FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kevzara (sarilumab) in one or more subsets of the paediatric population in chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis) (see section 4.2 for information on paediatric use).
Croatian: (sarilumaba) u jednoj ili više podskupina pedijatrijske populacije za liječenje kroničnog idiopatskog artritisa (uključujući reumatoidni artritis, spondiloartritis, psorijatični artritis i juvenilni idiopatski artritis) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: For these reasons, comparison of the incidence of antibodies to Kevzara with the incidence of antibodies to other products may be misleading.
Croatian: Zbog toga usporedba incidencije protutijela na lijek Kevzara s incidencijom protutijela na druge lijekove može navesti na krivi trag.
English: After use, place the pre-filled syringe/ pre-filled pen into a puncture-resistant container and discard as required by local regulations.
Croatian: Nakon primjene, napunjenu štrcaljku/napunjenu brizgalicu treba odložiti u neprobojan spremnik i zbrinuti u skladu s nacionalnim propisima.
English: 50 to 100
Croatian: 1 na 10 osoba).
English: Both doses of Kevzara + MTX were superior to placebo + MTX in the change from baseline in mTSS at 24 and 52 weeks (see Table 5).
Croatian: Obje doze lijeka Kevzara + MTX-a bile su superiorne placebu + MTX-u s obzirom na promjenu početnog mTSS rezultata u 24. i 52. tjednu (vidjeti Tablicu 5).
English: If you are unsure when to inject your next dose: ask your doctor, pharmacist or nurse for instructions.
Croatian: Ako niste sigurni kada trebate injicirati sljedeću dozu, obratite se za upute svom liječniku, ljekarniku ili medicinskoj sestri.
English: Anti Drug Antibody (ADA) formation may affect pharmacokinetics of Kevzara.
Croatian: Nastanak protutijela na lijek može utjecati na farmakokinetiku lijeka Kevzara.
English: • chronic or recurrent infection;
Croatian: • koji imaju kroničnu ili rekurentnu infekciju
English: • The other ingredients are arginine, histidine, polysorbate 20, sucrose, and water for injections.
Croatian: • Drugi sastojci su arginin, histidin, polisorbat 20, saharoza i voda za injekcije.
English: It contains 150 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.
Croatian: Sadrži 150 mg lijeka Kevzara za injekciju koja se daje pod kožu (potkožna injekcija) jedanput svaka dva tjedna.
English: Keep holding the pen firmly against your skin.
Croatian: Nastavite držati brizgalicu čvrsto priljubljenom uz kožu.
English: Store pre-filled syringe/pre-filled pen in the original carton in order to protect from light.
Croatian: Napunjenu štrcaljku/napunjenu brizgalicu čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Reports of gastrointestinal perforation were primarily reported as complications of diverticulitis including lower GI perforation and abscess.
Croatian: Slučajevi gastrointestinalne perforacije prvenstveno su prijavljeni kao komplikacija divertikulitisa, a uključivali su perforaciju i apsces u donjem dijelu probavnog sustava.
English: Kevzara should not be injected into skin that is tender, damaged, or has bruises or scars.
Croatian: Kevzara se ne smije se injicirati u kožu koja je osjetljiva na dodir, oštećena ili prekrivena modricama ili ožiljcima.
English: The absolute bioavailability for sarilumab after SC injection was estimated to be 80% by population PK analysis.
Croatian: Temeljem populacijske farmakokinetičke analize procjenjuje se da apsolutna bioraspoloživost sarilumaba nakon supkutane injekcije iznosi 80%.
English: Kevzara should not be administered to patients with known hypersensitivity to sarilumab (see section 4.3).
Croatian: Kevzara se ne smije primjenjivati u bolesnika s poznatom preosjetljivošću na sarilumab (vidjeti dio 4.3).
English: • Contact details of the prescriber for Kevzara.
Croatian: • Kontaktne podatke liječnika koji je propisao lijek Kevzara
English: Treatment with Kevzara is not recommended in patients with active hepatic disease or hepatic impairment (see sections 4.2 and 4.8).
Croatian: Ne preporučuje se liječenje lijekom Kevzara u bolesnika s aktivnom bolešću jetre ili oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 4.8).
