qanastek/EMEA-V3 huggingface dataset:
If an adverse event occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician.
Jekk ikun hemm episodju avvers waqt l- għoti ta 'Soliris, l- infużjoni tista' tingħata aktar bil- mod jew titwaqqaf fid- diskrezzjoni tat- tabib.
If the infusion is slowed, the total infusion time may not exceed two hours.
Jekk l- infużjoni tingħata aktar bil- mod, il- ħin totali ta 'l- infużjoni ma jistax jaqbeż is- sagħtejn.
There is no experience in children (see section 5.2) Elderly:
M’ hemmx esperjenza dwar l- użu fit- tfal (ara sezzjoni 5. 2).
Soliris may be administered to patients aged 65 years and over.
Soliris jista 'jingħata lil pazjenti ta' 65 sena u aktar.
There is no evidence to suggest that any special precautions are needed when older people are treated – although experience with Soliris in this patient population is still limited.
M' hemmx evidenza li tissuġġerixxi li jeħtieġu xi prekawzjonijiet speċjali meta jiġu kkurati persuni aktar anzjani - għalkemm l- esperjenza b' Soliris f' din il- popolazzjoni ta 'pazjenti għadha limitata.
The safety and efficacy of Soliris have not been studied in patients with renal impairment.
Is- sigurtà u l- effikaċja ta 'Soliris ma ġietx studjata f' pazjenti b' indeboliment renali.
The safety and efficacy of Soliris have not been studied in patients with hepatic impairment.
Is- sigurtà u l- effikaċja ta ’ Soliris ma ġietx studjata f’ pazjenti b’ indeboliment epatiku.
Hypersensitivity to eculizumab, murine proteins or to any of the excipients.
Sensittività eċċessiva għal eculizumab, proteini tal- ġrieden jew għal xi sustanzi mhux attivi.
Do not initiate Soliris therapy in patients:
Tibdiex terapija b’ Soliris f’ pazjenti:
• with unresolved Neisseria meningitidis infection. • who are not currently vaccinated against Neisseria meningitidis. • who have known or suspected hereditary complement deficiencies.
• b’ infezzjoni ta ’ Neisseria meningitidis mhux riżolta. • li ma jkunux imlaqqma kontra Neisseria meningitidis. • li jkollhom defiċjenzi komplementari ereditarji magħrufa jew suspettati.
Soliris is not expected to affect the aplastic component of anaemia in patients with PNH.
Soliris mhux mistenni li jaffettwa l- komponent aplastiku ta ’ l- anemija f’ pazjenti b’ PNH.
Meningococcal Infection:
Infezzjoni meningokokkali:
Due to its mechanism of action, the use of Soliris increases the patient’s susceptibility to meningococcal infection (Neisseria meningitidis).
Minħabba l- mekkaniżmu ta ’ azzjoni tiegħu, l- użu ta ’ Soliris ikabbar is - suxxettibilità tal- pazjent għal infezzjoni meningokokkali (Neisseria meningitidis).
These patients might be at risk of disease by uncommon serogroups (particularly Y, W135 and X), although meningococcal disease due to any serogroup may occur.
Dawn il- pazjenti jistgħu jkunu f’ riskju ta ’ mard minn serotipi mhux komuni (b’ mod partikolari Y, W135 u X), għalkemm jista ’ jseħħ mard meningokokkali dovut minn kwalunkwe serotip.
To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving Soliris and must be re-vaccinated according to current medical guidelines for vaccination use.
Biex jitnaqqas ir- riskju ta 'infezzjoni, il- pazjenti kollha għandhom jiġu mlaqqma mill- anqas ġimgħatejn qabel ma jirċievu Soliris u jridu jerġgħu jitlaqqmu skond linji gwida mediċi kurrenti dwar l- użu tat- tilqim.
Tetravalent vaccines against serotypes A, C, Y and W135 are strongly recommended, preferably conjugated ones.
Vaċċini tetravalenti kontra s- serotipi A, C, Y u W135 huma rakkomandati ħafna, preferibbilment dawk konjugati.
Vaccination may not be sufficient to prevent meningococcal infection.
It- tilqim jista 'ma jkunx suffiċjenti biex jevita infezzjoni meningokokkali.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.There have been 3 reported cases of meningococcal infection in Soliris treated patients: two in vaccinated PNH patients and one in an unvaccinated patient with idiopathic membranous glomerulonephropathy.
Kien hemm 3 każijiet irrapportati ta 'infezzjoni meningokokkali f' pazjenti kkurati b' Soliris: tnejn f' pazjenti PNH imlaqqam u ieħor f' pazjent mhux imlaqqam bi glomerulonefropatija idjopatika tal- membrana.
All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with antibiotics if necessary.
Il - pazjenti kollha għandhom jiġu mmonitorjati għal sinjali bikrija ta 'infezzjoni meningokokkali, valutati immedjatament jekk ikun hemm suspett ta' infezzjoni, u kkurati bl- antibijotiċi jekk ikun meħtieġ.
Patients should be informed of these signs and symptoms and steps taken to seek medical care immediately (see Patient Information Leaflet for a description).
Il - pazjenti għandhom jiġu infurmati b ’ dawn is- sinjali u sintomi u l- passi li għandhom jieħdu biex ifittxu kura medika immedjatament (ara l- Fuljett ta 'Tagħrif għall- Pazjent għal deskrizzjoni).
Other Systemic Infections:
Infezzjonijiet Sistemiċi Oħra:
Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active systemic infections.
Minħabba l- mekkaniżmu ta ’ azzjoni tiegħu, it- terapija b' Soliris għandha tingħata b' kawtela lil pazjenti b' infezzjonijiet sistemiċi attivi.
The overall severity and frequency of infections in Soliris treated patients was similar to placebo treated patients in clinical studies, although an increase in the number and severity of infections, particularly due to encapsulated bacteria, cannot
Il- ħruxija u frekwenza globali ta 'l -
3 be excluded.
3 infezzjonijiet f' pazjenti kkurati b' Soliris kienu simili għal pazjenti kkurati bi plaċebo fi studji kliniċi, għalkemm żieda fin- numru u l- ħruxija ta ’ l- infezzjonijiet, b’ mod partikolari minħabba batterji inkapsulati, ma tistax tiġi eskluża.
Patients should be provided with information from the Patient Information Leaflet to increase their awareness of potential serious infections and the signs and symptoms of them.
Il- pazjenti għandhom jingħataw informazzjoni mill- Fuljett ta ’ Tagħrif għall- Pazjent biex ikabbru l- għarfien tagħhom dwar infezzjonijiet serji potenzjali u s- sinjali u s- sintomi tagħhom.
Infusion Reactions:
Reazzjonijiet għall- infużjoni:
As with all therapeutic proteins, administration of Soliris may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis), though immune system disorders within 48 hours of Soliris administration did not differ from placebo treatment in PNH and non-PNH studies conducted with Soliris.
