoc analysis and should be interpreted cautiously.
Croatian: Ovi rezultati dobiveni su na osnovi post hoc analize te ih treba oprezno protumačiti.
English: These liver injuries may occur at any time during treatment, even after the first dose.
Croatian: Ta oštećenja jetre se mogu desiti u bilo koje vrijeme tijekom liječenja, čak i nakon prve doze.
English: Sixteen of the 29 were classified as major defects.
Croatian: Šesnaest od tih 29 klasificirano je kao teške prirođene mane.
English: There were 316 live births, 29 of which were reported to have birth defects.
Croatian: Bilo je 316 živorođene djece, od kojih je za 29 prijavljeno da imaju prirođene mane.
English: For those with a lower risk of PML, your doctor may repeat the test regularly to check if anything has changed if:
Croatian: Za one s nižim rizikom od PML-a, Vaš liječnik može redovito ponavljati test za provjeru da li se išta promijenilo ako:
English: • Speak with your partner or caregivers and inform them about your treatment.
Croatian: • Razgovarajte sa svojim partnerom ili skrbnicima i obavijestite ih o svom liječenju.
English: In-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Za vrijeme čuvanja i uvjete čuvanja prije uporabe odgovoran je korisnik.
English: IRIS may lead to your condition getting worse, including worsening of brain function.
Croatian: IRIS može dovesti do pogoršanja Vašeg stanja, uključujući pogoršanje funkcije mozga.
English: TYSABRI is not recommended for use in patients aged over 65 due to a lack of data in this population.
Croatian: TYSABRI se ne preporučuje za primjenu u bolesnika starijih od 65 godina uslijed nedostatka podataka za ovu populaciju.
English: Each carton contains one glass vial.
Croatian: Svako pakiranje sadrži jednu staklenu bočicu.
English: Signs of allergy to TYSABRI, during or shortly after your infusion:
Croatian: Znakove alergije na TYSABRI, tijekom ili ubrzo nakon infuzije:
English: Your symptoms will then usually improve gradually (this is called a remission).
Croatian: Potom se simptomi uglavnom postupno povlače (to se naziva remisija).
English: • Information about any registry or other monitoring system set up in the Member State and how to enter patients
Croatian: • Informacije o registru ili drugom sustavu praćenja uspostavljenom u državi članici te kako se uključuju bolesnici
English: These changes were reversible and did not appear to have any adverse toxicological consequences.
Croatian: Te promjene su reverzibilne i nemaju nikakve štetne toksikološke posljedice.
English: What are the symptoms of multiple sclerosis?
Croatian: Koji su simptomi multiple skleroze?
English: Antibodies were detected on only one occasion in an additional 4% of patients.
Croatian: Protutijela su pronađena samo jedanput u još 4% bolesnika.
English: These antibodies work by binding to proteins in the body so that the harmful effect of that protein is removed.
Croatian: Ta protutijela djeluju vezanjem na proteine u tijelu pa se time otklanja štetni učinak tih proteina.
English: When a relapse occurs, you may notice the symptoms suddenly, within a few hours, or slowly progressing over several days.
Croatian: Kod relapsa simptome možete primijetiti iznenada, unutar nekoliko sati, ili polagano kako napreduju tijekom nekoliko dana.
English: Signs of a possible liver problem:
Croatian: Znakove mogućih jetrenih problema:
English: Under normal conditions, VCAM-1 is not expressed in the brain parenchyma.
Croatian: U normalnim okolnostima VCAM-1 nije eksprimiran u parenhimu mozga.
English: Continuous dosing with TYSABRI is important, especially during the first few months of treatment.
Croatian: Kontinuirano liječenje TYSABRIJEM je važno, osobito tijekom prvih nekoliko mjeseci liječenja.
English: Diluted solution: After dilution, immediate use is recommended.
Croatian: Razrijeđena otopina: Nakon razrjeđivanja, preporučuje se primijeniti odmah.
English: Common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Croatian: Često (≥1/100 do <1/10), manje često (≥1/1000 do <1/100).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: The completed prospective TYSABRI pregnancy registry contained 355 pregnancies with available outcomes.
Croatian: Završen registar za prospektivno praćenje trudnoća s TYSABRIJEM sadržavao je 355 trudnoća s dostupnim ishodima.
English: • Treatment duration, especially beyond 2 years.
Croatian: • Trajanje liječenja, posebice dulje od 2 godine.
English: • If you have previously taken a medicine called an immunosuppressant.
Croatian: • Ako ste prethodno uzimali lijek nazvan imunosupresiv.
English: • Swelling of your face, lips or tongue
Croatian: • oticanje lica, usana ili jezika
English: For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet.
English: Speak to your doctor or nurse immediately if you notice any of the following
Croatian: Odmah razgovarajte sa svojim liječnikom ili medicinskom sestrom ako primijetite bilo što od sljedećeg
English: TYSABRI is contraindicated in children and adolescents below the age of 18 years (see section 4.3).
Croatian: TYSABRI je kontraindiciran u djece i adolescenata mlađih od 18 godina (vidjeti dio 4.3).
English: See section 4.3.
Croatian: Vidjeti dio 4.3.
English: • Do not use TYSABRI if you are pregnant unless you have discussed this with your doctor.
Croatian: • Ne uzimajte TYSABRI ako ste trudni, bez prethodnog razgovora s Vašim liječnikom.
