FrancophonIA/ELRC3.0 huggingface dataset:
English: • Instruction to immediately seek for medical attention after detection of symptoms suggestive for infection
Croatian: • upute da u slučaju simptoma koji mogu upućivati na infekciju valja odmah potražiti pomoć liječnika
English: 4 pre-filled SensoReady pens
Croatian: 4 napunjene SensoReady brizgalice
English: EU/1/17/1195/013 8 pre-filled syringes EU/1/17/1195/004 12 pre-filled syringes EU/1/17/1195/014 24 pre-filled syringes
Croatian: EU/1/17/1195/013 8 napunjenih štrcaljki EU/1/17/1195/004 12 napunjenih štrcaljki EU/1/17/1195/014 24 napunjene štrcaljke
English: By looking through the viewing window, the solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.
Croatian: Kad se pogleda kroz kontrolni prozorčić, otopina bi trebala biti bistra do blago opalescentna, bezbojna ili blago žućkasta i može sadržavati male prozirne ili bijele čestice proteina.
English: 1 pre-filled SensoReady pen
Croatian: 1 napunjena SensoReady brizgalica
English: 4 pre-filled SensoReady pens.
Croatian: 4 SensoReady napunjene brizgalice.
English: Among patients with ankylosing spondylitis who received etanercept, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
Croatian: Među bolesnicima s ankilozantnim spondilitisom koji su primali etanercept, klinički odgovor bio je očit u trenutku prvog kontrolnog pregleda (nakon 2 tjedna), a zadržan je i tijekom trajanja terapije od
English: 164 n = 193 n = 196 n = 196 n = 46 n = 96 n = 90
Croatian: 24a n = 193 tj.12
English: Efficacy response in placebo-controlled nr-AxSpa study: percent of patients achieving endpoints
Croatian: Odgovor djelotvornosti u placebom kontroliranom ispitivanju nr-AxSpa: Postotak bolesnika koji su postigli mjere ishoda Dvostruko slijepi klinički odgovori u 12. tjednu
English: The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.
Croatian: Preporučena doza je 25 mg etanercepta primijenjeno dva puta na tjedan ili 50 mg etanercepta primijenjeno jednom tjedno.
English: 4.1 Therapeutic indications
Croatian: 4.1 Terapijske indikacije Reumatoidni artritis
English: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients.
Croatian: Šest zloćudnih bolesti je zabilježeno u bolesnika liječenih etanerceptom u kliničkim ispitivanjima trajanja duljeg od 2 godine u 351 bolesnika s ankilozantnim spondilitisom.
English: Similarly, the significant advantages for etanercept monotherapy compared with methotrexate monotherapy were also observed after 24 months.
Croatian: primijećena je značajna prednost za etanercept kao monoterapiju u usporedbi s metotreksatom kao monoterapijom nakon 24 mjeseca.
English: Do not use this medicine after the expiry date which is stated on the carton and the label of the pre-filled syringe after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i napunjenoj štrcaljki iza oznake „Rok valjanosti“ ili EXP.
English: In a double-blind, placebo-controlled, randomised clinical study in adult patients with psoriatic arthritis, 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
Croatian: 184 bolesnika je također primilo polivalentno pneumokokno polisaharidno cjepivo u 4. tjednu.
English: Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi pre-filled syringe”.
Croatian: Detaljne upute kako ubrizgati Erelzi nalaze se u dijelu 7„Upute za primjenu napunjene štrcaljke Erelzi“.
English: Undesirable effects in paediatric patients with plaque psoriasis
Croatian: Nuspojave u pedijatrijskih bolesnika s plak psorijazom
English: Clinical responses among nr-AxSpa patients who received etanercept were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy.
Croatian: Klinički odgovori među bolesnicima s aksijalnim spondiloartritisom bez radiološkog dokaza koji su primali etanercept bili su uočljivi u vrijeme prvog posjeta (2 tjedna) i održani su kroz 2 godine liječenja.
English: 1 pre-filled syringe with a needle guard
Croatian: 1 napunjena štrcaljka sa štitnikom igle
English: Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi SensoReady pen”.