Bħal kull proteina terapewtika oħra, l- għoti ta 'Soliris jista' jirriżulta f' reazzjonijiet tal- infużjoni jew f' immunoġeniċità li jistgħu jikkawżaw reazzjonijiet allerġiċi jew ta 'sensittività eċċessiva (inkluż anafilassi), għalkemm id- disturbi tas- sistema immunitarja sa 48 siegħa mill- għoti ta' Soliris ma varjawx mill- kura bi plaċebo fi studji PNH u mhux PNH mwettqa b' Soliris.
In clinical trials, no PNH patients experienced an infusion reaction which required discontinuation of Soliris.
Fi provi kliniċi, ebda pazjent PNH ma esperjenza reazzjoni għall- infużjoni li kienet teħtieġ it- twaqqif ta 'Soliris.
Soliris administration should be interrupted in all patients experiencing severe infusion reactions and appropriate medical therapy administered.
L- għoti ta 'Soliris għandu jitwaqqaf f' kull pazjent li jġarrab reazzjonijiet severi għall- infużjoni u għandha tingħata terapija medika xierqa.
Infrequent, low titre antibody responses have been detected in Soliris treated patients across all PNH and non-PNH studies with a frequency (3.4%) similar to that of placebo (4.8%).
Kienu rilevati reazzjonijiet mhux frekwenti, titru baxx ta 'antikorpi f' pazjenti kkurati b' Soliris fl- istudji PNH u mhux PNH kollha bi frekwenza (3. 4%) simili għal dik ta' plaċebo (4. 8%).
No patients have been reported to develop neutralizing antibodies following therapy with Soliris, and there has been no observed correlation of antibody development to clinical response or adverse events.
L - ebda pazjent ma ġie rrapportat li żviluppa antikorpi li jinnewtralizzaw wara terapija b' Soliris, u ma ġiet osservata l- ebda korrelazzjoni bejn l- iżvilupp ta 'antikorpi u r- reazzjoni klinika jew l- episodji avversi.
Prior to initiating Soliris therapy, it is recommended that PNH patients should receive immunizations according to current immunization guidelines.
Tilqim Qabel ma tinbeda terapija b' Soliris, huwa rakkomandat li l- pazjenti PNH jirċievu tilqimiet skond il- linji gwida attwali dwar it- tilqim.
Additionally, all patients must be vaccinated against meningococcus at least 2 weeks prior to receiving Soliris.
Barra minn hekk, il- pazjenti kollha għandhom jiġu mlaqqmin kontra l- meningokokkus mill- anqas ġimagħtejn qabel ma jirċievu Soliris.
If available, tetravalent, conjugated vaccines are recommended (see meningococcal disease).
Jekk ikunu disponibbli, vaċċini konjugati, tetravalenti huma rakkomandati (ara mard meningokokkali).
Anticoagulant therapy:
Terapija kontra l- koagulazzjoni tad- demm:
Treatment with Soliris should not alter anticoagulant management.
Il- kura b’ Soliris m’ għandhiex tbiddel il- ġestjoni kontra l - koagulazzjoni tad- demm.
Laboratory Monitoring:
Monitoraġġ fil- laboratorju:
PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels.
Pazjenti PNH għandhom jiġu mmonitorjati għal sinjali u sintomi ta 'emolisi intravaskulari, fosthom il- livelli ta' lactate dehydrogenase (LHD) fis- serum.
PNH patients receiving Soliris therapy should be similarly monitored for intravascular haemolysis by measuring LDH levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).
Pazjenti PNH li jkunu qegħdin jirċievu terapija b' Soliris għandhom jiġu mmonitorjati wkoll għal emolisi intravaskulari billi jiġu mkejla l- livelli ta 'LDH, u jista' jkollhom bżonn aġġustament tad- doża fi ħdan l- iskeda tad - dożaġġ rakkomandata ta '14+ / - 2 ġranet matul il- fażi ta' manteniment (sa kull 12- il ġurnata).
Treatment Discontinuation:
Twaqqif tal- kura:
Patients who discontinue treatment with Soliris should be monitored for signs and symptoms of serious intravascular haemolysis.
Il- pazjenti li jwaqqfu l- kura b' Soliris għandhom jiġu mmonitorjati għal sinjali u sintomi ta 'emolisi intravaskulari serja.
Serious haemolysis is identified by serum LDH levels greater than the pre-treatment level, along with any of the following: greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in one week or less; a haemoglobin level of < 5 gm/dL or a decrease of > 4 gm/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis.
Emolisi serja hija identifikata minn livelli ta ’ LDH fis- serum ogħla mil- livell ta ’ qabel il- kura, flimkien ma ’ xi waħda minn dawn li ġejjin: tnaqqis assolut ta ’ aktar minn 25% fid- daqs tal- klonu PNH (fin- nuqqas ta ’ dilwizzjoni minħabba trasfużjoni) f’ ġimgħa waħda jew anqas; livell ta ’ l- emoglobina ta ’ < 5 gm/ dL jew tnaqqis ta ’ > 4 gm/ dL f’ ġimgħa waħda jew anqas; anġina; tibdil fl- istat mentali; żieda ta ’ 50% fil- livell ta ’ krejatinina fis- serum; jew trombożi.
Monitor any patient who discontinues Soliris for at least 8 weeks to detect serious haemolysis and other reactions.
Kwalunkwe pazjent li jwaqqaf Soliris għandu jiġi mmonitorjat għal mill- anqas 8 ġimgħat biex jiġu rilevati emolisi serja u reazzjonijiet oħra.
If serious haemolysis occurs after Soliris discontinuation, consider the following procedures/treatments: blood transfusion (packed RBCs), or exchange transfusion if the PNH RBCs are > 50% of the total RBCs by flow cytometry; anticoagulation; corticosteroids; or reinstitution of Soliris.
Jekk isseħħ emolisi serja wara t- twaqqif ta ’ Soliris, wieħed għandu jikkunsidra l- proċeduri/ trattamenti li ġejjin: trasfużjoni tad- demm (RBCs ippakkjati), jew trasfużjoni ta ’ skambju jekk ir- RBCs tal- PNH ikunu > 50% tar- RBCs totali biċ- ċitometrija tal- fluss; antikoagulazzjoni; kortikosterojdi; jew l- użu mill- ġdid ta ’ Soliris.
In PNH clinical studies, 16 patients discontinued the Soliris treatment regimen.
Fi studji kliniċi dwar il- PNH, 16- il pazjent waqqfu r- reġim ta ’ kura b’ Soliris.
Serious haemolysis was not observed.
Ma kinetx osservata emolisi serja.
This medicinal product contains 5.00 mmol sodium per dose (1 vial).
