FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe flares were observed in 15.6% of the Benlysta group compared to 23.7% of the placebo group over the 52 weeks of observation (observed treatment difference =8.1%; hazard ratio=0.64, p=0.0011).
Croatian: Tijekom 52 tjedna praćenja teške egzacerbacije su uočene u 15,6% bolesnika na lijeku Benlysta u usporedbi s 23,7% ispitanika na placebu (uočena razlika u liječenju = -8,1%; omjer hazarda=0,64; p=0,0011).
English: Patients should be advised that hypersensitivity reactions are possible, on the day of, or several days after administration, and be informed of potential signs and symptoms and the possibility of recurrence.
Croatian: Bolesnici bi trebali biti upoznati s mogućnošću pojave reakcija preosjetljivosti na dan primjene kao i nekoliko dan nakon toga, i biti informirani o mogućim znakovima i simptomima takvih reakcija te mogućnosti njihove ponovljene pojave.
English: Thereafter, patients can resume dosing on their usual day of administration, or start a new weekly schedule from the day that the missed dose was administered.
Croatian: Nakon toga bolesnik može nastaviti primjenjivati lijek prema uobičajenom rasporedu ili započeti novi raspored primjene jedanput tjedno,
English: Administration of subcutaneous or intravenous Benlysta may result in hypersensitivity reactions which can be severe, and fatal.
Croatian: Primjena lijeka Benlysta supkutanim ili intravenskim putem može rezultirati reakcijama preosjetljivosti koje mogu biti teške pa i smrtonosne.
English: • Use your free hand to gently pinch the skin around the injection site.
Croatian: • Drugom rukom nježno uhvatite nabor kože oko mjesta injiciranja. (Slika 7)
English: 4 pre-filled syringes.
Croatian: 4 napunjene brizgalice.
English: Observed difference vs placebo
Croatian: Opažena razlika naspram placeba
English: Table 2: Patients with low complement and positive anti-dsDNA at baseline
Croatian: Tablica 2: Bolesnici s ishodišno sniženim vrijednostima komplementa i pozitivnim anti-dsDNK
English: There have been reports of depression, suicidal thoughts, and suicide attempts including suicide during treatment with Benlysta.
Croatian: Tijekom liječenja lijekom Benlysta prijavljeni su slučajevi depresije, samoubilačkih misli i pokušaja samoubojstva, uključujući izvršena samoubojstva.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Multipack containing 12 pre-filled pens (3 packs of 4 pre-filled pens)-with blue box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - Višestruko pakiranje s 12 napunjenih brizgalica (3 pakiranja s 4 napunjene brizgalice)s plavim okvirom
English: The risk of first flare was reduced by 22% during the 52 weeks of observation in the group receiving Benlysta compared with the group receiving placebo (hazard ratio=0.78; p=0.0061).
Croatian: Rizik od prve egzacerbacije se tijekom 52-tjednog razdoblja promatranja smanjio za 22% u skupini koja je primala lijek Benlysta u odnosu na onu koja je primala placebo (omjer hazarda = 0,78; p = 0,0061).
English: Delayed-type, non-acute hypersensitivity reactions have also been observed and included symptoms such as rash, nausea, fatigue, myalgia, headache, and facial oedema.
Croatian: Primijećene su i neakutne reakcije kasne preosjetljivosti koje su uključivale simptome poput osipa, mučnine, umora, mialgije, glavobolje i edema lica.
English: • any medicine that affects your B cells (to treat cancer or inflammatory diseases).
Croatian: • ciklofosfamid (lijek koji se koristi za liječenje nekih oblika raka i autoimunih poremećaja) • bilo koji lijek koji utječe na B stanice (koji se koristi za liječenje raka ili upalnih bolesti).
English: What you need to know before you use Benlysta Do not use Benlysta:
Croatian: Što morate znati prije nego počnete primjenjivati lijek Benlysta Nemojte primijeniti lijek Benlysta:
English: Administration of Benlysta may result in severe or life-threatening hypersensitivity reactions and infusion reactions.
Croatian: Primjena lijeka Benlysta može dovesti do teških ili po život opasnih reakcija preosjetljivosti i infuzijskih reakcija.
English: • Firmly press the pen all the way down onto the injection site and hold in place.