Croatian: Detaljne upute kako ubrizgati Erelzi nalaze se u dijelu 7„Upute za primjenu Erelzi SensoReady napunjene brizgalice“.
English: 4 pre-filled syringes with a needle guard
Croatian: 4 napunjene štrcaljke sa štitnikom igle
English: Methotrexate doses were escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial and continued for up to 24 months.
Croatian: 7,5 mg tjedno do maksimalnih 20 mg tjedno te se s primjenom nastavilo tijekom najdulje 24 mjeseca.
English: A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Croatian: Za liječenje djece s juvenilnim idiopatskim artritisom (JIA) tjelesne težine manje od 25 kg bile bi prikladnije bočiceErelzi jačine 10 mg.
English: 25 mg BIW
Croatian: 25 mg.
English: Merkel cell carcinoma (see section 4.4)
Croatian: Karcinom Merkelovih stanica (vidjeti dio
English: INSTRUCTIONS ON USE ‘QR code to be included' + www.erelzi.eu 16.
Croatian: 15. UPUTE ZA UPORABU „Treba navesti QR kod“ + www.erelzi.eu 16. PODACI NA BRAILLEOVOM PISMU Erelzi 25 mg
English: Keep the pre-filled syringes and the pre-filled pens in the outer carton in order to protect from light.
Croatian: Napunjene štrcaljke i napunjene brizgalice čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Erelzi to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Croatian: Prije propisivanja Erelzija u osoba koje već neko vrijeme boluju, ili su nedavno oboljele, ili u kojih postoji povećana opasnost od razvoja demijelinizirajuće bolesti, preporučuje se pažljivo procijeniti odnos rizika i koristi, uključujući neurološku procjenu.
English: Erelzi 25 mg injection etanercept SC
Croatian: Erelzi 25 mg injekcija etanercept s.c.
English: The recommended dose of etanercept is 25 mg administered twice weekly or 50 mg administered once weekly.
Croatian: Preporučena doza etanercepta je 25 mg primijenjeno dva puta tjedno ili 50 mg primijenjeno jednom tjedno.
English: Each pre-filled syringe contains 25 mg etanercept.
Croatian: Jedna napunjena štrcaljka sadrži 25 mg etanercepta.
English: Among patients with psoriatic arthritis who received etanercept, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Croatian: Klinički odgovor u bolesnika s psorijatičnim artritisom koji su primali etanercept zamijećen je u vrijeme prve kontrole (4 tjedna) i održan je tijekom svih 6 mjeseci liječenja.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Croatian: kroničnu upalnu demijeliniziraj uću polineuropatiju demijeliniziraj uću polineuropatiju i multifokalnu motoričku neuropatiju (vidjeti dio 4.4), napadaj
English: Additionally, the pharmacokinetics of etanercept in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Croatian: ankilozantnim spondilitisom i plak psorijazom je slična.
English: Erelzi 25 mg solution for injection in pre-filled syringe.
Croatian: Erelzi 25 mg otopina za injekciju u napunjenoj štrcaljki.
English: Erelzi 25 mg solution for injection in pre-filled syringe etanercept
Croatian: Erelzi 25 mg otopina za injekciju u napunjenoj štrcaljki etanercept (etanerceptum)
English: Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
Croatian: atipične mikobakterijsk e, virusne infekcije i Legionellu)*
English: EU/1/17/1195/005 1 pre-filled syringe EU/1/17/1195/006 2 pre-filled syringes EU/1/17/1195/007 4 pre-filled syringes
Croatian: EU/1/17/1195/005 1 napunjena štrcaljka EU/1/17/1195/006 2 napunjene štrcaljke EU/1/17/1195/007 4 napunjene štrcaljke
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Croatian: Odrasli bolesnici s psorijatičnim artritisom Djelotvornost etanercepta ocijenjena je u 205 bolesnika sa psorijatičnim artritisom u randomiziranom,
English: The liquid should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein.
Croatian: Tekućina treba biti bistra ili blago opalescentna, bezbojna do blago žućkasta i može sadržavati male bijele ili gotovo prozirne čestice proteina.
English: Erelzi 50 mg solution for injection in pre-filled syringe.