Dan il- prodott mediċinali fih 5. 00 mmol sodju kull doża (kunjett wieħed).
To be taken into consideration by patients on a controlled sodium diet.
Pazjenti li qegħdin fuq dieta ta ’ sodju kkontrollat għandhom jikkunsidraw dan.
4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ (effetti fuq il- ħalib tas- sider)
For Soliris, no clinical data on exposed pregnancies are available.
Għal Soliris, m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal reproduction studies have not been conducted with eculizumab (see section 5.3).
Ma sarux studji dwar ir- riproduzzjoni ta ’ l- annimali b’ eculizumab (ara sezzjoni 5. 3).
4 Human IgG are known to cross human placental barrier, and thus eculizumab may potentially cause terminal complement inhibition in the foetal circulation.
L- IgG umani huma magħrufa li jaqsmu l- barriera tal- plaċenta umana, u b’ hekk eculizumab jista ’ potenzjalment jikkawża inibizzjoni tal- komplement terminali fiċ- ċirkolazzjoni tal- fetu.
Therefore, Soliris should be given to a pregnant woman only if clearly needed.
Għalhekk, Soliris għandu jingħata lil nisa tqal jekk ikun hemm bżonn ċar biss.
Woman of childbearing potential have to use adequate contraception methods during treatment and up to 5 months after treatment.
In- nisa li jistgħu jinqabdu tqal iridu jużaw kontraċezzjoni adegwata matul il- kura u sa 5 xhur wara l- kura.
It is not known whether eculizumab is secreted into human milk.
Mhux magħruf jekk eculizumab joħroġx fil- ħalib uman.
Since many medicinal products and immunoglobulins are secreted into human milk, and because of the potential for serious adverse reactions in nursing infants, lactation should be discontinued during treatment and up to 5 months after treatment.
Billi ħafna prodotti mediċinali u immunoglobulini joħorġu fil- ħalib uman, u minħabba l- potenzjal ta 'reazzjonijiet avversi serji fi trabi li jkunu qegħdin jiġu mreddgħa, it- treddigħ għandu jitwaqqaf matul il- kura u sa 5 xhur wara l- kura.
4.8 Undesirable effects Eculizumab for the treatment of PNH was studied in three clinical studies that included 195 eculizumab-treated patients and most of these patients have been enrolled in the E05-001 extension study.
Eculizumab għall- kura ta 'PNH ġie studjat fi tliet studji kliniċi li kienu jinkludu 195 pazjent ikkurat b' eculizumab u l- maġġoranza ta ’ dawn il- pazjenti ġew irreġistrati fl- istudju ta ’ estensjoni E05- 001.
There was one pivotal trial comparing the eculizumab-treatment arm to a placebo-treatment arm.
Kien hemm prova waħda pivitali li qabblet il- grupp ta ’ kura b’ eculizumab ma ’ grupp ta ’ kura bi plaċebo.
The most commonly reported adverse reactions are headache, nasopharyngitis, nausea, pyrexia, myalgia, fatigue, and herpes simplex, each occurring in 5 or more out of 100 patients.
L- aktar reazzjonijiet avversi rrapportati b’ mod komuni huma wġigħ ta ’ ras, nasofarinġite, dardir, deni, uġigħ fil- muskoli, għeja u herpes simplex, kollha jseħħu f’ 5 pazjenti jew aktar minn kull 100.
Adverse events reported at a very common (≥1/10) or common (> 5/100 and < 10/100) frequency with eculizumab in a total of 140 patients in C04-001 and C04-002 are listed by system organ class and preferred term in Table 1.
L- episodji avversi rrapportati bi frekwenza komuni ħafna (≥1/ 10) jew komuni (≥5/ 100 u < 10/ 100) b' eculizumab f' total ta '140 pazjent fi C04- 001 u C04- 002 huma elenkati bis- sistema tal- klassifika ta' l - organi u terminu preferut fit- Tabella 1.
Adverse events were mostly mild to moderate in severity.
Fil- biċċa l- kbira, l- episodji avversi huma ta 'severità ħafifa għal moderata.
Uncommon or rare events cannot be estimated due to limited patient exposure (195 PNH patients).
L- episodji mhux komuni jew rari ma jistgħux jiġu stmati minħabba esponiment limitat ta ’ pazjenti (195 pazjent PNH).
Table 1:
5 Tabella 1:
Adverse Events Reported in Studies C04-001 and C04-002 Adverse Event
Episodji Avversi Irrapportati fl- Istudji C04- 001 u C04- 002 Episodju Avvers Sistema tal- Klassifika ta 'l- Organi
Preferred Term
Komuni ħafna (> 1/ 10)
System Organ Class Infections and infestations
Infezzjonijiet u Infestazzjonijiet
Very Common (> 1/10) Urinary tract infection Nasopharyngitis Upper Respiratory Tract Infection
Infezzjoni ta ’ l- apparat urinarju Nasofarinġite Infezzjoni tan- Naħa ta ’ Fuq ta ’ l - Apparat Respiratorju
Common (5/100 – 1/10) Respiratory Tract Infection Herpes Simplex Sinusitis Viral Infection Gastroenteritis
Herpes Simplex Sinożite Infezzjoni Virali Gastro- enterite
Psychiatric disorders Nervous System Disorders
Disturbi Psikjatriċi Disturbi fis- Sistema Nervuża
Dizziness Headache
Sturdament Uġigħ ta 'ras
Insomnia
Nuqqas ta ’ Rqad
Epistaxis Pharyngolaryngeal pain Cough
Epistassi Uġigħ fil- farinġi u l- larinġi Sogħla
5 Gastrointestinal Disorders
Disturbi Gastro- intestinali
Diarrhoea Nausea
Dijarea Nawsja
Vomiting Abdominal Pain Abdominal Pain Upper Constipation
Rimettar Uġigħ Addominali Uġigħ Fil=Parti ta ’ Fuq ta ’ l - Addome Stitikezza
Skin and Subcutaneous Tissue Disorders
Disturbi fil- Ġilda u fit- Tessuti ta ’ Taħt il- Ġilda
Rash Pruritis
Raxx Ħakk
Musculoskeletal and Connective Tissue Disorders
Disturbi Muskolu- skeletali u tal - Connective Tissue
Back Pain Arthralgia
Uġigħ fid- dahar Atralġja
Myalgia Pain in extremity Muscle cramp
Majalġja Uġigħ fl- estremitajiet Bugħawwieġ
General Disorders and Administration Site Conditions
Disturbi Ġenerali u Kundizzjonijiet ta ’ Mnejn Jingħata Korriment, Avvelenament u Kumplikazzjonijiet Proċedurali
Pyrexia
Deni Kontużjoni
Influenza-Like Illness Fatigue
Mard jixbah lill- influwenza Għeja
In the C04-001 study, headache was the most common adverse event observed with eculizumab.
