natgillin/translations-raw huggingface dataset:
Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single non-steroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Bolniki so nadaljevali zdravljenje s stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ali prednizona (< 0,2 mg/kg/dan ali največ 10 mg).
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients).
merjeno z radioimunskimi testi (15 % pri etanerceptu in 4 % pri placebu) in s testom na Crithidia luciliae (3 % pri etanerceptu in 0 % pri placebu).
• Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Erelzi.
• Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom
Erelzi should be used with caution in patients with a history of hepatitis C.
Pri bolnikih z anamnezo hepatitisa C morate zdravilo Erelzi uporabljati previdno.
The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.
Priporočeni odmerek je 25 mg etanercepta dvakrat na teden ali 50 mg enkrat na teden.
The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Neželeni učinki, o katerih so poročali najpogosteje, so: reakcije na mestu injiciranja (kot so bolečina, oteklina, srbenje, rdečina in krvavitev na mestu vboda), okužbe (kot so okužbe zgornjih dihal,
Talk to your doctor before taking Erelzi.
Pred začetkom uporabe zdravila Erelzi se posvetujte z zdravnikom.
• Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Erelzi needs to be used with caution under these circumstances.
• Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri vas ali otroku kdaj pojavilo kongestivno srčno popuščanje.
In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with etanercept alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and the combination of etanercept and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
mediani odmerek 20 mg) ali z etanerceptom in metotreksatom (s sočasnim začetkom), in sicer pri 682 odraslih bolnikih z aktivnim revmatoidnim artritisom, pri katerih je bolezen trajala od 6 mesecev do 20 let (mediano trajanje 5 let) in pri katerih je bil odziv na najmanj eno od imunomodulirajočih antirevmatičnih zdravil (DMARD), razen metotreksata, manj kot zadovoljiv.
Elevated liver enzymes*
žolčnika in žolčevodov zvečane vrednosti jetrnih encimov*
Multipack: 12 (3 packs of 4) pre-filled syringes with a needle guard.
raztopina za injiciranje Skupno pakiranje: 12 (3 pakiranja s po 4) napolnjenih injekcijskih brizg z zapiralom igle
INFORMATION IN BRAILLE Erelzi 25 mg
etanercept 25 mg
Erelzi is available as 25 mg strength and 50 mg strength.
Zdravilo Erelzi je na voljo v jakosti 25 mg in 50 mg.
• Do not use the pen if it has been dropped with the cap removed.
• Ko pokrovček odstranite, ga zavrzite.
Each pre-filled syringe contains 25 mg etanercept.
Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta.
During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to etanercept.
Med obdobjem randomiziranega prekinjanja zdravljenja se je recidiv bolezni (izguba odziva PASI 75)
Do not shake the syringe.
Injekcijske brizge ne stresajte.
Erelzi treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
psoriatičnega artritisa, ankilozirajočega spondilitisa, radiografsko nezaznavnega aksialnega spondilartritisa, psoriaze v plakih ali otroške psoriaze v plakih.
If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Erelzi, and contact your doctor immediately.
Če se pri vas ali otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo
All healthcare professionals (HCPs) who are most likely to prescribe Erelzi for patients with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis, juvenile idiopathic arthritis, plaque psoriasis and paediatric plaque psoriasis are provided with a Patient Alert Card for distribution to patients receiving Erelzi.
juvenilnim idiopatskim artritisom, psoriazo v plakih in otroško psoriazo v plakih, so za bolnike, ki prejemajo zdravilo Erelzi, prejeli opozorilno kartico za bolnika.
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001).
Rezultat indeksa invalidnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom,
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe".
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7, "Navodila za uporabo zdravila Erelzi napolnjena injekcijska brizga".
Storage of the Erelzi pre-filled syringe
Shranjevanje zdravila Erelzi
Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi SensoReady pen”.
Podrobna navodila o injiciranju zdravila Erelzi so v poglavju 7 “Navodila za uporabo zdravila Erelzi napolnjen injekcijski peresnik SensoReady”.
Compared to placebo, patients with rheumatic diseases treated with etanercept had a significantly higher incidence of injection site reactions (36% vs. 9%).
pojavnost reakcij na mestu injiciranja pomembno večja (36 % proti 9 %).
The liquid should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein.
Tekočina mora biti bistra ali rahlo opalescentna, brezbarvna do nekoliko rumenkasta ter lahko vsebuje majhne bele ali skoraj prosojne delce beljakovine.