Croatian: • Čvrsto pritisnite brizgalicu do kraja na mjesto za injiciranje i držite je tako. (Slika 8)
English: The intravenous studies did not exclude patients with a history of psychiatric disorders.
Croatian: U ispitivanjima intravenske primjene mogli su sudjelovati bolesnici koji su u anamnezi imali psihijatrijske poremećaje.
English: Eligible patients had active SLE disease, defined as a SELENA-SLEDAI score ≥8 and positive anti-nuclear antibody (ANA or anti-dsDNA) test results (ANA titre ≥1:80 and/or a positive anti-dsDNA [≥30 units/ml])
Croatian: ≥ 8 i pozitivnim testom na antinuklearna protutijela (ANA ili anti-dsDNK) (ANA titar ≥ 1:80 i/ili pozitivan test na anti-dsDNK [≥ 30 jedinica/ml]) na probiru.
English: Black patients
Croatian: Bolesnici crne rase
English: Observed treatment difference vs. placebo (median difference)
Croatian: Opažena razlika u liječenju naspram placeba (medijan razlike)
English: Each 20 ml vial contains 400 mg belimumab.
Croatian: Jedna bočica od 20 ml sadrži 400 mg belimumaba.
English: In patients with low complement levels, normalization of C3 and C4 was observed by Week 52 in 42% and 53% of patients receiving Benlysta and in 21% and 20% of patients receiving placebo, respectively.
Croatian: U bolesnika s niskom razinom komplementa, normalizacija razine C3 i C4 opažena je do 52. tjedna u 42% odnosno 53% bolesnika koji su primali lijek Benlysta, te 21% odnosno 20% bolesnika koji su primali placebo.
English: Gauze pad or cotton wool ball
Croatian: Gaza ili pamučna vata
English: Tel.: + 48 (0)22 576 9000
Croatian: GSK Commercial Sp. z o.o. Tel.: + 48 (0)22 576 9000
English: There is 1 vial in each pack.
Croatian: Jedno pakiranje sadrži 1 bočicu.
English: How to administer the diluted solution
Croatian: 4) Kako primjenjivati razrijeđenu otopinu
English: Benlysta has not been studied in the following adult and paediatric patient groups, and is not recommended in:
Croatian: Benlysta nije ispitivana u sljedećim skupinama odraslih i pedijatrijskih bolesnika i njezina se primjena ne preporučuje kod: • teškog aktivnog lupusa središnjeg živčanog sustava
English: How Benlysta is used
Croatian: Što je Benlysta i za što se koristi
English: In clinical studies, serious infusion and hypersensitivity reactions affected approximately 0.9% of adult patients, and included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea.
Croatian: 0,9% odraslih bolesnika, te su uključivale pojavu anafilaktičke reakcije, bradikardije, hipotenzije, angioedema i dispneje.
English: • Insert the entire needle into the pinched area of the skin at a slight angle (45°), using a dart-like motion.
Croatian: • Brzim pokretom, nalik onome kod bacanja strelice za pikado, ubodite iglu cijelom dužinom u nabor kože pod blagim kutom (45°).
English: Benlysta is supplied as a 1 ml colourless to slightly yellow solution in a single use pre-filled syringe with a needle cap.
Croatian: Benlysta dolazi u obliku 1 ml bezbojne do blijedožute otopine u napunjenoj štrcaljki za jednokratnu uporabu sa zatvaračem igle.
English: Dispose and inspect Dispose of the used pen
Croatian: Bacite i pregledajte Bacite upotrijebljenu brizgalicu
English: The frequency categories used are:
Croatian: Koristile su se sljedeće kategorije učestalosti: Vrlo često
English: benlysta syringe
Croatian: benlysta brizgalica
English: • cyclophosphamide (a medicine to treat some cancers and autoimmune disorders)
Croatian: • ciklofosfamid (lijek koji se koristi za liječenje nekih oblika raka i autoimunih poremećaja) • bilo koji lijek koji utječe na B stanice (koji se koristi za liječenje raka ili upalnih bolesti)
English: FACIT-fatigue score improvement from baseline at week-52 (mean):
Croatian: Poboljšanje FACIT-fatigue zbroja u 52. tjednu u odnosu na ishodišnu vrijednost (srednja vrijednost):
English: Percent of patients with no worsening by BILAG index (%) Odds ratio (95% CI) vs placebo
Croatian: Omjer izgleda (95% CI) u odnosu na placebo Postotak bolesnika bez pogoršanja prema BILAG indeksu (%) Omjer izgleda (95% CI) u odnosu na placebo Postotak bolesnika bez pogoršanja prema PGA (%)
English: In patients with anti-dsDNA antibodies, 16% of patients treated with Benlysta converted to anti-dsDNA negative compared with 7% of the patients receiving placebo by Week 52.