English: ALT > 3 to 5 x ULN Treatment with Kevzara should be withheld until < 3 x ULN.
Croatian: ALT > 3 - 5 x GGN Treba odgoditi primjenu lijeka Kevzara dok vrijednost ne bude < 3 x GGN.
English: Once removed from the refrigerator, Kevzara should be administered within 14 days and should not be stored above 25 ºC.
Croatian: Nakon što se izvadi iz hladnjaka, Kevzara se mora primijeniti unutar 14 dana te se ne smije čuvati na temperaturi iznad 25ºC.
English: • Pull the needle out at the same angle it was injected.
Croatian: • Izvadite iglu iz kože pod istim kutom pod kojim ste je uboli.
English: MOBILITY MTX Inadequate Responders
Croatian: Bolesnici s nedovoljno dobrim odgovorom na MTX
English: How Kevzara works
Croatian: Kako Kevzara djeluje
English: Proper training should be provided to patients and/or caregivers on the preparation and administration of Kevzara prior to use.
Croatian: Prije nego što počnu primjenjivati lijek, bolesnike i/ili skrbnike treba pravilno poučiti kako pripremiti i primijeniti lijek Kevzara.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Kevzara.
Croatian: Ako se bilo što od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego što primijenite lijek Kevzara.
English: Treatment with Kevzara was associated with a higher incidence of transaminase elevations.
Croatian: Liječenje lijekom Kevzara bilo je povezano s višom incidencijom porasta vrijednosti transaminaza.
English: It contains 200 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.
Croatian: Sadrži 200 mg lijeka Kevzara za injekciju koja se daje pod kožu (potkožna injekcija) jedanput svaka dva tjedna.
English: In patients experiencing a decrease in absolute neutrophil count (ANC), modification of treatment regimen such as interruption of Kevzara or reduction in dose resulted in an increase or normalization of ANC (see section 4.2).
Croatian: U bolesnika sa smanjenim apsolutnim brojem neutrofila (ABN), prilagodba režima liječenja, kao što je privremeni prekid primjene ili smanjenje doze lijeka Kevzara, dovela je do porasta ili normalizacije ABN-a (vidjeti dio 4.2).
English: In the placebo-controlled population, one patient on Kevzara therapy experienced a gastrointestinal (GI) perforation (0.11 events per 100 patient-years).
Croatian: Gastrointestinalnu (GI) perforaciju je u placebom kontroliranoj populaciji doživio jedan bolesnik koji je primao lijek Kevzara (0,11 događaja na 100 bolesnik-godina).
English: Keep the remaining syringe in the carton in the refrigerator.
Croatian: Preostale štrcaljke čuvajte u kutiji u hladnjaku.
English: The recommended dose of Kevzara is 200 mg once every 2 weeks administered as a subcutaneous injection.
Croatian: Preporučena doza lijeka Kevzara iznosi 200 mg jedanput svaka 2 tjedna, a primjenjuje se supkutanom injekcijom.
English: Elevated levels of interleukin-6 (IL-6) may down-regulate CYP activity such as in patients with RA and hence increase drug levels compared to subjects without RA.
Croatian: Povišene vrijednosti interleukina-6 (IL-6) mogu smanjiti aktivnost CYP enzima u bolesnika s RA i tako povisiti razine lijeka u odnosu na ispitanike koji nemaju RA.
English: * q2w = every 2 weeks ‡ Visual analogue scale †p-value <0.01 for difference from placebo ††p-value <0.001 for difference from placebo †††p-value <0.0001 for difference from placebo
Croatian: ‡ Vizualna analogna ljestvica † p-vrijednost < 0,01 za razliku u odnosu na placebo †† p-vrijednost < 0,001 za razliku u odnosu na placebo ††† p-vrijednost < 0,0001 za razliku u odnosu na placebo
English: Sarilumab had no effect on maintenance of pregnancy or on the neonates evaluated up to 1 month after birth in body weight measurements, in parameters of functional or morphological development including skeletal evaluations, in immunophenotyping of peripheral blood lymphocytes, and in microscopic evaluations.