Fl- istudju C04- 001, l- uġigħ ta 'ras kien l- aktar episodju avvers komuni osservat b' eculizumab.
Headaches were observed in 44.2% (19/43 patients) of patients treated with eculizumab and 27.3% (12/44 patients) in placebo-treated patients and were mild/moderate in all but 1 eculizumab treated and 1 placebo-treated patients.
Kienu osservati weġgħat ta 'ras f' 44. 2% (19/ 43 pazjent) tal- pazjenti kkurati b' eculizumab u 27. 3% (12/ 44 pazjent) fil- pazjenti kkurati bi plaċebo u kienu ħfief/ moderati fil- pazjenti kollha għajr pazjent wieħed kkurat b' eculizumab u pazjent ikkurat bi plaċebo.
Most headaches were mild and did not persist after the initial administration phase of Soliris.
Il- biċċa l- kbira tal- weġgħat ta 'ras kienu ħfief u ma ppersistewx wara l- fażi inizjali ta' l- għoti ta 'Soliris.
In addition, the following adverse events were increased in frequency by 5% or more with Soliris as compared to placebo: nasopharyngitis (25.0%), nausea (17.1%), pyrexia (14.3%), myalgia (7.9%), fatigue (7.9%), and herpes simplex (5.7%).
Barra minn hekk, l- episodji avversi li ġejjin żdiedu fil- frekwenza b' 5% jew aktar b' Soliris meta mqabbel ma 'plaċebo: nasofarinġite (25. 0%), nawsja (17. 1%), deni (14. 3%), uġigħ fil- muskoli (7. 9%), għeja (7. 9%), u herpes simplex (5. 7%).
There was no evidence of an increased incidence of infection across PNH studies with eculizumab as compared to placebo, including serious infections, severe infections or multiple infections.
Ma kienx hemm evidenza ta 'inċidenza akbar ta' infezzjoni fl- istudji ta 'PNH b' eculizumab meta mqabbel ma' plaċebo, inkluż infezzjonijiet serji, infezzjonijiet severi jew infezzjonijiet multipli.
The most serious adverse event was meningococcal septicaemia in two vaccinated PNH patients (see section 4.4).
L- aktar episodju avvers serju kien settiċemija meningokokkali f’ żewġ pazjenti PNH imlaqqma (ara sezzjoni 4. 4).
Low titres of antibodies were detected in 2% patients with PNH treated with Soliris.
Titers baxxi ta ’ antikorpi kienu rilevati fi 2% tal- pazjenti b’ PNH ikkurati b’ Soliris.
As with all proteins there is a potential for immunogenicity.
Bħalma jiġri b’ kull proteina oħra hemm potenzjal ta ’ immunoġeniċità.
Safety Data From Other Clinical Studies Supportive safety data were obtained in 11 clinical studies that included 716 patients exposed to eculizumab in six disease populations other than PNH.
Tagħrif dwar is- Sigurtà tal- Mediċina Minn Studji Kliniċi Oħra Tagħrif ta 'sostenn dwar is- sigurtà tal- mediċina ġie miksub fi 11- il studju kliniku li kienu jinkludu 716- il pazjent esposti għal eculizumab f' sitt popolazzjonijiet ta' mard għajr PNH.
There was an un-vaccinated patient diagnosed with idiopathic membranous glomerulonephropathy who experienced meningococcal meningitis.
Kien hemm pazjent mhux imlaqqam iddijanjostikat bi glomerulonefropatija idjopatika tal- membrana li esperjenza meninġite meningokokkali..
With regard to other AEs and considering all double-blind, placebo-controlled studies in patients diagnosed with diseases other than PNH (N=526 patients with Soliris; N=221 patients with placebo), AEs reported with Soliris at a frequency of 2% or greater than the frequency reported with placebo were: upper respiratory tract infection, rash, and injury.
Rigward AEs (Adverse Reactions) oħra u meta jitqiesu l- istudji double - blind, placebo- controlled kollha f' pazjenti ddijanjostikati b' mard ieħor barra PNH (N=526 pazjent b' Soliris; N=221 pazjent bi plaċebo), l- AEs irrapportati b' Soliris bi frekwenza ta '2% jew aktar mill -
Immunomodulators, ATC code:
Immunomodulaturi, Kodiċi ATC:
Soliris is a recombinant humanised monoclonal IgG2/4k antibody that binds to the human C5 complement protein and inhibits the activation of terminal complement.
Soliris hu antikorp IgG2/ 4κ monoklonali rikombinanti umanizzat li jeħel mal- proteina tal- komplement C5 umana u jimpedixxi l- attivazzjoni tal- komplement terminali.
The Soliris antibody contains human constant regions and murine complementarity-determining regions grafted onto the human
L- antikorp ta ’ Soliris fih reġjuni kostanti umani u reġjuni ta ’ stabbiliment tal- komplimentarità mill- ġrieden imlaqqma fuq ir- reġjuni varjabbli ta ’ katini ħfief u tqal tal- qafas uman.
Soliris is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148kDa.
Soliris huwa kompost minn żewġ katini tqal ta ’ l- aċidu amminiku 448 u żewġ katini ħfief ta ’ l- aċidu amminiku 214 u għandu piż molekulari ta ’ madwar 148kDa.
Soliris is produced in a murine myeloma (NS0 cell line) expression system and purified by affinity and ion exchange chromatography.
Soliris huwa magħmul f’ sistema ta ’ espressjoni ta ’ myeloma tal- ġrieden (linja ta ’ ċelloli NSO) u ppurifikat bi kromatografija ta ’ l- affinità u ta ’ skambju tal- joni.
The bulk drug substance manufacturing process also includes specific viral inactivation and removal steps.
Il- proċess ta ’ produzzjoni tas- sustanza attiva fil- mediċina jinkludi wkoll inattivazzjoni virali speċifika u passi ta ’ tneħħija.
Mechanism of Action Eculizumab, the active ingredient in Soliris, is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9.
Eculizumab, l- ingredjent attiv f' Soliris, huwa inibitur tal- komplement terminali li jaqbad b' mod speċifiku mal- proteina komplementari C5 b' affinità kbira, u b' hekk jimpedixxi l- qasma tagħha f' C5a u C5b u jevita l- ġenerazzjoni tal- kumpless tal- komplement terminali C5b- 9.
Soliris therefore restores terminal complement regulation in the blood of PNH patients and inhibits terminal complement mediated intravascular haemolysis in PNH patients.
Soliris għalhekk irodd ir - regolazzjoni tal- komplement terminali fid- demm ta 'pazjenti PNH u jimpedixxi l- emolisi intravaskulari medjata mill- komplement terminali f' pazjenti PNH.
Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes.