Erelzi 25 mg solution for injection in pre-filled syringe etanercept
Erelzi 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept (etanerceptum)
Discard the needle cap. You may see a drop of liquid at the end of the needle.
Na konici igle lahko opazite kapljico, kar je normalno.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 25 MG PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ENOTE PAKIRANJA - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
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 12 months was higher in the etanercept group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).
(sprememba TSS ≤ 0,5) po 12 mesecih večji v skupini z etanerceptom kot v skupini s placebom (73 % proti 47 %, p ≤ 0,001).
Keep the pre-filled syringes and the pre-filled pens in the outer carton in order to protect from light.
Napolnjene injekcijske brizge in napolnjene injekcijske peresnike shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after Erelzi treatment.
Erelzi ali po njem pojavijo znaki/simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hiranje/hujšanje, nekoliko zvišana telesna temperatura).
What Erelzi contains
Kaj vsebuje navodilo
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - 25 MG PRE-FILLED SYRINGE
VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ BLUE BOX) - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
Serious allergic reactions are rare.
resne alergijske/
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
EU/1/17/1195/005 1 napolnjena injekcijska brizga EU/1/17/1195/006 2 napolnjeni injekcijski brizgi EU/1/17/1195/007 4 napolnjene injekcijske brizge
Elderly
vaskulitis
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi SensoReady pen".
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Navodila za uporabo zdravila Erelzi SensoReady injekcijski peresnik".
Erelzi 50 mg solution for injection in pre-filled syringe etanercept
Erelzi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi etanercept (etanerceptum)
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
• občutek živčnosti ali tesnobe, utripajoč občutek, nenadna pordelost kože in/ali občutek toplote; • hud izpuščaj, srbenje ali koprivnica (rdeče ali blede kožne spremembe nad ravnijo kože, ki pogosto srbijo).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - 50 MG PRE-FILLED PEN
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z BLUE BOX) - 50 MG
Caution should be exercised in patients being treated with Erelzi who have a previous history of blood dyscrasias.
zdravljenih z zdravilom Erelzi, ki imajo krvno diskrazijo v anamnezi.
Do not use the pen if the expiry date has passed.
Injekcijskega peresnika ne uporabljajte, če mu je potekel rok uporabnosti.
QUALITATIVE AND QUANTITATIVE COMPOSITION Erelzi 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
Erelzi 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta (etanerceptum).
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Pri bolnikih, ki so dobivali 25 mg dvakrat na teden ves čas študije, se je odziv
Keep the pre-filled SensoReady pens in the outer carton in order to protect from light.
Napolnjene injekcijske peresnike SensoReady shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - 25 MG PRE-FILLED SYRINGE
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z BLUE BOX) - 25 MG
Your Erelzi SensoReady pen:
Injekcijski peresnik SensoReady z zdravilom Erelzi:
Thrombocytopenia, anaemia, leukopenia, neutropenia
Bolezni krvi in limfatičnega sistema trombocitopenija, anemija, levkopenija, nevtropenija pancitopenija* aplastična anemija*
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - 50 MG PRE-FILLED SYRINGE
VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ BLUE BOX) - 50 MG NAPOLNJENA INJEKCIJSKA BRIZGA
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
EU/1/17/1195/001 1 napolnjena injekcijska brizga EU/1/17/1195/002 2 napolnjeni injekcijski brizgi EU/1/17/1195/003 4 napolnjene injekcijske brizge
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 50 MG PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ENOTE PAKIRANJA - 50 MG NAPOLNJENA INJEKCIJSKA BRIZGA
It should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein.
Raztopina mora biti bistra ali rahlo opalescentna, brezbarvna do rahlo rumenkasta in lahko vsebuje majhne bele ali skoraj prosojne delce beljakovine.
The solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.
Raztopina mora biti bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
Detailed instructions on how to inject Erelzi are provided in section 7, “Instructions for use of the Erelzi pre-filled syringe”.
Podrobna navodila o injiciranju zdravila Erelzi so v poglavju 7 “Navodila za uporabo zdravila Erelzi napolnjena injekcijska brizga”.
2 pre-filled SensoReady pens
1 napolnjen injekcijski peresnik SensoReady 2 napolnjena injekcijska peresnika SensoReady 4 napolnjeni injekcijski peresniki SensoReady
Erelzi 50 mg solution for injection in pre-filled syringe.
Erelzi 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Each pre-filled syringe contains 50 mg etanercept.