Croatian: U bolesnika s pozitivnim anti-dsDNK protutijelima, 16% onih liječenih lijekom Benlysta postiglo je do 52. tjedna konverziju tj. negativnost anti-dsDNK, u usporedbi sa 7% onih koji su primali placebo.
English: 1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) and needle cap.
Croatian: 1 ml otopine u staklenoj štrcaljki (staklo tipa 1) s pričvršćenom iglom (nehrđajući čelik) i zatvaračem igle.
English: • Dispose of the used pen and ring cap in a container with a tight-fitting lid.
Croatian: • Bacite upotrijebljenu brizgalicu i zatvarač s prstenom u spremnik koji se može čvrsto zatvoriti.
English: Inject Benlysta Insert the needle
Croatian: Injicirajte lijek Benlysta Ubodite iglu
English: Components of SLE Responder Index Percent of patients with reduction in SELENA-SLEDAI ≥4 (%) Odds ratio (95% CI) vs placebo
Croatian: Omjer izgleda (95% CI) u odnosu na placebo Komponente indeksa odgovora SLE-a Postotak bolesnika sa smanjenjem SELENA-SLEDAI rezultata za ≥ 4 (%)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED SYRINGE(S)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - NAPUNJENA(E) ŠTRCALJKA(E)
English: Very common Bacterial infections, e.g. bronchitis, urinary tract infection
Croatian: Infekcije i infestacije vrlo često bakterijske infekcije, npr. bronhitis,
English: Each 5 ml vial contains 120 mg belimumab.
Croatian: Jedna bočica od 5 ml sadrži 120 mg belimumaba.
English: Benlysta reported higher rates of nausea, vomiting and diarrhoea relative to placebo, and compared with normal-weight patients (BMI ≥18.5 to ≤30 kg/m2).
Croatian: Poremećaji probavnog sustava: Pretili bolesnici [indeks tjelesne mase (ITM) >30 kg/m2 liječeni intravenski primijenjenim lijekom Benlysta prijavili su veće stope mučnine, povraćanja i proljeva u odnosu na placebo, i u usporedbi s bolesnicima normalne težine (ITM ≥18,5 do ≤30 kg/m2).
English: • gauze pad or cotton wool ball (not included in the pack)
Croatian: Gaza ili pamučna vata (nije uključeno u pakiranje)
English: • burning sensation while passing urine
Croatian: • osjećaj pečenja dok mokrite
English: The package leaflet should be provided to the patient each time Benlysta is administered (see section 4.4).
Croatian: Svaki put kada se primjenjuje Benlysta, bolesniku treba dati uputu o lijeku (vidjeti dio 4.4).
English: • Do not use if the expiry date has passed.
Croatian: • Nemojte upotrijebiti štrcaljku ako joj je istekao rok valjanosti.
English: Proportion of SRI responders by visit
Croatian: Slika 1 Udio bolesnika s odgovorom prema SRI indeksu po posjetima
English: There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Benlysta.
Croatian: Tijekom liječenja lijekom Benlysta prijavljeni su slučajevi depresije, samoubilačkih misli i pokušaja samoubojstva.
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING CARTON -- PRE-FILLED PEN- Multipack containing 12 pre-filled pens (3 packs of 4 pre-filled pens)with out blue box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA - NAPUNJENA BRIZGALICA - Višestruko pakiranje s 12 napunjenih brizgalica (3 pakiranja s 4 napunjene brizgalice) - bez plavog okvira
English: The recommended dose regimen for children aged 5 years and older is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.
Croatian: Preporučeni režim primjene lijeka Benlysta u djece u dobi od 5 ili više godina je 10 mg/kg 0., 14. i
English: • Check the expiry date on the pre-filled pen.