Croatian: Erelzi 50 mg otopina za injekciju u napunjenoj štrcaljki.
English: Etanercept 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Croatian: U procjeni erozije nakon 12 i 24 mjeseca, etanercept 25 mg je bio značajno superioran metotreksatu.
English: Multipack: 12 (3 packs of 4) pre-filled syringes with a needle guard.
Croatian: Višestruko pakiranje: 12 (3 pakiranja po 4) napunjenih štrcaljki sa štitnikom igle.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - 25 MG PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)NAPUNJENA ŠTRCALJKA OD 25 MG
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use.
Croatian: Tijekom primjene etanercepta slučajevi središnje demijelinizacije prijavljeni su rijetko, dok su slučajevi periferne demijelinizacije prijavljeni vrlo rijetko.
English: You have been prescribed a 50 mg strength of Erelzi.
Croatian: Erelzija od 50 mg.
English: What you need for your injection: Included in the carton:
Croatian: Što Vam još treba za injekciju: • Alkoholni tupfer
English: Breast-feeding
Croatian: Etanercept
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the etanercept in combination with methotrexate group compared with the etanercept alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05).
Croatian: 24 mjeseca bio je veći kod kombinacije etanercepta s metotreksatom u usporedbi sa skupinom koja je uzimala samo etanercept i koja je uzimala samo metotreksat (62%, 50% odnosno 36%, p < 0,05).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE LABEL - 25 MG PRE-FILLED SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE - NAPUNJENA ŠTRCALJKA OD 25 MG
English: Erelzi 50 mg solution for injection in pre-filled syringe etanercept
Croatian: Erelzi 50 mg otopina za injekciju u napunjenoj štrcaljki Etanercept (etanerceptum)
English: Elderly
Croatian: Vaskulitis
English: Carefully remove the needle cap from the syringe.
Croatian: Kako se koristi Erelzi napunjena štrcaljka Pažljivo maknite poklopac igle sa štrcaljke.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED PEN LABEL - 50 MG PRE-FILLED PEN
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NA NALJEPNICI NAPUNJENE BRIZGALICE - NAPUNJENA BRIZGALICA OD 50 MG
English: The solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.
Croatian: Otopina bi trebala biti bistra do blago opalescentna, bezbojna do blijedožuta i može sadržavati male prozirne ili bijele čestice proteina.
English: Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also section 4.4), appendicitis, gastroenteritis,
Croatian: Teški štetni događaji uključivali su vodene kozice praćene znakovima i simptomima aseptičnog meningitisa uz oporavak bez posljedica (vidjeti također dio 4.4), apendicitis, gastroenteritis, depresiju/poremećaj osobnosti, kožni ulkus, ezofagitis/gastritis, septični šok uzrokovan streptokokom grupe A, dijabetes melitus tipa
English: Posology and administration are the same as for adults 18-64 years of age.
Croatian: Doziranje i način primjene jednaki su kao i u odraslih osoba starosti
English: EU/1/17/1195/001 1 pre-filled syringe EU/1/17/1195/002 2 pre-filled syringes EU/1/17/1195/003 4 pre-filled syringes
Croatian: EU/1/17/1195/001 1 napunjena štrcaljka EU/1/17/1195/002 2 napunjene štrcaljke EU/1/17/1195/003 4 napunjene štrcaljke
English: Keep the pre-filled SensoReady pens in the outer carton in order to protect from light.
Croatian: Napunjene SensoReady brizgalice čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: A 25 mg strength of Erelzi is available for doses of 25 mg.
Croatian: Za doze od 25 mg dostupna je jačina
English: The possibility exists for TNF-antagonists, including Erelzi, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Croatian: Budući da je TNF medijator upale te mijenja stanični imunološki odgovor, za sve antagoniste TNF-a, uključivši Erezli, postoji mogućnost utjecaja na obrambene reakcije bolesnika protiv infekcija i zloćudnih bolesti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 25 MG PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA JEDINIČNOG PAKIRANJA - NAPUNJENA ŠTRCALJKA OD 25 MG
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe".