Eculizumab jippreserva l- komponenti bikrija ta 'l - attivazzjoni komplementari li huma essenzjali għall- opsonizzazzjoni tal- mikro- organiżmi u t- tneħħija tal- kumplessi immunitarji.
Administration of Soliris results in a rapid and sustained reduction in terminal complement activity.
L- għoti ta 'SOLIRIS iwassal għal tnaqqis veloċi u sostnut fl- attività tal- kompliment terminali.
Eculizumab serum concentrations of approximately 35 microgram/ml are sufficient for essentially complete inhibition of terminal complement-mediated intravascular haemolysis in most PNH patients.
Konċentrazzjonijiet ta 'eculizumab fis- serum ta' madwar 35 mikrogramma/ ml huma suffiċjenti għal inibizzjoni tista ’ tgħid totali ta 'emolisi intravaskulari medjata bil- komplement terminali f' pazjenti PNH.
Administration of Soliris haemolytic activity.
L- għoti ta ’ Soliris irriżulta fi tnaqqis veloċi u sostnut fl- attività emolitika medjata mis- sistema komplementari.
The safety and efficacy of Soliris in PNH patients with haemolysis were assessed in a randomized, double-blind, placebo-controlled 26 week study (C04-001); PNH patients were also treated with Soliris in a single arm 52 week study (C04-002); and in a long term extension study (E05-001).
Studji Kliniċi Is- sigurtà u l- effikaċja ta 'Soliris f’ pazjenti PNH b’ emodijalisi kienu evalwati fi studju double- blind, ikkontrollat bil- plaċebo, magħmul b’ għażla każwali, fuq 26 ġimgħa (C04- 001); pazjenti PNH kienu kkurati wkoll b’ Soliris fi studju single arm ta ’ 52 ġimgħa (C04- 002); u fi studju ta ’ estensjoni fuq perjodu fit- tul (E05- 001).
Patients received meningococcal vaccination prior to receipt of Soliris.
Il- pazjenti ngħataw tilqima meningokokkali qabel ma bdew jirċievu Soliris.
In all studies, the dose of Soliris was 600 mg study drug every 7 ± 2 days for 4 weeks, followed by 900 mg 7 ± 2 days later, then 900 mg every 14 ± 2 days for the study duration.
Fl- istudji kollha, id- doża ta ’ Soliris kienet 600 mg mediċina ta 'studju kull 7 ijiem (jumejn aktar jew jumejn inqas) għal 4 ġimgħat, segwiti minn 900 mg 7 ijiem (jumejn aktar jew jumejn inqas) wara, imbagħad 900 mg kull 14- il jum (jumejn aktar jew jumejn inqas) għat- tul ta' l- istudju.
Soliris was administered as an intravenous infusion over 25 – 45 minutes.
Soliris ingħata bħala infużjoni fil- vini fuq 25 – 45 minuta.
In study C04-001 (TRIUMPH) PNH patients with at least 4 transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either Soliris (n = 43) or placebo (n = 44).
Fl- istudju C04- 001 (TRIUMPH), pazjenti PNH b' mill- anqas 4 trasfużjonijiet fl- aħħar 12- il xahar, konferma ċitometrika tal- fluss ta ’ mill- anqas 10% ċelloli PNH u ammont ta 'plejtlits ta' mill- anqas 100, 000/ mikrolitru ġew magħżula b’ mod każwali għal Soliris (n = 43) jew għal plaċebo (n = 44).
Prior to randomization, all patients underwent an initial observation period to confirm the need for RBC transfusion and to identify the haemoglobin concentration (the "set-point") which would define each patient’s haemoglobin stabilization and transfusion outcomes.
7 Qabel l- għażla każwali, il- pazjenti kollha kienu sottoposti għal perjodu ta ’ osservazzjoni inizjali biex tiġi kkonfermata l- ħtieġa għat- trasfużjoni ta ’ RBC u biex tiġi identifikata l- konċentrazzjoni ta ’ emoglobina (il- punt stabbilit) li kellha tiddefinixxi l- istabbilizzazzjoni ta ’ l- emoglobina u r- riżultati tat- trasfużjoni għal kull pazjent.
The haemoglobin set-point was less than or equal to 9 g/dL in patients with symptoms and was less than or equal to 7 g/dL in patients without symptoms.
Il- punt stabbilit ta ’ l- emoglobina kien inqas minn jew ugwali għal 9 g/ dL f’ pazjenti bis- sintomi u anqas minn jew ugwali għal 7 g/ dL f’ pazjenti mingħajr sintomi.
Primary efficacy endpoints were haemoglobin stabilization (patients who maintained a haemoglobin concentration above the haemoglobin set-point and avoid any RBC transfusion for the entire 26 week period) and blood transfusion requirement.
L - endpoints primarji ta ’ l- effikaċja kienu l- istabbilizzazzjoni ta ’ l- emoglobina (pazjenti li żammew konċentrazzjoni ta ’ emoglobina ’ l fuq mill- punt stabbilit ta ’ l- emoglobina u evitaw kwalunkwe trasfużjoni ta ’ RBC għall- perjodu sħiħ ta ’ 26 ġimgħa) u l- ħtieġa għat- trasfużjoni tad- demm.
Fatigue and health-related quality of life were relevant secondary endpoints.
L- għeja u l- kwalità tal- ħajja b’ rabta mas- saħħa kienu endpoints sekondarji rilevanti.
Haemolysis was monitored mainly by the measurement of serum LDH levels, and the proportion of PNH RBCs was monitored by flow cytometry.
L- emolisi kienet immonitorjata prinċipalment bil- kejl tal- livelli ta ’ LDH fis- serum, u l- proporzjon ta ’ PNH RBCs kien immonitorjat biċ- ċitometrija tal- fluss.
Patients receiving anticoagulants and systemic corticosteroids at baseline continued these medications.
Il- pazjenti li kienu qegħdin jirċievu sustanzi kontra l - koagulazzjoni tad- demm u kortikosterojdi sistemiċi fil- linja bażika komplew dawn il- medikazzjonijiet.
Major baseline characteristics were balanced (see table 2).
Il- karatteristiċi prinċipali tal- linja bażi kienu bbilanċjati (ara tabella 2).
In the non-controlled study C04-002 (SHEPHERD), PNH patients with at least one transfusion in the prior 24 months and at least 30,000 platelets/microliter received Soliris over a 52-week period.
Fl- istudju mhux ikkontrollat C04- 002 (SHEPHERD), pazjenti PNH b’ mill- anqas trasfużjoni waħda fl - aħħar 24 xahar u mill- anqas 30, 000 pjastrina/ mikrolitru rċevew Soliris fuq perjodu ta ’ 52 ġimgħa.
Concomitant medications included anti-thrombotic agents in 63% of the patients and systemic corticosteroids in 40% of the patients.