Croatian: • Provjerite rok valjanosti na napunjenoj brizgalici. (Slika 1)
English: Injecting Benlysta
Croatian: Injiciranje lijeka Benlysta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON-VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - BOČICA
English: How to store Benlysta
Croatian: Kako čuvati lijek Benlysta
English: Preparation of 120 mg solution for infusion
Croatian: Priprema 120 mg otopine za infuziju Rekonstitucija
English: Components of SLE responder index Percent of patients with reduction in SELENASLEDAI ≥4
Croatian: Komponente indeksa odgovora SLE-a Postotak bolesnika sa smanjenjem
English: How to reconstitute Benlysta
Croatian: 1) Kako rekonstituirati lijek Benlysta
English: 1 pre-filled pen.
Croatian: 1 napunjena brizgalica.
English: A clear to opalescent, colourless to pale yellow solution, with a pH of 6.
Croatian: Bistra do opalescentna, bezbojna do blijedožuta otopina pH vrijednosti
English: Severe flares over 52 weeks:
Croatian: Teške egzacerbacije su tijekom 52-tjednog razdoblja
English: EU/1/11/700/006 1 pre-filled syringe EU/1/11/700/007 4 pre-filled syringes
Croatian: EU/1/11/700/006 1 napunjena štrcaljka EU/1/11/700/007 4 napunjene štrcaljke
English: Very common Diarrhoea, nausea
Croatian: Poremećaji probavnog sustava vrlo često proljev, mučnina
English: Your doctor will decide if you can use Benlysta.
Croatian: Liječnik će odlučiti možete li primijeniti lijek Benlysta.
English: Patients who had severe active lupus nephritis and patients who had severe active central nervous system (CNS) lupus were excluded.
Croatian: Bolesnici s teškim aktivnim lupusnim nefritisom ili s teškim aktivnim lupusom središnjeg živčanog sustava bili su isključeni iz ispitivanja.
English: Angioedema, urticaria, rash
Croatian: manje često angioedem, urtikarija, osip
English: Weight-normalised belimumab dosing leads to decreased exposure for underweight subjects (BMI <18.5) and to increased exposure for obese subjects (BMI ≥30).
Croatian: <18,5) i do povećanja izloženosti za pretile osobe (ITM >30).
English: Benlysta has not been studied in the following patient groups and is not recommended in:
Croatian: Benlysta nije ispitivana u sljedećim skupinama bolesnika i njezina se primjena ne preporučuje kod: • teškog aktivnog lupusa središnjeg živčanog sustava
English: • Peel back the film of the tray and remove the pre-filled pen.
Croatian: • Skinite pokrovni film s podloška i izvadite napunjenu brizgalicu.
English: The package leaflet should be provided to the patient each time Benlysta is administered (see section 4.2).
Croatian: Svaki put kada se primjenjuje Benlysta, bolesniku treba dati uputu o lijeku (vidjeti dio 4.2).
English: Solution of Benlysta diluted in sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection may be stored at 2°C to 8°C or room temperature (15°C to 25°C).
Croatian: Otopina lijeka Benlysta razrijeđena u 0,9%-tnoj (9 mg/ml) otopini natrijevog klorida, 0,45%-tnoj (4,5 mg/ml) otopini natrijevog klorida ili otopini Ringerovog laktata za injekcije može se čuvati na temperaturi od 2°C do 8°C ili na sobnoj temperaturi (15°C - 25°C).
English: The reconstituted medicinal product is diluted to 250 ml with sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection.
Croatian: Rekonstituirani lijek razrjeđuje se do 250 ml s 0,9%-tnom (9 mg/ml) otopinom natrijevog klorida, 0,45%-tnom (4,5 mg/ml) otopinom natrijevog klorida ili otopinom Ringerovog laktata za injekciju.
English: Using such medicines in combination with Benlysta may make your immune system less effective.
Croatian: Vaš imunološki sustav manje učinkovitim.
English: Benlysta is supplied as a 1 ml colourless to slightly yellow solution in a single use pre-filled pen.
Croatian: Benlysta dolazi u obliku 1 ml bezbojne do blijedožute otopine u napunjenoj brizgalici za jednokratnu uporabu.
English: From a 250 ml infusion bag or bottle of sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection, withdraw and discard a volume equal to the volume of the reconstituted Benlysta solution required for the patient's dose.