English: • The longer that you are on treatment especially if you have been on treatment for more than two years.
Croatian: • Što se dulje liječite, osobito ako se liječite dulje od dvije godine.
English: These antibodies are a sign that you have been infected by JC virus.
Croatian: Ta su protutijela znak da ste zaraženi JC virusom.
English: In other clinical trials, cases of additional opportunistic infections have been reported, some of which were fatal.
Croatian: U drugim kliničkim ispitivanjima zabilježeni su slučajevi dodatnih oportunističkih infekcija, od kojih su neke bile smrtonosne.
English: MS causes inflammation in the brain that damages the nerve cells.
Croatian: MS uzrokuje upalu u mozgu koja oštećuje živčane stanice.
English: Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Croatian: Pokažite svoju Karticu s upozorenjima za bolesnika i ovu Uputu o lijeku bilo kojem liječniku koji je uključen u Vaše liječenje, a ne samo svom neurologu.
English: Study features and results are presented in the table below.
Croatian: Značajke i rezultati ispitivanja prikazani su u donjoj tablici.
English: PML usually leads to severe disability or death (see section 4.4).
Croatian: PML obično dovodi do teškog invaliditeta ili smrti (vidjeti dio 4.4).
English: These studies showed no evidence of teratogenic effects or effects on growth of offspring.
Croatian: Ta ispitivanja nisu dokazala teratogene učinke ili utjecaj na rast mladunčadi.
English: In clinical trials, TYSABRI approximately halved the progression of the disabling effects of MS and also decreased the number of MS attacks by about two-thirds.
Croatian: U kliničkim ispitivanjima TYSABRI je približno prepolovio napredovanje onesposobljujućih učinaka MS i smanjio broj napadaja MS za oko dvije trećine.
English: Estimates of the total natalizumab removal after 3 plasma exchanges (over a 5-8 day interval) was approximately 70-80%.
Croatian: Procjena potpunog uklanjanja natalizumaba nakon tri izmjene plazme (u intervalu od 5-8 dana) bila je približno 70-80%.
English: Speak to your doctor as soon as possible if you think you have an infection.
Croatian: Obratite se što prije Vašemu liječniku ako mislite da imate infekciju.
English: Always use this medicine exactly as described in this leaflet or as your doctor has told you.
Croatian: Uvijek primijenite lijek točno onako kako je opisano u ovoj Uputi ili kako Vam je rekao Vaš liječnik.
English: After dilution, do not shake.
Croatian: Nakon razrjeđivanja, ne tresti.
English: Progression on EDSS
Croatian: Progresija EDSS-a
English: This compares to approximately 40% seen in earlier studies in which measurements occurred after natalizumab discontinuation over a similar period of observation.
Croatian: To je uspoređeno s približno 40%, što je uočeno u ranijim ispitivanjima gdje je mjerenje provedeno nakon ukidanja natalizumaba u sličnom periodu promatranja.
English: • It is important to continue with your medicine for as long as you and your doctor decide that it is helping you.
Croatian: • Važno je da nastavite liječenje onoliko dugo koliko liječnik smatra da Vam pomaže.
English: PML may lead to severe disability or death.
Croatian: PML može dovesti do teške onesposobljenosti ili smrti.
English: If you have any further questions on TYSABRI, ask your doctor.
Croatian: Ako imate dodatnih pitanja o TYSABRIJU, obratite se svom liječniku.
English: JC virus is a common virus which infects many people but does not normally cause noticeable illness.
Croatian: JC virus je čest virus koji inficira mnogo ljudi, ali normalno ne uzrokuje vidljivu bolest.
English: − Weight loss
Croatian: − gubitak težine
English: Median age was 37 years, with a median disease duration of 5 years.
Croatian: Medijan dobi bio je 37 godina, a medijan trajanja liječenja 5 godina.
English: • Information about the following adverse reactions:
Croatian: • Informacije o sljedećim nuspojavama:
English: TYSABRI is used to treat multiple sclerosis (MS).
Croatian: TYSABRI se primjenjuje za liječenje multiple skleroze (MS).
English: The effect of natalizumab on newborn/infants is unknown.
Croatian: Učinak natalizumaba na novorođenčad/dojenčad je nepoznat.
English: Live vaccines have not been studied.
Croatian: Živa cjepiva nisu ispitivana.
English: The change in clearance was not clinically significant.
Croatian: Promjena klirensa nije klinički značajna.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27th June 2006
Croatian: Datum prvog odobrenja: 27. lipnja, 2006.
English: Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Croatian: Odmah obavijestite Vašeg liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate postati trudni.
English: TYSABRI must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: TYSABRI se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: Dilute before infusion.
Croatian: Razrijediti prije infuzije.
English: The physician information about TYSABRI shall contain the following key elements:
Croatian: Informacije za liječnika o TYSABRIJU trebaju sadržavati sljedeće ključne elemente:
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Croatian: Bolesnike treba savjetovati da obavijeste svog partnera ili skrbnika o svom liječenju, jer oni mogu primijetiti simptome kojih bolesnik nije svjestan.
English: • The recommended dose for adults is 300 mg given once every 4 weeks.
Croatian: • Preporučena doza za odrasle je 300 mg svaka 4 tjedna.
English: Educational guidance
Croatian: Smjernice za edukaciju