Il - medikazzjonijiet konkomitanti kienu jinkludu aġenti anti- trombotiċi fi 63% tal- pazjenti u kortikosterojdi sistemiċi f’ 40% tal- pazjenti.
Baseline characteristics are shown in Table 2.
Tabella 2:
C04-001
Demografiċi u Karatteristiċi tal- Pazjenti f' C04- 001 u C04- 002
Mean Age (SD)
Età medja (SD)
38.4 (13.4)
38. 4 (13. 4)
42.1 (15.5)
42. 1 (15. 5)
41.1 (14.4)
41. 1 (14. 4)
Gender - Female (%)
Sess - Nisa (%)
29 (65.9)
29 (65. 9)
23 (53.5)
23 (53. 5)
49 (50.5)
49 (50. 5)
History of Aplastic Anemia or MDS (%)
Storja ta 'Aplastic Anemia jew MDS (%)
12 (27.3)
12 (27. 3)
8 (18.7)
8 (18. 7)
29 (29.9)
29 (29. 9)
Concomitant Anticoagulants (%)
Antikoagulanti mogħtija mal- Prodott (%)
20 (45.5)
20 (45. 5)
24 (55.8)
24 (55. 8)
Concomitant Steroids/Immunosuppressant
Sterojdi/ Trattamenti immunosuppressanti
Treatments (%)
mogħtija mal- Prodott (%)
16 (36.4)
16 (36. 4)
14 (32.6)
14 (32. 6)
46 (47.4)
46 (47. 4)
Discontinued treatment
Trattament imwaqqaf
10
8. 0
2
(Q1, Q3))
1
24. 0)
18.0 (12.0, PRBC in previous 12 months (median (Q1,Q3))
Livell medju ta 'Hgb (g/ dL) fil=punt stabbilit( SD)
17.0 (13.5, 25.0)
7. 7 (0. 75)
24.0)
7. 8 (0. 79)
8.0 (4.0, 24.0)4
N/ A
Mean Hgb level (g/dL) at setpoint (SD)
Livelli ta 'LDH ta' qabel it- trattament (medjan, U/ L)
7.7 (0.75)
2, 234. 5
7.8 (0.79)
2, 032. 0
N/A
2, 051. 0
Pre-treatment LDH levels (median, U/L) Free Haemoglobin at baseline (median, mg/dL)
Emoglobina libera fil- linja bażi (medjan, mg/ dL)
2,234.5 46.2
46. 2
2,032.0 40.5
40. 5
2,051.0 34.9
34. 9
In TRIUMPH, study patients treated with Soliris had significantly reduced (p < 0.001) haemolysis resulting in improvements in anaemia as indicated by increased haemoglobin stabilization and reduced need for RBC transfusions compared to placebo treated patients (see table 3).
Fi TRIUMPH, il- pazjenti fl- istudju kkurati b’ Soliris kellhom emolisi mnaqqsa b’ mod sinifikanti (p < 0. 001) li rriżultat f’ titjib fl- anemija kif indikat minn żieda fl- istabbilizzazzjoni ta ’ l- emoglobina u ħtieġa anqas għal trasfużjonijiet ta ’ RBC meta mqabbel mal- pazjenti ttrattati bil- plaċebo (ara tabella 3).
These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; > 25 units).
Dawn l- effetti dehru fost pazjenti f’ kull wieħed mit- tliet strati ta ’ trasfużjoni ta ’ RBC ta ’ qabel l - istudju (4 - 14- il unità; 15 – 25 unità; > 25 unit).
After 3 weeks of Soliris treatment, patients reported less fatigue and improved health- related quality of life.
Wara 3 ġimgħat ta ’ kura b’ Soliris, il- pazjenti rrapportaw anqas għeja u kwalità tal- ħajja aħjar relatata mas- saħħa.
Because of the study sample size and duration, the effects of Soliris on thrombotic events could not be determined.
Minħabba d- daqs u ż- żmien li dam il- kampjun ta ’ l- istudju, l- effetti ta ’ Soliris fuq l- episodji trombotiċi ma setgħux jiġu determinati.
In SHEPHERD study, 96 of the 97 enrolled patients completed the study (one patient died following a thrombotic event).
Fl - istudju SHEPHERD, 96 mis- 97 pazjent irreġistrat ikkompletaw l- istudju (pazjent wieħed miet wara episodju trombotiku).
A reduction in intravascular haemolysis as measured by serum LDH levels was sustained for the treatment period and resulted in increased transfusion avoidance, a reduced need for RBC transfusion and less fatigue.
Tnaqqis fl- emolisi intravaskulari kif imkejjel mil- livelli ta ’ LDH fis- serum kien sostnut għall- perjodu tal- kura u rriżulta f’ evitar akbar ta ’ trasfużjonijiet, ħtieġa anqas għal trasfużjoni ta ’ RBC u anqas għeja.
See Table 3.
Ara Tabella 3.
Efficacy Outcomes in C04-001 and C04-002
Riżultati ta ’ l- Effikaċja f’ C04- 001 u C04- 002
Percentage of patients with
Perċentwali ta ’ pazjenti b’ livelli
stabilized Hemoglobin levels at end of study PRBC transfused during
ta ’ Emoglobina stabbilizzati fit - tmiem ta ’ l- istudju PRBC trasfużi matul il- kura
treatment (median) Transfusion Avoidance during
(medjan) Evitar tat- Trasfużjonijiet matul
treatment (%) LDH levels at end of study
il- kura (%) Livelli ta ’ LDH fit- tmiem ta ’ l -
< 0.001 51
< 0. 001
(median, U/L) LDH AUC at end of study
istudju (medjan, U/ L) LDH AUC fit- tmiem ta ’ l- istudju
(median, U/L x Day) Free Hemoglobin at end of study
(medjan, U/ L x Ġurnata) Emoglobina libera fit- tmiem ta ’
(median, mg/dL)
l- istudju (medjan, mg/ dL)
FACIT-Fatigue (effect size)
FACIT- Għeja (daqs ta ’ l- effett)
* Results from study C04-002 refer to pre- versus post-treatment comparisons.
* Ir- riżultati mill- istudju C04- 002 jirreferu għal paraguni ta ’ qabel vs wara l- kura.
8 From the 195 patients that originated in C04-001, C04-002 and other initial studies, Soliris-treated PNH patients were enrolled in a long term extension study (E05-001).
Mill- 195 pazjent li oriġinaw f’ C04- 001, C04- 002 u studji oħra inizjali, il- pazjenti PNH ikkurati b’ Soliris ġew irreġistrati fi studju ta ’ estensjoni fuq perjodu twil (E05- 001).
All patients sustained a reduction in intravascular haemolysis over a total Soliris exposure time ranging from 10 to 54 months.
Il- pazjenti kollha esperjenzaw tnaqqis fl- emolisi intravaskulari fuq perjodu totali ta ’ esponiment għal Soliris li varja minn 10 sa 54 xahar.