Croatian: Iz infuzijske vrećice ili boce od 250 ml 0,9%-tne (9 mg/ml) otopine natrijevog klorida, 0,45%-tne (4,5 mg/ml) otopine natrijevog klorida ili otopine Ringerovog laktata za injekcije, izvucite i odbacite volumen jednak volumenu rekonstituirane otopine lijeka Benlysta potrebne za bolesnikovu dozu.
English: • Check the expiry date on the pre-filled syringe.
Croatian: • Provjerite rok valjanosti na napunjenoj štrcaljki. (Slika 1)
English: After reconstitution, a volume of 5 ml (corresponding to 400 mg belimumab) can be withdrawn from each 20 ml vial.
Croatian: Nakon rekonstitucije, volumen od 5 ml (koji odgovara 400 mg belimumaba) može se izvući iz svake bočice od 20 ml.
English: From a 250 ml (or 100 ml) infusion bag or bottle of sodium chloride 9 mg/ml (0.9%), sodium chloride 4.5 mg/ml (0.45%), or Lactated Ringer's solution for injection, withdraw and discard a volume equal to the volume of the reconstituted Benlysta solution required for the patient's dose.
Croatian: Iz infuzijske vrećice ili boce od 250 ml (ili 100 ml) 0,9%-tne (9 mg/ml) otopine natrijevog klorida, 0,45%-tne (4,5 mg/ml) otopine natrijevog klorida ili otopine Ringerovog laktata za injekcije, izvucite i odbacite volumen jednak volumenu rekonstituirane otopine lijeka Benlysta potrebne za bolesnikovu dozu.
English: ≤7.5 mg/day during weeks 24 through 52* (%) Observed treatment difference vs. placebo (%)
Croatian: na ≤ 7,5 mg/dan, tijekom 24. do 52. tjedna* (%)
English: In patients with anti-dsDNA antibodies at baseline, by Week 52, 18% of patients treated with Benlysta had converted to anti-dsDNA negative compared with 15% of the patients receiving placebo.
Croatian: Među bolesnicima koji su imali anti-dsDNK protutijela na početku ispitivanja, 18% onih liječenih lijekom Benlysta postiglo je do 52. tjedna konverziju tj. negativnost anti-dsDNK, u usporedbi s 15% onih koji su primali placebo.
English: Using the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) Juvenile SLE Response Evaluation Criteria, a higher proportion of paediatric patients receiving Benlysta demonstrated improvement compared with placebo (Table 4).
Croatian: Paediatric Rheumatology International Trials Organisation/American College of Rheumatology, PRINTO/ACR),
English: 1 pre-filled syringe.
Croatian: 1 napunjena štrcaljka.
English: Reductions in naïve and transitional B cells, as well as the SLE B cell subset were observed as early as Week 8.
Croatian: SLE B limfocita, opaženo je već u 8. tjednu.
English: • if you have a current or long-term infection or if you often get infections.
Croatian: Obratite se svom liječniku prije nego primijenite lijek Benlysta: • ako imate trenutnu ili dugotrajnu infekciju ili ako često imate infekcije.
English: Women of childbearing potential must use effective contraception during Benlysta treatment and for at least 4 months after the last treatment.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom
English: Benlysta 200 mg injection belimumab
Croatian: Benlysta 200 mg injekcija belimumab s.c. supkutano
English: Fertility
Croatian: Benlysta
English: FACIT-fatigue score improvement from baseline at week-52 (mean)
Croatian: Poboljšanje FACIT-fatigue zbroja u 52. tjednu u odnosu na ishodišnu vrijednost (srednja vrijednost)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - PRE-FILLED PEN(S)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - NAPUNJENA(E) BRIZGALICA(E)
English: • no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores, and
Croatian: A ili dva nova boda zahvaćenosti organskih sustava kategorije BILAG B, i
English: Adverse reaction(s)
Croatian: Nuspojava(e)
English: Benlysta 120 mg powder for concentrate for solution for infusion belimumab
Croatian: Benlysta 120 mg prašak za koncentrat za otopinu za infuziju belimumab
English: Citric acid monohydrate (E330) Sodium citrate (E331) Sucrose
Croatian: 6.1 Popis pomoćnih tvari citratna kiselina hidrat (E330) natrijev citrat (E331) saharoza polisorbat 80
English: After reconstitution, a volume of 1.5 ml (corresponding to 120 mg belimumab) can be withdrawn from each 5 ml vial.