Croatian: Sarilumab nije utjecao ni na očuvanje skotnosti ni na mladunčad, kod koje se do mjesec dana nakon okota provodila ocjena tjelesne težine te parametara funkcionalnog ili morfološkog razvoja (uključujući ocjene razvoja kostura),
English: • HIV infection;
Croatian: • koji imaju HIV infekciju
English: Component (range)
Croatian: Sastavnica (raspon)
English: If you stop using Kevzara
Croatian: Ako prestanete primjenjivati lijek Kevzara
English: There were no bleeding events associated with decreases in platelet count.
Croatian: Nije bilo događaja krvarenja povezanih s padom broja trombocita.
English: At Week 4 the mean LDL increased by 14 mg/dL; mean triglycerides increased by 23 mg/dL; and mean HDL increased by 3 mg/dL. After Week 4 no additional increases were observed.
Croatian: 4. tjedna porasla je za 14 mg/dl, srednja vrijednost triglicerida za 23 mg/dl, a srednja vrijednost HDL-a za 3 mg/dl.
English: Lipid parameters (LDL, HDL, and triglycerides) were first assessed at 4 weeks following initiation of Kevzara+ DMARDs in the placebo-controlled population.
Croatian: Lipidi Lipidni parametri (LDL, HDL i trigliceridi) su u placebom kontroliranoj populaciji prvi put ocijenjeni
English: Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections.
Croatian: Pomoćne tvari: histidin, arginin, polisorbat 20, saharoza, voda za injekcije.
English: Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled syringe.
Croatian: Kevzara je bistra, bezbojna do blijedo žuta otopina za injekciju koja dolazi u napunjenoj štrcaljki.
English: Treatment with Kevzara 200 mg and 150 mg + MTX inhibited the progression of structural damage by 91% and 68%, respectively, compared to placebo + MTX at Week 52.
Croatian: Liječenje lijekom Kevzara u dozi od 200 mg ili 150 mg + MTX-om inhibiralo je progresiju strukturnog oštećenja u 52. tjednu za 91% odnosno 68% u usporedbi s placebom + MTX-om.
English: Do not expose the syringe to direct sunlight.
Croatian: Nemojte izlagati štrcaljku izravnoj sunčevoj svjetlosti.
English: • Write down the date of removal from the refrigerator in the space provided on the outer carton.
Croatian: • Upišite datum kada ste štrcaljku izvadili iz hladnjaka u za to predviđeno mjesto na kutiji.
English: (see section 5.2).Interaction of sarilumab with substrates of other CYPs (CYP2C9, CYP 2C19, CYP2D6) has not been studied.
Croatian: enzima (CYP2C9, CYP 2C19, CYP2D6) nije se ispitivala.
English: ALT and AST levels should be monitored 4 to 8 weeks after start of therapy and every 3 months thereafter.
Croatian: Vrijednosti ALT-a i AST-a treba pratiti 4 do 8 tjedana nakon početka liječenja i zatim kontrolirati svaka 3 mjeseca nakon toga.
English: General health status was assessed by the Short Form health survey (SF-36).
Croatian: Short Form, SF-36).
English: Do not recycle your used puncture-resistant container.
Croatian: Nemojte reciklirati neprobojni spremnik.
English: • Using the pen at room temperature may make the injection more comfortable.
Croatian: • Ako pričekate da se brizgalica ugrije na sobnu temperaturu, injekcija bi Vam mogla biti ugodnija.
English: These injection site reactions (including erythema and pruritus) were mild in severity for the majority of patients.
Croatian: U većine su bolesnika te reakcije na mjestu injiciranja (uključujući eritem i pruritus) bile blage.
English: • Hold the syringe in the middle of the syringe body with the needle pointing away from you.
Croatian: • Uhvatite štrcaljku za srednji dio tijela i usmjerite iglu od sebe.
English: In the Kevzara +DMARDs long-term safety population, the rates of infections and serious infection were 57.3 and 3.4 events per 100-patient years, respectively.
Croatian: DMARD-ove iznosila je 57,3, a stopa ozbiljnih infekcija 3,4 događaja na 100 bolesnik-godina.
English: Animal studies showed no impairment of male or female fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala da lijek utječe na plodnost mužjaka ili ženki (vidjeti dio 5.3).