There were fewer thrombotic events with Soliris treatment than during the same period of time prior to treatment.
Kien hemm anqas episodji trombotiċi bil- kura b’ Soliris milli matul l- istess perjodu ta ’ żmien qabel il- kura.
However, this finding was shown in non-controlled clinical trials.
Madankollu, dan ir- riżultat deher fi studji kliniċi mhux ikkontrollati.
Pharmacokinetics and Drug Metabolism:
Farmakokinetika u Metaboliżmu tal- Mediċina:
Human antibodies undergo endocytotic digestion in the cells of the reticuloendothelial system.
L- antikorpi umani jgħaddu minn diġestjoni endoċitotika fiċ- ċelloli tas- sistema retikuloendoteljali.
Eculizumab contains only naturally occurring amino acids and has no known active metabolites.
Eculizumab fih biss aċidi amminiċi li jseħħu b' mod naturali u ma fih ebda metaboliti attivi magħrufa.
Human antibodies are predominately catabolized by lysosomal enzymes to small peptides and amino acids.
L- antikorpi umani huma katabolizzati l- aktar minn enzimi lisożomali għal peptidi żgħar u aċidi amminiċi.
No specific studies have been performed to evaluate the hepatic, renal, lung, or gastrointestinal routes of excretion/elimination for Soliris.
Ma sarux studji speċifiċi biex jiġu evalwati r- rotot ta 'tneħħija/ eliminazzjoni mill- fwied, kliewi, pulmun, jew gastrointestinali għal Soliris.
In normal kidneys, antibodies are not excreted and are excluded from filtration by their size.
Fi kliewi normali, l- antikorpi ma jiġux imneħħija u huma esklużi minn filtrazzjoni minħabba d- daqs tagħhom.
Pharmacokinetic Parameters:
Parametri Farmakokinetiċi:
In 40 patients with PNH, a 1-compartmental model was used to estimate pharmacokinetic parameters after multiple doses.
F’ 40 pazjent b’ PNH, intuża mudell ta ’ kompartiment wieħed biex jiġu kkalkulati l- parametri farmakokinetiċi wara diversi dożi.
Mean clearance was 0.31 ± 0.12 ml/hr/kg, mean volume of distribution was 110.3 ± 17.9 ml/kg, and mean elimination half-live was 11.3 ± 3.4 days.
It- tneħħija medja kienet 0. 31 ± 0. 12 ml/ siegħa/ kg, il- volum medju tad- distribuzzjoni kien 110. 3 ± 17. 9 ml/ kg, u l- half life medja ta ’ l- eliminazzjoni kienet 11. 3 ± 3. 4- il ġurnata.
Based on these data, the onset of steady state is predicted to be approximately 49 – 56 days..
Fuq il- bażi ta ’ din l- informazzjoni, il- bidu ta ’ l- istat fiss huwa previst li hu madwar 49 – 56 jum.
Pharmacodynamic activity correlates directly with eculizumab serum concentrations and maintenance of trough levels above ≥ 35 microgram/ml results in essentially complete blockade of haemolytic activity in the majority of patients.
L- attività farmakodinamika tikkorrelata direttament mal- konċentrazzjonijiet ta 'eculizumab fis- serum u ż- żamma ta' livelli minimi 'l fuq minn≥35 mikrogramma/ ml twassal tista' tgħid għal imblokk totali ta 'l- attività emolitika fil- maġġoranza tal- pazjenti.
Special Populations:
Popolazzjonijiet Speċjali:
Formal studies have not been conducted to evaluate the pharmacokinetics of Soliris administration in special patient populations based on gender, race, age (paediatric or geriatric), or renal or hepatic impairment.
9 Ma twettqux studji formali biex tiġi evalwata l- farmakokinetika ta 'l- għoti ta' Soliris f' popolazzjonijiet speċjali ta 'pazjenti fuq il- bażi tas- sess, razza, età (tfal jew xjuħ), jew indeboliment renali jew tal - fwied.
The specificity of eculizumab for C5 in human serum was evaluated in two in vitro studies.
L- ispeċifiċità ta 'eculizumab għal C5 fis- serum uman kienet evalwata f' żewġ studji in vitro.
The tissue cross-reactivity of eculizumab was evaluated by assessing binding to a panel of 38 human tissues.
Ir- reattività ta 'eculizumab mat- tessut kienet evalwata billi ġiet imkejla r- rabta ma' penil ta '38 tessut uman.
C5 expression in the human tissue panel examined in this study is consistent with published reports of C5 expression, as C5 has been reported in smooth muscle, striated muscle, and renal proximal tubular epithelium.
L- espressjoni C5 fil- panel tat- tessut uman eżaminat f' dan l- istudju hija konsistenti ma 'rapporti ppubblikati ta' l- espressjoni C5, billi C5 ġiet irrapportata f' muskolu mieles, muskolu mtarraz, u fl - epitelju tubulari fil- qrib renali.
No unexpected tissue cross-reactivity was observed.
Ma ġiet osservata l- ebda reattività mhux mistennija mat- tessut.
In a 26 week toxicity study performed in mice with a surrogate antibody directed against murine C5, treatment did not affect any of the toxicity parameters examined.
Fi studju ta '26 ġimgħa dwar it- tossiċità mwettaq fil- ġrieden b' antikorp sostitut dirett kontra C5 tal - ġrieden, il- kura ma affettwat ebda parametru tat- tossiċità eżaminat.
Haemolytic activity during the course of the study was effectively blocked in both female and male mice.
L- attività emolitika matul il- kors ta 'l- istudju kienet imblokkata b' mod effettiv kemm fil- ġrieden nisa kif ukoll irġiel.
Animal reproduction studies have not been conducted with eculizumab.
Ma twettqux studji tar- riproduzzjoni fl- annimali b' eculizumab.
No clear treatment-related effects or adverse effects were observed in reproductive toxicology studies in mice with a surrogate terminal complement inhibitory antibody.
Ma kienu osservati ebda effetti marbuta mal- kura jew effetti avversi fi studji tat- tossikoloġija riproduttiva fi ġrieden b' antikorp sostitut li jimpedixxi l- komplement terminali.
When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose (approximately 4 times the
Meta l- esponiment ta ’ l- omm għall- antikorp seħħ waqt l - organoġenesi, żewġ każijiet ta ’ displasja tar- retina u każ ta ’ ftuq taż- żokra kienu osservati fost 230 ferħ imwielda minn ommijiet esposti għad- doża aktar għolja ta ’ l- antikorp (madwar 4 darbiet id- doża massima rakkomandata ta ’ Soliris fil- bniedem, ibbażata fuq paragun tal- piż tal- ġisem); madankollu, l - esponiment ma żiedx it- telf tal- fetu jew il- mewt tal- frieħ tat- twelid.