Croatian: Nakon rekonstitucije, volumen od 1,5 ml (koji odgovara 120 mg belimumaba) može se izvući iz svake bočice od 5 ml.
English: 120 mg vial
Croatian: 120 mg bočica
English: If you already had these symptoms before you started treatment with Benlysta: Tell your doctor immediately if you notice any changes in these symptoms.
Croatian: Ako ste te simptome već imali i prije početka liječenja lijekom Benlysta:
English: Your doctor will decide if you can be given Benlysta
Croatian: Vaš liječnik će odlučiti smijete li primati lijek Benlysta
English: Benlysta 400 mg powder for concentrate for solution for infusion belimumab
Croatian: Benlysta 400 mg prašak za koncentrat za otopinu za infuziju belimumab
English: Before diluting Benlysta
Croatian: 2) Prije razrjeđivanja lijeka Benlysta
English: • Dispose of the used syringe and needle cap in a container with a tight-fitting lid.
Croatian: • Bacite upotrijebljenu štrcaljku i zatvarač igle u spremnik koji se može čvrsto zatvoriti.
English: Gold needle guard Expiry date
Croatian: Zlatni štitnik igle Rok valjanosti
English: Benlysta was administered intravenously to black patients in a randomised (2:1), double-blind, placebo-controlled, 52-week Phase III/IV study (EMBRACE).
Croatian: U randomiziranom (2:1), dvostruko slijepom, placebom kontroliranom ispitivanju faze III/IV u trajanju od 52 tjedna (EMBRACE) lijek Benlysta se bolesnicima crne rase primjenjivao intravenski.
English: (Figure 2) Injecting cold Benlysta may take longer and may be uncomfortable.
Croatian: • Ostavite štrcaljku na sobnoj temperaturi 30 minuta. (Slika 2) Injiciranje hladnog lijeka Benlysta može produljiti trajanje injekcije i biti neugodno.
English: EU/1/11/700/003 1 pre-filled pen EU/1/11/700/004 4 pre-filled pens
Croatian: EU/1/11/700/003 1 napunjena brizgalica EU/1/11/700/004 4 napunjene brizgalice
English: After reconstitution, a volume of 1.5 ml (corresponding to 120 mg belimumab) can be withdrawn from each vial.
Croatian: Nakon rekonstitucije, volumen od 1,5 ml (koji odgovara 120 mg belimumaba) može se izvući iz svake bočice.
English: Preparation of 400 mg solution for infusion
Croatian: Priprema 400 mg otopine za infuziju Rekonstitucija
English: After reconstitution, a volume of 5 ml (corresponding to 400 mg belimumab) can be withdrawn from each vial.
Croatian: Nakon rekonstitucije, volumen od 5 ml (koji odgovara 400 mg belimumaba) može se izvući iz svake bočice.
English: However, consistent with results from other studies, in black patients with high disease activity (low complement and positive anti-dsDNA at baseline, n=141) the SRI-S2K response was 45.1% for Benlysta 10 mg/kg compared with 24.0% for placebo (odds ratio 3.00; 95% CI: 1.35, 6.68).
Croatian: SRI-S2K indeksu iznosila je 45,1% za skupinu koja je primala lijek Benlysta u dozi od 10 mg/kg, u usporedbi s 24,0% za placebo skupinu (omjer izgleda: 3,00; 95% CI: 1,35; 6,68).
English: • container with a tight-fitting lid for syringe disposal (not included in the pack).
Croatian: • gazu ili pamučnu vatu (nije uključeno u pakiranje) • spremnik koji se može čvrsto zatvoriti, za odlaganje štrcaljke (nije uključen u pakiranje).
English: Benlysta 400 mg powder for concentrate for solution for infusion Type 1 glass vials (20 ml), sealed with a siliconised chlorobutyl rubber stopper and a flip-off aluminum seal containing 400 mg of powder.
Croatian: Staklene (tip 1) bočice (20 ml), zatvorene silikoniziranim klorobutilnim gumenim čepom i zaštitnim aluminijskim prstenom sadrže 400 mg praška.
English: Delayed-type, non-acute hypersensitivity reactions
Croatian: manje često anafilaktička reakcija rijetko neakutne reakcije kasne preosjetljivosti