English: Upper respiratory tract infection Urinary tract infection Nasopharyngitis Oral herpes
Croatian: Infekcije i infestacije često infekcija gornjih dišnih putova infekcija mokraćnih putova nazofaringitis oralni herpes
English: No dosage adjustment is required in patients with mild to moderate renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
English: Following single-dose sarilumab administration, in patients with RA, ANC decreased to the nadir between 3 to 4 days and thereafter recovered towards baseline (see section 4.4).
Croatian: Nakon primjene jedne doze sarilumaba u bolesnika s RA, najniža vrijednost (nadir) ABN-a zabilježena je između 3. i 4. dana, a nakon toga se počela vraćati prema početnoj vrijednosti (vidjeti dio 4.4).
English: Use Kevzara with caution in patients with previous history of intestinal ulceration or diverticulitis.
Croatian: Lijek Kevzara treba primjenjivati uz oprez u bolesnika koji u anamnezi imaju ulceracije crijeva ili divertikulitis.
English: For single use only Read the package leaflet before use.
Croatian: Samo za jednokratnu uporabu Prije uporabe pročitajte uputu o lijeku.
English: In both studies, patients treated with either 200 mg or 150 mg of Kevzara + DMARDs every two weeks had higher ACR20, ACR50, and ACR70 response rates versus placebo-treated patients at Week 24.
Croatian: U oba su ispitivanja bolesnici liječeni lijekom Kevzara u dozi od 200 mg ili 150 mg + DMARD-ovima svaka 2 tjedna imali više stope odgovora ACR20, ACR50 i ACR70 u 24. tjednu nego bolesnici koji su primali placebo.
English: The overall rates of infections and serious infections in the Kevzara monotherapy population were consistent with rates in the Kevzara + DMARDs population.
Croatian: Ukupne stope infekcija i ozbiljnih infekcija u populaciji liječenoj monoterapijom lijekom Kevzara bile su u skladu sa stopama zabilježenima u populaciji koja je primala lijek Kevzara + DMARD-ove.
English: Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen.
Croatian: Kevzara je bistra, bezbojna do blijedo žuta otopina za injekciju koja dolazi u napunjenoj brizgalici.
English: • you have recently had any vaccination or are going to have a vaccination.
Croatian: • ako ste nedavno primili ili trebate primiti bilo koje cjepivo
English: In patients who develop a platelet count less than 50 x 103/ µL, treatment with Kevzara should be discontinued.
Croatian: U bolesnika kojima broj trombocita padne ispod 50 x 103/µl potrebno je prekinuti liječenje lijekom Kevzara.
English: In the placebo-controlled population, malignancies occurred at the same rate in patients receiving either Kevzara + DMARDs or placebo + DMARDs (1.0 events per 100 patient-years).
Croatian: Stopa zloćudnih bolesti u placebom kontroliranoj populaciji bila je jednaka neovisno o tome jesu li bolesnici primali lijek Kevzara + DMARD-ove ili placebo + DMARD-ove (1,0 događaj na 100 bolesnik-godina).
English: Lay the syringe on a flat surface and allow it to warm up to room temperature (<25°C) for at least 30 minutes.
Croatian: Položite štrcaljku na ravnu površinu i pričekajte najmanje 30 minuta da se ugrije na sobnu temperaturu (< 25°C).
English: Do not inject into skin that is tender, damaged or has bruises or scars.
Croatian: Nemojte injicirati lijek u kožu koja je osjetljiva na dodir, oštećena ili prekrivena modricama ili ožiljcima.
English: In patients who develop an ANC less than 0.5 x 109/L, treatment with Kevzara should be discontinued.
Croatian: U bolesnika kojima ABN padne ispod 0,5 x 109/l potrebno je prekinuti liječenje lijekom Kevzara.
English: The excretion of sarilumab in Cynomolgus monkey's milk has not been studied.
Croatian: Nije se ispitivalo izlučivanje sarilumaba u mlijeko ženki makaki majmuna.
English: Placebo cDMARDs (N = 181)
Croatian: Placebo kDMARD (N = 181)
English: Comprehensive instructions for the administration of Kevzara in a pre-filled syringe/pre-filled pen are given in the package leaflet.