No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of eculizumab or its effect on fertility.
Ma sarux studji fuq l- annimali biex jiġi evalwat il- potenzjal ġenotossiku u karċinoġeniku ta ’ eculizumab jew l- effett tiegħu fuq il- fertilità.
Sodium phosphate monobasic Sodium phosphate dibasic Sodium chloride Polysorbate 80 Water for injections
Sodium phosphate monobasic Sodium phosphate dibasic Sodium chloride Polysorbate 80 Ilma għall- injezzjonijiet
30 months
30 xahar..
After dilution, the medicinal product should be used immediately.
Wara dilwizzjoni, il- prodott mediċinali għandu jintuża immedjatament.
However, chemical and physical stability has been demonstrated for 24 hours at 2 – 8 °C.
Madankollu, l- istabbiltà kimika u fiżika ġiet murija għal 24 siegħa f’ temperatura ta ’ 2 – 8 °C.
Store in a refrigerator (2°C - 8º C) Do not freeze.
Aħżen fi friġġ (2°C - 8°C).
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u tal- kontenut
30 ml of concentrate in a vial (Type I glass) with a stopper (butyl, siliconised), and a seal (aluminium) with flip-off cap (polypropylene),.
30ml ta ’ konċentrat f’ kunjett (Ħġieġ ta 'Tip I) b' tapp (butyl, silikonizzat), u siġill (aluminju) b’ għatu tat- tip flip- off (polipropelin).
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u tipi oħra ta ’ manipular
Soliris should be administered by a health care professional.
Soliris għandu jingħata minn professjonist fil- qasam mediku.
Soliris therapy must not be initiated without prior vaccination against Neisseria meningitidis at least 2 weeks prior to initial administration.
It- terapija b’ Soliris ma għandhiex tinbeda mingħajr tilqim minn qabel kontra Neisseria meningitidis mill- anqas ġimagħtejn qabel ma jibda jingħata.
All patients should be administered a meningococcal vaccine at least two weeks prior to the first dose of Soliris (see section 4.4).
Il- pazjenti kollha għandhom jingħataw vaċċin meningokokkali għallinqas ġimagħtejn qabel l- ewwel doża ta 'Soliris (ara sezzjoni 4. 4).
Prior to administration, the Soliris solution should be visually inspected for particulate matter and discolouration.
Qabel l- għoti, is- soluzzjoni ta ’ Soliris għandha tiġi spezzjonata viżwalment għal frak jew telf fil- kulur.
Reconstitution and dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
Ir- rikostituzzjoni u d- dilwizzjoni għandhom isiru skond regoli ta ’ prattika tajba, b’ mod partikolari fir - rigward tal- asettiku.
Withdraw the total amount of Soliris from the vial(s) using a sterile syringe.
Iġbed l- ammont totali ta 'Soliris mill- kunjett( i) billi tuża siringa sterilizzata.
10 Transfer the recommended dose to an infusion bag.
Ittrasferixxi d- doża rakkomandata għal ġo borża ta 'l- infużjoni.
Dilute Soliris to a final concentration of 5 mg/ml by addition to the infusion bag using 0.9% sodium chloride, 0.45% sodium chloride, or 5% Dextrose in water, as the diluent.
Iddilwa Soliris għal konċentrazzjoni finali ta '5mg/ ml b’ żieda mal- borża ta' infużjoni billi tuża 0. 9% sodium chloride, 0. 45% sodium chloride, jew 5% Dextrose fl- ilma, bħala d- dilwent.
The final volume of a 5 mg/ml diluted solution is 120 ml for 600 mg doses or 180 ml for 900 mg doses.
Il- volum finali ta 'soluzzjoni dilwita ta' 5mg/ ml huwa 120ml għal dożi ta '600mg jew 180ml għal dożi ta' 900mg.
Gently agitate the infusion bag containing the diluted solution to ensure thorough mixing of the product and diluent.
Ħawwad b' mod ġentili l- borża ta 'l- infużjoni li fiha s- soluzzjoni dilwita biex tiżgura taħlita sewwa tal - prodott mediċinali u d- dilwent.
The diluted solution should be allowed to warm to room temperature prior to administration by exposure to ambient air.
Qabel ma tingħata, is- soluzzjoni dilwita għandha titħalla tisħon għat- temperatura tal- kamra billi tkun esposta għall- arja ta 'l- ambjent.
Discard any unused portion left in a vial, as the product contains no preservatives.
Armi kwalunkwe porzjon li jifdal f’ kunjett, billi l- prodott ma fihx preservattivi.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Alexion Europe SAS 54-56 avenue Hoche 75008 Paris FRANCE
Alexion Europe SAS 54- 56 avenue Hoche 75008 Paris FRANZA
20 June 2007
20 ġunju 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
< Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu >
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U D- DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
228 Bath Road Slough Berkshire SL1 4DX United Kingdom
228 Bath Road Slough Berkshire SL1 4DX Renju Unit
Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom
Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD Renju Unit
The MAH shall agree the details of a distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Il- MAH għandu jiftiehem id- dettalji ta ’ sistema ta ’ distribuzzjoni ma ’ l- Awtoritajiet Nazzjonali Kompetenti u jrid jimplimenta tali programm fil- pajjiżi konċernati sabiex jiżgura li:
• drug distribution will only be possible after checking that the patient has effectively received a meningococcal vaccination with a written confirmation • prior to distribution, all health care professionals are provided with information on the following key safety concerns:
id- distribuzzjoni tal- mediċina se tkun possibbli biss wara li jiġi ċċekkjat li l- pazjent fil- fatt • ikun ħa tilqima meningokokkali b’ konferma bil- miktub qabel ma jordnaw il- mediċina, il- professjonisti kollha tal- kura tas- saħħa jingħataw tagħrif • dwar l- informazzjoni kruċjali ta ’ sigurtà li ġejjin:
o o o o o o
o Uġigħ ta ’ ras o Ir- reazzjoni għall- infużjoni
Headache Infusion reaction Neisseria and general infection Risk of serious haemolysis following eculizumab discontinuation and proposed management Pregnancy and need of adequate contraception in women of childbearing potential Immunogenicity
14 Neisseria u infezzjoni ġenerali o Ir- riskju ta ’ emolisi serja wara t- twaqqif ta ’ eculizumab u l- ġestjoni proposta o It- tqala u l- bżonn ta ’ kontraċezzjoni adegwata f’ nisa li jistgħu jinqabdu tqal o L- immunoġeniċità o L- indeboliment renali u tal- fwied. o
Prior to launch, the MAH shall agree on the implementation of a patient card system in each Member State.
Qabel ma jintroduċih, il- MAH għandu jiftiehem fuq l- implimentazzjoni ta ’ sistema ta ’ kard għall- pazjent f’ kull Stat Membru.