Croatian: Iscrpne upute za primjenu nalaze se u uputi o lijeku, dio 7 “Upute za primjenu napunjene štrcaljke Erelzi”.
English: Store your boxed pen in a refrigerator, between 2 °C to 8 °C and out of the sight and reach of children.
Croatian: Čuvajte kutiju sa svojom brizgalicom u hladnjaku na temperaturi između 2 °C do
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 50 MG PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA JEDINIČNOG PAKIRANJA - NAPUNJENA BRIZGALICA OD 50 MG
English: 50 mg BIW
Croatian: NAPUNJENA BRIZGALICA OD 50 MG
English: Each pre-filled syringe contains 50 mg etanercept.
Croatian: Jedna napunjena brizgalica sadrži 50 mg etanercepta.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE LABEL - 50 MG PRE-FILLED SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE - NAPUNJENA ŠTRCALJKA OD 50 MG
English: It should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein.
Croatian: Trebala bi biti bistra ili blago opalescentna, bezbojna do blijedožuta i može sadržavati bijele ili gotovo prozirne čestice proteina.
English: Responses were measured using the ACR Pedi 30, defined as ≥ 30% improvement in at least three of six and ≥ 30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Croatian: Odgovori su mjereni upotrebom ACR Pedi 30, definirano kao ≥ 30% poboljšanje u najmanje 3 od 6 i ≥ 30% pogoršanje u ne više od jednom od 6
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi SensoReady pen".
Croatian: Iscrpne upute za primjenu nalaze se u uputi o lijeku, dio 7 “Upute za primjenu Erelzi SensoReady brizgalice”.
English: Abbreviation: sPGA-static Physician Global Assessment a. p < 0.0001 compared with placebo
Croatian: Kratice: sPGA-statička opća procjena liječnika a.
English: Storage of the Erelzi pre-filled syringe
Croatian: Upute za primjenu napunjene štrcaljke Erelzi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - 25 MG PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)NAPUNJENA ŠTRCALJKA OD 25 MG
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - 50 MG PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)NAPUNJENA BRIZGALICA OD 50 MG
English: ACR Responsesa ACR 20
Croatian: ACR odgovoria
English: Erelzi 50 mg solution for injection in pre-filled pen etanercept
Croatian: Erelzi 50 mg otopina za injekciju u napunjenoj brizgalici Etanercept (etanerceptum)
English: 24a wk
Croatian: 24a n = tj.
English: Keep the pre-filled SensoReady pen in the outer carton in order to protect from light.
Croatian: Napunjenu SensoReady brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: 25 mg etanercept administered twice weekly is the recommended dose.
Croatian: Preporučena doza etanercepta je 25 mg primijenjeno dva puta na tjedan.
English: EXPIRY DATE
Croatian: naljepnica i datum valjanosti
English: 50 mg QW
Croatian: 50 mg 2xtj.
English: • Once removed, throw away the cap. Do not try to re-attach the cap.
Croatian: • Nakon što ga skinete, odložite poklopac.
English: What is in this leaflet:
Croatian: Uključeno u kutiju:
English: • Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Erelzi in case the infection worsens.
Croatian: • Hepatitis C: obavijestite liječnika ako Vi ili dijete imate hepatitis C.
English: NAME OF THE MEDICINAL PRODUCT Erelzi 25 mg injection etanercept
Croatian: Erelzi 25 mg injekcija etanercept
English: Then continue to inject the medicine on the usual day(s).
Croatian: Nakon toga nastavite s primjenom Erelzija uobičajenim danima.
English: Erelzi 50 mg solution for injection in pre-filled pen.
Croatian: Erelzi 50 mg otopina za injekciju u napunjenoj brizgalici.
English: PC SN NN
Croatian: • h/ml.
English: Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the post-marketing period (see section 4.8).
Croatian: Solidni tumori i hematopoetske zloćudne bolesti (izuzimajući rak kože) Nakon stavljanja u promet zabilježeni su slučajevi raznih zloćudnih bolesti (uključujući karcinome dojke i pluća te limfome) (vidjeti dio 4.8).