Croatian: Detaljne upute za primjenu lijeka Kevzara u napunjenoj štrcaljki/napunjenoj brizgalici navedene su u uputi o lijeku.
English: ACR50
Croatian: ACR20 ACR50 ACR70
English: Lay the pen on a flat surface and allow it to warm up to room temperature (<25°C) for at least 60 minutes.
Croatian: Položite brizgalicu na ravnu površinu i pričekajte najmanje 60 minuta da se ugrije na sobnu temperaturu (< 25°C).
English: ACR50 response, n (%)
Croatian: Odgovor ACR50, n (%)
English: These elevations were transient and did not result in any clinically evident hepatic injury in clinical studies (see section 4.8).
Croatian: U kliničkim je ispitivanjima taj porast bio prolazan i nije doveo ni do kakvog klinički primjetnog oštećenja jetre (vidjeti dio 4.8).
English: This device is a single-dose pre-filled syringe (called “syringe” in these instructions).
Croatian: Ovo pomagalo je jednodozna napunjena štrcaljka (koja se u ovim uputama naziva ‘štrcaljkom').
English: The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a light-orange polypropylene finger flange.
Croatian: Napunjena štrcaljka za jednokratnu uporabu ima zatvarač igle načinjen od stiren-butadienskog elastomera, a opremljena je bijelim polistirenskim potisnikom klipa i svijetlonarančastim polipropilenskim rubnikom za prste.
English: Among opportunistic infections, tuberculosis, candidiasis, and pneumocystis were reported with Kevzara.
Croatian: Od oportunističkih infekcija, kod primjene lijeka Kevzara prijavljene su tuberkuloza, kandidijaza i pneumonija uzrokovana gljivicom Pneumocystis jirovecii.
English: In the placebo-controlled population, the proportion of patients who discontinued treatment due to hypersensitivity reactions was higher among those treated with Kevzara (0.9% in 200 mg group, 0.5% in 150 mg group) than placebo (0.2%).
Croatian: Udio bolesnika koji su prekinuli liječenje zbog reakcija preosjetljivosti u placebom kontroliranoj populaciji bio je veći među bolesnicima liječenima lijekom Kevzara (0,9% u skupini koja je primala dozu od 200 mg i 0,5% u onoj koja je primala dozu od 150 mg) nego među onima koji su primali placebo (0,2%).
English: Keep the remaining pen in the carton in the refrigerator.
Croatian: Preostale brizgalice čuvajte u kutiji u hladnjaku.
English: Pull the pen away from your skin.
Croatian: Podignite brizgalicu s kože.
English: Mild to moderate renal impairment did not affect the pharmacokinetics of sarilumab.
Croatian: Blago do umjereno oštećenje funkcije bubrega nije utjecalo na farmakokinetiku sarilumaba.
English: ACR20 response, n (%)
Croatian: Odgovor ACR20, n (%)
English: Do not use the syringe if it has been damaged or the needle cap is missing or not attached.
Croatian: Nemojte upotrijebiti štrcaljku ako je oštećena, ako joj nedostaje zatvarač igle ili ako zatvarač igle nije pričvršćen.
English: Liver enzyme abnormalities are summarised in Table 2.
Croatian: Jetreni enzimi Odstupanja u vrijednostima jetrenih enzima sažeto su prikazana u Tablici 2.
English: The safety and efficacy of Kevzara have not been studied in patients with hepatic impairment, including patients with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serology (see section 4.4).
Croatian: uključujući bolesnike sero pozitivne na virus hepatitisa B (HBV) ili virus hepatitisa C (HCV) (vidjeti dio 4.4).
English: ACR70 response, n (%)
Croatian: Odgovor ACR70, n (%)
English: No formal study of the effect of renal impairment on the pharmacokinetics of sarilumab was conducted.
Croatian: Nije provedeno formalno ispitivanje učinka oštećenja funkcije bubrega na farmakokinetiku sarilumaba.
English: Initiating treatment with Kevzara is not recommended in patients with elevated transaminases, ALT or AST greater than 1.5 x ULN.