Ena napolnjena injekcijska brizga vsebuje 50 mg etanercepta.
Erelzi solution for injection in pre-filled syringe
Priprava napolnjene injekcijske brizge z zdravilom Erelzi na injiciranje
In a fourth study, the safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly vs. 25 mg etanercept administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
V četrti, dvojno slepi in s placebom nadzorovani študiji so pri 356 bolnikih z aktivnim ankilozirajočim spondilitisom vrednotili varnost in učinkovitost dajanja etanercepta v odmerku 50 mg enkrat na teden
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK - 50 MG PRE-FILLED PEN
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ENOTE PAKIRANJA - 50 MG NAPOLNJEN INJEKCIJSKI PERESNIK
Erelzi 25 mg solution for injection in pre-filled syringe.
Erelzi 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Erelzi 25 mg injection etanercept SC
Erelzi 25 mg injekcija etanercept (etanerceptum) s.c.
n = 166 n =
50 mg 1x/teden n = 166 n =
• Swelling of the face, throat, hands, or feet
• težave pri požiranju ali dihanju; • otekanje obraza, žrela, rok ali nog;
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE LABEL - 25 MG PRE-FILLED SYRINGE
BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
Do not use if the safety seal has been broken.
Zdravila ne uporabljajte, če injekcijski peresnik ni originalno zaprt.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the post-marketing period (see section 4.8).
Čvrste in hematopoetične maligne bolezni (razen kožnega raka) V obdobju trženja zdravila so prejeli več poročil o raznih malignih boleznih (vključno z rakom dojke in pljuč ter limfomi) (glejte poglavje 4.8).
These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin;
Med temi so bili abscesi (na različnih mestih), bakteriemija,
Antibodies to etanercept
etanercept etanercept + metotreksat
In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) etanercept subcutaneously twice weekly.
V prvem delu študije so vsi bolniki 2-krat tedensko prejemali po 0,4 mg/kg
1 pre-filled SensoReady pen
Prikaz injekcijskega peresnika SensoReady z zdravilom
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE LABEL - 50 MG PRE-FILLED SYRINGE
BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE - 50 MG NAPOLNJENA INJEKCIJSKA BRIZGA
Keep the pre-filled SensoReady pen in the outer carton in order to protect from light.
Napolnjen injekcijski peresnik SensoReady shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Pancytopenia* Aplastic anaemia*
bakterijo Legionella)*
• Do not shake the pen.
• Ne stresajte injekcijskega peresnika.
The solution is clear or slightly opalescent, colourless to slightly yellowish.
raztopina za injiciranje (injekcija) Raztopina je bistra ali rahlo opalescentna, brezbarvna do rahlo rumenkasta.
Respiratory, thoracic, and mediastinal disorders
kortikosteroide, ali peroralne antihistaminike.
Paediatric plaque psoriasis outcomes at 12 weeks Etanercept 0.8 mg/kg Once Weekly (N = 106)
0,8 mg/kg enkrat na teden (n = 106)
Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)*
(vključno s krvavitvijo, podplutbami, eritemom, srbenjem,
No treatment was given for the majority of injection site reactions in the etanercept treatment groups, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines.
V skupinah, ki so prejemale etanercept, večine reakcij na mestu injiciranja ni bilo potrebno zdraviti.
If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
apatija, blaga vročina) ali kakšne druge okužbe, to nemudoma povejte zdravniku.
• Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.
težave z dihanjem, motnje mišljenja, zaznavanja ali vida; • znaki vnetja krvnih žil, kot so bolečina, vročina, rdečina ali toplina kože ali srbenje.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TEXT FOR TRAY BACK - 25 MG PRE-FILLED SYRINGE
BESEDILO NA HRBTNI STRANI PODSTAVKA - 25 MG NAPOLNJENA INJEKCIJSKA BRIZGA
The needle cap should not be removed while allowing the pre-filled syringe to reach room temperature.
Med čakanjem, da se napolnjena injekcijska brizga segreje na sobno temperaturo, pokrovčka igle ne smete odstraniti.
Hypoglycaemia in patients treated for diabetes
Hipoglikemija pri bolnikih, ki se zdravijo zaradi sladkorne bolezni Po uvedbi etanercepta so pri bolnikih, ki so prejemali zdravila za zdravljenje sladkorne bolezni,
Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products, as well as the parent compound.
ki zazna tako ELISA reaktivne razgradne produkte kot tudi izhodno snov.
red, or scaly skin patches or lesions (“psoriasis skin lesions”).
trdovratnega kašlja, zatrdlin ali izrastkov na koži;
Each pre-filled pen contains 50 mg etanercept.