English: NAME OF THE MEDICINAL PRODUCT Erelzi 50 mg injection etanercept
Croatian: Erelzi 50 mg injekcija etanercept
English: In study 4, the etanercept-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p < 0.0001).
Croatian: (38%) u usporedbi sa skupinom liječenom placebom (2%) (p<0,0001).
English: • This means the medicine has been delivered.
Croatian: U skladu s time potrebno je ažurirati uputu o lijeku.
English: Wegener's granulomatosis
Croatian: GuillainBarréov sindrom,
English: Etanercept is recommended for use in patients as defined in section 4.1.
Croatian: Preporučena je primjena etanercepta u bolesnika kako je definirano u dijelu 4.1. Bolesnici koji „nisu pokazali odgovor“ u ciljnoj populaciji definirani su kao oni s nedostatnim odgovorom (PASI< 50 ili
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I
English: Administration of Erelzi should be discontinued if a patient develops a serious infection.
Croatian: U slučaju razvoja ozbiljne infekcije primjena Erelzija mora se obustaviti.
English: depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection.
Croatian: peritonitis, pneumoniju, pijelonefritis, sepsu, septični artritis, sinusitis, infekciju kože, ulkus kože, infekciju mokraćnog sustava, vaskulitis i infekciju rane.
English: Store this medicine sealed in its outer box to protect it from light.
Croatian: Čuvanje Erelzi napunjene štrcaljke Čuvajte ovaj lijek zatvoren u kutiji radi zaštite od svjetlosti.
English: For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), Erelzi can slow down the structural damage to those joints caused by the disease.
Croatian: Erelzi može usporiti napredovanje strukturnog oštećenja zglobova koje uzrokuje bolest u bolesnika s više simetrično bolnih ili otečenih zglobova (npr. šake, zapešća i stopala).
English: Information for patients
Croatian: Znanstveni zaključci
English: It is also not recommended in combination with systemic cancer therapies other than LHRH analogues.
Croatian: U zaključku, PRAC nije preporučio kombinaciju radija-223 i drugih sustavnih terapija protiv raka,osim analoga LHRH-a.
English: • In patients with a high baseline risk of fracture, carefully consider the benefit of treatment against the risks.
Croatian: Nadalje, u bolesnika s visokim početnim rizikom od prijeloma, potrebno je pažljivo procijeniti nadmašuje li korist od liječenja njegove rizike.
English: More about the procedure
Croatian: Opći zaključak
English: It is thought that Xofigo, which is taken up by the bone, accumulates at sites where the bone is already damaged, for example by osteoporosis or micro-fractures, increasing the risk of fracture.
Croatian: Vjeruje se da se lijek Xofigo nakuplja na mjestima velike koštane razgradnje kao što su mjesta degenerativne bolesti kostiju (osteoporoza) ili nedavni (mikro-) prijelomi, zbog čega se povećava rizik od prijeloma.
English: Therefore such preventive measures should be considered before starting or resuming treatment with Xofigo.
Croatian: Uz to treba razmotriti preventivne mjere, kao što je primjena bisfosfonata ili denosumaba, prije početka ili nastavka liječenja lijekom Xofigo.
English: In another randomised, double blind, placebo controlled phase III trial (ALSYMPCA), a statistically significant overall survival benefit of treatment with Xofigo could not be demonstrated in the subgroups of patients with fewer than 6 metastases (HR for radium-223 to placebo 0.901; 95% CI [0.5531.466], p=0.674) or a baseline total alkaline phosphatase (ALP) <220 U/L (HR 0.823 95% CI 0.6331.068, p=0.142), indicating that efficacy may be diminished in patients with a low level of osteoblastic activity from their bone metastases.
Croatian: Uistinu, statistički značajna korist od liječenja u smislu ukupnog preživljenja nije mogla biti pokazana ni u podskupini bolesnika s početnim ukupnim ALP < 220 U/l (HR 0,823; 95 % CI [0,633 - 1,068], p=0,142).
English: Monitoring should continue for at least 24 months.
Croatian: U pogledu opaženog odgođenog rizika od prijeloma, ta dva aspekta potrebno je pažljivo pratiti tijekom najmanje 24 mjeseca nakon početka liječenja.