Croatian: Ne preporučuje se započeti liječenje lijekom Kevzara u bolesnika s povišenim vrijednostima transaminaza, ALT-a ili AST-a više od 1,5 x GGN.
English: This device is a single-dose pre-filled pen (called “pen” in these instructions).
Croatian: Ovo pomagalo je jednodozna napunjena brizgalica (koja se u ovim uputama naziva ‘brizgalicom').
English: Each pre-filled syringe contains 1.14 ml of solution delivering one single dose.
Croatian: Jedna napunjena brizgalica sadrži 1,14 ml otopine i isporučuje jednu dozu.
English: It is available in pack sizes of 1 or 2 or a multipack of 6 pre-filled pens (3 packs of 2).
Croatian: Dostupna je u pakiranjima od 1 ili 2 napunjene štrcaljke ili višestrukom pakiranju od 6 napunjenih štrcaljki (3 pakiranja od 2 napunjene štrcaljke).
English: What Kevzara is used for
Croatian: Za što se Kevzara koristi
English: Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., absolute neutrophil count (ANC) less than 2 x 109/L.
Croatian: Ne preporučuje se započeti liječenje lijekom Kevzara u bolesnika s niskim brojem neutrofila, tj. apsolutnim brojem neutrofila (ABN) manjim od 2 x 109/l.
English: • Neutrophil count should be monitored 4 to 8 weeks after start of therapy and according to clinical judgment thereafter.
Croatian: • Broj neutrofila treba pratiti 4 do 8 tjedana nakon početka liječenja, a nakon toga prema kliničkoj prosudbi.
English: Learning how to use the pre-filled syringe
Croatian: Kako upotrijebiti napunjenu štrcaljku
English: sanofi-aventis groupe: 54, rue la Boétie 75008 Paris France
Croatian: sanofi-aventis groupe: 54, rue La Boétie 75008 Paris Francuska
English: The primary endpoints were the proportion of patients who achieved an ACR20 response at Week 24 and the changes from baseline HAQ-DI score at Week 12.
Croatian: Primarne mjere ishoda bile su udio bolesnika koji su postigli odgovor ACR20 u 24. tjednu te promjene HAQ-DI rezultata od početka ispitivanja do 12. tjedna.
English: Kevzara has not been studied in patients with severe renal impairment (see section 5.2).
Croatian: Kevzara se nije ispitivala u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: * q2w=every two weeks † p-value <0.001 ††p-value <0.0001 ‡ Primary end point
Croatian: † p-vrijednost < 0,001 †† p-vrijednost < 0,0001 ‡ Primarna mjera ishoda
English: Patients treated with Kevzara + MTX (47.6% in the 200 mg treatment group and 47.0% in the 150 mg treatment group) achieved a clinically relevant improvement in HAQ-DI (change from baseline of
Croatian: Bolesnici liječeni lijekom Kevzara + MTX-om (47,6% onih u skupini koja je primala dozu od 200 mg i 47,0% onih u skupini koja je primala dozu od 150 mg) ostvarili su klinički značajno poboljšanje
English: Kevzara can then be resumed at 150 mg every 2 weeks and increased to 200 mg every 2 weeks as clinically appropriate.
Croatian: Liječenje lijekom Kevzara može se zatim nastaviti dozom od 150 mg svaka 2 tjedna, koja se nakon toga može povećati na 200 mg svaka
English: Learning how to use the pre-filled pen
Croatian: Kako upotrijebiti napunjenu brizgalicu
English: 200 mg solution for injection
Croatian: 200 mg otopina za injekciju
English: The parts of the Kevzara pre-filled pen are shown in this picture.
Croatian: Dijelovi Kevzara napunjene brizgalice prikazani su na sljedećoj slici.
English: What Kevzara is and what it is used for 2.
Croatian: Što je Kevzara i za što se koristi
English: Solution for injection (injection) Clear, colourless to pale yellow sterile solution of approximately pH 6.0.
Croatian: Bistra, bezbojna do blijedo žuta sterilna otopina, čija pH vrijednost iznosi približno 6,0.
English: After use, put the syringe into a puncture-resistant container.
Croatian: Nakon uporabe odložite brizgalicu u neprobojan spremnik.