Ena napolnjen injekcijski peresnik vsebuje 50 mg etanercepta.
Erelzi 50 mg solution for injection in pre-filled pen
Erelzi 50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
Multipack: 8 (2 packs of 4) pre-filled syringes with a needle guard.
Skupno pakiranje: 8 (2 pakiranji s po 4) napolnjenih injekcijskih brizg z zapiralom igle Skupno pakiranje: 12 (3 pakiranja s po 4) napolnjenih injekcijskih brizg z zapiralom igle Skupno pakiranje: 24 (6 pakiranj s po 4) napolnjenih injekcijskih brizg z zapiralom igle
Undesirable effects in paediatric patients with juvenile idiopathic arthritis
Vrste okužb, ki so jih opazili v kliničnih preskušanjih pri bolnikih z juvenilnim idiopatskim artritisom,
List of the names, pharmaceutical forms, strength of the medicinal product, route of administration, marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in imetnikov dovoljenj za promet z zdravilom v državah članicah
United Kingdom Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire RG14 1JN
Velika Britanija Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire RG14 1 JN
Cell Pharm GmbH Theodor-Heuss-Str. 52 61118 Bad Vilbel Germany
Nemčija cell pharm GmbH Theodor-Heuss-Str. 52 61118 Bad Vilbel Germany
Information for patients
Znanstveni zaključki
• In patients with a high baseline risk of fracture, carefully consider the benefit of treatment against the risks.
Poleg tega je treba pri bolnikih z velikim izhodiščnim tveganjem za zlome natančno oceniti koristnost zdravljenja za odtehtanje tveganja.
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.
Zdravilo Xofigo naj bi se kopičilo na mestih velike kostne premene, na primer na mestih degenerativne kostne bolezni (osteoporoze) ali nedavnih (mikro) zlomov, kar povečuje tveganje za zlome.
Monitoring should continue for at least 24 months.
Glede na ugotovljeno zapoznelo tveganje za zlome je treba oba vidika natančno spremljati vsaj 24 mesecev po začetku zdravljenja.
Therefore such preventive measures should be considered before starting or resuming treatment with Xofigo.
Poleg tega je treba pred začetkom ali nadaljevanjem zdravljenja z zdravilom Xofigo razmisliti o preventivnih ukrepih, na primer o uporabi bisfosfonatov ali denosumaba.
It is also not recommended in combination with systemic cancer therapies other than LHRH analogues.
Skratka, odbor PRAC je odsvetoval kombiniranje [223Ra]radija z vsemi drugimi sistemskimi zdravili proti raku razen z analogi LHRH.
Information for healthcare professionals
Podlaga za priporočilo odbora PRAC
• Xofigo should only be used as monotherapy or in combination with an LHRH analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, who are in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.
V splošnem je odbor PRAC presodil, da naj se zdravilo Xofigo uporablja samo kot monoterapija ali v kombinaciji z analogom luteinizirajoči hormon sproščajočega hormona (LHRH) za zdravljenje odraslih bolnikov z metastatskim proti kastraciji odpornim rakom prostate (mCRPC), simptomatičnimi kostnimi metastazami in brez znanih visceralnih metastaz, v napredovanju po vsaj dveh predhodnih vrstah sistemskega zdravljenja mCRPC (poleg analogov LHRH), ali bolnikov, za katere nobeno razpoložljivo sistemsko zdravljenje mCRPC ni primerno.
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.
Poleg tega v študiji ALSYMPCA pri podskupinah bolnikov z manj kot šestimi kostnimi metastazami ni bilo mogoče dokazati statistično pomembne koristi za celokupno preživetje (HR med [223Ra]radijem in placebom: 0,901; 95-odstotni IZ [0,553-1,466].
In addition, the combination used in this study is now contraindicated.
Te značilnosti se skladajo z odobreno indikacijo.
• In mildly symptomatic patients, the benefit of treatment should be carefully assessed against its risks, considering that high osteoblastic activity is likely to be required for treatment benefit (see below for more information).
Odbor PRAC je presodil, da je treba pri odraslih s CRPC in blago simptomatičnimi kostnimi metastazami natančno oceniti, ali koristnost zdravljenja odtehta tveganja, ob upoštevanju, da bo za koristnost zdravljenja verjetno potrebna visoka osteoblastna aktivnost.